119-hr5791

[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.
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