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1 An Act to Amend the Federal Food, Drug, and Cosmetic Act to Revise and Extend the Animal Drug User Fee Program H.R.6432 (2008)

handle is hein.animal/actamfed0001 and id is 1 raw text is: H. R. 6432 nt fiundred unth Congrss of the inited 6tatts of a1mtrica AT THE SECOND SESSION Begun and held at the City of Washington on Thursday, the third day of January, two thousand and eight 3n 3et To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. TABLE OF CONTENTS. The table of contents of this Act is as follows: Sec. 1. Table of contents. Sec. 2. References in Act. TITLE I-ANIMAL DRUG USER FEE AMENDMENTS Sec. 101. Short title; finding. Sec. 102. Definitions. Sec. 103. Authority to assess and use animal drug fees. Sec. 104. Reauthorization; reporting requirements. Sec. 105. Antimicrobial animal drug distribution reports. Sec. 106. Savings clause. Sec. 107. Effective date. Sec. 108. Sunset dates. TITLE II-ANIMAL GENERIC DRUG USER FEE Sec. 201. Short title; findings. Sec. 202. Fees relating to abbreviated applications for generic new animal drugs. Sec. 203. Accountability and reports. Sec. 204. Sunset dates. TITLE III-TECHNICAL CORRECTIONS TO FDAAA Sec. 301. Consideration of certain petitions. Sec. 302. Registry and results data bank. SEC. 2. REFERENCES IN ACT. Except as otherwise specified, amendments made by this Act to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). TITLE I-ANIMAL DRUG USER FEE AMENDMENTS SEC. 101. SHORT TITLE; FINDING. (a) SHORT TITLE.-This title may be cited as the Animal Drug User Fee Amendments of 2008. (b) FINDING.-Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting

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