Notice2025-17256
Agency Forms Undergoing Paperwork Reduction Act Review
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
September 9, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 172 (Tuesday, September 9, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 172 (Tuesday, September 9, 2025)]
[Notices]
[Pages 43446-43447]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17256]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-25-0600]
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 Drug 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 June 16, 2025, to obtain
comments from the public and affected agencies. CDC received no public
comments 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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 Drug Susceptibility Testing (OMB Control No. 0920-0600,
Exp. 9/30/2025)--Extension--National Center for HIV, Viral Hepatitis,
STD, and Tuberculosis 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 from participants in the CDC Model Performance
Evaluation Program (MPEP) for Mycobacterium tuberculosis Drug
Susceptibility Testing for a period of three years. Extension of this
information 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''
from ``CDC Model Performance Evaluation Program (MPEP) for
Mycobacterium tuberculosis and Nontuberculous Mycobacteria Drug
Susceptibility Testing'' to reflect that nontuberculous mycobacteria
are no longer included in the program.
Tuberculosis (TB) is a continuing public health problem. The
overall number of cases, and associated incidence rate, in the United
States has increased over the past several years. High rates are
reported among non-U.S.-born persons, correctional populations, people
experiencing homelessness, and individuals reported to have diabetes.
To reach the goal of eliminating TB, this
[[Page 43447]]
data collection is designed to monitor and evaluate performance and
practices among U.S. laboratories performing M. tuberculosis
susceptibility testing.
Participation in this program is one way in which laboratories can
ensure high-quality laboratory testing, resulting in accurate and
reliable testing results. By providing an evaluation program to assess
the ability of laboratories to test for drug resistant M. tuberculosis
strains, this provides 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 isolates. The performance evaluation isolates
are sent to participating laboratories twice each 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 OMB 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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondent Form name respondents responses per response
respondent (hours)
----------------------------------------------------------------------------------------------------------------
Domestic Laboratory...................... Online Survey Instrument 70 2 15/60
Webshots.
Participant Biosafety 70 1 5/60
Compliance Agreement.
MPEP Mycobacterium 70 2 30/60
tuberculosis Results
Worksheet.
MPEP Mycobacterium 4 2 15/60
tuberculosis Minimum
Inhibitory Concentration
(MIC) Results Form.
----------------------------------------------------------------------------------------------------------------
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. 2025-17256 Filed 9-8-25; 8:45 am]
BILLING CODE 4163-18-P
</pre></body>
</html>Indexed from Federal Register on September 9, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.