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U.S. Department of Health and Human Services

Advisory Committees

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December 4-5, 2012: Blood Products Advisory Committee Meeting Announcement

Center

Date

Time

Location

CBER

December 4-5, 2012

December 4 from 12 noon to 5:30 p.m.
December 5 from 8:00 a.m. to 4:30 p.m.

5630 Fishers Lane,  FDA Conference Room
Room 1066
Rockville, MD 20857

Agenda

On December 4, 2012, the Committee will meet in open session to discuss labeling of Red Blood Cells with historical antigen typing results. On December 5, 2012, the Committee will meet in open session to discuss performance data considerations for infectious disease assays used to screen organ donors.

Meeting Materials

Materials for this meeting will be available on the Blood Products Advisory Committee meeting page - December 4 and 5, 2012.

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 27, 2012.
  • Oral presentations on December 4, 2012 from the public will be scheduled between approximately 3 p.m. and 4 p.m.  Oral presentations on December 5, 2012 from the public will be scheduled between approximately 1:15 p.m. and 2:15 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 19, 2012.  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 20, 2012.
  • For those unable to attend in person, the meeting will also be Webcast.  The Webcast will be available at the following link.
  • Blood Products Advisory Committee Day 1, December 4, 2012disclaimer icon 
  • Blood Products Advisory Committee Day 2, December 5, 2012disclaimer icon 

 

Contact Information

  • Bryan Emery or Pearline Muckelvene
    1401 Rockville Pike, HFM-71, Rockville, MD 20852
    301-827-1277 or 301-827-1281
    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. each day December 4-5, 2012 at the links 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 at   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).