listed below for an Annual Report. Responses to ONLs that are not labeled as Annual Reports or that state that an update will be submitted in the future are NOT sufficient to keep the DMF in active status. FDA does not acknowledge, whether via e-mail or letter, any submission after the original DMF. Submissions that cover multiple DMFs MUST have a copy submitted for each DMF. When a company changes one part of a DMF, they should not resubmit the entire DMF. For DMFs in CTD format, the company should resubmit the entire changed “Document” (Section)—e.g., a change in the material used in the synthesis requires that the company resubmit Section S.2.3. All submissions must be paginated within the submission. For DMFs in CTD format, the company only resubmits the entire changed “Document” (Section)—e.g., a change in the material used in the synthesis requires resubmitting Section S.2.3. Pages that replace an already-numbered page from a previous submission should also contain the page number in the current submission (e.g. a page replacing Page 10 in the original submission may be page 14 in the new submission). For DMFs in CTD format, only the pages within the changed “Document” (Section) are subject to re-numbering.` No pages are ever physically replaced in a DMF. Electronic DMFs (Category 3) At this time, the FDA doesn't require that companies file DMFs electronically. They continue to accept paper DMFs. Beginning May 5, 2017 new DMFs and submissions to existing DMFs must be submitted using the eCTD standard. See Electronic Common Technical Document (eCTD)' All electronic submissions must have a pre-assigned number to populate in the US regional.xml. If a company converts a paper DMF to electronic format, they don't need to request a pre-assigned number. See also Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. To make sure you have the most recent versions of the specifications referenced in this guidance please check Electronic Common Technical Document (eCTD). Companies are encouraged to submit their DMFs in electronic form, including updating current paper DMFs. Note that all applications to CDER, including DMFs that are submitted in electronic format MUST be in ECTD format, unless a waiver is granted. Waivers are not granted for DMFs. All Letters of Authorization for electronic DMFs should specify that the DMF has been submitted in electronic format. A company may not