H. Rept. 116-55 1 (2019-05-10)

handle is hein.congrecreports/crptxacip0001 and id is 1 raw text is: AUTHENTICATE
U.S. GOVERNMENT
INFORMATION
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                    116TH CONGRESS                                     JREPT. 116 55
                        1st Session    HOUSE OF REPRESENTATIVES              Part 1







                           CREATING AND RESTORING EQUAL ACCESS TO
                                 EQUIVALENT SAMPLES ACT OF 2019



                                       MAY 10, 2019.-Ordered to be printed



                       Mr. PALLONE, from the Committee on Energy and Commerce,
                                          submitted the following


                                              REPORT

                                            [To accompany H.R. 965]

                              [Including cost estimate of the Congressional Budget Office]

                      The Committee on Energy and Commerce, to whom was referred
                    the bill (H.R. 965) to promote competition in the market for drugs
                    and biological products by facilitating the timely entry of lower-cost
                    generic and biosimilar versions of those drugs and biological prod-
                    ucts, having considered the same, report favorably thereon with an
                    amendment and recommend that the bill as amended do pass.

                                                 CONTENTS
                                                                                     Page
                    Purpose and Sum m ary  ...........................................................................................  6
                    Background and Need for the  Legislation  ............................................................  6
                    Com m ittee  H earings  ...............................................................................................  7
                    Com m ittee  Consideration  .......................................................................................  7
                    C om m ittee  V otes  ......................................................................................................  8
                    Oversight Findings  ..................................................................................................  10
                    New Budget Authority, Entitlement Authority, and Tax Expenditures .............    10
                    Congressional Budget Office  Estimate   ...................................................................  10
                    Federal M andates  Statem ent  .................................................................................  13
                    Statement of General Performance Goals and Objectives ....................................  13
                    Duplication  of Federal Program s  ............................................................................  13
                    Com m ittee  Cost  Estim ate  .......................................................................................  13
                    Earmarks, Limited Tax Benefits, and Limited Tariff Benefits ...........................  13
                    Advisory Com m ittee  Statem ent  ..............................................................................  13
                    Applicability  to  Legislative  Branch  ........................................................................  13
                    Section-by-Section  Analysis of the  Legislation  ......................................................  13
                    Changes in Existing Law Made by the Bill, as Reported .....................................  16
                      The amendment is as follows:
                      Strike all after the enacting clause and insert the following:


36-328

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