04-11277. 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 [phone].

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.

Form name	Number of respondents	Numbers of response per respondent	Average burden per response (in hrs.)	Total burden (in hrs.)
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
* 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.

Dated: May 13, 2004.

Alvin Hall,

Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.