H.R. 5791House119th Congress (2025-2027)In Committee

BLOOD Centers Act

Sponsored by Tony WiedRep. Tony Wied (R-WI)
Introduced October 17, 2025

AI-Generated Summary

Updated November 23, 2025 at 8:04 PM UTC

The BLOOD Centers Act directs the Department of Health and Human Services to set up a faster approval system for blood‑center operators who want to add apheresis collection devices at new sites. The goal is to shorten the review time from the usual schedule to 30 days, helping expand blood‑collection capacity while still protecting product safety. The rule applies to operators with existing biologics licenses and meeting specific size or accreditation standards.

Key Provisions

  • Within 180 days of the law’s enactment, HHS (through the FDA Commissioner) must create an expedited review process for blood centers that want to add an apheresis collection device to an existing biologics license at a new location.
  • Under the new process, the FDA must approve such supplemental applications within 30 days of receipt, unless it shows a specific safety, purity, or potency concern for that location or a systemic failure by the operator.
  • The fast‑track applies only to operators that already hold a biologics license for at least one blood‑center site and either have FDA‑registered licenses at three or more locations, or are accredited in good standing by a recognized blood‑collection accreditation organization.
  • Key terms are defined: “BLA” means biologics license application; “blood center” means a human blood donation center; “expedited procedure” refers to the new fast‑track process; “Secretary” means the HHS Secretary acting through the FDA Commissioner.

Legislative Activity

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1 earlier action
HouseIntro Referral Latest Action

Referred to the House Committee on Energy and Commerce.

October 17, 2025

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HouseIntro Referral

Introduced in House

October 17, 2025

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

October 17, 2025

Floor Debate

2 members

What members said about H.R. 5791 on the floor

2 Republicans
Monica De La Cruz
Rep. Monica De La CruzR-TX-15 · Dec 16, 2025

Under clause 7 of rule XII, sponsors were added to public bills and resolutions, as follows: H.R. 116: Mr. Jack. H.R. 154: Mr. Landsman. H.R. 158: Mr. Landsman. H.R. 220: Ms. Escobar. H.R. 251: Mr.…

Monica De La Cruz
Rep. Monica De La CruzR-TX-15 · Jul 9, 2026

Under clause 7 of rule XII, sponsors were added to public bills and resolutions, as follows: H.R. 7: Mr. Van Epps. H.R. 138: Ms. Norton, Ms. Hoyle of Oregon, and Mr. Calvert. H.R. 491: Ms. Wilson of…

Tony Wied
Rep. Tony WiedR-WI-8 · Jan 21, 2026

Mr. Speaker, I rise today in recognition of January as National Blood Donor Month. Each winter, blood centers across the Nation experience reduced donor turnout, while the need for blood remains…

Bill Text

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Introduced in HouseIssued October 17, 2025

I

119th CONGRESS

1st Session

H. R. 5791

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.

1.

Short title

This Act may be cited as the Boosting Lifesaving Operations, Opening Donation Centers Act or the BLOOD Centers Act.

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.