Document ID: FDA-2012-N-0001-0040
Agency: fda
Document Type: Notice
Title: Gastrointestinal Drugs Advisory Committee: Notice of Meeting
Posted Date: 2012-03-23T04:00Z

[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Notices]
[Page 17078]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6971]

[[Page 17078]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Gastrointestinal Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Gastrointestinal Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 31, 2012, from 8 
a.m. to 4:30 p.m.
    Location: FDA White Oak Campus, Building 31, the Great Room, White 
Oak Conference Center (Rm. 1503), 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002. Information regarding special accommodations due 
to a disability, visitor parking, and transportation may be accessed 
at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the 
heading ``Resources for You,'' click on ``Public Meetings at the FDA 
White Oak Campus.'' Please note that visitors to the White Oak Campus 
must enter through Building 1.
    Contact Person: Minh Doan, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., WO31-2417, 
Silver Spring, MD 20993-0002, (301) 796-9001, Fax: (301) 847-8533, 
email: GIDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow 
the prompts to the desired center or product area. Please call the 
Information Line for up-to-date information on this meeting. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site and call the appropriate 
advisory committee hotline/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: The committee will discuss new drug application (NDA) 200-
436, synthetic human secretin, sponsored by Repligen Corporation, 
proposed for use with magnetic resonance imaging (MRI) to improve 
pancreatic duct visualization for the detection of duct abnormalities 
to enhance clinical decision making in patients with known or suspected 
pancreatitis.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before May 
16, 2012. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Those individuals interested in making 
formal oral presentations should notify the contact person and submit a 
brief statement of the general nature of the evidence or arguments they 
wish to present, the names and addresses of proposed participants, and 
an indication of the approximate time requested to make their 
presentation on or before May 8, 2012. Time allotted for each 
presentation may be limited. If the number of registrants requesting to 
speak is greater than can be reasonably accommodated during the 
scheduled open public hearing session, FDA may conduct a lottery to 
determine the speakers for the scheduled open public hearing session. 
The contact person will notify interested persons regarding their 
request to speak by May 9, 2012.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Minh Doan at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 19, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6971 Filed 3-22-12; 8:45 am]
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