Page:United States Statutes at Large Volume 121.djvu/967

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[121 STAT. 946]
[121 STAT. 946]
PUBLIC LAW 110-000—MMMM. DD, 2007

121 STAT. 946

participate in complementary approaches to gather and analyze such data and information, including— ‘‘(I) approaches that are complementary with respect to assessing the safety of use of a drug 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); and ‘‘(II) existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or successor databases. ‘‘(v) AUTHORITY FOR CONTRACTS.—The Secretary may enter into contracts with public and private entities to fulfill the requirements of this subparagraph. ‘‘(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.— ‘‘(A) PURPOSE.—The Secretary shall establish collaborations with public, academic, and private entities, which may include the Centers for Education and Research on Therapeutics under section 912 of the Public Health Service Act, to provide for advanced analysis of drug safety data described in paragraph (3)(C) and other information that is publicly available or is provided by the Secretary, in order to— ‘‘(i) improve the quality and efficiency of postmarket drug safety risk-benefit analysis; ‘‘(ii) provide the Secretary with routine access to outside expertise to study advanced drug safety questions; and ‘‘(iii) enhance the ability of the Secretary to make timely assessments based on drug safety data. ‘‘(B) PRIVACY.—Such analysis shall not disclose individually identifiable health information when presenting such drug safety signals and trends or when responding to inquiries regarding such drug safety signals and trends. ‘‘(C) PUBLIC PROCESS FOR PRIORITY QUESTIONS.—At least biannually, the Secretary shall seek recommendations from the Drug Safety and Risk Management Advisory Committee (or any successor committee) and from other advisory committees, as appropriate, to the Food and Drug Administration on— ‘‘(i) priority drug safety questions; and ‘‘(ii) mechanisms for answering such questions, including through— ‘‘(I) active risk identification under paragraph (3); and ‘‘(II) when such risk identification is not sufficient, postapproval studies and clinical trials under subsection (o)(3). ‘‘(D) PROCEDURES FOR THE DEVELOPMENT OF DRUG SAFETY COLLABORATIONS.— ‘‘(i) IN GENERAL.—Not later than 180 days after the date of the establishment of the active postmarket risk identification and analysis system under this subsection, the Secretary shall establish and implement procedures under which the Secretary may routinely contract with one or more qualified entities to—

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