OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201905-0579-005 · OMB 0579-0013 · Active

Forms and Documents
DocumentTypeStatusAvailability
Form APHIS Form 2001 Virus-Serum-Toxin Act and Regulations - Business Form and Instruction Modified Repair queued
Form APHIS Form 2081 Virus-Serum-Toxin Act and Regulations - Individual Form Modified Available
Form APHIS Form 2081 Virus-Serum-Toxin Act and Regulations - State Form Modified Repair queued
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
IC IDCollectionTypeStatusForm
231059 Virus-Serum-Toxin Act and Regulations - Foreign Gov't Unchanged
2084 Virus-Serum-Toxin Act and Regulations - Business Form and Instruction Modified
200319 Virus-Serum-Toxin Act and Regulations - Individual Form Modified
183917 Virus-Serum-Toxin Act and Regulations - State Form Modified
ICR Details
0579-0013 201905-0579-005
Active 201804-0579-004
USDA/APHIS
Virus-Serum-Toxin Act and Regulations in 9 CFR Subchapter, Parts 101-124
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 05/29/2019
Retrieve Notice of Action (NOA) 05/20/2019
  Inventory as of this Action Requested Previously Approved
02/28/2022 02/28/2022 02/28/2022
298,820,801 0 298,820,801
122,998 0 122,998
0 0 0
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).
US Code: 21 USC 151-159 Name of Law: VIRUS-SERUM-TOXIN ACT
  
None
Not associated with rulemaking
  83 FR 4024 01/29/2018
83 FR 47874 09/21/2018
No
4
IC Title Form No. Form Name
Virus-Serum-Toxin Act and Regulations - Individual APHIS Form 2081, APHIS Form 2080 Adverse Event Report Follow-Up Information ,   Adverse Event Report
Virus-Serum-Toxin Act and Regulations - Business APHIS Form 2081, APHIS Form 2009, APHIS Form 2015, APHIS Form 2017, APHIS Form 2046S, APHIS Form 2070, APHIS Form 2071, APHIS Form 2001, APHIS Form 2007, APHIS Form 2020, APHIS Form 2046, APHIS Form 2047, APHIS Form 2049, APHIS Form 2008, APHIS Form 2008A, APHIS Form 2047S, APHIS Form 2048, APHIS Form 2072, APHIS Form 2080, APHIS Form 2018, APHIS Form 2003, APHIS Form 2005 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 - State APHIS Form 2081, APHIS Form 2080 Adverse Event Report Follow-Up Information ,   Adverse Event Report
Virus-Serum-Toxin Act and Regulations - Foreign Gov't
  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
No
No
$1,932,946
No
    No
    No
No
No
No
Uncollected
Donna Malloy 301 734-3277
  No
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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
05/20/2019