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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Regulatory Authority Council (RAC) Letter - Q-Pan

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service

                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448


Our STN:  BL 125419/0

ID Biomedical Corporation of Quebec
(dba GlaxoSmithKline Biologicals)
Attention:  Michael Schwartz, Ph.D.
2301 Renaissance Boulevard,
P.O. Box 61540
King or Prussia, PA 19406-2772

Dear Dr. Schwartz:

We have received your May 24, 2013, resubmission to your biologics license application for Influenza A (H5N1) Virus Monovalent Vaccine for active immunization for the prevention of disease in persons 18 years of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine, on May 24, 2013

We consider this a complete, Class 2 response to our action letter.  Therefore, the user fee goal date is November 23, 2013.

If you have any questions, please contact the Regulatory Project Managers, LCDR Jeremy Wally, Ph.D. or Kirk Prutzman, Ph.D., at (301) 796-2640.

Sincerely yours,

Wellington Sun, M.D.
Division of Vaccines and
Related Product Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research