[Federal Register Volume 69, Number 97 (Wednesday, May 19, 2004)]
[Notices]
[Pages 28893-28894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11277]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-04-52]


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 Dale Verell, CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-E11, 
Atlanta, GA 30333. Written comments should be received within 60 days 
of this notice.

Proposed Project

    CDC Model Performance Evaluation Program, 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.

There are no costs to respondents.

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                                                                    Numbers of    Average burden
                    Form name                        Number of     response per    per response    Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
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Enrollments (new)...............................             100               1            3/60               5
HIV Testing Survey..............................           1,000               1               1            333*
CD4+ T-cell determinations Survey...............             325               1           30/60             54*
HIV-1 Ab PE Results Form........................             900               2           10/60             300
HIV-1 RNA PE Results Form.......................             210               2           10/60              70
CD4+ T-cell determinations PE Results Form......             300               2           10/60             100
                                                 -----------------
    Totals......................................  ..............  ..............  ..............            862
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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 was divided by three to determine annualized hourly burden for the three-
  year approval period.



[[Page 28894]]

    Dated: May 13, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-11277 Filed 5-18-04; 8:45 am]
BILLING CODE 4163-18-P