Notice2024-08952
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Without Physical Examination and Removal of a Foreign Manufacturer's Goods From Detention Without Physical Examination; Draft Guidance for Industry; Reopening of the Comment Period
Primary source
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Published
April 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration is reopening the comment period for the draft guidance for industry entitled "Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products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Without Physical Examination and Removal of a Foreign Manufacturer's Goods From Detention Without Physical Examination; Draft Guidance for Industry; Availability" that published in the Federal Register of February 12, 2024.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.
Full Text
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<title>Federal Register, Volume 89 Issue 82 (Friday, April 26, 2024)</title>
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[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32441-32442]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Examination; Draft Guidance for Industry; Reopening of the Comment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period for the draft guidance for industry entitled ``Recommendations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:
<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,
[[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 <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-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 <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.
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: <a href="/cdn-cgi/l/email-protection#c497b0a1b2a1aaea86a8ababa0a3ababa084a2a0a5eaacacb7eaa3abb2"><span class="__cf_email__" data-cfemail="9ecdeafbe8fbf0b0dcf2f1f1faf9f1f1fadef8faffb0f6f6edb0f9f1e8">[email protected]</span></a>; 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
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