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Federal forms, ICRs, and supporting documents

Information Collection Request

CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis and Nontuberculous Mycobacteria Drug Susceptibility Testing

ICR 201812-0920-003 · OMB 0920-0600 · Active

Forms and Documents
DocumentTypeStatusAvailability
Participant Biosafety Compliance Letter of Agreement Form and Instruction Modified Available
MPEP Mycobacterium Tuberculosis Results Form Modified Repair queued
Minimum Inhibitory Concentration Reports Form New Repair queued
Online Survey Instrument Form Modified Repair queued
Project Determination.pdf Supplementary Document Uploaded 2018-12-10 Available
Att. 14 PIA_Assessment.pdf Supplementary Document Uploaded 2018-12-10 Repair queued
Att. 13-Final Aggregate Report.pdf Supplementary Document Uploaded 2018-12-10 Available
Att. 12-Aggregate Report Letter.docx Supplementary Document Uploaded 2018-12-10 Available
Att. 11-Reminder Telephone Script.docx Supplementary Document Uploaded 2018-12-10 Available
Att. 10-Reminder Email.docx Supplementary Document Uploaded 2018-12-10 Repair queued
Att. 6-Instructions to participants.docx Supplementary Document Uploaded 2018-12-10 Repair queued
Att. 5-Preshipment Email.docx Supplementary Document Uploaded 2018-12-10 Repair queued
Att. 3-Explanation of changes.docx Supplementary Document Uploaded 2018-12-10 Available
Att. 2 60 Day FRN Published.pdf Supplementary Document Uploaded 2018-12-10 Available
Att. 1-Authorizing Legislation.docx Supplementary Document Uploaded 2018-12-10 Repair queued
SSB.docx Supporting Statement B Uploaded 2018-12-10 Available
SSA.docx Supporting Statement A Uploaded 2018-12-10 Available
IC Document Collections
IC IDCollectionTypeStatusForm
7065 Participant Biosafety Compliance Letter of Agreement Form and Instruction Modified
46480 MPEP Mycobacterium Tuberculosis Results Form Modified
234452 Minimum Inhibitory Concentration Reports Form New
192388 Online Survey Instrument Form Modified
ICR Details
0920-0600 201812-0920-003
Active 201601-0920-019
HHS/CDC 0920-0600
CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis and Nontuberculous Mycobacteria Drug Susceptibility Testing
Revision of a currently approved collection   No
Regular
Approved without change 02/14/2019
Retrieve Notice of Action (NOA) 01/08/2019
  Inventory as of this Action Requested Previously Approved
02/28/2022 36 Months From Approved 03/31/2019
408 0 558
129 0 156
4,755 0 0
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..
US Code: 42 USC 241 Name of Law: PHSA
  
None
Not associated with rulemaking
  83 FR 43876 08/28/2018
83 FR 66270 12/26/2018
No
  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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.
$76,772
Yes Part B of Supporting Statement
    No
    No
No
No
No
Uncollected
Shari Steinberg 404 639-4942 [email protected]
  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
01/08/2019