Proposed Rule2024-11987
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Appendix 1; Extension of Comment Period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
May 31, 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 a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled "Hazard Analysis and Risk-Based Preventive Controls for Human Food" which were announced in the Federal Register of February 2, 2024. 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
<html>
<head>
<title>Federal Register, Volume 89 Issue 106 (Friday, May 31, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 106 (Friday, May 31, 2024)]
[Proposed Rules]
[Pages 47108-47109]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-11987]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 89, No. 106 / Friday, May 31, 2024 / Proposed
Rules
[[Page 47108]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 117
[Docket No. FDA-2016-D-2343]
Hazard Analysis and Risk-Based Preventive Controls for Human
Food; Draft Guidance for Industry; Appendix 1; Extension of Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
extending the comment period for a revised draft Introduction, and a
revised draft Appendix 1, within a multichapter guidance for industry
entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human
Food'' which were announced in the Federal Register of February 2,
2024. 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 February 2, 2024 (89 FR 7315). Submit either electronic or
written comments by August 2, 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; Appendix 1.''
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 February 2, 2024
(89 FR 7315), we published a notice announcing the availability of a
revised draft Introduction, and a revised draft Appendix 1, within a
multichapter guidance entitled ``Hazard Analysis and Risk-Based
Preventive Controls for Human Food.'' The notice of availability opened
a docket with a 120-day comment period, to close on June 3, 2024.
We have received a request to extend the comment period for the
revised draft Introduction, and revised draft Appendix 1. The request
conveys that additional time would be helpful for stakeholders to fully
evaluate and develop meaningful comments to the Introduction and
Appendix which are
[[Page 47109]]
highly complex and detailed. We have considered the request and have
concluded that an extension of the comment period by 60 days, until
August 2, 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: May 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11987 Filed 5-30-24; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on May 31, 2024.
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.