APHIS Form 2015 Transmittal of Labeling 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: XX/XXXX

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

TRANSMITTAL OF LABELING
OR OUTLINES
2. DATE OR CVB MAIL LOG NO. OF PRIOR RELATED CORRESPONDENCE

3. VET BIOLOGICS ESTABLISHMENT NO. 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. No.
Copies

A. Type

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

D. Use Remaining
Inventories of
Replaced Label
(X)

F. Assigned
Label No
(APHIS Use)

E. Comments

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

11. PAGE NUMBERS AMENDED OR ADDED

10. TYPE OF SUBMISSION
New Outline

Complete Revision

Pages
Amended

Pages
Added

12. DATE OR CVB MAIL LOG NO. OF
LAST COMPLETE REVISION

13. COMMENTS

14. SIGNATURE OF ESTABLISHMENT REPRESENTATIVE

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.

 CVB EXCEPTIONS ATTACHED

16. REVIEWED BY

17. DATE RETURNED

18. CVB MAIL LOG NO.

APHIS FORM 2015
AUG 2017

Previous editions are obsolete.

INSTRUCTIONS FOR APHIS FORM 2015
This form is intended as a cover page for paper submissions of labeling
materials, an Outline of Production, or a Special Outline. It is not needed for
submissions via the NCAH Portal. Submit one copy of this form for each paper
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.

11. PAGES AMENDED OR ADDED
Specify the page numbers being amended or added. Leave this item blank for a
Complete Revision.
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.
13. COMMENTS
Optional. Explanatory comments or requests may be added here.

2. DATE OF RELATED PRIOR CORRESPONDENCE
Enter the submission date of the last related Outline or labeling submission (as
applicable) for this product.

14. SIGNATURE OF ESTABLISHMENT REPRESENTATIVE
This form should be signed by the APHIS liaison or an alternate liaison.

3. VETERINARY BIOLOGICS ESTABLISHMENT NUMBER
Enter the veterinary biologics establishment number assigned by APHIS.

15. PRINTED NAME AND TITLE
Add the printed name and position title of the person signing in Item 14.

4. DATE SUBMITTED
Self-explanatory. For complete revisions of Outlines of Production, this date
should agree with the date on the revised cover page of the Outline. For page
amendments, the date should agree with the date on the new page(s). If the
Outline is not mailed on this date, enter the date mailed in Item 13, Comments.

THE FOLLOWING ITEMS ARE FOR CENTER FOR VETERINARY BIOLOGICS
USE ONLY

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.
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.
7. PRELICENSE (X)
If the product has not yet been licensed at the time of this submission, place an
“X” in this box.
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.
F. Assigned Label Number
For APHIS Use Only. When the label is processed, it is assigned an APHIS label
number, which will be noted here.
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.

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.