【正文】 TITLE VIREAGANUDALL FOUNDATIONSec. 601. The ReaganUdall Foundation for the Food and Drug Administration.Sec. 602. Office of the Chief Scientist.Sec. 603. Critical path publicprivate partnerships. TITLE VIICONFLICTS OF INTERESTSec. 701. Conflicts of interest. TITLE VIIICLINICAL TRIAL DATABASESSec. 801. Expanded clinical trial registry data bank. TITLE IXENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS Subtitle APostmarket Studies and SurveillanceSec. 901. Postmarket studies and clinical trials regarding human drugs。39。39。39。39。39。39。39。39。39。, with respect to a mercial investigational new drug application, means such an application to which information was submitted during the relevant period.39。 and inserting ``200839。 after ``refused for filing39。[[Page 121 STAT. 827]] (B) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively。39。 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) purposes of this subparagraph, the term `positron emission tomography drug39。. (b) Fee Revenue 736(b) (21 . 379h(b)) is amended to read as follows: ``(b) Fee Revenue ``(1) In 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。. ``(B) Amount each of the fiscal years 2008 through 2012, the amount determined under this subparagraph is the sum of ``(i) $392,783,000。 ``(IV) for fiscal year 2011, $55,000,000。39。39。 (D) by inserting after subparagraph (B) the following: ``(C) the average annual change in the cost, per fulltime equivalent position of the Food and Drug Administration, of all personnel pensation and benefits paid with respect to such positions for the first 5 years of the preceding 6 fiscal years.39。 and inserting ``fiscal year 200839。 and inserting ``For fiscal year 2009 and subsequent fiscal years,39。 and inserting ``human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph),39。 and (iii) by inserting before the period the following: ``, and the change in the total number of active mercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12month period for which data on such submissions is available39。 and (D) by adding at the end the following: ``(C) The NOTE: Contracts. Study. Secretary shall contract with an independent accounting firm to study the adjustment for changes in review activities applied in setting fees and revenue amounts for fiscal year 2009 and to make remendations, if warranted, for future changes in the methodology for calculating the adjustment. NOTE: Effective date. After review of the remendations, the Secretary shall, if warranted, make appropriate changes to the methodology, and the changes shall be effective for each of the fiscal years 2010 through 2012. The Secretary shall not make any adjustment for changes in review activities for any fiscal year after 2009 unless such study has been pleted.39。39。 or ``(II) $65,000,000. ``(iii) ``(I) Fiscal year making the determination under clause (ii), an amount described in subclause (I) of such clause for fiscal year 2009 or 2010 shall be taken into account[[Page 121 STAT. 831]] only if subclauses (I) and (II) of clause (i) apply to such fiscal year. ``(II) Relation to subparagraph (A).The Secretary shall limit any decrease under this paragraph if such a limitation is necessary to provide for the 3 months of operating reserves described in subparagraph (A).39。 and inserting ``200739。 the following: ``to a person who is named as the applicant in a human drug application39。 after ``one or more fees assess