part_subject: "FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS"
subpart_code: "A"
subpart_subject: "General Provisions"
section_number: "54.3"
section_subject: "Scope."
cfr_reference: "21 CFR 54.3"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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The requirements in this part apply to any applicant who submits a marketing application for a human drug, biological product, or device and who submits covered clinical studies. The applicant is responsible for making the appropriate certification or disclosure statement where the applicant either contracted with one or more clinical investigators to conduct the studies or submitted studies conducted by others not under contract to the applicant.