2011-18095. Effects of Ischemia Reperfusion Injury on Outcomes in Kidney Transplantation; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) is announcing a public workshop to discuss the effects of ischemia/reperfusion injury (IRI) on outcomes in kidney transplantation. This public workshop is intended to obtain information from health care providers, academia, and industry on various aspects of the pathophysiology, clinical management, and outcomes following IRI. The meeting will include a discussion of animal models, devices, and clinical trial design. The input from this public workshop will help in developing topics for further discussion and may serve to inform recommendations on clinical trial design for products for the mitigation of IRI and/or for the prophylaxis and/or treatment of delayed graft function (DGF) and related conditions in kidney transplant recipients.

Date and Time: The public workshop will be held on September 8, 2011, from 9 a.m. to 6 p.m. and on September 9, 2011, from 8 a.m. to 3 p.m.

Location: The public workshop will be held at the Crowne Plaza, 8777 Georgia Ave., Silver Spring, MD 20910, 301-589-0800. Seating is available only on a first-come-first-served basis.

Contact Persons: Christine Moser or Ramou Mauer, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6209, Silver Spring, MD 20993-0002, 301-796-1300 or 301-796-1600.

Registration: Registration is free for the public workshop. Interested parties are encouraged to register early because space is limited. Seating will be available on a first-come-first-served basis. To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax number) to [e-mail]. Persons without access to the Internet can call Christine Moser, 301-796-1300, or Ramou Mauer, 301-796-1600, to register.

Persons needing a sign language interpreter or other special accommodations should notify Christine Moser or Ramou Mauer (see Contact Persons) at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

FDA is announcing a public workshop regarding effects of IRI on outcome in kidney transplantation and medical product development for the prevention and/or treatment of DGF in kidney transplant recipients. This public workshop will include scientific discussion on the following topics:

• Pathophysiology and contributing factors to IRI,
• Downstream measures of response to IRI,
• Current management strategies and outcomes in patients with DGF,
• Animal models in IRI and DGF,
• Device issues related to DGF, and
• Clinical trial issues related to the recipient in development of medical products for the management of DGF and related conditions in kidney transplantation.

The Agency encourages individuals, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons to attend this public workshop.

Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, Rm. 6-30, Rockville, MD 20857.

Transcripts will also be available on the Internet at http://www.fda.gov/​Drugs/​NewsEvents/​ucm206132.htm approximately 45 days after the workshop.

Dated: July 13, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.