Opportunity Information: Apply for RFA FD 24 038
The grant opportunity titled "Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers (U01) Clinical Trial Optional" (Funding Opportunity Number RFA FD 24 038) is a discretionary funding announcement issued by the U.S. Food and Drug Administration (FDA). It uses a cooperative agreement mechanism (U01), which typically means the funded project is not only supported financially but is also expected to involve substantial involvement from the funding agency during the life of the award. In practical terms, applicants should anticipate a more collaborative relationship with FDA than they would under a standard research grant, with agency input potentially shaping milestones, coordination, and deliverables.
The central purpose of the opportunity is to stimulate and support novel approaches that can move therapeutic development forward for ultra-rare cancers in both pediatric and adult populations. It explicitly includes not only cancers that are ultra-rare by incidence, but also molecularly defined subsets of otherwise more common cancers. That detail is important because it signals FDA interest in precision-oncology contexts where a biomarker-defined group may be small enough to face many of the same barriers as traditional ultra-rare diseases, such as limited patient numbers, difficulty powering trials, and challenges in generating sufficient evidence to support regulatory decisions.
This announcement is labeled "Clinical Trial Optional," meaning proposed projects may include clinical trials but are not required to. Applicants can propose non-trial activities that still materially support therapeutic development in ultra-rare cancers, such as innovative clinical development strategies, new trial designs suited to very small populations, approaches to endpoint selection and validation, methods to leverage real-world data, efficient ways to generate evidence across multiple sites, or other development-enabling tools and frameworks. The emphasis is on "new approaches" that address the unique scientific, operational, and evidentiary challenges of developing therapies when patient populations are extremely limited and heterogeneous.
Eligibility is broad and includes many standard U.S. applicant categories: state, county, and local governments; special districts; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities; nonprofit organizations with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other entities. A notable feature of this specific opportunity is that foreign participation is allowed and explicitly welcomed in several forms. Non-U.S. entities (foreign organizations) may apply directly, non-U.S. components of U.S. organizations are eligible, and foreign components as defined under the HHS Grants Policy Statement are permitted. This is particularly relevant for ultra-rare cancers, where international collaboration can be essential to find enough patients, harmonize protocols, and assemble meaningful datasets.
In terms of funding details, the award ceiling is listed as $500,000, and the opportunity anticipates making a single award (Expected Awards: 1). With only one expected award, the program appears highly competitive and likely focused on selecting one strong, high-impact project that can serve as a model or platform for broader use in ultra-rare oncology therapeutic development. The activity category is listed under "Agriculture, Consumer Protection, Food and Nutrition" with CFDA number 93.103, reflecting the FDA program classification rather than the disease area itself. The original application closing date was April 5, 2024, and the opportunity record indicates a creation date of January 31, 2024.
Overall, this NOFO is designed for organizations that can propose credible, creative, and implementable strategies to reduce the time, uncertainty, and logistical barriers involved in bringing therapies to patients with ultra-rare cancers. The cooperative agreement format, the openness to clinical trials without requiring them, and the explicit allowance for foreign applicants all point to an FDA-driven effort to catalyze practical development solutions, especially where conventional trial and evidence-generation pathways are difficult to execute in very small, biomarker-selected, or geographically dispersed patient populations.Apply for RFA FD 24 038
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers (U01) Clinical Trial Optional" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on 2024-01-31.
- Applicants must submit their applications by 2024-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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| Funding Opportunity |
|---|
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U19) Clinical Trials Not Allowed Apply for RFA FD 24 033 Funding Number: RFA FD 24 033 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $15,000,000 |
| Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed Apply for RFA FD 24 032 Funding Number: RFA FD 24 032 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $360,000 |
| Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U19) Clinical Trials Not Allowed Apply for RFA FD 24 039 Funding Number: RFA FD 24 039 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $340,000 |
| Drug Development Tools Research Grants (U01) Clinical Trials Optional Apply for RFA FD 24 030 Funding Number: RFA FD 24 030 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed Apply for RFA FD 24 031 Funding Number: RFA FD 24 031 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Alliance to Support the Activities of the Integrated Food Safety System (IFSS), including the Grade “A” Milk Safety and National Shellfish Sanitation Programs (U01) Clinical Trials Not Allowed Apply for RFA FD 24 034 Funding Number: RFA FD 24 034 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01) Clinical Trials Not Allowed Apply for RFA FD 24 016 Funding Number: RFA FD 24 016 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional Apply for RFA FD 24 037 Funding Number: RFA FD 24 037 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,100,000 |
| Development and Maintenance of the Animal Food Regulatory Program Standards (U19) Clinical Trial Not Allowed Apply for RFA FD 24 035 Funding Number: RFA FD 24 035 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Convener and Organizer of Activities and Engagements Related to Processes, Surveillance, and Policy Development of Medical Products for Ongoing Public Health Activities, U01 Clinical Trial Not Allowed Apply for RFA FD 24 036 Funding Number: RFA FD 24 036 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $700,000 |
| FY 2024 SNAP Fraud Framework Implementation Grant Apply for USDA FNS SNAP FFIG 2024 Funding Number: USDA FNS SNAP FFIG 2024 Agency: Food and Nutrition Service Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trials Optional Apply for RFA FD 24 040 Funding Number: RFA FD 24 040 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,500,000 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 24 041 Funding Number: RFA FD 24 041 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01 Clinical Trial Required) Apply for RFA FD 19 024 Funding Number: RFA FD 19 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed) Apply for PAR 19 306 Funding Number: PAR 19 306 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Building an Integrated Information Technology Infrastructure for State Regulatory Programs (U2F) [Clinical Trial Not Allowed] Apply for RFA FD 22 021 Funding Number: RFA FD 22 021 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 24 216 Funding Number: PAR 24 216 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U18) - Clinical Trials Not Allowed Apply for RFA FD 24 017 Funding Number: RFA FD 24 017 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Animal and Veterinary Innovation Centers (U18) Apply for PAR 24 251 Funding Number: PAR 24 251 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,250,000 |
| Single Source Cooperative Agreement to Support HPAI H5N1 Research at Cornell University (U18) - Clinical Trails Not Allowed Apply for RFA FD 24 042 Funding Number: RFA FD 24 042 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,150,000 |
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