Opportunity Information: Apply for RFA FD 24 037
The Food and Drug Administration (FDA) is offering a discretionary cooperative agreement under Funding Opportunity Number RFA-FD-24-037 titled "Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional." The central focus of this opportunity is to advance how digital health technologies (DHTs) can be used for remote data acquisition during clinical investigations, specifically in ways that strengthen and modernize evidence generation for drug and biological product development. In practice, this means the FDA is looking to support work that helps clinical research teams capture meaningful, high-quality data from participants outside traditional clinic visits, such as through wearable sensors, connected devices, mobile apps, or other digital tools, while still meeting the scientific and regulatory expectations needed for product development.
Because this is a U01 cooperative agreement, the project is expected to involve substantial programmatic involvement from the FDA compared with a standard research grant. Cooperative agreements are typically used when the funding agency anticipates an active partnership role, such as helping shape milestones, providing scientific or regulatory input, facilitating coordination, or ensuring that outputs align with broader public health and regulatory needs. The listing notes "Clinical Trials Optional," which generally signals that applicants may propose projects that include clinical trials, but a clinical trial is not required to be responsive. The activity is categorized under Agriculture, Consumer Protection, Food and Nutrition, and it is associated with CFDA/Assistance Listing number 93.103.
This competition is open to a wide range of applicant organizations. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including those other than small businesses); small businesses; and other eligible entities. Importantly, the FOA explicitly allows participation from non-U.S. entities: foreign organizations are eligible to apply, non-U.S. components of U.S. organizations may participate, and foreign components (as defined in the HHS Grants Policy Statement) are allowed. This international eligibility suggests the FDA is open to globally developed expertise and infrastructure in digital measurement, remote monitoring, and data quality approaches that can inform U.S.-relevant drug and biologics development.
Financially, the opportunity lists an award ceiling of $1,100,000, with an expectation of making one award. The FOA was created on March 14, 2024, and the original closing date for applications was May 20, 2024. Overall, the opportunity is aimed at producing actionable knowledge, methods, or resources that improve the use of DHT-derived remote data in clinical investigations, helping ensure that digitally collected endpoints and measurements are reliable, interpretable, and fit for regulatory-grade decision-making in drug and biological product development.Apply for RFA FD 24 037
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional" 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 2024-03-14.
- Applicants must submit their applications by 2024-05-20. (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 $1,100,000.00 in funding.
- The number of recipients for this funding is limited to 1 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.
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Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is an FDA discretionary cooperative agreement under Funding Opportunity Number (FON) RFA-FD-24-037, titled "Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional."
What is the main goal of the opportunity?
The central goal is to advance how digital health technologies (DHTs) can be used for remote data acquisition during clinical investigations, in ways that strengthen and modernize evidence generation for drug and biological product development.
What does "digital health technologies (DHTs)" mean in this context?
Based on the opportunity description, DHTs include tools used to collect data from participants outside traditional clinic visits, such as wearable sensors, connected devices, mobile apps, or other digital tools.
What does "remote data acquisition" refer to?
Remote data acquisition refers to capturing meaningful, high-quality data from study participants outside of in-person clinic visits (for example, using wearable sensors, connected devices, or mobile apps), while still meeting scientific and regulatory expectations needed for drug and biologics development.
What kinds of outputs is FDA looking to support?
The opportunity is aimed at producing actionable knowledge, methods, or resources that improve the use of DHT-derived remote data in clinical investigations, including work that helps ensure digitally collected endpoints and measurements are reliable, interpretable, and fit for regulatory-grade decision-making.
How does this funding relate to drug and biological product development?
The supported work is intended to strengthen evidence generation for drug and biological product development by improving how DHT-based measurements and endpoints are collected and used during clinical investigations.
What does the U01 cooperative agreement mechanism mean for applicants?
Because this is a U01 cooperative agreement, the project is expected to involve substantial programmatic involvement from the FDA compared with a standard research grant. The description indicates FDA may take an active partnership role, such as helping shape milestones, providing scientific or regulatory input, facilitating coordination, or helping ensure outputs align with broader public health and regulatory needs.
Does FDA expect to be actively involved during the project?
Yes. The cooperative agreement structure is typically used when the funding agency anticipates an active partnership role. The listing notes substantial FDA involvement compared with a standard grant.
Are clinical trials required for this opportunity?
No. The opportunity is labeled "Clinical Trials Optional," which generally signals that applicants may propose projects that include clinical trials, but a clinical trial is not required to be responsive.
Can an application include a clinical trial?
Yes. "Clinical Trials Optional" generally indicates a clinical trial may be proposed, but it is not required.
What topic area or category is this opportunity listed under?
The activity is categorized under Agriculture, Consumer Protection, Food and Nutrition.
What is the CFDA/Assistance Listing number for this opportunity?
The CFDA/Assistance Listing number associated with this opportunity is 93.103.
Who is eligible to apply?
Eligible applicants include: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (501(c)(3) and non-501(c)(3)); for-profit organizations (including those other than small businesses); small businesses; and other eligible entities.
Are nonprofit organizations eligible?
Yes. Both 501(c)(3) and non-501(c)(3) nonprofit organizations are listed as eligible.
Are for-profit companies eligible?
Yes. For-profit organizations are eligible, including entities other than small businesses. Small businesses are also listed as eligible.
Are universities and colleges eligible?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are eligible.
Are tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other Native American tribal organizations are listed as eligible.
Are government entities eligible?
Yes. State, county, and local governments, as well as special district governments and independent school districts, are listed as eligible applicants.
Can non-U.S. organizations apply?
Yes. The FOA explicitly allows participation from non-U.S. entities. Foreign organizations are eligible to apply.
Can non-U.S. components of U.S. organizations participate?
Yes. Non-U.S. components of U.S. organizations may participate.
Are foreign components allowed?
Yes. Foreign components (as defined in the HHS Grants Policy Statement) are allowed.
What does the international eligibility suggest about the program?
Based on the description provided, it suggests FDA is open to globally developed expertise and infrastructure in digital measurement, remote monitoring, and data quality approaches that can inform U.S.-relevant drug and biologics development.
How much funding is available per award?
The opportunity lists an award ceiling of $1,100,000.
How many awards does FDA expect to make?
The opportunity indicates an expectation of making one award.
When was the FOA created?
The FOA was created on March 14, 2024.
What was the application closing date?
The original closing date for applications was May 20, 2024.
What is FDA trying to improve about DHT-derived data in clinical investigations?
The opportunity emphasizes improving the use of DHT-derived remote data so that digitally collected endpoints and measurements are reliable, interpretable, and suitable for regulatory-grade decision-making in drug and biological product development.
What kinds of DHT use cases are implied by the description?
The description highlights remote monitoring and data capture outside clinic visits, implying use cases where participants generate data in everyday settings through wearables, connected devices, mobile apps, or other digital tools, with a focus on maintaining data quality and regulatory relevance.
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