BLOOD Centers Act

[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 t