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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 201810-0920-006 · OMB 0920-0576 · Historical Inactive

Forms and Documents
DocumentTypeStatusAvailability
Inventory of Select Agents Guidance Form and Instruction Unchanged Available
Training Guidance Form and Instruction Unchanged Available
Incident Response Plan Template Form and Instruction Unchanged Repair queued
Incident Response Plan Guidance Form and Instruction Unchanged Available
Request Regarding a Restricted Experiment Guidance Form and Instruction Unchanged Repair queued
BioSafety Plan Template Form and Instruction Unchanged Available
BioiSafety Plan Guidance Form and Instruction Unchanged Available
Security Plan Template Form and Instruction Unchanged Available
Security Plan - Guidance Form and Instruction Unchanged Repair queued
Request for Exclusion - Guidance Form and Instruction Unchanged Repair queued
Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance Form and Instruction Unchanged Repair queued
Form 0920-0576 Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance Form and Instruction Unchanged Available
Form APHIS/CDC FORM 4C Att 4C_Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C Form and Instruction Unchanged Repair queued
Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance Form and Instruction Unchanged Repair queued
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance Form and Instruction Unchanged Available
Application for Registration (APHIS/CDC Form 1) - Guidance Form and Instruction Unchanged Repair queued
Form APHIS/CDC FORM 4B Report of Identification of a Select Agent or Toxin from a Proficiency Test Form and Instruction Unchanged Available
Administrative Review Form Unchanged Repair queued
Form APHIS/CDC FORM 3 Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure Form and Instruction Unchanged Repair queued
Records Form Unchanged Repair queued
Form APHIS/CDC FORM 2 Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) Form and Instruction 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 Repair queued
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 (APHIS/CDC Form 1) Form Unchanged Available
Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) Form Unchanged Available
Form 0920-0576 Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen Form and Instruction Unchanged Repair queued
Request for Exclusions Form Unchanged Repair queued
Attachment 1 - SATRN Screenprints_2017-09-18.docx Supplementary Document Uploaded 2018-10-19 Available
Non-substantive change request-180812.docx Justification for No Material/Nonsubstantive Change Uploaded 2018-10-19 Available
APHIS-CDC Form 4A 0920-0576_2018-08-08.docx Supplementary Document Uploaded 2018-10-19 Repair queued
APHIS-CDC Form 4A (revised) 0920-0576_2018-08-08.docx Supplementary Document Uploaded 2018-10-19 Available
0920-0576-Non-substantive change request 27APR2018.docx Justification for No Material/Nonsubstantive Change Uploaded 2018-04-27 Available
Att6 - SORN-EFSAP.DOC Supplementary Document Uploaded 2017-12-18 Repair queued
Att5 - SORN-NSAR.PDF Supplementary Document Uploaded 2017-12-18 Available
NonSubChangeRequest.docx Justification for No Material/Nonsubstantive Change Uploaded 2017-12-18 Available
Att2a-60-DayComments.pdf Supplementary Document Uploaded 2017-08-03 Repair queued
Att2-60-Day.pdf Supplementary Document Uploaded 2017-08-03 Available
0920-0576-SSB 06JUL2017.DOCX Supporting Statement B Uploaded 2017-08-03 Available
0920-0576 SSA 06JUL2017.doc Supporting Statement A Uploaded 2017-08-03 Repair queued
Attachment 4 - System of Record 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
227819 Inventory of Select Agents Guidance Form and Instruction Unchanged
227818 Training Guidance Form and Instruction Unchanged
227817 Incident Response Plan Template Form and Instruction Unchanged
227816 Incident Response Plan Guidance Form and Instruction Unchanged
227815 Request Regarding a Restricted Experiment Guidance Form and Instruction Unchanged
227814 BioSafety Plan Template Form and Instruction Unchanged
227813 BioiSafety Plan Guidance Form and Instruction Unchanged
227811 Security Plan Template Form and Instruction Unchanged
227809 Security Plan - Guidance Form and Instruction Unchanged
227807 Request for Exclusion - Guidance Form and Instruction Unchanged
227806 Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance Form and Instruction Unchanged
227783 Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance Form and Instruction Unchanged
227782 Att 4C_Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C Form and Instruction Unchanged
227779 Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance Form and Instruction Unchanged
227769 Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance Form and Instruction Unchanged
227767 Application for Registration (APHIS/CDC Form 1) - Guidance Form and Instruction Unchanged
227499 Report of Identification of a Select Agent or Toxin from a Proficiency Test Form and Instruction Unchanged
217521 Administrative Review Form Unchanged
217520 Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure Form and Instruction Unchanged
217519 Records Form Unchanged
217518 Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) Form and Instruction 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 (APHIS/CDC Form 1) Form Unchanged
217507 Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) Form Unchanged
217505 Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen Form and Instruction Unchanged
217504 Request for Exclusions Form Unchanged
ICR Details
0920-0576 201810-0920-006
Historical Inactive 201804-0920-015
HHS/CDC 0920-0576 18AXH
Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)
No material or nonsubstantive change to a currently approved collection   No
Regular
Withdrawn and continue 10/24/2018
Retrieve Notice of Action (NOA) 10/23/2018
CDC may resubmit the change request after the relevant SORN(s) have been updated.
  Inventory as of this Action Requested Previously Approved
10/31/2020 10/31/2020 01/31/2021
7,869 0 7,869
8,347 0 8,347
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
Security Plan Template NA Security Plan Template
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
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
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
Training none Training
Records none Records
Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure NA, APHIS/CDC FORM 3 INCIDENT FORM TO REPORT POTENTIAL THEFT, LOSS, RELEASE, OR OCCUPATIONAL EXPOSURE ,   Incident Notification and Reporting APHIS/CDC Form 3 (Theft/Loss/Release)
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
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) APHIS/CDC FORM 2, none REQUEST FOR TRANSFER SELECT AGENTS AND TOXINS ,   Request to 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)
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
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
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
No
No
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
Thelma Sims 4046394771
  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.
10/23/2018