Document ID: FDA-2013-N-0001-0067
Agency: fda
Document Type: Notice
Title: Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Steatohepatitis; Public Workshop see FDA-2013-N-0001-0134
Posted Date: 2013-07-31T04:00Z

[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Notices]
[Pages 46351-46352]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18352]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Trial Designs and Endpoints for Liver Disease Secondary to 
Nonalcoholic Steatohepatitis; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug 
Evaluation and Research in cosponsorship with the American Association 
for the Study of Liver Diseases (AASLD) is announcing a 2-day public 
workshop entitled ``Trial Designs and Endpoints for Liver Disease 
Secondary to Nonalcoholic fatty liver disease (NAFLD).'' There are no 
approved treatments for NAFLD and its complications of nonalcoholic 
steatohepatitis (NASH) and liver fibrosis and cirrhosis. This workshop 
will provide a forum to discuss trial design, including endpoints for 
clinical trials in NAFLD, to promote efficient drug development in this 
area and thus improved treatments for patients.
    Date and Time: The public workshop will be held on September 5 and 
6, 2013, from 8 a.m. to 5 p.m.
    Location: The meeting will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Building 31 Conference Center, in the Great 
Room (room 1503), Silver Spring, MD 20993. Entrance for the public 
meeting participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

[[Page 46352]]

    Contact Person: Anissa Davis, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-5016, FAX: 301-796-9904, email: 
Anissa.Davis@fda.hhs.gov.
    Registration: There is no fee to attend the public workshop, but 
attendees must register online at http://www.aasld.org/additionalmeetings/Pages/aasldfdanash.aspx before September 1, 2013. 
(FDA has verified this Web site address but is not responsible for 
subsequent changes to the Web site after this document publishes in the 
Federal Register.) Space is limited, and registration will be on a 
first-come, first-served basis. Those without Internet access should 
contact Anissa Davis (see Contact Person) to register. Onsite 
registration will not be available.
    If you need special accommodations due to a disability, please 
contact Anissa Davis (see Contact Person) at least 7 days in advance.
    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 (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: This workshop will provide a forum to 
discuss the key issues in the design of clinical trials of drugs for 
the treatment of liver disease secondary to NAFLD. Stakeholders, 
including industry sponsors, those from academia, patients with NAFLD-
associated liver disease, and FDA, will be engaged to address 
challenging issues related to selection of endpoints and assessment 
methodologies in clinical trials. Trial design strategies and possible 
candidates for endpoints will be explored. The state of knowledge of 
the natural history of NAFLD will also be discussed.

    Dated: July 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18352 Filed 7-30-13; 8:45 am]
BILLING CODE 4160-01-P