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  4. POSTPONED- Blood Products Advisory Committee April 2-3, 2020 Meeting Announcement - 04/02/2020 - 04/03/2020
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Advisory Committee Meeting

Event Title
POSTPONED- Blood Products Advisory Committee April 2-3, 2020 Meeting Announcement
April 2 - 3, 2020

Postponed

Date:
April 2 - 3, 2020
Day1:
- ET
Day2:
- ET
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States



UPDATED INFORMATION (as of 3/11/2020): The FDA, like other government agencies, is taking the necessary steps to ensure the agency is prepared to continue our vital public health mission in the event that our day-to-day operations are impacted by the COVID-19 public health emergency. Therefore, we are canceling or postponing all non-essential meetings through the month of April. We will reassess on an ongoing basis for future months. Where possible the agency will leverage technology to host meetings allowing for remote participation.

The April 2-3, 2020 meeting of the Blood Products Advisory Committee is postponed

Please contact Christina Vert, MS, Designated Federal Officer, via email (christina.vert@fda.hhs.gov) or phone (240-402-8054) with questions.

 

Agenda
On April 2, 2020, in the morning, the BPAC will meet in open session to discuss and make recommendations on strategies to reduce the risk of Zika virus (ZIKV) transmission by blood and blood components. The committee will discuss whether universal testing of blood donations for ZIKV is an appropriate strategy considering the decline of ZIKV cases in the U.S. and worldwide. In the afternoon, the committee will meet in open session to hear an update on the Transfusion Transmissible Infections Monitoring System (TTIMS).  Sponsored by the FDA, National Heart, Lung and Blood Institute and Office of the Assistant Secretary for Health, TTIMS collects incidence, prevalence and risk factor data for certain transfusion-transmitted infections, including HIV, in U.S. blood donations. 

On April 3, 2020, the committee will meet in open session to discuss and make recommendations on testing for hepatitis B surface antigen (HBsAg) in blood donations.  The committee will discuss whether testing for HBsAg can be discontinued considering the sensitivity of hepatitis B virus nucleic acid testing and hepatitis B anti-core testing of blood donations in the U.S.

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.

  • Written submissions may be made to the contact person on or before March 25, 2020.
  • On April 2, 2020, oral presentations from the public will be scheduled between approximately 10:50 a.m. to 11:20 a.m. and 3:15 p.m. to 3:45 p.m.
  • On April 3, 2020, oral presentations from the public will be scheduled between approximately 11:00 a.m. to 11:30 a.m.
  • Those individuals interested in making 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 March 16, 2020. 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 March 17, 2020.

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

Webcast Information
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 held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. The link for the webcast (both days) is available for both days at:  https://collaboration.fda.gov/bpacapril20/

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.

Information regarding ground transportation, airport information, lodging, driving directions; visitor parking and security can be accessed at the Public Meetings at White Oak main page.

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

FR Notice: MEETING IS POSTPONED


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 April 2-3, 2020 Meeting Waivers for Conflicts of Interest pdf (39.10 KB) FDA