View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
MPEP Mycobacterium Tuberculosis Results
none
Attachment G: MPEP Mycobacterium Tuberculosis Results
MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Enrollment Form
none
Enrollment form
Online Survey Instrument
none
Attachment H: Screen Shots of Survey Instrument
Participant Biosafety Compliance Letter of Agreement
none
Attachment D: Participant Biosafety Compliance Letter of Agreement
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.
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
Agency Contact:
Petunia Gissendaner 4046390164
Common Form ICR:
No
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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