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H. Rept. 114-557 1 (2016-05-10)

handle is hein.congrecreports/crptxrnz0001 and id is 1 raw text is: AUT-ENTICATED US. GOVERNMENT INFORMATION GP 114TH CONGRESS REPORT 2d Session HOUSE OF REPRESENTATIVES 114-557 OPIOID REVIEW MODERNIZATION ACT OF 2016 MAY 10, 2016.-Committed to the Committee of the Whole House on the State of the Union and ordered to be printed Mr. UPTON, from the Committee on Energy and Commerce, submitted the following REPORT [To accompany H.R. 4976] [Including cost estimate of the Congressional Budget Office] The Committee on Energy and Commerce, to whom was referred the bill (H.R. 4976) to require the Commissioner of Food and Drugs to seek recommendations from an advisory committee of the Food and Drug Administration before approval of certain new drugs that are opioids without abuse-deterrent properties, and for other pur- poses, having considered the same, report favorably thereon with- out amendment and recommend that the bill do pass. CONTENTS Page Purpose and Sum m ary ............................................................................................ 2 Background and Need for Legislation ................................................................... 2 H earings ................................................................................................................... Com m ittee Consideration ........................................................................................ 2 C om m ittee V otes ...................................................................................................... 2 Com m ittee Oversight Findings .............................................................................. 2 Statement of General Performance Goals and Objectives ................................... 2 New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 3 Earmark, Limited Tax Benefits, and Limited Tariff Benefits ............................ 3 Com m ittee Cost Estim ate ....................................................................................... 3 Congressional Budget Office Estimate ................................................................... 3 Federal M andates Statem ent ................................................................................. 4 Duplication of Federal Program s ............................................................................ 4 Disclosure of Directed Rule M akings ..................................................................... 4 Advisory Com m ittee Statem ent .............................................................................. 4 Applicability to Legislative Branch ....................................................................... 4 Section-by-Section Analysis of the Legislation ..................................................... 4 Changes in Existing Law Made by the Bill, as Reported ..................................... 5 59-006

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