21 U.S. Code § 379j–51 - Definitions
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For purposes of this subpart:
(1)
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.
(2)
The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—
(3)
The term “biosimilar biological product” means a product for which a biosimilar biological product application has been approved.
(4)
(A)
Subject to subparagraph (B), the term “biosimilar biological product application” means an application for licensure of a biological product under section
262
(k) of title
42.
(B)
Such term does not include—
(ii)
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;
(5)
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.
(6)
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.
(7)
(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—
(A)
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;
(10)
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).
(11)
The term “financial hold”—
(A)
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
(13)
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:
(A)
The activities necessary for the review of submissions in connection with biosimilar biological product development, biosimilar biological product applications, and supplements.
(B)
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.
(C)
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.
(D)
Activities necessary for the release of lots of biosimilar biological products under section
262
(k) of title
42.
(E)
Monitoring of research conducted in connection with the review of biosimilar biological product applications.
(F)
Postmarket safety activities with respect to biologics approved under biosimilar biological product applications or supplements, including the following activities:
(i)
Collecting, developing, and reviewing safety information on biosimilar biological products, including adverse-event reports.
(ii)
Developing and using improved adverse-event data-collection systems, including information technology systems.
(iii)
Developing and using improved analytical tools to assess potential safety problems, including access to external data bases.
(14)
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.
Source
(June 25, 1938, ch. 675, § 744G, as added Pub. L. 112–144, title IV, § 402,July 9, 2012, 126 Stat. 1026.)
Termination of Section
For termination of section by section 404(a) ofPub. L. 112–144, see Effective and Termination Dates note set out below.
Effective and Termination Dates
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.”
Finding
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.”
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