Ortho-phthalates for Food Contact Use; Reopening of Comment Period; Request for Information
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Abstract
The Food and Drug Administration (FDA or we) is reopening the comment period for the notice titled "Ortho-phthalates for Food Contact Use; Request for Information," which published in the Federal Register of May 20, 2022. We are taking this action in response to a request from stakeholders to extend the comment period to allow additional time for interested parties to develop and submit data, other information, and comments for this request for information.
Full Text
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<title>Federal Register, Volume 87 Issue 186 (Tuesday, September 27, 2022)</title>
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[Federal Register Volume 87, Number 186 (Tuesday, September 27, 2022)]
[Notices]
[Pages 58502-58503]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20832]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0571]
Ortho-phthalates for Food Contact Use; Reopening of Comment
Period; Request for Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of comment period; request for information.
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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the
comment period for the notice titled ``Ortho-phthalates for Food
Contact Use; Request for Information,'' which published in the Federal
Register of May 20, 2022. We are taking this action in response to a
request from stakeholders to extend the comment period to allow
additional time for interested parties to develop and submit data,
other information, and comments for this request for information.
DATES: FDA is reopening the comment period on the notice ``Ortho-
phthalates for Food Contact Use; Request for Information,'' which
published in the Federal Register on May 20, 2022 (87 FR 31090). Submit
either electronic or written comments by December 27, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 27, 2022. 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:
<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
[[Page 58503]]
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-2022-N-0571 for ``Ortho-phthalates for Food Contact Use; Reopening
of the Comment Period; Request for Information.'' 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 <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.
FOR FURTHER INFORMATION CONTACT: Jessica Urbelis, Center for Food
Safety and Applied Nutrition (HFS-275), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 240-402-5187; or Meadow Platt,
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: In the Federal Register of May 20, 2022 (87
FR 31090), FDA published a notice with a 60-day comment period to
request data and information on the current food contact uses, use
levels, dietary exposure, and safety data on any ortho-phthalates
currently used in food contact applications. We originally gave
interested persons until July 19, 2022, to provide data and
information.
Following publication of the notice, FDA received a request to
allow interested parties additional time to comment. The request
asserted that 60 days was insufficient to respond fully to FDA's
specific requests for comments and to allow potential respondents to
thoroughly evaluate and address pertinent issues and requested that FDA
extend the comment period by an additional 6 months. We have considered
this request and, because the request came too late for us to extend
the comment period before it expired, we are reopening the comment
period for 90 days. FDA believes that this additional 90 days will
allow time for interested parties to submit data and other information
to support our review of the current use levels and safe use of certain
ortho-phthalates in food contact applications.
Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20832 Filed 9-26-22; 8:45 am]
BILLING CODE 4164-01-P
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