Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VIII New Protein Consultations March 2010
Not for implementation. Contains non-binding recommendations.
Contains Nonbinding Recommendations
Draft — Not for Implementation
Table of Contents and Introduction (Part I)
Information for all regulatory submissions
- Part I: Introduction
- Part II: Common Elements
- Part III: General Considerations - Electronic Format
- Part IX: FDA References
- Part X: Appendices
- Quick Links to Forms, Instructions and Downloadable Folders
Regulatory submissions for program areas
- Part IV: Food or Color Additive Submissions
- Part V: Food Contact Substance Submissions
- Part VI: GRAS Notices
- Part VII: Biotechnology Final Consultations
- Part VIII: New Protein Consultations
All parts [Printable PDF Version]
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.
- General Information about New Protein Consultation Submissions
- New Protein Consultation Submissions in Electronic Format
- Electronic Amendments and Supplements to New Protein Consultation Submissions
A. General Information about New Protein Consultation Submissions
- 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.
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)
- 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
- 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.
Outline Representing the Folders and Subfolders in the “Main directory” of a New Protein Consultation Submission Roadmap
- Main directory
- Incoming Correspondence
- Submission Form
- Main directory
- 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.
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.
- 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).
- 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.”
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
- 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 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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.