Information Collection Request

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

ICR 201701-0920-008 · OMB 0920-0576 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Administrative Review Form Unchanged Available
Notification of Potential Theft, Loss, or Release Form Unchanged Available
Records Form Unchanged Available
Request to Transfer Select Agents and Toxins Form Unchanged Repair queued
Training Form Unchanged Repair queued
Incident Response Plan Form Unchanged Repair queued
Request Regarding a Restricted Experiment Form Unchanged Repair queued
Biosafety Plan Form Unchanged Available
Security Plan Form Unchanged Available
Request for Expedited Review Form Unchanged Repair queued
Documentation of Self-Inspection Form Unchanged Available
Amendment to a Certificate of Registration Form Unchanged Repair queued
Application for Registration Form Modified Repair queued
Request for Exemption Form Unchanged Available
Report of Identification of a Select Agent or Toxin Form Unchanged Available
Request for Exclusions Form Unchanged Available
0920-0576 Change request_1 26 2017.docx Justification for No Material/Nonsubstantive Change Uploaded 2017-01-26 Repair queued
Non-substantive change request_2016-12-01.docx Justification for No Material/Nonsubstantive Change Uploaded 2016-12-01 Available
Supporting Statement B.doc Supporting Statement B Uploaded 2015-07-23 Available
Supporting Statement A.doc Supporting Statement A Uploaded 2015-07-23 Repair queued
Attachment 4 - System of Record Notice.PDF Supplementary Document Uploaded 2015-07-16 Available
Attachment 3 - Public Comments.docx Supplementary Document Uploaded 2015-07-16 Available
Attachment 2 - 60-day Federal Register Notice.pdf Supplementary Document Uploaded 2015-07-16 Available
Attachment 1 - CDC Select Agent Regulations.pdf Supplementary Document Uploaded 2015-07-16 Available
IC Document Collections
IC IDCollectionTypeStatusForm
217521 Administrative Review Form Unchanged
217520 Notification of Potential Theft, Loss, or Release Form Unchanged
217519 Records Form Unchanged
217518 Request to Transfer Select Agents and Toxins Form Unchanged
217517 Training Form Unchanged
217516 Incident Response Plan Form Unchanged
217515 Request Regarding a Restricted Experiment Form Unchanged
217514 Biosafety Plan Form Unchanged
217512 Security Plan Form Unchanged
217511 Request for Expedited Review Form Unchanged
217510 Documentation of Self-Inspection Form Unchanged
217509 Amendment to a Certificate of Registration Form Unchanged
217508 Application for Registration Form Modified
217507 Request for Exemption Form Unchanged
217505 Report of Identification of a Select Agent or Toxin Form Unchanged
217504 Request for Exclusions Form Unchanged
ICR Details
0920-0576 201701-0920-008
Historical Active 201609-0920-014
HHS/CDC 0920-17NX
Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 01/30/2017
Retrieve Notice of Action (NOA) 01/27/2017
  Inventory as of this Action Requested Previously Approved
12/31/2018 12/31/2018 12/31/2018
5,322 0 5,322
8,528 0 8,528
0 0 0

The Centers for Disease Control and Prevention collects information under 42CFR Part 73, with the purpose of ensuring select agents or toxins are managed appropriately to prevent any threats to human health or safety. This request for change is to modify the wording of selected questions on the Application for Registration form to clarify their meaning and intent. The affected sections are (1) Form 1, Sec. 6A, Building and Suite/Room Specific Security; (2) Form 1, Sec. 7A, PI Info and Select Agent and Toxin Locations.; (3) Form 1, Att. C, Work with Animals; (4) Form 1, Att. E, Work with Arthropods; and (5) Form 1, Att. F, BSL3 Ag Labs.

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

Not associated with rulemaking

  80 FR 18242 04/03/2015
80 FR 44130 07/24/2015
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 5,322 5,322 0 0 0 0
Annual Time Burden (Hours) 8,528 8,528 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$15,694,401
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Renita Macaluso 770 488-6458 [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.
01/27/2017