Electronic Applications and Submissions--FY 2004 Performance Report to Congress

This section reports on goals from the "Electronic Applications and Submissions" section of the PDUFA III commitment letter. These goals relate to the Information Technology (IT) initiatives/activities of PDUFA III. A detailed description of the goals, the annual performance targets, and definitions of terms can be found in Appendix A. This section reports on accomplishments in FY 2004.

Centralize the accountability and funding for all PDUFA IT initiatives/activities under the FDA/CIO: The Agency will centralize the accountability and funding for all PDUFA Information Technology initiatives/activities for CBER, CDER, Office of Regulatory Affairs (ORA), and Office of the Commissioner (OC) under the leadership of the FDA Chief Information Officer (CIO). The July 2001 HHS IT five-year plan states that infrastructure consolidation across the department should be achieved, including standardization. The Agency CIO will be responsible for ensuring that all PDUFA III IT infrastructure and IT investments support the Agency's common IT goals, fit into a common computing environment, and follow good IT management practices (section XII, paragraph a).

FY 2004 Accomplishments: In FY 2004, the FDA implemented a formal Agency IT investment governance process with direct involvement of the FDA's Management Council and with the establishment of an Agency Enterprise Architecture Review Board (EARB). As part of this Agency process, the PDUFA IT investment governance incorporates the oversight and approval by both the Agency CIO and Agency management with representatives from the PDUFA program and IT organizations. Specifically, the Agency integrated the PDUFA IT investment governance process with the Agency IT investment process to ensure alignment and linkage to Agency strategic goals.

To assist the governance process, an Agency IT Portfolio Management System was implemented to document and track IT investments starting with the Fiscal Year 2005 budget cycle. The initial implementation provided a mechanism to document all IT investments with input and access throughout the Agency. Since the initial implementation, the Portfolio Management tool has been enhanced to incorporate Department, Agency, and Center tracking and reporting requirements. The Portfolio Management tool is used throughout the investment process to validate and track the IT investment portfolio in support of the FDA mission and target enterprise architecture, and to facilitate prioritizing, approving, and monitoring IT investments for the entire Agency.

In March 2004, all Center, ORA, and OC IT directors and their supporting staff started reporting directly to the CIO. Through this framework the CIO is able to work more closely with IT Directors and their customers to ensure their service demands are met, while consistently meeting the demands of the FDA, Department of Health and Human Services and Office of Management and Budget. It provides a means to drive technology change in a uniform way through direct communication and for ensuring that all IT infrastructure and IT investments support the Agency's common IT goals, fit into a common computing environment, and follow good IT management practices.

Periodically review and evaluate the progress of IT initiatives against project milestones: The Agency CIO will chair quarterly briefings on PDUFA IT issues to periodically review and evaluate the progress of IT initiatives against project milestones, discuss alternatives when projects are not progressing, and review proposals for new initiatives. On an annual basis, an assessment will be conducted of progress against PDUFA III IT goals and established program milestones, including appropriate changes to plans. A documented summary of the assessment will be drafted and forwarded to the Commissioner. A version of the study report redacted to remove confidential commercial or security information, or other information exempt from disclosure, will be made available to the public. The project milestones, assessment, and changes will be part of the annual PDUFA III report (section XII, paragraph b).

FY 2004 Accomplishments: This report satisfies this annual requirement. In addition, the Agency reported IT progress to stakeholders at the PDUFA IT quarterly briefings (October 2003, February 2004, May 2004, and September 2004) and through PhRMA/BIO PDUFA updates (January 2004, May 2004, and September 2004).

Implement a common solution for the secure exchange of application content: FDA will implement a common solution in CBER, CDER, ORA, and OC for the secure exchange of content, including secure e-mail, electronic signatures, and secure submission of, and access to, application components (section XII, paragraph c).

FY 2004 Accomplishments: The FDA has continued to participate in discussions on the Secure Access For Everyone (SAFE) standard for the biopharmaceutical industry. The FDA has been performing an advisory role on the SAFE initiative that is being developed by industry to deliver a regulatory compliant, industry owned, globally scaleable, and legally enforceable infrastructure standard and associated operating rules for both large and small organizations. The SAFE model will meet business requirements for authentication, signature, integrity, liability, and privacy through the use of existing technology and standards tailored to meet the trust needs of the biopharmaceutical industry. The FDA will continue to support this effort in alignment with the PDUFA electronic signature goal and the overall PDUFA objective for the FDA and industry to increase the number of electronic submissions.

Deliver a single point of entry for the receipt and processing of all electronic submissions in a highly secure environment: FDA will deliver a single point of entry for the receipt and processing of all electronic submissions in a highly secure environment. This will support CBER, CDER, OC, and ORA. The system should automate the current electronic submission processes such as checking the content of electronic submissions for completeness and electronically acknowledging submissions (section XII, paragraph d).

FY 2004 Accomplishments: The FDA, working through the PDUFA Business Workgroup, initiated an electronic submission gateway project. This project is a replacement of the current electronic gateway used for mandatory safety reporting by drug and biologic manufacturers. Requirements from each of the FDA organizations are included in the overall system requirements and architecture documents. The initial implementation of the electronic gateway will handle PDUFA applications and submissions, and will include the functionality of the current electronic gateway. At the end of FY2004, the FDA was in the process of reviewing contractor proposals and plans on awarding the contract in the first quarter of FY2005.

Provide a format and review system for the electronic submission of the Common Technical Document (e-CTD): FDA will provide a specification format for the electronic submission of the Common Technical Document (e-CTD), and provide an electronic review system for this new format that will be used by CBER, CDER, and ORA reviewers. Implementation should include training to ensure successful deployment. This project will serve as the foundation for automation of other types of electronic submissions. The review software will be made available to the public (section XII, paragraph e).

Conduct an objective analysis and develop a plan for consolidation of PDUFA III IT infrastructure: Within the first 12 months, FDA will conduct an objective analysis and develop a plan for consolidation of PDUFA III IT infrastructure and desktop management services activities that will access and prioritize the consolidation possibilities among CBER, CDER, ORA, and OC to achieve technical efficiencies, target potential savings, and realize cost efficiencies. Based upon the results of this analysis, to the extent appropriate, FDA will establish common IT infrastructure and architecture components according to specific milestones and dates. A documented summary of analysis will be forwarded to the Commissioner. A version of the study report redacted to remove confidential commercial or security information, or other information exempt from disclosure, will be made available to the public (section XII, paragraph f).

FY 2004 Accomplishments: FDA has consolidated IT support and infrastructure services following a "Shared Services" concept. In October 2003 the FDA Office of IT Shared Services (OITSS) was established to support the FDA mission by delivering infrastructure support services. The OITSS is responsible for on-site desktop management, server/network management, help desk services, e-mail administration, telecommunications, IT asset and inventory management, remote access, and IT security and training. Each Center is assigned a Client Services Representative to improve support and communications between OITSS and the Center.

As a new organization, the OITSS has been establishing processes and procedures in an effort to consolidate a number of functions. These include:

Continuity of Operations Plan (COOP) -- Established a call center process for handling COOP exercises requested by the COOP coordinators across the agency; established an IT COOP team from across the IT functional areas.
Service Level Agreements (SLA) have been developed between IT Shared Services and its customers. Performance metrics is reported to the customers on a monthly basis.
Centralized the personal computer procurement process to facilitate lower prices and support costs.
Change Control Board was established to ensure that all infrastructure changes are coordinated across organizations.
Implemented additional after hour support coverage for remote access users.
Development of a Blackberry (handheld electronic mail) procurement and support process.
Development of an improved telecommunications process to address gaps in the office move process.
Consolidation of infrastructure support contracts into a single contract. One of the performance goals of this contract is server consolidation.

Implement Capability Maturity Model (CMM) and include other industry best practices to ensure quality, efficiency, and cost effectiveness: FDA will implement CMM in CBER, CDER, ORA, and OC for PDUFA IT infrastructure and investments, and include other industry best practices to ensure that PDUFA III IT products and projects are of high quality and produced with optimal efficiency and cost effectiveness. This includes the development of project plans and schedules, goals, estimates of required resources, issues and risks/mitigation plans for each PDUFA III IT initiative (section XII, paragraph g).

FY 2004 Accomplishments: In FY 2004, the Agency continued to strengthen the FDA's IT project management capabilities.

The Project Management Office (PMO), working through the IT PM Steering Committee, approved the first formal Software Development Life Cycle (SDLC) process for the Agency in December 2003.
The PMO established a Web-based Process Asset Library for project management tools and templates. The PMO has also provided and will provide on-site consulting from project management experts.
In the beginning of FY 2004, the project management certification-training program was initiated for over 60 project managers. The IT project management certification training program is continuing, and the FDA will have certified project managers by the end of 2004.

Use same software applications where common business needs exist: Where common business needs exist, CBER, CDER, ORA, and OC will use the same software applications, such as eCTD software, and commercial off-the-shelf (COTS) solutions (section XII, paragraph h).

FY 2004 Accomplishments: During FY2004 the FDA decided to address this objective by separating our Electronic Regulatory Submission Review program into two functional areas, Electronic Submissions, and Regulatory Review and Tracking Systems.

Based on this decision the FDA focused on the electronic submission process within FDA and industry as part of the FDA Enterprise Architecture (EA) effort. The goal of this effort is to develop a target PDUFA electronic submission architecture. The PDUFA electronic submissions target architecture will include the strategic imperatives, stakeholders, business processes, data, application functions, and the relationships of each of these components to each other. The objective is to build on the implementation of the eCTD and the development of the electronic submission gateway to define a common process for the electronic submission of PDUFA submission types.

Develop a PDUFA III IT 5-year plan. Within six months of authorization, a PDUFA III IT five-year plan will be developed. Progress will be measured against the milestones described in the plan (section XII, paragraph i).

FY 2004 Accomplishments: An update to the March 2003 PDUFA IT Plan was completed in June 2004 and released at the September 2004 PDUFA IT quarterly briefing.