View Information Collection Request (ICR) Package
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COMMENT
Time Remaining
Days
HR
Min
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OMB Control No:
0920-0600
ICR Reference No:
202511-0920-002
Status:
Received in OIRA
Previous ICR Reference No:
202509-0920-001
Agency/Subagency:
HHS/CDC
Agency Tracking No:
0920-0600
Title:
[NCHHSTP] CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
11/25/2025
Requested
Previously Approved
Expiration Date
36 Months From Approved
12/31/2025
Responses
358
408
Time Burden (Hours)
113
129
Cost Burden (Dollars)
0
0
Abstract:
The goal of the study is to collect and analyze the performance and practices of clinical and public health laboratories in the United States that perform drug susceptibility testing of isolates belonging to the Mycobacterium tuberculosis complex (MTBC), a genetically related group of Mycobacterium species that can cause tuberculosis in humans. The TB Model Performance Evaluation Program (MPEP) assesses the ability of laboratories to test for drug resistant MTBC strains, providing laboratories a self-assessment tool to aid in optimizing their skills in susceptibility testing. This Revision has a few minor edits.
Authorizing Statute(s):
US Code:
42 USC 241
Name of Law: PHSA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
90 FR 25295
06/16/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 43446
09/09/2025
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
MPEP Mycobacterium Tuberculosis Results
n/a
Results Worksheet
Minimum Inhibitory Concentration Reports
n/a
MIC Results Form
Online Survey Instrument
n/a
Online Survey Instrument Webshots
Participant Biosafety Compliance Letter of Agreement
n/a
Participant Biosafety Compliance Agreement
ICR Summary of Burden
Total Request
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
358
408
0
-50
0
0
Annual Time Burden (Hours)
113
129
0
-16
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
There are minor edits to instruments and documents and a slight reduction in expected number of respondents.
Annual Cost to Federal Government:
$105,003
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Kevin Joyce 404 639-1944 kdj7@cdc.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
11/25/2025
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