[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 941 Enrolled Bill (ENR)]

        H.R.941

                    One Hundred Seventeenth Congress

                                 of the

                        United States of America


                          AT THE FIRST SESSION

           Begun and held at the City of Washington on Sunday,
          the third day of January, two thousand and twenty-one


                                 An Act


 
 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 
    two 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 ``$31,009,000 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) 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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.