Page:United States Statutes at Large Volume 82.djvu/388

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[82 STAT. 346]
[82 STAT. 346]
PUBLIC LAW 90-000—MMMM. DD, 1968

346

PUBLIC LAW 90-399-JULY 13, 1968

[82 STAT.

application filed pursuant to subsection (b) with respect to any new annnal drug if the Secretary finds— " (A) that experience or scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved; " (B) that new evidence not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when • such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved or that subparagraph (H) of paragraph (1) of subsection (d) applies to such drug; " (C) on the basis of new information before him with respect to such drug, evaluated together with the evidence available to him when the application was approved, that there is a lack of substantial evidence 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; " (I)) that the application contains any untrue statement of a material fact; or " (E) that the applicant has made any changes from the ^standpoint of safety or effectiveness beyond the variations provided for in the application unless he 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. The supplemental application shall be treated in the same manner as the original application. If the Secretary (or in his absence the officer acting as Secretary) finds that there is an imminent hazard to the health of man or of the animals for which such drug is intended, he may suspend the approval of such application immediately, and give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing under this subsection; but the authority conferred by this sentence to suspend the approval of an application shall not be delegated. "(2) The Secretary may also, after due notice and opportunity for hearing to the applicant, issue an order withdrawing the approval of an application with respect to any new animal drug under this section if the Secretary finds— " (A) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports in accordance with a regulation or order under subsection (1), or the applicant has refused to permit access to, or copying or verification of, such records as required by paragraph (2) of such subsection; " (B) that on the basis of new information before him, ev^aluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to assure and preserve its identity, strength, (uiality, and purity and were not made adequate within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or " (C) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the labeling of such drug, based on a fair evaluation of all material facts, is false or misleading in any particular