OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 202006-0920-017 · OMB 0920-0576 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Inventory of Select Agents Guidance Form and Instruction Removed Repair queued
Training Guidance Form and Instruction Removed Repair queued
Incident Response Plan Template Form and Instruction Removed Repair queued
Incident Response Plan Guidance Form and Instruction Removed Repair queued
Request Regarding a Restricted Experiment Guidance Form and Instruction Removed Repair queued
BioSafety Plan Template Form and Instruction Removed Repair queued
BioiSafety Plan Guidance Form and Instruction Removed Repair queued
Security Plan Template Form and Instruction Removed Repair queued
Security Plan - Guidance Form and Instruction Removed Repair queued
Request for Exclusion - Guidance Form and Instruction Removed Repair queued
Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance Form and Instruction Removed Repair queued
Form 0920-0576 Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance Form and Instruction Removed Repair queued
Att 4C_Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C Form and Instruction Removed Repair queued
Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance Form and Instruction Removed Missing upstream
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance Form and Instruction Removed Repair queued
Application for Registration (APHIS/CDC Form 1) - Guidance Form and Instruction Removed Repair queued
Report of Identification of a Select Agent or Toxin from a Proficiency Test Form and Instruction Removed Repair queued
Form 0920-0576 Administrative Review Form Modified Repair queued
Form APHIS/CDC FORM 3 Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure Form and Instruction Modified Repair queued
Form 0920-0576 Records Form Modified Repair queued
Form APHIS/CDC FORM 2 Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) Form and Instruction Modified Repair queued
Form 0920-0576 Training Form Modified Available
Form 0920-0576 Incident Response Plan Form Modified Repair queued
Form 0920-0576 Request Regarding a Restricted Experiment Form Modified Repair queued
Form 0920-0576 Biosafety Plan Form Modified Repair queued
Form 0920-0576 Security Plan Form Modified Repair queued
Form 0920-0576 Request for Expedited Review Form Modified Repair queued
Form 0920-0576 Documentation of Self-Inspection Form Modified Repair queued
Form 0920-0576 Amendment to a Certificate of Registration Form Modified Repair queued
Form APHIS/CDC FORM 1 Application for Registration (APHIS/CDC Form 1) Form Modified Repair queued
Form 0920-0576 Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) Form Modified Repair queued
Form 0920-0576 Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen Form and Instruction Modified Repair queued
Form 0920-0576 Request for Exclusions Form Modified Repair queued
Attachment 3 - System of Record Notice.PDF Supplementary Document Uploaded 2020-07-20 Repair queued
Attachment 2 - 60-DayFRN-CDC-2020-0034-0001.pdf Supplementary Document Uploaded 2020-07-20 Repair queued
Attachment 1 - CDC Select Agent Regulations.pdf Supplementary Document Uploaded 2020-07-20 Repair queued
Supporting Statement B.docx Supporting Statement B Uploaded 2020-07-20 Missing upstream
0920-0576-2020REv-Supporting Statement A ICROv1200713 final.docx Supporting Statement A Uploaded 2020-07-20 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
227819 Inventory of Select Agents Guidance Form and Instruction Removed
227818 Training Guidance Form and Instruction Removed
227817 Incident Response Plan Template Form and Instruction Removed
227816 Incident Response Plan Guidance Form and Instruction Removed
227815 Request Regarding a Restricted Experiment Guidance Form and Instruction Removed
227814 BioSafety Plan Template Form and Instruction Removed
227813 BioiSafety Plan Guidance Form and Instruction Removed
227811 Security Plan Template Form and Instruction Removed
227809 Security Plan - Guidance Form and Instruction Removed
227807 Request for Exclusion - Guidance Form and Instruction Removed
227806 Request for Exemption of Select Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) - Guidance Form and Instruction Removed
227783 Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) - Guidance Form and Instruction Removed
227782 Att 4C_Federal Law Enforcement Reporting Seizure of Select Agent of Toxin (APHIS/CDC) Form 4C Form and Instruction Removed
227779 Report of Theft, Loss or Release of Select Agent or Toxin (APHIS/CDC Form 3) - Guidance Form and Instruction Removed
227769 Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance Form and Instruction Removed
227767 Application for Registration (APHIS/CDC Form 1) - Guidance Form and Instruction Removed
227499 Report of Identification of a Select Agent or Toxin from a Proficiency Test Form and Instruction Removed
217521 Administrative Review Form Modified
217520 Incident Form to Report Potential Theft, Loss, Release, or Occpational Exposure Form and Instruction Modified
217519 Records Form Modified
217518 Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) Form and Instruction Modified
217517 Training Form Modified
217516 Incident Response Plan Form Modified
217515 Request Regarding a Restricted Experiment Form Modified
217514 Biosafety Plan Form Modified
217512 Security Plan Form Modified
217511 Request for Expedited Review Form Modified
217510 Documentation of Self-Inspection Form Modified
217509 Amendment to a Certificate of Registration Form Modified
217508 Application for Registration (APHIS/CDC Form 1) Form Modified
217507 Request for Exemption of Select Agent Agent and Toxin for an Investigational Product (APHIS/CDC Form 5) Form Modified
217505 Report of Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen Form and Instruction Modified
217504 Request for Exclusions Form Modified
ICR Details
0920-0576 202006-0920-017
Received in OIRA 201804-0920-015
HHS/CDC 0920-0576
Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)
Revision of a currently approved collection   No
Regular 07/21/2020
  Requested Previously Approved
36 Months From Approved 01/31/2021
4,453 7,869
4,467 8,347
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. The requested revisions to the data collection are primarily changes to the forms to clarify instructions, correct editorial errors from previous submission, and reformat the structure of the forms based on the day-to-day processing of these 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
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 (APHIS/CDC Form 4C) ,   Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report
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
Request for Exclusion - Guidance NA Guidance Document for Exclusion of Select Agents and Toxins
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
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) - Guidance NA Guidance Document for the completion of APHIS/CDC Form 2
Application for Registration (APHIS/CDC Form 1) - Guidance NA Guidance Document for the completion of APHIS/CDC Form 1
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 FROM A PROFICIENCY TEST (APHIS/CDC FORM 4B) ,   REPORTING THE IDENTIFICATION OF A SELECT AGENT OR TOXIN: PROFICIENCY TESTING REPORT
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 Exclusions 0920-0576 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) 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 Regarding a Restricted Experiment 0920-0576 Request Regarding Restricted Experiment
Incident Response Plan 0920-0576 Incident Response Plan
Request to Transfer Select Agents and Toxins (APHIS/CDC Form 2) APHIS/CDC FORM 2 REQUEST FOR TRANSFER SELECT AGENTS AND TOXINS
Inventory of Select Agents Guidance NA Guidance document for the completion of Inventory Records of Select Agents
Training Guidance NA Guidance Document for the completion of Training
Incident Response Plan Template NA Incident Response Plan Template
Incident Response Plan Guidance NA Guidance Document for the completion of Incident Response Plan
Request Regarding a Restricted Experiment Guidance NA Guidance Document for the completion of Restricted Experiment Request
BioSafety Plan Template NA BioSafety Plan Template
BioiSafety Plan Guidance NA Guidance Documnet for the completion of BioSafety Plan
Security Plan Template NA Security Plan Template
Security Plan - Guidance NA Guidance Document for the completion of Security Plan
Security Plan 0920-0576 Secuity Plan
Biosafety Plan 0920-0576 Biosafety Plan
Training 0920-0576 Training
Records 0920-0576 Records
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
  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 7,869 0 -72 -3,344 0
Annual Time Burden (Hours) 4,467 8,347 0 -2,205 -1,675 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Using Information Technology
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.
07/21/2020