# Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)

Source: https://welltoldgrants.com/grants/for-fd-24-008-identification-and-evaluation-of-possible-approaches-to/  
Official notice: https://www.grants.gov/search-results-detail/351131

> Food and Drug Administration plans to offer grants of up to $350,000 (at least $350,000) to any type of organization. It expects to make one award. It is a forecast, and no dates have been set yet.

| Field | Value |
|---|---|
| Opportunity number | FOR-FD-24-008 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | not set |
| Award ceiling | $350,000 |
| Award floor | $350,000 |
| Expected awards | 1 |
| Total funding | not stated |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- 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
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- 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.

## 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.

## Questions people ask

### Who can apply for Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)?

Food and Drug Administration accepts applications from any type of organization. The notice adds further conditions, so read its eligibility section.

### What is the deadline for Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)?

Forecast, no dates yet. Confirm the date and time in the official notice on Grants.gov.

### How much funding is available?

Awards of up to $350,000 each.