BETHESDA, Md. — The FDA’s Vaccines and Related Biological Products Advisory Committee will meet Feb. 22 to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2010-11 influenza season.
The committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.
Interested people 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 Feb. 19.
Oral presentations from the public will be scheduled between approximately 11:20 a.m. and 12:20 p.m.
Those who want 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 Feb. 11.
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, the FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.
The contact person, Christine Walsh, will notify interested persons regarding their request to speak by Feb. 12.
Walsh’s address is 1401 Rockville Pike, HFM-71, Rockville, MD 20852. She can also be reached by phone at ?301-827-0314?, by fax at 301-827-0294 or by ?e-mail at Christine.Walsh@fda.hhs.gov
For up-to-date information on this meeting, call the FDA Advisory Committee Information Line? at 800-741-8138 or 301-443-0572.
The FDA intends to make background material available to the public no later than two business days before the meeting.
