Page:United States Statutes at Large Volume 121.djvu/933

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[121 STAT. 912]
[121 STAT. 912]
PUBLIC LAW 110-000—MMMM. DD, 2007

121 STAT. 912

PUBLIC LAW 110–85—SEPT. 27, 2007 ‘‘(aa) the certification process under subparagraph (E)(iii) when approval, licensure, or clearance is sought; and ‘‘(bb) whether there should be a delay of submission when approval, licensure, or clearance will not be sought. ‘‘(v) ADDITIONAL PROVISIONS.—The regulations under this subparagraph shall also establish— ‘‘(I) a standard format for the submission of clinical trial information under this paragraph to the registry and results data bank; ‘‘(II) additional information on clinical trials and results that is written in nontechnical, understandable language for patients; ‘‘(III) considering the experience under the pilot quality control project described in paragraph (5)(C), procedures for quality control, including using representative samples, with respect to completeness and content of clinical trial information under this subsection, to help ensure that data elements are not false or misleading and are non-promotional; ‘‘(IV) the appropriate timing and requirements for updates of clinical trial information, and whether and, if so, how such updates should be tracked; ‘‘(V) a statement to accompany the entry for an applicable clinical trial when the primary and secondary outcome measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the submission of such information in paragraph (2)(C); and ‘‘(VI) additions or modifications to the manner of reporting of the data elements established under subparagraph (C). ‘‘(vi) CONSIDERATION OF WORLD HEALTH ORGANIZATION DATA SET.—The Secretary shall consider the status of the consensus data elements set for reporting clinical trial results of the World Health Organization when issuing the regulations under this subparagraph. ‘‘(vii) PUBLIC MEETING.—The Secretary shall hold a public meeting no later than 18 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007 to provide an opportunity for input from interested parties with regard to the regulations to be issued under this subparagraph. ‘‘(E) SUBMISSION OF RESULTS INFORMATION.— ‘‘(i) IN GENERAL.—Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an applicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraph (C) not later than 1 year, or such other period as may be provided by regulation under subparagraph (D), after the earlier of—

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