Você está na página 1de 1

Federal Register / Vol. 71, No.

83 / Monday, May 1, 2006 / Notices 25593

based on internal pilot testing of the Committee at a future open meeting of Dated: April 21, 2006.
survey instrument at the agency. the full committee. Information Jason Brodsky,
Dated: April 24, 2006. regarding CBER’s scientific program is Acting Associate Commissioner for External
outlined in its Strategic Plan of 2004 Relations.
Jeffrey Shuren,
Assistant Commissioner for Policy. and is available to the public on the [FR Doc. E6–6508 Filed 4–28–06; 8:45 am]
[FR Doc. E6–6461 Filed 4–28–06; 8:45 am]
Internet at: http://www.fda.gov/cber/ BILLING CODE 4160–01–S
inside/mission.htm. Information
BILLING CODE 4160–01–S
regarding FDA’s Critical Path to New
Medical Products is available to the DEPARTMENT OF HEALTH AND
public on the Internet at: http:// HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES www.fda.gov/oc/initiatives/ Food and Drug Administration
criticalpath/.
Food and Drug Administration Procedure: On May 19, 2006, from 8 Vaccines and Related Biological
a.m. to 1 p.m., the meeting is open to Products Advisory Committee; Notice
Research Review Subcommittee of the
the public. Interested persons may of Meeting
Vaccines and Related Biological
Products Advisory Committee; Notice present data, information, or views, AGENCY: Food and Drug Administration,
of Meeting orally or in writing, on issues pending HHS.
before the committee. Written
AGENCY: Food and Drug Administration, ACTION: Notice.
submissions may be made to the contact
HHS. person by May 12, 2006. Oral This notice announces a forthcoming
ACTION: Notice. presentations from the public will be meeting of a public advisory committee
This notice announces a forthcoming scheduled between approximately 12 of the Food and Drug Administration
meeting of a public advisory committee p.m. to 1 p.m. Time allotted for each (FDA). The meeting will be open to the
of the Food and Drug Administration presentation may be limited. Those public.
(FDA). At least one portion of the desiring to make formal oral Name of Committee: Vaccines and
meeting will be closed to the public. presentations should notify the contact Related Biological Products Advisory
Name of the Subcommittee: Research person before May 12, 2006, and submit Committee.
Review Subcommittee of the Vaccines a brief statement of the general nature of General Function of the Committee:
and Related Biological Products the evidence or arguments they wish to To provide advice and
Advisory Committee. present, the names and addresses of recommendations to the agency on
General Function of the Committee: proposed participants, and an FDA’s regulatory issues.
To provide advice and indication of the approximate time Date and Time: The meeting will be
recommendations to the agency on requested to make their presentation. held on May 18, 2006, from 9 a.m. to
FDA’s regulatory issues. 4:45 p.m.
Closed Committee Deliberations: On Location: Hilton Hotel, Washington
Date and Time: The meeting will be
held on May 19, 2006, from 8 a.m. to May 19, 2006, from 2 p.m. to 4:30 p.m., DC North/Gaithersburg, 620 Perry
4:30 p.m. the meeting will be closed to the public. Pkwy., Gaithersburg, MD 20877.
Location: Hilton Hotel, Washington The meeting will be closed to permit Contact Person: Christine Walsh or
DC North/Gaithersburg, 620 Perry discussion where disclosure would Denise Royster, Center for Biologics
Pkwy., Gaithersburg, MD 20877. constitute a clearly unwarranted Evaluation and Research (HFM–71),
Contact Person: Christine Walsh or invasion of personal privacy (5 U.S.C. Food and Drug Administration, 1401
Denise Royster, Center for Biologics 552b(c)(6) and to permit discussion and Rockville Pike, Rockville, MD 20852,
Evaluation and Research (HFM–71), review of trade secret and/or 301–827–0314, or FDA Advisory
Food and Drug Administration, 1401 confidential information (5 U.S.C. Committee Information Line, 1–800–
Rockville Pike, Rockville, MD 20852, 552b(c)(4). The subcommittee will 741–8138 (301–443–0572 in the
301–827–0314, or FDA Advisory discuss internal research programs in Washington, DC area), code
Committee Information Line, 1–800– the Office of Vaccines Research and 3014512391. Please call the Information
741–8138 (301–443–0572 in the Review, CBER. Line for up-to-date information on this
Washington, DC area), code meeting.
Persons attending FDA’s advisory
3014512391. Please call the Information Agenda: The committee will hear
committee meetings are advised that the presentations and make
Line for up-to-date information on this
meeting. agency is not responsible for providing recommendations on the safety and
Agenda: On May 19, 2006, the access to electrical outlets. efficacy of GARDASIL (Human
subcommittee will listen to FDA welcomes the attendance of the Papillomavirus [Types 6,11,16,18]
presentations about the research public at its advisory committee Recombinant Vaccine) manufactured by
program at the Office of Vaccines meetings and will make every effort to Merck.
Research and Review (OVRR), Center for accommodate persons with physical Procedure: Interested persons may
Biologics Evaluation and Research disabilities or special needs. If you present data, information, or views,
(CBER). The program is intended to require special accommodations due to orally or in writing, on issues pending
provide dynamic, responsive, cutting a disability, please contact Christine before the committee. Written
edge research to contribute to OVRR’s Walsh or Denise Royster at least 7 days submissions may be made to the contact
regulatory mission and facilitate in advance of the meeting. person by May 11, 2006. Oral
cchase on PROD1PC60 with NOTICES

development of safe and effective presentations from the public will be


biological products. The subcommittee Notice of this meeting is given under scheduled between approximately 1:30
will discuss the program and make the Federal Advisory Committee Act (5 p.m. and 2:30 p.m. Time allotted for
recommendations to the Vaccines and U.S.C. app. 2). each presentation may be limited. Those
Related Biological Products Advisory desiring to make formal oral

VerDate Aug<31>2005 18:29 Apr 28, 2006 Jkt 208001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\01MYN1.SGM 01MYN1

Você também pode gostar