BLOOD Centers Act
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
This bill aims to speed up the approval process for certain changes made to blood centers’ licenses, specifically when adding apheresis collection devices. It directs the Health and Human Services Secretary to create a streamlined review process for supplemental applications. The expedited process will be available to blood centers that meet specific criteria related to their existing licenses and accreditation.
Key provisions
- The Secretary of Health and Human Services will establish an expedited approval process for BLA supplements.
- This process applies to adding apheresis collection devices to existing blood center licenses.
- The Secretary must approve supplemental applications within 30 days unless there’s a safety concern.
- Blood centers must hold a biologics license at least one site and have approval at 3 or more FDA-registered locations, or be accredited by a recognized organization.
- The expedited procedure is defined as the streamlined review process established by the Secretary.
Who is affected
- Blood centers
- Blood donation centers
- Food and Drug Administration (FDA)
- Health and Human Services Secretary
- Biologics License Application (BLA) applicants
Notable changes
- Creates a dedicated expedited review process for blood center license supplements.
Bill text
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Sponsors
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18 on record
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