13612 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Notices 

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 2, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–5487 Filed 3–6–12; 8:45 am] 

BILLING CODE 4160–01–P 

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. 

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: 

AIDAC@fda.hhs.gov, 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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