Information Collection Request

Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)

ICR 200808-0920-002 · OMB 0920-0576 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-0576 Application for Registration Form and Instruction Modified Available
Form 0920-0576 Request for Exemption/Exclusion Form and Instruction New Available
Form 0920-0576 Report of Identification of Select Agent or Toxin Form and Instruction New Available
Form 0920-0576 Notification of Theft, Loss or Release Form and Instruction New Available
Form 0920-0576 Request to Transer Select Agent or Toxin Form and Instruction New Repair queued
Attachment 2A-Response to Sheets on Proposed Data Collections.htm Supplementary Document Uploaded 2008-07-08 Available
Attachment 2A- comment from Sheets.ProposedDataCollection.doc Supplementary Document Uploaded 2008-07-08 Available
Attachment 2A-Upham comment and response to Federal Register Notice 0920-0576.htm Supplementary Document Uploaded 2008-07-08 Available
Attachment 2A-Response to Demmin comments 16May08.pdf - Adobe Acrobat Standard (UNCLASSIFIED).txt Supplementary Document Uploaded 2008-07-08 Available
Attachment 2A-CDC form comments.Demmin. 16May08.pdf Supplementary Document Uploaded 2008-07-08 Available
Attachment 2A-Response to Cook comments on OMB Control No. 0920-0576-1.htm Supplementary Document Uploaded 2008-07-08 Available
Attachment 2A-WU Comments from Cook.pdf Supplementary Document Uploaded 2008-07-08 Available
Attachment 2-60Day FRN.pdf Supplementary Document Uploaded 2008-07-07 Available
Attachment 5-Revisions to APHIS-CDC Forms.doc Supplementary Document Uploaded 2008-07-07 Available
Attachment 3-APHIS-CDC Form 5.pdf Supplementary Document Uploaded 2008-07-07 Available
Attachment 3-APHIS-CDC Form 4.pdf Supplementary Document Uploaded 2008-07-07 Available
Attachment 3-APHIS-CDC Form 3.pdf Supplementary Document Uploaded 2008-07-07 Available
Attachment 3-APHIS-CDC Form 2.pdf Supplementary Document Uploaded 2008-07-07 Available
Attachment 3-APHIS-CDC Form 1.pdf Supplementary Document Uploaded 2008-07-07 Available
CDC Select Agent Program Supporting Statement 7-16 08.doc Supporting Statement A Uploaded 2008-07-16 Available
IC Document Collections
IC IDCollectionTypeStatusForm
7036 Application for Registration Form and Instruction Modified
186031 Inspections Instruction New
186030 Amendment to Registration Application Instruction New
186029 Ensure secure recordkeeping system Instruction New
186028 Adminstrative Review Instruction New
186027 Documentation of Training Instruction New
186026 Documentation of Self-Inspection Instruction New
186025 Request for Expedited Review Instruction New
186024 Request for Exemption/Exclusion Form and Instruction New
186023 Report of Identification of Select Agent or Toxin Form and Instruction New
186022 Notification of Theft, Loss or Release Form and Instruction New
186021 Request to Transer Select Agent or Toxin Form and Instruction New
ICR Details
0920-0576 200808-0920-002
Historical Active 200601-0920-003
HHS/CDC
Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)
Revision of a currently approved collection   No
Regular
Approved with change 12/07/2008
Retrieve Notice of Action (NOA) 08/06/2008
The text indicates the estimated cost to the government as: $13,376,078.00. The burden summary must reflect that estimate. Costs to respondent are estimated at $295,585.47. This amount should be noted in the burden summary.
  Inventory as of this Action Requested Previously Approved
12/31/2011 36 Months From Approved 03/31/2009
6,167 0 5,324
9,657 0 7,785
0 0 0

CDC is requesting three-year approval to continue data collection and reporting on 5 forms as required under the Final Rule 42 CFR Part 73. The data collection forms include Registration Application for entities, Requests to Transfer, Report theft, loss or Identification of Select Agents or Toxins, and Request for Exemption. Additional data collection is done through reports and reviews.

PL: Pub.L. 107 - 188 Subtitle A Name of Law: Public Health Security and Bioterrorism Preparedness and Response Act of 2002
  
None

0920-AA09 Final or interim final rulemaking 70 FR 13294 03/18/2005

  73 FR 14252 03/18/2008
73 FR 39702 07/10/2008
Yes

  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 6,167 5,324 0 0 843 0
Annual Time Burden (Hours) 9,657 7,785 0 0 1,872 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$13,276,078
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Maryam Daneshvar 4046394604

  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.
08/06/2008