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

Forms and Documents

Document Name	Status
Participant Biosafety Compliance Letter of Agreement Form and Instruction	Modified
MPEP Mycobacterium Tuberculosis Results Form	Modified
Minimum Inhibitory Concentration Reports Form	New
Online Survey Instrument Form	Modified
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	2018-12-10
SSA.docx Supporting Statement A	2018-12-10

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	Modified
234452	Minimum Inhibitory Concentration Reports Form	New
192388	Online Survey Instrument Form	Modified

ICR Details

OMB Control No: 0920-0600	ICR Reference No: 201812-0920-003
Status: Active	Previous ICR Reference No: 201601-0920-019
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/14/2019
	Date Received in OIRA: 01/08/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2022	36 Months From Approved	03/31/2019
Responses	408	0	558
Time Burden (Hours)	129	0	156
Cost Burden (Dollars)	4,755	0	0

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Abstract: As part of the continuing effort to assess and monitor the quality and effectiveness of laboratory testing systems which support public health objectives of tuberculosis treatment programs, CDC requests a three-year extension of the CDC Model Performance Evaluation Program (MPEP). The program was established to analyze the performance and practices of all known clinical and public health laboratories in the United States that perform drug susceptibility testing of isolates belonging to the Mycobacterium tuberculosis complex (MTBC). Information collected will be used to evaluate and improve competency of laboratory staff and ensure the quality of test procedures being performed on clinical specimens. Revisions include a reduction in burden due to fewer laboratories participating in the program, minor modifications to the forms, and the addition of a results form..

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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:
	83 FR 43876	08/28/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 66270	12/26/2018
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
Online Survey Instrument	none	Survey Instrument - Screenshots
Minimum Inhibitory Concentration Reports	none	Minimum Inhibitory Concentration Report Form
Participant Biosafety Compliance Letter of Agreement	none	Biosafety Compliance Letter of Agreement
MPEP Mycobacterium Tuberculosis Results	none	Results Worksheet

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ICR Summary of Burden

	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	408	558	0	-150	0	0
Annual Time Burden (Hours)	129	156	0	-27	0	0
Annual Cost Burden (Dollars)	4,755	0	0	4,755	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This revision includes a reduction in burden due to a reduction in the number of participating laboratories, minor modifications to the forms and instructions, and the addition of a MIC results report form. The burden has been reduced from 156 to 129 annual burden hours.

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Annual Cost to Federal Government: $76,772

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? Uncollected

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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: 01/08/2019

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