Page:United States Statutes at Large Volume 121.djvu/925

 121 STAT. 904

21 USC 355 note.

PUBLIC LAW 110–85—SEPT. 27, 2007

(1) striking paragraph (4); and (2) redesignating paragraphs (5), (6), (7), and (8) as paragraphs (4), (5), (6), and (7), respectively. (c) EFFECTIVE DATE.—The amendments made by this section shall take effect on October 1, 2007.

TITLE VIII—CLINICAL TRIAL DATABASES SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

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(a) IN GENERAL.—Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended by— (1) redesignating subsections (j) and (k) as subsections (k) and (l), respectively; and (2) inserting after subsection (i) the following: ‘‘(j) EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.— ‘‘(1) DEFINITIONS; REQUIREMENT.— ‘‘(A) DEFINITIONS.—In this subsection: ‘‘(i) APPLICABLE CLINICAL TRIAL.—The term ‘applicable clinical trial’ means an applicable device clinical trial or an applicable drug clinical trial. ‘‘(ii) APPLICABLE DEVICE CLINICAL TRIAL.—The term ‘applicable device clinical trial’ means— ‘‘(I) a prospective clinical study of health outcomes comparing an intervention with a device subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and ‘‘(II) a pediatric postmarket surveillance as required under section 522 of the Federal Food, Drug, and Cosmetic Act. ‘‘(iii) APPLICABLE DRUG CLINICAL TRIAL.— ‘‘(I) IN GENERAL.—The term ‘applicable drug clinical trial’ means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of this Act. ‘‘(II) CLINICAL INVESTIGATION.—For purposes of subclause (I), the term ‘clinical investigation’ has the meaning given that term in section 312.3 of title 21, Code of Federal Regulations (or any successor regulation). ‘‘(III) PHASE I.—For purposes of subclause (I), the term ‘phase I’ has the meaning given that term in section 312.21 of title 21, Code of Federal Regulations (or any successor regulation). ‘‘(iv) CLINICAL TRIAL INFORMATION.—The term ‘clinical trial information’ means, with respect to an applicable clinical trial, those data elements that the responsible party is required to submit under paragraph (2) or under paragraph (3).

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