[NCHHSTP] CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing

Forms and Documents

Document Name	Status
Participant Biosafety Compliance Letter of Agreement Form and Instruction	Modified
MPEP Mycobacterium Tuberculosis Results Form and Instruction	Modified
Minimum Inhibitory Concentration Reports Form and Instruction	Modified
Online Survey Instrument Form and Instruction	Modified
SSB.docx Supporting Statement B	2025-11-25
SSA_8.27.2025_final.docx Supporting Statement A	2025-11-25
Att. 14-PIA Form.pdf Supplementary Document	2025-09-04
Att. 13-Final Report.pdf Supplementary Document	2025-09-04
Att. 12-Final Report Letter.docx Supplementary Document	2025-09-04
Att. 11-Expected Results Report.pdf Supplementary Document	2025-09-04
Att. 10-Reminder Email.docx Supplementary Document	2025-09-04
Att. 7-Instructions for Participants.docx Supplementary Document	2025-09-04
Att. 6-Preshipment Email.docx Supplementary Document	2025-09-04
Att. 3-Explanation of changes.docx Supplementary Document	2025-09-04
Att. 2-60 Day FRN Published.pdf Supplementary Document	2025-09-04
Att. 1-Authorizing Legislation.docx Supplementary Document	2025-09-04

IC Document Collections

IC ID	Document Title	Status
7065	Participant Biosafety Compliance Letter of Agreement Form and Instruction	Modified
46480	MPEP Mycobacterium Tuberculosis Results Form and Instruction	Modified
234452	Minimum Inhibitory Concentration Reports Form and Instruction	Modified
192388	Online Survey Instrument Form and Instruction	Modified

ICR Details

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	11/30/2025
Responses	358	408
Time Burden (Hours)	113	129
Cost Burden (Dollars)	0	0

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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.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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

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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.

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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

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Common Form ICR:  No

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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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