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
Form Attachment #7 Centers for Disease Control and Prevention Performance Evaluation Program for Mycobacterium Tuberculosis/Non-tuberculosis Mycobacteria Drug Susceptibility Testing Program Form	Modified
Form Attachment #4 Centers for Disease Control and Prevention Performance Evaluation program for Mycobacterium tuberculosis/Non-tuberculous Mycobacteria Drug Susceptibility Testing Program Form	New
Form Attachment 8 Centers for Disease Control and Prevention Performance Evaluation program for Mycobacterium tuberculosis/Non-tuberculous Mycobacteria Drug Susceptibility Testing Program Form and Instruction	New
#12 Aggregate Results Letter.doc Supplementary Document	2006-12-01
#13 Proposed Final Results Report.doc Supplementary Document	2006-12-01
#13 FAX Contact.doc Supplementary Document	2006-12-01
#11 Prelim Results Letter.doc Supplementary Document	2006-12-01
#11 Prelim Results Form.doc Supplementary Document	2006-12-01
#10a Phone Script.doc Supplementary Document	2006-12-01
#9 NTM Case History Form.doc Supplementary Document	2006-12-01
LIST OF ATTACHMENTS.doc Supplementary Document	2006-12-01
#6 Pre-Shipment Letter.doc Supplementary Document	2006-12-01
#5 Acceptance Letter Template.doc Supplementary Document	2006-12-01
#3 Program Description.doc Supplementary Document	2006-12-01
Title Page 112406.doc Supplementary Document	2006-12-01
#5 Decline Letter - edited.doc Supplementary Document	2006-12-01
42 USC 241.pdf Supplementary Document	2006-12-01
0920-0600 60-Day FRN.pdf Supplementary Document	2006-12-01
0920 0600 Supporting Statement A	2007-03-05

IC Document Collections

IC ID	Document Title	Status
7065	Centers for Disease Control and Prevention Performance Evaluation Program for Mycobacterium Tuberculosis/Non-tuberculosis Mycobacteria Drug Susceptibility Testing Program Form	Modified
46481	Centers for Disease Control and Prevention Performance Evaluation program for Mycobacterium tuberculosis/Non-tuberculous Mycobacteria Drug Susceptibility Testing Program Form	New
46480	Centers for Disease Control and Prevention Performance Evaluation program for Mycobacterium tuberculosis/Non-tuberculous Mycobacteria Drug Susceptibility Testing Program Form and Instruction	New

ICR Details

OMB Control No: 0920-0600	ICR Reference No: 200612-0920-006
Status: Historical Active	Previous ICR Reference No: 200307-0920-004
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/07/2007
	Date Received in OIRA: 12/18/2006
Terms of Clearance: Approved consistent with submission of revised CDC supporting statement.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2010	36 Months From Approved	03/31/2007
Responses	334	0	330
Time Burden (Hours)	165	0	165
Cost Burden (Dollars)	0	0	0

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Abstract: The CDC Mycobacterium tuberculosis/nontuberculosis Drug Susceptibility Testing Program assesses the capability of both domestic and international laboratories in detecting drug resistance in Mycobacterium tuberculosis and non-tuberculosis agents of human infection. In addition the program evaluates documents and different testing practices in various laboratory settings with different test methodologies. This information will assist with monitoring and improving standardized protocols for ensuring accurate results for TB treatment, control and prevention.

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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:
	71 FR 26968	05/09/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 70516	12/05/2006
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
Centers for Disease Control and Prevention Performance Evaluation Program for Mycobacterium Tuberculosis/Non-tuberculosis Mycobacteria Drug Susceptibility Testing Program	Attachment #7	Laboratory Information Change Form
Centers for Disease Control and Prevention Performance Evaluation program for Mycobacterium tuberculosis/Non-tuberculous Mycobacteria Drug Susceptibility Testing Program	Attachment 8	Results Form
Centers for Disease Control and Prevention Performance Evaluation program for Mycobacterium tuberculosis/Non-tuberculous Mycobacteria Drug Susceptibility Testing Program	Attachment #4	Laboratory Enrollment Form

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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	334	330	0	4	0	0
Annual Time Burden (Hours)	165	165	0	0	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: There was a slight increase in the number of respondents. However, this increase did not resulted in an increase in the total burden hours.

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Annual Cost to Federal Government: $190,245

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? No

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)? Uncollected

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: 12/15/2006

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