Title: TRANSPLANT Act of 2021
Policy area: Health

Summary:
Timely ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed Therapies Act of 2021 or the TRANSPLANT Act of 2021
This bill modifies and reauthorizes through FY2026 the C.W. Bill Young Cell Transplantation Program, which provides support to patients who need a potentially life-saving bone marrow transplant or umbilical cord blood transplant.
The bill also requires the Department of Health and Human Services to conduct a periodic review of the science of using adult stem cells and birthing tissues in therapeutic treatments.
In addition, the Government Accountability Office must report on the regenerative medicine workforce.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 288 Introduced in Senate (IS)]

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117th CONGRESS
  1st Session
                                 S. 288

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 8, 2021

  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 2021'' or 
the ``TRANSPLANT Act of 2021''.

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 Secretary shall convene the Advisory Council at 
        least 2 times each calendar 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 by inserting ``goal of increasing collections of 
        high quality'' before ``cord blood units,''.
            (2) Eliminating deadwood.--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 new subsection:
    ``(o) Periodic Review of State of Science.--
            ``(1) Review.--Not less frequently than every 2 years, 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 birthing tissues 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, 2025, the 
        Secretary shall--
                    ``(A) complete the second 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 ``$31,000,000 for each of 
fiscal years 2022 through 2026''.

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 2022 through 2026.''.

SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDICINE.

    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.''.

SEC. 5. GAO REPORT ON REGENERATIVE MEDICINE WORKFORCE.

    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 a specialized health care workforce in the field 
of regenerative medicine. 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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