Research Review Subcommittee of the Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 25593 [E6-6508]

Download as PDF Federal Register / Vol. 71, No. 83 / Monday, May 1, 2006 / Notices based on internal pilot testing of the survey instrument at the agency. Dated: April 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–6461 Filed 4–28–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Research Review Subcommittee of the Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. cchase on PROD1PC60 with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of the Subcommittee: Research Review Subcommittee of the 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 May 19, 2006, from 8 a.m. to 4:30 p.m. Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. Contact Person: Christine Walsh 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), code 3014512391. Please call the Information Line for up-to-date information on this meeting. Agenda: On May 19, 2006, the subcommittee will listen to presentations about the research program at the Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). The program is intended to provide dynamic, responsive, cutting edge research to contribute to OVRR’s regulatory mission and facilitate development of safe and effective biological products. The subcommittee will discuss the program and make recommendations to the Vaccines and Related Biological Products Advisory VerDate Aug<31>2005 18:29 Apr 28, 2006 Jkt 208001 Committee at a future open meeting of the full committee. Information regarding CBER’s scientific program is outlined in its Strategic Plan of 2004 and is available to the public on the Internet at: https://www.fda.gov/cber/ inside/mission.htm. Information regarding FDA’s Critical Path to New Medical Products is available to the public on the Internet at: https:// www.fda.gov/oc/initiatives/ criticalpath/. Procedure: On May 19, 2006, from 8 a.m. to 1 p.m., the meeting is open to the public. 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 by May 12, 2006. Oral presentations from the public will be scheduled between approximately 12 p.m. to 1 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 12, 2006, 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. Closed Committee Deliberations: On May 19, 2006, from 2 p.m. to 4:30 p.m., the meeting will be closed to the public. The meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6) and to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4). The subcommittee will discuss internal research programs in the Office of Vaccines Research and Review, CBER. 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 Christine Walsh or Denise Royster at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 25593 Dated: April 21, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–6508 Filed 4–28–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 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 May 18, 2006, from 9 a.m. to 4:45 p.m. Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. Contact Person: Christine Walsh 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), code 3014512391. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will hear presentations and make recommendations on the safety and efficacy of GARDASIL (Human Papillomavirus [Types 6,11,16,18] Recombinant Vaccine) manufactured by Merck. 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 by May 11, 2006. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral E:\FR\FM\01MYN1.SGM 01MYN1

Agencies

[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)]
[Notices]
[Page 25593]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6508]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Research Review Subcommittee of the 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). At least one 
portion of the meeting will be closed to the public.
    Name of the Subcommittee: Research Review Subcommittee of the 
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 May 19, 2006, from 8 
a.m. to 4:30 p.m.
    Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry 
Pkwy., Gaithersburg, MD 20877.
    Contact Person: Christine Walsh 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), code 3014512391. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On May 19, 2006, the subcommittee will listen to 
presentations about the research program at the Office of Vaccines 
Research and Review (OVRR), Center for Biologics Evaluation and 
Research (CBER). The program is intended to provide dynamic, 
responsive, cutting edge research to contribute to OVRR's regulatory 
mission and facilitate development of safe and effective biological 
products. The subcommittee will discuss the program and make 
recommendations to the Vaccines and Related Biological Products 
Advisory Committee at a future open meeting of the full committee. 
Information regarding CBER's scientific program is outlined in its 
Strategic Plan of 2004 and is available to the public on the Internet 
at: https://www.fda.gov/cber/inside/mission.htm. Information regarding 
FDA's Critical Path to New Medical Products is available to the public 
on the Internet at: https://www.fda.gov/oc/initiatives/ criticalpath/.
    Procedure: On May 19, 2006, from 8 a.m. to 1 p.m., the meeting is 
open to the public. 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 by May 12, 2006. 
Oral presentations from the public will be scheduled between 
approximately 12 p.m. to 1 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before May 12, 2006, 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.
    Closed Committee Deliberations: On May 19, 2006, from 2 p.m. to 
4:30 p.m., the meeting will be closed to the public. The meeting will 
be closed to permit discussion where disclosure would constitute a 
clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6) 
and to permit discussion and review of trade secret and/or confidential 
information (5 U.S.C. 552b(c)(4). The subcommittee will discuss 
internal research programs in the Office of Vaccines Research and 
Review, CBER.
    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 Christine Walsh or 
Denise Royster at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 21, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-6508 Filed 4-28-06; 8:45 am]
BILLING CODE 4160-01-S

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