[Federal Register Volume 75, Number 129 (Wednesday, July 7, 2010)]
[Notices]
[Page 39032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16591]
[[Page 39032]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES>
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
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.
Date and Time: The meeting will be held on September 7, 2010, from
8 a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD. The hotel phone number is 301-977-
8900.
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, e-mail:
[email protected], 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 September 7, 2010, the committee will discuss new drug
application (NDA) 20-0327, for ceftaroline fosamil for injection,
submitted by Cerexa, Inc., and the requested indications of: (1)
Treatment of adults with community acquired bacterial pneumonia (CABP);
and (2) complicated skin and skin structure infections (cSSSI). The
morning session will be devoted to discussing the CABP indication, and
the afternoon session to discussing the cSSSI indication.
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
August 23, 2010. Oral presentations from the public will be scheduled
between approximately 11 a.m. to 11:30 a.m. and 3:30 p.m. to 4 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 August 13, 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 August 16, 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 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: July 1, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-16591 Filed 7-6-10; 8:45 am]
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