Opportunity Information: Apply for FOR FD 23 007
The grant opportunity titled "Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required" (Funding Opportunity Number: FOR FD 23 007) is a discretionary grant program run by the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). Its central goal is to fund clinical trials that evaluate the safety and/or effectiveness of medical products intended for rare diseases or rare conditions, specifically in situations where there is a clear unmet medical need. The emphasis is not on early discovery research, but on generating clinical evidence that can directly support a regulatory outcome, such as pursuing a new indication for an already-developed product or enabling a change in the product's labeling based on clinical trial results.
A defining feature of this announcement is that clinical trials are required. In practical terms, applicants are expected to propose and conduct a real, well-designed human study that tests an orphan product with the intent of producing data that could be used to move the product closer to approval or to broaden or revise how an existing product can be used. The FDA is looking for trials that meaningfully assess efficacy (how well the product works) and/or safety (the risks and tolerability), and that are structured in a way that produces credible evidence suitable for regulatory decision-making. Because rare disease research often faces challenges like small patient populations and limited clinical sites, the program explicitly encourages collaborative, efficient, and innovative trial approaches that make the best use of scarce participants and resources.
Beyond supporting individual trials, the FDA frames this program as a way to strengthen the overall rare disease development ecosystem. By funding studies that are designed to be practical, rigorous, and efficient, the agency expects to increase the number of treatments that ultimately achieve approval for rare diseases and conditions. The intended impact is broad: not only advancing specific products through critical clinical evidence, but also improving how rare disease trials are planned and executed, which can help future programs across multiple conditions.
The funding instrument is an R01-style grant, and it falls under the broad activity category of Consumer Protection, Science and Technology, and other Research and Development, with CFDA number 93.103. The award ceiling is listed as $650,000, and the FDA anticipated making around 20 awards under this opportunity. The announcement was created on July 5, 2022, with an original closing date of October 25, 2022, indicating a time-limited application window for that cycle.
Eligibility is notably broad, which reflects the reality that rare disease product development can involve many different types of organizations. Eligible applicants include various levels of government (state, county, city/township, special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, other tribal organizations, public housing and Indian housing authorities, nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those nonprofit categories), for-profit organizations other than small businesses, and small businesses. The listing also includes an "Others" category with a note to consult additional eligibility details in the full announcement, which typically clarifies any special conditions or exceptions.
In summary, this FOA is designed for organizations that are ready to run a clinical trial of an orphan product aimed at a rare disease or condition where current options are limited or inadequate. The FDA is using this program to fund trials that can directly support regulatory steps like a new indication or labeling change, while also pushing the field toward smarter, more collaborative, and more efficient trial models that can accelerate the pace of rare disease treatment development.Apply for FOR FD 23 007
- 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 "Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required" 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 Jul 05, 2022.
- Applicants must submit their applications by Oct 25, 2022. (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 $650,000.00 in funding.
- The number of recipients for this funding is limited to 20 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).
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| Funding Opportunity |
|---|
| Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models Apply for RFA FD 23 016 Funding Number: RFA FD 23 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 23 012 Funding Number: RFA FD 23 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,200,000 |
| Evaluation of oral modified release drug tablet to support the approval of additional strengths Apply for RFA FD 23 013 Funding Number: RFA FD 23 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $450,000 |
| Novel approaches to support therapeutic development in ultra-rare cancers Apply for RFA FD 23 008 Funding Number: RFA FD 23 008 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 |
| 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 |
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