Endpoints and Trial Designs To Advance Drug Development in Kidney Transplantation; Public Meeting, 62096-62097 [2023-19405]
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Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices
orally or in writing, on issues pending
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ADDRESSES) on or before November 2,
2023, will be provided to the
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accommodated during the scheduled
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speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 26, 2023.
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Notice of this meeting is given under
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also serves as notice that, pursuant to 21
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meeting to take place using an online
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No participant will be prejudiced by
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will be served by allowing for this
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modification to FDA’s advisory
committee meeting procedures.
Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19407 Filed 9–7–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
II. Topics for Discussion at the Public
Meeting
[Docket No. FDA–2023–N–3137]
Endpoints and Trial Designs To
Advance Drug Development in Kidney
Transplantation; Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public meeting.
The Food and Drug
Administration (FDA or we) is
announcing the following public
meeting on ‘‘Endpoints and Trial
Designs To Advance Drug Development
in Kidney Transplantation.’’
DATES: The public meeting will be held
on November 9, 2023, from 8 a.m. to
4:30 p.m. Eastern Time. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/about-fda/visitorinformation.
FOR FURTHER INFORMATION CONTACT:
Ozlem Belen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave, Bldg. 22, Rm. 6118,
Silver Spring, MD 20993–0002, 301–
796–0676.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
The goal of this public meeting is to
facilitate discussion among FDA,
academicians, and industry
representatives on endpoint and trial
designs to promote drug development in
kidney transplantation. The last drug
FDA approved for use in prophylaxis of
organ rejection in kidney transplant was
belatacept in 2011. It is well established
that kidney transplantation offers a clear
survival and quality-of-life advantage to
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patients with end-stage kidney disease.
The current treatment options have
resulted in excellent short-term graft
and patient survival but not without
long-term side effects. FDA recognizes
the importance of offering safe and
effective drugs with a tolerable adverse
effect profile to preserve kidney
allografts for patients. This public
meeting aims to discuss current and
future potential endpoints and trial
designs that can promote development
in this area of unmet need.
The topics of discussion include:
• Efficacy endpoints for prophylaxis
of kidney transplant rejection trials:
current state of primary endpoints and
future potential endpoints.
• Biopsy proven acute rejection
efficacy failure: long-term impact,
impact of treatment, and grade of
rejection.
• Noninferiority trials: identifying
clinically important noninferiority
margin, safety, and secondary efficacy
endpoints.
• Enrichment as a tool in trial design:
identifying target populations.
III. Attending the Public Meeting
Registration: If you wish to attend the
public meeting (either in person or via
Zoom), please register by October 26,
2023, at 4 p.m. Eastern Time. Visit the
registration page here: https://kidneytransplantationworkshop.eventbrite.com.
Registration is free and based on
space availability, with priority given to
early registrants. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning at 7:30 a.m. Eastern Time. We
will let registrants know if registration
closes before the day of the public
meeting/public workshop.
If you need special accommodations
due to a disability, please contact
ONDPublicMTGSupport@fda.hhs.gov
no later than October 18, 2023.
Streaming Webcast of the Public
Meeting: This public meeting will also
be virtual via Zoom. Zoom links will be
sent using the email provided by
persons who register. We will post a
link to the archived recording on https://
wcms-internet.fda.gov/drugs/newsevents-human-drugs/endpoints-andtrial-designs-advance-drugdevelopment-kidney-transplantation11092023?check_logged_in=1
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Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices
approximately 1 week after the public
meeting.
FDA has verified the website
addresses in this document, as of the
date this document publishes in the
Federal Register, but websites are
subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. A link to
the transcript will also be available at
https://www.fda.gov/about-fda/officeimmunology-and-inflammationdivision-rheumatology-and-transplantmedicine-drtm.
Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19405 Filed 9–7–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
Advisory Council on Blood Stem Cell
Transplantation (ACBSCT or Advisory
Council) has scheduled public meetings.
Information about the Advisory Council
and the agenda for these meetings can
be found on the ACBSCT website at:
https://bloodstemcell.hrsa.gov/about/
advisory-council.
DATES: Thursday, September 28, 2023,
2:00 p.m.–6:00 p.m. Eastern Standard
Time; and Thursday, October 26, 2023,
2:00 p.m.–6:00 p.m. Eastern Standard
Time.
SUMMARY:
Both meetings will be held
virtually by webinar. A link to register
and join each meeting will be posted at
least 10 days prior to the meeting date
at: https://bloodstemcell.hrsa.gov/
about/advisory-council.
FOR FURTHER INFORMATION CONTACT:
Shelley Tims Grant, Designated Federal
Official, at the HRSA Health Systems
Bureau, Division of Transplantation,
5600 Fishers Lane, 8W–67, Rockville,
MD 20857; 301–443–8036; or
ACBSCTHRSA@hrsa.gov.
SUPPLEMENTARY INFORMATION: The
Advisory Council provides advice and
lotter on DSK11XQN23PROD with NOTICES1
ADDRESSES:
VerDate Sep<11>2014
17:30 Sep 07, 2023
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recommendations to the Secretary of
Health and Human Services on policy,
program development, and other
matters of significance concerning the
activities under the authority of 42
U.S.C. 274k (section 379 of the Public
Health Service Act), as amended, and
Public Law 109–129, as amended. The
Advisory Council may transmit its
recommendations through the
Administrator of HRSA on matters
related to the activities of the C.W. Bill
Young Cell Transplantation Program
and National Cord Blood Inventory.
The agenda for the September 28,
2023, meeting is being finalized and
may include the following topics: the
Department of Health and Human
Services’ periodic review of the state of
the science of using adult stem cells and
birthing tissues to develop new types of
therapies for patients, for the purpose of
considering potential inclusion of such
new therapies in the C.W. Bill Young
Cell Transplantation Program; criteria
for defining a high-quality cord blood
unit for banking specifications; the
unmet needs in blood stem cell
transplantation and cellular therapy;
strategies to improve rates of donation
for adult blood stem cell donors; and
other areas to increase blood stem cell
donation and transplantation. The
agenda for the October 26, 2023,
meeting will be determined based on
discussion, priorities, and/or action
items from the September 28, 2023
meeting. All agenda items will be
posted on the Advisory Council’s
website no later than 10 days prior to
the respective meeting dates. Agenda
items are subject to change as priorities
dictate. Refer to the Advisory Council’s
website for any updated information
concerning the meeting. Members of the
public will have the opportunity to
provide comments. Public participants
may submit written statements in
advance of the scheduled meetings; oral
comments will be honored in the order
they are requested and may be limited
as time allows. Requests to submit a
written statement or make oral
comments to the Advisory Council
should be sent to Shelley Tims Grant,
using the contact information above at
least 3 business days prior to the
meeting. Individuals who plan to attend
and need special assistance or other
reasonable accommodations should
notify the Advisory Council at the
address and phone number listed above
at least 10 business days prior to the
meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–19398 Filed 9–7–23; 8:45 am]
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62097
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Advisory
Council on Drug Abuse, September 12,
2023, 10:30 a.m. to September 12, 2023,
05:00 p.m., National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 which
was published in the Federal Register
on August 21, 2023, FR Doc 2023–
17889, 88 FR 56847.
This notice is being amended to
change the open session start time from
12:45 p.m. to 1:00 p.m. The open
session will now be held from 1:00 p.m.
to 5:00 p.m. on September 12, 2023. The
meeting is partially closed to the public.
Dated: September 1, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–19406 Filed 9–7–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Notice of Meeting for the
Interdepartmental Serious Mental
Illness Coordinating Committee
(ISMICC)
Substance Abuse and Mental
Health Services Administration,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Secretary of Health and
Human Services announces a meeting of
the Interdepartmental Serious Mental
Illness Coordinating Committee
(ISMICC).
The meeting will provide information
on federal efforts related to serious
mental illness (SMI) and serious
emotional disturbance (SED).
DATES: October 18, 2023, 10:00 a.m. to
4:00 p.m. (EDT)/Open.
ADDRESSES: The meeting is open to the
public and can be accessed virtually
only by accessing: https://
www.zoomgov.com/j/1608742409?
pwd=NjdoRlpGU2NoOH
paTzZVWXR3N0k4UT09, or by dialing
646–828–7666, webinar ID: 160 874
2409, passcode: 446018. Agenda with
call-in information will be posted on the
SUMMARY:
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]]>Agencies
[Federal Register Volume 88, Number 173 (Friday, September 8, 2023)]
[Notices]
[Pages 62096-62097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19405]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3137]
Endpoints and Trial Designs To Advance Drug Development in Kidney
Transplantation; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
following public meeting on ``Endpoints and Trial Designs To Advance
Drug Development in Kidney Transplantation.''
DATES: The public meeting will be held on November 9, 2023, from 8 a.m.
to 4:30 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/about-fda/visitor-information.
FOR FURTHER INFORMATION CONTACT: Ozlem Belen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave, Bldg. 22, Rm. 6118, Silver Spring, MD 20993-0002, 301-
796-0676.
SUPPLEMENTARY INFORMATION:
I. Background
The goal of this public meeting is to facilitate discussion among
FDA, academicians, and industry representatives on endpoint and trial
designs to promote drug development in kidney transplantation. The last
drug FDA approved for use in prophylaxis of organ rejection in kidney
transplant was belatacept in 2011. It is well established that kidney
transplantation offers a clear survival and quality-of-life advantage
to patients with end-stage kidney disease. The current treatment
options have resulted in excellent short-term graft and patient
survival but not without long-term side effects. FDA recognizes the
importance of offering safe and effective drugs with a tolerable
adverse effect profile to preserve kidney allografts for patients. This
public meeting aims to discuss current and future potential endpoints
and trial designs that can promote development in this area of unmet
need.
II. Topics for Discussion at the Public Meeting
The topics of discussion include:
Efficacy endpoints for prophylaxis of kidney transplant
rejection trials: current state of primary endpoints and future
potential endpoints.
Biopsy proven acute rejection efficacy failure: long-term
impact, impact of treatment, and grade of rejection.
Noninferiority trials: identifying clinically important
noninferiority margin, safety, and secondary efficacy endpoints.
Enrichment as a tool in trial design: identifying target
populations.
III. Attending the Public Meeting
Registration: If you wish to attend the public meeting (either in
person or via Zoom), please register by October 26, 2023, at 4 p.m.
Eastern Time. Visit the registration page here: https://kidney-transplantation-workshop.eventbrite.com.
Registration is free and based on space availability, with priority
given to early registrants. Early registration is recommended because
seating is limited; therefore, FDA may limit the number of participants
from each organization. If time and space permit, onsite registration
on the day of the public meeting will be provided beginning at 7:30
a.m. Eastern Time. We will let registrants know if registration closes
before the day of the public meeting/public workshop.
If you need special accommodations due to a disability, please
contact [email protected] no later than October 18, 2023.
Streaming Webcast of the Public Meeting: This public meeting will
also be virtual via Zoom. Zoom links will be sent using the email
provided by persons who register. We will post a link to the archived
recording on https://wcms-internet.fda.gov/drugs/news-events-human-drugs/endpoints-and-trial-designs-advance-drug-development-kidney-transplantation-11092023?check_logged_in=1
[[Page 62097]]
approximately 1 week after the public meeting.
FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. A link to the transcript will also be available at
https://www.fda.gov/about-fda/office-immunology-and-inflammation-division-rheumatology-and-transplant-medicine-drtm.
Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19405 Filed 9-7-23; 8:45 am]
BILLING CODE 4164-01-P
