Page:United States Statutes at Large Volume 121.djvu/930

 PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 909

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a link to the posted Food and Drug Administration assessment of the results of such trial. ‘‘(cc) Food and Drug Administration public health advisories regarding the drug or device that is the subject of the applicable clinical trial, if any. ‘‘(dd) For an applicable drug clinical trial, the Food and Drug Administration action package for approval document required under section 505(l)(2) of the Federal Food, Drug, and Cosmetic Act. ‘‘(ee) For an applicable device clinical trial, in the case of a premarket application under section 515 of the Federal Food, Drug, and Cosmetic Act, the detailed summary of information respecting the safety and effectiveness of the device required under section 520(h)(1) of such Act, or, in the case of a report under section 510(k) of such Act, the section 510(k) summary of the safety and effectiveness data required under section 807.95(d) of title 21, Code of Federal Regulations (or any successor regulation). ‘‘(II) NIH INFORMATION.—The Secretary shall ensure that the registry data bank includes links to the following information: ‘‘(aa) Medline citations to any publications focused on the results of an applicable clinical trial. ‘‘(bb) The entry for the drug that is the subject of an applicable drug clinical trial in the National Library of Medicine database of structured product labels, if available. ‘‘(iii) RESULTS FOR EXISTING DATA BANK ENTRIES.— The Secretary may include the links described in clause (ii) for data bank entries for clinical trials submitted to the data bank prior to enactment of the Food and Drug Administration Amendments Act of 2007, as available. ‘‘(B) INCLUSION OF RESULTS.—The Secretary, acting through the Director of NIH, shall— ‘‘(i) expand the registry data bank to include the results of applicable clinical trials (referred to in this subsection as the ‘registry and results data bank’); ‘‘(ii) ensure that such results are made publicly available through the Internet; ‘‘(iii) post publicly a glossary for the lay public explaining technical terms related to the results of clinical trials; and ‘‘(iv) in consultation with experts on risk communication, provide information with the information included under subparagraph (C) in the registry and results data bank to help ensure that such information does not mislead the patients or the public. ‘‘(C) BASIC RESULTS.—Not later than 1 year after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall include in

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