Federal Register: March 14, 2011 (Volume 76, Number 49)


Page 13646

From the Federal Register Online via GPO Access []


Page 13646


Food and Drug Administration

Docket No. FDA-2011-N-0002

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 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 April 6, 2011, between approximately 9 a.m. and 4 p.m. and on April 7, 2011, between approximately 8:30 a.m. and 3:30 p.m.

Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry

Pkwy., Gaithersburg, MD 20877.

Contact Person: 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), and follow the prompts to the desired center or product area. 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 the morning of April 6, 2011, the committee will meet in open session to hear updates of the research programs in the Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and

Allergenic Products, Office of Vaccines Research and Review, Center for

Biologics Evaluation and Research, FDA. In the afternoon of April 6, 2011, the committee will meet in open session and will be briefed on the use of immunological markers for demonstration of effectiveness of meningococcal serogroups A, C, Y, and W-135 conjugate vaccines administered to children less than 2 years of age. On April 7, 2011, the committee will meet in open session to review and discuss approaches to licensure of meningococcal serogroup B vaccines.

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 default.htm. Scroll down to the appropriate advisory committee link.

Procedure: On April 6, 2011, from approximately 9 a.m to 10:50 a.m. and from approximately 12:30 p.m to 4 p.m., the meeting is open to the public. On April 7, 2011, the entire 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 on or before March 30, 2011. Oral presentations from the public will be scheduled between approximately 10:20 a.m. and 10:50 a.m. and between approximately 2:30 p.m. and 3 p.m. on April 6, 2011, and between approximately 1:30 p.m. and 2 p.m. on April 7, 2011. 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 March 22, 2011. 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 March 23, 2011.

Closed Committee Deliberations: On April 6, 2011, between approximately 10:50 a.m. and 11:30 a.m., 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)). The committee will discuss the report of the intramural research programs and make recommendations regarding personnel staffing decisions.

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 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

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: March 4, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

FR Doc. 2011-5727 Filed 3-11-11; 8:45 am