No CRS summary available for this bill.
This section directs the Secretary of Health and Human Services, acting through the Food and Drug Administration (FDA), not later than 180 days after enactment, to establish an expedited process—pursuant to section 351(a)(2) of the Public Health Service Act (42 U.S.C. 262(a)(2))—for approving supplemental biologics license applications (BLAs) submitted by owners or operators of blood centers (i.e., human blood donation centers) to add an apheresis collection device to an existing BLA at a previously unlicensed location. Under the process, the Secretary must approve such supplemental BLAs within 30 days of submission unless there is (1) a specific concern regarding the safety, purity, or potency of products at the location or (2) a systemic failure by the applicant to meet standards ensuring the continued safety, purity, or potency of products at other licensed locations. The process applies only if the applicant holds a BLA for at least one blood center site and either (1) has FDA-approved BLAs at three or more registered locations under that license or (2) is accredited and in good standing by an organization with standards meeting or exceeding FDA requirements for blood collection.