GrantPostedDiscretionary
Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities
Food and Drug Administration
RFA-FD-25-023Application Deadline
Aug 9, 2025
Closed
Days Remaining
0
Deadline passed
Award Ceiling
$3,000,000
Total Program Funding
—
Grant Opportunity Analysis
The Food and Drug Administration (FDA) is offering a grant opportunity titled "Reducing Fraud and Lowering Barriers to the Production of Drugs in Shortage by Outsourcing Facilities." This initiative aims to enhance understanding of drug shortages and identify vulnerable products, particularly those prone to health fraud, while supporting outsourcing facilities in the development of critical medications. The FDA plans to allocate up to $3 million to fund two research projects over a maximum period of three years, with applications due by August 8, 2025. Interested applicants can reach out to Patrick Johnson at patrick.johnson@fda.hhs.gov for further information and are encouraged to review the detailed funding announcement available at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-25-023.html.
Eligible Applicants
Others
Additional Eligibility Information
- Eligible Applicants Eligible Organizations Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations Small Businesses For-Profit Organizations (Other than Small Businesses) Local Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Federal Governments Eligible Agencies of the Federal Government U.S. Territory or Possession Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations N/A Foreign Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. Required Registrations Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the HHS Grants Policy Statement for additional information System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks. Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
Grant Documents
RFA-FD-25-023.html
HTML•110 KB•Jul 26, 2025
AI Summary
The U.S. Food and Drug Administration (FDA) announces funding opportunities aimed at understanding and addressing drug shortages and their susceptibility to fraud. The primary goal is to identify vulnerable drug products, especially those regularly in shortage or historically associated with fraudulent activities, and to support outsourcing facilities in developing these drugs. This initiative seeks to strengthen the pharmaceutical supply chain and mitigate public health risks associated with inadequate access to essential medications.
The FDA plans to allocate $3 million to support up to two research projects through the R01 Research Project Grant mechanism. Eligible applicants include various organizations such as higher education institutions and nonprofit organizations. Funding will be available for a maximum of three years, with an application due date of August 8, 2025.
The successful applicants will conduct research to identify drugs that are at risk for shortages or fraud, collaborate with healthcare providers to determine needs, and manage a sub-grant program to facilitate outsourcing facilities' research and production efforts. This initiative underscores the FDA's commitment to promoting drug quality, increasing supply, and protecting public health by reducing vulnerabilities to health fraud.
Related Grant Opportunities
Project Timeline
postedOriginal Opportunity PostedJul 23, 2025
deadlineApplication DeadlineAug 9, 2025
expiryArchive DateSep 8, 2025
Funding Details
Award Ceiling
$3,000,000
Expected Awards
2
No cost sharing required
Agency & Classification
Agency
Food and Drug Administration(HHS-FDA)
Funding Category
Food and Nutrition
Funding Instrument
Grant
Grantor Contact
CFDA Numbers
93.103