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;[...]

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

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.

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 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.

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.

[FR Doc. 2024-27289 Filed 11-20-24; 8:45 am]

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