Page:United States Statutes at Large Volume 118.djvu/928

 118 STAT. 898 PUBLIC LAW 108–282—AUG. 2, 2004 ‘‘(B) include an evaluation of all available target animal safety and effectiveness information, including anecdotal information; ‘‘(C) state the expert panel’s opinion regarding whether the benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm being caused by the absence of an approved or conditionally approved new animal drug for the minor species in question; ‘‘(D) include information from which labeling can be writ ten; and ‘‘(E) include a recommendation regarding whether the new animal drug should be limited to use under the professional supervision of a licensed veterinarian. ‘‘(3) A qualified expert panel, as used in this section, is a panel that— ‘‘(A) is composed of experts qualified by scientific training and experience to evaluate the target animal safety and effectiveness of the new animal drug under consideration; ‘‘(B) operates external to FDA; and ‘‘(C) is not subject to the Federal Advisory Committee Act, 5 U.S.C. App. 2. The Secretary shall define the criteria for selection of a qualified expert panel and the procedures for the operation of the panel by regulation. ‘‘(4) Within 180 days after the receipt of a request for listing a new animal drug in the index, the Secretary shall grant or deny the request. The Secretary shall grant the request if the request for indexing continues to meet the eligibility criteria in subsection (a) and the Secretary finds, on the basis of the report of the qualified expert panel and other information available to the Secretary, that the benefits of using the new animal drug for the proposed use in a minor species outweigh its risks to the target animal, taking into account the harm caused by the absence of an approved or conditionally approved new animal drug for the minor species in question. If the Secretary denies the request, the Secretary shall thereafter provide due notice and the opportunity for an informal conference. The decision of the Secretary following an informal conference shall constitute final agency action subject to judicial review. ‘‘(e)(1) The index established under subsection (a) shall include the following information for each listed drug— ‘‘(A) the name and address of the person who holds the index listing; ‘‘(B) the name of the drug and the intended use and condi tions of use for which it is being indexed; ‘‘(C) product labeling; and ‘‘(D) conditions and any limitations that the Secretary deems necessary regarding use of the drug. ‘‘(2) The Secretary shall publish the index, and revise it periodi cally. ‘‘(3) The Secretary may establish by regulation a process for reporting changes in the conditions of manufacturing or labeling of indexed products. ‘‘(f)(1) If the Secretary finds, after due notice to the person who requested the index listing and an opportunity for an informal conference, that— Publication. Deadline. Regulations.

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