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 Form	Modified
0013.virus.serum.toxic.act.ss.doc Supporting Statement A	2008-03-03
0013 total.79.pdf Supplementary Document	2007-10-23
0013.71.xls Supplementary Document	2007-10-23

IC Document Collections

IC ID	Document Title	Status
2084	Virus-Serum-Toxin Act and Regulations Form	Modified
183917	Virus-Serum-Toxin Act and Regulations in 9 CFR, Subchapter, Parts 101 - 124	New

ICR Details

OMB Control No: 0579-0013	ICR Reference No: 200710-0579-015
Status: Historical Active	Previous ICR Reference No: 200411-0579-003
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: 12/07/2008
	Date Received in OIRA: 03/03/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2011	36 Months From Approved	12/31/2008
Responses	21,726	0	20,105
Time Burden (Hours)	80,937	0	51,617
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this collection is to help us to ensure that biological products used in the United States 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:
	72 FR 148	08/02/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 42	03/03/2008
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
Virus-Serum-Toxin Act and Regulations	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 2046, 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 in 9 CFR, Subchapter, Parts 101 - 124

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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	21,726	20,105	0	0	1,621	0
Annual Time Burden (Hours)	80,937	51,617	0	0	29,320	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 adjusted increase of +29,320 hours of burden due to the fact that this collection accounts for the time and cost associated with labeling records (which was not included in the previous collection)and because of the change in time required to complete VS Form 2015.

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Annual Cost to Federal Government: $191,120,861

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]? Uncollected

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)? Uncollected

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: 03/03/2008

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