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H. Rept. 119-706 1 (2026-06-18)

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INFORMATION 4















                     119TH CONGRESS                                         REPORT
                        2d Session  J  HOUSE   OF REPRESENTATIVES           119-706







                                     FDA   MODERNIZATION ACT 3.0




                      JUNE 18, 2026.-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. 2821]

                      The  Committee   on Energy  and Commerce,   to whom   was referred
                    the bill (H.R. 2821) to require the Secretary of Health and  Human
                    Services, acting through  the Commissioner   of Food  and  Drugs, to
                    publish  a final rule relating to nonclinical testing methods, having
                    considered  the same, reports favorably thereon without  amendment
                    and  recommends   that the bill do pass.

                                                 CONTENTS
                                                                                     Page
                    Purpose and Sum m ary ........................................................................................... .  1
                    Background and Need for Legislation  ....................................................................  2
                    C om m ittee  A ction  ................................................................................................... .  3
                    C om m ittee  V otes  .....................................................................................................  3
                    Oversight Findings and  Recommendations     ...........................................................  5
                    New Budget Authority, Entitlement Authority, and Tax Expenditures .............     5
                    Congressional Budget Office  Estimate   ...................................................................  5
                    Federal M andates  Statem ent  .................................................................................  5
                    Statement of General Performance Goals and Objectives .................             5
                    Duplication of Federal Program s  ............................................................................  5
                    Related Committee and Subcommittee Hearings .................................................  5
                    Com m ittee Cost  Estim ate  .......................................................................................  6
                    Earmark, Limited Tax Benefits, and Limited Tariff Benefits ..............           6
                    Advisory Com m ittee  Statem ent  ..............................................................................  6
                    Applicability  to  Legislative  Branch  ........................................................................  6
                    Section-by-Section  Analysis of the  Legislation  ......................................................  6
                    Changes in Existing Law Made by the Bill, as Reported .................             7
                    Minority, Additional, or Dissenting  Views  ...........................................................  65

                                          PURPOSE   AND  SUMMARY

                      H.R.  2821 requires the  Secretary of Health and  Human   Services
                    (HHS)   to publish an  interim final rule amending   certain regula-
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