Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
View forecast on Grants.gov →Forecasted — not yet open · no update since November 30, 2023
- Posted
- November 24, 2023
- Closes
- See announcement
- Award ceiling
- $350,000
- Award floor
- $350,000
- Expected awards
- 1
- Cost sharing
- No
- Instrument
- Cooperative Agreement
- Assistance listing
- 93.103
- Category
- Agriculture, Consumer Protection, Food and Nutrition
Program funding history
Awards made under Assistance Listing 93.103 across FY2025–FY2027, from public federal spending records.
- FY2025 obligated
- $213M
- FY2026 obligated
- $215.3M
- FY2027 (to date) obligated
- $0
- Awards in window
- 849
Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, Yale Univ, Food & Agriculture, California Department of
Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →
Synopsis
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 can apply
- Public housing authorities/Indian housing authorities
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Public and State controlled institutions of higher education
- Small businesses
- Native American tribal organizations (other than Federally recognized tribal governments)
- State governments
- Special district governments
- County governments
- City or township governments
- Native American tribal governments (Federally recognized)
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Independent school districts
- For profit organizations other than small businesses
- Private institutions of higher education
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "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 statementfrom the review of the previous new (A0) application.
How to apply
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