Source: http://www2.law.cornell.edu/uscode/text/21/379j
Timestamp: 2013-12-11 10:09:18
Document Index: 580739852

Matched Legal Cases: ['§ 379', 'art 3', '§ 379', '§ 379', '§ 738', '§ 102', '§ 2', '§ 2', '§ 212', '§ 450', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 212', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 2', '§ 102', '§ 2', '§ 379', '§ 379', 'art 10', 'art 11', 'art 12', 'art 13', 'art 14', 'art 15', 'art 16', 'art 20', 'art 25']

21 USC § 379j - Authority to assess and use device fees | Title 21 - Food and Drugs | U.S. Code | LII / Legal Information Institute
USC › Title 21 › Chapter 9 › Subchapter VII › Part C › Subpart 3 › § 379j › prevnext
21 USC § 379j - Authority to assess and use device fees
Types of fees (1)
In general Beginning in fiscal year 2013, the Secretary shall assess and collect fees in accordance with this section.
Premarket application, premarket report, supplement, and submission fee, and annual fee for periodic reporting concerning a class III device (A)
In general Except as provided in subparagraph (B) and subsections (d), (e), and (f) of this section, each person who submits any of the following, on or after October 1, 2012, shall be subject to a fee established under subsection (c) of this section for the fiscal year involved in accordance with the following:
An application under section 360j
(m) of this title is not subject to any fee under subparagraph (A).
Further manufacturing use
State or Federal Government sponsors
Premarket notifications by third parties
Pediatric conditions of use
Subsequent proposal of adult conditions of use
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 360e
(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.
Refunds (i)
Application refused for filing
Application withdrawn before filing
Application withdrawn before first action
Modular applications withdrawn before first action
The Secretary shall refund 75 percent of the application fee paid for an application submitted under section 360e
(c)(4) of this title that is withdrawn before a second portion is submitted and before a first action on the first portion.
Later withdrawn modular applications
If an application submitted under section 360e
(c)(4) of this title 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.
Sole discretion to refund
Annual establishment registration fee (A)
In general Except as provided in subparagraph (B) and subsection (f), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under section 360 of this title beginning with its registration for fiscal year 2008.
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 [1]
[25 U.S.C. 450 et seq.]), unless a device manufactured by the establishment is to be distributed commercially.
Payment The fee required under subparagraph (A) shall be due once each fiscal year, upon the later of—
Fee amounts (1)
In general Subject to subsections (c), (d), (e), (f), and (i), for each of fiscal years 2013 through 2017, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3).
Base fee amounts specified For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:
Fee Type Fiscal Year 2013 Fiscal Year 2014 Fiscal Year 2015 Fiscal Year 2016 Fiscal Year 2017 Premarket Application
Total revenue amounts specified For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:
In general The Secretary shall, 60 days before the start of each fiscal year after September 30, 2012, establish fees under subsection (a), based on amounts specified under subsection (b) and the adjustments provided under this subsection, and publish such fees, and the rationale for any adjustments to such fees, in the Federal Register.
Adjustment to total revenue amounts For fiscal year 2014 and each subsequent fiscal year, the Secretary shall adjust the total revenue amount specified in subsection (b)(3) for such fiscal year by multiplying such amount by the applicable inflation adjustment under subparagraph (B) for such year.
Applicable inflation adjustment to total revenue amounts The applicable inflation adjustment for a fiscal year is—
for fiscal year 2015 and each subsequent fiscal year, the product of—
Base inflation adjustment to total revenue amounts (i)
Adjustment to base fee amounts For each of fiscal years 2014 through 2017, the base fee amounts specified in subsection (b)(2) shall be adjusted as needed, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).
Volume-based adjustments to establishment registration base fees For each of fiscal years 2014 through 2017, after the base fee amounts specified in subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment registration fee amounts specified in such subsection shall be further adjusted, as the Secretary estimates is necessary in order for total fee collections for such fiscal year to generate the total revenue amounts, as adjusted under paragraph (2).
Limit The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of device applications.
In general The Secretary may use unobligated carryover balances from fees collected in previous fiscal years to ensure that sufficient fee revenues are available in that fiscal year, so long as the Secretary maintains unobligated carryover balances of not less than 1 month of operating reserves for the first month of the next fiscal year.
Notice to Congress Not later than 14 days before the Secretary anticipates the use of funds described in subparagraph (A), the Secretary shall provide notice to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives.
Small businesses; fee waiver and fee reduction regarding premarket approval fees (1)
In general The Secretary shall grant a waiver of the fee required under subsection (a) of this section for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term “small business” means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (v) and clauses (vii), (ix), and (x) of subsection (a)(2)(A) may be paid at a reduced rate in accordance with paragraph (2)(C).
Rules relating to premarket approval fees (A)
Definition For purposes of this paragraph, the term “small business” means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.
Evidence of qualification (i)
Firms submitting tax returns to the United States Internal Revenue Service
Firms not submitting tax returns to the United States Internal Revenue Service
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—
Request for fee waiver or reduction An applicant seeking a fee waiver or reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a) of this section. The decision of the Secretary regarding whether an entity qualifies for such a waiver or reduction is not reviewable.
Small businesses; fee reduction regarding premarket notification submissions (1)
In general For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved is a small business, the fee specified in subsection (a)(2)(A)(viii) of this section may be paid at a reduced rate in accordance with paragraph (2)(C).
Rules relating to premarket notification submissions (A)
Definition For purposes of this subsection, the term “small business” means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.
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).
Request for reduction An applicant seeking a fee reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a) of this section. The decision of the Secretary regarding whether an entity qualifies for such a reduction is not reviewable.
In general The Secretary may, at the Secretary’s sole discretion, grant a waiver or reduction of fees under subsection (a)(2) or (a)(3) if the Secretary finds that such waiver or reduction is in the interest of public health.
Limitation The sum of all fee waivers or reductions granted by the Secretary in any fiscal year under paragraph (1) shall not exceed 2 percent of the total fee revenue amounts established for such year under subsection (c).
Duration The authority provided by this subsection terminates October 1, 2017.
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.
No registration Registration information submitted under section 360 of this title 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 360 of this title.
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—
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.
In general Subject to paragraph (2)(C), fees authorized under subsection (a) of this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of device applications.
Authorizations of appropriations For each of the fiscal years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount specified under subsection (b)(3) for the fiscal year, as adjusted under subsection (c) and, for fiscal year 2017 only, as further adjusted under paragraph (4).
Offset If the cumulative amount of fees collected during fiscal years 2013, 2014, and 2015, added to the amount estimated to be collected for fiscal year 2016, which estimate shall be based upon the amount of fees received by the Secretary through June 30, 2016, exceeds the cumulative amount appropriated pursuant to paragraph (3) for these four fiscal years, the 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 2017.
Written requests for refunds To qualify for consideration for a refund under subsection (a)(2)(D) of this section, a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due.
Construction This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of device applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.
(June 25, 1938, ch. 675, § 738, as added Pub. L. 107–250, title I, § 102(a),Oct. 26, 2002, 116 Stat. 1591; amended Pub. L. 108–214, § 2(a)(2), (d)(2)(A), (B), (3)(A),Apr. 1, 2004, 118 Stat. 572, 576, 577; Pub. L. 109–43, § 2(a),Aug. 1, 2005, 119 Stat. 439; Pub. L. 110–85, title II, § 212,Sept. 27, 2007, 121 Stat. 844.)
For termination of section by section 107 ofPub. L. 107–250, see Effective and Termination Dates note set out under section 379i of this title.
The Indian Self Determination and Educational Assistance Act, referred to in subsec. (a)(3)(B), probably means the Indian Self-Determination and Education Assistance Act, Pub. L. 93–638, Jan. 4, 1975, 88 Stat. 2203, which is classified principally to subchapter II (§ 450 et seq.) of chapter 14 of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 450 of Title 25 and Tables.
2007—Subsec. (a)(1). Pub. L. 110–85, §§ 212(a)(1)(A), 217, temporarily substituted “Beginning in fiscal year 2008” for “Beginning on October 26, 2002”. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (a)(2). Pub. L. 110–85, §§ 212(a)(1)(B), 217, temporarily amended heading generally. Prior to amendment, heading read as follows: “Premarket application, premarket report, supplement, and submission fee”. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (a)(2)(A)(iii). Pub. L. 110–85, §§ 212(a)(2)(A), 217, temporarily substituted “a fee equal to 75 percent of the fee that applies” for “a fee equal to the fee that applies”. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (a)(2)(A)(iv). Pub. L. 110–85, §§ 212(a)(2)(B), 217, temporarily substituted “15 percent” for “21.5 percent”. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (a)(2)(A)(v). Pub. L. 110–85, §§ 212(a)(2)(C), 217, temporarily substituted “7 percent” for “7.2 percent”. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (a)(2)(A)(vi), (vii). Pub. L. 110–85, §§ 212(a)(2)(D), (E), 217, temporarily added cl. (vi) and redesignated former cl. (vi) as (vii). Former cl. (vii) redesignated (viii). See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (a)(2)(A)(viii). Pub. L. 110–85, §§ 212(a)(2)(D), (F), 217, temporarily redesignated cl. (vii) as (viii), substituted “1.84 percent” for “1.42 percent”, and struck out “, subject to any adjustment under subsection (e)(2)(C)(ii) of this section” before period at end. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (a)(2)(A)(ix), (x). Pub. L. 110–85, §§ 212(a)(2)(G), 217, temporarily added cls. (ix) and (x). See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (a)(2)(C). Pub. L. 110–85, §§ 212(a)(3), 217, temporarily amended subpar. (C) generally. Prior to amendment, text read as follows: “The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, or premarket notification submission except that invoices for applications submitted between October 1, 2002, and October 26, 2002, shall be payable on October 30, 2002. Applicants submitting portions of applications pursuant to section 360e
(c)(3) of this title shall pay such fees upon submission of the first portion of such applications. The fees credited to fiscal year 2003 under this section shall include all fees payable from October 1, 2002, through September 30, 2003.” See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (a)(2)(D)(iii). Pub. L. 110–85, §§ 212(a)(4)(A), 217, temporarily struck out at end “The Secretary shall have sole discretion to refund a fee or portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.” See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (a)(2)(D)(iv) to (vi). Pub. L. 110–85, §§ 212(a)(4)(B), 217, temporarily added cls. (iv) to (vi). See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (a)(3). Pub. L. 110–85, §§ 212(a)(5), 217, temporarily added par. (3). See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (b). Pub. L. 110–85, §§ 212(b), 217, temporarily amended subsec. (b) generally. Prior to amendment, text read as follows: “Except as provided in subsections (c), (d), (e), (g), and (h) of this section, the fees under subsection (a) of this section shall be established to generate the following revenue amounts: $25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004; and $29,785,000 in fiscal year 2005. If legislation is enacted after October 26, 2002, requiring the Secretary to fund additional costs of the retirement of Federal personnel, fee revenue amounts under this subsection shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of device applications.” See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (c). Pub. L. 110–85, §§ 212(c)(1)(A), 217, temporarily made technical amendment to heading. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (c)(1). Pub. L. 110–85, §§ 212(c)(1)(B), 217, temporarily struck out at end “The fees established for fiscal year 2006 shall be based on a premarket application fee of $259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600.”. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (c)(2), (3). Pub. L. 110–85, §§ 212(c)(2)(A), (B), 217, temporarily added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4). See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (c)(4). Pub. L. 110–85, §§ 212(c)(2)(A), (C), 217, temporarily redesignated par. (3) as (4) and substituted in subpar. (A) “The Secretary” for “For fiscal years 2006 and 2007, the Secretary” and “for the first month of the next fiscal year” for “for the first month of fiscal year 2008”. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (d)(1). Pub. L. 110–85, §§ 212(d)(1), 217, temporarily struck out “, partners, and parent firms” after “affiliates” and substituted “clauses (i) through (v) and clauses (vii), (ix), and (x) of subsection (a)(2)(A)” for “clauses (i) through (vi) of subsection (a)(2)(A) of this section”. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (d)(2)(A). Pub. L. 110–85, §§ 212(d)(2)(A), 217, temporarily struck out “, partners, and parent firms” before period at end. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (d)(2)(B). Pub. L. 110–85, §§ 212(d)(2)(B)(i), (ii), 217, temporarily designated first sentence as cl. (i) and second to fourth sentences as cl. (ii) and inserted cl. headings. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (d)(2)(B)(ii). Pub. L. 110–85, §§ 212(d)(2)(B)(iii), (iv), 217, temporarily struck out “, partners, and parent firms” after “its affiliates” and after “such affiliates” and substituted “If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.” for “If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively.” See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (d)(2)(B)(iii). Pub. L. 110–85, §§ 212(d)(2)(B)(v), 217, temporarily added cl. (iii). See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (d)(2)(C). Pub. L. 110–85, §§ 212(d)(3), 217, temporarily amended subpar. (C) generally. Prior to amendment, text read as follows: “Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) of this section may be paid at a reduced rate of 38 percent of the fee established under such subsection for a premarket application, a premarket report, or a supplement.” See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (e)(1). Pub. L. 110–85, §§ 212(e)(1), 217, temporarily substituted “2008” for “2004” and “(a)(2)(A)(viii)” for “(a)(2)(A)(vii)”. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (e)(2)(A). Pub. L. 110–85, §§ 212(e)(2)(A), 217, temporarily struck out “, partners, and parent firms” before period at end. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (e)(2)(B). Pub. L. 110–85, §§ 212(e)(2)(B)(i), (ii), 217, temporarily inserted cl. headings and designated first sentence as cl. (i) and second to fourth sentences as cl. (ii). See Effective and Termination Dates of 2007 Amendment below.
Subsec. (e)(2)(B)(ii). Pub. L. 110–85, §§ 212(e)(2)(B)(iii), (iv), 217, temporarily struck out “, partners, and parent firms” after “its affiliates” and after “such affiliates” and substituted “If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.” for “If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively.” See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (e)(2)(B)(iii). Pub. L. 110–85, §§ 212(e)(2)(B)(v), 217, temporarily added cl. (iii). See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (e)(2)(C). Pub. L. 110–85, §§ 212(e)(3), 217, temporarily amended subpar. (C) generally. Prior to amendment, subpar. (C) contained provisions, for fiscal year 2004 and each subsequent fiscal year, authorizing in cl. (i) a reduced fee for a premarket notification submission, and directing in cl. (ii) the Secretary how to determine an adjustment per fee revenue amount. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (f). Pub. L. 110–85, §§ 212(f), 217, temporarily amended subsec. (f) generally. Prior to amendment, text read as follows: “A premarket application, premarket report, supplement, or premarket notification submission submitted by a person subject to fees under subsection (a) of this section shall be considered incomplete and shall not be accepted by the Secretary until all fees owed by such person have been paid.” See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (g)(1). Pub. L. 110–85, §§ 212(g)(1), 217, temporarily added par. (1) and struck out former par. (1). Prior to amendment, par. (1) related to performance goals for fiscal years 2003 through 2005, with respect to the amount appropriated under the salaries and expenses account of the Food and Drug Administration, for devices and radiological products, and termination of the program after fiscal year 2005. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (g)(2). Pub. L. 110–85, §§ 212(g)(2), 217, temporarily amended par. (2) generally. Prior to amendment, text read as follows: “If the Secretary does not assess fees under subsection (a) of this section during any portion of a fiscal year because of subparagraph (C) or (D) 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, and premarket notification submissions, and at any time in such fiscal year, notwithstanding the provisions of subsection (a) of this section relating to the date fees are to be paid.” See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (h)(3). Pub. L. 110–85, §§ 212(h)(1), 217, temporarily amended par. (3) generally, substituting provisions authorizing appropriations for fiscal years 2008 to 2012 for provisions authorizing appropriations for fiscal years 2003 to 2007. See Effective and Termination Dates of 2007 Amendment note below.
Subsec. (h)(4). Pub. L. 110–85, §§ 212(h)(2), 217, temporarily amended par. (4) generally. Prior to amendment, text read as follows: “Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year 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 a subsequent fiscal year.” See Effective and Termination Dates of 2007 Amendment note below.
2005—Subsec. (a)(2)(A). Pub. L. 109–43, § 2(a)(7), substituted “subsection (c)(1)” for “subsection (c)(5)”.
Subsec. (b). Pub. L. 109–43, § 2(a)(1), inserted “and” after “2004;” and substituted “2005” for “2005; $32,615,000 in fiscal year 2006, and $35,000,000 in fiscal year 2007”.
Subsec. (c). Pub. L. 109–43, § 2(a)(2)(A), substituted “Annual fee setting” for “Adjustments” in heading.
Subsec. (c)(1). Pub. L. 109–43, § 2(a)(2)(B)–(D), redesignated par. (5) as (1), substituted “In general” for “Annual fee setting” in heading, “publish in the Federal Register fees under subsection (a) of this section. The fees” for “establish, for the next fiscal year, and publish in the Federal Register, fees under subsection (a) of this section, based on the revenue amounts established under subsection (b) of this section and the adjustment provided under this subsection and subsection (e)(2)(C)(ii) of this section, except that the fees”, “2006” for “2003”, and “$259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600.” for “$154,000.” in text, and struck out former par. (1) which required an annual inflation adjustment of the revenues established in subsec. (b).
Subsec. (c)(2). Pub. L. 109–43, § 2(a)(2)(B), (C), redesignated par. (6) as (2) and struck out former par. (2) which required an annual adjustment of the fee revenues established in subsec. (b) to reflect changes in the workload of the Secretary for the process for the review of device applications.
Subsec. (c)(3). Pub. L. 109–43, § 2(a)(2)(B), (E), added par. (3) and struck out former par. (3) which required an annual compensating adjustment of the fee revenues established in subsec. (b).
Subsec. (c)(4). Pub. L. 109–43, § 2(a)(2)(B), struck out par. (4) which provided for a fiscal year 2007 adjustment of the fee revenues established in subsec. (b) to provide for operating reserves of carryover user fees.
Subsec. (c)(5), (6). Pub. L. 109–43, § 2(a)(2)(C), redesignated pars. (5) and (6) as (1) and (2), respectively.
Subsec. (d)(1). Pub. L. 109–43, § 2(a)(3)(A), inserted after first sentence “For the purposes of this paragraph, the term ‘small business’ means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms.”
Subsec. (d)(2)(A). Pub. L. 109–43, § 2(a)(3)(B), struck out cl. (i) designation and heading before “For purposes”, substituted “paragraph,” for “subsection,” and “$100,000,000” for “$30,000,000”, and struck out heading and text of clause (ii). Text read as follows: “The Secretary may adjust the $30,000,000 threshold established in clause (i) if the Secretary has evidence from actual experience that this threshold results in a reduction in revenues from premarket applications, premarket reports, and supplements that is 16 percent or more than would occur without small business exemptions and lower fee rates. To adjust this threshold, the Secretary shall publish a notice in the Federal Register setting out the rationale for the adjustment, and the new threshold.”
Subsec. (d)(2)(C). Pub. L. 109–43, § 2(a)(7), substituted “subsection (c)(1)” for “subsection (c)(5)”.
Subsec. (e)(2)(A). Pub. L. 109–43, § 2(a)(4), substituted “$100,000,000” for “$30,000,000”.
Subsec. (e)(2)(C). Pub. L. 109–43, § 2(a)(7), substituted “subsection (c)(1)” for “subsection (c)(5)” in cls. (i) and (ii).
Subsec. (g)(1)(B)(i). Pub. L. 109–43, § 2(a)(5)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows: “For fiscal year 2005, the Secretary is expected to meet all of the performance goals identified for the fiscal year if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is equal to or greater than the sum of—
Subsec. (g)(1)(B)(ii). Pub. L. 109–43, § 2(a)(5)(A)(ii), added introductory provisions and struck out former introductory provisions which read as follows: “For fiscal year 2005, if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is less than the sum that applies under clause (i) for fiscal year 2005, the following applies:”.
Subsec. (g)(1)(C). Pub. L. 109–43, § 2(a)(5)(B)(i), substituted “2005 and” for “2003 through” and inserted “more than 1 percent” after “years, is”.
Subsec. (g)(1)(C)(ii). Pub. L. 109–43, § 2(a)(5)(B)(ii), substituted “amount that applies” for “sum that applies”.
Subsec. (g)(1)(D)(i). Pub. L. 109–43, § 2(a)(5)(C), inserted “more than 1 percent” after “year, is”.
Subsec. (h)(3)(D), (E). Pub. L. 109–43, § 2(a)(6), added subpar. (D) and struck out former subpars. (D) and (E) which read as follows:
Subsec. (a). Pub. L. 108–214, § 2(d)(2)(A), designated introductory provisions of subsec. (a) as par. (1), inserted heading, substituted “this section.” for “this section as follows:”, and redesignated former par. (1) as (2).
Subsec. (a)(1)(A). Pub. L. 108–214, § 2(a)(2)(A)(i), substituted, in introductory provisions, “subsections (d) and (e)” for “subsection (d)”, in cl. (iv), “clause (i)” for “clause (i), subject to any adjustment under subsection (c)(3) of this section”, and, in cl. (vii), “clause (i), subject to any adjustment under subsection (e)(2)(C)(ii)” for “clause (i), subject to any adjustment under subsection (c)(3) of this section and any adjustment under subsection (e)(2)(C)(ii)”.
Subsec. (a)(1)(D)(i), (ii). Pub. L. 108–214, § 2(a)(2)(A)(ii), substituted “application, report,” for “application”.
Subsec. (d)(1). Pub. L. 108–214, § 2(d)(2)(B)(i), substituted “subsection (a)(2)(A)” for “subsection (a)(1)(A)” in last sentence.
Subsec. (d)(2)(B). Pub. L. 108–214, § 2(a)(2)(B), substituted “firms, which show” for “firms. which show” in second sentence.
Subsec. (e)(1). Pub. L. 108–214, § 2(a)(2)(C)(i), (d)(2)(B)(ii), substituted “For fiscal year 2004 and each subsequent fiscal year, where” for “Where” and “subsection (a)(2)(A)(vii)” for “subsection (a)(1)(A)(vii)”.
Subsec. (e)(2)(B). Pub. L. 108–214, § 2(a)(2)(C)(ii)(I), substituted “firms, which show” for “firms. which show”.
Subsec. (e)(2)(C). Pub. L. 108–214, § 2(a)(2)(C)(ii)(II), (d)(2)(B)(iii), substituted “For fiscal year 2004 and each subsequent fiscal year, where” for “Where” in cl. (i), “subsection (a)(2)(A)(vii)” for “subsection (a)(1)(A)(vii)” in cls. (i) and (ii), and “subsection (a)(2)(A)(i)” for “subsection (a)(1)(A)(i)” in cl. (ii).
Subsec. (f). Pub. L. 108–214, § 2(a)(2)(D), struck out “for filing” after “accepted”.
Subsec. (h)(2)(B). Pub. L. 108–214, § 2(a)(2)(E), designated existing provisions as cl. (i), inserted heading, redesignated former cls. (i) and (ii) as subcls. (I) and (II), respectively, of cl. (i), redesignated former subcls. (I) and (II) of cl. (i) as items (aa) and (bb), respectively, of cl. (i)(II), and added cl. (ii).
Subsec. (j). Pub. L. 108–214, § 2(d)(2)(B)(iv), substituted “subsection (a)(2)(D)” for “subsection (a)(1)(D)”.
Amendment by Pub. L. 110–85effective Oct. 1, 2007, except for certain premarket fees under this subpart, and ceases to be effective Oct. 1, 2012, see sections 216 and 217 ofPub. L. 110–85, set out as notes under section 379i of this title.
Section effective Oct. 26, 2002, except for certain premarket fees, and ceases to be effective Oct. 1, 2007, see sections 106 and 107 ofPub. L. 107–250, set out as notes under section 379i of this title.
Pub. L. 107–250, title I, § 102(b),Oct. 26, 2002, 116 Stat. 1600, as amended by Pub. L. 108–214, § 2(d)(2)(C), (3)(B),Apr. 1, 2004, 118 Stat. 577, provided that: “A person submitting a premarket report to the Secretary of Health and Human Services is exempt from the fee under section 738(a)(2)(A)(ii) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j
(a)(2)(A)(ii)] (as added by subsection (a) of this section) if—
“(1) the premarket report is the first such report submitted to the Secretary by the person; and
“(2) before October 1, 2002, the person submitted a premarket application to the Secretary for the same device as the device for which the person is submitting the premarket report.”
21 USCDescription of ChangeSession YearPublic LawStatutes at Large § 379j2012112-144 [Sec.] 203(a)-(f)126 Stat. 1002-1005 § 379j2012112-193 [Sec.] 2(b)(1)126 Stat. 1443 This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.21 CFR - Food and Drugs21 CFR 5 - ORGANIZATION21 CFR 7 - ENFORCEMENT POLICY21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION21 CFR Part 20 - PUBLIC INFORMATION21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS