[Federal Register Volume 88, Number 66 (Thursday, April 6, 2023)]
[Notices]
[Pages 20525-20526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07187]


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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Children; Draft Guidance for Industry; Reopening of the Comment Period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.

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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comment period for the draft guidance entitled ``Action Levels for Lead 
in Food Intended for Babies and Young Children; Draft Guidance for 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DATES: FDA is reopening the comment period on the draft guidance 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comments on the draft guidance by May 8, 2023, to ensure that we 
consider your comment on the draft guidance before we begin work on the 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:
     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-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 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: 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