Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices 42907 

Register of August 11, 2009 (74 FR 

40207). The amendment is being made 

to reflect a change in the Agenda 

portion of the document. There are no 

other changes. 

FOR FURTHER INFORMATION CONTACT: 

Kalyani Bhatt, 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: 

Kalyani.Bhatt@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington DC area), codes 3014512529 

or 3014512535. Please call the 

Information Line for up-to-date 

information on this meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 11, 2009, 

FDA announced that a meeting of the 

Anesthetic and Life Support Drugs 

Advisory Committee and the Drug 

Safety and Risk Management Advisory 

Committee would be held on September 

23, 2009, from 8 a.m. to 4:30 p.m. On 

page 40207, in the second column, the 

Agenda portion of the document is 

changed to read as follows: 

Agenda: The committees will discuss 

new drug application (NDA) 21–217, 

EXALGO (hydromorphone HC1), 

Neuromed Pharmaceuticals, Inc., a 

modified-release hydromorphone drug 

product indicated for the treatment of 

moderate-to-severe pain in opioidtolerant patients. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: August 19, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20377 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

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 October 6, 2009, from 8 a.m. to 4 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: 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 new 

drug application (NDA) 021–825, proposed 

trade name FERRIPROX (deferiprone) filmcoated tablets and oral solution, 

manufactured by ApoPharma Inc. The 

proposed indications (uses) for this product 

is as an iron chelating agent, which is a drug 

that binds with iron in the body and helps 

to make elimination of iron easier, reducing 

iron build-up. There are two specific 

proposed indications (uses) of FERRIPROX: 

(1) the treatment of iron overload, or buildup in patients with transfusion-dependent 

thalassemia, an inherited blood disorder that 

necessitates frequent transfusion of normal 

blood which can lead to iron build-up due 

to the iron content in the blood a patient 

receives; and (2) for the treatment of iron 

overload in patients with other transfusiondependent anemias (other blood disorders 

that require frequent transfusions) for which 

the use of other iron chelating agents has 

been considered inappropriate. 

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 

September 21, 2009. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 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 September 11, 

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 September 14, 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/ 

AdvisoryCommittees/AboutAdvisory

Committees/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 19, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20378 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Agency Information Collection 

Activities: Crew Member’s Declaration 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: 30–Day notice and request for 

comments; Revision of an existing 

information collection: 1651–0021. 

SUMMARY: U.S. Customs and Border 

Protection (CBP) of the Department of 

Homeland Security has submitted the 

following information collection request 

to the Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act: Crew Member’s 

Declaration. This is a proposed 

extension and revision of an 

information collection that was 


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