[Federal Register: November 4, 2008 (Volume 73, Number 214)]
[Notices]
[Page 65607-65608]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no08-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
Antiviral 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Antiviral 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 December 2, 2008, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
589-5200.
Contact Person: Paul Tran, Center for Drug Evaluation and Research
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express
delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-
7001, FAX: 301-827-6776, e-mail: paul.tran@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014512531. 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 December 2, 2008, the committee will begin with a closed
session from 8 a.m. to 10:30 a.m., to permit discussion and review of
trade secret and/or confidential information. Following the closed
session, from 10:30 a.m. to 5 p.m., the meeting will be open to the
public. The committee will discuss the safety and efficacy of new drug
application (NDA) 20-725, Creon (pancrelipase delayed-release
capsules), Solvay Pharmaceuticals, Inc., for the treatment of exocrine
pancreatic insufficiency.
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/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
Procedure: On December 2, 2008, from 10:30 a.m. to 5 p.m., the
meeting is open to the public. 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 November 17, 2008. Oral presentations from the public will be
scheduled between approximately 1:45 p.m. and 2:45 p.m. Those desiring
to make 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 November 6, 2008. 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 November 7, 2008.
Closed Committee Deliberations: On December 2, 2008, the meeting
will be closed from 8 a.m. to 10:30 a.m., to permit discussion and
review of trade secret and/or confidential information (5 U.S.C.
552b(c)(4)). During this session, the committee will discuss relevant
manufacturing issues and how they impact the clinical safety of the
pancreatic enzyme product.
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 Paul Tran 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/oc/advisory/
default.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).
[[Page 65608]]
Dated: October 27, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26244 Filed 11-3-08; 8:45 am]
BILLING CODE 4160-01-S