[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4672 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  2d Session
                                S. 4672

To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and 
                          for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 23, 2020

  Mr. Reed (for himself, Mr. Burr, Ms. Smith, and Mr. Scott of South 
   Carolina) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To reauthorize the Stem Cell Therapeutic and Research Act of 2005, 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 ``Timely ReAuthorization of Necessary 
Stem-cell Programs Lends Access to Needed Therapies Act of 2020'' or 
the ``TRANSPLANT Act of 2020''.

SEC. 2. REAUTHORIZATION OF THE C.W. BILL YOUNG CELL TRANSPLANTATION 
              PROGRAM.

    (a) Advisory Council Meetings.--Subsection (a) of section 379 of 
the Public Health Service Act (42 U.S.C. 274k) is amended by adding at 
the end the following new paragraph:
            ``(7) The Advisory Council shall meet not less frequently 
        than 2 times per year.''.
    (b) Increasing Collection.--
            (1) Technical clarification.--Effective as if included in 
        the enactment of Public Law 114-104 (the Stem Cell Therapeutic 
        and Research Reauthorization Act of 2015), the amendment to 
        section 379(d)(2)(B) of the Public Health Service Act (42 
        U.S.C. 274k(d)(2)(B)) in section 2(a)(2) of Public Law 114-104 
        is amended--
                    (A) by inserting ``through'' before ``remote 
                collection,''; and
                    (B) by inserting ``goal of increasing collections 
                of high quality'' before ``cord blood units,''.
            (2) Technical update.--Subparagraph (B) of section 
        379(d)(2) of the Public Health Service Act (42 U.S.C. 
        274k(d)(2)) is amended by striking the second and third 
        sentences in such subparagraph.
    (c) Periodic Review of State of Science.--Section 379 of the Public 
Health Service Act (42 U.S.C. 274k) is amended by adding at the end the 
following:
    ``(o) Periodic Review of State of Science.--
            ``(1) Review.--The Secretary, in consultation with the 
        Director of the National Institutes of Health, the Commissioner 
        of Food and Drugs, the Administrator of the Health Resources 
        and Services Administration, the Advisory Council, and other 
        stakeholders, where appropriate given relevant expertise, shall 
        conduct a review of the state of the science of using adult 
        stem cells and birth tissue products to develop new types of 
        therapies for patients, for the purpose of considering the 
        potential inclusion of such new types of therapies in the 
        Program.
            ``(2) Recommendations.--Not later than June 30, 2023, and 
        every 3 years thereafter, the Secretary shall--
                    ``(A) complete the review required by paragraph 
                (1); and
                    ``(B) informed by such review, 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 recommendations on the 
                appropriateness of the inclusion of new types of 
                therapies in the Program.''.
    (d) Authorization of Appropriations.--Section 379B of the Public 
Health Service Act (42 U.S.C. 274m) is amended by striking 
``$33,000,000 for fiscal year 2015 and $30,000,000 for each of fiscal 
years 2016 through 2020'' and inserting ``$30,000,000 for each of 
fiscal years 2021 through 2025''.

SEC. 3. CORD BLOOD INVENTORY.

    Subsection (g) of section 2 of the Stem Cell Therapeutic and 
Research Act of 2005 (42 U.S.C. 274k note) is amended to read as 
follows:
    ``(g) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $23,000,000 for each of fiscal 
years 2021 through 2025.''.

SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDICINE.

    (a) National Institutes of Health.--Section 402 of the Public 
Health Service Act (42 U.S.C. 282) is amended by adding at the end the 
following:
    ``(o) Regenerative Medicine.--The Director of NIH shall, as 
appropriate, continue to consult with the directors of relevant 
institutes and centers of the National Institutes of Health, other 
relevant experts from such institutes and centers, and relevant experts 
within the Food and Drug Administration, to further the field of 
regenerative medicine using adult stem cells, including autologous stem 
cells, therapeutic tissue engineering products, human cell and tissue 
products, human gene therapies, and genetically modified cells.''.
    (b) GAO Report.--Not later than 2 years after the date of enactment 
of this Act, the Comptroller General of the United States shall 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 a report that assesses the workforce related to the 
C.W. Bill Young Cell Transplantation Program established under section 
379 of the Public Health Service Act (42 U.S.C. 274k). The report shall 
include--
            (1) an overview of the current employment levels, in both 
        commercial and academic settings, for--
                    (A) positions necessary for the collection and 
                transplantation of stem cell therapeutics, including 
                bone marrow and cord blood; and
                    (B) positions in the field of regenerative medicine 
                using adult stem cells and related to product 
                development;
            (2) the identification of gaps, if any, in the projected 
        workforce capacity for--
                    (A) positions described in paragraph (1)(A); and
                    (B) the field of regenerative medicine using adult 
                stem cells, including workforce gaps related to the 
                development of new cellular therapies using adult stem 
                cells;
            (3) an overview of the availability of training programs 
        related to the development, refinement, and utilization of 
        adult stem cells, including training on good manufacturing 
        practices for such activities, and the performance of such 
        programs; and
            (4) recommendations, if any, for improving the workforce 
        capacity related to--
                    (A) the positions described in paragraph (1)(A); or
                    (B) the field of regenerative medicine using adult 
                stem cells.
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