Opportunity Information: Apply for RFA FD 17 001
Expanded Access to Investigational Therapies (R01) is a discretionary grant opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), focused on improving how the United States handles "expanded access" to investigational medical products. Expanded access refers to situations where patients, typically those with serious or life-threatening conditions who lack satisfactory treatment options and cannot enroll in a clinical trial, may seek access to an investigational therapy outside the standard research setting. The central aim of this funding opportunity is to support research that maps the current expanded access landscape and then produces a practical, well-justified framework for strengthening the system nationwide.
A major emphasis of the grant is to develop guiding principles and an ethical framework that can be used consistently across stakeholders. The project is expected to take seriously the real-world ethical tensions that expanded access creates, such as how to balance compassion and urgency against uncertainty about risks and benefits, how to ensure decisions are fair and transparent, and how to avoid unequal access driven by geography, income, institutional resources, or patient influence. The opportunity explicitly calls out barriers like regional and economic bias, reflecting a concern that expanded access may currently advantage patients who live near major academic centers, have well-connected clinicians, or can shoulder related costs and administrative burdens. By improving understanding of these barriers, the funded work should help researchers and policymakers identify where the system fails patients and what reforms are most likely to reduce inequities.
The grant also seeks detailed analysis of scientific considerations, especially the ripple effects expanded access can have on a product's clinical development program. When an investigational product is provided outside a trial, it can complicate the evidence base used to evaluate that product, potentially introducing data that are hard to interpret because patients receiving expanded access are often sicker, have multiple comorbidities, or receive the product under less controlled conditions. The funded research is intended to address how expanded access interacts with ongoing trials, what types of data are feasible and meaningful to collect in these settings, and how to think about safety and potential efficacy signals without undermining the integrity of the development pathway.
Regulatory considerations are another core component, with a specific focus on the role of the FDA and on methods for collecting and evaluating safety and efficacy information from expanded access use. The opportunity anticipates that the final framework will offer guidance on what information should be gathered, how it should be reported, and how it can be evaluated responsibly, recognizing that expanded access is not designed primarily to generate generalizable knowledge in the way clinical trials are. The project is therefore expected to clarify how to align expanded access processes with regulatory realities, including expectations for documentation, oversight, and appropriate communication between clinicians, sponsors, and regulators.
The announcement also highlights business and financial realities that can determine whether expanded access is offered at all. Applicants are expected to examine financial considerations for both small and large companies, including workable business models for manufacturing, supplying, and supporting an investigational product outside the context of a formal development program. This includes practical concerns like production capacity, distribution logistics, and administrative overhead. The opportunity further calls for analysis of liability and legal considerations associated with providing unapproved therapies outside a research protocol, since legal risk can influence company willingness to participate. It also asks applicants to address what happens after a product is approved, particularly in cases where a patient who previously received the product through expanded access may lose access because the newly approved therapy is unaffordable. That point signals an interest in continuity-of-care issues and the ethical and policy implications of transitioning from investigational access to the commercial marketplace.
Finally, the grant is designed to support recommendations about what an optimal expanded access system should look like in terms of structure, governance, and accountability. This includes proposing improvements to the guidance and structure of ethics review committees involved in evaluating expanded access requests, as well as developing ideas for reporting systems and accountability mechanisms for companies that provide investigational products via expanded access. Another priority is improving information sharing among key decision makers, especially the treating provider, the product sponsor, and the FDA, so that patients can be directed toward the most appropriate pathway as efficiently as possible. That includes clarifying when a clinical trial is the best option, when an expanded access program is appropriate, and when an individual patient request might be necessary, with the overarching goal of reducing delays, confusion, and inconsistent decision making.
In terms of administrative details provided in the source, this opportunity is identified as RFA-FD-17-001 and uses the R01 grant mechanism. It was posted by the FDA under CFDA number 93.103, with an original application closing date of January 13, 2017, and a creation date of October 24, 2016. The expected number of awards was one, with an award ceiling of $300,000. Eligibility is listed broadly as "Others" with additional eligibility details referenced in the full announcement, indicating that the applicant pool may extend beyond standard academic institutions depending on the specific eligibility language in the complete funding notice. Overall, the opportunity is best understood as a targeted, policy-relevant research grant meant to produce a usable national framework that addresses ethics, science, regulation, economics, and system governance in a coordinated way, with a strong emphasis on fairness and practical implementation.Apply for RFA FD 17 001
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Expanded Access to Investigational Therapies (R01)" 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 Oct 24, 2016.
- Applicants must submit their applications by Jan 13, 2017. (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 $300,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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| Funding Opportunity |
|---|
| CVM Vet-LIRN Veterinary Diagnostic Laboratory Program (U18) Apply for PAR 17 141 Funding Number: PAR 17 141 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $75,000 |
| Search and Rescue peer-to-peer opioids prescriber education campaign Apply for RFA FD 17 008 Funding Number: RFA FD 17 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Conformance with the Manufactured Food Regulatory Program Standards (MFRPS) (U18) Apply for RFA FD 17 005 Funding Number: RFA FD 17 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) (U18) Apply for RFA FD 17 007 Funding Number: RFA FD 17 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $70,000 |
| Identification of Target Peptide Sequences for Zika IgM Diagnostic Device Apply for RFA FD 17 002 Funding Number: RFA FD 17 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $299,150 |
| Food Safety Preventive Controls and Produce Safety Standards: Building Competency in Latin America in Support of the U.S. Food Safety Modernization Act Apply for RFA FD 17 011 Funding Number: RFA FD 17 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,100,000 |
| Creation and Implementation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC) Apply for RFA FD 18 002 Funding Number: RFA FD 18 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $30,000 |
| Global Pediatric Clinical Trials Network Apply for RFA FD 17 014 Funding Number: RFA FD 17 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) Apply for RFA FD 17 013 Funding Number: RFA FD 17 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Building Research Capacity in Global Tobacco Product Regulation Program (U18) Apply for RFA FD 18 003 Funding Number: RFA FD 18 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $450,000 |
| Vet-LIRN Network Capacity-Building Projects Apply for PAR 18 604 Funding Number: PAR 18 604 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $225,000 |
| National Laboratory Curriculum Framework Development Apply for RFA FD 18 005 Funding Number: RFA FD 18 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Cooperative Agreement to Support the Western Center for Food Safety (U19) Apply for RFA FD 18 008 Funding Number: RFA FD 18 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Data Standards for Clinical Research and Drug Development (U24) Apply for RFA FD 18 015 Funding Number: RFA FD 18 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01) Apply for RFA FD 18 010 Funding Number: RFA FD 18 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems (U01) Apply for RFA FD 18 019 Funding Number: RFA FD 18 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Three-Dimensional Approach for Modeling Nasal Mucociliary Clearance via Computational Fluid Dynamics (CFD) (U01) Apply for RFA FD 18 020 Funding Number: RFA FD 18 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $280,000 |
| Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery (U01) Apply for RFA FD 18 014 Funding Number: RFA FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $380,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01) Apply for RFA FD 18 012 Funding Number: RFA FD 18 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 18 011 Funding Number: RFA FD 18 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
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