H.R.3988 - Generic Drug and Biosimilar User Fee Act of 2012

To amend the Federal Food, Drug, and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars. view all titles (5)

All Bill Titles

  • Short: Generic Drug and Biosimilar User Fee Act of 2012 as introduced.
  • Short: Biosimilar User Fee Act of 2012 as introduced.
  • Short: Generic Drug User Fee Amendments of 2012 as introduced.
  • Official: To amend the Federal Food, Drug, and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars. as introduced.
  • Official: Generic Drug and Biosimilar User Fee Act of 2012 as introduced.

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Introduced
 
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Senate
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President
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02/08/12
 
 
 
 
 
 
 

Official Summary

Generic Drug and Biosimilar User Fee Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), beginning FY2013, to assess and collect the following fees related to generic drugs: (1) a one-time backlog fee for abbreviated new

Official Summary

Generic Drug and Biosimilar User Fee Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), beginning FY2013, to assess and collect the following fees related to generic drugs:
(1) a one-time backlog fee for abbreviated new drug applications pending on October 1, 2012;
(2) a drug master file fee;
(3) an abbreviated new drug application and prior approval supplement filing fee, as well as an additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file; and
(4) a generic drug facility fee and active pharmaceutical ingredient facility fee. Provides that submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee. Sets forth provisions relating to fee amounts and due dates. Terminates the above provisions on October 1, 2017. Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified safety, access, and transparency goals with respect to generic drugs. Biosimilar User Fee Act of 2012 - Directs the Secretary, beginning FY2013, to assess and collect the following fees related to biosimilar biological products:
(1) biosimilar program development fees, encompassing an initial biosimilar biological development fee, an annual biosimilar biological product development fee, and a reactivation fee;
(2) a biosimilar biological product application and supplement fee;
(3) a biosimilar biological product establishment fee; and
(4) a biosimilar biological product fee. Waives the above fees for the first biosimilar biological product application of a small business. Terminates the above provisions on October 1, 2017. Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified goals with respect to biosimilar biological products.

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