Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plan Varieties Intended for Food Use

Contains Nonbinding Recommendations
Instructions for Completing Form FDA 3666
OMB Control No. 0910-0583

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)
I.

General Instructions

II.

Specific Instructions for Each Part of the Form

III.

FDA Internet Resources

I.

General Instructions
•

Form FDA 3666 (available on FDA’s website at https://www.fda.gov/aboutfda/reports-manuals-forms/forms) is intended to help you assemble and
transmit a New Protein Consultation (NPC) 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 3666.

•

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 an NPC to be uploaded and submitted online via Form FDA
3666. You may use the same COSM account for future submissions. We
encourage firms to submit their NPC 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 NPC 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 NPC 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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Contains Nonbinding Recommendations

•

II.

Additional information about New Protein Consultations is available on
FDA’s Internet Site (see Internet Resource #1 in Part 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 an amendment or supplement to
a previously established NPC;
• 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 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.”
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 transmission 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 attached 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
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The date of any correspondence, sent to you by FDA, relevant to an amendment
or supplement you are transmitting;

4. Part IV –Information About the New Protein
In Part IV, you:
• Tell us the name of the new protein;
• Have an option to provide any registry designations for the new protein; and
• Describe the purpose or intended technical effect of the new protein.
5. Part V –Information About Genetic Material
In Part V, you provide information about the introduced genetic material (including
identity and source).
6. Part VI – Scientific Evaluation of the Food Safety of the New Protein
Part VI provides a checklist for those elements of an NPC that do not get
completed directly on Form 3666:
• Whether there is a history of safe use in food or feed;
• Whether you have included an assessment of the amino acid similarity
between the new protein and known allergens and toxins;
• Whether you have included information about the overall stability of the
protein, and the resistance of the protein to enzymatic degradation using
appropriate in vitro assays; and
• Whether you included any other information, you want us to consider in
evaluating your NPC.
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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