Engrossed in House — H.R. 5160

119th CONGRESS

2d Session

H. R. 5160

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 Stem Cell Therapeutic and Research Reauthorization Act of 2025.

Sec. 2. Reauthorization of the C.W. Bill Young Cell Transplantation Program

Section 379B of the Public Health Service Act (42 U.S.C. 274m) is amended—

(1)

by striking appropriated $31,009,000 and inserting the following:

appropriated—
(1)
$31,009,000;

(2)

in paragraph (1), as so inserted, by striking the period at the end and inserting ; and; and

(3)

by adding at the end the following:

(2)
$33,009,000 for each of fiscal years 2027 through 2031.

Sec. 3. Cord blood inventory

(a) In general

Section 2(a) of the Stem Cell Therapeutic and Research Act of 2005 (42 U.S.C. 274k note) is amended by striking at least 150,000 new units of high-quality cord blood and inserting a sufficient supply, as determined by the Secretary, of high-quality cord blood units.

(b) Application

Section 2(c) of such Act (42 U.S.C. 274k note) is amended—

(1)

in paragraph (2), by striking in perpetuity or; and

(2)

by amending paragraph (5) to read as follows:

(5)
if the Secretary determines through an assessment, or through petition by the applicant, that a cord blood bank is no longer operational, does not meet the requirements described in subsection (d)(4), or does not meet the requirements of section 379(d)(4) of the Public Health Service Act, and as a result may not distribute the high-quality units, the Secretary may transfer the units collected pursuant to this section to another qualified cord blood bank or entity approved by the Secretary to ensure continued availability of high-quality cord blood units.

(c) Duration of Contracts

Section 2(d)(4) of such Act (42 U.S.C. 274k note) is amended to read as follows:

(4) Consideration of best science
The Secretary shall take into consideration current scientific and clinical information in order to maximize the availability of high-quality cord blood units meeting applicable clinical and quality standards for transplant when entering into contracts under this section, or when extending a period of funding under such a contract under paragraph (2).

(d) Inventory management

Section 2 of such Act (42 U.S.C. 274k note) is amended—

(1)

by redesignating subsections (e), (f), and (g) and as subsections (f), (g), and (h), respectively; and

(2)

by inserting after subsection (d) the following:

(e) Inventory management
(1) In general
The Secretary shall manage the size and composition of the National Cord Blood Inventory to maximize clinical utility, ensure genetic diversity, and promote the efficient use of resources.
(2) Considerations
In carrying out paragraph (1), the Secretary may—
(A)
on the Secretary’s own initiative or upon petition by a qualified cord blood bank, make determinations regarding the continued storage of cord blood units based on the best available scientific and clinical evidence; or
(B)
prioritize the collection, retention, or disposition of cord blood units based on scientific, clinical, or operational considerations that the Secretary determines to be relevant.

(e) Definitions

Section 2(g) of such Act, as redesignated by subsection (d)(1) of this section, is amended—

(1)

by redesignating paragraphs (4) and (5) as paragraphs (5) and (6), respectively; and

(2)

by inserting after paragraph (3) the following:

(4)
The term high quality cord blood unit means a cord blood unit that meets current industry standards and any requirements of the Food and Drug Administration.

(f) Authorization of appropriations

Section 2(h) of such Act, as redesignated by subsection (d)(1) of this section, is amended by striking fiscal years 2022 through 2026 and inserting fiscal years 2027 through 2031.