African Medical Devices Regulatory Harmonization Program
ID: 341844Type: Forecasted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Eligible Applicants

Others

Funding Category

Science and Technology and other Research and Development

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The Food and Drug Administration (FDA) is forecasting a cooperative agreement opportunity titled the African Medical Devices Regulatory Harmonization Program. This initiative aims to establish harmonized approaches, standards, and guidelines to enhance the innovation, development, regulation, and availability of medical devices that comply with quality and safety standards across the African continent. The program is crucial for ensuring consistent regulatory oversight of medical devices, thereby preventing the use or export of substandard products that could adversely affect health and increase costs. Interested applicants can reach out to Shashi Malhotra, Grants Management Specialist, at shashi.malhotra@fda.hhs.gov or by phone at 240-402-7592 for further details, as there is no cost-sharing requirement and the opportunity is categorized under discretionary funding with CFDA number 93.103.

    Point(s) of Contact
    Shashi Malhotra Grants Management Specialist
    (240) 402-7592
    shashi.malhotra@fda.hhs.gov
    Files
    No associated files provided.
    Similar Opportunities
    Manufactured Foods Flexible Funding Model (MF-FFM)
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Manufactured Foods Flexible Funding Model (MF-FFM)" aimed at advancing a nationally integrated food safety system. This cooperative agreement seeks to support initiatives related to Manufactured Food Regulatory Program Standards (MFRPS), dietary supplement safety, and state compliance and enforcement infrastructure, with a focus on enhancing food safety practices across jurisdictions. The program is critical for ensuring that state regulatory programs maintain high-quality standards and best practices in food safety. Interested applicants, which include state, local, territorial, and tribal agencies, as well as non-profit training entities collaborating with higher education institutions, can reach out to Gordana Zuber at gordana.zuber@fda.hhs.gov or by phone at 301-348-1747 for further details. The estimated project start date is July 1, 2023, with approximately 50 awards expected under this discretionary funding opportunity.
    Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Animal Food Regulatory Program Standards Implementation Development and Maintenance, with Mutual Reliance Initiatives." This cooperative agreement aims to enhance the capabilities of State animal food regulatory programs to fully implement the Animal Feed Regulatory Program Standards (AFRPS) and to develop standardized processes that promote mutual reliance between federal and state regulatory efforts. The initiative is crucial for establishing a nationally integrated animal food safety system, ensuring that state programs can effectively manage animal food safety regulations. Interested organizations must meet specific eligibility criteria, including the ability to enter into a 20.88 information disclosure agreement with the FDA, and the funding amount is set at $10.6 million, with approximately 30 awards expected. For further inquiries, applicants can contact Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-402-7610.
    Collaborations to Enhance Drug Development and Regulatory Science
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is inviting applications for a federal grant titled "Collaborations to Enhance Drug Development and Regulatory Science." This opportunity aims to establish cooperative agreements that support Public-Private Partnerships and collaborative activities under the Critical Path Initiative, focusing on innovative projects that enhance drug product development, advanced manufacturing, and the translation of scientific discoveries into therapeutics. The initiative is crucial for fostering innovation in drug safety, efficacy, quality, and performance, with a total funding ceiling of $5 million available for six expected awards in fiscal year 2024. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call (240) 402-7610 for further information.
    Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F) Clinical Trials Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F)," aimed at enhancing state manufactured food regulatory programs. This cooperative agreement seeks to support the development and maintenance of Manufactured Food Regulatory Program Standards (MFRPS) to ensure high-quality regulatory frameworks that improve food safety and reduce foodborne illness hazards. Eligible applicants include state, tribal, and territorial food safety programs with existing FDA food safety inspection contracts or those willing to enter into such contracts, with funding amounts ranging from $340,000 to $1,285,000 per year. Interested parties can contact Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information, with applications expected to align with the fiscal year 2024 timeline.
    Animal Food Regulatory Program Alliance
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a cooperative agreement opportunity titled "Animal Food Regulatory Program Alliance," aimed at enhancing the national food safety system through improved collaboration among federal and state agencies. The primary objective of this program is to support the development of a national integrated animal food safety system, which includes sharing best practices, conducting training programs, and advancing the Animal Food Regulatory Program Standards (AFRPS). This initiative is crucial for ensuring public health and consumer protection in the regulation of manufactured foods. Interested national associations or organizations that represent state animal food regulatory programs can apply for funding, with a total award amount of $600,000. For further inquiries, applicants may contact Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610. The fiscal year for this opportunity is 2025.
    Cooperative Agreement to Support Effective Dissemination of Clinical Practice Guidelines
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a cooperative agreement opportunity titled "Cooperative Agreement to Support Effective Dissemination of Clinical Practice Guidelines." This initiative aims to support the dissemination of clinical practice guidelines, particularly those developed with prior FDA cooperative agreements, by requiring applicants to propose a comprehensive plan for developing, evaluating, and distributing materials that facilitate this dissemination, with a strong emphasis on equity. The funding for this opportunity has an award ceiling and floor of $1,000,000, with one award expected to be made in fiscal year 2025. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for further details.
    OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity titled "OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed." This cooperative agreement aims to enhance the FDA's Office of Minority Health and Health Equity (OMHHE) initiatives by promoting education, outreach, and public awareness regarding the use and potential risks associated with skin lightening products, such as hydroquinone. The funding is crucial for developing innovative, community-based strategies that will strengthen the scientific foundation for public health education on this topic. Interested applicants can apply for a funding amount of $250,000, with the opportunity forecasted for fiscal year 2025. For further inquiries, applicants may contact Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610.
    OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a grant opportunity titled "OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed." This initiative aims to enhance the FDA's Office of Minority Health and Health Equity (OMHHE) efforts by funding research and community-based strategies that promote education and public awareness regarding the risks associated with over-the-counter skin lightening products containing hydroquinone and/or mercury. The grant, which has a fixed award amount of $250,000, is open to unrestricted applicants and is part of the fiscal year 2024 funding cycle. Interested parties can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for further information.
    Retail Food Safety Regulatory Association Collaboration CAP
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a cooperative agreement opportunity titled "Retail Food Safety Regulatory Association Collaboration CAP," aimed at enhancing retail food safety initiatives across the United States. This opportunity is specifically designed for non-profit national organizations affiliated with higher education institutions, whose members include regulatory personnel focused on retail food safety, as permitted by the Food Safety Modernization Act (FSMA). The initiative seeks to reduce foodborne illness by advancing practices in retail food protection, conducting relevant research, and fostering collaboration among stakeholders. The total funding available for this opportunity is $4 million, with an expected five awards to be made, and interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-402-7610 for further details.
    Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is announcing a funding opportunity for a Cooperative Agreement titled "Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)." This initiative aims to support research and development of practices that mitigate risks associated with nitrosamine impurities in human drugs, thereby enhancing public health safety while ensuring access to essential therapeutic drugs. The FDA seeks to fund one award with a total funding amount of $350,000, with no cost-sharing or matching requirements. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information. The opportunity is forecasted for fiscal year 2024, and applicants may submit multiple distinct applications, adhering to guidelines regarding overlapping submissions.