H. Rept. 115-827 1 (2018-07-16)

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                    115TH CONGRESS                                        REPORT
                       2d Session     HOUSE OF REPRESENTATIVES            115-827







                     OVER-THE-COUNTER MONOGRAPH SAFETY, INNOVATION,
                                      AND REFORM ACT OF 2018



                     JULY 16, 2018.-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

                                             together with

                                          ADDITIONAL VIEWS

                                          [To accompany H.R. 5333]

                              [Including cost estimate of the Congressional Budget Office]

                      The Committee on Energy and Commerce, to whom was referred
                    the bill (H.R. 5333) to amend the Federal Food, Drug, and Cos-
                    metic Act to clarify the regulatory framework with respect to cer-
                    tain nonprescription drugs that are marketed without an approved
                    new drug application, and for other purposes, having considered
                    the same, report favorably thereon with an amendment and rec-
                    ommend that the bill as amended do pass.

                                                CONTENTS
                                                                                   Page
                    P urpose  an d  Sum m ary  ............................................................................................  22
                    Background and  Need  for  Legislation  ....................................................................  23
                    C om m ittee  A ction  ....................................................................................................  23
                    C om m ittee  V otes  ......................................................................................................  23
                    Oversight Findings and  Recommendations    ...........................................................  25
                    New Budget Authority, Entitlement Authority, and Tax Expenditures .............  25
                    Congressional Budget Office  Estim ate  ...................................................................  25
                    Federal M andates  Statem ent  .................................................................................  46
                    Statement of General Performance Goals and Objectives ....................................  46
                    Duplication  of  Federal Program s  ............................................................................  46
                    Com m ittee  Cost  E stim ate  .......................................................................................  46
                    Earmark, Limited Tax Benefits, and Limited Tariff Benefits .............................  47
                    Disclosure  of Directed  Rule  M akings  .....................................................................  47
                    A dvisory  Com m ittee  Statem ent  ..............................................................................  47
                       79-006

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