Page:United States Statutes at Large Volume 122.djvu/3540

 12 2 STA T .35 1 7PUBLIC LA W 11 0– 31 6— AU G .1 4, 200 8‘ ‘ (B)AMOUNT O F F E E .—Eachgen e ri cne w ani m a ld r u g spo nsor shall pa y only 1 such f ee each fiscal year , as follows

‘‘(i) 1 0 0 percen t of the amount of the generic new animal drug sponsor fee pu b lished for that fiscal year under subsection (c)( 3 ) for an applicant with more than 6 appro v ed abbreviated applications. ‘‘(ii) 75 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c)(3) for an applicant with more than 1 and fewer than 7 approved abbreviated applications. ‘‘(iii) 50 percent of the amount of the generic new animal drug sponsor fee published for that fiscal year under subsection (c)(3) for an applicant with 1 or fewer approved abbreviated applications. ‘‘(b) F EE AMOUNT S .—E x cept as provided in subsection (a)(1) and subsections (c), (d), (f), and (g), the fees re q uired under sub - section (a) shall be established to generate fee revenue amounts as follows: ‘‘(1) T OT AL FEE R E V ENUES FOR A P PL IC ATION FEES.—The total fee revenues to be collected in abbreviated application fees under subsection (a)(1) shall be $ 1, 4 4 9 ,000 for fiscal year 2 009, $1,532,000 for fiscal year 2010, $1,619,000 for fiscal year 2011, $1,712,000 for fiscal year 2012, and $1, 8 09,000 for fiscal year 2013. ‘‘(2) TOTAL FEE REVENUES FOR PRO D UCT FEES.—The total fee revenues to be collected in generic new animal drug product fees under subsection (a)(2) shall be $1,691,000 for fiscal year 2009, $1,787,000 for fiscal year 2010, $1,889,000 for fiscal year 2011, $1,997,000 for fiscal year 2012, and $2,111,000 for fiscal year 2013. ‘‘(3) TOTAL FEE REVENUES FOR SPONSOR FEES.—The total fee revenues to be collected in generic new animal drug sponsor fees under subsection (a)(3) shall be $1,691,000 for fiscal year 2009, $1,787,000 for fiscal year 2010, $1,889,000 for fiscal year 2011, $1,997,000 for fiscal year 2012, and $2,111,000 for fiscal year 2013. ‘‘(c) AD J USTMENTS.— ‘‘(1) W OR K LOAD ADJUSTMENT.—The fee revenues shall be ad j usted each fiscal year after fiscal year 2009 to reflect changes in review wor k load. With respect to such adjustment: ‘‘(A) This adjustment shall be determined by the S ec- retary based on a weighted average of the change in the total number of abbreviated applications for generic new animal drugs, manufacturing supplemental abbreviated applications for generic new animal drugs, investigational generic new animal drug study submissions, and investiga- tional generic new animal drug protocol submissions sub- mitted to the Secretary. The Secretary shall publish in the Federal R egister the fees resulting from this adjust- ment and the supporting methodologies. ‘‘(B) U nder no circumstances shall this workload adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year estab- lished in subsection (b). ‘‘(2) FINAL Y EAR ADJUSTMENT.—For fiscal year 2013, the Secretary may further increase the fees to provide for up to Fed e ralR e gist er ,pub li c ati on.

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