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

ICR 202101-0920-019

OMB: 0920-0576

Federal Form Document

Forms and Documents
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Status
Form
Unchanged
Form and Instruction
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Form and Instruction
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Form
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Form
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Form
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Form
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Form and Instruction
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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 202101-0920-019
Received in OIRA 202006-0920-017
HHS/CDC 0920-0576-21CN
Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)
No material or nonsubstantive change to a currently approved collection   No
Regular 01/29/2021
  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 requested non-substantive change is a simple program name change on multiple 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
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
Security Plan 0920-0576 Secuity Plan
Biosafety Plan 0920-0576 Biosafety Plan
Records 0920-0576 Records
Training 0920-0576 Training
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
Application for Registration (APHIS/CDC Form 1) APHIS/CDC FORM 1 Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins
Amendment to a Certificate of Registration 0920-0576 Amendment to Registration
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) APHIS/CDC FORM 2 REQUEST FOR TRANSFER SELECT AGENTS AND TOXINS
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
Administrative Review 0920-0576 Administrative Review
Documentation of Self-Inspection 0920-0576 Documentation of self-inspection
Request for Expedited Review 0920-0576 Request for Expedited Review
Request Regarding a Restricted Experiment 0920-0576 Request Regarding Restricted Experiment
Incident Response Plan 0920-0576 Incident Response Plan

  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
The estimate of respondents has decreased and the burden decreased because of IT implementation.

$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.
01/29/2021


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