FDA Office of Compliance (OC) - Strategic Implementation

PRESOLICITATION NOTICE ONLY. THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE PROPOSALS THE ANTICIPATED AWARD IS A 1-YEAR HUBZONE SET-ASIDE The Office of Compliance requires support in the following areas to enable effective execution of cross-office compliance priorities. These priorities reflect the administration's emphasis on speed, coordination, accountability, and consistent execution of regulatory priorities, specifically, Executive Order 14017 (America’s Supply Chains), Executive Order 14110 (Safe, Secure, and Trustworthy AI), and the Executive Orders for Regulatory Relief for Domestic Pharmaceutical Manufacturing (May 2025) and Ensuring Lawful Governance (Feb 2025). Independently, and not as an agent of the Government, the contractor shall furnish the necessary personnel, materials, services, facilities and otherwise do all the things necessary for, or incidentally, the performance of the work described below. Task: Strategic Implementation and Leadership Coordination Support The contractor shall provide the following services to support Office of Compliance leadership execution of cross office compliance priorities: Area 1- Leadership Coordination and Decision Support: The contractor shall provide services that will enable CDER OC to provide a framework for structured support for cross-office leadership engagement, ensuring that decision-relevant information is synthesized, surfaced, and acted upon in a timely manner. By facilitating communication across senior leaders and translating complex, multi-office inputs into clear decision frameworks, this work enables CDER compliance leadership to respond with speed and coherence to rapidly evolving priorities. Area 2- Enterprise Alignment: The Contractor shall provide support by facilitating structured communication mechanisms, developing shared reference materials, for CDER OC management to identify and resolve inconsistencies in how compliance initiatives are being interpreted or applied across offices. This includes monitoring implementation activities across component offices, flagging divergences early, and leadership providing communication in issuing clarifying guidance where needed. The goal is to ensure that CDER Compliance speaks and acts with one voice on compliance matters, regardless of which office is at the point of execution- thus reducing the risk of fragmented or conflicting execution that could undermine CDER Compliance’s ability to meet its commitments. Area 3-Milestone Tracking: The volume and velocity of high-visibility compliance initiatives currently facing CDER — driven by Presidential Executive Orders, HHS directives, and internal FDA priorities — demand a disciplined, centralized approach to tracking deliverables, deadlines, and interdependencies across component offices. The Vendor shall provide a framework that ensures that milestone tracking is not just a reporting exercise but a genuine organizational capability — one that is embedded in leadership practice, supported by clear accountability, and resilient enough to keep pace with CDER's evolving compliance demands. The vendor shall support the office in its assessment of how work flows across OMQ, OCQC, OUDLC, ODSIR, OSI, and OPRO to design a tracking framework that reflects how the organization operates. This may include identifying where accountability is unclear, where handoffs between offices create delays, and where existing processes need to be redesigned to support reliable milestone execution. Area 4- Strategic Implementation Planning: the contractor shall support execution planning for Presidential, HHS, FDA, and CDER compliance priorities. This includes supporting OC’s efforts to efficiently utilize resources, processes, and systems to achieve outcomes that advance FDA’s mission. Deliverables include but not limited to: Conducting assessments of the existing strategic and operational plans, procedures, and practices to document and/or define the business processes; develop baseline me...