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

Agency: Food and Drug Administration

Assistance Listings: 93.103 -- Food and Drug Administration Research

Last Updated: July 23, 2025

Description

The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER)/Office of Compliance (OC)/Office of Compounding Quality and Compliance (OCQC), is announcing this Funding Opportunity Announcement (FOA).

The goals of this grant are to better understand the landscape of drug shortage products, including those vulnerable to health fraud, and identify opportunities for outsourcing facilities to meet drug shortage needs to strengthen the supply chain. Funding would also support outsourcing facilities’ research and development of products that mitigate persistent drug shortages to increase supply of critical medications and stabilize the drug supply chain to prevent health fraud. 

Eligibility

Eligible applicants

Government

  • County governments
  • City or township governments
  • Special district governments
  • Public and Indian housing authorities
  • State governments
  • Federally recognized Native American tribal governments

Nonprofit

  • Other Native American tribal organizations
  • Nonprofits non-higher education with 501(c)(3)
  • Nonprofits non-higher education without 501(c)(3)

Education

  • Public and state institutions of higher education
  • Private institutions of higher education
  • Independent school districts

Business

  • Small businesses
  • For-profit organizations other than small businesses

Miscellaneous

  • Other

Additional information

1. 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))

Grantor contact information

Description

Patrick Johnson Grantor

Email

Work

patrick.johnson@fda.hhs.gov

Documents

No documents are currently available.

Link to additional information

RFA-FD-25-023 Notice of Funding Opportunity

Closing: August 9, 2025

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$--

Program Funding

2

Expected awards

$--

Award Minimum

$3,000,000

Award Maximum

Funding opportunity number:

RFA-FD-25-023

Cost sharing or matching requirement:

No

Funding instrument type:

Grant

Opportunity Category:

Discretionary

Opportunity Category Explanation:

--

Category of Funding Activity:

Agriculture

Consumer protection

Food and nutrition

Category Explanation:

--

History

Version:

1

Posted date:

July 23, 2025

Archive date:

September 8, 2025

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