Revision of the Requirements for Spore-Forming Microorganisms

The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with spore- forming microorganisms. FDA is amending the regulations due to advances in facility, system, and equipment design and in sterilization technologies that will allow work with spore-forming microorganisms to be performed in multiproduct manufacturing areas. We are publishing this rule because the existing requirement for always using separate, dedicated facilities and equipment for work with spore-forming microorganisms 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this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. We are issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that we will receive any significant comments opposing the rule. 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.