Select Agent Registration

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form VS 16-7 Additional Information for Cell Cultures and Their Products	Form	Modified	Available
Form PPQ 526 Application and Permit to Move Live Plant Pests or Noxious Weeds	Form	Modified	Available
Form VS 16-3 Application for Permit to Import or Transport Controlled Material or Organisms or Vectors	Form	Modified	Available
Form APHIS-CDC Form 5 Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational/Experimental Product	Form and Instruction	Modified	Available
Form APHIS-CDC Form 4 Report of the Identification of a Select Agent or Toxin in a Clinical or Diagnostic Laboratory	Form and Instruction	Modified	Available
Form APHIS-CDC Form 3 Report of Theft, Loss, or Release of Select Agents and Toxins	Form and Instruction	Modified	Available
Form APHIS-CDC Form 2 Report of Transfer of Select Agents and Toxins	Form and Instruction	Modified	Available
Form APHIS-CDC Form 1 Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins	Form and Instruction	Modified	Available
Form APHIS-CDC Form 5 Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational/Experimental Product	Form and Instruction	New	Available
Form APHIS-CDC Form 4 Report of the Identification of a Select Agent or Toxin in a Clinical or Diagnostic Laboratory	Form and Instruction	New	Available
Form APHIS-CDC Form 3 Report of Theft, Loss, or Release of Select Agents and Toxins	Form and Instruction	New	Available
Form APHIS-CDC Form 2 Report of Transfer of Select Agents and Toxins	Form and Instruction	New	Available
Form APHIS-CDC Form 1 Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins	Form and Instruction	New	Available
Form PPQ 526 Application and Permit to Move Live Plant Pests or Noxious Weeds	Form	New	Available
Form VS 16-7 Additional Information for Cell Cultures and Their Products	Form	New	Available
Form VS 16-3 Application for Permit to Import or Transport Controlled Material or Organisms or Vectors	Form	New	Available
SS.doc	Supporting Statement A	Uploaded 2008-10-31	Available
APHIS 71.pdf	Supplementary Document	Uploaded 2008-10-16	Available
APHIS 79 for 0579-0213.pdf	Supplementary Document	Uploaded 2008-10-02	Available

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0579-0213	ICR Reference No: 200805-0579-002
Status: Historical Active	Previous ICR Reference No: 200509-0579-001
Agency/Subagency: USDA/APHIS	Agency Tracking No:
Title: Select Agent Registration
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/07/2008
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/04/2008
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	36 Months From Approved	12/31/2008
Responses	755	0	545
Time Burden (Hours)	1,286	0	938
Cost Burden (Dollars)	0	0	0

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Abstract: To create an effective, uniform, consistent, and efficient system that requires persons who possess, use, or transfer select agents and toxins to register those agents with either APHIS or CDC.

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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:
	73 FR 126	06/30/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 208	10/27/2008
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	PPQ 526, APHIS-CDC Form 2, APHIS-CDC Form 3, APHIS-CDC Form 4, 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 Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins ,   Report of Transfer of Select Agents and Toxins ,   Report of Theft, Loss, or Release of Select Agents and Toxins ,   Report of the Identification of a Select Agent or Toxin in a Clinical or Diagnostic Laboratory ,   Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational/Experimental Product
Select Agent Registration	VS 16-3, VS 16-7, PPQ 526, APHIS-CDC Form 2, APHIS-CDC Form 4, APHIS-CDC Form 3, APHIS-CDC Form 5, APHIS-CDC Form 1	Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins ,   Report of Transfer of Select Agents and Toxins ,   Report of Theft, Loss, or Release of Select Agents and Toxins ,   Report of the Identification of a Select Agent or Toxin in a Clinical or Diagnostic Laboratory ,   Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational/Experimental 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

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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	755	545	0	0	210	0
Annual Time Burden (Hours)	1,286	938	0	0	348	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: There is an increase of +348 hours for this collection because of the increased number of respondents participating in the registration process.

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Annual Cost to Federal Government: $120,292

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 11/04/2008

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