[Food and Drug Administration](https://www.fda.gov/)

August 9, 2025

Up to $3,000,000 total; up to 2 awards; maximum project period 3 years

Supports research and sub-grant programs to address drug shortages and health fraud by enabling outsourcing facilities to increase supply of critical medications.

Foreign organizations are not eligible; clinical trials are not allowed.

--- ## Description This opportunity from the FDA’s Center for Drug Evaluation and Research (CDER), Office of Compliance (OC), and Office of Compounding Quality and Compliance (OCQC) aims to address persistent drug shortages and associated health fraud risks. The grant supports research to understand the landscape of drug shortage products, identify those most vulnerable to fraud, and establish a sub-grant program for outsourcing facilities to develop solutions. The ultimate goal is to strengthen the drug supply chain by increasing the availability of critical medications and reducing opportunities for counterfeit and fraudulent products. --- ## Due Dates - Application Due: August 9, 2025, by 11:59 PM local time of the applicant organization - Open Date (Earliest Submission): July 23, 2025 - No Letters of Intent required No late applications will be accepted. --- ## Funding Amount - Total funding available: $3,000,000 (FY 2025) - Expected number of awards: up to 2 - Maximum per award: $3,000,000 - Maximum project period: 3 years - No cost sharing or matching required --- ## Eligibility Eligible applicants include: - Public and private institutions of higher education - Nonprofits (with or without 501(c)(3) status), excluding foreign organizations - For-profit organizations, including small businesses - State, county, city, township, and special district governments - Independent school districts - Public housing authorities/Indian housing authorities - Native American tribal governments (federally recognized and other) - U.S. territories and possessions - Faith-based and community-based organizations - Regional organizations **Important restrictions:** - Foreign organizations and foreign components are not eligible. - Only U.S.-based entities may apply. **Required registrations:** - System for Award Management (SAM) - Unique Entity Identifier (UEI) - eRA Commons - Grants.gov All registrations must be completed before application submission and may take 6 weeks or more. --- ## Application Process - Applications must be submitted electronically via [Grants.gov](https://www.grants.gov/search-results-detail/360124), NIH ASSIST, or institutional system-to-system solutions. - Follow the [How to Apply - Application Guide](https://grants.nih.gov/grants/guide/url_redirect.php?id=82400) and the program-specific instructions in the Notice of Funding Opportunity ([full NOFO](https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-023.html)). - Only applications not proposing clinical trials are accepted. - Applications must include a Data Management and Sharing Plan. - Page limits and other requirements as specified in the NOFO must be followed. --- ## Additional Information - The award supports both research and the establishment of a sub-grant program for outsourcing facilities. - The project should focus on drugs approved before 2000 or listed in the 2020 FDA List of Essential Medicines that are prone to shortages or fraud. - Applicants may submit more than one scientifically distinct application. - The review will focus on significance, investigator(s), innovation, approach, and environment, with specific criteria related to drug shortages and outsourcing facility experience. - Annual and final progress reporting is required. --- ## External Links - [Grants.gov Opportunity Listing](https://www.grants.gov/search-results-detail/360124) - [Full Notice of Funding Opportunity (NIH Guide)](https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-023.html) - [FDA Center for Drug Evaluation and Research](https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder) - [How to Apply - Application Guide](https://grants.nih.gov/grants/guide/url_redirect.php?id=82400) --- ## Contact Information | Contact Type | Name | Email | Notes | |-----------------------------|------------------|-----------------------------------------|--------------------------------| | Scientific/Research Contact | Meghan Murphy | [meghan.murphy@fda.hhs.gov](mailto:meghan.murphy@fda.hhs.gov) | CDER, FDA | | Grants Management Contact | Patrick Johnson | [patrick.johnson@fda.hhs.gov](mailto:patrick.johnson@fda.hhs.gov) | Office of Acquisitions and Grants Services | | Grants.gov Support | Grants.gov Help | [support@grants.gov](mailto:support@grants.gov) | Technical application help | | eRA Commons Support | eRA Service Desk | [eRA Service Desk](https://www.era.nih.gov/need-help) | Electronic submission issues |

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

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