Source: https://www.law.cornell.edu/uscode/text/21/379j%e2%80%9312
Timestamp: 2015-09-04 06:35:19
Document Index: 373191083

Matched Legal Cases: ['§ 379', 'art 4', '§ 379', '§ 379', '§\u202f379', '§\u202f740', '§\u202f3', '§\u202f103', '§\u202f103', '§\u202f103', '§\u202f103', '§\u202f103', '§\u202f103', '§\u202f103', '§\u202f103', '§\u202f103', '§\u202f103', '§\u202f103', '§\u202f103', '§\u202f103', '§\u202f107']

21 U.S. Code § 379j–12 - Authority to assess and use animal drug fees | US Law | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter VII › Part C › Subpart 4 › § 379j–12 21 U.S. Code § 379j–12 - Authority to assess and use animal drug fees
§ 379j–12.
Authority to assess and use animal drug fees
(a) Types of feesBeginning in fiscal year 2004, the Secretary shall assess and collect fees in accordance with this section as follows:
(A) In generalEach person that submits, on or after September 1, 2003, an animal drug application or a supplemental animal drug application shall be subject to a fee as follows:
A fee established in subsection (c) for an animal drug application, except an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title.
(ii) A fee established in subsection (c), in an amount that is equal to 50 percent of the amount of the fee under clause (i), for—
a supplemental animal drug application for which safety or effectiveness data are required; and
an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title.
If an animal drug application or a supplemental animal drug application was submitted by a person that paid the fee for such application or supplement, was accepted for filing, and was not approved or was withdrawn (without a waiver or refund), the submission of an animal drug application or a supplemental animal drug application for the same product by the same person (or the person’s licensee, assignee, or successor) shall not be subject to a fee under subparagraph (A).
(A) In generalEach person—
who is named as the applicant in an animal drug application or supplemental animal drug application for an animal drug product which has been submitted for listing under section 360 of this title; and
who, after September 1, 2003, had pending before the Secretary an animal drug application or supplemental animal drug application,
(B) Payment; fee due dateSuch fee shall be payable for the fiscal year in which the animal drug product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the animal drug product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be due each subsequent fiscal year that the product remains listed, upon the later of—
who owns or operates, directly or through an affiliate, an animal drug establishment;
(B) Payment; fee due dateThe annual establishment fee shall be assessed in each fiscal year in which the animal drug product named in the application is assessed a fee under paragraph (2) unless the animal drug establishment listed in the application does not engage in the manufacture of the animal drug product during the fiscal year. The fee under this paragraph for a fiscal year shall be due upon the later of—
An establishment shall be assessed only one fee per fiscal year under this section, subject to clause (ii).
(ii) Certain manufacturers
If a single establishment manufactures both animal drug products and prescription drug products, as defined in section 379g(3) of this title, such establishment shall be assessed both the animal drug establishment fee and the prescription drug establishment fee, as set forth in section 379h(a)(2) of this title, within a single fiscal year.
who meets the definition of an animal drug sponsor within a fiscal year; and
who, after September 1, 2003, had pending before the Secretary an animal drug application, a supplemental animal drug application, or an investigational animal drug submission,
(B) Payment; fee due dateThe fee under this paragraph for a fiscal year shall be due upon the later of—
(1) In generalSubject to subsections (c), (d), (f), and (g)—
for fiscal year 2014, the fees required under subsection (a) shall be established to generate a total revenue amount of $23,600,000; and
for each of fiscal years 2015 through 2018, the fees required under subsection (a) shall be established to generate a total revenue amount of $21,600,000.
(2) Types of feesOf the total revenue amount determined for a fiscal year under paragraph (1)—
20 percent shall be derived from fees under subsection (a)(1) (relating to animal drug applications and supplements);
27 percent shall be derived from fees under subsection (a)(2) (relating to animal drug products);
26 percent shall be derived from fees under subsection (a)(3) (relating to animal drug establishments); and
27 percent shall be derived from fees under subsection (a)(4) (relating to animal drug sponsors).
(2) Inflation adjustmentFor fiscal year 2015 and subsequent fiscal years, the revenue amounts established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, by an amount equal to the sum of—
the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 of the preceding 4 fiscal years for which data are available, multiplied by the average proportion of personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available; and
the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; not seasonally adjusted; all items less food and energy; annual index) for the first 3 years of the preceding 4 years for which data are available multiplied by the average proportion of all costs other than personnel compensation and benefits costs to total Food and Drug Administration costs for the first 3 years of the preceding 4 fiscal years for which data are available.
The adjustment made each fiscal year under this paragraph shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2014 under this paragraph.
(3) Workload adjustmentFor fiscal year 2015 and subsequent fiscal years, after the revenue amounts established in subsection (b) are adjusted for inflation in accordance with paragraph (2), the revenue amounts shall be further adjusted for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of animal drug applications. With respect to such adjustment—
such adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of animal drug applications, supplemental animal drug applications for which data with respect to safety or effectiveness are required, manufacturing supplemental animal drug applications, investigational animal drug study submissions, and investigational animal drug protocol submissions submitted to the Secretary;
the Secretary shall publish in the Federal Register the fees resulting from such adjustment and the supporting methodologies; and
under no circumstances shall such adjustment result in fee revenues for a fiscal year that are less than the fee revenues for that fiscal year established in subsection (b), as adjusted for inflation under paragraph (2).
For fiscal year 2018, the Secretary may, in addition to other adjustments under this subsection, further increase the fees under this section, if such an adjustment is necessary, to provide for up to 3 months of operating reserves of carryover user fees for the process for the review of animal drug applications for the first 3 months of fiscal year 2019. If the Food and Drug Administration has carryover balances for the process for the review of animal drug applications in excess of 3 months of such operating reserves, then this adjustment will not be made. If this adjustment is necessary, then the rationale for the amount of the increase shall be contained in the annual notice setting fees for fiscal year 2018.
(d) Fee waiver or reduction
(1) In generalThe Secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection (a) where the Secretary finds that—
the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances;
the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of animal drug applications for such person;
(C) the animal drug application or supplemental animal drug application is intended solely to provide for use of the animal drug in—
a Type B medicated feed (as defined in section 558.3(b)(3) of title 21, Code of Federal Regulations (or any successor regulation)) intended for use in the manufacture of Type C free-choice medicated feeds; or
a Type C free-choice medicated feed (as defined in section 558.3(b)(4) of title 21, Code of Federal Regulations (or any successor regulation));
the animal drug application or supplemental animal drug application is intended solely to provide for a minor use or minor species indication; or
the sponsor involved is a small business submitting its first animal drug application to the Secretary for review.
In paragraph (1)(E), the term “small business” means an entity that has fewer than 500 employees, including employees of affiliates.
(A) In generalThe fees authorized by this section—
subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year, and
shall be available to defray increases in the costs of the resources allocated for the process for the review of animal drug applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2003 multiplied by the adjustment factor.
(B) ComplianceThe Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of animal drug applications—
For each of the fiscal years 2014 through 2018, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under subsection (c) and paragraph (4).
(4) Offset of overcollections; recovery of collection shortfalls
(A) Offset of overcollections
If the sum of the cumulative amount of fees collected under this section for fiscal years 2014 through 2016 and the amount of fees estimated to be collected under this section for fiscal year 2017 (including any increased fee collections attributable to subparagraph (B)), exceeds the cumulative amount appropriated pursuant to paragraph (3) for the fiscal years 2014 through 2017, the excess amount 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 2018.
(B) Recovery of collection shortfalls
(i) Fiscal year 2016
For fiscal year 2016, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2014 falls below the amount of fees authorized for fiscal year 2014 under paragraph (3).
(ii) Fiscal year 2017
For fiscal year 2017, the amount of fees otherwise authorized to be collected under this section shall be increased by the amount, if any, by which the amount collected under this section and appropriated for fiscal year 2015 falls below the amount of fees authorized for fiscal year 2015 under paragraph (3).
(iii) Fiscal year 2018
For fiscal year 2018, the amount of fees otherwise authorized to be collected under this section (including any reduction in the authorized amount under subparagraph (A)), shall be increased by the cumulative amount, if any, by which the amount collected under this section and appropriated for fiscal years 2016 and 2017 (including estimated collections for fiscal year 2017) falls below the cumulative amount of fees authorized under paragraph (3) for fiscal years 2016 and 2017.
(k) Abbreviated new animal drug applicationsThe Secretary shall—
to the extent practicable, segregate the review of abbreviated new animal drug applications from the process for the review of animal drug applications; and
adopt other administrative procedures to ensure that review times of abbreviated new animal drug applications do not increase from their current level due to activities under the user fee program.
(June 25, 1938, ch. 675, § 740, as added Pub. L. 108–130, § 3, Nov. 18, 2003, 117 Stat. 1363; amended Pub. L. 110–316, title I, § 103, Aug. 14, 2008, 122 Stat. 3510; Pub. L. 113–14, title I, § 103, June 13, 2013, 127 Stat. 454.)
For termination of section by section 107(a) of Pub. L. 113–14, see Termination Date note below.
2013—Pub. L. 113–14 amended section generally. Prior to amendment, section related to authority to assess and use animal drug fees.
2008—Subsec. (a)(1)(A)(i). Pub. L. 110–316, § 103(a)(1), inserted “, except an animal drug application subject to the criteria set forth in section 360b(d)(4) of this title” after “for an animal drug application”.
Subsec. (a)(1)(A)(ii). Pub. L. 110–316, § 103(a)(2), amended cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: “A fee established in subsection (b) of this section for a supplemental animal drug application for which safety or effectiveness data are required, in an amount that is equal to 50 percent of the amount of the fee under clause (i).”
Subsec. (b)(1). Pub. L. 110–316, § 103(b)(1), substituted “and supplemental and other animal drug application fees” for “and supplemental animal drug application fees” and “$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013.” for “$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008.”
Subsec. (b)(2). Pub. L. 110–316, § 103(b)(2), substituted “$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013.” for “$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008.”
Subsec. (b)(3). Pub. L. 110–316, § 103(b)(3), substituted “$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013.” for “$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008.”
Subsec. (b)(4). Pub. L. 110–316, § 103(b)(4), substituted “$3,815,000 for fiscal year 2009, $4,320,000 for fiscal year 2010, $4,862,000 for fiscal year 2011, $5,442,000 for fiscal year 2012, and $6,061,000 for fiscal year 2013.” for “$1,250,000 in fiscal year 2004, $2,000,000 in fiscal year 2005, and $2,500,000 in fiscal years 2006, 2007, and 2008.”
Subsec. (c)(1). Pub. L. 110–316, § 103(c)(1)–(3), redesignated par. (2) as (1), substituted “The fee revenues shall be adjusted each fiscal year after fiscal year 2009” for “After the fee revenues are adjusted for inflation in accordance with paragraph (1), the fee revenues shall be further adjusted each fiscal year after fiscal year 2004” in introductory provisions, struck out “, as adjusted for inflation under paragraph (1)” before period in subpar. (B), and struck out former par. (1) relating to inflation adjustment.
Subsec. (c)(2). Pub. L. 110–316, § 103(c)(2), (4), redesignated par. (3) as (2) and substituted “2013” for “2008” in two places and “2014” for “2009”. Former par. (2) redesignated (1).
Subsec. (c)(3) to (5). Pub. L. 110–316, § 103(c)(2), redesignated pars. (4) and (5) as (3) and (4), respectively. Former par. (3) redesignated (2).
Subsec. (g)(3)(A) to (E). Pub. L. 110–316, § 103(d), amended subpars. (A) to (E) generally. Prior to amendment, subpars. (A) to (E) read as follows:
“(A) $5,000,000 for fiscal year 2004;
“(B) $8,000,000 for fiscal year 2005;
“(C) $10,000,000 for fiscal year 2006;
“(D) $10,000,000 for fiscal year 2007; and
“(E) $10,000,000 for fiscal year 2008;”.
Subsec. (g)(4). Pub. L. 110–316, § 103(e), amended par. (4) generally. Prior to amendment, par. (4) read as follows: “Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriations 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.”
Pub. L. 113–14, title I, § 107(a), June 13, 2013, 127 Stat. 464, provided that: “Section 740 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) shall cease to be effective October 1, 2018.”