118 STAT. 899 PUBLIC LAW 108–282—AUG. 2, 2004 ‘‘(A) the expert panel failed to meet the requirements as set forth by the Secretary by regulation; ‘‘(B) on the basis of new information before the Secretary, evaluated together with the evidence available to the Secretary when the new animal drug was listed in the index, the benefits of using the new animal drug for the indexed use do not outweigh its risks to the target animal; ‘‘(C) the conditions of subsection (c)(2) of this section are no longer satisfied; ‘‘(D) the manufacture of the new animal drug is not in accordance with current good manufacturing practices; ‘‘(E) the labeling, distribution, or promotion of the new animal drug is not in accordance with the index entry; ‘‘(F) the conditions and limitations of use associated with the index listing have not been followed; or ‘‘(G) the request for indexing contains any untrue statement of material fact, the Secretary shall remove the new animal drug from the index. The decision of the Secretary following an informal conference shall constitute final agency action subject to judicial review. ‘‘(2) If the Secretary finds that there is a reasonable probability that the use of the drug would present a risk to the health of humans or other animals, the Secretary may— ‘‘(A) suspend the listing of such drug immediately; ‘‘(B) give the person listed in the index prompt notice of the Secretary’s action; and ‘‘(C) afford that person the opportunity for an informal conference. The decision of the Secretary following an informal conference shall constitute final agency action subject to judicial review. ‘‘(g) For purposes of indexing new animal drugs under this section, to the extent consistent with the public health, the Sec retary shall promulgate regulations for exempting from the oper ation of section 512 minor species new animal drugs and animal feeds bearing or containing new animal drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of minor spe cies animal drugs. Such regulations may, at the discretion of the Secretary, among other conditions relating to the protection of the public health, provide for conditioning such exemption upon the establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such article, of data (including but not limited to analytical reports by investigators) obtained as a result of such investigational use of such article, as the Secretary finds will enable the Secretary to evaluate the safety and effectiveness of such article in the event of the filing of a request for an index listing pursuant to this section. ‘‘(h) The labeling of a new animal drug that is the subject of an index listing shall state, prominently and conspicuously— ‘‘(1) ‘NOT APPROVED BY FDA.—Legally marketed as an FDA indexed product. Extra label use is prohibited.’; ‘‘(2) except in the case of new animal drugs indexed for use in an early life stage of a food producing animal, ‘This product is not to be used in animals intended for use as food for humans or other animals.’; and Regulations.
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