Source: https://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title21-chapter9-subchapter7-partC-subpart8&saved=%7CZ3JhbnVsZWlkOlVTQy1wcmVsaW0tdGl0bGUyMS1zZWN0aW9uMzc5ai01MQ%3D%3D%7C%7C%7C0%7Cfalse%7Cprelim&edition=prelim
Timestamp: 2020-08-14 23:53:43
Document Index: 58875108

Matched Legal Cases: ['art 8', 'art 8', 'art 8', 'art 8', '§744', '§402', '§402', '§402', '§404', '§405', '§405', '§405', 'art 8', '§401', 'art 8', '§744', '§402', '§3101', '§403', '§905', '§3856', '§3856', '§905', '§403', '§403', '§905', '§3856', '§3101', '§3856', '§744', '§403', '§404', '§903', '§903', '§405', '§404', '§405', '§405']

[USC02] 21 USC CHAPTER 9, SUBCHAPTER VII, Part C, subpart 8: fees relating to biosimilar biological products
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21 USC CHAPTER 9, SUBCHAPTER VII, Part C, subpart 8: fees relating to biosimilar biological products
subpart 8—fees relating to biosimilar biological products
(2) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—
(7)(A) The term "biosimilar biological product establishment" means a foreign or domestic place of business—
(8) The term "biosimilar initial advisory meeting"—
(9) The term "costs of resources allocated for the process for the review of biosimilar biological product applications" means the expenses in connection with the process for the review of biosimilar biological product applications for—
(11) The term "financial hold"—
(June 25, 1938, ch. 675, §744G, as added Pub. L. 112–144, title IV, §402, July 9, 2012, 126 Stat. 1026; amended Pub. L. 115–52, title IV, §402, Aug. 18, 2017, 131 Stat. 1028.)
2017—Par. (1). Pub. L. 115–52, §402(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: "The term 'adjustment factor' applicable to a fiscal year that is the Consumer Price Index for all urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) of the preceding fiscal year divided by such Index for September 2011."
Pub. L. 112–144, title IV, §404(a), July 9, 2012, 126 Stat. 1038, which provided that this section and section 379j–52 of this title would cease to be effective Oct. 1, 2017, was repealed by Pub. L. 115–52, title IV, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035.
[Pub. L. 115–52, title III, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035, provided that the repeal of section 404(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]
Pub. L. 112–144, title IV, §405, July 9, 2012, 126 Stat. 1039, provided that:
"(a) In General.—Except as provided under subsection (b), the amendments made by this title [enacting this section and sections 379j–52 and 379j–53 of this title and amending sections 379d–4 and 379g of this title] shall take effect on the later of—
"(b) Exception.—Fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], as added by this title, shall be assessed for all biosimilar biological product applications received on or after October 1, 2012, regardless of the date of the enactment of this title."
Pub. L. 112–144, title IV, §401(b), July 9, 2012, 126 Stat. 1026, provided that: "The Congress finds that the fees authorized by the amendments made in this title [enacting this section and sections 379j–52 and 379j–53 of this title and amending sections 379d–4 and 379g of this title] will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."
The annual biosimilar biological product development fee for each fiscal year will be due on the later of—
The annual biosimilar biological product development fee for each fiscal year will be due on the date specified in clause (ii), unless the person has—
A person may discontinue participation in the biosimilar biological product development program for a product, effective October 1 of a fiscal year, by, not later than August 1 of the preceding fiscal year—
Except in extraordinary circumstances, the Secretary shall not consider an investigational new drug application to have been received under section 355(i)(2) of this title if—
Notwithstanding section 355(i)(2) of this title, except in extraordinary circumstances, the Secretary shall prohibit the sponsor of a clinical investigation from continuing the investigation if—
Any person who pays a fee under subparagraph (A), (B), or (D) of paragraph (1) for a product before October 1, 2017, but submits a biosimilar biological product application for that product after such date, shall—
Each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for each biosimilar biological product that—
The biosimilar biological product program fee for a fiscal year shall be due on the later of—
For fiscal year 2018, fees under subsection (a) shall be established to generate a total revenue amount equal to the sum of—
For each of the fiscal years 2019 through 2022, fees under subsection (a) shall, except as provided in subsection (c), be established to generate a total revenue amount equal to the sum of—
The Secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from, respectively—
For purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—
The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—
After review of the report described in clause (i) and receipt and review of public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—
Beginning with the first fiscal year for which the capacity planning adjustment under paragraph (2) is effective, the Secretary may, in addition to the adjustments under paragraphs (1) and (2)—
For fiscal year 2018 and each subsequent fiscal year, the Secretary shall, not later than 60 days before the start of each such fiscal year—
(June 25, 1938, ch. 675, §744H, as added Pub. L. 112–144, title IV, §402, July 9, 2012, 126 Stat. 1029; amended Pub. L. 114–255, div. A, title III, §3101(a)(2)(V), Dec. 13, 2016, 130 Stat. 1155; Pub. L. 115–52, title IV, §403, title IX, §905(b)(4), Aug. 18, 2017, 131 Stat. 1028, 1090; Pub. L. 116–136, div. A, title III, §3856(b)(1), Mar. 27, 2020, 134 Stat. 458.)
2020—Subsec. (f)(2)(B). Pub. L. 116–136, §3856(b)(1), amended Pub. L. 115–52, §905(b)(4). See 2017 Amendment note below.
2017—Subsec. (a). Pub. L. 115–52, §403(a)(1), substituted "fiscal year 2018" for "fiscal year 2013" in introductory provisions.
Subsec. (d)(1). Pub. L. 115–52, §403(d), substituted "affiliate shall pay" for "affiliate shall pay—" and "not a small business." for "not a small business; and", struck out subpar. (A) designation before "application fees for all", and struck out subpar. (B) which read as follows: "all supplement fees for all supplements to biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small business."
Subsec. (f)(2)(B). Pub. L. 115–52, §905(b)(4), as amended by Pub. L. 116–136, §3856(b)(1), substituted "limitations" for "limitation" in heading, designated existing provisions as cl. (i) and inserted heading, and added cl. (ii).
2016—Subsec. (a)(1)(A)(v). Pub. L. 114–255, §3101(a)(2)(V)(i), which directed technical amendment in paragraph (1)(A)(v) to reference in original act which appears in text as reference to July 9, 2012, was executed by making the amendment in introductory provisions and in subcl. (I), to reflect the probable intent of Congress.
Pub. L. 116–136, div. A, title III, §3856(b)(2), Mar. 27, 2020, 134 Stat. 458, provided that: "The amendment made by paragraph (1) [amending Pub. L. 115–52 which amended this section] shall take effect as of the enactment of the FDA Reauthorization Act of 2017 (Public Law 115–52)."
Beginning with fiscal year 2018, the report under this subsection shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—
(A) The difference between the aggregate number of biosimilar biological product applications and supplements filed and the aggregate number of approvals issued by the agency, accounting for—
For each of the goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—
In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for the process for the review of biosimilar biological product applications for the first 5 fiscal years after fiscal year 2022, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—
(June 25, 1938, ch. 675, §744I, as added Pub. L. 112–144, title IV, §403, July 9, 2012, 126 Stat. 1037; amended Pub. L. 115–52, title IV, §404, title IX, §§903(d), 904(d), Aug. 18, 2017, 131 Stat. 1035, 1081, 1087.)
2017—Subsec. (a). Pub. L. 115–52, §903(d), designated existing provisions as par. (1), inserted heading, and added pars. (2) to (4).
Pub. L. 115–52, title IV, §405(b), Aug. 18, 2017, 131 Stat. 1035, provided that: "Section 744I of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–53] shall cease to be effective January 31, 2023."
Pub. L. 112–144, title IV, §404(b), July 9, 2012, 126 Stat. 1038, which provided that this section would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title IV, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035.
[Pub. L. 115–52, title III, §405(c)(1), Aug. 18, 2017, 131 Stat. 1035, provided that the repeal of section 404(b) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]