Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities

The U.S. Department of Health and Human Services, through the Food and Drug Administration (FDA), has announced a forecasted discretionary grant opportunity titled "Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities." This initiative aligns with the FDA's mission to ensure public health and safety by fostering a more resilient pharmaceutical supply chain and addressing persistent drug shortages that threaten access to critical medications. The primary goal of this grant program is to better understand and address the vulnerabilities in the drug supply chain, particularly products prone to shortages or health fraud. Funding will support the work of outsourcing facilities in identifying shortage-prone drugs and exploring opportunities to contribute to their production. Additionally, the grant will enable outsourcing facilities to conduct research and development aimed at alleviating persistent shortages. These efforts are expected to bolster the availability of critical medications, improve supply chain resilience, and reduce instances of health-related fraud. The program anticipates issuing two awards under Assistance Listing 93.103 – Food and Drug Administration Research – with a total program funding of $3,000,000. The maximum (ceiling) award amount is also set at $3,000,000 per recipient. There is no cost-sharing or matching requirement associated with this opportunity, making it more accessible to a broad range of potential applicants. Eligibility for this funding is wide-ranging and includes public and private institutions of higher education, various types of nonprofit organizations (with or without 501(c)(3) IRS status), local and state governments, small and large for-profit entities, and tribal, regional, and special district governments. Faith-based and community organizations, independent school districts, and housing authorities are also eligible. However, non-U.S. organizations and foreign components of U.S.-based organizations are not eligible to apply, as defined by the NIH Grants Policy Statement. As of the most recent update on July 21, 2025, the opportunity remains in a forecasted stage. Key estimated dates for the application open, submission deadline, award announcement, and project start are not yet available. Applicants should monitor Grants.gov for updates regarding specific timelines and submission requirements. While application questions or instructions have not yet been provided, applicants can prepare by closely reviewing the goals and eligible use cases outlined by the FDA and considering how their research and manufacturing capabilities align with the program’s objectives. For inquiries about the grant, interested parties should contact Patrick Johnson at the Food and Drug Administration via email at patrick.johnson@fda.hhs.gov. Additional resources and updates related to this grant opportunity can be accessed on the Grants.gov portal under the opportunity number FOR-FD-25-023.