a) Application Form

Form 356h must be completed and signed with each submission. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM321897.pdf

M4 represents the CTD (the fourth multidisciplinary category addressed by the ICH). The E, S, and Q represent the specific topics the ICH addresses: efficacy, safety, and quality. R states the revision number.