Virus-Serum-Toxin Act and Regulations in 9 CFR Subchapter, Parts 101-124

Forms and Documents

Document Name	Status
Form APHIS 2001 Virus-Serum-Toxin Act and Regulations - Business Form	Modified
2011 SS 0013.docx Supporting Statement A	2011-12-14
2011 APHIS 79 - 0013.xls Supplementary Document	2011-12-07
2011 APHIS 71 - 0013.xls Supplementary Document	2011-12-07

IC Document Collections

IC ID	Document Title	Status
2084	Virus-Serum-Toxin Act and Regulations - Business Form	Modified
200319	Virus-Serum-Toxin Act and Regulations - Individual	New
183917	Virus-Serum-Toxin Act and Regulations - State	Modified

ICR Details

OMB Control No: 0579-0013	ICR Reference No: 201110-0579-002
Status: Historical Active	Previous ICR Reference No: 200710-0579-015
Agency/Subagency: USDA/APHIS	Agency Tracking No:
Title: Virus-Serum-Toxin Act and Regulations in 9 CFR Subchapter, Parts 101-124
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: 02/28/2012
	Date Received in OIRA: 12/15/2011
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB approves this collction of information for a period of 18 months. During that time, APHIS should develop a plan by which the forms associated with this collection can be submitted electronically. During that period, APHIS should also take into consideration the public comment received on this collection and determine whether it is feasible to waive the requirements for minor changes to labels, as suggested. When submitting this collection for reapproval, APHIS should also submit a written response to both of these issues.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2013	36 Months From Approved	02/29/2012
Responses	19,304	0	21,726
Time Burden (Hours)	74,386	0	80,937
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this collection is to verify that compliance requirements for biological products used in the United States are met (i.e., the products are pure, safe, potent, and effective).

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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:
	76 FR 122	06/24/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 77767	12/14/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Virus-Serum-Toxin Act and Regulations - Individual
Virus-Serum-Toxin Act and Regulations - Business	APHIS 2046, APHIS 2018, APHIS 2047, APHIS 2046S (spanish), APHIS 2005, APHIS 2001, APHIS 2008, APHIS 2008A, APHIS 2047S (Spanish), APHIS 2003, APHIS 2007, APHIS 2015, APHIS 2017, APHIS 2020	APPLICATION FOR US VETERINARY BIOLOGICS ESTABLISHMENT LICENSE ,   APPLICATION FOR US VETERINARY BIOLOGICAL PRODUCT LICENSE ,   QUALIFICATIONS OF VETERINARY BIOLOGICS PERSONNEL ,   TRANSMITTAL OF LABLES AND CIRCULARS OR OUTLINES ,   OFFICIAL EXPORT CERTIFICATE FOR ANIMAL BIOLOGICAL PRODUCTS ,   REQUEST FOR REFERENCE, REAGENT, OR REAGENT SEED MATERIAL ,   APPLICATION FOR UNITED STATES VETERINARY BIOLOGICAL PRODUCT PERMIT ,   AHIPMENT AND RECEIPT OF BIOLOGICS SAMPLES ,   VETERINARY BIOLOGICS PRODUCTION AND TEST REPORT ,   CONTINUATION FOR VETERINARY BIOLOGICS PRODUCTION AND TEST REPORT ,   CERTIFICATE OF LICENSING AND INSPECTION ,   CERTIFICADO DE LICENCIA E INSPECCION ,   CERTIFICATE OF LICENSING AND INSPECTION ,   CERTIFICADO DE LICENCIA E INSPECTION
Virus-Serum-Toxin Act and Regulations - State

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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	19,304	21,726	0	-28	-2,394	0
Annual Time Burden (Hours)	74,386	80,937	0	-13	-6,538	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: In the previous information collection there were 500 total respondents and in the current collection there are 202 total respondents; a decrease of -298 total respondents from the previous collection due to fewer requests for licenses. The Autogenous Biologics Labels were deleted from the collection causing a program change decrease of -30 respondents and -30 responses resulting in a decrease of -15 burden hours. However, with the addition of the Individual IC (Due diligence petition and certification statement of true and completed copy and Request for restriction on distribution and use of veterinary biological product) there is a program change increase of +1 respondent and +2 responses with an increase of +2 burden hours. The total program change is -29 respondents, -28 responses and -13 hours. With fewer request for licenses there were adjustments to both the State and business ICs. There is an adjustment to the State IC with a decrease of -42 responses and -1 burden hour. Under the Business IC there was an adjustment of -2,352 responses and -6,537 burden hours to the various recordkeeping responses. The total adjustment is -2,394 responses and -6,538 total burden hours.

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Annual Cost to Federal Government: $451,034

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: 12/15/2011

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