32188 Federal Register / Vol. 75, No. 108 / Monday, June 7, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

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 July 22 and 23, 2010, from 8 

a.m. to 4:30 p.m. 

Location: The Marriott Inn and 

Conference Center, University of 

Maryland University College, 3501 

University Boulevard East, Adelphi, 

MD. The conference center telephone 

number is 301–985–7300. 

Contact Person: Kristine T. Khuc, c/o 

Melanie Whelan, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6100, Silver Spring, 

MD 20993–0002, FAX: 301–847–8737, 

to reach by telephone before June 8, 

2010, please call 301–827–7001; to 

reach by telephone after June 8, 2010, 

please call 301 796–9001, e-mail: 

Kristine.khuc@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), codes 

3014512529 and 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 committee hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The committees will discuss 

Risk Evaluation and Mitigation 

Strategies (REMS) for extended-release 

and long-acting opioid analgesics. As a 

part of the materials for the meeting, 

FDA anticipates presenting a proposal 

for a class-wide opioid REMS and will 

solicit feedback from the advisory 

committees and public on the 

components of that proposal. The need 

for adequate pain control is an element 

of good medical practice. In this 

context, some persons suffering from 

pain need access to potent opioid drug 

products; however, inappropriate 

prescribing, addiction, and death due to 

prescription opioid abuse and misuse 

have been increasing over the last 

decade. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

For this particular meeting, FDA 

anticipates that the briefing materials 

will not contain information that, under 

certain circumstances, could be 

considered exempt from public 

disclosure under the Freedom of 

Information Act. Therefore, FDA 

anticipates making the briefing 

materials available on our Web site no 

later than 2 weeks before the day the 

advisory committee meeting is 

scheduled to occur. 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 July 8, 2010. Oral 

presentations from the public will be 

scheduled between approximately 8:15 

a.m. and 9:15 a.m. on July 23, 2010. 

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 June 29, 

2010. 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 July 2, 2010. 

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 Kristine T. 

Khuc 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: June 2, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–13535 Filed 6–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Endocrinologic and Metabolic 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: Endocrinologic 

and Metabolic 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 July 15, 2010, from 8 a.m. to 5 

p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, The Ballrooms, 620 

Perry Pkwy., Gaithersburg, MD. The 

hotel telephone number is 301–977– 

8900. 

Contact Person: Paul Tran, c/o 

Melanie Whelan, Food and Drug 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

Federal Register / Vol. 75, No. 108 / Monday, June 7, 2010 / Notices 32189 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6100, Silver Spring, 

MD 20993–0002, FAX: 301–847–8737, 

to reach by telephone before June 8, 

2010, please call 301–827–7001; to 

reach by telephone after June 8, 2010, 

please call 301–796–9001, e-mail: 

Paul.Tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512536. 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: On July 15, 2010, the 

committee will discuss the safety and 

efficacy of new drug application (NDA) 

22–580, proposed tradename QNEXA 

(phentermine/topiramate) Controlled 

Release Capsules, by VIVUS, Inc., as an 

adjunct to diet and exercise for weight 

management in patients with a body 

mass index of 30 kilograms (kg) per 

square meter, or a body mass index 

equal to or greater than 27 kg per square 

meter if accompanied by weight-related 

co-morbidities. 

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 June 30, 2010. 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 June 22, 2010. 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 June 23, 2010. 

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 Paul Tran 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: June 2, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–13534 Filed 6–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Joint Meeting of the Endocrinologic 

and Metabolic 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: Endocrinologic 

and Metabolic 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 July 13, 2010, from 8 a.m. to 6 

p.m. and on July 14, 2010, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, The Ballrooms, 620 

Perry Pkwy., Gaithersburg, MD. The 

hotel telephone number is 301–977– 

8900. 

Contact Person: Paul Tran, c/o 

Melanie Whelan, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 6100, Silver Spring, 

MD 20993–0002, FAX: 301–847–8737, 

to reach by telephone before June 8, 

2010, please call 301–827–7001; to 

reach by telephone after June 8, 2010, 

please call 301–796–9001, e-mail: 

paul.tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), codes 

3014512536 and 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 committee hot 

line/phone line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On both days, the 

committees will focus primarily on the 

cardiovascular safety of AVANDIA 

(rosiglitazone maleate) Tablets, 

GlaxoSmithKline, a drug approved for 

blood glucose control in adults with 

type 2 diabetes mellitus. Data specific to 

rosiglitazone to be presented will 

include results from the Rosiglitazone 

Evaluated for Cardiac Outcome and 

Regulation of Glycemia in Diabetes 

(RECORD) Trial, observational data, 

health claims data, and a meta-analysis 

of controlled clinical trials. In addition, 

the FDA will present its meta-analysis 

of several trials of ACTOS (pioglitazone 

hydrochloride) Tablets, Takeda 

Pharmaceuticals North America, Inc., 

another thiazolidinedione for the same 

indication, in response to public 

documents comparing the safety of 

rosiglitazone to pioglitazone based on 

different meta-analyses performed on 

each of these two drugs. 

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 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES