Select Agent Registration

Forms and Documents

Document Name	Status
Form APHIS-CDC Form 4A Select Agent Registration (Private Sector) Form and Instruction	Modified
Form APHIS-CDC Form 4A Select Agent Registration (State, Local & Tribal) Form and Instruction	Modified
SS 2012.doc Supporting Statement A	2012-11-30
2012 APHIS 71 .xlsx Supplementary Document	2012-10-12
APHIS 79 -2012.xls Supplementary Document	2012-10-09

IC Document Collections

IC ID	Document Title	Status
2397	Select Agent Registration (Private Sector) Form and Instruction	Modified
186793	Select Agent Registration (State, Local & Tribal) Form and Instruction	Modified

ICR Details

OMB Control No: 0579-0213	ICR Reference No: 201207-0579-003
Status: Historical Active	Previous ICR Reference No: 201203-0579-013
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 with change	Conclusion Date: 11/30/2012
	Date Received in OIRA: 10/15/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2015	36 Months From Approved	02/28/2015
Responses	4,754	0	1,164
Time Burden (Hours)	12,368	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:
0579-AD09	Final or interim final rulemaking	77 FR 194	10/05/2012

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Select Agent Registration (Private Sector)	APHIS/CDC Form 4C, VS 16-3, VS 16-7, PPQ 526, APHIS-CDC Form 4A, APHIS-CDC Form 4B, APHIS/CDC Form 1, APHIS/CDC Form 2, APHIS/CDC Form 3, APHIS/CDC Form 5	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 ,   Request for Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational Product
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, APHIS/CDC Form 2, APHIS/CDC Form 3, APHIS/CDC Form 5	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 ,   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: 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 ,   Request for Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational Product

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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	4,754	1,164	0	3,335	255	0
Annual Time Burden (Hours)	12,368	2,290	0	9,823	255	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: 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.

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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: 10/15/2012

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