Page:United States Statutes at Large Volume 118.djvu/927

 118 STAT. 897 PUBLIC LAW 108–282—AUG. 2, 2004 ‘‘(F) information sufficient to support the conclusion that the proposed use of the new animal drug is safe under section 512(d) with respect to individuals exposed to the new animal drug through its manufacture or use; and ‘‘(G) such other information as the Secretary may deem necessary to make this eligibility determination. ‘‘(2) Within 90 days after the submission of a request for a determination of eligibility for indexing based on subsection (a)(1)(A) of this section, or 180 days for a request submitted based on subsection (a)(1)(B) of this section, the Secretary shall grant or deny the request, and notify the person who requested such deter mination of the Secretary’s decision. The Secretary shall grant the request if the Secretary finds that— ‘‘(A) the same drug in the same dosage form for the same intended use is not approved or conditionally approved; ‘‘(B) the proposed use of the drug meets the conditions of subparagraph (A) or (B) of subsection (a)(1), as appropriate; ‘‘(C) the person requesting the determination has estab lished appropriate specifications for the manufacture and con trol of the new animal drug and has demonstrated an under standing of the requirements of current good manufacturing practices; ‘‘(D) the new animal drug will not significantly affect the human environment; and ‘‘(E) the new animal drug is safe with respect to individuals exposed to the new animal drug through its manufacture or use. If the Secretary denies the request, the Secretary shall thereafter provide due notice and an opportunity for an informal conference. A decision of the Secretary to deny an eligibility request following an informal conference shall constitute final agency action subject to judicial review. ‘‘(d)(1) With respect to a new animal drug for which the Sec retary has made a determination of eligibility under subsection (c), the person who made such a request may ask that the Secretary add the new animal drug to the index established under subsection (a). The request for addition to the index shall include— ‘‘(A) a copy of the Secretary’s determination of eligibility issued under subsection (c); ‘‘(B) a written report that meets the requirements in sub section (d)(2) of this section; ‘‘(C) a proposed index entry; ‘‘(D) facsimile labeling; ‘‘(E) anticipated annual distribution of the new animal drug; ‘‘(F) a written commitment to manufacture the new animal drug and animal feeds bearing or containing such new animal drug according to current good manufacturing practices; ‘‘(G) a written commitment to label, distribute, and promote the new animal drug only in accordance with the index entry; ‘‘(H) upon specific request of the Secretary, information submitted to the expert panel described in paragraph (3); and ‘‘(I) any additional requirements that the Secretary may prescribe by general regulation or specific order. ‘‘(2) The report required in paragraph (1) shall— ‘‘(A) be authored by a qualified expert panel; Reports. Records. Deadline. Notification.

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