[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26561-26562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09176]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0451]


Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient 
Statements; Draft Guidance for Industry; Availability; Agency 
Information Collection Activities; Proposed Collection; Comment 
Request; 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comment period for the draft guidance entitled ``Labeling of Plant-
Based Milk Alternatives and Voluntary Nutrient Statements; Guidance for 
Industry,'' which was announced in the Federal Register of February 23, 
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DATES: FDA is reopening the comment period on the draft guidance 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 February 23, 2023 (88 FR 11449). Submit either electronic or 
written comments on the draft guidance by July 31, 2023, to ensure that 
we consider your comment on the draft guidance before we begin work on 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-2023-D-0451 for ``Labeling of Plant-Based Milk Alternatives and 
Voluntary Nutrient Statements; Draft Guidance for Industry; 
Availability; Agency Information Collection Activities; Proposed 
Collection; Comment Request.'' 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

[[Page 26562]]

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: Jeanmaire Hryshko, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2371; 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 February 23, 2023 
(88 FR 11449), we published a notice of availability for a draft 
guidance entitled ``Labeling of Plant-Based Milk Alternatives and 
Voluntary Nutrient Statements; Draft Guidance for Industry; 
Availability; Agency Information Collection Activities; Proposed 
Collection; Comment Request.'' This action opened a docket with a 60-
day comment period.
    We have received requests for a 90-day extension of the comment 
period for the draft guidance. We have concluded that it is reasonable 
to reopen the comment period for 90 days, until July 31, 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 90 days allows adequate time for 
interested persons to submit comments.

    Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09176 Filed 4-28-23; 8:45 am]
BILLING CODE 4164-01-P


