ANIMAL DRUG USER FEE STUDY.

SEC. 108. ANIMAL DRUG USER FEE STUDY. (a) Study.— The Secretary, in consultation with manufacturers of animal drug products and other interested persons, shall undertake a study to evaluate whether, and under what conditions, to impose user fees to supplement appropriated funds in order to improve the process of reviewing applications (including abbreviated and supplemental applications) for new animal drugs under section 512 of the Federal Food, Drug, and Cosmetic Act. The study shall include— (1) an assessment of the overall review process for animal drugs at the Center for Veterinary Medicine, including the number of applications received, and the average times for interim and final decisions on each type of application, (2) the current allocation of funds to the animal drug review process, (3) recommendations for goals for decision making times on applications submitted to the Center for Veterinary Medicine and for additional resources required to meet the goals, and (4) recommendations for supplementing the resources for the animal drug review process through user fees. (b) Completion.— The results of the study required by subsection (a) shall be presented no later than January 4, 1994, to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.