[Federal Register: January 11, 2008 (Volume 73, Number 8)]
[Notices]
[Page 2055-2056]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja08-52]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Anti-Infective 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: Anti-Infective Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
[[Page 2056]]
Date and Time: The meeting will be held on February 27 and 28,
2008, from 8 a.m. to 5 p.m.
Location: Crowne Plaza Silver Spring, The Ballrooms, 8777 Georgia
Ave., Silver Spring, MD, 301-589-0800.
Contact Person: Sohail Mosaddegh, 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: sohail.mosaddegh@fda.hhs.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512530. 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 February 27, 2008, the committee will discuss new drug
application (NDA) 022-110, telavancin powder for reconstitution and
intravenous administration, Theravance, Inc., proposed for the
treatment of complicated skin and skin structure infection. On February
28, 2008, the committee will discuss NDA 022-132, ceftobiprole
medocaril (500 milligrams), lyophilized powder for reconstitution and
intravenous administration, Johnson and Johnson Pharmaceutical Research
and Development, LLC, proposed for the treatment of complicated skin
and skin structure infection.
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: 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
February 12, 2008. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 noon. 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 February 4, 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 February 5, 2008.
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 Sohail Mosaddegh 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).
Dated: January 7, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-343 Filed 1-10-08; 8:45 am]
BILLING CODE 4160-01-S