Notice2021-21403
Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments; 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
October 1, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled "Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments" that appeared in the Federal Register of August 9, 2021. The Agency is taking this action to allow interested persons additional time to submit comments.
Full Text
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<title>Federal Register, Volume 86 Issue 188 (Friday, October 1, 2021)</title>
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[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54455-54456]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21403]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0843]
Genus Medical Technologies LLC Versus Food and Drug
Administration; Request for Information and Comments; Extension of
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information and comments; extension of
comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice entitled ``Genus Medical
Technologies LLC Versus Food and Drug Administration; Request for
Information and Comments'' that appeared in the Federal Register of
August 9, 2021. The Agency is taking this action to allow interested
persons additional time to submit comments.
DATES: FDA is extending the comment period for the notice published on
August 9, 2021 (86 FR 43553). Submit either electronic or written
comments by November 30, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 30, 2021. 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 November 30, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is 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-N-0843 for ``Genus Medical Technologies LLC Versus Food and
Drug Administration; Request for Information and Comments.'' 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.'' The Agency will
review this copy, including
[[Page 54456]]
the claimed confidential information, in its 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: Alexandra Lucas, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 301-796-0230,
<a href="/cdn-cgi/l/email-protection#4a0e383f2d150e2f3c23292f151e382b2439233e2325241503243b3f2338330a2c2e2b64222239642d253c"><span class="__cf_email__" data-cfemail="2662545341796243504f45437972544748554f524f4948796f4857534f545f66404247084e4e5508414950">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 9, 2021
(86 FR 43553), FDA published a notice announcing that implementation of
a decision from the U.S. Court of Appeals for the District of Columbia
Circuit in Genus Med. Techs., LLC v. FDA, 2021 U.S. app. Lexis 10928
(April 16, 2021) is expected to require some approved products to
transition from drug status to device status. That notice provides a
60-day comment period and solicits public comment to inform the
Agency's deliberations about products potentially impacted by the Genus
decision and the way in which impacted products should be transitioned
from drug to device status.
FDA is extending the comment period until November 30, 2021, based
on requests FDA received from relevant stakeholders. The Agency
believes that an additional 60 days will allow adequate time for
interested persons to submit comments to inform the Agency's
implementation of the Genus decision.
Dated: September 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21403 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P
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