Opportunity Information: Apply for RFA FD 19 010
This grant opportunity, issued by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA), focuses on improving how bioequivalence is demonstrated for topical drug products. The central problem it targets is that proving two topical products perform the same in the skin (bioequivalence, or BE) is often difficult, slow, or expensive using traditional methods. To address that, the FDA is seeking research that advances non-invasive technologies, especially quantitative approaches based on tomography, to measure how much drug actually gets into the skin and how it moves through skin layers over time. The ultimate goal is to create a scientifically sound cutaneous pharmacokinetics (PK) method that can serve as a practical alternative pathway for demonstrating BE for topical products.
The project emphasis is on measuring drug availability "at or near the site of action within the skin," rather than relying on blood levels, which often do not reflect topical performance. The FDA is specifically looking for work that can characterize and compare both the rate and the extent of drug presence within the skin after a topical product is applied. In practice, that means developing tools and methods capable of repeatedly measuring the relative amount of drug at multiple depths beneath the skin surface, such as within the epidermis and dermis. A key expectation is that the resulting method will support serial measurements over time in the same area or subject, allowing researchers to build a time course of drug behavior in the skin (cutaneous PK) without needing invasive sampling techniques that disrupt the skin barrier or require extensive tissue collection.
The opportunity supports a broad set of research and development activities needed to make this type of measurement approach credible and usable. That includes the design or refinement of hardware (apparatus), the underlying measurement methodology, the development of study designs suited to topical product evaluation, and robust data analysis methods. The FDA is looking for an approach that is accurate, sensitive, and reproducible, and also fast enough to be useful in real development and regulatory settings. The emphasis on reproducibility and sensitivity signals the agency is looking beyond proof-of-concept demonstrations and toward methods that could eventually be standardized and compared across labs, products, and study populations.
From a funding and administrative standpoint, this is a discretionary cooperative agreement (U01), meaning the FDA expects substantial involvement during the project rather than a hands-off grant model. The funding opportunity number is RFA-FD-19-010, it falls under CFDA 93.103, and it is categorized under Agriculture, Consumer Protection, Food and Nutrition, reflecting FDA's consumer protection mission and regulatory science interests. The award ceiling is $1,500,000, and the agency anticipated making one award, indicating a single, relatively large and focused project rather than many smaller ones. The listing also states "Clinical Trial Not Allowed," which generally means applicants should not propose clinical trial activities as defined by NIH/FDA grant policy; instead, the work is expected to be technology and methods development, validation, and related non-trial research aimed at enabling future BE assessments.
Eligibility is broad and includes many types of organizations that could plausibly contribute to instrumentation and translational regulatory science work. Eligible applicants include state and local governments, tribal governments and organizations, public and private institutions of higher education, nonprofits (with and without 501(c)(3) status), for-profit organizations (including small businesses), and other entities as clarified in the full announcement. That range is consistent with the technical nature of the effort, since relevant expertise could come from universities, medical imaging or device companies, pharmaceutical sciences groups, or collaborative consortia that combine engineering, dermatology, pharmacokinetics, and regulatory science.
In short, the opportunity is designed to push forward non-invasive, tomography-enabled measurement of drug levels within skin layers so that topical drug products can be compared using cutaneous PK metrics. If successful, the funded work would help lay the groundwork for a more efficient and scientifically defensible way to establish bioequivalence for topical therapies, potentially reducing reliance on slower or more invasive approaches and supporting faster development and approval of equivalent topical products.Apply for RFA FD 19 010
- 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 "Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed)" 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 Feb 11, 2019.
- Applicants must submit their applications by Apr 11, 2019. (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 $1,500,000.00 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, 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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| Funding Opportunity |
|---|
| 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 |
| Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional Apply for PAR 19 216 Funding Number: PAR 19 216 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Implementation of the Animal Feed Regulatory Program Standards (U18 Clinical Trial Not Allowed) Apply for RFA FD 19 021 Funding Number: RFA FD 19 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial Optional) Apply for RFA FD 19 020 Funding Number: RFA FD 19 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 019 Funding Number: RFA FD 19 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required Apply for RFA FD 19 015 Funding Number: RFA FD 19 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $37,500,000 |
| Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities. (U01) Clinical Trial Not Allowed Apply for RFA FD 19 013 Funding Number: RFA FD 19 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,500,000 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 19 016 Funding Number: RFA FD 19 016 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 Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U01) Clinical Trials Not Allowed Apply for RFA FD 19 026 Funding Number: RFA FD 19 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed Apply for RFA FD 19 025 Funding Number: RFA FD 19 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,600,000 |
| Renewal Application: Critical Path Public Private Partnerships (U18) Clinical Trials Optional Apply for RFA FD 19 027 Funding Number: RFA FD 19 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000,000 |
| Implementation of U.S. Food Safety Modernization Act - Identifying, Researching, and Implementing Alternative Methods to Expand the Reach across the Global Supply Chain (U01) - Clinical Trials Not Allowed Apply for RFA FD 19 022 Funding Number: RFA FD 19 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,750,000 |
| Cigar Tobacco Reference Products Program (UC2) Clinical Trials Not Allowed Apply for RFA FD 20 002 Funding Number: RFA FD 20 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,400,000 |
| Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 029 Funding Number: RFA FD 19 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 028 Funding Number: RFA FD 19 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Heart Failure Collaboratory (R18) Clinical Trials Optional Apply for RFA FD 20 005 Funding Number: RFA FD 20 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,150,000 |
| Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food Safety Modernization Act (FSMA) Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 20 006 Funding Number: RFA FD 20 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 20 004 Funding Number: RFA FD 20 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
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