0910-AB76 200510 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 CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback) This rulemaking is one of a number of actions being taken to amend the biologics regulations to remove, revise, or update the regulations applicable to blood, blood components, and blood derivatives. These actions are based on FDA's comprehensive review of the biologics regulations and on reports by the U.S. House of Representatives Committee on Government Reform and Oversight's, Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute of Medicine, as well as on public comments. In this rulemaking, FDA will amend the biologics regulations to require that blood establishments prepare and follow written procedures for appropriate action when it is determined that blood and blood components pose an increased risk for transmitting hepatitis C virus (HCV) infection because they have been collected from a donor who, at a later date, tested reactive for evidence of HCV. The HIV lookback regulations will be amended for consistency. Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 606 21 CFR 610 21 USC 321 21 USC 331 21 USC 351 to 353 21 USC 355 21 USC 360 21 USC 360c 21 USC 360d 21 USC 360h to 360j 21 USC 371 21 USC 374 42 USC 216 42 USC 262 42 USC 263a 42 USC 264 21 USC 372 21 USC 381 42 USC 263 No NPRM 11/16/2000 65 FR 69377 NPRM Comment Period End 02/14/2001 Final Action 12/00/2005 No Businesses None NA Not Collected 0910-AB26 Related to Paula McKeever S. 0910 Food and Drug Administration FDA 301 827-1520 301 443-9718 paula.mckeever@fda.hhs.gov Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45, Rockville MD 20857-0001