Source: https://www.law.cornell.edu/uscode/text/21/379j%E2%80%9352
Timestamp: 2019-08-19 05:42:47
Document Index: 90204247

Matched Legal Cases: ['§ 379', 'art 8', '§ 379', '§ 379', '§\u202f379', '§\u202f744', '§\u202f402', '§\u202f3101', '§\u202f403', '§\u202f905', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f905', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f403', '§\u202f3101', '§\u202f3101']

21 U.S. Code § 379j–52 - Authority to assess and use biosimilar biological product fees | US Law | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter VII › Part C › Subpart 8 › § 379j–52
21 U.S. Code § 379j–52 - Authority to assess and use biosimilar biological product fees
§ 379j–52.
(a) Types of feesBeginning in fiscal year 2018, the Secretary shall assess and collect fees in accordance with this section as follows:
(1) Biosimilar biological product development program fees
(A) Initial biosimilar biological product development fee
Each person that submits to the Secretary a meeting request described under clause (ii) or a clinical protocol for an investigational new drug protocol described under clause (iii) shall pay for the product named in the meeting request or the investigational new drug application the initial biosimilar biological product development fee established under subsection (c)(5).
(ii) Meeting request
(iii) Clinical protocol for IND
A clinical protocol for an investigational new drug protocol described in this clause is a clinical protocol consistent with the provisions of section 355(i) of this title, including any regulations promulgated under section 355(i) of this title, (referred to in this section as “investigational new drug application”) describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for a product.
(iv) Due dateThe initial biosimilar biological product development fee shall be due by the earlier of the following:
(v) Transition ruleEach person that has submitted an investigational new drug application prior to July 9, 2012, shall pay the initial biosimilar biological product development fee by the earlier of the following:
(B) Annual biosimilar biological product development fee
A person that pays an initial biosimilar biological product development fee for a product shall pay for such product, beginning in the fiscal year following the fiscal year in which the initial biosimilar biological product development fee was paid, an annual fee established under subsection (c)(5) for the biosimilar biological product development program (referred to in this section as “annual biosimilar biological product development fee”).
(ii) Due dateThe annual biosimilar biological product development fee for each fiscal year will be due on the later of—
(iii) ExceptionThe annual biosimilar biological product development fee for each fiscal year will be due on the date specified in clause (ii), unless the person has—
If a person submits a marketing application for a biosimilar biological product before October 1 of a fiscal year and such application is accepted for filing on or after October 1 of such fiscal year, the person may request a refund equal to the annual biosimilar biological product development fee paid by the person for the product for such fiscal year. To qualify for consideration for a refund under this clause, a person shall submit to the Secretary a written request for such refund not later than 180 days after the marketing application is accepted for filing.
(C) Discontinuation of fee obligationA 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—
(D) Reactivation fee
(i) In generalA person that has discontinued participation in the biosimilar biological product development program for a product under subparagraph (C) shall, if the person seeks to resume participation in such program, pay a fee (referred to in this section as “reactivation fee”) by the earlier of the following:
Not later than 5 days after the Secretary grants a request by such person for a biosimilar biological product development meeting for the product (after the date on which such participation was discontinued).
Upon the date of submission (after the date on which such participation was discontinued) by such person of an investigational new drug application describing an investigation that the Secretary determines is intended to support a biosimilar biological product application for that product.
(ii) Application of annual fee
(i) No biosimilar biological product development meetings
(ii) No receipt of investigational new drug applicationsExcept 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—
(iii) Financial holdNotwithstanding 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—
(iv) No acceptance of biosimilar biological product applications or supplements
(F) Limits regarding fees
Except as provided in subparagraph (B)(iv), the Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D).
(ii) No waivers, exemptions, or reductions
(2) Biosimilar biological product application fee
(A) In generalEach person that submits, on or after October 1, 2017, a biosimilar biological product application shall be subject to the following fees:
A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval.
A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required for approval. Such fee shall be equal to half of the amount of the fee described in clause (i).
(B) Rule of applicability; treatment of certain previously paid feesAny 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—
be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted; and
be entitled to no reduction of such application fees based on the amount of fees paid for that product before October 1, 2017, under such subparagraph (A), (B), or (D).
(C) Payment due date
Any fee required by subparagraph (A) shall be due upon submission of the application for which such fee applies.
(D) Exception for previously filed application
If a biosimilar biological product application was submitted by a person that paid the fee for such application, was accepted for filing, and was not approved or was withdrawn (without a waiver), the submission of a biosimilar biological product 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).
(E) Refund of application fee if application refused for filing or withdrawn before filing
The Secretary shall refund 75 percent of the fee paid under this paragraph for any application which is refused for filing or withdrawn without a waiver before filing.
(F) Fees for applications previously refused for filing or withdrawn before filing
A biosimilar biological product application that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest, unless the fee is waived under subsection (d).
(3) Biosimilar biological product program fee
(A) In generalEach 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—
is identified in such a biosimilar biological product application approved as of October 1 of such fiscal year; and
as of October 1 of such fiscal year, does not appear on a list, developed and maintained by the Secretary, of discontinued biosimilar biological products.
(B) Due dateThe biosimilar biological product program fee for a fiscal year shall be due on the later of—
(C) One fee per product per year
The biosimilar biological product program fee shall be paid only once for each product for each fiscal year.
A person who is named as the applicant in a biosimilar biological product application shall not be assessed more than 5 biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application.
(4) Biosimilar biological product fee
Each person who is named as the applicant in a biosimilar biological product application shall pay for each such biosimilar biological product the annual fee established under subsection (c)(5).
(B) Due dateThe biosimilar biological product fee for a fiscal year shall be due on the later of—
(1) Fiscal year 2018For fiscal year 2018, fees under subsection (a) shall be established to generate a total revenue amount equal to the sum of—
$45,000,000; and
the dollar amount equal to the fiscal year 2018 adjustment (as determined under subsection (c)(4)).
(2) Subsequent fiscal yearsFor 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 annual base revenue for the fiscal year (as determined under paragraph (4));
the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2)); and
the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3)).
(3) Allocation of revenue amount among fees; limitations on fee amounts
(A) AllocationThe Secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from, respectively—
initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1);
biosimilar biological product application fees under subsection (a)(2); and
biosimilar biological product program fees under subsection (a)(3).
(B) Limitations on fee amounts
Until the first fiscal year for which the capacity planning adjustment under subsection (c)(2) is effective, the amount of any fee under subsection (a) for a fiscal year after fiscal year 2018 shall not exceed 125 percent of the amount of such fee for fiscal year 2018.
(C) Biosimilar biological product development fees
The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.
The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.
(4) Annual base revenue
For purposes of paragraph (2), the dollar amount of the annual base revenue for a fiscal year shall be the dollar amount of the total revenue amount for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(3).
(A) In generalFor 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—
such annual base revenue for the fiscal year under subsection (b); and
the inflation adjustment percentage under subparagraph (B).
(B) Inflation adjustment percentageThe inflation adjustment percentage under this subparagraph for a fiscal year is 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 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 379j–51(13) of this title) for the first 3 years of the preceding 4 fiscal years; 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; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 379j–51(13) of this title) for the first 3 years of the preceding 4 fiscal years.
(2) Capacity planning adjustment
Beginning with the fiscal year described in subparagraph (B)(ii)(II), the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications.
(B) Capacity planning methodology
(i) Development; evaluation and report
The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of biosimilar biological product applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. The report shall be published for public comment not later than September 30, 2020.
(ii) Establishment and implementationAfter 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—
incorporate such approaches and attributes as the Secretary determines appropriate; and
be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established.
Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(2)(A) (the annual base revenue for the fiscal year) and (b)(2)(B) (the dollar amount of the inflation adjustment for the fiscal year).
The Secretary shall publish in the Federal Register notice under paragraph (5) the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.
(3) Operating reserve adjustment
(A) Interim application; fee reduction
Until the first fiscal year for which the capacity planning adjustment under paragraph (2) is effective, the Secretary may, in addition to the adjustment under paragraph (1), reduce the fee revenue and fees under this section for a fiscal year as the Secretary determines appropriate for long-term financial planning purposes.
(B) General application and methodologyBeginning 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)—
reduce the fee revenue and fees under this section as the Secretary determines appropriate for long-term financial planning purposes; or
increase the fee revenue and fees under this section if such an adjustment is necessary to provide for not more than 21 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications.
(C) Federal Register notice
If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5)(B) establishing fee revenue and fees for the fiscal year involved.
(4) Fiscal year 2018 adjustment
For fiscal year 2018, the Secretary shall adjust the fee revenue and fees under this section in such amount (if any) as needed to reflect an updated assessment of the workload for the process for the review of biosimilar biological product applications.
The Secretary shall publish under paragraph (5)(B) a description of the methodology used to calculate the fiscal year 2018 adjustment under this paragraph in the Federal Register notice establishing fee revenue and fees for fiscal year 2018.
No adjustment under this paragraph shall result in an increase in fee revenue and fees under this section in excess of $9,000,000.
(5) Annual fee settingFor fiscal year 2018 and each subsequent fiscal year, the Secretary shall, not later than 60 days before the start of each such fiscal year—
establish, for the fiscal year, initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1), biosimilar biological product application fees under subsection (a)(2), and biosimilar biological product program fees under subsection (a)(3), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and
publish such fee revenue and fees in the Federal Register.
The total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications.
(d) Application fee waiver for small business
(1) Waiver of application fee
The Secretary shall grant to a person who is named in a biosimilar biological product application a waiver from the application fee assessed to that person under subsection (a)(2)(A) for the first biosimilar biological product application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent biosimilar biological product applications submitted to the Secretary for review in the same manner as an entity that is not a small business.
(3) Small business defined
In this subsection, the term “small business” means an entity that has fewer than 500 employees, including employees of affiliates, and does not have a drug product that has been approved under a human drug application (as defined in section 379g of this title) or a biosimilar biological product application (as defined in section 379j–51(4) of this title) and introduced or delivered for introduction into interstate commerce.
A biosimilar biological product application or supplement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid.
(f) Crediting and availability of fees
(B) Use of fees and limitations
(ii) Leasing and necessary equipment
Beginning on October 1, 2023, the authorities under section 379j–51(9)(C) of this title shall include only leasing and necessary scientific equipment.
The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs described in such subparagraph are not more than 15 percent below the level specified in such subparagraph.
(D) Provision for early payments
For each of fiscal years 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equivalent to the total amount of fees assessed for such fiscal year under this section.
(g) Collection of unpaid fees
(h) Written requests for waivers and refunds
To qualify for consideration for a waiver under subsection (d), or for a refund of any fee collected in accordance with subsection (a)(2)(A), a person shall submit to the Secretary a written request for such waiver or refund not later than 180 days after such fee is due.
(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.)
For termination of section by section 405(a) of Pub. L. 115–52, see Effective and Termination Dates note below.
2017—Subsec. (a). Pub. L. 115–52, § 403(a)(1), substituted “fiscal year 2018” for “fiscal year 2013” in introductory provisions.
Subsec. (a)(1). Pub. L. 115–52, § 403(a)(2), substituted “Biosimilar biological product” for “Biosimilar” in heading.
Subsec. (a)(1)(A)(i). Pub. L. 115–52, § 403(a)(3), substituted “(c)(5)” for “(b)(1)(A)”.
Subsec. (a)(1)(B)(i). Pub. L. 115–52, § 403(a)(4), substituted “(c)(5) for the biosimilar biological product development program” for “(b)(1)(B) for biosimilar biological product development”.
Subsec. (a)(1)(B)(ii). Pub. L. 115–52, § 403(a)(5), substituted “annual biosimilar biological product development fee” for “annual biosimilar biological product development program fee” in introductory provisions.
Subsec. (a)(1)(B)(iii). Pub. L. 115–52, § 403(a)(6), substituted “annual biosimilar biological product development fee” for “annual biosimilar development program fee”.
Subsec. (a)(1)(B)(iv). Pub. L. 115–52, § 403(a)(7), added cl. (iv).
Subsec. (a)(1)(C). Pub. L. 115–52, § 403(a)(8), substituted “for a product, effective October 1 of a fiscal year, by,” for “for a product effective October 1 of a fiscal year by,” in introductory provisions.
Subsec. (a)(1)(D)(i). Pub. L. 115–52, § 403(a)(9)(A), inserted “, if the person seeks to resume participation in such program,” before “pay a fee” in introductory provisions.
Subsec. (a)(1)(D)(i)(I). Pub. L. 115–52, § 403(a)(9)(B), inserted “by such person” after “grants a request”.
Subsec. (a)(1)(D)(i)(II). Pub. L. 115–52, § 403(a)(9)(C), inserted “by such person” after “discontinued)”.
Subsec. (a)(1)(E). Pub. L. 115–52, § 403(a)(10), struck out “biosimilar development program” after “pay” in heading.
Subsec. (a)(1)(F). Pub. L. 115–52, § 403(a)(11)(A), struck out “biosimilar development program” after “regarding” in heading.
Subsec. (a)(1)(F)(i). Pub. L. 115–52, § 403(a)(11)(B), amended cl. (i) generally. Prior to amendment, text read as follows: “The Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D).”
Subsec. (a)(2). Pub. L. 115–52, § 403(a)(12)(A), struck out “and supplement” after “application” in heading.
Subsec. (a)(2)(A), (B). Pub. L. 115–52, § 403(a)(12)(B), amended subpars. (A) and (B) generally. Prior to amendment, subpars. (A) and (B) related to the fee for a biosimilar biological product application or a supplement submitted on or after Oct. 1, 2012, and to a reduction in certain fees, respectively.
Subsec. (a)(2)(C). Pub. L. 115–52, § 403(a)(12)(D), struck out “or supplement” after “application”.
Subsec. (a)(2)(D). Pub. L. 115–52, § 403(a)(12)(C)–(E), in heading, struck out “or supplement” after “application” and in text, substituted “application was submitted” for “application or supplement was submitted”, “application, was accepted” for “application or supplement, was accepted”, and “application for the same product” for “application or a supplement for the same product”.
Subsec. (a)(2)(E). Pub. L. 115–52, § 403(a)(12)(D), struck out “or supplement” after “application”.
Subsec. (a)(2)(F). Pub. L. 115–52, § 403(c)(2), substituted “subsection (d)” for “subsection (c)”.
Pub. L. 115–52, § 403(a)(12)(D), struck out “or supplement” after “application”.
Subsec. (a)(3). Pub. L. 115–52, § 403(a)(13), amended par. (3) generally. Prior to amendment, par. (3) consisted of subpars. (A) to (E) relating to biosimilar biological product establishment fee, assessment, due date, assessment and division of fee for a biosimilar biological product establishment that manufactures for multiple applicants, and exception for new products, respectively.
Subsec. (a)(4)(A). Pub. L. 115–52, § 403(c)(3), substituted “subsection (c)(5)” for “subsection (b)(1)(F)”.
Subsec. (b). Pub. L. 115–52, § 403(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) consisted of pars. (1) and (2) which related to fee amounts and limit to total amount of fees, respectively.
Subsec. (c). Pub. L. 115–52, § 403(c)(4), added subsec. (c). Former subsec. (c) redesignated (d).
Subsec. (d). Pub. L. 115–52, § 403(c)(1), redesignated subsec. (c) as (d). Former subsec. (d) redesignated (e).
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. (e). Pub. L. 115–52, § 403(e), substituted “all such fees” for “all fees”.
Pub. L. 115–52, § 403(c)(1), redesignated subsec. (d) as (e). Former subsec. (e) redesignated (f).
Subsec. (e)(2)(B). Pub. L. 115–52, § 905(b)(4), substituted “limitations” for “limitation” in heading, designated existing provisions as cl. (i) and inserted heading, and added cl. (ii), effective Aug. 18, 2017. Subsec. (e) subsequently redesignated (f) effective Oct. 1, 2017, by Pub. L. 115–52, § 403(c)(1). See Amendment note below.
Subsec. (f). Pub. L. 115–52, § 403(c)(1), redesignated subsec. (e) as (f). Former subsec. (f) redesignated (g).
Subsec. (f)(2)(C). Pub. L. 115–52, § 403(f)(1)(A), added subpar. (C) and struck out former subpar. (C). Prior to amendment, text read as follows: “Until the date of enactment of an Act making appropriations through September 30, 2013, for the salaries and expenses account of the Food and Drug Administration, fees authorized by this section for fiscal year 2013 may be collected and shall be credited to such account and remain available until expended.”
Subsec. (f)(2)(D). Pub. L. 115–52, § 403(f)(1)(B), struck out “in subsequent years” after “payments” in heading and “(after fiscal year 2013)” after “fiscal year” in text.
Subsec. (f)(3). Pub. L. 115–52, § 403(f)(2), substituted “2018 through 2022” for “2013 through 2017”.
Subsec. (g). Pub. L. 115–52, § 403(c)(1), redesignated subsec. (f) as (g). Former subsec. (g) redesignated (h).
Subsec. (h). Pub. L. 115–52, § 403(c)(2), substituted “subsection (d)” for “subsection (c)”.
Pub. L. 115–52, § 403(c)(1), redesignated subsec. (g) as (h). Former subsec. (h) redesignated (i).
Subsec. (i). Pub. L. 115–52, § 403(c)(1), redesignated subsec. (h) as (i).
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.
Subsec. (a)(2)(B). Pub. L. 114–255, § 3101(a)(2)(V)(ii), substituted “Biosimilar User Fee Act of 2012” for “Biosimilars User Fee Act of 2012”.
Amendment by section 403 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2017, see section 406 of Pub. L. 115–52, set out as a note under section 379j–51 of this title.
Section ceases to be effective Oct. 1, 2022, see section 405(a) of Pub. L. 115–52, set out as a note under section 379j–51 of this title.
Section effective Oct. 1, 2012, with fees under this subpart to be assessed for all biosimilar biological product applications received on or after Oct. 1, 2012, see section 405 of Pub. L. 112–144, set out as a note under section 379j–51 of this title.