Document ID: FDA-2010-N-0001-0151
Agency: fda
Document Type: Notice
Title: Meetings: Gastrointestinal Drugs Advisory Committee
Posted Date: 2010-12-02T05:00Z

[Federal Register: December 2, 2010 (Volume 75, Number 231)]
[Notices]               
[Page 75176-75177]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de10-22]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

 
Gastrointestinal Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory 
committee

[[Page 75177]]

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 January 12, 2011, from 8 
a.m to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002, Bldg. 31, the Great Room, White Oak Conference 
Center (rm. 1503). 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 ``White Oak Conference Center Parking 
and Transportation Information for FDA Advisory Committee Meetings.'' 
Please note that visitors to the White Oak Campus must have a valid 
driver's license or other picture ID, and must enter through Building 
1.
    Contact Person: Kristine T. Khuc, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, e-mail: kristine.khuc@fda.hhs.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512538. 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 hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: On January 12, 2011, the committee will discuss the safety 
and efficacy of new drug application (NDA) 022-486, for Solpura 
(liprotamase) Capsules, by Alnara Pharmaceuticals, for the proposed 
indication (use) in the treatment of exocrine pancreatic insufficiency 
due to cystic fibrosis, chronic pancreatitis, pancreatectomy (surgical 
removal of all or part of the pancreas), or other conditions that may 
impair or limit function of the pancreas. The pancreas is an organ 
involved, in part, in the digestion of food through the use of 
specialized proteins called enzymes. Exocrine pancreatic insufficiency 
is a decreased ability to digest food due to deficient enzyme 
production by the pancreas.
    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 
December 28, 2010. Oral presentations from the public will be scheduled 
between approximately 1 p.m. to 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 December 17, 2010. 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 December 20, 2010.
    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 Kristine T. Khuc 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: November 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30274 Filed 12-1-10; 8:45 am]
BILLING CODE 4160-01-P