Opportunity Information: Apply for RFA FD 21 014
This funding opportunity, issued by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA), supports research to improve how stakeholders evaluate user interface design differences between generic drug-device combination products and their reference listed drugs (RLDs). The central aim is to build practical, scientifically grounded methods that can determine when design differences in the user interface matter for real-world use, and when they do not, with a focus on how those differences could affect safe and effective use by intended end users. The work is meant to inform regulatory decision-making and reduce uncertainty for developers, ultimately helping more generic combination products reach the market and improving consistent patient access to needed therapies.
A key emphasis of the project is developing approaches to categorize user interface design differences into meaningful groupings, such as "minor design differences" versus "other design differences." In the context of drug-device combination products, the "user interface" includes elements that shape how a patient, caregiver, or healthcare professional interacts with the product, such as device shape and ergonomics, controls and feedback, labeling and instructions for use, dose setting or dose delivery mechanisms, auditory or tactile cues, packaging configurations, and any design features that could influence user behaviors or error patterns. The proposed methods should help distinguish differences that are unlikely to alter user performance from those that could plausibly change how the product is used, including the potential for misuse, confusion, or dosing errors.
Another major objective is to explore alternatives to comparative use human factors (CUHF) studies for assessing "other design differences." CUHF studies are often used to compare how users interact with a proposed generic and the RLD, but they can be expensive, time-consuming, and sometimes difficult to design in a way that yields clear regulatory conclusions. This grant encourages the investigation of different assessment approaches, including in vivo and/or in vitro methods, that might serve as substitutes or complements to CUHF depending on the nature of the design differences. In practice, this could include bench testing, simulated-use testing, performance-based studies with instrumented devices, analytical frameworks that link specific design attributes to likely use outcomes, or other experimental methods that can quantify user interaction and resulting performance without always relying on full comparative human factors trials.
The expected output is not simply academic knowledge, but methods that are usable by multiple communities involved in generic drug-device development and evaluation. That includes FDA reviewers and policy staff, pharmaceutical and device manufacturers developing generics, and academic researchers who study human factors, usability, and device performance. By creating clearer, evidence-based ways to judge whether user interface differences affect substitutability, the project is intended to support more predictable development pathways for generic combination products. That predictability matters because even small uncertainties about usability equivalence can delay approvals, increase development costs, and reduce the availability of generics.
Administratively, this opportunity is offered as a cooperative agreement (U01), which typically means substantial involvement or partnership from the funding agency during the project period compared with a standard grant. Clinical trials are listed as optional, indicating that applicants may propose human-subject research if appropriate, but it is not inherently required to meet the goals. The program falls under FDA-related research and development activities (CFDA 93.103) and is framed broadly within consumer protection, health, and science and technology.
The eligibility pool is wide and includes federal- and state-recognized public entities (such as state, county, and local governments), public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including entities other than small businesses and small businesses), tribal governments and tribal organizations, and certain housing authorities, with additional details referenced in the full eligibility text. The funding opportunity number is RFA-FD-21-014, it was created on December 10, 2020, and the original application due date was February 15, 2021. The award ceiling is listed as $500,000, and FDA anticipated making about three awards.
In practical terms, the grant is aimed at strengthening the toolkit used to decide when a generic drug-device combination product can be considered substitutable for its RLD from a user interaction standpoint. By improving the science around user interface differences and how to evaluate their impact, the work supports regulatory clarity and helps generic manufacturers design products that users can operate correctly and confidently, which in turn can improve continuity of care and access to affordable medicines.Apply for RFA FD 21 014
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, health, science and technology and other research and development sector is offering a public funding opportunity titled "Development of Methods to Evaluate the Impact of Design Differences to the User Interface of Generic Drug-Device Combination Products in Comparison to their Reference Listed Drugs (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 Dec 10, 2020.
- Applicants must submit their applications by Feb 15, 2021. (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 $500,000.00 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, Others (see text field entitled Additional Information on Eligibility for clarification).
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| Cutaneous pharamcokinetic-based approaches to establish bioequivalence of topically applied drug products Apply for RFA FD 22 017 Funding Number: RFA FD 22 017 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $1,500,000 |
| Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products Apply for RFA FD 22 018 Funding Number: RFA FD 22 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial Optional Apply for RFA FD 22 016 Funding Number: RFA FD 22 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $600,000 |
| In Vitro Based Approaches to Evaluate the Bioequivalence of Generic Rectal and Vaginal Products Apply for RFA FD 22 014 Funding Number: RFA FD 22 014 Agency: Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Development of advanced analytical methods for the characterization of complex generics Apply for RFA FD 22 013 Funding Number: RFA FD 22 013 Agency: Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $300,000 |
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