[Federal Register Volume 66, Number 128 (Tuesday, July 3, 2001)]
[Notices]
[Pages 35248-35249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16628]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30DAY-40-01]


Agency Forms Undergoing Paperwork Reduction Act Review

    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.

Proposed Project

    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.

[[Page 35249]]



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                                                                 No. of
                  Respondents                      No. of      respondents    Average  burden per response  (in
                                                 respondents  per response                  hrs)
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MPEP Enrollment Form..........................           100             1  6/60
Retroviral Survey.............................         1,000             1  30/60
TLI Survey....................................           325             1  30/60
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
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    Dated: June 25, 2001.
Nancy Cheal,
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]
BILLING CODE 4163-18-P