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Title 42

Displaying title 42, up to date as of 9/08/2026. Title 42 was last amended 8/13/2026.
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Title 42Public HealthPart / Section
Chapter IPublic Health Service, Department of Health and Human Services2 – 199
Subchapter AGeneral Provisions2 – 12
Part 11Clinical Trials Registration and Results Information Submission11.2 – 11.66
Subpart AGeneral Provisions11.2 – 11.10
§ 11.2What is the purpose of this part?
§ 11.4To whom does this part apply?
§ 11.6What are the requirements for the submission of truthful information?
§ 11.8In what format must clinical trial information be submitted?
§ 11.10What definitions apply to this part?
Subpart BRegistration11.20 – 11.35
§ 11.20Who must submit clinical trial registration information?
§ 11.22Which applicable clinical trials must be registered?
§ 11.24When must clinical trial registration information be submitted?
§ 11.28What constitutes clinical trial registration information?
§ 11.35By when will the NIH Director post clinical trial registration information submitted under § 11.28?
Subpart CResults Information Submission11.40 – 11.54
§ 11.40Who must submit clinical trial results information?
§ 11.42For which applicable clinical trials must clinical trial results information be submitted?
§ 11.44When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42?
§ 11.48What constitutes clinical trial results information?
§ 11.52By when will the NIH Director post submitted clinical trial results information?
§ 11.54What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission?
Subpart DAdditional Submission of Clinical Trial Information11.60 – 11.64
§ 11.60What requirements apply to the voluntary submission of clinical trial information for clinical trials of FDA-regulated drug products (including biological products) and device products?
§ 11.62What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health?
§ 11.64When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?
Subpart EPotential Legal Consequences of Non-Compliance11.66
§ 11.66What are potential legal consequences of not complying with the requirements of this part?