H.R. 5791

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5791 Introduced in House (IH)]

<DOC>

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 Representatives 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''.

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 submitted 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 device.
(b) Deadline.--Under the expedited procedure, the Secretary shall 
approve a supplemental application described 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 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 registered 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 ``expedited 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.
<all>