3.0.0 3988 2019-11-15T21:18:13Z 2019-11-15T21:18:13Z House H HR 2012-02-08 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. MURPHY of Pennsylvania:H.R. 3988.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to the power granted toCongress under Article I, Section 8, Clause 3 of the UnitedStates Constitution.____________________[Page H641]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-02-10T15:14:10Z Referred to 2012-02-08T14:52:40Z Food and Drug Administration Reform Act of 2012 112 5651 HR 2012-06-04 Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 420. Related bill CRS Food and Drug Administration Safety and Innovation Act 112 2516 S 2012-05-07 Placed on Senate Legislative Calendar under General Orders. Calendar No. 389. Related bill CRS Food and Drug Administration Safety and Innovation Act 112 3187 S 2012-07-09 Became Public Law No: 112-144. Related bill CRS 2012-02-10 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-02-08 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-02-08 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-02-08 Introduced in House IntroReferral 1000 9 Library of Congress M001151 Rep. Murphy, Tim [R-PA-18] Tim Murphy R PA 18 N P000034 Rep. Pallone, Frank, Jr. [D-NJ-6] FRANK PALLONE D NJ 6 2012-02-08 True P000373 Rep. Pitts, Joseph R. [R-PA-16] JOSEPH PITTS R PA R. 16 2012-02-08 True W000215 Rep. Waxman, Henry A. [D-CA-30] HENRY WAXMAN D CA A. 30 2012-02-08 True D000355 Rep. Dingell, John D. [D-MI-15] JOHN DINGELL D MI D. 15 2012-02-21 False Health Administrative law and regulatory procedures Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Government employee pay, benefits, personnel management Government information and archives Government studies and investigations Health care costs and insurance Health care coverage and access Health information and medical records Health programs administration and funding Prescription drugs User charges and fees Health 00 2012-02-08 Introduced in House 2012-05-10T21:24:19Z 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 Short Titles as Introduced Generic Drug and Biosimilar User Fee Act of 2012 Short Titles as Introduced for portions of this bill Biosimilar User Fee Act of 2012 Short Titles as Introduced for portions of this bill Generic Drug User Fee Amendments of 2012 Display Title Generic Drug and Biosimilar User Fee Act of 2012 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars. Introduced in House 2012-02-08T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr3988ih/xml/BILLS-112hr3988ih.xml 2012-02-10 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.