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Advisory Committee Meeting

Event Title
Blood Products Advisory Committee November 22, 2019 Meeting Announcement
November 22, 2019

Scheduled

Date:
November 22, 2019
Time:
8:30 AM - 4:45 PM ET
Location:
Event Location
Tommy Douglas
Conference Center

10000 New Hampshire Ave
Silver Spring, MD 20993
United States



Center Date Time Location
CBER November 22, 2019 8:30 a.m. to 4:45 p.m. Tommy Douglas Conference Center
10000 New Hampshire Avenue
Silver Spring, MD 20993

Agenda
On November 22, 2019, the BPAC will meet in open session to discuss scientific considerations for cold stored platelet products intended for transfusion, including product characterization, duration of storage and clinical indications for use. The committee will hear presentations on available characterization and functional studies of cold stored platelets, clinical studies, and the potential role of cold stored platelets in clinical care in military and civilian patient populations. The committee will also discuss the clinical studies needed to support the indications for use of cold stored platelet products stored beyond 3 days.

Meeting Materials
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 website 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 website after the meeting.

Materials for this meeting will be available at the Blood Products Advisory Committee meeting material page.

Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

  • On November 22, 2019, oral presentations from the public will be scheduled between approximately 2:35 p.m. and 3:35 p.m.
  • Written submissions may be made to the contact person on or before November 13, 2019.
  • 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 November 4, 2019. 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 5, 2019.

For those unable to attend in person, the meeting will also be available via webcast.

Webcast Information- Updated 11/18/19
CBER plans to provide a free of charge, live webcast of the Blood Products Advisory Committee meeting.

While CBER is working to make webcasts available to the public for all advisory committee meetings, there are instances where the webcast transmission may not successful; staff will work to re-establish the transmission as soon as possible.

The link for the webcast is available at: https://www.ustream.tv/channel/Y3bDz3eBTFb

Contact Information

  • Christina Vert, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD  20993-0002, by e-mail: Christina.Vert@fda.hhs.gov or by phone 240-402-8054 or
  • Joanne Lipkind, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6270, Silver Spring, MD  20993-0002, by e-mail: Joanne.Lipkind@fda.hhs.gov; or by phone 240-402-8106
  • 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.

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 Blood Products Advisory Committee meeting material page or 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 Christina Vert at least 7 days in advance of the meeting.

The Tommy Douglas Conference Center is located 1.3 miles from the FDA, driving directions and other information may be accessed at:  https://www.tommydouglascenter.com/.

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

BPAC Meeting Nov 22, 2019


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 website or call the committee’s Designated Federal Officer (see Contact Information) 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 disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings 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).


Event Materials

Title File Type/Size Source Organization
Blood Products Advisory Committee November 22, 2019 Meeting Draft Agenda pdf (61.84 KB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Draft Roster pdf (185.39 KB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Issue Summary- Topic I- Considerations for Cold Stored Platelets Intended for Transfusion pdf (167.04 KB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Waivers for Conflict of Interest pdf (24.42 KB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Issue Summary Questions- Topic I- Considerations for Cold Stored Platelets Intended for Transfusion pdf (46.66 KB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Draft Agenda Revised pdf (42.22 KB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Draft Roster Revised pdf (181.41 KB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Final Agenda pdf (87.61 KB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Final Roster pdf (215.56 KB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Transcript pdf (3.13 MB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Summary Minutes pdf (152.96 KB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Presentation- Considerations for Cold Stored Platelets Intended for Transfusion pdf (419.52 KB) FDA
Blood Products Advisory Committee November 22, 2019 Meeting Presentation- Cold-Stored Platelets Hospital-Based Blood Bank Experience pdf (804.73 KB) FDA