Opportunity Information: Apply for RFA FD 18 016
This grant opportunity, issued by the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services, focuses on modernizing how clinical research and post-market surveillance data can be exchanged and reused by leveraging HL7 Fast Healthcare Interoperability Resources (FHIR). The FDA Center for Drug Evaluation and Research (CDER) is dealing with an increasing volume of regulatory and research data coming from many different sources and submitted in many different formats. That diversity creates friction, adds cost, and increases the chance of inconsistency or misinterpretation. The agency is especially interested in making better use of Real World Data (RWD), meaning routinely collected health and health care delivery data, because it can support more efficient clinical research, improve regulatory submissions, and strengthen post-approval monitoring. In that context, HL7 FHIR is viewed as an emerging de facto standard for representing and exchanging RWD, and FDA is using this program to explore and extend FHIR so it better supports research and regulatory needs.
The main purpose of the award is exploratory and standards-oriented rather than purely academic. The core objective is to investigate methods for applying the HL7 FHIR standard to the information exchange requirements of clinical research and post-market research and surveillance, then turn that work into concrete, standards-track deliverables. The most important expected output is the development of new or improved FHIR components (such as resources, profiles, and extensions) that are intended for submission to HL7 for potential inclusion in the public FHIR specification. If HL7 accepts them through its normal consensus and ballot processes, those components become openly available for anyone to use, which is a key part of the public benefit of the project. The notice also makes clear that the timing of HL7 balloting might extend beyond the grant period, depending on how the work aligns with HL7 cycles, but the grant is still expected to produce standards-ready artifacts.
Applicants are expected to begin by identifying one or more real, well-defined usage scenarios where a FHIR-based approach could measurably improve efficiency and accuracy. Example scenarios mentioned include submitting study data to CDER, enabling the use of real world data for regulatory or research purposes, and supporting post-market research and surveillance workflows. For each chosen scenario, the work is not supposed to assume FHIR is automatically the best answer; instead, applicants must perform a risk-benefit analysis comparing a FHIR-based approach to available alternatives. This forces the project to address practical tradeoffs, such as implementation complexity, fitness for regulatory use, interoperability, and long-term maintainability.
A major emphasis of the project is building and demonstrating technology pathways that enable use of RWD without exchanging sensitive personal data. The opportunity explicitly states that no Protected Health Information (PHI) or Personally Identifiable Information (PII) will be exchanged. Within those constraints, the awardee is expected to develop proof-of-concept artifacts that show how the selected scenarios could work in practice. Those artifacts may include new FHIR resources, extensions, and profiles, and they must be developed following HL7 rules and procedures for FHIR development. In addition to building the artifacts, the recipient is expected to propose practical approaches for implementing the solutions, meaning guidance that helps others adopt the work in real systems rather than leaving it as a theoretical model.
The grant also requires a comprehensive white paper as a capstone deliverable. That paper must summarize what was accomplished, outline realistic paths forward for using the outputs, and capture best practices as well as any concerns, limitations, or open questions that should be addressed in follow-on work. In other words, the project is expected to produce both standards contributions and a well-documented narrative that helps the broader community understand how to apply them in clinical research and post-market contexts.
The application itself must include several concrete elements. It needs an overall program plan describing the approach and process that will be used to standardize the selected area. It must clearly define and justify the scope for the project period, including the usage scenarios and the more specific use cases derived from them. It must explain how the applicant will coordinate and collaborate to engage subject matter experts and stakeholders who would be affected by or responsible for adopting the standards work (for example, regulators, industry, clinical research organizations, health systems, standards participants, and technical implementers). Finally, it must assess what existing FHIR resources already support the proposed use cases and estimate what new or modified resources and profiles will be needed.
Administratively, this is a discretionary cooperative agreement (U24), meaning the FDA expects substantial involvement during the project rather than a hands-off grant structure. The opportunity number is RFA-FD-18-016 under CFDA 93.103. Eligible applicants are broad and include various levels of government, public and private institutions of higher education, tribal governments and organizations, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations, and small businesses. The posting indicates an award ceiling of $250,000, with up to three expected awards. The opportunity was created March 28, 2018, with an original closing date of June 11, 2018.
Overall, the grant is aimed at producing practical, standards-based building blocks that make it easier to represent, exchange, and reuse research and post-market surveillance data using FHIR, while also documenting the lessons learned so regulators and the broader health data ecosystem can move toward more consistent, efficient, and interoperable use of real world data.Apply for RFA FD 18 016
- 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 "Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24)" 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 Mar 28, 2018.
- Applicants must submit their applications by Jun 11, 2018. (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 $250,000.00 in funding.
- The number of recipients for this funding is limited to 3 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.
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Frequently Asked Questions (FAQs)
What is the focus of this FDA grant opportunity?
This opportunity focuses on modernizing how clinical research and post-market surveillance data can be exchanged and reused by leveraging the HL7 Fast Healthcare Interoperability Resources (FHIR) standard, with particular attention to using Real World Data (RWD) more effectively for regulatory and research needs.
Which FDA organization is sponsoring the work described?
The work is described as being driven by the FDA Center for Drug Evaluation and Research (CDER) within the U.S. Food and Drug Administration (FDA), part of the Department of Health and Human Services (HHS).
Why is FDA interested in FHIR for this work?
FDA CDER is facing increasing volumes of regulatory and research data coming from many sources and in many formats. This diversity creates friction, increases cost, and raises the risk of inconsistency or misinterpretation. FHIR is viewed as an emerging de facto standard for representing and exchanging Real World Data, and the program is intended to explore and extend FHIR so it better supports research and regulatory needs.
What is meant by Real World Data (RWD) in this opportunity?
Real World Data (RWD) is described as routinely collected health and health care delivery data. The opportunity emphasizes RWD because it can support more efficient clinical research, improve regulatory submissions, and strengthen post-approval monitoring.
Is this grant primarily academic research, or more standards development?
The purpose is exploratory and standards-oriented rather than purely academic. A central expectation is to translate findings into concrete deliverables on a standards track, especially FHIR artifacts suitable for submission to HL7.
What are the most important deliverables expected from awardees?
The most important expected output is the development of new or improved FHIR components such as resources, profiles, and extensions that are intended for submission to HL7 for potential inclusion in the public FHIR specification. A comprehensive white paper is also required as a capstone deliverable.
What does it mean that the deliverables are "standards-track"?
It means the artifacts are intended to be developed in a way that aligns with HL7 rules and procedures and are prepared for submission to HL7, where they may go through HL7 consensus and ballot processes for potential inclusion in the public FHIR specification.
Do the FHIR artifacts have to be submitted to HL7?
The opportunity states that the components are intended for submission to HL7 for potential inclusion in the public FHIR specification, and that the grant is expected to produce standards-ready artifacts aligned to HL7 processes.
Does HL7 acceptance have to occur during the grant period?
Not necessarily. The opportunity notes that the timing of HL7 balloting may extend beyond the grant period depending on how the work aligns with HL7 cycles, but the project is still expected to produce standards-ready artifacts.
What kinds of use scenarios are applicants expected to start with?
Applicants are expected to identify one or more real, well-defined usage scenarios where a FHIR-based approach could measurably improve efficiency and accuracy. Example scenarios include submitting study data to CDER, enabling use of RWD for regulatory or research purposes, and supporting post-market research and surveillance workflows.
Is the project allowed to assume FHIR is automatically the best solution?
No. For each chosen scenario, applicants are expected to perform a risk-benefit analysis comparing a FHIR-based approach to available alternatives, addressing practical tradeoffs such as implementation complexity, fitness for regulatory use, interoperability, and long-term maintainability.
What is the role of risk-benefit analysis in the proposed work?
The risk-benefit analysis is meant to evaluate whether FHIR is appropriate for each usage scenario and to compare it to alternatives. The intent is to force practical evaluation of tradeoffs, not just a theoretical endorsement of FHIR.
What constraints apply regarding sensitive data like PHI or PII?
The opportunity explicitly states that no Protected Health Information (PHI) or Personally Identifiable Information (PII) will be exchanged. A major emphasis is on building and demonstrating technology pathways that enable use of Real World Data without exchanging sensitive personal data.
What types of proof-of-concept outputs are expected?
Within the constraint that no PHI/PII is exchanged, the awardee is expected to develop proof-of-concept artifacts showing how the selected scenarios could work in practice. These artifacts may include new FHIR resources, extensions, and profiles developed according to HL7 rules and procedures.
Beyond technical artifacts, what implementation guidance is expected?
The recipient is expected to propose practical approaches for implementing the solutions, providing guidance that helps others adopt the work in real systems rather than leaving it as a purely theoretical model.
What is required in the capstone white paper?
The white paper must summarize what was accomplished, outline realistic paths forward for using the outputs, and capture best practices as well as concerns, limitations, and open questions that should be addressed in follow-on work.
What must the application include in terms of planning and scope?
The application must include an overall program plan describing the approach and process to standardize the selected area. It must clearly define and justify the scope for the project period, including the usage scenarios and the specific use cases derived from them.
What collaboration and stakeholder engagement expectations are described?
The application must explain how the applicant will coordinate and collaborate to engage subject matter experts and stakeholders affected by or responsible for adopting the standards work. Examples mentioned include regulators, industry, clinical research organizations, health systems, standards participants, and technical implementers.
Do applicants need to evaluate existing FHIR coverage for their use cases?
Yes. The application must assess what existing FHIR resources already support the proposed use cases and estimate what new or modified resources and profiles will be needed.
What funding mechanism is used for this opportunity?
This is a discretionary cooperative agreement (U24), which indicates FDA expects substantial involvement during the project rather than a hands-off grant structure.
What is the opportunity number and CFDA listing provided?
The opportunity number is RFA-FD-18-016, under CFDA 93.103.
Who is eligible to apply, based on the notice?
Eligibility is broad and includes various levels of government, public and private institutions of higher education, tribal governments and organizations, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations, and small businesses.
What is the award ceiling and how many awards are expected?
The posting indicates an award ceiling of $250,000, with up to three expected awards.
When was this opportunity posted and what dates are provided for closing?
The opportunity was created March 28, 2018, with an original closing date of June 11, 2018.
What is the overall intended public benefit of this work?
If HL7 accepts the submitted components through its consensus and ballot processes, they can become part of the public FHIR specification and be openly available for anyone to use. The broader goal is to produce practical, standards-based building blocks and documented lessons learned that enable more consistent, efficient, and interoperable use of RWD for clinical research and post-market surveillance.
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| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFD FD 18 018 Funding Number: RFD FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Apply for RFA FD 18 009 Funding Number: RFA FD 18 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act Apply for RFA FD 18 013 Funding Number: RFA FD 18 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,200,000 |
| Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01) Apply for RFA FD 18 022 Funding Number: RFA FD 18 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) Apply for RFA FD 18 025 Funding Number: RFA FD 18 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,000,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFA FD 18 018 Funding Number: RFA FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) Apply for RFA FD 18 024 Funding Number: RFA FD 18 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 18 827 Funding Number: PAR 18 827 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
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| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
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| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) Apply for RFA FD 19 009 Funding Number: RFA FD 19 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 010 Funding Number: RFA FD 19 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional) Apply for RFA FD 19 003 Funding Number: RFA FD 19 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional Apply for RFA FD 19 011 Funding Number: RFA FD 19 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional Apply for PAR 19 190 Funding Number: PAR 19 190 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
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