0910-AE93 0910-AB26 200010 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Gen. Reqs. for Blood, Blood Compon., and Plasma Derivatives; Notification of Deferred Donors In multiple rulemakings, the Food and Drug Administration is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is based on a comprehensive review of the regulations that has been performed by FDA. It is also based on reports by the U.S. House of Representatives Committee on Government Reform and Oversight, Subcommittee on House Resources and Intergovernmental Relations; the General Accounting Office; the Institute of Medicine; as well as public comments. Some of the subjects intended to be addressed in the rulemakings include: "Lookback" requirements for hepatitis C virus; notification of consignees and end users of product safety information for plasma derivative products; notification of deferred donors; requirements for donor suitability and testing and infectious agent clearance. These actions are intended to help ensure the continued safety of the Nation's blood supply. Other Significant Previously Published in The Unified Agenda Final Rule Stage Undetermined No 21 CFR 600 21 CFR 601 21 CFR 606 21 CFR 607 21 CFR 610 21 CFR 640 21 CFR 660 21 CFR 680 21 USC 321 42 USC 216 42 USC 262 42 USC 263 42 USC 263a 42 USC 264 42 USC 300aa-25 21 USC 331 21 USC 351 21 USC 352 21 USC 353 21 USC 355 21 USC 360 21 USC 371 21 USC 374 No NPRM 08/19/1999 64 FR 45355 Final Action 03/00/2001 See RIN 0910-AB76. No Businesses None NA Not Collected 0910-AB76 Related to Not Procurement Related No