[Federal Register Volume 69, Number 155 (Thursday, August 12, 2004)]
[Notices]
[Pages 49905-49906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-04-0274]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    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) 498-1210 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Human 
Resources and Housing Branch, New Executive Office Building, Room 
10235, Washington, DC 20503 or by fax to (202) 395-6974. Written 
comments should be received within 30 days of this notice.

Proposed Project

    CDC Model Performance Evaluation Program (MPEP) for Retroviral and 
AIDS-Related Testing, OMB No. 0920-0274--Revision--Public Health 
Practice Program Office (PHPPO), Centers for Disease Control and 
Prevention (CDC).
    In 1986, the Centers for Disease Control and Prevention (CDC) 
implemented the Model Performance Evaluation Program (MPEP) to evaluate 
the performance of laboratories conducting testing to detect human 
immunodeficiency virus type 1 (HIV-1) antibody (Ab), and to support 
CDC's mission of improving public health and preventing disease through 
continuously improving laboratory practices.
    High-quality HIV-1 antibody testing is essential to meeting the 
public health objectives for the prevention and control of this 
retrovirus infection. High-quality CD4\+\ T-cell determinations and 
HIV-1 viral RNA (viral load) determinations are essential to HIV-
infected patient care and management, and the mission of reducing 
retrovirus-associated morbidity and mortality. Prevention programs, 
diagnostic clinics, and seroprevalence studies rely not only on 
accurate antibody testing results to document HIV infection but also 
accurate CD4\+\ T-cell determinations and HIV-1 viral RNA 
determinations. The impetus for developing this program came from the 
recognized need to assess the quality of retroviral and AIDS-related 
laboratory testing and to ensure that the quality of testing was 
adequate to meet medical and public health needs. The objectives of the 
MPEP are to: (1) Develop appropriate methods for evaluating quality in 
laboratory testing systems (including test selection, sample 
collection, and reporting and interpreting test results); (2) develop 
strategies for identifying and correcting testing quality failures; and 
(3) evaluate the effect of testing quality on public health.
    This external quality assessment program will be made available at 
no cost (for receipt of sample panels) to sites conducting testing to 
detect human immunodeficiency virus type 1 (HIV-1) antibody (Ab), 
CD4\+\ T-cell determinations, and HIV-1 viral RNA determinations. This 
program will offer laboratories/testing sites an opportunity for:
     Assuring accurate tests are being provided by the 
laboratory/testing site through external quality assessment;
     Improving testing quality through self-evaluation in a 
non-regulatory environment;
     Testing well-characterized samples from a source outside 
the test kit manufacturer;
     Discovering potential testing problems so that procedures 
can be adjusted to eliminate them;
     Comparison of testing results with others at a national 
and international level; and
     Ability to consult with CDC staff to discuss testing 
issues.
    The burden is estimated to be approximately 1057 hours.

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                                                                                  Number of      Average burden
                         Form name                              Number of       responses per   per response (in
                                                               respondents       respondent           hrs.)
----------------------------------------------------------------------------------------------------------------
Enrollments (new).........................................               100                 1              3/60
HIV Testing Survey........................................             1,000                 1               * 1
CD4+ T-cell determinations Survey.........................               325                 1            *30/60
HIV-1 Ab PE Results Form..................................               900                 2             10/60
HIV-1 RNA PE Results Form.................................               210                 2             10/60
CD4+ T-cell determinations PE Results Form................               300                 2             10/60
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* Both the HIV and the CD4+ T-cell determinations surveys are performed every other year; therefore, the total
  hour burden for these two surveys are divided by two.



[[Page 49906]]

    Dated: August 5, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-18437 Filed 8-11-04; 8:45 am]
BILLING CODE 4163-18-P