The FDA, an agency within HHS, is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The FDA is responsible for the oversight of more than $2.8 trillion in consumption of food, medical products, and tobacco. The FDA-regulated products account for about 20 cents of every dollar spent by U.S. consumers and regulates about 78 percent of the U.S. food supply. The FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. The FDA also plays a significant role in the Nation’s counter terrorism capability. The FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats. The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. The law builds on FDA’s ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA’s decision-making process. The Cures Act authorized $500 million over 9 years to help FDA cover the cost of implementing the law. The FDA is composed of multiple Centers and Offices. Each Center/Office at FDA has a specific mission and the Information Technology (IT) systems strategically and efficiently support each Center’s and Office’s mission critical work. The FDA CIO’s office, The Office of Digital Transformation (ODT), scope of responsibility includes providing support for IT to support the FDA mission and Business that includes modernization, strategic, governance, operational, and oversight of enterprise IT landscape. In the execution of these responsibilities, the ODT supports the agency’s mission and executes planned and unplanned priorities and to achieve goals outlined in the FDA Modernization Action Plans (e.g. Technology Modernization Action Plan (TMAP), Data Modernization Action Plan (DMAP), Enterprise Modernization Action Plan, Leadership Modernization Action Plan, and Cybersecurity Modernization Action Plan (CMAP) etc. see https://www.fda.gov/about-fda/office-digitaltransformation/odt-reports. The FDA Chief Information Officer (CIO) released FDA IT Strategic plan in 2023 https://www.fda.gov/about-fda/office-digital-transformation/fdainformation-technology-strategy-fy-2024-fy-2027 and the FDA Information Technology (IT) Operating Plan. The FDA has adopted the Technology Business Management (TBM) model aligned to FDA’s digital information strategy. TBM information is provided in Attachment 1 – TBM Layers and Diagrams. The FDA CIO established the following goals and objectives to expedite digital modernization: 1) Create a shared OneFDA ecosystem 2) Strengthen IT Infrastructure 3) Modernize Enterprise Services and Capabilities 4) Share Data for Mission Outcome 5) Adopt AI and Mission-Driven Innovations 6) Cultivate Talent and Leadership The purpose of this FDA Enterprise IT Application Development BPA is to establish an enterprise-wide contracting vehicle for modernizing the FDA IT landscape and implement the OneFDA goal along with other goals listed above. This BPA is being structured such that Full Time Employees (FTEs) and Contractor resources are interactive, collaborative, multifunctional, agile, and scalable. The IT systems developed under this BPA will strategically and efficiently support each Center’s and Office’s mission critical work.
