PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 947
dkrause on GSDDPC44 with PUBLAW
‘‘(I) classify, analyze, or aggregate data described in paragraph (3)(C) and information that is publicly available or is provided by the Secretary; ‘‘(II) allow for prompt investigation of priority drug safety questions, including— ‘‘(aa) unresolved safety questions for drugs or classes of drugs; and ‘‘(bb) for a newly-approved drugs, safety signals from clinical trials used to approve the drug and other preapproval trials; rare, serious drug side effects; and the safety of use in domestic populations not included, or underrepresented, in the trials used to approve the drug (such as older people, people with comorbidities, pregnant women, or children); ‘‘(III) perform advanced research and analysis on identified drug safety risks; ‘‘(IV) focus postapproval studies and clinical trials under subsection (o)(3) more effectively on cases for which reports under paragraph (1) and other safety signal detection is not sufficient to resolve whether there is an elevated risk of a serious adverse event associated with the use of a drug; and ‘‘(V) carry out other activities as the Secretary deems necessary to carry out the purposes of this paragraph. ‘‘(ii) REQUEST FOR SPECIFIC METHODOLOGY.—The procedures described in clause (i) shall permit the Secretary to request that a specific methodology be used by the qualified entity. The qualified entity shall work with the Secretary to finalize the methodology to be used. ‘‘(E) USE OF ANALYSES.—The Secretary shall provide the analyses described in this paragraph, including the methods and results of such analyses, about a drug to the sponsor or sponsors of such drug. ‘‘(F) QUALIFIED ENTITIES.— ‘‘(i) IN GENERAL.—The Secretary shall enter into contracts with a sufficient number of qualified entities to develop and provide information to the Secretary in a timely manner. ‘‘(ii) QUALIFICATION.—The Secretary shall enter into a contract with an entity under clause (i) only if the Secretary determines that the entity has a significant presence in the United States and has one or more of the following qualifications: ‘‘(I) The research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this paragraph, including the capability and expertise to provide the Secretary de-identified data consistent with the requirements of this subsection. ‘‘(II) An information technology infrastructure in place to support electronic data and operational standards to provide security for such data.
VerDate Aug 31 2005
13:52 Jan 23, 2009