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
Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices 59731 

consequences: Addiction, overdose, and 

death. 

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 October 14, 2010. 

Oral presentations from the public will 

be scheduled between approximately 

10:45 a.m. and 11:45 a.m. on October 

22, 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 October 6, 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 October 7, 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 Kalyani 

Bhatt 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: September 22, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–24251 Filed 9–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the 

Subcommittee for Planning the Annual 

Strategic Plan Updating Process of the 

Interagency Autism Coordinating 

Committee (IACC). 

The purpose of the Subcommittee 

meeting is to plan the process for 

updating the IACC Strategic Plan for 

Autism Spectrum Disorder Research. 

The meeting will be open to the public 

and will also be accessible by webinar 

and conference call. 

Name of Committee: Interagency Autism 

Coordinating Committee (IACC). 

Type of meeting: Subcommittee for 

Planning the Annual Strategic Plan Updating 

Process. 

Date: October 6, 2010. 

Time: 9 a.m. to 12 p.m. Eastern Time. 

Agenda: To discuss plans for updating the 

IACC Strategic Plan for ASD Research. 

Place: The National Institute of Mental 

Health, Neuroscience Center, 6001 Executive 

Boulevard, Conference Room 8120, 

Rockville, MD 20852. 

Webinar Access: https:// 

www2.gotomeeting.com/register/927802003. 

Registration: http://www.acclaroresearch.

com/oarc/10–06–10_IACC. Pre-registration is 

recommended to expedite check-in. Seating 

in the meeting room is limited to room 

capacity and on a first come, first served 

basis. 

Conference Call: Dial: 888–848–6715, 

Access code: 5341736. 

Contact Person: Ms. Lina Perez, Office of 

Autism Research Coordination, Office of the 

Director, National Institute of Mental Health, 

NIH, 6001 Executive Boulevard, NSC, Room 

8200, Bethesda, MD 20892–9669, Phone: 

(301) 443–6040, E-mail: 

IACCPublicInquiries@mail.nih.gov. 

Please Note: The meeting will be open to 

the public and accessible via webinar and 

conference call. Members of the public who 

participate using the conference call phone 

number will be able to listen to the meeting 

but will not be heard. If you experience any 

technical problems with the conference call, 

please-mail IACCTechSupport@acclaro

research.com. 

If you experience any technical problems 

with the web presentation tool, please 

contact GoToWebinar at (800) 263–6317. To 

access the web presentation tool on the 

Internet the following computer capabilities 

are required: (A) Internet Explorer 5.0 or 

later, Netscape Navigator 6.0 or later or 

Mozilla Firefox 1.0 or later; (B) Windows® 

2000, XP Home, XP Pro, 2003 Server or Vista; 

(C) Stable 56k, cable modem, ISDN, DSL or 

better Internet connection; (D) Minimum of 

Pentium 400 with 256 MB of RAM 

(Recommended); (E) Java Virtual Machine 

enabled (Recommended). 

Individuals who participate in person or by 

using these electronic services and who need 

special assistance, such as captioning of the 

conference call or other reasonable 

accommodations, should submit a request to 

the Contact Person listed on this notice at 

least 7 days prior to the meeting. 

This notice is being published less than 15 

days prior to the meeting due to the urgent 

need for the Subcommittee to discuss the 

upcoming update of the IACC Strategic Plan 

prior to the IACC meeting scheduled for 

October 22, 2010. 

Schedule is subject to change. 

Information about the IACC is available on 

the Web site: http://www.iacc.hhs.gov. 

Dated: September 22, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–24280 Filed 9–27–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Member 

Conflict Review, Program 

Announcement (PA) 07–318, 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: 1 p.m.–3 p.m., November 

15, 2010 (Closed). 

Place: National Institute for 

Occupational Safety and Health 

(NIOSH), CDC, 1095 Willowdale Road, 

Morgantown, West Virginia 26506, 

telephone: (304)285–6143. 

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. 


srobinson on DSKHWCL6B1PROD with NOTICES