Page:United States Statutes at Large Volume 118.djvu/925

 118 STAT. 895 PUBLIC LAW 108–282—AUG. 2, 2004 longer in effect. The Secretary shall thereafter provide an oppor tunity for an informal hearing to the applicant on the issue whether the conditional approval shall be reinstated. ‘‘(e)(1) The Secretary shall issue an order withdrawing condi tional approval of an application filed pursuant to subsection (a) if the Secretary finds that another person has received approval under section 512 for the same drug in the same dosage form for the same intended use and that person is able to assure the availability of sufficient quantities of the drug to meet the needs for which the drug is intended. ‘‘(2) The Secretary shall, after due notice and opportunity for an informal hearing to the applicant, issue an order withdrawing conditional approval of an application filed pursuant to subsection (a) if the Secretary finds that— ‘‘(A) any of the provisions of section 512(e)(1) (A) through (B) or (D) through (F) are applicable; or ‘‘(B) on the basis of new information before the Secretary with respect to such drug, evaluated together with the evidence available to the Secretary when the application was condi tionally approved, that there is not a reasonable expectation that such drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof. ‘‘(3) The Secretary may also, after due notice and opportunity for an informal hearing to the applicant, issue an order withdrawing conditional approval of an application filed pursuant to subsection (a) if the Secretary finds that any of the provisions of section 512(e)(2) are applicable. ‘‘(f)(1) The label and labeling of a new animal drug with a conditional approval under this section shall— ‘‘(A) bear the statement, ‘conditionally approved by FDA pending a full demonstration of effectiveness under application number’; and ‘‘(B) contain such other information as prescribed by the Secretary. ‘‘(2) An intended use that is the subject of a conditional approval under this section shall not be included in the same product label with any intended use approved under section 512. ‘‘(g) A conditionally approved new animal drug application may not be amended or supplemented to add indications for use. ‘‘(h) 180 days prior to the termination date established under subsection (d) of this section, an applicant shall have submitted all the information necessary to support a complete new animal drug application in accordance with section 512(b)(1) or the condi tional approval issued under this section is no longer in effect. Following review of this information, the Secretary shall either— ‘‘(1) issue an order approving the application under section 512(c) if the Secretary finds that none of the grounds for denying approval specified in section 512(d)(1) applies, or ‘‘(2) give the applicant an opportunity for a hearing before the Secretary under section 512(d) on the question whether such application can be approved. Upon issuance of an order approving the application, product labeling and administrative records of approval shall be modified accordingly. If the Secretary has not issued an order under section 512(c) approving such application prior to the termination date established under subsection (d) of this section, the conditional Records. Deadline.

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