[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