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

32190 Federal Register / Vol. 75, No. 108 / Monday, June 7, 2010 / Notices 

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 28, 2010. Oral 

presentations from the public will be 

scheduled between approximately 8:15 

a.m. and 9:15 a.m. on July 14, 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 18, 

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 21, 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. 2010–13533 Filed 6–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Interest Projects (SIPs): SIP 10–033, 

Innovative Approaches To Preventing 

Teen Pregnancy Among Underserved 

Populations and SIP 10–035, Impact of 

High School Start Times on the Health 

and Academic Performance of High 

School Students, Initial Review 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

Time and Date: 11 a.m.–5:30 p.m., June 21, 

2010 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘SIP 10–033, Innovative 

Approaches to Preventing Teen Pregnancy 

among Underserved Populations & SIP 10– 

035, Impact of High School Start Times on 

the Health and Academic Performance of 

High School Students.’’ 

Contact Person for More Information: 

Michelle Mathieson, Public Health Analyst, 

National Center for Chronic Disease and 

Health Promotion, Office of the Director, 

Extramural Research Program Office, CDC, 

4770 Buford Highway, NE., Mailstop K–92, 

Atlanta, GA 30341, Telephone: (770) 488– 

3068, E-mail: mth8@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: May 28, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–13518 Filed 6–4–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Interest Projects (SIPs): Examining the 

Impact of Cognitive Impairment on CoOccurring Chronic Conditions SIP 10– 

037 and Epidemiologic Follow-Up 

Study of Newly Diagnosed Epilepsy 

SIP 10–039, Initial Review 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

Time and Date: 8:30 a.m.–6 p.m., June 23, 

2010 (Closed). 

Place: W Hotel—Buckhead, 3377 Peachtree 

Road, NE., Atlanta, GA 30326, (678) 500– 

3100. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Examining the Impact of 

Cognitive Impairment on Co-Occurring 

Chronic Conditions SIP 10–037 and 

Epidemiologic Follow-up Study of Newly 

Diagnosed Epilepsy SIP 10–039.’’ 

Contact Person for More Information: 

Michelle Mathieson, Public Health Analyst, 

National Center for Chronic Disease and 

Health Promotion, Office of the Director, 

Extramural Research Program Office, CDC, 

4770 Buford Highway, NE., Mailstop K–92, 

Atlanta, GA 30341, Telephone: (770) 488– 

3068, E-mail: mth8@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: May 28, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–13519 Filed 6–4–10; 8:45 am] 

BILLING CODE 4163–18–P 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES