Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 63839-63840 [2012-25484]

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 63840 Federal Register / Vol. 77, No. 201 / Wednesday, October 17, 2012 / Notices 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 Donald W. Jehn or Denise Royster 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, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012–25484 Filed 10–16–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on DSK4VPTVN1PROD 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: Endocrinologic and Metabolic 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 November 7, 2012, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center (Rm. 1503), 10903 New Hampshire Ave., 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/Advisory Committees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the VerDate Mar<15>2010 18:49 Oct 16, 2012 Jkt 229001 White Oak Campus must enter through Building 1. Contact Person: Paul Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, WO31–2417, Silver Spring, MD 20993–0002, (301) 796– 9001, Fax: (301) 847–8533, email: EMDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), to find out further information regarding FDA advisory committee information. 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: The committee will discuss the safety and efficacy of a new drug application (NDA) 200677, pasireotide injection (proposed trade name SIGNIFOR) for subcutaneous administration, submitted by Novartis Pharmaceuticals Corporation. Pasireotide is an analog (a chemical compound that resembles another compound in structure) of somatostatin. The proposed indication (use) for pasireotide injection is the treatment of patients with Cushing’s disease who require medical intervention (Cushing’s disease is a rare medical condition of excessive cortisol secretion that is secondary to a tumor located in the pituitary gland). 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 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 2, 2012. Oral presentations from the public will be scheduled between approximately 1 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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 25, 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 26, 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 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 Paul Tran 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/Advisory Committees/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, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012–25483 Filed 10–16–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming teleconference meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one E:\FR\FM\17OCN1.SGM 17OCN1

Agencies

[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Notices]
[Pages 63839-63840]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25484]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Vaccines and Related Biological Products 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: 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 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

[[Page 63840]]

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 Donald W. Jehn or 
Denise Royster 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, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-25484 Filed 10-16-12; 8:45 am]
BILLING CODE 4160-01-P

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