[Federal Register Volume 89, Number 178 (Friday, September 13, 2024)]
[Notices]
[Pages 74965-74966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://www.ihg.com/holidayinn/hotels/us/en/gaithersburg/wasrv/hoteldetail.
    Answers to commonly asked questions about FDA advisory committee 
meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    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 https://www.regulations.gov 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: 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, 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.
    <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 https://www.regulations.gov 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 https://www.regulations.gov. 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: 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: 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 https://www.fda.gov/AdvisoryCommittees/default.htm 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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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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