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Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201507-0920-006 · OMB 0920-0576 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Application for Registration Form Removed Repair queued
Administrative Review Form New Available
Notification of Potential Theft, Loss, or Release Form New Available
Records Form New Repair queued
Request to Transfer Select Agents and Toxins Form New Available
Training Form New Repair queued
Incident Response Plan Form New Available
Request Regarding a Restricted Experiment Form New Available
Biosafety Plan Form New Available
Security Plan Form New Available
Request for Expedited Review Form New Repair queued
Documentation of Self-Inspection Form New Available
Amendment to a Certificate of Registration Form New Available
Application for Registration Form New Available
Request for Exemption Form New Available
Report of Identification of a Select Agent or Toxin Form New Available
Request for Exclusions Form New Available
Report of Identification of Select Agent or Toxin Form Removed Available
Notification of Theft, Loss or Release Form Removed Available
Request to Transer Select Agent or Toxin Form Removed Available
Supporting Statement B.doc Supporting Statement B Uploaded 2015-07-23 Available
Supporting Statement A.doc Supporting Statement A Uploaded 2015-07-23 Available
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
7036 Application for Registration Form Removed
217521 Administrative Review Form New
217520 Notification of Potential Theft, Loss, or Release Form New
217519 Records Form New
217518 Request to Transfer Select Agents and Toxins Form New
217517 Training Form New
217516 Incident Response Plan Form New
217515 Request Regarding a Restricted Experiment Form New
217514 Biosafety Plan Form New
217512 Security Plan Form New
217511 Request for Expedited Review Form New
217510 Documentation of Self-Inspection Form New
217509 Amendment to a Certificate of Registration Form New
217508 Application for Registration Form New
217507 Request for Exemption Form New
217505 Report of Identification of a Select Agent or Toxin Form New
217504 Request for Exclusions Form New
186031 Inspections Instruction Removed
186030 Amendment to Registration Application Instruction Removed
186028 Adminstrative Review Instruction Removed
186026 Request for Exclusion/Restricted Instruction Removed
186025 Request for Expedited Review Instruction Removed
186024 Request for Exemption Instruction Removed
186023 Report of Identification of Select Agent or Toxin Form Removed
186022 Notification of Theft, Loss or Release Form Removed
186021 Request to Transer Select Agent or Toxin Form Removed
ICR Details
0920-0576 201507-0920-006
Historical Active 201412-0920-009
HHS/CDC 19723
Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)
Revision of a currently approved collection   No
Regular
Approved without change 12/15/2015
Retrieve Notice of Action (NOA) 07/28/2015
  Inventory as of this Action Requested Previously Approved
12/31/2018 36 Months From Approved 12/31/2015
5,322 0 6,370
8,528 0 8,923
0 0 0
The Centers for Disease Control and Prevention is requesting a revision to forms used to collect 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.
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
16
IC Title Form No. Form Name
Incident Response Plan none Incident Response Plan
Request to Transfer Select Agents and Toxins none Request to Transfer Select Agents and Toxins
Training none Training
Records none Records
Notification of Potential Theft, Loss, or Release none Notification of Theft, Loss, or Release
Administrative Review none Administrative Review
Notification of Theft, Loss or Release none Report of Theft, Loss or Release of Select Agents and Toxins (APHIS/CDC Form 3)
Report of Identification of Select Agent or Toxin none, none, none Reporting the Identification ,   4B ,   4C
Documentation of Self-Inspection none Documentation of self-inspection
Request for Expedited Review none Request for Expedited Review
Request Regarding a Restricted Experiment none Request Regarding Restricted Experiment
Request for Exemption
Request for Expedited Review
Request for Exclusion/Restricted
Adminstrative Review
Amendment to Registration Application
Inspections
Request to Transer Select Agent or Toxin none Request to Transfer
Application for Registration none Application for Registration
Request for Exclusions none Request for Exclusions
Report of Identification of a Select Agent or Toxin none Report of Identification of a Select Agent or Toxin
Request for Exemption none Request for Exemption
Application for Registration none Application for Registration
Amendment to a Certificate of Registration none Amendment to Registration
Security Plan none Secuity Plan
Biosafety Plan none Biosafety Plan
  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 6,370 0 -728 -320 0
Annual Time Burden (Hours) 8,528 8,923 0 85 -480 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The requested revisions involve changes to some forms and a reduction in burden and respondents due to a decrease in the number of respondents now involved in this program.
$15,694,401
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Carol Marsh 404 639-4773 [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.
07/28/2015