Advisory Committee Meeting
Event Title
Blood Products Advisory Committee July 18-19, 2018 Meeting Announcement
July 17 - 18, 2018
- Date:
- July 17 - 18, 2018
- Time:
-
8:00 AM - 3:00 PM ET
- Location:
-
Event LocationWhite Oak Campus: The Great Room
Conference Center
10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States
Agenda
On July 18, 2018, the Blood Products Advisory Committee will meet in open session to discuss and provide advice regarding bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. The Committee will discuss the available strategies to control the risk of bacterial contamination of platelets with 5-day and 7-day dating, including bacterial testing using culture-based devices and rapid bacterial detection devices and implementation of pathogen reduction technology.
On July 19, 2018, the Committee will function as a medical device panel. The Committee will meet in open session to discuss and provide advice regarding the device reclassification from class III to class II of nucleic acid and serology-based point-of-care and laboratory-based in vitro diagnostic devices indicated for use as aids in the diagnosis of human immunodeficiency virus (HIV) infection. The devices that will be discussed by the Committee during the meeting are post-amendment devices that currently are classified into class III under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)).
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 July 11, 2018.
- Oral presentations on July 18, 2018 from the public will be scheduled between approximately
2:15 p.m. to 3:15 p.m. Oral presentations on July 19, 2018 from the public will be scheduled between approximately 12:30 p.m. to 1:30 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 July 5, 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
July 6, 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 July 18-19, 2018:
https://collaboration.fda.gov/bpac0718/
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 approximately 2 weeks and 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. July 18, 2018 and 8:00 a.m. July 19, 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
Day 1
Day 2
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).