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	Repair queued
Form APHIS Form 2072 Application for Authorization to Ship Biological Product Samples for Confirmatory Testing by APHIS	Form and Instruction	Modified	Repair queued
Form APHIS Form 2071 Application for Authorization to Ship Experimental Veterinary Biological Products	Form and Instruction	Modified	Repair queued
Form APHIS Form 2070 Application for Authorization to Ship Master Seed or Cell Samples for Confirmatory Testing by APHIS	Form and Instruction	Modified	Repair queued
Form APHIS Form 2049 Veterinary Biologics Regulatory E-Submission Form Policy, Evaluation, and Licensing	Form	Modified	Repair queued
Form APHIS Form 2048 Center for Veterinary Biologics Inspection and Compliance E-Submission Form	Form	Modified	Repair queued
Form APHIS Form 2047S Certificate of Licensing and Inspection (Restricted) (Spanish)	Form	Modified	Repair queued
Form APHIS Form 2047 Certificate of Licensing and Inspection (Restricted)	Form	Modified	Repair queued
Form APHIS Form 2046S Certificate of Licensing and Inspection (Unrestricted) (Spanish)	Form	Modified	Repair queued
Form APHIS Form 2046 Certificate of Licensing and Inspection (Unrestricted)	Form	Modified	Repair queued
Form APHIS Form 2020 Shipment and Receipt of Biologics Samples	Form	Modified	Repair queued
Form APHIS Form 2017 Official Export Certificate for Animal Biological Products	Form	Modified	Repair queued
Form APHIS Form 2015 Transmittal of Labeling or Outlines	Form and Instruction	Modified	Repair queued
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	Repair queued
Form APHIS Form 2008 Veterinary Biologics Production and Test Report	Form	Modified	Repair queued
Form APHIS Form 2007 Contact and Qualifications of Veterinary Biologics Personnel	Form and Instruction	Modified	Repair queued
Form APHIS Form 2005 Application for United States Veterinary Biological Product Permit	Form	Modified	Repair queued
Form APHIS Form 2003 Application for United States Veterinary Biological Product License	Form and Instruction	Modified	Repair queued
Form APHIS Form 2001 Application for United States Veterinary Biologics Establishment License	Form and Instruction	Modified	Repair queued
Form APHIS Form 2001 Business	Form and Instruction	Modified	Repair queued
Form APHIS Form 2080 Adverse Event Report	Form	Modified	Repair queued
Form APHIS Form 2080 Individual	Form	Modified	Repair queued
Form APHIS Form 2080 Adverse Event Report	Form	Modified	Repair queued
Form APHIS Form 2080 State	Form	Modified	Repair queued
0013 2022 SS.docx	Supporting Statement A	Uploaded 2022-02-16	Repair queued
0013 2022 APHIS 79.xlsx	Supplementary Document	Uploaded 2022-02-07	Repair queued
0013 2022 APHIS 71.xlsx	Supplementary Document	Uploaded 2022-02-07	Repair queued

IC Document Collections

Information collection document groups

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

ICR Details

OMB Control No: 0579-0013	ICR Reference No: 202202-0579-003
Status: Active	Previous ICR Reference No: 201905-0579-005
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: 03/26/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/23/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2027	36 Months From Approved	03/31/2024
Responses	435,797,533	0	298,820,801
Time Burden (Hours)	43,072	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:
	86 FR 40446	07/28/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 10169	02/23/2022
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
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 2009, APHIS Form 2015, APHIS Form 2017, APHIS Form 2046S, APHIS Form 2070, APHIS Form 2020, APHIS Form 2071, APHIS Form 2001, APHIS Form 2007, 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 ,   Request for Reference, Reagent, or Reagent Seed Material ,   Adverse Event Report
Foreign Gov't
Individual	APHIS Form 2080	Adverse Event Report
State	APHIS Form 2080	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	435,797,533	298,820,801	0	-14,624	136,991,356	0
Annual Time Burden (Hours)	43,072	122,998	0	-88,605	8,679	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This request for renewal reflects an increase of 136,976,732 responses and a decrease of 79,926 hours of burden, largely attributable to significant increases in package labeling, adjustments to several activities previously overestimated, adjustments to response times, and the discontinuance of three activities that are no longer used.

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Annual Cost to Federal Government: $2,606,101

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? No

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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: 02/23/2022

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