Aphis 2005 Application For United States Veterinary Biological Prod

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. DATE XX/XXXX

This application must be submitted for issuance of a U.S. Veterinary Biological Product Permit. This information will be used to determine if the product may be brought into the U.S., or for approval of transit shipment of biological products move through the U.S. (9 CFR 104).

U.S. DEPARTMENT OF AGRICULTURE ANIMAL AND PLANT HEALTH INSPECTION SERVICE VETERINARY SERVICES, CENTER FOR VETERINARY BIOLOGICS APPLICATION FOR UNITED STATES VETERINARY BIOLOGICAL PRODUCT PERMIT INITIAL RENEWAL

INSTRUCTIONS: Submit one copy of application for each product. If more space is needed, attach additional sheets and refer to item number. Enclose supporting documents.

1. DATE SUBMITTED

2. TYPE OF APPLICATION

RESEARCH AND EVALUATION (Complete all items except 10 through 15)

GENERAL SALE AND DISTRIBUTION (Complete all items except 6, 7, 8, 9, and 15)

TRANSIT SHIPMENT ONLY (Complete all items except 9 through 14)

3. NAME AND ADDRESS OF APPLICANT (Include Number, Street or RFD Number, City, State, and ZIP Code)

4. NAME AND ADDRESS OF PRODUCER

5. NAME OF PRODUCT (one only)

FOR EACH SHIPMENT OF SAME PRODUCT GIVE:

6. ESTIMATED ARRIVAL DATE

7. ESTIMATED QUANTITY

8. U.S. PORT OF ENTRY

9. IF PRODUCT FOR RESEARCH AND EVALUATION - FURNISH NAME AND LOCATION OF INSTITUTION DOING RESEARCH (If same as Item 3, so state. Enclose brief description of product; methods of propagation including composition of medium; species of animals or cell cultures used; method of inactivation or attenuation; recommendation for use; and proposed plan of evaluation pursuant to 9 CFR 104.4(a).)

10. IF PRODUCT FOR GENERAL DISTRIBUTION AND SALE - (Enclose Manufacturer's or Producer's agreement regarding preparation, testing, and labeling of products, and inspection facilities. Enclose supporting documents specified in 9 CFR 104.5).)

11. ADDRESS OF STORAGE FACILITIES (If different from Item 4)

12. TYPE OF ORGANIZATION CORPORATION PARTNERSHIP INDIVIDUAL

13. IF CORPORATION, GIVE STATE IN WHICH INCORPORATED (Enclosed certified copy of Articles of Incorporation)

14. PRINCIPAL OFFICERS OR PARTNERS

A. NAME OF EACH

B. TITLE

C. BUSINESS ADDRESS (Include Number, Street, or RFD Number, City, State, and ZIP Code)

15. IF TRANSIT SHIPMENT GIVE:

A. DESTINATION

B. CARRIER(S)

C. SCHEDULE (Dates in transit)

Arrival

Departure

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 permit to import the herein named biological product for the purpose specified in item 2 above. If a permit is issued under this application, the recipient expressly agrees to conform strictly to all rules, regulations and orders of the Department governing the importation of veterinary biological products and that the product will not be labeled or advertised so as to mislead or deceive in any particular.

16. SIGNATURE OF AUTHORIZED OFFICIAL

17. TITLE

18. DATE SIGNED

APHIS FORM 2005 Previous editions are obsolete.

OCT 2011