PUBLIC LAW 108–130—NOV. 18, 2003
117 STAT. 1365
31 of each year. Such fee shall be paid only once for each animal drug product for a fiscal year in which the fee is payable. ‘‘(3) ANIMAL DRUG ESTABLISHMENT FEE.—Each person— ‘‘(A) who owns or operates, directly or through an affiliate, an animal drug establishment, and ‘‘(B) who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under section 510, and ‘‘(C) who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application, shall be assessed an annual fee established in subsection (b) for each animal drug establishment listed in its approved animal drug application as an establishment that manufactures the animal drug product named in the application. The annual establishment fee shall be assessed in each fiscal year in which the animal drug product named in the application is assessed a fee under paragraph (2) unless the animal drug establishment listed in the application does not engage in the manufacture of the animal drug product during the fiscal year. The fee shall be paid on or before January 31 of each year. The establishment shall be assessed only one fee per fiscal year under this section: Provided, however, That where a single establishment manufactures both animal drug products and prescription drug products, as defined in section 735(3), such establishment shall be assessed both the animal drug establishment fee and the prescription drug establishment fee, as set forth in section 736(a)(2), within a single fiscal year. ‘‘(4) ANIMAL DRUG SPONSOR FEE.—Each person— ‘‘(A) who meets the definition of an animal drug sponsor within a fiscal year; and ‘‘(B) who, after September 1, 2003, had pending before the Secretary an animal drug application, a supplemental animal drug application, or an investigational animal drug submission, shall be assessed an annual fee established under subsection (b). The fee shall be paid on or before January 31 of each year. Each animal drug sponsor shall pay only one such fee each fiscal year. ‘‘(b) FEE AMOUNTS.—Except as provided in subsection (a)(1) and subsections (c), (d), (f), and (g), the fees required under subsection (a) shall be established to generate fee revenue amounts as follows: ‘‘(1) TOTAL FEE REVENUES FOR APPLICATION AND SUPPLEMENT FEES.—The total fee revenues to be collected in animal drug application fees under subsection (a)(1)(A)(i) and supplemental animal drug application fees under subsection (a)(1)(A)(ii) shall be $1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008. ‘‘(2) TOTAL FEE REVENUES FOR PRODUCT FEES.—The total fee revenues to be collected in product fees under subsection (a)(2) shall be $1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008.
VerDate 11-MAY-2000
10:15 Aug 27, 2004
Jkt 019194
PO 00000
Frm 00317
Fmt 6580
Sfmt 6581
Deadline.
Deadline.
D:\STATUTES\2003\19194PT2.001
APPS10
PsN: 19194PT2
�
