Form APHIS Form 2001 APHIS Form 2001 Application for United States Veterinary Biologics Estab

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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

LEAVE BLANK FOR INITIAL APPLICATIONS
USDA ESTABLISHMENT LICENSE NUMBER

APPLICATION FOR
UNITED STATES VETERINARY BIOLOGICS ESTABLISHMENT LICENSE
2. IF CHANGE OF LICENSE, SPECIFY REASON

1. TYPE OF APPLICATION ("X" one)

3. DATE SUBMITTED

CHANGE OF LICENSE
(specify reason in block 2)

INITIAL

5.ADDRESS FOR OFFICIAL MAIL FROM VETERINARY BIOLOGICS (IF DIFFERENT FROM
IBLOCK 4.)

4. NAME AND COMPLETE ADDRESS OF APPLICANT

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

11. APHIS FORM 2003 FOR AT LEAST ONE PRODUCT

A. WITH THIS
APPLICATION (X)

B. DATE OR CVB MAIL LOG ID OF
PREVIOUS SUBMISSION

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

APHIS FORM 2001
APR 2015

18. TITLE

Previous editions are obsolete.

19. DATE SIGNED

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.