Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop, 49530 [2013-19684]

Download as PDF 49530 Federal Register / Vol. 78, No. 157 / Wednesday, August 14, 2013 / Notices identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 801 have been approved under OMB control number 0910–0485; the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910–0231; the collections of information in 21 CFR part 814, subpart H have been approved under OMB control number 0910–0332; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073. V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (See ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: August 8, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–19686 Filed 8–13–13; 8:45 am] BILLING CODE 4160–01–P 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, tkelley on DSK3SPTVN1PROD with NOTICES HHS. ACTION: Notice of public workshop. The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological SUMMARY: VerDate Mar<15>2010 16:16 Aug 13, 2013 Jkt 229001 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 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 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 https:// 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 https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received within 30 days of this notice. SUMMARY: E:\FR\FM\14AUN1.SGM 14AUN1

Agencies

[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.

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

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 https://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 https://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

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