[Federal Register Volume 89, Number 225 (Thursday, November 21, 2024)]
[Notices]
[Pages 92130-92131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27289]
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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; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments; extension of
comment period.
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SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the notice of public meeting; request for comments,
published in the Federal Register of August 12, 2024. In that notice,
FDA announced a public meeting entitled ``Development of an Enhanced
Systematic Process for the Food and Drug Administration's Post-Market
Assessment of Chemicals in Food.'' FDA hosted the public meeting on
September 25, 2024, and is now extending the comment period to allow
interested persons additional time to submit comments about approaches
to systematic post-market assessment of chemicals in food.
DATES: FDA is extending the comment period announced in the notice of
public meeting; request for comments published August 12, 2024 (89 FR
65633). Either electronic or written comments must be submitted by
January 21, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 21, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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
[[Page 92131]]
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
the Food and Drug Administration's Post-Market Assessment of Chemicals
in Food; Public Meeting; Extension of the Comment Period.'' 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: Keronica Richardson, Office of Policy,
Regulations, and Information, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 12, 2024,
we published a notice announcing a public meeting entitled
``Development of an Enhanced Systematic Process for FDA's Post-Market
Assessment of Chemicals in Food.'' The notice explained that the public
meeting would 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 (89 FR 65633 at 65635). We also provided an
opportunity for public comment during the meeting. The docket for
public comments was scheduled to close on December 6, 2024.
On September 25, 2024, we hosted the public meeting at the FDA
White Oak Campus. A transcript of the meeting is available at https://www.fda.gov/media/182622/download?attachment.
We have received a request for a 60-day extension of the comment
period. In general, the request explained that trade associations
representing various parts of the food supply chain faced significant
challenges to providing comment by December 6, 2024, and noted that the
comment period overlapped with the holiday season and other FDA
initiatives.
We have considered the requests and are extending the comment
period until January 21, 2025. We believe that the extension will allow
adequate time for interested persons to submit comments.
Dated: November 13, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-27289 Filed 11-20-24; 8:45 am]
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