Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 6187 [E8-1889]

Download as PDF Federal Register / Vol. 73, No. 22 / Friday, February 1, 2008 / Notices industry representative. A current curriculum vitae and the name of the committee of interest should be sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT) within 30 days (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee (persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA has a special interest in ensuring that women, minority groups, individuals with physical disabilities, and small businesses are adequately represented on its advisory committees, and therefore, encourages nominations for appropriately qualified candidates from these groups. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: January 24, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–1815 Filed 1–31–08; 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. mstockstill on PROD1PC66 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: 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 February 20, 2008, from 8:30 a.m. to approximately 4 p.m., and on February 21, 2008 from 8:30 a.m. to approximately 4:30 p.m. Location: Hilton Hotel 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, VerDate Aug<31>2005 18:22 Jan 31, 2008 Jkt 214001 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. 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 and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On February 20, 2008, the committee will discuss and make recommendations on a rotavirus vaccine manufactured by GlaxoSmithKline Biologicals. On February 21, 2008, in the morning, the committee will discuss the selection of strains to be included in the influenza vaccine for the 2008— 2009 influenza season. In the afternoon, the committee will discuss clinical development of influenza vaccines for pandemic and pre-pandemic uses. 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/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and 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 February 13, 2008. Oral presentations from the public will be scheduled between approximately 1 p.m. and 1:30 p.m. on February 20, 2008, and approximately 11:20 a.m. and 11:50 a.m. and 2:45 p.m. and 3:15 p.m. on February 21, 2008. Those desiring to make 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 February 6, 2008. 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 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 6187 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 February 7, 2008. 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. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/ default.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: January 24, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–1889 Filed 1–31–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, February 22, 2008, 8 a.m. to February 22, 2008, 5 p.m., Holiday Inn Georgetown, 2101 Wisconsin Avenue, NW., Washington, DC 20007, which was published in the Federal Register on January 22, 2008, 73 FR 3733–3735. The meeting will be held February 21, 2008, 6 p.m. to February 22, 2008, 7 p.m. The meeting location remains the same. The meeting is closed to the public. Dated: January 25, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08–435 Filed 1–31–08; 8:45 am] BILLING CODE 4140–01–M E:\FR\FM\01FEN1.SGM 01FEN1

Agencies

[Federal Register Volume 73, Number 22 (Friday, February 1, 2008)]
[Notices]
[Page 6187]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-1889]


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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 February 20, 2008, from 
8:30 a.m. to approximately 4 p.m., and on February 21, 2008 from 8:30 
a.m. to approximately 4:30 p.m.
    Location: Hilton Hotel 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. 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 and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On February 20, 2008, the committee will discuss and make 
recommendations on a rotavirus vaccine manufactured by GlaxoSmithKline 
Biologicals. On February 21, 2008, in the morning, the committee will 
discuss the selection of strains to be included in the influenza 
vaccine for the 2008--2009 influenza season. In the afternoon, the 
committee will discuss clinical development of influenza vaccines for 
pandemic and pre-pandemic uses.
    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/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and 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 
February 13, 2008. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 1:30 p.m. on February 20, 2008, and 
approximately 11:20 a.m. and 11:50 a.m. and 2:45 p.m. and 3:15 p.m. on 
February 21, 2008. Those desiring to make 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 
February 6, 2008. 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 February 7, 
2008.
    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.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/
default.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: January 24, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-1889 Filed 1-31-08; 8:45 am]
BILLING CODE 4160-01-S

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