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Federal Forecasted GRANTS-GOV-351131

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

Food and Drug Administration (HHS) · Competitive grant · Science & Technology

At a glance

Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) is a federal competitive grant from Food and Drug Administration for the science & technology sector. Funding is up to $350K. Eligible applicants: Special district governments; For profit organizations other than small businesses; Small businesses; Native American tribal organizations (other than Federally recognized tribal governments); Nonprofits that do not have. Applications are accepted on a rolling basis. Apply via the official listing at www.grants.gov.

Amount
Up to $350K
Deadline
Rolling
Type
Competitive
Status
Forecasted

About this program

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

Special district governments; For profit organizations other than small businesses; Small businesses; Native American tribal organizations (other than Federally recognized tribal governments); Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Independent school districts; Others (see text field entitled "Additional Information on Eligibility" for clarification); State governments; Public and State controlled institutions of higher education; County governments; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; 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"; Public housing authorities/Indian housing authorities; City or township governments; Native American tribal governments (Federally recognized). 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

Apply through Grants.gov using funding opportunity number FOR-FD-24-008. Register your organization (SAM.gov + Grants.gov) before the deadline, then submit the application package listed in the official notice.

Apply at official source