AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.

SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.(a) Types of Fees.—Section 740(a) (21 U.S.C. 379j–12(a)) is amended—(1) in paragraph (1)(A)(i), by inserting after “for an animal drug application” the following: “, except an animal drug application subject to the criteria set forth in section 512(d)(4)”; and(2) by amending paragraph (1)(A)(ii) to read as follows:“(ii) A fee established in subsection (b), in an amount that is equal to 50 percent of the amount of the fee under clause (i), for—“(I) a supplemental animal drug application for which safety or effectiveness data are required; and“(II) an animal drug application subject to the criteria set forth in section 512(d)(4).”.(b) Fee Amounts.—(1) Total fee revenues for application and supplement fees.—Section 740(b)(1) (21 U.S.C. 379j–12(b)(1)) is amended—(A) by striking “and supplemental animal drug application fees” and inserting “and supplemental and other animal drug application fees”; and(B) by striking “$1,250,000” and all that follows through the period at the end and inserting “$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013.”.(2) Total fee revenues for product fees.—Section 740(b)(2) (21 U.S.C. 379j–12(b)(2)) is amended by striking “$1,250,000” and all that follows through the period at the end and inserting “$3,815,000 for fiscal year 2009, $4,320,000 122 STAT. 3511 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013.”.(3) Total fee revenues for establishment fees.—Section 740(b)(3) (21 U.S.C. 379j–12(b)(3)) is amended by striking “$1,250,000” and all that follows through the period at the end and inserting “$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013.”.(4) Total fee revenues for sponsor fees.—Section 740(b)(4) (21 U.S.C. 379j–12(b)(4)) is amended by striking “$1,250,000” and all that follows through the period at the end and inserting “$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013.”.(c) Adjustments to Fees.—Section 740(c) (21 U.S.C. 379j–12(c)) is amended—(1) by striking paragraph (1);(2) by redesignating paragraphs (2) through (5) as paragraphs (1) through (4), respectively;(3) in paragraph (1), as so redesignated—(A) in the matter preceding subparagraph (A), by striking “After the fee revenues are adjusted for inflation in accordance with paragraph (1), the fee revenues shall be further adjusted each fiscal year after fiscal year 2004” and inserting “The fee revenues shall be adjusted each fiscal year after fiscal year 2009”; and(B) in subparagraph (B), by striking “, as adjusted for inflation under paragraph (1)”; and(4) in paragraph (2), as so redesignated—(A) by striking “2008” each place it appears and inserting “2013”; and(B) by striking “2009” and inserting “2014”.(d) Authorization of Appropriations.—Subparagraphs (A) through (E) of section 740(g)(3) (21 U.S.C. 379j–12(g)(3)) are amended to read as follows:“(A) $15,260,000 for fiscal year 2009;“(B) $17,280,000 for fiscal year 2010;“(C) $19,448,000 for fiscal year 2011;“(D) $21,768,000 for fiscal year 2012; and“(E) $24,244,000 for fiscal year 2013;”.(e) Offset.—Section 740(g)(4) (21 U.S.C. 379j–12(g)(4)) is amended to read as follows:“(4) Offset.—If the sum of the cumulative amount of fees collected under this section for fiscal years 2009 through 2011 and the amount of fees estimated to be collected under this section for fiscal year 2012 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2009 through 2012, the excess amount shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2013.”.