[Federal Register Volume 64, Number 195 (Friday, October 8, 1999)]
[Notices]
[Pages 54898-54899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26272]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30DAY-01-00]
Agency Forms Undergoing Paperwork Reduction Act Review
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) 639-7090. Send written
comments to CDC, Desk Officer; Human Resources and Housing Branch, New
Executive Office Building, Room 10235; Washington, DC 20503. Written
comments should be received within 30 days of this notice.
[[Page 54899]]
Proposed Project
1. Evaluation of the Effectiveness of Targeted Lookback for
Identifying Transfusion Recipients Who Receive Blood That May Have
Contained Hepatitis C Virus--NEW--National Center for Infectious
Disease (NCID)--The Food and Drug Administration (FDA) has recently
issued guidelines for 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
assay. 1 Blood collection establishments will identify
potentially HCV-contaminated blood products and inform transfusion
services of these units. The transfusion services will then attempt to
notify the recipients of these products and encourage these recipients
to be tested for HCV infection. CDC, in collaboration with the Agency
for Health Care Policy and Research (AHCPR) and the FDA, has been
charged with the responsibility of evaluating this nationwide
notification process. The objective of this study is to evaluate the
effectiveness of the targeted lookback for identifying persons infected
with HCV, obtaining appropriate medical follow-up, and promoting
healthy lifestyles and behaviors. The evaluation has three specific
aims:
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\1\ Food and Drug Administration. Guidance For Industry.
Current Good Manufacturing Practice for Blood and Blood Components:
(1) Quarantine and Disposition of Units from Prior Collections from
Donors with Repeatedly Reactive Screening Tests for Antibody to
Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the
Notification of Consignees and Blood Recipients of Donor Test
Results for Anti-HCV. Rockville, MD: Center for Biologics Evaluation
and Research, FDA; September 1998.
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1. Determine the effectiveness of targeted lookback for identifying
prior transfusion recipients with HCV infection, including the
proportion of recipients identified who are ultimately tested, the
proportion of those tested who are HCV positive, the reasons persons do
not receive notification, and the reasons persons do not avail
themselves of testing.
2. Determine the effectiveness of targeted lookback for encouraging
and obtaining appropriate medical follow-up and promoting healthy
lifestyles and behaviors among persons found positive for HCV
infection, including proportion of HCV-positive persons who seek
medical evaluation and outcome of that evaluation (severity of liver
disease, anti-viral therapy, quality of counseling), and reactions/
impact of notification on HCV-negative persons.
3. Determine the cost-effectiveness of targeted lookback, including
resources (cost, personnel, etc.) utilized by blood collection groups
and transfusion services for implementation and costs of medical
evaluation and management.
The evaluation will comprise the following components:
1. A nationwide survey of blood collection establishments.
2. A nationwide survey of transfusion services.
3. A follow-up study of transfusion recipients presumed to have
been notified of their potential HCV exposure. This detailed study will
involve contacting and interviewing transfusion recipients from a
sample of transfusion services in defined geographic areas.
4. A follow-up study of notified transfusion recipients who obtain
HCV testing offered by blood collection centers.
The total annual burden hours are 12,040.
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Number of Avg. burden/
Respondents Number of responses/ response (in
respondents respondents hours)
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Blood collection establishments................................. 140 1 5
Transfusion services............................................ 5,000 1 5
Transfusion recipients (first telephone contact)................ 5,000 1 0.2
Transfusion recipients (second telephone contact)............... 2,000 1 0.5
Transfusion recipients (follow-up interview and study).......... 200 3 0.5
Transfusion recipients (first interview of recipients tested at 500 1 0.2
ARC/ABC).......................................................
Transfusion recipients (follow-up interview and study of 100 3 0.5
recipients tested at ARC/ABC)..................................
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Dated: October 4, 1999.
Nancy Cheal,
Acting Associate Director for Policy, Planning, and Evaluation, Centers
for Disease Control and Prevention (CDC).
[FR Doc. 99-26272 Filed 10-7-99; 8:45 am]
BILLING CODE 4163-18-P