Food and Drug Administration
Modified release (MR) oral drug products are considered to have a high risk for alcohol dose dumping (ADD) because they contain large quantities of drug(s), designed to release over a prolonged period of time. Accidental exposure of these products to alcohol can result in the relatively rapid release of large quantities of drug with severe side effects, including death. To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose dumping assessment in 0%, 5%, 20%, and 40% alcoholic dissolution media for all prospective generic versions of MR oral drug products. To date, ADD assessments have not been harmonized globally. For instance, the U.S. FDA recommends testing up to 40% alcoholic media while the European Medicines Agency recommends testing up to 20% alcoholic media. This type of difference can present a challenge for formulators designing products for multiple markets, as historical data has shown release from MR oral products do not always follow a linear response (either increasing or decreasing) to increasing alcohol concentrations. In addition, interpretation of an ADD assessment may be limited by the inability of the test to predict in vivo behavior. The purpose of this research is to develop tools that 1) facilitate the development of MR generic drug products that have a low potential for ADD, 2) support regulatory decision making during the assessment of such products, and 3) provide evidence that enables FDA to develop more specific recommendations for efficiently demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high risk drugs.
$250,000 – $250,000
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Who can apply: Government & Tribal, Schools & Colleges, Individuals, Nonprofits, Small Businesses, For-Profit Businesses
Nationwide (USA)
Federal Government
This is a forecasted opportunity. Watch Grants.gov for the official notice; applications open once it is posted. You'll need SAM.gov (UEI) and Grants.gov registrations.
Substance Abuse and Mental Health Services Adminis
The purpose of this program is to support organizations in mobilizing and connecting community resources to increase access to long-term recovery support for people with substance use disorders and co-occurring substance use and mental disorders.
Last verified Oct 19, 2026
Centers for Disease Control and Prevention - ERA
The purpose of the R01 grant program is to (1) improve understanding of the risks and conditions associated with occupational diseases and injuries, (2) identify and evaluate methods to reduce risks and prevent or minimize exposure to hazardous workplace conditions, and (3) translate scientific findings into practical prevention strategies, interventions, and products that reduce work-related illnesses and injuries. The Research Project Grant (R01) supports a discrete, specified research project in scientific areas that reflect the investigator's expertise and interests and that align with the mission of NIOSH. Applicants must concisely describe the occupational health problem their proposal addresses and explain how the proposed research activities will lead to outputs that help address this problem. Applicants should clearly describe the expected impacts of the proposed research, both during the project period and beyond.
Last verified Oct 19, 2026
Centers for Disease Control and Prevention - ERA
This Notice of Funding Opportunity (NOFO) supports research to develop, implement, monitor, and evaluate technology-driven and cost-effective tools that reduce the global human rabies burden. It also measures progress toward canine rabies elimination, with an emphasis on high-burden countries. Priority research areas include: Electronic systems for tracking human and dog rabies vaccinations. Managing human rabies exposure investigations. Enhancing rabies laboratory information management systems. Modeling the economic impact of dog-mediated rabies interventions. Estimating rabies-susceptible dog populations. The research is intended to generate data-driven strategies that help accelerate progress toward global canine rabies elimination and protect public health.
Last verified Oct 19, 2026
Centers for Disease Control - NCCDPHP
This notice of funding opportunity (NOFO) will help build a workforce that's prepared to collect and use high-quality cancer data. This work is essential to understand the impact of cancer and inform public health action, research, and policy. This NOFO will support the National Program of Cancer Registries (NPCR) by: Strengthening the cancer surveillance workforce. Improving NPCR cancer data quality and completeness. Promoting the value and use of NPCR cancer surveillance data. The recipient will support certified Oncology Data Specialists (ODS) and other cancer surveillance professionals with education, credentialing, and professional development. These activities are intended to ensure the cancer surveillance workforce has the knowledge, skills, and resources to meet emerging needs and new technologies. The recipient will develop, maintain, and advance best practices, tools, and partnerships that support NPCR priorities and ensure timely, complete, and high-quality NPCR cancer surveillance data. This includes improving access to the expertise of ODS through technical assistance and guidance for NPCR registries and staff. In addition, the recipient will strengthen collaboration and communication strategies to promote the value and use of NPCR cancer surveillance data. The goal of these efforts is to help more people recognize that NPCR cancer surveillance data is a valuable resource for cancer research and public health decision-making. As a cooperative agreement, CDC will work closely with the recipient to provide technical assistance, support coordination with NPCR and partners, monitor progress, and help ensure a prepared cancer surveillance workforce that can meet current and future public health needs.
Last verified Oct 19, 2026