Notice2023-07187
Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry; Reopening of the Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 6, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance entitled "Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry," which was announced in the Federal Register of January 25, 2023. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 66 (Thursday, April 6, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 66 (Thursday, April 6, 2023)]
[Notices]
[Pages 20525-20526]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-07187]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0278]
Action Levels for Lead in Food Intended for Babies and Young
Children; Draft Guidance for Industry; Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; reopening of the comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is reopening the
comment period for the draft guidance entitled ``Action Levels for Lead
in Food Intended for Babies and Young Children; Draft Guidance for
Industry,'' which was announced in the Federal Register of January 25,
2023. We are taking this action in response to requests for an
extension to allow interested persons additional time to submit
comments.
DATES: FDA is reopening the comment period on the draft guidance
published
[[Page 20526]]
January 25, 2023 (88 FR 4797). Submit either electronic or written
comments on the draft guidance by May 8, 2023, to ensure that we
consider your comment on the draft guidance before we begin work on the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:
<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 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-D-0278 for ``Action Levels for Lead in Food Intended for
Babies and Young Children; Draft Guidance for Industry.'' Received
comments 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: Eileen Abt, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-1700; or Philip Chao, Center for Food
Safety and Applied Nutrition, Office of Regulations and Policy (HFS-
024), Food and Drug Administration, 5001 Campus Dr., College Park, MD
20740, 240-402-2378.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 25, 2023
(88 FR 4797), we published a notice of availability for a draft
guidance entitled ``Action Levels for Lead in Food Intended for Babies
and Young Children; Draft Guidance for Industry.'' This action opened a
docket with a 60-day comment period to receive comments related to
action levels for lead in processed food intended for babies and young
children.
We have received a request for a 60-day extension of the comment
period for the draft guidance to provide additional time to provide
analytical data. In the interest of balancing the public health
importance of establishing action levels for lead in food labeled for
babies and young and granting additional time to submit comments before
we finalize the draft guidance, we have concluded that it is reasonable
to reopen the comment period for 30 days, until May 8, 2023. We are
reopening the comment period because the request for an extension of
the comment period arrived too late for us to extend the comment
period. We believe that an additional 30 days allows adequate time for
interested persons to submit comments.
Dated: April 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07187 Filed 4-5-23; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on April 6, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.