Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VI GRAS Notices March 2010
Not for implementation.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Draft — Not for Implementation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]
VI. Information Specific to Generally Recognized as Safe Notice Submissions
Section VI of this document addresses submission of GRAS notices. The GRAS notification procedure is a voluntary procedure in which you inform us of your view that a particular use of a substance is exempt from the premarket approval requirements of the Act based on your determination that such use is GRAS in accordance with 21 CFR 170.30. We assign a file number (GRAS Notice No. (GRN)) to your submission and respond to you by letter.
- General Information about Generally Recognized as Safe Notice Submissions
- Generally Recognized as Safe Notice Submissions in Electronic Format
- Electronic Amendments and Supplements to GRAS Notice Submissions
A. General Information about Generally Recognized as Safe Notice Submissions
- How do the parts on Form FDA 3667 relate to the elements of a GRAS notice?
Table VI-1 shows the elements of a GRAS notice and links each element to the applicable part of Form FDA 3667.
Elements of a GRAS Notice as Shown on Form FDA 3667
Element of a GRAS Notice Applicable Part on Form FDA 3667 Introductory information about the submission I Information about the notifier (and any attorney or agent acting on behalf of the notifier) II General administrative information III Intended use IV Identity V and VI Method of manufacture VI Specifications VI Dietary exposure VI Self-limiting levels of use VI Common use in food before 1958 (if applicable) VI Comprehensive discussion of the basis for the GRAS determination VI Bibliography VI Signature VII N/A VIII (List of Attachments)
- How should I organize a new GRAS notice submission?
You should organize a new GRAS notice as a document presenting the elements of a GRAS notice in an order corresponding to that of the elements listed on Form FDA 3667. A summary of these elements is listed in Table VI-1 of this document and described in the instructions for Form FDA 3667 (see Appendix 5). If you include any data or information not identified on Form FDA 3667, you should place these data or information in a logical place in your submission based on the type of information.
B. Generally Recognized as Safe Notice Submissions in Electronic Format
- How should I organize an electronic GRAS notice submission?
You should organize an electronic GRAS notice submission using the foldering structure available in a downloadable GRAS Notice Submission Roadmap (see instructions in Appendix 5 and the roadmap in Appendix 15). The entire GRAS Notice Submission Roadmap is organized under the folder entitled “Main directory.” The “Main directory” includes three first-level folders, entitled “Administrative,” “GRAS Notice,” 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 VI-1, below.
Outline Representing the Folders and Subfolders in the “Main directory” of a GRAS Notice Submission Roadmap
- ·Main directory
- GRAS Notice
- Incoming Correspondence
- Submission Form
- ·Main directory
- When should I use the specific folders and subfolders in the GRAS Notice Submission Roadmap?
You should use these folders and subfolders as shown in Table VI-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 GRAS Notice Submission Roadmap*
Folder/Subfolder When to Use it Administrative Any time you transmit a new GRAS notice or a redacted electronic file(s) GRASNotice Only when you transmit a new GRAS notice 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 GRAS notice or after we have responded to your GRAS notice IncomingCorrespondence/ Amendment Any time you transmit information while we are reviewing your GRAS notice IncomingCorrespondence/ Supplement Any time you transmit information after we have responded to your GRAS notice
* If you are transmitting an amendment or supplement to your GRAS notice, you should re-name “Main directory”to reflect the file number we assigned to your notice.
- How should I name files in an electronic GRAS notice 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 GRAS notice submissions are included in the examples in Table VI-3 (below).
- What files should I place in each folder and subfolder?
Placement of Files in the GRAS Notice Submission Roadmap
Folder/Subfolder File Name Information in File Administrative Form3667_..._YYYY-MM-DD.pdf Form FDA 3667 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 3667 Administrative DesignationOfConfidential Information_..._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 GRASNotice GRASNotice_..._YYYY-MM-DD.pdf File containing the following information not placed on the form:
- Table of Contents
- Any additional information about identity not covered in Part IV of Form FDA 3667
- Method of manufacture
- Specifications for food-grade material
- Dietary exposure
- Self-limiting levels of use
- Common use in food before 1958 (if applicable)
- Comprehensive discussion of the basis for the determination of GRAS status
- Other Information
GRASNotice [Miscellaneous]_..._YYYY-MM-DD.pdf One or more files containing miscellaneous information you ask FDA to consider in evaluating your GRAS notice (e.g., technical bulletins) IncomingCorrespondence/ Submission Form YYYY-MM-DD- Form3667_..._.pdf Form FDA 3667 with responsive material completed IncomingCorrespondence/ Amendment YYYY-MM-DD_Amendment_....pdf When applicable, file(s) containing the information you submit to us during our review of your GRAS notice. An amendment addressing more than one topic should include a Table of Contents. IncomingCorrespondence/ Supplement YYYY-MM-DD_Supplement_....pdf When applicable, file containing the information you submit to us after we respond to your GRAS notice. A supplement addressing more than one topic should include a Table of Contents.
C. Electronic Amendments and Supplements to GRAS Notice Submissions
- What recommendations apply to amendments and supplements to GRAS notice 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 GRAS notice, you should organize your submission as a single file. If an amendment or supplement addresses more than one topic, the file should 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 GRAS Notice Submission.
 We have issued a proposed rule that would establish this procedure in 21 CFR 170.36 (Federal Register of April 17, 1997; 62 FR 18938). As of the date of this guidance publication we have not yet issued a final rule based on that proposed rule.
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.