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

ICR 202109-0920-003

OMB: 0920-0576

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Unchanged
Form and Instruction
Modified
Form
Unchanged
Form and Instruction
Modified
Form
Unchanged
Form
Unchanged
Form
Unchanged
Form
Unchanged
Form
Unchanged
Form
Unchanged
Form
Unchanged
Form
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Form
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Form and Instruction
Modified
Form
Unchanged
Justification for No Material/Nonsubstantive Change
2021-09-10
Justification for No Material/Nonsubstantive Change
2021-07-07
Justification for No Material/Nonsubstantive Change
2021-03-05
Justification for No Material/Nonsubstantive Change
2021-01-29
Supplementary Document
2020-07-20
Supplementary Document
2020-07-20
Supplementary Document
2020-07-20
Supporting Statement B
2020-07-20
Supporting Statement A
2020-07-20
ICR Details
0920-0576 202109-0920-003
Received in OIRA 202107-0920-002
HHS/CDC 0920-0576-21IA
Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)
No material or nonsubstantive change to a currently approved collection   No
Regular 09/10/2021
  Requested Previously Approved
01/31/2024 01/31/2024
4,453 4,453
4,467 4,467
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 nonmaterial/non-substantive changes clarifies the meaning/intent of questions on a few forms.

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

  85 FR 18980 04/03/2020
85 FR 43844 07/20/2020
No

16
IC Title Form No. Form Name
Administrative Review 0920-0576 Administrative Review
Amendment to a Certificate of Registration 0920-0576 Amendment to Registration
Application for Registration (APHIS/CDC Form 1) APHIS/CDC FORM 1 Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins
Biosafety Plan 0920-0576 Biosafety Plan
Documentation of Self-Inspection 0920-0576 Documentation of self-inspection
Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure APHIS/CDC FORM 3 INCIDENT FORM TO REPORT POTENTIAL THEFT, LOSS, RELEASE, OR OCCUPATIONAL EXPOSURE
Incident Response Plan 0920-0576 Incident Response Plan
Records 0920-0576 Records
Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen 0920-0576 APHIS/CDC FORM 4A - REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN FROM A CLINICAL/DIAGNOSTIC SPECIMEN
Request Regarding a Restricted Experiment 0920-0576 Request Regarding Restricted Experiment
Request for Exclusions 0920-0576 Request for Exclusions
Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) 0920-0576 Request for Exemption
Request for Expedited Review 0920-0576 Request for Expedited Review
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) APHIS/CDC Form 2 Request to Transfer Select Agents and Toxins
Security Plan 0920-0576 Secuity Plan
Training 0920-0576 Training

  Total Request 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 4,453 4,453 0 0 0 0
Annual Time Burden (Hours) 4,467 4,467 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$19,896,009
No
    Yes
    Yes
No
No
No
No
Kevin Joyce 404 639-1944 [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.
09/10/2021


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