[Federal Register Volume 64, Number 235 (Wednesday, December 8, 1999)]
[Notices]
[Pages 68691-68692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31743]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control And Prevention
[60Day-00-11]


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, the Centers for Disease Control and 
Prevention is providing opportunity for public comment on proposed data 
collection 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 Seleda Perryman, CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. Written comments should be received within 60 days 
of this notice.

1. Proposed Projects

    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), Division of Laboratory Systems 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 
only cost to the participants will be the time required to complete the 
survey, i.e., approximately 30 minutes each. 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. There is 
no cost to the respondent.

[[Page 68692]]



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                                                                    No. of
                      No. of respondents                        responses per     Hrs/response       Response
                                                                  respondent                          burden
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100..........................................................              30            30/60               50
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    Dated: December 1, 1999.
Nancy Cheal,
Acting Associate Director for Policy Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 99-31743 Filed 12-7-99; 8:45 am]
BILLING CODE 4163-18-P