[Federal Register Volume 74, Number 241 (Thursday, December 17, 2009)]
[Notices]
[Pages 66968-66969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29967]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-10-0595]


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) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-5806. 
Written comments should be received within 30 days of this notice.

Proposed Project

    Performance Evaluation Program for HIV Rapid Testing (OMB Control 
No. 0920-0595, expiration date 3/31/2010)--Revision--National Center 
for Preparedness, Detection, and Control of Infectious Diseases 
(NCPDCID), Centers for Disease Control and Prevention (CDC).

Brief Description and Background

    To support CDC's mission of improving public health and preventing 
disease through continuously improving laboratory practices, CDC is 
requesting approval from the Office of Management

[[Page 66969]]

and Budget (OMB) to continue data collection activities of the HIV 
rapid testing performance evaluation program (MPEP HIV RT) and to make 
changes to the results form.
    This program offers external performance evaluation (PE) twice a 
year for rapid HIV tests approved by the U.S. Food and Drug 
Administration (FDA). Participation in PE programs is expected to lead 
to improved HIV testing performance because participants have the 
opportunity to identify areas for improvement in their testing 
practices. This program helps to ensure accurate HIV rapid testing 
which is the foundation for HIV prevention and intervention programs.
    This program offers laboratories/testing sites opportunities for:
    (1) Assuring that the laboratories/testing sites are providing 
accurate test results through external quality assessment;
    (2) Improving testing quality through self-evaluation in a non-
regulatory environment;
    (3) Testing well characterized samples from a source outside the 
test kit manufacturer;
    (4) Discovering potential testing problems so that laboratories/
testing sites can adjust procedures to reduce and eliminate errors;
    (5) Comparing individual laboratory/testing site results to others 
at the national and international level, and;
    (6) Consulting with CDC staff to discuss testing issues.
    Program participants receive PE samples twice each year and report 
testing results to CDC. In addition to conducting the performance 
evaluation, participants in the MPEP HIV Rapid Testing program are 
required to complete a biennial (every other year) laboratory practices 
questionnaire. The burden for the Laboratory Practices Questionnaire 
has been adjusted for the average per year, since respondents complete 
the survey every two years. In addition, with this request, CDC is 
adding an Enrollment Form for new participants and an Information 
Change Form to enable participants to update current contact 
information. CDC does not charge any fees to sites participating in 
this external quality assessment program.
    There is no cost to respondents to participate in this program. The 
total annualized burden for this data collection is 387 hours.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
                 Form                          Respondents           Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
HIV Rapid Testing Results Form........  Labs....................             660               2           10/60
HIV Rapid Testing Questionnaire.......  Labs....................             330               1           30/60
Enrollment Form.......................  Labs....................              10               1            3/60
Information Change Form...............  Labs....................              20               1            3/60
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    Dated: December 9, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer Centers for Disease Control and 
Prevention.
[FR Doc. E9-29967 Filed 12-16-09; 8:45 am]
BILLING CODE 4163-18-P