Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 59729 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Fungai Chanetsa, MPH, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3135, 

MSC 7770, Bethesda, MD 20892, 301–408– 

9436, fungai.chanetsa@nih.hhs.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: AIDS/HIV Innovative Research 

Applications. 

Date: November 16–18, 2010. 

Time: 8 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Kenneth A Roebuck, PhD, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5106, 

MSC 7852, Bethesda, MD 20892, (301) 435– 

1166, roebuckk@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Genes, Genomes, and Genetics. 

Date: November 17, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance Mayflower Hotel, 1127 

Connecticut Avenue, NW., Washington, DC 

20036. 

Contact Person: Maria DeBernardi, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6158, 

MSC 7892, Bethesda, MD 20892, 301–435– 

1355, debernardima@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Fellowship: 

Technology Development. 

Date: November 17–18, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Alessandra M. Bini, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5142, 

MSC 7840, Bethesda, MD 20892, 301–435– 

1024, binia@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Special 

Topics: Bioanalytical and Imaging 

Technologies. 

Date: November 17–18, 2010. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Vonda K. Smith, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6188, 

MSC 7892, Bethesda, MD 20892, 301–435– 

1789, smithvo@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Arthritis, Connective Tissue and 

Skin Special Emphasis Panel. 

Date: November 17, 2010. 

Time: 2:30 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Jean D. Sipe, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4106, 

MSC 7814, Bethesda, MD 20892, 301–435– 

1743, sipej@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; ODCS 

Member Conflicts. 

Date: November 17, 2010. 

Time: 3 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Priscilla B. Chen, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4104, 

MSC 7814, Bethesda, MD 20892, (301) 435– 

1787, chenp@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Fellowship: 

Genes, Genomes, and Genetics. 

Date: November 18–19, 2010. 

Time: 8 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications, 

Place: Hyatt at Fisherman’s Wharf, 555 

North Point Street, San Francisco, CA 94133. 

Contact Person: Michael A. Marino, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2216, 

MSC 7890, Bethesda, MD 20892, (301) 435– 

0601, marinomi@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR–10– 

082: Shared Instrumentation: S10 Flow 

Cytometry Review. 

Date: November 18–19, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance Baltimore Harborplace 

Hotel, 202 East Pratt Street, Baltimore, MD 

21202. 

Contact Person: Jonathan Arias, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5170, 

MSC 7840, Bethesda, MD 20892, 301–435– 

2406, ariasj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Small 

Business: Respiratory Sciences. 

Date: November 18–19, 2010. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Ghenima Dirami, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4122, 

MSC 7814, Bethesda, MD 20892, 301–594– 

1321, diramig@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 22, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–24279 Filed 9–27–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Vaccines and Related Biological 

Products 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). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Vaccines and 

Related Biological Products 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 November 16, 2010, from 9 a.m. 

to approximately 4 p.m. and on 

November 17, 2010, from 8:30 a.m. to 

approximately 1:15 p.m. 

Location: Hilton Silver Spring Hotel, 

Maryland Ballroom, 8727 Colesville Rd., 

Silver Spring, MD 20910. 

Contact Person: Donald W. Jehn or 

Denise Royster, Food and Drug 

Administration, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville, Pike, Rockville, MD 20852, 

301–827–0314, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512391. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 


srobinson on DSKHWCL6B1PROD with NOTICES
59730 Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 

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 November 16, 2010, the 

committee will meet in open session to 

review and discuss the pathway to 

licensure for protective antigen-based 

anthrax vaccines for a post-exposure 

prophylaxis indication using the animal 

rule. On November 17, 2010, the 

committee will meet in open session to 

review and discuss the effectiveness of 

vaccinating males and females with 

Gardasil manufactured by Merck & Co. 

for the prevention of anal dysplasia and 

anal 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: On November 16, 2010, 

from 9 a.m. until approximately 11:45 

a.m. and from 2 p.m. until 

approximately 4 p.m. and on November 

17, 2010, the meeting is open to the 

public. 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 10, 2010. Oral presentations 

from the public will be scheduled 

between approximately 2:15 p.m. and 

2:45 p.m. on November 16, 2010, and 

between approximately 11:45 a.m. and 

12:15 p.m. on November 17, 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 

November 2, 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 3, 2010. 

Closed Committee Deliberations: On 

November 16, 2010, between 12 p.m. 

and approximately 2 p.m., the meeting 

will be closed to permit discussion and 

review of trade secret and/or 

confidential commercial information (5 

U.S.C. 552b(c)(4)). The committee will 

hear firms discuss protocols they 

propose to use for the pathway to 

licensure for protective antigen-based 

anthrax vaccines for a post-exposure 

prophylaxis indication using the animal 

rule. 

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 Donald W. 

Jehn or Denise Royster 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/About

AdvisoryCommittees/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: September 23, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–24253 Filed 9–27–10; 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 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 October 21, 2010, from 8:30 

a.m. to 4:30 p.m. and on October 22, 

2010, from 8:30 a.m. to 4 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: Kalyani Bhatt, 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, email: 

kalyani.bhatt@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 committee will discuss 

considerations for the design of 

postmarketing studies for new drug 

applications (NDAs) 22–272, OxyContin 

(oxycodone hydrochloride controlledrelease) Tablets, manufactured by 

Purdue Pharma, Inc., and NDA 22–321, 

EMBEDA (morphine sulfate extendedrelease with a sequestered naltrexone 

hydrochloride inner core) Capsules, 

manufactured by Alpharma 

Pharmaceuticals, LLC and King 

Pharmaceuticals Research & 

Development, Inc., approved for the 

management of moderate to severe pain 

when a continuous, around-the-clock 

opioid analgesic is needed for an 

extended period of time. The 

postmarketing studies are intended to be 

epidemiological or observational studies 

that will assess the known serious risks 

of these products and whether productspecific properties which are intended 

to discourage misuse and abuse actually 

result in a decrease in the risks of 

misuse and abuse, and their 


srobinson on DSKHWCL6B1PROD with NOTICES