Page:United States Statutes at Large Volume 121.djvu/995

 121 STAT. 974

PUBLIC LAW 110–85—SEPT. 27, 2007 after the date of the enactment of the Food and Drug Administration Amendments Act of 2007. ‘‘(4) NOTIFICATION.—The sponsor of a human drug application shall notify the Secretary not later than 365 days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application, including the date on which the sponsor intends to submit the application. Such notification shall be a legally binding commitment to pay for the user fee to be assessed in accordance with this section. ‘‘(c) PRIORITY REVIEW USER FEE.— ‘‘(1) IN GENERAL.—The Secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2). Such fee shall be in addition to any fee required to be submitted by the sponsor under chapter VII. ‘‘(2) FEE AMOUNT.—The amount of the priority review user fee shall be determined each fiscal year by the Secretary and based on the average cost incurred by the agency in the review of a human drug application subject to priority review in the previous fiscal year. ‘‘(3) ANNUAL FEE SETTING.—The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2007, for that fiscal year, the amount of the priority review user fee. ‘‘(4) PAYMENT.— ‘‘(A) IN GENERAL.—The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 505(b)(1) or section 351 of the Public Health Services Act for which the priority review voucher is used. ‘‘(B) COMPLETE APPLICATION.—An application described under subparagraph (A) for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the Secretary’s procedures for paying such fees. ‘‘(C) NO WAIVERS, EXEMPTIONS, REDUCTIONS, OR REFUNDS.—The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section. ‘‘(5) OFFSETTING COLLECTIONS.—Fees collected pursuant to this subsection for any fiscal year— ‘‘(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and ‘‘(B) shall not be collected for any fiscal year except to the extent provided in advance in appropriation Acts.’’.

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SEC. 1103. IMPROVING GENETIC TEST SAFETY AND QUALITY.

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(a) REPORT.—If the Secretary’s Advisory Committee on Genetics, Health, and Society does not complete and submit the Regulatory Oversight of Genetic/Genomic Testing Report & Action Recommendations to the Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’) by July of 2008, the Secretary shall enter into a contract with the Institute of

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