Page:United States Statutes at Large Volume 121.djvu/944

 PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 923

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‘‘(ii) is the holder of an approved covered application. ‘‘(B) COVERED APPLICATION.—The term ‘covered application’ means— ‘‘(i) an application under subsection (b) for a drug that is subject to section 503(b); and ‘‘(ii) an application under section 351 of the Public Health Service Act. ‘‘(C) NEW SAFETY INFORMATION; SERIOUS RISK.—The terms ‘new safety information’, ‘serious risk’, and ‘signal of a serious risk’ have the meanings given such terms in section 505–1(b). ‘‘(3) STUDIES AND CLINICAL TRIALS.— ‘‘(A) IN GENERAL.—For any or all of the purposes specified in subparagraph (B), the Secretary may, subject to subparagraph (D), require a responsible person for a drug to conduct a postapproval study or studies of the drug, or a postapproval clinical trial or trials of the drug, on the basis of scientific data deemed appropriate by the Secretary, including information regarding chemically-related or pharmacologically-related drugs. ‘‘(B) PURPOSES OF STUDY OR CLINICAL TRIAL.—The purposes referred to in this subparagraph with respect to a postapproval study or postapproval clinical trial are the following: ‘‘(i) To assess a known serious risk related to the use of the drug involved. ‘‘(ii) To assess signals of serious risk related to the use of the drug. ‘‘(iii) To identify an unexpected serious risk when available data indicates the potential for a serious risk. ‘‘(C) ESTABLISHMENT OF REQUIREMENT AFTER APPROVAL OF COVERED APPLICATION.—The Secretary may require a postapproval study or studies or postapproval clinical trial or trials for a drug for which an approved covered application is in effect as of the date on which the Secretary seeks to establish such requirement only if the Secretary becomes aware of new safety information. ‘‘(D) DETERMINATION BY SECRETARY.— ‘‘(i) POSTAPPROVAL STUDIES.—The Secretary may not require the responsible person to conduct a study under this paragraph, unless the Secretary makes a determination that the reports under subsection (k)(1) and the active postmarket risk identification and analysis system as available under subsection (k)(3) will not be sufficient to meet the purposes set forth in subparagraph (B). ‘‘(ii) POSTAPPROVAL CLINICAL TRIALS.—The Secretary may not require the responsible person to conduct a clinical trial under this paragraph, unless the Secretary makes a determination that a postapproval study or studies will not be sufficient to meet the purposes set forth in subparagraph (B). ‘‘(E) NOTIFICATION; TIMETABLES; PERIODIC REPORTS.— ‘‘(i) NOTIFICATION.—The Secretary shall notify the responsible person regarding a requirement under this

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