Food and Drug Administration · Department of Health and Human Services
Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
Key facts
- Deadline
- Forecast — no date yet
- Award size
- Up to $350K
- Cost share / match ?
- Not required
- Who can apply
- Tribal organization, Public college or university, Larger business, Tribal government, State government, Anyone (unrestricted), Special district (utility, fire, etc.), County government, Nonprofit without 501(c)(3), Private college or university, Nonprofit with 501(c)(3), School district, City or town government, Small business, Other (see eligibility)
- Where
- Anywhere in the U.S., including Tennessee
Before you apply: federal grants require an active SAM.gov registration (Unique Entity ID) and a Grants.gov account. Registration is free but can take weeks, so start now, not when the deadline is close. Grant-ready checklist
How this fits you
- Available in Tennessee (nationwide program)
- No cost share required
- Tennessee recipients since 2023: 18
Tell us who you are to see whether you're eligible.
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Official notice: https://simpler.grants.gov/opportunity/cd0c6205-ae0e-44fd-adf9-44db71b94674 · Printed from grantme.click/grants/a441863b-2712-4894-9345-2d91b27f0330
Read the official notice View on Grants.gov Sign in to save
About this grant
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.
Eligibility (from the notice)
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.
Who in Tennessee has won this program
18 awards to Tennessee recipients in 5 counties since federal FY2023. Largest shown:
| Recipient | Where | Amount | FY |
|---|---|---|---|
| University Of Tennessee | Knoxville, Knox County | $6.5M | 2020 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $2.5M | 2019 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $2.4M | 2020 |
| University Of Tennessee | Memphis, Shelby County | $2M | 2017 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.9M | 2020 |
| Franklin Special School District | Franklin, Williamson County | $1.8M | 2025 |
| University Of Tennessee | Knoxville, Knox County | $1.8M | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $1.6M | 2022 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.3M | 2021 |
| Tennessee Department Of Health | Nashville, Davidson County | $1.3M | 2020 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.3M | 2016 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.2M | 2025 |
Source: USAspending.gov. Past awards show who this program funds; they don't guarantee future awards.
About the program (93.103)
Food and Drug Administration Research — General Grant Funding
How applications are judged
Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the specific evaluation criteria that applies.
Matching requirements
This program has no statutory formula.
Matching requirements are not applicable to this assistance listing.
MOE requirements are not applicable to this assistance listing.
Examples of funded projects
Not Applicable.