[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Notices]
[Page 13612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5455]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2012-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.

DATES: Date and Time: The meeting will be held on April 3, 2012, from 8 
a.m. to 5 p.m. and on April 4, 2012, from 8 a.m. to 3:30 p.m.
    Location: DoubleTree by Hilton Hotel Washington DC/Silver Spring, 
The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel 
telephone number is: 301 589-5200.
    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: 
<a href="/cdn-cgi/l/email-protection#2c6d65686d6f6c4a484d0244445f024b435a"><span class="__cf_email__" data-cfemail="c5848c81848685a3a1a4ebadadb6eba2aab3">[email protected]</span></a>, 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 hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On April 3, 2012, during the morning session, the committee 
will discuss the development of an animal model of pneumonic plague 
(plague infection with extensive lung involvement) in African Green 
Monkeys and provide advice concerning the relevance of the animal model 
to pneumonic plague in humans resulting from exposure to Yersinia 
pestis (the bacteria that causes plague) in a bioterrorism event.
    During the afternoon session, the committee will discuss the data 
provided to support the safety and efficacy of ciprofloxacin for the 
treatment of pneumonic plague in humans. The National Institute of 
Allergy and Infectious Diseases (NIAID) has submitted efficacy data for 
ciprofloxacin, based on treatment in an animal model of plague. Safety 
and other supportive information is derived from clinical studies and 
post-marketing experience in humans.
    On April 4, 2012, the committee will discuss the data provided to 
support the safety and efficacy of levofloxacin for the treatment of 
pneumonic plague in humans. Johnson and Johnson Pharmaceutical Research 
and Development, LLC (on behalf of Janssen Pharmaceuticals, Inc.), has 
submitted efficacy supplements for LEVAQUIN (levofloxacin) tablets, 
injection, and oral solution (NDA 20-634, NDA 20-635, and NDA 21-721, 
respectively) for treatment of pneumonic plague. Efficacy data for 
levofloxacin is based on treatment in an animal model of plague. Safety 
and other supportive information is derived from clinical studies and 
post-marketing experience in humans.
    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 
March 19, 2012. Oral presentations from the public will be scheduled 
between approximately 10 a.m. to 10:30 a.m. and 2:30 p.m. to 3 p.m. on 
April 3, 2012, and between approximately 11 a.m. to 11:30 a.m. on April 
4, 2012. 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 March 16, 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 March 19, 
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 1, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-5455 Filed 3-6-12; 8:45 am]
BILLING CODE 4160-01-P


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