This document is not a NEPA document. It is an FDA notice of availability for a final industry guidance entitled 'Facility Readiness: Goal Date Decisions Under GDUFA,' published June 18, 2024. The guidance explains how FDA will assign goal dates for original abbreviated new drug applications based on a facility's readiness for inspection as certified on Form FDA 356h, implementing a GDUFA III commitment. No environmental review, alternatives analysis, or impact assessment is involved.