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

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 fu Grant Number: FOR-FD-24-008. Expected awards: 1.

Eligibility requirements

All of the following criteria must be met:

• 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 resubmissio

What the funding covers

• Award Range: $350K to $350K
• Expected Number of Awards: 1

How to apply

1. 1Check eligibility: Confirm your organization type (e.g., nonprofit, state government), project alignment, and deadlines from the opportunity synopsis.
2. 2Register: Create a Grants.gov account via Login.gov, complete SAM.gov and UEI registration, and authorize organization representatives (takes 2-4 weeks).
3. 3Prepare application: Select "Apply" to open Workspace, download forms (e.g., SF-424), complete offline/online with validation checks, and upload supporting docs like budgets and narratives.
4. 4Submit and track: Check package for errors, sign/submit via Authorized Organization Representative (AOR), and monitor status with your tracking number
5. 5Applications must be submitted through grants.gov
6. 6Grant Number: FOR-FD-24-008
7. 7Posted: 2023-11-24

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