# Presentation: 525683

## FDAMA/PDUFA 2 - Can FDA Achieve a Paperless Environment by 2002?

- Ralph Lillie
- Office of Information Technology
- CDER, FDA

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## IT Evolution at FDA

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***IT Evolution at FDA***

## IT Evolution

- Pre-PDUFA, PDUFA I
- No Formal Project Prioritization
- Flexible Standards, Local Options
- FDAMA/PDUFA II/Clinger-Cohen
- Goal - Paperless Receipt and Processing Applications by 2002
- Information Systems Architecture (ISA) Standards
- Need for a Production Environment
- SOPs, Process Monitoring/Support
- 24hr Environment

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Challenges

- Standards
- Current and Future Transport/Database
- Electronic Submissions
- Documents Evolving into Data
- Technology - Keeping Pace
- Review at Home
- Communications
- Videoconferencing/Webcasting/Bandwidth
- Cost Management

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## ERSR Commitments 

**By 2002**
- Official Submissions Can Be Received and Archived Electronically
- Electronic Submissions and Reviews Accessed from the Reviewer’s Desktop Computer
- Standardized Analytical Tools
- Publicly Releasable Material Available on the Internet

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Pre-marketing Application

- Industry Generates an e-IND, e-NDA Original, Amending and Supplemental Submission

- FDA parses e-IND into EDR, Scientific Databases, and tracking databases

**Pre-marketing Application**

- Exchange between FDA and Industry via secure e-mail

- Formal reviews archived in E-Doc Check-in

**Review Process**** **

**AERS**

- Adverse event reports submitted to FDA

- Adverse event reports received through Gateway

- Databases populated, submissions archived in EDR and available to reviewers at desktop

- Field Inspectors access information electronically and enter inspection data

**Post-marketing**

**INDUSTRY**

**FDA**

**EDR**

**SURVEILLANCE**

**REVIEW**

- Databases populated, submissions archived in EDR and available to reviewers at desktop

**RESEARCH**
**REG AFFAIRS**

**RESEARCH**
**REG AFFAIRS**

**PUBLIC**

**E Reading Room**

- Internet Access to Reviews,
-  Current Labeling

- MEDWATCH

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Technology Approach

- Careful Prioritization for Efforts in Support of PDUFA II
- Benefit/Risk Analysis of IT Solutions
- Strategy:
- Develop Production Solutions with Prioritized Functions and Implement
- Consider Two Paths:
- Expand Existing Solution for Additional Functions, or
- Throw-away in Favor of New, Cheaper Technology That Includes Existing Functionality Plus Additional Functions
- Determine Using TCO Approach

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Current and Near-Term Application Architecture

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Target Architecture

**Corporate Data & Doc Web Applications**

- Distributed Servers
- Desktop Cost Savings

- O/S
- Bandwidth

**Infrastructure**

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Data Transport Models

- Current Standards
- Pre-market - SAS Transport and PDF
- Post-market - SGML and PDF
- Proposed Concurrent Transport Standards
- XML

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Exchange Format

- Oracle

- Other

- SQL Server

- SAS

- Exchange Format

- CDER Review Tool or Database

- Custom Extraction Program

- Industry

- FDA/CDER

- Oracle CMC

- PK Analysis

- Excel

- Local COTS Review Tool

- COTS Extract Tool

**XML **
**Specification**

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## CIO/OIRM

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***CIO/OIRM***

## OIRM - CIO

- IT Investment Oversight
- IT Business Planning Process
- IT Investment Review Board
- Technical Review Board
- PDUFA ERSR Program
- Information Management Advisory Board (IMAB)
- Information Management Working Group (IMWG)
- Information Systems Architecture (ISA)

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Information Systems Architecture (ISA) - 1

- Objectives:
- Provide Common User Interface to All Information Systems, Services, and Databases from any Location within FDA
- Provide Uniform Capability to Communicate and Exchange Information Electronically with Any Other User Across FDA
- Define Standards for Application Development, Internal and External Information Access, and Systems Interoperability

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Information Systems Architecture (ISA) - 2

- Current Standards:
- Office Automation Suite, Electronic Messaging, Network Operating System, Desktop Operating System, Document Management/Workflow/Imaging, Agency Financial Management System, Database Configuration Standards,Internet/Intranet Standards
- Agency Forms Package

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Center for Drug Evaluation and Research

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***Center for Drug Evaluation and Research***

## CDER - Changes Underway

- Administrative
- Re-Engineer Procurement/Contract Processes
- Infrastructure and Support Issues
- Improve Architecture thru Desktop Support
- Improvement Project
- Facilitate Transition to CMM Level 2
- Requirements Management
- Project Planning, Tracking & Oversight
- Quality Assurance
- Configuration Management

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## CDER Projects Supporting ERSR

**Division Files System (DFS)**
- Gives Reviewers Capability to Track Reviews Electronically
- Provides Electronic Repository of Internally Generated Reviews and Action Letters
- Accessible from Reviewers' Desktops; Official Archive
- Implemented, V 2.0 - July 2000
**E-Doc Query**
- Provides On-line Search and Retrieval Tools for Access to Documents, Data, and Images
- Enables Query Capability for Electronic Document Metadata and Application Tracking Across Multiple Repositories
- Initial - July 2000

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## CDER Projects Supporting ERSR

**E-Doc Check-in**
- Provide an On-line Repository of Documents of Interest to CDER Whether Related to Specific Submissions or Not
- In Conceptual stage
**Corporate Database Redesign**
- Major Redesign of CDER’s Submission Tracking System
- Focusing on Data Requirements that Directly Support Logging and Review Tracking of Pre-submissions and Submissions
- Completed Data and Functional Requirements
- On Target for 2001 Completion of Software Development and Data Migration from Legacy Database

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## CDER Projects Supporting ERSR

**Electronic Charge and History Card**
- Entry of Documents and Correspondence Received by CDER to Allow Linkage to DFS Documents
- Linked to DFS 2.0
**Secure E-mail**
- Allow Secure Communication Between CDER E-mail Users and Industry Over the Internet
- Continue to Enroll Firms Using World Secure Server

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## CDER Projects Supporting ERSR

**ICH M2 and E2B Maintenance**
- Provide International Specifications for the Electronic Submission of Adverse Drug Experience Reports and Future Electronic NDA Submissions
**Electronic Document Room** **(EDR) 2000/2002**
- Provide Receipt, Storage, Archiving and On-line Use of Electronic Submissions
- In Lock-step with Guidance Development

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## CDER Projects Supporting ERSR

**Adverse Event Reporting System (AERS)**
- AERS v2.0 in Production
- Electronic Submission Component Expected to Reduce  Cost and Time Required to Provide Access to the Over 260,000 AEs Submitted Each Year to CDER.
**FACTS / EES**
- Provides an Electronic Interface with ORA Field System to Ensure Timely Inspection Requests and Status Notification
**Remote Connectivity**
- Provides Access to CDER Documents, Data and Knowledge from Home or Travel Locations
- Proposed Pilots Using RAS & Laptops

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Center for Biologics Evaluation and Research

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***Center for Biologics Evaluation and Research***

## CBER Electronic Cycle

**E-Submission:**
**Federal Express**

**Secure **
**E-Mail, **
**Fax, Letter**

**Review Team**

**Paper****Document****Library**

**Submissions**
**Tracking**
**Document**
**and  Amendments**

**Communications**
**Tracking****Letters**
**Telecons****Meeting Summaries**

**Review Notes****Clinical****Product**
**Pharm/Tox****Biostat**

**Electronic Document Room (EDR)**
**e-Submission **
**Repository & **
**Archive**

**Filed****Documents &****Responses**

**Document**
**Tracking****Records, Queries**

**Document Control Center (DCC)**

**RMS**
**(IND/BLA)**

**Queries &**
**Reports**

**Correspondence**

**RPM**

**DATS**

**RMS**
**(IND/BLA)**

**RMS**
**(IND/BLA)**

*The Architecture*

**Industry**

***CBER Electronic Cycle***

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Changes/Challenges

- Digital Signatures and Encryption
- Web Applications
- Reviews at Remote Locations
- New Technology
- Improve Project Management

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## CBER Projects Supporting ERSR

**Document Accountability and Tracking System (DATS) v1.0**
- Provides General e-Submission Tracking Capability
- Shipment Receipt Information, Submission Data Logging
- Check-in/Check-out Circulation
- Security, Inventory, Audit Trail
- Phase I Completed in 1999
- Phase II in Analysis Phase - Targeted for June 2001
**Electronic Document Room (EDR)**
- Provides E-Submission Storage Capability, Document Retrieval to Desktop, Security, Audit Control, Backup and Archive
- Phase I User Acceptance Test Completed (March 2000)
- Updates based on Guidance

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Regulatory Management System (RMS) - IND 1.0
Generation of IND Letters - Teleconference and Meeting Summaries
Includes Applications for Tracking, Planning, Review, Surveillance, Compliance, and Import/Export
Completed in 1998
RMS - BLA 2.1
Provide BLA Tracking and Reporting Capabilities
Refine Data from Legacy BRMS System and Migrate to New BLA Database
Application Software and Data Migration Interface Enters User Acceptance Testing (April 2000)
Production Data Conversion (July 2000)

- Generation of IND Letters - Teleconference and Meeting Summaries
- Includes Applications for Tracking, Planning, Review, Surveillance, Compliance, and Import/Export
- Completed in 1998
**RMS - BLA 2.1**
- Provide BLA Tracking and Reporting Capabilities
- Refine Data from Legacy BRMS System and Migrate to New BLA Database
- Application Software and Data Migration Interface Enters User Acceptance Testing (April 2000)
- Production Data Conversion (July 2000)

***CBER Projects Supporting ERSR***

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## CBER Projects Supporting ERSR

**Basic Infrastructure - 1999/2000**
- Standard Desktop Software Suite
- Desktop Hardware Upgrades
- Dark Fiber Network Integration
- Standard Reviewer Software
- Dual Monitor Platforms

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Office of Regulatory Affairs

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***Office of Regulatory Affairs***

## ORA Changes/Challenges

- Analysis of Functional Requirements
- Infrastructure to Support Receipt and Retrieval of Electronic Documents
- Completed January 1999
- Implementation of Infrastructure to Support Requirements Pending Final Architecture from Centers

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## ORA  - Electronic Tech Copy 

- Options for field access to data:
- Physical media
- Network Access to EDR
- Network Access to Shared Databases or Applications

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## ORA - EES/FACTS

**FACTS / EES**
- Electronic Interface (s) between Centers and ORA
- Ability to Request a Variety of Inspections
- Provide Centers with Inspection Scheduling Information
- Inspection Outcome Information Quickly

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Guidances/Rulemaking

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***Guidances/Rulemaking***

## Guidances

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Rulemaking

**Currently Under Consideration**
- Electronic  Submission of Final Printed Labeling Text
**In-Progress**
- Proposed Rule - Electronic Submission of all ADR Reports
- ADR Proposed Rule

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Conclusions

- The Agency is Moving Towards a Production Based IT Environment
- CDER, CBER, ORA and OIRM/CIO are Actively Coordinating
- We are Moving Ahead with All Current Initiatives
- 2002 is Still the Target

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000

## Websites

***E-mail***

**CDER Electronic Submission Coordinator (PDUFA):****  **
**	****ESUB@CDER.FDA.GOV**
**CDER Electronic Submissions Coordinator (Generic Drugs):**
**	****ESUB_OGD@CDER.FDA.GOV**
**CBER Electronic Submissions Coordinator:**
**	****ESUBPREP@CBER.FDA.GOV**

- CDER ERSR Page
- http://www.fda.gov/cder/regulatory/ersr/default.htm

- FDAMA - Can FDA Achieve a Paperless Environment by 2002?

- May 9, 2000