This document is not a NEPA filing. It is an FDA notice of availability published in the Federal Register on November 18, 2025, announcing a final guidance document (Guidance 3 of 4) in the Patient-Focused Drug Development series, covering how stakeholders can select, develop, or modify clinical outcome assessments for use in medical product development and regulatory decision-making. No environmental review, federal land action, or NEPA process is involved. No impacts, mitigations, alternatives, or comment periods apply.12