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) 639-7090. Send written comments to CDC, Desk Officer; Human Resources and Housing Branch, New Executive Office Building, Room 10235; Washington, DC 20503. Written comments should be received within 30 days of this notice.
Model Performance Evaluation Program for Retroviral and AIDS-Related Testing—Revision—OMB No. 0920-0274 Public Health Practice Program Office (PHPPO), Centers for Disease Control and Prevention (CDC). The Centers for Disease Control and Prevention Model Performance Evaluation Program (MPEP) currently assesses the performance of laboratories that test for human immunodeficiency virus type 1 (HIV-1) antibody, human T-lymphotropic virus types I and II (HTLV-I/II) antibody, perform CD4 T-cell testing or T-lymphocyte immunophenotyping (TLI) by flow cytometry or alternate methods, perform HIV-1 ribonucleic acid (RNA) determinations (viral load), and test for HIV-1 p24 antigen through the use of mailed sample panels. The CDC MPEP is proposing to use annual data collection documents to gain updated information on the characteristics of testing laboratories and their testing practices.
Two data collection instruments, or survey questionnaires will be used. The first data collection instrument will be concerned with laboratories that perform HIV-1 antibody (Ab) testing, HTLV-I/II Ab testing, HIV-1 viral RNA determinations, and HIV-1 p24 antigen (Ag) testing. Laboratories enrolled in the MPEP will be mailed a survey questionnaire and be asked to complete the sections pertinent to their laboratory's testing. The survey instrument will collect demographic information related to laboratory type, primary purpose for testing, types of specimens tested, minimum education requirements of testing personnel, laboratory director, and laboratory supervisor, and training required of testing personnel. The demographic section will be followed by more specific sections related directly to HIV-1 Ab testing, HTLV-I/II Ab testing, HIV-1 RNA, and HIV-1 p24 Ag testing. Included in the latter sections will be questions related to the types of tests performed, the algorithm of testing, how test results are interpreted, how results are reported, how specimens may be rejected for testing, if some testing is referred to other laboratories, and what quality control and quality assurance procedures are conducted by the laboratory. Similarly, the TLI survey questionnaire will also collect demographic information about each laboratory, as well as, the type(s) of flow cytometer used, educational and training requirements of testing personnel, the types of monoclonal antibodies used in testing, how specimens are received, prepared, and stored, how test results are recorded and reported to the test requestor, and what quality control and quality assurance procedures are practiced.
Information collected through the use of these instruments will enable CDC to determine if laboratories are conforming to published recommendations and guidelines, whether education and training requirements of testing personnel are conforming to current legislative requirements, and whether problems in testing can be identified through the collection of information. Information collected through the survey instruments will then be compared statistically with the performance evaluation results reported by the enrolled laboratories to determine if characteristics of laboratories that perform well can be distinguished from laboratories not performing as well. Upon enrolling in the MPEP, participants are assigned an MPEP number used to report testing results and survey questionnaire responses allowing the individual responses of each laboratory participant to be treated in confidence. When participants respond to the surveys by sending CDC completed questionnaires, the collected information is developed into aggregate reports. A copy of the completed report is provided to each participating laboratory. Total annual burden for this data collection is 941 hours. Start Printed Page 35249
|Respondents||No. of respondents||No. of respondents per response||Average burden per response (in hrs)|
|MPEP Enrollment Form||100||1||6/60|
|HIV-1 Ab PE Results Form||900||2||10/60|
|HIV-1 p24 Ag PE Results Form||175||2||10/60|
|HIV-1 RNA PE Results Form||210||2||10/60|
|HTLV I/II Ab PE Results Form||225||2||10/60|
|TLI PE Results Form||300||2||10/60|
Dated: June 25, 2001.
Acting Associate Director for Policy, Planning, and Evaluation, Centers for Disease Control and Prevention.
[FR Doc. 01-16628 Filed 7-2-01; 8:45 am]
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