Notice2024-20889
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments-ProSense Cryoablation System
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
September 13, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Full Text
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<title>Federal Register, Volume 89 Issue 178 (Friday, September 13, 2024)</title>
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[Federal Register Volume 89, Number 178 (Friday, September 13, 2024)]
[Notices]
[Pages 74965-74966]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-20889]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4057]
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting; Establishment of Public Docket;
Request for Comments--ProSense Cryoablation System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee (the
Committee). The general function of the Committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.
DATES: The meeting will be held on November 7, 2024, from 9 a.m. to 6
p.m. eastern time.
ADDRESSES: Holiday Inn Gaithersburg, Two Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel's telephone number is 301-948-8900.
The hotel's link can be found at: <a href="https://www.ihg.com/holidayinn/hotels/us/en/gaithersburg/wasrv/hoteldetail">https://www.ihg.com/holidayinn/hotels/us/en/gaithersburg/wasrv/hoteldetail</a>.
Answers to commonly asked questions about FDA advisory committee
meetings may be accessed at: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2024-N-4057. The docket will close on December
9, 2024. 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
December 9, 2024. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
Comments received on or before October 17, 2024, will be provided
to the Committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
You may submit comments 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, 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-2024-N-4057 for ``General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting; Establishment of
a Public Docket; Request for 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
[[Page 74966]]
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.'' FDA will review
this copy, including 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 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 the 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: Candace Nalls, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002, 301-636-0510,
<a href="/cdn-cgi/l/email-protection#cf8caea1abaeacaae181aea3a3bc8fa9abaee1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="dc9fbdb2b8bdbfb9f292bdb0b0af9cbab8bdf2b4b4aff2bbb3aa">[email protected]</span></a>, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in
the Federal Register about last-minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's website at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
SUPPLEMENTARY INFORMATION: Agenda: On November 7, 2024, the Committee
will discuss, make recommendations, and vote on clinical information
related to a De Novo request for the ProSense Cryoablation System
sponsored by IceCure Medical Ltd. The discussion will focus on the
sponsor's proposed indication: ``for use in the treatment of patients
with early stage, low-risk breast cancer for the treatment of breast
cancer with adjuvant endocrine therapy.''
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting, and the background material
will be posted on FDA's website after the meeting. Background material
will be available at the location of the advisory committee meeting and
at <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. Scroll
down to the appropriate advisory committee meeting link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and written submissions to the Docket (see ADDRESSES) on
or before October 17, 2024, will be provided to the Committee. Oral
presentations from the public will be scheduled on November 7, 2024,
between approximately 1:45 p.m. and 2:45 p.m. eastern time. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
October 10, 2024. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by October 15,
2024. Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#aacccecbc5c7cbeacccecb84c2c2d984cdc5dc"><span class="__cf_email__" data-cfemail="d7b1b3b6b8bab697b1b3b6f9bfbfa4f9b0b8a1">[email protected]</span></a> or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Ann Marie Williams at <a href="/cdn-cgi/l/email-protection#96d7f8f8fbf7e4fff3b8c1fffafafff7fbe5d6f0f2f7b8fefeb8f1f9e0"><span class="__cf_email__" data-cfemail="99d8f7f7f4f8ebf0fcb7cef0f5f5f0f8f4ead9fffdf8b7f1f1b7fef6ef">[email protected]</span></a> or 301-796-
5966 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.).
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-20889 Filed 9-12-24; 8:45 am]
BILLING CODE 4164-01-P
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