Opportunity Information: Apply for RFA FD 23 008
Novel approaches to support therapeutic development in ultra-rare cancers (RFA-FD-23-008) is a federal funding opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). It is structured as a cooperative agreement, meaning funded projects are expected to involve substantial engagement from the federal sponsor during the life of the award, rather than operating as fully independent investigator-led grants. The overarching goal is to stimulate and support new, creative approaches that can move potential therapies forward for ultra-rare cancers affecting both pediatric and adult populations, and it also explicitly includes molecularly defined subsets of more common cancers when those subsets are rare enough to face similar development hurdles.
The core problem this program targets is that ultra-rare cancers often lack the usual conditions that make therapeutic development straightforward: patient populations are small and geographically dispersed, natural history and clinical outcome data can be limited, validated biomarkers and endpoints may be missing, and traditional trial designs can be difficult to execute. By encouraging novel approaches, the FDA is signaling interest in strategies that reduce these barriers and make it more feasible to generate evidence that can support therapeutic development and, ultimately, regulatory decision-making. While the brief description does not list specific project types, the intent typically aligns with efforts that improve the development pathway for rare oncology indications, such as innovative clinical trial approaches, data infrastructure to support evidence generation, methods to identify and validate meaningful endpoints, and other tools that can help translate early science into actionable development programs.
The opportunity falls under the broad activity category of Consumer Protection, Science and Technology, and other Research and Development, and it is associated with CFDA number 93.103. The award ceiling is $2,500,000, indicating that individual awards can be substantial and designed to support projects of meaningful scope. The announcement anticipates making about two awards, which suggests a competitive process and an emphasis on selecting a small number of high-impact projects rather than distributing many smaller grants.
Eligibility is wide and includes many common applicant types across government, academia, nonprofit, and industry. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and additional entities as clarified in the full announcement. This broad eligibility is consistent with the program goal, since progress in ultra-rare cancer therapy development often requires cross-sector capabilities spanning clinical networks, translational science, data systems, biostatistics, patient engagement, and operational trial expertise.
Key administrative details include a creation date of December 1, 2022, and an original application closing date of February 27, 2023. The combination of a cooperative agreement mechanism, a relatively high award ceiling, and a small number of expected awards indicates the FDA is looking for well-developed proposals with clear, practical pathways to improving how therapies are developed and evaluated in ultra-rare oncology settings, including rare molecular subsets that may not fit neatly into traditional cancer trial and approval paradigms.Apply for RFA FD 23 008
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, science and technology and other research and development sector is offering a public funding opportunity titled "Novel approaches to support therapeutic development in ultra-rare cancers" 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 Dec 01, 2022.
- Applicants must submit their applications by Feb 27, 2023. (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 $2,500,000.00 in funding.
- The number of recipients for this funding is limited to 2 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 (see text field entitled Additional Information on Eligibility for clarification).
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Browse more opportunities from the same category: Consumer Protection, Science and Technology and other Research and Development
Next opportunity: ENVIRONMENTAL JUSTICE COLLABORATIVE PROBLEM-SOLVING (EJCPS) COOPERATIVE AGREEMENT PROGRAM
Previous opportunity: Request for Information on Request for Information on Electric Vehicle No-Charge Events, including Interoperability
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA FD 23 008
Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 23 008) also looked into and applied for these:
| Funding Opportunity |
|---|
| In Vitro Based Approaches to Evaluate the Bioequivalence of Prospective Generic Rectal and Vaginal Products (U01) Clinical Trial Not Allowed Apply for RFA FD 23 014 Funding Number: RFA FD 23 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of Underrepresented Populations in Oncology Therapeutic Development (U01) Clinical Trial Optional Apply for RFA FD 23 006 Funding Number: RFA FD 23 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
| Site Selection in Oncology Clinical Trials: Considerations for Selecting Sites in Limited Geographic Regions or Areas of Political Unrest, Limiting Inspection Capabilities (U13) Clinical Trial not allowed. Apply for RFA FD 23 007 Funding Number: RFA FD 23 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $300,000 |
| Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional Apply for RFA FD 23 015 Funding Number: RFA FD 23 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $750,000 |
| Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional Apply for RFA FD 23 024 Funding Number: RFA FD 23 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,000,000 |
| Natural History and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional Apply for RFA FD 23 028 Funding Number: RFA FD 23 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
| Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed Apply for RFA FD 23 029 Funding Number: RFA FD 23 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,500,000 |
| Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for RFA FD 23 001 Funding Number: RFA FD 23 001 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $650,000 |
| Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed Apply for RFA FD 23 017 Funding Number: RFA FD 23 017 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional Apply for RFA FD 23 026 Funding Number: RFA FD 23 026 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA FD 23 008", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.