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. Alternatively, to obtain a copy of the data collection plans and instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar, CDC Reports Clearance Officer, 1600 Clifton Road, NE., MS-D74, Atlanta, Georgia 30333; comments may also be sent by e-mail to firstname.lastname@example.org.
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 a 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 clarify 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 information technology. Written comments should be received within 60 days of this notice.
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 continue data collection from participants in 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 domestic clinical and public health laboratories and international laboratories. Data collection from domestic laboratory participants occurs twice per year. Data collection from international laboratories is limited to those that have public health responsibilities for tuberculosis drug susceptibility testing and have obtained approval to participate by their national tuberculosis program. 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.
There is no cost to respondents to participate other than their time.Start Printed Page 28940
|Form||Respondents||Number of respondents||Number of responses per respondent||Average burden per response (in hours)||Total burden (in hours)|
|Susceptibility Testing Results Form||Labs||262||2||30/60||262|
|Laboratory Practices Questionnaire||Labs||132||1||30/60||66|
Dated: June 11, 2009.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-14313 Filed 6-17-09; 8:45 am]
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