PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 905
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‘‘(v) COMPLETION DATE.—The term ‘completion date’ means, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. ‘‘(vi) DEVICE.—The term ‘device’ means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act. ‘‘(vii) DRUG.—The term ‘drug’ means a drug as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act or a biological product as defined in section 351 of this Act. ‘‘(viii) ONGOING.—The term ‘ongoing’ means, with respect to a clinical trial of a drug or a device and to a date, that— ‘‘(I) 1 or more patients is enrolled in the clinical trial; and ‘‘(II) the date is before the completion date of the clinical trial. ‘‘(ix) RESPONSIBLE PARTY.—The term ‘responsible party’, with respect to a clinical trial of a drug or device, means— ‘‘(I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or ‘‘(II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information. ‘‘(B) REQUIREMENT.—The Secretary shall develop a mechanism by which the responsible party for each applicable clinical trial shall submit the identity and contact information of such responsible party to the Secretary at the time of submission of clinical trial information under paragraph (2). ‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK WITH RESPECT TO CLINICAL TRIAL INFORMATION.— ‘‘(A) IN GENERAL.— ‘‘(i) EXPANSION OF DATA BANK.—To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (referred to in this subsection as the ‘registry data bank’). The Director of NIH shall ensure that the registry data bank is made publicly available through the Internet.
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