NIH Seeks Approval to Keep Tracking Clinical Trial Data
Published Date: 2/19/2026
Notice
Summary
The National Institutes of Health (NIH) is asking for a 30-day public comment on their plan to keep and update a big list of clinical trials and their results. This affects researchers and medical folks who share trial info, helping everyone find trustworthy health study data. No big costs or changes are expected, but your feedback is welcome before the current approval expires on March 31, 2026.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
NIH Seeks 3-Year OMB Clearance
The NIH is asking OMB to approve the ClinicalTrials.gov information collection (OMB control number 0925-0586) for 3 years. The current approval expires on 03/31/2026, and the agency estimates total annualized respondent burden of 1,411,181 hours and says there are no costs to respondents other than their time.
Mandatory Registration and Results Rule Applies
The notice restates that 42 CFR part 11 requires registration and results submission for certain applicable clinical trials of drug, biological, and device products, whether or not the products are FDA approved, licensed, or cleared. Entities running those trials must register and submit results as required by the regulation.
Continued Public Access to Trial Data
NIH operates ClinicalTrials.gov to collect registration and results information to enhance patient enrollment and to track study progress for the benefit of public health. The registry is widely used by patients, physicians, and medical researchers and will continue to be maintained.
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Key Dates
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