Viruses, Serums, Toxins, and Analogous Products Suspension, Revocation or Termination of Biological Licenses or Permits

Forms and Documents

Document Name	Status
2009 ss 0318.doc Supporting Statement A	2010-05-06
71 2009 0318.xls Supplementary Document	2010-03-03
79 2009 0318.xls Supplementary Document	2010-03-03

IC Document Collections

IC ID	Document Title	Status
178880	Viruses, Serums, Toxins, and Analogous Products; Suspension, Revocation, or Termination of Biological Licenses or Permittes, Individuals and Households	Removed
178879	Viruses, Serums, Toxins, and Analogous Products Suspension, Revocation, or Termination of Biological Licenses or Permittes, Private Sector	Unchanged

ICR Details

OMB Control No: 0579-0318	ICR Reference No: 201005-0579-004
Status: Historical Active	Previous ICR Reference No: 201003-0579-001
Agency/Subagency: USDA/APHIS	Agency Tracking No:
Title: Viruses, Serums, Toxins, and Analogous Products Suspension, Revocation or Termination of Biological Licenses or Permits
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: 09/19/2010
	Date Received in OIRA: 05/06/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2013	36 Months From Approved	09/30/2010
Responses	60	0	60
Time Burden (Hours)	106	0	106
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this collection is to collect information that will assist APHIS in its efforts to prevent biological products from harming animals, the public, and the environment.

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Authorizing Statute(s): US Code: 21 USC 151-159 Name of Law: Virus-Serum-Toxin Act
  

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:
	74 FR 151	08/07/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 56	03/24/2010
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Viruses, Serums, Toxins, and Analogous Products Suspension, Revocation, or Termination of Biological Licenses or Permittes, Private Sector
Viruses, Serums, Toxins, and Analogous Products; Suspension, Revocation, or Termination of Biological Licenses or Permittes, Individuals and Households

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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	60	60	0	0	0	0
Annual Time Burden (Hours)	106	106	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is a revision of a currently approved information collection because the number of respondents has decreased from 60 to 55 respondents. This is because APHIS counted some of the respondents twice in the previous collection. There is no change in burden, merely a bookkeeping change to consolidate ICs.

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Annual Cost to Federal Government: $6,176

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]? Uncollected

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: 05/06/2010

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