Currently, tobacco product submissions are organized differently across application types and often, across applicants, and are received in a format that is not amenable for reviewers to organize and easily find what they need. This “unstructured” format is not conducive to automation and complicates analysis across applications and products. Familiarity with FDA’s supported technical file formats, data specifications and standards will aid in the creation of an electronic submission of sufficient functionality to facilitate its processing and review by CTP. CTP intends to be consistent, wherever possible, with existing paradigms, file formats, and data standards developed by other FDA Centers. CTP strives to leverage existing electronic standards and participate in existing standards bodies. Both FDA and industry have benefited from the use of common technical standards including searchability, reliability, accuracy, and harmonization of submission structure across application types. Such standards also facilitate the development of supporting tools by the commercial market for regulatory submission creation, review, and analysis. FDA regulations avoid technical details on submission format and organization as technologies change over time. These details are outlined in technical specifications and guidance documents and adopted industry standards. Historically, independent standards associations have helped drive eSubmission standards and FDA has participated as a member. FDA can endorse such standards through Federal Register notice. FDA is currently evolving towards using the Health Level Seven (HL7) Regulated Product Submission (RPS) standard for its submissions. For CTP the structure is named the electronic Tobacco Technical Document or eTTD. CTP is testing a draft eTTD specification with software companies that provide eCTD solutions to regulated industry to ensure technical viability. Once validated, the eTTD will proceed for public comment.