Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed
The summary for the Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed grant is detailed below.
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Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed: 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.
Federal Grant Title: | Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed |
Federal Agency Name: | Food and Drug Administration (HHS-FDA) |
Grant Categories: | Agriculture Consumer Protection Food and Nutrition |
Type of Opportunity: | Discretionary |
Funding Opportunity Number: | RFA-FD-24-020 |
Type of Funding: | Cooperative Agreement |
CFDA Numbers: | 93.103 |
CFDA Descriptions: | Information not provided |
Current Application Deadline: | February 27th, 2024 |
Original Application Deadline: | February 27th, 2024 |
Posted Date: | December 21st, 2023 |
Creation Date: | December 21st, 2023 |
Archive Date: | March 28th, 2024 |
Total Program Funding: | $350,000 |
Maximum Federal Grant Award: | $350,000 |
Minimum Federal Grant Award: | |
Expected Number of Awards: | 1 |
Cost Sharing or Matching: | No |
Last Updated: | December 21st, 2023 |
- Applicants Eligible for this Grant
- 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 - Unrestricted (i.e., open to any type of entity below), subject to any clarification in text field entitled "Additional Information on Eligibility"
- Grant Announcement Contact
- Terrin Brown
Grantor
Phone 2404027610
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