[Federal Register Volume 66, Number 51 (Thursday, March 15, 2001)]
[Notices]
[Pages 15121-15122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6388]



[[Page 15121]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-01-26]


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) 639-7090.
    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 for other 
forms of information technology. Send comments to Anne O'Connor, CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. Written comments should be received within 60 days 
of this notice.

Proposed Project

    Model Performance Evaluation Program for Retroviral and AIDS-
Related Testing--Extension--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. Other than their time, there will be no cost 
to the respondents.

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                                                                     Number of    Average burden
                   Respondents                       Number of      respondents    per  response   Total burden
                                                    respondents    per response      (in hrs)        (in hrs)
----------------------------------------------------------------------------------------------------------------
MPEP Enrollment Form............................             100               1            6/60              10
Retroviral Survey...............................           1,000               1           30/60             500
TLI Survey......................................             350               1           30/60             175
                                                 ---------------------------------------------------------------
      Total.....................................  ..............  ..............  ..............             685
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[[Page 15122]]

    Dated: March 8, 2001.
Charles Gollmar,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 01-6388 Filed 3-14-01; 8:45 am]
BILLING CODE 4163-18-P