PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 845
under section 515(c)(4) that is withdrawn before a second portion is submitted and before a first action on the first portion. ‘‘(v) LATER WITHDRAWN MODULAR APPLICATIONS.— If an application submitted under section 515(c)(4) is withdrawn after a second or subsequent portion is submitted but before any first action, the Secretary may return a portion of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of the portions submitted. ‘‘(vi) SOLE DISCRETION TO REFUND.—The Secretary shall have sole discretion to refund a fee or portion of the fee under clause (iii) or (v). A determination by the Secretary concerning a refund under clause (iii) or (v) shall not be reviewable.’’. (5) ANNUAL ESTABLISHMENT REGISTRATION FEE.—Section 738(a) (21 U.S.C. 379j(a)) is amended by adding after paragraph (2) the following: ‘‘(3) ANNUAL ESTABLISHMENT REGISTRATION FEE.— ‘‘(A) IN GENERAL.—Except as provided in subparagraph (B), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under section 510 beginning with its registration for fiscal year 2008. ‘‘(B) EXCEPTION.—No fee shall be required under subparagraph (A) for an establishment operated by a State or Federal governmental entity or an Indian tribe (as defined in the Indian Self Determination and Educational Assistance Act), unless a device manufactured by the establishment is to be distributed commercially. ‘‘(C) PAYMENT.—The fee required under subparagraph (A) shall be due once each fiscal year, upon the initial registration of the establishment or upon the annual registration under section 510.’’. (b) FEE AMOUNTS.—Section 738(b) (21 U.S.C. 379j(b)) is amended to read as follows: ‘‘(b) FEE AMOUNTS.—Except as provided in subsections (c), (d), (e), and (h) the fees under subsection (a) shall be based on the following fee amounts:
Fee Type
Fiscal Year 2008
Fiscal Year 2009
Fiscal Year 2010
Fiscal Year 2011
Fiscal Year 2012
Premarket Application ....
$185,000
$200,725
$217,787
$236,298
$256,384 ................
Establishment Registration ................................
$1,706
$1,851
$2,008
$2,179
$2,364.’’.
dkrause on GSDDPC44 with PUBLAW
(c) ANNUAL FEE SETTING.— (1) IN GENERAL.—Section 738(c) (21 U.S.C. 379j(c)(1)) is amended— (A) in the subsection heading, by striking ‘‘Annual Fee Setting’’ and inserting ‘‘ANNUAL FEE SETTING’’; and (B) in paragraph (1), by striking the last sentence.
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13:52 Jan 23, 2009
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