Medical Imaging Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 3667-3669 [2024-01016]
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Federal Register / Vol. 89, No. 13 / Friday, January 19, 2024 / Notices
• Grant recipients have a policy in
place for appropriate separation of
duties and internal controls
• Other, describe
• 10.7—Rewrite the question as
‘‘Describe how you select local agencies
for monitoring reviews. Attach a risk
assessment if subrecipients are
utilized.’’
• 10.8—Add boxes ‘‘Annually,’’ ‘‘Biannually,’’ ‘‘Tri-annually,’’ and ‘‘Other.’’
Please attach a monitoring schedule if
one has been developed.
• 10.9 and 10.10—Remove.
• 10.11—Revise the question to ‘‘How
many local agencies are currently on
corrective action plans?’’
• 10.12—Remove.
Section 11—Timely and Meaningful
Public Participation
• 11.1—Add explanation that Tribes
do not need to hold a public hearing but
must ensure participation through other
means.
• 11.2—Remove. Removing because
question is duplicative of 11.6.
• 11.3—Insert an option to add rows
for additional dates and locations that
they held public hearings on the
proposed use and distribution of their
LIHEAP funds.
• 11.6—Revise the question as
follows: ‘‘What changes did you make to
your LIHEAP plan as a result of public
participation and solicitation of input?’’
Section 12—Fair Hearing
• 12.4—Change question: ‘‘Describe
your fair hearing procedures for
households whose applications are
denied and/or not acted upon in a
timely manner.’’
• 12.5—Remove.
• 12.6—Remove.
Section 13—Reduction of Home Energy
Needs
• 13.3—Add the following
instructional sentence: ‘‘Impact can be
measured in many different ways by
using: logic model, data tracking system,
process evaluation, impact evaluation,
number of households served vs
applied, and performance management,
etc.’’
• 13.4—Add a space between ‘‘of’’
and ‘‘direct’’
• 13.5—Remove.
Section 14—Leveraging Incentive
Program
• 14.3—Add a space between ‘‘of’’
and ‘‘45’’
Section 15—Training
• 15.1a-c—Change question to be
consistent with each entity type (grant
recipient, local agency, vendor)
Æ Formal training provided virtually,
on-site, and/or formal training
conference
• Annually
• Biannually
• As needed
• Other, describe.
Section 17—Program Integrity
• 17.1b—Add ‘‘Posted in local
administering agencies offices.’’
• 17.4—Change ‘‘aliens’’ to ‘‘qualified
non-citizens’’ in intro text. The second
option in the question is phrased as
‘‘legal residence’’ but it needs to be
changed to ‘‘U.S. Citizen or Qualified
Non-Citizen.’’ The second box option
should read ‘‘Client’s submission of
certain Social Security Administration
Section 19—Certification Regarding
Drug-Free Workplace Requirements
• 19.1—Place of Performance: Add
instructional sentence that this must be
physical address. No PO Boxes allowed.
Section 21—New Change Assurances to
Section 21
• 21.1—Add the following
acknowledgment statement and a check
box: ‘‘By checking this box, the
prospective primary participant is
agreeing to the Assurances set out
above.’’
Section 22—Attachments
Add optional attachment section for
the following items: Policy Manual;
Subrecipient Contract; Model Plan
Participation Notes for Tribes.
Respondents: States, the District of
Columbia, U.S. territories, and tribal
governments.
Annual Burden Estimates
The estimated time per response for
the FY 2025 Model Plan has been
increased based on the revisions. The
estimated time per response for the FY
2026 Model Plan will reduce back after
revisions are in place and respondents
can duplicate response in OLDC.
Total annual
number of
respondents
Total annual
number of
responses per
respondent
Average
burden
hours per
response
LIHEAP Detailed Model Plan—FY24 ..............................................................
LIHEAP Detailed Model Plan—FY25 ..............................................................
LIHEAP Detailed Model Plan FY26 .................................................................
Estimated Total Burden Hours .................................................................
207
207
207
........................
1
1
1
........................
.5
1
.5
........................
Mary B. Jones,
ACF/OPRE Certifying Officer.
ACTION:
Food and Drug Administration
SUMMARY:
[Docket No. FDA–2023–N–5745]
BILLING CODE 4184–80–P
Medical Imaging Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
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Annual burden
hours for
each form
103.5
207
103.5
414
Notice; establishment of a
public docket; request for comments.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2024–00965 Filed 1–18–24; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
cards is accepted as proof of U.S.
Citizen or Qualified Non-Citizen.’’
• 17.4—Rewrite the question as
‘‘What are your procedures for ensuring
LIHEAP recipients are U.S. citizens or
qualified non-citizens who are eligible
to receive LIHEAP benefits?’’
• 17.6—Should also include how
electronic files are protected in a secure
location.
Instrument
Authority: 42 U.S.C. 8621.
3667
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Medical Imaging Drugs
Advisory Committee (the Committee).
The general function of the Committee
is to provide advice and
recommendations to FDA on regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
E:\FR\FM\19JAN1.SGM
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3668
Federal Register / Vol. 89, No. 13 / Friday, January 19, 2024 / Notices
The meeting will be held on
March 5, 2024, from 9 a.m. to 5:30 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 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–2023–N–5745.
The docket will close on March 4, 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 March 4, 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
February 20, 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:
ddrumheller on DSK120RN23PROD with NOTICES1
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• 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.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
VerDate Sep<11>2014
18:42 Jan 18, 2024
Jkt 262001
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:
• 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.
• 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–
2023–N–5745 for ‘‘Medical Imaging
Drugs 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
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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://
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
www.govinfo.gov/content/pkg/FR-201509-18/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:
Jessica Seo, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–7699, email:
MIDAC@fda.hhs.gov, 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
FDA’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 and/or video
conferencing platform. The Committee
will discuss efficacy and safety data
submitted in support of a new drug
application (NDA) 214511 for
pegulicianine for injection, the optical
imaging drug constituent of a drug/
device combination product, submitted
by Lumicell, Inc. The proposed
indication for pegulicianine is for use in
patients with breast cancer to assist in
the detection of cancerous tissue within
the lumpectomy cavity following
removal of the primary specimen during
lumpectomy surgery.
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. Background
material and the link to the online
teleconference and/or video conference
meeting will be available at https://
www.fda.gov/AdvisoryCommittees/
E:\FR\FM\19JAN1.SGM
19JAN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 13 / Friday, January 19, 2024 / Notices
Calendar/default.htm. Scroll down to
the appropriate advisory committee
meeting link. The meeting will include
slide presentations with audio and
video 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. All electronic and
written submissions to the Docket (see
ADDRESSES) on or before February 20,
2024, will be provided to the
Committee. Oral presentations from the
public will be scheduled between
approximately 2:30 p.m. and 3:30 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 February
9, 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 February 12, 2024.
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 Jessica Seo
(see FOR FURTHER INFORMATION CONTACT)
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/Advisory
Committees/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.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform. This waiver is in the
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18:42 Jan 18, 2024
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interest of allowing greater transparency
and opportunities for public
participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
The conditions for issuance of a waiver
under 21 CFR 10.19 are met.
Dated: January 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01016 Filed 1–18–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Notice of Proposed Purchased/
Referred Care Delivery Area
Redesignation for the Mashantucket
Pequot Tribal Nation in the State of
Connecticut
Indian Health Service,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
This Notice advises the public
that the Indian Health Service (IHS)
proposes to expand the geographic
boundaries of the Purchased/Referred
Care Delivery Area (PRCDA) for the
Mashantucket Pequot Tribal Nation to
include the counties of Fairfield,
Hartford, Litchfield, Middlesex, New
Haven, Tolland, and Windham in the
State of Connecticut. The current
PRCDA for the Mashantucket Pequot
Tribal Nation includes the Connecticut
county of New London. Mashantucket
Pequot Tribal Nation members residing
outside of the PRCDA are eligible for
direct care services, however, they are
not eligible for Purchased/Referred Care
(PRC) services. The sole purpose of this
expansion would be to authorize
additional Mashantucket Pequot Tribal
Nation members and IHS beneficiaries
to receive PRC services.
DATES: Comments must be submitted by
February 20, 2024.
ADDRESSES: Because of staff and
resource limitations, we cannot accept
comments by facsimile (FAX)
transmission. You may submit
comments in one of four ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a Comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Carl Mitchell, Director,
Division of Regulatory and Policy
Coordination, Indian Health Service,
SUMMARY:
PO 00000
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3669
5600 Fishers Lane, Mail Stop: 09E70,
Rockville, Maryland 20857.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
above address.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to the address
above. If you intend to deliver your
comments to the Rockville address,
please call telephone number (301) 443–
1116 in advance to schedule your
arrival with a staff member.
FOR FURTHER INFORMATION CONTACT:
CAPT John Rael, Director, Office of
Resource Access and Partnerships,
Indian Health Service, 5600 Fishers
Lane, Mail Stop: 10E85C, Rockville,
Maryland 20857. Telephone (301) 443–
0969 (This is not a toll free number).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment.
Background: The IHS provides
services under regulation in effect as of
September 15, 1987, and republished at
42 CFR part 136, subparts A–C. Subpart
C defines a Contract Health Service
Delivery Area (CHSDA), now referred to
as PRCDA, as the geographic area within
which PRC will be made available by
the IHS to members of an identified
Indian community who reside in the
PRCDA. Residence within a PRCDA by
a person who is within the scope of the
Indian health program, as set forth in 42
CFR 136.12, creates no legal entitlement
to PRC but only potential eligibility for
services. Services needed, but not
available at an IHS/Tribal facility, are
provided under the PRC program
depending on the availability of funds,
the relative medical priority of the
services to be provided, and the actual
availability and accessibility of alternate
resources in accordance with the
regulations.
The regulations at 42 CFR part 136,
subpart C provide that, unless otherwise
designated, a PRCDA shall consist of a
county which includes all or part of a
reservation and any county or counties
which have a common boundary with
the reservation. 42 CFR 136.22(a)(6).
The regulations also provide that after
consultation with the Tribal governing
body or bodies on those reservations
included within the PRCDA, the
Secretary may, from time to time,
E:\FR\FM\19JAN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 13 (Friday, January 19, 2024)]
[Notices]
[Pages 3667-3669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01016]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5745]
Medical Imaging Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Medical Imaging Drugs Advisory
Committee (the Committee). The general function of the Committee is to
provide advice and recommendations to FDA on regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.
[[Page 3668]]
DATES: The meeting will be held on March 5, 2024, from 9 a.m. to 5:30
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 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-2023-N-5745. The docket will close on March 4,
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 March
4, 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 February 20, 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:
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.
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:
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.
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-2023-N-5745 for ``Medical Imaging Drugs 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 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
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: Jessica Seo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7699, email: [email protected], 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 FDA'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 and/or video
conferencing platform. The Committee will discuss efficacy and safety
data submitted in support of a new drug application (NDA) 214511 for
pegulicianine for injection, the optical imaging drug constituent of a
drug/device combination product, submitted by Lumicell, Inc. The
proposed indication for pegulicianine is for use in patients with
breast cancer to assist in the detection of cancerous tissue within the
lumpectomy cavity following removal of the primary specimen during
lumpectomy surgery.
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. Background material and the
link to the online teleconference and/or video conference meeting will
be available at https://www.fda.gov/AdvisoryCommittees/
[[Page 3669]]
Calendar/default.htm. Scroll down to the appropriate advisory committee
meeting link. The meeting will include slide presentations with audio
and video 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.
All electronic and written submissions to the Docket (see ADDRESSES) on
or before February 20, 2024, will be provided to the Committee. Oral
presentations from the public will be scheduled between approximately
2:30 p.m. and 3:30 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 February 9, 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 February 12, 2024.
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 Jessica Seo (see FOR FURTHER INFORMATION CONTACT) 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.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. The conditions for issuance of a
waiver under 21 CFR 10.19 are met.
Dated: January 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01016 Filed 1-18-24; 8:45 am]
BILLING CODE 4164-01-P
