Notice2025-10860
Proposed Data Collection Submitted for Public Comment and Recommendations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 16, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Abstract
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 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 Drug Susceptibility Testing. CDC is requesting a three-year approval for extension of the currently approved project used to monitor and evaluate performances and practices among national laboratories' M. tuberculosis susceptibility testing.
Full Text
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<title>Federal Register, Volume 90 Issue 114 (Monday, June 16, 2025)</title>
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[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25295-25296]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10860]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-25-0600; Docket No. CDC-2025-0015]
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 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 Drug Susceptibility Testing. CDC is
requesting a three-year approval for extension of the currently
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 August 15, 2025.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2025-
0015 by either of the following methods:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow
the instructions for submitting comments.
<bullet> Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Please note: Submit all comments through the Federal eRulemaking
portal (<a href="http://www.regulations.gov">www.regulations.gov</a>) 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 Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570;
Email: <a href="/cdn-cgi/l/email-protection#5936343b193a3d3a773e362f"><span class="__cf_email__" data-cfemail="cea1a3ac8eadaaade0a9a1b8">[email protected]</span></a>.
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;
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; and
5. Assess information collection costs.
Proposed Project
CDC Model Performance Evaluation Program (MPEP) for Mycobacterium
tuberculosis Drug Susceptibility Testing (OMB Control No. 0920-0600,
Exp. 9/30/2025)--Extension--National Center for HIV, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The CDC is requesting an Extension of a currently approved
information collection request (ICR) titled CDC Model Performance
Evaluation Program (MPEP) for Mycobacterium tuberculosis (TB) Drug
Susceptibility Testing for a period of three years. The Extension
submitted for this ICR will not require changes in the scope of the
project.
As part of the Extension, CDC is requesting a non-substantive
change to 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 program.
While the overall number of cases of TB in the U.S. has remained
fairly stable, rates still remain high among foreign-born persons,
persons in correctional facilities, 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 U.S. laboratories
performing M. tuberculosis susceptibility testing. Participation in
this program is one way
[[Page 25296]]
laboratories can ensure high-quality laboratory testing, resulting in
accurate and reliable testing results.
Providing an evaluation program to assess the ability of
laboratories to test for drug resistant M. tuberculosis strains, gives
laboratories 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
inform continuous program improvement related to good performance,
training needs, and 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
participating laboratories twice a year. Participants also report
laboratory demographic data such as laboratory type and the number of
drug susceptibility tests performed annually.
Over the past three years, six final MPEP reports have been
distributed and published with an average of 58 participants per MPEP
isolate shipment. All state public health laboratories that perform
Mycobacterium tuberculosis drug susceptibility testing participated in
MPEP, along with approximately seven hospital, seven independent/
reference, and two federal laboratories; these participating
laboratories represent geographical and laboratory type variation. Drug
susceptibility testing results met consensus for 73% or 22 isolates of
the six panels with five isolates each (30) for first-line drugs,
highlighting challenges that laboratories experience with current
testing practices and methods. MPEP continues to select isolates with
both common and challenging resistance patterns for educational value.
CDC is requesting approval for 113 burden hours, a reduction of 16
burden hours due to the reduction in the number of respondents. There
is no cost to respondents to participate other than their time.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total
Type of respondent Form name respondents responses per response burden
respondent (hours) (hours)
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Domestic Laboratory............. Participant Biosafety 70 1 5/60 6
Compliance Agreement.
MPEP Mycobacterium 70 2 30/60 70
tuberculosis Results
Worksheet.
Online Survey 70 2 15/60 35
Instrument.
MPEP Mycobacterium 4 2 15/60 2
tuberculosis Minimum
Inhibitory
Concentration (MIC)
Results Form.
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Total....................... ....................... .............. .............. ........... 113
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Public Health
Ethics and Regulations, Office of Science, Centers for Disease Control
and Prevention.
[FR Doc. 2025-10860 Filed 6-13-25; 8:45 am]
BILLING CODE 4163-18-P
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