60706 Federal Register / Vol. 73, No. 199 / Tuesday, October 14, 2008 / Notices 

DATES: Submit written or electronic 

comments by October 20, 2008. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

James R. Hunter, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5146, 

Silver Spring, MD 20993–0002, 301– 

796–3156, e-mail: 

james.hunter@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The United States is a party to the 

1971 Convention on Psychotropic 

Substances (the Psychotropic 

Convention). Article 2 of the 

Psychotropic Convention provides that 

if a party to the convention or the World 

Health Organization (WHO) has 

information about a substance, which in 

its opinion may require international 

control or changes in such control, it 

should notify the Secretary-General of 

the United Nations (the SecretaryGeneral) and provide the SecretaryGeneral with information in support of 

its opinion. 

The Controlled Substances Act (21 

U.S.C. 811 et seq.) (Title II of the 

Comprehensive Drug Abuse Prevention 

and Control Act of 1970) provides that 

when WHO notifies the United States 

under Article 2 of the Psychotropic 

Convention that it has information that 

may justify: (1) Adding a drug or other 

substance to one of the schedules of the 

convention, (2) transferring a drug or 

substance from one schedule to another, 

or (3) deleting it from the schedules, the 

Secretary of State must transmit the 

notice to the Secretary of Health and 

Human Services (the Secretary of HHS). 

The Secretary of HHS must then publish 

the notice in the Federal Register and 

provide opportunity for interested 

persons to submit comments that HHS 

will consider in its preparation of the 

scientific and medical evaluations of the 

drug or substance. 

In the Federal Register of September 

5, 2008 (73 FR 51823), FDA published 

a notice requesting comments on the 

abuse potential, actual abuse, medical 

usefulness, trafficking, and impact of 

scheduling changes on availability for 

medical use of 10 drug substances. 

These comments will be considered in 

preparing the United States’ response to 

WHO regarding the abuse liability and 

diversion of these drugs. WHO will use 

this information to consider whether to 

recommend that certain international 

restrictions be placed on these drugs. 

Interested persons were originally 

given until October 6, 2008, to comment 

on the 10 named drug substances. 

II. Request for Comments 

Following publication of the 

September 5, 2008, notice, FDA 

received a request to allow interested 

persons additional time to comment. 

The requester asserted that the time 

period for comments was insufficient to 

respond fully to FDA’s specific request 

for comments and to allow potential 

respondents to thoroughly evaluate and 

address pertinent issues. Therefore, 

FDA has decided to reopen the 

comment period on the notice until 

October 20, 2008, to allow the public 

more time to review and comment on its 

contents. 

III. How to Submit Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the ten drug 

substances. Submit a single copy of 

electronic comments to http:// 

www.regulations.gov or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: October 7, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–24264 Filed 10–10–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

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). At least one portion of the 

meeting will be closed 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 November 13 and 14, 2008, 

from 8 a.m. to 4:30 p.m. 

Location: Holiday Inn, The Ballrooms, 

Two Montgomery Village Ave., 

Gaithersburg, MD. The hotel phone 

number is 301–948–8900. 

Contact Person: Kalyani Bhatt, Center 

for Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane, (for express delivery, 

5630 Fishers Lane, rm. 1093) Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6776, e-mail: 

Kalyani.Bhatt@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in 

Washington, DC area), codes 

3014512529 or 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 hot line/phone 

line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On November 13 and 14, 

2008, the committees will begin with a 

closed session, from 8 a.m. to 9:15 a.m. 

Following the closed session, from 9:15 

a.m. to 4:30 p.m., the meeting will be 

open to the public. On November 13, 

2008, the committees will discuss new 

drug application (NDA) 22–324, 


jlentini on PROD1PC65 with NOTICES
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. 


jlentini on PROD1PC65 with NOTICES