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H. Rept. 119-300 1 (2025-09-17)

handle is hein.congrecreports/crptxahrl0001 and id is 1 raw text is: AUT-ENTICATED US. GOVERNMENT INFORMATION GP 119TH CONGRESS REPORT 1st Session HOUSE OF REPRESENTATIVES 119-300 OVER-THE-COUNTER MONOGRAPH DRUG USER FEE AMENDMENTS SEPTEMBER 17, 2025.-Committed to the Committee of the Whole House on the State of the Union and ordered to be printed Mr. GUTHRIE, from the Committee on Energy and Commerce, submitted the following REPORT [To accompany H.R. 4273] The Committee on Energy and Commerce, to whom was referred the bill (H.R. 4273) to amend the Federal Food, Drug, and Cos- metic Act to revise and extend the user fee program for over-the- counter monograph drugs, and for other purposes, having consid- ered the same, reports favorably thereon with an amendment and recommends that the bill as amended do pass. CONTENTS Page Purpose and Sum m ary ............................................................................................ 5 Background and Need for Legislation .................................................................... 6 Com m ittee A ction ................................................................................................... . 6 C om m ittee V otes ..................................................................................................... 6 Oversight Findings and Recommendations ........................................................... 8 New Budget Authority, Entitlement Authority, and Tax Expenditures ............. 8 Congressional Budget Office Estimate ................................................................... 8 Federal M andates Statem ent ................................................................................. 8 Statement of General Performance Goals and Objectives ................. 8 Duplication of Federal Program s ............................................................................ 8 Related Committee and Subcommittee Hearings ................................................. 8 Com m ittee Cost Estim ate ....................................................................................... 9 Earmark, Limited Tax Benefits, and Limited Tariff Benefits .............. 9 Advisory Com m ittee Statem ent .............................................................................. 9 Applicability to Legislative Branch ........................................................................ 9 Section-by-Section Analysis of the Legislation ...................................................... 9 Changes in Existing Law Made by the Bill, as Reported ................. 10 The amendment is as follows: Strike all after the enacting clause and insert the following: 59-006