I 
119TH CONGRESS 
1ST SESSION H. R. 5791 
To direct the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, to establish an expedited process 
for the approval of certain biologics license application supplements for 
blood centers, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 17, 2025 
Mr. WIED (for himself, Ms. SCHRIER, and Mr. TIFFANY) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To direct the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, 
to establish an expedited process for the approval of 
certain biologics license application supplements for blood 
centers, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Boosting Lifesaving 
Operations, Opening Donation Centers Act’’ or the 
‘‘BLOOD Centers Act’’. 
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SEC. 2. EXPEDITED PROCESS FOR APPROVAL OF CERTAIN 
BLA SUPPLEMENTS FOR BLOOD CENTERS. 
(a) ESTABLISHMENT.—Not later than 180 days after 
the date of enactment of this Act, the Secretary, acting 
pursuant to section 351(a)(2) of the Public Health Service 
Act (42 U.S.C. 262(a)(2)), shall establish an expedited 
process for the approval of a supplemental application sub-
mitted by the owner or operator of a blood center seeking 
to add an apheresis collection device to an existing BLA 
license at a location not previously licensed for such a de-
vice. 
(b) DEADLINE.—Under the expedited procedure, the 
Secretary shall approve a supplemental application de-
scribed in subsection (a) not later than 30 days after the 
date of submission of the application unless the Secretary 
makes a showing that there is— 
(1) a specific concern for the safety, purity, or 
potency of products produced at the specific location 
subject to the supplemental application; or 
(2) a systemic failure by the owner or operator 
to meet standards designed to ensure the continued 
safety, purity, and potency of products produced at 
other locations under a biologics license. 
(c) APPLICABILITY.—The expedited procedure shall 
apply with respect to a supplemental application described 
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in subsection (a) if the owner or operator that submits 
the application— 
(1) holds a biologics license for at least one 
blood center site; and 
(2)(A) has been approved for a biologics license 
at 3 or more Food and Drug Administration reg-
istered locations under the biologics license referred 
to in paragraph (1); or 
(B) is accredited and in good standing for blood 
collection by an accreditation organization with 
standards that meet or exceed, as determined by the 
Secretary, all applicable regulatory requirements for 
blood collections. 
(d) DEFINITIONS.—In this section: 
(1) BLA.—The term ‘‘BLA’’ means a biologics 
license application. 
(2) BLOOD CENTER.—The term ‘‘blood center’’ 
means a human blood donation center. 
(3) EXPEDITED PROCEDURE.—The term ‘‘expe-
dited procedure’’ means the expedited procedure to 
be established under subsection (a). 
(4) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services acting 
through the Commissioner of Food and Drugs. 
Æ 
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