12 2 STA T .35 2 0PUBLIC LA W 110 – 31 6— AU G .1 4, 200 8as a dju s te dt or e fl e c t adjust m e n ts i nt h e total fee re v enues made under this section and chan g es in the total amounts collected by abbreviated a p plication fees , generic ne w animal drug sponsor fees, and generic new animal drug product fees .‘ ‘ (4)OF F SET . —I f the sum of the cumulative amount of fees collected under this section for the fiscal years 20 0 9 through 20 1 1 and the amount of fees estimated to be collected under this section for fiscal year 2012 e x ceeds the cumulative amount appropriated under paragraph ( 3 ) for the fiscal years 2009 through 2012, the excess amount shall be credited to the appro - priation account of the F ood and D rug A dministration as pro- vided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authori z ed to be collected under this section pursuant to appropriation Acts for fiscal year 2013. ‘‘(h) COL LE C T I O N OF U N PA I D FEES.—In any case where the S ecretary does not receive payment of a fee assessed under sub- section (a) within 30 days after it is due, such fee shall be treated as a claim of the United States G overnment subject to subchapter II of chapter 3 7 of title 31, United States Code. ‘‘(i) WR ITTEN R E QU ESTS FOR WAI V ERS, REDUCTIONS, AND REFUNDS.— T o q ualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accord- ance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 1 8 0 days after such fee is due. ‘‘(j) CONSTRUCTION.—This section may not be construed to require that the number of full-time equivalent positions in the Department of H ealth and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of abbreviated applications for generic new animal drugs, be reduced to offset the number of officers, employees, and advisory committees so engaged. ‘‘( k ) DEFINITIONS.—In this section and section 742
‘‘(1) A B BREVIATED APPLICATION FOR A G ENERIC NE W ANI M AL DRUG.—The terms ‘abbreviated application for a generic new animal drug ’ and ‘abbreviated application’ mean an abbreviated application for the approval of any generic new animal drug submitted under section 5 12(b)(2). Such term does not include a supplemental abbreviated application for a generic new animal drug. ‘‘(2) AD J USTMENT FACTOR.—The term ‘adjustment factor’ applicable to a fiscal year is the Consumer P rice Index for all urban consumers (all items
United States city average) for October of the preceding fiscal year divided by— ‘‘(A) for purposes of subsection (f)(1), such Index for October 2002; and ‘‘( B ) for purposes of subsection (g)(2)(A)(ii), such Index for October 2007. ‘‘(3) COSTS OF RESOURCES ALLOCATED FOR T H E PROCESS FOR THE REVIEW OF ABBREVIATED APPLICATIONS FOR GENERIC NEW ANIMAL DRUGS.—The term ‘costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs’ means the expenses incurred in connection with the process for the review of abbreviated applications for generic new animal drugs for— Deadlin e . Deadline.
�
