Source: https://www.law.cornell.edu/uscode/text/21/379j-51?quicktabs_8=2
Timestamp: 2015-05-07 01:17:17
Document Index: 792720604

Matched Legal Cases: ['§ 379', 'art 8', '§ 379', '§ 379', '§ 744', '§ 402', '§ 404', '§ 405', 'art 8', '§ 401', 'art 8']

21 U.S. Code § 379j–51 - Definitions | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter VII › Part C › Subpart 8 › § 379j–51 21 U.S. Code § 379j–51 - Definitions
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.
The term “biosimilar biological product” means a product for which a biosimilar biological product application has been approved.
Subject to subparagraph (B), the term “biosimilar biological product application” means an application for licensure of a biological product under section 262
an application filed under section 262
(k) of title 42 that cites as the reference product a bovine blood product for topical application licensed before September 1, 1992, or a large volume parenteral drug product approved before such date;
(k) of title 42 with respect to—
an application for licensure under section 262
(k) of title 42 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
For purposes of subparagraph (A)(ii), the term “manufactured” does not include packaging.
The term “biosimilar initial advisory meeting”—
a general discussion regarding whether licensure under section 262
(k) of title 42 may be feasible for a particular product; and
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—
collecting fees under section 379j–52 of this title 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”—
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 section 379j–52(a)(1) of this title; and
does not mean that any of the bases for a “clinical hold” under section 355
(i)(3) of this title 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:
Activities necessary for the release of lots of biosimilar biological products under section 262
Collecting, developing, and reviewing safety information on biosimilar biological products, including adverse-event reports.
(p) of this title (relating to risk evaluation and mitigation strategies).
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 section 262
(k)(4) of title 42.
(June 25, 1938, ch. 675, § 744G, as added Pub. L. 112–144, title IV, § 402,July 9, 2012, 126 Stat. 1026.)
Pub. L. 112–144, title IV, § 404(a),July 9, 2012, 126 Stat. 1038, provided that: “Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379j–51, 379j–52], as added by section 402 of this Act, shall cease to be effective October 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—
“(1) October 1, 2012; or
“(2) the date of the enactment of this title [July 9, 2012].
“(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.”