Form APHIS 2015 APHIS 2015 Transmittal of Labels and Circulars or Outlines

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 numbers for this information collection are 0579-0013 and 0579-XXXX. The time required to complete this
information collection is estimated to average 0.05 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.
No U.S. Veterinary Biological Product License may be issued until product labels, circulars and outline of products have been reviewed. (9 CFR 102, 112, and 114).

OMB Approved
0579-0013
0579-XXXX

1.NAME AND ADDRESS OF LICENSEE (Include ZIP Code)

U.S. DEPARTMENT OF AGRICULTURE
ANIMAL AND PLANT HEALTH INSPECTION SERVICE
VETERINARY SERVICES
CENTER FOR VETERINARY BIOLOGICS
AMES, IOWA 50010

TRANSMITTAL OF LABELS
AND CIRCULARS OR OUTLINES
NOTE: Submit original and 6 copies. Retain last copy.
2. DATE OF PRIOR RELATED CORRESPONDENCE

3. ESTABLISHMENT LICENSE NUMBER

5. NAME OF PRODUCT (Use separate form for each product)

4. DATE SUBMITTED

6. PROOUCT CODE 7. “X” IF NEW
PRODUCT

LABELS AND CIRCULARS SUBMITTED
TYPE

A.
NUMBER SETS

FINISHED
B.
C.
NUMBER COPIES
ITEM ON FILE BEING REPLACED
(Give Number(s))
OF EACH

D.
NUMBER SETS

SKETCHES
E.
F.
NUMBER COPIES
ITEM ON FILE BEING REPLACED
(Give Number(s))
OF EACH

8. CONTAINER
9. BOX
10. CIRCULARS
11. OTHER
OUTLINE SUBMITTED (Do not submit with same form covering Labels and Circulars)
12. NUMBER COPIES 13. TYPE OF SUBMISSION
NEW
ONLINE

COMPLETE
REVISION

14. PAGE NUMBERS AMENDED OR ADDED
PAGES
AMENDED

15. DATE OF PREVIOUS OUTLINE

PAGES
ADDED

16. COMMENTS

17. SIGNATURE OF LICENSEE REPRESENTATIVE

18.TITLE

REVIEW BY VETERINARY BIOLOGICS
19. EXCEPTIONS

20. REVIEWED BY (Signature, Veterinary Biologics)

APHIS FORM 2015
OCT 2011

21. DATE RETURNED

Previous editions are obsolete.