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U.S. Department of Health and Human Services

Advisory Committees

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March 18-19, 2014: Blood Products Advisory Committee Meeting Announcement

CenterDateTimeLocation
CBERMarch 18-19, 2014March 18 from 8:30 a.m. to approximately 4:30 p.m. and March 19 from 9:00 a.m. to 11:30 a.m.FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the great Room (rm. 1503)
Room 1066.
Silver Spring, MD 20993-0002

Agenda
On the morning of March 18, 2014, the committee will meet in open session to discuss the evaluation of the safety and effectiveness of the Immucor PreciseType™ HEA Molecular BeadChip Assay, manufactured by BioArray Solutions Limited.  In the afternoon, the committee will hear update presentations on the following topics:  (1) Report from the Presidential Commission for the Study of Bioethical Issues on the ethical implications of incidental findings in clinical, research, and direct-to-consumer contexts; (2) summary of the January 28-29, 2014, FDA public workshop on immune globulin-associated hemolysis; and (3) a summary of the December 4-5, 2013, HHS Advisory Committee on Blood and Tissue Safety and Availability.  On the morning of March 19, 2014, the committee will meet in open session to hear presentations on the research programs of the Laboratory Hemostasis, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA.

Meeting Materials
Materials for this meeting will be available at the Blood, Vaccines and Other Biologics Advisory Committee 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 11, 2014
  • Oral presentations on March 18, 2014 from the public will be scheduled between approximately 1:30 p.m. and 2:00 p.m.  On March 19, 2014 presentations will be scheduled between approximately 10:30 a.m. and 11:00 a.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 3, 2014.  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 4, 2014.
  • For those unable to attend in person, the meeting will also be Web cast.  The Web cast will be available at the following link.

Contact Information

  • Bryan Emery or Pearline Muckelvene
    1401 Rockville Pike, HFM-71, Rockville, MD 20852
    301-827-1281 or 301-827-1277
    FAX: 301-827-0294
    e-mail: Bryan.Emery@fda.hhs.gov or email: Pearline.Muckelvene@fda.hhs.gov
  • 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. March 18 and 19, 2014 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 Pearline Muckelvene 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