Opportunity ID: 351575
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-015 |
| Funding Opportunity Title: | Public Health Regulatory Systems Strengthening – U01 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 20, 2023 |
| Last Updated Date: | Feb 28, 2024 |
| Original Closing Date for Applications: | Feb 29, 2024 |
| Current Closing Date for Applications: | Mar 29, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $150,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Only the following organization is eligible to apply:Eligible OrganizationsThe Organization for Economic Cooperation and Development (OECD)Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of the Public Health Regulatory Systems Strengthening NOFO is to partner with the Organization for Economic Co-Operation and Development (OECD), primarily to address the growing threat of illicit trade in health products (drugs, vaccines, medical devices, food) through the development of a whole-of-governments approach that relies on targeted, risk based, and efficient data driven models. The data will be used to develop mitigation strategies and potential regulatory and enforcement solutions that address substandard, misleading, and falsified food and medical products sold both in informal markets and through legitimate channels and raise the profile and awareness of this issue within the global community. The proposed cooperative agreement will also include work on other FDA public health topics of interest, including, but not limited to, addressing mis- and dis-information; strengthening regulatory frameworks by advancing health equity; promoting the use of good regulatory practices to develop regulations that are efficient, transparent, modern, and based on science and risk principles; and enhancing patient engagements in product development and quality of care. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Zahara Graves
Grantor Email:zahara.graves@fda.hhs.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| Extending the close date. | Feb 28, 2024 | |
| Dec 20, 2023 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-015 |
| Funding Opportunity Title: | Public Health Regulatory Systems Strengthening – U01 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 20, 2023 |
| Last Updated Date: | Feb 28, 2024 |
| Original Closing Date for Applications: | Feb 29, 2024 |
| Current Closing Date for Applications: | Mar 29, 2024 |
| Archive Date: | Apr 30, 2024 |
| Estimated Total Program Funding: | $150,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Only the following organization is eligible to apply:Eligible OrganizationsThe Organization for Economic Cooperation and Development (OECD)Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of the Public Health Regulatory Systems Strengthening NOFO is to partner with the Organization for Economic Co-Operation and Development (OECD), primarily to address the growing threat of illicit trade in health products (drugs, vaccines, medical devices, food) through the development of a whole-of-governments approach that relies on targeted, risk based, and efficient data driven models. The data will be used to develop mitigation strategies and potential regulatory and enforcement solutions that address substandard, misleading, and falsified food and medical products sold both in informal markets and through legitimate channels and raise the profile and awareness of this issue within the global community. The proposed cooperative agreement will also include work on other FDA public health topics of interest, including, but not limited to, addressing mis- and dis-information; strengthening regulatory frameworks by advancing health equity; promoting the use of good regulatory practices to develop regulations that are efficient, transparent, modern, and based on science and risk principles; and enhancing patient engagements in product development and quality of care. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Zahara Graves
Grantor Email:zahara.graves@fda.hhs.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-FD-24-015 |
| Funding Opportunity Title: | Public Health Regulatory Systems Strengthening – U01 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 20, 2023 |
| Last Updated Date: | Dec 20, 2023 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Feb 29, 2024 |
| Archive Date: | Mar 30, 2024 |
| Estimated Total Program Funding: | $150,000 |
| Award Ceiling: | $150,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | Only the following organization is eligible to apply:
Eligible Organizations The Organization for Economic Cooperation and Development (OECD) Foreign Institutions |
Additional Information
| Agency Name: | Food and Drug Administration |
| Description: |
The purpose of the Public Health Regulatory Systems Strengthening NOFO is to partner with the Organization for Economic Co-Operation and Development (OECD), primarily to address the growing threat of illicit trade in health products (drugs, vaccines, medical devices, food) through the development of a whole-of-governments approach that relies on targeted, risk based, and efficient data driven models. The data will be used to develop mitigation strategies and potential regulatory and enforcement solutions that address substandard, misleading, and falsified food and medical products sold both in informal markets and through legitimate channels and raise the profile and awareness of this issue within the global community. The proposed cooperative agreement will also include work on other FDA public health topics of interest, including, but not limited to, addressing mis- and dis-information; strengthening regulatory frameworks by advancing health equity; promoting the use of good regulatory practices to develop regulations that are efficient, transparent, modern, and based on science and risk principles; and enhancing patient engagements in product development and quality of care. |
| Link to Additional Information: | – |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
Zahara Graves
Grantor Email:zahara.graves@fda.hhs.gov |
Related Documents
Packages
| Agency Contact Information: | Zahara Graves Grantor Email: zahara.graves@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-24-015 | FORM H | PKG00284239 | Dec 20, 2023 | Mar 29, 2024 | View |