[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8251 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 8251
To direct the Secretary of Health and Human Services to streamline
regulatory oversight of human cell and tissue products, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 6, 2024
Mr. Crenshaw (for himself and Ms. Barragan) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To direct the Secretary of Health and Human Services to streamline
regulatory oversight of human cell and tissue products, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``The HCT/P Modernization Act of
2024''.
SEC. 2. STREAMLINING REGULATORY OVERSIGHT OF HUMAN CELL AND TISSUE
PRODUCTS.
(a) Regulatory Classification Inquiries.--
(1) Inquiry described.--An inquiry described in this
paragraph is an inquiry--
(A) made by the manufacturer or sponsor of a human
cell and tissue product;
(B) to the Tissue Reference Group; and
(C) for information regarding the regulatory
classification of whether such product is subject to
regulation solely under section 361 of the Public
Health Service Act (42 U.S.C. 264) and part 1271 or
title 21, Code of Federal Regulations (or successor
regulations).
(2) Response by secretary.--Not later than 70 days after
receipt of a written inquiry described in subsection (a) from a
manufacturer or sponsor of a human cell and tissue product, the
Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall provide such manufacturer
or sponsor--
(A) a nonbinding, written statement on whether such
product is subject to regulation solely under section
361 of the Public Health Service Act (42 U.S.C. 264)
and part 1271 or title 21, Code of Federal Regulations
(or successor regulations); or
(B) a notification that the manufacturer or sponsor
must resubmit the inquiry with additional information.
(3) Request to meet with tissue reference group.--
(A) Request.--Upon receipt of a statement under
paragraph (2)(A), the manufacturer or sponsor of a
human cell and tissue product may request a meeting
with the Tissue Reference Group to discuss the decision
in such statement regarding the product's regulatory
classification.
(B) Meeting required.--Upon receipt of a request
under subparagraph (A), the Tissue Reference Group
shall hold a meeting with the requesting manufacturer
or sponsor.
(b) Public Meeting.--Not later than 90 days after the date of
enactment of this Act, the Secretary shall publish in the Federal
Register a notice to convene a public meeting to discuss and obtain
input and recommendations from relevant stakeholders, including
industry, tissue establishments, academic health centers, biomedical
consortia, research organizations, and patients, regarding--
(1) the definition of the term ``minimal manipulation''
under section 1271.3 of title 21, Code of Federal Regulations,
including--
(A) previous and current interpretations of such
term;
(B) the landscape of products which have been
identified by the Food and Drug Administration as
meeting--
(i) such definition of ``minimal
manipulation'';
(ii) the definition of ``more than
minimally manipulated'' as used the guidance of
the Food and Drug Administration titled
``Regulatory Considerations for Human Cells,
Tissues, and Cellular and Tissue-Based
Products: Minimal Manipulation and Homologous
Use'' (dated July 2020) (or any successor
guidance); or
(iii) neither the definition referred to in
clause (i) or (ii);
(C) the approximate scope of use of such products;
and
(D) any changes to the interpretation of ``minimal
manipulation'' that may be necessary to meet the risk
benefit of such products; and
(2) considerations in assessing homologous use of human
cell and tissue products, and the character and function of
human cell and tissue products, including--
(A) previous and current considerations of such
use, character, and function; and
(B) potential such considerations with respect to
products described in paragraph (1)(B).
(c) Updates to Regulations and Guidance.--
(1) In general.--Not later than 12 months after the date of
enactment of this Act, the Secretary shall update the criteria
for homologous use and the other criteria under section
1271.10(a) of title 21, Code of Federal Regulations, and the
definition of minimal manipulation under section 1271.3 of such
title 21, with the goals of--
(A) minimizing regulatory burden;
(B) protecting public health; and
(C) maintaining the existence of the current
pathways by which certain human cell and tissue
products are marketed under section 361 of the Public
Health Service Act (42 U.S.C. 264), certain biological
products are licensed under section 351 of the Public
Health Service Act (42 U.S.C. 351), and certain drugs
are approved under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355).
(2) Technical assistance; education.--The Secretary shall,
with respect to the regulation of human cell and tissue
products, including the updates under paragraph (1)--
(A) provide technical assistance to relevant
stakeholders, including industry, tissue
establishments, academic health centers, biomedical
consortia, research organizations, and patients; and
(B) at least every six months, initiate and conduct
workshops and other interactive and educational
sessions for such stakeholders.
(d) Reports to Congress.--
(1) Report on meeting.--Not later than 12 months after the
date of enactment of this Act, the Secretary shall submit a
report to the Congress on the results of the meeting under
subsection (b).
(2) Annual report.--Not later than March 1, 2025, and March
1 of each calendar year thereafter, the Secretary shall, with
respect to the previous calendar year, submit to the Committee
on Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives, and publish on the internet website of the
Department of Health and Human Services, a report on--
(A) the number and type of inquiries received by
the Tissue Reference Group;
(B) the average response time for inquiries
received by the Tissue Reference Group, including the
average response times for initial and final responses;
and
(C) with respect to final decisions issued by the
Tissue Reference Group, the number of human cell and
tissue products determined to be regulated under each
regulatory category.
(e) Definitions.--In this section:
(1) The term ``human cell and tissue product''--
(A) means a ``human cells, tissues, or cellular or
tissue based product'' as such term is defined in
section 1271.3 of title 21, Code of Federal Regulations
(or successor regulations); and
(B) includes any such product regardless of whether
it is approved for marketing, approved for
investigational use, or merely proposed.
(2) The term ``Secretary'' means the Secretary of Health
and Human Services, acting through the Commissioner of Food and
Drugs.
(3) The term ``Tissue Reference Group'' means the Tissue
Reference Group of the Food and Drug Administration.
<all>