Page:United States Statutes at Large Volume 122.djvu/3538

 12 2 STA T .35 15 PUBLIC LA W 11 0– 31 6— AU G .1 4, 200 8SEC.108 .S UN SE TDA TES. (a)AUTHORIZA TIO N.—The a m e nd men ts made by se c t io ns 102 and 10 3 cease to be e f fecti v e O ctobe r 1, 2013. (b) REP ORTIN G RE Q UIRE M ENT S .—The amendment made by sec - tion 10 4 ceases to be effective J an u ary 31, 2014. TI T LE II —AN I M AL G ENE R I CD R U GU S ER F EE SEC. 2 01. S HOR TT I T L E INDIN G S. (a) S HORT TIT L E.—This tit l e may be cited as the ‘ ‘Animal G eneric D ru gU ser F ee Act of 200 8’ ’. (b) FIN D INGS.— C ongress finds as follo w s
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(1) P rom p t approval of abbreviated applications for safe and effective generic new animal drugs will reduce animal healthcare costs and promote the well-being of animal health and the public health. (2) Animal health and the public health will be served by ma k ing additional funds available for the purpose of aug- menting the resources of the Food and Drug Administration that are devoted to the process for the review of abbreviated applications for the approval of generic new animal drugs. (3) The fees authori z ed by this title will be dedicated toward e x pediting the generic new animal drug development process and the review of abbreviated applications for generic new animal drugs, supplemental abbreviated applications for generic new animal drugs, and investigational submissions for generic new animal drugs as set forth in the goals identified in the letters from the Secretary of H ealth and Human Services to the Chairman of the Committee on E nergy and Commerce of the House of Representatives and the Chairman of the Com- mittee on Health, Education, L abor, and Pensions of the Senate as set forth in the Congressional Record. SEC. 202. FEES RELATING TO A B BRE V IATED A P PLICATIONS FOR GENERIC NE W ANI M AL DRUGS. (a) REDESIGNATION.—Chapter VI I (21 U.S.C. 3 7 1etse q .) is amended by redesignating sections 741, 742, and 74 6 as sections 74 5, 746, and 74 9, respectively. (b) AUTHORIT Y TO ASSESS AND USE GENERI CN E W ANIMAL DRUG FEES.—Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at the end the following: ‘ ‘ PART5—FE E S RE L AT ING T O GENERI C NE W ANI M AL D R U GS ‘ ‘SEC. 74 1. AUTHORIT Y TO ASSESS AND USE GENERIC NEW ANIMAL DRUG FEES. ‘‘(a) TYPES O F FEES.— B eginning with respect to fiscal year 2009, the Secretary shall assess and collect fees in accordance with this section as follows: ‘‘(1) A B BRE V IATED APPLICATION FEE.— ‘‘(A) IN GENERAL.—Each person that submits, on or after July 1, 2008, an abbreviated application for a generic Ef f ectiv e da te .21USC379j– 21. 21 USC 379 k, 379 l ,a n d 379 o . 21 USC 379j–21 note. 21USC3 0 1 note. A ni m a lG ene r ic D r ug U s er F ee Act of 200 8 . 21 USC 379j–11 note.

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