Page:United States Statutes at Large Volume 122.djvu/3539

 12 2 STA T .35 1 6PUBLIC LA W 11 0– 316 — AU G .1 4, 200 8newa n im a ldrugsh all b e sub j e ct t o a f ee as established in subsection ( b ) for such an a p plication .‘ ‘( B ) PAYMENT . —T he fee re q uired b y subparagraph ( A ) shall be due upon submission of the abbre v iated applica - tion. ‘‘( C ) EXC E P T IO N F O R PRE V IO USL Y FILE D APPLICATION.— I f an abbreviated application was submitted by a person that paid the fee for such application , was accepted for filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an abbreviated application for the same product by the same person (or the person ’ s licensee, assignee, or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 ) R EFUND OF FEE IF APPLICATION REFUSED FOR FILIN G .—The S ecretary shall refund 75 percent of the fee paid under subparagraph (B) for any abbreviated applica- tion which is refused for filing. ‘‘(E) REFUND OF FEE IF APPLICATION W IT H DRAWN.— If an abbreviated application is withdrawn after the application was filed, the Secretary may refund the fee or portion of the fee paid under subparagraph (B) if no substantial wor k was performed on the application after the application was filed. The Secretary shall have the sole discretion to refund the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable. ‘‘( 2 ) G ENERIC NEW ANIMAL DRUG PRODUCT FEE.—Each per- son— ‘‘(A) who is named as the applicant in an abbreviated application or supplemental abbreviated application for a generic new animal drug product which has been submitted for listing under section 5 10, and ‘‘(B) who, after September 1, 200 8, had pending before the Secretary an abbreviated application or supplemental abbreviated application, shall pay for each such generic new animal drug product the annual fee established in subsection (b). Such fee shall be payable for the fiscal year in which the generic new animal drug product is first submitted for listing under section 510, or is submitted for relisting under section 510 if the generic new animal drug product has been withdrawn from listing and relisted.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 J anuary 3 1 of each year. Such fee shall be paid only once for each generic new animal drug product for a fiscal year in which the fee is payable. ‘‘(3) GENERIC NEW ANIMAL DRUG SPONSOR FEE.— ‘‘(A) IN GENERAL.—Each person— ‘‘(i) who meets the definition of a generic new animal drug sponsor within a fiscal year, and ‘‘(ii) who, after September 1, 2008, had pending before the Secretary an abbreviated application, a supplemental abbreviated application, or an investiga- tional submission, shall be assessed an annual fee established under sub- section (b). The fee shall be paid on or before January 31 of each year. Deadlin e . Deadline.

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