Page:United States Statutes at Large Volume 121.djvu/870

 PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 849

dkrause on GSDDPC44 with PUBLAW

‘‘(f) EFFECT OF FAILURE TO PAY FEES.— ‘‘(1) NO ACCEPTANCE OF SUBMISSIONS.—A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, or periodic reporting concerning a class III device submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all fees owed by such person have been paid. ‘‘(2) NO REGISTRATION.—Registration information submitted under section 510 by an establishment subject to a registration fee shall be considered incomplete and shall not be accepted by the Secretary until the registration fee under subsection (a)(3) owed for the establishment has been paid. Until the fee is paid and the registration is complete, the establishment is deemed to have failed to register in accordance with section 510.’’. (g) CONDITIONS.—Section 738(g) (21 U.S.C. 379j(g)) is amended— (1) by striking paragraph (1) and inserting the following: ‘‘(1) PERFORMANCE GOALS; TERMINATION OF PROGRAM.— With respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if— ‘‘(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is more than 1 percent less than $205,720,000 multiplied by the adjustment factor applicable to such fiscal year; or ‘‘(B) fees were not assessed under subsection (a) for the previous fiscal year.’’; and (2) by amending paragraph (2) to read as follows: ‘‘(2) AUTHORITY.—If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.’’. (h) CREDITING AND AVAILABILITY OF FEES.— (1) AUTHORIZATION OF APPROPRIATIONS.—Section 738(h)(3) (21 U.S.C. 379j(h)(3)) is amended to read as follows: ‘‘(3) AUTHORIZATIONS OF APPROPRIATIONS.—There are authorized to be appropriated for fees under this section— ‘‘(A) $48,431,000 for fiscal year 2008; ‘‘(B) $52,547,000 for fiscal year 2009; ‘‘(C) $57,014,000 for fiscal year 2010; ‘‘(D) $61,860,000 for fiscal year 2011; and ‘‘(E) $67,118,000 for fiscal year 2012.’’.

VerDate Aug 31 2005

13:52 Jan 23, 2009

Jkt 059194

PO 00001

Frm 00847

Fmt 6580

Sfmt 6581

M:\STATUTES\2007\59194PT1.001

APPS10

PsN: 59194PT1

�