121 STAT. 844
PUBLIC LAW 110–85—SEPT. 27, 2007
SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES.
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(a) TYPES OF FEES.— (1) IN GENERAL.—Section 738(a) (21 U.S.C. 379j(a)) is amended— (A) in paragraph (1), by striking ‘‘Beginning on the date of the enactment of the Medical Device User Fee and Modernization Act of 2002’’ and inserting ‘‘Beginning in fiscal year 2008’’; and (B) by amending the designation and heading of paragraph (2) to read as follows: ‘‘(2) PREMARKET APPLICATION, PREMARKET REPORT, SUPPLEMENT, AND SUBMISSION FEE, AND ANNUAL FEE FOR PERIODIC REPORTING CONCERNING A CLASS III DEVICE.—’’. (2) FEE AMOUNTS.—Section 738(a)(2)(A) (21 U.S.C. 379j(a)(2)(A)) is amended— (A) in clause (iii), by striking ‘‘a fee equal to the fee that applies’’ and inserting ‘‘a fee equal to 75 percent of the fee that applies’’; (B) in clause (iv), by striking ‘‘21.5 percent’’ and inserting ‘‘15 percent’’; (C) in clause (v), by striking ‘‘7.2 percent’’ and inserting ‘‘7 percent’’; (D) by redesignating clauses (vi) and (vii) as clauses (vii) and (viii), respectively; (E) by inserting after clause (v) the following: ‘‘(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).’’; (F) in clause (viii), as so redesignated— (i) by striking ‘‘1.42 percent’’ and inserting ‘‘1.84 percent’’; and (ii) by striking ‘‘, subject to any adjustment under subsection (e)(2)(C)(ii)’’; and (G) by inserting after such clause (viii) the following: ‘‘(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i). ‘‘(x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).’’. (3) PAYMENT.—Section 738(a)(2)(C) (21 U.S.C. 379j(a)(2)(C)) is amended to read as follows: ‘‘(C) PAYMENT.—The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, or periodic reporting concerning a class III device. Applicants submitting portions of applications pursuant to section 515(c)(4) shall pay such fees upon submission of the first portion of such applications.’’. (4) REFUNDS.—Section 738(a)(2)(D) (21 U.S.C. 379j(a)(2)(D)) is amended— (A) in clause (iii), by striking the last two sentences; and (B) by adding after clause (iii) the following: ‘‘(iv) MODULAR APPLICATIONS WITHDRAWN BEFORE FIRST ACTION.—The Secretary shall refund 75 percent of the application fee paid for an application submitted
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