Opportunity Information: Apply for RFA FD 19 008
The grant opportunity "Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-FD-19-008) is a cooperative agreement offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It was created on February 7, 2019, with an original application deadline of April 11, 2019. The program sits under CFDA 93.103 and is categorized as a discretionary funding opportunity tied to areas such as consumer protection and food and nutrition, reflecting FDA's broader role in regulating medical products and supporting science that strengthens regulatory decision-making.
The main goal of this opportunity is to fund targeted research that clarifies how bioequivalence (BE) should be evaluated for certain topical drug products that present unique scientific and regulatory challenges. Specifically, it focuses on topical dosage forms intended for the nail (ungual products), scalp, vaginal, anal, or rectal use. These sites are not interchangeable from a BE perspective: they differ in anatomy, barriers to drug penetration, local environment (like moisture, pH, microbiome, and secretions), dosing conditions, and practical issues around sampling drug levels at the site of action. Because many topical products act locally rather than systemically, traditional pharmacokinetic methods that rely on measuring drug concentrations in blood may not be sensitive or relevant enough to prove that a generic product performs the same as the reference product.
A central emphasis of the funding announcement is the development of in vitro or ex vivo approaches for establishing bioequivalence using comparative product characterization. In practical terms, this means the FDA is interested in methods that can compare a proposed generic to a reference listed drug by measuring and matching critical attributes and performance-related characteristics without relying on human clinical endpoint trials. This can include laboratory-based testing (in vitro) and studies using excised tissues or biologically relevant models (ex vivo) that better mimic the real-world barrier properties of nails, scalp skin, vaginal mucosa, or rectal tissue. The larger intent is to improve the scientific foundation for alternative BE pathways that are more efficient, reproducible, and ethically and logistically simpler than clinical trials, while still being rigorous enough to support regulatory confidence in therapeutic equivalence.
The award mechanism is a U01 cooperative agreement, which typically means substantial scientific or programmatic involvement by the FDA during the project rather than a hands-off research grant. The funding cap (award ceiling) listed is $500,000, and the announcement anticipated making one award. Importantly, the opportunity explicitly states "Clinical Trial Not Allowed," signaling that proposed work should not include clinical intervention studies in human subjects designed to evaluate outcomes. Instead, applicants are expected to design research plans centered on method development, validation, and comparative characterization strategies that can be translated into practical BE recommendations for these specialized topical dosage forms.
Eligibility is broad and includes many types of organizations and institutions: federal-recognized tribal governments and organizations, state and local governments, public and private institutions of higher education, independent school districts, special district governments, public housing authorities/Indian housing authorities, nonprofits with or without 501(c)(3) status, for-profit organizations (including small businesses and other than small businesses), and additional entities as clarified in the full announcement. This wide eligibility reflects the applied nature of the work and the likelihood that progress could come from academic labs, contract research and development groups, small businesses developing testing platforms, or collaborations that combine formulation science, analytical chemistry, and physiologically relevant tissue modeling.
Overall, this opportunity is aimed at solving a very specific bottleneck in generic drug development and regulatory assessment for non-traditional topical sites: how to demonstrate that two products are truly equivalent in how they deliver drug locally when direct measurement at the site of action is hard and when clinical endpoint trials are expensive, variable, and time-consuming. By prioritizing in vitro and ex vivo, characterization-driven BE approaches, the FDA is effectively encouraging tools and methods that can streamline generic approvals, reduce unnecessary human testing, and improve confidence in equivalence determinations for topical products used on nails, scalp, and mucosal or rectal tissues.Apply for RFA FD 19 008
- 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: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (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 07, 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 $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, 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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| Funding Opportunity |
|---|
| 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 |
| 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 |
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