Government Asks Permission to Keep Doing Its Job
Published Date: 11/26/2025
Notice
Summary
The National Library of Medicine wants your thoughts on keeping and improving a big list of clinical trials and their results. This helps doctors, patients, and researchers find trustworthy info faster. If you’re involved in clinical trials or just curious, you can comment within 60 days—no extra costs, just your ideas to make things better!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Mandatory Trial Registration and Results Reporting
The rule requires registration of certain applicable clinical trials and submission of results under 42 CFR part 11 for drug, biological, and device trials, whether or not products are FDA-approved. NIH estimates a total annualized respondent burden of 1,411,181 hours and requests OMB approval for 3 years with an expiration date of 03/31/2026.
Continued Public Access to ClinicalTrials.gov Information
NIH will continue operating ClinicalTrials.gov to collect trial registrations and results so patients, physicians, and researchers can find trustworthy clinical study information and track study progress to benefit public health. The notice seeks public comment for 60 days and states there are no monetary costs to respondents other than their time.
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Key Dates
Department and Agencies
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