Document ID: FDA-2011-N-0002-0072
Agency: fda
Document Type: Notice
Title: Public Workshops: Effects of Ischemia Reperfusion Injury on Outcomes in Kidney Transplantation
Posted Date: 2011-07-19T04:00Z

[Federal Register Volume 76, Number 138 (Tuesday, July 19, 2011)]
[Notices]
[Pages 42716-42717]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18095]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Effects of Ischemia Reperfusion Injury on Outcomes in Kidney 
Transplantation; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    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 
IRIworkshop@fda.hhs.gov. 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:

[[Page 42717]]

     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.
[FR Doc. 2011-18095 Filed 7-18-11; 8:45 am]
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