Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities | RFA FD 25 023

Opportunity Information: Apply for RFA FD 25 023

The grant opportunity titled "Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities" (Funding Opportunity Number: RFA FD 25 023) is a discretionary grant announced by the U.S. Food and Drug Administration (FDA), specifically through CDER's Office of Compliance and the Office of Compounding Quality and Compliance. The core purpose is to strengthen the U.S. drug supply by focusing on medications that are in shortage, especially those that may be more vulnerable to health fraud when legitimate supply is tight. FDA is looking to fund work that maps and explains the current shortage landscape, identifies practical ways outsourcing facilities can step in to meet clinical needs, and supports research and development aimed at producing shortage drugs more reliably. In plain terms, the program is trying to reduce the openings that shortages create for counterfeit, substandard, or otherwise fraudulent products by stabilizing supply through legitimate, regulated production pathways.

A major emphasis of the FOA is on outsourcing facilities and the role they can play in addressing persistent or recurring shortages. The funding is intended not just for analysis of which shortage products are most problematic, but also for identifying and reducing real-world barriers that prevent outsourcing facilities from producing those products at scale or with consistency. That can include technical barriers (formulation, stability, sterility, sourcing of inputs), operational barriers (process controls, quality systems), or broader supply chain constraints that make it hard to keep critical medications available. The underlying public health logic is that when essential drugs are scarce, patients and providers may be pushed toward unverified sources, increasing the risk of fraud and harm. By supporting legitimate manufacturing and development work, the program aims to increase access to critical medications and make the supply chain less fragile.

The eligible applicant pool is broad and includes many common U.S. organizational types. Eligible applicants include public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including small businesses and other for-profits); and multiple levels of government such as state, county, and city or township governments, plus special district governments. The eligibility list also includes federally recognized and non-federally recognized Indian/Native American tribal governments, independent school districts, public housing authorities/Indian housing authorities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, the FOA is clear that foreign entities cannot apply: non-U.S. organizations are not eligible, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined in the NIH Grants Policy Statement) are not allowed under this announcement.

In terms of funding scale and competition, the announcement lists an award ceiling of $3,000,000 and anticipates making 2 awards. The activity category is listed under Agriculture, Consumer Protection, Food and Nutrition, and the CFDA number associated with the opportunity is 93.103. The original closing date is 2025-08-09, and the posting creation date is 2025-07-23. Taken together, that suggests a relatively targeted program with a small number of relatively large awards, meaning proposals likely need to be well-scoped, credible, and strongly aligned with FDA's goals around shortage mitigation, supply chain resiliency, and fraud prevention.

The FOA also spells out several required administrative registrations that must be completed before an application is submitted, and it warns that these steps can take time. Applicant organizations must have an active registration in the System for Award Management (SAM), which must be renewed at least annually and can take weeks to set up or renew. SAM registration is tied to a Unique Entity Identifier (UEI), and domestic organizations may also receive or confirm a Commercial and Government Entity (CAGE) code as part of that process. The opportunity also requires Grants.gov registration (which depends on active SAM status) and eRA Commons registration. For eRA Commons, organizations need to designate at least one Signing Official (SO) and have at least one Program Director/Principal Investigator (PD/PI) account set up. All PD/PIs must have eRA Commons accounts, and if the same person serves as both SO and PD/PI, they must hold two separate accounts to cover both roles. The notice highlights that registration can take 6 weeks or more overall, with eRA Commons accounts potentially taking up to 2 weeks, so the practical takeaway is that organizations should start registrations well ahead of the deadline because late submissions due to incomplete registrations are not treated as a valid excuse.

Finally, the FOA is flexible about who can serve as PD/PI, focusing on capability rather than a narrow credential requirement. Any individual with the skills, knowledge, and resources to carry out the proposed work may be named as the Program Director/Principal Investigator. That aligns with the program's applied nature: FDA is looking for proposals that can generate actionable understanding of shortage-related risks and produce real progress toward making shortage drugs available through legitimate outsourcing facility pathways, ultimately reducing the conditions that allow health fraud to spread when patients need medications the most.

• The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
• This funding opportunity was created on 2025-07-23.
• Applicants must submit their applications by 2025-08-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $3,000,000.00 in funding.
• The number of recipients for this funding is limited to 2 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA FD 25 023

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