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 (9 CFR 102). See instructions on reverse side for additional guidance.
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
				USDA PRODUCT CODE NUMBER
2. NAME AND ADDRESS OF APPLICANT (Include No., Street, or RFD No., City, State, ZIP Code)				1. VETERINARY BIOLOGICS ESTABLISHMENT NUMBER
				3. ADDRESS OF PREMISES TO BE USED (IF DIFFERENT FROM ITEM 2)
4. BIOLOGICAL PRODUCT TRUE NAME							5. APPLICANT’S INTERNAL WORKING IDENTIFIER FOR PRODUCT (IF APPLICABLE)
6. RELATIONSHIP OF NEW PRODUCT TO OTHER LICENSED, PRELICENSE, OR TERMINATED PRODUCTS FOR YOUR ESTABLISHMENT (See instructions on reverse for detailed guidance.)
7. OTHER COMMENTS
CHECKLIST FOR SUPPORTING MATERIAL
ITEMS SUBMITTED		DESCRIPTION				A. WITH THIS APPLICATION (X)				B. DATE OR CVB MAIL LOG ID OF PREV SUBMISSION
8. METHOD OF PRODUCTION		 OUTLINE OF PRODUCTION (9CFR 114.9) SIMILAR INFORMATION
9. PRIOR SUBMISSIONS (IF ANY) FOR THIS PRODUCT WHICH WERE PROCESSED BEFORE A USDA PRODUCT CODE WAS ASSIGNED
10. 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.
11. SIGNATURE OF AUTHORIZED OFFICIAL			12. TITLE		13. DATE SIGNED
FOR VETERINARY BIOLOGICS USE ONLY
14. DATE FINAL SUPPORTING MATERIAL RECEIVED	15. LICENSE APPROVED BY (Signature)				16. DATE APPROVED			17. CVB MAIL LOG NO.

APHIS FORM 2003 Previous editions are obsolete.

DEC 2012

INSTRUCTIONS FOR APHIS FORM 2003:

Submit one copy of the form. If additional space is needed, attach additional sheets and refer to Item No.

1 VETERINARY BIOLOGICS ESTABLISHMENT NUMBER

Enter the veterinary biologics establishment number assigned by APHIS, if one has been assigned.

2. NAME AND ADDRESS OF APPLICANT

Enter the establishment name and complete mailing address (street, city, state, ZIP) of the applicant. If the applicant has been assigned a veterinary biologics establishment number by APHIS, enter the mailing address on file with APHIS.

3. INTENDED SITE(S) OF MANUFACTURE AND TESTING

List the intended site(s) of manufacture and testing for this product.

4. BIOLOGICAL PRODUCT TRUE NAME

The True Name includes all of the antigenic fractions of the product for which a label claim is intended. See the current catalog of licensed biological products (www.aphis.usda.gov/animal_health/vet_biologics/vb_licensed_products.shtml) for examples. The True Name listed by the applicant on this application should be considered preliminary. APHIS assigns True Names according to numerous established conventions intended to promote standardization, so the True Name under which the product is licensed may differ.

5. APPLICANT’S INTERNAL WORKING IDENTIFIER FOR PRODUCT

Manufacturers frequently designate working identifiers for new products prior to being assigned a USDA product code. If such an identifier exists, it may be entered here.

6. RELATIONSHIP OF NEW PRODUCT TO OTHER LICENSED, PRELICENSE, OR TERMINATED PRODUCTS FOR YOUR ESTABLISHMENT

To facilitate product classification and licensing plan development, describe the relationship of this new product with other products licensed, or under development, by your establishment. This may include, but is not limited to, describing whether the new product is:

• Prepared from new or previously approved Master Seeds/Cells

• Part of a product line (cite other products in the line, especially those already licensed)

• A modification of an existing product (e.g., adding or deleting an antigen, change in adjuvant/preservative/dose volume)

• Manufactured or tested with new technology for your establishment

• Part of a split manufacture agreement

7. OTHER COMMENTS

Optional field for miscellaneous comments not covered elsewhere.

CHECKLIST OF SUPPORTING MATERIAL

This checklist is intended to ensure that APHIS has adequate information to assign a Product Code and True Name to the new product. If supporting material was not submitted previously, ensure that it provided with this application.

8. METHOD OF PRODUCTION

The most efficient means of describing how the product is made is to provide an Outline of Production, formatted according to 9 CFR 114.9. If an Outline is not yet available, provide information equivalent to that captured in an Outline of Production.

9. LIST OF PRIOR SUBMISSIONS (IF ANY) FOR THIS PRODUCT WHICH WERE PROCESSED BEFORE A USDA PRODUCT CODE WAS ASSIGNED

Manufacturers may submit documentation, such as requests to ship experimental product or proof-of-concept studies, before submitting a formal license application and being assigned a USDA product code. If such submissions exist for this product, please list them so that these uncoded submissions may be transferred to the licensing file for this product.

10. OTHER

APHIS may request additional information to support initial applications for certain products. If this has been requested for your product, briefly describe the purpose of the additional information in the line provided and attach supporting documentation.

11. 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.

12. TITLE

Enter the job title of the individual signing in Item 8.

13. DATE SIGNED

This date should correspond to the date the application is mailed. This will be the submission date cited in any return correspondence.

The remainder of this form is for internal use by the APHIS Veterinary Biologics Program (Center for Veterinary Biologics).