Page:United States Statutes at Large Volume 121.djvu/852

 PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 831

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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).’’. (5) LIMIT.—Paragraph (5) of section 736(c) (21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A), is amended by striking ‘‘2002’’ and inserting ‘‘2007’’. (d) FEE WAIVER OR REDUCTION.—Section 736(d) (21 U.S.C. 379h(d)) is amended— (1) in paragraph (1), in the matter preceding subparagraph (A)— (A) by inserting after ‘‘The Secretary shall grant’’ the following: ‘‘to a person who is named as the applicant in a human drug application’’; and (B) by inserting ‘‘to that person’’ after ‘‘one or more fees assessed’’; (2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; (3) by inserting after paragraph (1) the following: ‘‘(2) CONSIDERATIONS.—In determining whether to grant a waiver or reduction of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant.’’; and (4) in paragraph (4) (as redesignated by paragraph (2)), in subparagraph (A), by inserting before the period the following: ‘‘, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce’’. (e) CREDITING AND AVAILABILITY OF FEES.— (1) AUTHORIZATION OF APPROPRIATIONS.—Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amended to read as follows: ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For each of the fiscal years 2008 through 2012, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c) and paragraph (4) of this subsection.’’. (2) OFFSET.—Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is amended to read as follows: ‘‘(4) OFFSET.—If the sum of the cumulative amount of fees collected under this section for the fiscal years 2008 through 2010 and the amount of fees estimated to be collected under this section for fiscal year 2011 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2008 through 2011, the excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2012.’’. (f) EXEMPTION FOR ORPHAN DRUGS.—Section 736 (21 U.S.C. 379h) is further amended by adding at the end the following: ‘‘(k) ORPHAN DRUGS.—

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