Fda 3666 Early Food Safety Evaluation Npc Number Of A New Non-pes

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

EARLY FOOD SAFETY EVALUATION
OF A NEW NON-PESTICIDAL PROTEIN
PRODUCED BY A NEW PLANT VARIETY
(NEW PROTEIN CONSULTATION)

FDA USE ONLY

NPC 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)

2.

Supplement to NPC

Amendment to NPC No.

New

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 new protein (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
communication (yyyy/mm/dd):
No

PART II – INFORMATION ABOUT THE PERSON RESPONSIBLE FOR THE SUBMISSION
Position

Name of Contact Person

1a. Person
Responsible for
the Submission

Company (if applicable)

Mailing Address (number and street)

City

State or Province

Telephone Number

Fax Number

Zip Code/Postal Code

E-Mail Address

Name of Contact Person

1b. Agent
or Attorney
(if applicable)

Country

Position

Company (if applicable)

Mailing Address (number and street)

City

Telephone Number

FORM FDA 3666 (09/21)

State or Province

Fax Number

Zip Code/Postal Code

E-Mail Address

Page 1 of 4

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)
Electronic files on physical media
Paper
with paper signature page
If applicable give number and type of physical media

Number of volumes
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 NEW PROTEIN
1. Name of the new protein
(include both common name and systematic name as applicable)

Scientific Name Data

2. Registry No. of the new protein1 (optional)

Registry Id

3. Describe the purpose or intended technical effect of the new protein

Description

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))
1

FORM FDA 3666 (09/21)

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PART V – INFORMATION ABOUT THE GENETIC MATERIAL
Provide the information about the genetic material that encodes your new protein.
Identity of Introduced Genetic Material

Source of Introduced Genetic Material

Scientific Name Data

Genetic Material Source

Scientific Name Data

Genetic Material Source

Scientific Name Data

Genetic Material Source

Scientific Name Data

Genetic Material Source

Scientific Name Data

Genetic Material Source

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PART VI – SCIENTIFIC EVALUATION OF THE FOOD SAFETY OF THE NEW PROTEIN
(check list to help ensure your submission is complete – check all that apply)
1.

History of safe use in food or feed

2.

Assessment of the amino acid similarity between the new protein and known allergens and toxins

3.

Overall stability of the new protein and the resistance of the protein to enzymatic degradation using appropriate in vitro assays

4a. Did you include any other information that you want FDA to consider in evaluating your NPC?
Yes
No
4b. 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 3666 (09/21)

Printed Name and Title

Page 3 of 4

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

Folder Location (select from menu)

Attachment Name

(Page Number(s) for paper Copy Only)

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FORM FDA 3666 (09/21)

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