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[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]

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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.

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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 http://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
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