id	sid	tid	token	lemma	pos
ihlr-22950	1	1	the	the	DET
ihlr-22950	1	2	latest	late	ADJ
ihlr-22950	1	3	“	"	PUNCT
ihlr-22950	1	4	federal	federal	ADJ
ihlr-22950	1	5	movement	movement	NOUN
ihlr-22950	1	6	”	"	PUNCT
ihlr-22950	1	7	in	in	ADP
ihlr-22950	1	8	the	the	DET
ihlr-22950	1	9	food	food	NOUN
ihlr-22950	1	10	and	and	CCONJ
ihlr-22950	1	11	drug	drug	NOUN
ihlr-22950	1	12	law	law	NOUN
ihlr-22950	1	13	arena	arena	NOUN
ihlr-22950	1	14	:	:	PUNCT
ihlr-22950	1	15	the	the	DET
ihlr-22950	1	16	federal	federal	ADJ
ihlr-22950	1	17	right	right	NOUN
ihlr-22950	1	18	-	-	PUNCT
ihlr-22950	1	19	to	to	PART
ihlr-22950	1	20	-	-	PUNCT
ihlr-22950	1	21	try	try	VERB
ihlr-22950	1	22	or	or	CCONJ
ihlr-22950	1	23	rather	rather	ADV
ihlr-22950	1	24	right	right	ADJ
ihlr-22950	1	25	-	-	PUNCT
ihlr-22950	1	26	to	to	AUX
ihlr-22950	1	27	-	-	PUNCT
ihlr-22950	1	28	know	know	VERB
ihlr-22950	1	29	and	and	CCONJ
ihlr-22950	1	30	thus	thus	ADV
ihlr-22950	1	31	request	request	VERB
ihlr-22950	1	32	investigational	investigational	ADJ
ihlr-22950	1	33	therapies	therapy	NOUN
ihlr-22950	1	34	for	for	ADP
ihlr-22950	1	35	individuals	individual	NOUN
ihlr-22950	1	36	with	with	ADP
ihlr-22950	1	37	a	a	DET
ihlr-22950	1	38	life	life	NOUN
ihlr-22950	1	39	-	-	PUNCT
ihlr-22950	1	40	threatening	threaten	VERB
ihlr-22950	1	41	disease	disease	NOUN
ihlr-22950	1	42	or	or	CCONJ
ihlr-22950	1	43	condition	condition	NOUN
ihlr-22950	1	44	roseann	roseann	PROPN
ihlr-22950	1	45	b.	b.	PROPN
ihlr-22950	1	46	termini	termini	PROPN
ihlr-22950	1	47	*	*	PROPN
ihlr-22950	1	48	i.	i.	PROPN
ihlr-22950	1	49	introduction	introduction	NOUN
ihlr-22950	1	50	the	the	DET
ihlr-22950	1	51	national	national	ADJ
ihlr-22950	1	52	state	state	PROPN
ihlr-22950	1	53	movement	movement	NOUN
ihlr-22950	1	54	regarding	regard	VERB
ihlr-22950	1	55	right	right	NOUN
ihlr-22950	1	56	-	-	PUNCT
ihlr-22950	1	57	to	to	PART
ihlr-22950	1	58	-	-	PUNCT
ihlr-22950	1	59	try	try	VERB
ihlr-22950	1	60	state	state	NOUN
ihlr-22950	1	61	legislation	legislation	NOUN
ihlr-22950	1	62	spurred	spur	VERB
ihlr-22950	1	63	the	the	DET
ihlr-22950	1	64	enactment	enactment	NOUN
ihlr-22950	1	65	of	of	ADP
ihlr-22950	1	66	the	the	DET
ihlr-22950	1	67	federal	federal	ADJ
ihlr-22950	1	68	right	right	NOUN
ihlr-22950	1	69	-	-	PUNCT
ihlr-22950	1	70	to	to	PART
ihlr-22950	1	71	-	-	PUNCT
ihlr-22950	1	72	try	try	VERB
ihlr-22950	1	73	legislation	legislation	NOUN
ihlr-22950	1	74	passed	pass	VERB
ihlr-22950	1	75	in	in	ADP
ihlr-22950	1	76	2018.1	2018.1	NUM
ihlr-22950	1	77	yet	yet	ADV
ihlr-22950	1	78	,	,	PUNCT
ihlr-22950	1	79	even	even	ADV
ihlr-22950	1	80	prior	prior	ADV
ihlr-22950	1	81	to	to	ADP
ihlr-22950	1	82	the	the	DET
ihlr-22950	1	83	enactment	enactment	NOUN
ihlr-22950	1	84	of	of	ADP
ihlr-22950	1	85	the	the	DET
ihlr-22950	1	86	federal	federal	ADJ
ihlr-22950	1	87	right	right	NOUN
ihlr-22950	1	88	-	-	PUNCT
ihlr-22950	1	89	to	to	ADP
ihlr-22950	1	90	-	-	PUNCT
ihlr-22950	1	91	try	try	VERB
ihlr-22950	1	92	law	law	NOUN
ihlr-22950	1	93	,	,	PUNCT
ihlr-22950	1	94	the	the	DET
ihlr-22950	1	95	united	united	PROPN
ihlr-22950	1	96	states	states	PROPN
ihlr-22950	1	97	federal	federal	ADJ
ihlr-22950	1	98	food	food	NOUN
ihlr-22950	1	99	and	and	CCONJ
ihlr-22950	1	100	drug	drug	PROPN
ihlr-22950	1	101	administration	administration	PROPN
ihlr-22950	1	102	(	(	PUNCT
ihlr-22950	1	103	fda	fda	PROPN
ihlr-22950	1	104	)	)	PUNCT
ihlr-22950	1	105	has	have	AUX
ihlr-22950	1	106	had	have	VERB
ihlr-22950	1	107	mechanisms	mechanism	NOUN
ihlr-22950	1	108	in	in	ADP
ihlr-22950	1	109	place	place	NOUN
ihlr-22950	1	110	for	for	ADP
ihlr-22950	1	111	those	those	PRON
ihlr-22950	1	112	terminally	terminally	ADV
ihlr-22950	1	113	ill	ill	ADJ
ihlr-22950	1	114	who	who	PRON
ihlr-22950	1	115	do	do	AUX
ihlr-22950	1	116	not	not	PART
ihlr-22950	1	117	qualify	qualify	VERB
ihlr-22950	1	118	for	for	ADP
ihlr-22950	1	119	a	a	DET
ihlr-22950	1	120	clinical	clinical	ADJ
ihlr-22950	1	121	trial.2	trial.2	NOUN
ihlr-22950	1	122	does	do	AUX
ihlr-22950	1	123	the	the	DET
ihlr-22950	1	124	federal	federal	ADJ
ihlr-22950	1	125	right	right	ADJ
ihlr-22950	1	126	-	-	PUNCT
ihlr-22950	1	127	totry	totry	NOUN
ihlr-22950	1	128	act	act	NOUN
ihlr-22950	1	129	provide	provide	VERB
ihlr-22950	1	130	improved	improved	ADJ
ihlr-22950	1	131	access	access	NOUN
ihlr-22950	1	132	for	for	ADP
ihlr-22950	1	133	the	the	DET
ihlr-22950	1	134	desperately	desperately	ADV
ihlr-22950	1	135	ill	ill	ADJ
ihlr-22950	1	136	?	?	PUNCT
ihlr-22950	2	1	will	will	AUX
ihlr-22950	2	2	insurance	insurance	NOUN
ihlr-22950	2	3	companies	company	NOUN
ihlr-22950	2	4	provide	provide	VERB
ihlr-22950	2	5	reimbursement	reimbursement	NOUN
ihlr-22950	2	6	for	for	ADP
ihlr-22950	2	7	a	a	DET
ihlr-22950	2	8	patient	patient	NOUN
ihlr-22950	2	9	to	to	PART
ihlr-22950	2	10	undergo	undergo	VERB
ihlr-22950	2	11	such	such	ADJ
ihlr-22950	2	12	investigational	investigational	ADJ
ihlr-22950	2	13	therapies	therapy	NOUN
ihlr-22950	2	14	?	?	PUNCT
ihlr-22950	3	1	is	be	AUX
ihlr-22950	3	2	the	the	DET
ihlr-22950	3	3	manufacturer	manufacturer	NOUN
ihlr-22950	3	4	protected	protect	VERB
ihlr-22950	3	5	in	in	ADP
ihlr-22950	3	6	terms	term	NOUN
ihlr-22950	3	7	of	of	ADP
ihlr-22950	3	8	lawsuits	lawsuit	NOUN
ihlr-22950	3	9	?	?	PUNCT
ihlr-22950	4	1	that	that	PRON
ihlr-22950	4	2	is	be	AUX
ihlr-22950	4	3	,	,	PUNCT
ihlr-22950	4	4	does	do	AUX
ihlr-22950	4	5	the	the	DET
ihlr-22950	4	6	patient	patient	NOUN
ihlr-22950	4	7	relinquish	relinquish	VERB
ihlr-22950	4	8	the	the	DET
ihlr-22950	4	9	right	right	NOUN
ihlr-22950	4	10	to	to	PART
ihlr-22950	4	11	bring	bring	VERB
ihlr-22950	4	12	a	a	DET
ihlr-22950	4	13	legal	legal	ADJ
ihlr-22950	4	14	action	action	NOUN
ihlr-22950	4	15	?	?	PUNCT
ihlr-22950	5	1	will	will	AUX
ihlr-22950	5	2	physicians	physician	NOUN
ihlr-22950	5	3	comprehend	comprehend	VERB
ihlr-22950	5	4	the	the	DET
ihlr-22950	5	5	pathway	pathway	NOUN
ihlr-22950	5	6	and	and	CCONJ
ihlr-22950	5	7	advocate	advocate	VERB
ihlr-22950	5	8	for	for	ADP
ihlr-22950	5	9	their	their	PRON
ihlr-22950	5	10	patients	patient	NOUN
ihlr-22950	5	11	?	?	PUNCT
ihlr-22950	6	1	does	do	AUX
ihlr-22950	6	2	this	this	DET
ihlr-22950	6	3	new	new	ADJ
ihlr-22950	6	4	law	law	NOUN
ihlr-22950	6	5	guarantee	guarantee	VERB
ihlr-22950	6	6	“	"	PUNCT
ihlr-22950	6	7	any	any	DET
ihlr-22950	6	8	novel	novel	ADJ
ihlr-22950	6	9	federal	federal	ADJ
ihlr-22950	6	10	right	right	NOUN
ihlr-22950	6	11	”	"	PUNCT
ihlr-22950	6	12	?	?	PUNCT
ihlr-22950	7	1	this	this	DET
ihlr-22950	7	2	article	article	NOUN
ihlr-22950	7	3	provides	provide	VERB
ihlr-22950	7	4	a	a	DET
ihlr-22950	7	5	federal	federal	ADJ
ihlr-22950	7	6	primer	primer	NOUN
ihlr-22950	7	7	on	on	ADP
ihlr-22950	7	8	the	the	DET
ihlr-22950	7	9	investigational	investigational	ADJ
ihlr-22950	7	10	drug	drug	NOUN
ihlr-22950	7	11	,	,	PUNCT
ihlr-22950	7	12	biologic	biologic	NOUN
ihlr-22950	7	13	and	and	CCONJ
ihlr-22950	7	14	device	device	NOUN
ihlr-22950	8	1	process,3	process,3	NOUN
ihlr-22950	8	2	details	detail	NOUN
ihlr-22950	8	3	a	a	DET
ihlr-22950	8	4	similar	similar	ADJ
ihlr-22950	8	5	national	national	ADJ
ihlr-22950	8	6	right	right	NOUN
ihlr-22950	8	7	-	-	PUNCT
ihlr-22950	8	8	to	to	ADP
ihlr-22950	8	9	-	-	PUNCT
ihlr-22950	8	10	know	know	NOUN
ihlr-22950	8	11	movement	movement	NOUN
ihlr-22950	8	12	in	in	ADP
ihlr-22950	8	13	the	the	DET
ihlr-22950	8	14	*	*	PROPN
ihlr-22950	8	15	roseann	roseann	PROPN
ihlr-22950	8	16	b.	b.	PROPN
ihlr-22950	8	17	termini	termini	PROPN
ihlr-22950	8	18	,	,	PUNCT
ihlr-22950	8	19	b.	b.	PROPN
ihlr-22950	8	20	s.	s.	PROPN
ihlr-22950	8	21	magna	magna	PROPN
ihlr-22950	8	22	cum	cum	PROPN
ihlr-22950	8	23	laude	laude	PROPN
ihlr-22950	8	24	,	,	PUNCT
ihlr-22950	8	25	m.ed	m.ed	PROPN
ihlr-22950	8	26	.	.	PUNCT
ihlr-22950	9	1	fellow	fellow	PROPN
ihlr-22950	9	2	,	,	PUNCT
ihlr-22950	9	3	j.d	j.d	PROPN
ihlr-22950	9	4	.	.	PROPN
ihlr-22950	9	5	,	,	PUNCT
ihlr-22950	9	6	a	a	DET
ihlr-22950	9	7	food	food	NOUN
ihlr-22950	9	8	and	and	CCONJ
ihlr-22950	9	9	drug	drug	NOUN
ihlr-22950	9	10	law	law	NOUN
ihlr-22950	9	11	attorney	attorney	NOUN
ihlr-22950	9	12	,	,	PUNCT
ihlr-22950	9	13	teaches	teach	VERB
ihlr-22950	9	14	several	several	ADJ
ihlr-22950	9	15	food	food	NOUN
ihlr-22950	9	16	and	and	CCONJ
ihlr-22950	9	17	drug	drug	NOUN
ihlr-22950	9	18	law	law	NOUN
ihlr-22950	9	19	courses	course	NOUN
ihlr-22950	9	20	at	at	ADP
ihlr-22950	9	21	delaware	delaware	PROPN
ihlr-22950	9	22	law	law	PROPN
ihlr-22950	9	23	school	school	PROPN
ihlr-22950	9	24	,	,	PUNCT
ihlr-22950	9	25	widener	widener	PROPN
ihlr-22950	9	26	university	university	PROPN
ihlr-22950	9	27	school	school	NOUN
ihlr-22950	9	28	of	of	ADP
ihlr-22950	9	29	law	law	NOUN
ihlr-22950	9	30	and	and	CCONJ
ihlr-22950	9	31	is	be	AUX
ihlr-22950	9	32	the	the	DET
ihlr-22950	9	33	author	author	NOUN
ihlr-22950	9	34	of	of	ADP
ihlr-22950	9	35	food	food	NOUN
ihlr-22950	9	36	and	and	CCONJ
ihlr-22950	9	37	drug	drug	NOUN
ihlr-22950	9	38	law	law	NOUN
ihlr-22950	9	39	:	:	PUNCT
ihlr-22950	9	40	federal	federal	ADJ
ihlr-22950	9	41	regulation	regulation	NOUN
ihlr-22950	9	42	of	of	ADP
ihlr-22950	9	43	drugs	drug	NOUN
ihlr-22950	9	44	,	,	PUNCT
ihlr-22950	9	45	biologics	biologic	NOUN
ihlr-22950	9	46	,	,	PUNCT
ihlr-22950	9	47	medical	medical	ADJ
ihlr-22950	9	48	devices	device	NOUN
ihlr-22950	9	49	,	,	PUNCT
ihlr-22950	9	50	foods	food	NOUN
ihlr-22950	9	51	,	,	PUNCT
ihlr-22950	9	52	dietary	dietary	ADJ
ihlr-22950	9	53	supplements	supplement	NOUN
ihlr-22950	9	54	,	,	PUNCT
ihlr-22950	9	55	personal	personal	ADJ
ihlr-22950	9	56	care	care	NOUN
ihlr-22950	9	57	,	,	PUNCT
ihlr-22950	9	58	veterinary	veterinary	ADJ
ihlr-22950	9	59	and	and	CCONJ
ihlr-22950	9	60	tobacco	tobacco	NOUN
ihlr-22950	9	61	products	product	NOUN
ihlr-22950	9	62	www.fortipublications.com	www.fortipublications.com	X
ihlr-22950	9	63	(	(	PUNCT
ihlr-22950	9	64	2017	2017	NUM
ihlr-22950	9	65	)	)	PUNCT
ihlr-22950	9	66	.	.	PUNCT
ihlr-22950	10	1	ms	ms	PROPN
ihlr-22950	10	2	.	.	PROPN
ihlr-22950	10	3	termini	termini	PROPN
ihlr-22950	10	4	dedicates	dedicate	VERB
ihlr-22950	10	5	this	this	DET
ihlr-22950	10	6	article	article	NOUN
ihlr-22950	10	7	to	to	ADP
ihlr-22950	10	8	the	the	DET
ihlr-22950	10	9	memory	memory	NOUN
ihlr-22950	10	10	of	of	ADP
ihlr-22950	10	11	her	her	PRON
ihlr-22950	10	12	parents	parent	NOUN
ihlr-22950	10	13	who	who	PRON
ihlr-22950	10	14	instilled	instill	VERB
ihlr-22950	10	15	values	value	NOUN
ihlr-22950	10	16	that	that	PRON
ihlr-22950	10	17	fostered	foster	VERB
ihlr-22950	10	18	the	the	DET
ihlr-22950	10	19	determination	determination	NOUN
ihlr-22950	10	20	to	to	PART
ihlr-22950	10	21	write	write	VERB
ihlr-22950	10	22	this	this	DET
ihlr-22950	10	23	article	article	NOUN
ihlr-22950	10	24	.	.	PUNCT
ihlr-22950	11	1	she	she	PRON
ihlr-22950	11	2	specially	specially	ADV
ihlr-22950	11	3	acknowledges	acknowledge	VERB
ihlr-22950	11	4	ms	ms	PROPN
ihlr-22950	11	5	.	.	PROPN
ihlr-22950	11	6	janet	janet	PROPN
ihlr-22950	11	7	lindenmuth	lindenmuth	PROPN
ihlr-22950	11	8	,	,	PUNCT
ihlr-22950	11	9	m.s	m.s	PROPN
ihlr-22950	11	10	.	.	PROPN
ihlr-22950	11	11	,	,	PUNCT
ihlr-22950	11	12	research	research	NOUN
ihlr-22950	11	13	law	law	NOUN
ihlr-22950	11	14	librarian	librarian	NOUN
ihlr-22950	11	15	at	at	ADP
ihlr-22950	11	16	delaware	delaware	PROPN
ihlr-22950	11	17	law	law	PROPN
ihlr-22950	11	18	school	school	NOUN
ihlr-22950	11	19	who	who	PRON
ihlr-22950	11	20	provided	provide	VERB
ihlr-22950	11	21	valuable	valuable	ADJ
ihlr-22950	11	22	research	research	NOUN
ihlr-22950	11	23	for	for	ADP
ihlr-22950	11	24	this	this	DET
ihlr-22950	11	25	article	article	NOUN
ihlr-22950	11	26	.	.	PUNCT
ihlr-22950	12	1	finally	finally	ADV
ihlr-22950	12	2	,	,	PUNCT
ihlr-22950	12	3	ms	ms	PROPN
ihlr-22950	12	4	.	.	PROPN
ihlr-22950	12	5	termini	termini	PROPN
ihlr-22950	12	6	thanks	thank	NOUN
ihlr-22950	12	7	her	her	PRON
ihlr-22950	12	8	children	child	NOUN
ihlr-22950	12	9	and	and	CCONJ
ihlr-22950	12	10	non	non	ADJ
ihlr-22950	12	11	-	-	ADJ
ihlr-22950	12	12	lawyer	lawyer	ADJ
ihlr-22950	12	13	friends	friend	NOUN
ihlr-22950	12	14	for	for	ADP
ihlr-22950	12	15	reading	read	VERB
ihlr-22950	12	16	the	the	DET
ihlr-22950	12	17	drafts	draft	NOUN
ihlr-22950	12	18	of	of	ADP
ihlr-22950	12	19	this	this	DET
ihlr-22950	12	20	article	article	NOUN
ihlr-22950	12	21	to	to	PART
ihlr-22950	12	22	comport	comport	VERB
ihlr-22950	12	23	with	with	ADP
ihlr-22950	12	24	plain	plain	ADJ
ihlr-22950	12	25	language	language	NOUN
ihlr-22950	12	26	as	as	ADV
ihlr-22950	12	27	much	much	ADV
ihlr-22950	12	28	as	as	ADP
ihlr-22950	12	29	possible	possible	ADJ
ihlr-22950	12	30	considering	consider	VERB
ihlr-22950	12	31	this	this	DET
ihlr-22950	12	32	complex	complex	ADJ
ihlr-22950	12	33	area	area	NOUN
ihlr-22950	12	34	of	of	ADP
ihlr-22950	12	35	law	law	NOUN
ihlr-22950	12	36	.	.	PUNCT
ihlr-22950	13	1	“	"	PUNCT
ihlr-22950	13	2	we	we	PRON
ihlr-22950	13	3	now	now	ADV
ihlr-22950	13	4	arrive	arrive	VERB
ihlr-22950	13	5	at	at	ADP
ihlr-22950	13	6	the	the	DET
ihlr-22950	13	7	end	end	NOUN
ihlr-22950	13	8	of	of	ADP
ihlr-22950	13	9	our	our	PRON
ihlr-22950	13	10	journey	journey	NOUN
ihlr-22950	13	11	through	through	ADP
ihlr-22950	13	12	the	the	DET
ihlr-22950	13	13	thicket	thicket	NOUN
ihlr-22950	13	14	of	of	ADP
ihlr-22950	13	15	the	the	DET
ihlr-22950	13	16	food	food	NOUN
ihlr-22950	13	17	,	,	PUNCT
ihlr-22950	13	18	drug	drug	NOUN
ihlr-22950	13	19	and	and	CCONJ
ihlr-22950	13	20	cosmetic	cosmetic	PROPN
ihlr-22950	13	21	act	act	NOUN
ihlr-22950	13	22	.	.	PUNCT
ihlr-22950	14	1	we	we	PRON
ihlr-22950	14	2	are	be	AUX
ihlr-22950	14	3	mindful	mindful	ADJ
ihlr-22950	14	4	of	of	ADP
ihlr-22950	14	5	learned	learn	VERB
ihlr-22950	14	6	hand	hand	NOUN
ihlr-22950	14	7	’s	’s	PART
ihlr-22950	14	8	consoling	console	VERB
ihlr-22950	14	9	words	word	NOUN
ihlr-22950	14	10	on	on	ADP
ihlr-22950	14	11	his	his	PRON
ihlr-22950	14	12	foray	foray	NOUN
ihlr-22950	14	13	through	through	ADP
ihlr-22950	14	14	the	the	DET
ihlr-22950	14	15	internal	internal	PROPN
ihlr-22950	14	16	revenue	revenue	NOUN
ihlr-22950	14	17	act	act	PROPN
ihlr-22950	14	18	:	:	PUNCT
ihlr-22950	14	19	“	"	PUNCT
ihlr-22950	14	20	cross	cross	NOUN
ihlr-22950	14	21	-	-	NOUN
ihlr-22950	14	22	reference	reference	NOUN
ihlr-22950	14	23	to	to	ADP
ihlr-22950	14	24	cross	cross	NOUN
ihlr-22950	14	25	-	-	NOUN
ihlr-22950	14	26	reference	reference	NOUN
ihlr-22950	14	27	,	,	PUNCT
ihlr-22950	14	28	exception	exception	NOUN
ihlr-22950	14	29	upon	upon	SCONJ
ihlr-22950	14	30	exception	exception	NOUN
ihlr-22950	14	31	—	—	PUNCT
ihlr-22950	14	32	couched	couch	VERB
ihlr-22950	14	33	in	in	ADP
ihlr-22950	14	34	abstract	abstract	ADJ
ihlr-22950	14	35	terms	term	NOUN
ihlr-22950	14	36	.	.	PUNCT
ihlr-22950	14	37	.	.	PUNCT
ihlr-22950	14	38	.	.	PUNCT
ihlr-22950	15	1	but	but	CCONJ
ihlr-22950	15	2	successfully	successfully	ADV
ihlr-22950	15	3	concealed	conceal	VERB
ihlr-22950	15	4	,	,	PUNCT
ihlr-22950	15	5	.	.	PUNCT
ihlr-22950	15	6	.	.	PUNCT
ihlr-22950	16	1	.	.	PUNCT
ihlr-22950	17	1	which	which	PRON
ihlr-22950	17	2	it	it	PRON
ihlr-22950	17	3	is	be	AUX
ihlr-22950	17	4	my	my	PRON
ihlr-22950	17	5	duty	duty	NOUN
ihlr-22950	17	6	to	to	PART
ihlr-22950	17	7	extract	extract	VERB
ihlr-22950	17	8	,	,	PUNCT
ihlr-22950	17	9	but	but	CCONJ
ihlr-22950	17	10	.	.	PUNCT
ihlr-22950	17	11	.	.	PUNCT
ihlr-22950	18	1	.	.	PUNCT
ihlr-22950	19	1	only	only	ADV
ihlr-22950	19	2	after	after	ADP
ihlr-22950	19	3	the	the	DET
ihlr-22950	19	4	most	most	ADV
ihlr-22950	19	5	inordinate	inordinate	ADJ
ihlr-22950	19	6	expenditure	expenditure	NOUN
ihlr-22950	19	7	of	of	ADP
ihlr-22950	19	8	time	time	NOUN
ihlr-22950	19	9	.	.	PUNCT
ihlr-22950	19	10	”	"	PUNCT
ihlr-22950	19	11	i.	i.	PROPN
ihlr-22950	19	12	dilliard	dilliard	PROPN
ihlr-22950	19	13	,	,	PUNCT
ihlr-22950	19	14	the	the	DET
ihlr-22950	19	15	spirit	spirit	NOUN
ihlr-22950	19	16	of	of	ADP
ihlr-22950	19	17	liberty	liberty	PROPN
ihlr-22950	19	18	236	236	NUM
ihlr-22950	19	19	(	(	PUNCT
ihlr-22950	19	20	3rd	3rd	ADJ
ihlr-22950	19	21	ed	ed	NOUN
ihlr-22950	19	22	.	.	PROPN
ihlr-22950	19	23	1960	1960	NUM
ihlr-22950	19	24	)	)	PUNCT
ihlr-22950	19	25	,	,	PUNCT
ihlr-22950	19	26	united	united	PROPN
ihlr-22950	19	27	states	states	PROPN
ihlr-22950	19	28	v.	v.	ADP
ihlr-22950	19	29	french	french	ADJ
ihlr-22950	19	30	bronze	bronze	NOUN
ihlr-22950	19	31	tablets	tablet	NOUN
ihlr-22950	19	32	fbnh	fbnh	NOUN
ihlr-22950	19	33	enterprises	enterprise	NOUN
ihlr-22950	19	34	,	,	PUNCT
ihlr-22950	19	35	inc	inc	PROPN
ihlr-22950	19	36	.	.	PROPN
ihlr-22950	19	37	888	888	NUM
ihlr-22950	19	38	f.2d	f.2d	X
ihlr-22950	19	39	945	945	NUM
ihlr-22950	19	40	,	,	PUNCT
ihlr-22950	19	41	949	949	NUM
ihlr-22950	19	42	(	(	PUNCT
ihlr-22950	19	43	2nd	2nd	ADJ
ihlr-22950	19	44	cir	cir	NOUN
ihlr-22950	19	45	.	.	PROPN
ihlr-22950	19	46	1989	1989	NUM
ihlr-22950	19	47	)	)	PUNCT
ihlr-22950	19	48	.	.	PUNCT
ihlr-22950	20	1	author	author	NOUN
ihlr-22950	20	2	contact	contact	NOUN
ihlr-22950	20	3	rbtermini@widener.edu	rbtermini@widener.edu	PROPN
ihlr-22950	20	4	1	1	X
ihlr-22950	20	5	.	.	X
ihlr-22950	20	6	trickett	trickett	PROPN
ihlr-22950	20	7	wendler	wendler	PROPN
ihlr-22950	20	8	,	,	PUNCT
ihlr-22950	20	9	frank	frank	PROPN
ihlr-22950	20	10	mongiello	mongiello	PROPN
ihlr-22950	20	11	,	,	PUNCT
ihlr-22950	20	12	jordan	jordan	PROPN
ihlr-22950	20	13	mclinn	mclinn	PROPN
ihlr-22950	20	14	,	,	PUNCT
ihlr-22950	20	15	and	and	CCONJ
ihlr-22950	20	16	matthew	matthew	PROPN
ihlr-22950	20	17	bellina	bellina	PROPN
ihlr-22950	20	18	right	right	NOUN
ihlr-22950	20	19	to	to	PART
ihlr-22950	20	20	try	try	VERB
ihlr-22950	20	21	act	act	NOUN
ihlr-22950	20	22	of	of	ADP
ihlr-22950	20	23	2017	2017	NUM
ihlr-22950	20	24	,	,	PUNCT
ihlr-22950	20	25	pub	pub	NOUN
ihlr-22950	20	26	.	.	PUNCT
ihlr-22950	21	1	l.	l.	PROPN
ihlr-22950	21	2	no	no	INTJ
ihlr-22950	21	3	.	.	PROPN
ihlr-22950	22	1	115	115	NUM
ihlr-22950	22	2	-	-	SYM
ihlr-22950	22	3	176	176	NUM
ihlr-22950	22	4	,	,	PUNCT
ihlr-22950	22	5	132	132	NUM
ihlr-22950	22	6	stat	stat	NOUN
ihlr-22950	22	7	.	.	PUNCT
ihlr-22950	23	1	1372	1372	NUM
ihlr-22950	23	2	(	(	PUNCT
ihlr-22950	23	3	2018	2018	NUM
ihlr-22950	23	4	)	)	PUNCT
ihlr-22950	23	5	.	.	PUNCT
ihlr-22950	24	1	although	although	SCONJ
ihlr-22950	24	2	titled	title	VERB
ihlr-22950	24	3	right	right	NOUN
ihlr-22950	24	4	to	to	PART
ihlr-22950	24	5	try	try	VERB
ihlr-22950	24	6	act	act	NOUN
ihlr-22950	24	7	of	of	ADP
ihlr-22950	24	8	2017	2017	NUM
ihlr-22950	24	9	,	,	PUNCT
ihlr-22950	24	10	this	this	DET
ihlr-22950	24	11	law	law	NOUN
ihlr-22950	24	12	was	be	AUX
ihlr-22950	24	13	passed	pass	VERB
ihlr-22950	24	14	on	on	ADP
ihlr-22950	24	15	may	may	PROPN
ihlr-22950	24	16	30	30	NUM
ihlr-22950	24	17	,	,	PUNCT
ihlr-22950	24	18	2018	2018	NUM
ihlr-22950	24	19	.	.	PUNCT
ihlr-22950	25	1	2	2	NUM
ihlr-22950	25	2	.	.	NUM
ihlr-22950	25	3	21	21	NUM
ihlr-22950	25	4	u.s.c	u.s.c	NOUN
ihlr-22950	25	5	.	.	PUNCT
ihlr-22950	26	1	§	§	PROPN
ihlr-22950	26	2	360bbb	360bbb	NUM
ihlr-22950	26	3	(	(	PUNCT
ihlr-22950	26	4	2012	2012	NUM
ihlr-22950	26	5	)	)	PUNCT
ihlr-22950	26	6	(	(	PUNCT
ihlr-22950	26	7	expanding	expand	VERB
ihlr-22950	26	8	access	access	NOUN
ihlr-22950	26	9	to	to	ADP
ihlr-22950	26	10	unapproved	unapproved	ADJ
ihlr-22950	26	11	therapies	therapy	NOUN
ihlr-22950	26	12	and	and	CCONJ
ihlr-22950	26	13	diagnostics	diagnostic	NOUN
ihlr-22950	26	14	)	)	PUNCT
ihlr-22950	26	15	.	.	PUNCT
ihlr-22950	27	1	3	3	X
ihlr-22950	27	2	.	.	X
ihlr-22950	27	3	roseann	roseann	PROPN
ihlr-22950	27	4	b.	b.	PROPN
ihlr-22950	27	5	termini	termini	PROPN
ihlr-22950	27	6	,	,	PUNCT
ihlr-22950	27	7	food	food	NOUN
ihlr-22950	27	8	and	and	CCONJ
ihlr-22950	27	9	drug	drug	NOUN
ihlr-22950	27	10	law	law	NOUN
ihlr-22950	27	11	:	:	PUNCT
ihlr-22950	27	12	federal	federal	ADJ
ihlr-22950	27	13	regulation	regulation	NOUN
ihlr-22950	27	14	of	of	ADP
ihlr-22950	27	15	drugs	drug	NOUN
ihlr-22950	27	16	,	,	PUNCT
ihlr-22950	27	17	biologics	biologic	NOUN
ihlr-22950	27	18	,	,	PUNCT
ihlr-22950	27	19	medical	medical	ADJ
ihlr-22950	27	20	devices	device	NOUN
ihlr-22950	27	21	,	,	PUNCT
ihlr-22950	27	22	foods	food	NOUN
ihlr-22950	27	23	,	,	PUNCT
ihlr-22950	27	24	dietary	dietary	ADJ
ihlr-22950	27	25	supplements	supplement	NOUN
ihlr-22950	27	26	,	,	PUNCT
ihlr-22950	27	27	personal	personal	ADJ
ihlr-22950	27	28	care	care	NOUN
ihlr-22950	27	29	,	,	PUNCT
ihlr-22950	27	30	veterinary	veterinary	ADJ
ihlr-22950	27	31	and	and	CCONJ
ihlr-22950	27	32	tobacco	tobacco	NOUN
ihlr-22950	27	33	products	product	NOUN
ihlr-22950	27	34	131	131	NUM
ihlr-22950	27	35	-	-	SYM
ihlr-22950	27	36	34	34	NUM
ihlr-22950	27	37	(	(	PUNCT
ihlr-22950	27	38	9th	9th	ADJ
ihlr-22950	27	39	ed	ed	NOUN
ihlr-22950	27	40	.	.	PROPN
ihlr-22950	27	41	2017	2017	NUM
ihlr-22950	27	42	)	)	PUNCT
ihlr-22950	27	43	.	.	PUNCT
ihlr-22950	28	1	http://doi.org/10.18060/3911.0056	http://doi.org/10.18060/3911.0056	PROPN
ihlr-22950	28	2	102	102	NUM
ihlr-22950	28	3	indiana	indiana	PROPN
ihlr-22950	28	4	health	health	PROPN
ihlr-22950	28	5	law	law	PROPN
ihlr-22950	28	6	review	review	NOUN
ihlr-22950	29	1	[	[	X
ihlr-22950	29	2	vol	vol	NOUN
ihlr-22950	29	3	.	.	PUNCT
ihlr-22950	30	1	16:101	16:101	NUM
ihlr-22950	30	2	food	food	NOUN
ihlr-22950	30	3	and	and	CCONJ
ihlr-22950	30	4	drug	drug	NOUN
ihlr-22950	30	5	law	law	NOUN
ihlr-22950	30	6	arena	arena	NOUN
ihlr-22950	30	7	that	that	PRON
ihlr-22950	30	8	led	lead	VERB
ihlr-22950	30	9	to	to	ADP
ihlr-22950	30	10	federal	federal	ADJ
ihlr-22950	30	11	legislation	legislation	NOUN
ihlr-22950	30	12	perhaps	perhaps	ADV
ihlr-22950	30	13	comparable	comparable	ADJ
ihlr-22950	30	14	to	to	ADP
ihlr-22950	30	15	how	how	SCONJ
ihlr-22950	30	16	the	the	DET
ihlr-22950	30	17	federal	federal	ADJ
ihlr-22950	30	18	right	right	NOUN
ihlr-22950	30	19	-	-	PUNCT
ihlr-22950	30	20	to	to	PART
ihlr-22950	30	21	-	-	PUNCT
ihlr-22950	30	22	try	try	VERB
ihlr-22950	30	23	act4	act4	NOUN
ihlr-22950	30	24	was	be	AUX
ihlr-22950	30	25	enacted	enact	VERB
ihlr-22950	30	26	and	and	CCONJ
ihlr-22950	30	27	includes	include	VERB
ihlr-22950	30	28	a	a	DET
ihlr-22950	30	29	discussion	discussion	NOUN
ihlr-22950	30	30	about	about	ADP
ihlr-22950	30	31	the	the	DET
ihlr-22950	30	32	state	state	NOUN
ihlr-22950	30	33	right	right	NOUN
ihlr-22950	30	34	to	to	PART
ihlr-22950	30	35	try	try	VERB
ihlr-22950	30	36	movement	movement	NOUN
ihlr-22950	30	37	which	which	PRON
ihlr-22950	30	38	conceivably	conceivably	ADV
ihlr-22950	30	39	led	lead	VERB
ihlr-22950	30	40	to	to	ADP
ihlr-22950	30	41	the	the	DET
ihlr-22950	30	42	enactment	enactment	NOUN
ihlr-22950	30	43	of	of	ADP
ihlr-22950	30	44	the	the	DET
ihlr-22950	30	45	federal	federal	ADJ
ihlr-22950	30	46	right	right	NOUN
ihlr-22950	30	47	-	-	PUNCT
ihlr-22950	30	48	to	to	PART
ihlr-22950	30	49	-	-	PUNCT
ihlr-22950	30	50	try	try	VERB
ihlr-22950	30	51	act.5	act.5	PROPN
ihlr-22950	30	52	there	there	PRON
ihlr-22950	30	53	are	be	VERB
ihlr-22950	30	54	more	more	ADJ
ihlr-22950	30	55	queries	query	NOUN
ihlr-22950	30	56	than	than	ADP
ihlr-22950	30	57	unambiguous	unambiguous	ADJ
ihlr-22950	30	58	answers	answer	NOUN
ihlr-22950	30	59	regarding	regard	VERB
ihlr-22950	30	60	the	the	DET
ihlr-22950	30	61	recently	recently	ADV
ihlr-22950	30	62	enacted	enact	VERB
ihlr-22950	30	63	federal	federal	ADJ
ihlr-22950	30	64	right	right	NOUN
ihlr-22950	30	65	-	-	PUNCT
ihlr-22950	30	66	to	to	PART
ihlr-22950	30	67	-	-	PUNCT
ihlr-22950	30	68	try	try	VERB
ihlr-22950	30	69	act.6	act.6	PROPN
ihlr-22950	30	70	the	the	DET
ihlr-22950	30	71	federal	federal	ADJ
ihlr-22950	30	72	law	law	NOUN
ihlr-22950	30	73	in	in	ADP
ihlr-22950	30	74	essence	essence	NOUN
ihlr-22950	30	75	could	could	AUX
ihlr-22950	30	76	prove	prove	VERB
ihlr-22950	30	77	troublesome	troublesome	ADJ
ihlr-22950	30	78	and	and	CCONJ
ihlr-22950	30	79	confusing	confusing	ADJ
ihlr-22950	30	80	with	with	ADP
ihlr-22950	30	81	both	both	CCONJ
ihlr-22950	30	82	the	the	DET
ihlr-22950	30	83	state	state	NOUN
ihlr-22950	30	84	right	right	NOUN
ihlr-22950	30	85	-	-	PUNCT
ihlr-22950	30	86	to	to	AUX
ihlr-22950	30	87	-	-	PUNCT
ihlr-22950	30	88	try	try	VERB
ihlr-22950	30	89	measures	measure	NOUN
ihlr-22950	30	90	due	due	ADJ
ihlr-22950	30	91	to	to	ADP
ihlr-22950	30	92	,	,	PUNCT
ihlr-22950	30	93	for	for	ADP
ihlr-22950	30	94	instance	instance	NOUN
ihlr-22950	30	95	,	,	PUNCT
ihlr-22950	30	96	issues	issue	NOUN
ihlr-22950	30	97	of	of	ADP
ihlr-22950	30	98	national	national	ADJ
ihlr-22950	30	99	uniformity	uniformity	NOUN
ihlr-22950	30	100	and	and	CCONJ
ihlr-22950	30	101	preemption.7	preemption.7	PROPN
ihlr-22950	30	102	the	the	DET
ihlr-22950	30	103	recently	recently	ADV
ihlr-22950	30	104	enacted	enact	VERB
ihlr-22950	30	105	federal	federal	ADJ
ihlr-22950	30	106	right	right	NOUN
ihlr-22950	30	107	-	-	PUNCT
ihlr-22950	30	108	to	to	PART
ihlr-22950	30	109	-	-	PUNCT
ihlr-22950	30	110	try	try	VERB
ihlr-22950	30	111	act8	act8	NOUN
ihlr-22950	30	112	adequate	adequate	ADJ
ihlr-22950	30	113	safeguards	safeguard	NOUN
ihlr-22950	30	114	and	and	CCONJ
ihlr-22950	30	115	perhaps	perhaps	ADV
ihlr-22950	30	116	a	a	DET
ihlr-22950	30	117	false	false	ADJ
ihlr-22950	30	118	unrealistic	unrealistic	ADJ
ihlr-22950	30	119	sense	sense	NOUN
ihlr-22950	30	120	of	of	ADP
ihlr-22950	30	121	hope?9	hope?9	NOUN
ihlr-22950	30	122	a	a	DET
ihlr-22950	30	123	look	look	NOUN
ihlr-22950	30	124	back	back	ADV
ihlr-22950	30	125	provides	provide	VERB
ihlr-22950	30	126	insight	insight	NOUN
ihlr-22950	30	127	to	to	ADP
ihlr-22950	30	128	the	the	DET
ihlr-22950	30	129	current	current	ADJ
ihlr-22950	30	130	matter	matter	NOUN
ihlr-22950	30	131	.	.	PUNCT
ihlr-22950	31	1	in	in	ADP
ihlr-22950	31	2	2006	2006	NUM
ihlr-22950	31	3	,	,	PUNCT
ihlr-22950	31	4	the	the	DET
ihlr-22950	31	5	federal	federal	ADJ
ihlr-22950	31	6	courts	court	NOUN
ihlr-22950	31	7	grappled	grapple	VERB
ihlr-22950	31	8	with	with	ADP
ihlr-22950	31	9	this	this	DET
ihlr-22950	31	10	issue.10	issue.10	PROPN
ihlr-22950	31	11	appellate	appellate	ADJ
ihlr-22950	31	12	court	court	NOUN
ihlr-22950	31	13	was	be	AUX
ihlr-22950	31	14	faced	face	VERB
ihlr-22950	31	15	with	with	ADP
ihlr-22950	31	16	deciding	decide	VERB
ihlr-22950	31	17	if	if	SCONJ
ihlr-22950	31	18	there	there	PRON
ihlr-22950	31	19	was	be	VERB
ihlr-22950	31	20	a	a	DET
ihlr-22950	31	21	constitutionally	constitutionally	ADV
ihlr-22950	31	22	protected	protect	VERB
ihlr-22950	31	23	right	right	NOUN
ihlr-22950	31	24	to	to	ADP
ihlr-22950	31	25	potentially	potentially	ADV
ihlr-22950	31	26	lifesaving	lifesave	VERB
ihlr-22950	31	27	investigational	investigational	ADJ
ihlr-22950	31	28	medical	medical	ADJ
ihlr-22950	31	29	therapies	therapy	NOUN
ihlr-22950	31	30	in	in	ADP
ihlr-22950	31	31	the	the	DET
ihlr-22950	31	32	federal	federal	ADJ
ihlr-22950	31	33	case	case	NOUN
ihlr-22950	31	34	of	of	ADP
ihlr-22950	31	35	abigail	abigail	PROPN
ihlr-22950	31	36	alliance	alliance	PROPN
ihlr-22950	31	37	for	for	ADP
ihlr-22950	31	38	better	well	ADJ
ihlr-22950	31	39	access	access	NOUN
ihlr-22950	31	40	to	to	ADP
ihlr-22950	31	41	developmental	developmental	ADJ
ihlr-22950	31	42	drugs	drug	NOUN
ihlr-22950	31	43	and	and	CCONJ
ihlr-22950	31	44	washington	washington	PROPN
ihlr-22950	31	45	legal	legal	PROPN
ihlr-22950	31	46	foundation	foundation	PROPN
ihlr-22950	31	47	v.	v.	PROPN
ihlr-22950	31	48	von	von	PROPN
ihlr-22950	31	49	eschenbach	eschenbach	PROPN
ihlr-22950	31	50	(	(	PUNCT
ihlr-22950	31	51	abigail	abigail	PROPN
ihlr-22950	31	52	alliance).11	alliance).11	PROPN
ihlr-22950	31	53	in	in	ADP
ihlr-22950	31	54	abigail	abigail	PROPN
ihlr-22950	31	55	alliance	alliance	PROPN
ihlr-22950	31	56	,	,	PUNCT
ihlr-22950	31	57	the	the	DET
ihlr-22950	31	58	court	court	NOUN
ihlr-22950	31	59	of	of	ADP
ihlr-22950	31	60	appeals	appeal	NOUN
ihlr-22950	31	61	held	hold	VERB
ihlr-22950	31	62	that	that	SCONJ
ihlr-22950	31	63	terminally	terminally	ADV
ihlr-22950	31	64	ill	ill	ADJ
ihlr-22950	31	65	patients	patient	NOUN
ihlr-22950	31	66	do	do	AUX
ihlr-22950	31	67	not	not	PART
ihlr-22950	31	68	have	have	VERB
ihlr-22950	31	69	a	a	DET
ihlr-22950	31	70	constitutional	constitutional	ADJ
ihlr-22950	31	71	right	right	NOUN
ihlr-22950	31	72	to	to	PART
ihlr-22950	31	73	obtain	obtain	VERB
ihlr-22950	31	74	investigational	investigational	ADJ
ihlr-22950	31	75	drugs	drug	NOUN
ihlr-22950	31	76	prior	prior	ADV
ihlr-22950	31	77	to	to	ADP
ihlr-22950	31	78	the	the	DET
ihlr-22950	31	79	federal	federal	ADJ
ihlr-22950	31	80	food	food	NOUN
ihlr-22950	31	81	and	and	CCONJ
ihlr-22950	31	82	drug	drug	PROPN
ihlr-22950	31	83	administration	administration	PROPN
ihlr-22950	31	84	(	(	PUNCT
ihlr-22950	31	85	fda	fda	PROPN
ihlr-22950	31	86	)	)	PUNCT
ihlr-22950	31	87	approval.12	approval.12	PROPN
ihlr-22950	31	88	the	the	DET
ihlr-22950	31	89	united	united	PROPN
ihlr-22950	31	90	states	states	PROPN
ihlr-22950	31	91	supreme	supreme	PROPN
ihlr-22950	31	92	court	court	PROPN
ihlr-22950	31	93	declined	decline	VERB
ihlr-22950	31	94	to	to	PART
ihlr-22950	31	95	review	review	VERB
ihlr-22950	31	96	the	the	DET
ihlr-22950	31	97	federal	federal	ADJ
ihlr-22950	31	98	appeals	appeal	NOUN
ihlr-22950	31	99	court	court	NOUN
ihlr-22950	31	100	decision.13	decision.13	NOUN
ihlr-22950	31	101	however	however	ADV
ihlr-22950	31	102	,	,	PUNCT
ihlr-22950	31	103	according	accord	VERB
ihlr-22950	31	104	to	to	ADP
ihlr-22950	31	105	the	the	DET
ihlr-22950	31	106	goldwater	goldwater	PROPN
ihlr-22950	31	107	institute	institute	PROPN
ihlr-22950	31	108	,	,	PUNCT
ihlr-22950	31	109	in	in	ADP
ihlr-22950	31	110	the	the	DET
ihlr-22950	31	111	last	last	ADJ
ihlr-22950	31	112	few	few	ADJ
ihlr-22950	31	113	years	year	NOUN
ihlr-22950	31	114	,	,	PUNCT
ihlr-22950	31	115	approximately	approximately	ADV
ihlr-22950	31	116	41	41	NUM
ihlr-22950	31	117	states	state	NOUN
ihlr-22950	31	118	have	have	AUX
ihlr-22950	31	119	enacted	enact	VERB
ihlr-22950	31	120	legislation	legislation	NOUN
ihlr-22950	31	121	that	that	PRON
ihlr-22950	31	122	addresses	address	VERB
ihlr-22950	31	123	investigational	investigational	ADJ
ihlr-22950	31	124	drug	drug	NOUN
ihlr-22950	31	125	access	access	NOUN
ihlr-22950	31	126	by	by	ADP
ihlr-22950	31	127	the	the	DET
ihlr-22950	31	128	terminally	terminally	ADV
ihlr-22950	31	129	ill.14	ill.14	NOUN
ihlr-22950	31	130	these	these	DET
ihlr-22950	31	131	states	state	NOUN
ihlr-22950	31	132	include	include	VERB
ihlr-22950	31	133	:	:	PUNCT
ihlr-22950	31	134	alabama	alabama	PROPN
ihlr-22950	31	135	,	,	PUNCT
ihlr-22950	31	136	alaska	alaska	PROPN
ihlr-22950	31	137	,	,	PUNCT
ihlr-22950	31	138	arizona	arizona	PROPN
ihlr-22950	31	139	,	,	PUNCT
ihlr-22950	31	140	arkansas	arkansas	PROPN
ihlr-22950	31	141	,	,	PUNCT
ihlr-22950	31	142	california	california	PROPN
ihlr-22950	31	143	,	,	PUNCT
ihlr-22950	31	144	4	4	NUM
ihlr-22950	31	145	.	.	X
ihlr-22950	31	146	trickett	trickett	PROPN
ihlr-22950	31	147	wendler	wendler	PROPN
ihlr-22950	31	148	,	,	PUNCT
ihlr-22950	31	149	frank	frank	PROPN
ihlr-22950	31	150	mongiello	mongiello	PROPN
ihlr-22950	31	151	,	,	PUNCT
ihlr-22950	31	152	jordan	jordan	PROPN
ihlr-22950	31	153	mclinn	mclinn	PROPN
ihlr-22950	31	154	,	,	PUNCT
ihlr-22950	31	155	and	and	CCONJ
ihlr-22950	31	156	matthew	matthew	PROPN
ihlr-22950	31	157	bellina	bellina	PROPN
ihlr-22950	31	158	right	right	NOUN
ihlr-22950	31	159	to	to	PART
ihlr-22950	31	160	try	try	VERB
ihlr-22950	31	161	act	act	NOUN
ihlr-22950	31	162	of	of	ADP
ihlr-22950	31	163	2017	2017	NUM
ihlr-22950	31	164	,	,	PUNCT
ihlr-22950	31	165	pub	pub	NOUN
ihlr-22950	31	166	.	.	PUNCT
ihlr-22950	32	1	l.	l.	PROPN
ihlr-22950	32	2	no	no	INTJ
ihlr-22950	32	3	.	.	PROPN
ihlr-22950	33	1	115	115	NUM
ihlr-22950	33	2	-	-	SYM
ihlr-22950	33	3	176	176	NUM
ihlr-22950	33	4	,	,	PUNCT
ihlr-22950	33	5	132	132	NUM
ihlr-22950	33	6	stat	stat	NOUN
ihlr-22950	33	7	.	.	PUNCT
ihlr-22950	34	1	1372	1372	NUM
ihlr-22950	34	2	(	(	PUNCT
ihlr-22950	34	3	2018	2018	NUM
ihlr-22950	34	4	)	)	PUNCT
ihlr-22950	34	5	.	.	PUNCT
ihlr-22950	35	1	5	5	X
ihlr-22950	35	2	.	.	X
ihlr-22950	36	1	i	i	PRON
ihlr-22950	36	2	d.	d.	PROPN
ihlr-22950	36	3	6	6	NUM
ihlr-22950	36	4	.	.	PUNCT
ihlr-22950	37	1	i	i	PRON
ihlr-22950	37	2	d.	d.	PROPN
ihlr-22950	37	3	7	7	NUM
ihlr-22950	37	4	.	.	PUNCT
ihlr-22950	38	1	u.s	u.s	PROPN
ihlr-22950	38	2	.	.	PROPN
ihlr-22950	38	3	const	const	PROPN
ihlr-22950	38	4	.	.	PUNCT
ihlr-22950	38	5	art	art	NOUN
ihlr-22950	38	6	.	.	PUNCT
ihlr-22950	39	1	vi	vi	NOUN
ihlr-22950	39	2	,	,	PUNCT
ihlr-22950	39	3	cl	cl	NOUN
ihlr-22950	39	4	.	.	NOUN
ihlr-22950	40	1	2	2	NUM
ihlr-22950	40	2	.	.	X
ihlr-22950	40	3	the	the	DET
ihlr-22950	40	4	doctrine	doctrine	NOUN
ihlr-22950	40	5	of	of	ADP
ihlr-22950	40	6	preemption	preemption	NOUN
ihlr-22950	40	7	emanates	emanate	VERB
ihlr-22950	40	8	from	from	ADP
ihlr-22950	40	9	the	the	DET
ihlr-22950	40	10	supremacy	supremacy	NOUN
ihlr-22950	40	11	clause	clause	NOUN
ihlr-22950	40	12	(	(	PUNCT
ihlr-22950	40	13	article	article	NOUN
ihlr-22950	40	14	vi	vi	PROPN
ihlr-22950	40	15	,	,	PUNCT
ihlr-22950	40	16	clause	clause	NOUN
ihlr-22950	40	17	2	2	NUM
ihlr-22950	40	18	)	)	PUNCT
ihlr-22950	40	19	of	of	ADP
ihlr-22950	40	20	the	the	DET
ihlr-22950	40	21	united	united	PROPN
ihlr-22950	40	22	states	states	PROPN
ihlr-22950	40	23	constitution	constitution	PROPN
ihlr-22950	40	24	.	.	PUNCT
ihlr-22950	41	1	article	article	PROPN
ihlr-22950	41	2	vi	vi	PROPN
ihlr-22950	41	3	,	,	PUNCT
ihlr-22950	41	4	clause	clause	NOUN
ihlr-22950	41	5	2	2	NUM
ihlr-22950	41	6	prohibits	prohibit	VERB
ihlr-22950	41	7	states	state	NOUN
ihlr-22950	41	8	from	from	ADP
ihlr-22950	41	9	enacting	enact	VERB
ihlr-22950	41	10	laws	law	NOUN
ihlr-22950	41	11	that	that	PRON
ihlr-22950	41	12	conflict	conflict	NOUN
ihlr-22950	41	13	with	with	ADP
ihlr-22950	41	14	federal	federal	ADJ
ihlr-22950	41	15	law	law	NOUN
ihlr-22950	41	16	unless	unless	SCONJ
ihlr-22950	41	17	the	the	DET
ihlr-22950	41	18	federal	federal	ADJ
ihlr-22950	41	19	law	law	NOUN
ihlr-22950	41	20	contains	contain	VERB
ihlr-22950	41	21	explicit	explicit	ADJ
ihlr-22950	41	22	preemption	preemption	NOUN
ihlr-22950	41	23	language	language	NOUN
ihlr-22950	41	24	.	.	PUNCT
ihlr-22950	42	1	8	8	X
ihlr-22950	42	2	.	.	X
ihlr-22950	42	3	trickett	trickett	PROPN
ihlr-22950	42	4	wendler	wendler	PROPN
ihlr-22950	42	5	,	,	PUNCT
ihlr-22950	42	6	frank	frank	PROPN
ihlr-22950	42	7	mongiello	mongiello	PROPN
ihlr-22950	42	8	,	,	PUNCT
ihlr-22950	42	9	jordan	jordan	PROPN
ihlr-22950	42	10	mclinn	mclinn	PROPN
ihlr-22950	42	11	,	,	PUNCT
ihlr-22950	42	12	and	and	CCONJ
ihlr-22950	42	13	matthew	matthew	PROPN
ihlr-22950	42	14	bellina	bellina	PROPN
ihlr-22950	42	15	right	right	NOUN
ihlr-22950	42	16	to	to	PART
ihlr-22950	42	17	try	try	VERB
ihlr-22950	42	18	act	act	NOUN
ihlr-22950	42	19	of	of	ADP
ihlr-22950	42	20	2017	2017	NUM
ihlr-22950	42	21	,	,	PUNCT
ihlr-22950	42	22	pub	pub	NOUN
ihlr-22950	42	23	.	.	PUNCT
ihlr-22950	43	1	l.	l.	PROPN
ihlr-22950	43	2	no	no	INTJ
ihlr-22950	43	3	.	.	PROPN
ihlr-22950	44	1	115	115	NUM
ihlr-22950	44	2	-	-	SYM
ihlr-22950	44	3	176	176	NUM
ihlr-22950	44	4	,	,	PUNCT
ihlr-22950	44	5	132	132	NUM
ihlr-22950	44	6	stat	stat	NOUN
ihlr-22950	44	7	.	.	PUNCT
ihlr-22950	45	1	1372	1372	NUM
ihlr-22950	45	2	(	(	PUNCT
ihlr-22950	45	3	2018	2018	NUM
ihlr-22950	45	4	)	)	PUNCT
ihlr-22950	45	5	.	.	PUNCT
ihlr-22950	46	1	9	9	X
ihlr-22950	46	2	.	.	X
ihlr-22950	46	3	see	see	VERB
ihlr-22950	46	4	,	,	PUNCT
ihlr-22950	46	5	e.g.	e.g.	ADV
ihlr-22950	46	6	,	,	PUNCT
ihlr-22950	46	7	marilyn	marilyn	PROPN
ihlr-22950	46	8	j.	j.	PROPN
ihlr-22950	46	9	heine	heine	PROPN
ihlr-22950	46	10	&	&	CCONJ
ihlr-22950	46	11	bruce	bruce	PROPN
ihlr-22950	46	12	e.	e.	PROPN
ihlr-22950	46	13	johnson	johnson	PROPN
ihlr-22950	46	14	,	,	PUNCT
ihlr-22950	46	15	caution	caution	VERB
ihlr-22950	46	16	to	to	ADP
ihlr-22950	46	17	patients	patient	NOUN
ihlr-22950	46	18	on	on	ADP
ihlr-22950	46	19	‘	'	PUNCT
ihlr-22950	46	20	right	right	ADJ
ihlr-22950	46	21	to	to	PART
ihlr-22950	46	22	try	try	VERB
ihlr-22950	46	23	,	,	PUNCT
ihlr-22950	46	24	’	'	PUNCT
ihlr-22950	46	25	phila	phila	PROPN
ihlr-22950	46	26	.	.	PUNCT
ihlr-22950	47	1	inquirer	inquirer	PROPN
ihlr-22950	47	2	,	,	PUNCT
ihlr-22950	47	3	oct	oct	PROPN
ihlr-22950	47	4	.	.	PROPN
ihlr-22950	47	5	20	20	NUM
ihlr-22950	47	6	,	,	PUNCT
ihlr-22950	47	7	2017	2017	NUM
ihlr-22950	47	8	,	,	PUNCT
ihlr-22950	47	9	at	at	ADP
ihlr-22950	47	10	a15	a15	NOUN
ihlr-22950	47	11	.	.	PUNCT
ihlr-22950	48	1	see	see	VERB
ihlr-22950	48	2	also	also	ADV
ihlr-22950	48	3	amanda	amanda	PROPN
ihlr-22950	48	4	bennett	bennett	PROPN
ihlr-22950	48	5	,	,	PUNCT
ihlr-22950	48	6	the	the	DET
ihlr-22950	48	7	cost	cost	NOUN
ihlr-22950	48	8	of	of	ADP
ihlr-22950	48	9	hope	hope	NOUN
ihlr-22950	48	10	:	:	PUNCT
ihlr-22950	48	11	a	a	DET
ihlr-22950	48	12	memoir	memoir	NOUN
ihlr-22950	48	13	(	(	PUNCT
ihlr-22950	48	14	2012	2012	NUM
ihlr-22950	48	15	)	)	PUNCT
ihlr-22950	48	16	.	.	PUNCT
ihlr-22950	49	1	10	10	NUM
ihlr-22950	49	2	.	.	PUNCT
ihlr-22950	49	3	abigail	abigail	PROPN
ihlr-22950	49	4	all	all	PRON
ihlr-22950	49	5	.	.	PUNCT
ihlr-22950	50	1	for	for	ADP
ihlr-22950	50	2	better	well	ADJ
ihlr-22950	50	3	access	access	NOUN
ihlr-22950	50	4	to	to	ADP
ihlr-22950	50	5	dev	dev	PROPN
ihlr-22950	50	6	.	.	PUNCT
ihlr-22950	51	1	drugs	drug	NOUN
ihlr-22950	51	2	v.	v.	ADP
ihlr-22950	51	3	von	von	PROPN
ihlr-22950	51	4	eschenbach	eschenbach	PROPN
ihlr-22950	51	5	,	,	PUNCT
ihlr-22950	51	6	469	469	NUM
ihlr-22950	51	7	f.3d	f.3d	NUM
ihlr-22950	51	8	129	129	NUM
ihlr-22950	51	9	(	(	PUNCT
ihlr-22950	51	10	d.c	d.c	PROPN
ihlr-22950	51	11	.	.	PROPN
ihlr-22950	51	12	cir	cir	PROPN
ihlr-22950	51	13	.	.	PROPN
ihlr-22950	51	14	2006	2006	NUM
ihlr-22950	51	15	)	)	PUNCT
ihlr-22950	51	16	,	,	PUNCT
ihlr-22950	51	17	aff’d	aff’d	VERB
ihlr-22950	51	18	,	,	PUNCT
ihlr-22950	51	19	495	495	NUM
ihlr-22950	51	20	f.3d	f.3d	NUM
ihlr-22950	51	21	695	695	NUM
ihlr-22950	51	22	(	(	PUNCT
ihlr-22950	51	23	d.c	d.c	PROPN
ihlr-22950	51	24	.	.	PROPN
ihlr-22950	51	25	cir	cir	PROPN
ihlr-22950	51	26	.	.	PROPN
ihlr-22950	51	27	2007	2007	NUM
ihlr-22950	51	28	)	)	PUNCT
ihlr-22950	51	29	.	.	PUNCT
ihlr-22950	52	1	11	11	NUM
ihlr-22950	52	2	.	.	PUNCT
ihlr-22950	53	1	i	i	PRON
ihlr-22950	53	2	d.	d.	PROPN
ihlr-22950	53	3	12	12	NUM
ihlr-22950	53	4	.	.	PUNCT
ihlr-22950	54	1	i	i	PRON
ihlr-22950	54	2	d.	d.	PROPN
ihlr-22950	54	3	13	13	NUM
ihlr-22950	54	4	.	.	PUNCT
ihlr-22950	55	1	abigail	abigail	PROPN
ihlr-22950	55	2	all	all	PRON
ihlr-22950	55	3	.	.	PUNCT
ihlr-22950	56	1	for	for	ADP
ihlr-22950	56	2	better	well	ADJ
ihlr-22950	56	3	access	access	NOUN
ihlr-22950	56	4	to	to	ADP
ihlr-22950	56	5	dev	dev	PROPN
ihlr-22950	56	6	.	.	PUNCT
ihlr-22950	57	1	drugs	drug	NOUN
ihlr-22950	57	2	v.	v.	ADP
ihlr-22950	57	3	von	von	PROPN
ihlr-22950	57	4	eschenbach	eschenbach	PROPN
ihlr-22950	57	5	,	,	PUNCT
ihlr-22950	57	6	469	469	NUM
ihlr-22950	57	7	f.3d	f.3d	NUM
ihlr-22950	57	8	129	129	NUM
ihlr-22950	57	9	(	(	PUNCT
ihlr-22950	57	10	d.c	d.c	PROPN
ihlr-22950	57	11	.	.	PROPN
ihlr-22950	57	12	cir	cir	PROPN
ihlr-22950	57	13	.	.	PROPN
ihlr-22950	57	14	2006	2006	NUM
ihlr-22950	57	15	)	)	PUNCT
ihlr-22950	57	16	,	,	PUNCT
ihlr-22950	57	17	aff’d	aff’d	VERB
ihlr-22950	57	18	,	,	PUNCT
ihlr-22950	57	19	495	495	NUM
ihlr-22950	57	20	f.3d	f.3d	NUM
ihlr-22950	57	21	695	695	NUM
ihlr-22950	57	22	(	(	PUNCT
ihlr-22950	57	23	d.c	d.c	PROPN
ihlr-22950	57	24	.	.	PROPN
ihlr-22950	57	25	cir	cir	PROPN
ihlr-22950	57	26	.	.	PROPN
ihlr-22950	57	27	2007	2007	NUM
ihlr-22950	57	28	)	)	PUNCT
ihlr-22950	57	29	,	,	PUNCT
ihlr-22950	57	30	cert	cert	PROPN
ihlr-22950	57	31	.	.	PUNCT
ihlr-22950	57	32	denied	deny	VERB
ihlr-22950	57	33	,	,	PUNCT
ihlr-22950	57	34	552	552	NUM
ihlr-22950	57	35	u.s	u.s	PROPN
ihlr-22950	57	36	.	.	PROPN
ihlr-22950	57	37	1159	1159	NUM
ihlr-22950	57	38	(	(	PUNCT
ihlr-22950	57	39	2008	2008	NUM
ihlr-22950	57	40	)	)	PUNCT
ihlr-22950	57	41	.	.	PUNCT
ihlr-22950	58	1	14	14	NUM
ihlr-22950	58	2	.	.	X
ihlr-22950	59	1	alaska	alaska	PROPN
ihlr-22950	59	2	becomes	become	VERB
ihlr-22950	59	3	41st	41st	PROPN
ihlr-22950	59	4	state	state	NOUN
ihlr-22950	59	5	to	to	PART
ihlr-22950	59	6	enact	enact	VERB
ihlr-22950	59	7	right	right	NOUN
ihlr-22950	59	8	to	to	PART
ihlr-22950	59	9	try	try	VERB
ihlr-22950	59	10	legislation	legislation	NOUN
ihlr-22950	59	11	,	,	PUNCT
ihlr-22950	59	12	goldwater	goldwater	PROPN
ihlr-22950	59	13	inst	inst	PROPN
ihlr-22950	59	14	.	.	PUNCT
ihlr-22950	60	1	(	(	PUNCT
ihlr-22950	60	2	july	july	PROPN
ihlr-22950	60	3	13	13	NUM
ihlr-22950	60	4	,	,	PUNCT
ihlr-22950	60	5	2018	2018	NUM
ihlr-22950	60	6	)	)	PUNCT
ihlr-22950	60	7	,	,	PUNCT
ihlr-22950	60	8	http://righttotry.org/alaska-becomes-41st-state-to-enact-right-to-try-legislation/	http://righttotry.org/alaska-becomes-41st-state-to-enact-right-to-try-legislation/	PROPN
ihlr-22950	61	1	[	[	X
ihlr-22950	61	2	https://perma.cc/6sun-mc73	https://perma.cc/6sun-mc73	ADP
ihlr-22950	61	3	]	]	X
ihlr-22950	61	4	.	.	PUNCT
ihlr-22950	62	1	the	the	DET
ihlr-22950	62	2	goldwater	goldwater	PROPN
ihlr-22950	62	3	institute	institute	PROPN
ihlr-22950	62	4	is	be	AUX
ihlr-22950	62	5	a	a	DET
ihlr-22950	62	6	public	public	ADJ
ihlr-22950	62	7	policy	policy	NOUN
ihlr-22950	62	8	conservative	conservative	ADJ
ihlr-22950	62	9	based	base	VERB
ihlr-22950	62	10	organization	organization	NOUN
ihlr-22950	62	11	located	locate	VERB
ihlr-22950	62	12	in	in	ADP
ihlr-22950	62	13	phoenix	phoenix	PROPN
ihlr-22950	62	14	,	,	PUNCT
ihlr-22950	62	15	arizona	arizona	PROPN
ihlr-22950	62	16	.	.	PROPN
ihlr-22950	63	1	2018	2018	NUM
ihlr-22950	63	2	]	]	PUNCT
ihlr-22950	63	3	the	the	DET
ihlr-22950	63	4	latest	late	ADJ
ihlr-22950	63	5	“	"	PUNCT
ihlr-22950	63	6	federal	federal	ADJ
ihlr-22950	63	7	movement	movement	NOUN
ihlr-22950	63	8	”	"	PUNCT
ihlr-22950	63	9	in	in	ADP
ihlr-22950	63	10	the	the	DET
ihlr-22950	63	11	food	food	NOUN
ihlr-22950	63	12	and	and	CCONJ
ihlr-22950	63	13	drug	drug	NOUN
ihlr-22950	63	14	law	law	NOUN
ihlr-22950	63	15	arena	arena	NOUN
ihlr-22950	63	16	103	103	NUM
ihlr-22950	63	17	colorado	colorado	NOUN
ihlr-22950	63	18	,	,	PUNCT
ihlr-22950	63	19	connecticut	connecticut	PROPN
ihlr-22950	63	20	,	,	PUNCT
ihlr-22950	63	21	florida	florida	PROPN
ihlr-22950	63	22	,	,	PUNCT
ihlr-22950	63	23	georgia	georgia	PROPN
ihlr-22950	63	24	,	,	PUNCT
ihlr-22950	63	25	idaho	idaho	PROPN
ihlr-22950	63	26	,	,	PUNCT
ihlr-22950	63	27	illinois	illinois	PROPN
ihlr-22950	63	28	,	,	PUNCT
ihlr-22950	63	29	indiana	indiana	PROPN
ihlr-22950	63	30	,	,	PUNCT
ihlr-22950	63	31	iowa	iowa	PROPN
ihlr-22950	63	32	,	,	PUNCT
ihlr-22950	63	33	kentucky	kentucky	PROPN
ihlr-22950	63	34	,	,	PUNCT
ihlr-22950	63	35	louisiana	louisiana	PROPN
ihlr-22950	63	36	,	,	PUNCT
ihlr-22950	63	37	maine	maine	PROPN
ihlr-22950	63	38	,	,	PUNCT
ihlr-22950	63	39	maryland	maryland	PROPN
ihlr-22950	63	40	,	,	PUNCT
ihlr-22950	63	41	michigan	michigan	PROPN
ihlr-22950	63	42	,	,	PUNCT
ihlr-22950	63	43	minnesota	minnesota	PROPN
ihlr-22950	63	44	,	,	PUNCT
ihlr-22950	63	45	mississippi	mississippi	PROPN
ihlr-22950	63	46	,	,	PUNCT
ihlr-22950	63	47	missouri	missouri	PROPN
ihlr-22950	63	48	,	,	PUNCT
ihlr-22950	63	49	montana	montana	PROPN
ihlr-22950	63	50	,	,	PUNCT
ihlr-22950	63	51	nebraska	nebraska	PROPN
ihlr-22950	63	52	,	,	PUNCT
ihlr-22950	63	53	nevada	nevada	PROPN
ihlr-22950	63	54	,	,	PUNCT
ihlr-22950	63	55	new	new	PROPN
ihlr-22950	63	56	hampshire	hampshire	PROPN
ihlr-22950	63	57	,	,	PUNCT
ihlr-22950	63	58	north	north	PROPN
ihlr-22950	63	59	carolina	carolina	PROPN
ihlr-22950	63	60	,	,	PUNCT
ihlr-22950	63	61	north	north	NOUN
ihlr-22950	63	62	dakota	dakota	PROPN
ihlr-22950	63	63	,	,	PUNCT
ihlr-22950	63	64	ohio	ohio	PROPN
ihlr-22950	63	65	,	,	PUNCT
ihlr-22950	63	66	oklahoma	oklahoma	PROPN
ihlr-22950	63	67	,	,	PUNCT
ihlr-22950	63	68	oregon	oregon	PROPN
ihlr-22950	63	69	,	,	PUNCT
ihlr-22950	63	70	pennsylvania	pennsylvania	PROPN
ihlr-22950	63	71	,	,	PUNCT
ihlr-22950	63	72	south	south	PROPN
ihlr-22950	63	73	carolina	carolina	PROPN
ihlr-22950	63	74	,	,	PUNCT
ihlr-22950	63	75	south	south	PROPN
ihlr-22950	63	76	dakota	dakota	PROPN
ihlr-22950	63	77	,	,	PUNCT
ihlr-22950	63	78	tennessee	tennessee	PROPN
ihlr-22950	63	79	,	,	PUNCT
ihlr-22950	63	80	texas	texas	PROPN
ihlr-22950	63	81	,	,	PUNCT
ihlr-22950	63	82	utah	utah	PROPN
ihlr-22950	63	83	,	,	PUNCT
ihlr-22950	63	84	virginia	virginia	PROPN
ihlr-22950	63	85	,	,	PUNCT
ihlr-22950	63	86	washington	washington	PROPN
ihlr-22950	63	87	,	,	PUNCT
ihlr-22950	63	88	west	west	PROPN
ihlr-22950	63	89	virginia	virginia	PROPN
ihlr-22950	63	90	,	,	PUNCT
ihlr-22950	63	91	wisconsin	wisconsin	PROPN
ihlr-22950	63	92	,	,	PUNCT
ihlr-22950	63	93	and	and	CCONJ
ihlr-22950	63	94	wyoming.15	wyoming.15	PROPN
ihlr-22950	63	95	colorado	colorado	PROPN
ihlr-22950	63	96	was	be	AUX
ihlr-22950	63	97	the	the	DET
ihlr-22950	63	98	first	first	ADJ
ihlr-22950	63	99	state	state	NOUN
ihlr-22950	63	100	to	to	PART
ihlr-22950	63	101	enact	enact	VERB
ihlr-22950	63	102	right	right	ADJ
ihlr-22950	63	103	-	-	PUNCT
ihlr-22950	63	104	to	to	PART
ihlr-22950	63	105	-	-	PUNCT
ihlr-22950	63	106	try	try	VERB
ihlr-22950	63	107	legislation	legislation	NOUN
ihlr-22950	63	108	back	back	ADV
ihlr-22950	63	109	in	in	ADP
ihlr-22950	63	110	2014.16	2014.16	NUM
ihlr-22950	63	111	the	the	DET
ihlr-22950	63	112	colorado	colorado	PROPN
ihlr-22950	63	113	law	law	PROPN
ihlr-22950	63	114	right	right	NOUN
ihlr-22950	63	115	-	-	PUNCT
ihlr-22950	63	116	to	to	PART
ihlr-22950	63	117	-	-	PUNCT
ihlr-22950	63	118	try	try	VERB
ihlr-22950	63	119	act	act	NOUN
ihlr-22950	63	120	includes	include	VERB
ihlr-22950	63	121	investigational	investigational	ADJ
ihlr-22950	63	122	medical	medical	ADJ
ihlr-22950	63	123	devices.17	devices.17	PROPN
ihlr-22950	63	124	the	the	DET
ihlr-22950	63	125	federal	federal	ADJ
ihlr-22950	63	126	right	right	NOUN
ihlr-22950	63	127	-	-	PUNCT
ihlr-22950	63	128	to	to	PART
ihlr-22950	63	129	-	-	PUNCT
ihlr-22950	63	130	try	try	VERB
ihlr-22950	63	131	act18	act18	NOUN
ihlr-22950	63	132	does	do	AUX
ihlr-22950	63	133	not	not	PART
ihlr-22950	63	134	address	address	VERB
ihlr-22950	63	135	and	and	CCONJ
ihlr-22950	63	136	is	be	AUX
ihlr-22950	63	137	silent	silent	ADJ
ihlr-22950	63	138	regarding	regard	VERB
ihlr-22950	63	139	investigational	investigational	ADJ
ihlr-22950	63	140	devices	device	NOUN
ihlr-22950	63	141	.	.	PUNCT
ihlr-22950	64	1	however	however	ADV
ihlr-22950	64	2	,	,	PUNCT
ihlr-22950	64	3	prior	prior	ADJ
ihlr-22950	64	4	legislative	legislative	ADJ
ihlr-22950	64	5	bills	bill	NOUN
ihlr-22950	64	6	indicate	indicate	VERB
ihlr-22950	64	7	devices	device	NOUN
ihlr-22950	64	8	were	be	AUX
ihlr-22950	64	9	considered.19	considered.19	NOUN
ihlr-22950	64	10	this	this	PRON
ihlr-22950	64	11	could	could	AUX
ihlr-22950	64	12	prove	prove	VERB
ihlr-22950	64	13	problematic	problematic	ADJ
ihlr-22950	64	14	in	in	ADP
ihlr-22950	64	15	terms	term	NOUN
ihlr-22950	64	16	of	of	ADP
ihlr-22950	64	17	preemption	preemption	NOUN
ihlr-22950	64	18	issues.20	issues.20	PROPN
ihlr-22950	64	19	yet	yet	ADV
ihlr-22950	64	20	,	,	PUNCT
ihlr-22950	64	21	do	do	AUX
ihlr-22950	64	22	these	these	DET
ihlr-22950	64	23	laws	law	NOUN
ihlr-22950	64	24	provide	provide	VERB
ihlr-22950	64	25	those	those	PRON
ihlr-22950	64	26	who	who	PRON
ihlr-22950	64	27	are	be	AUX
ihlr-22950	64	28	desperately	desperately	ADV
ihlr-22950	64	29	ill	ill	ADJ
ihlr-22950	64	30	patients	patient	NOUN
ihlr-22950	64	31	with	with	ADP
ihlr-22950	64	32	“	"	PUNCT
ihlr-22950	64	33	unrealistic	unrealistic	ADJ
ihlr-22950	64	34	false	false	ADJ
ihlr-22950	64	35	hope	hope	NOUN
ihlr-22950	64	36	”	"	PUNCT
ihlr-22950	64	37	by	by	ADP
ihlr-22950	64	38	promising	promise	VERB
ihlr-22950	64	39	access	access	NOUN
ihlr-22950	64	40	to	to	ADP
ihlr-22950	64	41	therapies	therapy	NOUN
ihlr-22950	64	42	that	that	PRON
ihlr-22950	64	43	may	may	AUX
ihlr-22950	64	44	not	not	PART
ihlr-22950	64	45	work	work	VERB
ihlr-22950	64	46	or	or	CCONJ
ihlr-22950	64	47	may	may	AUX
ihlr-22950	64	48	cause	cause	VERB
ihlr-22950	64	49	harm	harm	NOUN
ihlr-22950	64	50	,	,	PUNCT
ihlr-22950	64	51	and	and	CCONJ
ihlr-22950	64	52	that	that	SCONJ
ihlr-22950	64	53	they	they	PRON
ihlr-22950	64	54	may	may	AUX
ihlr-22950	64	55	not	not	PART
ihlr-22950	64	56	even	even	ADV
ihlr-22950	64	57	receive?21	receive?21	PROPN
ihlr-22950	64	58	are	be	AUX
ihlr-22950	64	59	the	the	DET
ihlr-22950	64	60	state	state	NOUN
ihlr-22950	64	61	right	right	NOUN
ihlr-22950	64	62	-	-	PUNCT
ihlr-22950	64	63	to	to	PART
ihlr-22950	64	64	-	-	PUNCT
ihlr-22950	64	65	try	try	VERB
ihlr-22950	64	66	laws	law	NOUN
ihlr-22950	64	67	usurping	usurp	VERB
ihlr-22950	64	68	fda	fda	PROPN
ihlr-22950	64	69	authority?22	authority?22	PROPN
ihlr-22950	64	70	does	do	AUX
ihlr-22950	64	71	the	the	DET
ihlr-22950	64	72	recently	recently	ADV
ihlr-22950	64	73	enacted	enact	VERB
ihlr-22950	64	74	federal	federal	ADJ
ihlr-22950	64	75	right	right	NOUN
ihlr-22950	64	76	-	-	PUNCT
ihlr-22950	64	77	to	to	PART
ihlr-22950	64	78	-	-	PUNCT
ihlr-22950	64	79	try	try	VERB
ihlr-22950	64	80	act	act	NOUN
ihlr-22950	64	81	provide	provide	VERB
ihlr-22950	64	82	additional	additional	ADJ
ihlr-22950	64	83	benefits	benefit	NOUN
ihlr-22950	64	84	to	to	ADP
ihlr-22950	64	85	the	the	DET
ihlr-22950	64	86	patient	patient	NOUN
ihlr-22950	64	87	than	than	ADP
ihlr-22950	64	88	what	what	PRON
ihlr-22950	64	89	is	be	AUX
ihlr-22950	64	90	already	already	ADV
ihlr-22950	64	91	provided	provide	VERB
ihlr-22950	64	92	by	by	ADP
ihlr-22950	64	93	the	the	DET
ihlr-22950	64	94	fda	fda	PROPN
ihlr-22950	64	95	expanded	expand	VERB
ihlr-22950	64	96	use	use	NOUN
ihlr-22950	64	97	?	?	PUNCT
ihlr-22950	65	1	alternatively	alternatively	ADV
ihlr-22950	65	2	,	,	PUNCT
ihlr-22950	65	3	does	do	AUX
ihlr-22950	65	4	the	the	DET
ihlr-22950	65	5	federal	federal	ADJ
ihlr-22950	65	6	right	right	NOUN
ihlr-22950	65	7	-	-	PUNCT
ihlr-22950	65	8	to	to	PART
ihlr-22950	65	9	-	-	PUNCT
ihlr-22950	65	10	try	try	VERB
ihlr-22950	65	11	act	act	NOUN
ihlr-22950	65	12	deny	deny	VERB
ihlr-22950	65	13	access	access	NOUN
ihlr-22950	65	14	as	as	ADP
ihlr-22950	65	15	access	access	NOUN
ihlr-22950	65	16	is	be	AUX
ihlr-22950	65	17	contingent	contingent	ADJ
ihlr-22950	65	18	on	on	ADP
ihlr-22950	65	19	the	the	DET
ihlr-22950	65	20	physician	physician	NOUN
ihlr-22950	65	21	,	,	PUNCT
ihlr-22950	65	22	manufacturer	manufacturer	NOUN
ihlr-22950	65	23	and	and	CCONJ
ihlr-22950	65	24	insurance	insurance	NOUN
ihlr-22950	65	25	companies	company	NOUN
ihlr-22950	65	26	to	to	PART
ihlr-22950	65	27	acquiesce	acquiesce	VERB
ihlr-22950	65	28	?	?	PUNCT
ihlr-22950	66	1	who	who	PRON
ihlr-22950	66	2	pays	pay	VERB
ihlr-22950	66	3	for	for	ADP
ihlr-22950	66	4	access	access	NOUN
ihlr-22950	66	5	?	?	PUNCT
ihlr-22950	67	1	15	15	NUM
ihlr-22950	67	2	.	.	PUNCT
ihlr-22950	68	1	i	i	PRON
ihlr-22950	68	2	d.	d.	PROPN
ihlr-22950	68	3	16	16	NUM
ihlr-22950	68	4	.	.	PUNCT
ihlr-22950	69	1	access	access	NOUN
ihlr-22950	69	2	to	to	ADP
ihlr-22950	69	3	treatments	treatment	NOUN
ihlr-22950	69	4	for	for	ADP
ihlr-22950	69	5	terminally	terminally	ADV
ihlr-22950	69	6	ill	ill	ADJ
ihlr-22950	69	7	patients	patient	NOUN
ihlr-22950	69	8	,	,	PUNCT
ihlr-22950	69	9	colo	colo	PROPN
ihlr-22950	69	10	.	.	PUNCT
ihlr-22950	70	1	rev	rev	PROPN
ihlr-22950	70	2	.	.	PROPN
ihlr-22950	70	3	stat	stat	PROPN
ihlr-22950	70	4	.	.	PUNCT
ihlr-22950	71	1	ann	ann	PROPN
ihlr-22950	71	2	.	.	PUNCT
ihlr-22950	72	1	§	§	PROPN
ihlr-22950	72	2	25	25	NUM
ihlr-22950	72	3	-	-	SYM
ihlr-22950	72	4	45	45	NUM
ihlr-22950	72	5	(	(	PUNCT
ihlr-22950	72	6	west	west	NOUN
ihlr-22950	72	7	2014	2014	NUM
ihlr-22950	72	8	)	)	PUNCT
ihlr-22950	72	9	(	(	PUNCT
ihlr-22950	72	10	this	this	DET
ihlr-22950	72	11	article	article	NOUN
ihlr-22950	72	12	is	be	AUX
ihlr-22950	72	13	known	know	VERB
ihlr-22950	72	14	and	and	CCONJ
ihlr-22950	72	15	may	may	AUX
ihlr-22950	72	16	be	be	AUX
ihlr-22950	72	17	cited	cite	VERB
ihlr-22950	72	18	as	as	ADP
ihlr-22950	72	19	the	the	DET
ihlr-22950	72	20	“	"	PUNCT
ihlr-22950	72	21	right	right	NOUN
ihlr-22950	72	22	to	to	PART
ihlr-22950	72	23	try	try	VERB
ihlr-22950	72	24	act	act	NOUN
ihlr-22950	72	25	”	"	PUNCT
ihlr-22950	72	26	)	)	PUNCT
ihlr-22950	72	27	.	.	PUNCT
ihlr-22950	73	1	17	17	NUM
ihlr-22950	73	2	.	.	PUNCT
ihlr-22950	74	1	§	§	PROPN
ihlr-22950	74	2	25	25	NUM
ihlr-22950	74	3	-	-	SYM
ihlr-22950	74	4	45	45	NUM
ihlr-22950	74	5	-	-	PUNCT
ihlr-22950	74	6	102	102	NUM
ihlr-22950	74	7	(	(	PUNCT
ihlr-22950	74	8	west	west	NOUN
ihlr-22950	74	9	2014	2014	NUM
ihlr-22950	74	10	)	)	PUNCT
ihlr-22950	74	11	.	.	PUNCT
ihlr-22950	75	1	18	18	NUM
ihlr-22950	75	2	.	.	X
ihlr-22950	75	3	trickett	trickett	PROPN
ihlr-22950	75	4	wendler	wendler	PROPN
ihlr-22950	75	5	,	,	PUNCT
ihlr-22950	75	6	frank	frank	PROPN
ihlr-22950	75	7	mongiello	mongiello	PROPN
ihlr-22950	75	8	,	,	PUNCT
ihlr-22950	75	9	jordan	jordan	PROPN
ihlr-22950	75	10	mclinn	mclinn	PROPN
ihlr-22950	75	11	,	,	PUNCT
ihlr-22950	75	12	and	and	CCONJ
ihlr-22950	75	13	matthew	matthew	PROPN
ihlr-22950	75	14	bellina	bellina	PROPN
ihlr-22950	75	15	right	right	NOUN
ihlr-22950	75	16	to	to	PART
ihlr-22950	75	17	try	try	VERB
ihlr-22950	75	18	act	act	NOUN
ihlr-22950	75	19	of	of	ADP
ihlr-22950	75	20	2017	2017	NUM
ihlr-22950	75	21	,	,	PUNCT
ihlr-22950	75	22	pub	pub	NOUN
ihlr-22950	75	23	.	.	PUNCT
ihlr-22950	76	1	l.	l.	PROPN
ihlr-22950	76	2	no	no	INTJ
ihlr-22950	76	3	.	.	PROPN
ihlr-22950	77	1	115	115	NUM
ihlr-22950	77	2	-	-	SYM
ihlr-22950	77	3	176	176	NUM
ihlr-22950	77	4	,	,	PUNCT
ihlr-22950	77	5	132	132	NUM
ihlr-22950	77	6	stat	stat	NOUN
ihlr-22950	77	7	.	.	PUNCT
ihlr-22950	78	1	1372	1372	NUM
ihlr-22950	78	2	(	(	PUNCT
ihlr-22950	78	3	2018	2018	NUM
ihlr-22950	78	4	)	)	PUNCT
ihlr-22950	78	5	.	.	PUNCT
ihlr-22950	79	1	19	19	NUM
ihlr-22950	79	2	.	.	X
ihlr-22950	79	3	see	see	VERB
ihlr-22950	79	4	,	,	PUNCT
ihlr-22950	79	5	e.g.	e.g.	ADV
ihlr-22950	79	6	,	,	PUNCT
ihlr-22950	79	7	h.r	h.r	PROPN
ihlr-22950	79	8	.	.	PROPN
ihlr-22950	79	9	878	878	NUM
ihlr-22950	79	10	,	,	PUNCT
ihlr-22950	79	11	115th	115th	ADJ
ihlr-22950	79	12	cong	cong	NOUN
ihlr-22950	79	13	.	.	PUNCT
ihlr-22950	80	1	(	(	PUNCT
ihlr-22950	80	2	2017	2017	NUM
ihlr-22950	80	3	-	-	SYM
ihlr-22950	80	4	2018	2018	NUM
ihlr-22950	80	5	)	)	PUNCT
ihlr-22950	80	6	(	(	PUNCT
ihlr-22950	80	7	obligating	obligate	VERB
ihlr-22950	80	8	the	the	DET
ihlr-22950	80	9	federal	federal	ADJ
ihlr-22950	80	10	government	government	NOUN
ihlr-22950	80	11	to	to	PART
ihlr-22950	80	12	permit	permit	VERB
ihlr-22950	80	13	unrestricted	unrestricted	ADJ
ihlr-22950	80	14	manufacturing	manufacturing	NOUN
ihlr-22950	80	15	,	,	PUNCT
ihlr-22950	80	16	“	"	PUNCT
ihlr-22950	80	17	distribution	distribution	NOUN
ihlr-22950	80	18	,	,	PUNCT
ihlr-22950	80	19	prescribing	prescribing	NOUN
ihlr-22950	80	20	,	,	PUNCT
ihlr-22950	80	21	or	or	CCONJ
ihlr-22950	80	22	dispensing	dispensing	NOUN
ihlr-22950	80	23	of	of	ADP
ihlr-22950	80	24	an	an	DET
ihlr-22950	80	25	experimental	experimental	ADJ
ihlr-22950	80	26	drug	drug	NOUN
ihlr-22950	80	27	,	,	PUNCT
ihlr-22950	80	28	biological	biological	ADJ
ihlr-22950	80	29	product	product	NOUN
ihlr-22950	80	30	,	,	PUNCT
ihlr-22950	80	31	or	or	CCONJ
ihlr-22950	80	32	[	[	X
ihlr-22950	80	33	medical	medical	ADJ
ihlr-22950	80	34	]	]	X
ihlr-22950	80	35	device	device	NOUN
ihlr-22950	80	36	that	that	PRON
ihlr-22950	80	37	is	be	AUX
ihlr-22950	80	38	intended	intend	VERB
ihlr-22950	80	39	to	to	PART
ihlr-22950	80	40	treat	treat	VERB
ihlr-22950	80	41	a	a	DET
ihlr-22950	80	42	patient	patient	NOUN
ihlr-22950	80	43	who	who	PRON
ihlr-22950	80	44	has	have	AUX
ihlr-22950	80	45	been	be	AUX
ihlr-22950	80	46	diagnosed	diagnose	VERB
ihlr-22950	80	47	with	with	ADP
ihlr-22950	80	48	a	a	DET
ihlr-22950	80	49	terminal	terminal	ADJ
ihlr-22950	80	50	illness	illness	NOUN
ihlr-22950	80	51	.	.	PUNCT
ihlr-22950	80	52	”	"	PUNCT
ihlr-22950	80	53	)	)	PUNCT
ihlr-22950	80	54	;	;	PUNCT
ihlr-22950	80	55	see	see	VERB
ihlr-22950	80	56	also	also	ADV
ihlr-22950	80	57	h.r	h.r	PROPN
ihlr-22950	80	58	.	.	PROPN
ihlr-22950	80	59	2368	2368	NUM
ihlr-22950	80	60	,	,	PUNCT
ihlr-22950	80	61	115th	115th	ADJ
ihlr-22950	80	62	cong	cong	NOUN
ihlr-22950	80	63	.	.	PUNCT
ihlr-22950	81	1	(	(	PUNCT
ihlr-22950	81	2	2017	2017	NUM
ihlr-22950	81	3	-	-	SYM
ihlr-22950	81	4	2018	2018	NUM
ihlr-22950	81	5	)	)	PUNCT
ihlr-22950	81	6	(	(	PUNCT
ihlr-22950	81	7	“	"	PUNCT
ihlr-22950	81	8	this	this	DET
ihlr-22950	81	9	bill	bill	NOUN
ihlr-22950	81	10	requires	require	VERB
ihlr-22950	81	11	the	the	DET
ihlr-22950	81	12	federal	federal	ADJ
ihlr-22950	81	13	government	government	NOUN
ihlr-22950	81	14	to	to	PART
ihlr-22950	81	15	allow	allow	VERB
ihlr-22950	81	16	unrestricted	unrestricted	ADJ
ihlr-22950	81	17	manufacturing	manufacturing	NOUN
ihlr-22950	81	18	,	,	PUNCT
ihlr-22950	81	19	distribution	distribution	NOUN
ihlr-22950	81	20	,	,	PUNCT
ihlr-22950	81	21	prescribing	prescribing	NOUN
ihlr-22950	81	22	,	,	PUNCT
ihlr-22950	81	23	and	and	CCONJ
ihlr-22950	81	24	dispensing	dispensing	NOUN
ihlr-22950	81	25	of	of	ADP
ihlr-22950	81	26	experimental	experimental	ADJ
ihlr-22950	81	27	drugs	drug	NOUN
ihlr-22950	81	28	,	,	PUNCT
ihlr-22950	81	29	biological	biological	ADJ
ihlr-22950	81	30	products	product	NOUN
ihlr-22950	81	31	,	,	PUNCT
ihlr-22950	81	32	and	and	CCONJ
ihlr-22950	81	33	medical	medical	ADJ
ihlr-22950	81	34	devices	device	NOUN
ihlr-22950	81	35	that	that	PRON
ihlr-22950	81	36	are	be	AUX
ihlr-22950	81	37	authorized	authorize	VERB
ihlr-22950	81	38	by	by	ADP
ihlr-22950	81	39	state	state	NOUN
ihlr-22950	81	40	law	law	NOUN
ihlr-22950	81	41	and	and	CCONJ
ihlr-22950	81	42	intended	intend	VERB
ihlr-22950	81	43	to	to	PART
ihlr-22950	81	44	treat	treat	VERB
ihlr-22950	81	45	terminally	terminally	ADV
ihlr-22950	81	46	ill	ill	ADJ
ihlr-22950	81	47	patients	patient	NOUN
ihlr-22950	81	48	.	.	PUNCT
ihlr-22950	81	49	”	"	PUNCT
ihlr-22950	82	1	)	)	PUNCT
ihlr-22950	82	2	cong	cong	NOUN
ihlr-22950	82	3	.	.	PUNCT
ihlr-22950	83	1	res	re	NOUN
ihlr-22950	83	2	.	.	PUNCT
ihlr-22950	84	1	serv	serv	PROPN
ihlr-22950	84	2	.	.	PROPN
ihlr-22950	84	3	,	,	PUNCT
ihlr-22950	84	4	h.r	h.r	PROPN
ihlr-22950	84	5	.	.	PROPN
ihlr-22950	84	6	2368	2368	NUM
ihlr-22950	84	7	:	:	PUNCT
ihlr-22950	85	1	right	right	ADJ
ihlr-22950	85	2	to	to	PART
ihlr-22950	85	3	try	try	VERB
ihlr-22950	85	4	act	act	NOUN
ihlr-22950	85	5	,	,	PUNCT
ihlr-22950	85	6	govtrack	govtrack	NOUN
ihlr-22950	85	7	,	,	PUNCT
ihlr-22950	85	8	https://www.govtrack.us/congress/bills/115/hr2368/summary	https://www.govtrack.us/congress/bills/115/hr2368/summary	PROPN
ihlr-22950	86	1	[	[	AUX
ihlr-22950	86	2	https://perma.cc/	https://perma.cc/	VERB
ihlr-22950	86	3	gkr4	gkr4	NOUN
ihlr-22950	86	4	-	-	PUNCT
ihlr-22950	86	5	23aw	23aw	NOUN
ihlr-22950	86	6	]	]	PUNCT
ihlr-22950	86	7	.	.	PUNCT
ihlr-22950	87	1	20	20	NUM
ihlr-22950	87	2	.	.	PUNCT
ihlr-22950	88	1	u.s	u.s	PROPN
ihlr-22950	88	2	.	.	PROPN
ihlr-22950	88	3	const	const	PROPN
ihlr-22950	88	4	.	.	PUNCT
ihlr-22950	88	5	art	art	NOUN
ihlr-22950	88	6	.	.	PUNCT
ihlr-22950	89	1	vi	vi	X
ihlr-22950	89	2	,	,	PUNCT
ihlr-22950	89	3	cl.2	cl.2	PROPN
ihlr-22950	89	4	.	.	PUNCT
ihlr-22950	90	1	the	the	DET
ihlr-22950	90	2	doctrine	doctrine	NOUN
ihlr-22950	90	3	of	of	ADP
ihlr-22950	90	4	preemption	preemption	NOUN
ihlr-22950	90	5	emanates	emanate	VERB
ihlr-22950	90	6	from	from	ADP
ihlr-22950	90	7	the	the	DET
ihlr-22950	90	8	supremacy	supremacy	NOUN
ihlr-22950	90	9	clause	clause	NOUN
ihlr-22950	90	10	(	(	PUNCT
ihlr-22950	90	11	article	article	NOUN
ihlr-22950	90	12	vi	vi	PROPN
ihlr-22950	90	13	,	,	PUNCT
ihlr-22950	90	14	clause	clause	NOUN
ihlr-22950	90	15	2	2	NUM
ihlr-22950	90	16	)	)	PUNCT
ihlr-22950	90	17	of	of	ADP
ihlr-22950	90	18	the	the	DET
ihlr-22950	90	19	united	united	PROPN
ihlr-22950	90	20	states	states	PROPN
ihlr-22950	90	21	constitution	constitution	PROPN
ihlr-22950	90	22	.	.	PUNCT
ihlr-22950	91	1	article	article	PROPN
ihlr-22950	91	2	vi	vi	PROPN
ihlr-22950	91	3	,	,	PUNCT
ihlr-22950	91	4	clause	clause	NOUN
ihlr-22950	91	5	2	2	NUM
ihlr-22950	91	6	prohibits	prohibit	VERB
ihlr-22950	91	7	states	state	NOUN
ihlr-22950	91	8	from	from	ADP
ihlr-22950	91	9	enacting	enact	VERB
ihlr-22950	91	10	laws	law	NOUN
ihlr-22950	91	11	that	that	PRON
ihlr-22950	91	12	conflict	conflict	NOUN
ihlr-22950	91	13	with	with	ADP
ihlr-22950	91	14	federal	federal	ADJ
ihlr-22950	91	15	law	law	NOUN
ihlr-22950	91	16	unless	unless	SCONJ
ihlr-22950	91	17	the	the	DET
ihlr-22950	91	18	federal	federal	ADJ
ihlr-22950	91	19	law	law	NOUN
ihlr-22950	91	20	contains	contain	VERB
ihlr-22950	91	21	explicit	explicit	ADJ
ihlr-22950	91	22	preemption	preemption	NOUN
ihlr-22950	91	23	language	language	NOUN
ihlr-22950	91	24	.	.	PUNCT
ihlr-22950	92	1	21	21	NUM
ihlr-22950	92	2	.	.	PUNCT
ihlr-22950	93	1	see	see	VERB
ihlr-22950	93	2	alison	alison	PROPN
ihlr-22950	93	3	bateman	bateman	PROPN
ihlr-22950	93	4	-	-	PUNCT
ihlr-22950	93	5	house	house	PROPN
ihlr-22950	93	6	&	&	CCONJ
ihlr-22950	93	7	arthur	arthur	PROPN
ihlr-22950	93	8	caplan	caplan	PROPN
ihlr-22950	93	9	,	,	PUNCT
ihlr-22950	93	10	drug	drug	NOUN
ihlr-22950	93	11	-	-	PUNCT
ihlr-22950	93	12	right	right	NOUN
ihlr-22950	93	13	bills	bill	NOUN
ihlr-22950	93	14	give	give	VERB
ihlr-22950	93	15	patients	patient	NOUN
ihlr-22950	93	16	false	false	ADJ
ihlr-22950	93	17	hope	hope	NOUN
ihlr-22950	93	18	,	,	PUNCT
ihlr-22950	93	19	phila	phila	PROPN
ihlr-22950	93	20	.	.	PUNCT
ihlr-22950	94	1	inquirer	inquirer	PROPN
ihlr-22950	94	2	,	,	PUNCT
ihlr-22950	94	3	nov	nov	PROPN
ihlr-22950	94	4	.	.	PROPN
ihlr-22950	94	5	16	16	NUM
ihlr-22950	94	6	,	,	PUNCT
ihlr-22950	94	7	2014	2014	NUM
ihlr-22950	94	8	,	,	PUNCT
ihlr-22950	94	9	at	at	ADP
ihlr-22950	94	10	b1	b1	NOUN
ihlr-22950	94	11	(	(	PUNCT
ihlr-22950	94	12	concluding	conclude	VERB
ihlr-22950	94	13	that	that	DET
ihlr-22950	94	14	state	state	NOUN
ihlr-22950	94	15	“	"	PUNCT
ihlr-22950	94	16	right	right	NOUN
ihlr-22950	94	17	to	to	PART
ihlr-22950	94	18	try	try	VERB
ihlr-22950	94	19	”	"	PUNCT
ihlr-22950	94	20	laws	law	NOUN
ihlr-22950	94	21	could	could	AUX
ihlr-22950	94	22	actually	actually	ADV
ihlr-22950	94	23	harm	harm	VERB
ihlr-22950	94	24	a	a	DET
ihlr-22950	94	25	terminally	terminally	ADV
ihlr-22950	94	26	ill	ill	ADJ
ihlr-22950	94	27	patient	patient	NOUN
ihlr-22950	94	28	.	.	PUNCT
ihlr-22950	95	1	22	22	NUM
ihlr-22950	95	2	.	.	PUNCT
ihlr-22950	96	1	u.s	u.s	PROPN
ihlr-22950	96	2	.	.	PROPN
ihlr-22950	96	3	const	const	PROPN
ihlr-22950	96	4	.	.	PUNCT
ihlr-22950	96	5	art	art	NOUN
ihlr-22950	96	6	.	.	PUNCT
ihlr-22950	97	1	vi	vi	X
ihlr-22950	97	2	,	,	PUNCT
ihlr-22950	97	3	cl.2	cl.2	PROPN
ihlr-22950	97	4	.	.	PUNCT
ihlr-22950	98	1	the	the	DET
ihlr-22950	98	2	doctrine	doctrine	NOUN
ihlr-22950	98	3	of	of	ADP
ihlr-22950	98	4	preemption	preemption	NOUN
ihlr-22950	98	5	emanates	emanate	VERB
ihlr-22950	98	6	from	from	ADP
ihlr-22950	98	7	the	the	DET
ihlr-22950	98	8	supremacy	supremacy	NOUN
ihlr-22950	98	9	clause	clause	NOUN
ihlr-22950	98	10	(	(	PUNCT
ihlr-22950	98	11	article	article	NOUN
ihlr-22950	98	12	vi	vi	PROPN
ihlr-22950	98	13	,	,	PUNCT
ihlr-22950	98	14	clause	clause	NOUN
ihlr-22950	98	15	2	2	NUM
ihlr-22950	98	16	)	)	PUNCT
ihlr-22950	98	17	of	of	ADP
ihlr-22950	98	18	the	the	DET
ihlr-22950	98	19	united	united	PROPN
ihlr-22950	98	20	states	states	PROPN
ihlr-22950	98	21	constitution	constitution	PROPN
ihlr-22950	98	22	.	.	PUNCT
ihlr-22950	99	1	article	article	PROPN
ihlr-22950	99	2	vi	vi	PROPN
ihlr-22950	99	3	,	,	PUNCT
ihlr-22950	99	4	clause	clause	NOUN
ihlr-22950	99	5	2	2	NUM
ihlr-22950	99	6	prohibits	prohibit	VERB
ihlr-22950	99	7	states	state	NOUN
ihlr-22950	99	8	from	from	ADP
ihlr-22950	99	9	enacting	enact	VERB
ihlr-22950	99	10	laws	law	NOUN
ihlr-22950	99	11	that	that	PRON
ihlr-22950	99	12	conflict	conflict	NOUN
ihlr-22950	99	13	with	with	ADP
ihlr-22950	99	14	federal	federal	ADJ
ihlr-22950	99	15	law	law	NOUN
ihlr-22950	99	16	unless	unless	SCONJ
ihlr-22950	99	17	the	the	DET
ihlr-22950	99	18	federal	federal	ADJ
ihlr-22950	99	19	law	law	NOUN
ihlr-22950	99	20	contains	contain	VERB
ihlr-22950	99	21	explicit	explicit	ADJ
ihlr-22950	99	22	preemption	preemption	NOUN
ihlr-22950	99	23	language	language	NOUN
ihlr-22950	99	24	.	.	PUNCT
ihlr-22950	100	1	104	104	NUM
ihlr-22950	100	2	indiana	indiana	PROPN
ihlr-22950	100	3	health	health	PROPN
ihlr-22950	100	4	law	law	PROPN
ihlr-22950	100	5	review	review	NOUN
ihlr-22950	100	6	[	[	X
ihlr-22950	100	7	vol	vol	NOUN
ihlr-22950	100	8	.	.	PUNCT
ihlr-22950	101	1	16:101	16:101	NUM
ihlr-22950	101	2	is	be	AUX
ihlr-22950	101	3	informed	inform	VERB
ihlr-22950	101	4	consent	consent	NOUN
ihlr-22950	101	5	adequately	adequately	ADV
ihlr-22950	101	6	explained	explain	VERB
ihlr-22950	101	7	or	or	CCONJ
ihlr-22950	101	8	in	in	ADP
ihlr-22950	101	9	reality	reality	NOUN
ihlr-22950	101	10	a	a	DET
ihlr-22950	101	11	protection	protection	NOUN
ihlr-22950	101	12	mechanism	mechanism	NOUN
ihlr-22950	101	13	for	for	ADP
ihlr-22950	101	14	physicians?23	physicians?23	ADJ
ihlr-22950	101	15	these	these	PRON
ihlr-22950	101	16	are	be	AUX
ihlr-22950	101	17	complex	complex	ADJ
ihlr-22950	101	18	questions	question	NOUN
ihlr-22950	101	19	without	without	ADP
ihlr-22950	101	20	straightforward	straightforward	ADJ
ihlr-22950	101	21	answers	answer	NOUN
ihlr-22950	101	22	and	and	CCONJ
ihlr-22950	101	23	there	there	PRON
ihlr-22950	101	24	are	be	VERB
ihlr-22950	101	25	various	various	ADJ
ihlr-22950	101	26	participants	participant	NOUN
ihlr-22950	101	27	involved	involve	VERB
ihlr-22950	101	28	in	in	ADP
ihlr-22950	101	29	this	this	DET
ihlr-22950	101	30	process	process	NOUN
ihlr-22950	101	31	besides	besides	SCONJ
ihlr-22950	101	32	the	the	DET
ihlr-22950	101	33	patient	patient	NOUN
ihlr-22950	101	34	and	and	CCONJ
ihlr-22950	101	35	the	the	DET
ihlr-22950	101	36	health	health	NOUN
ihlr-22950	101	37	care	care	NOUN
ihlr-22950	101	38	provider	provider	NOUN
ihlr-22950	101	39	.	.	PUNCT
ihlr-22950	102	1	drug	drug	NOUN
ihlr-22950	102	2	and	and	CCONJ
ihlr-22950	102	3	medical	medical	ADJ
ihlr-22950	102	4	device	device	NOUN
ihlr-22950	102	5	manufacturers	manufacturer	NOUN
ihlr-22950	102	6	,	,	PUNCT
ihlr-22950	102	7	distributors	distributor	NOUN
ihlr-22950	102	8	,	,	PUNCT
ihlr-22950	102	9	insurers	insurer	NOUN
ihlr-22950	102	10	and	and	CCONJ
ihlr-22950	102	11	the	the	DET
ihlr-22950	102	12	health	health	NOUN
ihlr-22950	102	13	care	care	NOUN
ihlr-22950	102	14	providers	provider	NOUN
ihlr-22950	102	15	have	have	VERB
ihlr-22950	102	16	a	a	DET
ihlr-22950	102	17	significant	significant	ADJ
ihlr-22950	102	18	role	role	NOUN
ihlr-22950	102	19	.	.	PUNCT
ihlr-22950	103	1	to	to	PART
ihlr-22950	103	2	establish	establish	VERB
ihlr-22950	103	3	the	the	DET
ihlr-22950	103	4	tone	tone	NOUN
ihlr-22950	103	5	of	of	ADP
ihlr-22950	103	6	how	how	SCONJ
ihlr-22950	103	7	the	the	DET
ihlr-22950	103	8	national	national	ADJ
ihlr-22950	103	9	state	state	PROPN
ihlr-22950	103	10	movement	movement	PROPN
ihlr-22950	103	11	spurred	spur	VERB
ihlr-22950	103	12	federal	federal	ADJ
ihlr-22950	103	13	legislation	legislation	NOUN
ihlr-22950	103	14	in	in	ADP
ihlr-22950	103	15	the	the	DET
ihlr-22950	103	16	food	food	NOUN
ihlr-22950	103	17	and	and	CCONJ
ihlr-22950	103	18	drug	drug	NOUN
ihlr-22950	103	19	law	law	NOUN
ihlr-22950	103	20	realm	realm	NOUN
ihlr-22950	103	21	,	,	PUNCT
ihlr-22950	103	22	the	the	DET
ihlr-22950	103	23	bioengineered	bioengineere	VERB
ihlr-22950	103	24	act24	act24	NOUN
ihlr-22950	103	25	provides	provide	VERB
ihlr-22950	103	26	insight	insight	NOUN
ihlr-22950	103	27	.	.	PUNCT
ihlr-22950	104	1	next	next	ADV
ihlr-22950	104	2	,	,	PUNCT
ihlr-22950	104	3	a	a	DET
ihlr-22950	104	4	federal	federal	ADJ
ihlr-22950	104	5	primer	primer	NOUN
ihlr-22950	104	6	provides	provide	VERB
ihlr-22950	104	7	a	a	DET
ihlr-22950	104	8	synopsis	synopsis	NOUN
ihlr-22950	104	9	of	of	ADP
ihlr-22950	104	10	the	the	DET
ihlr-22950	104	11	federal	federal	ADJ
ihlr-22950	104	12	investigation	investigation	NOUN
ihlr-22950	104	13	drug	drug	NOUN
ihlr-22950	104	14	and	and	CCONJ
ihlr-22950	104	15	medical	medical	ADJ
ihlr-22950	104	16	device	device	NOUN
ihlr-22950	104	17	process	process	NOUN
ihlr-22950	104	18	.	.	PUNCT
ihlr-22950	105	1	following	follow	VERB
ihlr-22950	105	2	this	this	PRON
ihlr-22950	105	3	,	,	PUNCT
ihlr-22950	105	4	by	by	ADP
ihlr-22950	105	5	way	way	NOUN
ihlr-22950	105	6	of	of	ADP
ihlr-22950	105	7	illustration	illustration	NOUN
ihlr-22950	105	8	,	,	PUNCT
ihlr-22950	105	9	is	be	AUX
ihlr-22950	105	10	an	an	DET
ihlr-22950	105	11	overview	overview	NOUN
ihlr-22950	105	12	of	of	ADP
ihlr-22950	105	13	the	the	DET
ihlr-22950	105	14	federal	federal	ADJ
ihlr-22950	105	15	right	right	NOUN
ihlr-22950	105	16	-	-	PUNCT
ihlr-22950	105	17	to	to	AUX
ihlr-22950	105	18	-	-	PUNCT
ihlr-22950	105	19	try	try	VERB
ihlr-22950	105	20	legislation	legislation	NOUN
ihlr-22950	105	21	and	and	CCONJ
ihlr-22950	105	22	a	a	DET
ihlr-22950	105	23	state	state	NOUN
ihlr-22950	105	24	comparison	comparison	NOUN
ihlr-22950	105	25	using	use	VERB
ihlr-22950	105	26	the	the	DET
ihlr-22950	105	27	right	right	NOUN
ihlr-22950	105	28	-	-	PUNCT
ihlr-22950	105	29	to	to	PART
ihlr-22950	105	30	-	-	PUNCT
ihlr-22950	105	31	try	try	VERB
ihlr-22950	105	32	legislation	legislation	NOUN
ihlr-22950	105	33	enacted	enact	VERB
ihlr-22950	105	34	in	in	ADP
ihlr-22950	105	35	maryland	maryland	NOUN
ihlr-22950	105	36	as	as	ADP
ihlr-22950	105	37	an	an	DET
ihlr-22950	105	38	illustration.25	illustration.25	NOUN
ihlr-22950	105	39	finally	finally	ADV
ihlr-22950	105	40	,	,	PUNCT
ihlr-22950	105	41	the	the	DET
ihlr-22950	105	42	focus	focus	NOUN
ihlr-22950	105	43	of	of	ADP
ihlr-22950	105	44	this	this	DET
ihlr-22950	105	45	article	article	NOUN
ihlr-22950	105	46	is	be	AUX
ihlr-22950	105	47	on	on	ADP
ihlr-22950	105	48	the	the	DET
ihlr-22950	105	49	individual	individual	ADJ
ihlr-22950	105	50	patient	patient	NOUN
ihlr-22950	105	51	’s	’s	PART
ihlr-22950	105	52	right	right	NOUN
ihlr-22950	105	53	to	to	PART
ihlr-22950	105	54	try	try	VERB
ihlr-22950	105	55	or	or	CCONJ
ihlr-22950	105	56	request	request	VERB
ihlr-22950	105	57	an	an	DET
ihlr-22950	105	58	investigational	investigational	ADJ
ihlr-22950	105	59	product	product	NOUN
ihlr-22950	105	60	.	.	PUNCT
ihlr-22950	106	1	ii	ii	PROPN
ihlr-22950	106	2	.	.	PUNCT
ihlr-22950	107	1	a	a	DET
ihlr-22950	107	2	federal	federal	ADJ
ihlr-22950	107	3	rush	rush	NOUN
ihlr-22950	107	4	to	to	ADP
ihlr-22950	107	5	enactment	enactment	NOUN
ihlr-22950	107	6	—	—	PUNCT
ihlr-22950	107	7	perhaps	perhaps	ADV
ihlr-22950	107	8	a	a	DET
ihlr-22950	107	9	lesson	lesson	NOUN
ihlr-22950	107	10	learned	learn	VERB
ihlr-22950	107	11	from	from	ADP
ihlr-22950	107	12	the	the	DET
ihlr-22950	107	13	right	right	NOUN
ihlr-22950	107	14	-	-	PUNCT
ihlr-22950	107	15	to	to	ADP
ihlr-22950	107	16	-	-	PUNCT
ihlr-22950	107	17	know	know	VERB
ihlr-22950	107	18	and	and	CCONJ
ihlr-22950	107	19	the	the	DET
ihlr-22950	107	20	national	national	ADJ
ihlr-22950	107	21	bioengineered	bioengineere	VERB
ihlr-22950	107	22	food	food	NOUN
ihlr-22950	107	23	disclosure	disclosure	NOUN
ihlr-22950	107	24	standard	standard	NOUN
ihlr-22950	107	25	for	for	ADP
ihlr-22950	107	26	years	year	NOUN
ihlr-22950	107	27	,	,	PUNCT
ihlr-22950	107	28	consumers	consumer	NOUN
ihlr-22950	107	29	advocated	advocate	VERB
ihlr-22950	107	30	for	for	ADP
ihlr-22950	107	31	a	a	DET
ihlr-22950	107	32	right	right	NOUN
ihlr-22950	107	33	-	-	PUNCT
ihlr-22950	107	34	to	to	AUX
ihlr-22950	107	35	-	-	PUNCT
ihlr-22950	107	36	know	know	VERB
ihlr-22950	107	37	on	on	ADP
ihlr-22950	107	38	food	food	NOUN
ihlr-22950	107	39	labelling	labelling	NOUN
ihlr-22950	107	40	of	of	ADP
ihlr-22950	107	41	bioengineered	bioengineere	VERB
ihlr-22950	107	42	food.26	food.26	NOUN
ihlr-22950	107	43	finally	finally	ADV
ihlr-22950	107	44	,	,	PUNCT
ihlr-22950	107	45	the	the	DET
ihlr-22950	107	46	national	national	ADJ
ihlr-22950	107	47	bioengineered	bioengineere	VERB
ihlr-22950	107	48	food	food	NOUN
ihlr-22950	107	49	disclosure	disclosure	NOUN
ihlr-22950	107	50	standard	standard	NOUN
ihlr-22950	107	51	(	(	PUNCT
ihlr-22950	107	52	bioengineered	bioengineere	VERB
ihlr-22950	107	53	food	food	NOUN
ihlr-22950	107	54	disclosure	disclosure	NOUN
ihlr-22950	107	55	)	)	PUNCT
ihlr-22950	107	56	,	,	PUNCT
ihlr-22950	107	57	was	be	AUX
ihlr-22950	107	58	passed	pass	VERB
ihlr-22950	107	59	july	july	PROPN
ihlr-22950	107	60	29	29	NUM
ihlr-22950	107	61	,	,	PUNCT
ihlr-22950	107	62	2016	2016	NUM
ihlr-22950	107	63	which	which	PRON
ihlr-22950	107	64	amended	amend	VERB
ihlr-22950	107	65	the	the	DET
ihlr-22950	107	66	agricultural	agricultural	ADJ
ihlr-22950	107	67	marketing	marketing	NOUN
ihlr-22950	107	68	act.27	act.27	PROPN
ihlr-22950	107	69	as	as	ADP
ihlr-22950	107	70	background	background	NOUN
ihlr-22950	107	71	,	,	PUNCT
ihlr-22950	107	72	several	several	ADJ
ihlr-22950	107	73	states	state	NOUN
ihlr-22950	107	74	passed	pass	VERB
ihlr-22950	107	75	genetically	genetically	ADV
ihlr-22950	107	76	modified	modify	VERB
ihlr-22950	107	77	organisms	organism	NOUN
ihlr-22950	107	78	(	(	PUNCT
ihlr-22950	107	79	gmo	gmo	PROPN
ihlr-22950	107	80	)	)	PUNCT
ihlr-22950	107	81	laws.28	laws.28	NOUN
ihlr-22950	107	82	for	for	ADP
ihlr-22950	107	83	example	example	NOUN
ihlr-22950	107	84	,	,	PUNCT
ihlr-22950	107	85	in	in	ADP
ihlr-22950	107	86	2013	2013	NUM
ihlr-22950	107	87	,	,	PUNCT
ihlr-22950	107	88	connecticut	connecticut	PROPN
ihlr-22950	107	89	passed	pass	VERB
ihlr-22950	107	90	a	a	DET
ihlr-22950	107	91	law	law	NOUN
ihlr-22950	107	92	with	with	ADP
ihlr-22950	107	93	a	a	DET
ihlr-22950	107	94	“	"	PUNCT
ihlr-22950	107	95	trigger	trigger	NOUN
ihlr-22950	107	96	clause	clause	NOUN
ihlr-22950	107	97	”	"	PUNCT
ihlr-22950	107	98	which	which	PRON
ihlr-22950	107	99	means	mean	VERB
ihlr-22950	107	100	the	the	DET
ihlr-22950	107	101	gmo	gmo	PROPN
ihlr-22950	107	102	law	law	NOUN
ihlr-22950	107	103	would	would	AUX
ihlr-22950	107	104	only	only	ADV
ihlr-22950	107	105	go	go	VERB
ihlr-22950	107	106	into	into	ADP
ihlr-22950	107	107	effect	effect	NOUN
ihlr-22950	107	108	if	if	SCONJ
ihlr-22950	107	109	nearby	nearby	ADJ
ihlr-22950	107	110	states	state	NOUN
ihlr-22950	107	111	also	also	ADV
ihlr-22950	107	112	passed	pass	VERB
ihlr-22950	107	113	gmo	gmo	PROPN
ihlr-22950	107	114	labeling	labeling	NOUN
ihlr-22950	107	115	laws.29	laws.29	NOUN
ihlr-22950	107	116	similarly	similarly	ADV
ihlr-22950	107	117	,	,	PUNCT
ihlr-22950	107	118	in	in	ADP
ihlr-22950	107	119	2014	2014	NUM
ihlr-22950	107	120	,	,	PUNCT
ihlr-22950	107	121	maine	maine	PROPN
ihlr-22950	107	122	passed	pass	VERB
ihlr-22950	107	123	a	a	DET
ihlr-22950	107	124	gmo	gmo	PROPN
ihlr-22950	107	125	labeling	labeling	NOUN
ihlr-22950	107	126	law	law	NOUN
ihlr-22950	107	127	that	that	PRON
ihlr-22950	107	128	required	require	VERB
ihlr-22950	107	129	foods	food	NOUN
ihlr-22950	107	130	containing	contain	VERB
ihlr-22950	107	131	(	(	PUNCT
ihlr-22950	107	132	gmo	gmo	PROPN
ihlr-22950	107	133	)	)	PUNCT
ihlr-22950	107	134	to	to	PART
ihlr-22950	107	135	be	be	AUX
ihlr-22950	107	136	labeled	label	VERB
ihlr-22950	107	137	as	as	ADP
ihlr-22950	107	138	such	such	ADJ
ihlr-22950	107	139	however	however	ADV
ihlr-22950	107	140	it	it	PRON
ihlr-22950	107	141	contained	contain	VERB
ihlr-22950	107	142	a	a	DET
ihlr-22950	107	143	“	"	PUNCT
ihlr-22950	107	144	trigger	trigger	NOUN
ihlr-22950	107	145	clause”.30	clause”.30	PUNCT
ihlr-22950	107	146	in	in	ADP
ihlr-22950	107	147	2015	2015	NUM
ihlr-22950	107	148	,	,	PUNCT
ihlr-22950	107	149	the	the	DET
ihlr-22950	107	150	maine	maine	PROPN
ihlr-22950	107	151	legislature	legislature	NOUN
ihlr-22950	107	152	proposed	propose	VERB
ihlr-22950	107	153	a	a	DET
ihlr-22950	107	154	new	new	ADJ
ihlr-22950	107	155	law	law	NOUN
ihlr-22950	107	156	that	that	PRON
ihlr-22950	107	157	would	would	AUX
ihlr-22950	107	158	remove	remove	VERB
ihlr-22950	107	159	the	the	DET
ihlr-22950	107	160	trigger	trigger	NOUN
ihlr-22950	107	161	23	23	NUM
ihlr-22950	107	162	.	.	PUNCT
ihlr-22950	107	163	21	21	NUM
ihlr-22950	107	164	u.s.c	u.s.c	NOUN
ihlr-22950	107	165	.	.	PUNCT
ihlr-22950	108	1	§	§	PROPN
ihlr-22950	108	2	360bbb-0a	360bbb-0a	NUM
ihlr-22950	108	3	(	(	PUNCT
ihlr-22950	108	4	2018	2018	NUM
ihlr-22950	108	5	)	)	PUNCT
ihlr-22950	108	6	;	;	PUNCT
ihlr-22950	108	7	trickett	trickett	NOUN
ihlr-22950	108	8	wendler	wendler	NOUN
ihlr-22950	108	9	,	,	PUNCT
ihlr-22950	108	10	frank	frank	PROPN
ihlr-22950	108	11	mongiello	mongiello	PROPN
ihlr-22950	108	12	,	,	PUNCT
ihlr-22950	108	13	jordan	jordan	PROPN
ihlr-22950	108	14	mclinn	mclinn	PROPN
ihlr-22950	108	15	,	,	PUNCT
ihlr-22950	108	16	and	and	CCONJ
ihlr-22950	108	17	matthew	matthew	PROPN
ihlr-22950	108	18	bellina	bellina	PROPN
ihlr-22950	108	19	right	right	NOUN
ihlr-22950	108	20	to	to	PART
ihlr-22950	108	21	try	try	VERB
ihlr-22950	108	22	act	act	NOUN
ihlr-22950	108	23	of	of	ADP
ihlr-22950	108	24	2017	2017	NUM
ihlr-22950	108	25	,	,	PUNCT
ihlr-22950	108	26	pub	pub	NOUN
ihlr-22950	108	27	.	.	PUNCT
ihlr-22950	109	1	l.	l.	PROPN
ihlr-22950	109	2	no	no	INTJ
ihlr-22950	109	3	.	.	PROPN
ihlr-22950	110	1	115	115	NUM
ihlr-22950	110	2	-	-	SYM
ihlr-22950	110	3	176	176	NUM
ihlr-22950	110	4	,	,	PUNCT
ihlr-22950	110	5	132	132	NUM
ihlr-22950	110	6	stat	stat	NOUN
ihlr-22950	110	7	.	.	PUNCT
ihlr-22950	111	1	1372	1372	NUM
ihlr-22950	111	2	(	(	PUNCT
ihlr-22950	111	3	2018	2018	NUM
ihlr-22950	111	4	)	)	PUNCT
ihlr-22950	111	5	;	;	PUNCT
ihlr-22950	111	6	md	md	PROPN
ihlr-22950	111	7	.	.	PROPN
ihlr-22950	111	8	code	code	PROPN
ihlr-22950	111	9	ann	ann	PROPN
ihlr-22950	111	10	.	.	PROPN
ihlr-22950	111	11	,	,	PUNCT
ihlr-22950	111	12	health	health	NOUN
ihlr-22950	111	13	-	-	PUNCT
ihlr-22950	111	14	gen	gen	PROPN
ihlr-22950	111	15	.	.	PROPN
ihlr-22950	111	16	§	§	PROPN
ihlr-22950	111	17	21	21	NUM
ihlr-22950	111	18	-	-	PUNCT
ihlr-22950	111	19	2b-01	2b-01	NUM
ihlr-22950	111	20	(	(	PUNCT
ihlr-22950	111	21	west	west	NOUN
ihlr-22950	111	22	2018	2018	NUM
ihlr-22950	111	23	)	)	PUNCT
ihlr-22950	111	24	(	(	PUNCT
ihlr-22950	111	25	see	see	VERB
ihlr-22950	111	26	appendix	appendix	NOUN
ihlr-22950	111	27	v	v	NOUN
ihlr-22950	111	28	)	)	PUNCT
ihlr-22950	111	29	.	.	PUNCT
ihlr-22950	112	1	24	24	NUM
ihlr-22950	112	2	.	.	PUNCT
ihlr-22950	112	3	national	national	ADJ
ihlr-22950	112	4	bioengineered	bioengineere	VERB
ihlr-22950	112	5	food	food	NOUN
ihlr-22950	112	6	disclosure	disclosure	NOUN
ihlr-22950	112	7	standard	standard	NOUN
ihlr-22950	112	8	,	,	PUNCT
ihlr-22950	112	9	pub	pub	NOUN
ihlr-22950	112	10	.	.	PUNCT
ihlr-22950	113	1	l.	l.	PROPN
ihlr-22950	113	2	no	no	INTJ
ihlr-22950	113	3	.	.	PROPN
ihlr-22950	114	1	114	114	NUM
ihlr-22950	114	2	-	-	SYM
ihlr-22950	114	3	216	216	NUM
ihlr-22950	114	4	,	,	PUNCT
ihlr-22950	114	5	130	130	NUM
ihlr-22950	114	6	stat	stat	NOUN
ihlr-22950	114	7	.	.	PUNCT
ihlr-22950	115	1	834	834	NUM
ihlr-22950	115	2	(	(	PUNCT
ihlr-22950	115	3	2016	2016	NUM
ihlr-22950	115	4	)	)	PUNCT
ihlr-22950	115	5	.	.	PUNCT
ihlr-22950	116	1	25	25	NUM
ihlr-22950	116	2	.	.	X
ihlr-22950	116	3	md	md	PROPN
ihlr-22950	116	4	.	.	PROPN
ihlr-22950	116	5	code	code	PROPN
ihlr-22950	116	6	ann	ann	PROPN
ihlr-22950	116	7	.	.	PROPN
ihlr-22950	116	8	,	,	PUNCT
ihlr-22950	117	1	health	health	NOUN
ihlr-22950	117	2	-	-	PUNCT
ihlr-22950	117	3	gen	gen	PROPN
ihlr-22950	117	4	.	.	PROPN
ihlr-22950	117	5	§	§	PROPN
ihlr-22950	117	6	21	21	NUM
ihlr-22950	117	7	-	-	PUNCT
ihlr-22950	117	8	2b-01	2b-01	NUM
ihlr-22950	117	9	(	(	PUNCT
ihlr-22950	117	10	west	west	NOUN
ihlr-22950	117	11	2018	2018	NUM
ihlr-22950	117	12	)	)	PUNCT
ihlr-22950	117	13	.	.	PUNCT
ihlr-22950	118	1	26	26	NUM
ihlr-22950	118	2	.	.	X
ihlr-22950	118	3	national	national	ADJ
ihlr-22950	118	4	bioengineered	bioengineere	VERB
ihlr-22950	118	5	food	food	NOUN
ihlr-22950	118	6	disclosure	disclosure	NOUN
ihlr-22950	118	7	standard	standard	NOUN
ihlr-22950	118	8	,	,	PUNCT
ihlr-22950	118	9	pub	pub	NOUN
ihlr-22950	118	10	.	.	PUNCT
ihlr-22950	119	1	l.	l.	PROPN
ihlr-22950	119	2	no	no	INTJ
ihlr-22950	119	3	.	.	PROPN
ihlr-22950	120	1	114	114	NUM
ihlr-22950	120	2	-	-	SYM
ihlr-22950	120	3	216	216	NUM
ihlr-22950	120	4	,	,	PUNCT
ihlr-22950	120	5	130	130	NUM
ihlr-22950	120	6	stat	stat	NOUN
ihlr-22950	120	7	.	.	PUNCT
ihlr-22950	121	1	834	834	NUM
ihlr-22950	121	2	(	(	PUNCT
ihlr-22950	121	3	2016	2016	NUM
ihlr-22950	121	4	)	)	PUNCT
ihlr-22950	121	5	;	;	PUNCT
ihlr-22950	121	6	see	see	VERB
ihlr-22950	121	7	lawrence	lawrence	PROPN
ihlr-22950	121	8	o.	o.	PROPN
ihlr-22950	121	9	gostin	gostin	PROPN
ihlr-22950	121	10	,	,	PUNCT
ihlr-22950	121	11	genetically	genetically	ADV
ihlr-22950	121	12	modified	modify	VERB
ihlr-22950	121	13	food	food	NOUN
ihlr-22950	121	14	labeling	labeling	NOUN
ihlr-22950	121	15	:	:	PUNCT
ihlr-22950	121	16	a	a	DET
ihlr-22950	121	17	“	"	PUNCT
ihlr-22950	121	18	right	right	NOUN
ihlr-22950	121	19	to	to	PART
ihlr-22950	121	20	know	know	VERB
ihlr-22950	121	21	”	"	PUNCT
ihlr-22950	121	22	?	?	PUNCT
ihlr-22950	121	23	,	,	PUNCT
ihlr-22950	121	24	jama	jama	PROPN
ihlr-22950	121	25	network	network	NOUN
ihlr-22950	121	26	(	(	PUNCT
ihlr-22950	121	27	dec	dec	PROPN
ihlr-22950	121	28	.	.	PROPN
ihlr-22950	121	29	13	13	NUM
ihlr-22950	121	30	,	,	PUNCT
ihlr-22950	121	31	2016	2016	NUM
ihlr-22950	121	32	)	)	PUNCT
ihlr-22950	121	33	,	,	PUNCT
ihlr-22950	121	34	https://jamanetwork.com/journals/jama/fullarticle/2592487	https://jamanetwork.com/journals/jama/fullarticle/2592487	X
ihlr-22950	122	1	[	[	X
ihlr-22950	122	2	https://perma.cc/g427-n7um	https://perma.cc/g427-n7um	NOUN
ihlr-22950	122	3	]	]	PUNCT
ihlr-22950	122	4	.	.	PUNCT
ihlr-22950	123	1	27	27	NUM
ihlr-22950	123	2	.	.	PUNCT
ihlr-22950	124	1	i	i	PRON
ihlr-22950	124	2	d.	d.	PROPN
ihlr-22950	124	3	28	28	NUM
ihlr-22950	124	4	.	.	PUNCT
ihlr-22950	125	1	see	see	VERB
ihlr-22950	125	2	,	,	PUNCT
ihlr-22950	125	3	e.g.	e.g.	ADV
ihlr-22950	125	4	,	,	PUNCT
ihlr-22950	125	5	conn	conn	PROPN
ihlr-22950	125	6	.	.	PUNCT
ihlr-22950	126	1	gen	gen	PROPN
ihlr-22950	126	2	.	.	PROPN
ihlr-22950	126	3	stat	stat	PROPN
ihlr-22950	126	4	.	.	PUNCT
ihlr-22950	127	1	§	§	PROPN
ihlr-22950	127	2	21a-92c	21a-92c	PROPN
ihlr-22950	127	3	(	(	PUNCT
ihlr-22950	127	4	2013	2013	NUM
ihlr-22950	127	5	)	)	PUNCT
ihlr-22950	127	6	;	;	PUNCT
ihlr-22950	127	7	me	i	PRON
ihlr-22950	127	8	.	.	PUNCT
ihlr-22950	128	1	rev	rev	PROPN
ihlr-22950	128	2	.	.	PROPN
ihlr-22950	128	3	stat	stat	PROPN
ihlr-22950	128	4	.	.	PUNCT
ihlr-22950	129	1	ann	ann	PROPN
ihlr-22950	129	2	.	.	PUNCT
ihlr-22950	130	1	tit	tit	PROPN
ihlr-22950	130	2	.	.	PUNCT
ihlr-22950	131	1	22	22	NUM
ihlr-22950	131	2	,	,	PUNCT
ihlr-22950	131	3	§	§	PROPN
ihlr-22950	131	4	2593	2593	NUM
ihlr-22950	131	5	(	(	PUNCT
ihlr-22950	131	6	2014	2014	NUM
ihlr-22950	131	7	)	)	PUNCT
ihlr-22950	131	8	;	;	PUNCT
ihlr-22950	131	9	vt	vt	PROPN
ihlr-22950	131	10	.	.	PROPN
ihlr-22950	131	11	stat	stat	PROPN
ihlr-22950	131	12	.	.	PUNCT
ihlr-22950	132	1	ann	ann	PROPN
ihlr-22950	132	2	.	.	PUNCT
ihlr-22950	133	1	tit	tit	PROPN
ihlr-22950	133	2	.	.	PROPN
ihlr-22950	134	1	9	9	NUM
ihlr-22950	134	2	,	,	PUNCT
ihlr-22950	134	3	§	§	PROPN
ihlr-22950	134	4	3043	3043	NUM
ihlr-22950	134	5	(	(	PUNCT
ihlr-22950	134	6	west	west	NOUN
ihlr-22950	134	7	2014	2014	NUM
ihlr-22950	134	8	)	)	PUNCT
ihlr-22950	134	9	.	.	PUNCT
ihlr-22950	135	1	29	29	NUM
ihlr-22950	135	2	.	.	X
ihlr-22950	135	3	conn	conn	PROPN
ihlr-22950	135	4	.	.	PUNCT
ihlr-22950	135	5	gen	gen	PROPN
ihlr-22950	135	6	.	.	PROPN
ihlr-22950	135	7	stat	stat	PROPN
ihlr-22950	135	8	.	.	PUNCT
ihlr-22950	136	1	§	§	PROPN
ihlr-22950	136	2	21a-92c	21a-92c	PROPN
ihlr-22950	136	3	(	(	PUNCT
ihlr-22950	136	4	2013	2013	NUM
ihlr-22950	136	5	)	)	PUNCT
ihlr-22950	136	6	.	.	PUNCT
ihlr-22950	137	1	30	30	NUM
ihlr-22950	137	2	.	.	PUNCT
ihlr-22950	138	1	me	i	PRON
ihlr-22950	138	2	.	.	PUNCT
ihlr-22950	139	1	rev	rev	PROPN
ihlr-22950	139	2	.	.	PROPN
ihlr-22950	139	3	stat	stat	PROPN
ihlr-22950	139	4	.	.	PUNCT
ihlr-22950	140	1	ann	ann	PROPN
ihlr-22950	140	2	.	.	PUNCT
ihlr-22950	141	1	tit	tit	PROPN
ihlr-22950	141	2	.	.	PUNCT
ihlr-22950	142	1	22	22	NUM
ihlr-22950	142	2	,	,	PUNCT
ihlr-22950	142	3	§	§	PROPN
ihlr-22950	142	4	2592	2592	NUM
ihlr-22950	142	5	(	(	PUNCT
ihlr-22950	142	6	2014	2014	NUM
ihlr-22950	142	7	)	)	PUNCT
ihlr-22950	142	8	.	.	PUNCT
ihlr-22950	143	1	2018	2018	NUM
ihlr-22950	143	2	]	]	PUNCT
ihlr-22950	143	3	the	the	DET
ihlr-22950	143	4	latest	late	ADJ
ihlr-22950	143	5	“	"	PUNCT
ihlr-22950	143	6	federal	federal	ADJ
ihlr-22950	143	7	movement	movement	NOUN
ihlr-22950	143	8	”	"	PUNCT
ihlr-22950	143	9	in	in	ADP
ihlr-22950	143	10	the	the	DET
ihlr-22950	143	11	food	food	NOUN
ihlr-22950	143	12	and	and	CCONJ
ihlr-22950	143	13	drug	drug	NOUN
ihlr-22950	143	14	law	law	NOUN
ihlr-22950	143	15	arena	arena	NOUN
ihlr-22950	143	16	105	105	NUM
ihlr-22950	143	17	clause	clause	NOUN
ihlr-22950	143	18	requirement	requirement	NOUN
ihlr-22950	143	19	that	that	PRON
ihlr-22950	143	20	relies	rely	VERB
ihlr-22950	143	21	on	on	ADP
ihlr-22950	143	22	other	other	ADJ
ihlr-22950	143	23	states.31	states.31	NOUN
ihlr-22950	143	24	finally	finally	ADV
ihlr-22950	143	25	,	,	PUNCT
ihlr-22950	143	26	vermont	vermont	PROPN
ihlr-22950	143	27	enacted	enact	VERB
ihlr-22950	143	28	a	a	DET
ihlr-22950	143	29	gmo	gmo	PROPN
ihlr-22950	143	30	law	law	NOUN
ihlr-22950	143	31	without	without	ADP
ihlr-22950	143	32	a	a	DET
ihlr-22950	143	33	trigger	trigger	NOUN
ihlr-22950	143	34	clause.32	clause.32	NOUN
ihlr-22950	143	35	possibly	possibly	ADV
ihlr-22950	143	36	the	the	DET
ihlr-22950	143	37	federal	federal	ADJ
ihlr-22950	143	38	bioengineered	bioengineere	VERB
ihlr-22950	143	39	food	food	NOUN
ihlr-22950	143	40	disclosure	disclosure	NOUN
ihlr-22950	143	41	law	law	NOUN
ihlr-22950	143	42	was	be	AUX
ihlr-22950	143	43	enacted	enact	VERB
ihlr-22950	143	44	in	in	ADP
ihlr-22950	143	45	response	response	NOUN
ihlr-22950	143	46	to	to	ADP
ihlr-22950	143	47	state	state	NOUN
ihlr-22950	143	48	(	(	PUNCT
ihlr-22950	143	49	gmo	gmo	PROPN
ihlr-22950	143	50	)	)	PUNCT
ihlr-22950	143	51	legislation	legislation	NOUN
ihlr-22950	143	52	such	such	ADJ
ihlr-22950	143	53	as	as	ADP
ihlr-22950	143	54	the	the	DET
ihlr-22950	143	55	vermont	vermont	NOUN
ihlr-22950	143	56	gmo	gmo	PROPN
ihlr-22950	143	57	law.33	law.33	PROPN
ihlr-22950	143	58	the	the	DET
ihlr-22950	143	59	united	united	PROPN
ihlr-22950	143	60	states	states	PROPN
ihlr-22950	143	61	department	department	PROPN
ihlr-22950	143	62	of	of	ADP
ihlr-22950	143	63	agriculture	agriculture	NOUN
ihlr-22950	143	64	is	be	AUX
ihlr-22950	143	65	tasked	task	VERB
ihlr-22950	143	66	with	with	ADP
ihlr-22950	143	67	the	the	DET
ihlr-22950	143	68	responsibility	responsibility	NOUN
ihlr-22950	143	69	of	of	ADP
ihlr-22950	143	70	promulgating	promulgate	VERB
ihlr-22950	143	71	regulations	regulation	NOUN
ihlr-22950	143	72	to	to	PART
ihlr-22950	143	73	implement	implement	VERB
ihlr-22950	143	74	the	the	DET
ihlr-22950	143	75	bioengineered	bioengineere	VERB
ihlr-22950	143	76	food	food	NOUN
ihlr-22950	143	77	disclosure.34	disclosure.34	NOUN
ihlr-22950	143	78	yet	yet	ADV
ihlr-22950	143	79	,	,	PUNCT
ihlr-22950	143	80	prior	prior	ADV
ihlr-22950	143	81	to	to	ADP
ihlr-22950	143	82	the	the	DET
ihlr-22950	143	83	bioengineered	bioengineere	VERB
ihlr-22950	143	84	food	food	NOUN
ihlr-22950	143	85	disclosure	disclosure	NOUN
ihlr-22950	143	86	law	law	NOUN
ihlr-22950	143	87	,	,	PUNCT
ihlr-22950	143	88	companies	company	NOUN
ihlr-22950	143	89	initiated	initiate	VERB
ihlr-22950	143	90	proactive	proactive	ADJ
ihlr-22950	143	91	disclosure	disclosure	NOUN
ihlr-22950	143	92	and	and	CCONJ
ihlr-22950	143	93	either	either	CCONJ
ihlr-22950	143	94	eliminate	eliminate	VERB
ihlr-22950	143	95	gmo	gmo	PROPN
ihlr-22950	143	96	ingredients	ingredient	NOUN
ihlr-22950	143	97	or	or	CCONJ
ihlr-22950	143	98	disclose	disclose	VERB
ihlr-22950	143	99	gmo	gmo	PROPN
ihlr-22950	143	100	ingredients	ingredient	NOUN
ihlr-22950	143	101	.	.	PUNCT
ihlr-22950	144	1	for	for	ADP
ihlr-22950	144	2	example	example	NOUN
ihlr-22950	144	3	,	,	PUNCT
ihlr-22950	144	4	in	in	ADP
ihlr-22950	144	5	july	july	PROPN
ihlr-22950	144	6	2016	2016	NUM
ihlr-22950	144	7	,	,	PUNCT
ihlr-22950	144	8	the	the	DET
ihlr-22950	144	9	dannon	dannon	PROPN
ihlr-22950	144	10	yogurt	yogurt	PROPN
ihlr-22950	144	11	company	company	PROPN
ihlr-22950	144	12	removed	remove	VERB
ihlr-22950	144	13	gmo	gmo	PROPN
ihlr-22950	144	14	ingredients	ingredient	NOUN
ihlr-22950	144	15	in	in	ADP
ihlr-22950	144	16	some	some	DET
ihlr-22950	144	17	products	product	NOUN
ihlr-22950	144	18	and	and	CCONJ
ihlr-22950	144	19	disclosed	disclose	VERB
ihlr-22950	144	20	gmo	gmo	PROPN
ihlr-22950	144	21	ingredients	ingredient	NOUN
ihlr-22950	144	22	in	in	ADP
ihlr-22950	144	23	the	the	DET
ihlr-22950	144	24	labeling	labeling	NOUN
ihlr-22950	144	25	of	of	ADP
ihlr-22950	144	26	other	other	ADJ
ihlr-22950	144	27	products.35	products.35	NOUN
ihlr-22950	144	28	yet	yet	ADV
ihlr-22950	144	29	,	,	PUNCT
ihlr-22950	144	30	with	with	ADP
ihlr-22950	144	31	any	any	DET
ihlr-22950	144	32	law	law	NOUN
ihlr-22950	144	33	that	that	PRON
ihlr-22950	144	34	is	be	AUX
ihlr-22950	144	35	shepherded	shepherd	VERB
ihlr-22950	144	36	through	through	ADP
ihlr-22950	144	37	and	and	CCONJ
ihlr-22950	144	38	31	31	NUM
ihlr-22950	144	39	.	.	PUNCT
ihlr-22950	145	1	me	i	PRON
ihlr-22950	145	2	.	.	PUNCT
ihlr-22950	146	1	rev	rev	PROPN
ihlr-22950	146	2	.	.	PROPN
ihlr-22950	146	3	stat	stat	PROPN
ihlr-22950	146	4	.	.	PUNCT
ihlr-22950	147	1	ann	ann	PROPN
ihlr-22950	147	2	.	.	PUNCT
ihlr-22950	148	1	tit	tit	PROPN
ihlr-22950	148	2	.	.	PUNCT
ihlr-22950	149	1	22	22	NUM
ihlr-22950	149	2	,	,	PUNCT
ihlr-22950	149	3	§	§	PROPN
ihlr-22950	149	4	§	§	PROPN
ihlr-22950	149	5	2591	2591	NUM
ihlr-22950	149	6	-	-	SYM
ihlr-22950	149	7	2595	2595	NUM
ihlr-22950	149	8	(	(	PUNCT
ihlr-22950	149	9	2015	2015	NUM
ihlr-22950	149	10	)	)	PUNCT
ihlr-22950	149	11	.	.	PUNCT
ihlr-22950	150	1	“	"	PUNCT
ihlr-22950	150	2	this	this	DET
ihlr-22950	150	3	bill	bill	NOUN
ihlr-22950	150	4	requires	require	VERB
ihlr-22950	150	5	disclosure	disclosure	NOUN
ihlr-22950	150	6	of	of	ADP
ihlr-22950	150	7	genetic	genetic	ADJ
ihlr-22950	150	8	engineering	engineering	NOUN
ihlr-22950	150	9	at	at	ADP
ihlr-22950	150	10	the	the	DET
ihlr-22950	150	11	point	point	NOUN
ihlr-22950	150	12	of	of	ADP
ihlr-22950	150	13	retail	retail	ADJ
ihlr-22950	150	14	sale	sale	NOUN
ihlr-22950	150	15	of	of	ADP
ihlr-22950	150	16	food	food	NOUN
ihlr-22950	150	17	and	and	CCONJ
ihlr-22950	150	18	seed	seed	NOUN
ihlr-22950	150	19	stock	stock	NOUN
ihlr-22950	150	20	and	and	CCONJ
ihlr-22950	150	21	provides	provide	VERB
ihlr-22950	150	22	that	that	DET
ihlr-22950	150	23	food	food	NOUN
ihlr-22950	150	24	or	or	CCONJ
ihlr-22950	150	25	seed	seed	NOUN
ihlr-22950	150	26	stock	stock	NOUN
ihlr-22950	150	27	for	for	ADP
ihlr-22950	150	28	which	which	PRON
ihlr-22950	150	29	the	the	DET
ihlr-22950	150	30	disclosure	disclosure	NOUN
ihlr-22950	150	31	is	be	AUX
ihlr-22950	150	32	not	not	PART
ihlr-22950	150	33	made	make	VERB
ihlr-22950	150	34	is	be	AUX
ihlr-22950	150	35	considered	consider	VERB
ihlr-22950	150	36	to	to	PART
ihlr-22950	150	37	be	be	AUX
ihlr-22950	150	38	misbranded	misbrande	VERB
ihlr-22950	150	39	and	and	CCONJ
ihlr-22950	150	40	subject	subject	ADJ
ihlr-22950	150	41	to	to	ADP
ihlr-22950	150	42	the	the	DET
ihlr-22950	150	43	sanctions	sanction	NOUN
ihlr-22950	150	44	for	for	ADP
ihlr-22950	150	45	misbranding	misbranding	NOUN
ihlr-22950	150	46	.	.	PUNCT
ihlr-22950	151	1	the	the	DET
ihlr-22950	151	2	bill	bill	NOUN
ihlr-22950	151	3	provides	provide	VERB
ihlr-22950	151	4	that	that	PRON
ihlr-22950	151	5	food	food	NOUN
ihlr-22950	151	6	or	or	CCONJ
ihlr-22950	151	7	seed	seed	NOUN
ihlr-22950	151	8	stock	stock	NOUN
ihlr-22950	151	9	may	may	AUX
ihlr-22950	151	10	not	not	PART
ihlr-22950	151	11	be	be	AUX
ihlr-22950	151	12	labeled	label	VERB
ihlr-22950	151	13	as	as	ADP
ihlr-22950	151	14	natural	natural	ADJ
ihlr-22950	151	15	if	if	SCONJ
ihlr-22950	151	16	it	it	PRON
ihlr-22950	151	17	has	have	AUX
ihlr-22950	151	18	been	be	AUX
ihlr-22950	151	19	genetically	genetically	ADV
ihlr-22950	151	20	engineered	engineer	VERB
ihlr-22950	151	21	.	.	PUNCT
ihlr-22950	152	1	the	the	DET
ihlr-22950	152	2	bill	bill	NOUN
ihlr-22950	152	3	exempts	exempt	VERB
ihlr-22950	152	4	products	product	NOUN
ihlr-22950	152	5	produced	produce	VERB
ihlr-22950	152	6	without	without	ADP
ihlr-22950	152	7	knowledge	knowledge	NOUN
ihlr-22950	152	8	that	that	SCONJ
ihlr-22950	152	9	the	the	DET
ihlr-22950	152	10	products	product	NOUN
ihlr-22950	152	11	,	,	PUNCT
ihlr-22950	152	12	or	or	CCONJ
ihlr-22950	152	13	items	item	NOUN
ihlr-22950	152	14	used	use	VERB
ihlr-22950	152	15	in	in	ADP
ihlr-22950	152	16	their	their	PRON
ihlr-22950	152	17	production	production	NOUN
ihlr-22950	152	18	,	,	PUNCT
ihlr-22950	152	19	were	be	AUX
ihlr-22950	152	20	genetically	genetically	ADV
ihlr-22950	152	21	engineered	engineer	VERB
ihlr-22950	152	22	;	;	PUNCT
ihlr-22950	152	23	animal	animal	NOUN
ihlr-22950	152	24	products	product	NOUN
ihlr-22950	152	25	derived	derive	VERB
ihlr-22950	152	26	from	from	ADP
ihlr-22950	152	27	an	an	DET
ihlr-22950	152	28	animal	animal	NOUN
ihlr-22950	152	29	that	that	PRON
ihlr-22950	152	30	was	be	AUX
ihlr-22950	152	31	not	not	PART
ihlr-22950	152	32	genetically	genetically	ADV
ihlr-22950	152	33	engineered	engineer	VERB
ihlr-22950	152	34	but	but	CCONJ
ihlr-22950	152	35	was	be	AUX
ihlr-22950	152	36	fed	feed	VERB
ihlr-22950	152	37	genetically	genetically	ADV
ihlr-22950	152	38	engineered	engineer	VERB
ihlr-22950	152	39	food	food	NOUN
ihlr-22950	152	40	;	;	PUNCT
ihlr-22950	152	41	and	and	CCONJ
ihlr-22950	152	42	products	product	NOUN
ihlr-22950	152	43	with	with	ADP
ihlr-22950	152	44	only	only	ADV
ihlr-22950	152	45	a	a	DET
ihlr-22950	152	46	minimum	minimum	ADJ
ihlr-22950	152	47	content	content	NOUN
ihlr-22950	152	48	produced	produce	VERB
ihlr-22950	152	49	by	by	ADP
ihlr-22950	152	50	genetic	genetic	ADJ
ihlr-22950	152	51	engineering	engineering	NOUN
ihlr-22950	152	52	.	.	PUNCT
ihlr-22950	153	1	the	the	DET
ihlr-22950	153	2	bill	bill	NOUN
ihlr-22950	153	3	also	also	ADV
ihlr-22950	153	4	provides	provide	VERB
ihlr-22950	153	5	that	that	SCONJ
ihlr-22950	153	6	the	the	DET
ihlr-22950	153	7	disclosure	disclosure	NOUN
ihlr-22950	153	8	requirements	requirement	NOUN
ihlr-22950	153	9	do	do	AUX
ihlr-22950	153	10	not	not	PART
ihlr-22950	153	11	apply	apply	VERB
ihlr-22950	153	12	to	to	ADP
ihlr-22950	153	13	restaurants	restaurant	NOUN
ihlr-22950	153	14	,	,	PUNCT
ihlr-22950	153	15	alcoholic	alcoholic	ADJ
ihlr-22950	153	16	beverages	beverage	NOUN
ihlr-22950	153	17	or	or	CCONJ
ihlr-22950	153	18	medical	medical	ADJ
ihlr-22950	153	19	food	food	NOUN
ihlr-22950	153	20	.	.	PUNCT
ihlr-22950	154	1	the	the	DET
ihlr-22950	154	2	disclosure	disclosure	NOUN
ihlr-22950	154	3	provisions	provision	NOUN
ihlr-22950	154	4	are	be	AUX
ihlr-22950	154	5	administered	administer	VERB
ihlr-22950	154	6	by	by	ADP
ihlr-22950	154	7	the	the	DET
ihlr-22950	154	8	department	department	PROPN
ihlr-22950	154	9	of	of	ADP
ihlr-22950	154	10	agriculture	agriculture	PROPN
ihlr-22950	154	11	,	,	PUNCT
ihlr-22950	154	12	conservation	conservation	NOUN
ihlr-22950	154	13	and	and	CCONJ
ihlr-22950	154	14	forestry	forestry	NOUN
ihlr-22950	154	15	.	.	PUNCT
ihlr-22950	154	16	”	"	PUNCT
ihlr-22950	155	1	an	an	DET
ihlr-22950	155	2	act	act	NOUN
ihlr-22950	155	3	to	to	PART
ihlr-22950	155	4	protect	protect	VERB
ihlr-22950	155	5	maine	maine	NOUN
ihlr-22950	155	6	food	food	NOUN
ihlr-22950	155	7	consumers	consumer	NOUN
ihlr-22950	155	8	’	'	PUNCT
ihlr-22950	155	9	right	right	NOUN
ihlr-22950	155	10	to	to	PART
ihlr-22950	155	11	know	know	VERB
ihlr-22950	155	12	about	about	ADP
ihlr-22950	155	13	genetically	genetically	ADV
ihlr-22950	155	14	engineered	engineer	VERB
ihlr-22950	155	15	food	food	NOUN
ihlr-22950	155	16	and	and	CCONJ
ihlr-22950	155	17	seed	seed	NOUN
ihlr-22950	155	18	stock	stock	NOUN
ihlr-22950	155	19	:	:	PUNCT
ihlr-22950	155	20	summary	summary	NOUN
ihlr-22950	155	21	,	,	PUNCT
ihlr-22950	155	22	office	office	NOUN
ihlr-22950	155	23	of	of	ADP
ihlr-22950	155	24	legislative	legislative	ADJ
ihlr-22950	155	25	information	information	NOUN
ihlr-22950	155	26	,	,	PUNCT
ihlr-22950	155	27	https://www.mainelegislatu	https://www.mainelegislatu	PROPN
ihlr-22950	155	28	re.org/	re.org/	VERB
ihlr-22950	155	29	legis	legis	PROPN
ihlr-22950	155	30	/	/	SYM
ihlr-22950	155	31	bills	bill	NOUN
ihlr-22950	155	32	/	/	SYM
ihlr-22950	155	33	bills_126th	bills_126th	NOUN
ihlr-22950	155	34	/billtexts	/billtext	NOUN
ihlr-22950	155	35	/	/	SYM
ihlr-22950	155	36	hp049001	hp049001	PROPN
ihlr-22950	155	37	.asp	.asp	PUNCT
ihlr-22950	156	1	[	[	X
ihlr-22950	156	2	https://perma.cc/lf5h-mcl3	https://perma.cc/lf5h-mcl3	X
ihlr-22950	156	3	]	]	X
ihlr-22950	156	4	.	.	PUNCT
ihlr-22950	157	1	32	32	NUM
ihlr-22950	157	2	.	.	PUNCT
ihlr-22950	158	1	vt	vt	PROPN
ihlr-22950	158	2	.	.	PROPN
ihlr-22950	158	3	stat	stat	PROPN
ihlr-22950	158	4	.	.	PUNCT
ihlr-22950	159	1	ann	ann	PROPN
ihlr-22950	159	2	.	.	PUNCT
ihlr-22950	160	1	tit	tit	PROPN
ihlr-22950	160	2	.	.	PROPN
ihlr-22950	161	1	9	9	NUM
ihlr-22950	161	2	,	,	PUNCT
ihlr-22950	161	3	§	§	PROPN
ihlr-22950	161	4	3043	3043	NUM
ihlr-22950	161	5	(	(	PUNCT
ihlr-22950	161	6	west	west	NOUN
ihlr-22950	161	7	2014	2014	NUM
ihlr-22950	161	8	)	)	PUNCT
ihlr-22950	161	9	.	.	PUNCT
ihlr-22950	162	1	33	33	NUM
ihlr-22950	162	2	.	.	PUNCT
ihlr-22950	163	1	vt	vt	PROPN
ihlr-22950	163	2	.	.	PROPN
ihlr-22950	163	3	stat	stat	PROPN
ihlr-22950	163	4	.	.	PUNCT
ihlr-22950	164	1	ann	ann	PROPN
ihlr-22950	164	2	.	.	PUNCT
ihlr-22950	165	1	tit	tit	PROPN
ihlr-22950	165	2	.	.	PUNCT
ihlr-22950	166	1	9	9	NUM
ihlr-22950	166	2	§	§	PROPN
ihlr-22950	166	3	3043	3043	NUM
ihlr-22950	166	4	(	(	PUNCT
ihlr-22950	166	5	west	west	NOUN
ihlr-22950	166	6	2014	2014	NUM
ihlr-22950	166	7	)	)	PUNCT
ihlr-22950	166	8	;	;	PUNCT
ihlr-22950	166	9	national	national	ADJ
ihlr-22950	166	10	bioengineered	bioengineere	VERB
ihlr-22950	166	11	food	food	NOUN
ihlr-22950	166	12	disclosure	disclosure	NOUN
ihlr-22950	166	13	standard	standard	NOUN
ihlr-22950	166	14	,	,	PUNCT
ihlr-22950	166	15	pub	pub	NOUN
ihlr-22950	166	16	.	.	PUNCT
ihlr-22950	167	1	l.	l.	PROPN
ihlr-22950	168	1	no	no	INTJ
ihlr-22950	168	2	.	.	PROPN
ihlr-22950	169	1	114	114	NUM
ihlr-22950	169	2	-	-	SYM
ihlr-22950	169	3	216	216	NUM
ihlr-22950	169	4	,	,	PUNCT
ihlr-22950	169	5	130	130	NUM
ihlr-22950	169	6	stat	stat	NOUN
ihlr-22950	169	7	.	.	PUNCT
ihlr-22950	170	1	834	834	NUM
ihlr-22950	170	2	(	(	PUNCT
ihlr-22950	170	3	2016	2016	NUM
ihlr-22950	170	4	)	)	PUNCT
ihlr-22950	170	5	.	.	PUNCT
ihlr-22950	171	1	34	34	NUM
ihlr-22950	171	2	.	.	PUNCT
ihlr-22950	171	3	national	national	ADJ
ihlr-22950	171	4	bioengineered	bioengineere	VERB
ihlr-22950	171	5	food	food	NOUN
ihlr-22950	171	6	disclosure	disclosure	NOUN
ihlr-22950	171	7	standard	standard	NOUN
ihlr-22950	171	8	,	,	PUNCT
ihlr-22950	171	9	pub	pub	NOUN
ihlr-22950	171	10	.	.	PUNCT
ihlr-22950	172	1	l.	l.	PROPN
ihlr-22950	172	2	no	no	INTJ
ihlr-22950	172	3	.	.	PROPN
ihlr-22950	173	1	114	114	NUM
ihlr-22950	173	2	-	-	SYM
ihlr-22950	173	3	216	216	NUM
ihlr-22950	173	4	,	,	PUNCT
ihlr-22950	173	5	130	130	NUM
ihlr-22950	173	6	stat	stat	NOUN
ihlr-22950	173	7	.	.	PUNCT
ihlr-22950	174	1	834	834	NUM
ihlr-22950	174	2	(	(	PUNCT
ihlr-22950	174	3	2016	2016	NUM
ihlr-22950	174	4	)	)	PUNCT
ihlr-22950	174	5	.	.	PUNCT
ihlr-22950	175	1	“	"	PUNCT
ihlr-22950	175	2	public	public	ADJ
ihlr-22950	175	3	law	law	NOUN
ihlr-22950	175	4	114	114	NUM
ihlr-22950	175	5	-	-	SYM
ihlr-22950	175	6	216	216	NUM
ihlr-22950	175	7	amended	amend	VERB
ihlr-22950	175	8	the	the	DET
ihlr-22950	175	9	agricultural	agricultural	ADJ
ihlr-22950	175	10	marketing	marketing	NOUN
ihlr-22950	175	11	act	act	NOUN
ihlr-22950	175	12	of	of	ADP
ihlr-22950	175	13	1946	1946	NUM
ihlr-22950	175	14	(	(	PUNCT
ihlr-22950	175	15	7	7	NUM
ihlr-22950	175	16	u.s.c	u.s.c	NOUN
ihlr-22950	175	17	.	.	PUNCT
ihlr-22950	176	1	1621	1621	NUM
ihlr-22950	176	2	et	et	PROPN
ihlr-22950	176	3	seq	seq	PROPN
ihlr-22950	176	4	.	.	PUNCT
ihlr-22950	176	5	)	)	PUNCT
ihlr-22950	177	1	,	,	PUNCT
ihlr-22950	177	2	as	as	SCONJ
ihlr-22950	177	3	amended	amend	VERB
ihlr-22950	177	4	(	(	PUNCT
ihlr-22950	177	5	amended	amend	VERB
ihlr-22950	177	6	act	act	NOUN
ihlr-22950	177	7	)	)	PUNCT
ihlr-22950	177	8	,	,	PUNCT
ihlr-22950	177	9	by	by	ADP
ihlr-22950	177	10	adding	add	VERB
ihlr-22950	177	11	subtitles	subtitle	NOUN
ihlr-22950	177	12	e	e	PROPN
ihlr-22950	177	13	and	and	CCONJ
ihlr-22950	177	14	f.	f.	PROPN
ihlr-22950	177	15	subtitle	subtitle	PROPN
ihlr-22950	177	16	e	e	PROPN
ihlr-22950	177	17	of	of	ADP
ihlr-22950	177	18	the	the	DET
ihlr-22950	177	19	amended	amend	VERB
ihlr-22950	177	20	act	act	NOUN
ihlr-22950	177	21	directs	direct	VERB
ihlr-22950	177	22	the	the	DET
ihlr-22950	177	23	secretary	secretary	NOUN
ihlr-22950	177	24	to	to	PART
ihlr-22950	177	25	establish	establish	VERB
ihlr-22950	177	26	the	the	DET
ihlr-22950	177	27	national	national	ADJ
ihlr-22950	177	28	bioengineered	bioengineere	VERB
ihlr-22950	177	29	food	food	NOUN
ihlr-22950	177	30	disclosure	disclosure	NOUN
ihlr-22950	177	31	standard	standard	NOUN
ihlr-22950	177	32	(	(	PUNCT
ihlr-22950	177	33	nbfds	nbfds	NOUN
ihlr-22950	177	34	)	)	PUNCT
ihlr-22950	177	35	for	for	ADP
ihlr-22950	177	36	disclosing	disclose	VERB
ihlr-22950	177	37	any	any	DET
ihlr-22950	177	38	be	be	NOUN
ihlr-22950	177	39	food	food	NOUN
ihlr-22950	177	40	and	and	CCONJ
ihlr-22950	177	41	any	any	DET
ihlr-22950	177	42	food	food	NOUN
ihlr-22950	177	43	that	that	PRON
ihlr-22950	177	44	may	may	AUX
ihlr-22950	177	45	be	be	AUX
ihlr-22950	177	46	bioengineered	bioengineere	VERB
ihlr-22950	177	47	.	.	PUNCT
ihlr-22950	178	1	subtitle	subtitle	NOUN
ihlr-22950	178	2	e	e	PROPN
ihlr-22950	178	3	also	also	ADV
ihlr-22950	178	4	directs	direct	VERB
ihlr-22950	178	5	the	the	DET
ihlr-22950	178	6	secretary	secretary	NOUN
ihlr-22950	178	7	to	to	PART
ihlr-22950	178	8	establish	establish	VERB
ihlr-22950	178	9	requirements	requirement	NOUN
ihlr-22950	178	10	and	and	CCONJ
ihlr-22950	178	11	procedures	procedure	NOUN
ihlr-22950	178	12	necessary	necessary	ADJ
ihlr-22950	178	13	to	to	PART
ihlr-22950	178	14	carry	carry	VERB
ihlr-22950	178	15	out	out	ADP
ihlr-22950	178	16	the	the	DET
ihlr-22950	178	17	new	new	ADJ
ihlr-22950	178	18	standard	standard	NOUN
ihlr-22950	178	19	.	.	PUNCT
ihlr-22950	179	1	additionally	additionally	ADV
ihlr-22950	179	2	,	,	PUNCT
ihlr-22950	179	3	the	the	DET
ihlr-22950	179	4	amended	amend	VERB
ihlr-22950	179	5	act	act	NOUN
ihlr-22950	179	6	directs	direct	VERB
ihlr-22950	179	7	the	the	DET
ihlr-22950	179	8	secretary	secretary	NOUN
ihlr-22950	179	9	to	to	PART
ihlr-22950	179	10	conduct	conduct	VERB
ihlr-22950	179	11	a	a	DET
ihlr-22950	179	12	study	study	NOUN
ihlr-22950	179	13	to	to	PART
ihlr-22950	179	14	identify	identify	VERB
ihlr-22950	179	15	potential	potential	ADJ
ihlr-22950	179	16	technological	technological	ADJ
ihlr-22950	179	17	challenges	challenge	NOUN
ihlr-22950	179	18	related	relate	VERB
ihlr-22950	179	19	to	to	ADP
ihlr-22950	179	20	electronic	electronic	ADJ
ihlr-22950	179	21	or	or	CCONJ
ihlr-22950	179	22	digital	digital	ADJ
ihlr-22950	179	23	disclosure	disclosure	NOUN
ihlr-22950	179	24	methods	method	NOUN
ihlr-22950	179	25	.	.	PUNCT
ihlr-22950	180	1	see	see	VERB
ihlr-22950	180	2	7	7	NUM
ihlr-22950	180	3	u.s.c	u.s.c	NOUN
ihlr-22950	180	4	.	.	PUNCT
ihlr-22950	180	5	1639b(c)(1	1639b(c)(1	NUM
ihlr-22950	180	6	)	)	PUNCT
ihlr-22950	180	7	.	.	PUNCT
ihlr-22950	181	1	subtitle	subtitle	PROPN
ihlr-22950	181	2	f	f	PROPN
ihlr-22950	181	3	addresses	address	VERB
ihlr-22950	181	4	federal	federal	ADJ
ihlr-22950	181	5	preemption	preemption	NOUN
ihlr-22950	181	6	of	of	ADP
ihlr-22950	181	7	state	state	NOUN
ihlr-22950	181	8	and	and	CCONJ
ihlr-22950	181	9	local	local	ADJ
ihlr-22950	181	10	genetic	genetic	ADJ
ihlr-22950	181	11	engineering	engineering	NOUN
ihlr-22950	181	12	labeling	labeling	NOUN
ihlr-22950	181	13	requirements	requirement	NOUN
ihlr-22950	181	14	.	.	PUNCT
ihlr-22950	182	1	subtitle	subtitle	PROPN
ihlr-22950	182	2	f	f	PROPN
ihlr-22950	182	3	also	also	ADV
ihlr-22950	182	4	specifies	specify	VERB
ihlr-22950	182	5	that	that	SCONJ
ihlr-22950	182	6	certification	certification	NOUN
ihlr-22950	182	7	of	of	ADP
ihlr-22950	182	8	food	food	NOUN
ihlr-22950	182	9	under	under	ADP
ihlr-22950	182	10	the	the	DET
ihlr-22950	182	11	u.s	u.s	PROPN
ihlr-22950	182	12	.	.	PROPN
ihlr-22950	182	13	department	department	PROPN
ihlr-22950	182	14	of	of	ADP
ihlr-22950	182	15	agriculture	agriculture	PROPN
ihlr-22950	182	16	’s	’s	PART
ihlr-22950	182	17	(	(	PUNCT
ihlr-22950	182	18	usda	usda	PROPN
ihlr-22950	182	19	)	)	PUNCT
ihlr-22950	182	20	national	national	ADJ
ihlr-22950	182	21	organic	organic	ADJ
ihlr-22950	182	22	program	program	NOUN
ihlr-22950	182	23	(	(	PUNCT
ihlr-22950	182	24	nop	nop	PROPN
ihlr-22950	182	25	)	)	PUNCT
ihlr-22950	182	26	(	(	PUNCT
ihlr-22950	182	27	7	7	NUM
ihlr-22950	182	28	cfr	cfr	NOUN
ihlr-22950	182	29	part	part	NOUN
ihlr-22950	182	30	205	205	NUM
ihlr-22950	182	31	)	)	PUNCT
ihlr-22950	182	32	shall	shall	AUX
ihlr-22950	182	33	be	be	AUX
ihlr-22950	182	34	considered	consider	VERB
ihlr-22950	182	35	sufficient	sufficient	ADJ
ihlr-22950	182	36	to	to	PART
ihlr-22950	182	37	make	make	VERB
ihlr-22950	182	38	claims	claim	NOUN
ihlr-22950	182	39	about	about	ADP
ihlr-22950	182	40	the	the	DET
ihlr-22950	182	41	absence	absence	NOUN
ihlr-22950	182	42	of	of	ADP
ihlr-22950	182	43	bioengineering	bioengineere	VERB
ihlr-22950	182	44	in	in	ADP
ihlr-22950	182	45	the	the	DET
ihlr-22950	182	46	food	food	NOUN
ihlr-22950	182	47	.	.	PUNCT
ihlr-22950	182	48	”	"	PUNCT
ihlr-22950	183	1	national	national	ADJ
ihlr-22950	183	2	bioengineered	bioengineere	VERB
ihlr-22950	183	3	food	food	NOUN
ihlr-22950	183	4	disclosure	disclosure	NOUN
ihlr-22950	183	5	standard	standard	NOUN
ihlr-22950	183	6	,	,	PUNCT
ihlr-22950	183	7	83	83	NUM
ihlr-22950	183	8	fed	feed	VERB
ihlr-22950	183	9	.	.	PUNCT
ihlr-22950	184	1	reg	reg	PROPN
ihlr-22950	184	2	.	.	PUNCT
ihlr-22950	184	3	19860	19860	NUM
ihlr-22950	184	4	(	(	PUNCT
ihlr-22950	184	5	proposed	propose	VERB
ihlr-22950	184	6	may	may	AUX
ihlr-22950	184	7	4	4	NUM
ihlr-22950	184	8	,	,	PUNCT
ihlr-22950	184	9	2018	2018	NUM
ihlr-22950	184	10	)	)	PUNCT
ihlr-22950	184	11	(	(	PUNCT
ihlr-22950	184	12	to	to	PART
ihlr-22950	184	13	be	be	AUX
ihlr-22950	184	14	codified	codify	VERB
ihlr-22950	184	15	at	at	ADP
ihlr-22950	184	16	7	7	NUM
ihlr-22950	184	17	c.f.r	c.f.r	NOUN
ihlr-22950	184	18	.	.	PUNCT
ihlr-22950	185	1	pt	pt	PROPN
ihlr-22950	185	2	.	.	PROPN
ihlr-22950	185	3	66	66	NUM
ihlr-22950	185	4	)	)	PUNCT
ihlr-22950	185	5	.	.	PUNCT
ihlr-22950	186	1	35	35	NUM
ihlr-22950	186	2	.	.	PUNCT
ihlr-22950	187	1	see	see	VERB
ihlr-22950	187	2	dannon	dannon	NOUN
ihlr-22950	187	3	announces	announces	AUX
ihlr-22950	187	4	breakthrough	breakthrough	VERB
ihlr-22950	187	5	sweeping	sweeping	ADJ
ihlr-22950	187	6	commitment	commitment	NOUN
ihlr-22950	187	7	for	for	ADP
ihlr-22950	187	8	sustainable	sustainable	ADJ
ihlr-22950	187	9	agriculture	agriculture	NOUN
ihlr-22950	187	10	,	,	PUNCT
ihlr-22950	187	11	more	more	ADJ
ihlr-22950	187	12	natural	natural	ADJ
ihlr-22950	187	13	ingredients	ingredient	NOUN
ihlr-22950	187	14	and	and	CCONJ
ihlr-22950	187	15	greater	great	ADJ
ihlr-22950	187	16	transparency	transparency	NOUN
ihlr-22950	187	17	,	,	PUNCT
ihlr-22950	187	18	dannon	dannon	PROPN
ihlr-22950	187	19	(	(	PUNCT
ihlr-22950	187	20	apr	apr	PROPN
ihlr-22950	187	21	.	.	PROPN
ihlr-22950	187	22	27	27	NUM
ihlr-22950	187	23	,	,	PUNCT
ihlr-22950	187	24	2016	2016	NUM
ihlr-22950	187	25	)	)	PUNCT
ihlr-22950	187	26	,	,	PUNCT
ihlr-22950	187	27	106	106	NUM
ihlr-22950	187	28	indiana	indiana	PROPN
ihlr-22950	187	29	health	health	PROPN
ihlr-22950	187	30	law	law	PROPN
ihlr-22950	187	31	review	review	NOUN
ihlr-22950	188	1	[	[	X
ihlr-22950	188	2	vol	vol	NOUN
ihlr-22950	188	3	.	.	PUNCT
ihlr-22950	189	1	16:101	16:101	NUM
ihlr-22950	189	2	reactive	reactive	NOUN
ihlr-22950	189	3	to	to	ADP
ihlr-22950	189	4	state	state	NOUN
ihlr-22950	189	5	legislation	legislation	NOUN
ihlr-22950	189	6	,	,	PUNCT
ihlr-22950	189	7	as	as	ADP
ihlr-22950	189	8	the	the	DET
ihlr-22950	189	9	federal	federal	ADJ
ihlr-22950	189	10	bioengineered	bioengineere	VERB
ihlr-22950	189	11	food	food	NOUN
ihlr-22950	189	12	disclosure	disclosure	NOUN
ihlr-22950	189	13	law	law	NOUN
ihlr-22950	189	14	,	,	PUNCT
ihlr-22950	189	15	questions	question	NOUN
ihlr-22950	189	16	remain	remain	VERB
ihlr-22950	189	17	such	such	ADJ
ihlr-22950	189	18	as	as	ADP
ihlr-22950	189	19	exemptions	exemption	NOUN
ihlr-22950	189	20	and	and	CCONJ
ihlr-22950	189	21	implementation	implementation	NOUN
ihlr-22950	189	22	time.36	time.36	NOUN
ihlr-22950	189	23	a	a	DET
ihlr-22950	189	24	comparative	comparative	ADJ
ihlr-22950	189	25	analogy	analogy	NOUN
ihlr-22950	189	26	is	be	AUX
ihlr-22950	189	27	applicable	applicable	ADJ
ihlr-22950	189	28	to	to	ADP
ihlr-22950	189	29	the	the	DET
ihlr-22950	189	30	federal	federal	ADJ
ihlr-22950	189	31	right	right	NOUN
ihlr-22950	189	32	-	-	PUNCT
ihlr-22950	189	33	to	to	PART
ihlr-22950	189	34	-	-	PUNCT
ihlr-22950	189	35	try	try	VERB
ihlr-22950	189	36	act	act	NOUN
ihlr-22950	189	37	in	in	ADP
ihlr-22950	189	38	terms	term	NOUN
ihlr-22950	189	39	of	of	ADP
ihlr-22950	189	40	reactive	reactive	ADJ
ihlr-22950	189	41	legislation	legislation	NOUN
ihlr-22950	189	42	to	to	PART
ihlr-22950	189	43	state	state	VERB
ihlr-22950	189	44	right	right	NOUN
ihlr-22950	189	45	to	to	PART
ihlr-22950	189	46	try	try	VERB
ihlr-22950	189	47	legislation	legislation	NOUN
ihlr-22950	189	48	.	.	PUNCT
ihlr-22950	190	1	for	for	ADP
ihlr-22950	190	2	example	example	NOUN
ihlr-22950	190	3	,	,	PUNCT
ihlr-22950	190	4	why	why	SCONJ
ihlr-22950	190	5	are	be	AUX
ihlr-22950	190	6	medical	medical	ADJ
ihlr-22950	190	7	foods	food	NOUN
ihlr-22950	190	8	not	not	PART
ihlr-22950	190	9	included	include	VERB
ihlr-22950	190	10	nor	nor	CCONJ
ihlr-22950	190	11	addressed	address	VERB
ihlr-22950	190	12	in	in	ADP
ihlr-22950	190	13	the	the	DET
ihlr-22950	190	14	federal	federal	ADJ
ihlr-22950	190	15	right	right	NOUN
ihlr-22950	190	16	-	-	PUNCT
ihlr-22950	190	17	to	to	PART
ihlr-22950	190	18	-	-	PUNCT
ihlr-22950	190	19	try	try	VERB
ihlr-22950	190	20	act?37	act?37	PROPN
ihlr-22950	190	21	these	these	PRON
ihlr-22950	190	22	are	be	AUX
ihlr-22950	190	23	unanswered	unanswered	ADJ
ihlr-22950	190	24	queries	query	NOUN
ihlr-22950	190	25	.	.	PUNCT
ihlr-22950	191	1	does	do	AUX
ihlr-22950	191	2	the	the	DET
ihlr-22950	191	3	federal	federal	ADJ
ihlr-22950	191	4	law	law	NOUN
ihlr-22950	191	5	provide	provide	VERB
ihlr-22950	191	6	anything	anything	PRON
ihlr-22950	191	7	new	new	ADJ
ihlr-22950	191	8	to	to	ADP
ihlr-22950	191	9	a	a	DET
ihlr-22950	191	10	terminally	terminally	ADV
ihlr-22950	191	11	ill	ill	ADJ
ihlr-22950	191	12	patient	patient	NOUN
ihlr-22950	191	13	?	?	PUNCT
ihlr-22950	192	1	does	do	AUX
ihlr-22950	192	2	the	the	DET
ihlr-22950	192	3	patient	patient	NOUN
ihlr-22950	192	4	understand	understand	VERB
ihlr-22950	192	5	the	the	DET
ihlr-22950	192	6	right	right	NOUN
ihlr-22950	192	7	to	to	PART
ihlr-22950	192	8	bring	bring	VERB
ihlr-22950	192	9	a	a	DET
ihlr-22950	192	10	lawsuit	lawsuit	NOUN
ihlr-22950	192	11	is	be	AUX
ihlr-22950	192	12	thwarted?38	thwarted?38	PROPN
ihlr-22950	192	13	was	be	AUX
ihlr-22950	192	14	there	there	PRON
ihlr-22950	192	15	political	political	ADJ
ihlr-22950	192	16	pressure	pressure	NOUN
ihlr-22950	192	17	to	to	PART
ihlr-22950	192	18	enact	enact	VERB
ihlr-22950	192	19	federal	federal	ADJ
ihlr-22950	192	20	right	right	NOUN
ihlr-22950	192	21	-	-	PUNCT
ihlr-22950	192	22	to	to	AUX
ihlr-22950	192	23	-	-	PUNCT
ihlr-22950	192	24	try	try	VERB
ihlr-22950	192	25	legislation	legislation	NOUN
ihlr-22950	192	26	?	?	PUNCT
ihlr-22950	193	1	did	do	AUX
ihlr-22950	193	2	the	the	DET
ihlr-22950	193	3	state	state	NOUN
ihlr-22950	193	4	right	right	NOUN
ihlr-22950	193	5	-	-	PUNCT
ihlr-22950	193	6	to	to	PART
ihlr-22950	193	7	-	-	PUNCT
ihlr-22950	193	8	try	try	VERB
ihlr-22950	193	9	acts	act	NOUN
ihlr-22950	193	10	spur	spur	VERB
ihlr-22950	193	11	the	the	DET
ihlr-22950	193	12	federal	federal	ADJ
ihlr-22950	193	13	legislation	legislation	NOUN
ihlr-22950	193	14	?	?	PUNCT
ihlr-22950	194	1	unequivocally	unequivocally	ADV
ihlr-22950	194	2	,	,	PUNCT
ihlr-22950	194	3	the	the	DET
ihlr-22950	194	4	state	state	NOUN
ihlr-22950	194	5	right	right	NOUN
ihlr-22950	194	6	-	-	PUNCT
ihlr-22950	194	7	to	to	PART
ihlr-22950	194	8	-	-	PUNCT
ihlr-22950	194	9	try	try	VERB
ihlr-22950	194	10	legislative	legislative	ADJ
ihlr-22950	194	11	movement	movement	NOUN
ihlr-22950	194	12	did	do	AUX
ihlr-22950	194	13	spur	spur	VERB
ihlr-22950	194	14	federal	federal	ADJ
ihlr-22950	194	15	action	action	NOUN
ihlr-22950	194	16	.	.	PUNCT
ihlr-22950	195	1	perhaps	perhaps	ADV
ihlr-22950	195	2	uniformity	uniformity	NOUN
ihlr-22950	195	3	is	be	AUX
ihlr-22950	195	4	preferred	prefer	VERB
ihlr-22950	195	5	rather	rather	ADV
ihlr-22950	195	6	than	than	ADP
ihlr-22950	195	7	various	various	ADJ
ihlr-22950	195	8	state	state	NOUN
ihlr-22950	195	9	laws	law	NOUN
ihlr-22950	195	10	.	.	PUNCT
ihlr-22950	196	1	however	however	ADV
ihlr-22950	196	2	,	,	PUNCT
ihlr-22950	196	3	the	the	DET
ihlr-22950	196	4	state	state	NOUN
ihlr-22950	196	5	right	right	NOUN
ihlr-22950	196	6	-	-	PUNCT
ihlr-22950	196	7	totry	totry	NOUN
ihlr-22950	196	8	certainly	certainly	ADV
ihlr-22950	196	9	fostered	foster	VERB
ihlr-22950	196	10	congress	congress	PROPN
ihlr-22950	196	11	to	to	PART
ihlr-22950	196	12	act	act	VERB
ihlr-22950	196	13	in	in	ADP
ihlr-22950	196	14	2018.39	2018.39	NUM
ihlr-22950	196	15	prior	prior	ADV
ihlr-22950	196	16	to	to	ADP
ihlr-22950	196	17	delving	delve	VERB
ihlr-22950	196	18	into	into	ADP
ihlr-22950	196	19	the	the	DET
ihlr-22950	196	20	federal	federal	ADJ
ihlr-22950	196	21	right	right	NOUN
ihlr-22950	196	22	-	-	PUNCT
ihlr-22950	196	23	to	to	PART
ihlr-22950	196	24	-	-	PUNCT
ihlr-22950	196	25	try	try	VERB
ihlr-22950	196	26	act,40	act,40	VERB
ihlr-22950	196	27	the	the	DET
ihlr-22950	196	28	following	follow	VERB
ihlr-22950	196	29	primer	primer	NOUN
ihlr-22950	196	30	details	detail	NOUN
ihlr-22950	196	31	the	the	DET
ihlr-22950	196	32	investigational	investigational	ADJ
ihlr-22950	196	33	drug	drug	NOUN
ihlr-22950	196	34	schemata	schemata	NOUN
ihlr-22950	196	35	.	.	PUNCT
ihlr-22950	197	1	iii	iii	X
ihlr-22950	197	2	.	.	PUNCT
ihlr-22950	197	3	federal	federal	ADJ
ihlr-22950	197	4	primer	primer	NOUN
ihlr-22950	197	5	—	—	PUNCT
ihlr-22950	197	6	investigational	investigational	ADJ
ihlr-22950	197	7	human	human	ADJ
ihlr-22950	197	8	drugs	drug	NOUN
ihlr-22950	197	9	and	and	CCONJ
ihlr-22950	197	10	biological	biological	ADJ
ihlr-22950	197	11	drug	drug	NOUN
ihlr-22950	197	12	products	product	NOUN
ihlr-22950	197	13	and	and	CCONJ
ihlr-22950	197	14	expanded	expand	VERB
ihlr-22950	197	15	access	access	NOUN
ihlr-22950	197	16	the	the	DET
ihlr-22950	197	17	food	food	NOUN
ihlr-22950	197	18	and	and	CCONJ
ihlr-22950	197	19	drug	drug	NOUN
ihlr-22950	197	20	administration	administration	NOUN
ihlr-22950	197	21	is	be	AUX
ihlr-22950	197	22	the	the	DET
ihlr-22950	197	23	oldest	old	ADJ
ihlr-22950	197	24	comprehensive	comprehensive	ADJ
ihlr-22950	197	25	consumer	consumer	NOUN
ihlr-22950	197	26	http://www.dannon.com/the-dannon-pledge-on-sustainable-agriculture-naturality-and-transparency/	http://www.dannon.com/the-dannon-pledge-on-sustainable-agriculture-naturality-and-transparency/	NOUN
ihlr-22950	197	27	[	[	X
ihlr-22950	197	28	https://perma.cc/u5b9-ng77	https://perma.cc/u5b9-ng77	X
ihlr-22950	197	29	]	]	X
ihlr-22950	197	30	.	.	PUNCT
ihlr-22950	198	1	36	36	NUM
ihlr-22950	198	2	.	.	PUNCT
ihlr-22950	199	1	see	see	VERB
ihlr-22950	199	2	jennifer	jennifer	PROPN
ihlr-22950	199	3	a.	a.	PROPN
ihlr-22950	199	4	staman	staman	PROPN
ihlr-22950	199	5	,	,	PUNCT
ihlr-22950	199	6	cong	cong	PROPN
ihlr-22950	199	7	.	.	PUNCT
ihlr-22950	200	1	research	research	NOUN
ihlr-22950	200	2	serv	serv	PROPN
ihlr-22950	200	3	.	.	PROPN
ihlr-22950	200	4	,	,	PUNCT
ihlr-22950	200	5	r43705	r43705	PROPN
ihlr-22950	200	6	,	,	PUNCT
ihlr-22950	200	7	legal	legal	ADJ
ihlr-22950	200	8	issues	issue	NOUN
ihlr-22950	200	9	with	with	ADP
ihlr-22950	200	10	federal	federal	ADJ
ihlr-22950	200	11	labeling	labeling	NOUN
ihlr-22950	200	12	of	of	ADP
ihlr-22950	200	13	gen	gen	PROPN
ihlr-22950	200	14	et	et	PROPN
ihlr-22950	200	15	ic	ic	PROPN
ihlr-22950	200	16	ally	ally	PROPN
ihlr-22950	200	17	engineered	engineer	VERB
ihlr-22950	200	18	food	food	NOUN
ihlr-22950	200	19	:	:	PUNCT
ihlr-22950	200	20	in	in	ADP
ihlr-22950	200	21	brief	brief	ADJ
ihlr-22950	200	22	(	(	PUNCT
ihlr-22950	200	23	2016	2016	NUM
ihlr-22950	200	24	)	)	PUNCT
ihlr-22950	200	25	.	.	PUNCT
ihlr-22950	201	1	http://nationalaglawcenter.org/wp-content/uploads/assets/crs/r43705.pdf	http://nationalaglawcenter.org/wp-content/uploads/assets/crs/r43705.pdf	NOUN
ihlr-22950	202	1	[	[	X
ihlr-22950	202	2	https://perma.cc/pw4hy982	https://perma.cc/pw4hy982	NOUN
ihlr-22950	202	3	]	]	X
ihlr-22950	202	4	;	;	PUNCT
ihlr-22950	202	5	see	see	VERB
ihlr-22950	202	6	also	also	ADV
ihlr-22950	202	7	greg	greg	PROPN
ihlr-22950	202	8	jaffe	jaffe	PROPN
ihlr-22950	202	9	,	,	PUNCT
ihlr-22950	202	10	the	the	DET
ihlr-22950	202	11	abcs	abc	NOUN
ihlr-22950	202	12	of	of	ADP
ihlr-22950	202	13	gmo	gmo	PROPN
ihlr-22950	202	14	disclosure	disclosure	NOUN
ihlr-22950	202	15	in	in	ADP
ihlr-22950	202	16	the	the	DET
ihlr-22950	202	17	united	united	PROPN
ihlr-22950	202	18	states	states	PROPN
ihlr-22950	202	19	,	,	PUNCT
ihlr-22950	202	20	ctr	ctr	PROPN
ihlr-22950	202	21	for	for	ADP
ihlr-22950	202	22	science	science	NOUN
ihlr-22950	202	23	pub	pub	NOUN
ihlr-22950	202	24	.	.	PUNCT
ihlr-22950	203	1	int	int	NOUN
ihlr-22950	203	2	.	.	PUNCT
ihlr-22950	204	1	(	(	PUNCT
ihlr-22950	204	2	sept	sept	PROPN
ihlr-22950	204	3	.	.	PROPN
ihlr-22950	204	4	25	25	NUM
ihlr-22950	204	5	,	,	PUNCT
ihlr-22950	204	6	2017	2017	NUM
ihlr-22950	204	7	)	)	PUNCT
ihlr-22950	204	8	,	,	PUNCT
ihlr-22950	204	9	https://cspinet.org/news/abcs-gmo-disclosure-united-states-20170925	https://cspinet.org/news/abcs-gmo-disclosure-united-states-20170925	PUNCT
ihlr-22950	204	10	[	[	X
ihlr-22950	204	11	https://perma.cc/2lwa-5p9k	https://perma.cc/2lwa-5p9k	X
ihlr-22950	204	12	]	]	X
ihlr-22950	204	13	.	.	PUNCT
ihlr-22950	205	1	37	37	NUM
ihlr-22950	205	2	.	.	PUNCT
ihlr-22950	206	1	medical	medical	ADJ
ihlr-22950	206	2	foods	food	NOUN
ihlr-22950	206	3	is	be	AUX
ihlr-22950	206	4	defined	define	VERB
ihlr-22950	206	5	under	under	ADP
ihlr-22950	206	6	the	the	DET
ihlr-22950	206	7	federal	federal	ADJ
ihlr-22950	206	8	,	,	PUNCT
ihlr-22950	206	9	food	food	NOUN
ihlr-22950	206	10	,	,	PUNCT
ihlr-22950	206	11	drug	drug	NOUN
ihlr-22950	206	12	and	and	CCONJ
ihlr-22950	206	13	cosmetic	cosmetic	ADJ
ihlr-22950	206	14	act	act	NOUN
ihlr-22950	206	15	in	in	ADP
ihlr-22950	206	16	section	section	NOUN
ihlr-22950	206	17	5(b	5(b	NUM
ihlr-22950	206	18	)	)	PUNCT
ihlr-22950	206	19	of	of	ADP
ihlr-22950	206	20	the	the	DET
ihlr-22950	206	21	orphan	orphan	NOUN
ihlr-22950	206	22	drug	drug	NOUN
ihlr-22950	206	23	act	act	NOUN
ihlr-22950	206	24	21	21	NUM
ihlr-22950	206	25	(	(	PUNCT
ihlr-22950	206	26	u.s.c	u.s.c	ADJ
ihlr-22950	206	27	.	.	PUNCT
ihlr-22950	207	1	§	§	PROPN
ihlr-22950	207	2	360ee(b)(3	360ee(b)(3	NUM
ihlr-22950	207	3	)	)	PUNCT
ihlr-22950	207	4	)	)	PUNCT
ihlr-22950	207	5	as	as	SCONJ
ihlr-22950	207	6	follows	follow	VERB
ihlr-22950	207	7	:	:	PUNCT
ihlr-22950	207	8	“	"	PUNCT
ihlr-22950	207	9	a	a	DET
ihlr-22950	207	10	food	food	NOUN
ihlr-22950	207	11	which	which	PRON
ihlr-22950	207	12	is	be	AUX
ihlr-22950	207	13	formulated	formulate	VERB
ihlr-22950	207	14	to	to	PART
ihlr-22950	207	15	be	be	AUX
ihlr-22950	207	16	consumed	consume	VERB
ihlr-22950	207	17	or	or	CCONJ
ihlr-22950	207	18	administered	administer	VERB
ihlr-22950	207	19	enterally	enterally	ADV
ihlr-22950	207	20	under	under	ADP
ihlr-22950	207	21	the	the	DET
ihlr-22950	207	22	supervision	supervision	NOUN
ihlr-22950	207	23	of	of	ADP
ihlr-22950	207	24	a	a	DET
ihlr-22950	207	25	physician	physician	NOUN
ihlr-22950	207	26	and	and	CCONJ
ihlr-22950	207	27	which	which	PRON
ihlr-22950	207	28	is	be	AUX
ihlr-22950	207	29	intended	intend	VERB
ihlr-22950	207	30	for	for	ADP
ihlr-22950	207	31	the	the	DET
ihlr-22950	207	32	specific	specific	ADJ
ihlr-22950	207	33	dietary	dietary	ADJ
ihlr-22950	207	34	management	management	NOUN
ihlr-22950	207	35	of	of	ADP
ihlr-22950	207	36	a	a	DET
ihlr-22950	207	37	disease	disease	NOUN
ihlr-22950	207	38	or	or	CCONJ
ihlr-22950	207	39	condition	condition	NOUN
ihlr-22950	207	40	for	for	ADP
ihlr-22950	207	41	which	which	PRON
ihlr-22950	207	42	distinctive	distinctive	ADJ
ihlr-22950	207	43	nutritional	nutritional	ADJ
ihlr-22950	207	44	requirements	requirement	NOUN
ihlr-22950	207	45	,	,	PUNCT
ihlr-22950	207	46	based	base	VERB
ihlr-22950	207	47	on	on	ADP
ihlr-22950	207	48	recognized	recognize	VERB
ihlr-22950	207	49	scientific	scientific	ADJ
ihlr-22950	207	50	principles	principle	NOUN
ihlr-22950	207	51	,	,	PUNCT
ihlr-22950	207	52	are	be	AUX
ihlr-22950	207	53	established	establish	VERB
ihlr-22950	207	54	by	by	ADP
ihlr-22950	207	55	medical	medical	ADJ
ihlr-22950	207	56	evaluation	evaluation	NOUN
ihlr-22950	207	57	.	.	PUNCT
ihlr-22950	207	58	”	"	PUNCT
ihlr-22950	208	1	21	21	NUM
ihlr-22950	208	2	u.s.c	u.s.c	NOUN
ihlr-22950	208	3	.	.	PUNCT
ihlr-22950	209	1	§	§	NOUN
ihlr-22950	209	2	360ee(b)(3	360ee(b)(3	NUM
ihlr-22950	209	3	)	)	PUNCT
ihlr-22950	209	4	(	(	PUNCT
ihlr-22950	209	5	2017	2017	NUM
ihlr-22950	209	6	)	)	PUNCT
ihlr-22950	209	7	.	.	PUNCT
ihlr-22950	210	1	38	38	NUM
ihlr-22950	210	2	.	.	NOUN
ihlr-22950	210	3	21	21	NUM
ihlr-22950	210	4	u.s.c	u.s.c	NOUN
ihlr-22950	210	5	.	.	PUNCT
ihlr-22950	211	1	§	§	PROPN
ihlr-22950	211	2	360bbb-0a(b	360bbb-0a(b	NUM
ihlr-22950	211	3	)	)	PUNCT
ihlr-22950	211	4	(	(	PUNCT
ihlr-22950	211	5	2017	2017	NUM
ihlr-22950	211	6	)	)	PUNCT
ihlr-22950	211	7	(	(	PUNCT
ihlr-22950	211	8	1	1	X
ihlr-22950	211	9	)	)	PUNCT
ihlr-22950	211	10	alleged	allege	VERB
ihlr-22950	211	11	acts	act	NOUN
ihlr-22950	211	12	or	or	CCONJ
ihlr-22950	211	13	omissions	omission	NOUN
ihlr-22950	211	14	.	.	PUNCT
ihlr-22950	212	1	with	with	ADP
ihlr-22950	212	2	respect	respect	NOUN
ihlr-22950	212	3	to	to	ADP
ihlr-22950	212	4	any	any	DET
ihlr-22950	212	5	alleged	alleged	ADJ
ihlr-22950	212	6	act	act	NOUN
ihlr-22950	212	7	or	or	CCONJ
ihlr-22950	212	8	omission	omission	NOUN
ihlr-22950	212	9	with	with	ADP
ihlr-22950	212	10	respect	respect	NOUN
ihlr-22950	212	11	to	to	ADP
ihlr-22950	212	12	an	an	DET
ihlr-22950	212	13	eligible	eligible	ADJ
ihlr-22950	212	14	investigational	investigational	ADJ
ihlr-22950	212	15	drug	drug	NOUN
ihlr-22950	212	16	provided	provide	VERB
ihlr-22950	212	17	to	to	ADP
ihlr-22950	212	18	an	an	DET
ihlr-22950	212	19	eligible	eligible	ADJ
ihlr-22950	212	20	patient	patient	NOUN
ihlr-22950	212	21	pursuant	pursuant	NOUN
ihlr-22950	212	22	to	to	ADP
ihlr-22950	212	23	section	section	NOUN
ihlr-22950	212	24	561b	561b	NUM
ihlr-22950	212	25	of	of	ADP
ihlr-22950	212	26	the	the	DET
ihlr-22950	212	27	federal	federal	ADJ
ihlr-22950	212	28	food	food	NOUN
ihlr-22950	212	29	,	,	PUNCT
ihlr-22950	212	30	drug	drug	NOUN
ihlr-22950	212	31	,	,	PUNCT
ihlr-22950	212	32	and	and	CCONJ
ihlr-22950	212	33	cosmetic	cosmetic	ADJ
ihlr-22950	212	34	act	act	NOUN
ihlr-22950	212	35	and	and	CCONJ
ihlr-22950	212	36	in	in	ADP
ihlr-22950	212	37	compliance	compliance	NOUN
ihlr-22950	212	38	with	with	ADP
ihlr-22950	212	39	such	such	ADJ
ihlr-22950	212	40	section	section	NOUN
ihlr-22950	212	41	,	,	PUNCT
ihlr-22950	212	42	no	no	DET
ihlr-22950	212	43	liability	liability	NOUN
ihlr-22950	212	44	in	in	ADP
ihlr-22950	212	45	a	a	DET
ihlr-22950	212	46	cause	cause	NOUN
ihlr-22950	212	47	of	of	ADP
ihlr-22950	212	48	action	action	NOUN
ihlr-22950	212	49	shall	shall	AUX
ihlr-22950	212	50	lie	lie	VERB
ihlr-22950	212	51	against	against	ADP
ihlr-22950	212	52	(	(	PUNCT
ihlr-22950	212	53	a	a	X
ihlr-22950	212	54	)	)	PUNCT
ihlr-22950	212	55	a	a	DET
ihlr-22950	212	56	sponsor	sponsor	NOUN
ihlr-22950	212	57	or	or	CCONJ
ihlr-22950	212	58	manufacturer	manufacturer	NOUN
ihlr-22950	212	59	;	;	PUNCT
ihlr-22950	212	60	or	or	CCONJ
ihlr-22950	212	61	(	(	PUNCT
ihlr-22950	212	62	b	b	X
ihlr-22950	212	63	)	)	PUNCT
ihlr-22950	212	64	a	a	DET
ihlr-22950	212	65	prescriber	prescriber	NOUN
ihlr-22950	212	66	,	,	PUNCT
ihlr-22950	212	67	dispenser	dispenser	NOUN
ihlr-22950	212	68	,	,	PUNCT
ihlr-22950	212	69	or	or	CCONJ
ihlr-22950	212	70	other	other	ADJ
ihlr-22950	212	71	individual	individual	ADJ
ihlr-22950	212	72	entity	entity	NOUN
ihlr-22950	212	73	(	(	PUNCT
ihlr-22950	212	74	other	other	ADJ
ihlr-22950	212	75	than	than	ADP
ihlr-22950	212	76	a	a	DET
ihlr-22950	212	77	sponsor	sponsor	NOUN
ihlr-22950	212	78	or	or	CCONJ
ihlr-22950	212	79	manufacturer	manufacturer	NOUN
ihlr-22950	212	80	)	)	PUNCT
ihlr-22950	212	81	,	,	PUNCT
ihlr-22950	212	82	unless	unless	SCONJ
ihlr-22950	212	83	the	the	DET
ihlr-22950	212	84	relevant	relevant	ADJ
ihlr-22950	212	85	conduct	conduct	NOUN
ihlr-22950	212	86	constitutes	constitute	VERB
ihlr-22950	212	87	reckless	reckless	ADJ
ihlr-22950	212	88	or	or	CCONJ
ihlr-22950	212	89	willful	willful	ADJ
ihlr-22950	212	90	misconduct	misconduct	NOUN
ihlr-22950	212	91	,	,	PUNCT
ihlr-22950	212	92	gross	gross	ADJ
ihlr-22950	212	93	negligence	negligence	NOUN
ihlr-22950	212	94	,	,	PUNCT
ihlr-22950	212	95	or	or	CCONJ
ihlr-22950	212	96	an	an	DET
ihlr-22950	212	97	intentional	intentional	ADJ
ihlr-22950	212	98	tort	tort	NOUN
ihlr-22950	212	99	under	under	ADP
ihlr-22950	212	100	any	any	DET
ihlr-22950	212	101	applicable	applicable	ADJ
ihlr-22950	212	102	state	state	NOUN
ihlr-22950	212	103	law	law	NOUN
ihlr-22950	212	104	.	.	PUNCT
ihlr-22950	213	1	39	39	NUM
ihlr-22950	213	2	.	.	PUNCT
ihlr-22950	214	1	trickett	trickett	PROPN
ihlr-22950	214	2	wendler	wendler	PROPN
ihlr-22950	214	3	,	,	PUNCT
ihlr-22950	214	4	frank	frank	PROPN
ihlr-22950	214	5	mongiello	mongiello	PROPN
ihlr-22950	214	6	,	,	PUNCT
ihlr-22950	214	7	jordan	jordan	PROPN
ihlr-22950	214	8	mclinn	mclinn	PROPN
ihlr-22950	214	9	,	,	PUNCT
ihlr-22950	214	10	and	and	CCONJ
ihlr-22950	214	11	matthew	matthew	PROPN
ihlr-22950	214	12	bellina	bellina	PROPN
ihlr-22950	214	13	right	right	NOUN
ihlr-22950	214	14	to	to	PART
ihlr-22950	214	15	try	try	VERB
ihlr-22950	214	16	act	act	NOUN
ihlr-22950	214	17	of	of	ADP
ihlr-22950	214	18	2017	2017	NUM
ihlr-22950	214	19	,	,	PUNCT
ihlr-22950	214	20	pub	pub	NOUN
ihlr-22950	214	21	.	.	PUNCT
ihlr-22950	215	1	l.	l.	PROPN
ihlr-22950	215	2	no	no	INTJ
ihlr-22950	215	3	.	.	PROPN
ihlr-22950	216	1	115	115	NUM
ihlr-22950	216	2	-	-	SYM
ihlr-22950	216	3	176	176	NUM
ihlr-22950	216	4	,	,	PUNCT
ihlr-22950	216	5	132	132	NUM
ihlr-22950	216	6	stat	stat	NOUN
ihlr-22950	216	7	.	.	PUNCT
ihlr-22950	217	1	1372	1372	NUM
ihlr-22950	217	2	(	(	PUNCT
ihlr-22950	217	3	2018	2018	NUM
ihlr-22950	217	4	)	)	PUNCT
ihlr-22950	217	5	.	.	PUNCT
ihlr-22950	218	1	40	40	NUM
ihlr-22950	218	2	.	.	PUNCT
ihlr-22950	219	1	i	i	PRON
ihlr-22950	219	2	d.	d.	PROPN
ihlr-22950	219	3	2018	2018	NUM
ihlr-22950	219	4	]	]	PUNCT
ihlr-22950	220	1	the	the	DET
ihlr-22950	220	2	latest	late	ADJ
ihlr-22950	220	3	“	"	PUNCT
ihlr-22950	220	4	federal	federal	ADJ
ihlr-22950	220	5	movement	movement	NOUN
ihlr-22950	220	6	”	"	PUNCT
ihlr-22950	220	7	in	in	ADP
ihlr-22950	220	8	the	the	DET
ihlr-22950	220	9	food	food	NOUN
ihlr-22950	220	10	and	and	CCONJ
ihlr-22950	220	11	drug	drug	NOUN
ihlr-22950	220	12	law	law	NOUN
ihlr-22950	220	13	arena	arena	NOUN
ihlr-22950	220	14	107	107	NUM
ihlr-22950	220	15	protection	protection	NOUN
ihlr-22950	220	16	agency	agency	NOUN
ihlr-22950	220	17	in	in	ADP
ihlr-22950	220	18	the	the	DET
ihlr-22950	220	19	united	united	PROPN
ihlr-22950	220	20	states	states	PROPN
ihlr-22950	220	21	federal	federal	PROPN
ihlr-22950	220	22	government.41	government.41	PROPN
ihlr-22950	220	23	striking	strike	VERB
ihlr-22950	220	24	the	the	DET
ihlr-22950	220	25	appropriate	appropriate	ADJ
ihlr-22950	220	26	balance	balance	NOUN
ihlr-22950	220	27	between	between	ADP
ihlr-22950	220	28	free	free	ADJ
ihlr-22950	220	29	enterprise	enterprise	NOUN
ihlr-22950	220	30	principles	principle	NOUN
ihlr-22950	220	31	and	and	CCONJ
ihlr-22950	220	32	obligatory	obligatory	ADJ
ihlr-22950	220	33	government	government	NOUN
ihlr-22950	220	34	intervention	intervention	NOUN
ihlr-22950	220	35	is	be	AUX
ihlr-22950	220	36	one	one	NUM
ihlr-22950	220	37	of	of	ADP
ihlr-22950	220	38	the	the	DET
ihlr-22950	220	39	most	most	ADV
ihlr-22950	220	40	debated	debate	VERB
ihlr-22950	220	41	components	component	NOUN
ihlr-22950	220	42	of	of	ADP
ihlr-22950	220	43	fda	fda	PROPN
ihlr-22950	220	44	regulation.42	regulation.42	NOUN
ihlr-22950	220	45	at	at	ADP
ihlr-22950	220	46	the	the	DET
ihlr-22950	220	47	forefront	forefront	NOUN
ihlr-22950	220	48	,	,	PUNCT
ihlr-22950	220	49	it	it	PRON
ihlr-22950	220	50	is	be	AUX
ihlr-22950	220	51	critical	critical	ADJ
ihlr-22950	220	52	to	to	PART
ihlr-22950	220	53	understand	understand	VERB
ihlr-22950	220	54	the	the	DET
ihlr-22950	220	55	mission	mission	NOUN
ihlr-22950	220	56	of	of	ADP
ihlr-22950	220	57	the	the	DET
ihlr-22950	220	58	fda	fda	PROPN
ihlr-22950	220	59	as	as	SCONJ
ihlr-22950	220	60	follows	follow	VERB
ihlr-22950	220	61	:	:	PUNCT
ihlr-22950	220	62	“	"	PUNCT
ihlr-22950	220	63	the	the	DET
ihlr-22950	220	64	food	food	NOUN
ihlr-22950	220	65	and	and	CCONJ
ihlr-22950	220	66	drug	drug	NOUN
ihlr-22950	220	67	administration	administration	NOUN
ihlr-22950	220	68	is	be	AUX
ihlr-22950	220	69	responsible	responsible	ADJ
ihlr-22950	220	70	for	for	ADP
ihlr-22950	220	71	protecting	protect	VERB
ihlr-22950	220	72	the	the	DET
ihlr-22950	220	73	public	public	ADJ
ihlr-22950	220	74	health	health	NOUN
ihlr-22950	220	75	by	by	ADP
ihlr-22950	220	76	ensuring	ensure	VERB
ihlr-22950	220	77	the	the	DET
ihlr-22950	220	78	safety	safety	NOUN
ihlr-22950	220	79	,	,	PUNCT
ihlr-22950	220	80	efficacy	efficacy	NOUN
ihlr-22950	220	81	,	,	PUNCT
ihlr-22950	220	82	and	and	CCONJ
ihlr-22950	220	83	security	security	NOUN
ihlr-22950	220	84	of	of	ADP
ihlr-22950	220	85	human	human	ADJ
ihlr-22950	220	86	and	and	CCONJ
ihlr-22950	220	87	veterinary	veterinary	ADJ
ihlr-22950	220	88	drugs	drug	NOUN
ihlr-22950	220	89	,	,	PUNCT
ihlr-22950	220	90	biological	biological	ADJ
ihlr-22950	220	91	products	product	NOUN
ihlr-22950	220	92	,	,	PUNCT
ihlr-22950	220	93	and	and	CCONJ
ihlr-22950	220	94	medical	medical	ADJ
ihlr-22950	220	95	devices	device	NOUN
ihlr-22950	220	96	;	;	PUNCT
ihlr-22950	220	97	and	and	CCONJ
ihlr-22950	220	98	by	by	ADP
ihlr-22950	220	99	ensuring	ensure	VERB
ihlr-22950	220	100	the	the	DET
ihlr-22950	220	101	safety	safety	NOUN
ihlr-22950	220	102	of	of	ADP
ihlr-22950	220	103	our	our	PRON
ihlr-22950	220	104	nation	nation	NOUN
ihlr-22950	220	105	’s	’s	PART
ihlr-22950	220	106	food	food	NOUN
ihlr-22950	220	107	supply	supply	NOUN
ihlr-22950	220	108	,	,	PUNCT
ihlr-22950	220	109	cosmetics	cosmetic	NOUN
ihlr-22950	220	110	,	,	PUNCT
ihlr-22950	220	111	and	and	CCONJ
ihlr-22950	220	112	products	product	NOUN
ihlr-22950	220	113	that	that	PRON
ihlr-22950	220	114	emit	emit	VERB
ihlr-22950	220	115	radiation	radiation	NOUN
ihlr-22950	220	116	.	.	PUNCT
ihlr-22950	221	1	”43	”43	PROPN
ihlr-22950	221	2	yet	yet	ADV
ihlr-22950	221	3	,	,	PUNCT
ihlr-22950	221	4	public	public	ADJ
ihlr-22950	221	5	protection	protection	NOUN
ihlr-22950	221	6	is	be	AUX
ihlr-22950	221	7	paramount.44	paramount.44	NOUN
ihlr-22950	221	8	keeping	keep	VERB
ihlr-22950	221	9	the	the	DET
ihlr-22950	221	10	mission	mission	NOUN
ihlr-22950	221	11	of	of	ADP
ihlr-22950	221	12	the	the	DET
ihlr-22950	221	13	fda	fda	PROPN
ihlr-22950	221	14	in	in	ADP
ihlr-22950	221	15	the	the	DET
ihlr-22950	221	16	forefront	forefront	NOUN
ihlr-22950	221	17	,	,	PUNCT
ihlr-22950	221	18	the	the	DET
ihlr-22950	221	19	fda	fda	PROPN
ihlr-22950	221	20	aims	aim	VERB
ihlr-22950	221	21	to	to	PART
ihlr-22950	221	22	foster	foster	VERB
ihlr-22950	221	23	and	and	CCONJ
ihlr-22950	221	24	protect	protect	VERB
ihlr-22950	221	25	public	public	ADJ
ihlr-22950	221	26	health	health	NOUN
ihlr-22950	221	27	through	through	ADP
ihlr-22950	221	28	prompt	prompt	ADJ
ihlr-22950	221	29	and	and	CCONJ
ihlr-22950	221	30	efficient	efficient	ADJ
ihlr-22950	221	31	review	review	NOUN
ihlr-22950	221	32	of	of	ADP
ihlr-22950	221	33	clinical	clinical	ADJ
ihlr-22950	221	34	research	research	NOUN
ihlr-22950	221	35	and	and	CCONJ
ihlr-22950	221	36	taking	take	VERB
ihlr-22950	221	37	appropriate	appropriate	ADJ
ihlr-22950	221	38	action	action	NOUN
ihlr-22950	221	39	on	on	ADP
ihlr-22950	221	40	the	the	DET
ihlr-22950	221	41	marketing	marketing	NOUN
ihlr-22950	221	42	of	of	ADP
ihlr-22950	221	43	regulated	regulated	ADJ
ihlr-22950	221	44	products	product	NOUN
ihlr-22950	221	45	in	in	ADP
ihlr-22950	221	46	a	a	DET
ihlr-22950	221	47	timely	timely	ADJ
ihlr-22950	221	48	manner.45	manner.45	NOUN
ihlr-22950	221	49	yet	yet	ADV
ihlr-22950	221	50	,	,	PUNCT
ihlr-22950	221	51	this	this	PRON
ihlr-22950	221	52	could	could	AUX
ihlr-22950	221	53	be	be	AUX
ihlr-22950	221	54	deemed	deem	VERB
ihlr-22950	221	55	insufficient	insufficient	ADJ
ihlr-22950	221	56	for	for	ADP
ihlr-22950	221	57	those	those	PRON
ihlr-22950	221	58	who	who	PRON
ihlr-22950	221	59	are	be	AUX
ihlr-22950	221	60	desperately	desperately	ADV
ihlr-22950	221	61	ill	ill	ADJ
ihlr-22950	221	62	and	and	CCONJ
ihlr-22950	221	63	seeking	seek	VERB
ihlr-22950	221	64	treatment	treatment	NOUN
ihlr-22950	221	65	for	for	ADP
ihlr-22950	221	66	experimental	experimental	ADJ
ihlr-22950	221	67	products	product	NOUN
ihlr-22950	221	68	in	in	ADP
ihlr-22950	221	69	a	a	DET
ihlr-22950	221	70	timely	timely	ADJ
ihlr-22950	221	71	manner.46	manner.46	NOUN
ihlr-22950	221	72	access	access	NOUN
ihlr-22950	221	73	to	to	ADP
ihlr-22950	221	74	unapproved	unapproved	ADJ
ihlr-22950	221	75	drugs	drug	NOUN
ihlr-22950	221	76	includes	include	VERB
ihlr-22950	221	77	participation	participation	NOUN
ihlr-22950	221	78	in	in	ADP
ihlr-22950	221	79	a	a	DET
ihlr-22950	221	80	clinical	clinical	ADJ
ihlr-22950	221	81	trial	trial	NOUN
ihlr-22950	221	82	detailed	detailed	ADJ
ihlr-22950	221	83	below.47	below.47	NOUN
ihlr-22950	221	84	eligibility	eligibility	NOUN
ihlr-22950	221	85	parameters	parameter	NOUN
ihlr-22950	221	86	are	be	AUX
ihlr-22950	221	87	specified	specify	VERB
ihlr-22950	221	88	in	in	ADP
ihlr-22950	221	89	a	a	DET
ihlr-22950	221	90	protocol.48	protocol.48	NOUN
ihlr-22950	221	91	however	however	ADV
ihlr-22950	221	92	,	,	PUNCT
ihlr-22950	221	93	even	even	ADV
ihlr-22950	221	94	if	if	SCONJ
ihlr-22950	221	95	the	the	DET
ihlr-22950	221	96	eligibility	eligibility	NOUN
ihlr-22950	221	97	criteria	criterion	NOUN
ihlr-22950	221	98	in	in	ADP
ihlr-22950	221	99	a	a	DET
ihlr-22950	221	100	study	study	NOUN
ihlr-22950	221	101	protocol	protocol	NOUN
ihlr-22950	221	102	is	be	AUX
ihlr-22950	221	103	not	not	PART
ihlr-22950	221	104	appropriate	appropriate	ADJ
ihlr-22950	221	105	for	for	ADP
ihlr-22950	221	106	a	a	DET
ihlr-22950	221	107	specific	specific	ADJ
ihlr-22950	221	108	patient	patient	ADJ
ihlr-22950	221	109	treatment	treatment	NOUN
ihlr-22950	221	110	,	,	PUNCT
ihlr-22950	221	111	it	it	PRON
ihlr-22950	221	112	may	may	AUX
ihlr-22950	221	113	be	be	AUX
ihlr-22950	221	114	possible	possible	ADJ
ihlr-22950	221	115	to	to	PART
ihlr-22950	221	116	obtain	obtain	VERB
ihlr-22950	221	117	the	the	DET
ihlr-22950	221	118	investigational	investigational	ADJ
ihlr-22950	221	119	treatment	treatment	NOUN
ihlr-22950	221	120	as	as	ADP
ihlr-22950	221	121	a	a	DET
ihlr-22950	221	122	special	special	ADJ
ihlr-22950	221	123	exception	exception	NOUN
ihlr-22950	221	124	termed	term	VERB
ihlr-22950	221	125	expanded	expand	VERB
ihlr-22950	221	126	access	access	NOUN
ihlr-22950	221	127	generally	generally	ADV
ihlr-22950	221	128	referred	refer	VERB
ihlr-22950	221	129	to	to	ADP
ihlr-22950	221	130	as	as	ADV
ihlr-22950	221	131	compassionate	compassionate	ADJ
ihlr-22950	221	132	use.49	use.49	PROPN
ihlr-22950	221	133	expanded	expand	VERB
ihlr-22950	221	134	access	access	NOUN
ihlr-22950	221	135	,	,	PUNCT
ihlr-22950	221	136	or	or	CCONJ
ihlr-22950	221	137	as	as	SCONJ
ihlr-22950	221	138	indicated	indicate	VERB
ihlr-22950	221	139	,	,	PUNCT
ihlr-22950	221	140	popularly	popularly	ADV
ihlr-22950	221	141	referred	refer	VERB
ihlr-22950	221	142	to	to	ADP
ihlr-22950	221	143	as	as	ADP
ihlr-22950	221	144	compassionate	compassionate	ADJ
ihlr-22950	221	145	use	use	NOUN
ihlr-22950	221	146	,	,	PUNCT
ihlr-22950	221	147	is	be	AUX
ihlr-22950	221	148	the	the	DET
ihlr-22950	221	149	use	use	NOUN
ihlr-22950	221	150	outside	outside	ADP
ihlr-22950	221	151	of	of	ADP
ihlr-22950	221	152	a	a	DET
ihlr-22950	221	153	clinical	clinical	ADJ
ihlr-22950	221	154	trial50	trial50	NOUN
ihlr-22950	221	155	of	of	ADP
ihlr-22950	221	156	an	an	DET
ihlr-22950	221	157	investigational	investigational	ADJ
ihlr-22950	221	158	medical	medical	ADJ
ihlr-22950	221	159	product	product	NOUN
ihlr-22950	221	160	that	that	PRON
ihlr-22950	221	161	has	have	VERB
ihlr-22950	221	162	41	41	NUM
ihlr-22950	221	163	.	.	PUNCT
ihlr-22950	222	1	the	the	DET
ihlr-22950	222	2	fda	fda	PROPN
ihlr-22950	222	3	history	history	PROPN
ihlr-22950	222	4	office	office	PROPN
ihlr-22950	222	5	,	,	PUNCT
ihlr-22950	222	6	u.s	u.s	PROPN
ihlr-22950	222	7	.	.	PROPN
ihlr-22950	222	8	food	food	PROPN
ihlr-22950	222	9	&	&	CCONJ
ihlr-22950	222	10	drug	drug	PROPN
ihlr-22950	222	11	admin	admin	PROPN
ihlr-22950	222	12	.	.	PROPN
ihlr-22950	222	13	,	,	PUNCT
ihlr-22950	222	14	https://www.fda.gov/aboutfda/	https://www.fda.gov/aboutfda/	X
ihlr-22950	222	15	history	history	NOUN
ihlr-22950	222	16	/	/	SYM
ihlr-22950	222	17	fdahistoryoffice	fdahistoryoffice	NOUN
ihlr-22950	222	18	/	/	SYM
ihlr-22950	222	19	default.htm	default.htm	X
ihlr-22950	223	1	[	[	X
ihlr-22950	223	2	https://perma.cc/3jva-b8fe	https://perma.cc/3jva-b8fe	X
ihlr-22950	223	3	]	]	X
ihlr-22950	223	4	(	(	PUNCT
ihlr-22950	223	5	last	last	ADJ
ihlr-22950	223	6	updated	update	VERB
ihlr-22950	223	7	feb	feb	PROPN
ihlr-22950	223	8	.	.	PROPN
ihlr-22950	223	9	1	1	NUM
ihlr-22950	223	10	,	,	PUNCT
ihlr-22950	223	11	2018	2018	NUM
ihlr-22950	223	12	)	)	PUNCT
ihlr-22950	223	13	;	;	PUNCT
ihlr-22950	223	14	ben	ben	PROPN
ihlr-22950	223	15	panko	panko	PROPN
ihlr-22950	223	16	,	,	PUNCT
ihlr-22950	223	17	where	where	SCONJ
ihlr-22950	223	18	did	do	AUX
ihlr-22950	223	19	the	the	DET
ihlr-22950	223	20	fda	fda	PROPN
ihlr-22950	223	21	come	come	VERB
ihlr-22950	223	22	from	from	ADP
ihlr-22950	223	23	,	,	PUNCT
ihlr-22950	223	24	and	and	CCONJ
ihlr-22950	223	25	what	what	PRON
ihlr-22950	223	26	does	do	AUX
ihlr-22950	223	27	it	it	PRON
ihlr-22950	223	28	do	do	VERB
ihlr-22950	223	29	?	?	PUNCT
ihlr-22950	223	30	,	,	PUNCT
ihlr-22950	223	31	smithsonian.com	smithsonian.com	X
ihlr-22950	223	32	(	(	PUNCT
ihlr-22950	223	33	feb	feb	PROPN
ihlr-22950	223	34	.	.	PROPN
ihlr-22950	223	35	8	8	NUM
ihlr-22950	223	36	,	,	PUNCT
ihlr-22950	223	37	2017	2017	NUM
ihlr-22950	223	38	)	)	PUNCT
ihlr-22950	223	39	,	,	PUNCT
ihlr-22950	223	40	https://www.smithsonianmag.com/science-nature/origins-fda-what-does-it-do-180962054/	https://www.smithsonianmag.com/science-nature/origins-fda-what-does-it-do-180962054/	NOUN
ihlr-22950	224	1	[	[	X
ihlr-22950	224	2	https://perma.cc/m2pe-687d	https://perma.cc/m2pe-687d	X
ihlr-22950	224	3	]	]	X
ihlr-22950	224	4	.	.	PUNCT
ihlr-22950	225	1	42	42	NUM
ihlr-22950	225	2	.	.	PUNCT
ihlr-22950	226	1	roseann	roseann	PROPN
ihlr-22950	226	2	b.	b.	PROPN
ihlr-22950	226	3	termini	termini	PROPN
ihlr-22950	226	4	,	,	PUNCT
ihlr-22950	226	5	food	food	NOUN
ihlr-22950	226	6	and	and	CCONJ
ihlr-22950	226	7	drug	drug	NOUN
ihlr-22950	226	8	law	law	NOUN
ihlr-22950	226	9	:	:	PUNCT
ihlr-22950	226	10	federal	federal	ADJ
ihlr-22950	226	11	regulation	regulation	NOUN
ihlr-22950	226	12	of	of	ADP
ihlr-22950	226	13	drugs	drug	NOUN
ihlr-22950	226	14	,	,	PUNCT
ihlr-22950	226	15	biologics	biologic	NOUN
ihlr-22950	226	16	,	,	PUNCT
ihlr-22950	226	17	medical	medical	ADJ
ihlr-22950	226	18	devices	device	NOUN
ihlr-22950	226	19	,	,	PUNCT
ihlr-22950	226	20	foods	food	NOUN
ihlr-22950	226	21	,	,	PUNCT
ihlr-22950	226	22	dietary	dietary	ADJ
ihlr-22950	226	23	supplements	supplement	NOUN
ihlr-22950	226	24	,	,	PUNCT
ihlr-22950	226	25	personal	personal	ADJ
ihlr-22950	226	26	care	care	NOUN
ihlr-22950	226	27	,	,	PUNCT
ihlr-22950	226	28	veterinary	veterinary	ADJ
ihlr-22950	226	29	and	and	CCONJ
ihlr-22950	226	30	tobacco	tobacco	NOUN
ihlr-22950	226	31	products	product	NOUN
ihlr-22950	226	32	5	5	NUM
ihlr-22950	226	33	(	(	PUNCT
ihlr-22950	226	34	9th	9th	ADJ
ihlr-22950	226	35	ed	ed	NOUN
ihlr-22950	226	36	.	.	PROPN
ihlr-22950	226	37	2017	2017	NUM
ihlr-22950	226	38	)	)	PUNCT
ihlr-22950	226	39	.	.	PUNCT
ihlr-22950	227	1	43	43	NUM
ihlr-22950	227	2	.	.	PUNCT
ihlr-22950	228	1	what	what	PRON
ihlr-22950	228	2	we	we	PRON
ihlr-22950	228	3	do	do	VERB
ihlr-22950	228	4	,	,	PUNCT
ihlr-22950	228	5	u.s	u.s	PROPN
ihlr-22950	228	6	.	.	PROPN
ihlr-22950	228	7	food	food	PROPN
ihlr-22950	228	8	&	&	CCONJ
ihlr-22950	228	9	drug	drug	PROPN
ihlr-22950	228	10	admin	admin	PROPN
ihlr-22950	228	11	.	.	PROPN
ihlr-22950	228	12	,	,	PUNCT
ihlr-22950	229	1	https://www.fda.gov/aboutfda/whatwedo	https://www.fda.gov/aboutfda/whatwedo	PROPN
ihlr-22950	230	1	[	[	X
ihlr-22950	230	2	https://perma.cc/42xl-ep2b	https://perma.cc/42xl-ep2b	X
ihlr-22950	230	3	]	]	X
ihlr-22950	230	4	(	(	PUNCT
ihlr-22950	230	5	last	last	ADJ
ihlr-22950	230	6	updated	update	VERB
ihlr-22950	230	7	mar	mar	PROPN
ihlr-22950	230	8	.	.	PROPN
ihlr-22950	230	9	28	28	NUM
ihlr-22950	230	10	,	,	PUNCT
ihlr-22950	230	11	2018	2018	NUM
ihlr-22950	230	12	)	)	PUNCT
ihlr-22950	230	13	.	.	PUNCT
ihlr-22950	231	1	44	44	NUM
ihlr-22950	231	2	.	.	PUNCT
ihlr-22950	232	1	i	i	PRON
ihlr-22950	232	2	d.	d.	PROPN
ihlr-22950	232	3	45	45	NUM
ihlr-22950	232	4	.	.	PUNCT
ihlr-22950	233	1	fda	fda	PROPN
ihlr-22950	233	2	center	center	PROPN
ihlr-22950	233	3	for	for	ADP
ihlr-22950	233	4	drug	drug	NOUN
ihlr-22950	233	5	evaluation	evaluation	NOUN
ihlr-22950	233	6	and	and	CCONJ
ihlr-22950	233	7	research	research	NOUN
ihlr-22950	233	8	(	(	PUNCT
ihlr-22950	233	9	cder	cder	NOUN
ihlr-22950	233	10	)	)	PUNCT
ihlr-22950	233	11	strategic	strategic	ADJ
ihlr-22950	233	12	plan	plan	NOUN
ihlr-22950	233	13	2013	2013	NUM
ihlr-22950	233	14	-	-	SYM
ihlr-22950	233	15	2017	2017	NUM
ihlr-22950	233	16	,	,	PUNCT
ihlr-22950	233	17	u.s	u.s	PROPN
ihlr-22950	233	18	.	.	PROPN
ihlr-22950	233	19	food	food	PROPN
ihlr-22950	233	20	&	&	CCONJ
ihlr-22950	233	21	drug	drug	PROPN
ihlr-22950	233	22	admin	admin	PROPN
ihlr-22950	233	23	.	.	PROPN
ihlr-22950	233	24	,	,	PUNCT
ihlr-22950	233	25	3	3	NUM
ihlr-22950	233	26	,	,	PUNCT
ihlr-22950	233	27	https://www.fda.gov/downloads/aboutfda/centersoffices/officeof	https://www.fda.gov/downloads/aboutfda/centersoffices/officeof	PROPN
ihlr-22950	233	28	medicalproductsandtobacco	medicalproductsandtobacco	PROPN
ihlr-22950	233	29	/	/	SYM
ihlr-22950	233	30	cder	cder	NOUN
ihlr-22950	233	31	/	/	SYM
ihlr-22950	233	32	ucm376545.pdf	ucm376545.pdf	PROPN
ihlr-22950	234	1	[	[	X
ihlr-22950	234	2	https://perma.cc/n3w9-uqcx	https://perma.cc/n3w9-uqcx	NOUN
ihlr-22950	234	3	]	]	PUNCT
ihlr-22950	234	4	.	.	PUNCT
ihlr-22950	235	1	46	46	NUM
ihlr-22950	235	2	.	.	PUNCT
ihlr-22950	236	1	clinical	clinical	ADJ
ihlr-22950	236	2	trials	trial	NOUN
ihlr-22950	236	3	have	have	VERB
ihlr-22950	236	4	eligibility	eligibility	NOUN
ihlr-22950	236	5	criteria	criterion	NOUN
ihlr-22950	236	6	and	and	CCONJ
ihlr-22950	236	7	at	at	ADP
ihlr-22950	236	8	times	time	NOUN
ihlr-22950	236	9	patients	patient	NOUN
ihlr-22950	236	10	are	be	AUX
ihlr-22950	236	11	ineligible	ineligible	ADJ
ihlr-22950	236	12	.	.	PUNCT
ihlr-22950	237	1	see	see	VERB
ihlr-22950	237	2	,	,	PUNCT
ihlr-22950	237	3	e.g.	e.g.	ADV
ihlr-22950	237	4	,	,	PUNCT
ihlr-22950	237	5	expanded	expand	VERB
ihlr-22950	237	6	access	access	NOUN
ihlr-22950	237	7	(	(	PUNCT
ihlr-22950	237	8	sometimes	sometimes	ADV
ihlr-22950	237	9	called	call	VERB
ihlr-22950	237	10	“	"	PUNCT
ihlr-22950	237	11	compassionate	compassionate	ADJ
ihlr-22950	237	12	use	use	NOUN
ihlr-22950	237	13	”	"	PUNCT
ihlr-22950	237	14	)	)	PUNCT
ihlr-22950	237	15	,	,	PUNCT
ihlr-22950	237	16	u.s	u.s	PROPN
ihlr-22950	237	17	.	.	PROPN
ihlr-22950	237	18	food	food	PROPN
ihlr-22950	237	19	&	&	CCONJ
ihlr-22950	237	20	drug	drug	PROPN
ihlr-22950	237	21	admin	admin	PROPN
ihlr-22950	237	22	.	.	PROPN
ihlr-22950	237	23	,	,	PUNCT
ihlr-22950	237	24	https://www.fda.gov/newsevents/publichealthfocus/expandedaccesscompassionateuse/defau	https://www.fda.gov/newsevents/publichealthfocus/expandedaccesscompassionateuse/defau	PROPN
ihlr-22950	237	25	lt.htm	lt.htm	PROPN
ihlr-22950	238	1	[	[	X
ihlr-22950	238	2	https://perma.cc/kqk7-8q7x	https://perma.cc/kqk7-8q7x	X
ihlr-22950	238	3	]	]	PUNCT
ihlr-22950	238	4	(	(	PUNCT
ihlr-22950	238	5	last	last	ADJ
ihlr-22950	238	6	updated	update	VERB
ihlr-22950	238	7	june	june	PROPN
ihlr-22950	238	8	19	19	NUM
ihlr-22950	238	9	,	,	PUNCT
ihlr-22950	238	10	2018	2018	NUM
ihlr-22950	238	11	)	)	PUNCT
ihlr-22950	238	12	.	.	PUNCT
ihlr-22950	239	1	47	47	NUM
ihlr-22950	239	2	.	.	PUNCT
ihlr-22950	240	1	learn	learn	VERB
ihlr-22950	240	2	about	about	ADP
ihlr-22950	240	3	clinical	clinical	ADJ
ihlr-22950	240	4	studies	study	NOUN
ihlr-22950	240	5	,	,	PUNCT
ihlr-22950	240	6	u.s	u.s	PROPN
ihlr-22950	240	7	.	.	PROPN
ihlr-22950	240	8	nat’l	nat’l	PROPN
ihlr-22950	240	9	libr	libr	PROPN
ihlr-22950	240	10	.	.	PUNCT
ihlr-22950	241	1	of	of	ADP
ihlr-22950	241	2	med	med	PROPN
ihlr-22950	241	3	.	.	PROPN
ihlr-22950	241	4	,	,	PUNCT
ihlr-22950	241	5	https://clinicaltrials.gov/ct2/	https://clinicaltrials.gov/ct2/	AUX
ihlr-22950	241	6	about	about	ADP
ihlr-22950	241	7	-	-	PUNCT
ihlr-22950	241	8	studies	study	NOUN
ihlr-22950	241	9	/	/	SYM
ihlr-22950	241	10	learn	learn	NOUN
ihlr-22950	241	11	[	[	X
ihlr-22950	241	12	https://perma.cc/l6f2-p9kq	https://perma.cc/l6f2-p9kq	X
ihlr-22950	241	13	]	]	X
ihlr-22950	241	14	(	(	PUNCT
ihlr-22950	241	15	last	last	ADJ
ihlr-22950	241	16	updated	update	VERB
ihlr-22950	241	17	jan	jan	PROPN
ihlr-22950	241	18	.	.	PROPN
ihlr-22950	241	19	2017	2017	NUM
ihlr-22950	241	20	)	)	PUNCT
ihlr-22950	241	21	.	.	PUNCT
ihlr-22950	242	1	48	48	NUM
ihlr-22950	242	2	.	.	PUNCT
ihlr-22950	243	1	i	i	PRON
ihlr-22950	243	2	d.	d.	PROPN
ihlr-22950	243	3	49	49	NUM
ihlr-22950	243	4	.	.	PUNCT
ihlr-22950	243	5	21	21	NUM
ihlr-22950	243	6	c.f.r	c.f.r	NOUN
ihlr-22950	243	7	.	.	PUNCT
ihlr-22950	244	1	§	§	PROPN
ihlr-22950	244	2	312.300	312.300	NUM
ihlr-22950	244	3	(	(	PUNCT
ihlr-22950	244	4	2018	2018	NUM
ihlr-22950	244	5	)	)	PUNCT
ihlr-22950	244	6	.	.	PUNCT
ihlr-22950	245	1	50	50	NUM
ihlr-22950	245	2	.	.	PUNCT
ihlr-22950	246	1	the	the	DET
ihlr-22950	246	2	u.s	u.s	PROPN
ihlr-22950	246	3	.	.	PROPN
ihlr-22950	246	4	national	national	PROPN
ihlr-22950	246	5	library	library	NOUN
ihlr-22950	246	6	of	of	ADP
ihlr-22950	246	7	medicine	medicine	NOUN
ihlr-22950	246	8	’s	’s	PART
ihlr-22950	246	9	website	website	NOUN
ihlr-22950	246	10	,	,	PUNCT
ihlr-22950	246	11	clinicaltrials.gov	clinicaltrials.gov	X
ihlr-22950	246	12	,	,	PUNCT
ihlr-22950	246	13	contains	contain	VERB
ihlr-22950	246	14	108	108	NUM
ihlr-22950	246	15	indiana	indiana	PROPN
ihlr-22950	246	16	health	health	PROPN
ihlr-22950	246	17	law	law	NOUN
ihlr-22950	246	18	review	review	NOUN
ihlr-22950	246	19	[	[	X
ihlr-22950	246	20	vol	vol	NOUN
ihlr-22950	246	21	.	.	PUNCT
ihlr-22950	247	1	16:101	16:101	NUM
ihlr-22950	247	2	not	not	PART
ihlr-22950	247	3	been	be	AUX
ihlr-22950	247	4	yet	yet	ADV
ihlr-22950	247	5	approved	approve	VERB
ihlr-22950	247	6	by	by	ADP
ihlr-22950	247	7	the	the	DET
ihlr-22950	247	8	fda.51	fda.51	PROPN
ihlr-22950	247	9	the	the	DET
ihlr-22950	247	10	fda	fda	PROPN
ihlr-22950	247	11	approval	approval	NOUN
ihlr-22950	247	12	rate	rate	NOUN
ihlr-22950	247	13	for	for	ADP
ihlr-22950	247	14	compassionate	compassionate	ADJ
ihlr-22950	247	15	use	use	NOUN
ihlr-22950	247	16	therapy	therapy	NOUN
ihlr-22950	247	17	is	be	AUX
ihlr-22950	247	18	ninety	ninety	NUM
ihlr-22950	247	19	-	-	PUNCT
ihlr-22950	247	20	nine	nine	NUM
ihlr-22950	247	21	percent.52	percent.52	NOUN
ihlr-22950	247	22	treating	treat	VERB
ihlr-22950	247	23	a	a	DET
ihlr-22950	247	24	patient	patient	NOUN
ihlr-22950	247	25	as	as	ADP
ihlr-22950	247	26	a	a	DET
ihlr-22950	247	27	special	special	ADJ
ihlr-22950	247	28	exception	exception	NOUN
ihlr-22950	247	29	entails	entail	VERB
ihlr-22950	247	30	modifying	modify	VERB
ihlr-22950	247	31	the	the	DET
ihlr-22950	247	32	informed	informed	ADJ
ihlr-22950	247	33	consent	consent	NOUN
ihlr-22950	247	34	form	form	NOUN
ihlr-22950	247	35	,	,	PUNCT
ihlr-22950	247	36	sending	send	VERB
ihlr-22950	247	37	the	the	DET
ihlr-22950	247	38	request	request	NOUN
ihlr-22950	247	39	to	to	ADP
ihlr-22950	247	40	the	the	DET
ihlr-22950	247	41	fda	fda	PROPN
ihlr-22950	247	42	,	,	PUNCT
ihlr-22950	247	43	and	and	CCONJ
ihlr-22950	247	44	acquiring	acquire	VERB
ihlr-22950	247	45	permission	permission	NOUN
ihlr-22950	247	46	from	from	ADP
ihlr-22950	247	47	an	an	DET
ihlr-22950	247	48	institutional	institutional	ADJ
ihlr-22950	247	49	review	review	NOUN
ihlr-22950	247	50	board	board	NOUN
ihlr-22950	247	51	(	(	PUNCT
ihlr-22950	247	52	irb).53	irb).53	NOUN
ihlr-22950	247	53	however	however	ADV
ihlr-22950	247	54	,	,	PUNCT
ihlr-22950	247	55	when	when	SCONJ
ihlr-22950	247	56	treatment	treatment	NOUN
ihlr-22950	247	57	involves	involve	VERB
ihlr-22950	247	58	the	the	DET
ihlr-22950	247	59	emergency	emergency	NOUN
ihlr-22950	247	60	use	use	NOUN
ihlr-22950	247	61	of	of	ADP
ihlr-22950	247	62	an	an	DET
ihlr-22950	247	63	investigational	investigational	ADJ
ihlr-22950	247	64	drug	drug	NOUN
ihlr-22950	247	65	and	and	CCONJ
ihlr-22950	247	66	approval	approval	NOUN
ihlr-22950	247	67	from	from	ADP
ihlr-22950	247	68	an	an	DET
ihlr-22950	247	69	irb	irb	NOUN
ihlr-22950	247	70	can	can	AUX
ihlr-22950	247	71	not	not	PART
ihlr-22950	247	72	be	be	AUX
ihlr-22950	247	73	obtained	obtain	VERB
ihlr-22950	247	74	before	before	ADP
ihlr-22950	247	75	treatment	treatment	NOUN
ihlr-22950	247	76	,	,	PUNCT
ihlr-22950	247	77	treatment	treatment	NOUN
ihlr-22950	247	78	may	may	AUX
ihlr-22950	247	79	begin	begin	VERB
ihlr-22950	247	80	without	without	ADP
ihlr-22950	247	81	prior	prior	ADJ
ihlr-22950	247	82	irb	irb	NOUN
ihlr-22950	247	83	approval	approval	NOUN
ihlr-22950	247	84	provided	provide	VERB
ihlr-22950	247	85	the	the	DET
ihlr-22950	247	86	irb	irb	NOUN
ihlr-22950	247	87	is	be	AUX
ihlr-22950	247	88	notified	notify	VERB
ihlr-22950	247	89	of	of	ADP
ihlr-22950	247	90	the	the	DET
ihlr-22950	247	91	emergency	emergency	NOUN
ihlr-22950	247	92	expanded	expand	VERB
ihlr-22950	247	93	access	access	NOUN
ihlr-22950	247	94	use	use	NOUN
ihlr-22950	247	95	within	within	ADP
ihlr-22950	247	96	five	five	NUM
ihlr-22950	247	97	working	work	VERB
ihlr-22950	247	98	days	day	NOUN
ihlr-22950	247	99	of	of	ADP
ihlr-22950	247	100	treatment.54	treatment.54	NOUN
ihlr-22950	247	101	it	it	PRON
ihlr-22950	247	102	also	also	ADV
ihlr-22950	247	103	requires	require	VERB
ihlr-22950	247	104	agreement	agreement	NOUN
ihlr-22950	247	105	of	of	ADP
ihlr-22950	247	106	the	the	DET
ihlr-22950	247	107	manufacturer	manufacturer	NOUN
ihlr-22950	247	108	to	to	PART
ihlr-22950	247	109	provide	provide	VERB
ihlr-22950	247	110	the	the	DET
ihlr-22950	247	111	requested	request	VERB
ihlr-22950	247	112	information	information	NOUN
ihlr-22950	247	113	about	about	ADP
ihlr-22950	247	114	publicly	publicly	ADV
ihlr-22950	247	115	and	and	CCONJ
ihlr-22950	247	116	privately	privately	ADV
ihlr-22950	247	117	funded	fund	VERB
ihlr-22950	247	118	trials	trial	NOUN
ihlr-22950	247	119	concerning	concern	VERB
ihlr-22950	247	120	safety	safety	NOUN
ihlr-22950	247	121	and	and	CCONJ
ihlr-22950	247	122	efficacy	efficacy	NOUN
ihlr-22950	247	123	studies	study	NOUN
ihlr-22950	247	124	for	for	ADP
ihlr-22950	247	125	phase	phase	NOUN
ihlr-22950	247	126	ii	ii	PROPN
ihlr-22950	247	127	drug	drug	NOUN
ihlr-22950	247	128	approval	approval	NOUN
ihlr-22950	247	129	process	process	NOUN
ihlr-22950	247	130	,	,	PUNCT
ihlr-22950	247	131	phase	phase	NOUN
ihlr-22950	247	132	iii	iii	NUM
ihlr-22950	247	133	drug	drug	NOUN
ihlr-22950	247	134	approval	approval	NOUN
ihlr-22950	247	135	process	process	NOUN
ihlr-22950	247	136	and	and	CCONJ
ihlr-22950	247	137	post	post	VERB
ihlr-22950	247	138	market	market	NOUN
ihlr-22950	247	139	phase	phase	NOUN
ihlr-22950	247	140	iv	iv	NUM
ihlr-22950	247	141	initiatives	initiative	NOUN
ihlr-22950	247	142	to	to	PART
ihlr-22950	247	143	require	require	VERB
ihlr-22950	247	144	increased	increase	VERB
ihlr-22950	247	145	disclosure	disclosure	NOUN
ihlr-22950	247	146	of	of	ADP
ihlr-22950	247	147	clinical	clinical	ADJ
ihlr-22950	247	148	trial	trial	NOUN
ihlr-22950	247	149	information	information	NOUN
ihlr-22950	247	150	remain	remain	VERB
ihlr-22950	247	151	in	in	ADP
ihlr-22950	247	152	the	the	DET
ihlr-22950	247	153	forefront	forefront	NOUN
ihlr-22950	247	154	.	.	PUNCT
ihlr-22950	248	1	as	as	ADP
ihlr-22950	248	2	of	of	ADP
ihlr-22950	248	3	july	july	PROPN
ihlr-22950	248	4	21	21	NUM
ihlr-22950	248	5	,	,	PUNCT
ihlr-22950	248	6	2018	2018	NUM
ihlr-22950	248	7	,	,	PUNCT
ihlr-22950	248	8	there	there	PRON
ihlr-22950	248	9	were	be	VERB
ihlr-22950	248	10	278,399	278,399	NUM
ihlr-22950	248	11	research	research	NOUN
ihlr-22950	248	12	studies	study	NOUN
ihlr-22950	248	13	in	in	ADP
ihlr-22950	248	14	all	all	DET
ihlr-22950	248	15	50	50	NUM
ihlr-22950	248	16	states	state	NOUN
ihlr-22950	248	17	and	and	CCONJ
ihlr-22950	248	18	in	in	ADP
ihlr-22950	248	19	204	204	NUM
ihlr-22950	248	20	countries	country	NOUN
ihlr-22950	248	21	.	.	PUNCT
ihlr-22950	249	1	u.s	u.s	PROPN
ihlr-22950	249	2	.	.	PROPN
ihlr-22950	249	3	nat’l	nat’l	PROPN
ihlr-22950	249	4	libr	libr	PROPN
ihlr-22950	249	5	.	.	PUNCT
ihlr-22950	250	1	of	of	ADP
ihlr-22950	250	2	med	med	PROPN
ihlr-22950	250	3	.	.	PROPN
ihlr-22950	250	4	,	,	PUNCT
ihlr-22950	250	5	https://clinicaltrials.gov	https://clinicaltrials.gov	PROPN
ihlr-22950	250	6	[	[	X
ihlr-22950	250	7	https://perma.cc/8269-62rt	https://perma.cc/8269-62rt	X
ihlr-22950	250	8	]	]	X
ihlr-22950	250	9	.	.	PUNCT
ihlr-22950	251	1	51	51	NUM
ihlr-22950	251	2	.	.	NUM
ihlr-22950	251	3	expanded	expand	VERB
ihlr-22950	251	4	access	access	NOUN
ihlr-22950	251	5	categories	category	NOUN
ihlr-22950	251	6	for	for	ADP
ihlr-22950	251	7	drugs	drug	NOUN
ihlr-22950	251	8	(	(	PUNCT
ihlr-22950	251	9	including	include	VERB
ihlr-22950	251	10	biologics	biologic	NOUN
ihlr-22950	251	11	)	)	PUNCT
ihlr-22950	251	12	,	,	PUNCT
ihlr-22950	251	13	u.s	u.s	PROPN
ihlr-22950	251	14	.	.	PROPN
ihlr-22950	251	15	food	food	PROPN
ihlr-22950	251	16	&	&	CCONJ
ihlr-22950	251	17	drug	drug	PROPN
ihlr-22950	251	18	admin	admin	PROPN
ihlr-22950	251	19	.	.	PROPN
ihlr-22950	251	20	,	,	PUNCT
ihlr-22950	252	1	https://www.fda.gov/newsevents/publichealthfocus/expandedaccesscompassionateuse/	https://www.fda.gov/newsevents/publichealthfocus/expandedaccesscompassionateuse/	PROPN
ihlr-22950	252	2	ucm431774.htm	ucm431774.htm	PROPN
ihlr-22950	253	1	[	[	X
ihlr-22950	253	2	https://perma.cc/57nw-tqv6	https://perma.cc/57nw-tqv6	X
ihlr-22950	253	3	]	]	X
ihlr-22950	253	4	(	(	PUNCT
ihlr-22950	253	5	last	last	ADJ
ihlr-22950	253	6	updated	update	VERB
ihlr-22950	253	7	jan	jan	PROPN
ihlr-22950	253	8	.	.	PROPN
ihlr-22950	253	9	4	4	NUM
ihlr-22950	253	10	,	,	PUNCT
ihlr-22950	253	11	2018	2018	NUM
ihlr-22950	253	12	)	)	PUNCT
ihlr-22950	253	13	.	.	PUNCT
ihlr-22950	254	1	52	52	NUM
ihlr-22950	254	2	.	.	PUNCT
ihlr-22950	254	3	expanded	expand	VERB
ihlr-22950	254	4	access	access	NOUN
ihlr-22950	254	5	inds	ind	NOUN
ihlr-22950	254	6	and	and	CCONJ
ihlr-22950	254	7	protocols	protocol	NOUN
ihlr-22950	254	8	2009	2009	NUM
ihlr-22950	254	9	-	-	SYM
ihlr-22950	254	10	2017	2017	NUM
ihlr-22950	254	11	,	,	PUNCT
ihlr-22950	254	12	u.s	u.s	PROPN
ihlr-22950	254	13	.	.	PROPN
ihlr-22950	254	14	food	food	PROPN
ihlr-22950	254	15	&	&	CCONJ
ihlr-22950	254	16	drug	drug	PROPN
ihlr-22950	254	17	admin	admin	PROPN
ihlr-22950	254	18	.	.	PROPN
ihlr-22950	254	19	,	,	PUNCT
ihlr-22950	254	20	https://www.fda.gov/newsevents/publichealthfocus/expandedaccesscompassionateuse/ucm4	https://www.fda.gov/newsevents/publichealthfocus/expandedaccesscompassionateuse/ucm4	PROPN
ihlr-22950	254	21	43572.htm	43572.htm	NOUN
ihlr-22950	255	1	[	[	X
ihlr-22950	255	2	https://perma.cc/74k3-g75z	https://perma.cc/74k3-g75z	X
ihlr-22950	255	3	]	]	X
ihlr-22950	255	4	(	(	PUNCT
ihlr-22950	255	5	last	last	ADJ
ihlr-22950	255	6	updated	update	VERB
ihlr-22950	255	7	feb	feb	PROPN
ihlr-22950	255	8	.	.	PROPN
ihlr-22950	255	9	21	21	NUM
ihlr-22950	255	10	,	,	PUNCT
ihlr-22950	255	11	2018	2018	NUM
ihlr-22950	255	12	)	)	PUNCT
ihlr-22950	255	13	.	.	PUNCT
ihlr-22950	256	1	see	see	VERB
ihlr-22950	256	2	appendix	appendix	VERB
ihlr-22950	256	3	i	i	PRON
ihlr-22950	256	4	at	at	ADP
ihlr-22950	256	5	the	the	DET
ihlr-22950	256	6	conclusion	conclusion	NOUN
ihlr-22950	256	7	of	of	ADP
ihlr-22950	256	8	this	this	DET
ihlr-22950	256	9	article	article	NOUN
ihlr-22950	256	10	.	.	PUNCT
ihlr-22950	257	1	see	see	AUX
ihlr-22950	257	2	also	also	ADV
ihlr-22950	257	3	expanded	expand	VERB
ihlr-22950	257	4	access	access	NOUN
ihlr-22950	257	5	inds	ind	NOUN
ihlr-22950	257	6	and	and	CCONJ
ihlr-22950	257	7	protocols	protocol	NOUN
ihlr-22950	257	8	2009	2009	NUM
ihlr-22950	257	9	-	-	SYM
ihlr-22950	257	10	2015	2015	NUM
ihlr-22950	257	11	,	,	PUNCT
ihlr-22950	257	12	u.s	u.s	PROPN
ihlr-22950	257	13	.	.	PROPN
ihlr-22950	257	14	food	food	PROPN
ihlr-22950	257	15	&	&	CCONJ
ihlr-22950	257	16	drug	drug	PROPN
ihlr-22950	257	17	admin	admin	PROPN
ihlr-22950	257	18	.	.	PROPN
ihlr-22950	257	19	,	,	PUNCT
ihlr-22950	257	20	https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredeveloped	https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredeveloped	PROPN
ihlr-22950	257	21	andapproved	andapprove	VERB
ihlr-22950	257	22	/	/	SYM
ihlr-22950	257	23	drugandbiologicapprovalreports/	drugandbiologicapprovalreports/	PROPN
ihlr-22950	257	24	indactivityreports	indactivityreport	NOUN
ihlr-22950	257	25	/	/	SYM
ihlr-22950	257	26	ucm373560	ucm373560	ADJ
ihlr-22950	257	27	.h	.h	PUNCT
ihlr-22950	258	1	tm	tm	PROPN
ihlr-22950	259	1	[	[	X
ihlr-22950	259	2	https://perma.cc/q9rt-2a2l	https://perma.cc/q9rt-2a2l	X
ihlr-22950	259	3	]	]	PUNCT
ihlr-22950	259	4	.	.	PUNCT
ihlr-22950	260	1	53	53	NUM
ihlr-22950	260	2	.	.	PUNCT
ihlr-22950	261	1	i	i	PRON
ihlr-22950	261	2	d.	d.	PROPN
ihlr-22950	261	3	see	see	AUX
ihlr-22950	261	4	also	also	ADV
ihlr-22950	261	5	expanded	expand	VERB
ihlr-22950	261	6	access	access	NOUN
ihlr-22950	261	7	to	to	ADP
ihlr-22950	261	8	investigational	investigational	ADJ
ihlr-22950	261	9	drugs	drug	NOUN
ihlr-22950	261	10	for	for	ADP
ihlr-22950	261	11	treatment	treatment	NOUN
ihlr-22950	261	12	use	use	NOUN
ihlr-22950	261	13	—	—	PUNCT
ihlr-22950	261	14	questions	question	NOUN
ihlr-22950	261	15	and	and	CCONJ
ihlr-22950	261	16	answers	answer	NOUN
ihlr-22950	261	17	,	,	PUNCT
ihlr-22950	261	18	guidance	guidance	NOUN
ihlr-22950	261	19	for	for	ADP
ihlr-22950	261	20	industry	industry	NOUN
ihlr-22950	261	21	,	,	PUNCT
ihlr-22950	261	22	u.s	u.s	PROPN
ihlr-22950	261	23	.	.	PROPN
ihlr-22950	261	24	dep’t	dep’t	PROPN
ihlr-22950	261	25	of	of	ADP
ihlr-22950	261	26	health	health	PROPN
ihlr-22950	261	27	and	and	CCONJ
ihlr-22950	261	28	human	human	ADJ
ihlr-22950	261	29	services	service	NOUN
ihlr-22950	261	30	,	,	PUNCT
ihlr-22950	261	31	food	food	NOUN
ihlr-22950	261	32	&	&	CCONJ
ihlr-22950	261	33	drug	drug	PROPN
ihlr-22950	261	34	admin	admin	PROPN
ihlr-22950	261	35	.	.	PROPN
ihlr-22950	261	36	,	,	PUNCT
ihlr-22950	261	37	ctr	ctr	PROPN
ihlr-22950	261	38	.	.	PROPN
ihlr-22950	262	1	for	for	ADP
ihlr-22950	262	2	drug	drug	NOUN
ihlr-22950	262	3	evaluation	evaluation	NOUN
ihlr-22950	262	4	and	and	CCONJ
ihlr-22950	262	5	res	re	NOUN
ihlr-22950	262	6	.	.	PROPN
ihlr-22950	262	7	,	,	PUNCT
ihlr-22950	262	8	ctr	ctr	PROPN
ihlr-22950	262	9	.	.	PUNCT
ihlr-22950	263	1	for	for	ADP
ihlr-22950	263	2	biologics	biologic	NOUN
ihlr-22950	263	3	evaluation	evaluation	NOUN
ihlr-22950	263	4	and	and	CCONJ
ihlr-22950	263	5	res	re	NOUN
ihlr-22950	263	6	.	.	PUNCT
ihlr-22950	264	1	(	(	PUNCT
ihlr-22950	264	2	oct	oct	PROPN
ihlr-22950	264	3	.	.	PROPN
ihlr-22950	264	4	2017	2017	NUM
ihlr-22950	264	5	)	)	PUNCT
ihlr-22950	264	6	,	,	PUNCT
ihlr-22950	264	7	https://www.fda.gov/downloads/drugs/guidances/ucm351261.pdf	https://www.fda.gov/downloads/drugs/guidances/ucm351261.pdf	NOUN
ihlr-22950	264	8	.	.	PUNCT
ihlr-22950	265	1	“	"	PUNCT
ihlr-22950	265	2	a	a	DET
ihlr-22950	265	3	physician	physician	NOUN
ihlr-22950	265	4	submitting	submit	VERB
ihlr-22950	265	5	an	an	DET
ihlr-22950	265	6	individual	individual	ADJ
ihlr-22950	265	7	patient	patient	NOUN
ihlr-22950	265	8	expanded	expand	VERB
ihlr-22950	265	9	access	access	NOUN
ihlr-22950	265	10	ind	ind	NOUN
ihlr-22950	265	11	using	use	VERB
ihlr-22950	265	12	form	form	NOUN
ihlr-22950	265	13	fda	fda	PROPN
ihlr-22950	265	14	3926	3926	NUM
ihlr-22950	265	15	may	may	AUX
ihlr-22950	265	16	select	select	VERB
ihlr-22950	265	17	the	the	DET
ihlr-22950	265	18	appropriate	appropriate	ADJ
ihlr-22950	265	19	box	box	NOUN
ihlr-22950	265	20	on	on	ADP
ihlr-22950	265	21	that	that	DET
ihlr-22950	265	22	form	form	NOUN
ihlr-22950	265	23	to	to	PART
ihlr-22950	265	24	request	request	VERB
ihlr-22950	265	25	a	a	DET
ihlr-22950	265	26	waiver	waiver	NOUN
ihlr-22950	265	27	under	under	ADP
ihlr-22950	265	28	§	§	PROPN
ihlr-22950	265	29	56.105	56.105	NUM
ihlr-22950	265	30	of	of	ADP
ihlr-22950	265	31	the	the	DET
ihlr-22950	265	32	requirements	requirement	NOUN
ihlr-22950	265	33	in	in	ADP
ihlr-22950	265	34	§	§	PROPN
ihlr-22950	265	35	56.108(c	56.108(c	PROPN
ihlr-22950	265	36	)	)	PUNCT
ihlr-22950	265	37	,	,	PUNCT
ihlr-22950	265	38	which	which	PRON
ihlr-22950	265	39	relate	relate	VERB
ihlr-22950	265	40	to	to	ADP
ihlr-22950	265	41	full	full	ADJ
ihlr-22950	265	42	irb	irb	NOUN
ihlr-22950	265	43	review	review	NOUN
ihlr-22950	265	44	.	.	PUNCT
ihlr-22950	266	1	fda	fda	PROPN
ihlr-22950	266	2	concludes	conclude	VERB
ihlr-22950	266	3	that	that	SCONJ
ihlr-22950	266	4	such	such	DET
ihlr-22950	266	5	a	a	DET
ihlr-22950	266	6	waiver	waiver	NOUN
ihlr-22950	266	7	is	be	AUX
ihlr-22950	266	8	appropriate	appropriate	ADJ
ihlr-22950	266	9	for	for	ADP
ihlr-22950	266	10	individual	individual	ADJ
ihlr-22950	266	11	patient	patient	NOUN
ihlr-22950	266	12	expanded	expand	VERB
ihlr-22950	266	13	access	access	NOUN
ihlr-22950	266	14	inds	ind	VERB
ihlr-22950	266	15	when	when	SCONJ
ihlr-22950	266	16	the	the	DET
ihlr-22950	266	17	physician	physician	NOUN
ihlr-22950	266	18	obtains	obtain	VERB
ihlr-22950	266	19	concurrence	concurrence	NOUN
ihlr-22950	266	20	by	by	ADP
ihlr-22950	266	21	the	the	DET
ihlr-22950	266	22	irb	irb	PROPN
ihlr-22950	266	23	chairperson	chairperson	NOUN
ihlr-22950	266	24	or	or	CCONJ
ihlr-22950	266	25	another	another	DET
ihlr-22950	266	26	designated	designate	VERB
ihlr-22950	266	27	irb	irb	NOUN
ihlr-22950	266	28	member	member	NOUN
ihlr-22950	266	29	before	before	SCONJ
ihlr-22950	266	30	treatment	treatment	NOUN
ihlr-22950	266	31	use	use	NOUN
ihlr-22950	266	32	begins	begin	VERB
ihlr-22950	266	33	.	.	PUNCT
ihlr-22950	267	1	a	a	DET
ihlr-22950	267	2	physician	physician	NOUN
ihlr-22950	267	3	submitting	submit	VERB
ihlr-22950	267	4	an	an	DET
ihlr-22950	267	5	individual	individual	ADJ
ihlr-22950	267	6	patient	patient	NOUN
ihlr-22950	267	7	expanded	expand	VERB
ihlr-22950	267	8	access	access	NOUN
ihlr-22950	267	9	ind	ind	NOUN
ihlr-22950	267	10	using	use	VERB
ihlr-22950	267	11	form	form	NOUN
ihlr-22950	267	12	fda	fda	PROPN
ihlr-22950	267	13	1571	1571	NUM
ihlr-22950	267	14	may	may	AUX
ihlr-22950	267	15	include	include	VERB
ihlr-22950	267	16	a	a	DET
ihlr-22950	267	17	separate	separate	ADJ
ihlr-22950	267	18	waiver	waiver	NOUN
ihlr-22950	267	19	request	request	NOUN
ihlr-22950	267	20	with	with	ADP
ihlr-22950	267	21	the	the	DET
ihlr-22950	267	22	application	application	NOUN
ihlr-22950	267	23	.	.	PUNCT
ihlr-22950	267	24	”	"	PUNCT
ihlr-22950	268	1	i	i	PRON
ihlr-22950	268	2	d.	d.	VERB
ihlr-22950	268	3	at	at	ADP
ihlr-22950	268	4	6	6	NUM
ihlr-22950	268	5	.	.	PUNCT
ihlr-22950	268	6	further	far	ADV
ihlr-22950	268	7	,	,	PUNCT
ihlr-22950	268	8	the	the	DET
ihlr-22950	268	9	guidance	guidance	NOUN
ihlr-22950	268	10	defines	define	NOUN
ihlr-22950	268	11	and	and	CCONJ
ihlr-22950	268	12	institutional	institutional	ADJ
ihlr-22950	268	13	review	review	NOUN
ihlr-22950	268	14	board	board	NOUN
ihlr-22950	268	15	(	(	PUNCT
ihlr-22950	268	16	irb	irb	PROPN
ihlr-22950	268	17	)	)	PUNCT
ihlr-22950	268	18	as	as	SCONJ
ihlr-22950	268	19	follows	follow	VERB
ihlr-22950	268	20	.	.	PUNCT
ihlr-22950	269	1	“	"	PUNCT
ihlr-22950	269	2	an	an	DET
ihlr-22950	269	3	institutional	institutional	ADJ
ihlr-22950	269	4	review	review	NOUN
ihlr-22950	269	5	board	board	NOUN
ihlr-22950	269	6	(	(	PUNCT
ihlr-22950	269	7	irb	irb	PROPN
ihlr-22950	269	8	)	)	PUNCT
ihlr-22950	269	9	means	mean	VERB
ihlr-22950	269	10	any	any	DET
ihlr-22950	269	11	board	board	NOUN
ihlr-22950	269	12	,	,	PUNCT
ihlr-22950	269	13	committee	committee	NOUN
ihlr-22950	269	14	,	,	PUNCT
ihlr-22950	269	15	or	or	CCONJ
ihlr-22950	269	16	other	other	ADJ
ihlr-22950	269	17	group	group	NOUN
ihlr-22950	269	18	formally	formally	ADV
ihlr-22950	269	19	designated	designate	VERB
ihlr-22950	269	20	by	by	ADP
ihlr-22950	269	21	an	an	DET
ihlr-22950	269	22	institution	institution	NOUN
ihlr-22950	269	23	to	to	PART
ihlr-22950	269	24	review	review	VERB
ihlr-22950	269	25	,	,	PUNCT
ihlr-22950	269	26	to	to	PART
ihlr-22950	269	27	approve	approve	VERB
ihlr-22950	269	28	the	the	DET
ihlr-22950	269	29	initiation	initiation	NOUN
ihlr-22950	269	30	of	of	ADP
ihlr-22950	269	31	,	,	PUNCT
ihlr-22950	269	32	and	and	CCONJ
ihlr-22950	269	33	to	to	PART
ihlr-22950	269	34	conduct	conduct	VERB
ihlr-22950	269	35	periodic	periodic	ADJ
ihlr-22950	269	36	review	review	NOUN
ihlr-22950	269	37	of	of	ADP
ihlr-22950	269	38	biomedical	biomedical	ADJ
ihlr-22950	269	39	research	research	NOUN
ihlr-22950	269	40	involving	involve	VERB
ihlr-22950	269	41	human	human	ADJ
ihlr-22950	269	42	subjects	subject	NOUN
ihlr-22950	269	43	.	.	PUNCT
ihlr-22950	270	1	the	the	DET
ihlr-22950	270	2	primary	primary	ADJ
ihlr-22950	270	3	purpose	purpose	NOUN
ihlr-22950	270	4	of	of	ADP
ihlr-22950	270	5	irb	irb	NOUN
ihlr-22950	270	6	review	review	NOUN
ihlr-22950	270	7	is	be	AUX
ihlr-22950	270	8	to	to	PART
ihlr-22950	270	9	assure	assure	VERB
ihlr-22950	270	10	that	that	SCONJ
ihlr-22950	270	11	the	the	DET
ihlr-22950	270	12	rights	right	NOUN
ihlr-22950	270	13	and	and	CCONJ
ihlr-22950	270	14	welfare	welfare	NOUN
ihlr-22950	270	15	of	of	ADP
ihlr-22950	270	16	human	human	ADJ
ihlr-22950	270	17	subjects	subject	NOUN
ihlr-22950	270	18	are	be	AUX
ihlr-22950	270	19	protected	protect	VERB
ihlr-22950	270	20	,	,	PUNCT
ihlr-22950	270	21	including	include	VERB
ihlr-22950	270	22	by	by	ADP
ihlr-22950	270	23	determining	determine	VERB
ihlr-22950	270	24	that	that	DET
ihlr-22950	270	25	informed	informed	ADJ
ihlr-22950	270	26	consent	consent	NOUN
ihlr-22950	270	27	is	be	AUX
ihlr-22950	270	28	obtained	obtain	VERB
ihlr-22950	270	29	in	in	ADP
ihlr-22950	270	30	accordance	accordance	NOUN
ihlr-22950	270	31	with	with	ADP
ihlr-22950	270	32	and	and	CCONJ
ihlr-22950	270	33	to	to	ADP
ihlr-22950	270	34	the	the	DET
ihlr-22950	270	35	extent	extent	NOUN
ihlr-22950	270	36	required	require	VERB
ihlr-22950	270	37	by	by	ADP
ihlr-22950	270	38	federal	federal	ADJ
ihlr-22950	270	39	requirements	requirement	NOUN
ihlr-22950	270	40	.	.	PUNCT
ihlr-22950	271	1	institutions	institution	NOUN
ihlr-22950	271	2	may	may	AUX
ihlr-22950	271	3	have	have	VERB
ihlr-22950	271	4	their	their	PRON
ihlr-22950	271	5	own	own	ADJ
ihlr-22950	271	6	irb	irb	NOUN
ihlr-22950	271	7	to	to	PART
ihlr-22950	271	8	oversee	oversee	VERB
ihlr-22950	271	9	human	human	ADJ
ihlr-22950	271	10	subjects	subject	NOUN
ihlr-22950	271	11	research	research	NOUN
ihlr-22950	271	12	conducted	conduct	VERB
ihlr-22950	271	13	within	within	ADP
ihlr-22950	271	14	the	the	DET
ihlr-22950	271	15	institution	institution	NOUN
ihlr-22950	271	16	or	or	CCONJ
ihlr-22950	271	17	by	by	ADP
ihlr-22950	271	18	the	the	DET
ihlr-22950	271	19	staff	staff	NOUN
ihlr-22950	271	20	of	of	ADP
ihlr-22950	271	21	the	the	DET
ihlr-22950	271	22	institution	institution	NOUN
ihlr-22950	271	23	.	.	PUNCT
ihlr-22950	272	1	if	if	SCONJ
ihlr-22950	272	2	the	the	DET
ihlr-22950	272	3	patient	patient	NOUN
ihlr-22950	272	4	’s	’s	PART
ihlr-22950	272	5	physician	physician	NOUN
ihlr-22950	272	6	does	do	AUX
ihlr-22950	272	7	not	not	PART
ihlr-22950	272	8	have	have	VERB
ihlr-22950	272	9	access	access	NOUN
ihlr-22950	272	10	to	to	ADP
ihlr-22950	272	11	a	a	DET
ihlr-22950	272	12	local	local	ADJ
ihlr-22950	272	13	irb	irb	NOUN
ihlr-22950	272	14	,	,	PUNCT
ihlr-22950	272	15	an	an	DET
ihlr-22950	272	16	independent	independent	ADJ
ihlr-22950	272	17	irb	irb	NOUN
ihlr-22950	272	18	may	may	AUX
ihlr-22950	272	19	be	be	AUX
ihlr-22950	272	20	used	use	VERB
ihlr-22950	272	21	.	.	PUNCT
ihlr-22950	273	1	the	the	DET
ihlr-22950	273	2	department	department	PROPN
ihlr-22950	273	3	of	of	ADP
ihlr-22950	273	4	health	health	PROPN
ihlr-22950	273	5	and	and	CCONJ
ihlr-22950	273	6	human	human	PROPN
ihlr-22950	273	7	services	service	NOUN
ihlr-22950	273	8	’	'	PUNCT
ihlr-22950	273	9	office	office	NOUN
ihlr-22950	273	10	for	for	ADP
ihlr-22950	273	11	human	human	ADJ
ihlr-22950	273	12	research	research	NOUN
ihlr-22950	273	13	protections	protection	NOUN
ihlr-22950	273	14	maintains	maintain	VERB
ihlr-22950	273	15	a	a	DET
ihlr-22950	273	16	database	database	NOUN
ihlr-22950	273	17	of	of	ADP
ihlr-22950	273	18	registered	register	VERB
ihlr-22950	273	19	irbs	irb	NOUN
ihlr-22950	273	20	.	.	PUNCT
ihlr-22950	273	21	”	"	PUNCT
ihlr-22950	274	1	i	i	PRON
ihlr-22950	274	2	d.	d.	VERB
ihlr-22950	274	3	at	at	ADP
ihlr-22950	274	4	5	5	NUM
ihlr-22950	274	5	,	,	PUNCT
ihlr-22950	274	6	n.	n.	NOUN
ihlr-22950	274	7	11	11	NUM
ihlr-22950	274	8	.	.	PUNCT
ihlr-22950	275	1	54	54	NUM
ihlr-22950	275	2	.	.	NUM
ihlr-22950	275	3	21	21	NUM
ihlr-22950	275	4	c.f.r	c.f.r	NOUN
ihlr-22950	275	5	.	.	PUNCT
ihlr-22950	276	1	§	§	PROPN
ihlr-22950	276	2	56.104	56.104	NUM
ihlr-22950	276	3	(	(	PUNCT
ihlr-22950	276	4	2018	2018	NUM
ihlr-22950	276	5	)	)	PUNCT
ihlr-22950	276	6	.	.	PUNCT
ihlr-22950	277	1	2018	2018	NUM
ihlr-22950	277	2	]	]	PUNCT
ihlr-22950	277	3	the	the	DET
ihlr-22950	277	4	latest	late	ADJ
ihlr-22950	277	5	“	"	PUNCT
ihlr-22950	277	6	federal	federal	ADJ
ihlr-22950	277	7	movement	movement	NOUN
ihlr-22950	277	8	”	"	PUNCT
ihlr-22950	277	9	in	in	ADP
ihlr-22950	277	10	the	the	DET
ihlr-22950	277	11	food	food	NOUN
ihlr-22950	277	12	and	and	CCONJ
ihlr-22950	277	13	drug	drug	NOUN
ihlr-22950	277	14	law	law	NOUN
ihlr-22950	277	15	arena	arena	NOUN
ihlr-22950	277	16	109	109	NUM
ihlr-22950	277	17	investigational	investigational	ADJ
ihlr-22950	277	18	medical	medical	ADJ
ihlr-22950	277	19	product	product	NOUN
ihlr-22950	277	20	.	.	PUNCT
ihlr-22950	278	1	the	the	DET
ihlr-22950	278	2	health	health	NOUN
ihlr-22950	278	3	care	care	NOUN
ihlr-22950	278	4	practitioner	practitioner	NOUN
ihlr-22950	278	5	is	be	AUX
ihlr-22950	278	6	involved	involve	VERB
ihlr-22950	278	7	as	as	ADV
ihlr-22950	278	8	well	well	ADV
ihlr-22950	278	9	as	as	ADP
ihlr-22950	278	10	the	the	DET
ihlr-22950	278	11	insurance	insurance	NOUN
ihlr-22950	278	12	company	company	NOUN
ihlr-22950	278	13	.	.	PUNCT
ihlr-22950	279	1	as	as	SCONJ
ihlr-22950	279	2	noted	note	VERB
ihlr-22950	279	3	,	,	PUNCT
ihlr-22950	279	4	several	several	ADJ
ihlr-22950	279	5	entities	entity	NOUN
ihlr-22950	279	6	must	must	AUX
ihlr-22950	279	7	acquiesce	acquiesce	VERB
ihlr-22950	279	8	to	to	ADP
ihlr-22950	279	9	the	the	DET
ihlr-22950	279	10	expanded	expand	VERB
ihlr-22950	279	11	use	use	NOUN
ihlr-22950	279	12	.	.	PUNCT
ihlr-22950	280	1	iv	iv	X
ihlr-22950	280	2	.	.	PUNCT
ihlr-22950	280	3	federal	federal	ADJ
ihlr-22950	280	4	primer	primer	NOUN
ihlr-22950	280	5	mechanisms	mechanism	NOUN
ihlr-22950	280	6	investigational	investigational	ADJ
ihlr-22950	280	7	new	new	ADJ
ihlr-22950	280	8	drugs	drug	NOUN
ihlr-22950	280	9	(	(	PUNCT
ihlr-22950	280	10	ind	ind	NOUN
ihlr-22950	280	11	)	)	PUNCT
ihlr-22950	280	12	and	and	CCONJ
ihlr-22950	280	13	devices	device	NOUN
ihlr-22950	280	14	investigational	investigational	ADJ
ihlr-22950	280	15	new	new	ADJ
ihlr-22950	280	16	drugs	drug	NOUN
ihlr-22950	280	17	(	(	PUNCT
ihlr-22950	280	18	inds	inds	PROPN
ihlr-22950	280	19	)	)	PUNCT
ihlr-22950	280	20	a	a	DET
ihlr-22950	280	21	review	review	NOUN
ihlr-22950	280	22	of	of	ADP
ihlr-22950	280	23	the	the	DET
ihlr-22950	280	24	parameters	parameter	NOUN
ihlr-22950	280	25	for	for	ADP
ihlr-22950	280	26	investigational	investigational	ADJ
ihlr-22950	280	27	new	new	ADJ
ihlr-22950	280	28	drugs	drug	NOUN
ihlr-22950	280	29	is	be	AUX
ihlr-22950	280	30	daunting	daunt	VERB
ihlr-22950	280	31	.	.	PUNCT
ihlr-22950	281	1	yet	yet	ADV
ihlr-22950	281	2	,	,	PUNCT
ihlr-22950	281	3	in	in	ADP
ihlr-22950	281	4	a	a	DET
ihlr-22950	281	5	sense	sense	NOUN
ihlr-22950	281	6	it	it	PRON
ihlr-22950	281	7	should	should	AUX
ihlr-22950	281	8	be	be	AUX
ihlr-22950	281	9	in	in	ADP
ihlr-22950	281	10	order	order	NOUN
ihlr-22950	281	11	to	to	PART
ihlr-22950	281	12	protect	protect	VERB
ihlr-22950	281	13	the	the	DET
ihlr-22950	281	14	human	human	ADJ
ihlr-22950	281	15	being	being	NOUN
ihlr-22950	281	16	.	.	PUNCT
ihlr-22950	282	1	what	what	PRON
ihlr-22950	282	2	should	should	AUX
ihlr-22950	282	3	not	not	PART
ihlr-22950	282	4	be	be	AUX
ihlr-22950	282	5	formidable	formidable	ADJ
ihlr-22950	282	6	is	be	AUX
ihlr-22950	282	7	the	the	DET
ihlr-22950	282	8	process	process	NOUN
ihlr-22950	282	9	to	to	PART
ihlr-22950	282	10	obtain	obtain	VERB
ihlr-22950	282	11	a	a	DET
ihlr-22950	282	12	potential	potential	ADJ
ihlr-22950	282	13	lifesaving	lifesaving	NOUN
ihlr-22950	282	14	treatment	treatment	NOUN
ihlr-22950	282	15	.	.	PUNCT
ihlr-22950	283	1	that	that	PRON
ihlr-22950	283	2	is	is	ADV
ihlr-22950	283	3	,	,	PUNCT
ihlr-22950	283	4	the	the	DET
ihlr-22950	283	5	issue	issue	NOUN
ihlr-22950	283	6	and	and	CCONJ
ihlr-22950	283	7	perhaps	perhaps	ADV
ihlr-22950	283	8	the	the	DET
ihlr-22950	283	9	state	state	NOUN
ihlr-22950	283	10	right	right	NOUN
ihlr-22950	283	11	-	-	PUNCT
ihlr-22950	283	12	to	to	PART
ihlr-22950	283	13	-	-	PUNCT
ihlr-22950	283	14	try	try	VERB
ihlr-22950	283	15	and	and	CCONJ
ihlr-22950	283	16	now	now	ADV
ihlr-22950	283	17	the	the	DET
ihlr-22950	283	18	federal	federal	ADJ
ihlr-22950	283	19	right	right	NOUN
ihlr-22950	283	20	-	-	PUNCT
ihlr-22950	283	21	to	to	PART
ihlr-22950	283	22	-	-	PUNCT
ihlr-22950	283	23	try	try	VERB
ihlr-22950	283	24	act	act	NOUN
ihlr-22950	283	25	is	be	AUX
ihlr-22950	283	26	the	the	DET
ihlr-22950	283	27	panacea	panacea	NOUN
ihlr-22950	283	28	in	in	ADP
ihlr-22950	283	29	terms	term	NOUN
ihlr-22950	283	30	of	of	ADP
ihlr-22950	283	31	a	a	DET
ihlr-22950	283	32	patient	patient	NOUN
ihlr-22950	283	33	’s	’s	PART
ihlr-22950	283	34	right	right	NOUN
ihlr-22950	283	35	-	-	PUNCT
ihlr-22950	283	36	to	to	ADP
ihlr-22950	283	37	-	-	PUNCT
ihlr-22950	283	38	know	know	VERB
ihlr-22950	283	39	that	that	SCONJ
ihlr-22950	283	40	there	there	PRON
ihlr-22950	283	41	is	be	VERB
ihlr-22950	283	42	possibly	possibly	ADV
ihlr-22950	283	43	an	an	DET
ihlr-22950	283	44	experimental	experimental	ADJ
ihlr-22950	283	45	drug	drug	NOUN
ihlr-22950	283	46	.	.	PUNCT
ihlr-22950	284	1	the	the	DET
ihlr-22950	284	2	panacea	panacea	NOUN
ihlr-22950	284	3	is	be	AUX
ihlr-22950	284	4	a	a	DET
ihlr-22950	284	5	right	right	NOUN
ihlr-22950	284	6	-	-	PUNCT
ihlr-22950	284	7	to	to	AUX
ihlr-22950	284	8	-	-	PUNCT
ihlr-22950	284	9	request	request	VERB
ihlr-22950	284	10	a	a	DET
ihlr-22950	284	11	potentially	potentially	ADV
ihlr-22950	284	12	life	life	NOUN
ihlr-22950	284	13	extending	extend	VERB
ihlr-22950	284	14	treatment	treatment	NOUN
ihlr-22950	284	15	with	with	ADP
ihlr-22950	284	16	the	the	DET
ihlr-22950	284	17	caveat	caveat	NOUN
ihlr-22950	284	18	that	that	SCONJ
ihlr-22950	284	19	the	the	DET
ihlr-22950	284	20	treatment	treatment	NOUN
ihlr-22950	284	21	is	be	AUX
ihlr-22950	284	22	not	not	PART
ihlr-22950	284	23	necessarily	necessarily	ADV
ihlr-22950	284	24	a	a	DET
ihlr-22950	284	25	cure	cure	NOUN
ihlr-22950	284	26	and	and	CCONJ
ihlr-22950	284	27	the	the	DET
ihlr-22950	284	28	patient	patient	NOUN
ihlr-22950	284	29	may	may	AUX
ihlr-22950	284	30	not	not	PART
ihlr-22950	284	31	receive	receive	VERB
ihlr-22950	284	32	the	the	DET
ihlr-22950	284	33	treatment	treatment	NOUN
ihlr-22950	284	34	for	for	ADP
ihlr-22950	284	35	a	a	DET
ihlr-22950	284	36	variety	variety	NOUN
ihlr-22950	284	37	of	of	ADP
ihlr-22950	284	38	reasons	reason	NOUN
ihlr-22950	284	39	such	such	ADJ
ihlr-22950	284	40	as	as	ADP
ihlr-22950	284	41	cost	cost	NOUN
ihlr-22950	284	42	and	and	CCONJ
ihlr-22950	284	43	manufacturer	manufacturer	NOUN
ihlr-22950	284	44	willingness	willingness	NOUN
ihlr-22950	284	45	to	to	PART
ihlr-22950	284	46	supply	supply	VERB
ihlr-22950	284	47	the	the	DET
ihlr-22950	284	48	product	product	NOUN
ihlr-22950	284	49	.	.	PUNCT
ihlr-22950	285	1	in	in	ADP
ihlr-22950	285	2	brief	brief	ADJ
ihlr-22950	285	3	,	,	PUNCT
ihlr-22950	285	4	the	the	DET
ihlr-22950	285	5	types	type	NOUN
ihlr-22950	285	6	of	of	ADP
ihlr-22950	285	7	investigator	investigator	NOUN
ihlr-22950	285	8	new	new	ADJ
ihlr-22950	285	9	drugs	drug	NOUN
ihlr-22950	285	10	(	(	PUNCT
ihlr-22950	285	11	ind	ind	NOUN
ihlr-22950	285	12	)	)	PUNCT
ihlr-22950	285	13	include	include	VERB
ihlr-22950	285	14	the	the	DET
ihlr-22950	285	15	following	follow	VERB
ihlr-22950	285	16	:	:	PUNCT
ihlr-22950	285	17	investigator	investigator	NOUN
ihlr-22950	285	18	ind	ind	NOUN
ihlr-22950	285	19	,	,	PUNCT
ihlr-22950	285	20	emergency	emergency	NOUN
ihlr-22950	285	21	use	use	VERB
ihlr-22950	285	22	ind	ind	NOUN
ihlr-22950	285	23	,	,	PUNCT
ihlr-22950	285	24	and	and	CCONJ
ihlr-22950	285	25	treatment	treatment	NOUN
ihlr-22950	285	26	ind.55	ind.55	NOUN
ihlr-22950	285	27	once	once	SCONJ
ihlr-22950	285	28	a	a	DET
ihlr-22950	285	29	sponsor	sponsor	NOUN
ihlr-22950	285	30	submits	submit	VERB
ihlr-22950	285	31	an	an	DET
ihlr-22950	285	32	ind	ind	NOUN
ihlr-22950	285	33	application	application	NOUN
ihlr-22950	285	34	,	,	PUNCT
ihlr-22950	285	35	there	there	PRON
ihlr-22950	285	36	is	be	VERB
ihlr-22950	285	37	a	a	DET
ihlr-22950	285	38	thirty	thirty	NUM
ihlr-22950	285	39	-	-	PUNCT
ihlr-22950	285	40	day	day	NOUN
ihlr-22950	285	41	waiting	waiting	NOUN
ihlr-22950	285	42	period	period	NOUN
ihlr-22950	285	43	before	before	ADP
ihlr-22950	285	44	commencing	commence	VERB
ihlr-22950	285	45	any	any	DET
ihlr-22950	285	46	clinical	clinical	ADJ
ihlr-22950	285	47	trials	trial	NOUN
ihlr-22950	285	48	,	,	PUNCT
ihlr-22950	285	49	for	for	ADP
ihlr-22950	285	50	safety	safety	NOUN
ihlr-22950	285	51	reasons.56	reasons.56	ADJ
ihlr-22950	285	52	thirty	thirty	NUM
ihlr-22950	285	53	days	day	NOUN
ihlr-22950	285	54	is	be	AUX
ihlr-22950	285	55	too	too	ADV
ihlr-22950	285	56	lengthy	lengthy	ADJ
ihlr-22950	285	57	for	for	ADP
ihlr-22950	285	58	those	those	PRON
ihlr-22950	285	59	who	who	PRON
ihlr-22950	285	60	are	be	AUX
ihlr-22950	285	61	desperately	desperately	ADV
ihlr-22950	285	62	ill	ill	ADJ
ihlr-22950	285	63	.	.	PUNCT
ihlr-22950	286	1	that	that	PRON
ihlr-22950	286	2	is	be	AUX
ihlr-22950	286	3	why	why	SCONJ
ihlr-22950	286	4	fda	fda	PROPN
ihlr-22950	286	5	has	have	VERB
ihlr-22950	286	6	a	a	DET
ihlr-22950	286	7	compassionate	compassionate	ADJ
ihlr-22950	286	8	expanded	expand	VERB
ihlr-22950	286	9	use	use	NOUN
ihlr-22950	286	10	program	program	NOUN
ihlr-22950	286	11	available.57	available.57	PROPN
ihlr-22950	286	12	investigator	investigator	PROPN
ihlr-22950	286	13	ind	ind	NOUN
ihlr-22950	286	14	submissions	submission	NOUN
ihlr-22950	286	15	—	—	PUNCT
ihlr-22950	286	16	by	by	ADP
ihlr-22950	286	17	a	a	DET
ihlr-22950	286	18	physician	physician	NOUN
ihlr-22950	286	19	and	and	CCONJ
ihlr-22950	286	20	the	the	DET
ihlr-22950	286	21	investigation	investigation	NOUN
ihlr-22950	286	22	is	be	AUX
ihlr-22950	286	23	under	under	ADP
ihlr-22950	286	24	direct	direct	ADJ
ihlr-22950	286	25	control	control	NOUN
ihlr-22950	286	26	of	of	ADP
ihlr-22950	286	27	the	the	DET
ihlr-22950	286	28	physician	physician	NOUN
ihlr-22950	286	29	.	.	PUNCT
ihlr-22950	287	1	for	for	ADP
ihlr-22950	287	2	example	example	NOUN
ihlr-22950	287	3	,	,	PUNCT
ihlr-22950	287	4	a	a	DET
ihlr-22950	287	5	physician	physician	NOUN
ihlr-22950	287	6	could	could	AUX
ihlr-22950	287	7	propose	propose	VERB
ihlr-22950	287	8	a	a	DET
ihlr-22950	287	9	research	research	NOUN
ihlr-22950	287	10	ind	ind	NOUN
ihlr-22950	287	11	to	to	PART
ihlr-22950	287	12	suggest	suggest	VERB
ihlr-22950	287	13	studying	study	VERB
ihlr-22950	287	14	an	an	DET
ihlr-22950	287	15	unapproved	unapproved	ADJ
ihlr-22950	287	16	drug	drug	NOUN
ihlr-22950	287	17	.	.	PUNCT
ihlr-22950	288	1	a	a	DET
ihlr-22950	288	2	physician	physician	NOUN
ihlr-22950	288	3	could	could	AUX
ihlr-22950	288	4	also	also	ADV
ihlr-22950	288	5	propose	propose	VERB
ihlr-22950	288	6	a	a	DET
ihlr-22950	288	7	research	research	NOUN
ihlr-22950	288	8	ind	ind	NOUN
ihlr-22950	288	9	for	for	ADP
ihlr-22950	288	10	a	a	DET
ihlr-22950	288	11	new	new	ADJ
ihlr-22950	288	12	indication	indication	NOUN
ihlr-22950	288	13	or	or	CCONJ
ihlr-22950	288	14	for	for	ADP
ihlr-22950	288	15	a	a	DET
ihlr-22950	288	16	new	new	ADJ
ihlr-22950	288	17	patient	patient	NOUN
ihlr-22950	288	18	population.58	population.58	NOUN
ihlr-22950	288	19	emergency	emergency	NOUN
ihlr-22950	288	20	use	use	NOUN
ihlr-22950	288	21	inds	ind	NOUN
ihlr-22950	288	22	—	—	PUNCT
ihlr-22950	288	23	fda	fda	PROPN
ihlr-22950	288	24	permits	permit	VERB
ihlr-22950	288	25	use	use	NOUN
ihlr-22950	288	26	of	of	ADP
ihlr-22950	288	27	an	an	DET
ihlr-22950	288	28	experimental	experimental	ADJ
ihlr-22950	288	29	drug	drug	NOUN
ihlr-22950	288	30	in	in	ADP
ihlr-22950	288	31	an	an	DET
ihlr-22950	288	32	emergency	emergency	NOUN
ihlr-22950	288	33	situation	situation	NOUN
ihlr-22950	288	34	.	.	PUNCT
ihlr-22950	289	1	this	this	PRON
ihlr-22950	289	2	means	mean	VERB
ihlr-22950	289	3	that	that	SCONJ
ihlr-22950	289	4	there	there	PRON
ihlr-22950	289	5	is	be	VERB
ihlr-22950	289	6	insufficient	insufficient	ADJ
ihlr-22950	289	7	time	time	NOUN
ihlr-22950	289	8	for	for	ADP
ihlr-22950	289	9	submission	submission	NOUN
ihlr-22950	289	10	of	of	ADP
ihlr-22950	289	11	an	an	DET
ihlr-22950	289	12	ind.59	ind.59	PROPN
ihlr-22950	289	13	an	an	DET
ihlr-22950	289	14	emergency	emergency	NOUN
ihlr-22950	289	15	ind	ind	NOUN
ihlr-22950	289	16	can	can	AUX
ihlr-22950	289	17	be	be	AUX
ihlr-22950	289	18	used	use	VERB
ihlr-22950	289	19	for	for	ADP
ihlr-22950	289	20	those	those	DET
ihlr-22950	289	21	patients	patient	NOUN
ihlr-22950	289	22	who	who	PRON
ihlr-22950	289	23	do	do	AUX
ihlr-22950	289	24	not	not	PART
ihlr-22950	289	25	satisfy	satisfy	VERB
ihlr-22950	289	26	the	the	DET
ihlr-22950	289	27	conditions	condition	NOUN
ihlr-22950	289	28	of	of	ADP
ihlr-22950	289	29	an	an	DET
ihlr-22950	289	30	existing	exist	VERB
ihlr-22950	289	31	study	study	NOUN
ihlr-22950	289	32	protocol	protocol	NOUN
ihlr-22950	289	33	or	or	CCONJ
ihlr-22950	289	34	possibly	possibly	ADV
ihlr-22950	289	35	if	if	SCONJ
ihlr-22950	289	36	there	there	PRON
ihlr-22950	289	37	is	be	VERB
ihlr-22950	289	38	no	no	DET
ihlr-22950	289	39	approved	approve	VERB
ihlr-22950	289	40	study	study	NOUN
ihlr-22950	289	41	protocol.60	protocol.60	PROPN
ihlr-22950	289	42	55	55	NUM
ihlr-22950	289	43	.	.	PUNCT
ihlr-22950	289	44	21	21	NUM
ihlr-22950	289	45	c.	c.	PROPN
ihlr-22950	289	46	f.	f.	PROPN
ihlr-22950	289	47	r.	r.	PROPN
ihlr-22950	289	48	§	§	PROPN
ihlr-22950	289	49	312.34	312.34	NUM
ihlr-22950	289	50	(	(	PUNCT
ihlr-22950	289	51	2018	2018	NUM
ihlr-22950	289	52	)	)	PUNCT
ihlr-22950	289	53	(	(	PUNCT
ihlr-22950	289	54	treatment	treatment	NOUN
ihlr-22950	289	55	use	use	NOUN
ihlr-22950	289	56	of	of	ADP
ihlr-22950	289	57	an	an	DET
ihlr-22950	289	58	investigational	investigational	ADJ
ihlr-22950	289	59	new	new	ADJ
ihlr-22950	289	60	drug	drug	NOUN
ihlr-22950	289	61	)	)	PUNCT
ihlr-22950	289	62	.	.	PUNCT
ihlr-22950	290	1	56	56	NUM
ihlr-22950	290	2	.	.	NOUN
ihlr-22950	290	3	21	21	NUM
ihlr-22950	290	4	c.f.r	c.f.r	NOUN
ihlr-22950	290	5	.	.	PUNCT
ihlr-22950	291	1	§	§	PROPN
ihlr-22950	291	2	312.305	312.305	NUM
ihlr-22950	291	3	(	(	PUNCT
ihlr-22950	291	4	2018	2018	NUM
ihlr-22950	291	5	)	)	PUNCT
ihlr-22950	291	6	.	.	PUNCT
ihlr-22950	292	1	57	57	NUM
ihlr-22950	292	2	.	.	PUNCT
ihlr-22950	293	1	i	i	PRON
ihlr-22950	293	2	d.	d.	PROPN
ihlr-22950	293	3	(	(	PUNCT
ihlr-22950	293	4	requirements	requirement	NOUN
ihlr-22950	293	5	for	for	ADP
ihlr-22950	293	6	all	all	DET
ihlr-22950	293	7	expanded	expand	VERB
ihlr-22950	293	8	access	access	NOUN
ihlr-22950	293	9	uses	use	NOUN
ihlr-22950	293	10	)	)	PUNCT
ihlr-22950	293	11	.	.	PUNCT
ihlr-22950	294	1	58	58	NUM
ihlr-22950	294	2	.	.	PUNCT
ihlr-22950	295	1	i	i	PRON
ihlr-22950	295	2	d.	d.	PROPN
ihlr-22950	295	3	59	59	NUM
ihlr-22950	295	4	.	.	PUNCT
ihlr-22950	295	5	21	21	NUM
ihlr-22950	295	6	c.f.r	c.f.r	NOUN
ihlr-22950	295	7	.	.	PUNCT
ihlr-22950	296	1	§	§	PROPN
ihlr-22950	296	2	312.310(d	312.310(d	PROPN
ihlr-22950	296	3	)	)	PUNCT
ihlr-22950	296	4	(	(	PUNCT
ihlr-22950	296	5	2018	2018	NUM
ihlr-22950	296	6	)	)	PUNCT
ihlr-22950	296	7	.	.	PUNCT
ihlr-22950	297	1	60	60	NUM
ihlr-22950	297	2	.	.	PUNCT
ihlr-22950	297	3	expanded	expand	VERB
ihlr-22950	297	4	access	access	NOUN
ihlr-22950	297	5	to	to	ADP
ihlr-22950	297	6	investigational	investigational	ADJ
ihlr-22950	297	7	drugs	drug	NOUN
ihlr-22950	297	8	for	for	ADP
ihlr-22950	297	9	treatment	treatment	NOUN
ihlr-22950	297	10	use	use	NOUN
ihlr-22950	297	11	—	—	PUNCT
ihlr-22950	297	12	questions	question	NOUN
ihlr-22950	297	13	and	and	CCONJ
ihlr-22950	297	14	answers	answer	NOUN
ihlr-22950	297	15	,	,	PUNCT
ihlr-22950	297	16	guidance	guidance	NOUN
ihlr-22950	297	17	for	for	ADP
ihlr-22950	297	18	industry	industry	NOUN
ihlr-22950	297	19	,	,	PUNCT
ihlr-22950	297	20	supra	supra	PROPN
ihlr-22950	297	21	note	note	VERB
ihlr-22950	297	22	52	52	NUM
ihlr-22950	297	23	“	"	PUNCT
ihlr-22950	297	24	in	in	ADP
ihlr-22950	297	25	an	an	DET
ihlr-22950	297	26	emergency	emergency	NOUN
ihlr-22950	297	27	situation	situation	NOUN
ihlr-22950	297	28	(	(	PUNCT
ihlr-22950	297	29	either	either	CCONJ
ihlr-22950	297	30	an	an	DET
ihlr-22950	297	31	emergency	emergency	NOUN
ihlr-22950	297	32	use	use	NOUN
ihlr-22950	297	33	ind	ind	NOUN
ihlr-22950	297	34	or	or	CCONJ
ihlr-22950	297	35	emergency	emergency	NOUN
ihlr-22950	297	36	use	use	NOUN
ihlr-22950	297	37	protocol	protocol	NOUN
ihlr-22950	297	38	)	)	PUNCT
ihlr-22950	297	39	when	when	SCONJ
ihlr-22950	297	40	there	there	PRON
ihlr-22950	297	41	is	be	VERB
ihlr-22950	297	42	not	not	PART
ihlr-22950	297	43	sufficient	sufficient	ADJ
ihlr-22950	297	44	time	time	NOUN
ihlr-22950	297	45	to	to	PART
ihlr-22950	297	46	secure	secure	VERB
ihlr-22950	297	47	irb	irb	NOUN
ihlr-22950	297	48	review	review	NOUN
ihlr-22950	297	49	prior	prior	ADV
ihlr-22950	297	50	to	to	ADP
ihlr-22950	297	51	beginning	begin	VERB
ihlr-22950	297	52	treatment	treatment	NOUN
ihlr-22950	297	53	,	,	PUNCT
ihlr-22950	297	54	the	the	DET
ihlr-22950	297	55	emergency	emergency	NOUN
ihlr-22950	297	56	use	use	NOUN
ihlr-22950	297	57	of	of	ADP
ihlr-22950	297	58	the	the	DET
ihlr-22950	297	59	investigational	investigational	ADJ
ihlr-22950	297	60	drug	drug	NOUN
ihlr-22950	297	61	must	must	AUX
ihlr-22950	297	62	be	be	AUX
ihlr-22950	297	63	reported	report	VERB
ihlr-22950	297	64	to	to	ADP
ihlr-22950	297	65	the	the	DET
ihlr-22950	297	66	irb	irb	NOUN
ihlr-22950	297	67	within	within	ADP
ihlr-22950	297	68	5	5	NUM
ihlr-22950	297	69	working	working	NOUN
ihlr-22950	297	70	days	day	NOUN
ihlr-22950	297	71	of	of	ADP
ihlr-22950	297	72	emergency	emergency	NOUN
ihlr-22950	297	73	use	use	NOUN
ihlr-22950	297	74	,	,	PUNCT
ihlr-22950	297	75	as	as	SCONJ
ihlr-22950	297	76	required	require	VERB
ihlr-22950	297	77	under	under	ADP
ihlr-22950	297	78	§	§	PROPN
ihlr-22950	297	79	56.104(c	56.104(c	PROPN
ihlr-22950	297	80	)	)	PUNCT
ihlr-22950	297	81	.	.	PUNCT
ihlr-22950	297	82	”	"	PUNCT
ihlr-22950	298	1	i	i	PRON
ihlr-22950	298	2	d.	d.	PROPN
ihlr-22950	298	3	at	at	ADP
ihlr-22950	298	4	8	8	NUM
ihlr-22950	298	5	.	.	PUNCT
ihlr-22950	298	6	further	far	ADV
ihlr-22950	298	7	,	,	PUNCT
ihlr-22950	298	8	“	"	PUNCT
ihlr-22950	298	9	[	[	X
ihlr-22950	298	10	a	a	X
ihlr-22950	298	11	]	]	X
ihlr-22950	298	12	physician	physician	NOUN
ihlr-22950	298	13	submitting	submit	VERB
ihlr-22950	298	14	an	an	DET
ihlr-22950	298	15	individual	individual	ADJ
ihlr-22950	298	16	patient	patient	NOUN
ihlr-22950	298	17	expanded	expand	VERB
ihlr-22950	298	18	access	access	NOUN
ihlr-22950	298	19	ind	ind	NOUN
ihlr-22950	298	20	using	use	VERB
ihlr-22950	298	21	form	form	NOUN
ihlr-22950	298	22	fda	fda	PROPN
ihlr-22950	298	23	3926	3926	NUM
ihlr-22950	298	24	may	may	AUX
ihlr-22950	298	25	select	select	VERB
ihlr-22950	298	26	the	the	DET
ihlr-22950	298	27	appropriate	appropriate	ADJ
ihlr-22950	298	28	box	box	NOUN
ihlr-22950	298	29	on	on	ADP
ihlr-22950	298	30	that	that	DET
ihlr-22950	298	31	form	form	NOUN
ihlr-22950	298	32	to	to	PART
ihlr-22950	298	33	request	request	VERB
ihlr-22950	298	34	a	a	DET
ihlr-22950	298	35	waiver	waiver	NOUN
ihlr-22950	298	36	under	under	ADP
ihlr-22950	298	37	§	§	PROPN
ihlr-22950	298	38	56.105	56.105	NUM
ihlr-22950	298	39	of	of	ADP
ihlr-22950	298	40	the	the	DET
ihlr-22950	298	41	requirements	requirement	NOUN
ihlr-22950	298	42	in	in	ADP
ihlr-22950	298	43	§	§	PROPN
ihlr-22950	298	44	56.108(c	56.108(c	PROPN
ihlr-22950	298	45	)	)	PUNCT
ihlr-22950	298	46	,	,	PUNCT
ihlr-22950	298	47	which	which	PRON
ihlr-22950	298	48	relate	relate	VERB
ihlr-22950	298	49	to	to	ADP
ihlr-22950	298	50	full	full	ADJ
ihlr-22950	298	51	irb	irb	NOUN
ihlr-22950	298	52	review	review	NOUN
ihlr-22950	298	53	.	.	PUNCT
ihlr-22950	299	1	fda	fda	PROPN
ihlr-22950	299	2	concludes	conclude	VERB
ihlr-22950	299	3	that	that	SCONJ
ihlr-22950	299	4	such	such	DET
ihlr-22950	299	5	a	a	DET
ihlr-22950	299	6	waiver	waiver	NOUN
ihlr-22950	299	7	is	be	AUX
ihlr-22950	299	8	appropriate	appropriate	ADJ
ihlr-22950	299	9	for	for	ADP
ihlr-22950	299	10	individual	individual	ADJ
ihlr-22950	299	11	patient	patient	NOUN
ihlr-22950	299	12	expanded	expand	VERB
ihlr-22950	299	13	access	access	NOUN
ihlr-22950	299	14	inds	ind	VERB
ihlr-22950	299	15	when	when	SCONJ
ihlr-22950	299	16	the	the	DET
ihlr-22950	299	17	physician	physician	NOUN
ihlr-22950	299	18	obtains	obtain	VERB
ihlr-22950	299	19	concurrence	concurrence	NOUN
ihlr-22950	299	20	by	by	ADP
ihlr-22950	299	21	the	the	DET
ihlr-22950	299	22	irb	irb	PROPN
ihlr-22950	299	23	chairperson	chairperson	NOUN
ihlr-22950	299	24	or	or	CCONJ
ihlr-22950	299	25	110	110	NUM
ihlr-22950	299	26	indiana	indiana	PROPN
ihlr-22950	299	27	health	health	PROPN
ihlr-22950	299	28	law	law	PROPN
ihlr-22950	299	29	review	review	NOUN
ihlr-22950	300	1	[	[	X
ihlr-22950	300	2	vol	vol	NOUN
ihlr-22950	300	3	.	.	PUNCT
ihlr-22950	301	1	16:101	16:101	NUM
ihlr-22950	301	2	treatment	treatment	NOUN
ihlr-22950	301	3	inds	ind	NOUN
ihlr-22950	301	4	—	—	PUNCT
ihlr-22950	301	5	for	for	ADP
ihlr-22950	301	6	experimental	experimental	ADJ
ihlr-22950	301	7	drugs	drug	NOUN
ihlr-22950	301	8	showing	show	VERB
ihlr-22950	301	9	potential	potential	NOUN
ihlr-22950	301	10	in	in	ADP
ihlr-22950	301	11	clinical	clinical	ADJ
ihlr-22950	301	12	testing	testing	NOUN
ihlr-22950	301	13	for	for	ADP
ihlr-22950	301	14	serious	serious	ADJ
ihlr-22950	301	15	or	or	CCONJ
ihlr-22950	301	16	life	life	NOUN
ihlr-22950	301	17	-	-	PUNCT
ihlr-22950	301	18	threatening	threaten	VERB
ihlr-22950	301	19	conditions	condition	NOUN
ihlr-22950	301	20	and	and	CCONJ
ihlr-22950	301	21	conducted	conduct	VERB
ihlr-22950	301	22	during	during	ADP
ihlr-22950	301	23	the	the	DET
ihlr-22950	301	24	final	final	ADJ
ihlr-22950	301	25	clinical	clinical	ADJ
ihlr-22950	301	26	work	work	NOUN
ihlr-22950	301	27	and	and	CCONJ
ihlr-22950	301	28	during	during	ADP
ihlr-22950	301	29	fda	fda	PROPN
ihlr-22950	301	30	review	review	PROPN
ihlr-22950	301	31	.	.	PUNCT
ihlr-22950	302	1	once	once	ADV
ihlr-22950	302	2	an	an	DET
ihlr-22950	302	3	ind	ind	NOUN
ihlr-22950	302	4	is	be	AUX
ihlr-22950	302	5	filed	file	VERB
ihlr-22950	302	6	,	,	PUNCT
ihlr-22950	302	7	several	several	ADJ
ihlr-22950	302	8	years	year	NOUN
ihlr-22950	302	9	transpire	transpire	NOUN
ihlr-22950	302	10	prior	prior	ADV
ihlr-22950	302	11	to	to	ADP
ihlr-22950	302	12	full	full	ADJ
ihlr-22950	302	13	approval	approval	NOUN
ihlr-22950	302	14	.	.	PUNCT
ihlr-22950	303	1	however	however	ADV
ihlr-22950	303	2	,	,	PUNCT
ihlr-22950	303	3	there	there	PRON
ihlr-22950	303	4	are	be	VERB
ihlr-22950	303	5	programs	program	NOUN
ihlr-22950	303	6	that	that	PRON
ihlr-22950	303	7	facilitate	facilitate	VERB
ihlr-22950	303	8	and	and	CCONJ
ihlr-22950	303	9	expedite	expedite	VERB
ihlr-22950	303	10	development	development	NOUN
ihlr-22950	303	11	and	and	CCONJ
ihlr-22950	303	12	review	review	NOUN
ihlr-22950	303	13	of	of	ADP
ihlr-22950	303	14	new	new	ADJ
ihlr-22950	303	15	drugs	drug	NOUN
ihlr-22950	303	16	that	that	PRON
ihlr-22950	303	17	address	address	VERB
ihlr-22950	303	18	unmet	unmet	NOUN
ihlr-22950	303	19	medical	medical	ADJ
ihlr-22950	303	20	needs	need	NOUN
ihlr-22950	303	21	in	in	ADP
ihlr-22950	303	22	the	the	DET
ihlr-22950	303	23	treatment	treatment	NOUN
ihlr-22950	303	24	of	of	ADP
ihlr-22950	303	25	serious	serious	ADJ
ihlr-22950	303	26	or	or	CCONJ
ihlr-22950	303	27	life	life	NOUN
ihlr-22950	303	28	-	-	PUNCT
ihlr-22950	303	29	threatening	threaten	VERB
ihlr-22950	303	30	conditions	condition	NOUN
ihlr-22950	303	31	are	be	AUX
ihlr-22950	303	32	as	as	ADP
ihlr-22950	303	33	follows:61	follows:61	DET
ihlr-22950	303	34	fast	fast	ADJ
ihlr-22950	303	35	track	track	NOUN
ihlr-22950	303	36	which	which	PRON
ihlr-22950	303	37	means	mean	VERB
ihlr-22950	303	38	unmet	unmet	NOUN
ihlr-22950	303	39	medical	medical	ADJ
ihlr-22950	303	40	need	need	NOUN
ihlr-22950	303	41	must	must	AUX
ihlr-22950	303	42	be	be	AUX
ihlr-22950	303	43	established	establish	VERB
ihlr-22950	303	44	;	;	PUNCT
ihlr-22950	303	45	priority	priority	NOUN
ihlr-22950	303	46	review	review	NOUN
ihlr-22950	303	47	which	which	PRON
ihlr-22950	303	48	means	mean	VERB
ihlr-22950	303	49	a	a	DET
ihlr-22950	303	50	six	six	NUM
ihlr-22950	303	51	month	month	NOUN
ihlr-22950	303	52	review	review	NOUN
ihlr-22950	303	53	time	time	NOUN
ihlr-22950	303	54	period	period	NOUN
ihlr-22950	303	55	where	where	SCONJ
ihlr-22950	303	56	no	no	DET
ihlr-22950	303	57	sufficient	sufficient	ADJ
ihlr-22950	303	58	therapy	therapy	NOUN
ihlr-22950	303	59	exists	exist	VERB
ihlr-22950	303	60	;	;	PUNCT
ihlr-22950	303	61	accelerated	accelerate	VERB
ihlr-22950	303	62	approval	approval	NOUN
ihlr-22950	303	63	involving	involve	VERB
ihlr-22950	303	64	initial	initial	ADJ
ihlr-22950	303	65	clinical	clinical	ADJ
ihlr-22950	303	66	trials	trial	NOUN
ihlr-22950	303	67	disclose	disclose	VERB
ihlr-22950	303	68	disease	disease	NOUN
ihlr-22950	303	69	reduction	reduction	NOUN
ihlr-22950	303	70	and	and	CCONJ
ihlr-22950	303	71	survival	survival	NOUN
ihlr-22950	303	72	lengthened	lengthen	VERB
ihlr-22950	303	73	;	;	PUNCT
ihlr-22950	303	74	and	and	CCONJ
ihlr-22950	303	75	a	a	DET
ihlr-22950	303	76	breakthrough	breakthrough	NOUN
ihlr-22950	303	77	therapy	therapy	NOUN
ihlr-22950	303	78	designation	designation	NOUN
ihlr-22950	303	79	which	which	PRON
ihlr-22950	303	80	is	be	AUX
ihlr-22950	303	81	part	part	NOUN
ihlr-22950	303	82	of	of	ADP
ihlr-22950	303	83	fda	fda	PROPN
ihlr-22950	303	84	safety	safety	PROPN
ihlr-22950	303	85	and	and	CCONJ
ihlr-22950	303	86	innovation	innovation	NOUN
ihlr-22950	303	87	act.62	act.62	PROPN
ihlr-22950	303	88	v.	v.	ADP
ihlr-22950	303	89	federal	federal	ADJ
ihlr-22950	303	90	primer	primer	NOUN
ihlr-22950	303	91	—	—	PUNCT
ihlr-22950	303	92	investigational	investigational	ADJ
ihlr-22950	303	93	mechanisms	mechanism	NOUN
ihlr-22950	303	94	for	for	ADP
ihlr-22950	303	95	medical	medical	ADJ
ihlr-22950	303	96	devices	device	NOUN
ihlr-22950	303	97	investigational	investigational	ADJ
ihlr-22950	303	98	medical	medical	ADJ
ihlr-22950	303	99	device	device	NOUN
ihlr-22950	303	100	exemptions	exemption	NOUN
ihlr-22950	303	101	and	and	CCONJ
ihlr-22950	303	102	clinical	clinical	ADJ
ihlr-22950	303	103	trials	trial	NOUN
ihlr-22950	303	104	the	the	DET
ihlr-22950	303	105	federal	federal	ADJ
ihlr-22950	303	106	right	right	NOUN
ihlr-22950	303	107	-	-	PUNCT
ihlr-22950	303	108	to	to	PART
ihlr-22950	303	109	-	-	PUNCT
ihlr-22950	303	110	try	try	VERB
ihlr-22950	303	111	act63	act63	PROPN
ihlr-22950	303	112	does	do	AUX
ihlr-22950	303	113	not	not	PART
ihlr-22950	303	114	specifically	specifically	ADV
ihlr-22950	303	115	include	include	VERB
ihlr-22950	303	116	medical	medical	ADJ
ihlr-22950	303	117	devices	device	NOUN
ihlr-22950	303	118	yet	yet	ADV
ihlr-22950	303	119	arguably	arguably	ADV
ihlr-22950	303	120	perhaps	perhaps	ADV
ihlr-22950	303	121	it	it	PRON
ihlr-22950	303	122	does	do	VERB
ihlr-22950	303	123	in	in	ADP
ihlr-22950	303	124	the	the	DET
ihlr-22950	303	125	preamble	preamble	NOUN
ihlr-22950	303	126	and	and	CCONJ
ihlr-22950	303	127	was	be	AUX
ihlr-22950	303	128	expressly	expressly	ADV
ihlr-22950	303	129	incorporated	incorporate	VERB
ihlr-22950	303	130	in	in	ADP
ihlr-22950	303	131	prior	prior	ADJ
ihlr-22950	303	132	legislative	legislative	ADJ
ihlr-22950	303	133	proposals.64	proposals.64	NOUN
ihlr-22950	303	134	nevertheless	nevertheless	ADV
ihlr-22950	303	135	,	,	PUNCT
ihlr-22950	303	136	it	it	PRON
ihlr-22950	303	137	is	be	AUX
ihlr-22950	303	138	noteworthy	noteworthy	ADJ
ihlr-22950	303	139	to	to	PART
ihlr-22950	303	140	,	,	PUNCT
ihlr-22950	303	141	at	at	ADP
ihlr-22950	303	142	a	a	DET
ihlr-22950	303	143	minimum	minimum	NOUN
ihlr-22950	303	144	,	,	PUNCT
ihlr-22950	303	145	recognize	recognize	VERB
ihlr-22950	303	146	investigational	investigational	ADJ
ihlr-22950	303	147	devices	device	NOUN
ihlr-22950	303	148	.	.	PUNCT
ihlr-22950	304	1	similar	similar	ADJ
ihlr-22950	304	2	to	to	ADP
ihlr-22950	304	3	investigational	investigational	ADJ
ihlr-22950	304	4	drugs	drug	NOUN
ihlr-22950	304	5	,	,	PUNCT
ihlr-22950	304	6	investigational	investigational	ADJ
ihlr-22950	304	7	device	device	NOUN
ihlr-22950	304	8	exemptions	exemption	NOUN
ihlr-22950	304	9	(	(	PUNCT
ihlr-22950	304	10	ide	ide	NOUN
ihlr-22950	304	11	)	)	PUNCT
ihlr-22950	304	12	permit	permit	VERB
ihlr-22950	304	13	the	the	DET
ihlr-22950	304	14	use	use	NOUN
ihlr-22950	304	15	of	of	ADP
ihlr-22950	304	16	a	a	DET
ihlr-22950	304	17	device	device	NOUN
ihlr-22950	304	18	on	on	ADP
ihlr-22950	304	19	human	human	ADJ
ihlr-22950	304	20	subjects	subject	NOUN
ihlr-22950	304	21	in	in	ADP
ihlr-22950	304	22	clinical	clinical	ADJ
ihlr-22950	304	23	another	another	DET
ihlr-22950	304	24	designated	designate	VERB
ihlr-22950	304	25	irb	irb	NOUN
ihlr-22950	304	26	member	member	NOUN
ihlr-22950	304	27	before	before	SCONJ
ihlr-22950	304	28	treatment	treatment	NOUN
ihlr-22950	304	29	use	use	NOUN
ihlr-22950	304	30	begins	begin	VERB
ihlr-22950	304	31	.	.	PUNCT
ihlr-22950	305	1	a	a	DET
ihlr-22950	305	2	physician	physician	NOUN
ihlr-22950	305	3	submitting	submit	VERB
ihlr-22950	305	4	an	an	DET
ihlr-22950	305	5	individual	individual	ADJ
ihlr-22950	305	6	patient	patient	NOUN
ihlr-22950	305	7	expanded	expand	VERB
ihlr-22950	305	8	access	access	NOUN
ihlr-22950	305	9	ind	ind	NOUN
ihlr-22950	305	10	using	use	VERB
ihlr-22950	305	11	form	form	NOUN
ihlr-22950	305	12	fda	fda	PROPN
ihlr-22950	305	13	1571	1571	NUM
ihlr-22950	305	14	may	may	AUX
ihlr-22950	305	15	include	include	VERB
ihlr-22950	305	16	a	a	DET
ihlr-22950	305	17	separate	separate	ADJ
ihlr-22950	305	18	waiver	waiver	NOUN
ihlr-22950	305	19	request	request	NOUN
ihlr-22950	305	20	with	with	ADP
ihlr-22950	305	21	the	the	DET
ihlr-22950	305	22	application	application	NOUN
ihlr-22950	305	23	.	.	PUNCT
ihlr-22950	305	24	”	"	PUNCT
ihlr-22950	306	1	i	i	PRON
ihlr-22950	306	2	d.	d.	VERB
ihlr-22950	306	3	at	at	ADP
ihlr-22950	306	4	6	6	NUM
ihlr-22950	306	5	.	.	NOUN
ihlr-22950	306	6	61	61	NUM
ihlr-22950	306	7	.	.	PUNCT
ihlr-22950	307	1	fast	fast	ADJ
ihlr-22950	307	2	track	track	NOUN
ihlr-22950	307	3	,	,	PUNCT
ihlr-22950	307	4	breakthrough	breakthrough	NOUN
ihlr-22950	307	5	therapy	therapy	NOUN
ihlr-22950	307	6	,	,	PUNCT
ihlr-22950	307	7	accelerated	accelerate	VERB
ihlr-22950	307	8	approval	approval	NOUN
ihlr-22950	307	9	,	,	PUNCT
ihlr-22950	307	10	priority	priority	NOUN
ihlr-22950	307	11	review	review	PROPN
ihlr-22950	307	12	,	,	PUNCT
ihlr-22950	307	13	u.s	u.s	PROPN
ihlr-22950	307	14	.	.	PROPN
ihlr-22950	307	15	food	food	PROPN
ihlr-22950	307	16	&	&	CCONJ
ihlr-22950	307	17	drug	drug	PROPN
ihlr-22950	307	18	admin	admin	PROPN
ihlr-22950	307	19	.	.	PROPN
ihlr-22950	307	20	,	,	PUNCT
ihlr-22950	307	21	(	(	PUNCT
ihlr-22950	307	22	feb	feb	PROPN
ihlr-22950	307	23	.	.	PROPN
ihlr-22950	307	24	23	23	NUM
ihlr-22950	307	25	,	,	PUNCT
ihlr-22950	307	26	2018	2018	NUM
ihlr-22950	307	27	)	)	PUNCT
ihlr-22950	307	28	,	,	PUNCT
ihlr-22950	307	29	https://www.fda.gov/forpatients/approvals/fast/default.htm	https://www.fda.gov/forpatients/approvals/fast/default.htm	X
ihlr-22950	308	1	[	[	X
ihlr-22950	308	2	https://perma.cc/8hch-ntdc	https://perma.cc/8hch-ntdc	PROPN
ihlr-22950	308	3	.	.	NOUN
ihlr-22950	308	4	]	]	PUNCT
ihlr-22950	309	1	62	62	NUM
ihlr-22950	309	2	.	.	PUNCT
ihlr-22950	309	3	food	food	NOUN
ihlr-22950	309	4	and	and	CCONJ
ihlr-22950	309	5	drug	drug	PROPN
ihlr-22950	309	6	administration	administration	PROPN
ihlr-22950	309	7	safety	safety	PROPN
ihlr-22950	309	8	and	and	CCONJ
ihlr-22950	309	9	innovation	innovation	NOUN
ihlr-22950	309	10	act	act	PROPN
ihlr-22950	309	11	,	,	PUNCT
ihlr-22950	309	12	pub	pub	NOUN
ihlr-22950	309	13	.	.	PUNCT
ihlr-22950	310	1	l.	l.	PROPN
ihlr-22950	310	2	no	no	INTJ
ihlr-22950	310	3	.	.	PROPN
ihlr-22950	311	1	112	112	NUM
ihlr-22950	311	2	-	-	SYM
ihlr-22950	311	3	144	144	NUM
ihlr-22950	311	4	,	,	PUNCT
ihlr-22950	311	5	126	126	NUM
ihlr-22950	311	6	stat	stat	NOUN
ihlr-22950	311	7	.	.	PUNCT
ihlr-22950	312	1	993	993	NUM
ihlr-22950	312	2	(	(	PUNCT
ihlr-22950	312	3	2012	2012	NUM
ihlr-22950	312	4	)	)	PUNCT
ihlr-22950	312	5	(	(	PUNCT
ihlr-22950	312	6	codified	codify	VERB
ihlr-22950	312	7	as	as	SCONJ
ihlr-22950	312	8	amended	amend	VERB
ihlr-22950	312	9	at	at	ADP
ihlr-22950	312	10	21	21	NUM
ihlr-22950	312	11	u.s.c.a	u.s.c.a	PROPN
ihlr-22950	312	12	.	.	PUNCT
ihlr-22950	313	1	§	§	PROPN
ihlr-22950	313	2	301(1938	301(1938	NUM
ihlr-22950	313	3	)	)	PUNCT
ihlr-22950	313	4	)	)	PUNCT
ihlr-22950	313	5	.	.	PUNCT
ihlr-22950	314	1	see	see	VERB
ihlr-22950	314	2	also	also	ADV
ihlr-22950	314	3	21st	21st	ADJ
ihlr-22950	314	4	century	century	NOUN
ihlr-22950	314	5	cures	cure	NOUN
ihlr-22950	314	6	act	act	VERB
ihlr-22950	314	7	,	,	PUNCT
ihlr-22950	314	8	pub	pub	NOUN
ihlr-22950	314	9	.	.	PUNCT
ihlr-22950	315	1	l.	l.	PROPN
ihlr-22950	315	2	no	no	INTJ
ihlr-22950	315	3	.	.	PROPN
ihlr-22950	316	1	114	114	NUM
ihlr-22950	316	2	-	-	SYM
ihlr-22950	316	3	255	255	NUM
ihlr-22950	316	4	,	,	PUNCT
ihlr-22950	316	5	130	130	NUM
ihlr-22950	316	6	stat	stat	NOUN
ihlr-22950	316	7	.	.	PUNCT
ihlr-22950	317	1	1033	1033	NUM
ihlr-22950	317	2	(	(	PUNCT
ihlr-22950	317	3	2016	2016	NUM
ihlr-22950	317	4	)	)	PUNCT
ihlr-22950	317	5	(	(	PUNCT
ihlr-22950	317	6	which	which	PRON
ihlr-22950	317	7	is	be	AUX
ihlr-22950	317	8	intended	intend	VERB
ihlr-22950	317	9	to	to	PART
ihlr-22950	317	10	accelerate	accelerate	VERB
ihlr-22950	317	11	drug	drug	NOUN
ihlr-22950	317	12	and	and	CCONJ
ihlr-22950	317	13	medical	medical	ADJ
ihlr-22950	317	14	device	device	NOUN
ihlr-22950	317	15	approvals	approval	NOUN
ihlr-22950	317	16	)	)	PUNCT
ihlr-22950	317	17	.	.	PUNCT
ihlr-22950	318	1	63	63	NUM
ihlr-22950	318	2	.	.	PUNCT
ihlr-22950	318	3	trickett	trickett	PROPN
ihlr-22950	318	4	wendler	wendler	PROPN
ihlr-22950	318	5	,	,	PUNCT
ihlr-22950	318	6	frank	frank	PROPN
ihlr-22950	318	7	mongiello	mongiello	PROPN
ihlr-22950	318	8	,	,	PUNCT
ihlr-22950	318	9	jordan	jordan	PROPN
ihlr-22950	318	10	mclinn	mclinn	PROPN
ihlr-22950	318	11	,	,	PUNCT
ihlr-22950	318	12	and	and	CCONJ
ihlr-22950	318	13	matthew	matthew	PROPN
ihlr-22950	318	14	bellina	bellina	PROPN
ihlr-22950	318	15	right	right	NOUN
ihlr-22950	318	16	to	to	PART
ihlr-22950	318	17	try	try	VERB
ihlr-22950	318	18	act	act	NOUN
ihlr-22950	318	19	of	of	ADP
ihlr-22950	318	20	2017	2017	NUM
ihlr-22950	318	21	,	,	PUNCT
ihlr-22950	318	22	pub	pub	NOUN
ihlr-22950	318	23	.	.	PUNCT
ihlr-22950	319	1	l.	l.	PROPN
ihlr-22950	319	2	no	no	INTJ
ihlr-22950	319	3	.	.	PROPN
ihlr-22950	320	1	115	115	NUM
ihlr-22950	320	2	-	-	SYM
ihlr-22950	320	3	176	176	NUM
ihlr-22950	320	4	,	,	PUNCT
ihlr-22950	320	5	132	132	NUM
ihlr-22950	320	6	stat	stat	NOUN
ihlr-22950	320	7	.	.	PUNCT
ihlr-22950	321	1	1372	1372	NUM
ihlr-22950	321	2	(	(	PUNCT
ihlr-22950	321	3	2018	2018	NUM
ihlr-22950	321	4	)	)	PUNCT
ihlr-22950	321	5	.	.	PUNCT
ihlr-22950	322	1	64	64	NUM
ihlr-22950	322	2	.	.	PUNCT
ihlr-22950	323	1	the	the	DET
ihlr-22950	323	2	prior	prior	ADJ
ihlr-22950	323	3	legislative	legislative	ADJ
ihlr-22950	323	4	history	history	NOUN
ihlr-22950	323	5	details	detail	NOUN
ihlr-22950	323	6	that	that	SCONJ
ihlr-22950	323	7	medical	medical	ADJ
ihlr-22950	323	8	devices	device	NOUN
ihlr-22950	323	9	were	be	AUX
ihlr-22950	323	10	included	include	VERB
ihlr-22950	323	11	,	,	PUNCT
ihlr-22950	323	12	however	however	ADV
ihlr-22950	323	13	,	,	PUNCT
ihlr-22950	323	14	the	the	DET
ihlr-22950	323	15	law	law	NOUN
ihlr-22950	323	16	passed	passed	AUX
ihlr-22950	323	17	does	do	AUX
ihlr-22950	323	18	not	not	PART
ihlr-22950	323	19	address	address	VERB
ihlr-22950	323	20	medical	medical	ADJ
ihlr-22950	323	21	devices	device	NOUN
ihlr-22950	323	22	.	.	PUNCT
ihlr-22950	324	1	see	see	VERB
ihlr-22950	324	2	,	,	PUNCT
ihlr-22950	324	3	e.g.	e.g.	ADV
ihlr-22950	324	4	,	,	PUNCT
ihlr-22950	324	5	right	right	ADJ
ihlr-22950	324	6	to	to	PART
ihlr-22950	324	7	try	try	VERB
ihlr-22950	324	8	act	act	NOUN
ihlr-22950	324	9	of	of	ADP
ihlr-22950	324	10	2017	2017	NUM
ihlr-22950	324	11	,	,	PUNCT
ihlr-22950	324	12	h.r	h.r	PROPN
ihlr-22950	324	13	.	.	PROPN
ihlr-22950	324	14	878	878	NUM
ihlr-22950	324	15	,	,	PUNCT
ihlr-22950	324	16	115th	115th	ADJ
ihlr-22950	324	17	cong	cong	NOUN
ihlr-22950	324	18	.	.	PUNCT
ihlr-22950	325	1	(	(	PUNCT
ihlr-22950	325	2	2017	2017	NUM
ihlr-22950	325	3	-	-	SYM
ihlr-22950	325	4	2018	2018	NUM
ihlr-22950	325	5	)	)	PUNCT
ihlr-22950	325	6	(	(	PUNCT
ihlr-22950	325	7	requiring	require	VERB
ihlr-22950	325	8	the	the	DET
ihlr-22950	325	9	federal	federal	ADJ
ihlr-22950	325	10	government	government	NOUN
ihlr-22950	325	11	to	to	PART
ihlr-22950	325	12	allow	allow	VERB
ihlr-22950	325	13	unrestricted	unrestricted	ADJ
ihlr-22950	325	14	manufacturing	manufacturing	NOUN
ihlr-22950	325	15	,	,	PUNCT
ihlr-22950	325	16	distribution	distribution	NOUN
ihlr-22950	325	17	,	,	PUNCT
ihlr-22950	325	18	prescribing	prescribing	NOUN
ihlr-22950	325	19	,	,	PUNCT
ihlr-22950	325	20	and	and	CCONJ
ihlr-22950	325	21	dispensing	dispensing	NOUN
ihlr-22950	325	22	of	of	ADP
ihlr-22950	325	23	experimental	experimental	ADJ
ihlr-22950	325	24	drugs	drug	NOUN
ihlr-22950	325	25	,	,	PUNCT
ihlr-22950	325	26	biological	biological	ADJ
ihlr-22950	325	27	products	product	NOUN
ihlr-22950	325	28	,	,	PUNCT
ihlr-22950	325	29	and	and	CCONJ
ihlr-22950	325	30	medical	medical	ADJ
ihlr-22950	325	31	devices	device	NOUN
ihlr-22950	325	32	that	that	PRON
ihlr-22950	325	33	are	be	AUX
ihlr-22950	325	34	:	:	PUNCT
ihlr-22950	325	35	“	"	PUNCT
ihlr-22950	325	36	[	[	X
ihlr-22950	325	37	1	1	NUM
ihlr-22950	325	38	]	]	PUNCT
ihlr-22950	325	39	intended	intend	VERB
ihlr-22950	325	40	to	to	PART
ihlr-22950	325	41	treat	treat	VERB
ihlr-22950	325	42	a	a	DET
ihlr-22950	325	43	patient	patient	NOUN
ihlr-22950	325	44	who	who	PRON
ihlr-22950	325	45	has	have	AUX
ihlr-22950	325	46	been	be	AUX
ihlr-22950	325	47	diagnosed	diagnose	VERB
ihlr-22950	325	48	with	with	ADP
ihlr-22950	325	49	a	a	DET
ihlr-22950	325	50	terminal	terminal	ADJ
ihlr-22950	325	51	illness	illness	NOUN
ihlr-22950	325	52	;	;	PUNCT
ihlr-22950	325	53	and	and	CCONJ
ihlr-22950	325	54	[	[	X
ihlr-22950	325	55	2	2	NUM
ihlr-22950	325	56	]	]	PUNCT
ihlr-22950	325	57	authorized	authorize	VERB
ihlr-22950	325	58	by	by	ADP
ihlr-22950	325	59	.	.	PUNCT
ihlr-22950	325	60	.	.	PUNCT
ihlr-22950	325	61	.	.	PUNCT
ihlr-22950	326	1	state	state	NOUN
ihlr-22950	326	2	law	law	NOUN
ihlr-22950	326	3	.	.	PUNCT
ihlr-22950	326	4	”	"	PUNCT
ihlr-22950	327	1	i	i	PRON
ihlr-22950	327	2	d.	d.	PROPN
ihlr-22950	327	3	)	)	PUNCT
ihlr-22950	327	4	;	;	PUNCT
ihlr-22950	327	5	see	see	VERB
ihlr-22950	327	6	also	also	ADV
ihlr-22950	327	7	21	21	NUM
ihlr-22950	327	8	usc	usc	NOUN
ihlr-22950	327	9	360bbb-0	360bbb-0	NUM
ihlr-22950	327	10	(	(	PUNCT
ihlr-22950	327	11	b	b	NOUN
ihlr-22950	327	12	)	)	PUNCT
ihlr-22950	327	13	(	(	PUNCT
ihlr-22950	327	14	2017	2017	NUM
ihlr-22950	327	15	)	)	PUNCT
ihlr-22950	327	16	.	.	PUNCT
ihlr-22950	328	1	in	in	ADP
ihlr-22950	328	2	the	the	DET
ihlr-22950	328	3	preamble	preamble	NOUN
ihlr-22950	328	4	,	,	PUNCT
ihlr-22950	328	5	of	of	ADP
ihlr-22950	328	6	the	the	DET
ihlr-22950	328	7	right	right	NOUN
ihlr-22950	328	8	-	-	PUNCT
ihlr-22950	328	9	to	to	ADP
ihlr-22950	328	10	-	-	PUNCT
ihlr-22950	328	11	try	try	VERB
ihlr-22950	328	12	act	act	NOUN
ihlr-22950	328	13	,	,	PUNCT
ihlr-22950	328	14	the	the	DET
ihlr-22950	328	15	term	term	NOUN
ihlr-22950	328	16	“	"	PUNCT
ihlr-22950	328	17	medical	medical	ADJ
ihlr-22950	328	18	product	product	NOUN
ihlr-22950	328	19	”	"	PUNCT
ihlr-22950	328	20	is	be	AUX
ihlr-22950	328	21	used	use	VERB
ihlr-22950	328	22	.	.	PUNCT
ihlr-22950	329	1	trickett	trickett	PROPN
ihlr-22950	329	2	wendler	wendler	PROPN
ihlr-22950	329	3	,	,	PUNCT
ihlr-22950	329	4	frank	frank	PROPN
ihlr-22950	329	5	mongiello	mongiello	PROPN
ihlr-22950	329	6	,	,	PUNCT
ihlr-22950	329	7	jordan	jordan	PROPN
ihlr-22950	329	8	mclinn	mclinn	PROPN
ihlr-22950	329	9	,	,	PUNCT
ihlr-22950	329	10	and	and	CCONJ
ihlr-22950	329	11	matthew	matthew	PROPN
ihlr-22950	329	12	bellina	bellina	PROPN
ihlr-22950	329	13	right	right	NOUN
ihlr-22950	329	14	to	to	PART
ihlr-22950	329	15	try	try	VERB
ihlr-22950	329	16	act	act	NOUN
ihlr-22950	329	17	of	of	ADP
ihlr-22950	329	18	2017	2017	NUM
ihlr-22950	329	19	.	.	PUNCT
ihlr-22950	330	1	pub	pub	NOUN
ihlr-22950	330	2	.	.	PUNCT
ihlr-22950	331	1	l.	l.	PROPN
ihlr-22950	331	2	no	no	INTJ
ihlr-22950	331	3	.	.	PROPN
ihlr-22950	332	1	115	115	NUM
ihlr-22950	332	2	-	-	SYM
ihlr-22950	332	3	176	176	NUM
ihlr-22950	332	4	,	,	PUNCT
ihlr-22950	332	5	130	130	NUM
ihlr-22950	332	6	stat	stat	NOUN
ihlr-22950	332	7	.	.	PUNCT
ihlr-22950	333	1	834	834	NUM
ihlr-22950	333	2	(	(	PUNCT
ihlr-22950	333	3	2018	2018	NUM
ihlr-22950	333	4	)	)	PUNCT
ihlr-22950	333	5	.	.	PUNCT
ihlr-22950	334	1	medical	medical	ADJ
ihlr-22950	334	2	product	product	NOUN
ihlr-22950	334	3	is	be	AUX
ihlr-22950	334	4	defined	define	VERB
ihlr-22950	334	5	under	under	ADP
ihlr-22950	334	6	42	42	NUM
ihlr-22950	334	7	u.s	u.s	PROPN
ihlr-22950	334	8	.	.	PROPN
ihlr-22950	334	9	code	code	PROPN
ihlr-22950	334	10	§	§	PROPN
ihlr-22950	334	11	287a	287a	PROPN
ihlr-22950	334	12	.	.	PUNCT
ihlr-22950	335	1	“	"	PUNCT
ihlr-22950	335	2	the	the	DET
ihlr-22950	335	3	term	term	NOUN
ihlr-22950	335	4	‘	'	PUNCT
ihlr-22950	335	5	medical	medical	ADJ
ihlr-22950	335	6	product	product	NOUN
ihlr-22950	335	7	’	'	PUNCT
ihlr-22950	335	8	means	mean	VERB
ihlr-22950	335	9	a	a	DET
ihlr-22950	335	10	drug	drug	NOUN
ihlr-22950	335	11	,	,	PUNCT
ihlr-22950	335	12	device	device	NOUN
ihlr-22950	335	13	,	,	PUNCT
ihlr-22950	335	14	biological	biological	ADJ
ihlr-22950	335	15	product	product	NOUN
ihlr-22950	335	16	,	,	PUNCT
ihlr-22950	335	17	or	or	CCONJ
ihlr-22950	335	18	product	product	NOUN
ihlr-22950	335	19	that	that	PRON
ihlr-22950	335	20	is	be	AUX
ihlr-22950	335	21	a	a	DET
ihlr-22950	335	22	combination	combination	NOUN
ihlr-22950	335	23	of	of	ADP
ihlr-22950	335	24	drugs	drug	NOUN
ihlr-22950	335	25	,	,	PUNCT
ihlr-22950	335	26	devices	device	NOUN
ihlr-22950	335	27	,	,	PUNCT
ihlr-22950	335	28	and	and	CCONJ
ihlr-22950	335	29	biological	biological	ADJ
ihlr-22950	335	30	products	product	NOUN
ihlr-22950	335	31	.	.	PUNCT
ihlr-22950	335	32	”	"	PUNCT
ihlr-22950	336	1	42	42	NUM
ihlr-22950	336	2	u.s.c	u.s.c	ADJ
ihlr-22950	336	3	.	.	PUNCT
ihlr-22950	337	1	§	§	PROPN
ihlr-22950	337	2	287a	287a	PROPN
ihlr-22950	337	3	(	(	PUNCT
ihlr-22950	337	4	a)(4	a)(4	NUM
ihlr-22950	337	5	)	)	PUNCT
ihlr-22950	337	6	(	(	PUNCT
ihlr-22950	337	7	2018	2018	NUM
ihlr-22950	337	8	)	)	PUNCT
ihlr-22950	337	9	.	.	PUNCT
ihlr-22950	338	1	2018	2018	NUM
ihlr-22950	338	2	]	]	PUNCT
ihlr-22950	338	3	the	the	DET
ihlr-22950	338	4	latest	late	ADJ
ihlr-22950	338	5	“	"	PUNCT
ihlr-22950	338	6	federal	federal	ADJ
ihlr-22950	338	7	movement	movement	NOUN
ihlr-22950	338	8	”	"	PUNCT
ihlr-22950	338	9	in	in	ADP
ihlr-22950	338	10	the	the	DET
ihlr-22950	338	11	food	food	NOUN
ihlr-22950	338	12	and	and	CCONJ
ihlr-22950	338	13	drug	drug	NOUN
ihlr-22950	338	14	law	law	NOUN
ihlr-22950	338	15	arena	arena	NOUN
ihlr-22950	338	16	111	111	NUM
ihlr-22950	338	17	trials.65	trials.65	PROPN
ihlr-22950	338	18	an	an	DET
ihlr-22950	338	19	approved	approve	VERB
ihlr-22950	338	20	ide	ide	NOUN
ihlr-22950	338	21	stipulates	stipulate	VERB
ihlr-22950	338	22	the	the	DET
ihlr-22950	338	23	maximum	maximum	ADJ
ihlr-22950	338	24	amount	amount	NOUN
ihlr-22950	338	25	of	of	ADP
ihlr-22950	338	26	clinical	clinical	ADJ
ihlr-22950	338	27	sites	site	NOUN
ihlr-22950	338	28	and	and	CCONJ
ihlr-22950	338	29	the	the	DET
ihlr-22950	338	30	maximum	maximum	ADJ
ihlr-22950	338	31	number	number	NOUN
ihlr-22950	338	32	of	of	ADP
ihlr-22950	338	33	human	human	ADJ
ihlr-22950	338	34	subjects	subject	NOUN
ihlr-22950	338	35	that	that	PRON
ihlr-22950	338	36	may	may	AUX
ihlr-22950	338	37	be	be	AUX
ihlr-22950	338	38	enrolled	enrol	VERB
ihlr-22950	338	39	in	in	ADP
ihlr-22950	338	40	a	a	DET
ihlr-22950	338	41	study	study	NOUN
ihlr-22950	338	42	.	.	PUNCT
ihlr-22950	339	1	fda	fda	PROPN
ihlr-22950	339	2	has	have	VERB
ihlr-22950	339	3	the	the	DET
ihlr-22950	339	4	authority	authority	NOUN
ihlr-22950	339	5	to	to	PART
ihlr-22950	339	6	exempt	exempt	VERB
ihlr-22950	339	7	investigational	investigational	ADJ
ihlr-22950	339	8	use	use	NOUN
ihlr-22950	339	9	devices	device	NOUN
ihlr-22950	339	10	from	from	ADP
ihlr-22950	339	11	particular	particular	ADJ
ihlr-22950	339	12	requirements	requirement	NOUN
ihlr-22950	339	13	that	that	SCONJ
ihlr-22950	339	14	other	other	ADJ
ihlr-22950	339	15	devices	device	NOUN
ihlr-22950	339	16	must	must	AUX
ihlr-22950	339	17	abide	abide	VERB
ihlr-22950	339	18	by.66	by.66	NOUN
ihlr-22950	339	19	an	an	DET
ihlr-22950	339	20	approved	approve	VERB
ihlr-22950	339	21	ide	ide	NOUN
ihlr-22950	339	22	application	application	NOUN
ihlr-22950	339	23	permits	permit	VERB
ihlr-22950	339	24	shipment	shipment	NOUN
ihlr-22950	339	25	of	of	ADP
ihlr-22950	339	26	a	a	DET
ihlr-22950	339	27	device	device	NOUN
ihlr-22950	339	28	,	,	PUNCT
ihlr-22950	339	29	otherwise	otherwise	ADV
ihlr-22950	339	30	subject	subject	ADJ
ihlr-22950	339	31	to	to	ADP
ihlr-22950	339	32	marketing	marketing	NOUN
ihlr-22950	339	33	clearance.67	clearance.67	ADJ
ihlr-22950	339	34	an	an	DET
ihlr-22950	339	35	approved	approve	VERB
ihlr-22950	339	36	ide	ide	NOUN
ihlr-22950	339	37	permits	permit	NOUN
ihlr-22950	339	38	use	use	NOUN
ihlr-22950	339	39	in	in	ADP
ihlr-22950	339	40	a	a	DET
ihlr-22950	339	41	clinical	clinical	ADJ
ihlr-22950	339	42	trial	trial	NOUN
ihlr-22950	339	43	to	to	PART
ihlr-22950	339	44	gather	gather	VERB
ihlr-22950	339	45	safety	safety	NOUN
ihlr-22950	339	46	and	and	CCONJ
ihlr-22950	339	47	efficacy	efficacy	NOUN
ihlr-22950	339	48	data	datum	NOUN
ihlr-22950	339	49	necessary	necessary	ADJ
ihlr-22950	339	50	to	to	PART
ihlr-22950	339	51	substantiate	substantiate	VERB
ihlr-22950	339	52	some	some	DET
ihlr-22950	339	53	510(k	510(k	PROPN
ihlr-22950	339	54	)	)	PUNCT
ihlr-22950	339	55	submissions	submission	NOUN
ihlr-22950	339	56	and	and	CCONJ
ihlr-22950	339	57	for	for	ADP
ihlr-22950	339	58	pma’s.68	pma’s.68	PROPN
ihlr-22950	339	59	clinical	clinical	ADJ
ihlr-22950	339	60	studies	study	NOUN
ihlr-22950	339	61	are	be	AUX
ihlr-22950	339	62	a	a	DET
ihlr-22950	339	63	requisite	requisite	NOUN
ihlr-22950	339	64	for	for	ADP
ihlr-22950	339	65	a	a	DET
ihlr-22950	339	66	pma	pma	NOUN
ihlr-22950	339	67	and	and	CCONJ
ihlr-22950	339	68	in	in	ADP
ihlr-22950	339	69	some	some	DET
ihlr-22950	339	70	instances	instance	NOUN
ihlr-22950	339	71	a	a	DET
ihlr-22950	339	72	510(k	510(k	NOUN
ihlr-22950	339	73	)	)	PUNCT
ihlr-22950	339	74	and	and	CCONJ
ihlr-22950	339	75	require	require	VERB
ihlr-22950	339	76	:	:	PUNCT
ihlr-22950	339	77	an	an	DET
ihlr-22950	339	78	approved	approve	VERB
ihlr-22950	339	79	ide	ide	NOUN
ihlr-22950	339	80	by	by	ADP
ihlr-22950	339	81	an	an	DET
ihlr-22950	339	82	institutional	institutional	ADJ
ihlr-22950	339	83	review	review	NOUN
ihlr-22950	339	84	board	board	NOUN
ihlr-22950	339	85	(	(	PUNCT
ihlr-22950	339	86	irb	irb	PROPN
ihlr-22950	339	87	)	)	PUNCT
ihlr-22950	339	88	;	;	PUNCT
ihlr-22950	339	89	informed	inform	VERB
ihlr-22950	339	90	consent	consent	NOUN
ihlr-22950	339	91	from	from	ADP
ihlr-22950	339	92	patients	patient	NOUN
ihlr-22950	339	93	;	;	PUNCT
ihlr-22950	339	94	labeling	label	VERB
ihlr-22950	339	95	that	that	SCONJ
ihlr-22950	339	96	details	detail	NOUN
ihlr-22950	339	97	investigational	investigational	ADJ
ihlr-22950	339	98	use	use	NOUN
ihlr-22950	339	99	only	only	ADV
ihlr-22950	339	100	;	;	PUNCT
ihlr-22950	339	101	and	and	CCONJ
ihlr-22950	339	102	records	record	NOUN
ihlr-22950	339	103	and	and	CCONJ
ihlr-22950	339	104	reports.69	reports.69	VERB
ihlr-22950	339	105	vi	vi	PROPN
ihlr-22950	339	106	.	.	NOUN
ihlr-22950	339	107	expanded	expand	VERB
ihlr-22950	339	108	access	access	NOUN
ihlr-22950	339	109	to	to	ADP
ihlr-22950	339	110	medical	medical	ADJ
ihlr-22950	339	111	devices	device	NOUN
ihlr-22950	339	112	some	some	DET
ihlr-22950	339	113	patients	patient	NOUN
ihlr-22950	339	114	might	might	AUX
ihlr-22950	339	115	not	not	PART
ihlr-22950	339	116	be	be	AUX
ihlr-22950	339	117	eligible	eligible	ADJ
ihlr-22950	339	118	for	for	ADP
ihlr-22950	339	119	an	an	DET
ihlr-22950	339	120	investigational	investigational	ADJ
ihlr-22950	339	121	device	device	NOUN
ihlr-22950	339	122	clinical	clinical	ADJ
ihlr-22950	339	123	trial	trial	NOUN
ihlr-22950	339	124	.	.	PUNCT
ihlr-22950	340	1	fortunately	fortunately	ADV
ihlr-22950	340	2	,	,	PUNCT
ihlr-22950	340	3	similar	similar	ADJ
ihlr-22950	340	4	to	to	ADP
ihlr-22950	340	5	investigational	investigational	ADJ
ihlr-22950	340	6	drugs	drug	NOUN
ihlr-22950	340	7	,	,	PUNCT
ihlr-22950	340	8	there	there	PRON
ihlr-22950	340	9	are	be	VERB
ihlr-22950	340	10	methods	method	NOUN
ihlr-22950	340	11	available	available	ADJ
ihlr-22950	340	12	to	to	ADP
ihlr-22950	340	13	those	those	DET
ihlr-22950	340	14	patients	patient	NOUN
ihlr-22950	340	15	who	who	PRON
ihlr-22950	340	16	have	have	VERB
ihlr-22950	340	17	a	a	DET
ihlr-22950	340	18	life	life	NOUN
ihlr-22950	340	19	-	-	PUNCT
ihlr-22950	340	20	threatening	threaten	VERB
ihlr-22950	340	21	disease	disease	NOUN
ihlr-22950	340	22	for	for	ADP
ihlr-22950	340	23	which	which	PRON
ihlr-22950	340	24	there	there	PRON
ihlr-22950	340	25	are	be	VERB
ihlr-22950	340	26	no	no	DET
ihlr-22950	340	27	currently	currently	ADV
ihlr-22950	340	28	approved	approve	VERB
ihlr-22950	340	29	medical	medical	ADJ
ihlr-22950	340	30	device	device	NOUN
ihlr-22950	340	31	treatments	treatment	NOUN
ihlr-22950	340	32	.	.	PUNCT
ihlr-22950	341	1	these	these	PRON
ihlr-22950	341	2	include	include	VERB
ihlr-22950	341	3	emergency	emergency	NOUN
ihlr-22950	341	4	use	use	NOUN
ihlr-22950	341	5	,	,	PUNCT
ihlr-22950	341	6	treatment	treatment	NOUN
ihlr-22950	341	7	use	use	NOUN
ihlr-22950	341	8	,	,	PUNCT
ihlr-22950	341	9	and	and	CCONJ
ihlr-22950	341	10	compassionate	compassionate	ADJ
ihlr-22950	341	11	or	or	CCONJ
ihlr-22950	341	12	humanitarian	humanitarian	ADJ
ihlr-22950	341	13	use	use	NOUN
ihlr-22950	341	14	,	,	PUNCT
ihlr-22950	341	15	detailed	detail	VERB
ihlr-22950	341	16	below	below	ADV
ihlr-22950	341	17	.	.	PUNCT
ihlr-22950	342	1	a.	a.	NOUN
ihlr-22950	342	2	emergency	emergency	NOUN
ihlr-22950	342	3	use	use	NOUN
ihlr-22950	342	4	of	of	ADP
ihlr-22950	342	5	unapproved	unapproved	ADJ
ihlr-22950	342	6	medical	medical	ADJ
ihlr-22950	342	7	devices70	devices70	NOUN
ihlr-22950	342	8	an	an	DET
ihlr-22950	342	9	unapproved	unapproved	ADJ
ihlr-22950	342	10	device	device	NOUN
ihlr-22950	342	11	may	may	AUX
ihlr-22950	342	12	provide	provide	VERB
ihlr-22950	342	13	the	the	DET
ihlr-22950	342	14	single	single	ADJ
ihlr-22950	342	15	potential	potential	ADJ
ihlr-22950	342	16	life	life	NOUN
ihlr-22950	342	17	-	-	PUNCT
ihlr-22950	342	18	saving	save	VERB
ihlr-22950	342	19	alternative	alternative	NOUN
ihlr-22950	342	20	.	.	PUNCT
ihlr-22950	343	1	however	however	ADV
ihlr-22950	343	2	,	,	PUNCT
ihlr-22950	343	3	what	what	PRON
ihlr-22950	343	4	happens	happen	VERB
ihlr-22950	343	5	when	when	SCONJ
ihlr-22950	343	6	there	there	PRON
ihlr-22950	343	7	is	be	VERB
ihlr-22950	343	8	no	no	DET
ihlr-22950	343	9	ide	ide	NOUN
ihlr-22950	343	10	or	or	CCONJ
ihlr-22950	343	11	perhaps	perhaps	ADV
ihlr-22950	343	12	the	the	DET
ihlr-22950	343	13	proposed	propose	VERB
ihlr-22950	343	14	use	use	NOUN
ihlr-22950	343	15	is	be	AUX
ihlr-22950	343	16	not	not	PART
ihlr-22950	343	17	approved	approve	VERB
ihlr-22950	343	18	under	under	ADP
ihlr-22950	343	19	an	an	DET
ihlr-22950	343	20	existing	exist	VERB
ihlr-22950	343	21	ide	ide	NOUN
ihlr-22950	343	22	?	?	PUNCT
ihlr-22950	344	1	additionally	additionally	ADV
ihlr-22950	344	2	,	,	PUNCT
ihlr-22950	344	3	the	the	DET
ihlr-22950	344	4	physician	physician	NOUN
ihlr-22950	344	5	or	or	CCONJ
ihlr-22950	344	6	institution	institution	NOUN
ihlr-22950	344	7	may	may	AUX
ihlr-22950	344	8	not	not	PART
ihlr-22950	344	9	be	be	AUX
ihlr-22950	344	10	approved	approve	VERB
ihlr-22950	344	11	under	under	ADP
ihlr-22950	344	12	the	the	DET
ihlr-22950	344	13	ide	ide	NOUN
ihlr-22950	344	14	.	.	PUNCT
ihlr-22950	345	1	fda	fda	PROPN
ihlr-22950	345	2	will	will	AUX
ihlr-22950	345	3	use	use	VERB
ihlr-22950	345	4	enforcement	enforcement	NOUN
ihlr-22950	345	5	discretion	discretion	NOUN
ihlr-22950	345	6	,	,	PUNCT
ihlr-22950	345	7	if	if	SCONJ
ihlr-22950	345	8	a	a	DET
ihlr-22950	345	9	physician	physician	NOUN
ihlr-22950	345	10	utilizes	utilize	VERB
ihlr-22950	345	11	an	an	DET
ihlr-22950	345	12	unapproved	unapproved	ADJ
ihlr-22950	345	13	device	device	NOUN
ihlr-22950	345	14	on	on	ADP
ihlr-22950	345	15	an	an	DET
ihlr-22950	345	16	emergency	emergency	NOUN
ihlr-22950	345	17	basis	basis	NOUN
ihlr-22950	345	18	.	.	PUNCT
ihlr-22950	346	1	fda	fda	PROPN
ihlr-22950	346	2	prior	prior	ADJ
ihlr-22950	346	3	approval	approval	NOUN
ihlr-22950	346	4	is	be	AUX
ihlr-22950	346	5	not	not	PART
ihlr-22950	346	6	required	require	VERB
ihlr-22950	346	7	as	as	ADV
ihlr-22950	346	8	long	long	ADV
ihlr-22950	346	9	as	as	SCONJ
ihlr-22950	346	10	the	the	DET
ihlr-22950	346	11	following	follow	VERB
ihlr-22950	346	12	criteria	criterion	NOUN
ihlr-22950	346	13	for	for	ADP
ihlr-22950	346	14	emergency	emergency	NOUN
ihlr-22950	346	15	use	use	NOUN
ihlr-22950	346	16	are	be	AUX
ihlr-22950	346	17	met	meet	VERB
ihlr-22950	346	18	:	:	PUNCT
ihlr-22950	346	19	(	(	PUNCT
ihlr-22950	346	20	1	1	X
ihlr-22950	346	21	)	)	PUNCT
ihlr-22950	346	22	the	the	DET
ihlr-22950	346	23	human	human	ADJ
ihlr-22950	346	24	subject	subject	NOUN
ihlr-22950	346	25	is	be	AUX
ihlr-22950	346	26	confronted	confront	VERB
ihlr-22950	346	27	by	by	ADP
ihlr-22950	346	28	a	a	DET
ihlr-22950	346	29	life	life	NOUN
ihlr-22950	346	30	-	-	PUNCT
ihlr-22950	346	31	threatening	threaten	VERB
ihlr-22950	346	32	situation	situation	NOUN
ihlr-22950	346	33	necessitating	necessitate	VERB
ihlr-22950	346	34	the	the	DET
ihlr-22950	346	35	use	use	NOUN
ihlr-22950	346	36	of	of	ADP
ihlr-22950	346	37	the	the	DET
ihlr-22950	346	38	test	test	NOUN
ihlr-22950	346	39	article	article	NOUN
ihlr-22950	346	40	;	;	PUNCT
ihlr-22950	346	41	(	(	PUNCT
ihlr-22950	346	42	2	2	X
ihlr-22950	346	43	)	)	PUNCT
ihlr-22950	346	44	informed	informed	ADJ
ihlr-22950	346	45	consent	consent	NOUN
ihlr-22950	346	46	can	can	AUX
ihlr-22950	346	47	not	not	PART
ihlr-22950	346	48	be	be	AUX
ihlr-22950	346	49	obtained	obtain	VERB
ihlr-22950	346	50	from	from	ADP
ihlr-22950	346	51	the	the	DET
ihlr-22950	346	52	subject	subject	NOUN
ihlr-22950	346	53	because	because	SCONJ
ihlr-22950	346	54	of	of	ADP
ihlr-22950	346	55	an	an	DET
ihlr-22950	346	56	inability	inability	NOUN
ihlr-22950	346	57	to	to	PART
ihlr-22950	346	58	communicate	communicate	VERB
ihlr-22950	346	59	with	with	ADP
ihlr-22950	346	60	,	,	PUNCT
ihlr-22950	346	61	or	or	CCONJ
ihlr-22950	346	62	obtain	obtain	VERB
ihlr-22950	346	63	legally	legally	ADV
ihlr-22950	346	64	effective	effective	ADJ
ihlr-22950	346	65	consent	consent	NOUN
ihlr-22950	346	66	from	from	ADP
ihlr-22950	346	67	,	,	PUNCT
ihlr-22950	346	68	the	the	DET
ihlr-22950	346	69	subject	subject	NOUN
ihlr-22950	346	70	;	;	PUNCT
ihlr-22950	346	71	65	65	NUM
ihlr-22950	346	72	.	.	NOUN
ihlr-22950	346	73	21	21	NUM
ihlr-22950	346	74	c.f.r	c.f.r	NOUN
ihlr-22950	346	75	.	.	PUNCT
ihlr-22950	347	1	§	§	PROPN
ihlr-22950	347	2	812	812	NUM
ihlr-22950	347	3	(	(	PUNCT
ihlr-22950	347	4	2018	2018	NUM
ihlr-22950	347	5	)	)	PUNCT
ihlr-22950	347	6	.	.	PUNCT
ihlr-22950	348	1	66	66	NUM
ihlr-22950	348	2	.	.	PUNCT
ihlr-22950	349	1	i	i	PRON
ihlr-22950	349	2	d.	d.	PROPN
ihlr-22950	349	3	67	67	NUM
ihlr-22950	349	4	.	.	PUNCT
ihlr-22950	350	1	i	i	PRON
ihlr-22950	350	2	d.	d.	PROPN
ihlr-22950	350	3	68	68	NUM
ihlr-22950	350	4	.	.	PUNCT
ihlr-22950	351	1	i	i	PRON
ihlr-22950	351	2	d.	d.	PROPN
ihlr-22950	351	3	69	69	NUM
ihlr-22950	351	4	.	.	PUNCT
ihlr-22950	352	1	protection	protection	NOUN
ihlr-22950	352	2	of	of	ADP
ihlr-22950	352	3	human	human	ADJ
ihlr-22950	352	4	subjects	subject	NOUN
ihlr-22950	352	5	,	,	PUNCT
ihlr-22950	352	6	21	21	NUM
ihlr-22950	352	7	c.f.r	c.f.r	NOUN
ihlr-22950	352	8	.	.	PUNCT
ihlr-22950	353	1	§	§	PROPN
ihlr-22950	353	2	50	50	NUM
ihlr-22950	353	3	(	(	PUNCT
ihlr-22950	353	4	2018	2018	NUM
ihlr-22950	353	5	)	)	PUNCT
ihlr-22950	353	6	;	;	PUNCT
ihlr-22950	353	7	financial	financial	ADJ
ihlr-22950	353	8	disclosure	disclosure	NOUN
ihlr-22950	353	9	by	by	ADP
ihlr-22950	353	10	clinical	clinical	ADJ
ihlr-22950	353	11	investigators	investigator	NOUN
ihlr-22950	353	12	,	,	PUNCT
ihlr-22950	353	13	21	21	NUM
ihlr-22950	353	14	c.f.r	c.f.r	NOUN
ihlr-22950	353	15	.	.	PUNCT
ihlr-22950	354	1	§	§	PROPN
ihlr-22950	354	2	54	54	NUM
ihlr-22950	354	3	(	(	PUNCT
ihlr-22950	354	4	2018	2018	NUM
ihlr-22950	354	5	)	)	PUNCT
ihlr-22950	354	6	;	;	PUNCT
ihlr-22950	354	7	institutional	institutional	ADJ
ihlr-22950	354	8	review	review	NOUN
ihlr-22950	354	9	boards	board	NOUN
ihlr-22950	354	10	,	,	PUNCT
ihlr-22950	354	11	21	21	NUM
ihlr-22950	354	12	c.f.r	c.f.r	NOUN
ihlr-22950	354	13	.	.	PUNCT
ihlr-22950	355	1	§	§	PROPN
ihlr-22950	355	2	56	56	NUM
ihlr-22950	355	3	(	(	PUNCT
ihlr-22950	355	4	2018	2018	NUM
ihlr-22950	355	5	)	)	PUNCT
ihlr-22950	355	6	;	;	PUNCT
ihlr-22950	355	7	quality	quality	NOUN
ihlr-22950	355	8	system	system	NOUN
ihlr-22950	355	9	regulation	regulation	NOUN
ihlr-22950	355	10	,	,	PUNCT
ihlr-22950	355	11	design	design	NOUN
ihlr-22950	355	12	controls	control	NOUN
ihlr-22950	355	13	,	,	PUNCT
ihlr-22950	355	14	21	21	NUM
ihlr-22950	355	15	c.f.r	c.f.r	NOUN
ihlr-22950	355	16	.	.	PUNCT
ihlr-22950	356	1	§	§	PROPN
ihlr-22950	356	2	820(c	820(c	PROPN
ihlr-22950	356	3	)	)	PUNCT
ihlr-22950	356	4	(	(	PUNCT
ihlr-22950	356	5	2018	2018	NUM
ihlr-22950	356	6	)	)	PUNCT
ihlr-22950	356	7	.	.	PUNCT
ihlr-22950	357	1	70	70	NUM
ihlr-22950	357	2	.	.	PUNCT
ihlr-22950	358	1	exception	exception	NOUN
ihlr-22950	358	2	from	from	ADP
ihlr-22950	358	3	general	general	ADJ
ihlr-22950	358	4	requirements	requirement	NOUN
ihlr-22950	358	5	,	,	PUNCT
ihlr-22950	358	6	21	21	NUM
ihlr-22950	358	7	c.f.r	c.f.r	NOUN
ihlr-22950	358	8	.	.	PUNCT
ihlr-22950	359	1	§	§	PROPN
ihlr-22950	359	2	50.23(a	50.23(a	NUM
ihlr-22950	359	3	)	)	PUNCT
ihlr-22950	359	4	(	(	PUNCT
ihlr-22950	359	5	2018	2018	NUM
ihlr-22950	359	6	)	)	PUNCT
ihlr-22950	359	7	.	.	PUNCT
ihlr-22950	360	1	see	see	AUX
ihlr-22950	360	2	also	also	ADV
ihlr-22950	360	3	expanded	expand	VERB
ihlr-22950	360	4	access	access	NOUN
ihlr-22950	360	5	for	for	ADP
ihlr-22950	360	6	medical	medical	ADJ
ihlr-22950	360	7	devices	device	NOUN
ihlr-22950	360	8	,	,	PUNCT
ihlr-22950	360	9	u.s	u.s	PROPN
ihlr-22950	360	10	.	.	PROPN
ihlr-22950	360	11	food	food	PROPN
ihlr-22950	360	12	&	&	CCONJ
ihlr-22950	360	13	drug	drug	PROPN
ihlr-22950	360	14	admin	admin	PROPN
ihlr-22950	360	15	.	.	PROPN
ihlr-22950	360	16	,	,	PUNCT
ihlr-22950	360	17	https://www.fda.gov/medicaldevices/	https://www.fda.gov/medicaldevices/	NOUN
ihlr-22950	360	18	deviceregulationandguidance	deviceregulationandguidance	PROPN
ihlr-22950	360	19	/	/	SYM
ihlr-22950	360	20	howtomarketyourdevice	howtomarketyourdevice	NOUN
ihlr-22950	360	21	/	/	SYM
ihlr-22950	360	22	investigationaldeviceexemptionide	investigationaldeviceexemptionide	NOUN
ihlr-22950	360	23	/	/	SYM
ihlr-22950	360	24	ucm0	ucm0	NOUN
ihlr-22950	360	25	51345.htm	51345.htm	NUM
ihlr-22950	361	1	[	[	X
ihlr-22950	361	2	https://perma.cc/t53g-bbhe	https://perma.cc/t53g-bbhe	X
ihlr-22950	361	3	]	]	X
ihlr-22950	361	4	(	(	PUNCT
ihlr-22950	361	5	last	last	ADJ
ihlr-22950	361	6	updated	update	VERB
ihlr-22950	361	7	sept	sept	PROPN
ihlr-22950	361	8	.	.	PROPN
ihlr-22950	361	9	25	25	NUM
ihlr-22950	361	10	,	,	PUNCT
ihlr-22950	361	11	2018	2018	NUM
ihlr-22950	361	12	)	)	PUNCT
ihlr-22950	361	13	.	.	PUNCT
ihlr-22950	362	1	112	112	NUM
ihlr-22950	362	2	indiana	indiana	PROPN
ihlr-22950	362	3	health	health	PROPN
ihlr-22950	362	4	law	law	NOUN
ihlr-22950	362	5	review	review	NOUN
ihlr-22950	362	6	[	[	X
ihlr-22950	362	7	vol	vol	NOUN
ihlr-22950	362	8	.	.	PUNCT
ihlr-22950	363	1	16:101	16:101	NUM
ihlr-22950	363	2	(	(	PUNCT
ihlr-22950	363	3	3	3	NUM
ihlr-22950	363	4	)	)	PUNCT
ihlr-22950	363	5	time	time	NOUN
ihlr-22950	363	6	is	be	AUX
ihlr-22950	363	7	not	not	PART
ihlr-22950	363	8	sufficient	sufficient	ADJ
ihlr-22950	363	9	to	to	PART
ihlr-22950	363	10	obtain	obtain	VERB
ihlr-22950	363	11	consent	consent	NOUN
ihlr-22950	363	12	from	from	ADP
ihlr-22950	363	13	the	the	DET
ihlr-22950	363	14	subject	subject	NOUN
ihlr-22950	363	15	’s	’s	PART
ihlr-22950	363	16	legal	legal	ADJ
ihlr-22950	363	17	representative	representative	NOUN
ihlr-22950	363	18	;	;	PUNCT
ihlr-22950	363	19	and	and	CCONJ
ihlr-22950	363	20	(	(	PUNCT
ihlr-22950	363	21	4	4	X
ihlr-22950	363	22	)	)	PUNCT
ihlr-22950	363	23	there	there	PRON
ihlr-22950	363	24	is	be	VERB
ihlr-22950	363	25	available	available	ADJ
ihlr-22950	363	26	no	no	DET
ihlr-22950	363	27	alternative	alternative	ADJ
ihlr-22950	363	28	method	method	NOUN
ihlr-22950	363	29	of	of	ADP
ihlr-22950	363	30	approved	approve	VERB
ihlr-22950	363	31	or	or	CCONJ
ihlr-22950	363	32	generally	generally	ADV
ihlr-22950	363	33	recognized	recognize	VERB
ihlr-22950	363	34	therapy	therapy	NOUN
ihlr-22950	363	35	that	that	PRON
ihlr-22950	363	36	provides	provide	VERB
ihlr-22950	363	37	an	an	DET
ihlr-22950	363	38	equal	equal	ADJ
ihlr-22950	363	39	or	or	CCONJ
ihlr-22950	363	40	greater	great	ADJ
ihlr-22950	363	41	likelihood	likelihood	NOUN
ihlr-22950	363	42	of	of	ADP
ihlr-22950	363	43	saving	save	VERB
ihlr-22950	363	44	the	the	DET
ihlr-22950	363	45	life	life	NOUN
ihlr-22950	363	46	of	of	ADP
ihlr-22950	363	47	the	the	DET
ihlr-22950	363	48	subject.71	subject.71	PROPN
ihlr-22950	363	49	b.	b.	PROPN
ihlr-22950	363	50	treatment	treatment	NOUN
ihlr-22950	363	51	use	use	NOUN
ihlr-22950	363	52	of	of	ADP
ihlr-22950	363	53	investigational	investigational	ADJ
ihlr-22950	363	54	devices	device	NOUN
ihlr-22950	363	55	treatment	treatment	NOUN
ihlr-22950	363	56	use	use	NOUN
ihlr-22950	363	57	means	mean	VERB
ihlr-22950	363	58	that	that	SCONJ
ihlr-22950	363	59	an	an	DET
ihlr-22950	363	60	ide	ide	NOUN
ihlr-22950	363	61	trial	trial	NOUN
ihlr-22950	363	62	may	may	AUX
ihlr-22950	363	63	be	be	AUX
ihlr-22950	363	64	expanded	expand	VERB
ihlr-22950	363	65	to	to	PART
ihlr-22950	363	66	include	include	VERB
ihlr-22950	363	67	additional	additional	ADJ
ihlr-22950	363	68	patients	patient	NOUN
ihlr-22950	363	69	with	with	ADP
ihlr-22950	363	70	life	life	NOUN
ihlr-22950	363	71	-	-	PUNCT
ihlr-22950	363	72	threatening	threatening	ADJ
ihlr-22950	363	73	or	or	CCONJ
ihlr-22950	363	74	serious	serious	ADJ
ihlr-22950	363	75	diseases	disease	NOUN
ihlr-22950	363	76	if	if	SCONJ
ihlr-22950	363	77	the	the	DET
ihlr-22950	363	78	data	datum	NOUN
ihlr-22950	363	79	indicates	indicate	VERB
ihlr-22950	363	80	that	that	SCONJ
ihlr-22950	363	81	the	the	DET
ihlr-22950	363	82	device	device	NOUN
ihlr-22950	363	83	is	be	AUX
ihlr-22950	363	84	effective.72	effective.72	NOUN
ihlr-22950	363	85	the	the	DET
ihlr-22950	363	86	following	follow	VERB
ihlr-22950	363	87	parameters	parameter	NOUN
ihlr-22950	363	88	apply	apply	VERB
ihlr-22950	363	89	to	to	ADP
ihlr-22950	363	90	treatment	treatment	NOUN
ihlr-22950	363	91	use	use	NOUN
ihlr-22950	363	92	of	of	ADP
ihlr-22950	363	93	investigational	investigational	ADJ
ihlr-22950	363	94	devices:73	devices:73	NOUN
ihlr-22950	363	95	the	the	DET
ihlr-22950	363	96	device	device	NOUN
ihlr-22950	363	97	is	be	AUX
ihlr-22950	363	98	intended	intend	VERB
ihlr-22950	363	99	to	to	PART
ihlr-22950	363	100	treat	treat	VERB
ihlr-22950	363	101	or	or	CCONJ
ihlr-22950	363	102	diagnose	diagnose	VERB
ihlr-22950	363	103	a	a	DET
ihlr-22950	363	104	serious	serious	ADJ
ihlr-22950	363	105	or	or	CCONJ
ihlr-22950	363	106	immediately	immediately	ADV
ihlr-22950	363	107	lifethreatening	lifethreatene	VERB
ihlr-22950	363	108	disease	disease	NOUN
ihlr-22950	363	109	or	or	CCONJ
ihlr-22950	363	110	condition	condition	NOUN
ihlr-22950	363	111	;	;	PUNCT
ihlr-22950	363	112	there	there	PRON
ihlr-22950	363	113	is	be	VERB
ihlr-22950	363	114	no	no	DET
ihlr-22950	363	115	comparable	comparable	ADJ
ihlr-22950	363	116	or	or	CCONJ
ihlr-22950	363	117	satisfactory	satisfactory	ADJ
ihlr-22950	363	118	alternative	alternative	ADJ
ihlr-22950	363	119	device	device	NOUN
ihlr-22950	363	120	available	available	ADJ
ihlr-22950	363	121	to	to	PART
ihlr-22950	363	122	treat	treat	VERB
ihlr-22950	363	123	or	or	CCONJ
ihlr-22950	363	124	diagnose	diagnose	VERB
ihlr-22950	363	125	the	the	DET
ihlr-22950	363	126	disease	disease	NOUN
ihlr-22950	363	127	or	or	CCONJ
ihlr-22950	363	128	condition	condition	NOUN
ihlr-22950	363	129	in	in	ADP
ihlr-22950	363	130	the	the	DET
ihlr-22950	363	131	intended	intend	VERB
ihlr-22950	363	132	patient	patient	ADJ
ihlr-22950	363	133	population	population	NOUN
ihlr-22950	363	134	;	;	PUNCT
ihlr-22950	363	135	the	the	DET
ihlr-22950	363	136	device	device	NOUN
ihlr-22950	363	137	is	be	AUX
ihlr-22950	363	138	under	under	ADP
ihlr-22950	363	139	investigation	investigation	NOUN
ihlr-22950	363	140	in	in	ADP
ihlr-22950	363	141	a	a	DET
ihlr-22950	363	142	controlled	control	VERB
ihlr-22950	363	143	clinical	clinical	ADJ
ihlr-22950	363	144	trial	trial	NOUN
ihlr-22950	363	145	for	for	ADP
ihlr-22950	363	146	the	the	DET
ihlr-22950	363	147	same	same	ADJ
ihlr-22950	363	148	use	use	NOUN
ihlr-22950	363	149	under	under	ADP
ihlr-22950	363	150	an	an	DET
ihlr-22950	363	151	approved	approve	VERB
ihlr-22950	363	152	ide	ide	NOUN
ihlr-22950	363	153	,	,	PUNCT
ihlr-22950	363	154	or	or	CCONJ
ihlr-22950	363	155	all	all	DET
ihlr-22950	363	156	clinical	clinical	ADJ
ihlr-22950	363	157	trials	trial	NOUN
ihlr-22950	363	158	have	have	AUX
ihlr-22950	363	159	been	be	AUX
ihlr-22950	363	160	completed	complete	VERB
ihlr-22950	363	161	;	;	PUNCT
ihlr-22950	363	162	and	and	CCONJ
ihlr-22950	363	163	the	the	DET
ihlr-22950	363	164	sponsor	sponsor	NOUN
ihlr-22950	363	165	of	of	ADP
ihlr-22950	363	166	the	the	DET
ihlr-22950	363	167	controlled	control	VERB
ihlr-22950	363	168	clinical	clinical	ADJ
ihlr-22950	363	169	trial	trial	NOUN
ihlr-22950	363	170	is	be	AUX
ihlr-22950	363	171	pursuing	pursue	VERB
ihlr-22950	363	172	marketing	marketing	NOUN
ihlr-22950	363	173	approval	approval	NOUN
ihlr-22950	363	174	/	/	SYM
ihlr-22950	363	175	clearance	clearance	NOUN
ihlr-22950	363	176	of	of	ADP
ihlr-22950	363	177	the	the	DET
ihlr-22950	363	178	investigational	investigational	ADJ
ihlr-22950	363	179	device	device	NOUN
ihlr-22950	363	180	with	with	ADP
ihlr-22950	363	181	due	due	ADJ
ihlr-22950	363	182	diligence.74	diligence.74	ADJ
ihlr-22950	363	183	c.	c.	PROPN
ihlr-22950	363	184	humanitarian	humanitarian	ADJ
ihlr-22950	363	185	or	or	CCONJ
ihlr-22950	363	186	compassionate	compassionate	ADJ
ihlr-22950	363	187	use	use	NOUN
ihlr-22950	363	188	devices	device	NOUN
ihlr-22950	363	189	similar	similar	ADJ
ihlr-22950	363	190	to	to	ADP
ihlr-22950	363	191	human	human	ADJ
ihlr-22950	363	192	drugs	drug	NOUN
ihlr-22950	363	193	,	,	PUNCT
ihlr-22950	363	194	compassionate	compassionate	ADJ
ihlr-22950	363	195	use	use	NOUN
ihlr-22950	363	196	devices75	devices75	NOUN
ihlr-22950	363	197	provide	provide	VERB
ihlr-22950	363	198	an	an	DET
ihlr-22950	363	199	option	option	NOUN
ihlr-22950	363	200	for	for	ADP
ihlr-22950	363	201	a	a	DET
ihlr-22950	363	202	patient	patient	NOUN
ihlr-22950	363	203	that	that	PRON
ihlr-22950	363	204	has	have	VERB
ihlr-22950	363	205	a	a	DET
ihlr-22950	363	206	lifethreatening	lifethreatening	NOUN
ihlr-22950	363	207	or	or	CCONJ
ihlr-22950	363	208	serious	serious	ADJ
ihlr-22950	363	209	disease	disease	NOUN
ihlr-22950	363	210	or	or	CCONJ
ihlr-22950	363	211	condition	condition	NOUN
ihlr-22950	363	212	.	.	PUNCT
ihlr-22950	364	1	a	a	DET
ihlr-22950	364	2	humanitarian	humanitarian	ADJ
ihlr-22950	364	3	device	device	NOUN
ihlr-22950	364	4	,	,	PUNCT
ihlr-22950	364	5	(	(	PUNCT
ihlr-22950	364	6	hud	hud	PROPN
ihlr-22950	364	7	)	)	PUNCT
ihlr-22950	364	8	also	also	ADV
ihlr-22950	364	9	referred	refer	VERB
ihlr-22950	364	10	to	to	ADP
ihlr-22950	364	11	as	as	ADP
ihlr-22950	364	12	a	a	DET
ihlr-22950	364	13	compassionate	compassionate	ADJ
ihlr-22950	364	14	use	use	NOUN
ihlr-22950	364	15	device	device	NOUN
ihlr-22950	364	16	,	,	PUNCT
ihlr-22950	364	17	provides	provide	VERB
ihlr-22950	364	18	patients	patient	NOUN
ihlr-22950	364	19	with	with	ADP
ihlr-22950	364	20	a	a	DET
ihlr-22950	364	21	method	method	NOUN
ihlr-22950	364	22	to	to	PART
ihlr-22950	364	23	use	use	VERB
ihlr-22950	364	24	an	an	DET
ihlr-22950	364	25	investigational	investigational	ADJ
ihlr-22950	364	26	device	device	NOUN
ihlr-22950	364	27	not	not	PART
ihlr-22950	364	28	yet	yet	ADV
ihlr-22950	364	29	approved	approve	VERB
ihlr-22950	364	30	.	.	PUNCT
ihlr-22950	365	1	compassionate	compassionate	ADJ
ihlr-22950	365	2	use	use	NOUN
ihlr-22950	365	3	devices	device	NOUN
ihlr-22950	365	4	provide	provide	VERB
ihlr-22950	365	5	a	a	DET
ihlr-22950	365	6	possible	possible	ADJ
ihlr-22950	365	7	access	access	NOUN
ihlr-22950	365	8	to	to	ADP
ihlr-22950	365	9	those	those	DET
ihlr-22950	365	10	investigational	investigational	ADJ
ihlr-22950	365	11	devices	device	NOUN
ihlr-22950	365	12	that	that	PRON
ihlr-22950	365	13	have	have	AUX
ihlr-22950	365	14	not	not	PART
ihlr-22950	365	15	received	receive	VERB
ihlr-22950	365	16	fda	fda	PROPN
ihlr-22950	365	17	approval	approval	NOUN
ihlr-22950	365	18	or	or	CCONJ
ihlr-22950	365	19	clearance	clearance	NOUN
ihlr-22950	365	20	.	.	PUNCT
ihlr-22950	366	1	further	far	ADV
ihlr-22950	366	2	,	,	PUNCT
ihlr-22950	366	3	the	the	DET
ihlr-22950	366	4	patient	patient	NOUN
ihlr-22950	366	5	’s	’s	PART
ihlr-22950	366	6	physician	physician	NOUN
ihlr-22950	366	7	must	must	AUX
ihlr-22950	366	8	be	be	AUX
ihlr-22950	366	9	of	of	ADP
ihlr-22950	366	10	the	the	DET
ihlr-22950	366	11	medical	medical	ADJ
ihlr-22950	366	12	opinion	opinion	NOUN
ihlr-22950	366	13	the	the	DET
ihlr-22950	366	14	device	device	NOUN
ihlr-22950	366	15	may	may	AUX
ihlr-22950	366	16	provide	provide	VERB
ihlr-22950	366	17	a	a	DET
ihlr-22950	366	18	benefit	benefit	NOUN
ihlr-22950	366	19	in	in	ADP
ihlr-22950	366	20	treating	treat	VERB
ihlr-22950	366	21	or	or	CCONJ
ihlr-22950	366	22	perhaps	perhaps	ADV
ihlr-22950	366	23	even	even	ADV
ihlr-22950	366	24	diagnosing	diagnose	VERB
ihlr-22950	366	25	the	the	DET
ihlr-22950	366	26	disease	disease	NOUN
ihlr-22950	366	27	or	or	CCONJ
ihlr-22950	366	28	condition	condition	NOUN
ihlr-22950	366	29	.	.	PUNCT
ihlr-22950	367	1	compassionate	compassionate	ADJ
ihlr-22950	367	2	use	use	NOUN
ihlr-22950	367	3	can	can	AUX
ihlr-22950	367	4	be	be	AUX
ihlr-22950	367	5	for	for	ADP
ihlr-22950	367	6	patients	patient	NOUN
ihlr-22950	367	7	who	who	PRON
ihlr-22950	367	8	do	do	AUX
ihlr-22950	367	9	not	not	PART
ihlr-22950	367	10	meet	meet	VERB
ihlr-22950	367	11	the	the	DET
ihlr-22950	367	12	requirements	requirement	NOUN
ihlr-22950	367	13	for	for	ADP
ihlr-22950	367	14	inclusion	inclusion	NOUN
ihlr-22950	367	15	in	in	ADP
ihlr-22950	367	16	the	the	DET
ihlr-22950	367	17	clinical	clinical	ADJ
ihlr-22950	367	18	investigation	investigation	NOUN
ihlr-22950	367	19	and	and	CCONJ
ihlr-22950	367	20	for	for	ADP
ihlr-22950	367	21	devices	device	NOUN
ihlr-22950	367	22	that	that	PRON
ihlr-22950	367	23	are	be	AUX
ihlr-22950	367	24	in	in	ADP
ihlr-22950	367	25	a	a	DET
ihlr-22950	367	26	clinical	clinical	ADJ
ihlr-22950	367	27	trial	trial	NOUN
ihlr-22950	367	28	under	under	ADP
ihlr-22950	367	29	an	an	DET
ihlr-22950	367	30	investigational	investigational	ADJ
ihlr-22950	367	31	device	device	NOUN
ihlr-22950	367	32	exemption.76	exemption.76	NOUN
ihlr-22950	367	33	further	far	ADV
ihlr-22950	367	34	,	,	PUNCT
ihlr-22950	367	35	a	a	DET
ihlr-22950	367	36	compassionate	compassionate	ADJ
ihlr-22950	367	37	use	use	NOUN
ihlr-22950	367	38	device	device	NOUN
ihlr-22950	367	39	may	may	AUX
ihlr-22950	367	40	not	not	PART
ihlr-22950	367	41	be	be	AUX
ihlr-22950	367	42	in	in	ADP
ihlr-22950	367	43	a	a	DET
ihlr-22950	367	44	clinical	clinical	ADJ
ihlr-22950	367	45	investigation	investigation	NOUN
ihlr-22950	367	46	and	and	CCONJ
ihlr-22950	367	47	is	be	AUX
ihlr-22950	367	48	for	for	ADP
ihlr-22950	367	49	a	a	DET
ihlr-22950	367	50	small	small	ADJ
ihlr-22950	367	51	group	group	NOUN
ihlr-22950	367	52	or	or	CCONJ
ihlr-22950	367	53	an	an	DET
ihlr-22950	367	54	individual	individual	ADJ
ihlr-22950	367	55	patient	patient	NOUN
ihlr-22950	367	56	.	.	PUNCT
ihlr-22950	368	1	the	the	DET
ihlr-22950	368	2	criteria	criterion	NOUN
ihlr-22950	368	3	include	include	VERB
ihlr-22950	368	4	the	the	DET
ihlr-22950	368	5	following:77	following:77	NOUN
ihlr-22950	368	6	the	the	DET
ihlr-22950	368	7	patient	patient	NOUN
ihlr-22950	368	8	has	have	VERB
ihlr-22950	368	9	a	a	DET
ihlr-22950	368	10	life	life	NOUN
ihlr-22950	368	11	-	-	PUNCT
ihlr-22950	368	12	threatening	threatening	ADJ
ihlr-22950	368	13	or	or	CCONJ
ihlr-22950	368	14	serious	serious	ADJ
ihlr-22950	368	15	disease	disease	NOUN
ihlr-22950	368	16	or	or	CCONJ
ihlr-22950	368	17	condition	condition	NOUN
ihlr-22950	368	18	;	;	PUNCT
ihlr-22950	368	19	71	71	NUM
ihlr-22950	368	20	.	.	PUNCT
ihlr-22950	368	21	exception	exception	NOUN
ihlr-22950	368	22	from	from	ADP
ihlr-22950	368	23	general	general	ADJ
ihlr-22950	368	24	requirements	requirement	NOUN
ihlr-22950	368	25	,	,	PUNCT
ihlr-22950	368	26	21	21	NUM
ihlr-22950	368	27	c.f.r	c.f.r	NOUN
ihlr-22950	368	28	.	.	PUNCT
ihlr-22950	369	1	§	§	PROPN
ihlr-22950	369	2	50.23(a	50.23(a	NUM
ihlr-22950	369	3	)	)	PUNCT
ihlr-22950	369	4	(	(	PUNCT
ihlr-22950	369	5	2018	2018	NUM
ihlr-22950	369	6	)	)	PUNCT
ihlr-22950	369	7	.	.	PUNCT
ihlr-22950	370	1	72	72	NUM
ihlr-22950	370	2	.	.	PUNCT
ihlr-22950	371	1	treatment	treatment	NOUN
ihlr-22950	371	2	use	use	NOUN
ihlr-22950	371	3	of	of	ADP
ihlr-22950	371	4	an	an	DET
ihlr-22950	371	5	investigational	investigational	ADJ
ihlr-22950	371	6	new	new	ADJ
ihlr-22950	371	7	device	device	NOUN
ihlr-22950	371	8	,	,	PUNCT
ihlr-22950	371	9	21	21	NUM
ihlr-22950	371	10	c.f.r	c.f.r	NOUN
ihlr-22950	371	11	.	.	PUNCT
ihlr-22950	372	1	§	§	PROPN
ihlr-22950	372	2	812.36	812.36	NUM
ihlr-22950	372	3	(	(	PUNCT
ihlr-22950	372	4	2018	2018	NUM
ihlr-22950	372	5	)	)	PUNCT
ihlr-22950	372	6	.	.	PUNCT
ihlr-22950	373	1	73	73	NUM
ihlr-22950	373	2	.	.	PUNCT
ihlr-22950	374	1	i	i	PRON
ihlr-22950	374	2	d.	d.	PROPN
ihlr-22950	374	3	;	;	PUNCT
ihlr-22950	374	4	see	see	AUX
ihlr-22950	374	5	also	also	ADV
ihlr-22950	374	6	expanded	expand	VERB
ihlr-22950	374	7	access	access	NOUN
ihlr-22950	374	8	for	for	ADP
ihlr-22950	374	9	medical	medical	ADJ
ihlr-22950	374	10	devices	device	NOUN
ihlr-22950	374	11	,	,	PUNCT
ihlr-22950	374	12	supra	supra	PROPN
ihlr-22950	374	13	note	note	NOUN
ihlr-22950	374	14	69	69	NUM
ihlr-22950	374	15	.	.	PUNCT
ihlr-22950	375	1	74	74	NUM
ihlr-22950	375	2	.	.	PUNCT
ihlr-22950	375	3	expanded	expand	VERB
ihlr-22950	375	4	access	access	NOUN
ihlr-22950	375	5	for	for	ADP
ihlr-22950	375	6	medical	medical	ADJ
ihlr-22950	375	7	devices	device	NOUN
ihlr-22950	375	8	,	,	PUNCT
ihlr-22950	375	9	supra	supra	PROPN
ihlr-22950	375	10	note	note	NOUN
ihlr-22950	375	11	69	69	NUM
ihlr-22950	375	12	.	.	PUNCT
ihlr-22950	376	1	75	75	NUM
ihlr-22950	376	2	.	.	PUNCT
ihlr-22950	377	1	i	i	PRON
ihlr-22950	377	2	d.	d.	PROPN
ihlr-22950	377	3	76	76	NUM
ihlr-22950	377	4	.	.	PUNCT
ihlr-22950	378	1	i	i	PRON
ihlr-22950	378	2	d.	d.	PROPN
ihlr-22950	378	3	77	77	NUM
ihlr-22950	378	4	.	.	PUNCT
ihlr-22950	379	1	i	i	PRON
ihlr-22950	379	2	d.	d.	PROPN
ihlr-22950	379	3	2018	2018	NUM
ihlr-22950	379	4	]	]	PUNCT
ihlr-22950	380	1	the	the	DET
ihlr-22950	380	2	latest	late	ADJ
ihlr-22950	380	3	“	"	PUNCT
ihlr-22950	380	4	federal	federal	ADJ
ihlr-22950	380	5	movement	movement	NOUN
ihlr-22950	380	6	”	"	PUNCT
ihlr-22950	380	7	in	in	ADP
ihlr-22950	380	8	the	the	DET
ihlr-22950	380	9	food	food	NOUN
ihlr-22950	380	10	and	and	CCONJ
ihlr-22950	380	11	drug	drug	NOUN
ihlr-22950	380	12	law	law	NOUN
ihlr-22950	380	13	arena	arena	NOUN
ihlr-22950	380	14	113	113	NUM
ihlr-22950	380	15	no	no	INTJ
ihlr-22950	380	16	generally	generally	ADV
ihlr-22950	380	17	acceptable	acceptable	ADJ
ihlr-22950	380	18	alternative	alternative	ADJ
ihlr-22950	380	19	treatment	treatment	NOUN
ihlr-22950	380	20	for	for	ADP
ihlr-22950	380	21	the	the	DET
ihlr-22950	380	22	condition	condition	NOUN
ihlr-22950	380	23	exists	exist	VERB
ihlr-22950	380	24	;	;	PUNCT
ihlr-22950	380	25	and	and	CCONJ
ihlr-22950	380	26	time	time	NOUN
ihlr-22950	380	27	is	be	AUX
ihlr-22950	380	28	of	of	ADP
ihlr-22950	380	29	essence	essence	NOUN
ihlr-22950	380	30	which	which	PRON
ihlr-22950	380	31	does	do	AUX
ihlr-22950	380	32	not	not	PART
ihlr-22950	380	33	permit	permit	VERB
ihlr-22950	380	34	obtaining	obtain	VERB
ihlr-22950	380	35	an	an	DET
ihlr-22950	380	36	investigational	investigational	ADJ
ihlr-22950	380	37	device	device	NOUN
ihlr-22950	380	38	exemption.78	exemption.78	NOUN
ihlr-22950	380	39	submission	submission	NOUN
ihlr-22950	380	40	of	of	ADP
ihlr-22950	380	41	a	a	DET
ihlr-22950	380	42	humanitarian	humanitarian	ADJ
ihlr-22950	380	43	device	device	NOUN
ihlr-22950	380	44	exemption	exemption	NOUN
ihlr-22950	380	45	application	application	NOUN
ihlr-22950	380	46	is	be	AUX
ihlr-22950	380	47	necessary	necessary	ADJ
ihlr-22950	380	48	,	,	PUNCT
ihlr-22950	380	49	and	and	CCONJ
ihlr-22950	380	50	the	the	DET
ihlr-22950	380	51	approval	approval	NOUN
ihlr-22950	380	52	rate	rate	NOUN
ihlr-22950	380	53	is	be	AUX
ihlr-22950	380	54	approximately	approximately	ADV
ihlr-22950	380	55	99%.79	99%.79	NUM
ihlr-22950	380	56	the	the	DET
ihlr-22950	380	57	federal	federal	ADJ
ihlr-22950	380	58	right	right	NOUN
ihlr-22950	380	59	to	to	PART
ihlr-22950	380	60	try	try	VERB
ihlr-22950	380	61	act	act	NOUN
ihlr-22950	380	62	does	do	AUX
ihlr-22950	380	63	not	not	PART
ihlr-22950	380	64	address	address	VERB
ihlr-22950	380	65	compassionate	compassionate	ADJ
ihlr-22950	380	66	use	use	NOUN
ihlr-22950	380	67	for	for	ADP
ihlr-22950	380	68	medical	medical	ADJ
ihlr-22950	380	69	devices	device	NOUN
ihlr-22950	380	70	.	.	PUNCT
ihlr-22950	381	1	80	80	NUM
ihlr-22950	381	2	vii	vii	PROPN
ihlr-22950	381	3	.	.	PUNCT
ihlr-22950	382	1	fda	fda	PROPN
ihlr-22950	382	2	action	action	NOUN
ihlr-22950	382	3	prior	prior	ADV
ihlr-22950	382	4	to	to	ADP
ihlr-22950	382	5	the	the	DET
ihlr-22950	382	6	enactment	enactment	NOUN
ihlr-22950	382	7	of	of	ADP
ihlr-22950	382	8	the	the	DET
ihlr-22950	382	9	federal	federal	ADJ
ihlr-22950	382	10	right	right	NOUN
ihlr-22950	382	11	-	-	PUNCT
ihlr-22950	382	12	to	to	PART
ihlr-22950	382	13	-	-	PUNCT
ihlr-22950	382	14	try	try	VERB
ihlr-22950	382	15	legislation	legislation	NOUN
ihlr-22950	382	16	as	as	ADP
ihlr-22950	382	17	detailed	detailed	ADJ
ihlr-22950	382	18	above	above	ADV
ihlr-22950	382	19	,	,	PUNCT
ihlr-22950	382	20	despite	despite	SCONJ
ihlr-22950	382	21	state	state	NOUN
ihlr-22950	382	22	legislation	legislation	NOUN
ihlr-22950	382	23	,	,	PUNCT
ihlr-22950	382	24	a	a	DET
ihlr-22950	382	25	patient	patient	NOUN
ihlr-22950	382	26	who	who	PRON
ihlr-22950	382	27	is	be	AUX
ihlr-22950	382	28	ineligible	ineligible	ADJ
ihlr-22950	382	29	to	to	PART
ihlr-22950	382	30	obtain	obtain	VERB
ihlr-22950	382	31	an	an	DET
ihlr-22950	382	32	experimental	experimental	ADJ
ihlr-22950	382	33	therapy	therapy	NOUN
ihlr-22950	382	34	through	through	ADP
ihlr-22950	382	35	a	a	DET
ihlr-22950	382	36	clinical	clinical	ADJ
ihlr-22950	382	37	trial	trial	NOUN
ihlr-22950	382	38	has	have	AUX
ihlr-22950	382	39	had	have	VERB
ihlr-22950	382	40	the	the	DET
ihlr-22950	382	41	option	option	NOUN
ihlr-22950	382	42	to	to	PART
ihlr-22950	382	43	request	request	VERB
ihlr-22950	382	44	experimental	experimental	ADJ
ihlr-22950	382	45	therapy	therapy	NOUN
ihlr-22950	382	46	through	through	ADP
ihlr-22950	382	47	his	his	PRON
ihlr-22950	382	48	or	or	CCONJ
ihlr-22950	382	49	her	her	PRON
ihlr-22950	382	50	physician	physician	NOUN
ihlr-22950	382	51	to	to	PART
ihlr-22950	382	52	apply	apply	VERB
ihlr-22950	382	53	to	to	ADP
ihlr-22950	382	54	the	the	DET
ihlr-22950	382	55	fda	fda	PROPN
ihlr-22950	382	56	to	to	PART
ihlr-22950	382	57	obtain	obtain	VERB
ihlr-22950	382	58	experimental	experimental	ADJ
ihlr-22950	382	59	therapy	therapy	NOUN
ihlr-22950	382	60	under	under	ADP
ihlr-22950	382	61	expanded	expand	VERB
ihlr-22950	382	62	access	access	NOUN
ihlr-22950	382	63	or	or	CCONJ
ihlr-22950	382	64	compassionate	compassionate	ADJ
ihlr-22950	382	65	use	use	NOUN
ihlr-22950	382	66	.	.	PUNCT
ihlr-22950	383	1	according	accord	VERB
ihlr-22950	383	2	to	to	ADP
ihlr-22950	383	3	fda	fda	PROPN
ihlr-22950	383	4	,	,	PUNCT
ihlr-22950	383	5	expanded	expand	VERB
ihlr-22950	383	6	access	access	NOUN
ihlr-22950	383	7	or	or	CCONJ
ihlr-22950	383	8	as	as	SCONJ
ihlr-22950	383	9	indicated	indicate	VERB
ihlr-22950	383	10	compassionate	compassionate	ADJ
ihlr-22950	383	11	use	use	NOUN
ihlr-22950	383	12	is	be	AUX
ihlr-22950	383	13	the	the	DET
ihlr-22950	383	14	“	"	PUNCT
ihlr-22950	383	15	use	use	NOUN
ihlr-22950	383	16	of	of	ADP
ihlr-22950	383	17	investigational	investigational	ADJ
ihlr-22950	383	18	drugs	drug	NOUN
ihlr-22950	383	19	,	,	PUNCT
ihlr-22950	383	20	biologics	biologic	NOUN
ihlr-22950	383	21	or	or	CCONJ
ihlr-22950	383	22	medical	medical	ADJ
ihlr-22950	383	23	devices	device	NOUN
ihlr-22950	383	24	outside	outside	ADP
ihlr-22950	383	25	the	the	DET
ihlr-22950	383	26	clinical	clinical	ADJ
ihlr-22950	383	27	trial	trial	NOUN
ihlr-22950	383	28	setting	set	VERB
ihlr-22950	383	29	for	for	ADP
ihlr-22950	383	30	treatment	treatment	NOUN
ihlr-22950	383	31	purposes	purpose	NOUN
ihlr-22950	383	32	.	.	PUNCT
ihlr-22950	384	1	”81	”81	NOUN
ihlr-22950	384	2	further	far	ADV
ihlr-22950	384	3	,	,	PUNCT
ihlr-22950	384	4	to	to	PART
ihlr-22950	384	5	determine	determine	VERB
ihlr-22950	384	6	the	the	DET
ihlr-22950	384	7	suitability	suitability	NOUN
ihlr-22950	384	8	for	for	ADP
ihlr-22950	384	9	expanded	expand	VERB
ihlr-22950	384	10	access	access	NOUN
ihlr-22950	384	11	the	the	DET
ihlr-22950	384	12	following	follow	VERB
ihlr-22950	384	13	are	be	AUX
ihlr-22950	384	14	all	all	ADV
ihlr-22950	384	15	requisite:82	requisite:82	NOUN
ihlr-22950	385	1	[	[	X
ihlr-22950	385	2	the	the	DET
ihlr-22950	385	3	]	]	X
ihlr-22950	385	4	patient	patient	NOUN
ihlr-22950	385	5	has	have	VERB
ihlr-22950	385	6	a	a	DET
ihlr-22950	385	7	serious	serious	ADJ
ihlr-22950	385	8	disease	disease	NOUN
ihlr-22950	385	9	or	or	CCONJ
ihlr-22950	385	10	condition	condition	NOUN
ihlr-22950	385	11	,	,	PUNCT
ihlr-22950	385	12	or	or	CCONJ
ihlr-22950	385	13	[	[	X
ihlr-22950	385	14	his	his	PRON
ihlr-22950	385	15	or	or	CCONJ
ihlr-22950	385	16	her	her	PRON
ihlr-22950	385	17	]	]	X
ihlr-22950	385	18	life	life	NOUN
ihlr-22950	385	19	is	be	AUX
ihlr-22950	385	20	immediately	immediately	ADV
ihlr-22950	385	21	threatened	threaten	VERB
ihlr-22950	385	22	by	by	ADP
ihlr-22950	385	23	[	[	X
ihlr-22950	385	24	the	the	DET
ihlr-22950	385	25	]	]	X
ihlr-22950	385	26	disease	disease	NOUN
ihlr-22950	385	27	or	or	CCONJ
ihlr-22950	385	28	condition	condition	NOUN
ihlr-22950	385	29	;	;	PUNCT
ihlr-22950	386	1	[	[	X
ihlr-22950	386	2	t]here	t]here	PRON
ihlr-22950	386	3	is	be	AUX
ihlr-22950	386	4	no	no	DET
ihlr-22950	386	5	comparable	comparable	ADJ
ihlr-22950	386	6	or	or	CCONJ
ihlr-22950	386	7	satisfactory	satisfactory	ADJ
ihlr-22950	386	8	alternative	alternative	ADJ
ihlr-22950	386	9	therapy	therapy	NOUN
ihlr-22950	386	10	to	to	PART
ihlr-22950	386	11	diagnose	diagnose	VERB
ihlr-22950	386	12	,	,	PUNCT
ihlr-22950	386	13	monitor	monitor	NOUN
ihlr-22950	386	14	,	,	PUNCT
ihlr-22950	386	15	or	or	CCONJ
ihlr-22950	386	16	treat	treat	VERB
ihlr-22950	386	17	the	the	DET
ihlr-22950	386	18	disease	disease	NOUN
ihlr-22950	386	19	or	or	CCONJ
ihlr-22950	386	20	condition	condition	NOUN
ihlr-22950	386	21	;	;	PUNCT
ihlr-22950	386	22	enrollment	enrollment	NOUN
ihlr-22950	386	23	in	in	ADP
ihlr-22950	386	24	a	a	DET
ihlr-22950	386	25	clinical	clinical	ADJ
ihlr-22950	386	26	trial	trial	NOUN
ihlr-22950	386	27	is	be	AUX
ihlr-22950	386	28	not	not	PART
ihlr-22950	386	29	possible	possible	ADJ
ihlr-22950	386	30	;	;	PUNCT
ihlr-22950	386	31	[	[	X
ihlr-22950	386	32	any	any	DET
ihlr-22950	386	33	]	]	PUNCT
ihlr-22950	386	34	potential	potential	ADJ
ihlr-22950	386	35	patient	patient	ADJ
ihlr-22950	386	36	benefit	benefit	NOUN
ihlr-22950	386	37	justifies	justifie	NOUN
ihlr-22950	386	38	[	[	PUNCT
ihlr-22950	386	39	or	or	CCONJ
ihlr-22950	386	40	outweighs	outweigh	VERB
ihlr-22950	386	41	]	]	PUNCT
ihlr-22950	386	42	the	the	DET
ihlr-22950	386	43	potential	potential	ADJ
ihlr-22950	386	44	risks	risk	NOUN
ihlr-22950	386	45	of	of	ADP
ihlr-22950	386	46	treatment	treatment	NOUN
ihlr-22950	386	47	;	;	PUNCT
ihlr-22950	386	48	[	[	X
ihlr-22950	386	49	using	use	VERB
ihlr-22950	386	50	]	]	PUNCT
ihlr-22950	386	51	the	the	DET
ihlr-22950	386	52	investigational	investigational	ADJ
ihlr-22950	386	53	medical	medical	ADJ
ihlr-22950	386	54	product	product	NOUN
ihlr-22950	386	55	will	will	AUX
ihlr-22950	386	56	not	not	PART
ihlr-22950	386	57	[	[	PUNCT
ihlr-22950	386	58	impede	impede	VERB
ihlr-22950	386	59	the	the	DET
ihlr-22950	386	60	]	]	PUNCT
ihlr-22950	386	61	investigational	investigational	ADJ
ihlr-22950	386	62	trials	trial	NOUN
ihlr-22950	386	63	that	that	PRON
ihlr-22950	386	64	could	could	AUX
ihlr-22950	386	65	support	support	VERB
ihlr-22950	386	66	[	[	X
ihlr-22950	386	67	the	the	X
ihlr-22950	386	68	]	]	X
ihlr-22950	386	69	.	.	PUNCT
ihlr-22950	386	70	.	.	PUNCT
ihlr-22950	386	71	.	.	PUNCT
ihlr-22950	387	1	development	development	NOUN
ihlr-22950	387	2	or	or	CCONJ
ihlr-22950	387	3	marketing	marketing	NOUN
ihlr-22950	387	4	approval	approval	NOUN
ihlr-22950	387	5	for	for	ADP
ihlr-22950	387	6	the	the	DET
ihlr-22950	387	7	treatment	treatment	NOUN
ihlr-22950	387	8	indication.83	indication.83	NOUN
ihlr-22950	387	9	all	all	PRON
ihlr-22950	387	10	of	of	ADP
ihlr-22950	387	11	the	the	DET
ihlr-22950	387	12	above	above	ADJ
ihlr-22950	387	13	parameters	parameter	NOUN
ihlr-22950	387	14	are	be	AUX
ihlr-22950	387	15	straightforward	straightforward	ADJ
ihlr-22950	387	16	.	.	PUNCT
ihlr-22950	388	1	however	however	ADV
ihlr-22950	388	2	,	,	PUNCT
ihlr-22950	388	3	the	the	DET
ihlr-22950	388	4	issue	issue	NOUN
ihlr-22950	388	5	becomes	become	VERB
ihlr-22950	388	6	how	how	SCONJ
ihlr-22950	388	7	to	to	PART
ihlr-22950	388	8	obtain	obtain	VERB
ihlr-22950	388	9	the	the	DET
ihlr-22950	388	10	potentially	potentially	ADV
ihlr-22950	388	11	life	life	NOUN
ihlr-22950	388	12	-	-	PUNCT
ihlr-22950	388	13	extending	extend	VERB
ihlr-22950	388	14	product	product	NOUN
ihlr-22950	388	15	.	.	PUNCT
ihlr-22950	389	1	perhaps	perhaps	ADV
ihlr-22950	389	2	that	that	PRON
ihlr-22950	389	3	is	be	AUX
ihlr-22950	389	4	why	why	SCONJ
ihlr-22950	389	5	the	the	DET
ihlr-22950	389	6	state	state	NOUN
ihlr-22950	389	7	legislation84	legislation84	PROPN
ihlr-22950	389	8	and	and	CCONJ
ihlr-22950	389	9	now	now	ADV
ihlr-22950	389	10	the	the	DET
ihlr-22950	389	11	federal	federal	ADJ
ihlr-22950	389	12	right	right	NOUN
ihlr-22950	389	13	to	to	PART
ihlr-22950	389	14	try	try	VERB
ihlr-22950	389	15	act85	act85	NOUN
ihlr-22950	389	16	were	be	AUX
ihlr-22950	389	17	enacted	enact	VERB
ihlr-22950	389	18	.	.	PUNCT
ihlr-22950	390	1	following	follow	VERB
ihlr-22950	390	2	the	the	DET
ihlr-22950	390	3	introduction	introduction	NOUN
ihlr-22950	390	4	and	and	CCONJ
ihlr-22950	390	5	passage	passage	NOUN
ihlr-22950	390	6	of	of	ADP
ihlr-22950	390	7	several	several	ADJ
ihlr-22950	390	8	state	state	NOUN
ihlr-22950	390	9	right	right	NOUN
ihlr-22950	390	10	-	-	PUNCT
ihlr-22950	390	11	to	to	AUX
ihlr-22950	390	12	-	-	PUNCT
ihlr-22950	390	13	try	try	VERB
ihlr-22950	390	14	laws	law	NOUN
ihlr-22950	390	15	,	,	PUNCT
ihlr-22950	390	16	in	in	ADP
ihlr-22950	390	17	78	78	NUM
ihlr-22950	390	18	.	.	PUNCT
ihlr-22950	391	1	i	i	PRON
ihlr-22950	391	2	d.	d.	PROPN
ihlr-22950	391	3	79	79	NUM
ihlr-22950	391	4	.	.	PUNCT
ihlr-22950	392	1	i	i	PRON
ihlr-22950	392	2	d.	d.	PROPN
ihlr-22950	392	3	;	;	PUNCT
ihlr-22950	392	4	see	see	AUX
ihlr-22950	392	5	also	also	ADV
ihlr-22950	392	6	appendix	appendix	VERB
ihlr-22950	392	7	ii	ii	PROPN
ihlr-22950	392	8	.	.	PROPN
ihlr-22950	392	9	80	80	NUM
ihlr-22950	392	10	.	.	PUNCT
ihlr-22950	393	1	trickett	trickett	PROPN
ihlr-22950	393	2	wendler	wendler	PROPN
ihlr-22950	393	3	,	,	PUNCT
ihlr-22950	393	4	frank	frank	PROPN
ihlr-22950	393	5	mongiello	mongiello	PROPN
ihlr-22950	393	6	,	,	PUNCT
ihlr-22950	393	7	jordan	jordan	PROPN
ihlr-22950	393	8	mclinn	mclinn	PROPN
ihlr-22950	393	9	,	,	PUNCT
ihlr-22950	393	10	and	and	CCONJ
ihlr-22950	393	11	matthew	matthew	PROPN
ihlr-22950	393	12	bellina	bellina	PROPN
ihlr-22950	393	13	right	right	NOUN
ihlr-22950	393	14	to	to	PART
ihlr-22950	393	15	try	try	VERB
ihlr-22950	393	16	act	act	NOUN
ihlr-22950	393	17	of	of	ADP
ihlr-22950	393	18	2017	2017	NUM
ihlr-22950	393	19	,	,	PUNCT
ihlr-22950	393	20	pub	pub	NOUN
ihlr-22950	393	21	.	.	PUNCT
ihlr-22950	394	1	l.	l.	PROPN
ihlr-22950	394	2	no	no	INTJ
ihlr-22950	394	3	.	.	PROPN
ihlr-22950	395	1	115	115	NUM
ihlr-22950	395	2	-	-	SYM
ihlr-22950	395	3	176	176	NUM
ihlr-22950	395	4	,	,	PUNCT
ihlr-22950	395	5	132	132	NUM
ihlr-22950	395	6	stat	stat	NOUN
ihlr-22950	395	7	.	.	PUNCT
ihlr-22950	396	1	1372	1372	NUM
ihlr-22950	396	2	(	(	PUNCT
ihlr-22950	396	3	2018	2018	NUM
ihlr-22950	396	4	)	)	PUNCT
ihlr-22950	396	5	.	.	PUNCT
ihlr-22950	397	1	the	the	DET
ihlr-22950	397	2	federal	federal	ADJ
ihlr-22950	397	3	right	right	NOUN
ihlr-22950	397	4	to	to	PART
ihlr-22950	397	5	try	try	VERB
ihlr-22950	397	6	act	act	NOUN
ihlr-22950	397	7	does	do	AUX
ihlr-22950	397	8	not	not	PART
ihlr-22950	397	9	specifically	specifically	ADV
ihlr-22950	397	10	include	include	VERB
ihlr-22950	397	11	medical	medical	ADJ
ihlr-22950	397	12	devices	device	NOUN
ihlr-22950	397	13	.	.	PUNCT
ihlr-22950	398	1	perhaps	perhaps	ADV
ihlr-22950	398	2	intentional	intentional	ADJ
ihlr-22950	398	3	or	or	CCONJ
ihlr-22950	398	4	perhaps	perhaps	ADV
ihlr-22950	398	5	an	an	DET
ihlr-22950	398	6	oversight	oversight	NOUN
ihlr-22950	398	7	yet	yet	CCONJ
ihlr-22950	398	8	medical	medical	ADJ
ihlr-22950	398	9	devices	device	NOUN
ihlr-22950	398	10	should	should	AUX
ihlr-22950	398	11	have	have	AUX
ihlr-22950	398	12	been	be	AUX
ihlr-22950	398	13	included	include	VERB
ihlr-22950	398	14	.	.	PUNCT
ihlr-22950	399	1	81	81	NUM
ihlr-22950	399	2	.	.	PUNCT
ihlr-22950	399	3	expanded	expand	VERB
ihlr-22950	399	4	access	access	NOUN
ihlr-22950	399	5	(	(	PUNCT
ihlr-22950	399	6	sometimes	sometimes	ADV
ihlr-22950	399	7	called	call	VERB
ihlr-22950	399	8	“	"	PUNCT
ihlr-22950	399	9	compassionate	compassionate	ADJ
ihlr-22950	399	10	use	use	NOUN
ihlr-22950	399	11	”	"	PUNCT
ihlr-22950	399	12	)	)	PUNCT
ihlr-22950	399	13	,	,	PUNCT
ihlr-22950	399	14	supra	supra	PROPN
ihlr-22950	399	15	note	note	VERB
ihlr-22950	399	16	45	45	NUM
ihlr-22950	399	17	.	.	NOUN
ihlr-22950	399	18	82	82	NUM
ihlr-22950	399	19	.	.	PUNCT
ihlr-22950	400	1	requirements	requirement	NOUN
ihlr-22950	400	2	for	for	ADP
ihlr-22950	400	3	all	all	DET
ihlr-22950	400	4	expanded	expand	VERB
ihlr-22950	400	5	access	access	NOUN
ihlr-22950	400	6	uses	use	NOUN
ihlr-22950	400	7	,	,	PUNCT
ihlr-22950	400	8	21	21	NUM
ihlr-22950	400	9	c.f.r	c.f.r	NOUN
ihlr-22950	400	10	.	.	PUNCT
ihlr-22950	401	1	§	§	PROPN
ihlr-22950	401	2	312.305	312.305	NUM
ihlr-22950	401	3	(	(	PUNCT
ihlr-22950	401	4	2018	2018	NUM
ihlr-22950	401	5	)	)	PUNCT
ihlr-22950	401	6	.	.	PUNCT
ihlr-22950	402	1	83	83	NUM
ihlr-22950	402	2	.	.	PUNCT
ihlr-22950	402	3	expanded	expand	VERB
ihlr-22950	402	4	access	access	NOUN
ihlr-22950	402	5	(	(	PUNCT
ihlr-22950	402	6	sometimes	sometimes	ADV
ihlr-22950	402	7	called	call	VERB
ihlr-22950	402	8	“	"	PUNCT
ihlr-22950	402	9	compassionate	compassionate	ADJ
ihlr-22950	402	10	use	use	NOUN
ihlr-22950	402	11	”	"	PUNCT
ihlr-22950	402	12	)	)	PUNCT
ihlr-22950	402	13	,	,	PUNCT
ihlr-22950	402	14	supra	supra	PROPN
ihlr-22950	402	15	note	note	VERB
ihlr-22950	402	16	45	45	NUM
ihlr-22950	402	17	.	.	NOUN
ihlr-22950	402	18	84	84	NUM
ihlr-22950	402	19	.	.	PUNCT
ihlr-22950	403	1	goldwater	goldwater	PROPN
ihlr-22950	403	2	inst	inst	PROPN
ihlr-22950	403	3	.	.	PROPN
ihlr-22950	403	4	,	,	PUNCT
ihlr-22950	403	5	supra	supra	PROPN
ihlr-22950	403	6	note	note	PROPN
ihlr-22950	403	7	14	14	NUM
ihlr-22950	403	8	.	.	SYM
ihlr-22950	403	9	85	85	NUM
ihlr-22950	403	10	.	.	PUNCT
ihlr-22950	404	1	trickett	trickett	PROPN
ihlr-22950	404	2	wendler	wendler	PROPN
ihlr-22950	404	3	,	,	PUNCT
ihlr-22950	404	4	frank	frank	PROPN
ihlr-22950	404	5	mongiello	mongiello	PROPN
ihlr-22950	404	6	,	,	PUNCT
ihlr-22950	404	7	jordan	jordan	PROPN
ihlr-22950	404	8	mclinn	mclinn	PROPN
ihlr-22950	404	9	,	,	PUNCT
ihlr-22950	404	10	and	and	CCONJ
ihlr-22950	404	11	matthew	matthew	PROPN
ihlr-22950	404	12	bellina	bellina	PROPN
ihlr-22950	404	13	right	right	NOUN
ihlr-22950	404	14	to	to	PART
ihlr-22950	404	15	try	try	VERB
ihlr-22950	404	16	act	act	NOUN
ihlr-22950	404	17	of	of	ADP
ihlr-22950	404	18	2017	2017	NUM
ihlr-22950	404	19	,	,	PUNCT
ihlr-22950	404	20	pub	pub	NOUN
ihlr-22950	404	21	.	.	PUNCT
ihlr-22950	405	1	l.	l.	PROPN
ihlr-22950	405	2	no	no	INTJ
ihlr-22950	405	3	.	.	PROPN
ihlr-22950	406	1	115	115	NUM
ihlr-22950	406	2	-	-	SYM
ihlr-22950	406	3	176	176	NUM
ihlr-22950	406	4	,	,	PUNCT
ihlr-22950	406	5	132	132	NUM
ihlr-22950	406	6	stat	stat	NOUN
ihlr-22950	406	7	.	.	PUNCT
ihlr-22950	407	1	1372	1372	NUM
ihlr-22950	407	2	(	(	PUNCT
ihlr-22950	407	3	2018	2018	NUM
ihlr-22950	407	4	)	)	PUNCT
ihlr-22950	407	5	.	.	PUNCT
ihlr-22950	408	1	114	114	NUM
ihlr-22950	408	2	indiana	indiana	PROPN
ihlr-22950	408	3	health	health	PROPN
ihlr-22950	408	4	law	law	PROPN
ihlr-22950	408	5	review	review	NOUN
ihlr-22950	408	6	[	[	X
ihlr-22950	408	7	vol	vol	NOUN
ihlr-22950	408	8	.	.	PUNCT
ihlr-22950	409	1	16:101	16:101	NUM
ihlr-22950	409	2	february	february	NOUN
ihlr-22950	409	3	of	of	ADP
ihlr-22950	409	4	2015	2015	NUM
ihlr-22950	409	5	,	,	PUNCT
ihlr-22950	409	6	the	the	DET
ihlr-22950	409	7	fda	fda	PROPN
ihlr-22950	409	8	released	release	VERB
ihlr-22950	409	9	a	a	DET
ihlr-22950	409	10	proposed	propose	VERB
ihlr-22950	409	11	“	"	PUNCT
ihlr-22950	409	12	streamlined	streamlined	ADJ
ihlr-22950	409	13	”	"	PUNCT
ihlr-22950	409	14	procedure	procedure	NOUN
ihlr-22950	409	15	for	for	ADP
ihlr-22950	409	16	individual	individual	ADJ
ihlr-22950	409	17	patient	patient	NOUN
ihlr-22950	409	18	expanded	expand	VERB
ihlr-22950	409	19	access	access	NOUN
ihlr-22950	409	20	to	to	ADP
ihlr-22950	409	21	experimental	experimental	ADJ
ihlr-22950	409	22	drugs.86	drugs.86	PROPN
ihlr-22950	409	23	the	the	DET
ihlr-22950	409	24	fda	fda	PROPN
ihlr-22950	409	25	published	publish	VERB
ihlr-22950	409	26	a	a	DET
ihlr-22950	409	27	final	final	ADJ
ihlr-22950	409	28	version	version	NOUN
ihlr-22950	409	29	on	on	ADP
ihlr-22950	409	30	june	june	PROPN
ihlr-22950	409	31	2	2	NUM
ihlr-22950	409	32	,	,	PUNCT
ihlr-22950	409	33	2016	2016	NUM
ihlr-22950	409	34	,	,	PUNCT
ihlr-22950	409	35	entitled	entitle	VERB
ihlr-22950	409	36	“	"	PUNCT
ihlr-22950	409	37	individual	individual	ADJ
ihlr-22950	409	38	patient	patient	NOUN
ihlr-22950	409	39	expanded	expand	VERB
ihlr-22950	409	40	access	access	NOUN
ihlr-22950	409	41	applications	application	NOUN
ihlr-22950	409	42	–	–	PUNCT
ihlr-22950	409	43	form	form	NOUN
ihlr-22950	409	44	fda	fda	PROPN
ihlr-22950	409	45	3962”87	3962”87	NUM
ihlr-22950	409	46	,	,	PUNCT
ihlr-22950	409	47	along	along	ADP
ihlr-22950	409	48	with	with	ADP
ihlr-22950	409	49	patient	patient	NOUN
ihlr-22950	409	50	and	and	CCONJ
ihlr-22950	409	51	physician	physician	NOUN
ihlr-22950	409	52	information	information	NOUN
ihlr-22950	409	53	sheets	sheet	NOUN
ihlr-22950	409	54	and	and	CCONJ
ihlr-22950	409	55	related	relate	VERB
ihlr-22950	409	56	guidances	guidance	NOUN
ihlr-22950	409	57	for	for	ADP
ihlr-22950	409	58	all	all	DET
ihlr-22950	409	59	expanded	expand	VERB
ihlr-22950	409	60	access	access	NOUN
ihlr-22950	409	61	for	for	ADP
ihlr-22950	409	62	experimental	experimental	ADJ
ihlr-22950	409	63	drugs	drug	NOUN
ihlr-22950	409	64	and	and	CCONJ
ihlr-22950	409	65	for	for	ADP
ihlr-22950	409	66	charging	charge	VERB
ihlr-22950	409	67	for	for	ADP
ihlr-22950	409	68	experimental	experimental	ADJ
ihlr-22950	409	69	drugs	drug	NOUN
ihlr-22950	409	70	.	.	PUNCT
ihlr-22950	410	1	conditions	condition	NOUN
ihlr-22950	410	2	include	include	VERB
ihlr-22950	410	3	that	that	SCONJ
ihlr-22950	410	4	the	the	DET
ihlr-22950	410	5	possible	possible	ADJ
ihlr-22950	410	6	patient	patient	ADJ
ihlr-22950	410	7	benefit	benefit	NOUN
ihlr-22950	410	8	validates	validate	VERB
ihlr-22950	410	9	the	the	DET
ihlr-22950	410	10	potential	potential	ADJ
ihlr-22950	410	11	risks	risk	NOUN
ihlr-22950	410	12	,	,	PUNCT
ihlr-22950	410	13	the	the	DET
ihlr-22950	410	14	risk	risk	NOUN
ihlr-22950	410	15	from	from	ADP
ihlr-22950	410	16	the	the	DET
ihlr-22950	410	17	investigational	investigational	ADJ
ihlr-22950	410	18	drug	drug	NOUN
ihlr-22950	410	19	is	be	AUX
ihlr-22950	410	20	less	less	ADJ
ihlr-22950	410	21	than	than	ADP
ihlr-22950	410	22	that	that	PRON
ihlr-22950	410	23	from	from	ADP
ihlr-22950	410	24	the	the	DET
ihlr-22950	410	25	disease	disease	NOUN
ihlr-22950	410	26	or	or	CCONJ
ihlr-22950	410	27	condition	condition	NOUN
ihlr-22950	410	28	,	,	PUNCT
ihlr-22950	410	29	the	the	DET
ihlr-22950	410	30	use	use	NOUN
ihlr-22950	410	31	will	will	AUX
ihlr-22950	410	32	not	not	PART
ihlr-22950	410	33	interfere	interfere	VERB
ihlr-22950	410	34	with	with	ADP
ihlr-22950	410	35	drug	drug	NOUN
ihlr-22950	410	36	development	development	NOUN
ihlr-22950	410	37	,	,	PUNCT
ihlr-22950	410	38	and	and	CCONJ
ihlr-22950	410	39	the	the	DET
ihlr-22950	410	40	patient	patient	NOUN
ihlr-22950	410	41	can	can	AUX
ihlr-22950	410	42	not	not	PART
ihlr-22950	410	43	access	access	VERB
ihlr-22950	410	44	an	an	DET
ihlr-22950	410	45	existing	exist	VERB
ihlr-22950	410	46	clinical	clinical	ADJ
ihlr-22950	410	47	trial.88	trial.88	NOUN
ihlr-22950	410	48	the	the	DET
ihlr-22950	410	49	aim	aim	NOUN
ihlr-22950	410	50	of	of	ADP
ihlr-22950	410	51	revised	revise	VERB
ihlr-22950	410	52	form	form	NOUN
ihlr-22950	410	53	fda	fda	PROPN
ihlr-22950	410	54	3926	3926	NUM
ihlr-22950	410	55	procedures	procedure	NOUN
ihlr-22950	410	56	is	be	AUX
ihlr-22950	410	57	for	for	SCONJ
ihlr-22950	410	58	clarity	clarity	NOUN
ihlr-22950	410	59	purposes.89	purposes.89	NOUN
ihlr-22950	410	60	form	form	NOUN
ihlr-22950	410	61	fda	fda	PROPN
ihlr-22950	410	62	3926	3926	NUM
ihlr-22950	410	63	was	be	AUX
ihlr-22950	410	64	devised	devise	VERB
ihlr-22950	410	65	due	due	ADJ
ihlr-22950	410	66	to	to	ADP
ihlr-22950	410	67	complaints	complaint	NOUN
ihlr-22950	410	68	about	about	ADP
ihlr-22950	410	69	the	the	DET
ihlr-22950	410	70	prior	prior	ADJ
ihlr-22950	410	71	forms	form	NOUN
ihlr-22950	410	72	,	,	PUNCT
ihlr-22950	410	73	fda	fda	PROPN
ihlr-22950	410	74	1571	1571	NUM
ihlr-22950	410	75	and	and	CCONJ
ihlr-22950	410	76	1572	1572	NUM
ihlr-22950	410	77	,	,	PUNCT
ihlr-22950	410	78	which	which	PRON
ihlr-22950	410	79	were	be	AUX
ihlr-22950	410	80	used	use	VERB
ihlr-22950	410	81	for	for	ADP
ihlr-22950	410	82	all	all	DET
ihlr-22950	410	83	ind	ind	NOUN
ihlr-22950	410	84	submission	submission	NOUN
ihlr-22950	410	85	,	,	PUNCT
ihlr-22950	410	86	being	be	AUX
ihlr-22950	410	87	both	both	PRON
ihlr-22950	410	88	inappropriate	inappropriate	ADJ
ihlr-22950	410	89	and	and	CCONJ
ihlr-22950	410	90	too	too	ADV
ihlr-22950	410	91	burdensome	burdensome	ADJ
ihlr-22950	410	92	for	for	SCONJ
ihlr-22950	410	93	physicians	physician	NOUN
ihlr-22950	410	94	to	to	PART
ihlr-22950	410	95	complete	complete	VERB
ihlr-22950	410	96	for	for	ADP
ihlr-22950	410	97	individual	individual	ADJ
ihlr-22950	410	98	patient	patient	NOUN
ihlr-22950	410	99	access.90	access.90	ADP
ihlr-22950	410	100	the	the	DET
ihlr-22950	410	101	revised	revise	VERB
ihlr-22950	410	102	procedure	procedure	NOUN
ihlr-22950	410	103	,	,	PUNCT
ihlr-22950	410	104	which	which	PRON
ihlr-22950	410	105	now	now	ADV
ihlr-22950	410	106	also	also	ADV
ihlr-22950	410	107	specifically	specifically	ADV
ihlr-22950	410	108	applies	apply	VERB
ihlr-22950	410	109	to	to	ADP
ihlr-22950	410	110	biologics	biologic	NOUN
ihlr-22950	410	111	,	,	PUNCT
ihlr-22950	410	112	makes	make	VERB
ihlr-22950	410	113	the	the	DET
ihlr-22950	410	114	application	application	NOUN
ihlr-22950	410	115	process	process	NOUN
ihlr-22950	410	116	easier	easy	ADJ
ihlr-22950	410	117	for	for	ADP
ihlr-22950	410	118	physicians	physician	NOUN
ihlr-22950	410	119	;	;	PUNCT
ihlr-22950	410	120	however	however	ADV
ihlr-22950	410	121	,	,	PUNCT
ihlr-22950	410	122	it	it	PRON
ihlr-22950	410	123	relies	rely	VERB
ihlr-22950	410	124	on	on	ADP
ihlr-22950	410	125	obtaining	obtain	VERB
ihlr-22950	410	126	the	the	DET
ihlr-22950	410	127	agreement	agreement	NOUN
ihlr-22950	410	128	of	of	ADP
ihlr-22950	410	129	the	the	DET
ihlr-22950	410	130	manufacturer	manufacturer	NOUN
ihlr-22950	410	131	/	/	SYM
ihlr-22950	410	132	ind	ind	NOUN
ihlr-22950	410	133	holder	holder	NOUN
ihlr-22950	410	134	to	to	PART
ihlr-22950	410	135	provide	provide	VERB
ihlr-22950	410	136	the	the	DET
ihlr-22950	410	137	drug	drug	NOUN
ihlr-22950	410	138	and	and	CCONJ
ihlr-22950	410	139	to	to	PART
ihlr-22950	410	140	sign	sign	VERB
ihlr-22950	410	141	a	a	DET
ihlr-22950	410	142	letter	letter	NOUN
ihlr-22950	410	143	of	of	ADP
ihlr-22950	410	144	agreement	agreement	NOUN
ihlr-22950	410	145	(	(	PUNCT
ihlr-22950	410	146	loa	loa	NOUN
ihlr-22950	410	147	)	)	PUNCT
ihlr-22950	410	148	to	to	PART
ihlr-22950	410	149	allow	allow	VERB
ihlr-22950	410	150	access	access	NOUN
ihlr-22950	410	151	to	to	ADP
ihlr-22950	410	152	its	its	PRON
ihlr-22950	410	153	ind	ind	NOUN
ihlr-22950	410	154	submission	submission	NOUN
ihlr-22950	410	155	(	(	PUNCT
ihlr-22950	410	156	and	and	CCONJ
ihlr-22950	410	157	to	to	PART
ihlr-22950	410	158	contact	contact	VERB
ihlr-22950	410	159	the	the	DET
ihlr-22950	410	160	fda	fda	PROPN
ihlr-22950	410	161	when	when	SCONJ
ihlr-22950	410	162	no	no	DET
ihlr-22950	410	163	loa	loa	NOUN
ihlr-22950	410	164	can	can	AUX
ihlr-22950	410	165	be	be	AUX
ihlr-22950	410	166	obtained	obtain	VERB
ihlr-22950	410	167	or	or	CCONJ
ihlr-22950	410	168	in	in	ADP
ihlr-22950	410	169	a	a	DET
ihlr-22950	410	170	situation	situation	NOUN
ihlr-22950	410	171	with	with	ADP
ihlr-22950	410	172	an	an	DET
ihlr-22950	410	173	rems	rem	NOUN
ihlr-22950	410	174	)	)	PUNCT
ihlr-22950	410	175	,	,	PUNCT
ihlr-22950	410	176	and	and	CCONJ
ihlr-22950	410	177	retains	retain	VERB
ihlr-22950	410	178	the	the	DET
ihlr-22950	410	179	requirements	requirement	NOUN
ihlr-22950	410	180	for	for	ADP
ihlr-22950	410	181	patient	patient	ADJ
ihlr-22950	410	182	informed	inform	VERB
ihlr-22950	410	183	consent	consent	NOUN
ihlr-22950	410	184	and	and	CCONJ
ihlr-22950	410	185	irb	irb	VERB
ihlr-22950	410	186	approval.91	approval.91	PROPN
ihlr-22950	410	187	further	far	ADV
ihlr-22950	410	188	,	,	PUNCT
ihlr-22950	410	189	form	form	VERB
ihlr-22950	410	190	3926	3926	NUM
ihlr-22950	410	191	is	be	AUX
ihlr-22950	410	192	permitted	permit	VERB
ihlr-22950	410	193	for	for	ADP
ihlr-22950	410	194	certain	certain	ADJ
ihlr-22950	410	195	follow	follow	NOUN
ihlr-22950	410	196	-	-	PUNCT
ihlr-22950	410	197	up	up	NOUN
ihlr-22950	410	198	submissions.92	submissions.92	NOUN
ihlr-22950	410	199	treatment	treatment	NOUN
ihlr-22950	410	200	may	may	AUX
ihlr-22950	410	201	proceed	proceed	VERB
ihlr-22950	410	202	30	30	NUM
ihlr-22950	410	203	days	day	NOUN
ihlr-22950	410	204	after	after	SCONJ
ihlr-22950	410	205	the	the	DET
ihlr-22950	410	206	fda	fda	PROPN
ihlr-22950	410	207	receives	receive	VERB
ihlr-22950	410	208	the	the	DET
ihlr-22950	410	209	completed	complete	VERB
ihlr-22950	410	210	form	form	NOUN
ihlr-22950	410	211	fda	fda	PROPN
ihlr-22950	410	212	3926	3926	NUM
ihlr-22950	410	213	unless	unless	SCONJ
ihlr-22950	410	214	earlier	early	ADJ
ihlr-22950	410	215	notification	notification	NOUN
ihlr-22950	410	216	is	be	AUX
ihlr-22950	410	217	provided	provide	VERB
ihlr-22950	410	218	or	or	CCONJ
ihlr-22950	410	219	under	under	ADP
ihlr-22950	410	220	an	an	DET
ihlr-22950	410	221	emergency	emergency	NOUN
ihlr-22950	410	222	request.93	request.93	NOUN
ihlr-22950	410	223	there	there	PRON
ihlr-22950	410	224	are	be	VERB
ihlr-22950	410	225	followup	followup	ADJ
ihlr-22950	410	226	responsibilities	responsibility	NOUN
ihlr-22950	410	227	for	for	ADP
ihlr-22950	410	228	the	the	DET
ihlr-22950	410	229	physician	physician	NOUN
ihlr-22950	410	230	,	,	PUNCT
ihlr-22950	410	231	now	now	ADV
ihlr-22950	410	232	a	a	DET
ihlr-22950	410	233	sponsor	sponsor	NOUN
ihlr-22950	410	234	-	-	PUNCT
ihlr-22950	410	235	investigator.94	investigator.94	NOUN
ihlr-22950	410	236	these	these	DET
ihlr-22950	410	237	fda	fda	PROPN
ihlr-22950	410	238	procedures	procedure	NOUN
ihlr-22950	410	239	using	use	VERB
ihlr-22950	410	240	form	form	NOUN
ihlr-22950	410	241	fda	fda	PROPN
ihlr-22950	410	242	3926	3926	NUM
ihlr-22950	410	243	for	for	ADP
ihlr-22950	410	244	individual	individual	ADJ
ihlr-22950	410	245	expanded	expand	VERB
ihlr-22950	410	246	access	access	NOUN
ihlr-22950	410	247	are	be	AUX
ihlr-22950	410	248	patient	patient	ADJ
ihlr-22950	410	249	focused	focused	ADJ
ihlr-22950	410	250	and	and	CCONJ
ihlr-22950	410	251	streamlined.95	streamlined.95	VERB
ihlr-22950	410	252	the	the	DET
ihlr-22950	410	253	state	state	NOUN
ihlr-22950	410	254	of	of	ADP
ihlr-22950	410	255	maryland	maryland	PROPN
ihlr-22950	410	256	right	right	PROPN
ihlr-22950	410	257	-	-	PUNCT
ihlr-22950	410	258	to	to	PART
ihlr-22950	410	259	-	-	PUNCT
ihlr-22950	410	260	try	try	VERB
ihlr-22950	410	261	act,96	act,96	NOUN
ihlr-22950	410	262	is	be	AUX
ihlr-22950	410	263	intended	intend	VERB
ihlr-22950	410	264	to	to	PART
ihlr-22950	410	265	provide	provide	VERB
ihlr-22950	410	266	terminally	terminally	ADV
ihlr-22950	410	267	86	86	NUM
ihlr-22950	410	268	.	.	PUNCT
ihlr-22950	411	1	u.s	u.s	PROPN
ihlr-22950	411	2	.	.	PROPN
ihlr-22950	411	3	dep’t	dep’t	PROPN
ihlr-22950	411	4	of	of	ADP
ihlr-22950	411	5	health	health	PROPN
ihlr-22950	411	6	&	&	CCONJ
ihlr-22950	411	7	human	human	PROPN
ihlr-22950	411	8	servs	servs	PROPN
ihlr-22950	411	9	.	.	PUNCT
ihlr-22950	411	10	,	,	PUNCT
ihlr-22950	411	11	individual	individual	ADJ
ihlr-22950	411	12	patient	patient	NOUN
ihlr-22950	411	13	expanded	expand	VERB
ihlr-22950	411	14	access	access	NOUN
ihlr-22950	411	15	applications	application	NOUN
ihlr-22950	411	16	:	:	PUNCT
ihlr-22950	411	17	form	form	NOUN
ihlr-22950	411	18	fda	fda	PROPN
ihlr-22950	411	19	3926	3926	NUM
ihlr-22950	411	20	guidance	guidance	NOUN
ihlr-22950	411	21	for	for	ADP
ihlr-22950	411	22	industry	industry	NOUN
ihlr-22950	411	23	(	(	PUNCT
ihlr-22950	411	24	2017	2017	NUM
ihlr-22950	411	25	)	)	PUNCT
ihlr-22950	411	26	,	,	PUNCT
ihlr-22950	411	27	https://www.fda.gov/	https://www.fda.gov/	PROPN
ihlr-22950	411	28	downloads	download	VERB
ihlr-22950	411	29	/	/	SYM
ihlr-22950	411	30	drugs	drug	NOUN
ihlr-22950	411	31	/	/	SYM
ihlr-22950	411	32	guidancecomplianceregulatoryinformation	guidancecomplianceregulatoryinformation	NOUN
ihlr-22950	411	33	/	/	SYM
ihlr-22950	411	34	guidances	guidance	NOUN
ihlr-22950	411	35	/	/	SYM
ihlr-22950	411	36	ucm432717.pdf	ucm432717.pdf	NOUN
ihlr-22950	412	1	[	[	X
ihlr-22950	412	2	https://perma.cc/nwz5-tagc	https://perma.cc/nwz5-tagc	X
ihlr-22950	412	3	]	]	X
ihlr-22950	412	4	.	.	PUNCT
ihlr-22950	413	1	87	87	NUM
ihlr-22950	413	2	.	.	PUNCT
ihlr-22950	414	1	i	i	PRON
ihlr-22950	414	2	d.	d.	PROPN
ihlr-22950	414	3	medical	medical	PROPN
ihlr-22950	414	4	devices	devices	PROPN
ihlr-22950	414	5	follow	follow	VERB
ihlr-22950	414	6	a	a	DET
ihlr-22950	414	7	separate	separate	ADJ
ihlr-22950	414	8	pathway	pathway	NOUN
ihlr-22950	414	9	and	and	CCONJ
ihlr-22950	414	10	are	be	AUX
ihlr-22950	414	11	not	not	PART
ihlr-22950	414	12	included	include	VERB
ihlr-22950	414	13	in	in	ADP
ihlr-22950	414	14	this	this	DET
ihlr-22950	414	15	new	new	ADJ
ihlr-22950	414	16	guidance	guidance	NOUN
ihlr-22950	414	17	.	.	PUNCT
ihlr-22950	415	1	the	the	DET
ihlr-22950	415	2	guidance	guidance	NOUN
ihlr-22950	415	3	provides	provide	VERB
ihlr-22950	415	4	that	that	SCONJ
ihlr-22950	415	5	individual	individual	ADJ
ihlr-22950	415	6	patient	patient	NOUN
ihlr-22950	415	7	expanded	expand	VERB
ihlr-22950	415	8	access	access	NOUN
ihlr-22950	415	9	for	for	ADP
ihlr-22950	415	10	drugs	drug	NOUN
ihlr-22950	415	11	allows	allow	VERB
ihlr-22950	415	12	physicians	physician	NOUN
ihlr-22950	415	13	to	to	PART
ihlr-22950	415	14	request	request	VERB
ihlr-22950	415	15	access	access	NOUN
ihlr-22950	415	16	to	to	ADP
ihlr-22950	415	17	investigational	investigational	ADJ
ihlr-22950	415	18	drugs	drug	NOUN
ihlr-22950	415	19	outside	outside	ADV
ihlr-22950	415	20	of	of	ADP
ihlr-22950	415	21	a	a	DET
ihlr-22950	415	22	clinical	clinical	ADJ
ihlr-22950	415	23	trial	trial	NOUN
ihlr-22950	415	24	(	(	PUNCT
ihlr-22950	415	25	or	or	CCONJ
ihlr-22950	415	26	“	"	PUNCT
ihlr-22950	415	27	for	for	ADP
ihlr-22950	415	28	an	an	DET
ihlr-22950	415	29	approved	approve	VERB
ihlr-22950	415	30	drug	drug	NOUN
ihlr-22950	415	31	where	where	SCONJ
ihlr-22950	415	32	availability	availability	NOUN
ihlr-22950	415	33	is	be	AUX
ihlr-22950	415	34	limited	limit	VERB
ihlr-22950	415	35	by	by	ADP
ihlr-22950	415	36	a	a	DET
ihlr-22950	415	37	risk	risk	NOUN
ihlr-22950	415	38	evaluation	evaluation	NOUN
ihlr-22950	415	39	and	and	CCONJ
ihlr-22950	415	40	mitigation	mitigation	NOUN
ihlr-22950	415	41	strategy	strategy	NOUN
ihlr-22950	415	42	(	(	PUNCT
ihlr-22950	415	43	rems	rem	NOUN
ihlr-22950	415	44	)	)	PUNCT
ihlr-22950	415	45	”	"	PUNCT
ihlr-22950	415	46	)	)	PUNCT
ihlr-22950	415	47	for	for	ADP
ihlr-22950	415	48	those	those	DET
ihlr-22950	415	49	individual	individual	ADJ
ihlr-22950	415	50	patients	patient	NOUN
ihlr-22950	415	51	who	who	PRON
ihlr-22950	415	52	have	have	VERB
ihlr-22950	415	53	serious	serious	ADJ
ihlr-22950	415	54	or	or	CCONJ
ihlr-22950	415	55	immediately	immediately	ADV
ihlr-22950	415	56	life	life	NOUN
ihlr-22950	415	57	-	-	PUNCT
ihlr-22950	415	58	threatening	threaten	VERB
ihlr-22950	415	59	diseases	disease	NOUN
ihlr-22950	415	60	or	or	CCONJ
ihlr-22950	415	61	conditions	condition	NOUN
ihlr-22950	415	62	where	where	SCONJ
ihlr-22950	415	63	no	no	DET
ihlr-22950	415	64	other	other	ADJ
ihlr-22950	415	65	comparable	comparable	ADJ
ihlr-22950	415	66	or	or	CCONJ
ihlr-22950	415	67	satisfactory	satisfactory	ADJ
ihlr-22950	415	68	treatment	treatment	NOUN
ihlr-22950	415	69	is	be	AUX
ihlr-22950	415	70	available	available	ADJ
ihlr-22950	415	71	.	.	PUNCT
ihlr-22950	416	1	i	i	PRON
ihlr-22950	416	2	d.	d.	PROPN
ihlr-22950	416	3	88	88	NUM
ihlr-22950	416	4	.	.	PUNCT
ihlr-22950	417	1	i	i	PRON
ihlr-22950	417	2	d.	d.	PROPN
ihlr-22950	417	3	89	89	NUM
ihlr-22950	417	4	.	.	PUNCT
ihlr-22950	418	1	i	i	PRON
ihlr-22950	418	2	d.	d.	PROPN
ihlr-22950	418	3	90	90	NUM
ihlr-22950	418	4	.	.	PUNCT
ihlr-22950	419	1	i	i	PRON
ihlr-22950	419	2	d.	d.	PROPN
ihlr-22950	419	3	at	at	ADP
ihlr-22950	419	4	4	4	NUM
ihlr-22950	419	5	.	.	NOUN
ihlr-22950	419	6	91	91	NUM
ihlr-22950	419	7	.	.	PUNCT
ihlr-22950	420	1	i	i	PRON
ihlr-22950	420	2	d.	d.	PROPN
ihlr-22950	420	3	at	at	ADP
ihlr-22950	420	4	6	6	NUM
ihlr-22950	420	5	.	.	NOUN
ihlr-22950	420	6	92	92	NUM
ihlr-22950	420	7	.	.	PUNCT
ihlr-22950	421	1	i	i	PRON
ihlr-22950	421	2	d.	d.	PROPN
ihlr-22950	421	3	at	at	ADP
ihlr-22950	421	4	4	4	NUM
ihlr-22950	421	5	.	.	NUM
ihlr-22950	421	6	93	93	NUM
ihlr-22950	421	7	.	.	PUNCT
ihlr-22950	422	1	i	i	PRON
ihlr-22950	422	2	d.	d.	PROPN
ihlr-22950	422	3	at	at	ADP
ihlr-22950	422	4	7	7	NUM
ihlr-22950	422	5	.	.	NOUN
ihlr-22950	422	6	94	94	NUM
ihlr-22950	422	7	.	.	PUNCT
ihlr-22950	423	1	i	i	PRON
ihlr-22950	423	2	d.	d.	PROPN
ihlr-22950	423	3	at	at	ADP
ihlr-22950	423	4	5	5	NUM
ihlr-22950	423	5	.	.	SYM
ihlr-22950	423	6	95	95	NUM
ihlr-22950	423	7	.	.	PUNCT
ihlr-22950	424	1	see	see	VERB
ihlr-22950	424	2	i	i	PRON
ihlr-22950	424	3	d.	d.	PROPN
ihlr-22950	424	4	;	;	PUNCT
ihlr-22950	424	5	see	see	VERB
ihlr-22950	424	6	also	also	ADV
ihlr-22950	424	7	app	app	PROPN
ihlr-22950	424	8	.	.	PUNCT
ihlr-22950	424	9	iii	iii	PROPN
ihlr-22950	424	10	.	.	PROPN
ihlr-22950	425	1	96	96	NUM
ihlr-22950	425	2	.	.	PUNCT
ihlr-22950	426	1	see	see	VERB
ihlr-22950	426	2	right	right	NOUN
ihlr-22950	426	3	to	to	PART
ihlr-22950	426	4	try	try	VERB
ihlr-22950	426	5	act	act	PROPN
ihlr-22950	426	6	,	,	PUNCT
ihlr-22950	426	7	md	md	PROPN
ihlr-22950	426	8	.	.	PROPN
ihlr-22950	426	9	code	code	PROPN
ihlr-22950	426	10	ann	ann	PROPN
ihlr-22950	426	11	.	.	PROPN
ihlr-22950	426	12	,	,	PUNCT
ihlr-22950	426	13	health	health	PROPN
ihlr-22950	426	14	–	–	PUNCT
ihlr-22950	426	15	gen	gen	PROPN
ihlr-22950	426	16	.	.	PROPN
ihlr-22950	426	17	§	§	PROPN
ihlr-22950	426	18	21	21	NUM
ihlr-22950	426	19	-	-	PUNCT
ihlr-22950	426	20	2b-01	2b-01	NUM
ihlr-22950	426	21	(	(	PUNCT
ihlr-22950	426	22	lexisnexis	lexisnexis	NOUN
ihlr-22950	426	23	2017	2017	NUM
ihlr-22950	426	24	)	)	PUNCT
ihlr-22950	426	25	.	.	PUNCT
ihlr-22950	427	1	2018	2018	NUM
ihlr-22950	427	2	]	]	PUNCT
ihlr-22950	427	3	the	the	DET
ihlr-22950	427	4	latest	late	ADJ
ihlr-22950	427	5	“	"	PUNCT
ihlr-22950	427	6	federal	federal	ADJ
ihlr-22950	427	7	movement	movement	NOUN
ihlr-22950	427	8	”	"	PUNCT
ihlr-22950	427	9	in	in	ADP
ihlr-22950	427	10	the	the	DET
ihlr-22950	427	11	food	food	NOUN
ihlr-22950	427	12	and	and	CCONJ
ihlr-22950	427	13	drug	drug	NOUN
ihlr-22950	427	14	law	law	NOUN
ihlr-22950	427	15	arena	arena	NOUN
ihlr-22950	427	16	115	115	NUM
ihlr-22950	427	17	ill	ill	ADJ
ihlr-22950	427	18	patients	patient	NOUN
ihlr-22950	427	19	,	,	PUNCT
ihlr-22950	427	20	who	who	PRON
ihlr-22950	427	21	do	do	AUX
ihlr-22950	427	22	not	not	PART
ihlr-22950	427	23	have	have	VERB
ihlr-22950	427	24	the	the	DET
ihlr-22950	427	25	luxury	luxury	NOUN
ihlr-22950	427	26	of	of	ADP
ihlr-22950	427	27	waiting	wait	VERB
ihlr-22950	427	28	for	for	ADP
ihlr-22950	427	29	what	what	PRON
ihlr-22950	427	30	may	may	AUX
ihlr-22950	427	31	be	be	AUX
ihlr-22950	427	32	a	a	DET
ihlr-22950	427	33	lengthy	lengthy	ADJ
ihlr-22950	427	34	fda	fda	PROPN
ihlr-22950	427	35	approval	approval	NOUN
ihlr-22950	427	36	process	process	NOUN
ihlr-22950	427	37	to	to	PART
ihlr-22950	427	38	be	be	AUX
ihlr-22950	427	39	completed	complete	VERB
ihlr-22950	427	40	,	,	PUNCT
ihlr-22950	427	41	with	with	ADP
ihlr-22950	427	42	access	access	NOUN
ihlr-22950	427	43	to	to	ADP
ihlr-22950	427	44	recommended	recommend	VERB
ihlr-22950	427	45	experimental	experimental	ADJ
ihlr-22950	427	46	therapies	therapy	NOUN
ihlr-22950	427	47	,	,	PUNCT
ihlr-22950	427	48	including	include	VERB
ihlr-22950	427	49	drugs	drug	NOUN
ihlr-22950	427	50	,	,	PUNCT
ihlr-22950	427	51	biologics	biologic	NOUN
ihlr-22950	427	52	and	and	CCONJ
ihlr-22950	427	53	medical	medical	ADJ
ihlr-22950	427	54	devices	device	NOUN
ihlr-22950	427	55	,	,	PUNCT
ihlr-22950	427	56	where	where	SCONJ
ihlr-22950	427	57	a	a	DET
ihlr-22950	427	58	clinical	clinical	ADJ
ihlr-22950	427	59	trial	trial	NOUN
ihlr-22950	427	60	is	be	AUX
ihlr-22950	427	61	not	not	PART
ihlr-22950	427	62	available	available	ADJ
ihlr-22950	427	63	and	and	CCONJ
ihlr-22950	427	64	currently	currently	ADV
ihlr-22950	427	65	approved	approve	VERB
ihlr-22950	427	66	and	and	CCONJ
ihlr-22950	427	67	recognized	recognize	VERB
ihlr-22950	427	68	treatment	treatment	NOUN
ihlr-22950	427	69	options	option	NOUN
ihlr-22950	427	70	are	be	AUX
ihlr-22950	427	71	unlikely	unlikely	ADJ
ihlr-22950	427	72	to	to	PART
ihlr-22950	427	73	prolong	prolong	VERB
ihlr-22950	427	74	the	the	DET
ihlr-22950	427	75	patient	patient	NOUN
ihlr-22950	427	76	’s	’s	PART
ihlr-22950	427	77	life	life	NOUN
ihlr-22950	427	78	.	.	PUNCT
ihlr-22950	428	1	like	like	ADP
ihlr-22950	428	2	the	the	DET
ihlr-22950	428	3	fda	fda	PROPN
ihlr-22950	428	4	expanded	expand	VERB
ihlr-22950	428	5	access	access	NOUN
ihlr-22950	428	6	or	or	CCONJ
ihlr-22950	428	7	compassionate	compassionate	ADJ
ihlr-22950	428	8	use	use	NOUN
ihlr-22950	428	9	procedure	procedure	NOUN
ihlr-22950	428	10	,	,	PUNCT
ihlr-22950	428	11	the	the	DET
ihlr-22950	428	12	maryland	maryland	NOUN
ihlr-22950	428	13	right	right	NOUN
ihlr-22950	428	14	-	-	PUNCT
ihlr-22950	428	15	to	to	PART
ihlr-22950	428	16	-	-	PUNCT
ihlr-22950	428	17	try	try	VERB
ihlr-22950	428	18	act97	act97	NOUN
ihlr-22950	428	19	relies	rely	VERB
ihlr-22950	428	20	on	on	ADP
ihlr-22950	428	21	requests	request	NOUN
ihlr-22950	428	22	by	by	ADP
ihlr-22950	428	23	physicians	physician	NOUN
ihlr-22950	428	24	,	,	PUNCT
ihlr-22950	428	25	patient	patient	ADJ
ihlr-22950	428	26	informed	inform	VERB
ihlr-22950	428	27	consent	consent	NOUN
ihlr-22950	428	28	,	,	PUNCT
ihlr-22950	428	29	and	and	CCONJ
ihlr-22950	428	30	the	the	DET
ihlr-22950	428	31	agreement	agreement	NOUN
ihlr-22950	428	32	of	of	ADP
ihlr-22950	428	33	the	the	DET
ihlr-22950	428	34	manufacturer	manufacturer	NOUN
ihlr-22950	428	35	of	of	ADP
ihlr-22950	428	36	the	the	DET
ihlr-22950	428	37	therapy	therapy	NOUN
ihlr-22950	428	38	in	in	ADP
ihlr-22950	428	39	question	question	NOUN
ihlr-22950	428	40	to	to	PART
ihlr-22950	428	41	provide	provide	VERB
ihlr-22950	428	42	the	the	DET
ihlr-22950	428	43	therapy	therapy	NOUN
ihlr-22950	428	44	.	.	PUNCT
ihlr-22950	429	1	even	even	ADV
ihlr-22950	429	2	prior	prior	ADV
ihlr-22950	429	3	to	to	ADP
ihlr-22950	429	4	the	the	DET
ihlr-22950	429	5	enactment	enactment	NOUN
ihlr-22950	429	6	of	of	ADP
ihlr-22950	429	7	the	the	DET
ihlr-22950	429	8	federal	federal	ADJ
ihlr-22950	429	9	right	right	NOUN
ihlr-22950	429	10	-	-	PUNCT
ihlr-22950	429	11	to	to	ADP
ihlr-22950	429	12	-	-	PUNCT
ihlr-22950	429	13	try	try	VERB
ihlr-22950	429	14	act	act	NOUN
ihlr-22950	429	15	,	,	PUNCT
ihlr-22950	429	16	perhaps	perhaps	ADV
ihlr-22950	429	17	the	the	DET
ihlr-22950	429	18	related	related	ADJ
ihlr-22950	429	19	legislation	legislation	NOUN
ihlr-22950	429	20	in	in	ADP
ihlr-22950	429	21	various	various	ADJ
ihlr-22950	429	22	states	state	NOUN
ihlr-22950	429	23	such	such	ADJ
ihlr-22950	429	24	as	as	ADP
ihlr-22950	429	25	maryland	maryland	NOUN
ihlr-22950	429	26	provided	provide	VERB
ihlr-22950	429	27	the	the	DET
ihlr-22950	429	28	impetus	impetus	NOUN
ihlr-22950	429	29	to	to	ADP
ihlr-22950	429	30	the	the	DET
ihlr-22950	429	31	fda	fda	PROPN
ihlr-22950	429	32	to	to	PART
ihlr-22950	429	33	streamline	streamline	VERB
ihlr-22950	429	34	its	its	PRON
ihlr-22950	429	35	expanded	expand	VERB
ihlr-22950	429	36	access	access	NOUN
ihlr-22950	429	37	or	or	CCONJ
ihlr-22950	429	38	compassionate	compassionate	ADJ
ihlr-22950	429	39	use	use	NOUN
ihlr-22950	429	40	procedures	procedure	NOUN
ihlr-22950	429	41	for	for	ADP
ihlr-22950	429	42	drugs	drug	NOUN
ihlr-22950	429	43	and	and	CCONJ
ihlr-22950	429	44	biologics.98	biologics.98	NOUN
ihlr-22950	429	45	does	do	AUX
ihlr-22950	429	46	the	the	DET
ihlr-22950	429	47	federal	federal	ADJ
ihlr-22950	429	48	right	right	NOUN
ihlr-22950	429	49	-	-	PUNCT
ihlr-22950	429	50	to	to	PART
ihlr-22950	429	51	-	-	PUNCT
ihlr-22950	429	52	try	try	VERB
ihlr-22950	429	53	act	act	NOUN
ihlr-22950	429	54	provide	provide	VERB
ihlr-22950	429	55	anything	anything	PRON
ihlr-22950	429	56	further	far	ADV
ihlr-22950	429	57	than	than	ADP
ihlr-22950	429	58	what	what	PRON
ihlr-22950	429	59	fda	fda	PROPN
ihlr-22950	429	60	has	have	AUX
ihlr-22950	429	61	in	in	ADP
ihlr-22950	429	62	place	place	NOUN
ihlr-22950	429	63	?	?	PUNCT
ihlr-22950	430	1	perhaps	perhaps	ADV
ihlr-22950	430	2	the	the	DET
ihlr-22950	430	3	federal	federal	ADJ
ihlr-22950	430	4	rightto	rightto	NOUN
ihlr-22950	430	5	-	-	PUNCT
ihlr-22950	430	6	try	try	NOUN
ihlr-22950	430	7	act	act	NOUN
ihlr-22950	430	8	is	be	AUX
ihlr-22950	430	9	merely	merely	ADV
ihlr-22950	430	10	a	a	DET
ihlr-22950	430	11	step	step	NOUN
ihlr-22950	430	12	further	far	ADV
ihlr-22950	430	13	toward	toward	ADP
ihlr-22950	430	14	a	a	DET
ihlr-22950	430	15	sense	sense	NOUN
ihlr-22950	430	16	of	of	ADP
ihlr-22950	430	17	right	right	NOUN
ihlr-22950	430	18	-	-	PUNCT
ihlr-22950	430	19	to	to	ADP
ihlr-22950	430	20	-	-	PUNCT
ihlr-22950	430	21	request	request	NOUN
ihlr-22950	430	22	by	by	ADP
ihlr-22950	430	23	the	the	DET
ihlr-22950	430	24	patient.99	patient.99	NOUN
ihlr-22950	430	25	optimistically	optimistically	ADV
ihlr-22950	430	26	,	,	PUNCT
ihlr-22950	430	27	these	these	DET
ihlr-22950	430	28	laws	law	NOUN
ihlr-22950	430	29	increase	increase	VERB
ihlr-22950	430	30	the	the	DET
ihlr-22950	430	31	awareness	awareness	NOUN
ihlr-22950	430	32	of	of	ADP
ihlr-22950	430	33	patients	patient	NOUN
ihlr-22950	430	34	and	and	CCONJ
ihlr-22950	430	35	physicians	physician	NOUN
ihlr-22950	430	36	regarding	regard	VERB
ihlr-22950	430	37	state	state	NOUN
ihlr-22950	430	38	and	and	CCONJ
ihlr-22950	430	39	federal	federal	ADJ
ihlr-22950	430	40	procedures	procedure	NOUN
ihlr-22950	430	41	to	to	PART
ihlr-22950	430	42	obtain	obtain	VERB
ihlr-22950	430	43	experimental	experimental	ADJ
ihlr-22950	430	44	therapies	therapy	NOUN
ihlr-22950	430	45	.	.	PUNCT
ihlr-22950	431	1	it	it	PRON
ihlr-22950	431	2	is	be	AUX
ihlr-22950	431	3	important	important	ADJ
ihlr-22950	431	4	to	to	PART
ihlr-22950	431	5	remember	remember	VERB
ihlr-22950	431	6	though	though	SCONJ
ihlr-22950	431	7	that	that	SCONJ
ihlr-22950	431	8	both	both	PRON
ihlr-22950	431	9	state	state	NOUN
ihlr-22950	431	10	and	and	CCONJ
ihlr-22950	431	11	fda	fda	PROPN
ihlr-22950	431	12	procedures	procedure	NOUN
ihlr-22950	431	13	rely	rely	VERB
ihlr-22950	431	14	on	on	ADP
ihlr-22950	431	15	the	the	DET
ihlr-22950	431	16	willingness	willingness	NOUN
ihlr-22950	431	17	of	of	ADP
ihlr-22950	431	18	manufacturers	manufacturer	NOUN
ihlr-22950	431	19	to	to	PART
ihlr-22950	431	20	provide	provide	VERB
ihlr-22950	431	21	access	access	NOUN
ihlr-22950	431	22	to	to	ADP
ihlr-22950	431	23	drugs	drug	NOUN
ihlr-22950	431	24	,	,	PUNCT
ihlr-22950	431	25	biologics	biologic	NOUN
ihlr-22950	431	26	,	,	PUNCT
ihlr-22950	431	27	or	or	CCONJ
ihlr-22950	431	28	perhaps	perhaps	ADV
ihlr-22950	431	29	devices	device	NOUN
ihlr-22950	431	30	upon	upon	SCONJ
ihlr-22950	431	31	request	request	NOUN
ihlr-22950	431	32	and	and	CCONJ
ihlr-22950	431	33	insurers	insurer	NOUN
ihlr-22950	431	34	to	to	PART
ihlr-22950	431	35	pay	pay	VERB
ihlr-22950	431	36	.	.	PUNCT
ihlr-22950	432	1	section	section	NOUN
ihlr-22950	432	2	3	3	NUM
ihlr-22950	432	3	in	in	ADP
ihlr-22950	432	4	the	the	DET
ihlr-22950	432	5	federal	federal	ADJ
ihlr-22950	432	6	right	right	NOUN
ihlr-22950	432	7	-	-	PUNCT
ihlr-22950	432	8	to	to	PART
ihlr-22950	432	9	-	-	PUNCT
ihlr-22950	432	10	try	try	VERB
ihlr-22950	432	11	act	act	NOUN
ihlr-22950	432	12	is	be	AUX
ihlr-22950	432	13	of	of	ADP
ihlr-22950	432	14	particular	particular	ADJ
ihlr-22950	432	15	note.100	note.100	NOUN
ihlr-22950	432	16	sense	sense	NOUN
ihlr-22950	432	17	of	of	ADP
ihlr-22950	432	18	the	the	DET
ihlr-22950	432	19	senate	senate	PROPN
ihlr-22950	432	20	of	of	ADP
ihlr-22950	432	21	the	the	DET
ihlr-22950	432	22	federal	federal	ADJ
ihlr-22950	432	23	right	right	NOUN
ihlr-22950	432	24	-	-	PUNCT
ihlr-22950	432	25	to	to	AUX
ihlr-22950	432	26	-	-	PUNCT
ihlr-22950	432	27	try	try	VERB
ihlr-22950	432	28	act	act	NOUN
ihlr-22950	432	29	which	which	PRON
ihlr-22950	432	30	provides	provide	VERB
ihlr-22950	432	31	as	as	SCONJ
ihlr-22950	432	32	follows	follow	VERB
ihlr-22950	432	33	:	:	PUNCT
ihlr-22950	432	34	sec	sec	PROPN
ihlr-22950	432	35	.	.	PROPN
ihlr-22950	433	1	3	3	X
ihlr-22950	433	2	.	.	X
ihlr-22950	433	3	sense	sense	NOUN
ihlr-22950	433	4	of	of	ADP
ihlr-22950	433	5	the	the	DET
ihlr-22950	433	6	senate	senate	PROPN
ihlr-22950	433	7	.	.	PUNCT
ihlr-22950	434	1	it	it	PRON
ihlr-22950	434	2	is	be	AUX
ihlr-22950	434	3	the	the	DET
ihlr-22950	434	4	sense	sense	NOUN
ihlr-22950	434	5	of	of	ADP
ihlr-22950	434	6	the	the	DET
ihlr-22950	434	7	senate	senate	PROPN
ihlr-22950	434	8	that	that	PRON
ihlr-22950	434	9	section	section	NOUN
ihlr-22950	434	10	561b	561b	NUM
ihlr-22950	434	11	of	of	ADP
ihlr-22950	434	12	the	the	DET
ihlr-22950	434	13	federal	federal	ADJ
ihlr-22950	434	14	food	food	NOUN
ihlr-22950	434	15	,	,	PUNCT
ihlr-22950	434	16	drug	drug	NOUN
ihlr-22950	434	17	,	,	PUNCT
ihlr-22950	434	18	and	and	CCONJ
ihlr-22950	434	19	cosmetic	cosmetic	ADJ
ihlr-22950	434	20	act	act	NOUN
ihlr-22950	434	21	,	,	PUNCT
ihlr-22950	434	22	as	as	SCONJ
ihlr-22950	434	23	added	add	VERB
ihlr-22950	434	24	by	by	ADP
ihlr-22950	434	25	section	section	NOUN
ihlr-22950	434	26	2	2	NUM
ihlr-22950	434	27	—	—	PUNCT
ihlr-22950	434	28	(	(	PUNCT
ihlr-22950	434	29	1	1	X
ihlr-22950	434	30	)	)	PUNCT
ihlr-22950	434	31	does	do	AUX
ihlr-22950	434	32	not	not	PART
ihlr-22950	434	33	establish	establish	VERB
ihlr-22950	434	34	a	a	DET
ihlr-22950	434	35	new	new	ADJ
ihlr-22950	434	36	entitlement	entitlement	NOUN
ihlr-22950	434	37	or	or	CCONJ
ihlr-22950	434	38	modify	modify	VERB
ihlr-22950	434	39	an	an	DET
ihlr-22950	434	40	existing	exist	VERB
ihlr-22950	434	41	entitlement	entitlement	NOUN
ihlr-22950	434	42	,	,	PUNCT
ihlr-22950	434	43	or	or	CCONJ
ihlr-22950	434	44	otherwise	otherwise	ADV
ihlr-22950	434	45	establish	establish	VERB
ihlr-22950	434	46	a	a	DET
ihlr-22950	434	47	positive	positive	ADJ
ihlr-22950	434	48	right	right	NOUN
ihlr-22950	434	49	to	to	ADP
ihlr-22950	434	50	any	any	DET
ihlr-22950	434	51	party	party	NOUN
ihlr-22950	434	52	or	or	CCONJ
ihlr-22950	434	53	individual	individual	ADJ
ihlr-22950	434	54	(	(	PUNCT
ihlr-22950	434	55	emphasis	emphasis	NOUN
ihlr-22950	434	56	added	add	VERB
ihlr-22950	434	57	)	)	PUNCT
ihlr-22950	434	58	;	;	PUNCT
ihlr-22950	434	59	(	(	PUNCT
ihlr-22950	434	60	2	2	X
ihlr-22950	434	61	)	)	PUNCT
ihlr-22950	434	62	does	do	AUX
ihlr-22950	434	63	not	not	PART
ihlr-22950	434	64	establish	establish	VERB
ihlr-22950	434	65	any	any	DET
ihlr-22950	434	66	new	new	ADJ
ihlr-22950	434	67	mandates	mandate	NOUN
ihlr-22950	434	68	,	,	PUNCT
ihlr-22950	434	69	directives	directive	NOUN
ihlr-22950	434	70	,	,	PUNCT
ihlr-22950	434	71	or	or	CCONJ
ihlr-22950	434	72	additional	additional	ADJ
ihlr-22950	434	73	regulations	regulation	NOUN
ihlr-22950	434	74	;	;	PUNCT
ihlr-22950	434	75	(	(	PUNCT
ihlr-22950	434	76	3	3	X
ihlr-22950	434	77	)	)	PUNCT
ihlr-22950	434	78	only	only	ADV
ihlr-22950	434	79	expands	expand	VERB
ihlr-22950	434	80	the	the	DET
ihlr-22950	434	81	scope	scope	NOUN
ihlr-22950	434	82	of	of	ADP
ihlr-22950	434	83	individual	individual	ADJ
ihlr-22950	434	84	liberty	liberty	NOUN
ihlr-22950	434	85	and	and	CCONJ
ihlr-22950	434	86	agency	agency	NOUN
ihlr-22950	434	87	among	among	ADP
ihlr-22950	434	88	patients	patient	NOUN
ihlr-22950	434	89	,	,	PUNCT
ihlr-22950	434	90	in	in	ADP
ihlr-22950	434	91	limited	limited	ADJ
ihlr-22950	434	92	circumstances	circumstance	NOUN
ihlr-22950	434	93	;	;	PUNCT
ihlr-22950	434	94	(	(	PUNCT
ihlr-22950	434	95	4	4	X
ihlr-22950	434	96	)	)	PUNCT
ihlr-22950	434	97	is	be	AUX
ihlr-22950	434	98	consistent	consistent	ADJ
ihlr-22950	434	99	with	with	ADP
ihlr-22950	434	100	,	,	PUNCT
ihlr-22950	434	101	and	and	CCONJ
ihlr-22950	434	102	will	will	AUX
ihlr-22950	434	103	act	act	VERB
ihlr-22950	434	104	as	as	ADP
ihlr-22950	434	105	an	an	DET
ihlr-22950	434	106	alternative	alternative	ADJ
ihlr-22950	434	107	pathway	pathway	NOUN
ihlr-22950	434	108	alongside	alongside	NOUN
ihlr-22950	434	109	,	,	PUNCT
ihlr-22950	434	110	existing	exist	VERB
ihlr-22950	434	111	expanded	expand	VERB
ihlr-22950	434	112	access	access	NOUN
ihlr-22950	434	113	policies	policy	NOUN
ihlr-22950	434	114	of	of	ADP
ihlr-22950	434	115	the	the	DET
ihlr-22950	434	116	food	food	NOUN
ihlr-22950	434	117	and	and	CCONJ
ihlr-22950	434	118	drug	drug	NOUN
ihlr-22950	434	119	administration101	administration101	PROPN
ihlr-22950	434	120	(	(	PUNCT
ihlr-22950	434	121	emphasis	emphasis	NOUN
ihlr-22950	434	122	added	add	VERB
ihlr-22950	434	123	)	)	PUNCT
ihlr-22950	434	124	;	;	PUNCT
ihlr-22950	435	1	97	97	NUM
ihlr-22950	435	2	.	.	PUNCT
ihlr-22950	436	1	i	i	PRON
ihlr-22950	436	2	d.	d.	PROPN
ihlr-22950	436	3	;	;	PUNCT
ihlr-22950	436	4	see	see	VERB
ihlr-22950	436	5	also	also	ADV
ihlr-22950	436	6	app	app	PROPN
ihlr-22950	436	7	.	.	PUNCT
ihlr-22950	437	1	v.	v.	ADP
ihlr-22950	437	2	98	98	NUM
ihlr-22950	437	3	.	.	PUNCT
ihlr-22950	438	1	i	i	PRON
ihlr-22950	438	2	d.	d.	PROPN
ihlr-22950	438	3	99	99	NUM
ihlr-22950	438	4	.	.	PUNCT
ihlr-22950	439	1	roseann	roseann	PROPN
ihlr-22950	439	2	b.	b.	PROPN
ihlr-22950	439	3	termini	termini	PROPN
ihlr-22950	439	4	&	&	CCONJ
ihlr-22950	439	5	janet	janet	PROPN
ihlr-22950	439	6	m.	m.	PROPN
ihlr-22950	439	7	lis	lis	PROPN
ihlr-22950	439	8	,	,	PUNCT
ihlr-22950	439	9	‘	'	PUNCT
ihlr-22950	439	10	right	right	NOUN
ihlr-22950	439	11	-	-	PUNCT
ihlr-22950	439	12	to	to	PART
ihlr-22950	439	13	-	-	PUNCT
ihlr-22950	439	14	try	try	VERB
ihlr-22950	439	15	’	'	PUNCT
ihlr-22950	439	16	or	or	CCONJ
ihlr-22950	439	17	‘	'	PUNCT
ihlr-22950	439	18	right	right	ADJ
ihlr-22950	439	19	-	-	PUNCT
ihlr-22950	439	20	to	to	AUX
ihlr-22950	439	21	-	-	PUNCT
ihlr-22950	439	22	ask	ask	VERB
ihlr-22950	439	23	’	'	PUNCT
ihlr-22950	439	24	?	?	PUNCT
ihlr-22950	440	1	do	do	AUX
ihlr-22950	440	2	state	state	NOUN
ihlr-22950	440	3	right	right	ADJ
ihlr-22950	440	4	-	-	PUNCT
ihlr-22950	440	5	totry	totry	NOUN
ihlr-22950	440	6	laws	law	NOUN
ihlr-22950	440	7	offer	offer	VERB
ihlr-22950	440	8	an	an	DET
ihlr-22950	440	9	answer	answer	NOUN
ihlr-22950	440	10	for	for	ADP
ihlr-22950	440	11	terminally	terminally	ADV
ihlr-22950	440	12	ill	ill	ADJ
ihlr-22950	440	13	patients	patient	NOUN
ihlr-22950	440	14	seeking	seek	VERB
ihlr-22950	440	15	access	access	NOUN
ihlr-22950	440	16	to	to	ADP
ihlr-22950	440	17	investigational	investigational	ADJ
ihlr-22950	440	18	therapies	therapy	NOUN
ihlr-22950	440	19	?	?	PUNCT
ihlr-22950	440	20	,	,	PUNCT
ihlr-22950	440	21	38	38	NUM
ihlr-22950	440	22	pa	pa	PROPN
ihlr-22950	440	23	.	.	PROPN
ihlr-22950	440	24	law	law	PROPN
ihlr-22950	440	25	.	.	PUNCT
ihlr-22950	441	1	45	45	NUM
ihlr-22950	441	2	(	(	PUNCT
ihlr-22950	441	3	2016	2016	NUM
ihlr-22950	441	4	)	)	PUNCT
ihlr-22950	441	5	(	(	PUNCT
ihlr-22950	441	6	authors	author	NOUN
ihlr-22950	441	7	conclude	conclude	VERB
ihlr-22950	441	8	“	"	PUNCT
ihlr-22950	441	9	right	right	NOUN
ihlr-22950	441	10	-	-	PUNCT
ihlr-22950	441	11	to	to	ADP
ihlr-22950	441	12	-	-	PUNCT
ihlr-22950	441	13	ask	ask	VERB
ihlr-22950	441	14	”	"	PUNCT
ihlr-22950	441	15	provides	provide	VERB
ihlr-22950	441	16	autonomy	autonomy	NOUN
ihlr-22950	441	17	)	)	PUNCT
ihlr-22950	441	18	.	.	PUNCT
ihlr-22950	442	1	100	100	NUM
ihlr-22950	442	2	.	.	X
ihlr-22950	442	3	trickett	trickett	PROPN
ihlr-22950	442	4	wendler	wendler	PROPN
ihlr-22950	442	5	,	,	PUNCT
ihlr-22950	442	6	frank	frank	PROPN
ihlr-22950	442	7	mongiello	mongiello	PROPN
ihlr-22950	442	8	,	,	PUNCT
ihlr-22950	442	9	jordan	jordan	PROPN
ihlr-22950	442	10	mclinn	mclinn	PROPN
ihlr-22950	442	11	,	,	PUNCT
ihlr-22950	442	12	and	and	CCONJ
ihlr-22950	442	13	matthew	matthew	PROPN
ihlr-22950	442	14	bellina	bellina	PROPN
ihlr-22950	442	15	right	right	NOUN
ihlr-22950	442	16	to	to	PART
ihlr-22950	442	17	try	try	VERB
ihlr-22950	442	18	act	act	NOUN
ihlr-22950	442	19	of	of	ADP
ihlr-22950	442	20	2017	2017	NUM
ihlr-22950	442	21	,	,	PUNCT
ihlr-22950	442	22	pub	pub	NOUN
ihlr-22950	442	23	.	.	PUNCT
ihlr-22950	443	1	l.	l.	PROPN
ihlr-22950	443	2	no	no	INTJ
ihlr-22950	443	3	.	.	PROPN
ihlr-22950	444	1	115	115	NUM
ihlr-22950	444	2	-	-	SYM
ihlr-22950	444	3	176	176	NUM
ihlr-22950	444	4	,	,	PUNCT
ihlr-22950	444	5	132	132	NUM
ihlr-22950	444	6	stat	stat	NOUN
ihlr-22950	444	7	.	.	PUNCT
ihlr-22950	445	1	1372	1372	NUM
ihlr-22950	445	2	(	(	PUNCT
ihlr-22950	445	3	2018	2018	NUM
ihlr-22950	445	4	)	)	PUNCT
ihlr-22950	445	5	.	.	PUNCT
ihlr-22950	446	1	101	101	NUM
ihlr-22950	446	2	.	.	PUNCT
ihlr-22950	447	1	see	see	VERB
ihlr-22950	447	2	,	,	PUNCT
ihlr-22950	447	3	e.g.	e.g.	ADV
ihlr-22950	447	4	,	,	PUNCT
ihlr-22950	447	5	expanded	expand	VERB
ihlr-22950	447	6	access	access	NOUN
ihlr-22950	447	7	(	(	PUNCT
ihlr-22950	447	8	sometimes	sometimes	ADV
ihlr-22950	447	9	called	call	VERB
ihlr-22950	447	10	“	"	PUNCT
ihlr-22950	447	11	compassionate	compassionate	ADJ
ihlr-22950	447	12	use	use	NOUN
ihlr-22950	447	13	”	"	PUNCT
ihlr-22950	447	14	)	)	PUNCT
ihlr-22950	447	15	,	,	PUNCT
ihlr-22950	447	16	supra	supra	PROPN
ihlr-22950	447	17	note	note	PROPN
ihlr-22950	447	18	80	80	NUM
ihlr-22950	447	19	.	.	PUNCT
ihlr-22950	448	1	116	116	NUM
ihlr-22950	448	2	indiana	indiana	PROPN
ihlr-22950	448	3	health	health	PROPN
ihlr-22950	448	4	law	law	PROPN
ihlr-22950	448	5	review	review	NOUN
ihlr-22950	448	6	[	[	X
ihlr-22950	448	7	vol	vol	NOUN
ihlr-22950	448	8	.	.	PUNCT
ihlr-22950	449	1	16:101	16:101	NUM
ihlr-22950	449	2	(	(	PUNCT
ihlr-22950	449	3	5	5	NUM
ihlr-22950	449	4	)	)	PUNCT
ihlr-22950	449	5	will	will	AUX
ihlr-22950	449	6	not	not	PART
ihlr-22950	449	7	,	,	PUNCT
ihlr-22950	449	8	and	and	CCONJ
ihlr-22950	449	9	can	can	AUX
ihlr-22950	449	10	not	not	PART
ihlr-22950	449	11	,	,	PUNCT
ihlr-22950	449	12	create	create	VERB
ihlr-22950	449	13	a	a	DET
ihlr-22950	449	14	cure	cure	NOUN
ihlr-22950	449	15	or	or	CCONJ
ihlr-22950	449	16	effective	effective	ADJ
ihlr-22950	449	17	therapy	therapy	NOUN
ihlr-22950	449	18	where	where	SCONJ
ihlr-22950	449	19	none	none	NOUN
ihlr-22950	449	20	exists	exist	VERB
ihlr-22950	449	21	;	;	PUNCT
ihlr-22950	449	22	(	(	PUNCT
ihlr-22950	449	23	6	6	X
ihlr-22950	449	24	)	)	PUNCT
ihlr-22950	449	25	recognizes	recognize	VERB
ihlr-22950	449	26	that	that	SCONJ
ihlr-22950	449	27	the	the	DET
ihlr-22950	449	28	eligible	eligible	ADJ
ihlr-22950	449	29	terminally	terminally	ADV
ihlr-22950	449	30	ill	ill	ADJ
ihlr-22950	449	31	patient	patient	ADJ
ihlr-22950	449	32	population	population	NOUN
ihlr-22950	449	33	often	often	ADV
ihlr-22950	449	34	consists	consist	VERB
ihlr-22950	449	35	of	of	ADP
ihlr-22950	449	36	those	those	DET
ihlr-22950	449	37	patients	patient	NOUN
ihlr-22950	449	38	with	with	ADP
ihlr-22950	449	39	the	the	DET
ihlr-22950	449	40	highest	high	ADJ
ihlr-22950	449	41	risk	risk	NOUN
ihlr-22950	449	42	of	of	ADP
ihlr-22950	449	43	mortality	mortality	NOUN
ihlr-22950	449	44	,	,	PUNCT
ihlr-22950	449	45	and	and	CCONJ
ihlr-22950	449	46	use	use	NOUN
ihlr-22950	449	47	of	of	ADP
ihlr-22950	449	48	experimental	experimental	ADJ
ihlr-22950	449	49	treatments	treatment	NOUN
ihlr-22950	449	50	under	under	ADP
ihlr-22950	449	51	the	the	DET
ihlr-22950	449	52	criteria	criterion	NOUN
ihlr-22950	449	53	and	and	CCONJ
ihlr-22950	449	54	procedure	procedure	NOUN
ihlr-22950	449	55	described	describe	VERB
ihlr-22950	449	56	in	in	ADP
ihlr-22950	449	57	such	such	ADJ
ihlr-22950	449	58	section	section	NOUN
ihlr-22950	449	59	561a	561a	NUM
ihlr-22950	449	60	involves	involve	VERB
ihlr-22950	449	61	an	an	DET
ihlr-22950	449	62	informed	informed	ADJ
ihlr-22950	449	63	assumption	assumption	NOUN
ihlr-22950	449	64	of	of	ADP
ihlr-22950	449	65	risk	risk	NOUN
ihlr-22950	449	66	;	;	PUNCT
ihlr-22950	449	67	and	and	CCONJ
ihlr-22950	449	68	(	(	PUNCT
ihlr-22950	449	69	7	7	X
ihlr-22950	449	70	)	)	PUNCT
ihlr-22950	449	71	establishes	establish	VERB
ihlr-22950	449	72	national	national	ADJ
ihlr-22950	449	73	standards	standard	NOUN
ihlr-22950	449	74	and	and	CCONJ
ihlr-22950	449	75	rules	rule	NOUN
ihlr-22950	449	76	by	by	ADP
ihlr-22950	449	77	which	which	PRON
ihlr-22950	449	78	investigational	investigational	ADJ
ihlr-22950	449	79	drugs	drug	NOUN
ihlr-22950	449	80	may	may	AUX
ihlr-22950	449	81	be	be	AUX
ihlr-22950	449	82	provided	provide	VERB
ihlr-22950	449	83	to	to	PART
ihlr-22950	449	84	terminally	terminally	ADV
ihlr-22950	449	85	ill	ill	VERB
ihlr-22950	449	86	patients.102	patients.102	PRON
ihlr-22950	449	87	the	the	DET
ihlr-22950	449	88	alternative	alternative	ADJ
ihlr-22950	449	89	pathway	pathway	NOUN
ihlr-22950	449	90	is	be	AUX
ihlr-22950	449	91	that	that	PRON
ihlr-22950	449	92	of	of	ADP
ihlr-22950	449	93	expanded	expand	VERB
ihlr-22950	449	94	access	access	NOUN
ihlr-22950	449	95	discussed	discuss	VERB
ihlr-22950	449	96	above	above	ADV
ihlr-22950	449	97	.	.	PUNCT
ihlr-22950	450	1	again	again	ADV
ihlr-22950	450	2	,	,	PUNCT
ihlr-22950	450	3	a	a	DET
ihlr-22950	450	4	patient	patient	NOUN
ihlr-22950	450	5	who	who	PRON
ihlr-22950	450	6	is	be	AUX
ihlr-22950	450	7	ineligible	ineligible	ADJ
ihlr-22950	450	8	to	to	PART
ihlr-22950	450	9	obtain	obtain	VERB
ihlr-22950	450	10	an	an	DET
ihlr-22950	450	11	experimental	experimental	ADJ
ihlr-22950	450	12	therapy	therapy	NOUN
ihlr-22950	450	13	through	through	ADP
ihlr-22950	450	14	a	a	DET
ihlr-22950	450	15	clinical	clinical	ADJ
ihlr-22950	450	16	trial	trial	NOUN
ihlr-22950	450	17	could	could	AUX
ihlr-22950	450	18	request	request	VERB
ihlr-22950	450	19	that	that	SCONJ
ihlr-22950	450	20	his	his	PRON
ihlr-22950	450	21	or	or	CCONJ
ihlr-22950	450	22	her	her	PRON
ihlr-22950	450	23	physician	physician	NOUN
ihlr-22950	450	24	apply	apply	VERB
ihlr-22950	450	25	to	to	ADP
ihlr-22950	450	26	the	the	DET
ihlr-22950	450	27	fda	fda	PROPN
ihlr-22950	450	28	to	to	PART
ihlr-22950	450	29	obtain	obtain	VERB
ihlr-22950	450	30	an	an	DET
ihlr-22950	450	31	experimental	experimental	ADJ
ihlr-22950	450	32	therapy	therapy	NOUN
ihlr-22950	450	33	commonly	commonly	ADV
ihlr-22950	450	34	known	know	VERB
ihlr-22950	450	35	as	as	ADP
ihlr-22950	450	36	compassionate	compassionate	ADJ
ihlr-22950	450	37	use	use	NOUN
ihlr-22950	450	38	procedures	procedure	NOUN
ihlr-22950	450	39	.	.	PUNCT
ihlr-22950	451	1	the	the	DET
ihlr-22950	451	2	fda	fda	PROPN
ihlr-22950	451	3	approval	approval	NOUN
ihlr-22950	451	4	rate	rate	NOUN
ihlr-22950	451	5	for	for	ADP
ihlr-22950	451	6	expanded	expand	VERB
ihlr-22950	451	7	access	access	NOUN
ihlr-22950	451	8	or	or	CCONJ
ihlr-22950	451	9	compassionate	compassionate	ADJ
ihlr-22950	451	10	use	use	NOUN
ihlr-22950	451	11	therapy	therapy	NOUN
ihlr-22950	451	12	is	be	AUX
ihlr-22950	451	13	99	99	NUM
ihlr-22950	451	14	percent.103	percent.103	NOUN
ihlr-22950	451	15	one	one	NUM
ihlr-22950	451	16	question	question	NOUN
ihlr-22950	451	17	that	that	PRON
ihlr-22950	451	18	remains	remain	VERB
ihlr-22950	451	19	unanswered	unanswered	ADJ
ihlr-22950	451	20	is	be	AUX
ihlr-22950	451	21	whether	whether	SCONJ
ihlr-22950	451	22	physicians	physician	NOUN
ihlr-22950	451	23	and	and	CCONJ
ihlr-22950	451	24	patients	patient	NOUN
ihlr-22950	451	25	are	be	AUX
ihlr-22950	451	26	aware	aware	ADJ
ihlr-22950	451	27	of	of	ADP
ihlr-22950	451	28	the	the	DET
ihlr-22950	451	29	federal	federal	ADJ
ihlr-22950	451	30	expanded	expand	VERB
ihlr-22950	451	31	access	access	NOUN
ihlr-22950	451	32	or	or	CCONJ
ihlr-22950	451	33	compassionate	compassionate	ADJ
ihlr-22950	451	34	use	use	NOUN
ihlr-22950	451	35	mechanism	mechanism	NOUN
ihlr-22950	451	36	already	already	ADV
ihlr-22950	451	37	in	in	ADP
ihlr-22950	451	38	place	place	NOUN
ihlr-22950	451	39	.	.	PUNCT
ihlr-22950	452	1	another	another	DET
ihlr-22950	452	2	issue	issue	NOUN
ihlr-22950	452	3	is	be	AUX
ihlr-22950	452	4	whether	whether	SCONJ
ihlr-22950	452	5	physicians	physician	NOUN
ihlr-22950	452	6	are	be	AUX
ihlr-22950	452	7	willing	willing	ADJ
ihlr-22950	452	8	to	to	PART
ihlr-22950	452	9	expend	expend	VERB
ihlr-22950	452	10	the	the	DET
ihlr-22950	452	11	considerable	considerable	ADJ
ihlr-22950	452	12	time	time	NOUN
ihlr-22950	452	13	and	and	CCONJ
ihlr-22950	452	14	effort	effort	NOUN
ihlr-22950	452	15	needed	need	VERB
ihlr-22950	452	16	to	to	PART
ihlr-22950	452	17	pursue	pursue	VERB
ihlr-22950	452	18	expanded	expand	VERB
ihlr-22950	452	19	access	access	NOUN
ihlr-22950	452	20	.	.	PUNCT
ihlr-22950	453	1	viii	viii	PROPN
ihlr-22950	453	2	.	.	PUNCT
ihlr-22950	454	1	proactive	proactive	ADJ
ihlr-22950	454	2	solutions	solution	NOUN
ihlr-22950	454	3	and	and	CCONJ
ihlr-22950	454	4	recommendations	recommendation	NOUN
ihlr-22950	454	5	the	the	DET
ihlr-22950	454	6	intent	intent	NOUN
ihlr-22950	454	7	of	of	ADP
ihlr-22950	454	8	the	the	DET
ihlr-22950	454	9	federal	federal	ADJ
ihlr-22950	454	10	right	right	NOUN
ihlr-22950	454	11	-	-	PUNCT
ihlr-22950	454	12	to	to	PART
ihlr-22950	454	13	-	-	PUNCT
ihlr-22950	454	14	try	try	VERB
ihlr-22950	454	15	act	act	NOUN
ihlr-22950	454	16	is	be	AUX
ihlr-22950	454	17	not	not	PART
ihlr-22950	454	18	to	to	PART
ihlr-22950	454	19	undermine	undermine	VERB
ihlr-22950	454	20	fda	fda	PROPN
ihlr-22950	454	21	authority	authority	PROPN
ihlr-22950	454	22	.	.	PUNCT
ihlr-22950	455	1	rather	rather	ADV
ihlr-22950	455	2	the	the	DET
ihlr-22950	455	3	intent	intent	NOUN
ihlr-22950	455	4	is	be	AUX
ihlr-22950	455	5	to	to	PART
ihlr-22950	455	6	provide	provide	VERB
ihlr-22950	455	7	an	an	DET
ihlr-22950	455	8	individual	individual	ADJ
ihlr-22950	455	9	patient	patient	NOUN
ihlr-22950	455	10	with	with	ADP
ihlr-22950	455	11	the	the	DET
ihlr-22950	455	12	“	"	PUNCT
ihlr-22950	455	13	liberty”104	liberty”104	NOUN
ihlr-22950	455	14	to	to	PART
ihlr-22950	455	15	request	request	VERB
ihlr-22950	455	16	a	a	DET
ihlr-22950	455	17	potentially	potentially	ADV
ihlr-22950	455	18	life	life	NOUN
ihlr-22950	455	19	-	-	PUNCT
ihlr-22950	455	20	saving	save	VERB
ihlr-22950	455	21	therapy.105	therapy.105	NOUN
ihlr-22950	455	22	however	however	ADV
ihlr-22950	455	23	,	,	PUNCT
ihlr-22950	455	24	the	the	DET
ihlr-22950	455	25	following	follow	VERB
ihlr-22950	455	26	are	be	AUX
ihlr-22950	455	27	recommended	recommend	VERB
ihlr-22950	455	28	actions	action	NOUN
ihlr-22950	455	29	to	to	PART
ihlr-22950	455	30	comport	comport	VERB
ihlr-22950	455	31	with	with	ADP
ihlr-22950	455	32	the	the	DET
ihlr-22950	455	33	intent	intent	NOUN
ihlr-22950	455	34	of	of	ADP
ihlr-22950	455	35	the	the	DET
ihlr-22950	455	36	federal	federal	ADJ
ihlr-22950	455	37	right	right	NOUN
ihlr-22950	455	38	-	-	PUNCT
ihlr-22950	455	39	to	to	ADP
ihlr-22950	455	40	-	-	PUNCT
ihlr-22950	455	41	try	try	VERB
ihlr-22950	455	42	act	act	NOUN
ihlr-22950	455	43	:	:	PUNCT
ihlr-22950	455	44	•	•	ADP
ihlr-22950	455	45	the	the	DET
ihlr-22950	455	46	fda	fda	PROPN
ihlr-22950	455	47	and	and	CCONJ
ihlr-22950	455	48	the	the	DET
ihlr-22950	455	49	health	health	NOUN
ihlr-22950	455	50	care	care	NOUN
ihlr-22950	455	51	industry	industry	NOUN
ihlr-22950	455	52	should	should	AUX
ihlr-22950	455	53	utilize	utilize	VERB
ihlr-22950	455	54	a	a	DET
ihlr-22950	455	55	collaborative	collaborative	ADJ
ihlr-22950	455	56	approach	approach	NOUN
ihlr-22950	455	57	to	to	PART
ihlr-22950	455	58	ensure	ensure	VERB
ihlr-22950	455	59	awareness	awareness	NOUN
ihlr-22950	455	60	of	of	ADP
ihlr-22950	455	61	the	the	DET
ihlr-22950	455	62	expanded	expand	VERB
ihlr-22950	455	63	or	or	CCONJ
ihlr-22950	455	64	“	"	PUNCT
ihlr-22950	455	65	compassionate	compassionate	ADJ
ihlr-22950	455	66	”	"	PUNCT
ihlr-22950	455	67	use	use	NOUN
ihlr-22950	455	68	program	program	NOUN
ihlr-22950	455	69	in	in	ADP
ihlr-22950	455	70	place	place	NOUN
ihlr-22950	455	71	at	at	ADP
ihlr-22950	455	72	fda	fda	PROPN
ihlr-22950	455	73	.	.	PROPN
ihlr-22950	456	1	•	•	PROPN
ihlr-22950	456	2	congress	congress	PROPN
ihlr-22950	456	3	should	should	AUX
ihlr-22950	456	4	amend	amend	VERB
ihlr-22950	456	5	the	the	DET
ihlr-22950	456	6	federal	federal	ADJ
ihlr-22950	456	7	right	right	NOUN
ihlr-22950	456	8	-	-	PUNCT
ihlr-22950	456	9	to	to	PART
ihlr-22950	456	10	-	-	PUNCT
ihlr-22950	456	11	try	try	VERB
ihlr-22950	456	12	act	act	NOUN
ihlr-22950	456	13	to	to	PART
ihlr-22950	456	14	expressly	expressly	ADV
ihlr-22950	456	15	address	address	VERB
ihlr-22950	456	16	what	what	PRON
ihlr-22950	456	17	was	be	AUX
ihlr-22950	456	18	not	not	PART
ihlr-22950	456	19	clarified	clarify	VERB
ihlr-22950	456	20	in	in	ADP
ihlr-22950	456	21	the	the	DET
ihlr-22950	456	22	current	current	ADJ
ihlr-22950	456	23	federal	federal	ADJ
ihlr-22950	456	24	right	right	NOUN
ihlr-22950	456	25	-	-	PUNCT
ihlr-22950	456	26	to	to	PART
ihlr-22950	456	27	-	-	PUNCT
ihlr-22950	456	28	try	try	VERB
ihlr-22950	456	29	act	act	NOUN
ihlr-22950	456	30	such	such	ADJ
ihlr-22950	456	31	as	as	ADP
ihlr-22950	456	32	medical	medical	ADJ
ihlr-22950	456	33	devices,106	devices,106	PROPN
ihlr-22950	456	34	medical	medical	ADJ
ihlr-22950	456	35	foods107	foods107	PROPN
ihlr-22950	456	36	and	and	CCONJ
ihlr-22950	456	37	perhaps	perhaps	ADV
ihlr-22950	456	38	dietary	dietary	ADJ
ihlr-22950	456	39	102	102	NUM
ihlr-22950	456	40	.	.	PUNCT
ihlr-22950	457	1	trickett	trickett	PROPN
ihlr-22950	457	2	wendler	wendler	PROPN
ihlr-22950	457	3	,	,	PUNCT
ihlr-22950	457	4	frank	frank	PROPN
ihlr-22950	457	5	mongiello	mongiello	PROPN
ihlr-22950	457	6	,	,	PUNCT
ihlr-22950	457	7	jordan	jordan	PROPN
ihlr-22950	457	8	mclinn	mclinn	PROPN
ihlr-22950	457	9	,	,	PUNCT
ihlr-22950	457	10	and	and	CCONJ
ihlr-22950	457	11	matthew	matthew	PROPN
ihlr-22950	457	12	bellina	bellina	PROPN
ihlr-22950	457	13	right	right	NOUN
ihlr-22950	457	14	to	to	PART
ihlr-22950	457	15	try	try	VERB
ihlr-22950	457	16	act	act	NOUN
ihlr-22950	457	17	of	of	ADP
ihlr-22950	457	18	2017	2017	NUM
ihlr-22950	457	19	,	,	PUNCT
ihlr-22950	457	20	pub	pub	NOUN
ihlr-22950	457	21	.	.	PUNCT
ihlr-22950	458	1	l.	l.	PROPN
ihlr-22950	458	2	no	no	INTJ
ihlr-22950	458	3	.	.	PROPN
ihlr-22950	459	1	115	115	NUM
ihlr-22950	459	2	-	-	SYM
ihlr-22950	459	3	176	176	NUM
ihlr-22950	459	4	,	,	PUNCT
ihlr-22950	459	5	132	132	NUM
ihlr-22950	459	6	stat	stat	NOUN
ihlr-22950	459	7	.	.	PUNCT
ihlr-22950	460	1	1372	1372	NUM
ihlr-22950	460	2	(	(	PUNCT
ihlr-22950	460	3	2018	2018	NUM
ihlr-22950	460	4	)	)	PUNCT
ihlr-22950	460	5	.	.	PUNCT
ihlr-22950	461	1	103	103	NUM
ihlr-22950	461	2	.	.	PUNCT
ihlr-22950	462	1	see	see	VERB
ihlr-22950	462	2	jennifer	jennifer	PROPN
ihlr-22950	462	3	e.	e.	PROPN
ihlr-22950	462	4	miller	miller	PROPN
ihlr-22950	462	5	,	,	PUNCT
ihlr-22950	462	6	joseph	joseph	PROPN
ihlr-22950	462	7	s.	s.	PROPN
ihlr-22950	462	8	ross	ross	PROPN
ihlr-22950	462	9	,	,	PUNCT
ihlr-22950	462	10	kenneth	kenneth	PROPN
ihlr-22950	462	11	i.	i.	PROPN
ihlr-22950	462	12	moch	moch	PROPN
ihlr-22950	462	13	&	&	CCONJ
ihlr-22950	462	14	arthur	arthur	PROPN
ihlr-22950	462	15	l.	l.	PROPN
ihlr-22950	462	16	caplan	caplan	PROPN
ihlr-22950	462	17	,	,	PUNCT
ihlr-22950	462	18	characterizing	characterize	VERB
ihlr-22950	462	19	expanded	expand	VERB
ihlr-22950	462	20	access	access	NOUN
ihlr-22950	462	21	and	and	CCONJ
ihlr-22950	462	22	compassionate	compassionate	ADJ
ihlr-22950	462	23	use	use	NOUN
ihlr-22950	462	24	programs	program	NOUN
ihlr-22950	462	25	for	for	ADP
ihlr-22950	462	26	experimental	experimental	ADJ
ihlr-22950	462	27	drugs	drug	NOUN
ihlr-22950	462	28	,	,	PUNCT
ihlr-22950	462	29	10	10	NUM
ihlr-22950	462	30	biomed	biome	VERB
ihlr-22950	462	31	cent	cent	NOUN
ihlr-22950	462	32	.	.	PUNCT
ihlr-22950	463	1	res	re	NOUN
ihlr-22950	463	2	.	.	PUNCT
ihlr-22950	464	1	notes	note	VERB
ihlr-22950	464	2	350	350	NUM
ihlr-22950	464	3	(	(	PUNCT
ihlr-22950	464	4	2017	2017	NUM
ihlr-22950	464	5	)	)	PUNCT
ihlr-22950	464	6	https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5534121/	https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5534121/	PROPN
ihlr-22950	465	1	[	[	X
ihlr-22950	465	2	https://perma.cc/kj3g-f5aq	https://perma.cc/kj3g-f5aq	PROPN
ihlr-22950	465	3	]	]	PUNCT
ihlr-22950	465	4	.	.	PUNCT
ihlr-22950	466	1	see	see	VERB
ihlr-22950	466	2	also	also	ADV
ihlr-22950	466	3	app	app	PROPN
ihlr-22950	466	4	.	.	PUNCT
ihlr-22950	467	1	i.	i.	PROPN
ihlr-22950	467	2	104	104	NUM
ihlr-22950	467	3	.	.	PUNCT
ihlr-22950	468	1	trickett	trickett	PROPN
ihlr-22950	468	2	wendler	wendler	PROPN
ihlr-22950	468	3	,	,	PUNCT
ihlr-22950	468	4	frank	frank	PROPN
ihlr-22950	468	5	mongiello	mongiello	PROPN
ihlr-22950	468	6	,	,	PUNCT
ihlr-22950	468	7	jordan	jordan	PROPN
ihlr-22950	468	8	mclinn	mclinn	PROPN
ihlr-22950	468	9	,	,	PUNCT
ihlr-22950	468	10	and	and	CCONJ
ihlr-22950	468	11	matthew	matthew	PROPN
ihlr-22950	468	12	bellina	bellina	PROPN
ihlr-22950	468	13	right	right	NOUN
ihlr-22950	468	14	to	to	PART
ihlr-22950	468	15	try	try	VERB
ihlr-22950	468	16	act	act	NOUN
ihlr-22950	468	17	of	of	ADP
ihlr-22950	468	18	2017	2017	NUM
ihlr-22950	468	19	,	,	PUNCT
ihlr-22950	468	20	pub	pub	NOUN
ihlr-22950	468	21	.	.	PUNCT
ihlr-22950	469	1	l.	l.	PROPN
ihlr-22950	469	2	no	no	INTJ
ihlr-22950	469	3	.	.	PROPN
ihlr-22950	470	1	115	115	NUM
ihlr-22950	470	2	-	-	SYM
ihlr-22950	470	3	176	176	NUM
ihlr-22950	470	4	,	,	PUNCT
ihlr-22950	470	5	132	132	NUM
ihlr-22950	470	6	stat	stat	NOUN
ihlr-22950	470	7	.	.	PUNCT
ihlr-22950	471	1	1372	1372	NUM
ihlr-22950	471	2	(	(	PUNCT
ihlr-22950	471	3	2018	2018	NUM
ihlr-22950	471	4	)	)	PUNCT
ihlr-22950	471	5	.	.	PUNCT
ihlr-22950	472	1	105	105	NUM
ihlr-22950	472	2	.	.	NOUN
ihlr-22950	472	3	164	164	NUM
ihlr-22950	472	4	cong	cong	NOUN
ihlr-22950	472	5	.	.	PUNCT
ihlr-22950	473	1	rec	rec	PROPN
ihlr-22950	473	2	.	.	PUNCT
ihlr-22950	474	1	h43,55	h43,55	PROPN
ihlr-22950	474	2	-	-	SYM
ihlr-22950	474	3	66	66	NUM
ihlr-22950	474	4	(	(	PUNCT
ihlr-22950	474	5	daily	daily	ADJ
ihlr-22950	474	6	ed	ed	NOUN
ihlr-22950	474	7	.	.	PUNCT
ihlr-22950	475	1	may	may	AUX
ihlr-22950	475	2	22	22	NUM
ihlr-22950	475	3	,	,	PUNCT
ihlr-22950	475	4	2018	2018	NUM
ihlr-22950	475	5	)	)	PUNCT
ihlr-22950	475	6	;	;	PUNCT
ihlr-22950	475	7	trickett	trickett	NOUN
ihlr-22950	475	8	wendler	wendler	NOUN
ihlr-22950	475	9	,	,	PUNCT
ihlr-22950	475	10	frank	frank	PROPN
ihlr-22950	475	11	mongiello	mongiello	PROPN
ihlr-22950	475	12	,	,	PUNCT
ihlr-22950	475	13	jordan	jordan	PROPN
ihlr-22950	475	14	mclinn	mclinn	PROPN
ihlr-22950	475	15	,	,	PUNCT
ihlr-22950	475	16	and	and	CCONJ
ihlr-22950	475	17	matthew	matthew	PROPN
ihlr-22950	475	18	bellina	bellina	PROPN
ihlr-22950	475	19	right	right	NOUN
ihlr-22950	475	20	to	to	PART
ihlr-22950	475	21	try	try	VERB
ihlr-22950	475	22	act	act	NOUN
ihlr-22950	475	23	of	of	ADP
ihlr-22950	475	24	2017	2017	NUM
ihlr-22950	475	25	,	,	PUNCT
ihlr-22950	475	26	pub	pub	NOUN
ihlr-22950	475	27	.	.	PUNCT
ihlr-22950	476	1	l.	l.	PROPN
ihlr-22950	476	2	no	no	INTJ
ihlr-22950	476	3	.	.	PROPN
ihlr-22950	477	1	115	115	NUM
ihlr-22950	477	2	-	-	SYM
ihlr-22950	477	3	176	176	NUM
ihlr-22950	477	4	,	,	PUNCT
ihlr-22950	477	5	132	132	NUM
ihlr-22950	477	6	stat	stat	NOUN
ihlr-22950	477	7	.	.	PUNCT
ihlr-22950	478	1	1372	1372	NUM
ihlr-22950	478	2	(	(	PUNCT
ihlr-22950	478	3	2018	2018	NUM
ihlr-22950	478	4	)	)	PUNCT
ihlr-22950	478	5	(	(	PUNCT
ihlr-22950	478	6	“	"	PUNCT
ihlr-22950	478	7	[	[	X
ihlr-22950	478	8	i]t	i]t	X
ihlr-22950	478	9	is	be	AUX
ihlr-22950	478	10	the	the	DET
ihlr-22950	478	11	sense	sense	NOUN
ihlr-22950	478	12	of	of	ADP
ihlr-22950	478	13	the	the	DET
ihlr-22950	478	14	senate	senate	PROPN
ihlr-22950	478	15	that	that	PRON
ihlr-22950	478	16	section	section	NOUN
ihlr-22950	478	17	561b	561b	NUM
ihlr-22950	478	18	of	of	ADP
ihlr-22950	478	19	the	the	DET
ihlr-22950	478	20	federal	federal	ADJ
ihlr-22950	478	21	food	food	NOUN
ihlr-22950	478	22	,	,	PUNCT
ihlr-22950	478	23	drug	drug	NOUN
ihlr-22950	478	24	and	and	CCONJ
ihlr-22950	478	25	cosmetic	cosmetic	PROPN
ihlr-22950	478	26	act	act	NOUN
ihlr-22950	478	27	,	,	PUNCT
ihlr-22950	478	28	as	as	SCONJ
ihlr-22950	478	29	added	add	VERB
ihlr-22950	478	30	by	by	ADP
ihlr-22950	478	31	section	section	NOUN
ihlr-22950	478	32	2	2	NUM
ihlr-22950	478	33	.	.	PUNCT
ihlr-22950	478	34	.	.	PUNCT
ihlr-22950	478	35	.	.	PUNCT
ihlr-22950	479	1	(	(	PUNCT
ihlr-22950	479	2	4	4	X
ihlr-22950	479	3	)	)	PUNCT
ihlr-22950	479	4	is	be	AUX
ihlr-22950	479	5	consistent	consistent	ADJ
ihlr-22950	479	6	with	with	ADP
ihlr-22950	479	7	,	,	PUNCT
ihlr-22950	479	8	and	and	CCONJ
ihlr-22950	479	9	will	will	AUX
ihlr-22950	479	10	act	act	VERB
ihlr-22950	479	11	as	as	ADP
ihlr-22950	479	12	an	an	DET
ihlr-22950	479	13	alternative	alternative	ADJ
ihlr-22950	479	14	pathway	pathway	NOUN
ihlr-22950	479	15	alongside	alongside	NOUN
ihlr-22950	479	16	,	,	PUNCT
ihlr-22950	479	17	existing	exist	VERB
ihlr-22950	479	18	expanded	expand	VERB
ihlr-22950	479	19	access	access	NOUN
ihlr-22950	479	20	policies	policy	NOUN
ihlr-22950	479	21	of	of	ADP
ihlr-22950	479	22	the	the	DET
ihlr-22950	479	23	food	food	NOUN
ihlr-22950	479	24	and	and	CCONJ
ihlr-22950	479	25	drug	drug	NOUN
ihlr-22950	479	26	administration	administration	NOUN
ihlr-22950	479	27	.	.	PUNCT
ihlr-22950	479	28	”	"	PUNCT
ihlr-22950	480	1	)	)	PUNCT
ihlr-22950	480	2	106	106	NUM
ihlr-22950	480	3	.	.	PUNCT
ihlr-22950	481	1	the	the	DET
ihlr-22950	481	2	prior	prior	ADJ
ihlr-22950	481	3	legislative	legislative	ADJ
ihlr-22950	481	4	history	history	NOUN
ihlr-22950	481	5	details	detail	NOUN
ihlr-22950	481	6	that	that	SCONJ
ihlr-22950	481	7	medical	medical	ADJ
ihlr-22950	481	8	devices	device	NOUN
ihlr-22950	481	9	were	be	AUX
ihlr-22950	481	10	included	include	VERB
ihlr-22950	481	11	;	;	PUNCT
ihlr-22950	481	12	however	however	ADV
ihlr-22950	481	13	,	,	PUNCT
ihlr-22950	481	14	the	the	DET
ihlr-22950	481	15	law	law	NOUN
ihlr-22950	481	16	passed	passed	AUX
ihlr-22950	481	17	does	do	AUX
ihlr-22950	481	18	not	not	PART
ihlr-22950	481	19	address	address	VERB
ihlr-22950	481	20	medical	medical	ADJ
ihlr-22950	481	21	devices	device	NOUN
ihlr-22950	481	22	.	.	PUNCT
ihlr-22950	482	1	see	see	VERB
ihlr-22950	482	2	,	,	PUNCT
ihlr-22950	482	3	e.g.	e.g.	ADV
ihlr-22950	482	4	,	,	PUNCT
ihlr-22950	482	5	right	right	ADJ
ihlr-22950	482	6	to	to	PART
ihlr-22950	482	7	try	try	VERB
ihlr-22950	482	8	act	act	PROPN
ihlr-22950	482	9	,	,	PUNCT
ihlr-22950	482	10	h.r	h.r	PROPN
ihlr-22950	482	11	.	.	PROPN
ihlr-22950	482	12	878	878	NUM
ihlr-22950	482	13	,	,	PUNCT
ihlr-22950	482	14	115th	115th	ADJ
ihlr-22950	482	15	cong	cong	NOUN
ihlr-22950	482	16	.	.	PUNCT
ihlr-22950	483	1	(	(	PUNCT
ihlr-22950	483	2	20172018	20172018	NUM
ihlr-22950	483	3	]	]	PUNCT
ihlr-22950	483	4	the	the	DET
ihlr-22950	483	5	latest	late	ADJ
ihlr-22950	483	6	“	"	PUNCT
ihlr-22950	483	7	federal	federal	ADJ
ihlr-22950	483	8	movement	movement	NOUN
ihlr-22950	483	9	”	"	PUNCT
ihlr-22950	483	10	in	in	ADP
ihlr-22950	483	11	the	the	DET
ihlr-22950	483	12	food	food	NOUN
ihlr-22950	483	13	and	and	CCONJ
ihlr-22950	483	14	drug	drug	NOUN
ihlr-22950	483	15	law	law	NOUN
ihlr-22950	483	16	arena	arena	NOUN
ihlr-22950	483	17	117	117	NUM
ihlr-22950	483	18	supplements	supplement	NOUN
ihlr-22950	483	19	for	for	ADP
ihlr-22950	483	20	the	the	DET
ihlr-22950	483	21	desperately	desperately	ADV
ihlr-22950	483	22	ill	ill	ADJ
ihlr-22950	483	23	who	who	PRON
ihlr-22950	483	24	have	have	VERB
ihlr-22950	483	25	a	a	DET
ihlr-22950	483	26	life	life	NOUN
ihlr-22950	483	27	threatening	threaten	VERB
ihlr-22950	483	28	condition(s).108	condition(s).108	X
ihlr-22950	483	29	•	•	ADP
ihlr-22950	483	30	include	include	VERB
ihlr-22950	483	31	medical	medical	ADJ
ihlr-22950	483	32	devices	device	NOUN
ihlr-22950	483	33	through	through	ADP
ihlr-22950	483	34	deeming	deeming	ADJ
ihlr-22950	483	35	or	or	CCONJ
ihlr-22950	483	36	by	by	ADP
ihlr-22950	483	37	amendment.109	amendment.109	PROPN
ihlr-22950	483	38	•	•	PROPN
ihlr-22950	483	39	congress	congress	PROPN
ihlr-22950	483	40	should	should	AUX
ihlr-22950	483	41	amend	amend	VERB
ihlr-22950	483	42	the	the	DET
ihlr-22950	483	43	federal	federal	ADJ
ihlr-22950	483	44	right	right	NOUN
ihlr-22950	483	45	-	-	PUNCT
ihlr-22950	483	46	to	to	PART
ihlr-22950	483	47	-	-	PUNCT
ihlr-22950	483	48	try	try	VERB
ihlr-22950	483	49	act	act	NOUN
ihlr-22950	483	50	or	or	CCONJ
ihlr-22950	483	51	by	by	ADP
ihlr-22950	483	52	delegation	delegation	NOUN
ihlr-22950	483	53	to	to	ADP
ihlr-22950	483	54	fda	fda	PROPN
ihlr-22950	483	55	,	,	PUNCT
ihlr-22950	483	56	should	should	AUX
ihlr-22950	483	57	specify	specify	VERB
ihlr-22950	483	58	that	that	SCONJ
ihlr-22950	483	59	an	an	DET
ihlr-22950	483	60	advocate	advocate	NOUN
ihlr-22950	483	61	be	be	AUX
ihlr-22950	483	62	appointed	appoint	VERB
ihlr-22950	483	63	for	for	ADP
ihlr-22950	483	64	the	the	DET
ihlr-22950	483	65	patient	patient	NOUN
ihlr-22950	483	66	.	.	PUNCT
ihlr-22950	484	1	•	•	NUM
ihlr-22950	484	2	congress	congress	PROPN
ihlr-22950	484	3	could	could	AUX
ihlr-22950	484	4	amend	amend	VERB
ihlr-22950	484	5	the	the	DET
ihlr-22950	484	6	federal	federal	ADJ
ihlr-22950	484	7	right	right	NOUN
ihlr-22950	484	8	-	-	PUNCT
ihlr-22950	484	9	to	to	PART
ihlr-22950	484	10	-	-	PUNCT
ihlr-22950	484	11	try	try	VERB
ihlr-22950	484	12	act	act	NOUN
ihlr-22950	484	13	or	or	CCONJ
ihlr-22950	484	14	by	by	ADP
ihlr-22950	484	15	delegation	delegation	NOUN
ihlr-22950	484	16	should	should	AUX
ihlr-22950	484	17	provide	provide	VERB
ihlr-22950	484	18	clarity	clarity	NOUN
ihlr-22950	484	19	about	about	ADP
ihlr-22950	484	20	those	those	PRON
ihlr-22950	484	21	involved	involve	VERB
ihlr-22950	484	22	in	in	ADP
ihlr-22950	484	23	the	the	DET
ihlr-22950	484	24	process	process	NOUN
ihlr-22950	484	25	so	so	SCONJ
ihlr-22950	484	26	that	that	SCONJ
ihlr-22950	484	27	a	a	DET
ihlr-22950	484	28	patient	patient	NOUN
ihlr-22950	484	29	understands	understand	VERB
ihlr-22950	484	30	that	that	SCONJ
ihlr-22950	484	31	the	the	DET
ihlr-22950	484	32	sponsor	sponsor	NOUN
ihlr-22950	484	33	manufacturer	manufacturer	NOUN
ihlr-22950	484	34	,	,	PUNCT
ihlr-22950	484	35	prescriber	prescriber	NOUN
ihlr-22950	484	36	,	,	PUNCT
ihlr-22950	484	37	dispenser	dispenser	NOUN
ihlr-22950	484	38	or	or	CCONJ
ihlr-22950	484	39	other	other	ADJ
ihlr-22950	484	40	individual	individual	NOUN
ihlr-22950	484	41	entity110	entity110	PROPN
ihlr-22950	484	42	can	can	AUX
ihlr-22950	484	43	deny	deny	VERB
ihlr-22950	484	44	access	access	NOUN
ihlr-22950	484	45	by	by	ADP
ihlr-22950	484	46	not	not	PART
ihlr-22950	484	47	providing	provide	VERB
ihlr-22950	484	48	the	the	DET
ihlr-22950	484	49	requested	request	VERB
ihlr-22950	484	50	therapy	therapy	NOUN
ihlr-22950	484	51	as	as	ADV
ihlr-22950	484	52	well	well	ADV
ihlr-22950	484	53	as	as	ADP
ihlr-22950	484	54	understand	understand	VERB
ihlr-22950	484	55	the	the	DET
ihlr-22950	484	56	limitation	limitation	NOUN
ihlr-22950	484	57	as	as	ADP
ihlr-22950	484	58	to	to	ADP
ihlr-22950	484	59	liability	liability	NOUN
ihlr-22950	484	60	and	and	CCONJ
ihlr-22950	484	61	institute	institute	VERB
ihlr-22950	484	62	a	a	DET
ihlr-22950	484	63	legal	legal	ADJ
ihlr-22950	484	64	action.111	action.111	NOUN
ihlr-22950	484	65	•	•	NOUN
ihlr-22950	484	66	terminology	terminology	NOUN
ihlr-22950	484	67	—	—	PUNCT
ihlr-22950	484	68	the	the	DET
ihlr-22950	484	69	federal	federal	ADJ
ihlr-22950	484	70	-	-	PUNCT
ihlr-22950	484	71	right	right	NOUN
ihlr-22950	484	72	-	-	PUNCT
ihlr-22950	484	73	to	to	PART
ihlr-22950	484	74	-	-	PUNCT
ihlr-22950	484	75	try	try	VERB
ihlr-22950	484	76	act112	act112	ADV
ihlr-22950	484	77	correctly	correctly	ADV
ihlr-22950	484	78	references	reference	NOUN
ihlr-22950	484	79	eligible	eligible	ADJ
ihlr-22950	484	80	patient	patient	NOUN
ihlr-22950	484	81	yet	yet	ADV
ihlr-22950	484	82	should	should	AUX
ihlr-22950	484	83	use	use	VERB
ihlr-22950	484	84	the	the	DET
ihlr-22950	484	85	consistent	consistent	ADJ
ihlr-22950	484	86	terminology	terminology	NOUN
ihlr-22950	484	87	throughout	throughout	ADP
ihlr-22950	484	88	for	for	ADP
ihlr-22950	484	89	uniformity	uniformity	NOUN
ihlr-22950	484	90	purposes	purpose	NOUN
ihlr-22950	484	91	such	such	ADJ
ihlr-22950	484	92	as	as	ADP
ihlr-22950	484	93	life	life	NOUN
ihlr-22950	484	94	-	-	PUNCT
ihlr-22950	484	95	threatening	threaten	VERB
ihlr-22950	484	96	and	and	CCONJ
ihlr-22950	484	97	terminally	terminally	ADV
ihlr-22950	484	98	ill	ill	ADJ
ihlr-22950	484	99	which	which	PRON
ihlr-22950	484	100	2018	2018	NUM
ihlr-22950	484	101	)	)	PUNCT
ihlr-22950	484	102	(	(	PUNCT
ihlr-22950	484	103	as	as	SCONJ
ihlr-22950	484	104	introduced	introduce	VERB
ihlr-22950	484	105	in	in	ADP
ihlr-22950	484	106	the	the	DET
ihlr-22950	484	107	house	house	NOUN
ihlr-22950	484	108	on	on	ADP
ihlr-22950	484	109	feb	feb	PROPN
ihlr-22950	484	110	.	.	PROPN
ihlr-22950	484	111	6	6	NUM
ihlr-22950	484	112	,	,	PUNCT
ihlr-22950	484	113	2017	2017	NUM
ihlr-22950	484	114	)	)	PUNCT
ihlr-22950	484	115	(	(	PUNCT
ihlr-22950	484	116	this	this	DET
ihlr-22950	484	117	bill	bill	NOUN
ihlr-22950	484	118	requires	require	VERB
ihlr-22950	484	119	the	the	DET
ihlr-22950	484	120	“	"	PUNCT
ihlr-22950	484	121	[	[	X
ihlr-22950	484	122	t]he	t]he	ADJ
ihlr-22950	484	123	federal	federal	ADJ
ihlr-22950	484	124	government	government	NOUN
ihlr-22950	484	125	shall	shall	AUX
ihlr-22950	484	126	not	not	PART
ihlr-22950	484	127	take	take	VERB
ihlr-22950	484	128	any	any	DET
ihlr-22950	484	129	action	action	NOUN
ihlr-22950	484	130	to	to	PART
ihlr-22950	484	131	prohibit	prohibit	VERB
ihlr-22950	484	132	or	or	CCONJ
ihlr-22950	484	133	restrict—(1	restrict—(1	VERB
ihlr-22950	484	134	)	)	PUNCT
ihlr-22950	484	135	the	the	DET
ihlr-22950	484	136	production	production	NOUN
ihlr-22950	484	137	,	,	PUNCT
ihlr-22950	484	138	manufacture	manufacture	NOUN
ihlr-22950	484	139	,	,	PUNCT
ihlr-22950	484	140	distribution	distribution	NOUN
ihlr-22950	484	141	,	,	PUNCT
ihlr-22950	484	142	prescribing	prescribing	NOUN
ihlr-22950	484	143	,	,	PUNCT
ihlr-22950	484	144	or	or	CCONJ
ihlr-22950	484	145	dispensing	dispensing	NOUN
ihlr-22950	484	146	of	of	ADP
ihlr-22950	484	147	an	an	DET
ihlr-22950	484	148	experimental	experimental	ADJ
ihlr-22950	484	149	drug	drug	NOUN
ihlr-22950	484	150	,	,	PUNCT
ihlr-22950	484	151	biological	biological	ADJ
ihlr-22950	484	152	product	product	NOUN
ihlr-22950	484	153	,	,	PUNCT
ihlr-22950	484	154	or	or	CCONJ
ihlr-22950	484	155	device	device	NOUN
ihlr-22950	484	156	that—(a	that—(a	NOUN
ihlr-22950	484	157	)	)	PUNCT
ihlr-22950	484	158	is	be	AUX
ihlr-22950	484	159	intended	intend	VERB
ihlr-22950	484	160	to	to	PART
ihlr-22950	484	161	treat	treat	VERB
ihlr-22950	484	162	a	a	DET
ihlr-22950	484	163	patient	patient	NOUN
ihlr-22950	484	164	who	who	PRON
ihlr-22950	484	165	has	have	AUX
ihlr-22950	484	166	been	be	AUX
ihlr-22950	484	167	diagnosed	diagnose	VERB
ihlr-22950	484	168	with	with	ADP
ihlr-22950	484	169	a	a	DET
ihlr-22950	484	170	terminal	terminal	ADJ
ihlr-22950	484	171	illness	illness	NOUN
ihlr-22950	484	172	;	;	PUNCT
ihlr-22950	484	173	and	and	CCONJ
ihlr-22950	484	174	(	(	PUNCT
ihlr-22950	484	175	b	b	X
ihlr-22950	484	176	)	)	PUNCT
ihlr-22950	484	177	is	be	AUX
ihlr-22950	484	178	authorized	authorize	VERB
ihlr-22950	484	179	by	by	ADP
ihlr-22950	484	180	,	,	PUNCT
ihlr-22950	484	181	and	and	CCONJ
ihlr-22950	484	182	in	in	ADP
ihlr-22950	484	183	accordance	accordance	NOUN
ihlr-22950	484	184	with	with	ADP
ihlr-22950	484	185	,	,	PUNCT
ihlr-22950	484	186	state	state	NOUN
ihlr-22950	484	187	law	law	NOUN
ihlr-22950	484	188	.	.	PUNCT
ihlr-22950	484	189	.	.	PUNCT
ihlr-22950	484	190	.	.	PUNCT
ihlr-22950	484	191	”	"	PUNCT
ihlr-22950	484	192	)	)	PUNCT
ihlr-22950	484	193	.	.	PUNCT
ihlr-22950	485	1	107	107	NUM
ihlr-22950	485	2	.	.	PUNCT
ihlr-22950	486	1	the	the	DET
ihlr-22950	486	2	term	term	NOUN
ihlr-22950	486	3	“	"	PUNCT
ihlr-22950	486	4	medical	medical	ADJ
ihlr-22950	486	5	food	food	NOUN
ihlr-22950	486	6	”	"	PUNCT
ihlr-22950	486	7	,	,	PUNCT
ihlr-22950	486	8	as	as	SCONJ
ihlr-22950	486	9	defined	define	VERB
ihlr-22950	486	10	under	under	ADP
ihlr-22950	486	11	the	the	DET
ihlr-22950	486	12	federal	federal	ADJ
ihlr-22950	486	13	,	,	PUNCT
ihlr-22950	486	14	food	food	NOUN
ihlr-22950	486	15	,	,	PUNCT
ihlr-22950	486	16	drug	drug	NOUN
ihlr-22950	486	17	and	and	CCONJ
ihlr-22950	486	18	cosmetic	cosmetic	PROPN
ihlr-22950	486	19	act	act	NOUN
ihlr-22950	486	20	,	,	PUNCT
ihlr-22950	486	21	means	mean	VERB
ihlr-22950	486	22	“	"	PUNCT
ihlr-22950	486	23	a	a	DET
ihlr-22950	486	24	food	food	NOUN
ihlr-22950	486	25	which	which	PRON
ihlr-22950	486	26	is	be	AUX
ihlr-22950	486	27	formulated	formulate	VERB
ihlr-22950	486	28	to	to	PART
ihlr-22950	486	29	be	be	AUX
ihlr-22950	486	30	consumed	consume	VERB
ihlr-22950	486	31	or	or	CCONJ
ihlr-22950	486	32	administered	administer	VERB
ihlr-22950	486	33	enterally	enterally	ADV
ihlr-22950	486	34	under	under	ADP
ihlr-22950	486	35	the	the	DET
ihlr-22950	486	36	supervision	supervision	NOUN
ihlr-22950	486	37	of	of	ADP
ihlr-22950	486	38	a	a	DET
ihlr-22950	486	39	physician	physician	NOUN
ihlr-22950	486	40	and	and	CCONJ
ihlr-22950	486	41	which	which	PRON
ihlr-22950	486	42	is	be	AUX
ihlr-22950	486	43	intended	intend	VERB
ihlr-22950	486	44	for	for	ADP
ihlr-22950	486	45	the	the	DET
ihlr-22950	486	46	specific	specific	ADJ
ihlr-22950	486	47	dietary	dietary	ADJ
ihlr-22950	486	48	management	management	NOUN
ihlr-22950	486	49	of	of	ADP
ihlr-22950	486	50	a	a	DET
ihlr-22950	486	51	disease	disease	NOUN
ihlr-22950	486	52	or	or	CCONJ
ihlr-22950	486	53	condition	condition	NOUN
ihlr-22950	486	54	for	for	ADP
ihlr-22950	486	55	which	which	PRON
ihlr-22950	486	56	distinctive	distinctive	ADJ
ihlr-22950	486	57	nutritional	nutritional	ADJ
ihlr-22950	486	58	requirements	requirement	NOUN
ihlr-22950	486	59	,	,	PUNCT
ihlr-22950	486	60	based	base	VERB
ihlr-22950	486	61	on	on	ADP
ihlr-22950	486	62	recognized	recognize	VERB
ihlr-22950	486	63	scientific	scientific	ADJ
ihlr-22950	486	64	principles	principle	NOUN
ihlr-22950	486	65	,	,	PUNCT
ihlr-22950	486	66	are	be	AUX
ihlr-22950	486	67	established	establish	VERB
ihlr-22950	486	68	by	by	ADP
ihlr-22950	486	69	medical	medical	ADJ
ihlr-22950	486	70	evaluation	evaluation	NOUN
ihlr-22950	486	71	.	.	PUNCT
ihlr-22950	486	72	”	"	PUNCT
ihlr-22950	487	1	21	21	NUM
ihlr-22950	487	2	u.s.c	u.s.c	ADJ
ihlr-22950	487	3	.	.	PUNCT
ihlr-22950	488	1	§	§	PROPN
ihlr-22950	488	2	360ee(b)(3	360ee(b)(3	NUM
ihlr-22950	488	3	)	)	PUNCT
ihlr-22950	488	4	(	(	PUNCT
ihlr-22950	488	5	2018	2018	NUM
ihlr-22950	488	6	)	)	PUNCT
ihlr-22950	488	7	.	.	PUNCT
ihlr-22950	489	1	108	108	NUM
ihlr-22950	489	2	.	.	PUNCT
ihlr-22950	490	1	see	see	VERB
ihlr-22950	490	2	dietary	dietary	ADJ
ihlr-22950	490	3	supplement	supplement	NOUN
ihlr-22950	490	4	health	health	NOUN
ihlr-22950	490	5	and	and	CCONJ
ihlr-22950	490	6	education	education	NOUN
ihlr-22950	490	7	act	act	NOUN
ihlr-22950	490	8	of	of	ADP
ihlr-22950	490	9	1994	1994	NUM
ihlr-22950	490	10	,	,	PUNCT
ihlr-22950	490	11	pub	pub	NOUN
ihlr-22950	490	12	.	.	PUNCT
ihlr-22950	491	1	l.	l.	PROPN
ihlr-22950	491	2	no	no	INTJ
ihlr-22950	491	3	.	.	PROPN
ihlr-22950	492	1	103	103	NUM
ihlr-22950	492	2	-	-	SYM
ihlr-22950	492	3	417	417	NUM
ihlr-22950	492	4	,	,	PUNCT
ihlr-22950	492	5	108	108	NUM
ihlr-22950	492	6	stat	stat	NOUN
ihlr-22950	492	7	.	.	PUNCT
ihlr-22950	493	1	4325	4325	NUM
ihlr-22950	493	2	(	(	PUNCT
ihlr-22950	493	3	fda	fda	PROPN
ihlr-22950	493	4	regulates	regulate	VERB
ihlr-22950	493	5	dietary	dietary	ADJ
ihlr-22950	493	6	supplements	supplement	NOUN
ihlr-22950	493	7	post	post	ADJ
ihlr-22950	493	8	-	-	NOUN
ihlr-22950	493	9	market	market	NOUN
ihlr-22950	493	10	and	and	CCONJ
ihlr-22950	493	11	unlike	unlike	ADP
ihlr-22950	493	12	drugs	drug	NOUN
ihlr-22950	493	13	and	and	CCONJ
ihlr-22950	493	14	some	some	DET
ihlr-22950	493	15	medical	medical	ADJ
ihlr-22950	493	16	devices	device	NOUN
ihlr-22950	493	17	there	there	PRON
ihlr-22950	493	18	is	be	VERB
ihlr-22950	493	19	no	no	DET
ihlr-22950	493	20	pre	pre	NOUN
ihlr-22950	493	21	-	-	NOUN
ihlr-22950	493	22	approval	approval	NOUN
ihlr-22950	493	23	of	of	ADP
ihlr-22950	493	24	dietary	dietary	ADJ
ihlr-22950	493	25	supplements	supplement	NOUN
ihlr-22950	493	26	.	.	PUNCT
ihlr-22950	493	27	)	)	PUNCT
ihlr-22950	493	28	.	.	PUNCT
ihlr-22950	494	1	109	109	NUM
ihlr-22950	494	2	.	.	PUNCT
ihlr-22950	494	3	see	see	VERB
ihlr-22950	494	4	deeming	deeming	ADJ
ihlr-22950	494	5	tobacco	tobacco	NOUN
ihlr-22950	494	6	products	product	NOUN
ihlr-22950	494	7	to	to	PART
ihlr-22950	494	8	be	be	AUX
ihlr-22950	494	9	subject	subject	ADJ
ihlr-22950	494	10	to	to	ADP
ihlr-22950	494	11	the	the	DET
ihlr-22950	494	12	federal	federal	ADJ
ihlr-22950	494	13	food	food	NOUN
ihlr-22950	494	14	,	,	PUNCT
ihlr-22950	494	15	drug	drug	NOUN
ihlr-22950	494	16	,	,	PUNCT
ihlr-22950	494	17	and	and	CCONJ
ihlr-22950	494	18	cosmetic	cosmetic	ADJ
ihlr-22950	494	19	act	act	NOUN
ihlr-22950	494	20	,	,	PUNCT
ihlr-22950	494	21	as	as	SCONJ
ihlr-22950	494	22	amended	amend	VERB
ihlr-22950	494	23	by	by	ADP
ihlr-22950	494	24	the	the	DET
ihlr-22950	494	25	family	family	NOUN
ihlr-22950	494	26	smoking	smoking	NOUN
ihlr-22950	494	27	prevention	prevention	NOUN
ihlr-22950	494	28	and	and	CCONJ
ihlr-22950	494	29	tobacco	tobacco	NOUN
ihlr-22950	494	30	control	control	PROPN
ihlr-22950	494	31	act	act	PROPN
ihlr-22950	494	32	;	;	PUNCT
ihlr-22950	494	33	restrictions	restriction	NOUN
ihlr-22950	494	34	on	on	ADP
ihlr-22950	494	35	the	the	DET
ihlr-22950	494	36	sale	sale	NOUN
ihlr-22950	494	37	and	and	CCONJ
ihlr-22950	494	38	distribution	distribution	NOUN
ihlr-22950	494	39	of	of	ADP
ihlr-22950	494	40	tobacco	tobacco	NOUN
ihlr-22950	494	41	products	product	NOUN
ihlr-22950	494	42	and	and	CCONJ
ihlr-22950	494	43	required	require	VERB
ihlr-22950	494	44	warning	warning	NOUN
ihlr-22950	494	45	statements	statement	NOUN
ihlr-22950	494	46	for	for	ADP
ihlr-22950	494	47	tobacco	tobacco	NOUN
ihlr-22950	494	48	products	product	NOUN
ihlr-22950	494	49	,	,	PUNCT
ihlr-22950	494	50	81	81	NUM
ihlr-22950	494	51	fed	feed	VERB
ihlr-22950	494	52	.	.	PUNCT
ihlr-22950	495	1	reg	reg	PROPN
ihlr-22950	495	2	.	.	PUNCT
ihlr-22950	495	3	28973	28973	NUM
ihlr-22950	495	4	(	(	PUNCT
ihlr-22950	495	5	may	may	PROPN
ihlr-22950	495	6	10	10	NUM
ihlr-22950	495	7	,	,	PUNCT
ihlr-22950	495	8	2016	2016	NUM
ihlr-22950	495	9	)	)	PUNCT
ihlr-22950	495	10	(	(	PUNCT
ihlr-22950	495	11	to	to	PART
ihlr-22950	495	12	be	be	AUX
ihlr-22950	495	13	codified	codify	VERB
ihlr-22950	495	14	at	at	ADP
ihlr-22950	495	15	21	21	NUM
ihlr-22950	495	16	cfr	cfr	PROPN
ihlr-22950	495	17	pt	pt	PROPN
ihlr-22950	495	18	.	.	PROPN
ihlr-22950	495	19	1100	1100	NUM
ihlr-22950	495	20	,	,	PUNCT
ihlr-22950	495	21	21	21	NUM
ihlr-22950	495	22	cfr	cfr	PROPN
ihlr-22950	495	23	pt	pt	PROPN
ihlr-22950	495	24	.	.	PROPN
ihlr-22950	495	25	1140	1140	NUM
ihlr-22950	495	26	,	,	PUNCT
ihlr-22950	495	27	and	and	CCONJ
ihlr-22950	495	28	21	21	NUM
ihlr-22950	495	29	cfr	cfr	PROPN
ihlr-22950	495	30	pt	pt	PROPN
ihlr-22950	495	31	.	.	PROPN
ihlr-22950	495	32	1143	1143	NUM
ihlr-22950	495	33	)	)	PUNCT
ihlr-22950	495	34	(	(	PUNCT
ihlr-22950	495	35	as	as	ADP
ihlr-22950	495	36	an	an	DET
ihlr-22950	495	37	analogy	analogy	NOUN
ihlr-22950	495	38	and	and	CCONJ
ihlr-22950	495	39	example	example	NOUN
ihlr-22950	495	40	of	of	ADP
ihlr-22950	495	41	deeming	deeming	ADJ
ihlr-22950	495	42	regulations	regulation	NOUN
ihlr-22950	495	43	,	,	PUNCT
ihlr-22950	495	44	fda	fda	PROPN
ihlr-22950	495	45	issued	issue	VERB
ihlr-22950	495	46	deeming	deeming	ADJ
ihlr-22950	495	47	regulations	regulation	NOUN
ihlr-22950	495	48	which	which	PRON
ihlr-22950	495	49	extends	extend	VERB
ihlr-22950	495	50	fda	fda	PROPN
ihlr-22950	495	51	’s	’s	PART
ihlr-22950	495	52	authority	authority	NOUN
ihlr-22950	495	53	to	to	PART
ihlr-22950	495	54	include	include	VERB
ihlr-22950	495	55	the	the	DET
ihlr-22950	495	56	regulation	regulation	NOUN
ihlr-22950	495	57	of	of	ADP
ihlr-22950	495	58	electronic	electronic	ADJ
ihlr-22950	495	59	nicotine	nicotine	NOUN
ihlr-22950	495	60	delivery	delivery	NOUN
ihlr-22950	495	61	systems	system	NOUN
ihlr-22950	495	62	(	(	PUNCT
ihlr-22950	495	63	such	such	ADJ
ihlr-22950	495	64	as	as	ADP
ihlr-22950	495	65	e	e	NOUN
ihlr-22950	495	66	-	-	NOUN
ihlr-22950	495	67	cigarettes	cigarette	NOUN
ihlr-22950	495	68	and	and	CCONJ
ihlr-22950	495	69	vape	vape	NOUN
ihlr-22950	495	70	pens	pen	NOUN
ihlr-22950	495	71	)	)	PUNCT
ihlr-22950	495	72	,	,	PUNCT
ihlr-22950	495	73	all	all	DET
ihlr-22950	495	74	cigars	cigar	NOUN
ihlr-22950	495	75	,	,	PUNCT
ihlr-22950	495	76	hookah	hookah	PROPN
ihlr-22950	495	77	(	(	PUNCT
ihlr-22950	495	78	waterpipe	waterpipe	NOUN
ihlr-22950	495	79	)	)	PUNCT
ihlr-22950	495	80	tobacco	tobacco	NOUN
ihlr-22950	495	81	,	,	PUNCT
ihlr-22950	495	82	pipe	pipe	NOUN
ihlr-22950	495	83	tobacco	tobacco	NOUN
ihlr-22950	495	84	and	and	CCONJ
ihlr-22950	495	85	nicotine	nicotine	NOUN
ihlr-22950	495	86	gels	gel	NOUN
ihlr-22950	495	87	.	.	PUNCT
ihlr-22950	496	1	the	the	DET
ihlr-22950	496	2	final	final	ADJ
ihlr-22950	496	3	rule	rule	NOUN
ihlr-22950	496	4	deems	deem	VERB
ihlr-22950	496	5	products	product	NOUN
ihlr-22950	496	6	“	"	PUNCT
ihlr-22950	496	7	meeting	meet	VERB
ihlr-22950	496	8	the	the	DET
ihlr-22950	496	9	statutory	statutory	ADJ
ihlr-22950	496	10	definition	definition	NOUN
ihlr-22950	496	11	of	of	ADP
ihlr-22950	496	12	“	"	PUNCT
ihlr-22950	496	13	tobacco	tobacco	NOUN
ihlr-22950	496	14	product	product	NOUN
ihlr-22950	496	15	,	,	PUNCT
ihlr-22950	496	16	”	"	PUNCT
ihlr-22950	496	17	except	except	SCONJ
ihlr-22950	496	18	accessories	accessory	NOUN
ihlr-22950	496	19	of	of	ADP
ihlr-22950	496	20	the	the	DET
ihlr-22950	496	21	newly	newly	ADV
ihlr-22950	496	22	deemed	deem	VERB
ihlr-22950	496	23	tobacco	tobacco	NOUN
ihlr-22950	496	24	products	product	NOUN
ihlr-22950	496	25	,	,	PUNCT
ihlr-22950	496	26	to	to	PART
ihlr-22950	496	27	be	be	AUX
ihlr-22950	496	28	subject	subject	ADJ
ihlr-22950	496	29	to	to	ADP
ihlr-22950	496	30	the	the	DET
ihlr-22950	496	31	federal	federal	ADJ
ihlr-22950	496	32	food	food	NOUN
ihlr-22950	496	33	,	,	PUNCT
ihlr-22950	496	34	drug	drug	NOUN
ihlr-22950	496	35	,	,	PUNCT
ihlr-22950	496	36	and	and	CCONJ
ihlr-22950	496	37	cosmetic	cosmetic	ADJ
ihlr-22950	496	38	act	act	NOUN
ihlr-22950	496	39	(	(	PUNCT
ihlr-22950	496	40	the	the	DET
ihlr-22950	496	41	fd&c	fd&c	PROPN
ihlr-22950	496	42	act	act	PROPN
ihlr-22950	496	43	)	)	PUNCT
ihlr-22950	496	44	,	,	PUNCT
ihlr-22950	496	45	as	as	SCONJ
ihlr-22950	496	46	amended	amend	VERB
ihlr-22950	496	47	by	by	ADP
ihlr-22950	496	48	the	the	DET
ihlr-22950	496	49	family	family	NOUN
ihlr-22950	496	50	smoking	smoking	NOUN
ihlr-22950	496	51	prevention	prevention	NOUN
ihlr-22950	496	52	and	and	CCONJ
ihlr-22950	496	53	tobacco	tobacco	NOUN
ihlr-22950	496	54	control	control	PROPN
ihlr-22950	496	55	act	act	PROPN
ihlr-22950	496	56	(	(	PUNCT
ihlr-22950	496	57	tobacco	tobacco	NOUN
ihlr-22950	496	58	control	control	PROPN
ihlr-22950	496	59	act	act	PROPN
ihlr-22950	496	60	)	)	PUNCT
ihlr-22950	496	61	.	.	PUNCT
ihlr-22950	496	62	”	"	PUNCT
ihlr-22950	497	1	i	i	PRON
ihlr-22950	497	2	d.	d.	PROPN
ihlr-22950	497	3	)	)	PUNCT
ihlr-22950	497	4	.	.	PUNCT
ihlr-22950	498	1	110	110	NUM
ihlr-22950	498	2	.	.	NOUN
ihlr-22950	498	3	164	164	NUM
ihlr-22950	498	4	cong	cong	NOUN
ihlr-22950	498	5	.	.	PUNCT
ihlr-22950	499	1	rec	rec	PROPN
ihlr-22950	499	2	.	.	PUNCT
ihlr-22950	500	1	h43,56	h43,56	PROPN
ihlr-22950	500	2	(	(	PUNCT
ihlr-22950	500	3	daily	daily	PROPN
ihlr-22950	500	4	ed	ed	NOUN
ihlr-22950	500	5	.	.	PUNCT
ihlr-22950	501	1	may	may	AUX
ihlr-22950	501	2	22	22	NUM
ihlr-22950	501	3	,	,	PUNCT
ihlr-22950	501	4	2018	2018	NUM
ihlr-22950	501	5	)	)	PUNCT
ihlr-22950	501	6	(	(	PUNCT
ihlr-22950	501	7	§	§	PROPN
ihlr-22950	501	8	561b(b)(2	561b(b)(2	PROPN
ihlr-22950	501	9	)	)	PUNCT
ihlr-22950	501	10	determination	determination	NOUN
ihlr-22950	501	11	not	not	PART
ihlr-22950	501	12	to	to	PART
ihlr-22950	501	13	provide	provide	VERB
ihlr-22950	501	14	drug	drug	NOUN
ihlr-22950	501	15	)	)	PUNCT
ihlr-22950	501	16	.	.	PUNCT
ihlr-22950	502	1	111	111	NUM
ihlr-22950	502	2	.	.	PUNCT
ihlr-22950	503	1	i	i	PRON
ihlr-22950	503	2	d.	d.	PROPN
ihlr-22950	503	3	at	at	ADP
ihlr-22950	503	4	§	§	PROPN
ihlr-22950	503	5	561b(b	561b(b	PROPN
ihlr-22950	503	6	)	)	PUNCT
ihlr-22950	503	7	no	no	DET
ihlr-22950	503	8	liability	liability	NOUN
ihlr-22950	503	9	.	.	PUNCT
ihlr-22950	504	1	112	112	NUM
ihlr-22950	504	2	.	.	PUNCT
ihlr-22950	505	1	the	the	DET
ihlr-22950	505	2	federal	federal	ADJ
ihlr-22950	505	3	-	-	PUNCT
ihlr-22950	505	4	right	right	NOUN
ihlr-22950	505	5	-	-	PUNCT
ihlr-22950	505	6	to	to	ADP
ihlr-22950	505	7	-	-	PUNCT
ihlr-22950	505	8	try	try	VERB
ihlr-22950	505	9	act	act	NOUN
ihlr-22950	505	10	,	,	PUNCT
ihlr-22950	505	11	uses	use	VERB
ihlr-22950	505	12	the	the	DET
ihlr-22950	505	13	term	term	NOUN
ihlr-22950	505	14	“	"	PUNCT
ihlr-22950	505	15	terminal	terminal	ADJ
ihlr-22950	505	16	illness	illness	NOUN
ihlr-22950	505	17	”	"	PUNCT
ihlr-22950	505	18	and	and	CCONJ
ihlr-22950	505	19	“	"	PUNCT
ihlr-22950	505	20	eligible	eligible	ADJ
ihlr-22950	505	21	patient	patient	NOUN
ihlr-22950	505	22	”	"	PUNCT
ihlr-22950	505	23	in	in	ADP
ihlr-22950	505	24	sec	sec	PROPN
ihlr-22950	505	25	.	.	PROPN
ihlr-22950	505	26	2	2	NUM
ihlr-22950	505	27	.	.	X
ihlr-22950	505	28	trickett	trickett	PROPN
ihlr-22950	505	29	wendler	wendler	PROPN
ihlr-22950	505	30	,	,	PUNCT
ihlr-22950	505	31	frank	frank	PROPN
ihlr-22950	505	32	mongiello	mongiello	PROPN
ihlr-22950	505	33	,	,	PUNCT
ihlr-22950	505	34	jordan	jordan	PROPN
ihlr-22950	505	35	mclinn	mclinn	PROPN
ihlr-22950	505	36	,	,	PUNCT
ihlr-22950	505	37	and	and	CCONJ
ihlr-22950	505	38	matthew	matthew	PROPN
ihlr-22950	505	39	bellina	bellina	PROPN
ihlr-22950	505	40	right	right	NOUN
ihlr-22950	505	41	to	to	PART
ihlr-22950	505	42	try	try	VERB
ihlr-22950	505	43	act	act	NOUN
ihlr-22950	505	44	of	of	ADP
ihlr-22950	505	45	2017	2017	NUM
ihlr-22950	505	46	,	,	PUNCT
ihlr-22950	505	47	pub	pub	NOUN
ihlr-22950	505	48	.	.	PUNCT
ihlr-22950	506	1	l.	l.	PROPN
ihlr-22950	506	2	no	no	INTJ
ihlr-22950	506	3	.	.	PROPN
ihlr-22950	507	1	115	115	NUM
ihlr-22950	507	2	-	-	SYM
ihlr-22950	507	3	176	176	NUM
ihlr-22950	507	4	,	,	PUNCT
ihlr-22950	507	5	132	132	NUM
ihlr-22950	507	6	stat	stat	NOUN
ihlr-22950	507	7	.	.	PUNCT
ihlr-22950	508	1	1372	1372	NUM
ihlr-22950	508	2	(	(	PUNCT
ihlr-22950	508	3	2018	2018	NUM
ihlr-22950	508	4	)	)	PUNCT
ihlr-22950	508	5	.	.	PUNCT
ihlr-22950	509	1	118	118	NUM
ihlr-22950	509	2	indiana	indiana	PROPN
ihlr-22950	509	3	health	health	PROPN
ihlr-22950	509	4	law	law	PROPN
ihlr-22950	509	5	review	review	NOUN
ihlr-22950	509	6	[	[	X
ihlr-22950	509	7	vol	vol	NOUN
ihlr-22950	509	8	.	.	PUNCT
ihlr-22950	510	1	16:101	16:101	NUM
ihlr-22950	510	2	could	could	AUX
ihlr-22950	510	3	be	be	AUX
ihlr-22950	510	4	accomplished	accomplish	VERB
ihlr-22950	510	5	by	by	ADP
ihlr-22950	510	6	a	a	DET
ihlr-22950	510	7	technical	technical	ADJ
ihlr-22950	510	8	amendment.113	amendment.113	ADJ
ihlr-22950	510	9	•	•	NUM
ihlr-22950	510	10	informed	informed	ADJ
ihlr-22950	510	11	consent	consent	NOUN
ihlr-22950	510	12	-	-	PUNCT
ihlr-22950	510	13	perhaps	perhaps	ADV
ihlr-22950	510	14	congress	congress	PROPN
ihlr-22950	510	15	should	should	AUX
ihlr-22950	510	16	review	review	VERB
ihlr-22950	510	17	and	and	CCONJ
ihlr-22950	510	18	expand	expand	VERB
ihlr-22950	510	19	on	on	ADP
ihlr-22950	510	20	informed	informed	ADJ
ihlr-22950	510	21	consent	consent	NOUN
ihlr-22950	510	22	as	as	SCONJ
ihlr-22950	510	23	addressed	address	VERB
ihlr-22950	510	24	in	in	ADP
ihlr-22950	510	25	the	the	DET
ihlr-22950	510	26	maryland	maryland	NOUN
ihlr-22950	510	27	right	right	NOUN
ihlr-22950	510	28	-	-	PUNCT
ihlr-22950	510	29	to	to	PART
ihlr-22950	510	30	-	-	PUNCT
ihlr-22950	510	31	try	try	VERB
ihlr-22950	510	32	act	act	NOUN
ihlr-22950	510	33	as	as	SCONJ
ihlr-22950	510	34	it	it	PRON
ihlr-22950	510	35	is	be	AUX
ihlr-22950	510	36	comprehensive	comprehensive	ADJ
ihlr-22950	510	37	and	and	CCONJ
ihlr-22950	510	38	patient	patient	ADJ
ihlr-22950	511	1	centered.114	centered.114	NOUN
ihlr-22950	511	2	ix	ix	ADV
ihlr-22950	511	3	.	.	PUNCT
ihlr-22950	512	1	final	final	ADJ
ihlr-22950	512	2	commentary	commentary	NOUN
ihlr-22950	512	3	-	-	PUNCT
ihlr-22950	512	4	overall	overall	ADJ
ihlr-22950	512	5	benefit	benefit	NOUN
ihlr-22950	512	6	of	of	ADP
ihlr-22950	512	7	right	right	NOUN
ihlr-22950	512	8	-	-	PUNCT
ihlr-22950	512	9	to	to	PART
ihlr-22950	512	10	-	-	PUNCT
ihlr-22950	512	11	try	try	VERB
ihlr-22950	512	12	the	the	DET
ihlr-22950	512	13	federal	federal	ADJ
ihlr-22950	512	14	right	right	NOUN
ihlr-22950	512	15	-	-	PUNCT
ihlr-22950	512	16	to	to	ADP
ihlr-22950	512	17	-	-	PUNCT
ihlr-22950	512	18	try	try	VERB
ihlr-22950	512	19	act	act	NOUN
ihlr-22950	512	20	,	,	PUNCT
ihlr-22950	512	21	fda	fda	PROPN
ihlr-22950	512	22	’s	’s	PART
ihlr-22950	512	23	expanded	expand	VERB
ihlr-22950	512	24	access	access	NOUN
ihlr-22950	512	25	procedures	procedure	NOUN
ihlr-22950	512	26	known	know	VERB
ihlr-22950	512	27	as	as	ADP
ihlr-22950	512	28	compassionate	compassionate	ADJ
ihlr-22950	512	29	use	use	NOUN
ihlr-22950	512	30	procedures	procedure	NOUN
ihlr-22950	512	31	as	as	ADV
ihlr-22950	512	32	well	well	ADV
ihlr-22950	512	33	as	as	ADP
ihlr-22950	512	34	state	state	NOUN
ihlr-22950	512	35	right	right	NOUN
ihlr-22950	512	36	-	-	PUNCT
ihlr-22950	512	37	to	to	PART
ihlr-22950	512	38	-	-	PUNCT
ihlr-22950	512	39	try	try	VERB
ihlr-22950	512	40	laws	law	NOUN
ihlr-22950	512	41	may	may	AUX
ihlr-22950	512	42	more	more	ADV
ihlr-22950	512	43	properly	properly	ADV
ihlr-22950	512	44	be	be	AUX
ihlr-22950	512	45	seen	see	VERB
ihlr-22950	512	46	as	as	ADP
ihlr-22950	512	47	providing	provide	VERB
ihlr-22950	512	48	a	a	DET
ihlr-22950	512	49	right	right	NOUN
ihlr-22950	512	50	-	-	PUNCT
ihlr-22950	512	51	to	to	ADP
ihlr-22950	512	52	-	-	PUNCT
ihlr-22950	512	53	request.115	request.115	NOUN
ihlr-22950	512	54	both	both	CCONJ
ihlr-22950	512	55	the	the	DET
ihlr-22950	512	56	federal	federal	ADJ
ihlr-22950	512	57	right	right	NOUN
ihlr-22950	512	58	-	-	PUNCT
ihlr-22950	512	59	to	to	AUX
ihlr-22950	512	60	-	-	PUNCT
ihlr-22950	512	61	try	try	VERB
ihlr-22950	512	62	act	act	NOUN
ihlr-22950	512	63	and	and	CCONJ
ihlr-22950	512	64	the	the	DET
ihlr-22950	512	65	state	state	NOUN
ihlr-22950	512	66	right	right	NOUN
ihlr-22950	512	67	-	-	PUNCT
ihlr-22950	512	68	to	to	PART
ihlr-22950	512	69	-	-	PUNCT
ihlr-22950	512	70	try	try	VERB
ihlr-22950	512	71	laws	law	NOUN
ihlr-22950	512	72	do	do	AUX
ihlr-22950	512	73	appear	appear	VERB
ihlr-22950	512	74	to	to	PART
ihlr-22950	512	75	be	be	AUX
ihlr-22950	512	76	raising	raise	VERB
ihlr-22950	512	77	the	the	DET
ihlr-22950	512	78	awareness	awareness	NOUN
ihlr-22950	512	79	of	of	ADP
ihlr-22950	512	80	the	the	DET
ihlr-22950	512	81	potential	potential	ADJ
ihlr-22950	512	82	use	use	NOUN
ihlr-22950	512	83	of	of	ADP
ihlr-22950	512	84	and	and	CCONJ
ihlr-22950	512	85	empowering	empower	VERB
ihlr-22950	512	86	desperately	desperately	ADV
ihlr-22950	512	87	ill	ill	ADJ
ihlr-22950	512	88	patients	patient	NOUN
ihlr-22950	512	89	to	to	PART
ihlr-22950	512	90	request	request	VERB
ihlr-22950	512	91	experimental	experimental	ADJ
ihlr-22950	512	92	therapies.116	therapies.116	NOUN
ihlr-22950	512	93	for	for	ADP
ihlr-22950	512	94	example	example	NOUN
ihlr-22950	512	95	,	,	PUNCT
ihlr-22950	512	96	as	as	SCONJ
ihlr-22950	512	97	detailed	detailed	ADJ
ihlr-22950	512	98	above	above	ADV
ihlr-22950	512	99	,	,	PUNCT
ihlr-22950	512	100	the	the	DET
ihlr-22950	512	101	fda	fda	PROPN
ihlr-22950	512	102	revised	revise	VERB
ihlr-22950	512	103	form	form	NOUN
ihlr-22950	512	104	3926	3926	NUM
ihlr-22950	512	105	streamlines	streamline	NOUN
ihlr-22950	512	106	the	the	DET
ihlr-22950	512	107	process	process	NOUN
ihlr-22950	512	108	in	in	ADP
ihlr-22950	512	109	obtaining	obtain	VERB
ihlr-22950	512	110	fda	fda	PROPN
ihlr-22950	512	111	approval	approval	NOUN
ihlr-22950	512	112	for	for	ADP
ihlr-22950	512	113	compassionate	compassionate	ADJ
ihlr-22950	512	114	use.117	use.117	ADV
ihlr-22950	513	1	what	what	PRON
ihlr-22950	513	2	is	be	AUX
ihlr-22950	513	3	most	most	ADV
ihlr-22950	513	4	critical	critical	ADJ
ihlr-22950	513	5	at	at	ADP
ihlr-22950	513	6	this	this	DET
ihlr-22950	513	7	junction	junction	NOUN
ihlr-22950	513	8	is	be	AUX
ihlr-22950	513	9	to	to	PART
ihlr-22950	513	10	ensure	ensure	VERB
ihlr-22950	513	11	a	a	DET
ihlr-22950	513	12	user	user	NOUN
ihlr-22950	513	13	-	-	PUNCT
ihlr-22950	513	14	friendly	friendly	ADJ
ihlr-22950	513	15	approach	approach	NOUN
ihlr-22950	513	16	to	to	PART
ihlr-22950	513	17	navigate	navigate	VERB
ihlr-22950	513	18	the	the	DET
ihlr-22950	513	19	system	system	NOUN
ihlr-22950	513	20	to	to	PART
ihlr-22950	513	21	obtain	obtain	VERB
ihlr-22950	513	22	an	an	DET
ihlr-22950	513	23	experimental	experimental	ADJ
ihlr-22950	513	24	therapy	therapy	NOUN
ihlr-22950	513	25	for	for	ADP
ihlr-22950	513	26	an	an	DET
ihlr-22950	513	27	individual	individual	ADJ
ihlr-22950	513	28	human	human	ADJ
ihlr-22950	513	29	being	being	NOUN
ihlr-22950	513	30	.	.	PUNCT
ihlr-22950	514	1	it	it	PRON
ihlr-22950	514	2	is	be	AUX
ihlr-22950	514	3	uncertain	uncertain	ADJ
ihlr-22950	514	4	,	,	PUNCT
ihlr-22950	514	5	however	however	ADV
ihlr-22950	514	6	,	,	PUNCT
ihlr-22950	514	7	if	if	SCONJ
ihlr-22950	514	8	the	the	DET
ihlr-22950	514	9	state	state	NOUN
ihlr-22950	514	10	right	right	NOUN
ihlr-22950	514	11	-	-	PUNCT
ihlr-22950	514	12	to	to	PART
ihlr-22950	514	13	-	-	PUNCT
ihlr-22950	514	14	try	try	VERB
ihlr-22950	514	15	laws	law	NOUN
ihlr-22950	514	16	are	be	AUX
ihlr-22950	514	17	effective	effective	ADJ
ihlr-22950	514	18	in	in	ADP
ihlr-22950	514	19	accessing	access	VERB
ihlr-22950	514	20	experimental	experimental	ADJ
ihlr-22950	514	21	therapies	therapy	NOUN
ihlr-22950	514	22	or	or	CCONJ
ihlr-22950	514	23	whether	whether	SCONJ
ihlr-22950	514	24	any	any	DET
ihlr-22950	514	25	eventual	eventual	ADJ
ihlr-22950	514	26	access	access	NOUN
ihlr-22950	514	27	is	be	AUX
ihlr-22950	514	28	actually	actually	ADV
ihlr-22950	514	29	obtained	obtain	VERB
ihlr-22950	514	30	through	through	ADP
ihlr-22950	514	31	fda	fda	PROPN
ihlr-22950	514	32	procedures	procedure	NOUN
ihlr-22950	514	33	,	,	PUNCT
ihlr-22950	514	34	and	and	CCONJ
ihlr-22950	514	35	whether	whether	SCONJ
ihlr-22950	514	36	the	the	DET
ihlr-22950	514	37	state	state	NOUN
ihlr-22950	514	38	laws	law	NOUN
ihlr-22950	514	39	can	can	AUX
ihlr-22950	514	40	stand	stand	VERB
ihlr-22950	514	41	in	in	ADP
ihlr-22950	514	42	relation	relation	NOUN
ihlr-22950	514	43	to	to	ADP
ihlr-22950	514	44	the	the	DET
ihlr-22950	514	45	existing	exist	VERB
ihlr-22950	514	46	federal	federal	ADJ
ihlr-22950	514	47	right	right	NOUN
ihlr-22950	514	48	-	-	PUNCT
ihlr-22950	514	49	to	to	ADP
ihlr-22950	514	50	-	-	PUNCT
ihlr-22950	514	51	try118	try118	VERB
ihlr-22950	514	52	authority	authority	NOUN
ihlr-22950	514	53	and	and	CCONJ
ihlr-22950	514	54	principles	principle	NOUN
ihlr-22950	514	55	of	of	ADP
ihlr-22950	514	56	preemption.119	preemption.119	NOUN
ihlr-22950	514	57	however	however	ADV
ihlr-22950	514	58	,	,	PUNCT
ihlr-22950	514	59	when	when	SCONJ
ihlr-22950	514	60	patients	patient	NOUN
ihlr-22950	514	61	do	do	AUX
ihlr-22950	514	62	request	request	VERB
ihlr-22950	514	63	experimental	experimental	ADJ
ihlr-22950	514	64	therapies	therapy	NOUN
ihlr-22950	514	65	they	they	PRON
ihlr-22950	514	66	must	must	AUX
ihlr-22950	514	67	be	be	AUX
ihlr-22950	514	68	counseled	counsel	VERB
ihlr-22950	514	69	on	on	ADP
ihlr-22950	514	70	the	the	DET
ihlr-22950	514	71	process	process	NOUN
ihlr-22950	514	72	involved	involve	VERB
ihlr-22950	514	73	,	,	PUNCT
ihlr-22950	514	74	all	all	DET
ihlr-22950	514	75	potentially	potentially	ADV
ihlr-22950	514	76	available	available	ADJ
ihlr-22950	514	77	mechanisms	mechanism	NOUN
ihlr-22950	514	78	,	,	PUNCT
ihlr-22950	514	79	of	of	ADP
ihlr-22950	514	80	the	the	DET
ihlr-22950	514	81	possibility	possibility	NOUN
ihlr-22950	514	82	that	that	SCONJ
ihlr-22950	514	83	they	they	PRON
ihlr-22950	514	84	may	may	AUX
ihlr-22950	514	85	not	not	PART
ihlr-22950	514	86	receive	receive	VERB
ihlr-22950	514	87	the	the	DET
ihlr-22950	514	88	experimental	experimental	ADJ
ihlr-22950	514	89	therapy	therapy	NOUN
ihlr-22950	514	90	,	,	PUNCT
ihlr-22950	514	91	the	the	DET
ihlr-22950	514	92	potential	potential	ADJ
ihlr-22950	514	93	113	113	NUM
ihlr-22950	514	94	.	.	PUNCT
ihlr-22950	515	1	see	see	VERB
ihlr-22950	515	2	generally	generally	ADV
ihlr-22950	515	3	21	21	NUM
ihlr-22950	515	4	c.f.r	c.f.r	NOUN
ihlr-22950	515	5	.	.	PUNCT
ihlr-22950	516	1	§	§	PROPN
ihlr-22950	516	2	312.81	312.81	NUM
ihlr-22950	516	3	(	(	PUNCT
ihlr-22950	516	4	2018	2018	NUM
ihlr-22950	516	5	)	)	PUNCT
ihlr-22950	516	6	.	.	PUNCT
ihlr-22950	517	1	(	(	PUNCT
ihlr-22950	517	2	“	"	PUNCT
ihlr-22950	517	3	this	this	DET
ihlr-22950	517	4	section	section	NOUN
ihlr-22950	517	5	applies	apply	VERB
ihlr-22950	517	6	to	to	ADP
ihlr-22950	517	7	new	new	ADJ
ihlr-22950	517	8	drug	drug	NOUN
ihlr-22950	517	9	and	and	CCONJ
ihlr-22950	517	10	biological	biological	ADJ
ihlr-22950	517	11	products	product	NOUN
ihlr-22950	517	12	that	that	PRON
ihlr-22950	517	13	are	be	AUX
ihlr-22950	517	14	being	be	AUX
ihlr-22950	517	15	studied	study	VERB
ihlr-22950	517	16	for	for	ADP
ihlr-22950	517	17	their	their	PRON
ihlr-22950	517	18	safety	safety	NOUN
ihlr-22950	517	19	and	and	CCONJ
ihlr-22950	517	20	effectiveness	effectiveness	NOUN
ihlr-22950	517	21	in	in	ADP
ihlr-22950	517	22	treating	treat	VERB
ihlr-22950	517	23	lifethreatening	lifethreatening	NOUN
ihlr-22950	517	24	or	or	CCONJ
ihlr-22950	517	25	severely	severely	ADV
ihlr-22950	517	26	-	-	PUNCT
ihlr-22950	517	27	debilitating	debilitate	VERB
ihlr-22950	517	28	diseases.(a	diseases.(a	NOUN
ihlr-22950	517	29	)	)	PUNCT
ihlr-22950	517	30	for	for	ADP
ihlr-22950	517	31	purposes	purpose	NOUN
ihlr-22950	517	32	of	of	ADP
ihlr-22950	517	33	this	this	DET
ihlr-22950	517	34	section	section	NOUN
ihlr-22950	517	35	,	,	PUNCT
ihlr-22950	517	36	the	the	DET
ihlr-22950	517	37	term	term	NOUN
ihlr-22950	517	38	‘	'	PUNCT
ihlr-22950	517	39	lifethreatening	lifethreatening	NOUN
ihlr-22950	517	40	’	'	PUNCT
ihlr-22950	517	41	(	(	PUNCT
ihlr-22950	517	42	emphasis	emphasis	NOUN
ihlr-22950	517	43	added	add	VERB
ihlr-22950	517	44	)	)	PUNCT
ihlr-22950	517	45	means	mean	VERB
ihlr-22950	517	46	:	:	PUNCT
ihlr-22950	517	47	(	(	PUNCT
ihlr-22950	517	48	1	1	X
ihlr-22950	517	49	)	)	PUNCT
ihlr-22950	517	50	diseases	disease	NOUN
ihlr-22950	517	51	or	or	CCONJ
ihlr-22950	517	52	conditions	condition	NOUN
ihlr-22950	517	53	where	where	SCONJ
ihlr-22950	517	54	the	the	DET
ihlr-22950	517	55	likelihood	likelihood	NOUN
ihlr-22950	517	56	of	of	ADP
ihlr-22950	517	57	death	death	NOUN
ihlr-22950	517	58	is	be	AUX
ihlr-22950	517	59	high	high	ADJ
ihlr-22950	517	60	unless	unless	SCONJ
ihlr-22950	517	61	the	the	DET
ihlr-22950	517	62	course	course	NOUN
ihlr-22950	517	63	of	of	ADP
ihlr-22950	517	64	the	the	DET
ihlr-22950	517	65	disease	disease	NOUN
ihlr-22950	517	66	is	be	AUX
ihlr-22950	517	67	interrupted	interrupt	VERB
ihlr-22950	517	68	;	;	PUNCT
ihlr-22950	517	69	and	and	CCONJ
ihlr-22950	517	70	(	(	PUNCT
ihlr-22950	517	71	2	2	X
ihlr-22950	517	72	)	)	PUNCT
ihlr-22950	517	73	diseases	disease	NOUN
ihlr-22950	517	74	or	or	CCONJ
ihlr-22950	517	75	conditions	condition	NOUN
ihlr-22950	517	76	with	with	ADP
ihlr-22950	517	77	potentially	potentially	ADV
ihlr-22950	517	78	fatal	fatal	ADJ
ihlr-22950	517	79	outcomes	outcome	NOUN
ihlr-22950	517	80	,	,	PUNCT
ihlr-22950	517	81	where	where	SCONJ
ihlr-22950	517	82	the	the	DET
ihlr-22950	517	83	end	end	NOUN
ihlr-22950	517	84	point	point	NOUN
ihlr-22950	517	85	of	of	ADP
ihlr-22950	517	86	clinical	clinical	ADJ
ihlr-22950	517	87	trial	trial	NOUN
ihlr-22950	517	88	analysis	analysis	NOUN
ihlr-22950	517	89	is	be	AUX
ihlr-22950	517	90	survival	survival	NOUN
ihlr-22950	517	91	(	(	PUNCT
ihlr-22950	517	92	b	b	NOUN
ihlr-22950	517	93	)	)	PUNCT
ihlr-22950	517	94	for	for	ADP
ihlr-22950	517	95	purposes	purpose	NOUN
ihlr-22950	517	96	of	of	ADP
ihlr-22950	517	97	this	this	DET
ihlr-22950	517	98	section	section	NOUN
ihlr-22950	517	99	,	,	PUNCT
ihlr-22950	517	100	the	the	DET
ihlr-22950	517	101	term	term	NOUN
ihlr-22950	517	102	‘	'	PUNCT
ihlr-22950	517	103	severely	severely	ADV
ihlr-22950	517	104	debilitating	debilitating	ADJ
ihlr-22950	517	105	’	'	PUNCT
ihlr-22950	517	106	means	mean	VERB
ihlr-22950	517	107	diseases	disease	NOUN
ihlr-22950	517	108	or	or	CCONJ
ihlr-22950	517	109	conditions	condition	NOUN
ihlr-22950	517	110	that	that	PRON
ihlr-22950	517	111	cause	cause	VERB
ihlr-22950	517	112	major	major	ADJ
ihlr-22950	517	113	irreversible	irreversible	ADJ
ihlr-22950	517	114	morbidity	morbidity	NOUN
ihlr-22950	517	115	.	.	PUNCT
ihlr-22950	518	1	(	(	PUNCT
ihlr-22950	518	2	c	c	X
ihlr-22950	518	3	)	)	PUNCT
ihlr-22950	518	4	sponsors	sponsor	NOUN
ihlr-22950	518	5	are	be	AUX
ihlr-22950	518	6	encouraged	encourage	VERB
ihlr-22950	518	7	to	to	PART
ihlr-22950	518	8	consult	consult	VERB
ihlr-22950	518	9	with	with	ADP
ihlr-22950	518	10	fda	fda	PROPN
ihlr-22950	518	11	on	on	ADP
ihlr-22950	518	12	the	the	DET
ihlr-22950	518	13	applicability	applicability	NOUN
ihlr-22950	518	14	of	of	ADP
ihlr-22950	518	15	these	these	DET
ihlr-22950	518	16	procedures	procedure	NOUN
ihlr-22950	518	17	to	to	ADP
ihlr-22950	518	18	specific	specific	ADJ
ihlr-22950	518	19	products	product	NOUN
ihlr-22950	518	20	.	.	PUNCT
ihlr-22950	518	21	”	"	PUNCT
ihlr-22950	518	22	)	)	PUNCT
ihlr-22950	518	23	.	.	PUNCT
ihlr-22950	519	1	114	114	NUM
ihlr-22950	519	2	.	.	PUNCT
ihlr-22950	519	3	md	md	PROPN
ihlr-22950	519	4	.	.	PROPN
ihlr-22950	519	5	code	code	PROPN
ihlr-22950	519	6	ann	ann	PROPN
ihlr-22950	519	7	.	.	PROPN
ihlr-22950	519	8	,	,	PUNCT
ihlr-22950	520	1	health	health	NOUN
ihlr-22950	520	2	-	-	PUNCT
ihlr-22950	520	3	gen	gen	PROPN
ihlr-22950	520	4	.	.	PROPN
ihlr-22950	520	5	§	§	PROPN
ihlr-22950	520	6	21	21	NUM
ihlr-22950	520	7	-	-	SYM
ihlr-22950	520	8	2b	2b	NUM
ihlr-22950	520	9	(	(	PUNCT
ihlr-22950	520	10	west	west	NOUN
ihlr-22950	520	11	)	)	PUNCT
ihlr-22950	520	12	115	115	NUM
ihlr-22950	520	13	.	.	PUNCT
ihlr-22950	521	1	termini	termini	PROPN
ihlr-22950	521	2	&	&	CCONJ
ihlr-22950	521	3	lis	lis	PROPN
ihlr-22950	521	4	,	,	PUNCT
ihlr-22950	521	5	supra	supra	NOUN
ihlr-22950	521	6	note	note	NOUN
ihlr-22950	521	7	97	97	NUM
ihlr-22950	521	8	,	,	PUNCT
ihlr-22950	521	9	at	at	ADP
ihlr-22950	521	10	45	45	NUM
ihlr-22950	521	11	.	.	NOUN
ihlr-22950	521	12	116	116	NUM
ihlr-22950	521	13	.	.	PUNCT
ihlr-22950	522	1	trickett	trickett	PROPN
ihlr-22950	522	2	wendler	wendler	PROPN
ihlr-22950	522	3	,	,	PUNCT
ihlr-22950	522	4	frank	frank	PROPN
ihlr-22950	522	5	mongiello	mongiello	PROPN
ihlr-22950	522	6	,	,	PUNCT
ihlr-22950	522	7	jordan	jordan	PROPN
ihlr-22950	522	8	mclinn	mclinn	PROPN
ihlr-22950	522	9	,	,	PUNCT
ihlr-22950	522	10	and	and	CCONJ
ihlr-22950	522	11	matthew	matthew	PROPN
ihlr-22950	522	12	bellina	bellina	PROPN
ihlr-22950	522	13	right	right	NOUN
ihlr-22950	522	14	to	to	PART
ihlr-22950	522	15	try	try	VERB
ihlr-22950	522	16	act	act	NOUN
ihlr-22950	522	17	of	of	ADP
ihlr-22950	522	18	2017	2017	NUM
ihlr-22950	522	19	,	,	PUNCT
ihlr-22950	522	20	pub	pub	NOUN
ihlr-22950	522	21	.	.	PUNCT
ihlr-22950	523	1	l.	l.	PROPN
ihlr-22950	523	2	no	no	INTJ
ihlr-22950	523	3	.	.	PROPN
ihlr-22950	524	1	115	115	NUM
ihlr-22950	524	2	-	-	SYM
ihlr-22950	524	3	176	176	NUM
ihlr-22950	524	4	,	,	PUNCT
ihlr-22950	524	5	132	132	NUM
ihlr-22950	524	6	stat	stat	NOUN
ihlr-22950	524	7	.	.	PUNCT
ihlr-22950	525	1	1372	1372	NUM
ihlr-22950	525	2	(	(	PUNCT
ihlr-22950	525	3	2018	2018	NUM
ihlr-22950	525	4	)	)	PUNCT
ihlr-22950	525	5	.	.	PUNCT
ihlr-22950	526	1	see	see	AUX
ihlr-22950	526	2	also	also	ADV
ihlr-22950	526	3	expanded	expand	VERB
ihlr-22950	526	4	access	access	NOUN
ihlr-22950	526	5	(	(	PUNCT
ihlr-22950	526	6	sometimes	sometimes	ADV
ihlr-22950	526	7	called	call	VERB
ihlr-22950	526	8	“	"	PUNCT
ihlr-22950	526	9	compassionate	compassionate	ADJ
ihlr-22950	526	10	use	use	NOUN
ihlr-22950	526	11	”	"	PUNCT
ihlr-22950	526	12	)	)	PUNCT
ihlr-22950	526	13	,	,	PUNCT
ihlr-22950	526	14	supra	supra	PROPN
ihlr-22950	526	15	note	note	VERB
ihlr-22950	526	16	45	45	NUM
ihlr-22950	526	17	.	.	NOUN
ihlr-22950	526	18	117	117	NUM
ihlr-22950	526	19	.	.	PUNCT
ihlr-22950	527	1	the	the	DET
ihlr-22950	527	2	revised	revise	VERB
ihlr-22950	527	3	form	form	NOUN
ihlr-22950	527	4	fda	fda	PROPN
ihlr-22950	527	5	3926	3926	NUM
ihlr-22950	527	6	is	be	AUX
ihlr-22950	527	7	less	less	ADV
ihlr-22950	527	8	complicated	complicated	ADJ
ihlr-22950	527	9	and	and	CCONJ
ihlr-22950	527	10	provides	provide	VERB
ihlr-22950	527	11	a	a	DET
ihlr-22950	527	12	streamlined	streamlined	ADJ
ihlr-22950	527	13	process	process	NOUN
ihlr-22950	527	14	for	for	ADP
ihlr-22950	527	15	submission	submission	NOUN
ihlr-22950	527	16	to	to	ADP
ihlr-22950	527	17	fda	fda	PROPN
ihlr-22950	527	18	.	.	PUNCT
ihlr-22950	528	1	see	see	VERB
ihlr-22950	528	2	u.s	u.s	PROPN
ihlr-22950	528	3	.	.	PROPN
ihlr-22950	528	4	dep’t	dep’t	PROPN
ihlr-22950	528	5	of	of	ADP
ihlr-22950	528	6	health	health	PROPN
ihlr-22950	528	7	&	&	CCONJ
ihlr-22950	528	8	human	human	PROPN
ihlr-22950	528	9	servs	servs	PROPN
ihlr-22950	528	10	.	.	PUNCT
ihlr-22950	528	11	,	,	PUNCT
ihlr-22950	528	12	supra	supra	PROPN
ihlr-22950	528	13	note	note	PROPN
ihlr-22950	528	14	85	85	NUM
ihlr-22950	528	15	.	.	PUNCT
ihlr-22950	529	1	app	app	PROPN
ihlr-22950	529	2	.	.	PUNCT
ihlr-22950	529	3	iii	iii	PROPN
ihlr-22950	529	4	for	for	ADP
ihlr-22950	529	5	the	the	DET
ihlr-22950	529	6	timeline	timeline	NOUN
ihlr-22950	529	7	specifications	specification	NOUN
ihlr-22950	529	8	.	.	PUNCT
ihlr-22950	530	1	118	118	NUM
ihlr-22950	530	2	.	.	X
ihlr-22950	530	3	trickett	trickett	PROPN
ihlr-22950	530	4	wendler	wendler	PROPN
ihlr-22950	530	5	,	,	PUNCT
ihlr-22950	530	6	frank	frank	PROPN
ihlr-22950	530	7	mongiello	mongiello	PROPN
ihlr-22950	530	8	,	,	PUNCT
ihlr-22950	530	9	jordan	jordan	PROPN
ihlr-22950	530	10	mclinn	mclinn	PROPN
ihlr-22950	530	11	,	,	PUNCT
ihlr-22950	530	12	and	and	CCONJ
ihlr-22950	530	13	matthew	matthew	PROPN
ihlr-22950	530	14	bellina	bellina	PROPN
ihlr-22950	530	15	right	right	NOUN
ihlr-22950	530	16	to	to	PART
ihlr-22950	530	17	try	try	VERB
ihlr-22950	530	18	act	act	NOUN
ihlr-22950	530	19	of	of	ADP
ihlr-22950	530	20	2017	2017	NUM
ihlr-22950	530	21	,	,	PUNCT
ihlr-22950	530	22	pub	pub	NOUN
ihlr-22950	530	23	.	.	PUNCT
ihlr-22950	531	1	l.	l.	PROPN
ihlr-22950	531	2	no	no	INTJ
ihlr-22950	531	3	.	.	PROPN
ihlr-22950	532	1	115	115	NUM
ihlr-22950	532	2	-	-	SYM
ihlr-22950	532	3	176	176	NUM
ihlr-22950	532	4	,	,	PUNCT
ihlr-22950	532	5	132	132	NUM
ihlr-22950	532	6	stat	stat	NOUN
ihlr-22950	532	7	.	.	PUNCT
ihlr-22950	533	1	1372	1372	NUM
ihlr-22950	533	2	(	(	PUNCT
ihlr-22950	533	3	2018	2018	NUM
ihlr-22950	533	4	)	)	PUNCT
ihlr-22950	533	5	.	.	PUNCT
ihlr-22950	534	1	119	119	NUM
ihlr-22950	534	2	.	.	PUNCT
ihlr-22950	535	1	i	i	PRON
ihlr-22950	535	2	d.	d.	VERB
ihlr-22950	535	3	yet	yet	ADV
ihlr-22950	535	4	,	,	PUNCT
ihlr-22950	535	5	arguably	arguably	ADV
ihlr-22950	535	6	,	,	PUNCT
ihlr-22950	535	7	since	since	SCONJ
ihlr-22950	535	8	the	the	DET
ihlr-22950	535	9	federal	federal	ADJ
ihlr-22950	535	10	right	right	NOUN
ihlr-22950	535	11	-	-	PUNCT
ihlr-22950	535	12	to	to	PART
ihlr-22950	535	13	-	-	PUNCT
ihlr-22950	535	14	try	try	VERB
ihlr-22950	535	15	does	do	AUX
ihlr-22950	535	16	not	not	PART
ihlr-22950	535	17	expressly	expressly	ADV
ihlr-22950	535	18	cover	cover	VERB
ihlr-22950	535	19	medical	medical	ADJ
ihlr-22950	535	20	devices	device	NOUN
ihlr-22950	535	21	,	,	PUNCT
ihlr-22950	535	22	state	state	NOUN
ihlr-22950	535	23	right	right	NOUN
ihlr-22950	535	24	-	-	PUNCT
ihlr-22950	535	25	to	to	PART
ihlr-22950	535	26	-	-	PUNCT
ihlr-22950	535	27	try	try	VERB
ihlr-22950	535	28	could	could	AUX
ihlr-22950	535	29	prevail	prevail	VERB
ihlr-22950	535	30	and	and	CCONJ
ihlr-22950	535	31	provide	provide	VERB
ihlr-22950	535	32	a	a	DET
ihlr-22950	535	33	mechanism	mechanism	NOUN
ihlr-22950	535	34	for	for	ADP
ihlr-22950	535	35	experimental	experimental	ADJ
ihlr-22950	535	36	treatment	treatment	NOUN
ihlr-22950	535	37	in	in	ADP
ihlr-22950	535	38	that	that	DET
ihlr-22950	535	39	regard	regard	NOUN
ihlr-22950	535	40	.	.	PUNCT
ihlr-22950	536	1	2018	2018	NUM
ihlr-22950	536	2	]	]	PUNCT
ihlr-22950	536	3	the	the	DET
ihlr-22950	536	4	latest	late	ADJ
ihlr-22950	536	5	“	"	PUNCT
ihlr-22950	536	6	federal	federal	ADJ
ihlr-22950	536	7	movement	movement	NOUN
ihlr-22950	536	8	”	"	PUNCT
ihlr-22950	536	9	in	in	ADP
ihlr-22950	536	10	the	the	DET
ihlr-22950	536	11	food	food	NOUN
ihlr-22950	536	12	and	and	CCONJ
ihlr-22950	536	13	drug	drug	NOUN
ihlr-22950	536	14	law	law	NOUN
ihlr-22950	536	15	arena	arena	NOUN
ihlr-22950	536	16	119	119	NUM
ihlr-22950	536	17	risks	risk	NOUN
ihlr-22950	536	18	,	,	PUNCT
ihlr-22950	536	19	the	the	DET
ihlr-22950	536	20	costs	cost	NOUN
ihlr-22950	536	21	involved	involve	VERB
ihlr-22950	536	22	,	,	PUNCT
ihlr-22950	536	23	and	and	CCONJ
ihlr-22950	536	24	the	the	DET
ihlr-22950	536	25	limitation	limitation	NOUN
ihlr-22950	536	26	of	of	ADP
ihlr-22950	536	27	the	the	DET
ihlr-22950	536	28	right	right	NOUN
ihlr-22950	536	29	to	to	PART
ihlr-22950	536	30	institute	institute	VERB
ihlr-22950	536	31	a	a	DET
ihlr-22950	536	32	lawsuit	lawsuit	NOUN
ihlr-22950	536	33	.	.	PUNCT
ihlr-22950	537	1	finally	finally	ADV
ihlr-22950	537	2	,	,	PUNCT
ihlr-22950	537	3	as	as	SCONJ
ihlr-22950	537	4	indicated	indicate	VERB
ihlr-22950	537	5	,	,	PUNCT
ihlr-22950	537	6	there	there	PRON
ihlr-22950	537	7	is	be	VERB
ihlr-22950	537	8	no	no	DET
ihlr-22950	537	9	simple	simple	ADJ
ihlr-22950	537	10	definitive	definitive	ADJ
ihlr-22950	537	11	solution	solution	NOUN
ihlr-22950	537	12	.	.	PUNCT
ihlr-22950	538	1	yet	yet	ADV
ihlr-22950	538	2	,	,	PUNCT
ihlr-22950	538	3	perhaps	perhaps	ADV
ihlr-22950	538	4	the	the	DET
ihlr-22950	538	5	state	state	NOUN
ihlr-22950	538	6	right	right	NOUN
ihlr-22950	538	7	-	-	PUNCT
ihlr-22950	538	8	to	to	AUX
ihlr-22950	538	9	-	-	PUNCT
ihlr-22950	538	10	try	try	VERB
ihlr-22950	538	11	initiatives	initiative	NOUN
ihlr-22950	538	12	and	and	CCONJ
ihlr-22950	538	13	now	now	ADV
ihlr-22950	538	14	the	the	DET
ihlr-22950	538	15	federal	federal	ADJ
ihlr-22950	538	16	right	right	NOUN
ihlr-22950	538	17	-	-	PUNCT
ihlr-22950	538	18	to	to	PART
ihlr-22950	538	19	-	-	PUNCT
ihlr-22950	538	20	try	try	VERB
ihlr-22950	538	21	act,120	act,120	ADJ
ihlr-22950	538	22	albeit	albeit	SCONJ
ihlr-22950	538	23	with	with	ADP
ihlr-22950	538	24	realistic	realistic	ADJ
ihlr-22950	538	25	hope	hope	NOUN
ihlr-22950	538	26	,	,	PUNCT
ihlr-22950	538	27	may	may	AUX
ihlr-22950	538	28	serve	serve	VERB
ihlr-22950	538	29	a	a	DET
ihlr-22950	538	30	valuable	valuable	ADJ
ihlr-22950	538	31	substantive	substantive	ADJ
ihlr-22950	538	32	purpose	purpose	NOUN
ihlr-22950	538	33	by	by	ADP
ihlr-22950	538	34	providing	provide	VERB
ihlr-22950	538	35	a	a	DET
ihlr-22950	538	36	method	method	NOUN
ihlr-22950	538	37	for	for	SCONJ
ihlr-22950	538	38	patients	patient	NOUN
ihlr-22950	538	39	to	to	PART
ihlr-22950	538	40	assert	assert	VERB
ihlr-22950	538	41	their	their	PRON
ihlr-22950	538	42	desires	desire	NOUN
ihlr-22950	538	43	and	and	CCONJ
ihlr-22950	538	44	needs	need	NOUN
ihlr-22950	538	45	,	,	PUNCT
ihlr-22950	538	46	to	to	PART
ihlr-22950	538	47	foster	foster	ADJ
ihlr-22950	538	48	autonomy	autonomy	NOUN
ihlr-22950	538	49	,	,	PUNCT
ihlr-22950	538	50	to	to	PART
ihlr-22950	538	51	further	further	VERB
ihlr-22950	538	52	their	their	PRON
ihlr-22950	538	53	self	self	NOUN
ihlr-22950	538	54	-	-	PUNCT
ihlr-22950	538	55	determination	determination	NOUN
ihlr-22950	538	56	for	for	ADP
ihlr-22950	538	57	their	their	PRON
ihlr-22950	538	58	health	health	NOUN
ihlr-22950	538	59	care	care	NOUN
ihlr-22950	538	60	,	,	PUNCT
ihlr-22950	538	61	and	and	CCONJ
ihlr-22950	538	62	above	above	ADP
ihlr-22950	538	63	all	all	PRON
ihlr-22950	538	64	to	to	PART
ihlr-22950	538	65	maintain	maintain	VERB
ihlr-22950	538	66	their	their	PRON
ihlr-22950	538	67	human	human	ADJ
ihlr-22950	538	68	dignity	dignity	NOUN
ihlr-22950	538	69	.	.	PUNCT
ihlr-22950	539	1	120	120	NUM
ihlr-22950	539	2	.	.	PUNCT
ihlr-22950	540	1	i	i	PRON
ihlr-22950	540	2	d.	d.	PROPN
ihlr-22950	540	3	120	120	NUM
ihlr-22950	540	4	indiana	indiana	PROPN
ihlr-22950	540	5	health	health	PROPN
ihlr-22950	540	6	law	law	NOUN
ihlr-22950	540	7	review	review	NOUN
ihlr-22950	540	8	[	[	X
ihlr-22950	540	9	vol	vol	NOUN
ihlr-22950	540	10	.	.	PUNCT
ihlr-22950	541	1	16:101	16:101	NUM
ihlr-22950	541	2	x.	x.	NOUN
ihlr-22950	541	3	appendices	appendice	VERB
ihlr-22950	541	4	a.	a.	NOUN
ihlr-22950	541	5	appendix	appendix	PROPN
ihlr-22950	541	6	i	i	PRON
ihlr-22950	541	7	:	:	PUNCT
ihlr-22950	541	8	expanded	expand	VERB
ihlr-22950	541	9	access	access	NOUN
ihlr-22950	541	10	inds	ind	VERB
ihlr-22950	541	11	fy	fy	PROPN
ihlr-22950	541	12	2012	2012	NUM
ihlr-22950	541	13	-	-	SYM
ihlr-22950	541	14	2017121	2017121	NUM
ihlr-22950	541	15	expanded	expand	VERB
ihlr-22950	541	16	access	access	NOUN
ihlr-22950	541	17	inds	ind	NOUN
ihlr-22950	541	18	121	121	NUM
ihlr-22950	541	19	.	.	PUNCT
ihlr-22950	542	1	expanded	expand	VERB
ihlr-22950	542	2	access	access	NOUN
ihlr-22950	542	3	inds	ind	NOUN
ihlr-22950	542	4	and	and	CCONJ
ihlr-22950	542	5	protocols	protocol	NOUN
ihlr-22950	542	6	2009	2009	NUM
ihlr-22950	542	7	-	-	SYM
ihlr-22950	542	8	2017	2017	NUM
ihlr-22950	542	9	,	,	PUNCT
ihlr-22950	542	10	supra	supra	PROPN
ihlr-22950	542	11	note	note	NOUN
ihlr-22950	542	12	52	52	NUM
ihlr-22950	542	13	;	;	PUNCT
ihlr-22950	542	14	ind	ind	NOUN
ihlr-22950	542	15	investigational	investigational	ADJ
ihlr-22950	542	16	new	new	ADJ
ihlr-22950	542	17	drug	drug	NOUN
ihlr-22950	542	18	application	application	NOUN
ihlr-22950	542	19	,	,	PUNCT
ihlr-22950	542	20	u.s	u.s	PROPN
ihlr-22950	542	21	.	.	PROPN
ihlr-22950	542	22	food	food	PROPN
ihlr-22950	542	23	&	&	CCONJ
ihlr-22950	542	24	drug	drug	PROPN
ihlr-22950	542	25	admin	admin	PROPN
ihlr-22950	542	26	.	.	PUNCT
ihlr-22950	542	27	,	,	PUNCT
ihlr-22950	542	28	https://www.fda.gov/drugs/development	https://www.fda.gov/drugs/development	PROPN
ihlr-22950	542	29	approvalprocess	approvalprocess	NOUN
ihlr-22950	542	30	/	/	SYM
ihlr-22950	542	31	howdrugsaredevelopedandapproved	howdrugsaredevelopedandapproved	ADJ
ihlr-22950	542	32	/	/	SYM
ihlr-22950	542	33	approvalapplications	approvalapplication	NOUN
ihlr-22950	542	34	/	/	SYM
ihlr-22950	542	35	investigationalnewdr	investigationalnewdr	NOUN
ihlr-22950	542	36	ugindapplication	ugindapplication	NOUN
ihlr-22950	542	37	/	/	SYM
ihlr-22950	542	38	default.htm	default.htm	X
ihlr-22950	543	1	[	[	X
ihlr-22950	543	2	https://perma.cc/ga7y-74lz	https://perma.cc/ga7y-74lz	X
ihlr-22950	543	3	]	]	X
ihlr-22950	543	4	(	(	PUNCT
ihlr-22950	543	5	last	last	ADJ
ihlr-22950	543	6	updated	update	VERB
ihlr-22950	543	7	oct	oct	PROPN
ihlr-22950	543	8	.	.	PROPN
ihlr-22950	543	9	5	5	NUM
ihlr-22950	543	10	,	,	PUNCT
ihlr-22950	543	11	2017	2017	NUM
ihlr-22950	543	12	)	)	PUNCT
ihlr-22950	543	13	.	.	PUNCT
ihlr-22950	544	1	2018	2018	NUM
ihlr-22950	544	2	]	]	PUNCT
ihlr-22950	544	3	the	the	DET
ihlr-22950	544	4	latest	late	ADJ
ihlr-22950	544	5	“	"	PUNCT
ihlr-22950	544	6	federal	federal	ADJ
ihlr-22950	544	7	movement	movement	NOUN
ihlr-22950	544	8	”	"	PUNCT
ihlr-22950	544	9	in	in	ADP
ihlr-22950	544	10	the	the	DET
ihlr-22950	544	11	food	food	NOUN
ihlr-22950	544	12	and	and	CCONJ
ihlr-22950	544	13	drug	drug	NOUN
ihlr-22950	544	14	law	law	NOUN
ihlr-22950	544	15	arena	arena	NOUN
ihlr-22950	544	16	121	121	NUM
ihlr-22950	544	17	a.	a.	NOUN
ihlr-22950	544	18	appendix	appendix	NOUN
ihlr-22950	544	19	i	i	PRON
ihlr-22950	544	20	:	:	PUNCT
ihlr-22950	544	21	expanded	expand	VERB
ihlr-22950	544	22	access	access	NOUN
ihlr-22950	544	23	inds	ind	VERB
ihlr-22950	544	24	fy	fy	PROPN
ihlr-22950	544	25	2012	2012	NUM
ihlr-22950	544	26	-	-	SYM
ihlr-22950	544	27	2017	2017	NUM
ihlr-22950	544	28	(	(	PUNCT
ihlr-22950	544	29	cont’d	cont’d	NOUN
ihlr-22950	544	30	)	)	PUNCT
ihlr-22950	544	31	expanded	expand	VERB
ihlr-22950	544	32	access	access	NOUN
ihlr-22950	544	33	inds	ind	VERB
ihlr-22950	544	34	these	these	DET
ihlr-22950	544	35	reporting	reporting	NOUN
ihlr-22950	544	36	periods	period	NOUN
ihlr-22950	544	37	cover	cover	VERB
ihlr-22950	544	38	a	a	DET
ihlr-22950	544	39	one	one	NUM
ihlr-22950	544	40	-	-	PUNCT
ihlr-22950	544	41	year	year	NOUN
ihlr-22950	544	42	cohort	cohort	NOUN
ihlr-22950	544	43	starting	start	VERB
ihlr-22950	544	44	the	the	DET
ihlr-22950	544	45	day	day	NOUN
ihlr-22950	544	46	the	the	DET
ihlr-22950	544	47	final	final	ADJ
ihlr-22950	544	48	rule	rule	NOUN
ihlr-22950	544	49	for	for	ADP
ihlr-22950	544	50	expanded	expand	VERB
ihlr-22950	544	51	access	access	NOUN
ihlr-22950	544	52	to	to	ADP
ihlr-22950	544	53	investigational	investigational	ADJ
ihlr-22950	544	54	drugs	drug	NOUN
ihlr-22950	544	55	for	for	ADP
ihlr-22950	544	56	treatment	treatment	NOUN
ihlr-22950	544	57	use	use	NOUN
ihlr-22950	544	58	and	and	CCONJ
ihlr-22950	544	59	charging	charge	VERB
ihlr-22950	544	60	for	for	ADP
ihlr-22950	544	61	investigational	investigational	ADJ
ihlr-22950	544	62	drugs	drug	NOUN
ihlr-22950	544	63	went	go	VERB
ihlr-22950	544	64	into	into	ADP
ihlr-22950	544	65	effect	effect	NOUN
ihlr-22950	544	66	.	.	PUNCT
ihlr-22950	545	1	starting	start	VERB
ihlr-22950	545	2	with	with	ADP
ihlr-22950	545	3	fiscal	fiscal	ADJ
ihlr-22950	545	4	year	year	NOUN
ihlr-22950	545	5	2012	2012	NUM
ihlr-22950	545	6	,	,	PUNCT
ihlr-22950	545	7	the	the	DET
ihlr-22950	545	8	reporting	reporting	NOUN
ihlr-22950	545	9	period	period	NOUN
ihlr-22950	545	10	was	be	AUX
ihlr-22950	545	11	changed	change	VERB
ihlr-22950	545	12	to	to	ADP
ihlr-22950	545	13	a	a	DET
ihlr-22950	545	14	fiscal	fiscal	ADJ
ihlr-22950	545	15	year	year	NOUN
ihlr-22950	545	16	to	to	PART
ihlr-22950	545	17	match	match	VERB
ihlr-22950	545	18	the	the	DET
ihlr-22950	545	19	reporting	reporting	NOUN
ihlr-22950	545	20	period	period	NOUN
ihlr-22950	545	21	for	for	ADP
ihlr-22950	545	22	other	other	ADJ
ihlr-22950	545	23	ind	ind	NOUN
ihlr-22950	545	24	activity	activity	NOUN
ihlr-22950	545	25	reports	report	NOUN
ihlr-22950	545	26	.	.	PUNCT
ihlr-22950	546	1	122	122	NUM
ihlr-22950	546	2	indiana	indiana	PROPN
ihlr-22950	546	3	health	health	PROPN
ihlr-22950	546	4	law	law	PROPN
ihlr-22950	546	5	review	review	NOUN
ihlr-22950	546	6	[	[	X
ihlr-22950	546	7	vol	vol	NOUN
ihlr-22950	546	8	.	.	PUNCT
ihlr-22950	547	1	16:101	16:101	NUM
ihlr-22950	547	2	b.	b.	PROPN
ihlr-22950	547	3	appendix	appendix	ADJ
ihlr-22950	547	4	ii122	ii122	PROPN
ihlr-22950	547	5	compassionate	compassionate	ADJ
ihlr-22950	547	6	use	use	NOUN
ihlr-22950	547	7	ide	ide	NOUN
ihlr-22950	547	8	supplements	supplement	NOUN
ihlr-22950	547	9	year	year	NOUN
ihlr-22950	547	10	total	total	ADJ
ihlr-22950	547	11	submissions	submission	NOUN
ihlr-22950	547	12	evaluable	evaluable	ADJ
ihlr-22950	547	13	submissions	submission	NOUN
ihlr-22950	547	14	*	*	VERB
ihlr-22950	547	15	percent	percent	NOUN
ihlr-22950	547	16	approved	approve	VERB
ihlr-22950	547	17	*	*	PUNCT
ihlr-22950	547	18	*	*	PROPN
ihlr-22950	547	19	2012	2012	NUM
ihlr-22950	547	20	135	135	NUM
ihlr-22950	547	21	123	123	NUM
ihlr-22950	547	22	99.19	99.19	NUM
ihlr-22950	547	23	%	%	NOUN
ihlr-22950	547	24	2013	2013	NUM
ihlr-22950	547	25	181	181	NUM
ihlr-22950	547	26	175	175	NUM
ihlr-22950	547	27	98.86	98.86	NUM
ihlr-22950	547	28	%	%	NOUN
ihlr-22950	547	29	2014	2014	NUM
ihlr-22950	547	30	228	228	NUM
ihlr-22950	547	31	216	216	NUM
ihlr-22950	547	32	99.54	99.54	NUM
ihlr-22950	547	33	%	%	NOUN
ihlr-22950	547	34	2015	2015	NUM
ihlr-22950	547	35	215	215	NUM
ihlr-22950	547	36	208	208	NUM
ihlr-22950	547	37	99.04	99.04	NUM
ihlr-22950	547	38	%	%	NOUN
ihlr-22950	547	39	*	*	PUNCT
ihlr-22950	547	40	excludes	exclude	VERB
ihlr-22950	547	41	those	those	PRON
ihlr-22950	547	42	withdrawn	withdraw	VERB
ihlr-22950	547	43	or	or	CCONJ
ihlr-22950	547	44	converted	convert	VERB
ihlr-22950	547	45	to	to	ADP
ihlr-22950	547	46	emergency	emergency	NOUN
ihlr-22950	547	47	use	use	NOUN
ihlr-22950	547	48	while	while	SCONJ
ihlr-22950	547	49	under	under	ADP
ihlr-22950	547	50	review	review	NOUN
ihlr-22950	547	51	*	*	PUNCT
ihlr-22950	547	52	*	*	VERB
ihlr-22950	547	53	based	base	VERB
ihlr-22950	547	54	on	on	ADP
ihlr-22950	547	55	evaluable	evaluable	ADJ
ihlr-22950	547	56	submissions	submission	NOUN
ihlr-22950	547	57	compassionate	compassionate	ADJ
ihlr-22950	547	58	use	use	NOUN
ihlr-22950	547	59	requests	request	NOUN
ihlr-22950	547	60	without	without	ADP
ihlr-22950	547	61	an	an	DET
ihlr-22950	547	62	ide	ide	ADJ
ihlr-22950	547	63	year	year	NOUN
ihlr-22950	547	64	total	total	NOUN
ihlr-22950	547	65	submissions	submission	NOUN
ihlr-22950	547	66	evaluable	evaluable	ADJ
ihlr-22950	547	67	submissions	submission	NOUN
ihlr-22950	547	68	*	*	VERB
ihlr-22950	547	69	percent	percent	NOUN
ihlr-22950	547	70	approved	approve	VERB
ihlr-22950	547	71	*	*	PUNCT
ihlr-22950	547	72	*	*	NOUN
ihlr-22950	547	73	2012	2012	NUM
ihlr-22950	547	74	53	53	NUM
ihlr-22950	547	75	53	53	NUM
ihlr-22950	547	76	98.11	98.11	NUM
ihlr-22950	547	77	%	%	NOUN
ihlr-22950	547	78	2013	2013	NUM
ihlr-22950	547	79	138	138	NUM
ihlr-22950	547	80	134	134	NUM
ihlr-22950	547	81	91.79	91.79	NUM
ihlr-22950	547	82	%	%	NOUN
ihlr-22950	547	83	2014	2014	NUM
ihlr-22950	547	84	112	112	NUM
ihlr-22950	547	85	101	101	NUM
ihlr-22950	547	86	99.01	99.01	NUM
ihlr-22950	547	87	%	%	NOUN
ihlr-22950	547	88	2015	2015	NUM
ihlr-22950	547	89	170	170	NUM
ihlr-22950	547	90	167	167	NUM
ihlr-22950	547	91	98.80	98.80	NUM
ihlr-22950	547	92	%	%	NOUN
ihlr-22950	547	93	*	*	PUNCT
ihlr-22950	547	94	excludes	exclude	VERB
ihlr-22950	547	95	those	those	PRON
ihlr-22950	547	96	withdrawn	withdraw	VERB
ihlr-22950	547	97	or	or	CCONJ
ihlr-22950	547	98	converted	convert	VERB
ihlr-22950	547	99	to	to	ADP
ihlr-22950	547	100	emergency	emergency	NOUN
ihlr-22950	547	101	use	use	NOUN
ihlr-22950	547	102	while	while	SCONJ
ihlr-22950	547	103	under	under	ADP
ihlr-22950	547	104	review	review	NOUN
ihlr-22950	547	105	*	*	PUNCT
ihlr-22950	547	106	*	*	VERB
ihlr-22950	547	107	based	base	VERB
ihlr-22950	547	108	on	on	ADP
ihlr-22950	547	109	evaluable	evaluable	ADJ
ihlr-22950	547	110	submission	submission	NOUN
ihlr-22950	547	111	122	122	NUM
ihlr-22950	547	112	.	.	PUNCT
ihlr-22950	547	113	expanded	expand	VERB
ihlr-22950	547	114	access	access	NOUN
ihlr-22950	547	115	for	for	ADP
ihlr-22950	547	116	medical	medical	ADJ
ihlr-22950	547	117	devices	device	NOUN
ihlr-22950	547	118	,	,	PUNCT
ihlr-22950	547	119	supra	supra	PROPN
ihlr-22950	547	120	note	note	NOUN
ihlr-22950	547	121	69	69	NUM
ihlr-22950	547	122	.	.	PUNCT
ihlr-22950	547	123	2018	2018	NUM
ihlr-22950	547	124	]	]	PUNCT
ihlr-22950	547	125	the	the	DET
ihlr-22950	547	126	latest	late	ADJ
ihlr-22950	547	127	“	"	PUNCT
ihlr-22950	547	128	federal	federal	ADJ
ihlr-22950	547	129	movement	movement	NOUN
ihlr-22950	547	130	”	"	PUNCT
ihlr-22950	547	131	in	in	ADP
ihlr-22950	547	132	the	the	DET
ihlr-22950	547	133	food	food	NOUN
ihlr-22950	547	134	and	and	CCONJ
ihlr-22950	547	135	drug	drug	NOUN
ihlr-22950	547	136	law	law	NOUN
ihlr-22950	547	137	arena	arena	NOUN
ihlr-22950	547	138	123	123	NUM
ihlr-22950	547	139	c.	c.	NOUN
ihlr-22950	547	140	appendix	appendix	VERB
ihlr-22950	547	141	iii123	iii123	PROPN
ihlr-22950	547	142	individual	individual	ADJ
ihlr-22950	547	143	patient	patient	NOUN
ihlr-22950	547	144	expanded	expand	VERB
ihlr-22950	547	145	access	access	NOUN
ihlr-22950	547	146	ind	ind	NOUN
ihlr-22950	547	147	application	application	NOUN
ihlr-22950	547	148	for	for	ADP
ihlr-22950	547	149	emergency	emergency	NOUN
ihlr-22950	547	150	use	use	NOUN
ihlr-22950	547	151	:	:	PUNCT
ihlr-22950	547	152	initial	initial	ADJ
ihlr-22950	547	153	submission	submission	NOUN
ihlr-22950	547	154	time	time	NOUN
ihlr-22950	547	155	action	action	NOUN
ihlr-22950	547	156	supporting	support	VERB
ihlr-22950	547	157	documentation	documentation	NOUN
ihlr-22950	547	158	day	day	NOUN
ihlr-22950	547	159	0	0	NUM
ihlr-22950	547	160	-	-	SYM
ihlr-22950	547	161	1	1	NUM
ihlr-22950	547	162	contact	contact	NOUN
ihlr-22950	547	163	sponsor	sponsor	NOUN
ihlr-22950	547	164	/	/	SYM
ihlr-22950	547	165	manufacturer	manufacturer	NOUN
ihlr-22950	547	166	to	to	PART
ihlr-22950	547	167	obtain	obtain	VERB
ihlr-22950	547	168	their	their	PRON
ihlr-22950	547	169	agreement	agreement	NOUN
ihlr-22950	547	170	to	to	PART
ihlr-22950	547	171	provide	provide	VERB
ihlr-22950	547	172	expanded	expand	VERB
ihlr-22950	547	173	access	access	NOUN
ihlr-22950	547	174	to	to	ADP
ihlr-22950	547	175	the	the	DET
ihlr-22950	547	176	investigational	investigational	ADJ
ihlr-22950	547	177	drug	drug	NOUN
ihlr-22950	547	178	letter	letter	NOUN
ihlr-22950	547	179	of	of	ADP
ihlr-22950	547	180	authorization	authorization	NOUN
ihlr-22950	547	181	from	from	ADP
ihlr-22950	547	182	sponsor	sponsor	NOUN
ihlr-22950	547	183	/	/	SYM
ihlr-22950	547	184	manufacturer	manufacturer	NOUN
ihlr-22950	547	185	granting	grant	VERB
ihlr-22950	547	186	a	a	DET
ihlr-22950	547	187	right	right	NOUN
ihlr-22950	547	188	of	of	ADP
ihlr-22950	547	189	reference	reference	NOUN
ihlr-22950	547	190	to	to	ADP
ihlr-22950	547	191	the	the	DET
ihlr-22950	547	192	information	information	NOUN
ihlr-22950	547	193	contained	contain	VERB
ihlr-22950	547	194	in	in	ADP
ihlr-22950	547	195	their	their	PRON
ihlr-22950	547	196	existing	exist	VERB
ihlr-22950	547	197	ind	ind	NOUN
ihlr-22950	547	198	•	•	NOUN
ihlr-22950	547	199	letter	letter	NOUN
ihlr-22950	547	200	of	of	ADP
ihlr-22950	547	201	authorization	authorization	NOUN
ihlr-22950	547	202	(	(	PUNCT
ihlr-22950	547	203	see	see	VERB
ihlr-22950	547	204	online	online	ADJ
ihlr-22950	547	205	template	template	NOUN
ihlr-22950	547	206	)	)	PUNCT
ihlr-22950	547	207	to	to	PART
ihlr-22950	547	208	be	be	AUX
ihlr-22950	547	209	sent	send	VERB
ihlr-22950	547	210	to	to	ADP
ihlr-22950	547	211	fda	fda	PROPN
ihlr-22950	547	212	at	at	ADP
ihlr-22950	547	213	the	the	DET
ihlr-22950	547	214	time	time	NOUN
ihlr-22950	547	215	of	of	ADP
ihlr-22950	547	216	application	application	NOUN
ihlr-22950	547	217	submission	submission	NOUN
ihlr-22950	547	218	by	by	ADP
ihlr-22950	547	219	day	day	NOUN
ihlr-22950	547	220	15	15	NUM
ihlr-22950	547	221	day	day	NOUN
ihlr-22950	547	222	1	1	NUM
ihlr-22950	547	223	call	call	NOUN
ihlr-22950	547	224	fda	fda	PROPN
ihlr-22950	547	225	to	to	PART
ihlr-22950	547	226	obtain	obtain	VERB
ihlr-22950	547	227	fda	fda	PROPN
ihlr-22950	547	228	authorization	authorization	NOUN
ihlr-22950	547	229	for	for	ADP
ihlr-22950	547	230	the	the	DET
ihlr-22950	547	231	expanded	expand	VERB
ihlr-22950	547	232	access	access	NOUN
ihlr-22950	547	233	use	use	NOUN
ihlr-22950	547	234	information	information	NOUN
ihlr-22950	547	235	will	will	AUX
ihlr-22950	547	236	be	be	AUX
ihlr-22950	547	237	requested	request	VERB
ihlr-22950	547	238	by	by	ADP
ihlr-22950	547	239	the	the	DET
ihlr-22950	547	240	fda	fda	PROPN
ihlr-22950	547	241	representative	representative	NOUN
ihlr-22950	547	242	and	and	CCONJ
ihlr-22950	547	243	can	can	AUX
ihlr-22950	547	244	be	be	AUX
ihlr-22950	547	245	provided	provide	VERB
ihlr-22950	547	246	via	via	ADP
ihlr-22950	547	247	phone	phone	NOUN
ihlr-22950	547	248	,	,	PUNCT
ihlr-22950	547	249	fax	fax	NOUN
ihlr-22950	547	250	,	,	PUNCT
ihlr-22950	547	251	or	or	CCONJ
ihlr-22950	547	252	e	e	NOUN
ihlr-22950	547	253	-	-	NOUN
ihlr-22950	547	254	mail	mail	NOUN
ihlr-22950	547	255	day	day	NOUN
ihlr-22950	547	256	1	1	NUM
ihlr-22950	547	257	obtain	obtain	VERB
ihlr-22950	547	258	informed	informed	ADJ
ihlr-22950	547	259	consent	consent	NOUN
ihlr-22950	547	260	from	from	ADP
ihlr-22950	547	261	patient	patient	NOUN
ihlr-22950	547	262	or	or	CCONJ
ihlr-22950	547	263	their	their	PRON
ihlr-22950	547	264	legally	legally	ADV
ihlr-22950	547	265	authorized	authorize	VERB
ihlr-22950	547	266	representative	representative	NOUN
ihlr-22950	547	267	prior	prior	ADV
ihlr-22950	547	268	to	to	ADP
ihlr-22950	547	269	administering	administer	VERB
ihlr-22950	547	270	treatment	treatment	NOUN
ihlr-22950	547	271	posttreatment	posttreatment	NOUN
ihlr-22950	547	272	by	by	ADP
ihlr-22950	547	273	day	day	NOUN
ihlr-22950	547	274	5	5	NUM
ihlr-22950	547	275	notify	notify	VERB
ihlr-22950	547	276	institutional	institutional	ADJ
ihlr-22950	547	277	review	review	NOUN
ihlr-22950	547	278	board	board	NOUN
ihlr-22950	547	279	(	(	PUNCT
ihlr-22950	547	280	irb	irb	PROPN
ihlr-22950	547	281	)	)	PUNCT
ihlr-22950	547	282	of	of	ADP
ihlr-22950	547	283	the	the	DET
ihlr-22950	547	284	emergency	emergency	NOUN
ihlr-22950	547	285	expanded	expand	VERB
ihlr-22950	547	286	access	access	NOUN
ihlr-22950	547	287	use	use	NOUN
ihlr-22950	547	288	supporting	support	VERB
ihlr-22950	547	289	documentation	documentation	NOUN
ihlr-22950	547	290	as	as	SCONJ
ihlr-22950	547	291	required	require	VERB
ihlr-22950	547	292	by	by	ADP
ihlr-22950	547	293	the	the	DET
ihlr-22950	547	294	respective	respective	ADJ
ihlr-22950	547	295	applicable	applicable	ADJ
ihlr-22950	547	296	irb	irb	NOUN
ihlr-22950	547	297	123	123	NUM
ihlr-22950	547	298	.	.	PUNCT
ihlr-22950	548	1	emergency	emergency	NOUN
ihlr-22950	548	2	ind	ind	PROPN
ihlr-22950	548	3	timeline	timeline	PROPN
ihlr-22950	548	4	,	,	PUNCT
ihlr-22950	548	5	u.s	u.s	PROPN
ihlr-22950	548	6	.	.	PROPN
ihlr-22950	548	7	dep’t	dep’t	PROPN
ihlr-22950	548	8	of	of	ADP
ihlr-22950	548	9	health	health	PROPN
ihlr-22950	548	10	&	&	CCONJ
ihlr-22950	548	11	human	human	PROPN
ihlr-22950	548	12	servs	servs	PROPN
ihlr-22950	548	13	.	.	PUNCT
ihlr-22950	548	14	,	,	PUNCT
ihlr-22950	548	15	https://www.fda	https://www.fda	PROPN
ihlr-22950	548	16	.	.	PUNCT
ihlr-22950	549	1	gov	gov	PROPN
ihlr-22950	549	2	/	/	SYM
ihlr-22950	549	3	drugs	drug	NOUN
ihlr-22950	549	4	/	/	SYM
ihlr-22950	549	5	developmentapprovalprocess	developmentapprovalprocess	NOUN
ihlr-22950	549	6	/	/	SYM
ihlr-22950	549	7	howdrugsaredevelopedandapproved	howdrugsaredevelopedandapprove	VERB
ihlr-22950	549	8	/	/	SYM
ihlr-22950	549	9	approvalappl	approvalappl	NOUN
ihlr-22950	549	10	ications	ication	NOUN
ihlr-22950	549	11	/	/	SYM
ihlr-22950	549	12	investigationalnewdrugindapplication	investigationalnewdrugindapplication	NOUN
ihlr-22950	549	13	/	/	SYM
ihlr-22950	549	14	ucm597130.htm	ucm597130.htm	PROPN
ihlr-22950	550	1	[	[	X
ihlr-22950	550	2	https://perma.cc/d6qmaymh	https://perma.cc/d6qmaymh	X
ihlr-22950	550	3	]	]	X
ihlr-22950	550	4	(	(	PUNCT
ihlr-22950	550	5	last	last	ADJ
ihlr-22950	550	6	updated	update	VERB
ihlr-22950	550	7	feb	feb	PROPN
ihlr-22950	550	8	.	.	PROPN
ihlr-22950	550	9	20	20	NUM
ihlr-22950	550	10	,	,	PUNCT
ihlr-22950	550	11	2018	2018	NUM
ihlr-22950	550	12	)	)	PUNCT
ihlr-22950	550	13	.	.	PUNCT
ihlr-22950	551	1	124	124	NUM
ihlr-22950	551	2	indiana	indiana	PROPN
ihlr-22950	551	3	health	health	PROPN
ihlr-22950	551	4	law	law	PROPN
ihlr-22950	551	5	review	review	NOUN
ihlr-22950	551	6	[	[	X
ihlr-22950	551	7	vol	vol	NOUN
ihlr-22950	551	8	.	.	PUNCT
ihlr-22950	552	1	16:101	16:101	NUM
ihlr-22950	552	2	by	by	ADP
ihlr-22950	552	3	day	day	NOUN
ihlr-22950	552	4	15	15	NUM
ihlr-22950	552	5	submit	submit	NOUN
ihlr-22950	552	6	the	the	DET
ihlr-22950	552	7	expanded	expand	VERB
ihlr-22950	552	8	access	access	NOUN
ihlr-22950	552	9	ind	ind	NOUN
ihlr-22950	552	10	application	application	NOUN
ihlr-22950	552	11	to	to	ADP
ihlr-22950	552	12	the	the	DET
ihlr-22950	552	13	appropriate	appropriate	ADJ
ihlr-22950	552	14	review	review	NOUN
ihlr-22950	552	15	division	division	NOUN
ihlr-22950	552	16	in	in	ADP
ihlr-22950	552	17	the	the	DET
ihlr-22950	552	18	center	center	NOUN
ihlr-22950	552	19	for	for	ADP
ihlr-22950	552	20	drug	drug	NOUN
ihlr-22950	552	21	evaluation	evaluation	NOUN
ihlr-22950	552	22	and	and	CCONJ
ihlr-22950	552	23	research	research	NOUN
ihlr-22950	552	24	(	(	PUNCT
ihlr-22950	552	25	cder	cder	NOUN
ihlr-22950	552	26	)	)	PUNCT
ihlr-22950	552	27	at	at	ADP
ihlr-22950	552	28	fda	fda	PROPN
ihlr-22950	552	29	insert	insert	VERB
ihlr-22950	552	30	your	your	PRON
ihlr-22950	552	31	ind	ind	NOUN
ihlr-22950	552	32	number	number	NOUN
ihlr-22950	552	33	,	,	PUNCT
ihlr-22950	552	34	provided	provide	VERB
ihlr-22950	552	35	to	to	ADP
ihlr-22950	552	36	you	you	PRON
ihlr-22950	552	37	by	by	ADP
ihlr-22950	552	38	fda	fda	PROPN
ihlr-22950	552	39	staff	staff	NOUN
ihlr-22950	552	40	,	,	PUNCT
ihlr-22950	552	41	in	in	ADP
ihlr-22950	552	42	the	the	DET
ihlr-22950	552	43	appropriate	appropriate	ADJ
ihlr-22950	552	44	section	section	NOUN
ihlr-22950	552	45	of	of	ADP
ihlr-22950	552	46	the	the	DET
ihlr-22950	552	47	application	application	NOUN
ihlr-22950	552	48	form	form	NOUN
ihlr-22950	552	49	(	(	PUNCT
ihlr-22950	552	50	e.g.	e.g.	ADV
ihlr-22950	552	51	,	,	PUNCT
ihlr-22950	552	52	section	section	NOUN
ihlr-22950	552	53	titled	title	VERB
ihlr-22950	552	54	,	,	PUNCT
ihlr-22950	552	55	physician	physician	NOUN
ihlr-22950	552	56	’s	’s	PART
ihlr-22950	552	57	ind	ind	NOUN
ihlr-22950	552	58	number	number	NOUN
ihlr-22950	552	59	in	in	ADP
ihlr-22950	552	60	section	section	NOUN
ihlr-22950	552	61	3	3	NUM
ihlr-22950	552	62	of	of	ADP
ihlr-22950	552	63	form	form	NOUN
ihlr-22950	552	64	fda	fda	PROPN
ihlr-22950	552	65	3926	3926	NUM
ihlr-22950	552	66	)	)	PUNCT
ihlr-22950	552	67	form	form	NOUN
ihlr-22950	552	68	fda	fda	PROPN
ihlr-22950	552	69	39261	39261	NUM
ihlr-22950	552	70	letter	letter	NOUN
ihlr-22950	552	71	of	of	ADP
ihlr-22950	552	72	authorization2	authorization2	NOUN
ihlr-22950	552	73	from	from	ADP
ihlr-22950	552	74	sponsor	sponsor	NOUN
ihlr-22950	552	75	/	/	SYM
ihlr-22950	552	76	manufacturer	manufacturer	NOUN
ihlr-22950	552	77	1	1	NUM
ihlr-22950	552	78	form	form	NOUN
ihlr-22950	552	79	fda	fda	PROPN
ihlr-22950	552	80	1571	1571	NUM
ihlr-22950	552	81	and	and	CCONJ
ihlr-22950	552	82	1572	1572	NUM
ihlr-22950	552	83	are	be	AUX
ihlr-22950	552	84	also	also	ADV
ihlr-22950	552	85	accepted	accept	VERB
ihlr-22950	552	86	,	,	PUNCT
ihlr-22950	552	87	however	however	ADV
ihlr-22950	552	88	,	,	PUNCT
ihlr-22950	552	89	form	form	VERB
ihlr-22950	552	90	fda	fda	PROPN
ihlr-22950	552	91	3926	3926	NUM
ihlr-22950	552	92	is	be	AUX
ihlr-22950	552	93	a	a	DET
ihlr-22950	552	94	streamlined	streamlined	ADJ
ihlr-22950	552	95	form	form	NOUN
ihlr-22950	552	96	created	create	VERB
ihlr-22950	552	97	specifically	specifically	ADV
ihlr-22950	552	98	for	for	ADP
ihlr-22950	552	99	individual	individual	ADJ
ihlr-22950	552	100	patient	patient	ADJ
ihlr-22950	552	101	ind	ind	NOUN
ihlr-22950	552	102	submissions	submission	NOUN
ihlr-22950	552	103	,	,	PUNCT
ihlr-22950	552	104	including	include	VERB
ihlr-22950	552	105	those	those	PRON
ihlr-22950	552	106	for	for	ADP
ihlr-22950	552	107	emergency	emergency	NOUN
ihlr-22950	552	108	use	use	NOUN
ihlr-22950	552	109	.	.	PUNCT
ihlr-22950	552	110	2	2	NUM
ihlr-22950	552	111	in	in	ADP
ihlr-22950	552	112	the	the	DET
ihlr-22950	552	113	absence	absence	NOUN
ihlr-22950	552	114	of	of	ADP
ihlr-22950	552	115	a	a	DET
ihlr-22950	552	116	letter	letter	NOUN
ihlr-22950	552	117	of	of	ADP
ihlr-22950	552	118	authorization	authorization	NOUN
ihlr-22950	552	119	from	from	ADP
ihlr-22950	552	120	the	the	DET
ihlr-22950	552	121	sponsor	sponsor	NOUN
ihlr-22950	552	122	/	/	SYM
ihlr-22950	552	123	manufacturer	manufacturer	NOUN
ihlr-22950	552	124	,	,	PUNCT
ihlr-22950	552	125	the	the	DET
ihlr-22950	552	126	expanded	expand	VERB
ihlr-22950	552	127	access	access	NOUN
ihlr-22950	552	128	ind	ind	NOUN
ihlr-22950	552	129	application	application	NOUN
ihlr-22950	552	130	’s	’s	PART
ihlr-22950	552	131	sponsor	sponsor	NOUN
ihlr-22950	552	132	is	be	AUX
ihlr-22950	552	133	responsible	responsible	ADJ
ihlr-22950	552	134	for	for	ADP
ihlr-22950	552	135	providing	provide	VERB
ihlr-22950	552	136	the	the	DET
ihlr-22950	552	137	following	following	NOUN
ihlr-22950	552	138	in	in	ADP
ihlr-22950	552	139	the	the	DET
ihlr-22950	552	140	ind	ind	NOUN
ihlr-22950	552	141	application	application	NOUN
ihlr-22950	552	142	submission	submission	NOUN
ihlr-22950	552	143	:	:	PUNCT
ihlr-22950	552	144	•	•	NUM
ihlr-22950	552	145	description	description	NOUN
ihlr-22950	552	146	of	of	ADP
ihlr-22950	552	147	the	the	DET
ihlr-22950	552	148	facility	facility	NOUN
ihlr-22950	552	149	where	where	SCONJ
ihlr-22950	552	150	the	the	DET
ihlr-22950	552	151	drug	drug	NOUN
ihlr-22950	552	152	is	be	AUX
ihlr-22950	552	153	manufactured	manufacture	VERB
ihlr-22950	552	154	;	;	PUNCT
ihlr-22950	552	155	•	•	NUM
ihlr-22950	552	156	chemistry	chemistry	NOUN
ihlr-22950	552	157	,	,	PUNCT
ihlr-22950	552	158	manufacturing	manufacturing	NOUN
ihlr-22950	552	159	,	,	PUNCT
ihlr-22950	552	160	and	and	CCONJ
ihlr-22950	552	161	controls	control	VERB
ihlr-22950	552	162	information	information	NOUN
ihlr-22950	552	163	adequate	adequate	ADJ
ihlr-22950	552	164	to	to	PART
ihlr-22950	552	165	ensure	ensure	VERB
ihlr-22950	552	166	the	the	DET
ihlr-22950	552	167	proper	proper	ADJ
ihlr-22950	552	168	identification	identification	NOUN
ihlr-22950	552	169	,	,	PUNCT
ihlr-22950	552	170	quality	quality	NOUN
ihlr-22950	552	171	,	,	PUNCT
ihlr-22950	552	172	purity	purity	NOUN
ihlr-22950	552	173	,	,	PUNCT
ihlr-22950	552	174	and	and	CCONJ
ihlr-22950	552	175	strength	strength	NOUN
ihlr-22950	552	176	of	of	ADP
ihlr-22950	552	177	the	the	DET
ihlr-22950	552	178	investigational	investigational	ADJ
ihlr-22950	552	179	drug	drug	NOUN
ihlr-22950	552	180	;	;	PUNCT
ihlr-22950	552	181	•	•	NUM
ihlr-22950	552	182	pharmacology	pharmacology	NOUN
ihlr-22950	552	183	and	and	CCONJ
ihlr-22950	552	184	toxicology	toxicology	NOUN
ihlr-22950	552	185	information	information	NOUN
ihlr-22950	552	186	adequate	adequate	ADJ
ihlr-22950	552	187	to	to	PART
ihlr-22950	552	188	conclude	conclude	VERB
ihlr-22950	552	189	that	that	SCONJ
ihlr-22950	552	190	the	the	DET
ihlr-22950	552	191	drug	drug	NOUN
ihlr-22950	552	192	is	be	AUX
ihlr-22950	552	193	reasonably	reasonably	ADV
ihlr-22950	552	194	safe	safe	ADJ
ihlr-22950	552	195	at	at	ADP
ihlr-22950	552	196	the	the	DET
ihlr-22950	552	197	dose	dose	NOUN
ihlr-22950	552	198	and	and	CCONJ
ihlr-22950	552	199	duration	duration	NOUN
ihlr-22950	552	200	proposed	propose	VERB
ihlr-22950	552	201	for	for	ADP
ihlr-22950	552	202	the	the	DET
ihlr-22950	552	203	emergency	emergency	NOUN
ihlr-22950	552	204	use	use	NOUN
ihlr-22950	552	205	.	.	PUNCT
ihlr-22950	553	1	d.	d.	PROPN
ihlr-22950	553	2	appendix	appendix	VERB
ihlr-22950	553	3	iv	iv	NUM
ihlr-22950	553	4	federal	federal	ADJ
ihlr-22950	553	5	right	right	NOUN
ihlr-22950	553	6	to	to	PART
ihlr-22950	553	7	try124	try124	VERB
ihlr-22950	553	8	to	to	PART
ihlr-22950	553	9	authorize	authorize	VERB
ihlr-22950	553	10	the	the	DET
ihlr-22950	553	11	use	use	NOUN
ihlr-22950	553	12	of	of	ADP
ihlr-22950	553	13	unapproved	unapproved	ADJ
ihlr-22950	553	14	medical	medical	ADJ
ihlr-22950	553	15	products	product	NOUN
ihlr-22950	553	16	by	by	ADP
ihlr-22950	553	17	patients	patient	NOUN
ihlr-22950	553	18	diagnosed	diagnose	VERB
ihlr-22950	553	19	with	with	ADP
ihlr-22950	553	20	a	a	DET
ihlr-22950	553	21	terminal	terminal	ADJ
ihlr-22950	553	22	illness	illness	NOUN
ihlr-22950	553	23	in	in	ADP
ihlr-22950	553	24	accordance	accordance	NOUN
ihlr-22950	553	25	with	with	ADP
ihlr-22950	553	26	state	state	NOUN
ihlr-22950	553	27	law	law	NOUN
ihlr-22950	553	28	,	,	PUNCT
ihlr-22950	553	29	and	and	CCONJ
ihlr-22950	553	30	for	for	ADP
ihlr-22950	553	31	other	other	ADJ
ihlr-22950	553	32	purposes	purpose	NOUN
ihlr-22950	553	33	.	.	PUNCT
ihlr-22950	554	1	be	be	AUX
ihlr-22950	554	2	it	it	PRON
ihlr-22950	554	3	enacted	enact	VERB
ihlr-22950	554	4	by	by	ADP
ihlr-22950	554	5	the	the	DET
ihlr-22950	554	6	senate	senate	PROPN
ihlr-22950	554	7	and	and	CCONJ
ihlr-22950	554	8	house	house	PROPN
ihlr-22950	554	9	of	of	ADP
ihlr-22950	554	10	representatives	representative	NOUN
ihlr-22950	554	11	of	of	ADP
ihlr-22950	554	12	the	the	DET
ihlr-22950	554	13	united	united	PROPN
ihlr-22950	554	14	states	states	PROPN
ihlr-22950	554	15	of	of	ADP
ihlr-22950	554	16	america	america	PROPN
ihlr-22950	554	17	in	in	ADP
ihlr-22950	554	18	congress	congress	PROPN
ihlr-22950	554	19	assembled	assemble	VERB
ihlr-22950	554	20	,	,	PUNCT
ihlr-22950	554	21	section	section	NOUN
ihlr-22950	554	22	1	1	NUM
ihlr-22950	554	23	.	.	PUNCT
ihlr-22950	554	24	short	short	ADJ
ihlr-22950	554	25	title	title	NOUN
ihlr-22950	554	26	.	.	PUNCT
ihlr-22950	555	1	this	this	DET
ihlr-22950	555	2	act	act	NOUN
ihlr-22950	555	3	may	may	AUX
ihlr-22950	555	4	be	be	AUX
ihlr-22950	555	5	cited	cite	VERB
ihlr-22950	555	6	as	as	ADP
ihlr-22950	555	7	the	the	DET
ihlr-22950	555	8	“	"	PUNCT
ihlr-22950	555	9	trickett	trickett	NOUN
ihlr-22950	555	10	wendler	wendler	NOUN
ihlr-22950	555	11	,	,	PUNCT
ihlr-22950	555	12	frank	frank	PROPN
ihlr-22950	555	13	mongiello	mongiello	PROPN
ihlr-22950	555	14	,	,	PUNCT
ihlr-22950	555	15	jordan	jordan	PROPN
ihlr-22950	555	16	mclinn	mclinn	PROPN
ihlr-22950	555	17	,	,	PUNCT
ihlr-22950	555	18	and	and	CCONJ
ihlr-22950	555	19	matthew	matthew	PROPN
ihlr-22950	555	20	bellina	bellina	PROPN
ihlr-22950	555	21	right	right	NOUN
ihlr-22950	555	22	to	to	PART
ihlr-22950	555	23	try	try	VERB
ihlr-22950	555	24	act	act	NOUN
ihlr-22950	555	25	of	of	ADP
ihlr-22950	555	26	2017	2017	NUM
ihlr-22950	555	27	”	"	PUNCT
ihlr-22950	555	28	.	.	PUNCT
ihlr-22950	556	1	sec	sec	PROPN
ihlr-22950	556	2	.	.	PROPN
ihlr-22950	556	3	2	2	X
ihlr-22950	556	4	.	.	X
ihlr-22950	556	5	use	use	NOUN
ihlr-22950	556	6	of	of	ADP
ihlr-22950	556	7	unapproved	unapproved	ADJ
ihlr-22950	556	8	investigational	investigational	ADJ
ihlr-22950	556	9	drugs	drug	NOUN
ihlr-22950	556	10	by	by	ADP
ihlr-22950	556	11	patients	patient	NOUN
ihlr-22950	556	12	diagnosed	diagnose	VERB
ihlr-22950	556	13	with	with	ADP
ihlr-22950	556	14	a	a	DET
ihlr-22950	556	15	terminal	terminal	ADJ
ihlr-22950	556	16	illness	illness	NOUN
ihlr-22950	556	17	.	.	PUNCT
ihlr-22950	557	1	(	(	PUNCT
ihlr-22950	557	2	a	a	X
ihlr-22950	557	3	)	)	PUNCT
ihlr-22950	557	4	in	in	ADP
ihlr-22950	557	5	general.—chapter	general.—chapter	NOUN
ihlr-22950	557	6	v	v	NOUN
ihlr-22950	557	7	of	of	ADP
ihlr-22950	557	8	the	the	DET
ihlr-22950	557	9	federal	federal	ADJ
ihlr-22950	557	10	food	food	NOUN
ihlr-22950	557	11	,	,	PUNCT
ihlr-22950	557	12	drug	drug	NOUN
ihlr-22950	557	13	,	,	PUNCT
ihlr-22950	557	14	and	and	CCONJ
ihlr-22950	557	15	cosmetic	cosmetic	ADJ
ihlr-22950	557	16	act	act	NOUN
ihlr-22950	557	17	is	be	AUX
ihlr-22950	557	18	amended	amend	VERB
ihlr-22950	557	19	by	by	ADP
ihlr-22950	557	20	inserting	insert	VERB
ihlr-22950	557	21	after	after	ADP
ihlr-22950	557	22	section	section	NOUN
ihlr-22950	557	23	561a	561a	NUM
ihlr-22950	557	24	(	(	PUNCT
ihlr-22950	557	25	21	21	NUM
ihlr-22950	557	26	u.s.c	u.s.c	NOUN
ihlr-22950	557	27	.	.	PUNCT
ihlr-22950	558	1	360bbb–0	360bbb–0	NUM
ihlr-22950	558	2	)	)	PUNCT
ihlr-22950	558	3	the	the	DET
ihlr-22950	558	4	following	following	NOUN
ihlr-22950	558	5	:	:	PUNCT
ihlr-22950	558	6	124	124	NUM
ihlr-22950	558	7	.	.	PUNCT
ihlr-22950	558	8	trickett	trickett	PROPN
ihlr-22950	558	9	wendler	wendler	PROPN
ihlr-22950	558	10	,	,	PUNCT
ihlr-22950	558	11	frank	frank	PROPN
ihlr-22950	558	12	mongiello	mongiello	PROPN
ihlr-22950	558	13	,	,	PUNCT
ihlr-22950	558	14	jordan	jordan	PROPN
ihlr-22950	558	15	mclinn	mclinn	PROPN
ihlr-22950	558	16	,	,	PUNCT
ihlr-22950	558	17	and	and	CCONJ
ihlr-22950	558	18	matthew	matthew	PROPN
ihlr-22950	558	19	bellina	bellina	PROPN
ihlr-22950	558	20	right	right	NOUN
ihlr-22950	558	21	to	to	PART
ihlr-22950	558	22	try	try	VERB
ihlr-22950	558	23	act	act	NOUN
ihlr-22950	558	24	of	of	ADP
ihlr-22950	558	25	2017	2017	NUM
ihlr-22950	558	26	,	,	PUNCT
ihlr-22950	558	27	pub	pub	NOUN
ihlr-22950	558	28	.	.	PUNCT
ihlr-22950	559	1	l.	l.	PROPN
ihlr-22950	559	2	no	no	INTJ
ihlr-22950	559	3	.	.	PROPN
ihlr-22950	560	1	115	115	NUM
ihlr-22950	560	2	-	-	SYM
ihlr-22950	560	3	176	176	NUM
ihlr-22950	560	4	,	,	PUNCT
ihlr-22950	560	5	132	132	NUM
ihlr-22950	560	6	stat	stat	NOUN
ihlr-22950	560	7	.	.	PUNCT
ihlr-22950	561	1	1372	1372	NUM
ihlr-22950	561	2	(	(	PUNCT
ihlr-22950	561	3	2018	2018	NUM
ihlr-22950	561	4	)	)	PUNCT
ihlr-22950	561	5	.	.	PUNCT
ihlr-22950	562	1	2018	2018	NUM
ihlr-22950	562	2	]	]	PUNCT
ihlr-22950	562	3	the	the	DET
ihlr-22950	562	4	latest	late	ADJ
ihlr-22950	562	5	“	"	PUNCT
ihlr-22950	562	6	federal	federal	ADJ
ihlr-22950	562	7	movement	movement	NOUN
ihlr-22950	562	8	”	"	PUNCT
ihlr-22950	562	9	in	in	ADP
ihlr-22950	562	10	the	the	DET
ihlr-22950	562	11	food	food	NOUN
ihlr-22950	562	12	and	and	CCONJ
ihlr-22950	562	13	drug	drug	NOUN
ihlr-22950	562	14	law	law	NOUN
ihlr-22950	562	15	arena	arena	NOUN
ihlr-22950	562	16	125	125	NUM
ihlr-22950	562	17	“	"	PUNCT
ihlr-22950	562	18	sec	sec	PROPN
ihlr-22950	562	19	.	.	PUNCT
ihlr-22950	562	20	561b	561b	NUM
ihlr-22950	562	21	.	.	PUNCT
ihlr-22950	563	1	investigational	investigational	ADJ
ihlr-22950	563	2	drugs	drug	NOUN
ihlr-22950	563	3	for	for	ADP
ihlr-22950	563	4	use	use	NOUN
ihlr-22950	563	5	by	by	ADP
ihlr-22950	563	6	eligible	eligible	ADJ
ihlr-22950	563	7	patients	patient	NOUN
ihlr-22950	563	8	.	.	PUNCT
ihlr-22950	564	1	“	"	PUNCT
ihlr-22950	564	2	(	(	PUNCT
ihlr-22950	564	3	a	a	X
ihlr-22950	564	4	)	)	PUNCT
ihlr-22950	564	5	definitions.—for	definitions.—for	ADP
ihlr-22950	564	6	purposes	purpose	NOUN
ihlr-22950	564	7	of	of	ADP
ihlr-22950	564	8	this	this	DET
ihlr-22950	564	9	section	section	NOUN
ihlr-22950	564	10	—	—	PUNCT
ihlr-22950	564	11	“	"	PUNCT
ihlr-22950	564	12	(	(	PUNCT
ihlr-22950	564	13	1	1	X
ihlr-22950	564	14	)	)	PUNCT
ihlr-22950	564	15	the	the	DET
ihlr-22950	564	16	term	term	NOUN
ihlr-22950	564	17	‘	'	PUNCT
ihlr-22950	564	18	eligible	eligible	ADJ
ihlr-22950	564	19	patient	patient	NOUN
ihlr-22950	564	20	’	'	PUNCT
ihlr-22950	564	21	means	mean	VERB
ihlr-22950	564	22	a	a	DET
ihlr-22950	564	23	patient	patient	NOUN
ihlr-22950	564	24	—	—	PUNCT
ihlr-22950	564	25	“	"	PUNCT
ihlr-22950	564	26	(	(	PUNCT
ihlr-22950	564	27	a	a	X
ihlr-22950	564	28	)	)	PUNCT
ihlr-22950	564	29	who	who	PRON
ihlr-22950	564	30	has	have	AUX
ihlr-22950	564	31	been	be	AUX
ihlr-22950	564	32	diagnosed	diagnose	VERB
ihlr-22950	564	33	with	with	ADP
ihlr-22950	564	34	a	a	DET
ihlr-22950	564	35	life	life	NOUN
ihlr-22950	564	36	-	-	PUNCT
ihlr-22950	564	37	threatening	threaten	VERB
ihlr-22950	564	38	disease	disease	NOUN
ihlr-22950	564	39	or	or	CCONJ
ihlr-22950	564	40	condition	condition	NOUN
ihlr-22950	564	41	(	(	PUNCT
ihlr-22950	564	42	as	as	SCONJ
ihlr-22950	564	43	defined	define	VERB
ihlr-22950	564	44	in	in	ADP
ihlr-22950	564	45	section	section	NOUN
ihlr-22950	564	46	312.81	312.81	NUM
ihlr-22950	564	47	of	of	ADP
ihlr-22950	564	48	title	title	NOUN
ihlr-22950	564	49	21	21	NUM
ihlr-22950	564	50	,	,	PUNCT
ihlr-22950	564	51	code	code	NOUN
ihlr-22950	564	52	of	of	ADP
ihlr-22950	564	53	federal	federal	ADJ
ihlr-22950	564	54	regulations	regulation	NOUN
ihlr-22950	564	55	(	(	PUNCT
ihlr-22950	564	56	or	or	CCONJ
ihlr-22950	564	57	any	any	DET
ihlr-22950	564	58	successor	successor	NOUN
ihlr-22950	564	59	regulations	regulation	NOUN
ihlr-22950	564	60	)	)	PUNCT
ihlr-22950	564	61	)	)	PUNCT
ihlr-22950	564	62	;	;	PUNCT
ihlr-22950	564	63	“	"	PUNCT
ihlr-22950	564	64	(	(	PUNCT
ihlr-22950	564	65	b	b	X
ihlr-22950	564	66	)	)	PUNCT
ihlr-22950	564	67	who	who	PRON
ihlr-22950	564	68	has	have	AUX
ihlr-22950	564	69	exhausted	exhaust	VERB
ihlr-22950	564	70	approved	approve	VERB
ihlr-22950	564	71	treatment	treatment	NOUN
ihlr-22950	564	72	options	option	NOUN
ihlr-22950	564	73	and	and	CCONJ
ihlr-22950	564	74	is	be	AUX
ihlr-22950	564	75	unable	unable	ADJ
ihlr-22950	564	76	to	to	PART
ihlr-22950	564	77	participate	participate	VERB
ihlr-22950	564	78	in	in	ADP
ihlr-22950	564	79	a	a	DET
ihlr-22950	564	80	clinical	clinical	ADJ
ihlr-22950	564	81	trial	trial	NOUN
ihlr-22950	564	82	involving	involve	VERB
ihlr-22950	564	83	the	the	DET
ihlr-22950	564	84	eligible	eligible	ADJ
ihlr-22950	564	85	investigational	investigational	ADJ
ihlr-22950	564	86	drug	drug	NOUN
ihlr-22950	564	87	,	,	PUNCT
ihlr-22950	564	88	as	as	SCONJ
ihlr-22950	564	89	certified	certify	VERB
ihlr-22950	564	90	by	by	ADP
ihlr-22950	564	91	a	a	DET
ihlr-22950	564	92	physician	physician	NOUN
ihlr-22950	564	93	,	,	PUNCT
ihlr-22950	564	94	who	who	PRON
ihlr-22950	564	95	—	—	PUNCT
ihlr-22950	564	96	“	"	PUNCT
ihlr-22950	564	97	(	(	PUNCT
ihlr-22950	564	98	i	i	NOUN
ihlr-22950	564	99	)	)	PUNCT
ihlr-22950	564	100	is	be	AUX
ihlr-22950	564	101	in	in	ADP
ihlr-22950	564	102	good	good	ADJ
ihlr-22950	564	103	standing	stand	VERB
ihlr-22950	564	104	with	with	ADP
ihlr-22950	564	105	the	the	DET
ihlr-22950	564	106	physician	physician	NOUN
ihlr-22950	564	107	’s	’s	PART
ihlr-22950	564	108	licensing	licensing	NOUN
ihlr-22950	564	109	organization	organization	NOUN
ihlr-22950	564	110	or	or	CCONJ
ihlr-22950	564	111	board	board	NOUN
ihlr-22950	564	112	;	;	PUNCT
ihlr-22950	564	113	and	and	CCONJ
ihlr-22950	564	114	“	"	PUNCT
ihlr-22950	564	115	(	(	PUNCT
ihlr-22950	564	116	ii	ii	NOUN
ihlr-22950	564	117	)	)	PUNCT
ihlr-22950	564	118	will	will	AUX
ihlr-22950	564	119	not	not	PART
ihlr-22950	564	120	be	be	AUX
ihlr-22950	564	121	compensated	compensate	VERB
ihlr-22950	564	122	directly	directly	ADV
ihlr-22950	564	123	by	by	ADP
ihlr-22950	564	124	the	the	DET
ihlr-22950	564	125	manufacturer	manufacturer	NOUN
ihlr-22950	564	126	for	for	ADP
ihlr-22950	564	127	so	so	ADV
ihlr-22950	564	128	certifying	certifying	NOUN
ihlr-22950	564	129	;	;	PUNCT
ihlr-22950	564	130	and	and	CCONJ
ihlr-22950	564	131	“	"	PUNCT
ihlr-22950	564	132	(	(	PUNCT
ihlr-22950	564	133	c	c	NOUN
ihlr-22950	564	134	)	)	PUNCT
ihlr-22950	564	135	who	who	PRON
ihlr-22950	564	136	has	have	AUX
ihlr-22950	564	137	provided	provide	VERB
ihlr-22950	564	138	to	to	ADP
ihlr-22950	564	139	the	the	DET
ihlr-22950	564	140	treating	treat	VERB
ihlr-22950	564	141	physician	physician	NOUN
ihlr-22950	564	142	written	write	VERB
ihlr-22950	564	143	informed	inform	VERB
ihlr-22950	564	144	consent	consent	NOUN
ihlr-22950	564	145	regarding	regard	VERB
ihlr-22950	564	146	the	the	DET
ihlr-22950	564	147	eligible	eligible	ADJ
ihlr-22950	564	148	investigational	investigational	ADJ
ihlr-22950	564	149	drug	drug	NOUN
ihlr-22950	564	150	,	,	PUNCT
ihlr-22950	564	151	or	or	CCONJ
ihlr-22950	564	152	,	,	PUNCT
ihlr-22950	564	153	as	as	ADV
ihlr-22950	564	154	applicable	applicable	ADJ
ihlr-22950	564	155	,	,	PUNCT
ihlr-22950	564	156	on	on	ADP
ihlr-22950	564	157	whose	whose	DET
ihlr-22950	564	158	behalf	behalf	NOUN
ihlr-22950	564	159	a	a	DET
ihlr-22950	564	160	legally	legally	ADV
ihlr-22950	564	161	authorized	authorize	VERB
ihlr-22950	564	162	representative	representative	NOUN
ihlr-22950	564	163	of	of	ADP
ihlr-22950	564	164	the	the	DET
ihlr-22950	564	165	patient	patient	NOUN
ihlr-22950	564	166	has	have	AUX
ihlr-22950	564	167	provided	provide	VERB
ihlr-22950	564	168	such	such	ADJ
ihlr-22950	564	169	consent	consent	NOUN
ihlr-22950	564	170	;	;	PUNCT
ihlr-22950	564	171	“	"	PUNCT
ihlr-22950	564	172	(	(	PUNCT
ihlr-22950	564	173	2	2	X
ihlr-22950	564	174	)	)	PUNCT
ihlr-22950	564	175	the	the	DET
ihlr-22950	564	176	term	term	NOUN
ihlr-22950	564	177	‘	'	PUNCT
ihlr-22950	564	178	eligible	eligible	ADJ
ihlr-22950	564	179	investigational	investigational	ADJ
ihlr-22950	564	180	drug	drug	NOUN
ihlr-22950	564	181	’	'	PUNCT
ihlr-22950	564	182	means	mean	VERB
ihlr-22950	564	183	an	an	DET
ihlr-22950	564	184	investigational	investigational	ADJ
ihlr-22950	564	185	drug	drug	NOUN
ihlr-22950	564	186	(	(	PUNCT
ihlr-22950	564	187	as	as	SCONJ
ihlr-22950	564	188	such	such	ADJ
ihlr-22950	564	189	term	term	NOUN
ihlr-22950	564	190	is	be	AUX
ihlr-22950	564	191	used	use	VERB
ihlr-22950	564	192	in	in	ADP
ihlr-22950	564	193	section	section	NOUN
ihlr-22950	564	194	561	561	NUM
ihlr-22950	564	195	)	)	PUNCT
ihlr-22950	564	196	—	—	PUNCT
ihlr-22950	564	197	“	"	PUNCT
ihlr-22950	564	198	(	(	PUNCT
ihlr-22950	564	199	a	a	NOUN
ihlr-22950	564	200	)	)	PUNCT
ihlr-22950	564	201	for	for	ADP
ihlr-22950	564	202	which	which	PRON
ihlr-22950	564	203	a	a	DET
ihlr-22950	564	204	phase	phase	NOUN
ihlr-22950	564	205	1	1	NUM
ihlr-22950	564	206	clinical	clinical	ADJ
ihlr-22950	564	207	trial	trial	NOUN
ihlr-22950	564	208	has	have	AUX
ihlr-22950	564	209	been	be	AUX
ihlr-22950	564	210	completed	complete	VERB
ihlr-22950	564	211	;	;	PUNCT
ihlr-22950	564	212	“	"	PUNCT
ihlr-22950	564	213	(	(	PUNCT
ihlr-22950	564	214	b	b	X
ihlr-22950	564	215	)	)	PUNCT
ihlr-22950	564	216	that	that	PRON
ihlr-22950	564	217	has	have	AUX
ihlr-22950	564	218	not	not	PART
ihlr-22950	564	219	been	be	AUX
ihlr-22950	564	220	approved	approve	VERB
ihlr-22950	564	221	or	or	CCONJ
ihlr-22950	564	222	licensed	license	VERB
ihlr-22950	564	223	for	for	ADP
ihlr-22950	564	224	any	any	DET
ihlr-22950	564	225	use	use	NOUN
ihlr-22950	564	226	under	under	ADP
ihlr-22950	564	227	section	section	NOUN
ihlr-22950	564	228	505	505	NUM
ihlr-22950	564	229	of	of	ADP
ihlr-22950	564	230	this	this	DET
ihlr-22950	564	231	act	act	NOUN
ihlr-22950	564	232	or	or	CCONJ
ihlr-22950	564	233	section	section	NOUN
ihlr-22950	564	234	351	351	NUM
ihlr-22950	564	235	of	of	ADP
ihlr-22950	564	236	the	the	DET
ihlr-22950	564	237	public	public	ADJ
ihlr-22950	564	238	health	health	PROPN
ihlr-22950	564	239	service	service	PROPN
ihlr-22950	564	240	act	act	PROPN
ihlr-22950	564	241	;	;	PUNCT
ihlr-22950	564	242	“	"	PUNCT
ihlr-22950	564	243	(	(	PUNCT
ihlr-22950	564	244	c	c	X
ihlr-22950	564	245	)	)	PUNCT
ihlr-22950	564	246	(	(	PUNCT
ihlr-22950	564	247	i	i	NOUN
ihlr-22950	564	248	)	)	PUNCT
ihlr-22950	564	249	for	for	ADP
ihlr-22950	564	250	which	which	PRON
ihlr-22950	564	251	an	an	DET
ihlr-22950	564	252	application	application	NOUN
ihlr-22950	564	253	has	have	AUX
ihlr-22950	564	254	been	be	AUX
ihlr-22950	564	255	filed	file	VERB
ihlr-22950	564	256	under	under	ADP
ihlr-22950	564	257	section	section	NOUN
ihlr-22950	564	258	505(b	505(b	PROPN
ihlr-22950	564	259	)	)	PUNCT
ihlr-22950	564	260	of	of	ADP
ihlr-22950	564	261	this	this	DET
ihlr-22950	564	262	act	act	NOUN
ihlr-22950	564	263	or	or	CCONJ
ihlr-22950	564	264	section	section	NOUN
ihlr-22950	564	265	351(a	351(a	NUM
ihlr-22950	564	266	)	)	PUNCT
ihlr-22950	564	267	of	of	ADP
ihlr-22950	564	268	the	the	DET
ihlr-22950	564	269	public	public	ADJ
ihlr-22950	564	270	health	health	PROPN
ihlr-22950	564	271	service	service	PROPN
ihlr-22950	564	272	act	act	NOUN
ihlr-22950	564	273	;	;	PUNCT
ihlr-22950	564	274	or	or	CCONJ
ihlr-22950	564	275	“	"	PUNCT
ihlr-22950	564	276	(	(	PUNCT
ihlr-22950	564	277	ii	ii	NOUN
ihlr-22950	564	278	)	)	PUNCT
ihlr-22950	564	279	that	that	PRON
ihlr-22950	564	280	is	be	AUX
ihlr-22950	564	281	under	under	ADP
ihlr-22950	564	282	investigation	investigation	NOUN
ihlr-22950	564	283	in	in	ADP
ihlr-22950	564	284	a	a	DET
ihlr-22950	564	285	clinical	clinical	ADJ
ihlr-22950	564	286	trial	trial	NOUN
ihlr-22950	564	287	that	that	PRON
ihlr-22950	564	288	—	—	PUNCT
ihlr-22950	564	289	“	"	PUNCT
ihlr-22950	564	290	(	(	PUNCT
ihlr-22950	564	291	i	i	NOUN
ihlr-22950	564	292	)	)	PUNCT
ihlr-22950	564	293	is	be	AUX
ihlr-22950	564	294	intended	intend	VERB
ihlr-22950	564	295	to	to	PART
ihlr-22950	564	296	form	form	VERB
ihlr-22950	564	297	the	the	DET
ihlr-22950	564	298	primary	primary	ADJ
ihlr-22950	564	299	basis	basis	NOUN
ihlr-22950	564	300	of	of	ADP
ihlr-22950	564	301	a	a	DET
ihlr-22950	564	302	claim	claim	NOUN
ihlr-22950	564	303	of	of	ADP
ihlr-22950	564	304	effectiveness	effectiveness	NOUN
ihlr-22950	564	305	in	in	ADP
ihlr-22950	564	306	support	support	NOUN
ihlr-22950	564	307	of	of	ADP
ihlr-22950	564	308	approval	approval	NOUN
ihlr-22950	564	309	or	or	CCONJ
ihlr-22950	564	310	licensure	licensure	NOUN
ihlr-22950	564	311	under	under	ADP
ihlr-22950	564	312	section	section	NOUN
ihlr-22950	564	313	505	505	NUM
ihlr-22950	564	314	of	of	ADP
ihlr-22950	564	315	this	this	DET
ihlr-22950	564	316	act	act	NOUN
ihlr-22950	564	317	or	or	CCONJ
ihlr-22950	564	318	section	section	NOUN
ihlr-22950	564	319	351	351	NUM
ihlr-22950	564	320	of	of	ADP
ihlr-22950	564	321	the	the	DET
ihlr-22950	564	322	public	public	ADJ
ihlr-22950	564	323	health	health	PROPN
ihlr-22950	564	324	service	service	PROPN
ihlr-22950	564	325	act	act	NOUN
ihlr-22950	564	326	;	;	PUNCT
ihlr-22950	564	327	and	and	CCONJ
ihlr-22950	564	328	“	"	PUNCT
ihlr-22950	564	329	(	(	PUNCT
ihlr-22950	564	330	ii	ii	NOUN
ihlr-22950	564	331	)	)	PUNCT
ihlr-22950	564	332	is	be	AUX
ihlr-22950	564	333	the	the	DET
ihlr-22950	564	334	subject	subject	NOUN
ihlr-22950	564	335	of	of	ADP
ihlr-22950	564	336	an	an	DET
ihlr-22950	564	337	active	active	ADJ
ihlr-22950	564	338	investigational	investigational	ADJ
ihlr-22950	564	339	new	new	ADJ
ihlr-22950	564	340	drug	drug	NOUN
ihlr-22950	564	341	application	application	NOUN
ihlr-22950	564	342	under	under	ADP
ihlr-22950	564	343	section	section	NOUN
ihlr-22950	564	344	505(i	505(i	NUM
ihlr-22950	564	345	)	)	PUNCT
ihlr-22950	564	346	of	of	ADP
ihlr-22950	564	347	this	this	DET
ihlr-22950	564	348	act	act	NOUN
ihlr-22950	564	349	or	or	CCONJ
ihlr-22950	564	350	section	section	NOUN
ihlr-22950	564	351	351(a)(3	351(a)(3	NUM
ihlr-22950	564	352	)	)	PUNCT
ihlr-22950	564	353	of	of	ADP
ihlr-22950	564	354	the	the	DET
ihlr-22950	564	355	public	public	ADJ
ihlr-22950	564	356	health	health	PROPN
ihlr-22950	564	357	service	service	PROPN
ihlr-22950	564	358	act	act	PROPN
ihlr-22950	564	359	,	,	PUNCT
ihlr-22950	564	360	as	as	ADV
ihlr-22950	564	361	applicable	applicable	ADJ
ihlr-22950	564	362	;	;	PUNCT
ihlr-22950	564	363	and	and	CCONJ
ihlr-22950	564	364	126	126	NUM
ihlr-22950	564	365	indiana	indiana	PROPN
ihlr-22950	564	366	health	health	PROPN
ihlr-22950	564	367	law	law	PROPN
ihlr-22950	564	368	review	review	NOUN
ihlr-22950	565	1	[	[	X
ihlr-22950	565	2	vol	vol	NOUN
ihlr-22950	565	3	.	.	PUNCT
ihlr-22950	566	1	16:101	16:101	NUM
ihlr-22950	566	2	“	"	PUNCT
ihlr-22950	566	3	(	(	PUNCT
ihlr-22950	566	4	d	d	X
ihlr-22950	566	5	)	)	PUNCT
ihlr-22950	566	6	the	the	DET
ihlr-22950	566	7	active	active	ADJ
ihlr-22950	566	8	development	development	NOUN
ihlr-22950	566	9	or	or	CCONJ
ihlr-22950	566	10	production	production	NOUN
ihlr-22950	566	11	of	of	ADP
ihlr-22950	566	12	which	which	PRON
ihlr-22950	566	13	is	be	AUX
ihlr-22950	566	14	ongoing	ongoing	ADJ
ihlr-22950	566	15	and	and	CCONJ
ihlr-22950	566	16	has	have	AUX
ihlr-22950	566	17	not	not	PART
ihlr-22950	566	18	been	be	AUX
ihlr-22950	566	19	discontinued	discontinue	VERB
ihlr-22950	566	20	by	by	ADP
ihlr-22950	566	21	the	the	DET
ihlr-22950	566	22	manufacturer	manufacturer	NOUN
ihlr-22950	566	23	or	or	CCONJ
ihlr-22950	566	24	placed	place	VERB
ihlr-22950	566	25	on	on	ADP
ihlr-22950	566	26	clinical	clinical	ADJ
ihlr-22950	566	27	hold	hold	NOUN
ihlr-22950	566	28	under	under	ADP
ihlr-22950	566	29	section	section	NOUN
ihlr-22950	566	30	505(i	505(i	PROPN
ihlr-22950	566	31	)	)	PUNCT
ihlr-22950	566	32	;	;	PUNCT
ihlr-22950	566	33	and	and	CCONJ
ihlr-22950	566	34	“	"	PUNCT
ihlr-22950	566	35	(	(	PUNCT
ihlr-22950	566	36	3	3	X
ihlr-22950	566	37	)	)	PUNCT
ihlr-22950	566	38	the	the	DET
ihlr-22950	566	39	term	term	NOUN
ihlr-22950	566	40	‘	'	PUNCT
ihlr-22950	566	41	phase	phase	NOUN
ihlr-22950	566	42	1	1	NUM
ihlr-22950	566	43	trial	trial	NOUN
ihlr-22950	566	44	’	'	PUNCT
ihlr-22950	566	45	means	mean	VERB
ihlr-22950	566	46	a	a	DET
ihlr-22950	566	47	phase	phase	NOUN
ihlr-22950	566	48	1	1	NUM
ihlr-22950	566	49	clinical	clinical	ADJ
ihlr-22950	566	50	investigation	investigation	NOUN
ihlr-22950	566	51	of	of	ADP
ihlr-22950	566	52	a	a	DET
ihlr-22950	566	53	drug	drug	NOUN
ihlr-22950	566	54	as	as	SCONJ
ihlr-22950	566	55	described	describe	VERB
ihlr-22950	566	56	in	in	ADP
ihlr-22950	566	57	section	section	NOUN
ihlr-22950	566	58	312.21	312.21	NUM
ihlr-22950	566	59	of	of	ADP
ihlr-22950	566	60	title	title	NOUN
ihlr-22950	566	61	21	21	NUM
ihlr-22950	566	62	,	,	PUNCT
ihlr-22950	566	63	code	code	NOUN
ihlr-22950	566	64	of	of	ADP
ihlr-22950	566	65	federal	federal	ADJ
ihlr-22950	566	66	regulations	regulation	NOUN
ihlr-22950	566	67	(	(	PUNCT
ihlr-22950	566	68	or	or	CCONJ
ihlr-22950	566	69	any	any	DET
ihlr-22950	566	70	successor	successor	NOUN
ihlr-22950	566	71	regulations	regulation	NOUN
ihlr-22950	566	72	)	)	PUNCT
ihlr-22950	566	73	.	.	PUNCT
ihlr-22950	567	1	“	"	PUNCT
ihlr-22950	567	2	(	(	PUNCT
ihlr-22950	567	3	b	b	X
ihlr-22950	567	4	)	)	PUNCT
ihlr-22950	567	5	exemptions.—eligible	exemptions.—eligible	ADJ
ihlr-22950	567	6	investigational	investigational	ADJ
ihlr-22950	567	7	drugs	drug	NOUN
ihlr-22950	567	8	provided	provide	VERB
ihlr-22950	567	9	to	to	ADP
ihlr-22950	567	10	eligible	eligible	ADJ
ihlr-22950	567	11	patients	patient	NOUN
ihlr-22950	567	12	in	in	ADP
ihlr-22950	567	13	compliance	compliance	NOUN
ihlr-22950	567	14	with	with	ADP
ihlr-22950	567	15	this	this	DET
ihlr-22950	567	16	section	section	NOUN
ihlr-22950	567	17	are	be	AUX
ihlr-22950	567	18	exempt	exempt	ADJ
ihlr-22950	567	19	from	from	ADP
ihlr-22950	567	20	sections	section	NOUN
ihlr-22950	567	21	502(f	502(f	PROPN
ihlr-22950	567	22	)	)	PUNCT
ihlr-22950	567	23	,	,	PUNCT
ihlr-22950	567	24	503(b)(4	503(b)(4	NUM
ihlr-22950	567	25	)	)	PUNCT
ihlr-22950	567	26	,	,	PUNCT
ihlr-22950	567	27	505(a	505(a	NOUN
ihlr-22950	567	28	)	)	PUNCT
ihlr-22950	567	29	,	,	PUNCT
ihlr-22950	567	30	and	and	CCONJ
ihlr-22950	567	31	505(i	505(i	NUM
ihlr-22950	567	32	)	)	PUNCT
ihlr-22950	567	33	of	of	ADP
ihlr-22950	567	34	this	this	DET
ihlr-22950	567	35	act	act	NOUN
ihlr-22950	567	36	,	,	PUNCT
ihlr-22950	567	37	section	section	NOUN
ihlr-22950	567	38	351(a	351(a	NUM
ihlr-22950	567	39	)	)	PUNCT
ihlr-22950	567	40	of	of	ADP
ihlr-22950	567	41	the	the	DET
ihlr-22950	567	42	public	public	ADJ
ihlr-22950	567	43	health	health	PROPN
ihlr-22950	567	44	service	service	PROPN
ihlr-22950	567	45	act	act	PROPN
ihlr-22950	567	46	,	,	PUNCT
ihlr-22950	567	47	and	and	CCONJ
ihlr-22950	567	48	parts	part	NOUN
ihlr-22950	567	49	50	50	NUM
ihlr-22950	567	50	,	,	PUNCT
ihlr-22950	567	51	56	56	NUM
ihlr-22950	567	52	,	,	PUNCT
ihlr-22950	567	53	and	and	CCONJ
ihlr-22950	567	54	312	312	NUM
ihlr-22950	567	55	of	of	ADP
ihlr-22950	567	56	title	title	NOUN
ihlr-22950	567	57	21	21	NUM
ihlr-22950	567	58	,	,	PUNCT
ihlr-22950	567	59	code	code	NOUN
ihlr-22950	567	60	of	of	ADP
ihlr-22950	567	61	federal	federal	ADJ
ihlr-22950	567	62	regulations	regulation	NOUN
ihlr-22950	567	63	(	(	PUNCT
ihlr-22950	567	64	or	or	CCONJ
ihlr-22950	567	65	any	any	DET
ihlr-22950	567	66	successor	successor	NOUN
ihlr-22950	567	67	regulations	regulation	NOUN
ihlr-22950	567	68	)	)	PUNCT
ihlr-22950	567	69	,	,	PUNCT
ihlr-22950	567	70	provided	provide	VERB
ihlr-22950	567	71	that	that	SCONJ
ihlr-22950	567	72	the	the	DET
ihlr-22950	567	73	sponsor	sponsor	NOUN
ihlr-22950	567	74	of	of	ADP
ihlr-22950	567	75	such	such	ADJ
ihlr-22950	567	76	eligible	eligible	ADJ
ihlr-22950	567	77	investigational	investigational	ADJ
ihlr-22950	567	78	drug	drug	NOUN
ihlr-22950	567	79	or	or	CCONJ
ihlr-22950	567	80	any	any	DET
ihlr-22950	567	81	person	person	NOUN
ihlr-22950	567	82	who	who	PRON
ihlr-22950	567	83	manufactures	manufacture	VERB
ihlr-22950	567	84	,	,	PUNCT
ihlr-22950	567	85	distributes	distribute	VERB
ihlr-22950	567	86	,	,	PUNCT
ihlr-22950	567	87	prescribes	prescribe	VERB
ihlr-22950	567	88	,	,	PUNCT
ihlr-22950	567	89	dispenses	dispense	NOUN
ihlr-22950	567	90	,	,	PUNCT
ihlr-22950	567	91	introduces	introduce	NOUN
ihlr-22950	567	92	or	or	CCONJ
ihlr-22950	567	93	delivers	deliver	VERB
ihlr-22950	567	94	for	for	ADP
ihlr-22950	567	95	introduction	introduction	NOUN
ihlr-22950	567	96	into	into	ADP
ihlr-22950	567	97	interstate	interstate	PROPN
ihlr-22950	567	98	commerce	commerce	NOUN
ihlr-22950	567	99	,	,	PUNCT
ihlr-22950	567	100	or	or	CCONJ
ihlr-22950	567	101	provides	provide	VERB
ihlr-22950	567	102	to	to	ADP
ihlr-22950	567	103	an	an	DET
ihlr-22950	567	104	eligible	eligible	ADJ
ihlr-22950	567	105	patient	patient	NOUN
ihlr-22950	567	106	an	an	DET
ihlr-22950	567	107	eligible	eligible	ADJ
ihlr-22950	567	108	investigational	investigational	ADJ
ihlr-22950	567	109	drug	drug	NOUN
ihlr-22950	567	110	pursuant	pursuant	ADJ
ihlr-22950	567	111	to	to	ADP
ihlr-22950	567	112	this	this	DET
ihlr-22950	567	113	section	section	NOUN
ihlr-22950	567	114	is	be	AUX
ihlr-22950	567	115	in	in	ADP
ihlr-22950	567	116	compliance	compliance	NOUN
ihlr-22950	567	117	with	with	ADP
ihlr-22950	567	118	the	the	DET
ihlr-22950	567	119	applicable	applicable	ADJ
ihlr-22950	567	120	requirements	requirement	NOUN
ihlr-22950	567	121	set	set	VERB
ihlr-22950	567	122	forth	forth	ADP
ihlr-22950	567	123	in	in	ADP
ihlr-22950	567	124	sections	section	NOUN
ihlr-22950	567	125	312.6	312.6	NUM
ihlr-22950	567	126	,	,	PUNCT
ihlr-22950	567	127	312.7	312.7	NUM
ihlr-22950	567	128	,	,	PUNCT
ihlr-22950	567	129	and	and	CCONJ
ihlr-22950	567	130	312.8(d)(1	312.8(d)(1	NUM
ihlr-22950	567	131	)	)	PUNCT
ihlr-22950	567	132	of	of	ADP
ihlr-22950	567	133	title	title	NOUN
ihlr-22950	567	134	21	21	NUM
ihlr-22950	567	135	,	,	PUNCT
ihlr-22950	567	136	code	code	NOUN
ihlr-22950	567	137	of	of	ADP
ihlr-22950	567	138	federal	federal	ADJ
ihlr-22950	567	139	regulations	regulation	NOUN
ihlr-22950	567	140	(	(	PUNCT
ihlr-22950	567	141	or	or	CCONJ
ihlr-22950	567	142	any	any	DET
ihlr-22950	567	143	successor	successor	NOUN
ihlr-22950	567	144	regulations	regulation	NOUN
ihlr-22950	567	145	)	)	PUNCT
ihlr-22950	567	146	that	that	PRON
ihlr-22950	567	147	apply	apply	VERB
ihlr-22950	567	148	to	to	ADP
ihlr-22950	567	149	investigational	investigational	ADJ
ihlr-22950	567	150	drugs	drug	NOUN
ihlr-22950	567	151	.	.	PUNCT
ihlr-22950	568	1	“	"	PUNCT
ihlr-22950	568	2	(	(	PUNCT
ihlr-22950	568	3	c	c	X
ihlr-22950	568	4	)	)	PUNCT
ihlr-22950	568	5	use	use	NOUN
ihlr-22950	568	6	of	of	ADP
ihlr-22950	568	7	clinical	clinical	ADJ
ihlr-22950	568	8	outcomes	outcome	NOUN
ihlr-22950	568	9	.	.	PUNCT
ihlr-22950	568	10	—	—	PUNCT
ihlr-22950	568	11	“	"	PUNCT
ihlr-22950	568	12	(	(	PUNCT
ihlr-22950	568	13	1	1	X
ihlr-22950	568	14	)	)	PUNCT
ihlr-22950	568	15	in	in	ADP
ihlr-22950	568	16	general.—notwithstanding	general.—notwithstande	VERB
ihlr-22950	568	17	any	any	DET
ihlr-22950	568	18	other	other	ADJ
ihlr-22950	568	19	provision	provision	NOUN
ihlr-22950	568	20	of	of	ADP
ihlr-22950	568	21	this	this	DET
ihlr-22950	568	22	act	act	NOUN
ihlr-22950	568	23	,	,	PUNCT
ihlr-22950	568	24	the	the	DET
ihlr-22950	568	25	public	public	ADJ
ihlr-22950	568	26	health	health	PROPN
ihlr-22950	568	27	service	service	PROPN
ihlr-22950	568	28	act	act	PROPN
ihlr-22950	568	29	,	,	PUNCT
ihlr-22950	568	30	or	or	CCONJ
ihlr-22950	568	31	any	any	DET
ihlr-22950	568	32	other	other	ADJ
ihlr-22950	568	33	provision	provision	NOUN
ihlr-22950	568	34	of	of	ADP
ihlr-22950	568	35	federal	federal	ADJ
ihlr-22950	568	36	law	law	NOUN
ihlr-22950	568	37	,	,	PUNCT
ihlr-22950	568	38	the	the	DET
ihlr-22950	568	39	secretary	secretary	NOUN
ihlr-22950	568	40	may	may	AUX
ihlr-22950	568	41	not	not	PART
ihlr-22950	568	42	use	use	VERB
ihlr-22950	568	43	a	a	DET
ihlr-22950	568	44	clinical	clinical	ADJ
ihlr-22950	568	45	outcome	outcome	NOUN
ihlr-22950	568	46	associated	associate	VERB
ihlr-22950	568	47	with	with	ADP
ihlr-22950	568	48	the	the	DET
ihlr-22950	568	49	use	use	NOUN
ihlr-22950	568	50	of	of	ADP
ihlr-22950	568	51	an	an	DET
ihlr-22950	568	52	eligible	eligible	ADJ
ihlr-22950	568	53	investigational	investigational	ADJ
ihlr-22950	568	54	drug	drug	NOUN
ihlr-22950	568	55	pursuant	pursuant	ADJ
ihlr-22950	568	56	to	to	ADP
ihlr-22950	568	57	this	this	DET
ihlr-22950	568	58	section	section	NOUN
ihlr-22950	568	59	to	to	PART
ihlr-22950	568	60	delay	delay	VERB
ihlr-22950	568	61	or	or	CCONJ
ihlr-22950	568	62	adversely	adversely	ADV
ihlr-22950	568	63	affect	affect	VERB
ihlr-22950	568	64	the	the	DET
ihlr-22950	568	65	review	review	NOUN
ihlr-22950	568	66	or	or	CCONJ
ihlr-22950	568	67	approval	approval	NOUN
ihlr-22950	568	68	of	of	ADP
ihlr-22950	568	69	such	such	ADJ
ihlr-22950	568	70	drug	drug	NOUN
ihlr-22950	568	71	under	under	ADP
ihlr-22950	568	72	section	section	NOUN
ihlr-22950	568	73	505	505	NUM
ihlr-22950	568	74	of	of	ADP
ihlr-22950	568	75	this	this	DET
ihlr-22950	568	76	act	act	NOUN
ihlr-22950	568	77	or	or	CCONJ
ihlr-22950	568	78	section	section	NOUN
ihlr-22950	568	79	351	351	NUM
ihlr-22950	568	80	of	of	ADP
ihlr-22950	568	81	the	the	DET
ihlr-22950	568	82	public	public	ADJ
ihlr-22950	568	83	health	health	PROPN
ihlr-22950	568	84	service	service	PROPN
ihlr-22950	568	85	act	act	NOUN
ihlr-22950	568	86	unless	unless	SCONJ
ihlr-22950	568	87	—	—	PUNCT
ihlr-22950	568	88	“	"	PUNCT
ihlr-22950	568	89	(	(	PUNCT
ihlr-22950	568	90	a	a	X
ihlr-22950	568	91	)	)	PUNCT
ihlr-22950	568	92	the	the	DET
ihlr-22950	568	93	secretary	secretary	NOUN
ihlr-22950	568	94	makes	make	VERB
ihlr-22950	568	95	a	a	DET
ihlr-22950	568	96	determination	determination	NOUN
ihlr-22950	568	97	,	,	PUNCT
ihlr-22950	568	98	in	in	ADP
ihlr-22950	568	99	accordance	accordance	NOUN
ihlr-22950	568	100	with	with	ADP
ihlr-22950	568	101	paragraph	paragraph	NOUN
ihlr-22950	568	102	(	(	PUNCT
ihlr-22950	568	103	2	2	NUM
ihlr-22950	568	104	)	)	PUNCT
ihlr-22950	568	105	,	,	PUNCT
ihlr-22950	568	106	that	that	DET
ihlr-22950	568	107	use	use	NOUN
ihlr-22950	568	108	of	of	ADP
ihlr-22950	568	109	such	such	ADJ
ihlr-22950	568	110	clinical	clinical	ADJ
ihlr-22950	568	111	outcome	outcome	NOUN
ihlr-22950	568	112	is	be	AUX
ihlr-22950	568	113	critical	critical	ADJ
ihlr-22950	568	114	to	to	ADP
ihlr-22950	568	115	determining	determine	VERB
ihlr-22950	568	116	the	the	DET
ihlr-22950	568	117	safety	safety	NOUN
ihlr-22950	568	118	of	of	ADP
ihlr-22950	568	119	the	the	DET
ihlr-22950	568	120	eligible	eligible	ADJ
ihlr-22950	568	121	investigational	investigational	ADJ
ihlr-22950	568	122	drug	drug	NOUN
ihlr-22950	568	123	;	;	PUNCT
ihlr-22950	568	124	or	or	CCONJ
ihlr-22950	568	125	“	"	PUNCT
ihlr-22950	568	126	(	(	PUNCT
ihlr-22950	568	127	b	b	X
ihlr-22950	568	128	)	)	PUNCT
ihlr-22950	568	129	the	the	DET
ihlr-22950	568	130	sponsor	sponsor	NOUN
ihlr-22950	568	131	requests	request	VERB
ihlr-22950	568	132	use	use	NOUN
ihlr-22950	568	133	of	of	ADP
ihlr-22950	568	134	such	such	ADJ
ihlr-22950	568	135	outcomes	outcome	NOUN
ihlr-22950	568	136	.	.	PUNCT
ihlr-22950	569	1	“	"	PUNCT
ihlr-22950	569	2	(	(	PUNCT
ihlr-22950	569	3	2	2	X
ihlr-22950	569	4	)	)	PUNCT
ihlr-22950	569	5	limitation.—if	limitation.—if	VERB
ihlr-22950	569	6	the	the	DET
ihlr-22950	569	7	secretary	secretary	NOUN
ihlr-22950	569	8	makes	make	VERB
ihlr-22950	569	9	a	a	DET
ihlr-22950	569	10	determination	determination	NOUN
ihlr-22950	569	11	under	under	ADP
ihlr-22950	569	12	paragraph	paragraph	NOUN
ihlr-22950	569	13	(	(	PUNCT
ihlr-22950	569	14	1)(a	1)(a	NUM
ihlr-22950	569	15	)	)	PUNCT
ihlr-22950	569	16	,	,	PUNCT
ihlr-22950	569	17	the	the	DET
ihlr-22950	569	18	secretary	secretary	NOUN
ihlr-22950	569	19	shall	shall	AUX
ihlr-22950	569	20	provide	provide	VERB
ihlr-22950	569	21	written	write	VERB
ihlr-22950	569	22	notice	notice	NOUN
ihlr-22950	569	23	of	of	ADP
ihlr-22950	569	24	such	such	ADJ
ihlr-22950	569	25	determination	determination	NOUN
ihlr-22950	569	26	to	to	ADP
ihlr-22950	569	27	the	the	DET
ihlr-22950	569	28	sponsor	sponsor	NOUN
ihlr-22950	569	29	,	,	PUNCT
ihlr-22950	569	30	including	include	VERB
ihlr-22950	569	31	a	a	DET
ihlr-22950	569	32	public	public	ADJ
ihlr-22950	569	33	health	health	NOUN
ihlr-22950	569	34	justification	justification	NOUN
ihlr-22950	569	35	for	for	ADP
ihlr-22950	569	36	such	such	ADJ
ihlr-22950	569	37	determination	determination	NOUN
ihlr-22950	569	38	,	,	PUNCT
ihlr-22950	569	39	and	and	CCONJ
ihlr-22950	569	40	such	such	ADJ
ihlr-22950	569	41	notice	notice	NOUN
ihlr-22950	569	42	shall	shall	AUX
ihlr-22950	569	43	be	be	AUX
ihlr-22950	569	44	made	make	VERB
ihlr-22950	569	45	part	part	NOUN
ihlr-22950	569	46	of	of	ADP
ihlr-22950	569	47	the	the	DET
ihlr-22950	569	48	administrative	administrative	ADJ
ihlr-22950	569	49	record	record	NOUN
ihlr-22950	569	50	.	.	PUNCT
ihlr-22950	570	1	such	such	ADJ
ihlr-22950	570	2	determination	determination	NOUN
ihlr-22950	570	3	shall	shall	AUX
ihlr-22950	570	4	not	not	PART
ihlr-22950	570	5	be	be	AUX
ihlr-22950	570	6	delegated	delegate	VERB
ihlr-22950	570	7	below	below	ADP
ihlr-22950	570	8	the	the	DET
ihlr-22950	570	9	director	director	NOUN
ihlr-22950	570	10	of	of	ADP
ihlr-22950	570	11	the	the	DET
ihlr-22950	570	12	agency	agency	NOUN
ihlr-22950	570	13	center	center	NOUN
ihlr-22950	570	14	that	that	PRON
ihlr-22950	570	15	is	be	AUX
ihlr-22950	570	16	charged	charge	VERB
ihlr-22950	570	17	with	with	ADP
ihlr-22950	570	18	the	the	DET
ihlr-22950	570	19	premarket	premarket	NOUN
ihlr-22950	570	20	review	review	NOUN
ihlr-22950	570	21	of	of	ADP
ihlr-22950	570	22	the	the	DET
ihlr-22950	570	23	eligible	eligible	ADJ
ihlr-22950	570	24	investigational	investigational	ADJ
ihlr-22950	570	25	drug	drug	NOUN
ihlr-22950	570	26	.	.	PUNCT
ihlr-22950	571	1	“	"	PUNCT
ihlr-22950	571	2	(	(	PUNCT
ihlr-22950	571	3	d	d	NOUN
ihlr-22950	571	4	)	)	PUNCT
ihlr-22950	571	5	reporting	reporting	NOUN
ihlr-22950	571	6	.	.	PUNCT
ihlr-22950	571	7	—	—	PUNCT
ihlr-22950	571	8	“	"	PUNCT
ihlr-22950	571	9	(	(	PUNCT
ihlr-22950	571	10	1	1	NUM
ihlr-22950	571	11	)	)	PUNCT
ihlr-22950	571	12	in	in	ADP
ihlr-22950	571	13	general.—the	general.—the	DET
ihlr-22950	571	14	manufacturer	manufacturer	NOUN
ihlr-22950	571	15	or	or	CCONJ
ihlr-22950	571	16	sponsor	sponsor	NOUN
ihlr-22950	571	17	of	of	ADP
ihlr-22950	571	18	an	an	DET
ihlr-22950	571	19	eligible	eligible	ADJ
ihlr-22950	571	20	investigational	investigational	ADJ
ihlr-22950	571	21	drug	drug	NOUN
ihlr-22950	571	22	shall	shall	AUX
ihlr-22950	571	23	submit	submit	VERB
ihlr-22950	571	24	to	to	ADP
ihlr-22950	571	25	the	the	DET
ihlr-22950	571	26	secretary	secretary	NOUN
ihlr-22950	571	27	an	an	DET
ihlr-22950	571	28	annual	annual	ADJ
ihlr-22950	571	29	summary	summary	NOUN
ihlr-22950	571	30	of	of	ADP
ihlr-22950	571	31	any	any	DET
ihlr-22950	571	32	use	use	NOUN
ihlr-22950	571	33	of	of	ADP
ihlr-22950	571	34	such	such	ADJ
ihlr-22950	571	35	drug	drug	NOUN
ihlr-22950	571	36	under	under	ADP
ihlr-22950	571	37	this	this	DET
ihlr-22950	571	38	section	section	NOUN
ihlr-22950	571	39	.	.	PUNCT
ihlr-22950	572	1	the	the	DET
ihlr-22950	572	2	summary	summary	NOUN
ihlr-22950	572	3	shall	shall	AUX
ihlr-22950	572	4	include	include	VERB
ihlr-22950	572	5	the	the	DET
ihlr-22950	572	6	number	number	NOUN
ihlr-22950	572	7	of	of	ADP
ihlr-22950	572	8	doses	dose	NOUN
ihlr-22950	572	9	supplied	supply	VERB
ihlr-22950	572	10	,	,	PUNCT
ihlr-22950	572	11	the	the	DET
ihlr-22950	572	12	2018	2018	NUM
ihlr-22950	572	13	]	]	PUNCT
ihlr-22950	572	14	the	the	DET
ihlr-22950	572	15	latest	late	ADJ
ihlr-22950	572	16	“	"	PUNCT
ihlr-22950	572	17	federal	federal	ADJ
ihlr-22950	572	18	movement	movement	NOUN
ihlr-22950	572	19	”	"	PUNCT
ihlr-22950	572	20	in	in	ADP
ihlr-22950	572	21	the	the	DET
ihlr-22950	572	22	food	food	NOUN
ihlr-22950	572	23	and	and	CCONJ
ihlr-22950	572	24	drug	drug	NOUN
ihlr-22950	572	25	law	law	NOUN
ihlr-22950	572	26	arena	arena	NOUN
ihlr-22950	572	27	127	127	NUM
ihlr-22950	572	28	number	number	NOUN
ihlr-22950	572	29	of	of	ADP
ihlr-22950	572	30	patients	patient	NOUN
ihlr-22950	572	31	treated	treat	VERB
ihlr-22950	572	32	,	,	PUNCT
ihlr-22950	572	33	the	the	DET
ihlr-22950	572	34	uses	use	NOUN
ihlr-22950	572	35	for	for	ADP
ihlr-22950	572	36	which	which	PRON
ihlr-22950	572	37	the	the	DET
ihlr-22950	572	38	drug	drug	NOUN
ihlr-22950	572	39	was	be	AUX
ihlr-22950	572	40	made	make	VERB
ihlr-22950	572	41	available	available	ADJ
ihlr-22950	572	42	,	,	PUNCT
ihlr-22950	572	43	and	and	CCONJ
ihlr-22950	572	44	any	any	DET
ihlr-22950	572	45	known	know	VERB
ihlr-22950	572	46	serious	serious	ADJ
ihlr-22950	572	47	adverse	adverse	ADJ
ihlr-22950	572	48	events	event	NOUN
ihlr-22950	572	49	.	.	PUNCT
ihlr-22950	573	1	the	the	DET
ihlr-22950	573	2	secretary	secretary	NOUN
ihlr-22950	573	3	shall	shall	AUX
ihlr-22950	573	4	specify	specify	VERB
ihlr-22950	573	5	by	by	ADP
ihlr-22950	573	6	regulation	regulation	NOUN
ihlr-22950	573	7	the	the	DET
ihlr-22950	573	8	deadline	deadline	NOUN
ihlr-22950	573	9	of	of	ADP
ihlr-22950	573	10	submission	submission	NOUN
ihlr-22950	573	11	of	of	ADP
ihlr-22950	573	12	such	such	ADJ
ihlr-22950	573	13	annual	annual	ADJ
ihlr-22950	573	14	summary	summary	NOUN
ihlr-22950	573	15	and	and	CCONJ
ihlr-22950	573	16	may	may	AUX
ihlr-22950	573	17	amend	amend	VERB
ihlr-22950	573	18	section	section	NOUN
ihlr-22950	573	19	312.33	312.33	NUM
ihlr-22950	573	20	of	of	ADP
ihlr-22950	573	21	title	title	NOUN
ihlr-22950	573	22	21	21	NUM
ihlr-22950	573	23	,	,	PUNCT
ihlr-22950	573	24	code	code	NOUN
ihlr-22950	573	25	of	of	ADP
ihlr-22950	573	26	federal	federal	ADJ
ihlr-22950	573	27	regulations	regulation	NOUN
ihlr-22950	573	28	(	(	PUNCT
ihlr-22950	573	29	or	or	CCONJ
ihlr-22950	573	30	any	any	DET
ihlr-22950	573	31	successor	successor	NOUN
ihlr-22950	573	32	regulations	regulation	NOUN
ihlr-22950	573	33	)	)	PUNCT
ihlr-22950	573	34	to	to	PART
ihlr-22950	573	35	require	require	VERB
ihlr-22950	573	36	the	the	DET
ihlr-22950	573	37	submission	submission	NOUN
ihlr-22950	573	38	of	of	ADP
ihlr-22950	573	39	such	such	ADJ
ihlr-22950	573	40	annual	annual	ADJ
ihlr-22950	573	41	summary	summary	NOUN
ihlr-22950	573	42	in	in	ADP
ihlr-22950	573	43	conjunction	conjunction	NOUN
ihlr-22950	573	44	with	with	ADP
ihlr-22950	573	45	the	the	DET
ihlr-22950	573	46	annual	annual	ADJ
ihlr-22950	573	47	report	report	NOUN
ihlr-22950	573	48	for	for	ADP
ihlr-22950	573	49	an	an	DET
ihlr-22950	573	50	applicable	applicable	ADJ
ihlr-22950	573	51	investigational	investigational	ADJ
ihlr-22950	573	52	new	new	ADJ
ihlr-22950	573	53	drug	drug	NOUN
ihlr-22950	573	54	application	application	NOUN
ihlr-22950	573	55	for	for	ADP
ihlr-22950	573	56	such	such	ADJ
ihlr-22950	573	57	drug	drug	NOUN
ihlr-22950	573	58	.	.	PUNCT
ihlr-22950	574	1	“	"	PUNCT
ihlr-22950	574	2	(	(	PUNCT
ihlr-22950	574	3	2	2	X
ihlr-22950	574	4	)	)	PUNCT
ihlr-22950	574	5	posting	posting	NOUN
ihlr-22950	574	6	of	of	ADP
ihlr-22950	574	7	information.—the	information.—the	DET
ihlr-22950	574	8	secretary	secretary	NOUN
ihlr-22950	574	9	shall	shall	AUX
ihlr-22950	574	10	post	post	VERB
ihlr-22950	574	11	an	an	DET
ihlr-22950	574	12	annual	annual	ADJ
ihlr-22950	574	13	summary	summary	NOUN
ihlr-22950	574	14	report	report	NOUN
ihlr-22950	574	15	of	of	ADP
ihlr-22950	574	16	the	the	DET
ihlr-22950	574	17	use	use	NOUN
ihlr-22950	574	18	of	of	ADP
ihlr-22950	574	19	this	this	DET
ihlr-22950	574	20	section	section	NOUN
ihlr-22950	574	21	on	on	ADP
ihlr-22950	574	22	the	the	DET
ihlr-22950	574	23	internet	internet	NOUN
ihlr-22950	574	24	website	website	NOUN
ihlr-22950	574	25	of	of	ADP
ihlr-22950	574	26	the	the	DET
ihlr-22950	574	27	food	food	NOUN
ihlr-22950	574	28	and	and	CCONJ
ihlr-22950	574	29	drug	drug	NOUN
ihlr-22950	574	30	administration	administration	NOUN
ihlr-22950	574	31	,	,	PUNCT
ihlr-22950	574	32	including	include	VERB
ihlr-22950	574	33	the	the	DET
ihlr-22950	574	34	number	number	NOUN
ihlr-22950	574	35	of	of	ADP
ihlr-22950	574	36	drugs	drug	NOUN
ihlr-22950	574	37	for	for	ADP
ihlr-22950	574	38	which	which	PRON
ihlr-22950	574	39	clinical	clinical	ADJ
ihlr-22950	574	40	outcomes	outcome	NOUN
ihlr-22950	574	41	associated	associate	VERB
ihlr-22950	574	42	with	with	ADP
ihlr-22950	574	43	the	the	DET
ihlr-22950	574	44	use	use	NOUN
ihlr-22950	574	45	of	of	ADP
ihlr-22950	574	46	an	an	DET
ihlr-22950	574	47	eligible	eligible	ADJ
ihlr-22950	574	48	investigational	investigational	ADJ
ihlr-22950	574	49	drug	drug	NOUN
ihlr-22950	574	50	pursuant	pursuant	ADJ
ihlr-22950	574	51	to	to	ADP
ihlr-22950	574	52	this	this	DET
ihlr-22950	574	53	section	section	NOUN
ihlr-22950	574	54	was	be	AUX
ihlr-22950	574	55	—	—	PUNCT
ihlr-22950	574	56	“	"	PUNCT
ihlr-22950	574	57	(	(	PUNCT
ihlr-22950	574	58	a	a	X
ihlr-22950	574	59	)	)	PUNCT
ihlr-22950	574	60	used	use	VERB
ihlr-22950	574	61	in	in	ADP
ihlr-22950	574	62	accordance	accordance	NOUN
ihlr-22950	574	63	with	with	ADP
ihlr-22950	574	64	subsection	subsection	NOUN
ihlr-22950	574	65	(	(	PUNCT
ihlr-22950	574	66	c)(1)(a	c)(1)(a	PROPN
ihlr-22950	574	67	)	)	PUNCT
ihlr-22950	574	68	;	;	PUNCT
ihlr-22950	574	69	“	"	PUNCT
ihlr-22950	574	70	(	(	PUNCT
ihlr-22950	574	71	b	b	NOUN
ihlr-22950	574	72	)	)	PUNCT
ihlr-22950	574	73	used	use	VERB
ihlr-22950	574	74	in	in	ADP
ihlr-22950	574	75	accordance	accordance	NOUN
ihlr-22950	574	76	with	with	ADP
ihlr-22950	574	77	subsection	subsection	NOUN
ihlr-22950	574	78	(	(	PUNCT
ihlr-22950	574	79	c)(1)(b	c)(1)(b	NUM
ihlr-22950	574	80	)	)	PUNCT
ihlr-22950	574	81	;	;	PUNCT
ihlr-22950	574	82	and	and	CCONJ
ihlr-22950	574	83	“	"	PUNCT
ihlr-22950	574	84	(	(	PUNCT
ihlr-22950	574	85	c	c	X
ihlr-22950	574	86	)	)	PUNCT
ihlr-22950	574	87	not	not	PART
ihlr-22950	574	88	used	use	VERB
ihlr-22950	574	89	in	in	ADP
ihlr-22950	574	90	the	the	DET
ihlr-22950	574	91	review	review	NOUN
ihlr-22950	574	92	of	of	ADP
ihlr-22950	574	93	an	an	DET
ihlr-22950	574	94	application	application	NOUN
ihlr-22950	574	95	under	under	ADP
ihlr-22950	574	96	section	section	NOUN
ihlr-22950	574	97	505	505	NUM
ihlr-22950	574	98	of	of	ADP
ihlr-22950	574	99	this	this	DET
ihlr-22950	574	100	act	act	NOUN
ihlr-22950	574	101	or	or	CCONJ
ihlr-22950	574	102	section	section	NOUN
ihlr-22950	574	103	351	351	NUM
ihlr-22950	574	104	of	of	ADP
ihlr-22950	574	105	the	the	DET
ihlr-22950	574	106	public	public	ADJ
ihlr-22950	574	107	health	health	PROPN
ihlr-22950	574	108	service	service	PROPN
ihlr-22950	574	109	act	act	PROPN
ihlr-22950	574	110	.	.	PUNCT
ihlr-22950	574	111	”	"	PUNCT
ihlr-22950	574	112	.	.	PUNCT
ihlr-22950	575	1	(	(	PUNCT
ihlr-22950	575	2	b	b	X
ihlr-22950	575	3	)	)	PUNCT
ihlr-22950	575	4	no	no	DET
ihlr-22950	575	5	liability	liability	NOUN
ihlr-22950	575	6	.	.	PUNCT
ihlr-22950	575	7	—	—	PUNCT
ihlr-22950	576	1	(	(	PUNCT
ihlr-22950	576	2	1	1	X
ihlr-22950	576	3	)	)	PUNCT
ihlr-22950	576	4	alleged	allege	VERB
ihlr-22950	576	5	acts	act	NOUN
ihlr-22950	576	6	or	or	CCONJ
ihlr-22950	576	7	omissions.—with	omissions.—with	ADP
ihlr-22950	576	8	respect	respect	NOUN
ihlr-22950	576	9	to	to	ADP
ihlr-22950	576	10	any	any	DET
ihlr-22950	576	11	alleged	alleged	ADJ
ihlr-22950	576	12	act	act	NOUN
ihlr-22950	576	13	or	or	CCONJ
ihlr-22950	576	14	omission	omission	NOUN
ihlr-22950	576	15	with	with	ADP
ihlr-22950	576	16	respect	respect	NOUN
ihlr-22950	576	17	to	to	ADP
ihlr-22950	576	18	an	an	DET
ihlr-22950	576	19	eligible	eligible	ADJ
ihlr-22950	576	20	investigational	investigational	ADJ
ihlr-22950	576	21	drug	drug	NOUN
ihlr-22950	576	22	provided	provide	VERB
ihlr-22950	576	23	to	to	ADP
ihlr-22950	576	24	an	an	DET
ihlr-22950	576	25	eligible	eligible	ADJ
ihlr-22950	576	26	patient	patient	NOUN
ihlr-22950	576	27	pursuant	pursuant	NOUN
ihlr-22950	576	28	to	to	ADP
ihlr-22950	576	29	section	section	NOUN
ihlr-22950	576	30	561b	561b	NUM
ihlr-22950	576	31	of	of	ADP
ihlr-22950	576	32	the	the	DET
ihlr-22950	576	33	federal	federal	ADJ
ihlr-22950	576	34	food	food	NOUN
ihlr-22950	576	35	,	,	PUNCT
ihlr-22950	576	36	drug	drug	NOUN
ihlr-22950	576	37	,	,	PUNCT
ihlr-22950	576	38	and	and	CCONJ
ihlr-22950	576	39	cosmetic	cosmetic	ADJ
ihlr-22950	576	40	act	act	NOUN
ihlr-22950	576	41	and	and	CCONJ
ihlr-22950	576	42	in	in	ADP
ihlr-22950	576	43	compliance	compliance	NOUN
ihlr-22950	576	44	with	with	ADP
ihlr-22950	576	45	such	such	ADJ
ihlr-22950	576	46	section	section	NOUN
ihlr-22950	576	47	,	,	PUNCT
ihlr-22950	576	48	no	no	DET
ihlr-22950	576	49	liability	liability	NOUN
ihlr-22950	576	50	in	in	ADP
ihlr-22950	576	51	a	a	DET
ihlr-22950	576	52	cause	cause	NOUN
ihlr-22950	576	53	of	of	ADP
ihlr-22950	576	54	action	action	NOUN
ihlr-22950	576	55	shall	shall	AUX
ihlr-22950	576	56	lie	lie	VERB
ihlr-22950	576	57	against	against	ADP
ihlr-22950	576	58	—	—	PUNCT
ihlr-22950	576	59	(	(	PUNCT
ihlr-22950	576	60	a	a	X
ihlr-22950	576	61	)	)	PUNCT
ihlr-22950	576	62	a	a	DET
ihlr-22950	576	63	sponsor	sponsor	NOUN
ihlr-22950	576	64	or	or	CCONJ
ihlr-22950	576	65	manufacturer	manufacturer	NOUN
ihlr-22950	576	66	;	;	PUNCT
ihlr-22950	576	67	or	or	CCONJ
ihlr-22950	576	68	(	(	PUNCT
ihlr-22950	576	69	b	b	X
ihlr-22950	576	70	)	)	PUNCT
ihlr-22950	576	71	a	a	DET
ihlr-22950	576	72	prescriber	prescriber	NOUN
ihlr-22950	576	73	,	,	PUNCT
ihlr-22950	576	74	dispenser	dispenser	NOUN
ihlr-22950	576	75	,	,	PUNCT
ihlr-22950	576	76	or	or	CCONJ
ihlr-22950	576	77	other	other	ADJ
ihlr-22950	576	78	individual	individual	ADJ
ihlr-22950	576	79	entity	entity	NOUN
ihlr-22950	576	80	(	(	PUNCT
ihlr-22950	576	81	other	other	ADJ
ihlr-22950	576	82	than	than	ADP
ihlr-22950	576	83	a	a	DET
ihlr-22950	576	84	sponsor	sponsor	NOUN
ihlr-22950	576	85	or	or	CCONJ
ihlr-22950	576	86	manufacturer	manufacturer	NOUN
ihlr-22950	576	87	)	)	PUNCT
ihlr-22950	576	88	,	,	PUNCT
ihlr-22950	576	89	unless	unless	SCONJ
ihlr-22950	576	90	the	the	DET
ihlr-22950	576	91	relevant	relevant	ADJ
ihlr-22950	576	92	conduct	conduct	NOUN
ihlr-22950	576	93	constitutes	constitute	VERB
ihlr-22950	576	94	reckless	reckless	ADJ
ihlr-22950	576	95	or	or	CCONJ
ihlr-22950	576	96	willful	willful	ADJ
ihlr-22950	576	97	misconduct	misconduct	NOUN
ihlr-22950	576	98	,	,	PUNCT
ihlr-22950	576	99	gross	gross	ADJ
ihlr-22950	576	100	negligence	negligence	NOUN
ihlr-22950	576	101	,	,	PUNCT
ihlr-22950	576	102	or	or	CCONJ
ihlr-22950	576	103	an	an	DET
ihlr-22950	576	104	intentional	intentional	ADJ
ihlr-22950	576	105	tort	tort	NOUN
ihlr-22950	576	106	under	under	ADP
ihlr-22950	576	107	any	any	DET
ihlr-22950	576	108	applicable	applicable	ADJ
ihlr-22950	576	109	state	state	NOUN
ihlr-22950	576	110	law	law	NOUN
ihlr-22950	576	111	.	.	PUNCT
ihlr-22950	577	1	(	(	PUNCT
ihlr-22950	577	2	2	2	X
ihlr-22950	577	3	)	)	PUNCT
ihlr-22950	577	4	determination	determination	NOUN
ihlr-22950	577	5	not	not	PART
ihlr-22950	577	6	to	to	PART
ihlr-22950	577	7	provide	provide	VERB
ihlr-22950	577	8	drug.—no	drug.—no	NOUN
ihlr-22950	577	9	liability	liability	NOUN
ihlr-22950	577	10	shall	shall	AUX
ihlr-22950	577	11	lie	lie	VERB
ihlr-22950	577	12	against	against	ADP
ihlr-22950	577	13	a	a	DET
ihlr-22950	577	14	sponsor	sponsor	NOUN
ihlr-22950	577	15	manufacturer	manufacturer	NOUN
ihlr-22950	577	16	,	,	PUNCT
ihlr-22950	577	17	prescriber	prescriber	NOUN
ihlr-22950	577	18	,	,	PUNCT
ihlr-22950	577	19	dispenser	dispenser	NOUN
ihlr-22950	577	20	or	or	CCONJ
ihlr-22950	577	21	other	other	ADJ
ihlr-22950	577	22	individual	individual	ADJ
ihlr-22950	577	23	entity	entity	NOUN
ihlr-22950	577	24	for	for	ADP
ihlr-22950	577	25	its	its	PRON
ihlr-22950	577	26	determination	determination	NOUN
ihlr-22950	577	27	not	not	PART
ihlr-22950	577	28	to	to	PART
ihlr-22950	577	29	provide	provide	VERB
ihlr-22950	577	30	access	access	NOUN
ihlr-22950	577	31	to	to	ADP
ihlr-22950	577	32	an	an	DET
ihlr-22950	577	33	eligible	eligible	ADJ
ihlr-22950	577	34	investigational	investigational	ADJ
ihlr-22950	577	35	drug	drug	NOUN
ihlr-22950	577	36	under	under	ADP
ihlr-22950	577	37	section	section	NOUN
ihlr-22950	577	38	561b	561b	NUM
ihlr-22950	577	39	of	of	ADP
ihlr-22950	577	40	the	the	DET
ihlr-22950	577	41	federal	federal	ADJ
ihlr-22950	577	42	food	food	NOUN
ihlr-22950	577	43	,	,	PUNCT
ihlr-22950	577	44	drug	drug	NOUN
ihlr-22950	577	45	,	,	PUNCT
ihlr-22950	577	46	and	and	CCONJ
ihlr-22950	577	47	cosmetic	cosmetic	ADJ
ihlr-22950	577	48	act	act	NOUN
ihlr-22950	577	49	.	.	PUNCT
ihlr-22950	578	1	(	(	PUNCT
ihlr-22950	578	2	3	3	X
ihlr-22950	578	3	)	)	PUNCT
ihlr-22950	578	4	limitation.—except	limitation.—except	NOUN
ihlr-22950	578	5	as	as	ADV
ihlr-22950	578	6	set	set	VERB
ihlr-22950	578	7	forth	forth	ADP
ihlr-22950	578	8	in	in	ADP
ihlr-22950	578	9	paragraphs	paragraph	NOUN
ihlr-22950	578	10	(	(	PUNCT
ihlr-22950	578	11	1	1	NUM
ihlr-22950	578	12	)	)	PUNCT
ihlr-22950	578	13	and	and	CCONJ
ihlr-22950	578	14	(	(	PUNCT
ihlr-22950	578	15	2	2	NUM
ihlr-22950	578	16	)	)	PUNCT
ihlr-22950	578	17	,	,	PUNCT
ihlr-22950	578	18	nothing	nothing	PRON
ihlr-22950	578	19	in	in	ADP
ihlr-22950	578	20	this	this	DET
ihlr-22950	578	21	section	section	NOUN
ihlr-22950	578	22	shall	shall	AUX
ihlr-22950	578	23	be	be	AUX
ihlr-22950	578	24	construed	construe	VERB
ihlr-22950	578	25	to	to	PART
ihlr-22950	578	26	modify	modify	VERB
ihlr-22950	578	27	or	or	CCONJ
ihlr-22950	578	28	otherwise	otherwise	ADV
ihlr-22950	578	29	affect	affect	VERB
ihlr-22950	578	30	the	the	DET
ihlr-22950	578	31	right	right	NOUN
ihlr-22950	578	32	of	of	ADP
ihlr-22950	578	33	any	any	DET
ihlr-22950	578	34	person	person	NOUN
ihlr-22950	578	35	to	to	PART
ihlr-22950	578	36	bring	bring	VERB
ihlr-22950	578	37	a	a	DET
ihlr-22950	578	38	private	private	ADJ
ihlr-22950	578	39	action	action	NOUN
ihlr-22950	578	40	under	under	ADP
ihlr-22950	578	41	any	any	DET
ihlr-22950	578	42	state	state	NOUN
ihlr-22950	578	43	or	or	CCONJ
ihlr-22950	578	44	federal	federal	ADJ
ihlr-22950	578	45	product	product	NOUN
ihlr-22950	578	46	liability	liability	NOUN
ihlr-22950	578	47	,	,	PUNCT
ihlr-22950	578	48	tort	tort	NOUN
ihlr-22950	578	49	,	,	PUNCT
ihlr-22950	578	50	consumer	consumer	NOUN
ihlr-22950	578	51	protection	protection	NOUN
ihlr-22950	578	52	,	,	PUNCT
ihlr-22950	578	53	or	or	CCONJ
ihlr-22950	578	54	warranty	warranty	NOUN
ihlr-22950	578	55	law	law	NOUN
ihlr-22950	578	56	.	.	PUNCT
ihlr-22950	579	1	128	128	NUM
ihlr-22950	579	2	indiana	indiana	PROPN
ihlr-22950	579	3	health	health	PROPN
ihlr-22950	579	4	law	law	PROPN
ihlr-22950	579	5	review	review	NOUN
ihlr-22950	579	6	[	[	X
ihlr-22950	579	7	vol	vol	NOUN
ihlr-22950	579	8	.	.	PUNCT
ihlr-22950	580	1	16:101	16:101	NUM
ihlr-22950	580	2	sec	sec	PROPN
ihlr-22950	580	3	.	.	PROPN
ihlr-22950	581	1	3	3	X
ihlr-22950	581	2	.	.	X
ihlr-22950	581	3	sense	sense	NOUN
ihlr-22950	581	4	of	of	ADP
ihlr-22950	581	5	the	the	DET
ihlr-22950	581	6	senate	senate	PROPN
ihlr-22950	581	7	.	.	PUNCT
ihlr-22950	582	1	it	it	PRON
ihlr-22950	582	2	is	be	AUX
ihlr-22950	582	3	the	the	DET
ihlr-22950	582	4	sense	sense	NOUN
ihlr-22950	582	5	of	of	ADP
ihlr-22950	582	6	the	the	DET
ihlr-22950	582	7	senate	senate	PROPN
ihlr-22950	582	8	that	that	PRON
ihlr-22950	582	9	section	section	NOUN
ihlr-22950	582	10	561b	561b	NUM
ihlr-22950	582	11	of	of	ADP
ihlr-22950	582	12	the	the	DET
ihlr-22950	582	13	federal	federal	ADJ
ihlr-22950	582	14	food	food	NOUN
ihlr-22950	582	15	,	,	PUNCT
ihlr-22950	582	16	drug	drug	NOUN
ihlr-22950	582	17	,	,	PUNCT
ihlr-22950	582	18	and	and	CCONJ
ihlr-22950	582	19	cosmetic	cosmetic	ADJ
ihlr-22950	582	20	act	act	NOUN
ihlr-22950	582	21	,	,	PUNCT
ihlr-22950	582	22	as	as	SCONJ
ihlr-22950	582	23	added	add	VERB
ihlr-22950	582	24	by	by	ADP
ihlr-22950	582	25	section	section	NOUN
ihlr-22950	582	26	2	2	NUM
ihlr-22950	582	27	—	—	PUNCT
ihlr-22950	582	28	(	(	PUNCT
ihlr-22950	582	29	1	1	X
ihlr-22950	582	30	)	)	PUNCT
ihlr-22950	582	31	does	do	AUX
ihlr-22950	582	32	not	not	PART
ihlr-22950	582	33	establish	establish	VERB
ihlr-22950	582	34	a	a	DET
ihlr-22950	582	35	new	new	ADJ
ihlr-22950	582	36	entitlement	entitlement	NOUN
ihlr-22950	582	37	or	or	CCONJ
ihlr-22950	582	38	modify	modify	VERB
ihlr-22950	582	39	an	an	DET
ihlr-22950	582	40	existing	exist	VERB
ihlr-22950	582	41	entitlement	entitlement	NOUN
ihlr-22950	582	42	,	,	PUNCT
ihlr-22950	582	43	or	or	CCONJ
ihlr-22950	582	44	otherwise	otherwise	ADV
ihlr-22950	582	45	establish	establish	VERB
ihlr-22950	582	46	a	a	DET
ihlr-22950	582	47	positive	positive	ADJ
ihlr-22950	582	48	right	right	NOUN
ihlr-22950	582	49	to	to	ADP
ihlr-22950	582	50	any	any	DET
ihlr-22950	582	51	party	party	NOUN
ihlr-22950	582	52	or	or	CCONJ
ihlr-22950	582	53	individual	individual	NOUN
ihlr-22950	582	54	;	;	PUNCT
ihlr-22950	582	55	(	(	PUNCT
ihlr-22950	582	56	2	2	X
ihlr-22950	582	57	)	)	PUNCT
ihlr-22950	582	58	does	do	AUX
ihlr-22950	582	59	not	not	PART
ihlr-22950	582	60	establish	establish	VERB
ihlr-22950	582	61	any	any	DET
ihlr-22950	582	62	new	new	ADJ
ihlr-22950	582	63	mandates	mandate	NOUN
ihlr-22950	582	64	,	,	PUNCT
ihlr-22950	582	65	directives	directive	NOUN
ihlr-22950	582	66	,	,	PUNCT
ihlr-22950	582	67	or	or	CCONJ
ihlr-22950	582	68	additional	additional	ADJ
ihlr-22950	582	69	regulations	regulation	NOUN
ihlr-22950	582	70	;	;	PUNCT
ihlr-22950	582	71	(	(	PUNCT
ihlr-22950	582	72	3	3	X
ihlr-22950	582	73	)	)	PUNCT
ihlr-22950	582	74	only	only	ADV
ihlr-22950	582	75	expands	expand	VERB
ihlr-22950	582	76	the	the	DET
ihlr-22950	582	77	scope	scope	NOUN
ihlr-22950	582	78	of	of	ADP
ihlr-22950	582	79	individual	individual	ADJ
ihlr-22950	582	80	liberty	liberty	NOUN
ihlr-22950	582	81	and	and	CCONJ
ihlr-22950	582	82	agency	agency	NOUN
ihlr-22950	582	83	among	among	ADP
ihlr-22950	582	84	patients	patient	NOUN
ihlr-22950	582	85	,	,	PUNCT
ihlr-22950	582	86	in	in	ADP
ihlr-22950	582	87	limited	limited	ADJ
ihlr-22950	582	88	circumstances	circumstance	NOUN
ihlr-22950	582	89	;	;	PUNCT
ihlr-22950	582	90	(	(	PUNCT
ihlr-22950	582	91	4	4	X
ihlr-22950	582	92	)	)	PUNCT
ihlr-22950	582	93	is	be	AUX
ihlr-22950	582	94	consistent	consistent	ADJ
ihlr-22950	582	95	with	with	ADP
ihlr-22950	582	96	,	,	PUNCT
ihlr-22950	582	97	and	and	CCONJ
ihlr-22950	582	98	will	will	AUX
ihlr-22950	582	99	act	act	VERB
ihlr-22950	582	100	as	as	ADP
ihlr-22950	582	101	an	an	DET
ihlr-22950	582	102	alternative	alternative	ADJ
ihlr-22950	582	103	pathway	pathway	NOUN
ihlr-22950	582	104	alongside	alongside	NOUN
ihlr-22950	582	105	,	,	PUNCT
ihlr-22950	582	106	existing	exist	VERB
ihlr-22950	582	107	expanded	expand	VERB
ihlr-22950	582	108	access	access	NOUN
ihlr-22950	582	109	policies	policy	NOUN
ihlr-22950	582	110	of	of	ADP
ihlr-22950	582	111	the	the	DET
ihlr-22950	582	112	food	food	NOUN
ihlr-22950	582	113	and	and	CCONJ
ihlr-22950	582	114	drug	drug	NOUN
ihlr-22950	582	115	administration	administration	NOUN
ihlr-22950	582	116	;	;	PUNCT
ihlr-22950	582	117	(	(	PUNCT
ihlr-22950	582	118	5	5	X
ihlr-22950	582	119	)	)	PUNCT
ihlr-22950	582	120	will	will	AUX
ihlr-22950	582	121	not	not	PART
ihlr-22950	582	122	,	,	PUNCT
ihlr-22950	582	123	and	and	CCONJ
ihlr-22950	582	124	can	can	AUX
ihlr-22950	582	125	not	not	PART
ihlr-22950	582	126	,	,	PUNCT
ihlr-22950	582	127	create	create	VERB
ihlr-22950	582	128	a	a	DET
ihlr-22950	582	129	cure	cure	NOUN
ihlr-22950	582	130	or	or	CCONJ
ihlr-22950	582	131	effective	effective	ADJ
ihlr-22950	582	132	therapy	therapy	NOUN
ihlr-22950	582	133	where	where	SCONJ
ihlr-22950	582	134	none	none	NOUN
ihlr-22950	582	135	exists	exist	VERB
ihlr-22950	582	136	;	;	PUNCT
ihlr-22950	582	137	(	(	PUNCT
ihlr-22950	582	138	6	6	X
ihlr-22950	582	139	)	)	PUNCT
ihlr-22950	582	140	recognizes	recognize	VERB
ihlr-22950	582	141	that	that	SCONJ
ihlr-22950	582	142	the	the	DET
ihlr-22950	582	143	eligible	eligible	ADJ
ihlr-22950	582	144	terminally	terminally	ADV
ihlr-22950	582	145	ill	ill	ADJ
ihlr-22950	582	146	patient	patient	ADJ
ihlr-22950	582	147	population	population	NOUN
ihlr-22950	582	148	often	often	ADV
ihlr-22950	582	149	consists	consist	VERB
ihlr-22950	582	150	of	of	ADP
ihlr-22950	582	151	those	those	DET
ihlr-22950	582	152	patients	patient	NOUN
ihlr-22950	582	153	with	with	ADP
ihlr-22950	582	154	the	the	DET
ihlr-22950	582	155	highest	high	ADJ
ihlr-22950	582	156	risk	risk	NOUN
ihlr-22950	582	157	of	of	ADP
ihlr-22950	582	158	mortality	mortality	NOUN
ihlr-22950	582	159	,	,	PUNCT
ihlr-22950	582	160	and	and	CCONJ
ihlr-22950	582	161	use	use	NOUN
ihlr-22950	582	162	of	of	ADP
ihlr-22950	582	163	experimental	experimental	ADJ
ihlr-22950	582	164	treatments	treatment	NOUN
ihlr-22950	582	165	under	under	ADP
ihlr-22950	582	166	the	the	DET
ihlr-22950	582	167	criteria	criterion	NOUN
ihlr-22950	582	168	and	and	CCONJ
ihlr-22950	582	169	procedure	procedure	NOUN
ihlr-22950	582	170	described	describe	VERB
ihlr-22950	582	171	in	in	ADP
ihlr-22950	582	172	such	such	ADJ
ihlr-22950	582	173	section	section	NOUN
ihlr-22950	582	174	561a	561a	NUM
ihlr-22950	582	175	involves	involve	VERB
ihlr-22950	582	176	an	an	DET
ihlr-22950	582	177	informed	informed	ADJ
ihlr-22950	582	178	assumption	assumption	NOUN
ihlr-22950	582	179	of	of	ADP
ihlr-22950	582	180	risk	risk	NOUN
ihlr-22950	582	181	;	;	PUNCT
ihlr-22950	582	182	and	and	CCONJ
ihlr-22950	582	183	(	(	PUNCT
ihlr-22950	582	184	7	7	X
ihlr-22950	582	185	)	)	PUNCT
ihlr-22950	582	186	establishes	establish	VERB
ihlr-22950	582	187	national	national	ADJ
ihlr-22950	582	188	standards	standard	NOUN
ihlr-22950	582	189	and	and	CCONJ
ihlr-22950	582	190	rules	rule	NOUN
ihlr-22950	582	191	by	by	ADP
ihlr-22950	582	192	which	which	PRON
ihlr-22950	582	193	investigational	investigational	ADJ
ihlr-22950	582	194	drugs	drug	NOUN
ihlr-22950	582	195	may	may	AUX
ihlr-22950	582	196	be	be	AUX
ihlr-22950	582	197	provided	provide	VERB
ihlr-22950	582	198	to	to	ADP
ihlr-22950	582	199	terminally	terminally	ADV
ihlr-22950	582	200	ill	ill	ADJ
ihlr-22950	582	201	patients	patient	NOUN
ihlr-22950	582	202	.	.	PUNCT
ihlr-22950	583	1	e.	e.	PROPN
ihlr-22950	583	2	appendix	appendix	PROPN
ihlr-22950	583	3	v	v	NOUN
ihlr-22950	583	4	:	:	PUNCT
ihlr-22950	583	5	maryland	maryland	NOUN
ihlr-22950	583	6	as	as	ADP
ihlr-22950	583	7	an	an	DET
ihlr-22950	583	8	example	example	NOUN
ihlr-22950	583	9	of	of	ADP
ihlr-22950	583	10	state	state	NOUN
ihlr-22950	583	11	right	right	NOUN
ihlr-22950	583	12	to	to	PART
ihlr-22950	583	13	try	try	VERB
ihlr-22950	583	14	legislation125	legislation125	PROPN
ihlr-22950	583	15	title	title	NOUN
ihlr-22950	583	16	21	21	NUM
ihlr-22950	583	17	.	.	PUNCT
ihlr-22950	584	1	food	food	NOUN
ihlr-22950	584	2	,	,	PUNCT
ihlr-22950	584	3	drugs	drug	NOUN
ihlr-22950	584	4	,	,	PUNCT
ihlr-22950	584	5	and	and	CCONJ
ihlr-22950	584	6	cosmetics	cosmetic	NOUN
ihlr-22950	584	7	>	>	X
ihlr-22950	584	8	subtitle	subtitle	PROPN
ihlr-22950	584	9	2b	2b	NOUN
ihlr-22950	584	10	.	.	PUNCT
ihlr-22950	585	1	right	right	ADJ
ihlr-22950	585	2	to	to	PART
ihlr-22950	585	3	try	try	VERB
ihlr-22950	585	4	act	act	NOUN
ihlr-22950	585	5	.	.	PUNCT
ihlr-22950	586	1	(	(	PUNCT
ihlr-22950	586	2	a	a	X
ihlr-22950	586	3	)	)	PUNCT
ihlr-22950	586	4	in	in	ADP
ihlr-22950	586	5	general	general	ADJ
ihlr-22950	586	6	.	.	PUNCT
ihlr-22950	587	1	-	-	PUNCT
ihlr-22950	587	2	in	in	ADP
ihlr-22950	587	3	this	this	DET
ihlr-22950	587	4	subtitle	subtitle	NOUN
ihlr-22950	587	5	the	the	DET
ihlr-22950	587	6	following	follow	VERB
ihlr-22950	587	7	words	word	NOUN
ihlr-22950	587	8	have	have	VERB
ihlr-22950	587	9	the	the	DET
ihlr-22950	587	10	meanings	meaning	NOUN
ihlr-22950	587	11	indicated	indicate	VERB
ihlr-22950	587	12	.	.	PUNCT
ihlr-22950	588	1	(	(	PUNCT
ihlr-22950	588	2	b	b	NOUN
ihlr-22950	588	3	)	)	PUNCT
ihlr-22950	588	4	carrier	carrier	NOUN
ihlr-22950	588	5	.	.	PUNCT
ihlr-22950	589	1	-	-	PUNCT
ihlr-22950	589	2	“	"	PUNCT
ihlr-22950	589	3	carrier	carrier	NOUN
ihlr-22950	589	4	”	"	PUNCT
ihlr-22950	589	5	has	have	VERB
ihlr-22950	589	6	the	the	DET
ihlr-22950	589	7	meaning	meaning	NOUN
ihlr-22950	589	8	stated	state	VERB
ihlr-22950	589	9	in	in	ADP
ihlr-22950	589	10	§	§	PROPN
ihlr-22950	589	11	15	15	NUM
ihlr-22950	589	12	-	-	SYM
ihlr-22950	589	13	10a-01(c	10a-01(c	NUM
ihlr-22950	589	14	)	)	PUNCT
ihlr-22950	589	15	of	of	ADP
ihlr-22950	589	16	the	the	DET
ihlr-22950	589	17	insurance	insurance	NOUN
ihlr-22950	589	18	article	article	NOUN
ihlr-22950	589	19	.	.	PUNCT
ihlr-22950	590	1	(	(	PUNCT
ihlr-22950	590	2	c	c	X
ihlr-22950	590	3	)	)	PUNCT
ihlr-22950	590	4	eligible	eligible	ADJ
ihlr-22950	590	5	patient	patient	NOUN
ihlr-22950	590	6	.	.	PUNCT
ihlr-22950	591	1	-	-	PUNCT
ihlr-22950	591	2	“	"	PUNCT
ihlr-22950	591	3	eligible	eligible	ADJ
ihlr-22950	591	4	patient	patient	NOUN
ihlr-22950	591	5	”	"	PUNCT
ihlr-22950	591	6	means	mean	VERB
ihlr-22950	591	7	an	an	DET
ihlr-22950	591	8	individual	individual	NOUN
ihlr-22950	591	9	who	who	PRON
ihlr-22950	591	10	:	:	PUNCT
ihlr-22950	591	11	(	(	PUNCT
ihlr-22950	591	12	1	1	X
ihlr-22950	591	13	)	)	PUNCT
ihlr-22950	591	14	has	have	VERB
ihlr-22950	591	15	a	a	DET
ihlr-22950	591	16	terminal	terminal	ADJ
ihlr-22950	591	17	illness	illness	NOUN
ihlr-22950	591	18	,	,	PUNCT
ihlr-22950	591	19	attested	attest	VERB
ihlr-22950	591	20	to	to	ADP
ihlr-22950	591	21	by	by	ADP
ihlr-22950	591	22	the	the	DET
ihlr-22950	591	23	individual	individual	NOUN
ihlr-22950	591	24	’s	’s	PART
ihlr-22950	591	25	treating	treat	VERB
ihlr-22950	591	26	physician	physician	NOUN
ihlr-22950	591	27	;	;	PUNCT
ihlr-22950	591	28	(	(	PUNCT
ihlr-22950	591	29	2	2	X
ihlr-22950	591	30	)	)	PUNCT
ihlr-22950	591	31	has	have	AUX
ihlr-22950	591	32	considered	consider	VERB
ihlr-22950	591	33	all	all	DET
ihlr-22950	591	34	other	other	ADJ
ihlr-22950	591	35	treatment	treatment	NOUN
ihlr-22950	591	36	options	option	NOUN
ihlr-22950	591	37	currently	currently	ADV
ihlr-22950	591	38	approved	approve	VERB
ihlr-22950	591	39	by	by	ADP
ihlr-22950	591	40	the	the	DET
ihlr-22950	591	41	united	united	PROPN
ihlr-22950	591	42	states	states	PROPN
ihlr-22950	591	43	food	food	PROPN
ihlr-22950	591	44	and	and	CCONJ
ihlr-22950	591	45	drug	drug	NOUN
ihlr-22950	591	46	administration	administration	NOUN
ihlr-22950	591	47	;	;	PUNCT
ihlr-22950	591	48	(	(	PUNCT
ihlr-22950	591	49	3	3	X
ihlr-22950	591	50	)	)	PUNCT
ihlr-22950	591	51	has	have	AUX
ihlr-22950	591	52	received	receive	VERB
ihlr-22950	591	53	a	a	DET
ihlr-22950	591	54	recommendation	recommendation	NOUN
ihlr-22950	591	55	from	from	ADP
ihlr-22950	591	56	the	the	DET
ihlr-22950	591	57	individual	individual	NOUN
ihlr-22950	591	58	’s	’s	PART
ihlr-22950	591	59	treating	treat	VERB
ihlr-22950	591	60	physician	physician	NOUN
ihlr-22950	591	61	for	for	ADP
ihlr-22950	591	62	the	the	DET
ihlr-22950	591	63	use	use	NOUN
ihlr-22950	591	64	of	of	ADP
ihlr-22950	591	65	an	an	DET
ihlr-22950	591	66	investigational	investigational	ADJ
ihlr-22950	591	67	drug	drug	NOUN
ihlr-22950	591	68	,	,	PUNCT
ihlr-22950	591	69	biological	biological	ADJ
ihlr-22950	591	70	product	product	NOUN
ihlr-22950	591	71	,	,	PUNCT
ihlr-22950	591	72	or	or	CCONJ
ihlr-22950	591	73	device	device	NOUN
ihlr-22950	591	74	;	;	PUNCT
ihlr-22950	591	75	(	(	PUNCT
ihlr-22950	591	76	4	4	X
ihlr-22950	591	77	)	)	PUNCT
ihlr-22950	591	78	(	(	PUNCT
ihlr-22950	591	79	i	i	NOUN
ihlr-22950	591	80	)	)	PUNCT
ihlr-22950	591	81	has	have	AUX
ihlr-22950	591	82	given	give	VERB
ihlr-22950	591	83	informed	informed	ADJ
ihlr-22950	591	84	consent	consent	NOUN
ihlr-22950	591	85	for	for	ADP
ihlr-22950	591	86	the	the	DET
ihlr-22950	591	87	use	use	NOUN
ihlr-22950	591	88	of	of	ADP
ihlr-22950	591	89	the	the	DET
ihlr-22950	591	90	investigational	investigational	ADJ
ihlr-22950	591	91	125	125	NUM
ihlr-22950	591	92	.	.	PUNCT
ihlr-22950	591	93	md	md	PROPN
ihlr-22950	591	94	.	.	PROPN
ihlr-22950	591	95	code	code	PROPN
ihlr-22950	591	96	ann	ann	PROPN
ihlr-22950	591	97	.	.	PROPN
ihlr-22950	591	98	,	,	PUNCT
ihlr-22950	591	99	health	health	PROPN
ihlr-22950	591	100	–	–	PUNCT
ihlr-22950	591	101	gen	gen	PROPN
ihlr-22950	591	102	.	.	PROPN
ihlr-22950	591	103	§	§	PROPN
ihlr-22950	591	104	21	21	NUM
ihlr-22950	591	105	-	-	SYM
ihlr-22950	591	106	2b01	2b01	NUM
ihlr-22950	591	107	(	(	PUNCT
ihlr-22950	591	108	lexisnexis	lexisnexis	NOUN
ihlr-22950	591	109	2018	2018	NUM
ihlr-22950	591	110	)	)	PUNCT
ihlr-22950	591	111	2018	2018	NUM
ihlr-22950	591	112	]	]	PUNCT
ihlr-22950	591	113	the	the	DET
ihlr-22950	591	114	latest	late	ADJ
ihlr-22950	591	115	“	"	PUNCT
ihlr-22950	591	116	federal	federal	ADJ
ihlr-22950	591	117	movement	movement	NOUN
ihlr-22950	591	118	”	"	PUNCT
ihlr-22950	591	119	in	in	ADP
ihlr-22950	591	120	the	the	DET
ihlr-22950	591	121	food	food	NOUN
ihlr-22950	591	122	and	and	CCONJ
ihlr-22950	591	123	drug	drug	NOUN
ihlr-22950	591	124	law	law	NOUN
ihlr-22950	591	125	arena	arena	NOUN
ihlr-22950	591	126	129	129	NUM
ihlr-22950	591	127	drug	drug	NOUN
ihlr-22950	591	128	,	,	PUNCT
ihlr-22950	591	129	biological	biological	ADJ
ihlr-22950	591	130	product	product	NOUN
ihlr-22950	591	131	,	,	PUNCT
ihlr-22950	591	132	or	or	CCONJ
ihlr-22950	591	133	device	device	NOUN
ihlr-22950	591	134	;	;	PUNCT
ihlr-22950	591	135	or	or	CCONJ
ihlr-22950	591	136	(	(	PUNCT
ihlr-22950	591	137	ii	ii	NOUN
ihlr-22950	591	138	)	)	PUNCT
ihlr-22950	591	139	if	if	SCONJ
ihlr-22950	591	140	the	the	DET
ihlr-22950	591	141	individual	individual	NOUN
ihlr-22950	591	142	is	be	AUX
ihlr-22950	591	143	a	a	DET
ihlr-22950	591	144	minor	minor	ADJ
ihlr-22950	591	145	or	or	CCONJ
ihlr-22950	591	146	lacks	lack	VERB
ihlr-22950	591	147	the	the	DET
ihlr-22950	591	148	mental	mental	ADJ
ihlr-22950	591	149	capacity	capacity	NOUN
ihlr-22950	591	150	to	to	PART
ihlr-22950	591	151	provide	provide	VERB
ihlr-22950	591	152	informed	informed	ADJ
ihlr-22950	591	153	consent	consent	NOUN
ihlr-22950	591	154	,	,	PUNCT
ihlr-22950	591	155	has	have	VERB
ihlr-22950	591	156	a	a	DET
ihlr-22950	591	157	parent	parent	NOUN
ihlr-22950	591	158	or	or	CCONJ
ihlr-22950	591	159	legal	legal	ADJ
ihlr-22950	591	160	guardian	guardian	NOUN
ihlr-22950	591	161	who	who	PRON
ihlr-22950	591	162	has	have	AUX
ihlr-22950	591	163	given	give	VERB
ihlr-22950	591	164	informed	informed	ADJ
ihlr-22950	591	165	consent	consent	NOUN
ihlr-22950	591	166	on	on	ADP
ihlr-22950	591	167	the	the	DET
ihlr-22950	591	168	individual	individual	NOUN
ihlr-22950	591	169	’s	’s	PART
ihlr-22950	591	170	behalf	behalf	NOUN
ihlr-22950	591	171	for	for	ADP
ihlr-22950	591	172	the	the	DET
ihlr-22950	591	173	use	use	NOUN
ihlr-22950	591	174	of	of	ADP
ihlr-22950	591	175	the	the	DET
ihlr-22950	591	176	investigational	investigational	ADJ
ihlr-22950	591	177	drug	drug	NOUN
ihlr-22950	591	178	,	,	PUNCT
ihlr-22950	591	179	biological	biological	ADJ
ihlr-22950	591	180	product	product	NOUN
ihlr-22950	591	181	,	,	PUNCT
ihlr-22950	591	182	or	or	CCONJ
ihlr-22950	591	183	device	device	NOUN
ihlr-22950	591	184	;	;	PUNCT
ihlr-22950	591	185	(	(	PUNCT
ihlr-22950	591	186	5	5	X
ihlr-22950	591	187	)	)	PUNCT
ihlr-22950	591	188	is	be	AUX
ihlr-22950	591	189	ineligible	ineligible	ADJ
ihlr-22950	591	190	for	for	ADP
ihlr-22950	591	191	or	or	CCONJ
ihlr-22950	591	192	unable	unable	ADJ
ihlr-22950	591	193	to	to	PART
ihlr-22950	591	194	participate	participate	VERB
ihlr-22950	591	195	in	in	ADP
ihlr-22950	591	196	a	a	DET
ihlr-22950	591	197	clinical	clinical	ADJ
ihlr-22950	591	198	trial	trial	NOUN
ihlr-22950	591	199	;	;	PUNCT
ihlr-22950	591	200	and	and	CCONJ
ihlr-22950	591	201	(	(	PUNCT
ihlr-22950	591	202	6	6	X
ihlr-22950	591	203	)	)	PUNCT
ihlr-22950	591	204	has	have	VERB
ihlr-22950	591	205	documentation	documentation	NOUN
ihlr-22950	591	206	from	from	ADP
ihlr-22950	591	207	the	the	DET
ihlr-22950	591	208	individual	individual	NOUN
ihlr-22950	591	209	’s	’s	PART
ihlr-22950	591	210	treating	treat	VERB
ihlr-22950	591	211	physician	physician	NOUN
ihlr-22950	591	212	that	that	SCONJ
ihlr-22950	591	213	the	the	DET
ihlr-22950	591	214	individual	individual	NOUN
ihlr-22950	591	215	meets	meet	VERB
ihlr-22950	591	216	the	the	DET
ihlr-22950	591	217	requirements	requirement	NOUN
ihlr-22950	591	218	of	of	ADP
ihlr-22950	591	219	items	item	NOUN
ihlr-22950	591	220	(	(	PUNCT
ihlr-22950	591	221	1	1	X
ihlr-22950	591	222	)	)	PUNCT
ihlr-22950	591	223	through	through	ADP
ihlr-22950	591	224	(	(	PUNCT
ihlr-22950	591	225	5	5	NUM
ihlr-22950	591	226	)	)	PUNCT
ihlr-22950	591	227	of	of	ADP
ihlr-22950	591	228	this	this	DET
ihlr-22950	591	229	subsection	subsection	NOUN
ihlr-22950	591	230	.	.	PUNCT
ihlr-22950	592	1	(	(	PUNCT
ihlr-22950	592	2	d	d	X
ihlr-22950	592	3	)	)	PUNCT
ihlr-22950	592	4	health	health	NOUN
ihlr-22950	592	5	occupations	occupation	NOUN
ihlr-22950	592	6	board	board	PROPN
ihlr-22950	592	7	.	.	PUNCT
ihlr-22950	592	8	-	-	PUNCT
ihlr-22950	592	9	“	"	PUNCT
ihlr-22950	592	10	health	health	NOUN
ihlr-22950	592	11	occupations	occupation	NOUN
ihlr-22950	592	12	board	board	PROPN
ihlr-22950	592	13	”	"	PUNCT
ihlr-22950	592	14	means	mean	VERB
ihlr-22950	592	15	a	a	DET
ihlr-22950	592	16	board	board	NOUN
ihlr-22950	592	17	established	establish	VERB
ihlr-22950	592	18	under	under	ADP
ihlr-22950	592	19	the	the	DET
ihlr-22950	592	20	health	health	NOUN
ihlr-22950	592	21	occupations	occupation	NOUN
ihlr-22950	592	22	article	article	NOUN
ihlr-22950	592	23	that	that	PRON
ihlr-22950	592	24	issues	issue	VERB
ihlr-22950	592	25	licenses	license	NOUN
ihlr-22950	592	26	to	to	PART
ihlr-22950	592	27	practice	practice	VERB
ihlr-22950	592	28	a	a	DET
ihlr-22950	592	29	health	health	NOUN
ihlr-22950	592	30	occupation	occupation	NOUN
ihlr-22950	592	31	in	in	ADP
ihlr-22950	592	32	the	the	DET
ihlr-22950	592	33	state	state	NOUN
ihlr-22950	592	34	.	.	PUNCT
ihlr-22950	593	1	(	(	PUNCT
ihlr-22950	593	2	e	e	NOUN
ihlr-22950	593	3	)	)	PUNCT
ihlr-22950	593	4	informed	informed	ADJ
ihlr-22950	593	5	consent	consent	NOUN
ihlr-22950	593	6	.	.	PUNCT
ihlr-22950	593	7	-	-	PUNCT
ihlr-22950	593	8	“	"	PUNCT
ihlr-22950	593	9	informed	informed	ADJ
ihlr-22950	593	10	consent	consent	NOUN
ihlr-22950	593	11	”	"	PUNCT
ihlr-22950	593	12	means	mean	VERB
ihlr-22950	593	13	a	a	DET
ihlr-22950	593	14	written	write	VERB
ihlr-22950	593	15	document	document	NOUN
ihlr-22950	593	16	prepared	prepare	VERB
ihlr-22950	593	17	using	use	VERB
ihlr-22950	593	18	the	the	DET
ihlr-22950	593	19	informed	informed	ADJ
ihlr-22950	593	20	consent	consent	NOUN
ihlr-22950	593	21	form	form	NOUN
ihlr-22950	593	22	developed	develop	VERB
ihlr-22950	593	23	by	by	ADP
ihlr-22950	593	24	the	the	DET
ihlr-22950	593	25	office	office	NOUN
ihlr-22950	593	26	of	of	ADP
ihlr-22950	593	27	the	the	DET
ihlr-22950	593	28	attorney	attorney	NOUN
ihlr-22950	593	29	general	general	NOUN
ihlr-22950	593	30	in	in	ADP
ihlr-22950	593	31	accordance	accordance	NOUN
ihlr-22950	593	32	with	with	ADP
ihlr-22950	593	33	§	§	PROPN
ihlr-22950	593	34	21	21	NUM
ihlr-22950	593	35	-	-	SYM
ihlr-22950	593	36	2b-02(d)(1	2b-02(d)(1	NUM
ihlr-22950	593	37	)	)	PUNCT
ihlr-22950	593	38	of	of	ADP
ihlr-22950	593	39	this	this	DET
ihlr-22950	593	40	subtitle	subtitle	NOUN
ihlr-22950	593	41	that	that	SCONJ
ihlr-22950	593	42	:	:	PUNCT
ihlr-22950	593	43	(	(	PUNCT
ihlr-22950	593	44	1	1	X
ihlr-22950	593	45	)	)	PUNCT
ihlr-22950	593	46	is	be	AUX
ihlr-22950	593	47	signed	sign	VERB
ihlr-22950	593	48	by	by	ADP
ihlr-22950	593	49	the	the	DET
ihlr-22950	593	50	patient	patient	NOUN
ihlr-22950	593	51	or	or	CCONJ
ihlr-22950	593	52	a	a	DET
ihlr-22950	593	53	parent	parent	NOUN
ihlr-22950	593	54	or	or	CCONJ
ihlr-22950	593	55	legal	legal	ADJ
ihlr-22950	593	56	guardian	guardian	NOUN
ihlr-22950	593	57	of	of	ADP
ihlr-22950	593	58	the	the	DET
ihlr-22950	593	59	patient	patient	NOUN
ihlr-22950	593	60	;	;	PUNCT
ihlr-22950	593	61	(	(	PUNCT
ihlr-22950	593	62	2	2	X
ihlr-22950	593	63	)	)	PUNCT
ihlr-22950	593	64	is	be	AUX
ihlr-22950	593	65	attested	attest	VERB
ihlr-22950	593	66	to	to	ADP
ihlr-22950	593	67	by	by	ADP
ihlr-22950	593	68	the	the	DET
ihlr-22950	593	69	patient	patient	NOUN
ihlr-22950	593	70	’s	’s	PART
ihlr-22950	593	71	treating	treat	VERB
ihlr-22950	593	72	physician	physician	NOUN
ihlr-22950	593	73	and	and	CCONJ
ihlr-22950	593	74	a	a	DET
ihlr-22950	593	75	witness	witness	NOUN
ihlr-22950	593	76	;	;	PUNCT
ihlr-22950	593	77	and	and	CCONJ
ihlr-22950	593	78	(	(	PUNCT
ihlr-22950	593	79	3	3	X
ihlr-22950	593	80	)	)	PUNCT
ihlr-22950	593	81	at	at	ADP
ihlr-22950	593	82	a	a	DET
ihlr-22950	593	83	minimum	minimum	NOUN
ihlr-22950	593	84	:	:	PUNCT
ihlr-22950	593	85	(	(	PUNCT
ihlr-22950	593	86	i	i	NOUN
ihlr-22950	593	87	)	)	PUNCT
ihlr-22950	593	88	explains	explain	VERB
ihlr-22950	593	89	the	the	DET
ihlr-22950	593	90	currently	currently	ADV
ihlr-22950	593	91	approved	approve	VERB
ihlr-22950	593	92	products	product	NOUN
ihlr-22950	593	93	and	and	CCONJ
ihlr-22950	593	94	treatments	treatment	NOUN
ihlr-22950	593	95	for	for	ADP
ihlr-22950	593	96	the	the	DET
ihlr-22950	593	97	disease	disease	NOUN
ihlr-22950	593	98	or	or	CCONJ
ihlr-22950	593	99	condition	condition	NOUN
ihlr-22950	593	100	from	from	ADP
ihlr-22950	593	101	which	which	PRON
ihlr-22950	593	102	the	the	DET
ihlr-22950	593	103	patient	patient	NOUN
ihlr-22950	593	104	suffers	suffer	VERB
ihlr-22950	593	105	;	;	PUNCT
ihlr-22950	593	106	(	(	PUNCT
ihlr-22950	593	107	ii	ii	NOUN
ihlr-22950	593	108	)	)	PUNCT
ihlr-22950	593	109	attests	attest	VERB
ihlr-22950	593	110	to	to	ADP
ihlr-22950	593	111	the	the	DET
ihlr-22950	593	112	fact	fact	NOUN
ihlr-22950	593	113	that	that	SCONJ
ihlr-22950	593	114	the	the	DET
ihlr-22950	593	115	patient	patient	NOUN
ihlr-22950	593	116	concurs	concur	VERB
ihlr-22950	593	117	with	with	ADP
ihlr-22950	593	118	the	the	DET
ihlr-22950	593	119	patient	patient	NOUN
ihlr-22950	593	120	’s	’s	PART
ihlr-22950	593	121	treating	treat	VERB
ihlr-22950	593	122	physician	physician	NOUN
ihlr-22950	593	123	in	in	ADP
ihlr-22950	593	124	believing	believe	VERB
ihlr-22950	593	125	that	that	SCONJ
ihlr-22950	593	126	all	all	PRON
ihlr-22950	593	127	currently	currently	ADV
ihlr-22950	593	128	approved	approve	VERB
ihlr-22950	593	129	and	and	CCONJ
ihlr-22950	593	130	conventionally	conventionally	ADV
ihlr-22950	593	131	recognized	recognize	VERB
ihlr-22950	593	132	treatments	treatment	NOUN
ihlr-22950	593	133	are	be	AUX
ihlr-22950	593	134	unlikely	unlikely	ADJ
ihlr-22950	593	135	to	to	PART
ihlr-22950	593	136	prolong	prolong	VERB
ihlr-22950	593	137	the	the	DET
ihlr-22950	593	138	patient	patient	NOUN
ihlr-22950	593	139	’s	’s	PART
ihlr-22950	593	140	life	life	NOUN
ihlr-22950	593	141	;	;	PUNCT
ihlr-22950	593	142	(	(	PUNCT
ihlr-22950	593	143	iii	iii	X
ihlr-22950	593	144	)	)	PUNCT
ihlr-22950	593	145	identifies	identify	VERB
ihlr-22950	593	146	clearly	clearly	ADV
ihlr-22950	593	147	the	the	DET
ihlr-22950	593	148	specific	specific	ADJ
ihlr-22950	593	149	proposed	propose	VERB
ihlr-22950	593	150	investigational	investigational	ADJ
ihlr-22950	593	151	drug	drug	NOUN
ihlr-22950	593	152	,	,	PUNCT
ihlr-22950	593	153	biological	biological	ADJ
ihlr-22950	593	154	product	product	NOUN
ihlr-22950	593	155	,	,	PUNCT
ihlr-22950	593	156	or	or	CCONJ
ihlr-22950	593	157	device	device	NOUN
ihlr-22950	593	158	that	that	PRON
ihlr-22950	593	159	the	the	DET
ihlr-22950	593	160	patient	patient	NOUN
ihlr-22950	593	161	is	be	AUX
ihlr-22950	593	162	seeking	seek	VERB
ihlr-22950	593	163	to	to	PART
ihlr-22950	593	164	use	use	VERB
ihlr-22950	593	165	;	;	PUNCT
ihlr-22950	593	166	(	(	PUNCT
ihlr-22950	593	167	iv	iv	X
ihlr-22950	593	168	)	)	PUNCT
ihlr-22950	593	169	informs	inform	VERB
ihlr-22950	593	170	the	the	DET
ihlr-22950	593	171	provider	provider	NOUN
ihlr-22950	593	172	and	and	CCONJ
ihlr-22950	593	173	eligible	eligible	ADJ
ihlr-22950	593	174	patient	patient	NOUN
ihlr-22950	593	175	of	of	ADP
ihlr-22950	593	176	any	any	DET
ihlr-22950	593	177	known	know	VERB
ihlr-22950	593	178	or	or	CCONJ
ihlr-22950	593	179	anticipated	anticipate	VERB
ihlr-22950	593	180	side	side	NOUN
ihlr-22950	593	181	effects	effect	NOUN
ihlr-22950	593	182	,	,	PUNCT
ihlr-22950	593	183	risks	risk	NOUN
ihlr-22950	593	184	,	,	PUNCT
ihlr-22950	593	185	or	or	CCONJ
ihlr-22950	593	186	reported	report	VERB
ihlr-22950	593	187	patient	patient	ADJ
ihlr-22950	593	188	discomfort	discomfort	NOUN
ihlr-22950	593	189	that	that	PRON
ihlr-22950	593	190	is	be	AUX
ihlr-22950	593	191	likely	likely	ADV
ihlr-22950	593	192	related	relate	VERB
ihlr-22950	593	193	to	to	ADP
ihlr-22950	593	194	the	the	DET
ihlr-22950	593	195	treatment	treatment	NOUN
ihlr-22950	593	196	;	;	PUNCT
ihlr-22950	593	197	(	(	PUNCT
ihlr-22950	593	198	v	v	NOUN
ihlr-22950	593	199	)	)	PUNCT
ihlr-22950	593	200	describes	describe	VERB
ihlr-22950	593	201	the	the	DET
ihlr-22950	593	202	best	good	ADJ
ihlr-22950	593	203	and	and	CCONJ
ihlr-22950	593	204	worst	bad	ADJ
ihlr-22950	593	205	potential	potential	ADJ
ihlr-22950	593	206	outcomes	outcome	NOUN
ihlr-22950	593	207	of	of	ADP
ihlr-22950	593	208	using	use	VERB
ihlr-22950	593	209	the	the	DET
ihlr-22950	593	210	investigational	investigational	ADJ
ihlr-22950	593	211	drug	drug	NOUN
ihlr-22950	593	212	,	,	PUNCT
ihlr-22950	593	213	biological	biological	ADJ
ihlr-22950	593	214	product	product	NOUN
ihlr-22950	593	215	,	,	PUNCT
ihlr-22950	593	216	or	or	CCONJ
ihlr-22950	593	217	device	device	NOUN
ihlr-22950	593	218	with	with	ADP
ihlr-22950	593	219	a	a	DET
ihlr-22950	593	220	realistic	realistic	ADJ
ihlr-22950	593	221	description	description	NOUN
ihlr-22950	593	222	of	of	ADP
ihlr-22950	593	223	the	the	DET
ihlr-22950	593	224	most	most	ADV
ihlr-22950	593	225	likely	likely	ADJ
ihlr-22950	593	226	outcome	outcome	NOUN
ihlr-22950	593	227	,	,	PUNCT
ihlr-22950	593	228	including	include	VERB
ihlr-22950	593	229	the	the	DET
ihlr-22950	593	230	possibility	possibility	NOUN
ihlr-22950	593	231	that	that	SCONJ
ihlr-22950	593	232	new	new	ADJ
ihlr-22950	593	233	,	,	PUNCT
ihlr-22950	593	234	unanticipated	unanticipated	ADJ
ihlr-22950	593	235	,	,	PUNCT
ihlr-22950	593	236	different	different	ADJ
ihlr-22950	593	237	,	,	PUNCT
ihlr-22950	593	238	or	or	CCONJ
ihlr-22950	593	239	worse	bad	ADJ
ihlr-22950	593	240	symptoms	symptom	NOUN
ihlr-22950	593	241	might	might	AUX
ihlr-22950	593	242	result	result	VERB
ihlr-22950	593	243	and	and	CCONJ
ihlr-22950	593	244	that	that	SCONJ
ihlr-22950	593	245	death	death	NOUN
ihlr-22950	593	246	could	could	AUX
ihlr-22950	593	247	be	be	AUX
ihlr-22950	593	248	hastened	hasten	VERB
ihlr-22950	593	249	by	by	ADP
ihlr-22950	593	250	the	the	DET
ihlr-22950	593	251	proposed	propose	VERB
ihlr-22950	593	252	treatment	treatment	NOUN
ihlr-22950	593	253	,	,	PUNCT
ihlr-22950	593	254	based	base	VERB
ihlr-22950	593	255	on	on	ADP
ihlr-22950	593	256	the	the	DET
ihlr-22950	593	257	treating	treat	VERB
ihlr-22950	593	258	physician	physician	NOUN
ihlr-22950	593	259	’s	’s	PART
ihlr-22950	593	260	knowledge	knowledge	NOUN
ihlr-22950	593	261	of	of	ADP
ihlr-22950	593	262	the	the	DET
ihlr-22950	593	263	proposed	propose	VERB
ihlr-22950	593	264	treatment	treatment	NOUN
ihlr-22950	593	265	in	in	ADP
ihlr-22950	593	266	conjunction	conjunction	NOUN
ihlr-22950	593	267	with	with	ADP
ihlr-22950	593	268	an	an	DET
ihlr-22950	593	269	awareness	awareness	NOUN
ihlr-22950	593	270	of	of	ADP
ihlr-22950	593	271	the	the	DET
ihlr-22950	593	272	patient	patient	NOUN
ihlr-22950	593	273	’s	’s	PART
ihlr-22950	593	274	condition	condition	NOUN
ihlr-22950	593	275	;	;	PUNCT
ihlr-22950	593	276	(	(	PUNCT
ihlr-22950	593	277	vi	vi	X
ihlr-22950	593	278	)	)	PUNCT
ihlr-22950	593	279	makes	make	VERB
ihlr-22950	593	280	clear	clear	ADJ
ihlr-22950	593	281	that	that	SCONJ
ihlr-22950	593	282	the	the	DET
ihlr-22950	593	283	patient	patient	NOUN
ihlr-22950	593	284	’s	’s	PART
ihlr-22950	593	285	carrier	carrier	NOUN
ihlr-22950	593	286	and	and	CCONJ
ihlr-22950	593	287	health	health	NOUN
ihlr-22950	593	288	care	care	NOUN
ihlr-22950	593	289	provider	provider	NOUN
ihlr-22950	593	290	are	be	AUX
ihlr-22950	593	291	not	not	PART
ihlr-22950	593	292	obligated	obligate	VERB
ihlr-22950	593	293	to	to	PART
ihlr-22950	593	294	pay	pay	VERB
ihlr-22950	593	295	for	for	ADP
ihlr-22950	593	296	any	any	DET
ihlr-22950	593	297	care	care	NOUN
ihlr-22950	593	298	or	or	CCONJ
ihlr-22950	593	299	treatments	treatment	NOUN
ihlr-22950	593	300	that	that	PRON
ihlr-22950	593	301	are	be	AUX
ihlr-22950	593	302	necessary	necessary	ADJ
ihlr-22950	593	303	as	as	ADP
ihlr-22950	593	304	a	a	DET
ihlr-22950	593	305	result	result	NOUN
ihlr-22950	593	306	of	of	ADP
ihlr-22950	593	307	the	the	DET
ihlr-22950	593	308	use	use	NOUN
ihlr-22950	593	309	of	of	ADP
ihlr-22950	593	310	the	the	DET
ihlr-22950	593	311	investigational	investigational	ADJ
ihlr-22950	593	312	drug	drug	NOUN
ihlr-22950	593	313	,	,	PUNCT
ihlr-22950	593	314	biological	biological	ADJ
ihlr-22950	593	315	product	product	NOUN
ihlr-22950	593	316	,	,	PUNCT
ihlr-22950	593	317	or	or	CCONJ
ihlr-22950	593	318	device	device	NOUN
ihlr-22950	593	319	except	except	SCONJ
ihlr-22950	593	320	as	as	SCONJ
ihlr-22950	593	321	required	require	VERB
ihlr-22950	593	322	by	by	ADP
ihlr-22950	593	323	federal	federal	ADJ
ihlr-22950	593	324	or	or	CCONJ
ihlr-22950	593	325	state	state	NOUN
ihlr-22950	593	326	law	law	NOUN
ihlr-22950	593	327	or	or	CCONJ
ihlr-22950	593	328	contract	contract	NOUN
ihlr-22950	593	329	;	;	PUNCT
ihlr-22950	593	330	(	(	PUNCT
ihlr-22950	593	331	vii	vii	PROPN
ihlr-22950	593	332	)	)	PUNCT
ihlr-22950	593	333	makes	make	VERB
ihlr-22950	593	334	clear	clear	ADJ
ihlr-22950	593	335	that	that	SCONJ
ihlr-22950	593	336	the	the	DET
ihlr-22950	593	337	patient	patient	NOUN
ihlr-22950	593	338	’s	’s	PART
ihlr-22950	593	339	eligibility	eligibility	NOUN
ihlr-22950	593	340	for	for	ADP
ihlr-22950	593	341	hospice	hospice	NOUN
ihlr-22950	593	342	care	care	NOUN
ihlr-22950	593	343	may	may	AUX
ihlr-22950	593	344	be	be	AUX
ihlr-22950	593	345	withdrawn	withdraw	VERB
ihlr-22950	593	346	if	if	SCONJ
ihlr-22950	593	347	the	the	DET
ihlr-22950	593	348	patient	patient	NOUN
ihlr-22950	593	349	begins	begin	VERB
ihlr-22950	593	350	curative	curative	ADJ
ihlr-22950	593	351	treatment	treatment	NOUN
ihlr-22950	593	352	with	with	ADP
ihlr-22950	593	353	the	the	DET
ihlr-22950	593	354	investigational	investigational	ADJ
ihlr-22950	593	355	drug	drug	NOUN
ihlr-22950	593	356	,	,	PUNCT
ihlr-22950	593	357	biological	biological	ADJ
ihlr-22950	593	358	product	product	NOUN
ihlr-22950	593	359	,	,	PUNCT
ihlr-22950	593	360	or	or	CCONJ
ihlr-22950	593	361	device	device	NOUN
ihlr-22950	593	362	and	and	CCONJ
ihlr-22950	593	363	that	that	SCONJ
ihlr-22950	593	364	hospice	hospice	NOUN
ihlr-22950	593	365	care	care	NOUN
ihlr-22950	593	366	may	may	AUX
ihlr-22950	593	367	be	be	AUX
ihlr-22950	593	368	reinstated	reinstate	VERB
ihlr-22950	593	369	if	if	SCONJ
ihlr-22950	593	370	this	this	DET
ihlr-22950	593	371	treatment	treatment	NOUN
ihlr-22950	593	372	ends	end	VERB
ihlr-22950	593	373	and	and	CCONJ
ihlr-22950	593	374	the	the	DET
ihlr-22950	593	375	patient	patient	NOUN
ihlr-22950	593	376	meets	meet	VERB
ihlr-22950	593	377	hospice	hospice	NOUN
ihlr-22950	593	378	eligibility	eligibility	NOUN
ihlr-22950	593	379	requirements	requirement	NOUN
ihlr-22950	593	380	;	;	PUNCT
ihlr-22950	593	381	and	and	CCONJ
ihlr-22950	593	382	(	(	PUNCT
ihlr-22950	593	383	viii	viii	NOUN
ihlr-22950	593	384	)	)	PUNCT
ihlr-22950	593	385	states	state	NOUN
ihlr-22950	593	386	that	that	SCONJ
ihlr-22950	593	387	the	the	DET
ihlr-22950	593	388	patient	patient	NOUN
ihlr-22950	593	389	understands	understand	VERB
ihlr-22950	593	390	that	that	SCONJ
ihlr-22950	593	391	the	the	DET
ihlr-22950	593	392	patient	patient	NOUN
ihlr-22950	593	393	may	may	AUX
ihlr-22950	593	394	be	be	AUX
ihlr-22950	593	395	130	130	NUM
ihlr-22950	593	396	indiana	indiana	PROPN
ihlr-22950	593	397	health	health	NOUN
ihlr-22950	593	398	law	law	NOUN
ihlr-22950	593	399	review	review	NOUN
ihlr-22950	594	1	[	[	X
ihlr-22950	594	2	vol	vol	NOUN
ihlr-22950	594	3	.	.	PUNCT
ihlr-22950	595	1	16:101	16:101	NUM
ihlr-22950	595	2	liable	liable	ADJ
ihlr-22950	595	3	for	for	ADP
ihlr-22950	595	4	all	all	DET
ihlr-22950	595	5	expenses	expense	NOUN
ihlr-22950	595	6	relating	relate	VERB
ihlr-22950	595	7	to	to	ADP
ihlr-22950	595	8	the	the	DET
ihlr-22950	595	9	use	use	NOUN
ihlr-22950	595	10	of	of	ADP
ihlr-22950	595	11	the	the	DET
ihlr-22950	595	12	investigational	investigational	ADJ
ihlr-22950	595	13	drug	drug	NOUN
ihlr-22950	595	14	,	,	PUNCT
ihlr-22950	595	15	biological	biological	ADJ
ihlr-22950	595	16	product	product	NOUN
ihlr-22950	595	17	,	,	PUNCT
ihlr-22950	595	18	or	or	CCONJ
ihlr-22950	595	19	device	device	NOUN
ihlr-22950	595	20	and	and	CCONJ
ihlr-22950	595	21	that	that	SCONJ
ihlr-22950	595	22	this	this	DET
ihlr-22950	595	23	liability	liability	NOUN
ihlr-22950	595	24	extends	extend	VERB
ihlr-22950	595	25	to	to	ADP
ihlr-22950	595	26	the	the	DET
ihlr-22950	595	27	patient	patient	NOUN
ihlr-22950	595	28	’s	’s	PART
ihlr-22950	595	29	estate	estate	NOUN
ihlr-22950	595	30	,	,	PUNCT
ihlr-22950	595	31	but	but	CCONJ
ihlr-22950	595	32	not	not	PART
ihlr-22950	595	33	the	the	DET
ihlr-22950	595	34	heirs	heir	NOUN
ihlr-22950	595	35	or	or	CCONJ
ihlr-22950	595	36	legatees	legatee	NOUN
ihlr-22950	595	37	of	of	ADP
ihlr-22950	595	38	the	the	DET
ihlr-22950	595	39	patient	patient	NOUN
ihlr-22950	595	40	.	.	PUNCT
ihlr-22950	596	1	(	(	PUNCT
ihlr-22950	596	2	f	f	X
ihlr-22950	596	3	)	)	PUNCT
ihlr-22950	596	4	investigational	investigational	ADJ
ihlr-22950	596	5	drug	drug	NOUN
ihlr-22950	596	6	,	,	PUNCT
ihlr-22950	596	7	biological	biological	ADJ
ihlr-22950	596	8	product	product	NOUN
ihlr-22950	596	9	,	,	PUNCT
ihlr-22950	596	10	or	or	CCONJ
ihlr-22950	596	11	device	device	NOUN
ihlr-22950	596	12	.	.	PUNCT
ihlr-22950	596	13	-	-	PUNCT
ihlr-22950	597	1	“	"	PUNCT
ihlr-22950	597	2	investigational	investigational	ADJ
ihlr-22950	597	3	drug	drug	NOUN
ihlr-22950	597	4	,	,	PUNCT
ihlr-22950	597	5	biological	biological	ADJ
ihlr-22950	597	6	product	product	NOUN
ihlr-22950	597	7	,	,	PUNCT
ihlr-22950	597	8	or	or	CCONJ
ihlr-22950	597	9	device	device	NOUN
ihlr-22950	597	10	”	"	PUNCT
ihlr-22950	597	11	means	mean	VERB
ihlr-22950	597	12	a	a	DET
ihlr-22950	597	13	drug	drug	NOUN
ihlr-22950	597	14	,	,	PUNCT
ihlr-22950	597	15	biological	biological	ADJ
ihlr-22950	597	16	product	product	NOUN
ihlr-22950	597	17	,	,	PUNCT
ihlr-22950	597	18	or	or	CCONJ
ihlr-22950	597	19	device	device	NOUN
ihlr-22950	597	20	that	that	PRON
ihlr-22950	597	21	:	:	PUNCT
ihlr-22950	597	22	(	(	PUNCT
ihlr-22950	597	23	1	1	X
ihlr-22950	597	24	)	)	PUNCT
ihlr-22950	597	25	has	have	AUX
ihlr-22950	597	26	successfully	successfully	ADV
ihlr-22950	597	27	completed	complete	VERB
ihlr-22950	597	28	phase	phase	NOUN
ihlr-22950	597	29	i	i	PRON
ihlr-22950	597	30	of	of	ADP
ihlr-22950	597	31	a	a	DET
ihlr-22950	597	32	clinical	clinical	ADJ
ihlr-22950	597	33	trial	trial	NOUN
ihlr-22950	597	34	but	but	CCONJ
ihlr-22950	597	35	has	have	AUX
ihlr-22950	597	36	not	not	PART
ihlr-22950	597	37	yet	yet	ADV
ihlr-22950	597	38	been	be	AUX
ihlr-22950	597	39	approved	approve	VERB
ihlr-22950	597	40	for	for	ADP
ihlr-22950	597	41	general	general	ADJ
ihlr-22950	597	42	use	use	NOUN
ihlr-22950	597	43	by	by	ADP
ihlr-22950	597	44	the	the	DET
ihlr-22950	597	45	united	united	PROPN
ihlr-22950	597	46	states	states	PROPN
ihlr-22950	597	47	food	food	PROPN
ihlr-22950	597	48	and	and	CCONJ
ihlr-22950	597	49	drug	drug	NOUN
ihlr-22950	597	50	administration	administration	NOUN
ihlr-22950	597	51	;	;	PUNCT
ihlr-22950	597	52	and	and	CCONJ
ihlr-22950	597	53	(	(	PUNCT
ihlr-22950	597	54	2	2	X
ihlr-22950	597	55	)	)	PUNCT
ihlr-22950	597	56	remains	remain	VERB
ihlr-22950	597	57	under	under	ADP
ihlr-22950	597	58	investigation	investigation	NOUN
ihlr-22950	597	59	or	or	CCONJ
ihlr-22950	597	60	in	in	ADP
ihlr-22950	597	61	a	a	DET
ihlr-22950	597	62	clinical	clinical	ADJ
ihlr-22950	597	63	trial	trial	NOUN
ihlr-22950	597	64	approved	approve	VERB
ihlr-22950	597	65	by	by	ADP
ihlr-22950	597	66	the	the	DET
ihlr-22950	597	67	united	united	PROPN
ihlr-22950	597	68	states	states	PROPN
ihlr-22950	597	69	food	food	PROPN
ihlr-22950	597	70	and	and	CCONJ
ihlr-22950	597	71	drug	drug	NOUN
ihlr-22950	597	72	administration	administration	NOUN
ihlr-22950	597	73	.	.	PUNCT
ihlr-22950	598	1	(	(	PUNCT
ihlr-22950	598	2	g	g	NOUN
ihlr-22950	598	3	)	)	PUNCT
ihlr-22950	598	4	terminal	terminal	ADJ
ihlr-22950	598	5	illness	illness	NOUN
ihlr-22950	598	6	.	.	PUNCT
ihlr-22950	599	1	-	-	PUNCT
ihlr-22950	599	2	“	"	PUNCT
ihlr-22950	599	3	terminal	terminal	ADJ
ihlr-22950	599	4	illness	illness	NOUN
ihlr-22950	599	5	”	"	PUNCT
ihlr-22950	599	6	means	mean	VERB
ihlr-22950	599	7	a	a	DET
ihlr-22950	599	8	disease	disease	NOUN
ihlr-22950	599	9	or	or	CCONJ
ihlr-22950	599	10	condition	condition	NOUN
ihlr-22950	599	11	that	that	SCONJ
ihlr-22950	599	12	,	,	PUNCT
ihlr-22950	599	13	without	without	ADP
ihlr-22950	599	14	life	life	NOUN
ihlr-22950	599	15	-	-	PUNCT
ihlr-22950	599	16	sustaining	sustain	VERB
ihlr-22950	599	17	procedures	procedure	NOUN
ihlr-22950	599	18	,	,	PUNCT
ihlr-22950	599	19	will	will	AUX
ihlr-22950	599	20	result	result	VERB
ihlr-22950	599	21	in	in	ADP
ihlr-22950	599	22	death	death	NOUN
ihlr-22950	599	23	or	or	CCONJ
ihlr-22950	599	24	a	a	DET
ihlr-22950	599	25	state	state	NOUN
ihlr-22950	599	26	of	of	ADP
ihlr-22950	599	27	permanent	permanent	ADJ
ihlr-22950	599	28	unconsciousness	unconsciousness	NOUN
ihlr-22950	599	29	from	from	ADP
ihlr-22950	599	30	which	which	PRON
ihlr-22950	599	31	recovery	recovery	NOUN
ihlr-22950	599	32	is	be	AUX
ihlr-22950	599	33	unlikely	unlikely	ADJ
ihlr-22950	599	34	within	within	ADP
ihlr-22950	599	35	12	12	NUM
ihlr-22950	599	36	months	month	NOUN
ihlr-22950	599	37	.	.	PUNCT
ihlr-22950	600	1	f.	f.	PROPN
ihlr-22950	600	2	appendix	appendix	PROPN
ihlr-22950	600	3	vi126	vi126	PROPN
ihlr-22950	600	4	individual	individual	ADJ
ihlr-22950	600	5	patient	patient	NOUN
ihlr-22950	600	6	expanded	expand	VERB
ihlr-22950	600	7	access	access	NOUN
ihlr-22950	600	8	ind	ind	NOUN
ihlr-22950	600	9	application	application	NOUN
ihlr-22950	600	10	for	for	ADP
ihlr-22950	600	11	emergency	emergency	NOUN
ihlr-22950	600	12	use	use	NOUN
ihlr-22950	600	13	:	:	PUNCT
ihlr-22950	600	14	initial	initial	ADJ
ihlr-22950	600	15	submission	submission	NOUN
ihlr-22950	600	16	time	time	NOUN
ihlr-22950	600	17	action	action	NOUN
ihlr-22950	600	18	supporting	support	VERB
ihlr-22950	600	19	documentation	documentation	NOUN
ihlr-22950	600	20	day	day	NOUN
ihlr-22950	600	21	0	0	NUM
ihlr-22950	600	22	-	-	SYM
ihlr-22950	600	23	1	1	NUM
ihlr-22950	600	24	contact	contact	NOUN
ihlr-22950	600	25	sponsor	sponsor	NOUN
ihlr-22950	600	26	/	/	SYM
ihlr-22950	600	27	manufacturer	manufacturer	NOUN
ihlr-22950	600	28	to	to	PART
ihlr-22950	600	29	obtain	obtain	VERB
ihlr-22950	600	30	their	their	PRON
ihlr-22950	600	31	agreement	agreement	NOUN
ihlr-22950	600	32	to	to	PART
ihlr-22950	600	33	provide	provide	VERB
ihlr-22950	600	34	expanded	expand	VERB
ihlr-22950	600	35	access	access	NOUN
ihlr-22950	600	36	to	to	ADP
ihlr-22950	600	37	the	the	DET
ihlr-22950	600	38	investigational	investigational	ADJ
ihlr-22950	600	39	drug	drug	NOUN
ihlr-22950	600	40	letter	letter	NOUN
ihlr-22950	600	41	of	of	ADP
ihlr-22950	600	42	authorization	authorization	NOUN
ihlr-22950	600	43	from	from	ADP
ihlr-22950	600	44	sponsor	sponsor	NOUN
ihlr-22950	600	45	/	/	SYM
ihlr-22950	600	46	manufacturer	manufacturer	NOUN
ihlr-22950	600	47	granting	grant	VERB
ihlr-22950	600	48	a	a	DET
ihlr-22950	600	49	right	right	NOUN
ihlr-22950	600	50	of	of	ADP
ihlr-22950	600	51	reference	reference	NOUN
ihlr-22950	600	52	to	to	ADP
ihlr-22950	600	53	the	the	DET
ihlr-22950	600	54	information	information	NOUN
ihlr-22950	600	55	contained	contain	VERB
ihlr-22950	600	56	in	in	ADP
ihlr-22950	600	57	their	their	PRON
ihlr-22950	600	58	existing	exist	VERB
ihlr-22950	600	59	ind	ind	NOUN
ihlr-22950	600	60	•	•	NOUN
ihlr-22950	600	61	letter	letter	NOUN
ihlr-22950	600	62	of	of	ADP
ihlr-22950	600	63	authorization	authorization	NOUN
ihlr-22950	600	64	(	(	PUNCT
ihlr-22950	600	65	see	see	VERB
ihlr-22950	600	66	online	online	ADJ
ihlr-22950	600	67	template	template	NOUN
ihlr-22950	600	68	)	)	PUNCT
ihlr-22950	600	69	to	to	PART
ihlr-22950	600	70	be	be	AUX
ihlr-22950	600	71	sent	send	VERB
ihlr-22950	600	72	to	to	ADP
ihlr-22950	600	73	fda	fda	PROPN
ihlr-22950	600	74	at	at	ADP
ihlr-22950	600	75	the	the	DET
ihlr-22950	600	76	time	time	NOUN
ihlr-22950	600	77	of	of	ADP
ihlr-22950	600	78	application	application	NOUN
ihlr-22950	600	79	submission	submission	NOUN
ihlr-22950	600	80	by	by	ADP
ihlr-22950	600	81	day	day	NOUN
ihlr-22950	600	82	15	15	NUM
ihlr-22950	600	83	day	day	NOUN
ihlr-22950	600	84	1	1	NUM
ihlr-22950	600	85	call	call	NOUN
ihlr-22950	600	86	fda	fda	PROPN
ihlr-22950	600	87	to	to	PART
ihlr-22950	600	88	obtain	obtain	VERB
ihlr-22950	600	89	fda	fda	PROPN
ihlr-22950	600	90	authorization	authorization	NOUN
ihlr-22950	600	91	for	for	ADP
ihlr-22950	600	92	the	the	DET
ihlr-22950	600	93	expanded	expand	VERB
ihlr-22950	600	94	access	access	NOUN
ihlr-22950	600	95	use	use	NOUN
ihlr-22950	600	96	information	information	NOUN
ihlr-22950	600	97	will	will	AUX
ihlr-22950	600	98	be	be	AUX
ihlr-22950	600	99	requested	request	VERB
ihlr-22950	600	100	by	by	ADP
ihlr-22950	600	101	the	the	DET
ihlr-22950	600	102	fda	fda	PROPN
ihlr-22950	600	103	representative	representative	NOUN
ihlr-22950	600	104	and	and	CCONJ
ihlr-22950	600	105	can	can	AUX
ihlr-22950	600	106	be	be	AUX
ihlr-22950	600	107	provided	provide	VERB
ihlr-22950	600	108	via	via	ADP
ihlr-22950	600	109	phone	phone	NOUN
ihlr-22950	600	110	,	,	PUNCT
ihlr-22950	600	111	fax	fax	NOUN
ihlr-22950	600	112	,	,	PUNCT
ihlr-22950	600	113	or	or	CCONJ
ihlr-22950	600	114	e	e	NOUN
ihlr-22950	600	115	-	-	NOUN
ihlr-22950	600	116	mail	mail	NOUN
ihlr-22950	600	117	day	day	NOUN
ihlr-22950	600	118	1	1	NUM
ihlr-22950	600	119	obtain	obtain	VERB
ihlr-22950	600	120	informed	informed	ADJ
ihlr-22950	600	121	consent	consent	NOUN
ihlr-22950	600	122	from	from	ADP
ihlr-22950	600	123	patient	patient	NOUN
ihlr-22950	600	124	or	or	CCONJ
ihlr-22950	600	125	their	their	PRON
ihlr-22950	600	126	legally	legally	ADV
ihlr-22950	600	127	authorized	authorize	VERB
ihlr-22950	600	128	representative	representative	NOUN
ihlr-22950	600	129	prior	prior	ADV
ihlr-22950	600	130	to	to	ADP
ihlr-22950	600	131	administering	administer	VERB
ihlr-22950	600	132	treatment	treatment	NOUN
ihlr-22950	600	133	126	126	NUM
ihlr-22950	600	134	.	.	PUNCT
ihlr-22950	601	1	emergency	emergency	NOUN
ihlr-22950	601	2	ind	ind	PROPN
ihlr-22950	601	3	timeline	timeline	PROPN
ihlr-22950	601	4	,	,	PUNCT
ihlr-22950	601	5	supra	supra	PROPN
ihlr-22950	601	6	note	note	NOUN
ihlr-22950	601	7	123	123	NUM
ihlr-22950	601	8	.	.	PUNCT
ihlr-22950	602	1	2018	2018	NUM
ihlr-22950	602	2	]	]	PUNCT
ihlr-22950	602	3	the	the	DET
ihlr-22950	602	4	latest	late	ADJ
ihlr-22950	602	5	“	"	PUNCT
ihlr-22950	602	6	federal	federal	ADJ
ihlr-22950	602	7	movement	movement	NOUN
ihlr-22950	602	8	”	"	PUNCT
ihlr-22950	602	9	in	in	ADP
ihlr-22950	602	10	the	the	DET
ihlr-22950	602	11	food	food	NOUN
ihlr-22950	602	12	and	and	CCONJ
ihlr-22950	602	13	drug	drug	NOUN
ihlr-22950	602	14	law	law	NOUN
ihlr-22950	602	15	arena	arena	NOUN
ihlr-22950	602	16	131	131	NUM
ihlr-22950	602	17	posttreatment	posttreatment	NOUN
ihlr-22950	602	18	by	by	ADP
ihlr-22950	602	19	day	day	NOUN
ihlr-22950	602	20	5	5	NUM
ihlr-22950	602	21	notify	notify	VERB
ihlr-22950	602	22	institutional	institutional	ADJ
ihlr-22950	602	23	review	review	NOUN
ihlr-22950	602	24	board	board	NOUN
ihlr-22950	602	25	(	(	PUNCT
ihlr-22950	602	26	irb	irb	PROPN
ihlr-22950	602	27	)	)	PUNCT
ihlr-22950	602	28	of	of	ADP
ihlr-22950	602	29	the	the	DET
ihlr-22950	602	30	emergency	emergency	NOUN
ihlr-22950	602	31	expanded	expand	VERB
ihlr-22950	602	32	access	access	NOUN
ihlr-22950	602	33	use	use	NOUN
ihlr-22950	602	34	supporting	support	VERB
ihlr-22950	602	35	documentation	documentation	NOUN
ihlr-22950	602	36	as	as	SCONJ
ihlr-22950	602	37	required	require	VERB
ihlr-22950	602	38	by	by	ADP
ihlr-22950	602	39	the	the	DET
ihlr-22950	602	40	respective	respective	ADJ
ihlr-22950	602	41	applicable	applicable	ADJ
ihlr-22950	602	42	irb	irb	NOUN
ihlr-22950	602	43	by	by	ADP
ihlr-22950	602	44	day	day	NOUN
ihlr-22950	602	45	15	15	NUM
ihlr-22950	602	46	submit	submit	NOUN
ihlr-22950	602	47	the	the	DET
ihlr-22950	602	48	expanded	expand	VERB
ihlr-22950	602	49	access	access	NOUN
ihlr-22950	602	50	ind	ind	NOUN
ihlr-22950	602	51	application	application	NOUN
ihlr-22950	602	52	to	to	ADP
ihlr-22950	602	53	the	the	DET
ihlr-22950	602	54	appropriate	appropriate	ADJ
ihlr-22950	602	55	review	review	NOUN
ihlr-22950	602	56	division	division	NOUN
ihlr-22950	602	57	in	in	ADP
ihlr-22950	602	58	the	the	DET
ihlr-22950	602	59	center	center	NOUN
ihlr-22950	602	60	for	for	ADP
ihlr-22950	602	61	drug	drug	NOUN
ihlr-22950	602	62	evaluation	evaluation	NOUN
ihlr-22950	602	63	and	and	CCONJ
ihlr-22950	602	64	research	research	NOUN
ihlr-22950	602	65	(	(	PUNCT
ihlr-22950	602	66	cder	cder	NOUN
ihlr-22950	602	67	)	)	PUNCT
ihlr-22950	602	68	at	at	ADP
ihlr-22950	602	69	fda	fda	PROPN
ihlr-22950	602	70	insert	insert	VERB
ihlr-22950	602	71	your	your	PRON
ihlr-22950	602	72	ind	ind	NOUN
ihlr-22950	602	73	number	number	NOUN
ihlr-22950	602	74	,	,	PUNCT
ihlr-22950	602	75	provided	provide	VERB
ihlr-22950	602	76	to	to	ADP
ihlr-22950	602	77	you	you	PRON
ihlr-22950	602	78	by	by	ADP
ihlr-22950	602	79	fda	fda	PROPN
ihlr-22950	602	80	staff	staff	NOUN
ihlr-22950	602	81	,	,	PUNCT
ihlr-22950	602	82	in	in	ADP
ihlr-22950	602	83	the	the	DET
ihlr-22950	602	84	appropriate	appropriate	ADJ
ihlr-22950	602	85	section	section	NOUN
ihlr-22950	602	86	of	of	ADP
ihlr-22950	602	87	the	the	DET
ihlr-22950	602	88	application	application	NOUN
ihlr-22950	602	89	form	form	NOUN
ihlr-22950	602	90	(	(	PUNCT
ihlr-22950	602	91	e.g.	e.g.	ADV
ihlr-22950	602	92	,	,	PUNCT
ihlr-22950	602	93	section	section	NOUN
ihlr-22950	602	94	titled	title	VERB
ihlr-22950	602	95	,	,	PUNCT
ihlr-22950	602	96	physician	physician	NOUN
ihlr-22950	602	97	’s	’s	PART
ihlr-22950	602	98	ind	ind	NOUN
ihlr-22950	602	99	number	number	NOUN
ihlr-22950	602	100	in	in	ADP
ihlr-22950	602	101	section	section	NOUN
ihlr-22950	602	102	3	3	NUM
ihlr-22950	602	103	of	of	ADP
ihlr-22950	602	104	form	form	NOUN
ihlr-22950	602	105	fda	fda	PROPN
ihlr-22950	602	106	3926	3926	NUM
ihlr-22950	602	107	)	)	PUNCT
ihlr-22950	602	108	form	form	NOUN
ihlr-22950	602	109	fda	fda	PROPN
ihlr-22950	602	110	39261	39261	NUM
ihlr-22950	602	111	letter	letter	NOUN
ihlr-22950	602	112	of	of	ADP
ihlr-22950	602	113	authorization2	authorization2	NOUN
ihlr-22950	602	114	from	from	ADP
ihlr-22950	602	115	sponsor	sponsor	NOUN
ihlr-22950	602	116	/	/	SYM
ihlr-22950	602	117	manufacturer	manufacturer	NOUN
ihlr-22950	602	118	form	form	NOUN
ihlr-22950	602	119	fda	fda	PROPN
ihlr-22950	602	120	1571	1571	NUM
ihlr-22950	602	121	and	and	CCONJ
ihlr-22950	602	122	1572	1572	NUM
ihlr-22950	602	123	are	be	AUX
ihlr-22950	602	124	also	also	ADV
ihlr-22950	602	125	accepted	accept	VERB
ihlr-22950	602	126	,	,	PUNCT
ihlr-22950	602	127	however	however	ADV
ihlr-22950	602	128	,	,	PUNCT
ihlr-22950	602	129	form	form	VERB
ihlr-22950	602	130	fda	fda	PROPN
ihlr-22950	602	131	3926	3926	NUM
ihlr-22950	602	132	is	be	AUX
ihlr-22950	602	133	a	a	DET
ihlr-22950	602	134	streamlined	streamlined	ADJ
ihlr-22950	602	135	form	form	NOUN
ihlr-22950	602	136	created	create	VERB
ihlr-22950	602	137	specifically	specifically	ADV
ihlr-22950	602	138	for	for	ADP
ihlr-22950	602	139	individual	individual	ADJ
ihlr-22950	602	140	patient	patient	ADJ
ihlr-22950	602	141	ind	ind	NOUN
ihlr-22950	602	142	submissions	submission	NOUN
ihlr-22950	602	143	,	,	PUNCT
ihlr-22950	602	144	including	include	VERB
ihlr-22950	602	145	those	those	PRON
ihlr-22950	602	146	for	for	ADP
ihlr-22950	602	147	emergency	emergency	NOUN
ihlr-22950	602	148	use	use	NOUN
ihlr-22950	602	149	.	.	PUNCT
ihlr-22950	603	1	in	in	ADP
ihlr-22950	603	2	the	the	DET
ihlr-22950	603	3	absence	absence	NOUN
ihlr-22950	603	4	of	of	ADP
ihlr-22950	603	5	a	a	DET
ihlr-22950	603	6	letter	letter	NOUN
ihlr-22950	603	7	of	of	ADP
ihlr-22950	603	8	authorization	authorization	NOUN
ihlr-22950	603	9	from	from	ADP
ihlr-22950	603	10	the	the	DET
ihlr-22950	603	11	sponsor	sponsor	NOUN
ihlr-22950	603	12	/	/	SYM
ihlr-22950	603	13	manufacturer	manufacturer	NOUN
ihlr-22950	603	14	,	,	PUNCT
ihlr-22950	603	15	the	the	DET
ihlr-22950	603	16	expanded	expand	VERB
ihlr-22950	603	17	access	access	NOUN
ihlr-22950	603	18	ind	ind	NOUN
ihlr-22950	603	19	application	application	NOUN
ihlr-22950	603	20	’s	’s	PART
ihlr-22950	603	21	sponsor	sponsor	NOUN
ihlr-22950	603	22	is	be	AUX
ihlr-22950	603	23	responsible	responsible	ADJ
ihlr-22950	603	24	for	for	ADP
ihlr-22950	603	25	providing	provide	VERB
ihlr-22950	603	26	the	the	DET
ihlr-22950	603	27	following	following	NOUN
ihlr-22950	603	28	in	in	ADP
ihlr-22950	603	29	the	the	DET
ihlr-22950	603	30	ind	ind	NOUN
ihlr-22950	603	31	application	application	NOUN
ihlr-22950	603	32	submission	submission	NOUN
ihlr-22950	603	33	:	:	PUNCT
ihlr-22950	603	34	•	•	NUM
ihlr-22950	603	35	description	description	NOUN
ihlr-22950	603	36	of	of	ADP
ihlr-22950	603	37	the	the	DET
ihlr-22950	603	38	facility	facility	NOUN
ihlr-22950	603	39	where	where	SCONJ
ihlr-22950	603	40	the	the	DET
ihlr-22950	603	41	drug	drug	NOUN
ihlr-22950	603	42	is	be	AUX
ihlr-22950	603	43	manufactured	manufacture	VERB
ihlr-22950	603	44	;	;	PUNCT
ihlr-22950	603	45	•	•	NUM
ihlr-22950	603	46	chemistry	chemistry	NOUN
ihlr-22950	603	47	,	,	PUNCT
ihlr-22950	603	48	manufacturing	manufacturing	NOUN
ihlr-22950	603	49	,	,	PUNCT
ihlr-22950	603	50	and	and	CCONJ
ihlr-22950	603	51	controls	control	VERB
ihlr-22950	603	52	information	information	NOUN
ihlr-22950	603	53	adequate	adequate	ADJ
ihlr-22950	603	54	to	to	PART
ihlr-22950	603	55	ensure	ensure	VERB
ihlr-22950	603	56	the	the	DET
ihlr-22950	603	57	proper	proper	ADJ
ihlr-22950	603	58	identification	identification	NOUN
ihlr-22950	603	59	,	,	PUNCT
ihlr-22950	603	60	quality	quality	NOUN
ihlr-22950	603	61	,	,	PUNCT
ihlr-22950	603	62	purity	purity	NOUN
ihlr-22950	603	63	,	,	PUNCT
ihlr-22950	603	64	and	and	CCONJ
ihlr-22950	603	65	strength	strength	NOUN
ihlr-22950	603	66	of	of	ADP
ihlr-22950	603	67	the	the	DET
ihlr-22950	603	68	investigational	investigational	ADJ
ihlr-22950	603	69	drug	drug	NOUN
ihlr-22950	603	70	;	;	PUNCT
ihlr-22950	603	71	•	•	NUM
ihlr-22950	603	72	pharmacology	pharmacology	NOUN
ihlr-22950	603	73	and	and	CCONJ
ihlr-22950	603	74	toxicology	toxicology	NOUN
ihlr-22950	603	75	information	information	NOUN
ihlr-22950	603	76	adequate	adequate	ADJ
ihlr-22950	603	77	to	to	PART
ihlr-22950	603	78	conclude	conclude	VERB
ihlr-22950	603	79	that	that	SCONJ
ihlr-22950	603	80	the	the	DET
ihlr-22950	603	81	drug	drug	NOUN
ihlr-22950	603	82	is	be	AUX
ihlr-22950	603	83	reasonably	reasonably	ADV
ihlr-22950	603	84	safe	safe	ADJ
ihlr-22950	603	85	at	at	ADP
ihlr-22950	603	86	the	the	DET
ihlr-22950	603	87	dose	dose	NOUN
ihlr-22950	603	88	and	and	CCONJ
ihlr-22950	603	89	duration	duration	NOUN
ihlr-22950	603	90	proposed	propose	VERB
ihlr-22950	603	91	for	for	ADP
ihlr-22950	603	92	the	the	DET
ihlr-22950	603	93	emergency	emergency	NOUN
ihlr-22950	603	94	use	use	NOUN
ihlr-22950	603	95	.	.	PUNCT
ihlr-22950	604	1	section	section	NOUN
ihlr-22950	604	2	1	1	NUM
ihlr-22950	604	3	.	.	PUNCT
ihlr-22950	604	4	short	short	ADJ
ihlr-22950	604	5	title	title	NOUN
ihlr-22950	604	6	.	.	PUNCT
ihlr-22950	605	1	(	(	PUNCT
ihlr-22950	605	2	a	a	X
ihlr-22950	605	3	)	)	PUNCT
ihlr-22950	605	4	in	in	ADP
ihlr-22950	605	5	general.—chapter	general.—chapter	NOUN
ihlr-22950	605	6	v	v	NOUN
ihlr-22950	605	7	of	of	ADP
ihlr-22950	605	8	the	the	DET
ihlr-22950	605	9	federal	federal	ADJ
ihlr-22950	605	10	food	food	NOUN
ihlr-22950	605	11	,	,	PUNCT
ihlr-22950	605	12	drug	drug	NOUN
ihlr-22950	605	13	,	,	PUNCT
ihlr-22950	605	14	and	and	CCONJ
ihlr-22950	605	15	cosmetic	cosmetic	ADJ
ihlr-22950	605	16	act	act	NOUN
ihlr-22950	605	17	is	be	AUX
ihlr-22950	605	18	amended	amend	VERB
ihlr-22950	605	19	by	by	ADP
ihlr-22950	605	20	inserting	insert	VERB
ihlr-22950	605	21	after	after	ADP
ihlr-22950	605	22	section	section	NOUN
ihlr-22950	605	23	561a	561a	NUM
ihlr-22950	605	24	(	(	PUNCT
ihlr-22950	605	25	21	21	NUM
ihlr-22950	605	26	u.s.c	u.s.c	NOUN
ihlr-22950	605	27	.	.	PUNCT
ihlr-22950	606	1	360bbb–0	360bbb–0	NUM
ihlr-22950	606	2	)	)	PUNCT
ihlr-22950	606	3	the	the	DET
ihlr-22950	606	4	following	following	NOUN
ihlr-22950	606	5	:	:	PUNCT
ihlr-22950	606	6	“	"	PUNCT
ihlr-22950	606	7	sec	sec	PROPN
ihlr-22950	606	8	.	.	PUNCT
ihlr-22950	606	9	561b	561b	NUM
ihlr-22950	606	10	.	.	PUNCT
ihlr-22950	606	11	investigational	investigational	ADJ
ihlr-22950	606	12	drugs	drug	NOUN
ihlr-22950	606	13	for	for	ADP
ihlr-22950	606	14	use	use	NOUN
ihlr-22950	606	15	by	by	ADP
ihlr-22950	606	16	eligible	eligible	ADJ
ihlr-22950	606	17	patients	patient	NOUN
ihlr-22950	606	18	.	.	PUNCT
ihlr-22950	607	1	(	(	PUNCT
ihlr-22950	607	2	b	b	X
ihlr-22950	607	3	)	)	PUNCT
ihlr-22950	607	4	no	no	DET
ihlr-22950	607	5	liability	liability	NOUN
ihlr-22950	607	6	.	.	PUNCT
ihlr-22950	607	7	—	—	PUNCT
ihlr-22950	607	8	sec	sec	PROPN
ihlr-22950	607	9	.	.	PROPN
ihlr-22950	608	1	3	3	X
ihlr-22950	608	2	.	.	X
ihlr-22950	608	3	sense	sense	NOUN
ihlr-22950	608	4	of	of	ADP
ihlr-22950	608	5	the	the	DET
ihlr-22950	608	6	senate	senate	PROPN
ihlr-22950	608	7	.	.	PUNCT
