[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]
[[Page 16003]]
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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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