DEPARTMENT OF HEALTH & HUMAN SERVICES	Public Health Service Food and Drug Administration
		5600 Fishers Lane Rockville, MD 20857

Electronic Regulatory Submission and Review (ERSR) Program
PDUFA II "Information Management Advisory Board"

Charter

The Prescription Drug User Fee Act (PDUFA) is a joint initiative between the FDA and Regulated Industry to reduce the time required to evaluate drug applications without compromising review quality. Funded by PDUFA, the FDA Electronic Regulatory Submission and Review (ERSR) Program is a shared effort between CDER, CBER, ORA, and OIRM to define their information technology strategic plans for implementing electronic submission and review systems. Related to this, the FDA has established an "Information Management Advisory Board" with industry stakeholders to collaborate in the Agency’s investment of PDUFA funds toward the goal of an electronic regulatory submissions and review capability by the year 2002. The Board functions as a steering committee which ensures the PDUFA II Information Management (IM) Plan reflects the interest of all stakeholders, utilizes information management/technology best practices, and that the PDUFA II information management program implementation is consistent with said plan.

Purpose

Provide a forum for industry PDUFA stakeholders to participate in the Agency’s planning of information management systems that supports the PDUFA II goals.

Objectives

• To achieve a common electronic information environment by FY2002 which is used by the Agency and Industry to improve health care provision to the community at large.
• To recognize the FDA PDUFA II 5-Year IM Plan as the mechanism to track and monitor progress, milestones, and accomplishments related to the application of PDUFA funds toward achieving the timing and saving goals included in the FDAMA of 1997.
• To create an environment of mutual awareness of characteristics and standards associated with the Information Management Plan, for proper and timely participation and knowledge in the evolution of such characteristics and standards before they become components of published regulations.
• To support and actively promote the agreed standards and technical approaches embedded in the pursuit of these objectives, particularly in the FDA Electronic Regulatory Submission and Review Program, and in concert with the ICH initiative.
• To identify gaps in the Agency and Industry plans, and discuss mitigating strategies for these gaps such as adjustments to the associated expectations and resources.

Roles and Responsibilities

Office of the Chief Information Officer (OCIO)

• Oversee the development and maintenance of the Agency PDUFA II 5-Year IM Plan, and assure that all ERSR Program changes are reflected in updated versions of the Plan, and the Board is appropriately informed/involved
• Schedule and organize Advisory Board meetings
• Assure that meeting notes are taken and distributed to appropriate Board members and FDA Senior Management
• With the collaboration of Center/Offices, represent FDA at industry fori regarding matters of the overall FDA Information Management and Technology Program, FDA PDUFA II 5-Year IM Plan and related Agency IM activities

FDA Centers/Offices

• Implement the ERSR Program in accordance with the FDA PDUFA II 5-Year IM Plan.
• As appropriate, assist the OCIO and PhRMA/BIO with being aware of and understanding the technical nuances of the ERSR program
• Assure that the OCIO is informed of all technical and/or operational changes to the ERSR Program elements/systems
• Assist the OCIO with meeting notes and the distribution of appropriate ERSR Program information to PhRMA/BIO

PhRMA/BIO

• Advise the FDA Board members of industry perspectives on the PDUFA II 5-Year IM Plan, objectives and related information management and technology considerations
• Where appropriate and mutually agreed, augment the Agency with technical expertise that can provide vital assistance with the implementation of critical ERSR Program technologies/processes essential to achieving PDUFA II program goals and objectives
• Assure that appropriate FDA Advisory Board participants are involved in industry fori and that FDA Advisory Board members are advised of and have access to information that may have bearing upon ERSR Program technologies and implementation

Membership/Chairpersons

The Chief Information Officer (CIO) for the FDA and the PhRMA Information Management Liaison to the FDA will serve as Co-chairs of the Board. Other members will be composed of the BIO Information Management Liaison to the FDA, Directors of CDER and CBER, the Director of Information Technology of CDER, the CIO of CBER, the Deputy Director of ORA, and the Director of Information Systems of ORA. The principal membership includes:

• William Bristow II CIO, Office of Information Resources Management, FDA
• Donald Chi Director, Information Systems, ORA, FDA
• Ron Conner Chief Information Officer, CBER, FDA
• Gary Dykstra Deputy Director, Office of Regulatory Affairs (ORA), FDA
• David Isom Director, Office of Information Technology, CDER, FDA
• David MacFarlane, Ph.D. BIO Information Management Liaison to the FDA, Genentech, Inc.
• Claudio Spiguel, Ph.D. PhRMA Information Management Liaison to the FDA, Zeneca Pharmaceuticals
• Janet Woodcock, M.D. Director, Center for Drug Evaluation & Research, FDA
• Kathryn C. Zoon, M.D. Director, Center for Biologics Evaluation & Research, FDA

Board meeting attendance will be augmented by adjunct attendees as the need for their experience and skill becomes apparent.

Meetings

The Board will meet every quarter or on other occasions as determined by the Board members.