[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 [www.gpo.gov]
[FR Doc No: 2024-11987]


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 Proposed Rules
                                                 Federal Register
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 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.
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  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Food; Draft Guidance for Industry; Appendix 1; Extension of Comment 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DATES: FDA is extending the comment period on our draft guidance 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your comment on this draft guidance before it begins work on the final 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:
     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; Appendix 1.'' 
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 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