[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 941 Referred in Senate (RFS)]
<DOC>
117th CONGRESS
1st Session
H. R. 941
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 19, 2021
Received; read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
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.
Passed the House of Representatives April 15, 2021.
Attest:
CHERYL L. JOHNSON,
Clerk.