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GUIDANCE DOCUMENT

Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VIII New Protein Consultations March 2010

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Office of Food Additive Safety

Contains Nonbinding Recommendations

Draft — Not for Implementation

March 2010

Table of Contents and Introduction (Part I)


VIII. Information Specific to New Protein Consultation Submissions

Section VIII of this document addresses New Protein Consultation submissions.  You voluntarily submit a New Protein Consultation as described in our guidance entitled “Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use” (the New Protein Consultation guidance) (Ref.22).  We assign a file number (the NPC number) to your submission and respond to you by letter. 

  1. General Information about New Protein Consultation Submissions
  2. New Protein Consultation Submissions in Electronic Format
  3. Electronic Amendments and Supplements to New Protein Consultation Submissions

A. General Information about New Protein Consultation Submissions

  1. How do the parts on Form FDA 3666 relate to the elements of a New Protein Consultation?

    Table VIII-1 shows the elements of a New Protein Consultation and links each element to the applicable part of Form FDA 3666. 

    Table VIII-1
    Elements of a New Protein Consultation as Shown on Form FDA 3666
    Element of a New Protein Consultation Applicable Part on Form FDA 3666
    Introductory information about the submission I
    Information about the person responsible for the submission (and any attorney or agent acting on behalf of that person) II
    General administrative information III
    Information about the new protein IV
    Information about genetic material V
    Scientific evaluation of the food safety of the new protein VI
    Other pertinent information VI
    Signature VII
    N/A VIII (List of Attachments)
  2. How should I organize a New Protein Consultation?

    You should organize a New Protein Consultation as a document presenting the elements of a New Protein Consultation in an order corresponding to that of the elements listed on Form FDA 3666.  These items are also listed in Table VII-1 of this document and described in the instructions for Form FDA 3666 (see Appendix 9).  If you include any data or information not identified as an element on Form FDA 3666, you should place these data or information in a logical place in your submission based on the type of information.

B. New Protein Consultation Submissions in Electronic Format

  1. How should I organize an electronic New Protein Consultation submission?

    You should organize an electronic New Protein Consultation submission using the foldering structure available in a downloadable New Protein Consultation Submission Roadmap (see instructions in Appendix 9 and the roadmap in Appendix 15).  The entire New Protein Consultation Submission Roadmap is organized under the folder entitled “Main directory.”  The “Main directory” contains three first-level folders, entitled “Administrative,” “Submission,” and “Incoming Correspondence.”  The “Incoming Correspondence” folder includes three second-level subfolders entitled “Submission Form,” “Amendment” and “Supplement.”   We show these folders and subfolders, using an outline format, in Figure VIII-1, below.

    Figure VIII-1

    Outline Representing the Folders and Subfolders in the “Main directory” of a New Protein Consultation Submission Roadmap

    • Main directory
      • Administrative
      • Submission
      • Incoming Correspondence
        • Submission Form
        • Amendment
        • Supplement
  2. When should I use the specific folders and subfolders in the New Protein Consultation Submission Roadmap?

    You should use these folders and subfolders as shown in Table VIII-2.You should not place any specific files directly in “Main directory.” “Main directory” only contains folders. 

    Table VIII-2

    When to Use Specific Folders and Subfolders
    in the “Main Directory” of a New Protein Consultation Submission Roadmap*
    Folder/Subfolder When to Use it
    Administrative Any time you transmit a (new) New Protein Consultation or a redacted copy(s)
    Submission Only when you transmit a (new) New Protein Consultation
    IncomingCorrespondence You should not place any specific files directly in the Incoming Correspondence folder. The Incoming Correspondence folder only contains subfolders.
    Incoming Correspondence/Submission Form Any time you transmit information while we are reviewing your New Protein Consultation or after we have responded to your New Protein Consultation
    IncomingCorrespondence/ Amendment Any time you transmit information while we are reviewing your New Protein Consultation
    IncomingCorrespondence/ Supplement Any time you transmit information after we have responded to your New Protein Consultation

    *If you are transmitting an amendment or supplement to your New Protein Consultation, you should re-name the Main directory to reflect the file number we assigned to your submission.

  3. How should I name files in an electronic New Protein Consultation submission?

    You should name each file using both generic and specific elements as described in Section III.C and Appendix 12 of this document.  Generic elements in the file names specific to New Protein Consultation submissions are included in the examples in Table VIII-3 (below). 

  4. What files should I place in each folder of the “Main directory?”

    Table VIII-3 shows the files you should place in each folder and subfolder of the “Main directory.” 

    Table VIII-3

    Placement of Files in the New Protein Consultation Submission Roadmap
    Folder/Subfolder File Name Information in File
    Administrative Form3666_..._YYYY-MM-DD.pdf Form FDA 3666 with responsive material completed
    Administrative CoverLetter_..._YYYY-MM-DD.pdf Letter accompanying the submission if you choose to send a letter in addition to Form FDA 3666
    Administrative DesignationOfConfidentialInformation _..._YYYY-MM-DD.pdf A description of the data or information in your submission that you designated as nondisclosable information (21CFR 20 Subpart D).
    Administrative RedactedBySubmitter_..._YYYY-MM-DD.pdf Copy(ies) of one or more files in your submission modified by deletion of data or information you designated as nondisclosable information.
    Submission Submission_..._YYYY-MM-DD.pdf File containing
    • Table of Contents
    • Scientific evaluation of the food safety of the new protein
    • Other pertinent information
    Incoming Correspondence/ SubmissionForm YYYY-MM-DD_Form3666_..._.pdf Form FDA 3666 with responsive material completed
    Incoming Correspondence/ Amendment YYYY-MM-DD_Amendment_....pdf   When applicable, file containing the information you submit to us during our review of your New Protein Consultation. An amendment addressing more than one topic may include a Table of Contents.
    Incoming Correspondence/ Supplement YYYY-MM-DD_Supplement_....pdf   When applicable, file containing the information you submit to us after we respond to your New Protein Consultation. A supplement addressing more than one topic may include a Table of Contents.

C. Electronic Amendments and Supplements to New Protein Consultation Submissions

  1. What recommendations apply to amendments and supplements to New Protein Consultation submissions?

    You should refer to Section III.F of this document for general recommendations applying to amendments and supplements in electronic format. 

    When transmitting any amendment or supplement to a New Protein Consultation, you should organize your submission as a single file.  If an amendment or supplement addresses more than one topic, the file may include a Table of Contents with bookmarks to aid in navigating through the submission.  You then should place this file in the Incoming Correspondence/Amendment or Incoming Correspondence/Supplement subfolder in the New Protein Consultation Submission Roadmap.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.