HR5791-119

What This Bill Does

The BLOOD Centers Act speeds FDA review when an established blood center wants to add an apheresis collection device to an existing biologics license at a location that has not previously been licensed under that application. Within 180 days, HHS acting through FDA must establish an expedited supplemental application procedure. FDA must approve a qualifying application within 30 days unless it identifies a specific safety, purity, or potency concern at the location or a systemic failure by the owner or operator. The streamlined path is limited to experienced blood center owners: they must already hold a biologics license for at least one blood center site and either have approved locations under that license or hold qualifying accreditation in good standing.

Who Benefits and How

Blood center owners benefit because adding apheresis devices at new collection locations gets a 30-day FDA decision pathway. Blood donation centers benefit because the bill can speed expansion of platelet, plasma, or other apheresis collection capacity. Patients needing blood components benefit if expedited device approvals help blood centers increase component availability. Apheresis device vendors benefit indirectly if licensed blood centers can deploy devices across more sites faster.

Who Bears the Burden and How

FDA biologics license reviewers must build the expedited procedure within 180 days and decide eligible supplements within 30 days. Blood center compliance teams must prove license history, accreditation status, and location-specific safety readiness. Blood centers with safety, purity, potency, or systemic compliance problems remain exposed to denial under the expedited procedure. Federal regulators bear oversight risk because faster approvals still must protect blood product safety.

Key Provisions

• Requires HHS through FDA to establish an expedited procedure within 180 days.
• Requires FDA approval within 30 days unless specific safety, purity, potency, or systemic failure concerns exist.
• Applies to supplemental applications adding apheresis collection devices to existing biologics licenses.
• Limits eligibility to experienced blood center owners with licensed sites or qualifying accreditation.