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U.S. Department of Health and Human Services

Advisory Committees

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September 20, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Announcement

Center

Date

Time

Location

CBER

September 20, 2011

September 20, 2011 between approximately 1 p.m. and 4 p.m.

National Institutes of Health (NIH), Building 29B/Conference Room C.

NOTE: This is an amendment to previous meeting announcement

Agenda

On September 20, 2011, the committee will meet in open session via teleconference to hear an overview of the research program in the Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA.

Meeting Materials

Public Participation Information

The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the Internet at http://www.nih.gov/about/visitor/index.htm. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) Visitors must show two forms of identification, one of which must be a government-issued photo identification, one of which must be a government-issued photo identification such as a Federal employee badge, driver’s license, passport, green card, etc. Detailed information about security procedures is located at http://nih.gov/about/visitorsecurity/htm. Due to the limited available parking visitors are encouraged to use public participation.

  • Written submissions may be made to the contact person on or before September 13, 2011.
  • Oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 p.m. Those individuals 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 September 1, 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 September 2, 2011 .

Closed Committee Deliberations:

On September 20, 2011, between approximately 3:30 p.m. and 4:00 p.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.

Contact Information

  • Donald Jehn or Denise Royster
    1401 Rockville Pike, HFM-71, Rockville, MD 20852
    301-827-0314
    FAX: 301-827-0294
    e-mail: Donald.Jehn@fda.hhs.gov or email: denise.royster@fda.hhs.gov
  • 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.

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.

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.

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 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 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).