[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Pages 70840-70841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26902]



[[Page 70840]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-22-0600]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request titled ``CDC Model Performance Evaluation Program 
(MPEP) for Mycobacterium tuberculosis Susceptibility testing'' to the 
Office of Management and Budget (OMB) for review and approval. CDC 
previously published a ``Proposed Data Collection Submitted for Public 
Comment and Recommendations'' notice on August 27, 2021 to obtain 
comments from the public and affected agencies. CDC received one 
comment related to the previous notice. This notice serves to allow an 
additional 30 days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) Minimize the burden of the collection of information on those 
who are to respond, including, through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct 
written comments and/or suggestions regarding the items contained in 
this notice to the Attention: CDC Desk Officer, Office of Management 
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 
395-5806. Provide written comments within 30 days of notice 
publication.

Proposed Project

    CDC Model Performance Evaluation Program (MPEP) for Mycobacterium 
tuberculosis Susceptibility testing (OMB Control No. 0920-0600, Exp. 2/
20/2022)--Revision--National Center for HIV/AIDS, Viral Hepatitis, STD, 
TB Prevention (NCHHSTP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    The CDC is requesting a Revision to approved information collection 
from participants in the CDC Model Performance for Mycobacterium 
tuberculosis Drug Susceptibility Testing for a period of three years. 
Revision of this information will not require changes in the scope of 
the project. This Revision includes (a) modification of the 
Instructions to Participants Letter; (b) modification of the MPEP 
Mycobacterium tuberculosis Results Worksheet; (c) modification of 
online data collection instrument; (d) modification of the MPEP 
Mycobacterium tuberculosis Minimum Inhibitory Concentration Results 
Worksheet; (e) removal of Reminder Telephone Script; and (f) 
modification of 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, corrections, 
homeless populations, and individuals infected with HIV in major 
metropolitan areas. To reach the goal of eliminating TB, the Model 
Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis 
Susceptibility Testing is used to monitor and evaluate performance and 
practices among US 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 laboratories a self-assessment tool to test for drug 
resistant M. tuberculosis strains, the program aids laboratories 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) isolates. The PE isolates are 
sent to participants twice a year. Participants also report demographic 
data such as laboratory type and the number of drug susceptibility 
tests performed annually.
    CDC is requesting OMB approval for an estimated 129 annual burden 
hours. Participation of respondents is voluntary, and there is no cost 
to participants other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Domestic Laboratory................  Participant Biosafety                    80               1            5/60
                                      Compliance Letter of
                                      Agreement.
                                     MPEP Mycobacterium                       80               2           30/60
                                      tuberculosis Results
                                      Worksheet.
                                     Online Survey Instrument...              80               2           15/60
                                     MPEP Mycobacterium                        4               2           15/60
                                      tuberculosis Minimum
                                      Inhibitory Concentration
                                      Results Form.
----------------------------------------------------------------------------------------------------------------



[[Page 70841]]

Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-26902 Filed 12-10-21; 8:45 am]
BILLING CODE 4163-18-P