Revisions to the requirements applicable to blood, blood components, and source plasma.  Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA).  Direct final rule.
The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements.  FDA is issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that FDA will receive any significant comments opposing the rule.  Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule under FDA's usual procedures for notice and comment in the event the agency receives any significant adverse comments.  If FDA receives any significant adverse comment sufficient to terminate the direct final rule, FDA will consider such comments on the proposed rule in developing the final rule.  FDA is issuing this rule as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood, blood components, and Source Plasma.
D001769:Blood; D001771:Blood Banks / Q000331:legislation & jurisprudence*; D001773:Blood Cells; D001803:Blood Transfusion / Q000331:legislation & jurisprudence; D006801:Humans; D010949:Plasma; D010956:Plasmapheresis; D013048:Specimen Handling; D014481:United States