BLOOD Centers Act

Bill Number

H.R. 5791

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-10-17: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-07-10T08:06:36Z

AI-Generated Summary

Purpose of the Legislation

The BLOOD Centers Act (H.R. 5791) aims to improve the availability of blood donations by creating a faster approval process for blood centers to expand operations. Specifically, it directs the U.S. Food and Drug Administration (FDA) to expedite reviews for adding certain medical devices used in blood collection at new locations, helping to open more donation centers and boost the national blood supply.

Key Provisions

• Establishment of Expedited Process: Within 180 days of the bill's enactment, the Secretary of Health and Human Services (through the FDA Commissioner) must create a streamlined review process for supplemental applications to a biologics license application (BLA). A BLA is a formal request to the FDA to manufacture and sell biological products like blood components.
• Approval Deadline: The FDA must approve these supplemental applications within 30 days of submission, unless there are specific safety issues (e.g., concerns about the purity or effectiveness of blood products at the new site) or evidence of broader failures by the blood center to meet quality standards at other locations.
• Eligibility Criteria: The expedited process applies only to blood centers (defined as human blood donation facilities) that:
• Already hold a BLA for at least one site.
• Either have FDA approval for three or more registered locations under that license, or are accredited by an independent organization whose standards match or exceed FDA requirements for blood collection.
• Scope: The process covers adding an apheresis collection device (a machine that separates blood components like plasma or platelets during donation) to an existing BLA at a previously unlicensed location.

Significant Changes to Existing Law

This bill introduces a new expedited procedure under Section 351(a)(2) of the Public Health Service Act, which governs FDA approvals for biological products. Currently, supplemental BLA reviews can take longer without a fixed timeline, potentially delaying expansions. The 30-day approval mandate and clear exceptions for safety concerns represent a targeted acceleration, applying only to qualified blood centers and specific device additions, without altering core FDA safety standards.

Potential Impacts

• On Government Agencies: The FDA and Department of Health and Human Services will face a stricter 180-day deadline to implement the process and must adhere to the 30-day review timeline, potentially increasing administrative workload but reducing backlogs for eligible applications.
• On Citizens: Could lead to more blood donation centers nationwide, improving access to blood products for patients needing transfusions (e.g., in surgeries, emergencies, or treatments for conditions like cancer). This may enhance public health by addressing blood shortages without compromising product safety.
• On International Relations: Minimal direct impact, as the bill focuses on domestic blood collection; however, it could indirectly support U.S. medical exports or collaborations if a stronger blood supply bolsters healthcare resilience.

Main Stakeholders Affected

• Blood Centers and Operators: Primary beneficiaries, as they gain faster paths to expand using apheresis devices, enabling quicker setup of new donation sites.
• FDA and HHS: Responsible for implementing and enforcing the expedited process, balancing speed with safety oversight.
• Blood Donors and Recipients: Donors may have more convenient donation options; patients relying on blood products could see improved availability and reduced shortages.
• Accreditation Organizations: Those with FDA-recognized standards (e.g., groups like the AABB for blood banking) may see increased relevance for certifying centers.

Notable Legal, Constitutional, or Political Implications

• Legal Implications: Reinforces FDA's authority under existing public health laws while adding procedural efficiencies; the safety exceptions ensure compliance with requirements for product purity and potency, reducing risks of legal challenges over rushed approvals.
• Constitutional Implications: None significant, as it operates within Congress's commerce and public welfare powers without infringing on individual rights.
• Political Implications: Supports bipartisan efforts (introduced by representatives from both parties) to strengthen healthcare infrastructure, potentially appealing to public health advocates amid ongoing concerns about blood supply vulnerabilities (e.g., from pandemics or disasters). It prioritizes established, compliant entities, avoiding broad deregulation that could spark safety debates.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Wied, Tony [R-WI-8]

Cosponsors (13)

Rep. Schrier, Kim [D-WA-8], Rep. Tiffany, Thomas P. [R-WI-7], Rep. Vindman, Eugene Simon [D-VA-7], Rep. DelBene, Suzan K. [D-WA-1], Rep. Figures, Shomari [D-AL-2], Rep. Miller-Meeks, Mariannette [R-IA-1], Rep. Wilson, Joe [R-SC-2], Rep. Ryan, Patrick [D-NY-18], Rep. Taylor, David J. [R-OH-2], Rep. Bell, Wesley [D-MO-1], Rep. Bacon, Don [R-NE-2], Rep. Carbajal, Salud O. [D-CA-24], Rep. Meng, Grace [D-NY-6]

Recent Actions

• 2025-10-17: Referred to the House Committee on Energy and Commerce.
• 2025-10-17: Introduced in House
• 2025-10-17: Introduced in House

Bill Versions

• Boosting Lifesaving Operations, Opening Donation Centers Act — issued 2025-10-17 — PDF (3 pages)