Revision of the requirements for live vaccine processing. Direct final rule.
The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for the processing of live vaccines. FDA is amending the regulations due to advances in technology that will allow processing of live vaccines to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement regarding facilities and equipment for live vaccine processing is too prescriptive and is no longer necessary. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
D015415:Biomarkers / Q000032:analysis; D004345:Drug Industry / Q000331:legislation & jurisprudence; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D014613:Vaccines, Attenuated / Q000008:administration & dosage
D015415:Biomarkers; D014613:Vaccines, Attenuated