Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human)

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is issuing these amendments directly as a final rule because the agency believes they are noncontroversial and that there is little likelihood that there will be 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 any significant adverse comment is received sufficient to terminate the direct final rule within 30 days after the comment period ends, 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 products, including plasma derivatives. DATES: This rule is effective September 27, 1999. Submit written comments on or before July 28, 1999. If FDA receives no significant adverse comments within the specified comment period, the agency intends to publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date.