[Federal Register: July 16, 2003 (Volume 68, Number 136)]
[Notices]
[Page 42063-42064]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jy03-97]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-03-96]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call the CDC Reports
Clearance Officer on (404) 498-1210.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Send comments to Seleda Perryman, CDC
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24,
Atlanta, GA 30333. Written comments should be received within 60 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 were then to attempt to notify the recipients of
these products and encourage these recipients to be tested for HCV
infection. Recently, the FDA revised their original guidance, extending
the lookback period for these multiantigen screened donors and
including in the lookback process donors who tested anti-HCV positive
using an 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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[[Page 42064]]
CDC, in collaboration with the FDA, has been charged with the
responsibility of evaluating this nationwide notification process. An
interim nationwide survey (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 summarize the
lookback results. The objective of this 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 comprise the following components:
1. A nationwide survey of blood collection establishments.
2. A nationwide survey of transfusion services.
The total cost to respondents is their time to complete the survey.
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No. of Average burden
Respondents No. of responses per per response Total burden
respondents respondent (in hrs.) (in hrs.)
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Blood collection establishment.................. 140 1 5 700
Transfusion services............................ 5,000 1 5 25,000
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Total....................................... .............. .............. .............. 25,700
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Dated: July 10, 2003
Thomas A. Bartenfeld,
Acting Associate Director for Policy, Planning and Evaluation, Centers
for Disease Control and Prevention.
[FR Doc. 03-17944 Filed 7-15-03; 8:45 am]
BILLING CODE 4163-18-P