[Federal Register Volume 68, Number 43 (Wednesday, March 5, 2003)]
[Notices]
[Pages 10481-10482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5120]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-03-48]


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 Anne O'Connor, CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. Written comments should be received within 60 days 
of this notice.

[[Page 10482]]

Proposed Project

    Performance Evaluation Program for Rapid HIV Testing--New--Public 
Health Practice Program Office (PHPPO), Centers for Disease Control and 
Prevention (CDC).
    To support our mission of improving public health and preventing 
disease through continuously improving laboratory practices, the Model 
Performance Evaluation Program (MPEP), Division of Laboratory Systems, 
Public Health Practice Program Office, Centers for Disease Control and 
Prevention intends to provide a new HIV rapid testing performance 
evaluation program (HIV Rapid Testing MPEP). This program will offer 
external performance evaluation (PE) for rapid tests such as the 
OraQuick[reg] Rapid HIV-1 Antibody Test, recently approved as a waived 
test by the U.S. Food and Drug Administration, and for other licensed 
tests such as the Abbott-Murex SUDS[reg] HIV-1 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 testing practices. This program will help to ensure 
accurate testing as a basis for development of HIV prevention and 
intervention strategies.
    This external quality assessment program will be made available at 
no cost (for receipt of sample panels) to sites performing rapid 
testing for HIV antibodies. This program will offer laboratories/
testing sites an opportunity for:
    (1) Assuring that the laboratories/testing sites are providing 
accurate tests 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 eliminate them.
    (5) Comparing individual laboratory/testing site results to others 
at a national and international level, and consulting with CDC staff to 
discuss testing issues.
    Participants in the MPEP HIV Rapid Testing program will be required 
to complete a laboratory practices questionnaire survey annually. In 
addition, participants will be required to submit results twice/year 
after testing mailed performance evaluation samples. The estimated 
annualized cost to respondents is $2,625.00.

----------------------------------------------------------------------------------------------------------------
                                                                                          Average
                                                               Number of    Frequency     burden/       Total
                            Forms                             respondents       of        response   burden  (in
                                                                            responses    (in hours)     hours)
----------------------------------------------------------------------------------------------------------------
HIV Rapid Testing Questionnaire.............................          300            1        15/60           75
HIV Rapid Testing Results Booklet...........................          300            2        10/60          100
                                                             --------------
      Total.................................................  ...........  ...........  ...........          175
----------------------------------------------------------------------------------------------------------------


    Dated: February 27, 2003.
Thomas Bartenfeld,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 03-5120 Filed 3-4-03; 8:45 am]
BILLING CODE 4163-18-P