Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
ID: 351131Type: Forecasted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$350K - $350K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351131
Timeline
    Description

    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, ensuring public health safety while maintaining access to essential therapeutic drugs. The FDA seeks to enhance the safety of these drugs through innovative approaches and to establish sustainable practices among industry members, non-profits, and academic institutions after the funding period concludes. Interested applicants can apply for a funding amount of $350,000, with the opportunity forecasted for fiscal year 2024. For further inquiries, contact Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610.

    Point(s) of Contact
    Terrin Brown Grantor
    (240) 402-7610
    terrin.brown@fda.hhs.gov
    Files
    No associated files provided.
    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.
    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.
    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.
    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.
    Drug Development Tools Research Grants (U01) Clinical Trials Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering Drug Development Tools Research Grants (U01) to support research aimed at advancing drug development tools (DDTs) that have an accepted or reviewable Letter of Intent within the FDA's qualification program. These grants are intended for developers working towards their qualification plan or full qualification package, focusing on tools that can enhance public health by optimizing the drug development process, such as biomarkers or animal models. The funding opportunity provides up to $500,000 for a maximum two-year period, with applications due by May 13, 2024, and May 13, 2025. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov for further information and are encouraged to review the detailed announcement available at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-030.html.
    Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a cooperative agreement opportunity titled "Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01)," aimed at advancing research in Anesthesia, Addiction Medicine, and Pain Medicine. Applicants are required to propose comprehensive, evidence-based plans that focus on critical areas such as clinical trial endpoints for chronic pain, outcome measures for stimulant use disorders, and assessments of opioid clinical trials, among others. This initiative is vital for enhancing the understanding and management of analgesics and anesthetics, particularly in vulnerable populations. The FDA anticipates awarding five grants, each with a funding ceiling and floor of $2 million, with applications due for the fiscal year 2025. Interested parties can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for further information.
    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.
    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.
    Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography," which requires a clinical trial. This cooperative agreement aims to support research and development of non-invasive technologies to accurately measure the pharmacokinetics of topically applied drugs within the skin, facilitating the demonstration of bioequivalence for topical products. 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 by phone at 240-338-7494 for further information. Applications are expected to be submitted in fiscal year 2024, with specific guidelines regarding submission of distinct applications to avoid overlap.