Document ID: FDA-2015-N-0001-0007
Agency: fda
Document Type: Notice
Title: Gastroenterology Regulatory Endpoints and the Advancement of
Therapeutics; Public Workshop
Posted Date: 2015-01-29T05:00Z

[Federal Register Volume 80, Number 19 (Thursday, January 29, 2015)]
[Notices]
[Pages 4933-4934]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01625]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Gastroenterology Regulatory Endpoints and the Advancement of 
Therapeutics; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research, in cosponsorship with the American College of 
Gastroenterology, the American Gastroenterological Association, the 
Crohn's and Colitis Foundation of America, Inc., the North American 
Society for Pediatric Gastroenterology, Hepatology, and Nutrition, the 
North American Society for the Study of Celiac Disease, and the 
Pediatric Inflammatory Bowel Disease Foundation, is announcing a 2-day 
public workshop entitled ``Gastroenterology Regulatory Endpoints and 
the Advancement of Therapeutics (GREAT III).'' The purpose of this 
workshop is to provide a forum to consider issues related to selection 
of endpoints and clinical outcome measures appropriate for drug 
development in the following disease areas: Inflammatory bowel diseases 
and celiac disease.

DATES: The public workshop will be held on March 30 and 31, 2015, from 
8:30 a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public 
workshop 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.

FOR FURTHER INFORMATION CONTACT: Kelly Richards, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Rm. 5237, Silver Spring, MD 20993-0002, 240-402-4276, 
FAX: 301-796-9904, email: GREAT@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: This workshop will address endpoints for 
registration trials in inflammatory bowel diseases and celiac disease. 
Stakeholders, including industry sponsors, academia, patients and FDA, 
will address challenging issues related to selection of endpoints and 
assessment methodologies in clinical trials intended to support 
approval of products for treatment of inflammatory bowel diseases and 
celiac disease. The first day of the workshop will discuss the 
assessment of efficacy in Crohn's disease trials, including the use of 
patient-reported outcome measures and endoscopic evaluation, as well as 
the role of registries and patient participation in inflammatory bowel 
disease drug development programs. The second day of the workshop will 
discuss the appropriate target population for pharmacological therapy 
in celiac disease, and the definition and measurement of a treatment 
benefit in celiac disease registration trials, including the role and 
timing of

[[Page 4934]]

assessment of histological and serological endpoints.

I. Participation in the Public Workshop

    There is no fee to attend the public workshop, but attendees must 
register in advance. Space is limited and registration will be on a 
first-come, first-served basis. Persons interested in attending this 
workshop must register online at http://www.great3.org before March 1, 
2015. For those without Internet access, please contact Kelly Richards 
(see FOR FURTHER INFORMATION CONTACT) to register. Onsite registration 
will not be available.
    If you need special accommodations due to a disability, please 
contact Kelly Richards (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance.

II. Transcripts

    Transcripts of the workshop will be available for review at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and on the Internet 
at http://www.regulations.gov approximately 30 days after the workshop. 
A transcript will also be available in either hard copy or on CD-ROM 
after submission of a Freedom of Information request. Send written 
requests to the Division of Freedom of Information (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, 
MD 20857. Fax requests to 301-827-9267.

    Dated: January 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01625 Filed 1-28-15; 8:45 am]
BILLING CODE 4164-01-P