Page:United States Statutes at Large Volume 117.djvu/1383

 117 STAT. 1364

‘‘(1) ANIMAL DRUG APPLICATION AND SUPPLEMENT FEE.— ‘‘(A) IN GENERAL.—Each person that submits, on or after September 1, 2003, an animal drug application or a supplemental animal drug application shall be subject to a fee as follows: ‘‘(i) A fee established in subsection (b) for an animal drug application; and ‘‘(ii) A fee established in subsection (b) for a supplemental animal drug application for which safety or effectiveness data are required, in an amount that is equal to 50 percent of the amount of the fee under clause (i). ‘‘(B) PAYMENT.—The fee required by subparagraph (A) shall be due upon submission of the animal drug application or supplemental animal drug application. ‘‘(C) EXCEPTION FOR PREVIOUSLY FILED APPLICATION OR SUPPLEMENT.—If an animal drug application or a supplemental animal drug application was submitted by a person that paid the fee for such application or supplement, was accepted for filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an animal drug application or a supplemental animal drug application for the same product by the same person (or the person’s licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A). ‘‘(D) REFUND OF FEE IF APPLICATION REFUSED FOR FILING.—The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any animal drug application or supplemental animal drug application which is refused for filing. ‘‘(E) REFUND OF FEE IF APPLICATION WITHDRAWN.— If an animal drug application or a supplemental animal drug application is withdrawn after the application or supplement was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial work was performed on the application or supplement after the application or supplement was filed. The Secretary shall have the sole discretion to refund the fee under this paragraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable. ‘‘(2) ANIMAL DRUG PRODUCT FEE.—Each person— ‘‘(A) 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 ‘‘(B) who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application; shall pay for each such animal drug product the annual fee established in subsection (b). Such fee shall be payable for the fiscal year in which the animal drug product is first submitted for listing under section 510, or is submitted for relisting under section 510 if the animal drug product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before January

Deadline.

VerDate 11-MAY-2000

10:15 Aug 27, 2004

PUBLIC LAW 108–130—NOV. 18, 2003

Jkt 019194

PO 00000

Frm 00316

Fmt 6580

Sfmt 6581

D:\STATUTES\2003\19194PT2.001

APPS10

PsN: 19194PT2

�