Aphis 2003 Application For Us Veterinary Biological Product License

This application must be submitted for issuance of a U.S. Veterinary
Biological Product License. The application and attached supporting
documents will be used for determining the purity, safety, potency, and
efficacy of the product(9 CFR 102).

Public reporting burden for this collection of information is estimated to average 1.0
hours 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. Send comments regarding this burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to Department of Agriculture, Clearance Officer, OIRM, Room 404-W, Washington,
D.C. 20250; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, D.C. 20503.
U.S. DEPARTMENT OF AGRICULTURE
FORM APPROVED - OMB NO. 0579-0013
ANIMAL AND PLANT HEALTH INSPECTION SERVICE
FOR VETERINARY BIOLOGICS USE ONLY
VETERINARY SERVICES, CENTER FOR VETERINARY BIOLOGICS
PRODUCT CODE NO.

APPLICATION FOR
UNITED STATES VETERINARY BIOLOGICAL PRODUCT LICENSE

INSTRUCTIONS: Submit one copy for each product. If additional space is needed, attach
additional sheets and refer to Item No. Enclose supporting documents.

1. ESTABLISHMENT LICENSE NO.

2. NAME AND ADDRESS OF APPLICANT (Include No., Street, or RFD No., City, State, Zip Code)

3. ADDRESS OF PREMISES TO BE USED (If different from Item 2)

4. BIOLOGICAL PRODUCT TRUE NAME

5. HAS A LICENSE BEEN TERMINATED WHICH WAS ISSUED TO YOUR FIRM FOR THIS PRODUCT?

† NO

†

YES (If "yes," explain why):
CHECKLIST FOR SUPPORTING MATERIAL
A. WITH THIS
APPLICATION
("X")

ITEMS SUBMITTED

B.

FOR VETERINARY BIOLOGICS USE ONLY

DATE OF
PREVIOUS SUBMISSION

6. Outline of Production (Submit with APHIS Form 2015)
7. Labels or Sketches (Submit with APHIS Form 2015)
8. Blueprints, Plot Plans, and Legends (Submit if not on file)
9. Research Protocols and Data

(Specify)

a.
b.
c.
d.
e.
f.
10. Personnel Biographies (APHIS Form 2007, submit
unless previously sent)

11. 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 prepare the
herein named animal biological product for use in the treatment of domestic animals. If a license is issued under this application, the licensee expressly agrees
to comply with the provisions of the said Act, and all rules, regulations, and orders of the Department issued pursuant thereto governing the preparation, testing,
and distribution of the animal biological product, and that the animal biological product will not be labeled or advertised so as to mislead or deceive the
purchaser in any particular.
In case a product license is issued, it is further agreed that the biological product shall be subject to any additional requirements or restrictions stated therein.
12. SIGNATURE OF AUTHORIZED OFFICIAL

13. TITLE

14. DATE SIGNED

FOR VETERINARY BIOLOGICS USE ONLY
15. DATE FINAL SUPPORTING
MATERIAL RECEIVED

APHIS FORM 2003
OCT 2001

16. LICENSE APPROVED BY (Signature)

Previous editions are obsolete.

17. DATE APPROVED