[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Notices]
[Pages 46351-46352]
From the Federal Register Online via the Government Publishing 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:
[email protected].
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