The Department of Health and Human Services, Food and Drug Administration has a requirement to acquire the full range of technical and management services necessary to develop, maintain and enhance existing and to-be-determined CFSAN systems in support of all programs administered by CFSAN.

FDA is a scientific regulatory agency responsible for the safety of the nation’s domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products. CFSAN, under FDA Foods Program, is one of FDA’s six product centers providing services to consumers, domestic and foreign industry and other outside groups regarding field programs, agency administrative tasks, scientific analysis and support, and policy, planning and handling of critical issues related to food and cosmetics, which are implemented by twelve (12) offices. The following subsections detail the roles and responsibilities of the individual offices.

The Center has over 1,300 employees who range from secretaries and other support staff to highly specialized professionals such as chemists, microbiologists, toxicologists, food technologists, pathologists, molecular biologists, pharmacologists, nutritionists, epidemiologists, mathematicians, sanitarians, physicians and veterinarians. It is located in College Park, Maryland with several small remote sites in the United States. Other FDA Foods Program organizations are primarily located at several locations in Montgomery County, MD with the exception of ORA Field operations.

CFSAN has well established processes for managing its IT investments. These include:

• FDA Interim Informatics Governance Board (IIGB);
• IT Investment Review Board (ITIRB);
•  Participation through the IT Investment Life Cycle as described in the HHS Enterprise Performance Life Cycle (EPLC) framework

The FDA has consolidated the Agency’s information technology (IT) services in the Office of Information Management and Technology (OIMT). OIMT hosts most CFSAN regulatory IT systems on agency standard hardware and software at the consolidated Agency facilities in Ashburn, Virginia and White Oak, Maryland.

• The objectives of this Task Order as follows:
  •  Maintain CFSAN systems in a continued state of readiness, ensuring access, reliability, availability and usability to current and new users by enabling continued support and enhancement to the CFSAN IT applications
  • Position the FDA to meet changes in user needs for systems and data management, deployment strategies and requirements of the stakeholders of CFSAN IT applications
  • Ensure quality and code reusability through repeatable, managed processes equivalent to Capability Maturity Model Integration (CMMI)® Maturity Level 2 or 3
  • Develop new systems and major enhancements using an Agile/Scrum approach or another industry standard Agile methodology
  • Incorporate new business processes and data enhancements to support current and future regulations as they are introduced
  • Position the FDA to continuously enhance CFSAN capabilities for receiving, processing, reviewing, and analyzing electronic regulatory submissions and related data
  • Implement a Service Oriented Architecture (SOA) in order to enhance the integrity of business processes by utilizing reusable services and reduce cost by maintaining code to support common business activities in a single place
  • Develop an enterprise-wide view of the CFSAN business environment focusing on the portfolio of IT assets and data flow necessary to accomplish the mission of CFSAN as it evolves
  • Enhance system integration, standardization, usability, and data flow down-stream systems
  • Facilitate collaboration with Industry and utilization of the Platform as aService (Paas), Software as a Service (Saas), and Cloud technologies

  The BPA is divided into the following (9) task areas:

  • Task #1 – Project Management
  • Task #2 – Architecture Support Services
  • Task #3 – Development, Modernization, and Major Enhancement
  • Task #4 – Systems Integration and Engineering Services
  • Task #5 – Data Migration and Management Support
  • Task #6 – Operations and Maintenance (O&M) and Support Services
  • Task #7 – System and Data Disposition
  • Task #8 – Training Support
  • Task #9 – Transition Activities