Notice2025-06049
Growing, Harvesting, Processing, and Distribution of Poppy Seeds-Industry Practices Related to Opiate Alkaloids; Request for Information; 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
April 9, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is extending the comment period for a request for information on industry practices related to poppy seeds, such as information about growing, harvesting, processing, and distribution of poppy seeds, including industry practices to reduce the opiate alkaloid content of poppy seeds. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. We intend to use the information to help determine what type(s) of actions, if any, we should take to help ensure that poppy seed products do not pose a health risk when consumed.
Full Text
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<title>Federal Register, Volume 90 Issue 67 (Wednesday, April 9, 2025)</title>
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[Federal Register Volume 90, Number 67 (Wednesday, April 9, 2025)]
[Notices]
[Pages 15243-15244]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06049]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0168]
Growing, Harvesting, Processing, and Distribution of Poppy
Seeds--Industry Practices Related to Opiate Alkaloids; Request for
Information; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for a request for information on industry practices
related to poppy seeds, such as information about growing, harvesting,
processing, and distribution of poppy seeds, including industry
practices to
[[Page 15244]]
reduce the opiate alkaloid content of poppy seeds. We are taking this
action in response to requests for an extension to allow interested
persons additional time to submit comments. We intend to use the
information to help determine what type(s) of actions, if any, we
should take to help ensure that poppy seed products do not pose a
health risk when consumed.
DATES: FDA is extending the comment period on the notice published
January 15, 2025 (90 FR 3873). Either electronic or written comments on
the notice must be submitted by June 16, 2025.
ADDRESSES: You may submit comments and information as follows. Please
note that late, untimely filed comments will not be considered. The
<a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of June 9, 2025.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are received on or
before that date.
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-2021-P-0168 for ``Growing, Harvesting, Processing, and Distribution
of Poppy Seeds--Industry Practices Related to Opiate Alkaloids; Request
for Information.'' Received comments, those filed in a timely manner
(see ADDRESSES), 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: Jesse Lunzer, Office of Food Chemical
Safety, Dietary Supplements, and Innovation, Human Foods Program, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2879.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 15, 2025
(90 FR 3873), we published a notice requesting information on industry
practices related to poppy seeds, such as information about growing,
harvesting, processing, and distribution of poppy seeds, including
industry practices to reduce the opiate alkaloid content of poppy
seeds. We intend to use the information to help determine what type(s)
of actions, if any, we should take to help ensure that poppy seed
products do not pose a health risk when consumed. We provided a 90-day
comment period for the request for information.
We have received requests for a 90-day extension of the comment
period. In general, the requests explained that industry needed more
time to collect, review, and summarize the information requested for
the global supply chain.
We have considered the requests and are extending the comment
period for an additional 60 days. We believe that this extension will
allow adequate time for interested persons to submit comments.
Dated: March 28, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-06049 Filed 4-8-25; 8:45 am]
BILLING CODE 4164-01-P
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