the Cover Letter should state: Annual Report Original: Quality/Stability FDA's database is structured as follows: Application: Submission Amendment (called "Supporting Document") in the database) Amendments (Supporting Documents) are named by a Category and Subcategory For the Application Type “Drug Master File” the Submission Types are Original: Information containing changes to technical information are filed in the “Original” submission. For Categories and Subcategories, see list below. Note that a new DMF does not need a “Category” designation by the holder. Annual Report: There are no Amendments (Supporting Documents) Categories and Subcategories Letter of Authorization: There is only one Category with two Subcategories: Letter of Authorization Withdrawal of Authorization Categories of Amendments (Supporting Documents) in General Information Category: Closure Request Category: Reactivation (Used only when a DMF has been Closed.) Category: Administrative Subcategories under Administrative Category change in the holder name change in holder address change in ownership of the DMF (either internal name change, or change in ownership) change in the agent name or address. change in the contact person at the holder or agent. change in the subject of the DMF. change in the type of DMF Categories of Amendments (Supporting Documents) in Original Submission: Category: Quality Subcategories under Quality Category (with corresponding CTD Sections, where applicable). Changes to a Subsection e.g. changes in Control of Materials (S.2.3) not specifically listed below should be reported as the next level up e.g. should be reported as Manufacture Information S.2. New item: Additional item e.g. flavor added to a multi-item DMF Controls Information (specifications) S.4 and P.5 Dissolution Data (Usually applies to drug product only) P.5 Facility Information (changes in manufacturing and or testing sites) S.2.1 and P.3.1 Formulation Information (Usually applies to drug product only) P.1 and related sections Lot Release (batch analysis) S.4.4 and P.5.4 Manufacture Information S.2 and P.3 Microbiology Information New Strength (Usually applies to drug product only) P.1 and related sections Quality (Not covered by other subcategories) Packaging Information (Applies to packaging of the material that is the subject of the DMF e.g. plastic bags for packaging a bulk drug substance in a Type II DMF) S.6 and P.7 Stability Information S.7 and P.8 Response to Information Request Response to Deficiency Letter Category: Non-clinical Non-clinical Carcinogenicity Information A response to an Overdue Notice Letter (ONL) to retain activity of a DMF MUST be identified as an Annual Report (with additional amendments as applicable) and contain the information