Module 1
1.3.5 — Patent and Exclusivity Information
Related Sections
Up to1.3 — Administrative Information1.3.1 — Cover Letter
Cover letter identifying the submission type and key information
1.3.2 — Financial Disclosure
Financial disclosure forms (Form 3454/3455) for clinical investigators
1.3.3 — Debarment Certification
Debarment certification under Generic Drug Enforcement Act
1.3.4 — Environmental Assessment
Environmental assessment or categorical exclusion claim
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