[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32441-32442]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-5303]


Recommendations for Collecting Representative Samples for Food 
Testing Used as Evidence for Release of Certain Fish and Fishery 
Products Subject to Detention Without Physical Examination and Removal 
of a Foreign Manufacturer's Goods From Detention Without Physical 
Examination; Draft Guidance for Industry; Reopening of the Comment 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 is reopening the comment 
period for the draft guidance for industry entitled ``Recommendations 
for Collecting Representative Samples for Food Testing Used as Evidence 
for Release of Certain Fish and Fishery Products Subject to Detention 
Without Physical Examination and Removal of a Foreign Manufacturer's 
Goods From Detention Without Physical Examination; Draft Guidance for 
Industry; Availability'' that published in the Federal Register of 
February 12, 2024. We are taking this action in response to a request 
to extend the comment period to allow additional time for interested 
parties to submit comments.

DATES: FDA is reopening the comment period for the draft guidance for 
industry announced in the Federal Register on February 12, 2024 (89 FR 
9852). Submit either electronic or written comments on the draft 
guidance by June 25, 2024, to ensure that we consider your comments 
before we begin 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,

[[Page 32442]]

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-5303 for ``Recommendations for Collecting Representative 
Samples for Food Testing Used as Evidence for Release of Certain Fish 
and Fishery Products Subject to Detention Without Physical Examination 
and Removal of a Foreign Manufacturer's Goods From Detention Without 
Physical Examination; 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.

FOR FURTHER INFORMATION CONTACT: Steven Bloodgood, Division of Seafood 
Safety (HFS-325), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-5316, email: [email protected]; or Holli Kubicki, 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 12, 2024 
(89 FR 9852), the Food and Drug Administration (FDA or we) published a 
notice announcing the availability of a draft guidance for industry 
entitled ``Recommendations for Collecting Representative Samples for 
Food Testing Used as Evidence for Release of Certain Fish and Fishery 
Products Subject to Detention Without Physical Examination and Removal 
of a Foreign Manufacturer's Goods From Detention Without Physical 
Examination; Draft Guidance for Industry.'' We provided a 60-day 
comment period for the draft guidance.
    We have received a request for a 60-day extension of the comment 
period for the draft guidance to provide additional time to review and 
comment on the rationale for the sampling recommendations in the draft 
guidance. In the interest of balancing the public health importance of 
the sampling recommendations in the draft guidance and granting 
additional time to submit comments before we finalize the draft 
guidance, we have concluded that it is reasonable to reopen the comment 
period for 60 days, until June 25, 2024. 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 60 days allows adequate time for interested persons to 
submit comments.

    Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08952 Filed 4-25-24; 8:45 am]
BILLING CODE 4164-01-P