Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 69207 [2023-22106]
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Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
0910–0001. The collections of
information in 21 CFR 201.56 and
201.57 relating to certain prescription
product labeling requirements have
been approved under OMB control
number 0910–0572. The collections of
information pertaining to expedited
programs for serious conditions for
drugs and biologics and breakthrough
therapy-designation for drugs and
biologics have been approved under
OMB control number 0910–0765.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: October 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22189 Filed 10–4–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0008]
Radiological Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Radiological Devices
Panel of the Medical Devices Advisory
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.
DATES: The meeting will take place
virtually on November 7, 2023, from 9
a.m. to 12:15 p.m. eastern time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:37 Oct 04, 2023
Jkt 262001
FOR FURTHER INFORMATION CONTACT:
Jarrod Collier, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
MD 20993–0002, Jarrod.Collier@
fda.hhs.gov, 240–672–5763, 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 the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On
November 7, 2023, the committee will
discuss and make recommendations on
the classification of blood irradiator
devices for the prevention of metastasis,
which are currently unclassified preamendments devices, to class III
(general controls and premarket
approval).
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 and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down and select the
appropriate advisory committee meeting
link. The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 25, 2023.
Oral presentations from the public will
be scheduled on November 7, 2023,
between approximately 9:20 a.m. and
10:20 a.m. eastern time. Those
PO 00000
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Fmt 4703
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69207
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 17, 2023. 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 18, 2023.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov 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 Annmarie.williams@
fda.hhs.gov or 240–507–6496 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. app. 2).
Dated: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22106 Filed 10–4–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0937–0025
Agency Information Collection
Request. 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
SUMMARY:
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Notices]
[Page 69207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22106]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0008]
Radiological Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Radiological Devices Panel of
the Medical Devices Advisory 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.
DATES: The meeting will take place virtually on November 7, 2023, from
9 a.m. to 12:15 p.m. eastern time.
ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform. Answers to
commonly asked questions including information regarding special
accommodations due to a disability may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT: Jarrod Collier, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002,
[email protected], 240-672-5763, 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 the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On November
7, 2023, the committee will discuss and make recommendations on the
classification of blood irradiator devices for the prevention of
metastasis, which are currently unclassified pre-amendments devices, to
class III (general controls and premarket approval).
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
and the link to the online teleconference meeting room will be
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down and select the appropriate advisory committee
meeting link. The meeting will include slide presentations with audio
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 25, 2023. Oral presentations from the public will be scheduled
on November 7, 2023, between approximately 9:20 a.m. and 10:20 a.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 17, 2023. 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
18, 2023.
For press inquiries, please contact the Office of Media Affairs at
[email protected] 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 [email protected] or 240-507-
6496 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. app. 2).
Dated: September 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22106 Filed 10-4-23; 8:45 am]
BILLING CODE 4164-01-P
