[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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