[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Notices]
[Pages 22552-22553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08861]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-0600]


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 
(404) 639-7570 or send an email to [email protected]. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC 
20503 or by fax to (202) 395-5806. Written comments should be received 
within 30 days of this notice.

Proposed Project

    CDC Model Performance Evaluation Program (MPEP) for Mycobacterium 
tuberculosis and Nontuberculous Mycobacteria Drug Susceptibility 
Testing OMB  0920-0600 (exp. 5/31/2013),--Revision--National 
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    As part of the continuing effort to support domestic 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 (a) changing the title of 
the data collection to ``CDC Model Performance Evaluation (MPEP) for 
Mycobacterium tuberculosis Drug Susceptibility Testing'' to reflect 
that nontuberculous mycobacteria are no longer included in the test 
package; (b) replacement of Laboratory Enrollment Form with a 
Participant Biosafety Compliance Letter of Agreement; (c) revision of 
the Pre-shipment Email; (d) addition of Instructions to Participants 
Letter; (e) revision of the MPEP M. tuberculosis Results Worksheet; (f) 
entering survey results online using a modified data collection 
instrument; (g) modification of Reminder Email; (h) modification of 
Reminder Telephone Script; and (i) modification of the Aggregate Report 
Letter.
    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. To reach the goal of eliminating TB, the Model Performance 
Evaluation Program for Mycobacterium tuberculosis and

[[Page 22553]]

Non-tuberculous Mycobacterium Drug Susceptibility Testing is used to 
monitor and evaluate performance and practices among national 
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 strains, 
laboratories also have a self-assessment tool to aid in optimizing 
their skills in susceptibility testing. The information obtained from 
the laboratories on susceptibility 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. Data collection from 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.
    There is no cost to respondents to participate other than their 
time. The total estimated annual burden hours are 156.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
        Type of  respondent                   Form name             respondents    responses per   response (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Domestic Laboratory................  Participant Biosafety                    93               2            5/60
                                      Compliance Letter of
                                      Agreement.
MPEP                                 Mycobacterium tuberculosis               93               2           30/60
                                      Results Worksheet.
                                     Online Survey Instrument...              93               2           15/60
----------------------------------------------------------------------------------------------------------------


Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2013-08861 Filed 4-15-13; 8:45 am]
BILLING CODE 4163-18-P