In the nature of a substitute.

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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