HHS Issues Notice of Proposed Rulemaking for Clinical Trials Registration and Results Submission to ClinicalTrials.gov

On November 19, 2014, the Department of Health and Human Services (HHS) published, for a 90-day public comment period, a Notice of Proposed Rulemaking (NPRM) for Clinical Trials Registration and Results Submission. The proposed rule clarifies requirements for registering and submitting results information for clinical trials that study FDA-regulated drugs (including biological products) and devices and are subject to section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amended section 402(j) of the Public Health Service Act (the Act). It also addresses expansion of the registry and results data bank by rulemaking, as required by section 402(j) of the Act. Comments on the HHS proposed rule are due by February 19, 2015.

..Section 402(j) of the Act provides HHS with the authority to expand the requirements for information that must be submitted to the registry data bank to “to enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials” if the modifications meet the criteria of improving and not reducing the statutorily specified registration information.