Page:United States Statutes at Large Volume 117.djvu/1382

 PUBLIC LAW 108–130—NOV. 18, 2003

117 STAT. 1363

drug applications, or investigational animal drug submissions and, where appropriate, the actions necessary to place such applications, supplements or submissions in condition for approval. ‘‘(C) The inspection of animal drug establishments and other facilities undertaken as part of the Secretary’s review of pending animal drug applications, supplemental animal drug applications, and investigational animal drug submissions. ‘‘(D) Monitoring of research conducted in connection with the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions. ‘‘(E) The development of regulations and policy related to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions. ‘‘(F) Development of standards for products subject to review. ‘‘(G) Meetings between the agency and the animal drug sponsor. ‘‘(H) Review of advertising and labeling prior to approval of an animal drug application or supplemental animal drug application, but not such activities after an animal drug has been approved. ‘‘(9) The term ‘costs of resources allocated for the process for the review of animal drug applications’ means the expenses incurred in connection with the process for the review of animal drug applications 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 animal drug applications, supplemental animal drug applications, or investigational animal drug 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 section 740 and accounting for resources allocated for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions. ‘‘(10) The term ‘adjustment factor’ applicable to a fiscal year refers to the formula set forth in section 735(8) with the base or comparator year being 2003. ‘‘(11) The term ‘affiliate’ refers to the definition set forth in section 735(9). ‘‘SEC. 740. AUTHORITY TO ASSESS AND USE ANIMAL DRUG FEES.

21 USC 379j–12.

‘‘(a) TYPES OF FEES.—Beginning in fiscal year 2004, the Secretary shall assess and collect fees in accordance with this section as follows:

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