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Agenda
On the morning of November 17, 2016, the Committee will meet in open session to discuss strategies to manage iron deficiency associated with blood donation. The Committee will also discuss proposed procedures for assuring donor safety for collections of blood from female donors with hemoglobin values of 12.0-12.4g/dL or a hematocrit value between 36 and 38. In the afternoon, the Committee will meet in open session to discuss adverse reactions related to blood donation in teenage (16 to 18 years) donors, and the effectiveness of several mitigation measures. On November 18, 2016, the Committee will meet in open session to hear an informational session on Zika virus and blood safety in the United States. Following the informational session, the Committee will hear presentations on the following topics: (1) The Transfusion Transmissible Infections Monitoring System; (2) a summary of the FDA workshop on new methods to predict the immunogenicity of therapeutic coagulation proteins; and (3) a summary of the FDA workshop on preclinical evaluation of red blood cells for transfusion.

Meeting Materials
Materials for this meeting will be available at Blood, Vaccines and Other Biologics Advisory Committee main 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 November 4, 2016
• Oral presentations on November 17, 2016 from the public will be scheduled between approximately 11:00 a.m. to 11:45 p.m. and 4:00 p.m. to 4:30 p.m. Oral presentations on November 18, 2016 from the public will be scheduled between approximately 10:30 a.m. to 11:00 a.m. and 12:30 p.m. to 1:00 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 October 27, 2016. 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 October 28, 2016.
• For those unable to attend in person, the meeting will also be Web cast. The Web cast will be available at the following link.
  Blood Products Advisory Committee meeting November 17-18, 2016

Contact Information

• Bryan Emery or Joanne Lipkind
  10903 New Hampshire Ave., Bldg. 71, rm. 6132, Silver Spring, MD 20993-0002, 240-402-8054
  e-mail: Bryan.Emery@fda.hhs.gov or email: Joanne.Lipkind@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. November 17, 2016 and 8:30 a.m. November 18, 2016 at the link 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 Joanne Lipkind 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). Official FR Notice

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