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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form APHIS Form 2080 Adverse Event Report	Form	Modified	Repair queued
Form APHIS Form 2018 Request for Reference, Reagent, or Reagent Seed Material	Form	Modified	Available
Form APHIS Form 2081 Adverse Event Report Follow-Up Information	Form	Modified	Repair queued
Form APHIS Form 2072 Application for Authorization to Ship Biological Product Samples for Confirmatory Testing by APHIS	Form and Instruction	Modified	Available
Form APHIS Form 2071 Application for Authorization to Ship Experimental Veterinary Biological Products	Form and Instruction	Modified	Available
Form APHIS Form 2070 Application for Authorization to Ship Master Seed or Cell Samples for Confirmatory Testing by APHIS	Form and Instruction	Modified	Available
Form APHIS Form 2049 Veterinary Biologics Regulatory E-Submission Form Policy, Evaluation, and Licensing	Form	Modified	Available
Form APHIS Form 2048 Center for Veterinary Biologics Inspection and Compliance E-Submission Form	Form	Modified	Available
Form APHIS Form 2047S Certificate of Licensing and Inspection (Restricted) (Spanish)	Form	Modified	Available
Form APHIS Form 2047 Certificate of Licensing and Inspection (Restricted)	Form	Modified	Available
Form APHIS Form 2046S Certificate of Licensing and Inspection (Unrestricted) (Spanish)	Form	Modified	Available
Form APHIS Form 2046 Certificate of Licensing and Inspection (Unrestricted)	Form	Modified	Available
Form APHIS Form 2020 Shipment and Receipt of Biologics Samples	Form	Modified	Available
Form APHIS Form 2017 Official Export Certificate for Animal Biological Products	Form	Modified	Available
Form APHIS Form 2015 Transmittal of Labeling or Outlines	Form and Instruction	Modified	Available
Form APHIS Form 2009 Center for Veterinary Biologics Inspection and Compliance Facility Document Submission Worksheet	Form	Modified	Available
Form APHIS Form 2008A Continuation for Veterinary Biologics Production and Test Report	Form	Modified	Available
Form APHIS Form 2008 Veterinary Biologics Production and Test Report	Form	Modified	Available
Form APHIS Form 2007 Contact and Qualifications of Veterinary Biologics Personnel	Form and Instruction	Modified	Available
Form APHIS Form 2005 Application for United States Veterinary Biological Product Permit	Form	Modified	Available
Form APHIS Form 2003 Application for United States Veterinary Biological Product License	Form and Instruction	Modified	Available
Form APHIS Form 2001 Application for United States Veterinary Biologics Establishment License	Form and Instruction	Modified	Available
Form APHIS Form 2080 Adverse Event Report	Form	Modified	Available
Form APHIS Form 2081 Adverse Event Report Follow-Up Information	Form	Modified	Available
Form APHIS Form 2080 Adverse Event Report	Form	Modified	Available
Form APHIS Form 2081 Adverse Event Report Follow-Up Information	Form	Modified	Available
0579-0013 Nonsubstantive Change.pdf	Justification for No Material/Nonsubstantive Change	Uploaded 2019-05-17	Available
0579-0013 (mergers) 2018 APHIS 79.pdf	Supplementary Document	Uploaded 2018-08-27	Available
0579-0013 (mergers) 2018 APHIS 71.pdf	Supplementary Document	Uploaded 2018-08-27	Available
0579-0013 (mergers) 2018 SS.pdf	Supporting Statement A	Uploaded 2018-08-27	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
231059	Virus-Serum-Toxin Act and Regulations - Foreign Gov't		Unchanged
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Adverse Event Report
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Request for Reference, Reagent, or Reagent Seed Material
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Adverse Event Report Follow-Up Information
2084	Virus-Serum-Toxin Act and Regulations - Business	Form and Instruction	Modified	Application for Authorization to Ship Biological Product Samples for Confirmatory Testing by APHIS
2084	Virus-Serum-Toxin Act and Regulations - Business	Form and Instruction	Modified	Application for Authorization to Ship Experimental Veterinary Biological Products
2084	Virus-Serum-Toxin Act and Regulations - Business	Form and Instruction	Modified	Application for Authorization to Ship Master Seed or Cell Samples for Confirmatory Testing by APHIS
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Veterinary Biologics Regulatory E-Submission Form Policy, Evaluation, and Licensing
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Center for Veterinary Biologics Inspection and Compliance E-Submission Form
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Certificate of Licensing and Inspection (Restricted) (Spanish)
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Certificate of Licensing and Inspection (Restricted)
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Certificate of Licensing and Inspection (Unrestricted) (Spanish)
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Certificate of Licensing and Inspection (Unrestricted)
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Shipment and Receipt of Biologics Samples
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Official Export Certificate for Animal Biological Products
2084	Virus-Serum-Toxin Act and Regulations - Business	Form and Instruction	Modified	Transmittal of Labeling or Outlines
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Center for Veterinary Biologics Inspection and Compliance Facility Document Submission Worksheet
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Continuation for Veterinary Biologics Production and Test Report
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Veterinary Biologics Production and Test Report
2084	Virus-Serum-Toxin Act and Regulations - Business	Form and Instruction	Modified	Contact and Qualifications of Veterinary Biologics Personnel
2084	Virus-Serum-Toxin Act and Regulations - Business	Form	Modified	Application for United States Veterinary Biological Product Permit
2084	Virus-Serum-Toxin Act and Regulations - Business	Form and Instruction	Modified	Application for United States Veterinary Biological Product License
2084	Virus-Serum-Toxin Act and Regulations - Business	Form and Instruction	Modified	Application for United States Veterinary Biologics Establishment License
2084	Virus-Serum-Toxin Act and Regulations - Business	Other-Info System Screenshots	Modified
200319	Virus-Serum-Toxin Act and Regulations - Individual	Form	Modified	Adverse Event Report
200319	Virus-Serum-Toxin Act and Regulations - Individual	Form	Modified	Adverse Event Report Follow-Up Information
183917	Virus-Serum-Toxin Act and Regulations - State	Form	Modified	Adverse Event Report
183917	Virus-Serum-Toxin Act and Regulations - State	Form	Modified	Adverse Event Report Follow-Up Information

ICR Details

OMB Control No: 0579-0013	ICR Reference No: 201905-0579-005
Status: Historical Active	Previous ICR Reference No: 201804-0579-004
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/29/2019
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/20/2019
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2022	02/28/2022	02/28/2022
Responses	298,820,801	0	298,820,801
Time Burden (Hours)	122,998	0	122,998
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:
	83 FR 4024	01/29/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 47874	09/21/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Virus-Serum-Toxin Act and Regulations - Business	APHIS Form 2080, APHIS Form 2018, APHIS Form 2003, APHIS Form 2005, APHIS Form 2008, APHIS Form 2008A, APHIS Form 2047S, APHIS Form 2048, APHIS Form 2072, APHIS Form 2081, APHIS Form 2009, APHIS Form 2015, APHIS Form 2017, APHIS Form 2001, APHIS Form 2046S, APHIS Form 2070, APHIS Form 2071, APHIS Form 2007, APHIS Form 2020, APHIS Form 2046, APHIS Form 2047, APHIS Form 2049	Application for United States Veterinary Biologics Establishment License ,   Application for United States Veterinary Biological Product License ,   Application for United States Veterinary Biological Product Permit ,   Contact and Qualifications of Veterinary Biologics Personnel ,   Veterinary Biologics Production and Test Report ,   Continuation for Veterinary Biologics Production and Test Report ,   Center for Veterinary Biologics Inspection and Compliance Facility Document Submission Worksheet ,   Transmittal of Labeling or Outlines ,   Official Export Certificate for Animal Biological Products ,   Shipment and Receipt of Biologics Samples ,   Certificate of Licensing and Inspection (Unrestricted) ,   Certificate of Licensing and Inspection (Unrestricted) (Spanish) ,   Certificate of Licensing and Inspection (Restricted) ,   Certificate of Licensing and Inspection (Restricted) (Spanish) ,   Center for Veterinary Biologics Inspection and Compliance E-Submission Form ,   Veterinary Biologics Regulatory E-Submission Form Policy, Evaluation, and Licensing ,   Application for Authorization to Ship Master Seed or Cell Samples for Confirmatory Testing by APHIS ,   Application for Authorization to Ship Experimental Veterinary Biological Products ,   Application for Authorization to Ship Biological Product Samples for Confirmatory Testing by APHIS ,   Adverse Event Report Follow-Up Information ,   Request for Reference, Reagent, or Reagent Seed Material ,   Adverse Event Report
Virus-Serum-Toxin Act and Regulations - Foreign Gov't
Virus-Serum-Toxin Act and Regulations - Individual	APHIS Form 2080, APHIS Form 2081	Adverse Event Report Follow-Up Information ,   Adverse Event Report
Virus-Serum-Toxin Act and Regulations - State	APHIS Form 2080, APHIS Form 2081	Adverse Event Report Follow-Up Information ,   Adverse Event Report

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ICR Summary of Burden

table that charts list 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	298,820,801	298,820,801	0	0	0	0
Annual Time Burden (Hours)	122,998	122,998	0	0	0	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:

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Annual Cost to Federal Government: $1,932,946

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.     No

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.     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: 05/20/2019

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