RFA-FD-24-020: Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed
Closed
This grant is closed. A newer notice from the same program is open now: Flexible Funding Model - Advancing Domestic Mutual Reliance Through Strengthened Infrastructure Development and Maintenance for Manufactured Food Regulatory Programs (PAR-27-017). Status: Rolling or no fixed deadline. It is in our archive of Food and Drug Administration notices from 2023.
Food and Drug Administration offered grants of up to $350,000 to any type of organization. It expected to make one award worth $350,000 in total. Applications closed on February 27, 2024.
From the official notice on Grants.gov, last changed March 14, 2024. Checked November 7, 2026.
- Award ceiling$350,000
- Total funding$350,000
- Expected awards1
- Cost sharingNot required
- Funding typeCooperative Agreement
Key dates
| Posted | December 21, 2023 |
|---|---|
| Deadline | February 27, 2024 |
| Archived by Grants.gov | March 28, 2024 |
Who can apply
This opportunity was open to any type of organization.
All 15 applicant types the notice lists
- 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
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
Is this a realistic fit?
- Past Food and Drug Administration Research awards averaged $1.3 million; this notice allows up to $350,000 per award.
- Most of the program's money (35% over five years) went to nonprofits.
- No cost sharing or match is required.
What the grant funds
The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement. The proposed work directly supports the U.S. FDA’s stated goal of protecting public health from unacceptable risks from nitrosamine impurities in human drugs. Although significant experimental and policy/regulatory initiatives have been undertaken in this area, there remains a need for further research into and development and refinement of translational and implementable practices that will protect the public against nitrosamine risks while ensuring continued safe access to critical therapeutic drugs. The aim is to improve the safety of human drugs with potential nitrosamine impurity liabilities. In addition to the work outlined above, the award recipient will assess how best to ensure that this research and practices development continues among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends.
Who has won Food and Drug Administration Research grants before
From fiscal 2021 to 2025, Food and Drug Administration Research (93.103) awarded $1.2 billion across 940 grant awards, an average of $1.3 million per award.
| Recipient | State | Awards | Amount |
|---|---|---|---|
| The Critical Path Institute | Arizona | 13 | $94.0 million |
| National Environmental Health Association | Colorado | 9 | $55.4 million |
| Association of Food & Drug Officials | Pennsylvania | 14 | $50.3 million |
| The Medical Device Innovation Consortium | Virginia | 1 | $48.6 million |
| Duke University | North Carolina | 11 | $35.6 million |
Applying now
This notice no longer takes applications. Apply under the newer notice, PAR-27-017, which is open now.
The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.
Questions people ask
Is RFA-FD-24-020 still open?
No. It closed on February 27, 2024. A newer notice is open: PAR-27-017, rolling or no fixed deadline.
Who can apply for Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed?
Food and Drug Administration accepted applications from any type of organization.
What is the deadline for Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed?
Closed February 27, 2024. Applications are no longer accepted; the program's newer notices are on this page when there are any.
How much funding is available?
Awards of up to $350,000 each. About $350,000 in total for one award.
Who has won Food and Drug Administration Research grants before?
The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.
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