Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices 40207 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute of 

General Medical Sciences Special 

Emphasis Panel, August 17, 2009, 8 a.m. 

to August 17, 2009, 5 p.m., National 

Institutes of Health, Natcher Building, 

Room 3AN12, 45 Center Drive, 

Bethesda, MD, 20892 which was 

published in the Federal Register on 

July 24, 2009, 74 FR 36728. 

The meeting has been changed from 

August 17, 2009 to August 20, 2009. The 

meeting is closed to the public. 

Dated: August 4, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–19091 Filed 8–10–09; 8:45 am] 

BILLING CODE 4140–01–M 

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). The meeting will be open 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 23, 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 

Washington, DC area), codes 

3014512529 or 3014512535. 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 hotline/phone line 

to learn about possible modifications 

before coming to the meeting. 

Agenda: The committees will discuss 

new drug application (NDA) 21–217, 

EXALGO (hydromorphone HCl), a 

modified-release hydromorphone drug 

product indicated for the treatment of 

moderate-to-severe pain in opioidtolerant patients. 

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 9, 2009. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. to 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. 

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 3, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–19105 Filed 8–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission on Childhood 

Vaccines; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Commission on 

Childhood Vaccines (ACCV). 

Date and Time: September 17, 2009, 1 p.m. 

to 5:30 p.m. EDT; September 18, 9 a.m. to 12 

p.m. EDT. 

Place: Parklawn Building (and via audio 

conference call), Conference Rooms G & H, 

5600 Fishers Lane, Rockville, MD 20857. 

The ACCV will meet on Thursday, 

September 17 from 1 p.m. to 5:30 p.m. (EDT) 

and Friday, September 18 from 9 a.m. to 12 

p.m. (EDT). The public can join the meeting 

via audio conference call by dialing 1–800– 

369–1791 on September 17 & 18 and 

providing the following information: 

Leader’s Name: Dr. Geoffrey Evans. 

Password: ACCV. 

Agenda: The agenda items for the June 

meeting will include, but are not limited to: 

Updates from the Division of Vaccine Injury 

Compensation (DVIC), Department of Justice, 

National Vaccine Program Office, 

Immunization Safety Office (Centers for 

Disease Control and Prevention), National 

Institute of Allergy and Infectious Diseases 


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