Notice2024-07095
New Dietary Ingredient Notification Master Files for Dietary Supplements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Comment Request
Primary source
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Published
April 4, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "New Dietary Ingredient Notification Master Files for Dietary Supplements." The draft guidance, when finalized, will provide recommendations to the dietary supplement industry on Master Files for new dietary ingredients. The purpose of this draft guidance, when finalized, will be to help industry comply more easily with the new dietary ingredient notification requirement by providing recommendations on the submission and use of Master Files that contain identity, manufacturing, or safety data that can be used to support a new dietary ingredient notification. New dietary ingredient Master Files are submitted solely at the discretion of the Master File owner and are not required by statute or regulation.
Full Text
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<title>Federal Register, Volume 89 Issue 66 (Thursday, April 4, 2024)</title>
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[Federal Register Volume 89, Number 66 (Thursday, April 4, 2024)]
[Notices]
[Pages 23599-23600]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07095]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-0706]
New Dietary Ingredient Notification Master Files for Dietary
Supplements; Draft Guidance for Industry; Availability; Agency
Information Collection Activities; Comment Request
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availability of a draft guidance for industry entitled ``New Dietary
Ingredient Notification Master Files for Dietary Supplements.'' The
draft guidance, when finalized, will provide recommendations to the
dietary supplement industry on Master Files for new dietary
ingredients. The purpose of this draft guidance, when finalized, will
be to help industry comply more easily with the new dietary ingredient
notification requirement by providing recommendations on the submission
and use of Master Files that contain identity, manufacturing, or safety
data that can be used to support a new dietary ingredient notification.
New dietary ingredient Master Files are submitted solely at the
discretion of the Master File owner and are not required by statute or
regulation.
DATES: Submit either electronic or written comments on the draft
guidance by June 3, 2024 to ensure that we consider your comment on the
draft guidance before we begin work on the final version of the
guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-
[[Page 23600]]
2024-D-0706 for ``New Dietary Ingredient Notification Master Files for
Dietary Supplements.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 draft guidance to
the Office of Dietary Supplement Programs, 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 draft guidance.
FOR FURTHER INFORMATION CONTACT: Lisa Bieniek, 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, 240-402-2371; or Lauren Kleinman, 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
FDA is announcing the availability of a draft guidance for industry
titled, ``New Dietary Ingredient Notification Master Files for Dietary
Supplements.'' We are issuing the draft guidance consistent with our
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA 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 alternate approach if it
satisfies the requirements of the applicable statutes and regulations.
The draft guidance, when finalized, will provide recommendations to
industry on Master Files for new dietary ingredient notifications
(NDINs). For purposes of the guidance, a new dietary ingredient
notification Master File (NDIN Master File or Master File) is a file
containing identity, manufacturing, and/or safety information relating
to a new dietary ingredient (NDI) that the Master File owner submits to
FDA for use in evaluating a potential future NDIN by the Master File
owner or by another person designated by the Master File owner (e.g.,
business partner, supplement manufacturer). An NDIN Master File
contains information about an NDI, a dietary supplement containing an
NDI, or both. The Master File owner may refer to the Master File in an
NDIN or may grant written authorization to other parties to incorporate
information from the Master File by reference in NDINs. A written
authorization granting a right of reference to a Master File in an NDIN
does not include the right to see or copy the Master File.
The recommendations in this draft guidance expand upon and replace
the recommendations related to Master Files in FDA's revised draft
guidance, ``Dietary Supplements: New Dietary Ingredient Notifications
and Related Issues,'' dated August 2016. The purpose of this draft
guidance, when finalized, will be to help industry comply more easily
with the NDIN requirement in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by providing recommendations for the submission and use of
NDIN Master Files (see section 413(a)(2) of the FD&C Act (21 U.S.C.
350b(a)(2))). The draft guidance contains information on establishing
an NDIN Master File, updating or closing an NDIN Master File, the use
of data from an NDIN Master File by the Master File owner and other
parties authorized by the Master File owner, and FDA's role in
reviewing and administering NDIN Master Files. Master Files benefit
NDIN submitters with a right of reference by allowing them to refer to
data already on file with FDA, instead of having to develop the data
themselves and resubmit it in each NDIN for the same ingredient.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collection of information
in 21 CFR 190.6 has been approved under OMB control number 0910-0330,
and the collections of information in 21 CFR part 111 have been
approved under OMB control number 0910-0606.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> or <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Use the FDA website
listed in the previous sentence to find the most current version of the
guidance.
Dated: March 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07095 Filed 4-3-24; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on April 4, 2024.
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