Information Collection

Virus-Serum-Toxin Act and Regulations - Business

IC 2084 under ICR 201905-0579-005 · OMB 0579-0013.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0579-0013 can be found here:

2022-02-23 - Revision of a currently approved collection

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form APHIS Form 2001 Virus-Serum-Toxin Act and Regulations - Business	Form and Instruction
0579-0013 2018 NCAH Portal Screenshots.pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Other-Info System Screenshots
0579-0013 2018 ePermit Screenshots.pdf www.aphis.usda.gov/aphis/resources/permits/ct_login_epermits	Other-Info System Screenshots
APHIS Form 2001 Application for United States Veterinary Biologics Estab APHIS 2001 (Apr 2015)(Secured).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form and Instruction
APHIS Form 2003 Application for United States Veterinary Biological Prod APHIS 2003 (Aug 2017)(Secured).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form and Instruction
APHIS Form 2005 Application for United States Veterinary Biological Prod APHIS 2005 (Apr 2015)(Secured).pdf www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Form
APHIS Form 2007 Contact and Qualifications of Veterinary Biologics Perso APHIS 2007 (Apr 2015)(Secured).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form and Instruction
APHIS Form 2008 Veterinary Biologics Production and Test Report APHIS 2008 (Apr 2015)(Secured).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form
APHIS Form 2008A Continuation for Veterinary Biologics Production and Tes APHIS 2008A (May 2016)(Secured).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form
APHIS Form 2009 Center for Veterinary Biologics Inspection and Complianc APHIS 2009 (Aug 2017)(Secured).pdf www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Form
APHIS Form 2015 Transmittal of Labeling or Outlines APHIS 2015 (Aug 2017)(Secured).pdf www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Form and Instruction
APHIS Form 2017 Official Export Certificate for Animal Biological Produc APHIS 2017 (Apr 2015)(Secured).pdf www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Form
APHIS Form 2020 Shipment and Receipt of Biologics Samples APHIS 2020 (Apr 2015)(Secured).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form
APHIS Form 2046 Certificate of Licensing and Inspection (Unrestricted) APHIS 2046 ENG (Apr 2015)(Secured).pdf www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Form
APHIS Form 2046S Certificate of Licensing and Inspection (Unrestricted) ( APHIS 2046S SPA (Apr 2015)(Secured).pdf www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Form
APHIS Form 2047 Certificate of Licensing and Inspection (Restricted) APHIS 2047 ENG (Apr 2015)(Secured).pdf www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Form
APHIS Form 2047S Certificate of Licensing and Inspection (Restricted) (Sp APHIS 2047S SPA (Apr 2015)(Secured).pdf www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Form
APHIS Form 2048 Center for Veterinary Biologics Inspection and Complianc APHIS 2048 (Aug 2016)(Secured).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form
APHIS Form 2049 Veterinary Biologics Regulatory E-Submission Form Policy APHIS 2049 (Aug 2016)(Secured).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form
APHIS Form 2070 Application for Authorization to Ship Master Seed or Cel APHIS 2070 (Oct 2017)(Secured).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form and Instruction
APHIS Form 2071 Application for Authorization to Ship Experimental Veter APHIS 2071 (Oct 2015)(Secured).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form and Instruction
APHIS Form 2072 Application for Authorization to Ship Biological Product APHIS 2072 (Nov 2017)(Secured).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form and Instruction
APHIS Form 2081 Adverse Event Report Follow-Up Information APHIS 2081 SEP 2015 (SECURE).pdf www.aphis.usda.gov/aphis/resources/forms/ct_aphis_forms	Form
APHIS Form 2018 Request for Reference, Reagent, or Reagent Seed Material APHIS 2018 (Aug 2017) REV (Secure).pdf ncahappspub.aphis.usda.gov/NCAHPortal/public/	Form
APHIS Form 2080 Adverse Event Report APHIS 2080 (Mar 2019) REV (Secured).pdf www.aphis.usda.gov/aphis/resources/forms/ct_aphis_forms	Form

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Virus-Serum-Toxin Act and Regulations - Business

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 9 CFR 102 - 124

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	APHIS Form 2001	Application for United States Veterinary Biologics Establishment License	APHIS 2001 (Apr 2015)(Secured).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Form and Instruction	APHIS Form 2003	Application for United States Veterinary Biological Product License	APHIS 2003 (Aug 2017)(Secured).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Form	APHIS Form 2005	Application for United States Veterinary Biological Product Permit	APHIS 2005 (Apr 2015)(Secured).pdf	https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Yes	Yes	Fillable Printable
Form and Instruction	APHIS Form 2007	Contact and Qualifications of Veterinary Biologics Personnel	APHIS 2007 (Apr 2015)(Secured).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Form	APHIS Form 2008	Veterinary Biologics Production and Test Report	APHIS 2008 (Apr 2015)(Secured).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Form	APHIS Form 2008A	Continuation for Veterinary Biologics Production and Test Report	APHIS 2008A (May 2016)(Secured).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Form	APHIS Form 2009	Center for Veterinary Biologics Inspection and Compliance Facility Document Submission Worksheet	APHIS 2009 (Aug 2017)(Secured).pdf	https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Yes	Yes	Fillable Printable
Form and Instruction	APHIS Form 2015	Transmittal of Labeling or Outlines	APHIS 2015 (Aug 2017)(Secured).pdf	https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Yes	Yes	Fillable Printable
Form	APHIS Form 2017	Official Export Certificate for Animal Biological Products	APHIS 2017 (Apr 2015)(Secured).pdf	https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Yes	Yes	Fillable Printable
Form	APHIS Form 2020	Shipment and Receipt of Biologics Samples	APHIS 2020 (Apr 2015)(Secured).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Form	APHIS Form 2046	Certificate of Licensing and Inspection (Unrestricted)	APHIS 2046 ENG (Apr 2015)(Secured).pdf	https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Yes	Yes	Fillable Printable
Form	APHIS Form 2046S	Certificate of Licensing and Inspection (Unrestricted) (Spanish)	APHIS 2046S SPA (Apr 2015)(Secured).pdf	https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Yes	Yes	Fillable Printable
Form	APHIS Form 2047	Certificate of Licensing and Inspection (Restricted)	APHIS 2047 ENG (Apr 2015)(Secured).pdf	https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Yes	Yes	Fillable Printable
Form	APHIS Form 2047S	Certificate of Licensing and Inspection (Restricted) (Spanish)	APHIS 2047S SPA (Apr 2015)(Secured).pdf	https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/sa_bio_forms/ct_vb_forms	Yes	Yes	Fillable Printable
Form	APHIS Form 2048	Center for Veterinary Biologics Inspection and Compliance E-Submission Form	APHIS 2048 (Aug 2016)(Secured).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Form	APHIS Form 2049	Veterinary Biologics Regulatory E-Submission Form Policy, Evaluation, and Licensing	APHIS 2049 (Aug 2016)(Secured).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Form and Instruction	APHIS Form 2070	Application for Authorization to Ship Master Seed or Cell Samples for Confirmatory Testing by APHIS	APHIS 2070 (Oct 2017)(Secured).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Form and Instruction	APHIS Form 2071	Application for Authorization to Ship Experimental Veterinary Biological Products	APHIS 2071 (Oct 2015)(Secured).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Form and Instruction	APHIS Form 2072	Application for Authorization to Ship Biological Product Samples for Confirmatory Testing by APHIS	APHIS 2072 (Nov 2017)(Secured).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Other-Info System Screenshots			0579-0013 2018 NCAH Portal Screenshots.pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Other-Info System Screenshots			0579-0013 2018 ePermit Screenshots.pdf	https://www.aphis.usda.gov/aphis/resources/permits/ct_login_epermits	Yes	Yes	Fillable Fileable
Form	APHIS Form 2081	Adverse Event Report Follow-Up Information	APHIS 2081 SEP 2015 (SECURE).pdf	https://www.aphis.usda.gov/aphis/resources/forms/ct_aphis_forms	Yes	Yes	Fillable Fileable
Form	APHIS Form 2018	Request for Reference, Reagent, or Reagent Seed Material	APHIS 2018 (Aug 2017) REV (Secure).pdf	https://ncahappspub.aphis.usda.gov/NCAHPortal/public/	Yes	Yes	Fillable Fileable
Form	APHIS Form 2080	Adverse Event Report	APHIS 2080 (Mar 2019) REV (Secured).pdf	https://www.aphis.usda.gov/aphis/resources/forms/ct_aphis_forms	Yes	Yes	Fillable Fileable

Federal Enterprise Architecture Business Reference Module

Line of Business: Natural Resources

Subfunction: Agricultural Innovation and Services

Privacy Act System of Records

Title: APHIS-10 APHIS Comprehensive Electronic Permitting System (ePermits)

FR Citation: 73 FR 23406

Number of Respondents: 3,416

Number of Respondents for Small Entity: 3,245

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 3 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	298,809,332	298,809,332
Annual IC Time Burden (Hours)	101,621	101,621
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.