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 for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Enrollment Form Form	Removed
MPEP Mycobacterium Tuberculosis Results Form and Instruction	Modified
Online Survey Instrument Form and Instruction	Modified
SSB.docx Supporting Statement B	2013-04-18
Att B 60 Day FRN.pdf Supplementary Document	2013-04-23
Att C Explanation of changes.docx Supplementary Document	2013-04-23
Att A Authorizing Legislation.docx Supplementary Document	2013-04-18
0920-0600 Attachment 3c Acceptance Letter Template.doc Supplementary Document	2009-12-16
0920-0600 Attachment 3b Program Description.doc Supplementary Document	2009-12-16
Att L Final Aggregate Report.pdf Supplementary Document	2013-04-22
Att K Aggregate Report Letter.docx Supplementary Document	2013-04-22
Att J Reminder Telephone Script.docx Supplementary Document	2013-04-22
Att I Reminder Email.docx Supplementary Document	2013-04-22
Att F Instructions for particpants.docx Supplementary Document	2013-04-22
Att E Preshipment Email_page 1.docx Supplementary Document	2013-04-22
SSA (3).docx Supporting Statement A	2013-04-18

IC Document Collections

IC ID	Document Title	Status
7065	Participant Biosafety Compliance Letter of Agreement Form and Instruction	Modified
46481	MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Enrollment Form Form	Removed
46480	MPEP Mycobacterium Tuberculosis Results Form and Instruction	Modified
192388	Online Survey Instrument Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0600	ICR Reference No: 201304-0920-020
Status: Historical Active	Previous ICR Reference No: 201105-0920-008
Agency/Subagency: HHS/CDC	Agency Tracking No: 19286
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: 05/22/2013
	Date Received in OIRA: 04/30/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2016	36 Months From Approved	05/31/2013
Responses	558	0	338
Time Burden (Hours)	156	0	167
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 CDC Model Performance Evaluation Program (MPEP) 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). Adequate TB control depends on rapid isolation and identification of the etiologic agent, M. tuberculosis, and confirmation of the appropriate therapeutic regimen by anti-tuberculosis drug susceptibility testing. Respondents consist of staff at domestic laboratories that perform drug susceptibility testing on isolates of M. tuberculosis. Information collected will be used to evaluate and improve competency of staff and ensure the quality of test procedures being performed on clinical specimens.

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Authorizing Statute(s): US Code: 3 USC 301 Name of Law: General Powers and Duties of Public Health Service: Research and Investigations in General
  

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:
	78 FR 4148	01/18/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 22552	04/16/2013
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Online Survey Instrument	none	Attachment H: Screen Shots of Survey Instrument
MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Enrollment Form	none	Enrollment form
Participant Biosafety Compliance Letter of Agreement	none	Attachment D: Participant Biosafety Compliance Letter of Agreement
MPEP Mycobacterium Tuberculosis Results	none	Attachment G: MPEP Mycobacterium Tuberculosis Results

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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	558	338	0	220	0	0
Annual Time Burden (Hours)	156	167	0	-11	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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 is a request for a revision of a currently approved data collection. In this request, CDC is requesting approval for several revisions including: -- Changing the title of the data collection to "CDC Model Performance Evaluation (MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing" to reflect that nontuberculous mycobacteria are no longer included in the test package. -- The new software used to create the survey instrument generates a more user friendly format than the prior data collection instrument, thereby reducing burden. Also, the reduction in the number of participating laboratories from 96 to 93 reduces the burden hours from 167 to 156. The full revision details are located in SSA.15.

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Annual Cost to Federal Government: $65,560

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: 04/30/2013

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