Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 63225-63226 [2013-24832]

Download as PDF emcdonald on DSK67QTVN1PROD with NOTICES Federal Register / Vol. 78, No. 205 / Wednesday, October 23, 2013 / Notices Date and Time: The meeting will be held on November 5, 2013, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993– 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person for More Information: Caleb Briggs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, email: ODAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). 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 at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: During the morning session, there will be a presentation and general discussion of the potential applicability of pharmacological and cellular manipulation of the immune system, as a potential therapeutic intervention in various pediatric cancers. The recent, dramatic results of inhibition of the PD– 1/PD–L1 axis and checkpoint inhibitors on normal T cells in melanoma and other adult cancers strongly suggest a potential role for such agents in the management of childhood cancer. Information will be presented regarding pediatric development plans for two products that are in late stage development for various adult oncology indications. The subcommittee will consider and discuss issues relating to the development of each product for potential pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. The two products under consideration are: (1) Nivolumab, application submitted by Bristol-Myers Squibb Co. and (2) MK–3475, VerDate Mar<15>2010 18:13 Oct 22, 2013 Jkt 232001 application submitted by Merck Sharp & Dohme. During the afternoon session, information will be presented regarding pediatric development plans for LEE011, application submitted by Novartis Pharmaceuticals Corp., a product in early-stage development for adult and pediatric oncology indications. The subcommittee will consider and discuss issues relating to the development of this product for possible pediatric use and provide guidance to facilitate the formulation of Written Requests for pediatric studies, if appropriate. 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/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the subcommittee. Written submissions may be made to the contact person on or before October 30, 2013. Oral presentations from the public will be scheduled between approximately 10:15 a.m. to 10:45 a.m., and 1:20 p.m. to 1:50 p.m. Those individuals interested in making 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 28, 2013. 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 29, 2013. 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 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 63225 accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caleb Briggs 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/ AdvisoryCommittees/ 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 10, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–24798 Filed 10–22–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Ear, Nose and Throat 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: Ear, Nose and Throat 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 8, 2013, from 8 a.m. to 6 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993– 0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. E:\FR\FM\23OCN1.SGM 23OCN1 emcdonald on DSK67QTVN1PROD with NOTICES 63226 Federal Register / Vol. 78, No. 205 / Wednesday, October 23, 2013 / Notices For those unable to attend in person, the meeting will also be Webcast. The Webcast will be available at the following link: https:// collaboration.fda.gov/entdevices. Contact Person: Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver Spring, MD 20993, 301– 796–5290, Natasha.Facey@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). 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 at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On November 8, 2013, the committee will discuss, make recommendations, and vote on information regarding the premarket approval (PMA) application for the Nucleus® HybridTM L24 Implant System sponsored by Cochlear Americas. The proposed Indications for Use for the Nucleus® HybridTM L24 Implant System (as stated in the PMA) is as follows: The Nucleus® HybridTM L24 Implant System is intended for patients aged 18 years and older who have residual lowfrequency hearing sensitivity and bilateral severe to profound high frequency sensorineural hearing loss, and who obtain limited benefit from bilateral hearing aids. 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/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting 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 31, 2013. Oral presentations from the public will VerDate Mar<15>2010 18:13 Oct 22, 2013 Jkt 232001 be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making 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 22, 2013. 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 24, 2013. 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 at AnnMarie.Williams@ fda.hhs.gov or 301–796–5966 at least 7 days in advance of the meeting. Requests for sign language interpretation or Communication Access Realtime Translation (CART)/captioning must be made 2 weeks in advance of the meeting, no later than October 25, 2013. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ 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 18, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–24832 Filed 10–22–13; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1137] GlaxoSmithKline LLC; Withdrawal of Approval of the Indication for Treatment of Patients With Relapsed or Refractory, Low Grade, Follicular, or Transformed CD20 Positive NonHodgkin’s Lymphoma Who Have Not Received Prior Rituximab; BEXXAR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of the indication for treatment of patients with relapsed or refractory, low grade, follicular, or transformed CD20 positive non-Hodgkin’s lymphoma who have not received prior rituximab, for BEXXAR (tositumomab and iodine I 131 tositumomab) Injection held by GlaxoSmithKline LLP, P.O. Box 5089, 1250 South Collegeville Rd., Collegeville, PA 19426 (Glaxo). Glaxo has voluntarily requested that approval of this indication be withdrawn and has waived its opportunity for a hearing. DATES: Effective October 23, 2013. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993–0002, 301– 796–3601. SUPPLEMENTARY INFORMATION: FDA approved BEXXAR on June 27, 2003, for the treatment of patients with CD20 positive, relapsed or refractory, lowgrade, follicular, or transformed nonHodgkin’s lymphoma who have progressed during or after rituximab therapy. On December 22, 2004, FDA approved a new indication to include patients who have not received prior ¨ rituximab (the rituximab-naıve indication) under the Agency’s accelerated approval regulations for biological products, 21 CFR part 601, subpart E. On December 13, 2011, FDA requested that Glaxo voluntarily ¨ withdraw the rituximab-naıve indication for BEXXAR (tositumomab and iodine I 131 tositumomab) Injection because the postmarketing study intended to verify clinical benefit and required as a condition of approval under part 601, subpart E was not completed. Withdrawal of approval of ¨ the rituximab-naıve indication does not otherwise affect the approved indication for BEXXAR. SUMMARY: E:\FR\FM\23OCN1.SGM 23OCN1

Agencies

[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63225-63226]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24832]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Ear, Nose and Throat 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: Ear, Nose and Throat 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 8, 2013, from 8 
a.m. to 6 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 
20993-0002. Information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You,'' click on ``Public Meetings at the FDA White Oak 
Campus.'' Please note that visitors to the White Oak Campus must enter 
through Building 1.

[[Page 63226]]

    For those unable to attend in person, the meeting will also be 
Webcast. The Webcast will be available at the following link: https://collaboration.fda.gov/entdevices.
    Contact Person: Natasha Facey, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, rm. 1544, Silver Spring, MD 20993, 301-796-5290, 
Natasha.Facey@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: On November 8, 2013, the committee will discuss, make 
recommendations, and vote on information regarding the premarket 
approval (PMA) application for the Nucleus[supreg] HybridTM 
L24 Implant System sponsored by Cochlear Americas. The proposed 
Indications for Use for the Nucleus[supreg] HybridTM L24 
Implant System (as stated in the PMA) is as follows:
    The Nucleus[supreg] HybridTM L24 Implant System is 
intended for patients aged 18 years and older who have residual low-
frequency hearing sensitivity and bilateral severe to profound high 
frequency sensorineural hearing loss, and who obtain limited benefit 
from bilateral hearing aids.
    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/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
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 31, 2013. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those individuals interested in 
making 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 22, 2013. 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 24, 2013.
    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 at 
AnnMarie.Williams@fda.hhs.gov or 301-796-5966 at least 7 days in 
advance of the meeting. Requests for sign language interpretation or 
Communication Access Realtime Translation (CART)/captioning must be 
made 2 weeks in advance of the meeting, no later than October 25, 2013.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/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 18, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-24832 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P
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