H.R. 5791

119th CONGRESS 1st Session

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 · Sponsor: Mr. Wied · Committee: Committee on Energy and Commerce

Table of contents

• H.R. 5791
  • SEC. 1. Short title
  • SEC. 2. Expedited process for approval of certain BLA supplements for blood centers

SEC. 1. Short title

• This Act may be cited as the or the .

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 (), 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. 42 U.S.C. 262(a)(2)
• (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—
    • a specific concern for the safety, purity, or potency of products produced at the specific location subject to the supplemental application; or
    • 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—
    • holds a biologics license for at least one blood center site; and
  • (2)
    • 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
    • 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:
    • The term means a biologics license application. BLA
    • The term means a human blood donation center. blood center
    • The term means the expedited procedure to be established under subsection (a).
    • The term means the Secretary of Health and Human Services acting through the Commissioner of Food and Drugs.