OMB.report

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 201304-0920-020 · OMB 0920-0600 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Participant Biosafety Compliance Letter of Agreement Form and Instruction Modified Available
MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Enrollment Form Form Removed Available
MPEP Mycobacterium Tuberculosis Results Form and Instruction Modified Repair queued
Online Survey Instrument Form and Instruction Modified Available
SSB.docx Supporting Statement B Uploaded 2013-04-18 Available
Att B 60 Day FRN.pdf Supplementary Document Uploaded 2013-04-23 Available
Att C Explanation of changes.docx Supplementary Document Uploaded 2013-04-23 Repair queued
Att A Authorizing Legislation.docx Supplementary Document Uploaded 2013-04-18 Available
0920-0600 Attachment 3c Acceptance Letter Template.doc Supplementary Document Uploaded 2009-12-16 Available
0920-0600 Attachment 3b Program Description.doc Supplementary Document Uploaded 2009-12-16 Available
Att L Final Aggregate Report.pdf Supplementary Document Uploaded 2013-04-22 Available
Att K Aggregate Report Letter.docx Supplementary Document Uploaded 2013-04-22 Available
Att J Reminder Telephone Script.docx Supplementary Document Uploaded 2013-04-22 Available
Att I Reminder Email.docx Supplementary Document Uploaded 2013-04-22 Available
Att F Instructions for particpants.docx Supplementary Document Uploaded 2013-04-22 Repair queued
Att E Preshipment Email_page 1.docx Supplementary Document Uploaded 2013-04-22 Repair queued
SSA (3).docx Supporting Statement A Uploaded 2013-04-18 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
7065 Participant Biosafety Compliance Letter of Agreement Form and Instruction Modified
46481 MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Enrollment Form Form Removed
46480 MPEP Mycobacterium Tuberculosis Results Form and Instruction Modified
192388 Online Survey Instrument Form and Instruction Modified
ICR Details
0920-0600 201304-0920-020
Historical Active 201105-0920-008
HHS/CDC 19286
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 05/22/2013
Retrieve Notice of Action (NOA) 04/30/2013
  Inventory as of this Action Requested Previously Approved
05/31/2016 36 Months From Approved 05/31/2013
558 0 338
156 0 167
0 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, 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.
US Code: 3 USC 301 Name of Law: General Powers and Duties of Public Health Service: Research and Investigations in General
  
None
Not associated with rulemaking
  78 FR 4148 01/18/2013
78 FR 22552 04/16/2013
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 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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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.
$65,560
Yes Part B of Supporting Statement
Yes
No
No
No
Uncollected
Petunia Gissendaner 4046390164
  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.
04/30/2013