[Federal Register Volume 83, Number 167 (Tuesday, August 28, 2018)]
[Notices]
[Pages 43876-43877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18589]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-0600; Docket No. CDC-CDC-2008-0079]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled CDC Model Performance Evaluation 
Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing 
information collection. CDC is requesting a three-year approval for 
revision to the previously approved project used to monitor and 
evaluate performances and practices among national laboratories M. 
tuberculosis susceptibility testing.

DATES: CDC must receive written comments on or before October 29, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2008-
00791 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffery M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    CDC Model Performance Evaluation Program (MPEP) for Mycobacterium 
tuberculosis Susceptibility testing (OMB #0920-0600, expiration 3/31/
2019)--Revision--National Center for HIV/AIDS, Viral Hepatitis, STD, 
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    The CDC is requesting a revision to the approved information 
collection, CDC Model Performance for Mycobacterium tuberculosis Drug 
Susceptibility Testing (OMB Control Number 0920-0600). Clearance is 
requested for a period of three years. Revision of this information 
collection will not require changes in the scope of the study. This 
revision includes (a) modification of the Participant Biosafety 
Compliance Letter of Agreement; (b) modification of the Instructions to 
Participants Letter; (c) modification of the MPEP Mycobacterium Results 
Worksheet; (d) Request for approval of a MPEP Mycobacterium 
tuberculosis Minimum Inhibitory Concentration (MIC) Results Form for 
laboratories that perform Sensititre Drug Susceptibility Testing (DST) 
to record MIC results; and (e) reduction in request for burden hours.
    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 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

[[Page 43877]]

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. The 
total estimated annual burden hours are 129. There is no cost to 
respondents to participate other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Domestic Laboratory...........  Participant                   80               1            5/60               7
                                 Biosafety
                                 Compliance
                                 Letter of
                                 Agreement.
                                MPEP                          80               2           30/60              80
                                 Mycobacterium
                                 tuberculosis
                                 Results
                                 Worksheet.
                                Online Survey                 80               2           15/60              40
                                 Instrument.
                                MPEP                           4               2           15/60               2
                                 Mycobacterium
                                 tuberculosis
                                 Minimum
                                 Inhibitory
                                 Concentration
                                 Results Form.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             129
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Jeffrey M. Zirger,
Acting Chief, Information Collection Review Office, Office of 
Scientific Integrity, Office of the Associate Director for Science, 
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-18589 Filed 8-27-18; 8:45 am]
BILLING CODE 4163-18-P