80 FR 71802 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 221 (November 17, 2015)

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing information collection. CDC is requesting a three-year approval for extension to the previously approved project used to collect data from participants 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.

[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71802-71803]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29272]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-0600; Docket No. CDC-2015-0103]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on CDC Model 
Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis 
Susceptibility Testing information collection. CDC is requesting a 
three-year approval for extension to the previously approved project 
used to collect data from participants 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.

DATES: Written comments must be received on or before January 19, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0103 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted without 
change to Regulations.gov, including any personal information provided. 
For access to the docket to read background documents or comments 
received, go to Regulations.gov.
    Please note: All public comment should be submitted 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 the 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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 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 clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    CDC Model Performance Evaluation Program (MPEP) for Mycobacterium 
tuberculosis Susceptibility Testing (OMB #0920-0600, expiration. 5/31/
2016)--Extension--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 the Office of 
Management and Budget to extend approval of data collection from 
participants in the Model Performance Evaluation Program (MPEP) for 
Mycobacterium tuberculosis Drug Susceptibility Testing. There are no 
changes requested for approval to number of respondents, information 
collection forms, burden, and other methodology to collect data from 
participants.
    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 Drug Susceptibility 
Testing is used to monitor and evaluate performance and practices among 
national laboratories performing

[[Page 71803]]

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. The data 
collected over the previous three-year period enabled CDC to correlate 
testing practices with performance and to use this information to 
design training modules targeted to participants encouraging the 
adaptation of advanced testing methods. Extension of data collection 
will allow CDC to evaluate the effectiveness of these training modules 
by continually monitoring laboratory performance.
    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.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                        Number of    Average burden     Total
      Type of respondent              Form name          Number of    responses per   per response      burden
                                                        respondents    respondent      (in hours)       hours
----------------------------------------------------------------------------------------------------------------
Domestic Laboratory...........  Participant Biosafety            93               2            5/60           16
                                 Compliance Letter of
                                 Agreement.
                                MPEP Mycobacterium               93               2           30/60           93
                                 tuberculosis Results
                                 Worksheet.
                                Online Survey                    93               2           15/60           47
                                 Instrument.
                                                      ----------------------------------------------------------
    Total.....................  .....................            93               6  ..............          156
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Leroy A. Richardson,
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. 2015-29272 Filed 11-16-15; 8:45 am]
 BILLING CODE 4163-18-P