Notice of Meeting, 46444 [2012-19033]

Download as PDF 46444 Federal Register / Vol. 77, No. 150 / Friday, August 3, 2012 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT); Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research is announcing a 4-day public workshop entitled ‘‘Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT).’’ 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: Eosinophilic esophagitis, pediatric and adult inflammatory bowel disease, and parenteral nutrition-associated liver disease. SUMMARY: The public workshop will be held on September 19, 20, 21, and 24, 2012, from 8:30 a.m. to 5 p.m. ADDRESSES: The public workshop will be held at the Holiday Inn, 10000 Baltimore Ave., College Park, MD 20740. DATES: 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, Kevin.Bugin@fda.hhs.gov. TKELLEY on DSK3SPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: This workshop will address endpoints for registration trials. Stakeholders, including industry sponsors, academia, and FDA, will be engaged to address challenging issues related to selection of endpoints and assessment methodologies in registration trials. Facilitation of efficient drug development, in the context of these issues, will be discussed. Each day of the workshop will be devoted to a discussion of a single relevant disease area. The goal of the workshop day dedicated to eosinophilic esophagitis is to discuss its natural history, development of patient reported outcome measures, and biomarkers that might be used to study new treatments for both children and adults. The goal of the workshop day dedicated to pediatric inflammatory bowel disease (IBD) is to discuss issues related to the VerDate Mar<15>2010 17:33 Aug 02, 2012 Jkt 226001 extrapolation of efficacy data from adult to pediatric patients, the definition and measurement of treatment benefit, and dose-finding strategies in pediatric patients. The goal of the workshop day dedicated to adult IBD is to discuss the definition and measurement of efficacy in adult ulcerative colitis registration trials, including the timing of endpoint assessment and the roles of specific endpoints and measurement tools. The goal of the workshop day dedicated to parenteral nutrition-induced liver disease is to discuss endpoints and their measurement for clinical trials in which parenteral nutrition-induced liver disease is either an efficacy or safety outcome measure. Particpation 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.fda.contractmeetings.com before September 1, 2012. For those without Internet access, please contact Ann Brameyer (7910 Woodmont Ave., suite 310, Bethesda, MD 20814, Phone: 240– 316–3205, FAX: 240–316–3201) 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: July 31, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–19036 Filed 8–2–12; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00072 Fmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given of the meeting on of the Substance Abuse and Mental Heal Services Administration’s (SAMHSA) Center for Mental Health Services (CMHS) National Advisory Council on August 16, 2012. The meeting will include topics such as budget, homelessness, and recovery support services initiative. The meeting is open to the public and will be held online via Live Meeting. Participants can join the event directly at https://www.mymeetings.com/nc/ join.php?i=PW8699891&p= CSAUNDERS&t=c. Interested persons may present data, information, or views, orally or in writing, on issues pending before the Council. Written submissions should be forwarded to the contact person on or before one week prior to the meeting (August 9, 2012). Oral presentations from the public will be scheduled at the conclusion of the meeting. Individuals interested in making oral presentations are encouraged to notify the contact on or before one week prior (August 9, 2012) to the meeting. Five minutes will be allotted for each presentation. Substantive program information may be obtained after the meeting by accessing the SAMHSA Committee Web site, https://nac.samhsa.gov/, or by contacting Crystal C. Saunders. Council Name: Substance Abuse and Mental Health Services Administration, Center for Mental Health Services National Advisory Council. Date/Time/Type: August 16, 2012, 8:30–5:00 (OPEN). Place: Live meeting webcast. Contact: Crystal C. Saunders, Acting Designated Federal Official, SAMHSA, Center for Mental Health Services National Advisory Council, 1 Choke Cherry Road, Rockville, Maryland 20857, Telephone: 240–276–1117, Fax: 240–276–1395. Cathy J. Friedman, Public Health Analyst, SAMHSA. 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Agencies

[Federal Register Volume 77, Number 150 (Friday, August 3, 2012)]
[Notices]
[Page 46444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19033]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Notice of Meeting

    Pursuant to Public Law 92-463, notice is hereby given of the 
meeting on of the Substance Abuse and Mental Heal Services 
Administration's (SAMHSA) Center for Mental Health Services (CMHS) 
National Advisory Council on August 16, 2012.
    The meeting will include topics such as budget, homelessness, and 
recovery support services initiative.
    The meeting is open to the public and will be held online via Live 
Meeting. Participants can join the event directly at https://www.mymeetings.com/nc/join.php?i=PW8699891&p=CSAUNDERS&t=c. Interested 
persons may present data, information, or views, orally or in writing, 
on issues pending before the Council. Written submissions should be 
forwarded to the contact person on or before one week prior to the 
meeting (August 9, 2012). Oral presentations from the public will be 
scheduled at the conclusion of the meeting. Individuals interested in 
making oral presentations are encouraged to notify the contact on or 
before one week prior (August 9, 2012) to the meeting. Five minutes 
will be allotted for each presentation.
    Substantive program information may be obtained after the meeting 
by accessing the SAMHSA Committee Web site, https://nac.samhsa.gov/, or 
by contacting Crystal C. Saunders.
    Council Name: Substance Abuse and Mental Health Services 
Administration,
    Center for Mental Health Services National Advisory Council.
    Date/Time/Type: August 16, 2012, 8:30-5:00 (OPEN).
    Place: Live meeting webcast.
    Contact: Crystal C. Saunders, Acting Designated Federal Official, 
SAMHSA, Center for Mental Health Services National Advisory Council, 1 
Choke Cherry Road, Rockville, Maryland 20857, Telephone: 240-276-1117, 
Fax: 240-276-1395.

Cathy J. Friedman,
Public Health Analyst, SAMHSA.
[FR Doc. 2012-19033 Filed 8-2-12; 8:45 am]
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