For purposes of this subpart:
The term “adjustment factor” applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All items) for September of the preceding fiscal year divided by such Index for September 2011.
The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
one business entity controls, or has the power to control, the other business entity; or
a third party controls, or has power to control, both of the business entities.
The term “biosimilar biological product” means a specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved.
section 262(k) of title 42 Subject to subparagraph (B), the term “biosimilar biological product application” means an application for licensure of a biological product under .
Such term does not include—
a supplement to such an application;
section 262(k) of title 42 an application filed under that cites as the reference product a bovine blood product for topical application licensed before , or a large volume parenteral drug product approved before such date;
section 262(k) of title 42 an application filed under with respect to—
whole blood or a blood component for transfusion;
an in vitro diagnostic biological product; or
a biological product for further manufacturing use only; or
section 262(k) of title 42 an application for licensure under that is submitted by a State or Federal Government entity for a product that is not distributed commercially.
The term “biosimilar biological product development meeting” means any meeting, other than a biosimilar initial advisory meeting, regarding the content of a development program, including a proposed design for, or data from, a study intended to support a biosimilar biological product application.
The term “biosimilar biological product development program” means the program under this subpart for expediting the process for the review of submissions in connection with biosimilar biological product development.
The term “biosimilar biological product establishment” means a foreign or domestic place of business—
that is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other; and
at which one or more biosimilar biological products are manufactured in final dosage form.
For purposes of subparagraph (A)(ii), the term “manufactured” does not include packaging.
The term “biosimilar initial advisory meeting”—
means a meeting, if requested, that is limited to—
section 262(k) of title 42 a general discussion regarding whether licensure under may be feasible for a particular product; and
if so, general advice on the expected content of the development program; and
does not include any meeting that involves substantive review of summary data or full study reports.
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—
officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers employees and committees and to contracts with such contractors;
management of information, and the acquisition, maintenance, and repair of computer resources;
leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
section 379j–52 of this title collecting fees under and accounting for resources allocated for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.
The term “final dosage form” means, with respect to a biosimilar biological product, a finished dosage form which is approved for administration to a patient without substantial further manufacturing (such as lyophilized products before reconstitution).
The term “financial hold”—
section 379j–52(a)(1) of this title means an order issued by the Secretary to prohibit the sponsor of a clinical investigation from continuing the investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any fee for the product required under subparagraph (A), (B), or (D) of ; and
section 355(i)(3) of this title does not mean that any of the bases for a “clinical hold” under have been determined by the Secretary to exist concerning the investigation.
The term “person” includes an affiliate of such person.
The term “process for the review of biosimilar biological product applications” means the following activities of the Secretary with respect to the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements:
The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.
Actions related to submissions in connection with biosimilar biological product development, the issuance of action letters which approve biosimilar biological product applications or which set forth in detail the specific deficiencies in such applications, and where appropriate, the actions necessary to place such applications in condition for approval.
The inspection of biosimilar biological product establishments and other facilities undertaken as part of the Secretary’s review of pending biosimilar biological product applications and supplements.
section 262(k) of title 42 Activities necessary for the release of lots of biosimilar biological products under .
Monitoring of research conducted in connection with the review of biosimilar biological product applications.
Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities:
Collecting, developing, and reviewing safety information on biosimilar biological products, including adverse-event reports.
Developing and using improved adverse-event data-collection systems, including information technology systems.
Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
osection 355(p) of this title Implementing and enforcing section 355() of this title (relating to postapproval studies and clinical trials and labeling changes) and (relating to risk evaluation and mitigation strategies).
section 355(k)(5) of this title Carrying out (relating to adverse-event reports and postmarket safety activities).
section 262(k)(4) of title 42 The term “supplement” means a request to the Secretary to approve a change in a biosimilar biological product application which has been approved, including a supplement requesting that the Secretary determine that the biosimilar biological product meets the standards for interchangeability described in .
June 25, 1938, ch. 675, § 744GPub. L. 112–144, title IV, § 402126 Stat. 1026Pub. L. 115–52, title IV, § 402131 Stat. 1028Pub. L. 117–180, div. F, title IV, § 4002136 Stat. 2160(, as added , , ; amended , , ; , , .)
Termination of Section
section 4005(a) of Pub. L. 117–180For termination of section by , see Effective and Termination Dates note set out below.
Editorial Notes
Amendments
Pub. L. 117–180, § 4002(a)2022—Par. (1). , amended par. (1) generally. Prior to amendment, par. (1) read as follows: “The term ‘adjustment factor’ applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) for October of the preceding fiscal year divided by such Index for October 2011.”
Pub. L. 117–180, § 4002(b)Par. (4)(B)(iii)(II) to (IV). , redesignated subcls. (III) and (IV) as (II) and (III), respectively, and struck out former subcl. (II) which read as follows: “an allergenic extract product;”.
Pub. L. 115–52, § 402(a)2017—Par. (1). , 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. 115–52, § 402(b)Par. (3). , substituted “means a specific strength of a biological product in final dosage form” for “means a product”.
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Pub. L. 117–180, div. F, title IV, § 4006136 Stat. 2166
section 4001(a) of Pub. L. 117–180section 301 of this title21 U.S.C. 379j–51“The amendments made by this title [see , set out as a Short Title of 2022 Amendment note under ] shall take effect on , or the date of the enactment of this Act [], whichever is later, except that fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( et seq.) shall be assessed for all biosimilar biological product applications received on or after , regardless of the date of the enactment of this Act.”
, , , provided that:
Effective Date of 2017 Amendment
Pub. L. 115–52, title IV, § 406131 Stat. 1035
section 401(a) of Pub. L. 115–52section 301 of this title21 U.S.C. 379j–51“The amendments made by this title [see , set out as a Short Title of 2017 Amendment note under ] shall take effect on , or the date of the enactment of this Act [], whichever is later, except that fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [ et seq.] shall be assessed for all biosimilar biological product applications received on or after , regardless of the date of the enactment of this Act.”
, , , provided that:
Effective and Termination Dates
Pub. L. 117–180, div. F, title IV, § 4005(a)136 Stat. 2166
21 U.S.C. 379j–51“Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act (, 379j–52) shall cease to be effective .”
, , , provided that:
Pub. L. 115–52, title IV, § 405(a)131 Stat. 1035section 379j–52 of this titlePub. L. 117–180, div. F, title IV, § 4005(c)136 Stat. 2166, , , which provided that this section and would cease to be effective , was repealed by , , .
Pub. L. 117–180, div. F, title IV, § 4005(c)136 Stat. 2166section 405(a) of Pub. L. 115–52[, , , provided that the repeal of , formerly set out above, is effective .]
Pub. L. 112–144, title IV, § 404(a)126 Stat. 1038section 379j–52 of this titlePub. L. 115–52, title IV, § 405(c)(1)131 Stat. 1035, , , which provided that this section and would cease to be effective , was repealed by , , .
Pub. L. 115–52, title III, § 405(c)(1)131 Stat. 1035section 404(a) of Pub. L. 112–144[, , , provided that the repeal of , formerly set out above, is effective .]
Pub. L. 112–144, title IV, § 405126 Stat. 1039
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—
; or
the date of the enactment of this title [].
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 , regardless of the date of the enactment of this title.”
Savings
Pub. L. 117–180, div. F, title IV, § 4007136 Stat. 2167
section 4001(a) of Pub. L. 117–180section 301 of this title21 U.S.C. 379j–51“Notwithstanding the amendments made by this title [see , set out as a Short Title of 2022 Amendment note under ], part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act ( et seq.), as in effect on the day before the date of the enactment of this title [], shall continue to be in effect with respect to biosimilar biological product applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after , but before , with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.”
, , , provided that:
Pub. L. 115–52, title IV, § 407131 Stat. 1035
section 401(a) of Pub. L. 115–52section 301 of this title21 U.S.C. 379j–51“Notwithstanding the amendments made by this title [see , set out as a Short Title of 2017 Amendment note under ], part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [ et seq.], as in effect on the day before the date of the enactment of this title [], shall continue to be in effect with respect to biosimilar biological product applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after , but before , with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.”
, , , provided that:
Congressional Findings Concerning Fees Relating to Biosimilar Biological Products
Pub. L. 117–180, div. F, title IV, § 4001(b)136 Stat. 2160
section 4001(a) of Pub. L. 117–180section 301 of this title21 U.S.C. 379j–51“Congress finds that the fees authorized by the amendments made by this title [see , set out as a Short Title of 2022 Amendment note under ] 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 ( et seq.), 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.”
, , , provided that:
Pub. L. 115–52, title IV, § 401(b)131 Stat. 1028
section 401(a) of Pub. L. 115–52section 301 of this title21 U.S.C. 379j–51“The Congress finds that the fees authorized by the amendments made in this title [see , set out as a Short Title of 2017 Amendment note under ] 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 [ et seq.], 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.”
, , , provided that:
Pub. L. 112–144, title IV, § 401(b)126 Stat. 1026
“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.”
, , , provided that: