# Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers

Source: https://welltoldgrants.com/grants/rfa-fd-26-004-novel-approaches-to-support-therapeutic-development-in-ultra/  
Official notice: https://www.grants.gov/search-results-detail/362217

> Food and Drug Administration offered grants of up to $500,000 to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses. It expected to make about 3 awards worth $1.5 million in total. Applications closed on June 15, 2026.

| Field | Value |
|---|---|
| Opportunity number | RFA-FD-26-004 |
| Agency | Food and Drug Administration |
| Status | Forecast |
| Deadline | June 15, 2026 |
| Award ceiling | $500,000 |
| Award floor | not stated |
| Expected awards | 3 |
| Total funding | $1.5 million |
| Cost sharing | not required |
| Assistance Listings | 93.103 |

## Who can apply

- 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

## What the grant funds

Background The FDA Oncology Center of Excellence (OCE) aims to advance the development and regulation of oncology products for patients with cancer. The Pediatric Oncology Program and Rare Cancers Program were established to facilitate and expedite drug development for pediatric and other rare cancers. OCE’s Project Catalyst connects scientific knowledge, creative insight, and medical professionals to foster early-stage product innovation, which is particularly important to address the challenges related to product development for ultra-rare cancers. In collaboration with the National Institutes of Health (NIH) and the OCE, the Foundation for the National Institutes of Health (FNIH) recently launched the design phase of the Ultra-Rare Cancer Treatment Advancement Program (ULTRA), a new public-private partnership dedicated to accelerating the development of innovative ultra-rare cancer treatments. For the purposes of this NOFO, the FDA OCE refers to cancers with an approximate annual incidence in the U.S. of 300 to 400 people or less as ultra-rare (a more stringent criterion compared to the threshold for a rare disease specified in the Orphan Drug Act based on a U.S. prevalence of <200,000 people). Many of the challenges involved in drug development for ultra-rare cancers are similar to those for rare diseases and can include: Difficulty enrolling sufficient numbers of patients to clinical trials Limited financial incentives for drug development Insufficient understanding of the cancer pathophysiology, molecular characteristics, and natural history Limited or lack of timely access to molecular testing to determine eligibility for treatment with targeted therapies Complexities associated with designing clinical trials that are adequate to establish safety and effectiveness Advancing technologies such as single cell multi-omic analyses have helped define some ultra-rare cancers at the molecular level, providing new opportunities for targeted drug development. Pediatric oncology has several examples of tumor types with known translocation-induced, oncogenic driver fusion proteins. Other examples of ultra-rare cancers defined today by molecular pathology include: neuroectodermal tumors, pulmonary blastoma, desmoplastic small round cell tumor (DSRCT), epithelioid sarcoma, diffuse intrinsic pontine glioma, fibrolamellar carcinoma, and malignant rhabdoid tumors.

## Questions people ask

### Is RFA-FD-26-004 still open?

No. It closed on June 15, 2026. A newer notice is open: PAR-27-017, rolling or no fixed deadline.

### Who can apply for Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers?

Food and Drug Administration accepted applications from nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

### What is the deadline for Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers?

Closed June 15, 2026. Applications are no longer accepted; the program's newer notices are on this page when there are any.

### How much funding is available?

Awards of up to $500,000 each. About $1.5 million in total across about 3 awards.

### Who has won Food and Drug Administration Research grants before?

The largest recipients over five fiscal years were The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials. The program made 940 awards worth $1.2 billion in that time.