00-16436. 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 [phone]. 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.

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

Dated: June 23, 2000.

Nancy Cheal,

Acting Associate Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention (CDC).