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GUIDANCE DOCUMENT

Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VII Biotechnology Final Consultations March 2010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Not for implementation.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Draft — Not for Implementation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)


VII. Information Specific to Biotechnology Final Consultation Submissions

Section VII of this document addresses Biotechnology Final Consultation submissions.  A Biotechnology Final Consultation is a voluntary procedure for foods derived from new plant varieties.  Information about that consultation procedure is available in our guidance entitled “Guidance on Consultation Procedures. Foods Derived From New Plant Varieties” (the consultation procedures) (Ref. 20).  We assign a file number (Biotechnology Notification File No. (BNF)) to your submission and respond to you by letter.

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

A. General Information about Biotechnology Final Consultation Submissions

  1. How do the parts on Form FDA 3665 relate to the elements of a Biotechnology Final Consultation?

    Table VII-1 shows the elements of a Biotechnology Final Consultation and links each element to the applicable part of Form FDA 3665. 

    Table VII-1
    Elements of a Biotechnology Final Consultation as Shown on Form FDA 3665
    Element of a Biotechnology Final Consultation Applicable Part on Form FDA 3665
    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 food and the new plant variety from which it is derived IV
    Identity of new substances in the new plant variety V
    Summary of safety and nutritional assessment VI
    Signature VII
    N/A VIII (List of Attachments)
  2. How should I organize a Biotechnology Final Consultation?

    You should organize a new Biotechnology Final Consultation as a document presenting the elements of a Biotechnology Final Consultation in an order corresponding to that of the elements listed on Form FDA 3665.  These elements are also listed in Table VII-1 of this document and described in the instructions for Form FDA 3665 (see Appendix 7).  If you include any data or information not identified as an element on Form FDA 3665, you should place these data or information in a logical place in your submission based on the type of information.

B. Biotechnology Final Consultation Submissions in Electronic Format

  1. How should I organize an electronic Biotechnology Final Consultation submission?

    You should organize an electronic Biotechnology Final Consultation submission using the foldering structure available in the downloadable Biotechnology Final Consultation Submission Roadmap (see instructions in Appendix 7 and the roadmap in Appendix 15).  The entire Biotechnology Final Consultation Submission Roadmap is organized under the folder entitled “Main directory” in the Biotechnology Final Consultation Submission Roadmap.  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 VII-1, below.

    Figure VII-1

    Outline Representing the Folders and Subfolders in the “Main directory” of a Biotechnology Final 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 Biotechnology Final Consultation Submission Roadmap?

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

    Table VII-2
    When to Use Specific Folders and Subfolders in the “Main Directory” of a Biotechnology Final Consultation Submission Roadmap*
    Folder/Subfolder When to Use it
    Administrative Any time you transmit a new Biotechnology Final Consultation or a redacted copy(s)
    Submission Only when you transmit a new Biotechnology Final 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 Biotechnology Final Consultation or after we have responded to your Biotechnology Final Consultation
    Incoming Correspondence/ Amendment Any time you transmit information while we are reviewing your Biotechnology Final Consultation
    Incoming Correspondence/ Supplement Any time you transmit information after we have responded to your Biotechnology Final Consultation

    *If you are transmitting an amendment or supplement to your Biotechnology Final 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 Biotechnology Final 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 Biotechnology Final Consultation submissions are included in Table VII-3 (below). 

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

    Table VII-3 shows the files you should place in each folder and subfolder.

    Table VII-3
    Placement of Files in the Biotechnology Final Consultation Submission Roadmap
    Folder/Subfolder File Name Information in File
    Administrative Form3665_..._YYYY-MM-DD.pdf Form FDA 3665 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 3665
    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 the following information not placed on the form Table of Contents Summary of Safety and Nutritional Assessment   Other Information – e.g., Reference to a relevant earlier submission
    Incoming Correspondence/ SubmissionForm YYYY-MM-DD_ Form3665_..._.pdf Form FDA 3665 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 Biotechnology Final 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 Biotechnology Final Consultation. A supplement addressing more than one topic may include a Table of Contents.

C. Electronic Amendments and Supplements to Biotechnology Final Consultation Submissions

  1. What recommendations apply to amendments and supplements to Biotechnology Final 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 Biotechnology Final 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 Biotechnology Final 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.