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The Center for Food Safety and Applied Nutrition (CFSAN) IT System Lifecycle Development and Management Support Services on behalf of the Food and Drug Administration (FDA). The FDA is seeking Small Business (SB) sources to determine the availability and capability of small business manufacturers or small businesses capable of IT System Lifecycle Development and Management Support Services.

The FDA | CFSAN is in need of project management services. The Single Award Blanket Purchase Agreement (BPA) will be awarded by the FDA contracting manager. The Center for Food Safety and Applied Nutrition (CFSAN) is the branch of the United States Food and Drug Administration that regulates food, dietary supplements, cosmetics, drugs, biologics, medical devices, and radiological products.

The scope of this contract is to provide the full range of technical and management services necessary to develop, maintain, and enhance CFSAN systems. The general requirements include providing Custom Computer Programming Services (NAICS 541511) to the FDA and CFSAN; and to maintain, support, and evolve code, scripts, views, triggers, jobs, designs, documentation, reports, and templates.

There is also a need to establish an ordering vehicle that develops and maintains existing and future Computer to Plate (CTP) systems, which will process structured and unstructured data. The FDA expects between 2-5 new applications/systems to be added to the BPA per year over the duration of this contract. The ProSidian Engagement Team shall provide training services to CFSAN stakeholders for existing applications, application changes, or newly-developed applications. CFSAN will issue individual Task Orders for the Contractor to provide IT Lifecycle Support for the CFSAN IT portfolio of systems as needed. Representative tasks to be performed.

THE BLANKET PURCHASE AGREEMENT IS DIVIDED INTO THE FOLLOWING (9) TASK AREAS:

• Task 1: Project Management: Task Order level project management to establish control, management, monitoring and notification mechanisms to ensure the individual task orders stay on track to meet the important milestones and performance measures within the awarded task. DOCUMENTATION: The Contractor shall use FDA supplied templates which will be provided on each individual Task Order as applicable. If an FDA template does not exist, the Contractor may be tasked with drafting a template for approval by the COR.
• Task 2: O&M and DME Architecture Support Services: The Contractor shall provide the full range of architecture support services in order to formulate the integrated, end-to-end automated systems that provide enhanced IT capabilities necessary to support CFSAN business and mission processes. The goal is a stable evolutionary progression from an organization's current state to its envisioned future state by identifying tools and technologies that work together to satisfy the needs or changing business needs of the CFSAN users.
• Task 3: Development, Modernization, and Major Enhancement: The Contractor shall provide the complete range of system development lifecycle support services necessary to develop and enhance CFSAN IT systems and tools as well as their external interfaces to FDA Enterprise and Center Systems and applications. Tasks may encompass the complete lifecycle of activities required for database, application and tool development including, but not limited to requirements elicitation, analysis and validation; system design; code generation; testing; deployment; and documentation. The Contractor shall also develop, support and evolve designs, customizations and process automation such as interfaces, templates, scripts, workflows, interfaces to permit reviewer access to analytics/tools, and reports. Deliverable products shall be validated and tested to ensure that they meet applicable/specified standards, policy, business requirements.
• Task 4: Systems Integration and Engineering Services: The Contractor shall support CFSAN with integration services. The Contractor shall focus on the development and deployment of integrated information systems that reflect the introduction of a Service Oriented Architecture (SOA) orientation and, moreover, places an emphasis on the recommended acquisition and re-use of existing components—be they FDA components, HHS components, or components acquired from any other source.
• Task 5: Data Migration and Management Support: The Contractor shall provide data management support for activities related to the development and execution of data architectures, data policies, practices, and procedures that properly manage the full data lifecycle needs of CFSAN.
• Task 6: Operations and Maintenance (O&M) and Support Services: The Contractor shall provide the complete range of operations and maintenance support services necessary to maintain CFSAN IT systems. The Contractor shall be responsible for maintaining the "lights on" availability, reliability, and security of the CFSAN IT portfolio through the full range of O&M services. The Contractor shall maintain, support, and evolve code, scripts, views, triggers, jobs, designs, documentation, reports, and templates. The Contractor shall analyze and report on the impact of infrastructure, software upgrades, capacity, and all changes to the technical environment. These day-to-day operations, maintenance, and help desk support ensures that the systems perform their intended functions.
• Task 7: System and Data Disposition: The Contractor shall identify, recommend and implement the retirement and consolidation of systems, components, technologies, tools and data when they meet the appropriate disposition stage of the lifecycle as defined in the EPLC.
• Task 8: Training Support for O&M and DME: The Contractor shall provide training services to CFSAN stakeholders for existing applications, application changes, or newly developed applications. The Contractor shall assess the level of capability of the users and the need for training. The Contractor shall prepare a training plan, the training materials, and arrange and conduct training sessions. The training plan and materials shall be provided to the COR for review and approval prior to training.
• Task 9: Transition Activities: The Contractor shall provide the transition-in and transition-out of activities to develop, operate, and manage the CFSAN IT portfolio. It is the responsibility of both the incoming Contractor and outgoing Contractor to ensure a smooth transition, with minimal disruption to services and support for users. The purpose of the transition is to transfer expert knowledge, data, and artifacts that are used to support applications from the incumbent Contractor to the successor Contractor efficiently.

*** Enterprise Performance Lifecycle (EPLC) Agile Methodology: The Food and Drug Administration maintains a project management methodology framework that incorporates best government and commercial practices through a consistent and repeatable process, and provides a standard structure for planning, managing and overseeing IT projects over their entire life cycle. The HHS Enterprise Performance Life Cycle (EPLC) framework provides that methodology for HHS OPDIVs including FDA.

TEAM PROSIDIAN PERSONNEL SHALL HAVE EXPERIENCE IN THE FOLLOWING:

• Expertise and experience in designing, developing, implementing, communicating, administering and evaluating human resources programs, with emphasis in compensation and classification in large (i.e., over 4,000 employees) geographically dispersed organizations with a technical, multi-faceted mission of national scope.
• Demonstrated successful experience in designing and implementing innovative private and public sector compensation and pay for performance programs, and/or expertise in a unionized environment.
• Experience in job analysis and evaluation, with expertise in making accurate Fair Labor Standards Act (FLSA) exemption determinations, and demonstrated ability to successfully defend those decisions to employees, management, and/or outside parties.
• Expertise in state-of-the art compensation, pay for performance, and awards programs, with the ability to tailor such programs to a public-sector regulatory/operational organization.
• Knowledge of existing laws and regulations pertaining to the federal compensation, classification, performance, and recognition programs, and to the federal financial regulatory agencies.

APPLICATION ENGINEER – KEY PERSONNEL QUALIFICATIONS

• Analyzes functional business applications and design specifications for functional activities. Develops block diagrams and logic flow charts. Translates detailed design into computer software. Tests, debugs, and refines the computer software to produce