E9-30339. 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] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Model Performance Evaluation Program for Mycobacterium tuberculosis and Non-tuberculous Mycobacterium Drug Susceptibility Testing (OMB Control No. 0920-0600, expiration date 03/31/2010)—Revision—National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

As part of the continuing effort to support both domestic and global public health objectives for treatment of tuberculosis (TB), prevention of multi-drug resistance, and surveillance programs, CDC is requesting approval from the Office of Management and Budget to revise a currently approved data collection, the Model Performance Evaluation Program for Mycobacterium tuberculosis and Non-tuberculous Mycobacterium Drug Susceptibility Testing. This request includes changes to the Results Form and re-introduction of the Laboratory Practices Questionnaire.

While the overall number of cases of TB in the U.S. has decreased, rates still remain high among foreign-born persons, prisoners, homeless populations, and individuals infected with HIV in major metropolitan areas. The rate of TB cases detected in foreign-born persons has been reported to be more than nine times higher than the rate among the U.S. born population. CDC's goal to eliminate TB will be virtually impossible without considerable effort in assisting heavy disease burden countries in the reduction of tuberculosis. The Model Performance Evaluation Program for Mycobacterium tuberculosis and Non-tuberculous Mycobacterium Drug Susceptibility Testing program supports this role by monitoring and evaluating the level of performance and practices among national and international laboratories performing M. tuberculosis susceptibility testing. Participation in this program is one way laboratories can ensure high-quality laboratory testing, resulting in accurate and reliable testing results.

By providing an evaluation program to assess the ability of the laboratories to test for drug resistant M. tuberculosis and selected strains of Non-tuberculous Mycobacteria (NTM), laboratories also have a self-assessment tool to aid in optimizing their skills in susceptibility testing. The information obtained from laboratories on susceptibility testing practices and procedures is used to establish variables related to good performance, assessing training needs, and aid with the development of practice standards.

Participants in this program include clinical and public health laboratories. Participants register by submitting an Enrollment Form. Data collection from domestic laboratory participants occurs twice per year. The data collected in this program will include the susceptibility test results of primary and secondary drugs, drug concentrations, and test methods performed by laboratories on a set of performance evaluation (PE) samples. The PE samples are sent to participants twice a year. Participants also report demographic data such as laboratory type and the number of tests performed annually. Participants report this data every two years. The burden for the Laboratory Practices Questionnaire has been adjusted for the average per year, since responses are received every other year. Participants may submit changes about their laboratory using the Laboratory Information Change Form.

There is no cost to respondents to participate other than their time. The total annualized burden for this information collection request is 166 hours.

Estimate of Annualized Burden Hours

Form	Respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Enrollment form	Labs	4	1	5/60
Laboratory Change form	Labs	4	1	5/60
Susceptibility Testing Results Form	Labs	132	2	30/60
Laboratory Practices Questionnaire	Labs	66	1	30/60

Dated: December 14, 2009.

Maryam I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.