September 20-21, 2012: Meeting of the Blood Products Advisory Committee Announcement

Center	Date	Time	Location
CBER	September 20-21, 2012	September 20 from 8:00 a.m. to approximately 5:00 p.m. September 21 from 8:00 a.m. to approximately 4:00 p.m.	5630 Fishers Lane, Room 1066. Rockville, MD 20857

Agenda

On September 20, 2012, the committee will discuss hepatitis E virus and blood transfusion safety. In the afternoon, the committee will discuss Octapharma’s biologics license application for Pooled Plasma (Human, Solvent/Detergent Treated). On September 21, 2012, the committee will discuss considerations for strategies to further reduce the risk of bacterial contamination in Platelets.  In the late afternoon the committee will hear the following update: summary of September 6-7, 2012 public workshop on the risks and benefits of hydroxyethyl starch solutions.

Meeting Materials

Materials for this meeting will be available on the 2012 Meeting Materials, Blood Products Advisory Committee page.

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 September 13, 2012
• Oral presentations on September 20, 2012 from the public will be scheduled between approximately 10:30 a.m. and 11:15 a.m. and in the afternoon between approximately 3:30 p.m. and 4:00 p.m. Oral presentations on September 21, 2012 from the public will be scheduled between 1:00 p.m. and 2:00 p.m. 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 September 5, 2012. 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 6, 2012.
• For those unable to attend in person, the meeting will also be Web cast. The Web cast will be on the 2012 Meeting Materials, Blood Products Advisory Committee page. 
  • Blood Products Advisory Committee Day 1, September 20, 2012
  • Blood Products Advisory Committee Day 2, September 21, 2012

Contact Information

• Bryan Emery or Pearline Muckelvene
  1401 Rockville Pike, HFM-71, Rockville, MD 20852
  301-827-1281 or 301-827-1277
  FAX: 301-827-0294
  e-mail: Bryan.Emery@fda.hhs.gov or email: Pearline.Muckelvene@fda.hhs.gov
• FDA Advisory Committee Information Line
  1-800-741-8138 (301-443-0572 in the Washington, DC, 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. Seating for this meeting may be limited, so the public is encouraged to watch the free webcast if you are unable to attend. The link for the webcast will be available at 8 a.m. each day September 20-21, 2012 at the links above. 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 Bryan Emery or Pearline 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).