Opportunity Information: Apply for RFA FD 19 009
This grant opportunity, titled "Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required)," is a cooperative agreement offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). Its central goal is to fund research that improves how topical semisolid drug products (such as creams, ointments, gels, and lotions) are evaluated for bioequivalence when a proposed generic or test product is not compositionally identical to the reference product. Rather than focusing only on chemical sameness, the opportunity targets the practical question regulators and developers face: when formulations differ in ingredients or microstructure, can they still behave similarly on the skin and be perceived by users as essentially the same product?
A core emphasis is linking a product's "quality attributes" to its "functional properties." In this context, quality attributes include measurable physical and microstructural characteristics that describe how the formulation is built and organized, often referred to as the "arrangement of matter." The FDA is specifically interested in advanced physical characterization approaches, particularly rheological and mechanical measurements that quantify how a semisolid flows, deforms, and interacts with surfaces. Examples highlighted in the announcement include texture analysis and tribology. Texture analysis can capture properties like firmness, cohesiveness, spreadability, and stickiness, while tribology examines friction and lubrication behavior between surfaces, which can closely relate to how a product feels during application (for example, whether it drags, slips, or feels greasy).
The practical outcome the FDA is aiming for is a reliable, evidence-based way to predict human-perceived sensorial differences using objective laboratory measurements. The sensorial attributes of interest are the kinds of "look and feel" experiences that matter to patients and can influence correct use, adherence, and overall acceptance. The notice explicitly calls out perceptions such as grittiness versus smoothness (including silky-smoothness) and sensations like cooling. These are real-world attributes that may change when excipients, particle characteristics, microstructure, or processing conditions differ, even if the active ingredient and strength are the same. The research supported by this program is expected to clarify whether certain laboratory characterizations, especially those tied to microstructure and rheology, correlate with and potentially predict what human subjects report when they apply and evaluate different topical products.
The funding mechanism is a U01 cooperative agreement, meaning FDA is expected to have substantial involvement in the project compared to a standard research grant. The opportunity is labeled "Clinical Trial Required," reflecting that human subject testing is anticipated as part of the work, particularly to measure sensorial perception directly and relate it back to objective product characterizations. The overall idea is to build bridges between three layers of evidence: (1) compositional and microstructural differences between products, (2) quantifiable physical performance metrics (rheology, texture, tribology, and related tests), and (3) human sensory outcomes. If those links can be established in a rigorous way, it becomes more feasible to judge whether compositionally different test and reference topical products are likely to be comparable in use, supporting bioequivalence assessments and potentially improving the efficiency and scientific grounding of generic topical development.
Administratively, the opportunity number is RFA-FD-19-009, created February 11, 2019, with an original closing date of April 11, 2019. The program anticipated a single award, with an award ceiling of $1,000,000. Eligibility was broad and included many organization types: federal-recognized tribal governments and tribal organizations, state and local governments, public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations, and small businesses, among others as noted in the full announcement. Overall, the program reflects an FDA priority to strengthen the science used to evaluate topical semisolid products by moving beyond simple ingredient comparisons and toward predictive, mechanistically informed measures that capture both performance and patient-relevant sensory experience.Apply for RFA FD 19 009
- 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: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (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 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 $1,000,000.00 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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Frequently Asked Questions (FAQ)
What is the title of this grant opportunity?
The opportunity is titled "Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required)."
Which agency is offering this funding opportunity?
This is a cooperative agreement offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA).
What is the opportunity number?
The opportunity number is RFA-FD-19-009.
What is the main goal of the program?
The central goal is to fund research that improves how topical semisolid drug products are evaluated for bioequivalence when a proposed generic or test product is not compositionally identical to the reference product.
What types of products are in scope for this research?
The scope focuses on topical semisolid drug products such as creams, ointments, gels, and lotions.
What problem is FDA trying to solve with this grant?
The program targets the practical question of whether topical products that differ in ingredients or microstructure can still behave similarly on the skin and be perceived by users as essentially the same product, which is central to bioequivalence assessment for generic development.
Does the program focus only on chemical sameness of formulations?
No. Rather than focusing only on chemical sameness, the opportunity emphasizes how differences in formulation composition or microstructure may affect real-world performance and user perception.
What does the grant mean by "quality attributes" in topical formulations?
In this context, "quality attributes" are measurable physical and microstructural characteristics that describe how the formulation is built and organized, including the microstructure often described as the "arrangement of matter."
What are "functional properties" in the context of this opportunity?
"Functional properties" refer to how the product performs during use (for example, how it flows, spreads, deforms, and interacts with surfaces), and how those behaviors may connect to what users feel when applying the product.
What is the core scientific emphasis of the funded research?
A core emphasis is linking a product's measurable quality attributes (including microstructure) to its functional properties, and then connecting those objective measures to human-perceived sensorial outcomes.
What types of laboratory measurements are specifically highlighted by FDA?
The FDA specifically highlights advanced physical characterization approaches, particularly rheological and mechanical measurements. Examples called out include texture analysis and tribology.
What is rheology and why is it relevant here?
Rheology refers to measurements that quantify how a semisolid flows and deforms. It is relevant because flow and deformation behavior can strongly influence application performance and potentially relate to how the product feels on the skin.
What is texture analysis in this context?
Texture analysis refers to mechanical testing that can capture properties such as firmness, cohesiveness, spreadability, and stickiness, which may relate to both product performance and user experience during application.
What is tribology and why is it included?
Tribology examines friction and lubrication behavior between surfaces. It is included because friction and lubrication can closely relate to how a topical product feels during application (for example, whether it drags, slips, or feels greasy).
What are "sensorial attributes" as described in the opportunity?
Sensorial attributes are patient- and user-relevant "look and feel" experiences during application that can affect acceptance and correct use. The notice highlights perceptions such as grittiness versus smoothness (including silky-smoothness) and sensations like cooling.
Why does FDA care about sensorial differences between topical products?
Sensorial differences can influence correct use, adherence, and overall acceptance. The opportunity frames sensorial experience as a practical factor that matters to patients and can change even when the active ingredient and strength are the same.
What kinds of formulation differences could drive sensorial changes?
The information provided notes that excipients, particle characteristics, microstructure, and processing conditions may change sensorial attributes, even if the active ingredient and strength match the reference product.
What practical outcome is FDA aiming for through this research?
The practical outcome is a reliable, evidence-based way to predict human-perceived sensorial differences using objective laboratory measurements.
How does the program propose to connect lab tests to human perception?
The program aims to clarify whether laboratory characterizations tied to microstructure and rheology (including texture analysis and tribology) correlate with and potentially predict what human subjects report when they apply and evaluate topical products.
What are the "three layers of evidence" this program is trying to bridge?
The opportunity describes building bridges between: (1) compositional and microstructural differences between products, (2) quantifiable physical performance metrics (such as rheology, texture, tribology, and related tests), and (3) human sensory outcomes.
What funding mechanism is used for this opportunity?
The funding mechanism is a U01 cooperative agreement.
What does it mean that this is a cooperative agreement (U01)?
A U01 cooperative agreement means FDA is expected to have substantial involvement in the project compared to a standard research grant.
Is a clinical trial required under this opportunity?
Yes. The opportunity is labeled "Clinical Trial Required," reflecting that human subject testing is anticipated, particularly to measure sensorial perception directly and relate it back to objective product characterizations.
What role do human subjects play in the proposed research?
Human subjects are anticipated to be involved to directly measure sensorial perception when applying and evaluating topical products, enabling comparisons between subjective reports and objective laboratory measurements.
How might this research support generic topical drug development?
By establishing rigorous links between formulation differences, physical performance measures, and human sensory outcomes, the research could make it more feasible to judge whether compositionally different test and reference topical products are comparable in use, supporting bioequivalence assessments.
How many awards were anticipated?
The program anticipated a single award.
What was the award ceiling?
The award ceiling was $1,000,000.
When was the opportunity created and when did it close?
The opportunity was created on February 11, 2019, and had an original closing date of April 11, 2019.
Who was eligible to apply, based on the summary provided?
Eligibility was broad and included federal-recognized tribal governments and tribal organizations, state and local governments, public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations, and small businesses, among others as noted in the full announcement.
Does the opportunity emphasize microstructure as part of product understanding?
Yes. A stated focus is on microstructural characteristics and the "arrangement of matter," and how those characteristics may relate to functional behavior and sensorial perception.
What kinds of application-feel outcomes are explicitly mentioned?
The notice explicitly mentions perceptions such as grittiness versus smoothness (including silky-smoothness) and sensations like cooling, along with tribology-linked feel descriptors such as dragging, slipping, or greasiness.
What is the overall FDA priority reflected in this program?
The program reflects an FDA priority to strengthen the science used to evaluate topical semisolid products by moving beyond simple ingredient comparisons and toward predictive, mechanistically informed measures that capture both performance and patient-relevant sensory experience.
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| Funding Opportunity |
|---|
| 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 |
| 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 |
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