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Agenda
On June 22, 2018, in the morning open session, under Topic 1, the Committee will hear presentations on the research programs in the Laboratory of Emerging Pathogens (LEP), Laboratory of bacterial and TSE Agents (LBTSE) and from the Laboratory of Molecular Virology (LMV) in the Division of Emerging Transfusion-Transmitted Diseases (DETTD), Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), FDA. After the conclusion of the open session, the meeting will be closed to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6).

In the afternoon, in open session, under Topic II, the Committee will hear presentations on the research program in the Hemostasis Branch (HB), in the Division of Plasma Protein Therapeutics (DPPT), Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), FDA. After the open session, the meeting will be closed to the public to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6).

Meeting Materials
Materials for this meeting will be available at the Blood Products Advisory Committee meetings 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 June 15, 2018
• Oral presentations on June 22, 2018 from the public will be scheduled between approximately 12:25 p.m. to 12:55 p.m. and from 3:15 p.m. to 3:45 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 June 7, 2018. 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
  June 7, 2018.
• 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 June 22, 2018:
  https://collaboration.fda.gov/bpac0618/

Contact Information

• Bryan Emery or Joanne Lipkind
  10903 New Hampshire Ave., Bldg. 71, rm. 6268, Silver Spring, MD 20993-0002, 240-402-8054
  e-mail: [email protected] or email: [email protected]

• 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.

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. June 22, 2018 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

Recorded Webcast

• Part 1
• Part 2

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