[Congressional Record Volume 166, Number 210 (Friday, December 11, 2020)]
[Senate]
[Pages S7449-S7450]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 2704. Mr. McCONNELL (for Mr. Alexander) proposed an amendment to 
the bill H.R. 4764, to reauthorize the Stem Cell Therapeutic and 
Research Act of 2005, and for other purposes; as follows:

        Strike all after the enacting clause and insert the 
     following:

     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 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 than every two 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, 2024, the 
     Secretary shall--
       ``(A) complete the second review required by paragraph (1); 
     and

[[Page S7450]]

       ``(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.

       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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