This is an FDA notice of availability for draft Guidance for Industry (GFI) #187B, 'Heritable Intentional Genomic Alterations in Animals: The Approval Process,' published May 2, 2024. The draft guidance explains how FDA's approval process applies to heritable intentional genomic alterations (IGAs) in animals and is issued alongside a companion final guidance (GFI #187A) on FDA's risk-based regulatory approach. This is not a NEPA document; it is an FDA regulatory guidance notice. No environmental impact analysis, alternatives, or NEPA findings are present.