
[Federal Register Volume 78, Number 157 (Wednesday, August 14, 2013)]
[Notices]
[Page 49530]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Gastroenterology Regulatory Endpoints and the Advancement of 
Therapeutics; 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) 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, and 
the Pediatric IBD Foundation, is announcing a 2-day public workshop 
entitled ``Gastroenterology Regulatory Endpoints and the Advancement of 
Therapeutics (GREAT II).'' Partners and stakeholders planning the 
workshop also include patients and representatives from the Eunice 
Kennedy Shriver National Institute of Child Health and Human 
Development at the National Institutes of Health. The purpose of this 
workshop is to provide a forum to consider issues related to endpoints 
that can support drug development in the following disease areas: 
Pediatric and adult inflammatory bowel diseases.

DATES: The public workshop will be held on October 21 and 22, 2013, 
from 8:30 a.m. to 5 p.m.

ADDRESSES: The public workshop will be held at the National Institutes 
of Health, 31 Center Dr., Natcher Conference Center, Building 45, 
Bethesda, MD 20892-2178.

FOR FURTHER INFORMATION CONTACT: Kevin Bugin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-2302, FAX: 301-
796-9905, email: Kevin.Bugin@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: This workshop will address endpoints for 
registration trials. Stakeholders, including industry sponsors, 
academia, patients, and FDA, will be engaged to address challenging 
issues related to selection of endpoints and assessment methodologies 
in registration trials for products intended to treat adult and/or 
pediatric inflammatory bowel disease. The definition and measurement of 
treatment benefit in Crohn's disease registration trials, the role of 
existing and future clinical outcome assessments including development 
of patient reported outcome measures, timing of endpoint assessments, 
and dose-finding strategies will be discussed. In addition, there will 
be a followup to previous workshop discussions of endpoints and 
clinical trial design for ulcerative colitis registration trials. 
Strategies and methods to overcome the challenges of developing drugs 
in pediatric populations and facilitate the collection of dosing, 
safety, and efficacy information for drugs not currently approved for 
use in children will be discussed.
    Participation in the Public Workshop:
    Registration: 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.great2.org 
before October 1, 2013. For those without Internet access, please 
contact Kevin Bugin (see FOR FURTHER INFORMATION CONTACT) to register. 
Onsite registration will not be available.
    If you need special accommodations due to a disability, please 
contact Kevin Bugin (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance.
    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. Send faxed requests to 301-
827-9267.

    Dated: August 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19684 Filed 8-13-13; 8:45 am]
BILLING CODE 4160-01-P


