Federal Register / Vol. 73, No. 199 / Tuesday, October 14, 2008 / Notices 60707 

REMOXY XRT (oxycodone 

hydrochloride controlled-release) 

Capsules, Pain Therapeutics Inc., and its 

safety for the proposed indication of 

management of moderate to severe pain 

when a continuous, around-the-clock 

analgesic is needed for an extended 

period of time. The controlled-release 

characteristics of this formulation are 

purportedly less easily defeated than 

other formulations of controlled-release 

oxycodone. On November 14, 2008, the 

committees will discuss new drug 

application NDA 22–321, EMBEDA 

(morphine sulfate extended-release with 

sequestered naltrexone hydrochloride) 

Capsules, Alpharma Pharmaceuticals 

L.L.C., and its safety for the proposed 

indication of management of moderate 

to severe chronic pain. The naltrexone 

component of this formulation is 

intended to mitigate abuse of the 

product when attempts are made to 

defeat the controlled-release properties 

of the formulation. 

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/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2008 and scroll down to the 

appropriate advisory committee link. 

Procedure: On November 13 and 14, 

2008, from 9:15 a.m. to 4:30 p.m., 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 October 28, 2008. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. each day. 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 

20, 2008. 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 21, 2008. 

Closed Committee Deliberations: On 

November 13 and 14, 2008, from 8 a.m. 

to 9:15 a.m., the meeting will be closed 

to permit discussion and review of trade 

secret and/or confidential information 

(5 U.S.C. 552b(c)(4)). During these 

sessions, the committees will discuss 

the details of proprietary research 

reports and protocols addressing 

characteristics of different formulations. 

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 301–827–7001 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/ 

oc/advisory/default.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 6, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–24263 Filed 10–10–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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 Institute of 

Child Health and Human Development 

Special Emphasis Panel Program on 

Contraception and Reproductive Health 

Research. 

Date: November 6, 2008. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Gaithersburg Hilton, 620 Perry 

Parkway, Gaithersburg, MD 20877. 

Contact Person: Peter Zelazowski, PhD, 

Scientific Review Officer, Division of 

Scientific Review, Eunice Kennedy Shriver 

National Institute, of Child Health and 

Human Development, NIH, 6100 Executive 

Boulevard, Rm. 5B01, Bethesda, MD 20892– 

7510, 301–435–6902, 

peter.zelazowski@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: October 7, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–24295 Filed 10–10–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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 Institute of 

Child Health and Human Development Initial 

Review Group; Population Sciences 

Subcommittee. 

Date: November 6–7, 2008. 

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

Agenda: To review and evaluate grant 

applications. 


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