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H. Rept. 115-201 1 (2017-07-11)

handle is hein.congrecreports/crptxaiom0001 and id is 1 raw text is: AUTHENTICATED r U.S. GOVERNMENT INFORMATION 4 115TH CONGRESS REPORT 1st Session J HOUSE OF REPRESENTATIVES 115-201 FDA REAUTHORIZATION ACT OF 2017 JULY 11, 2017.-Committed to the Committee of the Whole House on the State of the Union and ordered to be printed Mr. WALDEN, from the Committee on Energy and Commerce, submitted the following REPORT [To accompany H.R. 2430] The Committee on Energy and Commerce, to whom was referred the bill (H.R. 2430) to amend the Federal Food, Drug, and Cos- metic Act to revise and extend the user-fee programs for prescrip- tion drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes, having considered the same, re- port favorably thereon with an amendment and recommend that the bill as amended do pass. CONTENTS Page Purpose and Sum m ary ........................................................................................... 36 Background and Need for Legislation .................................................................... 37 H earings ................................................................................................................... 37 Com m ittee Consideration ....................................................................................... 38 C om m ittee V otes ...................................................................................................... 39 Com m ittee Oversight Findings ............................................................................... 41 Statement of General Performance Goals and Objectives .................................... 41 New Budget Authority, Entitlement Authority, and Tax Expenditures ............ 41 Earmark, Limited Tax Benefits, and Limited Tariff Benefits ............... 41 Com m ittee Cost Estim ate ....................................................................................... 41 Congressional Budget Office Estimate ................................................................... 41 Federal M andates Statem ent ................................................................................. 41 Duplication of Federal Program s ........................................................................... 41 Disclosure of Directed Rule M akings ..................................................................... 41 Advisory Com m ittee Statem ent ............................................................................. 42 Applicability to Legislative Branch ........................................................................ 42 Section-by-Section Analysis of the Legislation ..................................................... 42 Changes in Existing Law Made by the Bill, as Reported ................. 50 The amendment is as follows: Strike all after the enacting clause and insert the following: SECTION 1. SHORT TITLE. This Act may be cited as the FDA Reauthorization Act of 2017. 69-006