Amendment to existing notification, prenotification consultation, or Master File (concerning a food contact substance)

Contains Nonbinding Recommendations

Instructions for Completing Form FDA 3480-A:
OMB No. 0910-0495; Expiration Date: 02/29/2016
Department of Health and Human Services
Food and Drug Administration
Amendment to an Existing Food Contact Notification (FCN),
Pre-Notification Consultation (PNC), or
Food Master File (FMF) in support of an FCN

I.

General Instructions

II.

Specific Instructions for Certain Items on the Form

III.

Folder Location Quick Reference (based on Internet Resource #1, Part V)

IV.

FDA Internet Resources

I.

General Instructions
•

Form FDA 3480-A is intended to serve as a standard organizing tool for use when
transmitting an amendment to an existing FCN, PNC, or FMF concerning a food
contact substance (FCS) to FDA. You should use From FDA 3480-A each time
you transmit such an amendment to a given submission.

•

Guidance on preparing and transmitting an amendment to a FCN, PNC, or FMF
for a FCS is available in Parts III and V of Internet Resource #1, listed in Section
IV of these instructions, below.

•

For information on working with PDF Form 3480-A (entering information,
designating confidential information) see Section III of Instructions for
Completing Form 3480 (Appendix 3a of Internet Resource #1.)

•

To prepare your amendment in electronic format, you should download a new
FCN foldering structure (do not re-submit documents previously submitted), and
place your completed form and attachment files in the appropriate folders (see
Part V.C.: Electronic Amendments to Food Contact Notifications and Appendix
15 of Internet Resource #1, below, for guidance and a link to the downloadable
foldering structure).

•

To transmit your submission (submission by one of the electronic means is
recommended; first two choices below):
o You may upload the completed FCN folder structure with included
documents to the Electronic Submission Gateway (ESG). For information
on using the ESG, see Internet Resource #2 in Section IV, below, of these
instructions.
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o You may send a single copy of the completed FCN folder structure with
included documents on physical media to (e.g., CD-ROM, DVD):
Notification Control Assistant, Office of Food Additive Safety, HFS-275,
5100 Paint Branch Parkway, College Park, MD 20740-3835.
o You may send the submission in paper format to the above address. If
only submitted in paper format, you should either submit five copies of the
amendment to a FCN, PNC or FMF (each including all attachments and a
signed copy of Form FDA 3480-A), or consult with FDA regarding the
number of paper copies to send. NOTE: Printing the form generates one
or more pages of (large) bar coded information added at the end of the
form; these represent the data you entered on Form 3480-A that we will
electronically capture as index data for your amendment. If you are
sending your submission in paper format only, please include all printed
barcode pages with your completed form.

II.

Specific Instructions for Certain Items on the Form
•

•
•

•

•
•

Item 1: Enter the date that you transmit the submission to FDA in the format
YYYY-MM-DD (e.g., 2007-12-23). If you submit the documents in electronic
format (via FDA ESG or by physical media), this date should match the date that
you would place in the first part of the filename of each document accompanying
the Form, as described under Item 8 below.
Item 2: You should check electronic submissions for viruses (with updated virus
protection software) before transmitting them to FDA; check the box to indicate
you have done this.
Item 3: FCN/PNC/FMF Number. Check the appropriate box for FCN, PNC, or
FMF, and enter the FDA assigned reference number for the FDA file to which the
information is to be added. Use leading zeros to make six digits, for example:
009999
Item 4:
o a. Indicate the mode of transmission (ESG Gateway or courier/mail) and
the format of your submission if you submit by courier/mail (electronic
physical media or paper).
o b. If submitted by courier/mail, describe in the space provided the type of
electronic media (e.g., CD-ROM, DVDs) and the number of discs, or the
number of volumes and copies for paper submissions.
Item 5: Provide information about the person submitting the amendment and
attorney or agent acting on behalf of that person.
Item 6: Briefly describe the information you have submitted. If your submission
is in response to an FDA request, check the applicable box and enter the date
(YYYY-MM-DD) when FDA made the request (e.g., by letter, e-mail, phone call,
or meeting). If the amendment, or part of the amendment, is not in response to an
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Contains Nonbinding Recommendations

•
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FDA request, explain the purpose of the amendment, e.g., to provide an update on
an ongoing toxicological study or correction to a calculation.
Item 7: an authorized official or agent signs and dates the form and provides
his/her title.
Item 8: List of Attachments.
o For electronic submissions:
 Click on “Insert” to insert the name of a file from the directory on
your local hard drive that is the FCN folder structure where you have
placed the attachment documents for your submission. Clicking on
“Clear” will remove the name if you need to change it. This assures
that the name of the file entered in the table matches the name of the
file included your submission (our system will automatically check
the filenames in the List of Attachments against the filenames of files
actually included in the folder structure of your submission).
Alternatively, type or paste the filename (name files according to the
File Naming Conventions in Appendix 12 of Reference 1, including
the 3-character extension (e.g., .pdf, .mol).
 NOTE: Documents you list are not actually “attached” in any way to
Form 3480-A; you must place the documents in the appropriate
folders in the FCN foldering structure according to Part V of Internet
Resource #1 and Section III: Folder Location Quick Reference,
below.
 Select the folder location (indicating the folder in the standard FCN
foldering structure in which you placed the document) from the pull
down menu. For example:

2007-12-07_ResponsesToFDA2007-11-20chemistryquestions(impurities, migration)
d ) df
2007-12-07_MigrationStudy_revised
chromatograms.pdf
2007-12-07_RevisedEA_ HPNHinPolypropylene.pdf

Chemistry
Chemistry/Studies
Environmental

o For paper submissions:
 List the title of each document included with Form FDA 3480-A.
 Enter the volume number and inclusive page numbers of each
document, as applicable.

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Contains Nonbinding Recommendations

III.

Folder Location Quick Reference (based on Internet Resource #1, Part V)

(Note: Chemistry, Safety, Environmental and Administrative information should not be
combined in a single file)
If the file is or contains:
Form 3480-A, administrative, regulatory
information, designation of nondisclosable
information, redacted copies

Place the file in the folder:
Administrative

Responses to a series of chemistry
Chemistry
questions, introductions to newly submitted
chemistry data
FCS identity, specifications, use,
manufacture, impurities, technical effect

Chemistry

Migration, stability or other chemistry
study data, data clarifications

Chemistry/Studies

Published chemistry information

Chemistry/References

Responses to a series of Safety/Toxicology
questions, introductions to newly
submitted data/info

Safety

Safety narrative

Safety

Comprehensive toxicological profile (CTP)
and/or literature search information for a
given substance (Chemical Name 1)

Safety/Chemical Name 1

Safety study reports, data of a given study
type, for a given substance (Chemical
Name 1)

Safety/Chemical Name 1/Studies/Study
Type

Published safety studies/information on a
given substance (Chemical Name 1)

Safety/Chemical Name 1/References

Responses to a series of environmental
Environmental
questions, introductions to newly submitted
environmental data/information
EA, Revised EA

Environmental

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Contains Nonbinding Recommendations

Environmental study reports & data

Environmental/Studies

Published environmental
studies/information

Environmental/References

Confidential information referenced in the
EA

Environmental/Confidential Environmental
Information

IV.

FDA Internet Resources

The following resources are available on FDA’s Internet site.
1. Guidance for Industry: Providing Regulatory Submissions in Electronic or
Paper format to the Office of Food Additive Safety
2. Electronic Submission Gateway
3. Guidance for Industry: Preparation of Food Contact Notifications:
Administrative
4. Guidance for Industry: Preparation of Premarket Notifications and Food
Additive Petitions for Food Contact Substances: Chemistry Recommendations
5. Guidance for Industry: Preparation of Premarket Notifications for Food Contact
Substances: Toxicology Recommendations
6. Guidance for Industry: Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety and
Applied Nutrition

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