Information Collection Request

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

ICR 202511-0920-002 · OMB 0920-0600 · Active

Forms and Documents
DocumentTypeStatusAvailability
Participant Biosafety Compliance Agreement Form and Instruction Modified Available
Participant Biosafety Compliance Letter of Agreement Form and Instruction Modified Available
Results Worksheet Form and Instruction Modified Repair queued
MPEP Mycobacterium Tuberculosis Results Form and Instruction Modified Available
MIC Results Form Form and Instruction Modified Available
Minimum Inhibitory Concentration Reports Form and Instruction Modified Available
Online Survey Instrument Webshots Form and Instruction Modified Available
Online Survey Instrument Form and Instruction Modified Available
SSB.docx Supporting Statement B Uploaded 2025-11-25 Available
SSB.docx Supporting Statement B Uploaded 2025-11-25 Available
SSA_8.27.2025_final.docx Supporting Statement A Uploaded 2025-11-25 Repair queued
SSA_8.27.2025_final.docx Supporting Statement A Uploaded 2025-11-25 Repair queued
Att. 14-PIA Form.pdf Supplementary Document Uploaded 2025-09-04 Available
Att. 14-PIA Form.pdf Supplementary Document Uploaded 2025-09-04 Repair queued
Att. 13-Final Report.pdf Supplementary Document Uploaded 2025-09-04 Available
Att. 13-Final Report.pdf Supplementary Document Uploaded 2025-09-04 Repair queued
Att. 12-Final Report Letter.docx Supplementary Document Uploaded 2025-09-04 Repair queued
Att. 12-Final Report Letter.docx Supplementary Document Uploaded 2025-09-04 Repair queued
Att. 11-Expected Results Report.pdf Supplementary Document Uploaded 2025-09-04 Repair queued
Att. 11-Expected Results Report.pdf Supplementary Document Uploaded 2025-09-04 Repair queued
Att. 10-Reminder Email.docx Supplementary Document Uploaded 2025-09-04 Repair queued
Att. 10-Reminder Email.docx Supplementary Document Uploaded 2025-09-04 Available
Att. 7-Instructions for Participants.docx Supplementary Document Uploaded 2025-09-04 Repair queued
Att. 7-Instructions for Participants.docx Supplementary Document Uploaded 2025-09-04 Available
Att. 6-Preshipment Email.docx Supplementary Document Uploaded 2025-09-04 Repair queued
Att. 6-Preshipment Email.docx Supplementary Document Uploaded 2025-09-04 Available
Att. 3-Explanation of changes.docx Supplementary Document Uploaded 2025-09-04 Available
Att. 3-Explanation of changes.docx Supplementary Document Uploaded 2025-09-04 Available
Att. 2-60 Day FRN Published.pdf Supplementary Document Uploaded 2025-09-04 Repair queued
Att. 2-60 Day FRN Published.pdf Supplementary Document Uploaded 2025-09-04 Missing upstream
Att. 1-Authorizing Legislation.docx Supplementary Document Uploaded 2025-09-04 Available
Att. 1-Authorizing Legislation.docx Supplementary Document Uploaded 2025-09-04 Available
IC Document Collections
IC IDCollectionTypeStatusForm
7065 Participant Biosafety Compliance Letter of Agreement Form and Instruction ModifiedParticipant Biosafety Compliance Agreement
7065 Participant Biosafety Compliance Letter of Agreement Form and Instruction Modified
46480 MPEP Mycobacterium Tuberculosis Results Form and Instruction ModifiedResults Worksheet
46480 MPEP Mycobacterium Tuberculosis Results Form and Instruction Modified
234452 Minimum Inhibitory Concentration Reports Form and Instruction ModifiedMIC Results Form
234452 Minimum Inhibitory Concentration Reports Form and Instruction Modified
192388 Online Survey Instrument Form and Instruction ModifiedOnline Survey Instrument Webshots
192388 Online Survey Instrument Form and Instruction Modified
ICR Details
0920-0600 202511-0920-002
Active 202509-0920-001
HHS/CDC 0920-0600
[NCHHSTP] CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing
Revision of a currently approved collection   No
Regular
Approved without change 12/29/2025
Retrieve Notice of Action (NOA) 11/25/2025
  Inventory as of this Action Requested Previously Approved
12/31/2028 36 Months From Approved 12/31/2025
358 0 408
113 0 129
0 0 0

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.

US Code: 42 USC 241 Name of Law: PHSA
  
None

Not associated with rulemaking

  90 FR 25295 06/16/2025
90 FR 43446 09/09/2025
No

  Total Approved 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
No
Yes
Miscellaneous Actions
There are minor edits to instruments and documents and a slight reduction in expected number of respondents.

$105,003
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Kevin Joyce 404 639-1944 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/25/2025