[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Notices]
[Pages 49447-49448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Endpoints for Clinical Trials 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 endpoints for clinical trials of drugs and 
therapeutic biologics in kidney transplantation. This public workshop 
is intended to provide information and gain perspective from health 
care providers, academia, and industry on the role of various clinical, 
laboratory, histologic, genomic/proteomic, safety, and other endpoints

[[Page 49448]]

used to evaluate patient and allograft outcome in clinical trials of 
kidney transplantation. The meeting will include a discussion of 
measure of patient and graft survival, evaluation of the allograft by 
histology and biomarkers, glomerular filtration rate or other measures 
of renal function, evaluation of safety, and other topics. The input 
from this public workshop will help in developing topics for further 
discussion and may serve to inform recommendations on potential 
endpoints in clinical trials of kidney transplantation.
    Date and Time: The public workshop will be held on September 10, 
2012, from 9 a.m. to 6 p.m., and on September 11, 2012, from 8 a.m. to 
3 p.m.
    Location: The public workshop will be held at the Sheraton Silver 
Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910, 301-589-0800. 
Seating is limited and available only on a first-come, first-served 
basis.

CONTACT PERSON FOR MORE INFORMATION: 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, email registration information (including 
name, title, firm name, address, telephone, and fax number) to 
[email protected]. 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 PERSON FOR MORE INFORMATION) at least 7 days in advance.
    SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop 
regarding potential clinical or surrogate endpoints and biomarkers for 
clinical trials of drugs and therapeutic biologics in kidney 
transplantation. This public workshop will include scientific 
discussion on the following topics:
     Patient and graft survival;
     Allograft rejection, both cellular and antibody-mediated, 
injury, and recurrent disease;
     Glomerular filtration rate, proteinuria, and other 
measures of renal function;
     Proteomic, genomic, and immunologic biomarkers;
     Measures of safety, including cardiovascular and metabolic 
outcomes;
     Medication adherence; and
     Consideration of composite endpoints.
    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 20852. 
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 Division of Freedom of Information (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, 
MD 20857. Transcripts will also be available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm305308.htm approximately 45 days after 
the workshop.

    Dated: August 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20105 Filed 8-15-12; 8:45 am]
BILLING CODE 4160-01-P