1. CVM ONADE eSubmitter Program June 5, 2014

2.  CVM achieved the goals of the 2009 Animal Drug User Fee Act (ADUFA) Reauthorization  Provided an electronic submission tool to the industry  Developed an online review environment  Electronic Document Submission and Review (EDSR) System is a collection of tools and systems that make up both the electronic submission and review systems at CVM ONADE  eSubmitter – Tool used to build electronic submissions  Web Trader or Web Trader Hosted Solution (WTHS) – Tool used to send electronic submissions  Gateway-to-Gateway (B-to-B) – Submission method that bypasses Web Trader  FDA Electronic Submission Gateway (ESG) – FDA gateway is a conduit or HIGHWAY along which submissions travel to reach their final destination  CVM Electronic Submission System (ESS) – CVM system used to receive sponsor submissions and to send CVM electronic responses  Submission Tracking and Reporting System (STARS) – CVM’s corporate database/tracking system 2 Background Information

3. CVM Review FDA ESG (Electronic Submission Gateway) FDA ESG (Electronic Submission Gateway) CVM Systems (including STARS) CVM ESS (Electronic Submission System) CVM ESS (Electronic Submission System) eReply Electronic Document Submission and Review System (EDSR) SPONSOR eSubmitter (Template-based tool to build submissions) Web Trader (Tool to submit documents in ZIP File) Zip File CVM ONADE

4. FDA ESG and CVM ESS Explained 4 FDA ESG (Electronic Submission Gateway)  FDA gateway or highway for electronic communication with outside parties  Acts as a firewall and allows only those submitters who have an account and a valid Digital Certificate (SSL) to pass through to CVM CVM ESS (Electronic Submission System)  CVM system that authenticates the submitter with CVM’s authentication program  Validates submitter’s ADOBE certificate  Validates submission information, such as o Document type and number, submitter is owner of file, etc.

5.  Electronic, question-based tool that permits the creation and submission of information  Originally developed in Center for Devices and Radiological Health (CDRH)  Now used by six centers (CBER, CDER, CDRH, CFSAN, CTP, and CVM)  Templates/data capturing forms (question and answer, file attachment capability) walk you through the process of compiling a complete and structured submission to FDA  Required information is clearly identified  Business rule logic require you to complete sections based on previous responses  Ensures all components are included  Standardizes and simplifies the process where possible 5 CVM ONADE eSubmitter Overview

6.  Eliminates any confusion on when to address  Environmental requirements  Form FDA 356v (eSubmitter Administrative Cover Form)  Simplifies ‘building of your submission’ by prompting you to attach all required information, such as  PDF for reports, labeling  SAS Xport files, non-proprietary XML files for data  Prompts you for referencing other files and applications, such as INAD, NADA, PMF, or VMF 6 Intuitive Submission Building

7.  Collection of templates was developed by CVM subject matter experts  Business rules and questions move you from question to question and screen to screen  Templates are available for all submission types, from simple to complex, such as: o New (J)INAD and (A)NADA file requests (A-0000) First submission by a “New to CVM” sponsor must be submitted via paper o (J)INAD – All submission types (protocols, data submissions, meeting requests, etc.) o (A)NADA – Original, supplements, and MCSRs o VMF – Original, supplements, and annual reports o Minor Use and Minor Species (MUMS) designation requests o General Correspondence (GC) – User fee waiver requests, meeting requests, etc. 7 eSubmitter Templates

8.  eSubmitter requires that you know the document type (and your document number), submission type, and submission classification code of the submission you wish to build  A unique Submission ID is created by the following matrix of codes: o Document Type: one letter (I, J, A, N, V, G) o Document Number: up to 6 digits (000000) o Submission Type: one letter (A, B, E, P, Z, etc.) o Submission Number: up to 4 digits (0000) o Submission Classification Code: two letters (EF, HF, etc.)  When unsure, please ask your CVM ONADE Project Manager o Once you start building your submission, you cannot change the unique Submission ID (i.e., you will have to start over) 8 Starting Your Submission

9.  MISSING DATA REPORT (under Output) displays all missing data that must be entered  DIGITAL SIGNATURE and PACKAGING PROCESS (under Output) walks you through the packaging of the data files and file attachments  Packaged as a single ZIP file that contains all of the answers to questions within a structured XML file, including any file attachments  Protected by an ADOBE digital signature (applied during packaging)  Once the submission is packaged, it can’t be altered 9 Finalizing eSubmitter Submission

10.  Most sponsors need to sign into Web Trader account to send a submission  Select eSubmitter (not electronic submission) as Submission Type  To bypass Web Trader, you can utilize gateway-to-gateway (B-to-B) submissions  Web Trader Hosted Solution (WTHS) launched June 2014  Web Trader permits up to 20 files at a time in the account  Recommended that you save files on your network for record keeping  Each single submission results in a total of 4 files in the account: o 1 - submission file o 1 - ack from FDA ESG that submission received o 1 - ack from FDA ESG that submission sent to the selected center o 1 - ack from CVM ESS with acceptance or rejection information 10 Web Trader Account

11.  Electronic receipt will include STARS Submission ID for validated submissions  Electronic copy of the FDA/CVM/ONADE correspondence will be provided after CVM closes out the submission  CVM correspondence (for example, protocol concurrences, technical section complete letters, approval letters, memorandum of conference, etc.) attached as PDF to message  Received within minutes versus postal service delivery for paper  You need to check Web Trader Accounts for messages unless utilizing B-to-B submissions 11 Electronic Communication

12.  US agents only need one FDA ESG account to submit on behalf of foreign firms they represent  21 CFR 514.1(a) requires US Agents to submit on behalf of foreign firms  To submit electronically, US Agents must apply their ADOBE digital signature during packaging (eSubmitter) and submit the Zip file via their Web Trader account  Consultants need a separate account for each firm on whose behalf they submit 12 US Agents and Consultants

13.  As agreed under ADUFA III and beginning October 1, 2014, CVM will replace the end-review amendment (ERA) procedures with shortened review times for qualifying reactivations and resubmissions  New procedures apply only to NADA and INAD submissions made through the eSubmitter electronic submission tool (i.e., new procedures are not available for paper submissions)  http://www.fda.gov/downloads/ForIndustry/UserFees/AnimalDrugUs erFeeActADUFA/UCM343226.pdf (page 5, lines 192 – 200) http://www.fda.gov/downloads/ForIndustry/UserFees/AnimalDrugUs erFeeActADUFA/UCM343226.pdf 13 Important ‘Benefit’ of eSubmitter Electronic Submission Tool

14.  Visit the CVM ONADE eSubmitter Program website  http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm22 6816.htm http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm22 6816.htm  Click on Getting Started and follow the outlined steps 14 How To Get Started