[Federal Register Volume 65, Number 126 (Thursday, June 29, 2000)]
[Notices]
[Pages 40098-40099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16436]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30DAY-45-00]


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 Projects

    1. Survey of Laboratory Practices for Nucleic Acid Amplification 
Tests for Mycobacterium tuberculosis (M.tb NAA)--New--As part of the 
continuing effort to support public health objectives of treatment, 
disease prevention and surveillance programs, the Public Health 
Practice Program Office (PHPPO), Centers for Disease Control and 
Prevention (CDC) seeks to collect information from both public health 
and private sector laboratories performing nucleic acid amplification 
tests for Mycobacterium tuberculosis. Mycobacterium tuberculosis (TB) 
infection has reemerged as a significant public health concern in the 
United States. Since TB is easily transmitted, early detection of 
infection is imperative for control and prevention. CDC guidelines have 
advocated the use of the acid-fast bacilli smear (AFB), followed by 
culture, to confirm a diagnosis of tuberculosis. However, research and 
development have led to the design and marketing of nucleic acid 
amplification-based methods for the rapid detection of Mycobacterium 
tuberculosis (M.tb) directly from clinical sputum specimens. Since the 
FDA approval of two commercial M.tb NAA, CDC has become keenly 
interested in the analytic accuracy and clinical utility of these 
tests, especially from the standpoint of early detection and control of 
tuberculosis.
    Literature reports indicate variability in sensitivities, 
specificities, and predictive values for M.tb NAA, depending on the 
experimental design, the population being studied, and the test 
methodology. Overall, both sensitivity and specificity are reported to 
be relatively high compared with AFB smear and culture results. 
However, there are several important potential sources of error 
including contamination problems inherent to nucleic acid technology, 
cross-contamination with other mycobacteria, sub-optimal laboratory 
practices, and unknown factors. The use of M.tb NAA tests for rapidly 
diagnosis may be useful for controlling TB, particularly in high 
prevalence populations. However, the clinical utility and efficacy of 
M.tb NAA tests remains in question. Because of the uncertainty 
surrounding the analytical accuracy and clinical validity of the tests, 
the potential sources of error, and the subsequent potential expense of 
incorrect treatment.
    The goal of the proposed project is to collect laboratory practice 
data, in conjunction with performance data, through a survey 
administered to current participants in the CDC's M.tb NAA Performance 
Evaluation Program, to determine if laboratory practices are associated 
with the risk of errors in these tests. Information collected in the 
survey will be on test methods, quality assurance, quality control and 
reporting practices, and test utilization. The survey will also collect 
demographic information regarding the types of laboratories where 
testing is performed. CDC will use this data as a primary source of 
critical information to develop laboratory guidelines and 
recommendations for performance and utilization of M.tb NAA tests. The 
benefit of this data and the subsequent recommendations to public 
health will be the utilization of enhanced testing practices in the 
control and elimination of M. tuberculosis infection in the United 
States. The total annualized burden is estimated to be 55 hours.

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                                                                      No. of        Avg. burden
                   Respondents                        No. of        responses/     per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Laboratories....................................             110               1           30/60              55
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............              55
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[[Page 40099]]

    Dated: June 23, 2000.
Nancy Cheal,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 00-16436 Filed 6-28-00; 8:45 am]
BILLING CODE 4163-18-P