2025-21244Notice

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.

Your PRIA Score

Score Hidden

Personalized for You

How does this regulation affect your finances?

Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.

Free to start

Key Dates

Published Date
11/26/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
National Institutes of Health
Source: View HTML
Back to Federal Register

Take It Personal

Get Your Personalized Policy View

Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.

Already have an account? Sign in