Module 1 — Environmental Assessment / Categorical Exclusion (OBX-319)

Document ID: M1-ENV
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): 21 CFR 25

Environmental Assessment / Categorical Exclusion — OBX-319

Environmental impact consideration for the OBX-319 application: a claim of categorical exclusion under 21 CFR 25.31 (or an Environmental Assessment if a claim cannot be made), addressing the expected introduction concentration and use. 21 CFR 25.