[Federal Register Volume 74, Number 116 (Thursday, June 18, 2009)]
[Notices]
[Pages 28938-28939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14312]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-09-0595]


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. 
Alternatively, to obtain a copy of the data collection plans and 
instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar, 
CDC Reports Clearance Officer, 1600 Clifton Road NE., MS-D74, Atlanta, 
Georgia 30333; comments may also be sent by e-mail to [email protected].
    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 clarify 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 information technology. Written comments 
should be received within 60 days of this notice.

Proposed Project

    The Model Performance Evaluation Program for HIV Rapid Testing 
(MPEP HIV-RT) (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 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). Examples of such tests are the OraQuick ADVANCE 
Rapid HIV-\1/2\ Antibody Test, the Uni-Gold Recombigen HIV test, the 
Clearview HIV \1/2\ STAT-PAK, the Clearview COMPLETE HIV \1/2\, and the 
MedMira Reveal G3 Rapid HIV-1 Antibody Test. 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. 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.

[[Page 28939]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Respondents                       Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Labs............................................             660               2           10/60             220
Labs............................................             330               1           30/60             165
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............             385
----------------------------------------------------------------------------------------------------------------


    Dated: June 11, 2009.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-14312 Filed 6-17-09; 8:45 am]
BILLING CODE 4163-18-P