[Federal Register Volume 69, Number 68 (Thursday, April 8, 2004)]
[Notices]
[Page 18580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-32-04]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 498-1210. Send written 
comments to CDC, Desk Officer, Human Resources and Housing Branch, New 
Executive Office Building, Room 10235, Washington, DC 20503 or by fax 
to (202) 395-6974. Written comments should be received within 30 days 
of this notice.

Proposed Project

    Final Evaluation of the Effectiveness of Targeted Lookback for 
Identifying Transfusion Recipients who receive Blood that may have been 
Contaminated with Hepatitis C Virus--New--National Center for 
Infectious Diseases (NCID), Centers for Disease Control and Prevention 
(CDC).
    In 1998 the Food and Drug Administration (FDA) issued guidelines to 
blood collection establishments and transfusion services for the 
notification of persons who received blood or blood components from 
donors who subsequently tested positive for antibody to hepatitis C 
virus (anti-HCV) using a licensed multiantigen screening assay. Blood 
collection establishments were to identify potentially HCV-contaminated 
blood products and inform transfusion services of these units. The 
transfusion services made an attempt to notify the recipients of these 
products and encouraged recipients to be tested for HCV infection. 
Recently, the FDA revised their original guidance to extend the 
lookback period for these multiantigen screened donors, and include in 
the lookback process donors who tested anti-HCV positive using the 
earlier single-antigen screening assay.\1\
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    \1\ Food and Drug Administration. Guidance For Industry. 
``Lookback'' for Hepatitis C Virus (HCV): Product Quarantine, 
Consignee Notification, Further Testing, Product Disposition, and 
Notification of Transfusion Recipients Based on Donor Test Results 
Indicating Infection with HCV Rockville, MD: Center for Biologics 
Evaluation and Research (CBER), December 2001.
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    CDC, in collaboration with the FDA, has been charged with the 
responsibility of evaluating this nationwide notification process. An 
interim nationwide survey (Evaluation of the Effectiveness of Targeted 
Lookback for Identifying Transfusion Recipients who receive Blood that 
may have been Contaminated with Hepatitis C Virus, OMB No. 0920-0462) 
of blood collection establishments and transfusion services was 
conducted in December 1999 to determine the progress that had been made 
to date, and to summarize the lookback results. The objective of this 
currently proposed study is to resurvey the blood collection 
establishments and transfusion services to obtain final results and 
assess the overall effectiveness of the targeted lookback for 
identifying persons infected with HCV. The evaluation has two specific 
aims:

    1. Determine the effectiveness of targeted lookback for 
identifying prior transfusion recipients with HCV infection, 
including the proportion of recipients identified who are still 
alive, the proportion of those alive who were successfully notified, 
the proportion of those notified who have already been tested, the 
proportion of those notified who get tested as a result of the 
notification, and the proportion of those tested who are HCV 
positive.
    2. Determine the cost-effectiveness of targeted lookback, 
including resources (person-hours, costs of recipient notification 
and testing, etc.) utilized by blood collection establishments and 
transfusion services for implementation of the lookback protocol.

    The evaluation will include the following components: (1) A 
nationwide survey of blood collection establishments; (2) A nationwide 
survey of transfusion services. The estimated annualized burden is 
15,480 hours.

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                                                                                     Number of    Average burden
              Survey site                       Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs)
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Blood Collection Establishment........  HCV Targeted Lookback                160               1               3
                                         Blood Collection
                                         Establishment Final
                                         Questionnaire.
Transfusion Services..................  HCV Targeted Lookback              5,000               1               3
                                         Transfusion Service
                                         Final Questionnaire.
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    Dated: April 1, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-7938 Filed 4-7-04; 8:45 am]
BILLING CODE 4163-18-P