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
Non-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

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

Package 1

Mandatory forms

351575 RR_SF424_5_0-5.0.pdf

351575 PHS398_CoverPageSupplement_5_0-5.0.pdf

351575 RR_OtherProjectInfo_1_4-1.4.pdf

351575 PerformanceSite_4_0-4.0.pdf

351575 RR_KeyPersonExpanded_4_0-4.0.pdf

351575 RR_Budget_3_0-3.0.pdf

351575 PHS398_ResearchPlan_5_0-5.0.pdf

351575 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf

Optional forms

351575 RR_SubawardBudget30_3_0-3.0.pdf

351575 PHS_AssignmentRequestForm_3_0-3.0.pdf

2025-07-11T17:40:52-05:00

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