Select Agent Registration

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form APHIS/CDC Form 4C Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report	Form and Instruction	Unchanged	Available
Form APHIS-CDC Form 4B Reporting the Identification of a Select Agent or Toxin: Proficiency Testing Report	Form and Instruction	Unchanged	Available
Form VS 16-7 Additional Information for Cell Cultures and Their Products	Form	Unchanged	Available
Form PPQ 526 Application and Permit to Move Live Plant Pests or Noxious Weeds	Form	Unchanged	Repair queued
Form VS 16-3 Application for Permit to Import or Transport Controlled Material or Organisms or Vectors	Form	Unchanged	Available
Form APHIS-CDC Form 5 Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational Product	Form and Instruction	Unchanged	Available
Form APHIS-CDC Form 4A Reporting the Identification of a Select Agent or Toxin in a Clinical/Diagnostic Specimen	Form and Instruction	Unchanged	Available
Form APHIS-CDC Form 3 Report of Theft, Loss, or Release of Select Agents and Toxins	Form and Instruction	Unchanged	Available
Form APHIS-CDC Form 2 Request to Transfer Select Agents and Toxins	Form and Instruction	Unchanged	Available
Form APHIS-CDC Form 1 Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins	Form and Instruction	Unchanged	Available
Form APHIS/CDC 4C Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report	Form and Instruction	Unchanged	Available
Form APHIS-CDC Form 4B Reporting the Identification of a Select Agent or Toxin: Proficiency Testing Report	Form and Instruction	Unchanged	Available
Form APHIS-CDC Form 5 Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational Product	Form and Instruction	Unchanged	Repair queued
Form APHIS-CDC Form 4A Reporting the Identification of a Select Agent or Toxin in a Clinical/Diagnostic Specimen	Form and Instruction	Unchanged	Available
Form APHIS-CDC Form 3 Report of Theft, Loss, or Release of Select Agents and Toxins	Form and Instruction	Unchanged	Repair queued
Form APHIS-CDC Form 2 Request to Transfer of Select Agents and Toxins	Form and Instruction	Unchanged	Available
Form APHIS-CDC Form 1 Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins	Form and Instruction	Unchanged	Available
Form PPQ 526 Application and Permit to Move Live Plant Pests or Noxious Weeds	Form	Unchanged	Available
Form VS 16-7 Additional Information for Cell Cultures and Their Products	Form	Unchanged	Available
Form VS 16-3 Application for Permit to Import or Transport Controlled Material or Organisms or Vectors	Form	Unchanged	Available
Nonsubstantive Change Request.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2012-03-30	Repair queued
SS 2011.doc	Supporting Statement A	Uploaded 2011-12-07	Available
APHIS 79 -2011.xls	Supplementary Document	Uploaded 2011-12-05	Available
APHIS 71.xls	Supplementary Document	Uploaded 2011-12-05	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
2397	Select Agent Registration	Form and Instruction	Unchanged	Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report
2397	Select Agent Registration	Form and Instruction	Unchanged	Reporting the Identification of a Select Agent or Toxin: Proficiency Testing Report
2397	Select Agent Registration	Form	Unchanged	Additional Information for Cell Cultures and Their Products
2397	Select Agent Registration	Form	Unchanged	Application and Permit to Move Live Plant Pests or Noxious Weeds
2397	Select Agent Registration	Form	Unchanged	Application for Permit to Import or Transport Controlled Material or Organisms or Vectors
2397	Select Agent Registration	Form and Instruction	Unchanged	Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational Product
2397	Select Agent Registration	Form and Instruction	Unchanged	Reporting the Identification of a Select Agent or Toxin in a Clinical/Diagnostic Specimen
2397	Select Agent Registration	Form and Instruction	Unchanged	Report of Theft, Loss, or Release of Select Agents and Toxins
2397	Select Agent Registration	Form and Instruction	Unchanged	Request to Transfer Select Agents and Toxins
2397	Select Agent Registration	Form and Instruction	Unchanged	Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins
186793	Select Agent Registration	Form and Instruction	Unchanged	Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report
186793	Select Agent Registration	Form and Instruction	Unchanged	Reporting the Identification of a Select Agent or Toxin: Proficiency Testing Report
186793	Select Agent Registration	Form and Instruction	Unchanged	Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational Product
186793	Select Agent Registration	Form and Instruction	Unchanged	Reporting the Identification of a Select Agent or Toxin in a Clinical/Diagnostic Specimen
186793	Select Agent Registration	Form and Instruction	Unchanged	Report of Theft, Loss, or Release of Select Agents and Toxins
186793	Select Agent Registration	Form and Instruction	Unchanged	Request to Transfer of Select Agents and Toxins
186793	Select Agent Registration	Form and Instruction	Unchanged	Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins
186793	Select Agent Registration	Form	Unchanged	Application and Permit to Move Live Plant Pests or Noxious Weeds
186793	Select Agent Registration	Form	Unchanged	Additional Information for Cell Cultures and Their Products
186793	Select Agent Registration	Form	Unchanged	Application for Permit to Import or Transport Controlled Material or Organisms or Vectors

ICR Details

OMB Control No: 0579-0213	ICR Reference No: 201203-0579-013
Status: Historical Active	Previous ICR Reference No: 201110-0579-016
Agency/Subagency: USDA/APHIS	Agency Tracking No:
Title: Select Agent Registration
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/16/2012
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/30/2012
Terms of Clearance: OMB approves the change in expiration date 10/31/2014 so that this collection and the CDC collection on the same subject have the same expiration date.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	02/28/2015	02/28/2015
Responses	1,164	0	1,164
Time Burden (Hours)	2,290	0	2,290
Cost Burden (Dollars)	0	0	0

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Abstract: 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

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Authorizing Statute(s): PL: Pub.L. 107 - 188 Bioterrorism Name of Law: Public Health Safety and Bioterrorism Preparedness and Response Act of 2002
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 100	05/24/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 239	12/13/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Select Agent Registration	APHIS-CDC Form 4B, APHIS/CDC 4C, PPQ 526, APHIS-CDC Form 2, APHIS-CDC Form 3, APHIS-CDC Form 4A, APHIS-CDC Form 5, APHIS-CDC Form 1, VS 16-3, VS 16-7	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 ,   Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins ,   Request to Transfer of Select Agents and Toxins ,   Report of Theft, Loss, or Release of Select Agents and Toxins ,   Reporting the Identification of a Select Agent or Toxin in a Clinical/Diagnostic Specimen ,   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: Proficiency Testing Report ,   Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report
Select Agent Registration	APHIS-CDC Form 1, APHIS-CDC Form 4B, APHIS/CDC Form 4C, VS 16-3, VS 16-7, PPQ 526, APHIS-CDC Form 2, APHIS-CDC Form 4A, 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 ,   Reporting the Identification of a Select Agent or Toxin in a Clinical/Diagnostic Specimen ,   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 ,   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

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ICR Summary of Burden

table that charts list of burden

	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	1,164	1,164	0	0	0	0
Annual Time Burden (Hours)	2,290	2,290	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The respondents registering agents and toxins for this program has increased from 655 to 1,163; an increase of 508 respondents participating in the registration process. This has resulted in an adjusted increase of + 409 annual responses and 1,004 hours for this collection.

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Annual Cost to Federal Government: $32,573

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 03/30/2012

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