Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice, 13348-13349 [2013-04535]

Download as PDF 13348 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices Dated: February 22, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–04543 Filed 2–26–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. erowe on DSK2VPTVN1PROD with NOTICES 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: Oncologic Drugs 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 May 2, 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: http://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: 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 http:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting VerDate Mar<15>2010 15:18 Feb 26, 2013 Jkt 229001 link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: During the morning session, the committee will discuss new drug application (NDA) 204408, with the established name tivozanib capsules, submitted by AVEO Pharmaceuticals, Inc. The proposed indication (use) for this product is for the treatment of advanced renal (kidney) cell carcinoma. During the afternoon session, the committee will discuss NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), submitted by Delcath Systems, Inc. The proposed indication (use) for this product is for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver. 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 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 April 18, 2013. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 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 April 10, 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 April 11, 2013. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 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 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 http://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: February 22, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–04542 Filed 2–26–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Science Board to the Food and Drug Administration. This meeting was announced in the Federal Register of January 30, 2013 (78 FR 6332). The amendment is being made to reflect changes in the Date and Time, Agenda, and Procedures portions of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Martha Monser, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 4286, Silver Spring, MD 20993, 301–796–4627, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington DC area). Please call the Information Line for up-to-date information on this meeting. E:\FR\FM\27FEN1.SGM 27FEN1 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices In the Federal Register of January 30, 2013, FDA announced that a meeting of the Science Board to the Food and Drug Administration would be held on February 27, 2013. 1. On page 6332, in the third column, the Date and Time portion of the document is changed to read as follows: Date and Time: The meeting will be held on Wednesday, February 27, 2013, from approximately 8:30 a.m. to 3:45 p.m. 2. On page 6333, in the first column, the Agenda portion of the document is changed to read as follows: Agenda: On February 27, 2013, the Science Board will be provided with updates and/or a draft report from the Center for Devices and Radiological Health Research Review subcommittee and the Global Health subcommittee. Progress updates will be presented regarding the Global Health subcommittee and the recently established Center for Biologics Evaluation and Research Review Postmarketing Safety Review subcommittee. Overviews of genomics activities at the Centers for Food Safety and Applied Nutrition and Veterinary Medicine will be presented, along with plans for an Agencywide working group to address crosscutting genomics activities. Finally, recipients of the fiscal year 2012 Scientific Achievement Awards (selected by the Science Board) will provide overviews of the activities for which the awards were given. 3. On page 6333, in the second column, in the Procedures section, the third sentence is changed to read as follows: Procedures: Oral presentations from the public will be scheduled between approximately 3 p.m. and 3:30 p.m. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. SUPPLEMENTARY INFORMATION: Dated: February 20, 2013. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2013–04535 Filed 2–26–13; 8:45 am] BILLING CODE 4160–01–P erowe on DSK2VPTVN1PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Psychopharmacologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. VerDate Mar<15>2010 15:18 Feb 26, 2013 Jkt 229001 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: Psychopharmacologic Drugs 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 March 21, 2013, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 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: http://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: Minh Doan, 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, PDAC@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 http:// 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 March 21, 2013, the committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Titan Pharmaceuticals, Inc., and its safety and efficacy for the proposed indication of maintenance treatment of opioid dependence. 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 13349 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 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 March 14, 2013. Oral presentations from the public will be scheduled between approximately 1:45 p.m. and 2:45 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 March 6, 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 March 7, 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 Minh Doan 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/ 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). E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13348-13349]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Science Board to the Food and Drug Administration Advisory 
Committee; Amendment of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of meeting of the Science Board to the Food and Drug 
Administration. This meeting was announced in the Federal Register of 
January 30, 2013 (78 FR 6332). The amendment is being made to reflect 
changes in the Date and Time, Agenda, and Procedures portions of the 
document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Martha Monser, Office of the Chief 
Scientist, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, rm. 4286, Silver Spring, MD 20993, 301-796-4627, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington DC area). Please call the Information Line for up-to-
date information on this meeting.

[[Page 13349]]


SUPPLEMENTARY INFORMATION:  In the Federal Register of January 30, 
2013, FDA announced that a meeting of the Science Board to the Food and 
Drug Administration would be held on February 27, 2013.
    1. On page 6332, in the third column, the Date and Time portion of 
the document is changed to read as follows:
    Date and Time: The meeting will be held on Wednesday, February 27, 
2013, from approximately 8:30 a.m. to 3:45 p.m.
    2. On page 6333, in the first column, the Agenda portion of the 
document is changed to read as follows:
    Agenda: On February 27, 2013, the Science Board will be provided 
with updates and/or a draft report from the Center for Devices and 
Radiological Health Research Review subcommittee and the Global Health 
subcommittee. Progress updates will be presented regarding the Global 
Health subcommittee and the recently established Center for Biologics 
Evaluation and Research Review Postmarketing Safety Review 
subcommittee. Overviews of genomics activities at the Centers for Food 
Safety and Applied Nutrition and Veterinary Medicine will be presented, 
along with plans for an Agencywide working group to address 
crosscutting genomics activities. Finally, recipients of the fiscal 
year 2012 Scientific Achievement Awards (selected by the Science Board) 
will provide overviews of the activities for which the awards were 
given.
    3. On page 6333, in the second column, in the Procedures section, 
the third sentence is changed to read as follows:
    Procedures: Oral presentations from the public will be scheduled 
between approximately 3 p.m. and 3:30 p.m.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: February 20, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-04535 Filed 2-26-13; 8:45 am]
BILLING CODE 4160-01-P