Drug Development Tools Research Grants (U01) Clinical Trials Optional
ID: 352224Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$500K - $500K

Eligible Applicants

Others

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) is offering funding through the Drug Development Tools Research Grants (U01) Clinical Trials Optional, aimed at supporting research focused on Drug Development Tools (DDTs) that have an accepted or reviewable Letter of Intent within the qualification programs at the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). The grants are intended to address significant gaps in drug development by facilitating the qualification of methods, materials, or measures designed to expedite the process, ultimately enhancing public health outcomes. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and government entities, with a funding ceiling of $500,000 per project over one or two years. Interested parties must submit their applications by May 13, 2024, or May 13, 2025, and can contact Terrin Brown at terrin.brown@fda.hhs.gov for further information.

    Point(s) of Contact
    Files
    Title
    Posted
    The U.S. Food and Drug Administration (FDA) is offering funding through the Notice of Funding Opportunity (NOFO) RFA-FD-24-030 to support research focused on Drug Development Tools (DDTs) that have a reviewable Letter of Intent within their qualification programs at the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). The grants aim to address significant gaps in drug development by facilitating the qualification of methods, materials, or measures designed to expedite the process. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and government entities, with an anticipated total award of up to $500,000 for selected projects over one or two years. The application deadlines are May 13, 2024, and May 13, 2025, with a detailed review process assessing the proposed project’s public health impact, alignment with FDA goals, methodological approach, and investigator qualifications. This initiative emphasizes the importance of advancing effective drug development tools to ultimately enhance public health outcomes.
    Similar Opportunities
    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.
    Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity titled "Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional." This initiative aims to develop and validate an in vitro mechanistic methodology to assess the performance of amorphous solid dispersion (ASD) drug products under various clinically relevant conditions, ultimately enhancing the understanding of how food and acid-reducing agents affect drug absorption. The funding, which ranges from $250,000 to $500,000, is intended to support research that correlates in vitro observations with in vivo outcomes, thereby informing regulatory decisions for high-risk generic oral drug products. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call (240) 402-7610 for further information, with applications being accepted for the fiscal year 2024.
    Center for Research on Complex Generics (U18) Clinical Trials Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for the establishment of a Center for Research on Complex Generics through a cooperative agreement. This initiative aims to enhance collaboration with the generic drug industry, focusing on identifying scientific challenges in generic product development and facilitating research that supports the FDA's mission to improve patient access to high-quality, safe, and effective generic drugs. The Center will serve as a hub for coordination among FDA, academia, and industry stakeholders, conducting research, hosting workshops, and providing public access to research outcomes. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-402-7610. The funding amount is set at $1.5 million, with one award anticipated for the fiscal year 2025.
    Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) has announced a funding opportunity for clinical studies of orphan products addressing unmet needs in rare diseases through the Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) program. This initiative aims to support clinical trials that evaluate the safety and efficacy of products intended for rare diseases, with the goal of increasing the number of approved treatments and improving drug development for conditions affecting approximately 30 million Americans. Eligible applicants include a wide range of organizations such as higher education institutions, non-profits, and for-profit entities, with grants available up to $650,000 per year for a maximum of four years. Interested parties should submit their applications by September 22, 2024, and can reach out to Shashi Malhotra at shashi.malhotra@fda.hhs.gov for further information.
    Critical Path Public Private Partnerships Clinical Trials Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a grant opportunity titled "Critical Path Public Private Partnerships Clinical Trials Optional," aimed at supporting the continuation of existing consortia groups established by the Critical Path Institute. This initiative seeks applications to manage and maintain these groups, fostering innovative projects in research, education, and outreach to enhance drug product innovation and accelerate the development of therapeutics. The grant, which has an award ceiling and floor of $20 million, is expected to result in one award, with applications being accepted for the fiscal year 2024. Interested applicants can contact Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information.
    Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for the identification of drug-related and formulation-related factors that contribute to alcohol dose dumping (ADD) in modified release oral drug products through a cooperative agreement. The objective of this research is to develop tools that facilitate the creation of generic MR drug products with a low potential for ADD, support regulatory decision-making, and provide evidence for the FDA to refine its recommendations regarding ADD assessments. This initiative is crucial as modified release oral drug products pose significant risks when exposed to alcohol, potentially leading to severe side effects, including death. The FDA anticipates awarding one grant with a funding amount of $250,000, and interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information. The opportunity is open to unrestricted applicants, and submissions must be scientifically distinct to avoid duplication.
    Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a federal grant opportunity titled "Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required." This grant aims to fund clinical trials that evaluate the efficacy and safety of products intended to address unmet needs in rare neurodegenerative diseases affecting both children and adults, thereby increasing the number of approved treatments in this critical area. The initiative is part of the FDA's broader effort to enhance drug development for rare diseases, which is vital for improving health outcomes in affected populations. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for more information, with funding amounts ranging from $650,000 to $900,000 for the fiscal year 2025.
    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.
    Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a federal grant opportunity titled "Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional." This initiative aims to develop physiologically based pharmacokinetic (PBPK) models to establish mechanistic in vitro in vivo correlations (IVIVCs) for long-acting injectables, specifically crystalline suspensions and polymer-based implants, by analyzing their unique characteristics and formulation attributes. The project is significant for enhancing the understanding of drug release mechanisms and disposition characteristics, ultimately contributing to safer and more effective drug formulations. Interested applicants, including independent school districts, public housing authorities, and non-domestic entities, can apply for a total estimated funding of $600,000, with an award ceiling of $300,000 for up to two awards. For further inquiries, contact Terrin Brown, Grants Management Specialist, at Terrin.Brown@fda.hhs.gov or call 240-402-7610.
    Minor Use Minor Species Development of Drugs (R01)
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity for research grants (R01) aimed at the development of new animal drugs for minor uses in major species or for minor species (MUMS). Eligible applicants include a variety of organizations such as higher education institutions, nonprofits, and for-profit entities engaged in veterinary drug development, with the goal of defraying costs associated with safety and effectiveness testing required for FDA approval of MUMS-designated drugs. This initiative underscores the FDA's commitment to enhancing veterinary medicine for less common uses and species, with funding available up to $250,000 per year for a maximum of three years. Interested parties must have an open Investigational New Animal Drug (INAD) file and a minor use or minor species designation, with application deadlines spanning from July 2024 to January 2027. For further details, applicants can contact Terrin Brown at terrin.brown@fda.hhs.gov.