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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Attachment D: Participant Biosafety Compliance Letter of Agreement	Form and Instruction	Unchanged	Available
Form 0920-0600 Att C M tuberculosis Results Worksheet	Form and Instruction	Unchanged	Available
Survey Screenshots	Form	Unchanged	Available
SSA 09FEB2016.docx	Supporting Statement A	Uploaded 2016-02-11	Available
SSB.docx	Supporting Statement B	Uploaded 2016-02-09	Available
Att K Final Aggregate Report.pdf	Supplementary Document	Uploaded 2016-01-29	Available
Att J. Aggregate Report Letter.docx	Supplementary Document	Uploaded 2016-01-29	Available
Att I Reminder Telephone Script.docx	Supplementary Document	Uploaded 2016-01-29	Repair queued
Att H Reminder Email.docx	Supplementary Document	Uploaded 2016-01-29	Available
Att G Instructions to particpants.docx	Supplementary Document	Uploaded 2016-01-29	Available
Att F Preshipment Email.docx	Supplementary Document	Uploaded 2016-01-29	Available
Att A Authorizing Legislation.docx	Supplementary Document	Uploaded 2016-01-29	Available
Att B 60 Day FRN.pdf	Supplementary Document	Uploaded 2016-01-29	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
7065	Participant Biosafety Compliance Letter of Agreement	Form and Instruction	Unchanged	Attachment D: Participant Biosafety Compliance Letter of Agreement
46480	MPEP Mycobacterium Tuberculosis Results	Form and Instruction	Unchanged	Att C M tuberculosis Results Worksheet
46480	MPEP Mycobacterium Tuberculosis Results	Instruction	Unchanged
192388	Online Survey Instrument	Form	Unchanged	Survey Screenshots

ICR Details

OMB Control No: 0920-0600	ICR Reference No: 201601-0920-019
Status: Historical Active	Previous ICR Reference No: 201503-0920-014
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/24/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/12/2016
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2019	36 Months From Approved	05/31/2016
Responses	558	0	558
Time Burden (Hours)	156	0	156
Cost Burden (Dollars)	0	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, the Centers for Disease Control and Prevention is requesting 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.

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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:
	80 FR 71802	11/17/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 6862	02/09/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
MPEP Mycobacterium Tuberculosis Results	0920-0600	Att C M tuberculosis Results Worksheet
Online Survey Instrument	none	Survey Screenshots
Participant Biosafety Compliance Letter of Agreement	none	Attachment D: Participant Biosafety Compliance Letter of Agreement

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ICR Summary of Burden

table that charts list 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	558	558	0	0	0	0
Annual Time Burden (Hours)	156	156	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $70,537

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

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: 02/12/2016

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