```

[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>
```