TRANSPLANT Act of 2021
PL 117-15 (H.R.941), enacted 05/26/2021

[117th Congress Public Law 15]
[From the U.S. Government Publishing Office]



[[Page 135 STAT. 277]]

Public Law 117-15
117th Congress

                                 An Act


 
 To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and 
        for other purposes. <<NOTE: May 26, 2021 -  [H.R. 941]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Timely 
ReAuthorization of Necessary Stem-cell Programs Lends Access to Needed 
Therapies Act of 2021. 42 USC 201 note.>> 
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 two times each calendar year.''.

    (b) Increasing Collection.--
            (1) <<NOTE: 42 USC 274k and note.>>  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) <<NOTE: Consultation.>>  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.

[[Page 135 STAT. 278]]

            ``(2) <<NOTE: Deadline.>>  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 ``$31,009,000 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) <<NOTE: Consultation.>>  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 <<NOTE: Assessment.>>  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;

[[Page 135 STAT. 279]]

            (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) <<NOTE: Recommenda- tions.>>  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.

    Approved May 26, 2021.

LEGISLATIVE HISTORY--H.R. 941:
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CONGRESSIONAL RECORD, Vol. 167 (2021):
            Apr. 14, 15, considered and passed House.
            May 17, considered and passed Senate.

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