51290 Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 

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 Tuesday, December 8, 2009, 

from 8 a.m. to 6 p.m. 

Location: Hilton, Washington, DC/ 

Rockville Executive Meeting Center, 

Plaza Ballroom, 1750 Rockville Pike, 

Rockville, MD 20852. 

Contact Person: Doreen Kezer, Office 

of Medical and Scientific Programs (HF33), Office of the Commissioner, Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827– 

1249, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 8732310001. 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: On December 8, 2009, the 

Pediatric Advisory Committee will meet 

to discuss pediatric-focused safety 

reviews, as mandated by the Best 

Pharmaceuticals for Children Act and 

the Pediatric Research Equity Act, for 

Abilify (aripiprazole), Argatroban 

(argatroban), Orencia (abatacept), 

Humira (adalimumab), Zemuron 

(rocuronium bromide), Cancidas 

(caspofungin acetate), Cardiolite 

(technetium Tc99 sestamibi), Evicel— 

fibrin sealant (human), Artiss—fibrin 

sealant (human), Voluven—6% 

hydroxyethyl starch 130/0.4 in 0.9% 

sodium chloride injection, Reyataz 

(atazanavir sulfate), Kaletra (lopinavir/ 

ritonavir), Aptivus (tipranavir), Zetia 

(ezetimibe), Vytorin (ezetimibe/ 

simvastatin), Ventolin HFA (albuterol 

sulfate). The committee will also receive 

a brief update on atypical antipsychotic 

drugs as requested by the Pediatric 

Advisory Committee Meeting on 

November 18, 2008. 

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 Tuesday, November 

24, 2009. 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 Monday, 

November 16, 2009. 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 Tuesday, November 

17, 2009. 

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 Doreen Kezer 

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: October 1, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24013 Filed 10–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of The Director, National 

Institutes of 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 

Director’s Council of Public 

Representatives. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: Director’s Council of 

Public Representatives. 

Date: October 30, 2009. 

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

Agenda: Key topics for this meeting will 

focus on emerging issues of public 

importance in biomedical and behavioral 

research. Further information will be 

available on the COPR Web site. 

Place: National Institutes of Health, 

Building 31, Conference Room 6, 9000 

Rockville Pike, Bethesda, MD 20852. 

Contact Person: Kelli L. Carrington 

Executive Secretary/Public Liaison Officer, 

Office of Communications and Public 

Liaison, Office of the Director, National 

Institutes of Health, 9000 Rockville Pike, 

Building 1, Room 344, Bethesda, MD 20892, 

301–594–4575, carringkmaiI.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.copr.nih.gov, where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 

Immunodeficiency Syndrome Research Loan 

Repayment Program; 93.187, Undergraduate 

Scholarship Program for Individuals from 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 192 / Tuesday, October 6, 2009 / Notices 51291 

Disadvantaged Backgrounds, National 

Institutes of Health, HHS) 

Dated: September 28, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23800 Filed 10–5–09; 8:45 am] 

BILLING CODE M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on Migrant 

Health; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: National Advisory Council on 

Migrant Health. 

Dates and Times: November 2, 2009, 8:30 

a.m. to 5 p.m.; November 3, 2009, 8:30 a.m. 

to 5 p.m. 

Place: Hilton Hotel, 1750 Rockville Pike, 

Rockville, Maryland 20852, Telephone: (301) 

468–1100, Fax: (301) 468–0308. 

Status: The meeting will be open to the 

public. 

Purpose: The purpose of the meeting is to 

discuss services and issues related to the 

health of migrant and seasonal farmworkers 

and their families and to formulate 

recommendations for the Secretary of Health 

and Human Services. 

Agenda: The agenda includes an overview 

of the Council’s general business activities. 

The Council will also hear presentations 

from experts on farmworker issues, including 

the status of farmworker health at the local 

and national levels. 

Agenda items are subject to change as 

priorities indicate. 

FOR FURTHER INFORMATION CONTACT: 

Gladys Cate, Office of Minority and 

Special Populations, Bureau of Primary 

Health Care, Health Resources and 

Services Administration, 5600 Fishers 

Lane, Rockville, Maryland 20857; 

telephone (301) 594–0367. 

Dated: September 29, 2009. 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E9–24045 Filed 10–5–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Orthopaedic and Rehabilitation 

Devices Panel of the Medical Devices 

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: Orthopaedic and 

Rehabilitation Devices Panel of the 

Medical Devices 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 4, 2009, from 8 a.m. 

to 5 p.m. 

Location: Holiday Inn, Walker/ 

Whetstone Room, Two Montgomery 

Village Ave., Gaithersburg, MD. 

Contact Person: Ronald P. Jean, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Silver 

Spring, MD, 20993, 301–796–5650, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512521. 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: On November 4, 2009, the 

committee will discuss, make 

recommendations and vote on a 

premarket approval application for the 

Dynesys Spinal System, sponsored by 

Zimmer Spine. The Dynesys Spinal 

System is indicated to provide spinal 

alignment and stabilization in skeletally 

mature patients at one or two 

contiguous levels from L1–S1. 

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 on the FDA Internet under the 

appropriate date 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 28, 2009. 

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 October 20, 2009. 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, 2009. 

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 Ann Marie 

Williams, Conference Management 

Staff, 301–796–5966, 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). 


jlentini on DSKJ8SOYB1PROD with NOTICES