Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices 64311 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the agency will continue 

to list BUSPAR (buspirone 

hydrochloride) Tablets, 10 mg, 15 mg, 

and 30 mg, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. FDA 

will not begin procedures to withdraw 

approval of approved ANDAs that refer 

to BUSPAR. Additional ANDAs for 

buspirone hydrochloride tablets, 10 mg, 

15 mg, and 30 mg, may also be approved 

by the agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: October 13, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–26214 Filed 10–18–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Eye Institute 

Special Emphasis Panel, NIH Training 

Grants. 

Date: December 6, 2010. 

Time: 8:30 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Daniel R. Kenshalo, PhD, 

Scientific Review Officer, Division of 

Extramural Research, National Eye Institute, 

National Institutes of Health, 5635 Fishers 

Lane, Suite 1300, MSC 9300. 301–451–2020. 

kenshalod@nei.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: October 13, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–26310 Filed 10–18–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Notice of Meeting; National 

Commission on Children and Disasters 

AGENCY: Administration for Children 

and Families, Department of Health and 

Human Services. 

ACTION: Notice of Meeting. 

DATES: The meeting will be held on 

Monday, November 15, 2010, from 9:30 

a.m. to 3:30 p.m. 

ADDRESSES: The meeting will be held at 

the Administration for Children and 

Families, 901 D Street, SW., 

Washington, DC 20024. To attend either 

in person or via teleconference, please 

register by 5 p.m., Eastern Time, 

November 10, 2010. To register, please 

e-mail Jacqueline.Officer@acf.hhs.gov 

with ‘‘Meeting Registration’’ in the 

subject line, or call (202) 205–9560. 

Registration must include your name, 

affiliation, and phone number. If you 

require a sign language interpreter or 

other special assistance, please call 

Jacqueline Officer at (202) 205–9560 or 

e-mail Jacqueline.Officer@acf.hhs.gov as 

soon as possible and no later than 5 

p.m. Eastern Time, November 1, 2010. 

Agenda: The Commission will: (1) 

Discuss a recommendation to establish 

a National Resource Center on Children 

and Disasters; (2) Discuss 

implementation strategies for 

recommendations published in the 2010 

Report to the President and Congress; 

and (3) Discuss potential issues for 

future study and changes to 

subcommittee structure. 

Written comments may be submitted 

electronically to 

Juliana.Sadovich@acf.hhs.gov with 

‘‘Public Comment’’ in the subject line. 

The Commission recommends that you 

include your name, mailing address and 

an e-mail address or other contact 

information in the body of your 

comment. This ensures that you can be 

identified as the submitter of the 

comment, and it allows the Commission 

to contact you if further information on 

the substance of the comment is needed 

or if your comment cannot be read due 

to technical difficulties. The 

Commission’s policy is that the 

Commission will not edit your 

comment, and any identifying or contact 

information provided in the body of a 

comment will be included as part of the 

comment placed in the official record. 

The Commission will provide an 

opportunity for public comments during 

the public meeting on November 15, 

2010. Those wishing to speak will be 

limited to three minutes each; speakers 

are encouraged to submit their remarks 

in writing in advance to ensure their 

comment is received in case there is 

inadequate time for all comments to be 

heard on November 15, 2010. 

Additional Information: Contact 

CAPT Juliana Sadovich, RN, PhD 

Director, Office of Human Services 

Emergency Preparedness and Response, 

e-mail Juliana.Sadovich@acf.hhs.gov or 

call (202) 401–9306. 

SUPPLEMENTARY INFORMATION: The 

National Commission on Children and 

Disasters is an independent Commission 

directed to conduct a comprehensive 

study to examine and assess the needs 

of children as they relate to preparation 

for, response to, and recovery from all 

hazards, building upon the evaluations 

of other entities and avoiding 

unnecessary duplication by reviewing 

the findings, conclusions, and 

recommendations of these entities. The 

Commission submitted reports to the 

President and the Congress on the 

Commission’s independent and specific 

findings, conclusions, and 

recommendations to address the needs 

of children as they relate to preparation 

for, response to, and recovery from all 

hazards, including major disasters and 

emergencies. 

Dated: October 13, 2010. 

David A. Hansell, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. 2010–26231 Filed 10–18–10; 8:45 am] 

BILLING CODE 4184–06–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP); 

Office of Liaison, Policy and Review 

Meeting of the NTP Board of Scientific 

Counselors 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health. 

mstockstill on DSKH9S0YB1PROD with NOTICES

64312 Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices 

ACTION: Meeting announcement and 

request for comments. 

SUMMARY: Pursuant to Public Law 92– 

463, notice is hereby given of a meeting 

of the NTP Board of Scientific 

Counselors (BSC). The BSC is a 

federally chartered, external advisory 

group composed of scientists from the 

public and private sectors that provides 

primary scientific oversight to the NTP 

Director and evaluates the scientific 

merit of the NTP’s intramural and 

collaborative programs. 

DATES: The BSC meeting will be held on 

November 30—December 1, 2010. The 

deadline for submission of written 

comments is November 9, 2010, and for 

pre-registration to attend the meeting, 

including registering to present oral 

comments, is November 16, 2010. 

Persons needing interpreting services in 

order to attend should contact 301–402– 

8180 (voice) or 301–435–1908 (TTY). 

For other accommodations while on the 

NIEHS campus, contact 919–541–2475 

or e-mail niehsoeeo@niehs.nih.gov. 

Requests should be made at least 7 

business days in advance of the event. 

ADDRESSES: The BSC meeting will be 

held in the Rodbell Auditorium, Rall 

Building at the NIEHS, 111 T.W. 

Alexander Drive, Research Triangle 

Park, NC 27709. Public comments on all 

agenda topics and any other 

correspondence should be submitted to 

Dr. Lori White, Designated Federal 

Officer for the BSC, NTP Office of 

Liaison, Policy and Review, NIEHS, P.O. 

Box 12233, K2–03, Research Triangle 

Park, NC 27709; telephone: 919–541– 

9834; fax: 919–541–0295; 

whiteld@niehs.nih.gov. Courier address: 

NIEHS, 530 Davis Drive, Room K2136, 

Morrisville, NC 27560. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Lori D. White (telephone: 919–541–9834 

or whiteld@niehs.nih.gov). 

SUPPLEMENTARY INFORMATION: 

Preliminary Agenda Topics and 

Availability of Meeting Materials 

• Report of the NIEHS/NTP Director. 

• Report of the NTP Associate 

Director. 

• Contract Concept: NTP Sperm 

Count and Vaginal Cytology. 

• Review of the Biomolecular 

Screening Branch. 

• Testing Program Proposed Research 

Projects. 

The preliminary agenda, roster of BSC 

members, background materials, public 

comments, and any additional 

information, when available, will be 

posted on the BSC meeting Web site 

(http://ntp.niehs.nih.gov/go/165) or may 

be requested in hardcopy from the 

Designated Federal Officer for the BSC 

(see ADDRESSES above). Updates to the 

preliminary agenda will also be posted 

to this site. The draft research concepts 

for the NTP testing program 

nominations should be available on the 

BSC meeting page (http://

ntp.niehs.nih.gov/go/165) by October 

19, 2010. 

Following the meeting, summary 

minutes will be prepared and made 

available on the BSC meeting Web site. 

Attendance and Registration 

The meeting is scheduled for 

November 30—December 1, 2010, 

beginning at 8 a.m. (Eastern Standard 

Time) and continuing to approximately 

5:30 p.m. on November 30 and until 

adjournment on December 1. This 

meeting is open to the public with 

attendance limited only by the space 

available. Individuals who plan to 

attend are encouraged to register online 

at the BSC meeting Web site (http:// 

ntp.niehs.nih.gov/go/165) by November 

16, 2010, to facilitate planning for the 

meeting. Registered attendees are 

encouraged to access the meeting Web 

site to stay abreast of the most current 

information regarding the meeting. The 

NTP is making plans to videocast the 

meeting through the Internet at http:// 

www.niehs.nih.gov/news/video/live. 

Request for Comments 

Written comments submitted in 

response to this notice should be 

received by November 9, 2010. 

Comments will be posted on the BSC 

meeting Web site and persons 

submitting them will be identified by 

their name and affiliation and/or 

sponsoring organization, if applicable. 

Persons submitting written comments 

should include their name, affiliation (if 

applicable), phone, e-mail, and 

sponsoring organization (if any) with 

the document. 

Time will be allotted during the 

meeting for the public to present oral 

comments to the BSC on the agenda 

topics. In addition to in-person oral 

comments at the meeting at the NIEHS, 

public comments can be presented by 

teleconference line. There will be 50 

lines for this call; availability will be on 

a first-come, first-served basis. The 

available lines will be open from 7:30 

a.m. until 5:30 p.m. on November 30, 

and 7:30 a.m. until adjournment on 

December 1, although public comments 

will be received only during the formal 

public comment periods, which are 

indicated on the preliminary agenda. 

Each organization is allowed one time 

slot per agenda topic. At least 7 minutes 

will be allotted to each speaker, and if 

time permits, may be extended to 10 

minutes at the discretion of the BSC 

chair. Persons wishing to present oral 

comments are encouraged to pre-register 

on the NTP meeting Web site and 

indicate whether they will present 

comments in-person or via the 

teleconference line. The access number 

for the teleconference line will be 

provided to registrants by e-mail prior to 

the meeting. Registration for oral 

comments will also be available on both 

meeting days, although time allowed for 

presentation by these registrants may be 

less than that for pre-registered speakers 

and will be determined by the number 

of persons who register at the meeting. 

Persons registering to make oral 

comments are asked to send a copy of 

their statement or PowerPoint slides to 

the Designated Federal Officer for the 

BSC (see ADDRESSES above) by 

November 16, 2010, to enable review by 

the BSC prior to the meeting. Written 

statements can supplement and may 

expand the oral presentation. If 

registering on-site and reading from 

written text, please bring 40 copies of 

the statement for distribution to the BSC 

and NTP staff and to supplement the 

record. 

Background Information on NTP 

Testing Program Nominations and 

Proposed Research Projects 

The NTP actively seeks to identify 

and select for study chemicals and other 

substances for which sufficient 

information is not available to 

adequately evaluate potential human 

health hazards. The NTP accomplishes 

this goal through a formal, open 

nomination and selection process. 

Substances considered appropriate for 

study generally fall into two broad, yet 

overlapping categories: (1) Substances 

judged to have high concern as possible 

public health hazards based on the 

extent of human exposure and/or 

suspicion of toxicity and (2) substances 

for which toxicological data gaps exist 

and additional studies would aid in 

assessing potential human health risks, 

e.g., by facilitating cross-species 

extrapolation or evaluating doseresponse relationships. Nominations are 

subject to a multi-step, formal process of 

review before selections for testing are 

made and toxicological studies are 

designed and implemented. The 

nomination review and selection 

process is accomplished through the 

participation of representatives from the 

NIEHS, the BSC, the NTP Executive 

Committee—the NTP Federal 

interagency policy body, and the public. 

The nomination review and selection 

process is described in further detail on 

the NTP Web site (http:// 

mstockstill on DSKH9S0YB1PROD with NOTICES

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