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:
201812-0920-003
Status:
Historical Active
Previous ICR Reference No:
201601-0920-019
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:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
02/14/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/08/2019
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2022
36 Months From Approved
03/31/2019
Responses
408
0
558
Time Burden (Hours)
129
0
156
Cost Burden (Dollars)
4,755
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, CDC requests 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. Revisions include a reduction in burden due to fewer laboratories participating in the program, minor modifications to the forms, and the addition of a results form..
Authorizing Statute(s):
US Code:
42 USC 241
Name of Law: PHSA
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:
83 FR 43876
08/28/2018
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 66270
12/26/2018
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
4
IC Title
Form No.
Form Name
MPEP Mycobacterium Tuberculosis Results
none
Results Worksheet
Minimum Inhibitory Concentration Reports
none
Minimum Inhibitory Concentration Report Form
Online Survey Instrument
none
Survey Instrument - Screenshots
Participant Biosafety Compliance Letter of Agreement
none
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
408
558
0
-150
0
0
Annual Time Burden (Hours)
129
156
0
-27
0
0
Annual Cost Burden (Dollars)
4,755
0
0
4,755
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 revision includes a reduction in burden due to a reduction in the number of participating laboratories, minor modifications to the forms and instructions, and the addition of a MIC results report form. The burden has been reduced from 156 to 129 annual burden hours.
Annual Cost to Federal Government:
$76,772
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
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:
Shari Steinberg 404 639-4942 sxw2@cdc.gov
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:
01/08/2019
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