Select Agent Registration

Forms and Documents

Document Name	Status
Form APHIS-CDC Form 1 Select Agent Registration Form and Instruction	Modified
Form VS 16-3 Select Agent Registration Form	Modified
CHANGE TO APHIS Fm 4.doc Justification for No Material/Nonsubstantive Change	2010-08-09
SS.doc Supporting Statement A	2008-10-31
APHIS 71.pdf Supplementary Document	2008-10-16
APHIS 79 for 0579-0213.pdf Supplementary Document	2008-10-02

IC Document Collections

IC ID	Document Title	Status
2397	Select Agent Registration Form and Instruction	Modified
186793	Select Agent Registration Form	Modified

ICR Details

OMB Control No: 0579-0213	ICR Reference No: 200909-0579-006
Status: Historical Active	Previous ICR Reference No: 200805-0579-002
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: 10/15/2010
	Date Received in OIRA: 08/11/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	12/31/2011	12/31/2011
Responses	755	0	755
Time Burden (Hours)	1,286	0	1,286
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

IC Title	Form No.	Form Name
Select Agent Registration	APHIS-CDC Form 4, APHIS-CDC Form 3, APHIS-CDC Form 5, APHIS-CDC Form 1, APHIS-CDC Form 4 (Revised), VS 16-3, VS 16-7, PPQ 526, APHIS-CDC Form 2	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 ,   Report of the Identification of a Select Agent or Toxin
Select Agent Registration	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, APHIS-CDC Form 4 (Revised), PPQ 526	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 ,   Report of the Identification of a Select Agent or Toxin

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ICR Summary 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	755	0	0	0	0
Annual Time Burden (Hours)	1,286	1,286	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: 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]? 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: 08/11/2010

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