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HHS/FDA RIN: 0910-AB76 Publication ID: Spring 2003 
Title: CGMP for Blood and Blood Components: Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (Lookback) 
Abstract: 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 HCV lookback regulations will be amended for consistency. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 606    21 CFR 610   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 371    21 USC 374    42 USC 216    42 USC 262    42 USC 263a    42 USC 264   
Legal Deadline:  None

Statement of Need: In the Federal Register of June 22, 1999 (64 FR 33309), FDA announced the availability of guidance, which updated previous guidance, providing recommendations for donor screening and further testing for antibodies to HCV, notification of consignees, transfusion recipient tracing and notification, and counseling by physicians regarding transfusion with blood components at increased risk for transmitting HCV (these activities are often called "lookback"). FDA believes that regulations should be established consistent with the previous recommendations, to assure that there is clear enforcement authority in case deficiencies in an establishment's lookback program are found and to provide clear instructions for continuing lookback activities.

Summary of the Legal Basis: The Public Health Service Act (21 U.S.C. 201 et seq.) and the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) authorize FDA to regulate biological products and to ensure that the products are safe, pure, potent, and effective. The Public Health Service Act also contains authority under which FDA can promulgate regulations to prevent the spread of communicable diseases. This rulemaking would assure that appropriate action is taken when blood has been collected which may potentially be capable of transmitting HCV; that persons who have been transfused with such blood components are notified so that they receive proper counseling and treatment; and that infected donors are notified. These regulations will therefore help prevent the further transmission of HCV.

Alternatives: FDA has considered permitting continued voluntary compliance with the recommendations that have already been issued. However, lookback will remain appropriate for the foreseeable future, and FDA believes that the procedures should be clearly established in the regulations.

Anticipated Costs and Benefits: FDA is in the process of analyzing the costs related to the rulemaking. Monetary burdens will be associated with the tracing of previous donations of donors, quarantining in-date products, identifying the recipients of previous blood donations, and notifying these recipients, as appropriate. FDA believes that these costs will be more than balanced by the public health benefits, including benefits related to the notification of past transfusion recipients who may be unaware that they may be infected with HCV.

Risks: FDA believes that there are minimum risks posed by requiring that appropriate lookback procedures for HCV be prepared and followed.

Action Date FR Cite
NPRM  11/16/2000  65 FR 69377   
NPRM Comment Period End  02/14/2001    
Final Action  12/00/2003    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
Related RINs: Related to 0910-AB26 
Agency Contact:
Paula S. McKeever
Senior Scientific Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45,
Rockville, MD 20857-0001
Phone:301 827-1520
Fax:301 443-9718

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