Notice2024-06118
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Extension of Comment Period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
March 22, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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and Drug Administration (FDA, we, or the Agency) is extending the comment period for two chapters of a multichapter draft guidance entitled "Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry," which were announced in the Federal Register of September 27, 2023.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-- 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.
Full Text
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<title>Federal Register, Volume 89 Issue 57 (Friday, March 22, 2024)</title>
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[Federal Register Volume 89, Number 57 (Friday, March 22, 2024)]
[Notices]
[Pages 20481-20482]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Food; Draft Guidance for Industry; Extension of Comment Period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extending the comment period for two chapters of a multichapter draft
guidance entitled ``Hazard Analysis and Risk-Based Preventive Controls
for Human Food: Draft Guidance for Industry,'' which were announced in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:
<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-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 <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.
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
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