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

ICR 201804-0920-015

OMB: 0920-0576

Federal Form Document

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Justification for No Material/Nonsubstantive Change
2018-04-27
Supplementary Document
2017-12-18
Supplementary Document
2017-12-18
Justification for No Material/Nonsubstantive Change
2017-12-18
Supplementary Document
2017-08-03
Supplementary Document
2017-08-03
Supporting Statement B
2017-08-03
Supporting Statement A
2017-08-03
Supplementary Document
2015-07-16
Supplementary Document
2015-07-16
IC Document Collections
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227819 Unchanged
227818 Unchanged
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217509 Unchanged
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ICR Details
0920-0576 201804-0920-015
Active 201712-0920-006
HHS/CDC 0920-0576 18ACH
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 05/03/2018
Retrieve Notice of Action (NOA) 05/01/2018
  Inventory as of this Action Requested Previously Approved
10/31/2020 10/31/2020 10/31/2020
7,869 0 7,869
8,347 0 8,407
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 Non-Substantive Change Request is to modify APHIS/CDC Form 4A to clarify the meaning/intent of the question for the select agent or toxin identified as Botulinum neurotoxins. The revised Form 4A will result in a decrease in 60 Burden Hours for regulated entities.

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

  81 FR 96456 12/30/2016
82 FR 36144 08/03/2017
Yes

33
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
Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) none Request for Exemption
Application for Registration (APHIS/CDC Form 1) APHIS/CDC FORM 1, none Application for Registration ,   Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins
Amendment to a Certificate of Registration none Amendment to Registration
Security Plan none Secuity Plan
Biosafety Plan none Biosafety Plan
Att 4C_Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C NA, APHIS/CDC FORM 4C Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report ,   Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report (APHIS/CDC Form 4C)
Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance 0920-0576 Guidance Document for the Completion of APHIS/CDC Form 4
Inventory of Select Agents Guidance NA Guidance document for the completion of Inventory Records of Select Agents
Application for Registration (APHIS/CDC Form 1) - Guidance NA Guidance Document for the completion of APHIS/CDC Form 1
Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance NA Guidance Document for the completion of APHIS/CDC Form 5
Request for Exclusion - Guidance NA Guidance Document for Exclusion of Select Agents and Toxins
Security Plan - Guidance NA Guidance Document for the completion of Security Plan
Security Plan Template NA Security Plan Template
BioiSafety Plan Guidance NA Guidance Documnet for the completion of BioSafety Plan
BioSafety Plan Template NA BioSafety Plan Template
Request Regarding a Restricted Experiment Guidance NA Guidance Document for the completion of Restricted Experiment Request
Incident Response Plan Guidance NA Guidance Document for the completion of Incident Response Plan
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance NA Guidance Document for the completion of APHIS/CDC Form 2
Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance NA Guidance Document for the completion of APHIS/CDC Form 3
Incident Response Plan Template NA Incident Response Plan Template
Training Guidance NA Guidance Document for the completion of Training
Request for Exclusions none Request for Exclusions
Training none Training
Records none Records
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) APHIS/CDC FORM 2, none Request to Transfer Select Agents and Toxins ,   REQUEST FOR TRANSFER SELECT AGENTS AND TOXINS
Report of Identification of a Select Agent or Toxin from a Proficiency Test NA, APHIS/CDC FORM 4B REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN: PROFICIENCY TESTING REPORT ,   REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN FROM A PROFICIENCY TEST (APHIS/CDC FORM 4B)
Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure NA, APHIS/CDC FORM 3 Incident Notification and Reporting APHIS/CDC Form 3 (Theft/Loss/Release) ,   INCIDENT FORM TO REPORT POTENTIAL THEFT, LOSS, RELEASE, OR OCCUPATIONAL EXPOSURE
Administrative Review none Administrative Review
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
Incident Response Plan none Incident Response 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 7,869 7,869 0 0 0 0
Annual Time Burden (Hours) 8,347 8,407 0 -60 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Cutting Redundancy
This Non-Substantive Change Request includes a revised Form 4A that will reduce 120 forms for approximately 8 entities, resulting in a reduction of 60 Burden Hours.

$20,210,121
Yes Part B of Supporting Statement
    Yes
    Yes
No
No
No
Uncollected
Jeffrey Zirger 404 639-7118 [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.
05/01/2018


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