121 STAT. 846
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Federal Register, publication.
VerDate Aug 31 2005
13:52 Jan 23, 2009
PUBLIC LAW 110–85—SEPT. 27, 2007
(2) ADJUSTMENT OF ANNUAL ESTABLISHMENT FEE.—Section 738(c) (21 U.S.C. 379j(c)), as amended by paragraph (1), is further amended— (A) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; (B) by inserting after paragraph (1) the following: ‘‘(2) ADJUSTMENT.— ‘‘(A) IN GENERAL.—When setting fees for fiscal year 2010, the Secretary may increase the fee under subsection (a)(3)(A) (applicable to establishments subject to registration) only if the Secretary estimates that the number of establishments submitting fees for fiscal year 2009 is fewer than 12,250. The percentage increase shall be the percentage by which the estimate of establishments submitting fees in fiscal year 2009 is fewer than 12,750, but in no case may the percentage increase be more than 8.5 percent over that specified in subsection (b) for fiscal year 2010. If the Secretary makes any adjustment to the fee under subsection (a)(3)(A) for fiscal year 2010, then such fee for fiscal years 2011 and 2012 shall be adjusted so that such fee for fiscal year 2011 is equal to the adjusted fee for fiscal year 2010 increased by 8.5 percent, and such fee for fiscal year 2012 is equal to the adjusted fee for fiscal year 2011 increased by 8.5 percent. ‘‘(B) PUBLICATION.—For any adjustment made under subparagraph (A), the Secretary shall publish in the Federal Register the Secretary’s determination to make the adjustment and the rationale for the determination.’’; and (C) in paragraph (4), as redesignated by this paragraph, in subparagraph (A)— (i) by striking ‘‘For fiscal years 2006 and 2007, the Secretary’’ and inserting ‘‘The Secretary’’; and (ii) by striking ‘‘for the first month of fiscal year 2008’’ and inserting ‘‘for the first month of the next fiscal year’’. (d) SMALL BUSINESSES; FEE WAIVER AND FEE REDUCTION REGARDING PREMARKET APPROVAL.— (1) IN GENERAL.—Section 738(d)(1) (21 U.S.C. 379j(d)(1)) is amended— (A) by striking ‘‘, partners, and parent firms’’; and (B) by striking ‘‘clauses (i) through (vi) of subsection (a)(2)(A)’’ and inserting ‘‘clauses (i) through (v) and clauses (vii), (ix), and (x) of subsection (a)(2)(A)’’. (2) RULES RELATING TO PREMARKET APPROVAL FEES.— (A) DEFINITION.—Section 738(d)(2)(A) (21 U.S.C. 379j(d)(2)(A)) is amended by striking ‘‘, partners, and parent firms’’. (B) EVIDENCE OF QUALIFICATION.—Section 738(d)(2)(B) (21 U.S.C. 379j(d)(2)(B)) is amended— (i) by striking ‘‘(B) EVIDENCE OF QUALIFICATION.— An applicant’’ and inserting the following: ‘‘(B) EVIDENCE OF QUALIFICATION.— ‘‘(i) IN GENERAL.—An applicant’’; (ii) by striking ‘‘The applicant shall support its claim’’ and inserting the following:
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