Regfo
Module 1administrativendaind

1.12 — Environmental Assessment / Categorical Exclusion

Environmental assessment or categorical exclusion claim per 21 CFR 25

Requirements by Phase

Phase 1
required
Phase 2
required
Phase 3
required
NDA
required

Environmental assessment or categorical exclusion claim per 21 CFR 25

Requirements by Phase

IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required

Content Requirements

  • Environmental assessment analyzing potential environmental impact (if required)
  • Categorical exclusion claim with citation of applicable exclusion category under 21 CFR 25.31
  • For most INDs: categorical exclusion applies (21 CFR 25.31(a))
  • For NDA: full environmental assessment or justified categorical exclusion

Expected Deliverables

  • Environmental assessment or categorical exclusion claim

ICH Guidelines: 21 CFR 25

Source: 21 CFR 25

References

21 CFR 25

Related Sections

Up toModule 1: Administrative Information and Prescribing Information
1.1 — Table of Contents

Complete table of contents for the submission

1.2 — Cover Letter

Cover letter identifying the IND submission type, serial number, and key information

1.3 — Administrative Information

Administrative information including contact details, certifications, and financial disclosures

1.4 — References

Letters of authorization, right of reference statements, and cross-references to other applications

1.5 — Application Status

Application status requests including withdrawal, inactivation, and reactivation

+6 more sections

Check your compliance against this section

Upload your study data and get instant gap analysis with specific regulatory citations.

Try Compliance Check