Program Expansion for Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas to add a Medical Device Module for Secure Regulatory Information Exchange (U01) | Apply Online

Opportunity Summary:

This funding opportunity, RFA FD 15 040, is a discretionary cooperative agreement from the U.S. Food and Drug Administration (CFDA 93.103) designed as a program expansion of an earlier FDA initiative (RFA FD 15 002) that focused on strengthening medical product regulatory systems and promoting regulatory cooperation across the Americas. The underlying goal is to improve regulatory capacity and collaboration in ways that directly support the FDA's public health mission, especially by improving how regulators generate, share, and use evidence for regulatory decisions. A central theme is the development and strengthening of data and information systems that can serve as reliable inputs for evidence-based regulatory actions.

The expanded scope introduced in this announcement centers specifically on medical devices and adds a medical device module to enable secure regulatory information exchange. The intent is to support development of an international, collaborative portal that participating regulators and partners can use to share and analyze medical device-related information. The portal is meant to handle high-value regulatory data such as audits of medical device manufacturers and assessments of organizations that perform auditing functions. In practical terms, the opportunity emphasizes building infrastructure that helps regulators compare findings, track compliance-related activities, and use shared information to inform oversight and decision-making across different jurisdictions.

A key requirement of the expanded work is that information exchanges through the portal must be effective, traceable, and secure. "Effective" implies the system should be usable and support real regulatory workflows rather than acting as a simple document repository. "Traceable" signals that the system should maintain clear records or audit trails showing what information was shared, by whom, and when, supporting accountability and confidence in the data. "Secure" highlights the need to protect sensitive regulatory information, which may include non-public details about manufacturers, audit results, and organizational performance. The announcement also stresses that the portal should be scalable so it can support both current participants and future growth, and that it should conform to appropriate data transmission standards so information can move reliably between organizations and systems without creating technical barriers.

The award structure is a cooperative agreement (U01), which generally indicates substantial involvement by the funding agency compared with a standard grant. While the summary text does not list detailed deliverables, the cooperative agreement format typically reflects an expectation of close coordination with FDA on planning, technical direction, and alignment with broader regulatory collaboration goals. The overall projected funding is up to $1,000,000, with an award ceiling of $1,000,000, and the FDA anticipated making one award. There is no cost-sharing or matching requirement stated.

Eligibility is narrowly limited: only the Pan American Health Organization (PAHO) is eligible to apply. This reflects the regional, multinational nature of the effort and positions PAHO as the coordinating entity for implementing and convening the collaborative work across the Americas. Administrative details provided in the source include a posted date of May 14, 2015, a current closing date of July 17, 2015, and an archive date of July 31, 2015. The listed FDA contact for access issues with the full announcement is Kimberly Pendleton Chew, Chief Grants Management Officer, at kimberly.pendleton@fda.hhs.gov.

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