[Federal Register: April 8, 2004 (Volume 69, Number 68)]
[Notices]
[Page 18580]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap04-58]
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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