Us Congress 2025-2026 Regular Session

Us Congress House Bill HB1082 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 1082
5	5	To require the Secretary of Health and Human Services to conduct a national,
6	6	evidence-based education campaign to increase public and health care
7	7	provider awareness regarding the potential risks and benefits of human
8	8	cell and tissue products transplants, and for other purposes.
9	9	IN THE HOUSE OF REPRESENTATIVES
10	10	FEBRUARY6, 2025
11	11	Mr. M
12	12	OOLENAAR(for himself and Mrs. DINGELL) introduced the following
13	13	bill; which was referred to the Committee on Energy and Commerce
14	14	A BILL
15	15	To require the Secretary of Health and Human Services
16	16	to conduct a national, evidence-based education campaign
17	17	to increase public and health care provider awareness
18	18	regarding the potential risks and benefits of human cell
19	19	and tissue products transplants, and for other purposes.
20	20	Be it enacted by the Senate and House of Representa-1
21	21	tives of the United States of America in Congress assembled, 2
22	22	SECTION 1. SHORT TITLE. 3
23	23	This Act may be cited as the ‘‘Shandra Eisenga 4
24	24	Human Cell and Tissue Product Safety Act’’. 5
25	25	SEC. 2. DEFINITIONS. 6
26	26	In this Act: 7
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29	29	•HR 1082 IH
30	30	(1) HUMAN CELL AND TISSUE PRODUCT .—The 1
31	31	terms ‘‘human cell and tissue product’’ and ‘‘human 2
32	32	cell and tissue products’’ have the meaning given the 3
33	33	term ‘‘human cells, tissues, or cellular or tissue- 4
34	34	based products’’ in section 1271.3(d) of title 21, 5
35	35	Code of Federal Regulations (or successor regula-6
36	36	tions). 7
37	37	(2) S
38	38	ECRETARY.—The term ‘‘Secretary’’ means 8
39	39	the Secretary of Health and Human Services. 9
40	40	(3) T
41	41	ISSUE REFERENCE GROUP .—The term 10
42	42	‘‘Tissue Reference Group’’ means the Tissue Ref-11
43	43	erence Group of the Food and Drug Administration. 12
44	44	SEC. 3. HUMAN CELL AND TISSUE PRODUCTS TRANSPLANT 13
45	45	PUBLIC AWARENESS CAMPAIGN. 14
46	46	The Secretary shall support the development and dis-15
47	47	semination of educational materials to inform health care 16
48	48	professionals and other appropriate professionals about 17
49	49	issues surrounding— 18
50	50	(1) organ, tissue, and eye donation, including 19
51	51	evidence-based methods to approach patients and 20
52	52	their families; 21
53	53	(2) the availability of any donor screening tests; 22
54	54	and 23
55	55	(3) other relevant aspects of donation. 24
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58	58	•HR 1082 IH
59	59	SEC. 4. CIVIL PENALTIES FOR VIOLATION OF REQUIRE-1
60	60	MENTS FOR HUMAN CELL AND TISSUE PROD-2
61	61	UCTS. 3
62	62	Section 368 of the Public Health Service Act (42 4
63	63	U.S.C. 271) is amended by adding at the end the fol-5
64	64	lowing: 6
65	65	‘‘(d)(1) Any person who, on or after the date of the 7
66	66	enactment of the Shandra Eisenga Human Cell and Tis-8
67	67	sue Product Safety Act, violates a requirement of subparts 9
68	68	C or D of section 1271 of title 21, Code of Federal Regu-10
69	69	lations, (or successor regulations) with respect to human 11
70	70	cell or tissue products regulated under section 361 shall 12
71	71	be liable to the United States for a civil penalty in an 13
72	72	amount not to exceed the sum of— 14
73	73	‘‘(A)(i) $20,000 for each violation; and 15
74	74	‘‘(ii) in the case of a violation that continues 16
75	75	after the Secretary provides written notice to such 17
76	76	person, $20,000 for each subsequent day on which 18
77	77	the violation continues; and 19
78	78	‘‘(B) an amount equal to the retail value of the 20
79	79	human cell and tissue products that are the subject 21
80	80	of the violation. 22
81	81	‘‘(2) The total civil penalty under paragraph (1) may 23
82	82	not exceed $10,000,000 for all such violations adjudicated 24
83	83	in a single proceeding. 25
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86	86	•HR 1082 IH
87	87	‘‘(3) In this subsection, the term ‘human cell and tis-1
88	88	sue products’ has the meaning given the term ‘human 2
89	89	cells, tissues, or cellular or tissue-based products’ in sec-3
90	90	tion 1271.3(d) of title 21, Code of Federal Regulations 4
91	91	(or successor regulations).’’. 5
92	92	SEC. 5. STREAMLINING REGULATORY OVERSIGHT OF 6
93	93	HUMAN CELL AND TISSUE PRODUCTS. 7
94	94	(a) I
95	95	NFORMATION ON HUMANCELL ANDTISSUE 8
96	96	P
97	97	RODUCTS.— 9
98	98	(1) W
99	99	EBSITE.—The Secretary, acting through 10
100	100	the Commissioner of Food and Drugs, shall publish 11
101	101	on the public website of the Food and Drug Admin-12
102	102	istration— 13
103	103	(A) educational materials about the Tissue 14
104	104	Reference Group; and 15
105	105	(B) best practices for obtaining a timely, 16
106	106	accurate recommendation regarding human cell 17
107	107	and tissue products from the Tissue Reference 18
108	108	Group. 19
109	109	(2) P
110	110	UBLIC INFORMATION.—Not later than 1 20
111	111	year after the date of the enactment of this Act, and 21
112	112	annually for the subsequent 3 years, the Secretary, 22
113	113	acting through the Commissioner of Food and 23
114	114	Drugs, shall publish on the public website of the 24
115	115	Food and Drug Administration— 25
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118	118	•HR 1082 IH
119	119	(A) the number of human cell and tissue 1
120	120	establishments that registered with the Food 2
121	121	and Drug Administration on or after January 3
122	122	1, 2019; 4
123	123	(B) the number of inspections conducted 5
124	124	by the Food and Drug Administration of 6
125	125	human cell and tissue establishments on or 7
126	126	after January 1, 2019, including a comparison 8
127	127	of the number of inspections for blood establish-9
128	128	ments with the number of inspections for such 10
129	129	human cell and tissue establishments; 11
130	130	(C) the number and type of inquiries to 12
131	131	the Tissue Reference Group in the preceding 13
132	132	year; and 14
133	133	(D) the average response time for submis-15
134	134	sions to the Tissue Reference Group in the pre-16
135	135	ceding year, including average initial and final 17
136	136	response time. 18
137	137	(3) E
138	138	DUCATION.—The Secretary, acting 19
139	139	through the Commissioner of Food and Drugs, shall, 20
140	140	with respect to the regulation of human cell and tis-21
141	141	sue products— 22
142	142	(A) provide information to relevant stake-23
143	143	holders, including industry, tissue establish-24
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146	146	•HR 1082 IH
147	147	ments, academic health centers, biomedical con-1
148	148	sortia, research organizations, and patients; and 2
149	149	(B) conduct workshops and other inter-3
150	150	active and educational sessions for such stake-4
151	151	holders to help support regulatory predictability 5
152	152	and scientific advancement, as appropriate. 6
153	153	(b) H
154	154	UMANCELL ANDTISSUEPRODUCTSCIENTIFIC 7
155	155	ANDREGULATORYUPDATES.—Section 3205 of the Food 8
156	156	and Drug Omnibus Reform Act of 2022 (title III of divi-9
157	157	sion FF of Public Law 117–328) is amended by striking 10
158	158	‘‘best practices’’ and all that follows through ‘‘other cel-11
159	159	lular therapies’’ and inserting ‘‘best practices on gener-12
160	160	ating scientific data necessary to further facilitate the de-13
161	161	velopment of certain human cell-, tissue-, and cellular- 14
162	162	based medical products (and the latest scientific informa-15
163	163	tion about such products), namely, stem cell and other cel-16
164	164	lular therapies’’. 17
165	165	(c) P
166	166	UBLICDOCKET.—Not later than 60 days after 18
167	167	the date of the enactment of this Act, the Secretary shall 19
168	168	establish a public docket to receive written comments re-20
169	169	lated to— 21
170	170	(1) the approaches recommended for discussion 22
171	171	during the public workshop described in section 23
172	172	3205 of the Food and Drug Omnibus Reform Act of 24
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175	175	•HR 1082 IH
176	176	2022 (title III of division FF of Public Law 117– 1
177	177	328); and 2
178	178	(2) modernizing the regulation of human cell 3
179	179	and tissue products, including considerations associ-4
180	180	ated with assessing minimal manipulation and ho-5
181	181	mologous use (as such terms are defined in section 6
182	182	1271.3 of title 21, Code of Federal Regulations (or 7
183	183	successor regulations)) of human cell and tissue 8
184	184	products. 9
185	185	(d) R
186	186	EPORT TOCONGRESS.—Not later than Sep-10
187	187	tember 30, 2026, the Secretary shall summarize the ap-11
188	188	proaches discussed in the public workshop described in 12
189	189	section 3205 of the Food and Drug Omnibus Reform Act 13
190	190	of 2022 (title III of division FF of Public Law 117–328) 14
191	191	and the public docket described in subsection (c), and de-15
192	192	velop recommendations regarding the regulation of human 16
193	193	cell and tissue products, including provisions under sec-17
194	194	tions 1271.10(a) and 1271.3 of title 21, Code of Federal 18
195	195	Regulations, taking into account— 19
196	196	(1) regulatory burden; 20
197	197	(2) scientific developments; 21
198	198	(3) access to human cell and tissue products 22
199	199	regulated under section 361 of the Public Health 23
200	200	Service Act (42 U.S.C. 264); and 24
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203	203	•HR 1082 IH
204	204	(4) protecting public health. 1
205	205	Æ
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