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U.S. Department of Health and Human Services

About FDA

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BsUFA Performance Reports

On July 9, 2012, the President signed into law FDASIA, which included the authorization of BsUFA.  The Federal Food, Drug, and Cosmetic Act, as amended by BsUFA, authorizes FDA to assess and collect fees for biosimilar biological products from October 2012 through September 2017.  FDA dedicates these fees to the efficient review of biosimilar submissions and to facilitating the development of safe and effective biosimilar products for the American public. 

FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are managing the biosimilar review program to ensure user fees collected under the Prescription Drug User Fee Act, the Medical Device User Fee Act, or the Generic Drug User Fee Act are not used to review applications under section 351(k) of the Public Health Service (PHS) Act.   The CDER Financial Council oversees the Center’s non-labor expenditures to ensure they are funded from the appropriate user fee versus non-user fee accounts.  Both Centers track employee workload activities through periodic time reporting to ensure that labor costs related to the process for the review of biosimilars (versus those for the review of other human drugs or medical devices) are recorded as BsUFA work and funded from appropriate accounts.  Annual performance reports are prepared by FDA’s Office of Planning in collaboration with the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research.
 
For additional information on these reports, please contact:
 
Office of Planning
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002
Phone: 301-796-4850
FAX: 301-847-3541