[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Pages 16003-16004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04718]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-5280]


Dietary Supplements: New Dietary Ingredient Notification 
Procedures and Timeframes: Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a final guidance for industry entitled ``Dietary 
Supplements: New Dietary Ingredient Notification Procedures and 
Timeframes: Guidance for Industry.'' The guidance focuses on frequently 
asked questions about the new dietary ingredient notification 
submission and review process. The guidance is intended to help 
manufacturers and distributors of new dietary ingredients and dietary 
supplements prepare and submit new dietary ingredient notifications to 
FDA.

DATES: The announcement of the guidance is published in the Federal 
Register on March 6, 2024

ADDRESSES: You may submit either electronic or written comments on FDA 
guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-D-5280 for ``Dietary Supplements: New Dietary Ingredient 
Notification Procedures and Timeframes: Guidance for Industry.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Dietary Supplement Programs, HFS-810, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Gerie Voss, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740; or Deirdre Jurand, Office of Regulations and 
Policy (HFS-024), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Dietary Supplements: New Dietary Ingredient Notification 
Procedures and Timeframes: Guidance for Industry.'' We are issuing this 
guidance consistent with our good guidance practices regulation (21 CFR 
10.115). The guidance represents our current thinking on this topic. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    In the Federal Register of July 5, 2011 (76 FR 39111), we announced 
the availability of a draft guidance for industry entitled ``Draft 
Guidance for Industry; Dietary Supplements: New Dietary Ingredient 
Notifications and Related Issues'' and gave interested parties an 
opportunity to submit comments by October 3, 2011. Among other topics, 
the July 2011 draft guidance discussed FDA's views and recommendations 
on when an ingredient intended for use in a dietary supplement is a new 
dietary ingredient (NDI), when the requirement to submit a new dietary 
ingredient notification (NDIN) to FDA applies, the types of data and 
information that manufacturers and distributors should consider when 
they

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evaluate the safety of a dietary supplement containing an NDI, what to 
include in an NDIN (including recommendations about identity and safety 
information), and the procedures for submitting an NDIN. We received 
significant comments and decided to issue a revised draft guidance.
    In the Federal Register of August 12, 2016 (81 FR 53486), we 
announced the availability of a revised draft guidance for industry 
entitled ``Dietary Supplements: New Dietary Ingredient Notifications 
and Related Issues; Revised Draft Guidance for Industry'' to replace 
the July 2011 draft guidance. In the notice of availability, we gave 
interested parties an opportunity to submit comments on the 2016 
revised draft guidance by October 11, 2016. On October 4, 2016, we 
extended the comment period for the revised draft guidance to December 
12, 2016 (81 FR 68434). We received numerous comments on the 2016 
revised draft guidance, including requests for FDA to separate the 2016 
revised draft guidance into discrete sections for ease of use. The 
final guidance whose availability we are announcing through this 
document reflects that approach. The guidance finalizes Section V of 
the 2016 revised draft guidance, ``NDI Notification Procedures and 
Timeframes,'' as well as several related questions from other sections. 
Changes since the revised draft guidance include providing the 
following: additional clarity on the procedures for preparing and 
submitting an NDIN; technical updates related to recent changes to our 
online submission portal for NDINs; and more information about 
communications with FDA during the NDIN review process. In addition, we 
made editorial changes to improve clarity. We understand the importance 
of finalizing other parts of the 2016 revised draft guidance, and we 
plan to finalize other individual sections as we complete our review 
and analysis of those sections.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The 
collections of information in 21 CFR 190.6 and found in the guidance 
have been approved under OMB control number 0910-0330.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: February 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04718 Filed 3-5-24; 8:45 am]
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