[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32490-32491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13669]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Issues in the Development of Medical Products for the Prophylaxis
and/or Treatment of Acute Antibody Mediated Rejection in Kidney
Transplant Recipients; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop regarding scientific issues in clinical development of medical
products (i.e., human drugs, therapeutic biological products, and
medical devices) for prophylaxis and/or treatment of acute antibody
mediated rejection (AMR) in kidney transplant recipients. This public
workshop is intended to provide information for and gain perspective
from health care providers, academia, and industry on various aspects
of development of medical products for prophylaxis and/or treatment of
acute AMR in kidney transplant recipients, including clinical trial
design and endpoints. The input from this public workshop will help in
developing topics for further discussion.
Date and Time: The public workshop will be held on June 28, 2010,
from 8 a.m. to 6:30 p.m. and on June 29, 2010, from 8 a.m. to 4 p.m.
Location: The public workshop will be held at the Crowne Plaza
Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is limited
and available only on a first-come, first-served basis.
Contacts: Christine Moser or Ramou Mauer, Center for Drug
Evaluation and Research, Food and Drug Administration, Office of
Antimicrobial Products, 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
[email protected]. Persons without access to the Internet can
call Christine Moser at 301-796-1300 or Ramou Mauer at 301-796-1600 to
register. Persons needing a sign language interpreter or other special
accommodations should notify Christine Moser or Ramou Mauer (see
Contacts) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding medical product development for the prophylaxis and/or
treatment of acute AMR in kidney transplant recipients. This public
workshop will focus on scientific considerations in the clinical
development of medical products for prophylaxis and/or treatment of
acute AMR in kidney transplant recipients, including the following
topics:
Definition and diagnosis of acute AMR
Importance of validation and standardization of devices
and diagnostic testing to establish the diagnosis of AMR and to
identify patients at high risk of AMR
Results of clinical trials evaluating treatment of acute
AMR
Endpoints to be evaluated to assess outcome
Outcomes achieved with currently used regimens
Additional discussion will include animal models in AMR, previous
experiences in desensitization and prophylaxis of AMR, and chronic AMR.
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
[[Page 32491]]
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 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: June 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13669 Filed 6-7-10; 8:45 am]
BILLING CODE 4160-01-S