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H. Rept. 108-287 1 (2003-09-30)

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                    108TH CONGRESS                                          REPORT
                        1st Session    HOUSE OF REPRESENTATIVES             108-287







                                ANIMAL DRUG USER FEE ACT OF 2003



                       SEPTEMBER 30, 2003.-Committed to the Committee of the Whole House on the
                                     State of the Union and ordered to be printed



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


                                              REPORT

                                            [To accompany H.R. 1260]

                              [Including cost estimate of the Congressional Budget Office]

                      The Committee on Energy and Commerce, to whom was referred
                    the bill (H.R. 1260) to amend the Federal Food, Drug, and Cos-
                    metic Act to establish a program of fees relating to animal drugs,
                    having considered the same, report favorably thereon without
                    amendment and recommend that the bill do pass.

                                                 CONTENTS
                                                                                     Page
                    Purpose and Sum m ary  ............................................................................................  1
                    Background and Need for Legislation  ....................................................................  2
                    H earings ...................................................................................................................  2
                    Com m ittee  Consideration  ........................................................................................  2
                    C om m ittee  V otes  ......................................................................................................  2
                    Com m ittee  Oversight  Findings  ..............................................................................  3
                    Statement of General Performance Goals and Objectives ...................................  3
                    New Budget Authority, Entitlement Authority, and Tax Expenditures .............        3
                    Com m ittee  Cost  Estim ate  .....................................................................................  3
                    Congressional Budget Office   Estimate  ..................................................................  3
                    Federal M andates  Statem ent  ................................................................................ .  6
                    Advisory Com  m ittee  Statem ent  ..............................................................................  6
                    Constitutional Authority  Statem  ent  .....................................................................  6
                    Applicability  to  Legislative  Branch  ........................................................................  6
                    Section-by-Section Analysis of the Legislation .....................................................  7
                    Changes in Existing Law Made by the Bill, as Reported .....................................  11

                                          PURPOSE AND SUMMARY

                      H.R. 1260 authorizes a program of fees by the Food and Drug
                    Administration (FDA) relating to the review of new animal drugs.


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