Meeting of the Blood Products Advisory Committee
| Center | Date | Time | Location |
|---|---|---|---|
| CBER | 01/09/2009 | 8:00 a.m. to 6:00 p.m. | Hilton Hotel, Washington, D.C./Rockville Executive Meeting Center |
Agenda
On the morning of January 9, 2009, the Committee will discuss CSL Behring’s Biologics License Application for plasma-derived fibrinogen concentrate for treatment of bleeding in congenital fibrinogen deficiency. In the afternoon, the Committee will hear an update on the “Food and Drug Administration Draft Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs.” Following this update, the Committee will discuss GTC Biotherapeutics’ Biologics License Application for recombinant Antithrombin III derived from genetically engineered goats for treatment of patients with hereditary Antithrombin III deficiency to prevent thrombosis during high risk situations like surgery and obstetrical procedures.
Revised as follows: “On the morning of January 9, 2009, the Committee will discuss CSL Behring’s Biologics License Application for plasma-derived fibrinogen concentrate for treatment of bleeding in congenital fibrinogen deficiency. In the afternoon, the Committee will hear an update on the ‘Food and Drug Administration Draft Guidance for Industry on Regulation of Genetically Engineered Animals Containing Heritable Recombinant Deoxyribonucleic Acid Constructs and an overview of the Center for Veterinary Medicine’s review of the new animal drug application pertaining to the genetically engineered animals producing milk that contains recombinant Antithrombin III and of the environmental assessment for that application. Following this update, the Committee will discuss GTC Biotherapeutics’ Biologics License Application for recombinant Antithrombin III derived from genetically engineered goats for treatment of patients with hereditary Antithrombin III deficiency to prevent thrombosis during high risk situations like surgery and obstetrical procedures.”
Meeting Materials
Materials for this meeting are available at http://www.fda.gov/ohrms/dockets/ac/cber09.html#BloodProducts.
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 December 19, 2008 .
- Oral presentations from the public will be scheduled between approximately 10:30 a.m. and 11:00 a.m. and between approximately 4:00 p.m. and 5:00 p.m. on January 9, 2009
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 December 22, 2008.
Contact Information
- William Freas, Ph.D.
1402 Rocklville Pike, HFM-71, Rockville, MD 20852
301-827-0314
301-827-0294
e-mail: William.Freas@fda.hhs.gov - FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington, DC, area)
code 3014519516
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. 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 Carlos Peña 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 http://www.fda.gov/oc/advisory/default.htm 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 (PDF - 24 KB)