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FORECAST · COOPERATIVE AGREEMENT

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

Food and Drug Administration · Food and Nutrition

Forecast. The agency expects to post this grant later (fiscal year 2024). Dates and amounts are estimates until the notice posts.
Expected deadline
Not stated
Who can apply
Anyone eligible under the notice (unrestricted)
Award range
Up to $350,000
Expected awards
1
Total program funding
Not stated
Your own money required
No cost sharing or matching required
Opportunity number
FOR-FD-24-008
Posted
Nov 24, 2023
Assistance listing
93.103

More on who can apply

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 it 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.

Open the official notice on Grants.gov ↗

What to do next

  1. This is a forecast: the agency expects to post the full notice later. Open it on Grants.gov and subscribe there to be told when it posts.
  2. Get your SAM.gov registration ("all awards") and Grants.gov account active now; both take time.
  3. Use the forecast's award range and eligibility to decide whether to prepare.
  4. Watch for the notice; the dates here are estimates and can change.

New to this? Applying for a federal grant, step by step · Register to apply · How to read the notice · Write the narrative · Build the budget · Agency contact: terrin.brown@fda.hhs.gov

From Grants.gov's official daily extract of Oct 25, 2026. The notice on Grants.gov and its attachments are what count. UX Contract is independent and not a government website.

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