This document is not a NEPA filing. It is a Federal Register notice from the Food and Drug Administration announcing the availability of a draft guidance document entitled 'E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials,' prepared under the auspices of the International Council for Harmonisation (ICH). The draft guidance provides principles for conducting clinical trials that include pregnant and breastfeeding women, covering safety monitoring, data collection, and participant recruitment. Comments are due by September 19, 2025. No environmental review is involved.12