[Federal Register Volume 68, Number 136 (Wednesday, July 16, 2003)]
[Notices]
[Pages 42063-42064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17944]


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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
                                                 -----------------
    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