Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed

Active
No
Status
Posted
Published Date
December 21st, 2023
Close Date
February 27th, 2024
Total Funding
$350,000.00
Award Ceiling
$350,000.00
Expected No. Awards
1
Opportunity No.
RFA-FD-24-020

Agency

Food and Drug Administration (HHS-FDA)

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Summary

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is announcing a Funding Opportunity Announcement (FOA) for a Cooperative Agreement. This opportunity aims to address the issue of nitrosamine impurities in human drugs and improve the safety of these drugs. The proposed work will involve the identification and evaluation of possible approaches to addressing nitrosamine impurities in drugs. Nitrosamine impurities pose risks to public health, and while significant efforts have been made in this area, further research, development, and refinement of translational and implementable practices are needed. The goal is to protect the public from nitrosamine risks while ensuring continued safe access to critical therapeutic drugs. In addition to the research and development work, the award recipient will also assess how to ensure the continuation of this research and practices development among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends. For more information, please refer to the Funding Opportunity Announcement.

Description

The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement.The proposed work directly supports the U.S. FDA’s stated goal of protecting public health from unacceptable risks from nitrosamine impurities in human drugs. Although significant experimental and policy/regulatory initiatives have been undertaken in this area, there remains a need for further research into and development and refinement of translational and implementable practices that will protect the public against nitrosamine risks while ensuring continued safe access to critical therapeutic drugs. The aim is to improve the safety of human drugs with potential nitrosamine impurity liabilities.In addition to the work outlined above, the award recipient will assess how best to ensure that this research and practices development continues among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends.

Contact Information

Opportunity Lifecycle

Title
Type
Grant

Similar Opportunities

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
Food and Drug Administration
The Food and Drug Administration (FDA) is offering a federal grant 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 funding opportunity falls under the category of Consumer Protection and is a Cooperative Agreement type of funding instrument. The grant does not require cost sharing or matching. The purpose of this funding opportunity is to examine the utility of an in vitro simulated gastrointestinal (GI) dissolution model for the assessment of in vitro performance of amorphous solid dispersion (ASD) drug products under different clinically relevant conditions. The goal is to develop and validate the in vitro mechanistic methodology to provide an improved understanding of the impact of food and acid reducing agents on the absorption for test and reference listed drug (RLD) drug products, taking into consideration their potentially different formulations and manufacturing. The bio predictive in vitro mechanistic methodology is intended to correlate the in vitro observations to in vivo outcomes, help define types of in vivo bioequivalence (BE) studies needed for ASD drug products, and inform regulatory decision-making related to mitigating the risk of potential failure modes for therapeutic equivalence for high-risk generic oral drug products. The grant has an award ceiling of $500,000 and an award floor of $250,000. It is expected that there will be 2 awards given. The eligible applicants for this grant opportunity are unrestricted, meaning any applicant organization may submit an application. However, each application must be scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time. For more information and to apply for this grant opportunity, you can contact Terrin Brown, the Grantor, at terrin.brown@fda.hhs.gov or (240) 402-7610. The last updated date for this grant opportunity is November 30, 2023.
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required
Food and Drug Administration
The Food and Drug Administration (FDA) is offering a grant opportunity titled "Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required". This grant aims to fund clinical trials of products that evaluate efficacy and/or safety in order to support a new indication or change in labeling to address unmet needs in rare diseases or conditions. The FDA expects that by funding collaborative, efficient, and/or innovative clinical trials, the number of approved treatments for rare diseases will increase, thereby having a positive impact on rare disease drug development. The grant does not require cost sharing or matching and falls under the category of Science and Technology and other Research and Development. The grant has a closing date of September 22, 2024, and the award ceiling is $650,000, with a minimum award floor of $200,000. It is expected that 20 awards will be granted. Eligible applicants include various types of organizations such as higher education institutions, nonprofits, for-profit organizations, governments, and foreign institutions. For more information, interested parties can visit the following website: [http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-001.html](http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-001.html). For any inquiries, the grantor contact is Shashi Malhotra, a Grants Management Specialist, who can be reached at shashi.malhotra@fda.hhs.gov or by phone at 2404027592.
Drug Development Tools Research Grants (U01) Clinical Trials Optional
Food and Drug Administration
The Food and Drug Administration (FDA) is offering Drug Development Tools Research Grants (U01) through a Cooperative Agreement funding instrument. This opportunity falls under the category of Food and Nutrition and is currently open for applications. The grants aim to support the development of drug development tools that have an accepted or reviewable Letter of Intent (LOI) within the FDA's Drug Development Tool Qualification Program. These tools are intended to fill unmet needs in drug development and will be made publicly available once qualified. The grants do not require cost sharing or matching requirements. The estimated total program funding is $6 million, with an expected number of 6 awards to be granted. The award ceiling and floor are both set at $500,000. The closing date for applications is May 13, 2025, and the archive date is June 12, 2025. Eligible applicants include developers of drug development tools who have an accepted or reviewable LOI within the FDA's Drug Development Tool Qualification Program and are working towards their qualification plan or full qualification package. Previous recipients of DDT research grant support from FDA-CDER/CBER are also eligible to apply if they have successfully progressed to the next submission milestone and are requesting additional funding for new DDT project needs addressing different aspects of the project. For more information and to apply, please visit the following link: [RFA-FD-24-030 Funding Opportunity Announcement](https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-030.html). If you have any questions, you can contact Terrin Brown, the grantor, at terrin.brown@fda.hhs.gov.
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
Food and Drug Administration
The Food and Drug Administration (FDA) is offering a federal grant opportunity titled "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". This grant aims to support research in developing tools that facilitate the development of modified release (MR) generic drug products with a low potential for alcohol dose dumping (ADD). Modified release oral drug products are designed to release drugs over a prolonged period of time and are at high risk for ADD when exposed to alcohol. Accidental exposure to alcohol can result in the rapid release of large quantities of drugs, leading to severe side effects and even death. To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose dumping assessment in various alcoholic dissolution media for prospective generic versions of MR oral drug products. Currently, there is a lack of global harmonization in ADD assessments. For example, the FDA recommends testing up to 40% alcoholic media, while the European Medicines Agency recommends testing up to 20% alcoholic media. This difference poses challenges for formulators designing products for multiple markets, as historical data has shown that release from MR oral products does not always follow a linear response to increasing alcohol concentrations. The purpose of this research is to develop tools that facilitate the development of MR generic drug products with a low potential for ADD. These tools will support regulatory decision making during the assessment of such products and provide evidence for the FDA to develop more specific recommendations for demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high-risk drugs. The grant has a funding ceiling and floor of $250,000 and is expected to result in one award. It falls under the category of funding activity for consumer protection. The grant is forecasted for the fiscal year 2024 and does not require cost sharing or matching. The opportunity is a cooperative agreement and is open to unrestricted eligible applicants. For more information, interested parties can contact Terrin Brown, the grantor, at terrin.brown@fda.hhs.gov or (240) 402-7610.