60300 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Notices 

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: 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 December 3, 2008. 

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 November 21, 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 

November 25, 2008. 

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 Elaine 

Ferguson 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 8, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–24199 Filed 10–9–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

General and Plastic Surgery 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: General and 

Plastic Surgery 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 18, 2008, from 8:30 

a.m. to 5 p.m., and November 19, 2008, 

from 8 a.m. to 12:30 p.m. 

Location: Marriott Gaithersburg 

Washingtonian Center, Salons C and D, 

9751 Washingtonian Blvd., 

Gaithersburg, MD. 

Contact Person: Lisa M. Lim, Center 

for Devices and Radiological Health 

(HFZ–410), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–3555, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512519. 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 18, 2008, the 

committee will receive an update on 

safety information collected on dermal 

fillers in the commercial setting, discuss 

current premarket and postmarket 

approved study designs, and make 

recommendations on general issues 

concerning the study of various dermal 

fillers. In addition, the committee will 

discuss the design of clinical trials for 

future premarket submissions seeking 

approval of dermal fillers for new 

intended uses. 

On November 19, 2008, the committee 

will discuss and make 

recommendations on general issues 

related to the clinical trials of cosmetic 

devices. Specifically, the committee will 

make recommendations on how to 

quantify the effects of devices with 

various types of energy sources, such as 

light-based products, light-based 

combination devices, ultrasound 

devices (including focused ultrasound 

devices), massagers combined with 

other energy modalities, cryogenic 

energy devices, radiofrequency ablation 

devices, and microwave systems, on 

dermatologic conditions. 

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: 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, 2008. 

Oral presentations from the public will 

be scheduled between approximately 9 

a.m. and 10 a.m., and between 1:15 p.m. 

and 2:15 p.m. on November 18, 2008, 

and between approximately 8:15 a.m. 

and 9:15 a.m. on November 19, 2008. 

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 

31, 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 November 3, 2008. 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Notices 60301 

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 AnnMarie 

Williams, Conference Management 

Staff, at 240–276–8932 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. 

Dated: October 3, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–24163 Filed 10–9–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, Operation of a Facility to 

Study Influenza Viruses, Vaccines, and 

Antimicrobials. 

Date: October 22, 2008. 

Time: 2:30 p.m. to 6:30 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: Thames E. Pickett, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892–7616, 301–496–2550, 

pickettte@niaid.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS). 

Dated: October 6, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–24211 Filed 10–9–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 

Allergy and Infectious Diseases Special 

Emphasis Panel, Review of an Unsolicited 

P01 Application, 

Date: November 12, 2008, 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 

20817(Telephone Conference Call). 

Contact Person: Quirijn Vos, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892, 301–451–2666, qvos@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS). 

Dated: October 6, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–24212 Filed 10–9–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; 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 

Dental and Craniofacial Research Special 

Emphasis Panel, Review of R21s, R01s. 

Date: November 18, 2008. 

Time: 1:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NIH, 1 Democracy Plaza, 6701 

Democracy Blvd, Room #666, Bethesda, MD 

(Telephone Conference Call). 

Contact Person: Rebecca Wagenaar Miller, 

PhD, Scientific Review Officer, Scientific 

Review Branch, National Inst of Dental & 

Craniofacial Research, National Institutes of 

Health, 6701 Democracy, Rm 666, Bethesda, 

MD 20892, 301–594–0652, 

rwagenaa@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: October 6, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–24213 Filed 10–9–08; 8:45 am] 

BILLING CODE 4140–01–P 

mstockstill on PROD1PC66 with NOTICES