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Advisory Committees

November 16-17, 2009: Blood Products Advisory Committee Meeting Announcement











November 16-17, 2009  


November 16, 2009 from 8:00 a.m. to approximately 5:30 p.m.
November 17, 2009 from 8:00 a.m. to approximately 5:00 p.m. 
Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814



On November 16, 2009, in the morning the Committee will hear updates on the following topics: the HHS Advisory Committee on Blood Safety and Availability, Dengue virus outbreak, and 2009 A/H1N1 Pandemic and the impact on blood safety and availability. The Committee will then discuss blood donor deferral for malaria risk associated with travel to Mexico. In the afternoon the Committee will discuss the design of a new phase III study of pathogen inactivation of human platelets using the Cerus, INTERCEPT Blood System. On November 17, 2009, in the morning the Committee will discuss blood pressure and pulse as blood donor eligibility criteria, and in the afternoon the committee will discuss the public health need and performance characteristics of over-the-counter home-use HIV test kits.

Meeting Materials

Public Participation Information

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 November 9, 2009.

Oral presentations from the public will be scheduled between approximately 11:00 a.m. and 11:30 a.m. 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 October 30, 2009. 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 November 2, 2009.

Closed Committee Deliberations

On November 17, 2009, from approximately 3 p.m. until 5 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). The committee will hear presentations and discuss sponsor, trade secret and confidential information.

Contact Information

  • William Freas or Pearline K. Muckelvene
    1401 Rockville Pike, HFM-71, Rockville, MD 20852
    FAX: 301-827-0294
    e-mail: email:
  • FDA Advisory Committee Information Line
    (301-443-0572 in the Washington, DC, area)
    code 3014519516
    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 William Freas or Pearline K. Muckelvene 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).

Page Last Updated: 08/17/2015
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