Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 7722-7724 [2024-02229]
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Federal Register / Vol. 89, No. 24 / Monday, February 5, 2024 / Notices
for Public Comments’’ or by using the
search function. You can also obtain
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: State child support
agencies are required to establish and
operate a federally approved statewide
Automated Data Processing (ADP) and
information retrieval system to assist in
child support services. The APD
process, established at 45 CFR part 95,
subpart F, is the procedure by which
states request and obtain approval for
Federal Financial Participation (FFP) in
their cost of acquiring ADP equipment
and services. The ACF OCSS Division of
State and Tribal Systems (DSTS)
oversees this process.
States are required to submit an initial
APD, containing information to assist
the Secretary of the Department of
Health and Human Services (HHS) in
determining if the state computerized
support enforcement project planning
and implementation meets federal
certification requirements for approving
FFP. States are then required to submit
annual APD updates to HHS to report
project status and request ongoing FFP
for systems development,
enhancements, operations, and
maintenance. As-needed APDs are also
submitted to acquire FFP when major
milestones are missed or significant
changes to project schedules occur.
Based on an assessment of the
information provided in the APD, states
that do not meet the federal
requirements necessary for approval are
required to conduct periodic
independent verification and validation
services for high-risk project oversight.
In addition to the APDs providing
HHS/ACF/OCSS with the information
necessary to determine the allowable
level of federal funding for state systems
projects, states also submit associated
procurement and data security
documents, such as requests for
proposals (RFPs), contracts, contract
amendments, and the biennial security
review reports.
Respondents: State child support
agencies.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
RFP and Contract ................................................................
Emergency Funding Request ..............................................
Biennial Reports ...................................................................
Advance Planning Document ..............................................
Operational Advance Planning Document ...........................
Independent Verification and Validation (ongoing) ..............
Independent Verification and Validation (semiannually) .....
Independent Verification and Validation (quarterly) ............
System Certification .............................................................
Estimated Total Annual Burden
Hours: 9,158.50.
Authority: 45 CFR part 95, subpart F.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–02166 Filed 2–2–24; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0018]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
lotter on DSK11XQN23PROD with NOTICES1
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Oncologic Drugs
Advisory Committee (the Committee).
The general function of the Committee
is to provide advice and
SUMMARY:
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17:56 Feb 02, 2024
Jkt 262001
Total number
of responses
per
respondent
50
21
54
44
10
3
4
10
3
4.5
1
1.5
3.6
3
12
6
12
3
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.
DATES: The meeting will be held on
March 15, 2024, from 8:30 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–2024–N–0018.
The docket will close on March 14,
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 14, 2024. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Average
burden hours
per response
4
2
1.5
120
30
10
16
30
240
Total
burden hours
900
42
121.5
19,008
900
360
384
3,600
2,160
Annual
burden hours
300
14
40.5
6,336
300
120
128
1,200
720
considered timely if they are received
on or before that date.
Comments received on or before
March 1, 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
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05FEN1
Federal Register / Vol. 89, No. 24 / Monday, February 5, 2024 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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–
2024–N–0018 for ‘‘Oncologic 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
VerDate Sep<11>2014
17:56 Feb 02, 2024
Jkt 262001
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-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:
Joyce Frimpong, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 240–
402–5343, email: ODAC@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 the
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. During the
morning session, the Committee will
discuss supplemental biologics license
application (sBLA) 125746.74 for
CARVYKTI (ciltacabtagene autoleucel),
suspension for intravenous infusion,
submitted by Janssen Biotech, Inc. The
proposed indication for this product is
for the treatment of adult patients with
relapsed or refractory multiple
myeloma, who have received at least
one prior line of therapy, including a
proteasome inhibitor, and an
immunomodulatory agent, and are
refractory to lenalidomide. The
Committee will have a general
PO 00000
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Fmt 4703
Sfmt 4703
7723
discussion focused on the overall
survival data in the Study MMY3002
(CARTITUDE–4) and the risk and
benefit of ciltacabtagene autoleucel in
the intended population. During the
afternoon session, the Committee will
discuss sBLA 125736.218 for ABECMA
(idecabtagene vicleucel), suspension for
intravenous infusion, submitted by
Celgene Corp., a Bristol-Myers Squibb
Co. The proposed indication is for the
treatment of adult patients with
relapsed or refractory multiple myeloma
who have received an
immunomodulatory agent, a proteasome
inhibitor, and an anti-CD38 monoclonal
antibody. The Committee will have a
general discussion focused on the
overall survival data in the Study MM–
003 (KarMMa–3) and the risk and
benefit of idecabtagene vicleucel in the
intended population.
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/
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 March 1, 2024,
will be provided to the Committee. Oral
presentations from the public will be
scheduled between approximately 11:10
a.m. to 11:40 a.m. and 4 p.m. to 4:30
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
22, 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
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Federal Register / Vol. 89, No. 24 / Monday, February 5, 2024 / Notices
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 23, 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 Joyce
Frimpong (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 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–02229 Filed 2–2–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
lotter on DSK11XQN23PROD with NOTICES1
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Small Health
Care Provider Quality Improvement
Program, OMB No. 0915–0387—
Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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17:56 Feb 02, 2024
Jkt 262001
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than April 5, 2024.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Joella Roland, the HRSA
Information Collection Clearance
Officer, at (301) 443–3983.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Small Health Care Provider Quality
Improvement Program, OMB No. 0915–
0387—Extension.
Abstract: This program is authorized
by the Public Health Service Act,
section 330A(g) (42 U.S.C. 254c(g)). This
authority permits the Federal Office of
Rural Health Policy (FORHP) to award
Small Health Care Provider Quality
Improvement grants that expand access
to, coordinate, and improve the quality
of basic health care services, and
enhance the delivery of health care, in
rural areas. Specifically, FORHP may
award grants to provide for the planning
and implementation of Small Health
Care Provider Quality Improvement
activities, including activities related to
increasing care coordination, enhancing
chronic disease management, and
improving patient health outcomes.
The purpose of the Small Health Care
Provider Quality Improvement Grant
Program is to provide support to rural
primary care providers for
implementation of quality improvement
activities. The goal of the program is to
promote the development of an
evidence-based culture and delivery of
coordinated care in the primary care
setting. Additional objectives of the
program include improved health
outcomes for patients, enhanced chronic
disease management, and better
engagement of patients and their
caregivers. Organizations participating
SUMMARY:
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in the program are required to use an
evidence-based quality improvement
model, perform tests of change focused
on improvement, and use health
information technology (HIT) to collect
and report data. HIT may include an
electronic patient registry or an
electronic health record and is a critical
component for improving quality and
patient outcomes. With HIT it is
possible to generate timely and
meaningful data, which helps providers
track and plan care. HRSA collects
information from grant recipients that
participate in this program using an
OMB-approved set of performance
measures and seeks to extend its
approved information collection.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993. These measures
cover the principal topic areas of
interest to FORHP, including: (1) access
to care, (2) population demographics, (3)
staffing, (4) consortium/network, (5)
sustainability, and (6) project specific
domains. All measures will speak to
FORHP’s progress toward meeting the
goals set. FORHP collects this
information to quantify the impact of
grant funding on access to health care,
quality of services, and improvement of
health outcomes. FORHP uses the data
for program improvement and grantees
use the data for performance tracking.
No changes are proposed from the
current data collection effort, but
FORHP estimates fewer respondents to
align with the current cohort of
grantees.
Likely Respondents: The respondents
would be the grant recipients (program
grantees, not patients who receive
health care services) of the Small Health
Care Provider Quality Improvement
Program grants.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
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]]>Agencies
[Federal Register Volume 89, Number 24 (Monday, February 5, 2024)]
[Notices]
[Pages 7722-7724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02229]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0018]
Oncologic 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 Oncologic 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.
DATES: The meeting will be held on March 15, 2024, from 8:30 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-2024-N-0018. The docket will close on March
14, 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
14, 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 March 1, 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
[[Page 7723]]
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-2024-N-0018 for ``Oncologic 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: Joyce Frimpong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-5343, 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 the 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. During the morning session, the Committee will
discuss supplemental biologics license application (sBLA) 125746.74 for
CARVYKTI (ciltacabtagene autoleucel), suspension for intravenous
infusion, submitted by Janssen Biotech, Inc. The proposed indication
for this product is for the treatment of adult patients with relapsed
or refractory multiple myeloma, who have received at least one prior
line of therapy, including a proteasome inhibitor, and an
immunomodulatory agent, and are refractory to lenalidomide. The
Committee will have a general discussion focused on the overall
survival data in the Study MMY3002 (CARTITUDE-4) and the risk and
benefit of ciltacabtagene autoleucel in the intended population. During
the afternoon session, the Committee will discuss sBLA 125736.218 for
ABECMA (idecabtagene vicleucel), suspension for intravenous infusion,
submitted by Celgene Corp., a Bristol-Myers Squibb Co. The proposed
indication is for the treatment of adult patients with relapsed or
refractory multiple myeloma who have received an immunomodulatory
agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
The Committee will have a general discussion focused on the overall
survival data in the Study MM-003 (KarMMa-3) and the risk and benefit
of idecabtagene vicleucel in the intended population.
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/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 March 1, 2024, will be provided to the Committee. Oral
presentations from the public will be scheduled between approximately
11:10 a.m. to 11:40 a.m. and 4 p.m. to 4:30 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 22, 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
[[Page 7724]]
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 23, 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 Joyce Frimpong (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 30, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02229 Filed 2-2-24; 8:45 am]
BILLING CODE 4164-01-P
