118 STAT. 573 PUBLIC LAW 108–214—APR. 1, 2004 (III) in clause (vii), by striking ‘‘clause (i),’’ and all that follows and inserting ‘‘clause (i), sub ject to any adjustment under subsection (e)(2)(C)(ii).’’; and (ii) in subparagraph (D), in each of clauses (i) and (ii), by striking ‘‘application’’ and inserting ‘‘application, report,’’; (B) in subsection (d)(2)(B), beginning in the second sentence, by striking ‘‘firms. which show’’ and inserting ‘‘firms, which show’’; (C) in subsection (e)— (i) in paragraph (1), by striking ‘‘Where’’ and inserting ‘‘For fiscal year 2004 and each subsequent fiscal year, where’’; and (ii) in paragraph (2)— (I) in subparagraph (B), beginning in the second sentence, by striking ‘‘firms. which show’’ and inserting ‘‘firms, which show’’; and (II) in subparagraph (C)(i), by striking ‘‘Where’’ and inserting ‘‘For fiscal year 2004 and each subse quent fiscal year, where’’; (D) in subsection (f), by striking ‘‘for filing’’; and (E) in subsection (h)(2)(B)— (i) in clause (ii), by redesignating subclauses (I) and (II) as items (aa) and (bb), respectively; (ii) by redesignating clauses (i) and (ii) as sub clauses (I) and (II), respectively; (iii) by striking ‘‘The Secretary’’ and inserting the following: ‘‘(i) IN GENERAL.—The Secretary’’; and (iv) by adding at the end the following: ‘‘(ii) MORE THAN 5 PERCENT.—To the extent such costs are more than 5 percent below the specified level in subparagraph (A)(ii), fees may not be collected under this section for that fiscal year.’’. (b) TITLE II; AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES.— (1) INSPECTIONS BY ACCREDITED PERSONS.—Section 704(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)), as added by section 201 of Public Law 107–250 (116 Stat. 1602), is amended— (A) in paragraph (1), in the first sentence, by striking ‘‘conducting inspections’’ and all that follows and inserting ‘‘conducting inspections of establishments that manufac ture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under section 510(h) or are inspections of such establishments required to register under section 510(i).’’; (B) in paragraph (5)(B), in the first sentence, by striking ‘‘or poses’’ and all that follows through the period and inserting ‘‘poses a threat to public health, fails to act in a manner that is consistent with the purposes of this subsection, or where the Secretary determines that there is a financial conflict of interest in the relationship between the accredited person and the owner or operator of a device establishment that the accredited person has inspected under this subsection.’’;
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