Opportunity Information: Apply for RFA FD 24 008
This FDA funding opportunity (RFA-FD-24-008) supports research aimed at improving how scientists measure what happens to a drug after it is applied to the skin. The central goal is to advance non-invasive technologies, especially quantitative tomography-based approaches, that can measure and compare the rate and extent of drug availability at or near the site of action within the skin while the subject is alive (in vivo). In practical terms, the FDA is looking for tools and study methods that can track how much drug is present in different layers of the skin over time, without relying on more invasive sampling techniques that may be slow, variable, or difficult to repeat.
The project focus is on building an accurate, sensitive, and reproducible way to rapidly estimate the relative amount of drug located at a series of depths beneath the skin surface. A key feature is repeated, serial measurement over time, so that a full cutaneous pharmacokinetic (PK) profile can be generated at selected depths, such as within the epidermis. This implies not just a one-time measurement, but a method that can be used to follow drug uptake, distribution, and decline in the skin across multiple timepoints, producing time-course data similar in spirit to traditional blood PK, but localized to skin layers where topical drugs act.
The funding is meant to cover the research and development needed to make this possible, including the design or refinement of hardware (apparatus), measurement procedures, clinical study designs, and data analysis methods. In other words, it is not limited to inventing a device; it also supports the supporting ecosystem needed to make the measurements scientifically credible, interpretable, and usable in a regulatory context. That includes demonstrating that the approach can produce consistent results, that it can detect meaningful differences, and that it can be applied in a way that supports comparisons between products.
A major intended downstream outcome is to enable an alternative, scientifically valid in vivo method for demonstrating bioequivalence (BE) of topical drug products. Bioequivalence for topical products can be challenging because drug levels in blood may not reflect local delivery to the skin, and conventional clinical endpoint studies can be expensive and time-consuming. By developing a dependable cutaneous PK approach, the FDA is signaling interest in tools that could make BE assessments more efficient while still being rigorous, potentially accelerating development and review of topical generics and other comparable products.
Mechanically, this opportunity is offered as a cooperative agreement (U01), which typically means substantial scientific involvement or partnership from the funding agency during the project, rather than a fully investigator-driven grant with minimal agency interaction. The title specifies "Clinical Trial Required," indicating the funded work is expected to include a clinical study component rather than being purely bench or engineering development. The agency listed is the Food and Drug Administration, and the activity category is associated with consumer protection and related areas (CFDA 93.103).
The opportunity is broadly open to many applicant types, including state, local, and tribal governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (including small businesses); and other unrestricted applicants. The original closing date was April 8, 2024. The award ceiling is $250,000, and the FDA anticipated making one award, suggesting a single, focused project will be supported rather than a large multi-award program.
Overall, the opportunity is essentially a targeted push to develop and validate non-invasive pharmacokinetic tomography (or similar quantitative imaging) as a practical way to measure topical drug presence within skin layers over time. The FDA is looking for a solution that is not only technically innovative but also reproducible and fit for purpose in comparative testing, with the longer-term aim of supporting more efficient regulatory pathways for establishing bioequivalence of topical products.Apply for RFA FD 24 008
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)" 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 2024-01-15.
- Applicants must submit their applications by 2024-04-08. (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 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, Unrestricted.
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| Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 005 Funding Number: RFA FD 24 005 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 24 011 Funding Number: RFA FD 24 011 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed Apply for RFA FD 24 010 Funding Number: RFA FD 24 010 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers (U01) Clinical Trial Optional Apply for RFA FD 24 038 Funding Number: RFA FD 24 038 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U19) Clinical Trials Not Allowed Apply for RFA FD 24 033 Funding Number: RFA FD 24 033 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $15,000,000 |
| Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed Apply for RFA FD 24 032 Funding Number: RFA FD 24 032 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $360,000 |
| Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U19) Clinical Trials Not Allowed Apply for RFA FD 24 039 Funding Number: RFA FD 24 039 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $340,000 |
| Drug Development Tools Research Grants (U01) Clinical Trials Optional Apply for RFA FD 24 030 Funding Number: RFA FD 24 030 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed Apply for RFA FD 24 031 Funding Number: RFA FD 24 031 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Alliance to Support the Activities of the Integrated Food Safety System (IFSS), including the Grade “A” Milk Safety and National Shellfish Sanitation Programs (U01) Clinical Trials Not Allowed Apply for RFA FD 24 034 Funding Number: RFA FD 24 034 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01) Clinical Trials Not Allowed Apply for RFA FD 24 016 Funding Number: RFA FD 24 016 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional Apply for RFA FD 24 037 Funding Number: RFA FD 24 037 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,100,000 |
| Development and Maintenance of the Animal Food Regulatory Program Standards (U19) Clinical Trial Not Allowed Apply for RFA FD 24 035 Funding Number: RFA FD 24 035 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Convener and Organizer of Activities and Engagements Related to Processes, Surveillance, and Policy Development of Medical Products for Ongoing Public Health Activities, U01 Clinical Trial Not Allowed Apply for RFA FD 24 036 Funding Number: RFA FD 24 036 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $700,000 |
| FY 2024 SNAP Fraud Framework Implementation Grant Apply for USDA FNS SNAP FFIG 2024 Funding Number: USDA FNS SNAP FFIG 2024 Agency: Food and Nutrition Service Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trials Optional Apply for RFA FD 24 040 Funding Number: RFA FD 24 040 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,500,000 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 24 041 Funding Number: RFA FD 24 041 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01 Clinical Trial Required) Apply for RFA FD 19 024 Funding Number: RFA FD 19 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed) Apply for PAR 19 306 Funding Number: PAR 19 306 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Building an Integrated Information Technology Infrastructure for State Regulatory Programs (U2F) [Clinical Trial Not Allowed] Apply for RFA FD 22 021 Funding Number: RFA FD 22 021 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
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