OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Select Agent Registration

ICR 201305-0579-007 · OMB 0579-0213 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form APHIS/CDC Form 5 Select Agent Registration (Private Sector) Form and Instruction Modified Repair queued
Form APHIS/CDC Form 1 ( Select Agent Registration (State, Local & Tribal) Form and Instruction Modified Available
Non-substantive change (5-20-13).docx Justification for No Material/Nonsubstantive Change Uploaded 2013-05-29 Repair queued
SS 2012.doc Supporting Statement A Uploaded 2012-11-30 Available
2012 APHIS 71 .xlsx Supplementary Document Uploaded 2012-10-12 Repair queued
APHIS 79 -2012.xls Supplementary Document Uploaded 2012-10-09 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
2397 Select Agent Registration (Private Sector) Form and Instruction Modified
186793 Select Agent Registration (State, Local & Tribal) Form and Instruction Modified
ICR Details
0579-0213 201305-0579-007
Historical Active 201207-0579-003
USDA/APHIS
Select Agent Registration
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 06/25/2013
Retrieve Notice of Action (NOA) 05/30/2013
  Inventory as of this Action Requested Previously Approved
11/30/2015 11/30/2015 11/30/2015
4,754 0 4,754
12,368 0 12,368
0 0 0
The purpose of this collection is to ensure that persons who possess, use, or transfer select agents and toxins to register those agents with either APHIS or CDC and meet all security and safety requirements
PL: Pub.L. 107 - 188 Bioterrorism Name of Law: Public Health Safety and Bioterrorism Preparedness and Response Act of 2002
  
None
0579-AD09 Final or interim final rulemaking 77 FR 194 10/05/2012
Yes
2
IC Title Form No. Form Name
Select Agent Registration (Private Sector) APHIS-CDC Form 4B, APHIS/CDC Form 4C, VS 16-3, VS 16-7, PPQ 526, APHIS-CDC Form 4A, APHIS/CDC Form 1 (Revised), APHIS/CDC Form 2, APHIS/CDC Form 3, APHIS/CDC Form 5 Request for Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational Product ,   Reporting the Identification of a Select Agent or Toxin in a Clinical/Diagnostic Specimen ,   Application for Permit to Import or Transport Controlled Material or Organisms or Vectors ,   Application and Permit to Move Live Plant Pests or Noxious Weeds ,   Additional Information for Cell Cultures and Their Products ,   Reporting the Identification of a Select Agent or Toxin: Proficiency Testing Report ,   Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report ,   Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins ,   Request to Transfer Select Agents and Toxins ,   Report of Theft, Loss, or Release of Select Agents and Toxins
Select Agent Registration (State, Local & Tribal) APHIS-CDC Form 4B, APHIS/CDC 4C, PPQ 526, APHIS-CDC Form 4A, VS 16-3, VS 16-7, APHIS/CDC Form 1 (Revised), APHIS/CDC Form 2, APHIS/CDC Form 3, APHIS/CDC Form 5 Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins ,   Request to Transfer Select Agents and Toxins ,   Report of Theft, Loss, or Release of Select Agents and Toxins ,   Request for Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational Product ,   Application for Permit to Import or Transport Controlled Material or Organisms or Vectors ,   Additional Information for Cell Cultures and Their Products ,   Application and Permit to Move Live Plant Pests or Noxious Weeds ,   Reporting the Identification of a Select Agent or Toxin in a Clinical/Diagnostic Specimen ,   Reporting the Identification of a Select Agent or Toxin: Proficiency Testing Report ,   Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report
  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 4,754 4,754 0 0 0 0
Annual Time Burden (Hours) 12,368 12,368 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
There is a program change of 386 additional respondents, 3,335 annual responses, and 9,823 hours. The reason for the program change is a result of final rulemaking that adds an Amendment to APHIS/CDC Form 1, recordkeeping for the State, a Security Plan, Biosafety/Biocontainment Plan, Request Regarding a Restricted Experiment, Incident Response Plan, and Training to this collection and for additional time required to complete APHIS/CDC Forms 1, 2, and 3 because more information has been added to these forms for the public to complete. There is also an adjustment of +69 respondents, +255 annual responses, and +255 burden hours due to an increase in the number of State respondents completing APHIS/CDC Form 4, and an increase in the number of responses per respondent for this form.
$32,573
No
No
No
No
No
Uncollected
Charles Divan 301 734-5960
  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.
05/30/2013