0583 Form FDA 3665 Instructions ver 2024

Contains Nonbinding Recommendations
Instructions for Completing Form FDA 3665
OMB Control No. 0910-0583
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
•

Form FDA 3665 (available on FDA’s website at https://www.fda.gov/aboutfda/reports-manuals-forms/forms) is intended to help you assemble and
transmit a Biotechnology Final Consultation (also known as a Biotechnology
Notification File (BNF)) 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.

•

FDA developed an electronic portal (an online submission module known as
COSM) for electronic submissions. COSM was specifically designed to aid
firms wishing to file submissions with FDA. COSM is a web-based tool that
walks users through a step-by-step process to assemble and send fully
electronic submissions to the agency, thereby eliminating the need for printing
and mailing of paper submissions. COSM allows safety, nutritional, and other
information in a BNF to be uploaded and submitted online via Form FDA
3665. You may use the same COSM account for future submissions. We
encourage firms to submit their BNF through COSM. Use of the portal
facilitates FDA review and also will allow submitters to obtain real-time status
updates of their submission. COSM’s data validation also helps prevent
incomplete notifications by ensuring that all required fields are completed
before the BNF is submitted. For COSM instructions and account management
information, visit the COSM website at https://www.fda.gov/food/registrationfood-facilities-and-other-submissions/cfsan-online-submission-module-cosm.

•

To transmit your submission:
o You may submit your BNF electronically via COSM at https://cfsanonlinesubmissions.fda.gov; 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:
FDA Office of Food Chemical Safety, Dietary Supplements and
Innovation, Innovative Foods Staff, HFS-200, 5001 Campus Drive,
College Park, MD 20740-3835.
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•
II.

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);

•

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., via an electronic portal
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
• 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.
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Contains Nonbinding Recommendations
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;
• 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(s), and any
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 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.

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III.

FDA Internet Resources

The following resources are available on FDA’s Internet site.
1. Biotechnology Guidance Documents & Regulatory Information
(https://www.fda.gov/food/guidance-documents-regulatory-informationtopic-food-and-dietary-supplements/biotechnology-guidance-documentsregulatory-information) - This website includes a list of, and hyperlinks to,
guidance documents associated with the preparation of Biotechnology Final
Consultations.
2. CFSAN Online Submission Module (COSM)
(https://www.fda.gov/food/registration-food-facilities-and-othersubmissions/cfsan-online-submission-module-cosm) - This website includes
information and links to instructions for COSM.
3. CFSAN Online Submission Module-Login (https://cfsanonlinesubmissions.fda.gov/farmonline/#/login) - This is the login webpage for
COSM.

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