Page:United States Statutes at Large Volume 111 Part 3.djvu/212

 Ill STAT. 2300 PUBLIC LAW 105-115—NOV. 21, 1997 (i) in the subparagraph heading, by striking "NOT ACCEPTED" and inserting "REFUSED"; (ii) by striking "50 percent" and inserting "75 percent"; (iii) by striking "subparagraph (B)(i)" and inserting "subparagraph (B); and (iv) by striking "not accepted" and inserting "refused"; and (C) by adding at the end the following: "(E) EXCEPTION FOR DESIGNATED ORPHAN DRUG OR INDICATION. —^A human drug application for a prescription drug product that has been designated as a drug for a rare disease or condition pursuant to section 526 shall not be subject to a fee under subparagraph (A), unless the human drug application includes an indication for other than a rare disease or condition. A supplement proposing to include a new indication for a rare disease or condition in a human drug application shall not be subject to a fee under subparagraph (A), if the drug has been designated pursuant to section 526 as a drug for a rare disease or condition with regard to the indication proposed in such supplement. "(F) EXCEPTION FOR SUPPLEMENTS FOR PEDIATRIC INDICATIONS.— ^A supplement to a human drug application proposing to include a new indication for use in pediatric populations shall not be assessed a fee under subparagraph (A). "(G) REFUND OF FEE IF APPLICATION WITHDRAWN. — If an application or supplement is withdrawn after the application or supplement was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the application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 a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a remnd under this paragraph shall not be reviewable."; (3) by striking paragraph (2) and inserting the following: "(2) PRESCRIPTION DRUG ESTABLISHMENT FEE. — "(A) IN GENERAL. —Except as provided in subparagraph (B), each person that— "(i) is named as the applicant in a human drug application; and "(ii) after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall be assessed an annual fee established in subsection (b) for each prescription drug establishment listed in its approved human drug application as an establishment that manufactures the prescription drug product named in the application. The sinnual establishment fee shall be assessed in each fiscal year in which the prescription drug product named in the application is assessed a fee under paragraph (3) unless the prescription drug establishment listed in the application does not engage in the msinufacture of the prescription drug product during the fiscal year. The establishment fee shall be payable on or before January 31 of each year. Each such establishment shall be assessed

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