According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to, respond to a collection of information unless it 

displays a valid OMB control number. The valid OMB control number for this information collection is 0579-0013. The time required to complete this information collection is

estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and 

completing and reviewing the collection of information.

OMB Approved

0579-0013

EXP: 02/2022

This application must be submitted for issuance of a United States Veterinary Biologics Establishment License. The information will assist in determining the 

qualifications of the establishment to prepare biological products (9 CFR 102). 

UNITED STATES DEPARTMENT OF AGRICULTURE 

ANIMAL AND PLANT HEALTH INSPECTION SERVICE

VETERINARY SERVICES, CENTER FOR VETERINARY BIOLOGICS

APPLICATION FOR

UNITED STATES VETERINARY BIOLOGICS ESTABLISHMENT LICENSE

LEAVE BLANK FOR INITIAL APPLICATIONS

USDA ESTABLISHMENT LICENSE NUMBER

1. TYPE OF APPLICATION ("X" one)

INITIAL CHANGE OF LICENSE 

(specify reason in block 2)

2. IF CHANGE OF LICENSE, SPECIFY REASON 3. DATE SUBMITTED

4. NAME AND COMPLETE ADDRESS OF APPLICANT 5 .ADDRESS FOR OFFICIAL MAIL FROM VETERINARY BIOLOGICS (IF DIFFERENT FROM

BLOCK 4.)

6. TYPE OF ORGANIZATION ("X" one)

 INDIVIDUAL PROPRIETORSHIP PARTNERSHIP CORPORATION STATE IN WHICH INCORPORATED_____________________________________________

7. NAME AND LOCATION OF SUBSIDIARIES TO OPERATE IN THE ESTABLISHMENT 8. NAME OF EACH MARKETING DIVISION

9. LIST THE LOCATION OF ALL PREMISES TO BE USED FOR PREPARATION, TESTING, AND INITIAL SHIPPING (if different from block 4)

10. PRINCIPAL OFFICERS OR PARTNERS

A. NAME B. TITLE C. BUSINESS ADDRESS

CHECKLIST OF SUPPORTING MATERIAL 

ITEM INSTRUCTIONS A. WITH THIS 

APPLICATION (X)

B. DATE OR CVB MAIL LOG ID OF

PREVIOUS SUBMISSION 

11. APHIS FORM 2003 FOR AT LEAST ONE PRODUCT INITIAL APPLICATIONS ONLY

12. ARTICLES OF INCORPORATION, INCLUDING FOR EACH 

SUBSIDIARY

13. LETTER(S) OF APPROVAL SIGNED BY AUTHORIZED OFFICER OF

EACH SUBSIDIARY

14. WATER QUALITY STATEMENT

15. FACILITY DOCUMENTS (9 CFR 108) SUBMIT TO VET BIOLOGICSINSPECTION AND COMPLIANCE

16. OTHER (specify) ___________________

CERTIFICATION

In accordance with the Act of Congress approved March 4, 1913 (37 Stat. 832-833; 21 U.S.C. 151-158), application is hereby made for a license to

maintain an establishment for the preparation of animal biological products for the use in the treatment of domestic animals. If a license is issued by the

United States Department of Agriculture under this application, the licensee expressly agrees to comply with the provision of the said Act, and all rules, 

regulations, and orders of the Department of Agriculture issued pursuant thereto relating to the operation of such establishment and the preparation, 

testing, and distribution of animal biological products prepared therein, and that the animal biological products will not be labeled or advertised so as to 

mislead or deceive the purchaser in any particular.

17. SIGNATURE OF AUTHORIZED OFFICIAL 18. TITLE 19. DATE SIGNED

APHIS FORM 2001 Previous editions are obsolete.

APR 2015
INSTRUCTIONS FOR APHIS FORM 2001 

Submit one copy of the form. If additional space is needed, attach additional

sheets and refer to Item No.

1. TYPE OF APPLICATION

Specify whether this is an initial application for an establishment license or a 

change in regulatory information associated with an existing license. If it is a 

change, also enter the assigned USDA establishment license number in the 

unnumbered block above block 3. 

2. REASON FOR CHANGE IN LICENSE

If a Change in License was selected in block 1, indicate the reason for 

the change. 

3. DATE SUBMITTED

Enter the date this application was mailed or electronically submitted to 

Center for Veterinary Biologics. 

4. NAME AND COMPLETE ADDRESS OF APPLICANT

Enter the establishment name and complete legal address (street, city, state, 

ZIP Code) of the applicant. If the applicant is a corporation, enter the name 

and address listed in the Articles of Incorporation. 

5. ADDRESS FOR OFFICIAL MAIL FROM VETERINARY BIOLOGICS

Enter a single address to which official correspondence should be mailed, 

if different from that entered in block 4. 

6. TYPE OF ORGANIZATION

Self-explanatory.

7. NAME AND LOCATION OF SUBSIDIARIES TO OPERATE IN THE

ESTABLISHMENT

A Subsidiary is defined as a corporation in which a corporate licensee owns in 

excess of 50 percent of the voting stock. List only those subsidiaries that will be 

used in the preparation and marketing of veterinary biologics.

8. NAME OF EACH MARKETING DIVISION

A Division is defined as a marketing unit established by the licensee, which may 

be named on labels, advertisements, and promotional material in addition to the 

name and address of the producer (licensee). 

9. LOCATION OF ALL PREMISES TO BE USED FOR PREPARATION, 

TESTING, AND INITIAL SHIPPING 

Enter the street address, city, state, and ZIP Code of all premises to be 

used. 

10. PRINCIPAL OFFICERS OR PARTNERS

Enter the name, title, and business address of each officer/partner in the 

applicant's organization. 

CHECKLIST OF SUPPORTING MATERIAL

The following checklist is intended to ensure that APHIS has adequate 

information to review an establishment license application. If supporting material 

was not submitted previously, ensure that it is provided with this application.

11. APHIS FORM 2003 FOR AT LEAST ONE PRODUCT

A Veterinary Biologics Establishment License is issued concurrently with a 

license(s) for product(s) to be prepared in the establishment. Thus, the applicant 

is expected to apply for a product license concurrently with the establishment 

license.

12. ARTICLES OF INCORPORATION, INCLUDING FOR EACH SUBSIDIARY

Self-explanatory.

13. LETTER(S) OF APPROVAL FROM EACH SUBSIDIARY

Subsidiaries appearing on an establishment license must provide informed 

consent, acknowledging they accept the regulatory responsibilities involved.

14. WATER QUALITY STATEMENT

Per 9 CFR 108, applicants must file a document verifying that the effluent waste 

(not incoming water) for the facility meets local regulatory standards. Some 

municipalities or rural areas do not have specific regulations regarding effluent 

waste. In such cases, the applicant should submit a letter from the appropriate 

local authority stating that the area has no regulations in this regard.

15. FACILITY DOCUMENTS

Submit facility documents, prepared in accordance with 9 CFR 108, for each 

premises listed in Item 9. 

16. OTHER

APHIS may request additional information to support initial applications for 

certain establishments. If this has been requested for your establishment, briefly 

describe the purpose of the additional information in the line provided and attach 

supporting documentation.

17. SIGNATURE OF AUTHORIZED OFFICIAL

The APHIS primary or alternate liaison for the establishment, if designated, 

should serve as the authorized official. If no liaison has yet been designated, an 

official authorized to assume responsibility for regulatory compliance on behalf of 

the establishment should sign.

18. TITLE

Enter the title of the individual signing in block 17. 

19. DATE SIGNED

Self-explanatory.