AUTHORITY TO ASSESS AND USE DEVICE FEES.

SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES.(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(iii), by striking the last two sentences; and(B) by adding after clause (iii) the following:“(iv) Modular applications withdrawn before first action.—The Secretary shall refund 75 percent of the application fee paid for an application submitted 121 STAT. 845 under section 515(c)(4) that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 TypeFiscal Year 2008Fiscal Year 2009Fiscal Year 2010Fiscal Year 2011Fiscal 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.”. (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.121 STAT. 846(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:121 STAT. 847 “(ii) Firms submitting tax returns to the united states internal revenue service.—The applicant shall support its claim”;(iii) by striking “, partners, and parent firms” each place it appears;(iv) by striking the last sentence and inserting “If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.”; and(v) by adding at the end the following:“(iii)Firms not submitting tax returns to the united states internal revenue service.—In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.”.(3) Reduced fees.—Section 738(d)(2)(C) (21 U.S.C. 379j(d)(2)(C)) is amended to read as follows:“(C) Reduced fees.—Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of—“(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, or periodic reporting concerning a class III device; and“(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.”.(e) Small Businesses; Fee Reduction Regarding Premarket Notification Submissions.—(1) In general.—Section 738(e)(1) (21 U.S.C. 379j(e)(1)) is amended—(A) by striking “2004” and inserting “2008”; and(B) by striking “(a)(2)(A)(vii)” and inserting “(a)(2)(A)(viii)”.(2) Rules relating to premarket notification submissions.—121 STAT. 848(A) Definition.—Section 738(e)(2)(A) (21 U.S.C. 379j(e)(2)(A)) is amended by striking “, partners, and parent firms”.(B) Evidence of qualification.—Section 738(e)(2)(B) (21 U.S.C. 379j(e)(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:“(ii) Firms submitting tax returns to the united states internal revenue service.—The applicant shall support its claim”;(iii) by striking “, partners, and parent firms” each place it appears;(iv) by striking the last sentence and inserting “If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.”; and(v) by adding at the end the following:“(iii)Firms not submitting tax returns to the united states internal revenue service.—In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.”.(3) Reduced fees.—Section 738(e)(2)(C) (21 U.S.C. 379j(e)(2)(C)) is amended to read as follows:“(C) Reduced fees.—For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 50 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection (c)(1).”.(f) Effect of Failure To Pay Fees.—Section 738(f) (21 U.S.C. 379j(f)) is amended to read as follows:121 STAT. 849 “(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.”.121 STAT. 850(2) Offset.—Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is amended to read as follows:“(4) Offset.—If the cumulative amount of fees collected during fiscal years 2008, 2009, and 2010, added to the amount estimated to be collected for fiscal year 2011, which estimate shall be based upon the amount of fees received by the Secretary through June 30, 2011, exceeds the amount of fees specified in aggregate in paragraph (3) for these four fiscal years, the aggregate amount in excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2012.”.