110 STAT. 3158 PUBLIC LAW 104-250—OCT. 9, 1996 that none of the grounds for denying approval specified in paragraph (3) appKes, or (B) give the appHcant notice of an opportunity for a hearing before the Secretary under paragraph (3) on the question whether such appHcation is approvable. The procedure governing such a hearing shall be the procedure set forth in the last two sentences of subsection (c)(1). "(3) If the Secretary, after due notice to the applicant in accordance with paragraph (2) and giving the applicant an opportunity for a hearing in accordance with such paragraph, finds, on the basis of information submitted to the Secretary as part of the application, on the basis of a preapproval inspection, or on the basis of any other information before the Secretary— "(A) that the application is incomplete, false, or misleading in any particular; "(B) that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such animal feed are inadequate to preserve the identity, strength, quality, and purity of the new animal drug therein; or "(C) that the facility manufactures animal feeds bearing or containing new animal drugs in a manner that does not accord with the specifications for manufacture or labels animal feeds bearing or containing new animal drugs in a manner that does not accord with the conditions or indications of use that are published pursuant to subsection (i), title Secretary shall issue an order refusing to approve the application. If, after such notice and opportunity for hearing, the Secretary finds that subparagraphs (A) through (C) do not apply, the Secretary shall issue an order approving the application. An order under this subsection approving an application Ifbr a lifcense to manufacture animal feeds bearing or containing new animal drugs shall permit a facility to manufacture only those animal feeds bearing or containing new animal drugs for which there are in effect regulations pursuant to subsection (i) relating to the use of such drugs in or on such animal feed. "(4)(A) The Secretary shall, after due notice and opportunity for hearing to the applicant, revoke a Hcense to manufacture animal feeds bearing or containing new animal drugs under this subsection if the Secretary finds— "(i) that the application for such hcense contains any untrue statement of a material fact; or "(ii) that the applicemt has made changes tiiat would cause the application to contain any imtrue statements of material fact or that would affect the safety or effectiveness of the animal feeds manufactured at the facility unless the applicant has supplemented the application by filing with the Secretary adequate information respecting all such changes and unless there is in effect an approval of the supplemental application. If the Secretary (or in the Secretary's absence the officer acting as the Secretary) finds that there is an imminent hazard to the health of humans or of the animals for which such animed feed is intended, the Secretary may suspend the license immediately, and give the applicant prompt notice of the action and afford the applicant the opportunity for an expedited hearing under this subsection; but the authority conferred by this sentence shall not be delegated.
Page:United States Statutes at Large Volume 110 Part 5.djvu/84