Source: https://uscode.house.gov/view.xhtml?req=(title:21%20section:379j%20edition:prelim)
Timestamp: 2020-02-23 12:29:29
Document Index: 588903765

Matched Legal Cases: ['art 3', '§ 379', '§738', '§102', '§2', '§2', '§212', '§203', '§2', '§203', '§905', '§5301', '§203', '§203', '§203', '§203', '§212', '§2', '§2', '§102', '§2']

[USC02] 21 USC 379j: Authority to assess and use device fees
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21 USC 379j: Authority to assess and use device fees Text contains those laws in effect on February 22, 2020
The fee required under subparagraph (A) shall be due once each fiscal year, upon the later of-
The applicable inflation adjustment for fiscal year 2018 and each subsequent fiscal year is the product of-
Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus-
For purposes of subparagraph (B), if the base inflation adjustment for a fiscal year under clause (i)-
For each of fiscal years 2018 through 2022, the Secretary shall-
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-
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-
The 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 device applications-
(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 ; Pub. L. 112–144, title II, §203(a)–(f), July 9, 2012, 126 Stat. 1002 ; Pub. L. 112–193, §2(b)(1), Oct. 5, 2012, 126 Stat. 1443 ; Pub. L. 115–52, title II, §203(a)–(f)(1), (2)(B)–(i), title IX, §905(b)(2), Aug. 18, 2017, 131 Stat. 1013–1016 , 1090.)
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 chapter 46 (§5301 et seq.) of Title 25, Indians. For complete classification of this Act to the Code, see Short Title note set out under section 5301 of Title 25 and Tables.
2017-Subsec. (a)(1). Pub. L. 115–52, §203(a)(1), substituted "fiscal year 2018" for "fiscal year 2013".
Subsec. (c)(2)(B). Pub. L. 115–52, §203(c)(2)(B), added subpar. (B) and struck out former subpar. (B). Prior to amendment, text read as follows: "The applicable inflation adjustment for a fiscal year is-
"(ii) for fiscal year 2015 and each subsequent fiscal year, the product of-
2012-Subsec. (a)(1). Pub. L. 112–144, §203(a)(1), substituted "fiscal year 2013" for "fiscal year 2008".
Subsec. (a)(3)(C). Pub. L. 112–144, §203(a)(3)(B), substituted "later of-" for "initial registration of the establishment or upon the annual registration under section 360 of this title." and added cls. (i) and (ii).
2007-Subsec. (a)(1). Pub. L. 110–85, §212(a)(1)(A), substituted "Beginning in fiscal year 2008" for "Beginning on October 26, 2002".
2005-Subsec. (a)(2)(A). Pub. L. 109–43, §2(a)(7), substituted "subsection (c)(1)" for "subsection (c)(5)".
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-
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-