Aphis 2003 Application For Us Veterinary Biological Product License

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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).
U.S. DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE VETERINARY SERVICES, CENTER FOR VETERINARY BIOLOGICS APPLICATION FOR UNITED STATES VETERINARY BIOLOGICAL PRODUCT LICENSE				FOR VETERINARY BIOLOGICS USE ONLY
				PRODUCT CODE NUMBER
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 NUMBER
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
ITEMS SUBMITTED		A. WITH THIS APPLICATION ("X")	B. DATE OF PREVIOUS SUBMISSION	FOR VETERINARY BIOLOGICS USE ONLY
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.
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	16. LICENSE APPROVED BY (Signature)					17. DATE APPROVED

APHIS FORM 2003 Previous editions are obsolete.

OCT 2011