Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices 64313 

ntp.niehs.nih.gov/, select ‘‘Nominations 

to the Testing Program’’). 

The NTP invites interested parties to 

submit written comments, provide 

supplementary information, or present 

oral comments at the BSC meeting on 

the nominated substances and 

preliminary study recommendations 

(see ‘‘Request for Comments’’ below). 

The NTP welcomes toxicology study 

information from completed, ongoing, 

or anticipated studies, as well as 

information on current U.S. production 

levels, use or consumption patterns, 

human exposure, environmental 

occurrence, or public health concerns 

for any of the nominated substances. 

The NTP is interested in identifying 

appropriate animal and non-animal 

experimental models for mechanisticbased research, including genetically 

modified rodents and high-throughput 

in vitro test methods, and as such, 

solicits comments regarding the use of 

specific in vivo and in vitro 

experimental approaches to address 

questions relevant to the nominated 

substances and issues under 

consideration. Although the deadline 

for submission of written comments to 

be considered at the BSC meeting is 

November 16, 2010 (see ‘‘Request for 

Comments’’ above), the NTP welcomes 

comments or additional information on 

these study nominations at any time. 

To facilitate review of the proposed 

research project by the BSC and the 

public, NTP staff developed a draft 

research concept document for the 

nomination recommended for study. A 

research concept is a brief document 

outlining the nomination or study 

rationale, and the significance, study 

approach, and expected outcome of a 

proposed research program tailored for 

each nomination. The purpose of a 

research concept is to outline the 

general elements of a program of study 

that would address the specific issues 

that prompted the nomination and the 

preliminary study recommendations. A 

research concept may also encompass 

larger public health issues or topics in 

toxicology that could be appropriately 

addressed through studies on the 

nominated substance(s). Draft research 

concepts should be available on the BSC 

meeting page (http://ntp.niehs.nih.gov/ 

go/165) by October 19, 2010. 

Background Information on the NTP 

Board of Scientific Counselors 

The BSC is a technical advisory body 

comprised of scientists from the public 

and private sectors that provides 

primary scientific oversight to the NTP. 

Specifically, the BSC advises the NTP 

on matters of scientific program content, 

both present and future, and conducts 

periodic review of the program for the 

purpose of determining and advising on 

the scientific merit of its activities and 

their overall scientific quality. Its 

members are selected from recognized 

authorities knowledgeable in fields such 

as toxicology, pharmacology, pathology, 

biochemistry, epidemiology, risk 

assessment, carcinogenesis, 

mutagenesis, molecular biology, 

behavioral toxicology, neurotoxicology, 

immunotoxicology, reproductive 

toxicology or teratology, and 

biostatistics. Members serve overlapping 

terms of up to four years. The BSC 

usually meets biannually. 

Dated: October 5, 2010. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2010–26023 Filed 10–18–10; 8:45 am] 

BILLING CODE 4140–01–P 

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 December 7, 2010, from 8 a.m. to 5 p.m. 

Location: FDA White Oak Campus, 10903 

New Hampshire Ave., Building 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993–0002. 

Information regarding special 

accommodations due to a disability, visitor 

parking, and transportation may be accessed 

at http://www.fda.gov/AdvisoryCommittees/

default.htm; under the heading ‘‘Resources 

for You’’, click on ‘‘White Oak Conference 

Center Parking and Transportation 

Information for FDA Advisory Committee 

Meetings’’. 

Contact Person: Paul Tran, Center for Drug 

Evaluation and Research, Food and Drug 

Administration, 10903 New Hampshire Ave., 

Bldg. 31, rm. 2417, Silver Spring, MD 20993– 

0002, 301–796–9001, FAX: 301–847–8540, email: 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-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 December 7, 2010, the 

committee will discuss the safety and 

efficacy of new drug application (NDA) 20– 

0063, proposed tradename CONTRAVE 

(naltrexone HCl/bupropion HCl) extendedrelease tablets, manufactured by Orexigen 

Therapeutics, Inc., for the treatment of 

obesity and weight management, including 

weight loss and maintenance of weight loss 

in patients with an initial body mass index 

(BMI) of equal to or greater than 30 kilograms 

(kg) per square meter, or a BMI equal to or 

greater than 27 kg per square meter with one 

or more risk factors (e.g. diabetes, 

dyslipidemia, or hypertension). The BMI is a 

measure of body weight (mass) based on a 

person’s weight and height, and is a widelyused tool for doctors in assessing optimum 

weights for a patient. 

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 

November 22, 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 November 12, 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 November 15, 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 

mstockstill on DSKH9S0YB1PROD with NOTICES

64314 Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices 

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/

AdvisoryCommittees/

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: October 14, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–26251 Filed 10–18–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

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 December 2, 2010, from 8 a.m. to 5 p.m. 

Location: FDA White Oak Campus, 10903 

New Hampshire Ave., Building 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993–0002. 

Information regarding special 

accommodations due to a disability, visitor 

parking, and transportation may be accessed 

at http://www.fda.gov/AdvisoryCommittees/

default.htm; under the heading ‘‘Resources 

for You’’, click on ‘‘White Oak Conference 

Center Parking and Transportation 

Information for FDA Advisory Committee 

Meetings’’. 

Contact Person: Nicole Vesely, Center for 

Drug Evaluation and Research, Food and 

Drug Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 2417, Silver Spring, MD 

20993–0002, 301–796–9001, FAX: 301–847– 

8533, 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 301–451–2542. 

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 December 2, 2010, during the 

morning session, the committee will discuss 

biologics license application (BLA) 125377, 

with the proposed trade name Yervoy 

(ipilimumab), manufactured by Bristol-Myers 

Squibb Company. The proposed indication 

(use) for this product is for the treatment of 

advanced melanoma in patients who have 

received prior therapy. During the afternoon 

session, the committee will discuss new drug 

application (NDA) 022–405, with the 

proposed trade name Zictifa (vandetanib) 

Tablets, manufactured by iPR 

Pharmaceuticals, Inc., represented by 

AstraZeneca Pharmaceuticals LP (authorized 

U.S. agent). The proposed indication (use) for 

this product is for the treatment of patients 

with unresectable (non-operable) locally 

advanced or metastatic medullary thyroid 

cancer. 

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 

November 16, 2010. Oral presentations from 

the public will be scheduled between 

approximately 10:30 a.m. and 11 a.m. and 

between approximately 3:30 p.m. and 4 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 

November 8, 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 November 9, 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 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: October 14, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–26247 Filed 10–18–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0487] 

Product Development Program for 

Interventions in Patients With Severe 

Bleeding Due to Trauma or Other 

Causes; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a 2-day public 

workshop entitled ‘‘Product 

Development Program for Interventions 

in Patients with Severe Bleeding Due to 

Trauma or Other Causes.’’ The purpose 

of this public workshop is to discuss 

possible paradigms for the evaluation of 

products indicated for use to stop severe 

bleeding. The workshop has been 

planned in partnership with the 

Department of Health and Human 

Services, Office of Public Health and 

Science; the National Heart, Lung and 

Blood Institute; and the Department of 

Defense. The public workshop will 

include presentations and panel 

discussions by experts from academic 

institutions, government agencies, and 

industry. 

Dates and Times: The public 

workshop will be held on December 9, 

2010, from 8 a.m. to 5:30 p.m. and 

December 10, 2010, from 8 a.m. to 

1 p.m. 

Location: The public workshop will 

be held at the Masur Auditorium, 10 

Center Dr., Bldg. 10, Clinical Center, 

National Institutes of Health, Bethesda, 

MD 20892. 

Contact Person: Rhonda Dawson, 

Center for Biologics Evaluation and 

Research (HFM–302), Food and Drug 

Administration, 1401 Rockville Pike, 

mstockstill on DSKH9S0YB1PROD with NOTICES