03-17944. 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 [phone].

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] .

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.

Respondents	No. of respondents	No. of responses per respondent	Average burden per response (in hrs.)	Total burden (in hrs.)
Blood collection establishment	140	1	5	700
Transfusion services	5,000	1	5	25,000
Total				25,700

Dated: July 10, 2003

Thomas A. Bartenfeld,

Acting Associate Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention.

Footnotes

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.