Aphis 2015 Transmittal Of Lables 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 number for this information collection is 0579-0013. The time required to complete this information collection is
estimated to average 0.05 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.
No U.S. Veterinary Biological Product License may be issued until product labeling and an outline of production have been reviewed. (9 CFR 102, 112, and 114).

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

OMB Approved
0579-0013
EXP. DATE 08/2013

1. NAME AND FULL MAILING ADDRESS OF SUBMITTER (Include ZIP Code)

TRANSMITTAL OF LABELING
OR OUTLINES

2. DATE OR CVB MAIL LOG NUMBER OF PRIOR RELATED CORRESPONDENCE

3. VET BIOLOGICS ESTABLISHMENT NUMBER 4. DATE SUBMITTED

5. NAME OF PRODUCT OR SPECIAL OUTLINE (Use separate form for each product or special outline)

6. PRODUCT CODE (or
Special Outline Number)

7. “X” IF
PRELICENSE

8. LABELING SUBMITTED (COMPLETE ONE LINE FOR EACH ITEM)
B. Number
Copies

A. Type

C. Item on File Being Replaced
(Give Number(s))

D. Use
Remaining
Inventories of
Replaced Label
(X)

E. Comments

OUTLINE OF PRODUCTION OR SPECIAL OUTLINE SUBMITTED (Do not submit with same form covering Labeling)
9. NUMBER COPIES

13. COMMENTS

10. TYPE OF SUBMISSION
NEW
COMPLETE
OUTLINE
REVISION

14. SIGNATURE OF ESTABLISHMENT REPRESENTATIVE

11. PAGE NUMBERS AMENDED OR ADDED
PAGES
AMENDED

PAGES
ADDED

12. DATE OR CVB MAIL LOG NUMBER
OF LAST COMPLETE REVISION

15.PRINTED NAME AND TITLE

REVIEW BY VETERINARY BIOLOGICS
In the absence of any attached applicable Exceptions (as noted by a checkmark in the box in Item 16), remaining inventories of replaced labels may be used through the last day of the
twelfth month after the Return Date in Item 18, provided that ongoing use was requested in Item 8D.
16. REVIEWED BY

 CVB EXCEPTIONS ATTACHED

17. DATE RETURNED

18. CVB MAIL LOG NUMBER

APHIS FORM 2015
SEPT 2012

Previous editions are obsolete.

INSTRUCTIONS FOR APHIS FORM 2015
This form is intended as a cover page for submissions of labeling materials, an Outline of Production, or a Special Outline.
Submit one copy of this form for each Outline, Special Outline, or group of labeling intended for one product. Use separate
forms for Outlines and labeling.
1. NAME AND FULL MAILING ADDRESS OF SUBMITTER
Enter the establishment name and complete mailing address (street,
city, state, ZIP) of the submitter. The processed form will be returned
to official mailing address on file for the establishment.
2. DATE OF RELATED PRIOR CORRESPONDENCE
Enter the submission date of the last related Outline or labeling
submission (as applicable) for this product.
3. VETERINARY BIOLOGICS ESTABLISHMENT NUMBER
Enter the veterinary biologics establishment number assigned by
APHIS.
4. DATE SUBMITTED
Self-explanatory. For Outlines of Production, this date should agree
with the date on the cover page of the Outline. If the Outline is not
mailed on this date, enter the date mailed in Item 13, Comments.
5. NAME OF PRODUCT OR SPECIAL OUTLINE
Enter the True Name of the product, as assigned by APHIS. If no True
Name has yet been assigned, list the components of the product. If
the submission is a Special Outline, enter the title of the Special
Outline.

OUTLINE OF PRODUCTION OR SPECIAL OUTLINE SUBMITTED
9. NO. COPIES
Enter the number of identical copies being submitted. The minimum is
two, each with original signatures. Each copy will be stamped by
APHIS upon processing, and all but one copy will be returned for the
submitter’s records.
10. TYPE OF SUBMISSION
Check all boxes that apply.
•
New Outline: No prior versions of this Outline have been
submitted to APHIS.
•
Complete Revision: A previously filed Outline is being replaced in
its entirety.
•
Pages Amended: Only selected pages, and not a complete
Outline, are being submitted for replacement.
•
Pages Added: Additional text or repagination necessitates the
addition of new pages to a previously filed Outline. Only affected
pages are being submitted.
11. PAGES AMENDED OR ADDED
Specify the page numbers being amended or added. Leave this item
blank for a Complete Revision.

6. PRODUCT CODE OR SPECIAL OUTLINE NUMBER
Enter the Product Code assigned by APHIS. If no Product Code has
yet been assigned, enter “Unassigned.” If the submission is a Special
Outline, add the unique identifier assigned by your Establishment to
the Special Outline.

12. DATE OF LAST COMPLETE REVISION
Enter the submission date of the last Complete Revision of this
Outline. Do not include the date of individual page amendments that
may have been submitted subsequent to the last Complete Revision.
Do not cite the date APHIS processed the last revision.

7. PRELICENSE (X)
If the product has not yet been licensed at the time of this submission,
place an “X” in this box.

13. COMMENTS
Optional. Explanatory comments or requests may be added here.

8. LABELING SUBMITTED
Complete one line for each piece of labeling submitted.
A. Type
Specify whether the item is a Container, Box, or Shipping label;
Circular (insert); or Other.
B. No. Copies
Specify the number of identical copies being submitted (minimum = 2).
Each copy will be stamped by APHIS, and all but one copy will be
returned for the submitter’s records.
C. Item on File Being Replaced
If the current submission is intended to replace previously submitted
labeling, specify the Label Number(s) assigned by APHIS to the
previous submission(s). The Label Number is added to the bottom
right corner of the label mounting sheet during processing.
D. Use Remaining Inventories of Replaced Items
Place a check (“X”) in this box if you wish to obtain permission to use
the existing inventories of the labeling being replaced. The default
period to use existing inventories is 1 year; adjusted to the last day of
the month, from the date the replacement label was approved.
(Example: If the replacement label was processed on July 15, 2012,
the superseded label may be used through July 31, 2013.) Longer
intervals may be requested, with justification, in the Comments column
(8E). If this item is not checked, the replaced labeling will be
inactivated and archived by APHIS immediately upon approval of the
replacement.
E. Comments
Optional. Explanatory comments or requests specific to an individual
piece of labeling may be added here.

APHIS FORM 2015 (Reverse)
SEPT 2012

14. SIGNATURE OF ESTABLISHMENT REPRESENTATIVE
This form should be signed by the APHIS liaison or an alternate
liaison.
15. PRINTED NAME AND TITLE
Add the printed name and position title of the person signing in Item
14.
THE FOLLOWING ITEMS ARE FOR CENTER FOR VETERINARY
BIOLOGICS USE ONLY
16. REVIEWED BY
Signature of CVB official reviewing the submission. If APHIS identifies
any exceptions or special circumstances regarding the submission,
they will be noted on an attached document. If APHIS attaches
documents to the return form, a check will appear in the box in this
item.
17. DATE RETURNED
This is the date the submission is processed and corresponds to the
date stamped on each label mounting sheet or approved Outline page.
18. CVB MAIL LOG NUMBER
The submission is assigned a unique tracking number when received
by the CVB. For improved efficiency, cite this number in future
communications regarding this submission.