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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2023-N-3137]

# 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                     *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                     *http://wcms-internet.fda.gov/​drugs/​news-events-human-drugs/​endpoints-and-trial-designs-advance-drug-development-kidney-transplantation-11092023?​check_​logged_​in=​1*      ( print 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