Fda 3665 Final Consultation For Food Derived From A New Plant Var

Form Approved: OMB Control No. 0910-0583;
Expiration Date: 08/31/2024 (See page 4 for OMB Statement)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

FINAL CONSULTATION
FOR FOOD DERIVED FROM
A NEW PLANT VARIETY
(BIOTECHNOLOGY FINAL
CONSULTATION)

FDA USE ONLY
BNF NUMBER

DATE OF RECEIPT

Transmit completed form and attachments electronically via the COSM online submission system (see Instructions); OR Transmit completed

form and attachments in paper format or in physical media to: Office of Food Chemical Safety, Dietary Supplements, and Innovation (HFS-200),
Human Foods Program, Food and Drug Administration, 5001 Campus Drive, College Park, MD, 20740-3835.

PART I – INTRODUCTORY INFORMATION ABOUT THE SUBMISSION
1. Type of Submission (Check one)
Amendment to BNF No.

New
2.

Supplement to BNF No.

All electronic files included in this submission have been checked and found to be virus free. (Check box to verify)

3a. For New Submissions Only: Most recent presubmission consultation (if any)
with FDA on the subject food (yyyy/mm/dd):
3b. For Amendments or Supplements: Is your
amendment or supplement submitted in
response to a communication from FDA?

(Check one)
Yes
If yes, enter the date of
No
communication (yyyy/mm/dd):

PART II – INFORMATION ABOUT THE NOTIFIER
Position

Name of Contact Person

1a. Notifier

Company (if applicable)

Mailing Address (number and street)

City

State or Province

Telephone Number

Fax Number

Country

E-Mail Address

Position

Name of Contact Person
1b. Agent
or Attorney
(if applicable)

Zip Code/Postal Code

Company (if applicable)

Mailing Address (number and street)

City

Telephone Number

FORM FDA 3665 (09/21)

State or Province
Fax Number

Zip Code/Postal Code

E-Mail Address

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Country

PART III – GENERAL ADMINISTRATIVE INFORMATION
1. Title of Submission
3. For paper submissions only:

2. Submission Format: (Check appropriate box(es))
Electronic Submission (COSM)
Paper

Electronic files on physical media
with paper signature page

Number of volumes

If applicable give number and type of physical media

Total number of pages

4. Does this submission incorporate any information in FDA’s files by reference? (Check one)
Yes (Proceed to Item 5)
No (Proceed to Item 6)
5. The submission incorporates by reference information from a previous submission to FDA as indicated below (Check all that apply) :
a) BNF No. BNF
b) NPC No. NPC
c) GRAS Notice No. GRN
d) GRAS Affirmation Petition No. GRP
e) Food Additive Petition No. FAP
f) Food Master File No. FMF
g) Other or Additional (describe or enter information as above)
6. Does the submission (including information that you are incorporating by reference) contain information
that you view as trade secret or as confidential commercial or financial information?
Yes (Proceed to Item 7)
No (Proceed to Part IV)
7. Have you designated information in your submission that you view as trade secret or as confidential commercial or financial information
(Check all that apply)
Yes, see attached Designation of Confidential Information
Yes, information is designated at the place where it occurs in the submission
No
8. Have you attached a redacted copy of some or all of the submission? (Check one)
Yes, a redacted copy of the complete submission
Yes, a redacted copy of part(s) of the submission
No

PART IV – INFORMATION ABOUT THE FOOD AND THE NEW PLANT VARIETY FROM WHICH IT IS DERIVED
1. Name of food derived from the new plant variety

2. Describe the various applications or uses of food derived from the new plant variety, including animal feed uses.

3. Common name of the plant variety from
which the food is derived

FORM FDA 3665 (09/21)

4. Scientific designation (genus and species)
of the plant variety from which the food is
derived

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5. Distinctive designation(s) and/or unique
identifier(s) that you use to identify the applicable transformation event(s)

PART IV – INFORMATION ABOUT THE FOOD AND THE NEW PLANT VARIETY FROM WHICH IT IS DERIVED
(Continued)
6. Describe the purpose or intended technical effect of the modification and any expected effect on the composition
or characteristic properties of the food.

PART V – IDENTITY OF NEW SUBSTANCES IN THE NEW PLANT VARIETY
Provide the information below about each new substance made in the new plant variety
Name of Substance

Registry Used
(e.g., CAS, IUB)1
(optional)

Registry No.
(optional)

Function

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1

Common registries used include CAS (Chemical Abstracts Service) and EC (Refers to Enzyme
Commission of the International Union of Biochemistry (IUB), now carried out by the Nomenclature
Committee of the International Union of Biochemistry and Molecular Biology (IUBMB))

PART VI – SUMMARY OF SAFETY AND NUTRITIONAL ASSESSMENT
(check list to help ensure your submission is complete - check all that apply)
1.

Summary of safety and nutritional assessment attached

2a. Did you include any other information that you want FDA to consider in evaluating your Biotechnology Final Consultation?
Yes
No
2b. Did you include this other information in the list of attachments?
Yes

No

PART VII – SIGNATURE
Signature of Responsible Official,
Agent, or Attorney

FORM FDA 3665 (09/21)

Printed Name and Title

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Date (mm/dd/yyyy)

PART VIII – LIST OF ATTACHMENTS
List your attached files or documents containing your submission, forms, amendments or supplements, and other pertinent information.
Clearly identify the attachment with appropriate descriptive file names (or titles for paper documents), preferably as suggested in the
guidance associated with this form. Number your attachments consecutively. When submitting paper documents, enter the inclusive page
numbers of each portion of the document below.
Attachment
Number

Attachment Name

Folder Location (select from menu)
(Page Number(s) for paper Copy Only)

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FORM FDA 3665 (09/21)

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