costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs

(3) Costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs The term “costs of resources allocated for the process for the review of abbreviated applications for generic new animal drugs” means the expenses in connection with the process for the review of abbreviated applications for generic new animal drugs for— (A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees consulted with respect to the review of specific abbreviated applications, supplemental abbreviated applications, or investigational submissions, and costs related to such officers, employees, committees, and contractors, including costs for travel, education, and recruitment and other personnel activities; (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 this section and accounting for resources allocated for the review of abbreviated applications, supplemental abbreviated applications, and investigational submissions.

Source

21 USC § 379j-21(k)(3)


Scoping language

In this section
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