Page:United States Statutes at Large Volume 121.djvu/848

 PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 827

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(B) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and (C) by inserting after subparagraph (D) the following: ‘‘(E) FEES FOR APPLICATIONS PREVIOUSLY REFUSED FOR FILING OR WITHDRAWN BEFORE FILING.—A human drug application or supplement that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived or reduced under subsection (d).’’; and (3) in paragraph (2)— (A) in subparagraph (A), by striking ‘‘subparagraph (B)’’ and inserting ‘‘subparagraphs (B) and (C)’’; and (B) by adding at the end the following: ‘‘(C) SPECIAL RULES FOR POSITRON EMISSION TOMOGRAPHY DRUGS.— ‘‘(i) IN GENERAL.—Except as provided in clause (ii), each person who is named as the applicant in an approved human drug application for a positron emission tomography drug shall be subject under subparagraph (A) to one-sixth of an annual establishment fee with respect to each such establishment identified in the application as producing positron emission tomography drugs under the approved application. ‘‘(ii) EXCEPTION FROM ANNUAL ESTABLISHMENT FEE.—Each person who is named as the applicant in an application described in clause (i) shall not be assessed an annual establishment fee for a fiscal year if the person certifies to the Secretary, at a time specified by the Secretary and using procedures specified by the Secretary, that— ‘‘(I) the person is a not-for-profit medical center that has only 1 establishment for the production of positron emission tomography drugs; and ‘‘(II) at least 95 percent of the total number of doses of each positron emission tomography drug produced by such establishment during such fiscal year will be used within the medical center. ‘‘(iii) DEFINITION.—For purposes of this subparagraph, the term ‘positron emission tomography drug’ has the meaning given to the term ‘compounded positron emission tomography drug’ in section 201(ii), except that paragraph (1)(B) of such section shall not apply.’’. (b) FEE REVENUE AMOUNTS.—Section 736(b) (21 U.S.C. 379h(b)) is amended to read as follows: ‘‘(b) FEE REVENUE AMOUNTS.— ‘‘(1) IN GENERAL.—For each of the fiscal years 2008 through 2012, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of— ‘‘(A) $392,783,000; and

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