FDA 3665 Biotechnology Notification and Instruction

Contains Nonbinding Recommendations
Instructions for Completing Form FDA 3665
OMB No. 0910-0704 Expiration Date: 02/28/2015
Department of Health and Human Services
Food and Drug Administration
Final Consultation for Food Derived from a New Plant Variety
(Biotechnology Final Consultation)
I.

General Instructions

II.

Specific Instructions for Each Part of the Form

III.

FDA Internet Resources

I.

General Instructions
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II.

Form FDA 3665 is intended to help you assemble and transmit a Biotechnology
Final Consultation to FDA.
Completion of this form can expedite processing of your submission, but does not
constitute a complete submission. Your completed submission should include the
items listed in Part VI of Form 3665.
To prepare your submission in electronic format, you should download a
Biotechnology Final Consultation foldering structure, then place your completed
form and files in the applicable folders (see Appendix 15 in Internet Resource #1
in Part III of these instructions for a link to the downloadable foldering structure).
To transmit your submission:
o You may upload the completed Biotechnology Final Consultation
foldering structure to the Electronic Submission Gateway (ESG). For
information on using the ESG, see Internet Resource #2 in Section III of
these instructions; or
o You may send the completed submission, either on paper (including the
form and all attachments) or in electronic format on physical media, to:
Office of Food Additive Safety, HFS-200, 5100 Paint Branch Parkway,
College Park, MD 20740-3835. When sending paper submissions, please
include all printed barcode pages with your completed form.
Additional information about Biotechnology Final Consultations is available on
FDA’s Internet Site (see Internet Resource #1 in Section III of these instructions).
Specific Instructions for Each Part of the Form

1. Part I – Introductory Information About the Submission
In Part I, you tell us:
 Whether your submission is a new submission, or is an amendment or supplement
to a previously established Biotechnology Notification File (BNF);

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Whether you have determined that all files provided in an electronic transmission
are free of computer viruses;
The date of your most recent meeting if any) with FDA before transmitting a new
submission; and
The date of any correspondence, sent to you by FDA, relevant to an amendment
or supplement you are transmitting.

2. Part II – Information About the Person Responsible for the Submission
In Part II, you identify:
 The person (i.e., the individual, partnership, corporation, association or other legal
entity) who is responsible for the submission;
 The contact person within any partnership, corporation, association, or other legal
entity; and
 Any agent or attorney who is authorized to act on behalf of the person who is
responsible for the submission. If the agent or attorney is the preferred contact
person, write “See agent or attorney” in the box for “Name of Contact Person” in
Part II, 1a.
3. Part III - General Administrative Information
In Part III, you tell us:
 The title of your submission;
 The format of your submission (i.e., paper, electronic, or electronic with a paper
signature page);
 The mode of delivery of any electronic submission (i.e., ESG or transmission on
physical media such as CD-ROM or DVD);
 Whether you are referring us to information already in our files;
 Whether you have designated in your submission any information that you view
as trade secret or as confidential commercial or financial information (see 21
CFR part 20 and Internet Resource #1 in Section III of these instructions); and
 Whether you have provided a redacted copy of some or all of the submission. A
redacted copy is a copy modified to remove data or information that you view as
trade secret or as confidential commercial or financial information.
4. Part IV –Information About the Food and the New Plant Variety From
Which It Is Derived
In Part IV, you:
 Tell us the name of the food (i.e., the common name of the plant) derived
from the new plant variety (e.g., corn, not corn meal and oil);
 Describe the various applications or uses of food derived from the new
plant variety, including animal feed uses;
 Tell us the common name and scientific name (genus and species) of the
new plant variety;

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Tell us the distinctive designation and/or unique identifier used to identify
the transformation event; and
Describe the purpose or intended technical effect of the modification, and
a expected effect on the composition or characteristic properties of the
food.

5. Part V –Identity of New Substances in the New Plant Variety
In Part V, you provide information about any new substances (proteins and other
metabolic products) made in the new plant variety including the name and function of the
new substance. You may also include any registry designations.
6. Part VI – Summary of Safety and Nutritional Assessment
In Part VI, you are prompted to attach your safety and nutritional assessment and tell us if
there is additional information for us to consider in evaluating your submission.
7. Part VII – Signature
In Part VII, you print or type the name and title of the responsible official (or agent or
attorney) who is signing the submission, and sign and date the form.
8. Part VIII - List of Attachments
In Part VIII, you should list all attachments you include in your submission (For
information about downloading and organizing the attachments in your submission please
refer to Appendix 15). If you are completing the form by electronic means use the
“Insert” button to browse for a file name that you want to insert in the box for
“Attachment Name.” Use the “Clear” button if you want to remove or replace the
“Attachment Name” you inserted. Select the folder location (indicating the folder in the
standard foldering structure in which you placed the document) from the pull down
menu. For paper submissions, you should number consecutively the pages within the
attachments and enter the inclusive page numbers of each portion of the complete paper
submission.
III.

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 Office of Food Additive Safety. This guidance document
includes a list of, and hyperlinks to, guidance documents associated with the
preparation of Biotechnology Final Consultations.
2. Electronic Submission Gateway.

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