[Federal Register Volume 89, Number 66 (Thursday, April 4, 2024)]
[Notices]
[Pages 23599-23600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Supplements; Draft Guidance for Industry; Availability; Agency 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availability of a draft guidance for industry entitled ``New Dietary 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draft guidance, when finalized, will provide recommendations to the 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 The purpose of this draft guidance, when finalized, will 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DATES: Submit either electronic or written comments on the draft 
guidance by June 3, 2024 to ensure that we consider your comment on the 
draft guidance before we begin work on the final version of the 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:
     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-

[[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 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 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 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: 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