42906 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices 

Provider Integration Subcommittee will 

meet at Sutter Amador Hospital in 

Jackson, California. The Home-Based 

Care Options for Seniors Subcommittee 

will meet at Madelyn Helling Library in 

Nevada City, California. The 

Subcommittees will return to the 

Sheraton Grand Hotel in Sacramento at 

4 p.m. Transportation to the site visits 

will not be provided to the public. The 

Thursday meeting will close at 4 p.m. 

The final session will be convened on 

Friday morning at 8:45 a.m. The 

meeting will open with a review of the 

Subcommittee site visits. The staff of the 

Office of Rural Health Policy will 

provide an update on the Department of 

Health and Human Services. The 

Committee will draft a letter to the 

Secretary or Designee and discuss the 

February 2010 meeting. The meeting 

will be adjourned at 11 a.m. 

For Further Information Contact: 

Anyone requiring information regarding 

the Committee should contact Jennifer 

Chang, MPH, Executive Secretary, 

National Advisory Committee on Rural 

Health and Human Services, Health 

Resources and Services Administration, 

Parklawn Building, Room 9A–55, 5600 

Fishers Lane, Rockville, MD 20857, 

Telephone (301) 443–0835, Fax (301) 

443–2803. 

Persons interested in attending any 

portion of the meeting should contact 

Michele Pray Gibson, Office of Rural 

Health Policy (ORHP), Telephone (301) 

443–0835. The Committee meeting 

agenda will be posted on ORHP’s Web 

site http://www.ruralhealth.hrsa.gov. 

Dated: August 19, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–20342 Filed 8–24–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Joint Meeting of the Anesthetic and 

Life Support Drugs Advisory 

Committee and the Drug Safety and 

Risk Management 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). At least one portion of the 

meeting will be closed to the public. 

Name of Committees: Anesthetic and Life 

Support Drugs Advisory Committee and the 

Drug Safety and Risk Management Advisory 

Committee. 

General Function of the Committees: To 

provide advice and recommendations to the 

agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on September 24, 2009, from 8 a.m. to 4:30 

p.m. 

Location: Holiday Inn, The Ballrooms, Two 

Montgomery Village Ave., Gaithersburg, MD. 

The hotel phone number is 301–948–8900. 

Contact Person: 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-todate 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 September 24, 2009, the 

committees will begin with a closed session 

from 8 a.m. to 9:15 a.m. Following the closed 

session, from 9:15 a.m. to 4:30 p.m., the 

meeting will be open to the public. 

The committees will discuss new drug 

application (NDA) 22–272, OXYCONTIN 

(oxycodone hydrochloride controlled-release) 

Tablets, Purdue Pharma L.P., and its safety 

for the proposed indication of management of 

moderate to severe pain when a continuous, 

around-the-clock analgesic is needed for an 

extended period of time. This formulation 

was previously reviewed and discussed by 

these committees on May 5, 2008, and will 

be considered again in light of new data. 

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 a http:// 

www.fda.gov/AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: On September 24, 2009, from 

9:15 a.m. to 4:30 p.m., the meeting is open 

to the public. 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 10, 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 1, 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 2, 2009. 

Closed Presentation of Data: On September 

24, 2009, from 8 a.m. to 9:15 a.m., the 

meeting will be closed to permit discussion 

and review of trade secret and/or confidential 

information (5 U.S.C. 552b(c)(4)). The 

meeting will be closed to permit discussion 

of confidential information regarding 

detailed protocols to evaluate the formulation 

of the drug product. 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 Kalyani 

Bhatt 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. E9–20376 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Joint Meeting of the Anesthetic and 

Life Support Drugs Advisory 

Committee and the Drug Safety and 

Risk Management Advisory 

Committee; Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of a meeting of the Anesthetic 

and Life Support Drugs Advisory 

Committee and the Drug Safety and Risk 

Management Advisory Committee. This 

meeting was announced in the Federal 


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