Agriculture Select Agent Services; Import and Transport Permits for Non-Select Materials

Forms and Documents

Document Name	Status
Form VS 16-3 Select Agent Registration (Private Sector) Form	Modified
SS 20190507.doc Supporting Statement A	2019-06-11
0213 71 20190503.xls Supplementary Document	2019-05-03
0213 79 20190503.xls Supplementary Document	2019-05-03

IC Document Collections

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

ICR Details

OMB Control No: 0579-0213	ICR Reference No: 201905-0579-001
Status: Active	Previous ICR Reference No: 201305-0579-007
Agency/Subagency: USDA/APHIS	Agency Tracking No:
Title: Agriculture Select Agent Services; Import and Transport Permits for Non-Select Materials
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/29/2019
	Date Received in OIRA: 06/12/2019
Terms of Clearance: Before this ICR is resubmitted, USDA should convert Form VS 16-3 to a common form.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved
Responses	3,283	0	0
Time Burden (Hours)	6,055	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection is to assess the risk of transporting or importing material(s), and ensure that appropriate safeguards, containments, and disposal requirements commensurate with the risk are implemented, to prevent the spread or introduction of disease.

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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
   US Code: 7 USC 8301 Name of Law: Animal Health Protection 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:
	84 FR 5407	02/21/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 25232	05/31/2019
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 (Private Sector)	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
State, Local, and Tribal Government

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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	3,283	0	0	3,283	0	0
Annual Time Burden (Hours)	6,055	0	0	6,055	0	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: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a reinstatement of an information collection resulting in 3,283 responses and 6,055 total burden hours. See question 15 of the supporting statement for additional information.

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Annual Cost to Federal Government: $163,355

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     Yes

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: 06/12/2019

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