The Food and Drug Administration (FDA) has announced a new funding opportunity, numbered FOR-FD-24-008, focusing on the identification and evaluation of approaches to address nitrosamine impurities in human drugs. This initiative is a part of the FDA’s ongoing efforts to ensure public health safety concerning the presence of nitrosamine in medications. The grant, categorized under agriculture, consumer protection, and food and nutrition, aims to advance research and develop practical solutions to mitigate risks associated with nitrosamine impurities.
This cooperative agreement invites a diverse range of applicants, including educational institutions, nonprofits, small businesses, government entities, and others, to contribute to this vital research area. The project’s main goal is to enhance the safety of human drugs by developing and refining strategies to manage potential nitrosamine impurity liabilities effectively. Additionally, the grant seeks to foster continued research and practice development among industry members, non-profits, and academic institutions even after the FDA funding concludes. With an award ceiling of $350,000, this funding opportunity represents a significant step in the FDA’s commitment to protecting public health from the risks posed by nitrosamines in pharmaceutical products.
Opportunity ID: 351131
General Information
| Document Type: | Grants Notice |
| Opportunity Number: | FOR-FD-24-008 |
| Opportunity Title: | Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | |
| Expected Number of Awards: | 1 |
| CFDA Number(s): | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Forecast 1 |
| Forecasted Date: | Nov 24, 2023 |
| Last Updated Date: | Nov 24, 2023 |
| Estimated Post Date: | |
| Estimated Application Due Date: | |
| Estimated Award Date: | |
| Estimated Project Start Date: | |
| Fiscal Year: | 2024 |
| Archive Date: | |
| Estimated Total Program Funding: | |
| Award Ceiling: | $ 350,000 |
| Award Floor: | $ 350,000 |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Small businesses For profit organizations other than small businesses Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) City or township governments Independent school districts Public housing authorities/Indian housing authorities Private institutions of higher education State governments County governments Native American tribal organizations (other than Federally recognized tribal governments) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept: •A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. •A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: | 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. |
| Link to Additional Information: | |
| Grantor Contact Information: |
Terrin Brown
Grantor 2403387494
|