CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis and Nontuberculous Mycobacteria Drug Susceptibility Testing

Forms and Documents

Document Name	Status
Form 0920-0600 Participant Biosafety Compliance Letter of Agreement Form	Modified
Form 0920-0600 MPEP Mycobacterium Tuberculosis Results Form	Modified
Form 0920-0600 Minimum Inhibitory Concentration Reports Form and Instruction	Modified
Form 0920-0600 Online Survey Instrument Form	Modified
60 Day FRN.pdf Supplementary Document	2021-12-15
Att. 14 PIA_Assessment Rev 2021.pdf Supplementary Document	2021-12-15
Att. 12-Final Aggregate Report.pdf Supplementary Document	2021-12-15
Att. 11-Aggregate Report Letter.docx Supplementary Document	2021-12-15
Att. 10-Reminder Email.docx Supplementary Document	2021-12-15
Att. 6-Instructions for Participants.docx Supplementary Document	2021-12-15
Att. 5-Preshipment Email.docx Supplementary Document	2021-12-15
Att. 3-Explanation of changes.docx Supplementary Document	2021-12-15
Att. 1-Authorizing Legislation-UNCHANGED.docx Supplementary Document	2021-12-15
Project Determination.pdf Supplementary Document	2018-12-10
Att. 14 PIA_Assessment.pdf Supplementary Document	2018-12-10
Att. 13-Final Aggregate Report.pdf Supplementary Document	2018-12-10
Att. 12-Aggregate Report Letter.docx Supplementary Document	2018-12-10
Att. 11-Reminder Telephone Script.docx Supplementary Document	2018-12-10
Att. 10-Reminder Email.docx Supplementary Document	2018-12-10
Att. 6-Instructions to participants.docx Supplementary Document	2018-12-10
Att. 5-Preshipment Email.docx Supplementary Document	2018-12-10
Att. 3-Explanation of changes.docx Supplementary Document	2018-12-10
Att. 2 60 Day FRN Published.pdf Supplementary Document	2018-12-10
Att. 1-Authorizing Legislation.docx Supplementary Document	2018-12-10
SSB.docx Supporting Statement B	2021-12-15
SSA.docx Supporting Statement A	2021-12-15

IC Document Collections

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

ICR Details

OMB Control No: 0920-0600	ICR Reference No: 202112-0920-009
Status: Received in OIRA	Previous ICR Reference No: 201812-0920-003
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0600
Title: CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis and Nontuberculous Mycobacteria 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: 12/15/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	02/28/2022
Responses	408	408
Time Burden (Hours)	129	129
Cost Burden (Dollars)	0	4,755

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Abstract: The Centers for Disease Control and Prevention (CDC) requests a revision to an approved information collection 0920-0600 (expiration date 02/20/2022) entitled, “CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing,” for a period of 3 years. Revision of this information consists of modifications to the Instructions to Participants letter, the MPEP Mycobacterium tuberculosis Results Worksheet, the MPEP Mycobacterium tuberculosis Minimum Inhibitory Concentration (MIC). Results form, and transition of online data collection instrument from one system to another.

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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:
	86 FR 48146	08/27/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 70840	12/13/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
MPEP Mycobacterium Tuberculosis Results	0920-0600	Att. 7-Results Worksheet
Minimum Inhibitory Concentration Reports	0920-0600	Att. 9-MIC Results Form
Online Survey Instrument	0920-0600	Att. 8-Survey Instrument Webshots
Participant Biosafety Compliance Letter of Agreement	0920-0600	Att. 4-Participant Biosafety Compliance Letter

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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	408	408	0	0	0	0
Annual Time Burden (Hours)	129	129	0	0	0	0
Annual Cost Burden (Dollars)	0	4,755	0	-4,755	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $78,705

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: 12/15/2021

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