Pediatric Advisory Committee; Notice of Meeting, 61139-61140 [E8-24356]

Download as PDF Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices jlentini on PROD1PC65 with NOTICES meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://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 https://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 VerDate Aug<31>2005 18:32 Oct 14, 2008 Jkt 217001 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 Pena, 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, e˜ mail: carlos.pena@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), PO 00000 Frm 00123 Fmt 4703 Sfmt 4703 61139 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 https://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 Pena E:\FR\FM\15OCN1.SGM 15OCN1 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 https://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: date of scheduled vacancies for each year, as indicated in this notice. 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. 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 DATES: 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 https:// www.fda.gov/oc/advisory/default.htm. ADDRESSES: 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. Current & Upcoming Vacancies Committee/Panel and Expertise Needed 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 1 Immediately 2 March 1, 2009 jlentini on PROD1PC65 with NOTICES 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 VerDate Aug<31>2005 18:32 Oct 14, 2008 Jkt 217001 PO 00000 Frm 00124 Fmt 4703 Sfmt 4703 E:\FR\FM\15OCN1.SGM 15OCN1

Agencies

[Federal Register Volume 73, Number 200 (Wednesday, October 15, 2008)]
[Notices]
[Pages 61139-61140]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24356]


-----------------------------------------------------------------------

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 Pe[ntilde]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, e-mail: 
carlos.pe[ntilde]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 https://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 Pe[ntilde]a

[[Page 61140]]

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 https://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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.