Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices 61139 

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 26, 2008. 

Oral presentations from the public will 

be scheduled between approximately 

8:30 a.m. and 9 a.m., and between 

approximately 3:30 p.m. and 4 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 18, 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 19, 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 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. 

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. E8–24357 Filed 10–14–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Pediatric 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: Pediatric 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. The committee 

also advises and makes 

recommendations to the Secretary under 

45 CFR 46.407 on research involving 

children as subjects that is conducted or 

supported by the Department of Health 

and Human Services, when that 

research is also regulated by FDA. 

Date and Time: The meeting will be 

held on Tuesday, November 18, 2008, 

from 8 a.m. to 5 p.m. 

Location: Holiday Inn Gaithersburg, 2 

Montgomery Village Rd., Gaithersburg, 

MD 20877. 

Contact Person: Carlos Pen ̃ a, Office of 

Science and Health Coordination, Office 

of the Commissioner (HF–33), Food and 

Drug Administration, 5600 Fishers 

Lane, (for express delivery, rm. 14B–08), 

Rockville, MD 20857, 301–827–3340, email: carlos.pen ̃ a@fda.hhs.gov, 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 November 18, 2008, the 

Pediatric Advisory Committee will hear 

and discuss reports by the agency, as 

mandated in section 17 of the Best 

Pharmaceuticals for Children Act 

(BPCA), on adverse event reports for 

BETOPTIC S (betaxolol), ALDARA 

(imiquimod), LAMICTAL (lamotrigine), 

LEVAQUIN (levofloxacin), 

SANDOSTATIN (octreotide), ZYPREXA 

(olanzapine), RISPERDAL (risperidone), 

LAMISIL (terbinafine), TIMOLOL GFS 

(timolol), and AMBIEN (zolpidem). The 

committee will be provided a written 

followup report on ZYVOX (linezolid), 

as requested by the committee at the 

November 16, 2006, Pediatric Advisory 

Committee meeting. The committee will 

also be updated on other activities, 

including the June 9 and 10, 2008, 

Pediatric Ethics Subcommittee meeting. 

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 October 27, 2008. 

Oral presentations from the public will 

be scheduled between approximately 

1:30 p.m. and 2:30 p.m. on November 

18, 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 17, 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 20, 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 Carlos Pen ̃ a 


jlentini on PROD1PC65 with NOTICES
61140 Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices 

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 7, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–24356 Filed 10–14–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Request for Nominations for Voting 

Members on Public Advisory Panels or 

Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting members to 

serve on the Device Good 

Manufacturing Practice Advisory 

Committee, certain device panels of the 

Medical Devices Advisory Committee, 

the National Mammography Quality 

Assurance Advisory Committee, and the 

Technical Electronic Products Radiation 

Safety Standards Committee in the 

Center for Devices and Radiological 

Health. Nominations will be accepted 

for current vacancies and those that will 

or may occur through August 31, 2009. 

FDA has a special interest in ensuring 

that women, minority groups, and 

individuals with disabilities are 

adequately represented on advisory 

committees and, therefore, encourages 

nominations of qualified candidates 

from these groups. 

DATES: Because scheduled vacancies 

occur on various dates throughout each 

year, no cutoff date is established for the 

receipt of nominations. However, when 

possible, nominations should be 

received at least 6 months before the 

date of scheduled vacancies for each 

year, as indicated in this notice. 

ADDRESSES: All nomination for 

membership should be sent 

electronically to CV@OC.FDA.GOV, or 

by mail to Advisory Committee 

Oversight & Management Staff (HF–4), 

5600 Fishers Lane, rm. 15A–12, 

Rockville, MD 20857. Information about 

becoming a member on a FDA advisory 

committee can also be obtained by 

visiting FDA’s Web site at http:// 

www.fda.gov/oc/advisory/default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen L. Walker, Center for Devices 

and Radiological Health (HFZ–17), Food 

and Drug Administration, 7520 Standish 

Pl., (MPN1), Rockville, MD 20855, 240– 

276–8938, e-mail: 

Kathleen.Walker@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Vacancies 

FDA is requesting nominations of 

voting members for vacancies listed as 

follows: 

TABLE 1. 

Committee/Panel and Expertise Needed 

Current & 

Upcoming 

Vacancies 

Approximate Date 

Needed 

Dental Products Panel of the Medical Devices Advisory Committee—dentists, engineers, and scientists who 

have expertise in the areas of dental implants, dental materials, periodontology, tissue engineering, and 

dental anatomy 

3 Immediately 

Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee—experts with broad, 

cross-cutting scientific, clinical, analytical, or mediation skills 

1 Immediately 

1 October 1, 2008 

Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee—otologists, 

neurotologists, audiologists 

3 November 1, 2008 

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee—transplant specialists, gastroenterologists, urologists, and nephrologists 3 January 1, 2009 

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee—surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic, and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians 2 September 1, 2009 

Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee—hematologists (benign and/or malignant hematology), hematopathologists (general and special hematology, coagulation and 

homeostasis, and hematological oncology), gynecologists with special interests in gynecological oncology, 

cytopathologists, and molecular pathologists with special interests in development of predictive and prognostic biomarkers 

2 Immediately 

2 March 1, 2009 

Immunology Devices Panel of the Medical Devices Advisory Committee—persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, 

or clinical laboratory medicine 

1 Immediately 

2 March 1, 2009 


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