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Advisory Committee Meeting

Event Title
Blood Products Advisory Committee March 20 - 21, 2019 Meeting Announcement
March 20-21, 2019

Scheduled

Blood Products Advisory Committee March 20 - 21, 2019 Meeting Announcement - 03/20/2019 - 03/21/2019


Date:
March 20-21, 2019
Time:
March 20, 2019
Location:
Event Location
White Oak Campus: The Great Room
The Great Room

10903 New Hampshire Ave
Bldg 31 Conference Center, The Great Room (Rm 1503)
Silver Spring, MD 20993
United States



Center Date Time Location
CBER March 20, 2019 8:00 a.m. to 4:45 p.m. FDA White Oak Campus,
White Oak Conference Center,
Building 31, Great Room (Rm. 1503),
10903 New Hampshire Avenue,
Silver Spring, MD 20993
CBER March 21, 2019 8:30 a.m. to 5:00 p.m. FDA White Oak Campus,
White Oak Conference Center,
Building 31, Great Room (Rm. 1503),
10903 New Hampshire Avenue,
Silver Spring, MD 20993

Agenda
On March 20, 2019, in the morning, 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 the ZIKV epidemic in the U.S. and worldwide. In the afternoon, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Biochemistry and Vascular Biology in the Division of Blood Components and Devices, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.

On March 21, 2019, the committee will meet in open session to discuss blood donation policies regarding men who have sex with men (MSM). The committee will hear presentations on the current epidemiology of HIV in the U.S.; global developments in MSM blood donor deferral policies; and, data on HIV incidence and prevalence among blood donors from the Transfusion-Transmitted Infection Monitoring System. The Committee will discuss a proposed HIV risk questionnaire study.  In addition, the committee will discuss a proposal for the use of pathogen reduction technology as an alternative procedure to a time-based deferral for MSM.

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 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 March 13, 2019.
  • On March 20, 2019, oral presentations from the public will be scheduled between approximately 11:10 a.m. and 11:40 a.m. and 3:15 p.m. to 3:45 p.m. On March 21, 2019, oral presentations from the public will be scheduled between approximately 11:25 a.m. to 11:55 p.m. and again between 3:00 p.m. to 4:00 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 March 5, 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 March 6, 2019.

Closed Committee Deliberations: On March 20, 2019, from 4:00 p.m. to 4:45 p.m., the meeting will be closed to Public to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)).

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/bpac0319

Contact Information

  • Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver Spring, MD 20993-0002, by e-mail: Prabhakara.Atreya@fda.hhs.gov  or by phone 240-402-8006 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 main 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 Prabhakara Atreya 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

Recorded Webcast

  1. March 20, 2019 Day 1 BPAC Meeting
    1. Part 1
    2. Part 2
    3. Part 3
  2. March 21, 2019 Day 2 BPAC Meeting
    1. Part 1
    2. Part 2
    3. Part 3
    4. Part 4


Event Materials

  • Blood Products Advisory Committee March 20-21, 2019 Meeting Draft Agenda (135.47 KB)
  • Blood Products Advisory Committee March 20-21, 2019 Meeting Issue Summary- Topic 3: Blood Donation Policies Regarding Men Who Have Sex with Men (MSM) (459.39 KB)
  • Blood Products Advisory Committee March 20-21, 2019 Meeting Issue Summary- Topic 1: Re-evaluation of Strategies to Reduce the Risk of Zika Virus (ZIKV) Transmission by Blood and Blood Components (350.54 KB)
  • Blood Products Advisory Committee March 20-21, 2019 Meeting Waiver for Conflicts of Interest (20.03 KB)
  • Blood Products Advisory Committee March 20-21, 2019 Meeting Draft Roster (246.21 KB)
  • Blood Products Advisory Committee March 20-21, 2019 Meeting Final Agenda (71.06 KB)
  • Blood Products Advisory Committee March 20-21, 2019 Meeting Final Roster (144.14 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - Evaluation of Strategies to Reduce the Risk of Zika Virus (ZIKV) Transmission by Blood and Blood Components (FDA) (613.53 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - Current Considerations for Reducing the Risk of Transfusion-Transmitted ZIKV (FDA) (201.24 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - Center for Biologics Evaluation and Research Overview (FDA) (814.75 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - Office of Blood Research and Review (OBRR) Overview (FDA) (156.17 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - Overview of the Division of Blood Components and Devices Research Programs (FDA) (447.15 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - Office of Blood Research and Review (OBRR) Overview (FDA) (156.17 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - Overview of the Division of Blood Components and Devices Research Programs (FDA) (447.15 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - Blood Donation Policies Regarding Men Who Have Sex with Men (MSM) - (FDA) (192.22 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - Pathogen Reduction of Platelet Donations as an Alternative Procedure to MSM Donor Deferral (FDA) (236.56 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - The Donor HIV Risk Questionnaire Study (HRQ) - (FDA) (178.73 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - TTIMS: Transfusion-Transmissible Infections Monitoring System - (FDA) (618.59 KB)
  • Blood Products Advisory Committee March 20- 21, 2019 Meeting Presentation - Site Visit Review: Summary Presentation (FDA)

  • 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 agency’s Web site and call the FDA Advisory Committee Information 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 disabilities. If you require accommodations due to a disability, please contact Lauren Tesh at (301) 796-9001 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).