Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Notices 60299 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

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. 

Date and Time: The meeting will be 

held on December 3, 2008, from 8 a.m. 

to 5 p.m. 

Location: Food and Drug 

Administration, Center for Drug 

Evaluation and Research Advisory 

Committee Conference Room, rm. 1066, 

5630 Fishers Lane, Rockville, MD. 

Contact Person: Janie Kim, 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: 

Janie.kim@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: The committee will discuss 

new drug application (NDA) 22–268, 

artemether 20 milligrams (mg)/ 

lumefantrine 120 mg, sponsored by 

Novartis Pharmaceuticals Corp., for the 

proposed indication of treatment of 

acute, uncomplicated malaria infection 

due to Plasmodium falciparum or mixed 

infections including P. falciparum. 

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 November 18, 2008. 

Oral presentations from the public will 

be scheduled between approximately 

11:30 a.m. and 12:30 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 7, 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 10, 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 Janie Kim 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: October 3, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–24197 Filed 10–9–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Cardiovascular and Renal 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: Cardiovascular 

and Renal 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 10, 2008, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, Maryland Ballroom, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel phone number is 301–589–5200. 

Contact Person: Elaine Ferguson, 

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: 

elaine.ferguson@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512533. 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: The committee will discuss 

new drug application (NDA) 22–349, 

IMAGIFY (perflubutane polymer 

microspheres) injectable suspension, 

Acusphere Inc., proposed for use as an 

ultrasound imaging agent indicated for 

patients with stable chest pain being 

evaluated for inducible ischemia for the 

detection of coronary artery disease 

based on assessment of myocardial 

perfusion and wall motion. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

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