[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Notices]
[Pages 65633-65635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3609]


Development of an Enhanced Systematic Process for the Food and 
Drug Administration's Post-Market Assessment of Chemicals in Food; 
Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
following public meeting entitled ``Development of an Enhanced 
Systematic Process for FDA's Post-Market Assessment of Chemicals in 
Food.'' This public meeting will assist in developing the post-market 
chemicals assessment program we will establish under the new FDA Human 
Foods Program. The purpose of the public meeting is to hear from 
interested parties about approaches to systematic post-market 
assessment of chemicals in food.

[[Page 65634]]


DATES: The public meeting will be held on September 25, 2024, from 
12:30 p.m. to 4:30 p.m. Eastern Time. FDA is establishing a docket for 
public comment on this meeting. The docket number is FDA-2024-N-3609. 
The docket will close on December 6, 2024. Submit electronic or written 
comments on this public meeting by December 6, 2024. See 
``Participating in the Public Meeting'' in the SUPPLEMENTARY 
INFORMATION section of this document for registration and other 
information regarding meeting participation.

ADDRESSES: The public meeting will be held virtually and with limited 
in-person attendance on the FDA White Oak campus. For more information 
on the public meeting, see https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before December 6, 2024. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 6, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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-2024-N-3609 for ``Development of an Enhanced Systematic Process for 
FDA's Post-Market Assessment of Chemicals in Food.'' Received comments, 
those filed in a timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: For general questions about the public 
meeting or for special accommodations due to disability: Jessica 
Rowden, 240-461-0669, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA endeavors to become more efficient, nimble, and prepared for 
the ever-changing and complex industries we regulate. In May 2024, FDA 
announced that we received approval for our reorganization proposal to 
create a unified Human Foods Program. These changes will allow us to 
more effectively realize the vision laid out in the FDA Food Safety 
Modernization Act, elevate the importance of nutrition, strengthen 
local, state, and international partnerships, and position FDA to 
regulate innovative food and agricultural products more effectively as 
we oversee the safety of the nation's food supply. One important goal 
of this reorganization is to have a modernized FDA that optimizes 
resources to help us meet our public health mission. FDA is planning to 
implement the reorganization on October 1, 2024.
    As part of this reorganization, we are developing a systematic 
process for conducting post-market assessments of chemicals in food. 
Such an assessment includes ingredients considered generally recognized 
as safe, food additives, color additives, food contact substances, and 
contaminants. We are holding a public meeting to discuss this 
systematic process with interested parties to hear ideas and 
perspectives to inform our thinking and help us further develop a 
systematic process. The systematic process is intended to guide our 
post-market assessment work in the new Human Foods Program and will 
include a transparent process to help ensure post-market assessments 
are conducted consistently across chemicals and are prioritized based 
on the greatest public health needs, support confidence in the food 
supply, and ensure that our food safety efforts continue to reflect the 
most current and best available science.

[[Page 65635]]

II. Topics for Discussion at the Public Meeting

    The public meeting will address a variety of topics related to 
development of an enhanced systematic process for FDA's post-market 
assessment of chemicals in food, including:
     Principles for the post-market assessment process,
     Steps in the post-market assessment process,
     Prioritizing chemicals for post-market assessment, and
     Engaging stakeholders throughout the post-market 
assessment process.

III. Participating in the Public Meeting

    Registration: This public meeting is a hybrid meeting offering both 
online and in-person attendance. Registration is free and open for 
virtual attendance. In-person attendance is free, but seating is 
limited. Please note that in-person registration will be accepted in 
the order of registration. We encourage organizations to consider 
attendance numbers to help accommodate as many groups as possible for 
in-person attendance. To register to attend the public meeting on the 
``Development of an Enhanced Systematic Process for FDA's Post-Market 
Assessment of Chemicals in Food,'' please register at https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food for in-person attendance by 
September 20, 2024, and for webcast attendance by September 24, 2024, 
at 11:59 p.m. Eastern Time. Registrants will receive confirmation when 
they have been accepted and will be provided the webcast link for those 
who plan to attend virtually.
    Request to Provide Open Public Comment: During online registration, 
you may indicate if you wish to make open public comments during the 
public meeting and which topic(s) you would like to address. All 
requests to make public comments must be received by September 3, 2024, 
at 11:59 p.m. Eastern Time. We will do our best to accommodate requests 
to make public comments. We are seeking to have a broad representation 
of ideas and issues presented at the meeting. Individuals and 
organizations with common interests are urged to consolidate or 
coordinate their comments. We will determine the amount of time for 
each public comment and will notify all registrants who requested an 
opportunity to make an open public comment.
    Streaming Webcast of the Public Meeting: This public meeting will 
be broadcast via Zoom.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
meeting website page at https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food.
    For more meeting specifics, please see https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-development-enhanced-systematic-process-fdas-post-market-assessment-chemicals-food. FDA will post an agenda and other meeting 
materials on this web page in advance of the meeting.

    Dated: August 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17791 Filed 8-9-24; 8:45 am]
BILLING CODE 4164-01-P