costs of resources allocated for the process for the review of biosimilar biological product applications

(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; (B) management of information, and the acquisition, maintenance, and repair of computer resources; (C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and (D) 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.

Source

21 USC § 379j-51(9)


Scoping language

None identified. Default scope is assumed to be the entire title.
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