CVM ONADE eSubmitter Program

June 5, 2014

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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

Background Information

CVM Review

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 toolto build submissions)

Web Trader (Tool to submit

documents in ZIP File)

Zip File

CVM ONADE

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FDA ESG and CVM ESS Explained

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 aso Document type and number,

submitter is owner of file, etc.

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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

CVM ONADE eSubmitter Overview

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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

Intuitive Submission Building

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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

papero (J)INAD – All submission types (protocols, data submissions, meeting

requests, etc.)o (A)NADA – Original, supplements, and MCSRso VMF – Original, supplements, and annual reportso Minor Use and Minor Species (MUMS) designation requestso General Correspondence (GC) – User fee waiver requests, meeting

requests, etc.

eSubmitter Templates

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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 Managero Once you start building your submission, you cannot change the unique

Submission ID (i.e., you will have to start over)

Starting Your Submission

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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

Finalizing eSubmitter Submission

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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 fileo 1 - ack from FDA ESG that submission receivedo 1 - ack from FDA ESG that submission sent to the selected centero 1 - ack from CVM ESS with acceptance or rejection information

Web Trader Account

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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

Electronic Communication

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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

US Agents and Consultants

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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/AnimalDrugUserFeeActADUFA/UCM343226.pdf (page 5, lines 192 – 200)

Important ‘Benefit’ of eSubmitter Electronic Submission Tool

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Visit the CVM ONADE eSubmitter Program website http://

www.fda.gov/ForIndustry/FDAeSubmitter/ucm226816.htm

Click on Getting Started and follow the outlined steps

How To Get Started