Opportunity ID: 351621
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-020 |
| Funding Opportunity Title: | Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator – Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 21, 2023 |
| Last Updated Date: | Mar 14, 2024 |
| Original Closing Date for Applications: | Feb 27, 2024 |
| Current Closing Date for Applications: | Feb 27, 2024 |
| Archive Date: | Mar 28, 2024 |
| Estimated Total Program Funding: | $350,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Native American tribal governments (Federally recognized) For profit organizations other than small businesses Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments Independent school districts State governments Special district governments Small businesses City or township governments |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
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. |
| Link to Additional Information: | RFA-FD-24-020 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| The link to the full announcement has been added. | Mar 14, 2024 | |
| Dec 21, 2023 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-020 |
| Funding Opportunity Title: | Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator – Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 21, 2023 |
| Last Updated Date: | Mar 14, 2024 |
| Original Closing Date for Applications: | Feb 27, 2024 |
| Current Closing Date for Applications: | Feb 27, 2024 |
| Archive Date: | Mar 28, 2024 |
| Estimated Total Program Funding: | $350,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” Native American tribal governments (Federally recognized) For profit organizations other than small businesses Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments Independent school districts State governments Special district governments Small businesses City or township governments |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
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. |
| Link to Additional Information: | RFA-FD-24-020 Funding Opportunity Announcement |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Email:terrin.brown@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-020 |
| Funding Opportunity Title: | Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator – Clinical Trials Not Allowed |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Agriculture Consumer Protection Food and Nutrition |
| Category Explanation: | – |
| Expected Number of Awards: | 1 |
| Assistance Listings: | 93.103 — Food and Drug Administration Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 21, 2023 |
| Last Updated Date: | Dec 21, 2023 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Feb 27, 2024 |
| Archive Date: | Mar 28, 2024 |
| Estimated Total Program Funding: | $350,000 |
| Award Ceiling: | $350,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Special district governments Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Private institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Small businesses For profit organizations other than small businesses Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled “Additional Information on Eligibility” |
| Additional Information on Eligibility: | – |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
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. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Terrin Brown
Grantor Phone 2404027610 Email:terrin.brown@fda.hhs.gov |
Related Documents
Packages
| Agency Contact Information: | Terrin Brown Grantor Email: terrin.brown@fda.hhs.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.103 | RFA-FD-24-020 | FORM H | PKG00284278 | Dec 21, 2023 | Feb 27, 2024 | View |
Package 1
Mandatory forms
Optional forms
Share This Post, Choose Your Platform!
About the Author: osnqt
