Oncologic Drugs Advisory Committee; Cancellation, 63839 [2012-25503]

Download as PDF Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Notices Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: October 11, 2012. Leslie Kux, Assistant Commissioner for Policy. Food and Drug Administration [Docket No. FDA–2012–N–0001] Oncologic Drugs Advisory Committee; Cancellation Food and Drug Administration, HHS. Notice. The meeting of the Oncologic Drugs Advisory Committee Meeting scheduled for November 8, 2012, is canceled. This cancellation applies to both the morning session and afternoon session of the meeting. This meeting was announced in the Federal Register of September 20, 2012 (77 FR 58399). The issues for which the FDA was seeking the scientific input of the committee have been resolved. SUMMARY: FOR FURTHER INFORMATION CONTACT: mstockstill on DSK4VPTVN1PROD with NOTICES 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), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. Dated: October 12, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. BILLING CODE 4160–01–P VerDate Mar<15>2010 18:49 Oct 16, 2012 Jkt 229001 Vaccines and Related Biological Products Advisory Committee; Notice of Meeting ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2012–25503 Filed 10–16–12; 8:45 am] [Docket No. FDA–2012–N–0001] Food and Drug Administration, HHS. BILLING CODE 4160–01–P ACTION: Food and Drug Administration AGENCY: [FR Doc. 2012–25494 Filed 10–16–12; 8:45 am] AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES 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: Vaccines and Related Biological Products 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 14, 2012, between approximately 8:30 a.m. and 4 p.m. and on November 15, 2012, between approximately 8:30 a.m. and 2:30 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. For those unable to attend in person, the meeting will also be Web cast. The link for the Web cast is available at: https://collaboration.fda.gov/vrbpac. Contact Person for More Information: Donald W. Jehn or Denise Royster, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 63839 information line to learn about possible modifications before coming to the meeting. Agenda: On November 14, 2012, the committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November 15, 2012, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax. 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 November 7, 2012. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2 p.m. on November 14, 2012, and between approximately 12:15 p.m. and 12:45 p.m. on November 15, 2012. 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 30, 2012. 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 31, 2012. 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 E:\FR\FM\17OCN1.SGM 17OCN1

Agencies

[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Notices]
[Page 63839]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25503]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Oncologic Drugs Advisory Committee; Cancellation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The meeting of the Oncologic Drugs Advisory Committee Meeting 
scheduled for November 8, 2012, is canceled. This cancellation applies 
to both the morning session and afternoon session of the meeting. This 
meeting was announced in the Federal Register of September 20, 2012 (77 
FR 58399). The issues for which the FDA was seeking the scientific 
input of the committee have been resolved.

FOR FURTHER INFORMATION CONTACT: 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), and follow the prompts to the desired center or 
product area. Please call the Information Line for up-to-date 
information on this meeting.

    Dated: October 12, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-25503 Filed 10-16-12; 8:45 am]
BILLING CODE 4160-01-P

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