[Federal Register Volume 89, Number 57 (Friday, March 22, 2024)]
[Notices]
[Pages 20481-20482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06118]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2343]


Hazard Analysis and Risk-Based Preventive Controls for Human 
Food; Draft Guidance for Industry; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
extending the comment period for two chapters of a multichapter draft 
guidance entitled ``Hazard Analysis and Risk-Based Preventive Controls 
for Human Food: Draft Guidance for Industry,'' which were announced in 
the Federal Register of September 27, 2023. The relevant draft chapters 
are entitled ``Chapter 11--

[[Page 20482]]

Food Allergen Program'' and ``Chapter 16--Acidified Foods.'' We are 
taking this action in response to a request for an extension to allow 
interested persons additional time to submit comments before FDA begins 
work on the final guidance.

DATES: FDA is extending the comment period on our draft guidance 
published September 27, 2023 (88 FR 66457). Submit either electronic or 
written comments by May 24, 2024, to ensure that the Agency considers 
your comment on this draft guidance before it begins work on the final 
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-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive 
Controls for Human Food: 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).

FOR FURTHER INFORMATION CONTACT: Linda Kahl, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2784.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 27, 
2023 (88 FR 66457), we published a notice announcing the availability 
of two chapters of a multichapter draft guidance entitled ``Hazard 
Analysis and Risk-Based Preventive Controls for Human Food.'' These 
draft chapters are entitled ``Chapter 11--Food Allergen Program'' and 
``Chapter 16--Acidified Foods.'' The notice of availability opened a 
docket with a 180-day comment period, to close on March 25, 2024.
    We have received a request to extend the comment period for the two 
draft guidance chapters. The request conveys that additional time would 
be helpful for stakeholders to fully evaluate the chapters and develop 
meaningful comments. We have considered the request and have concluded 
that an extension of the comment period by 60 days, until May 24, 2024, 
is appropriate. We believe that the extension will allow adequate time 
for interested persons to submit comments without significantly 
delaying the final guidance.

    Dated: March 19, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-06118 Filed 3-21-24; 8:45 am]
BILLING CODE 4164-01-P