Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices 40209 

The draft meeting agenda and a registration 

form will be available on or about August 21, 

2009, on the HRSA’s Program Web site at 

http://bloodcell.transplant.hrsa.gov/ABOUT/ 

Advisory_Council/index.html. 

The completed registration form should be 

submitted by facsimile to Professional and 

Scientific Associates (PSA), the logistical 

support contractor for the meeting, at fax 

number (703) 234–1701 ATTN: Rebecca 

Pascoe. Registration can also be completed 

electronically at https://www.team-psa.com/ 

dot/fall2009/acbsct. Individuals without 

access to the Internet who wish to register 

may call Rebecca Pascoe with PSA at (703) 

234–1747. 

FOR FURTHER INFORMATION CONTACT: 

Remy Aronoff, Executive Secretary, 

Healthcare Systems Bureau, Health 

Resources and Services Administration, 

5600 Fishers Lane, Room 12–105, 

Rockville, Maryland 20857; telephone 

(301) 443–3264. 

Dated: August 4, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–19110 Filed 8–10–09; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Oncologic 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: Oncologic 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 1, 2009, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel phone number is 301–589–5200. 

Contact Person: Nicole Vesely, 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, 301–827–6793, FAX: 301– 

827–6776, e-mail: 

nicole.vesely@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512542. 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 

the following topics: (1) Supplemental 

new drug application (sNDA) 021– 

673/S–009, CLOLAR (clofarabine) 

Injection for intravenous use, Genzyme 

Corp., proposed indication for the 

treatment of previously untreated adults 

aged 60 years or older with acute 

myeloid leukemia with at least one 

unfavorable baseline prognostic factor 

and (2) new drug application (NDA) 

022–489, proposed trade name 

ONRIGIN (laromustine) Injection, Vion 

Pharmaceuticals, Inc., proposed 

indication for remission induction 

therapy for patients 60 years or older 

with de novo poor-risk acute myeloid 

leukemia (AML). 

CLOLAR (clofarabine) Injection for 

intravenous use has a new proposed 

indication for treatment of AML in 

previously untreated adults aged 60 

years or older with at least one medical 

or health factor that increases the risk of 

an unfavorable outcome. Laromustine 

Injection, with the proposed trade name 

ONRIGIN, has a proposed use for 

‘‘remission induction therapy’’ for AML. 

This is an initial approach to AML 

treatment designed to induce, or bring 

about, remission (reduction or 

disappearance) of leukemia in patients 

60 years or older with de novo, or first 

occurrence, AML designated as ‘‘poorrisk,’’ or more likely to have a poor 

outcome. 

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 25, 2009. 

Oral presentations from the public will 

be scheduled between approximately 

10:45 a.m. and 11:15 a.m. and between 

approximately 3:30 p.m. and 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 

25, 2009. 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 26, 2009. 

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 Nicole 

Vesely 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/Advisory

Committees/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: August 3, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–19108 Filed 8–10–09; 8:45 am] 

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