Advisory Committee Meeting
Event Title
Blood Products Advisory Committee November 30- December 1, 2017 Meeting Announcement
November 30, 2017 - December 1, 2017
- Date:
- November 30, 2017 - December 1, 2017
- Time:
-
8:30 AM - 12:00 PM ET
- Location:
-
Event LocationTommy Douglas
Conference Center
10000 New Hampshire Ave
Silver Spring, MD 20993
United States
| Center | Date | Time | Location |
|---|---|---|---|
| CBER | November 30- December 1, 2017 | November 30, 2017 from 8:00 a.m. to approximately 5:45 p.m. and December 1, 2017 from 8:00 a.m. to approximately 3:30 p.m. |
10903 New Hampshire Avenue., Building 31 Conference Center, The Great Room, room 1503. Silver Spring, MD 20993-0002 |
Agenda
On November 30, 2017, the committee members will meet in open session to discuss bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. In the afternoon, the Committee will be seated as a device classification panel. In open session, the panel will discuss the appropriate device classification of human leukocyte antigen, human platelet antigen and human neutrophil antigen devices. On December 1, 2017, the committee members will meet in open session to discuss strategies to reduce the risk of transfusion-transmitted Zika virus. In the afternoon, an information session on the Transfusion Transmissible Infections Monitoring System will be presented to the Committee. Finally, the Committee will hear an update presentation on the April 6, 2017 FDA public workshop on emerging tick-borne diseases and blood safety.
Meeting Materials
Materials for this meeting will be available at the 2017 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 November 22, 2017
- Oral presentations on November 30, 2017 from the public will be scheduled between approximately 11:35 a.m. to 12:20 p.m. and 4:15 p.m. to 4:45 p.m. Oral presentations on December 1, 2017 from the public will be scheduled between approximately 10:45 a.m. to 11:30 a.m. and 3:00 p.m. to 3:30 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 November 14, 2017. 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 15, 2017.
- 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 30-December 1, 2017:
https://collaboration.fda.gov/bpac2017
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: [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.
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. December 30, 2017 and 8:00 a.m. November 1, 2017 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
November 30, 2017 Webcast
December 1, 2017 Webcast
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).