US Congress House Bill 3988 (Prior Session Legislation)

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Sponsorship: Bipartisan Bill
Status: Introduced on February 8 2012 - 25% progression, died in committee
Action: 2012-02-10 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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.

Generic Drug and Biosimilar User Fee Act of 2012

Rep. Tim Murphy [R-PA]	Rep. John Dingell [D-MI]	Rep. Frank Pallone [D-NJ]	Rep. Joseph Pitts [R-PA]
Rep. Henry Waxman [D-CA]

Date	Chamber	Action
2012-02-10	House	Referred to the Subcommittee on Health.
2012-02-08	House	Referred to the House Committee on Energy and Commerce.

SB2516 (Related) 2012-05-07 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 389.
HB5651 (Related) 2012-06-04 - Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 420.
SB3187 (Related) 2012-07-09 - Became Public Law No: 112-144.

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/house-bill/3988/all-info
Text	https://www.congress.gov/112/bills/hr3988/BILLS-112hr3988ih.pdf