1,000+ Opportunities
Find the right grant
Search federal, foundation, and corporate grants with AI — or browse by agency, topic, and state.
Orphan Products Grants Program is sponsored by U.S. Food and Drug Administration (FDA). This program awards grants to clinical investigators to support the development of safe and effective medical products (drugs, biologics, medical devices, and foods for medical purposes) for patients with rare diseases or conditions, defined as those affecting fewer than 200,000 persons in the United States.
Urea cycle disorders fall under this definition. The program funds clinical trials and natural history studies.
Get alerted about grants like this
Save a search for “U.S. Food and Drug Administration (FDA)” or related topics and get emailed when new opportunities appear.
Search similar grants →Extracted from the official opportunity page/RFP to help you evaluate fit faster.
Orphan Products Grants Program | FDA Skip to in this section menu Medical products for rare diseases and conditions Grant Programs to Support Development of Medical Products for Rare Diseases Orphan Products Grants Program Grant Programs to Support Development of Medical Products for Rare Diseases The FDA Office of Orphan Product Development (OOPD) administers several grant programs that provide incentives to promote and accelerate the development of innovative products for the treatment, prevention and diagnosis of rare diseases .
Orphan Products Grants Program The Orphan Drug Act (ODA) enacted by Congress in 1983 provides incentives to defray the costs of developing drugs, biologics, devices, and medical foods for rare diseases or conditions.
The Orphan Products Grants Program awards grants to clinical investigators to support the development of safe and effective medical products (drugs, biologics, medical devices, and foods for medical purposes) for patients with rare diseases or conditions. Rare diseases are statutorily defined as those affecting fewer than 200,000 persons in the United States.
Although there are over 7,000 rare diseases that affect more than 30 million Americans, prior to the incentives established by the ODA, there was little market interest in developing medical products for rare diseases. Clinical Trials Grants Program - Funds clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions (since 1983).
Learn more and view grants awarded . Natural History Studies Grants Program - Funds well-designed, protocol-driven natural history studies that address knowledge gaps, support clinical trials, and advance rare disease medical product development (since 2016). Learn more and view grants awarded .
Additional Rare Disease Grants OOPD also administers the FDA Rare Neurodegenerative Disease Grants Program . Established by the ACT for ALS Act in 2021, this program awards grants and contracts to cover the costs of research and development of interventions intended to prevent, diagnose, or treat amyotrophic lateral disease (ALS) and other rare neurodegenerative diseases in adults and children (since 2022).
Resources for Applicants and Grantees FAQs for Orphan Products Grant Applicants Technical Support and OOPD Grants Contacts
Based on current listing details, eligibility includes: Any foreign or domestic, public or private, for-profit or nonprofit entity (including state and local units of government) can apply. Applicants should confirm final requirements in the official notice before submission.
Current published award information indicates Not specified, multiple awards possible (clinical trial grants awarded in FY2024 totaled ~$17.2 million over four years, natural history studies ~$4.7 million over four years) Always verify allowable costs, matching requirements, and funding caps directly in the sponsor documentation.
The current target date is October 1, 2024. Build your timeline backwards from this date to cover registrations, approvals, attachments, and final submission checks.
Federal grant success rates typically range from 10-30%, varying by agency and program. Build a strong proposal with clear objectives, measurable outcomes, and a well-justified budget to improve your chances.
Requirements vary by sponsor, but typically include a project narrative, budget justification, organizational capability statement, and key personnel CVs. Check the official notice for the complete list of required attachments.
Yes — AI tools like Granted can help research funders, draft proposal sections, and check compliance. However, always review and customize AI-generated content to reflect your organization's unique strengths and the specific requirements of the solicitation.
Review timelines vary by funder. Federal agencies typically take 3-6 months from submission to award notification. Foundation grants may be faster, often 1-3 months. Check the program's timeline in the official solicitation for specific dates.
Many federal programs offer multi-year funding or allow competitive renewals. Check the official solicitation for continuation and renewal policies. Non-competing continuation applications are common for multi-year awards.
Past winners and funding trends for this program