Centers for Disease Control and Prevention Performance Evaluation Program for Mycobacterium Tuberculosis/Non-tuberculosis Mycobacteria Drug Susceptibility Testing Program

Forms and Documents

Document Name	Status
MPEP for M.TB and non--tuberculous Mycobacteria Drug Susceptibility Testing Laboratory Information Change Form	Modified
MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Enrollment Form Form	Modified
MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Results Worksheet Form	Modified
MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Laboratory Practices Questionnaire Form	New
0920-0600 IRB Determination.doc Supplementary Document	2009-12-16
0920-0600 Attachment 4h Analysis of Performance Results.doc Supplementary Document	2009-12-16
0920-0600 Attachment 2 60d FRN.pdf Supplementary Document	2009-12-16
0920-0600 Attachment 1 Authorizing Legislation.doc Supplementary Document	2009-12-16
0920-0600 Attachment 4i Analysis Rpt MTB NTM DST.pdf Supplementary Document	2009-12-16
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
0920-0600 Attachment 4g Aggregate Results Letter.doc Supplementary Document	2009-12-16
0920-0600 Attachment 4f Prelim Results Letter.doc Supplementary Document	2009-12-16
0920-0600 Attachment 4eii Phone Script.doc Supplementary Document	2009-12-16
0920-0600 Attachment 4ei Reminder Email.doc Supplementary Document	2009-12-16
0920-0600 Attachment 4b Shipment and Password Letter.doc Supplementary Document	2009-12-16
0920-0600 Attachment 4a Pre-Shipment Letter.doc Supplementary Document	2009-12-16
0920-0600 Attachment 4d NTM Case History Form.doc Supplementary Document	2009-12-16
0920-0600 Supporting Statement.2.10.doc Supporting Statement A	2010-02-11

IC Document Collections

IC ID	Document Title	Status
7065	MPEP for M.TB and non--tuberculous Mycobacteria Drug Susceptibility Testing Laboratory Information Change Form	Modified
46481	MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Enrollment Form Form	Modified
46480	MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Results Worksheet Form	Modified
192388	MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Laboratory Practices Questionnaire Form	New

ICR Details

OMB Control No: 0920-0600	ICR Reference No: 201003-0920-014
Status: Historical Active	Previous ICR Reference No: 200612-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Centers for Disease Control and Prevention Performance Evaluation Program for Mycobacterium Tuberculosis/Non-tuberculosis Mycobacteria Drug Susceptibility Testing Program
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: 05/03/2010
	Date Received in OIRA: 03/30/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2013	36 Months From Approved	04/30/2010
Responses	338	0	334
Time Burden (Hours)	167	0	165
Cost Burden (Dollars)	0	0	0

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Abstract: The CDC Model Performance Evaluation Program for Mycobacterium tuberculosis and Non-tuberculous Mycobacterium Drug Susceptibility Testing assesses the capability of domestic laboratories in detecting drug resistance in M.tuberculosis and non-tuberculous agents of human infection. This revsion reinstates the Laboratory Practices Questionnaire, and deletes all hardcopy forms. Foreign labs no longer participate in the program.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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:
	74 FR 28939	06/18/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 14164	03/24/2010
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
MPEP for M.TB and non--tuberculous Mycobacteria Drug Susceptibility Testing Laboratory Information Change	none	Laboratory Information Change
MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Results Worksheet	none	Results Worksheet
MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Enrollment Form	none	Enrollment form
MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Laboratory Practices Questionnaire	none	Laboratory practices questionnaire

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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	338	334	0	4	0	0
Annual Time Burden (Hours)	167	165	0	2	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: An additional 3 minutes were added to the response times in ICRAS for the enrollment and information change forms so ICRAS would record burden less than one hour.

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Annual Cost to Federal Government: $244,495

Does this IC contain surveys, censuses, or employ statistical methods? No

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 03/30/2010

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