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).
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
FAQs: Bioequivalence of Topical Products (U01 Clinical Trial Not Allowed) - RFA-FD-19-008
1) What is the name of this grant opportunity?
The opportunity is titled "Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed)."
2) What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-19-008.
3) Which federal agency is offering this funding?
This is a cooperative agreement offered by the U.S. Department of Health and Human Services (HHS) through the Food and Drug Administration (FDA).
4) What type of award mechanism is used for this opportunity?
The mechanism is a U01 cooperative agreement. This typically means the FDA is expected to have substantial scientific or programmatic involvement during the project, rather than providing a fully hands-off grant.
5) When was this opportunity created?
The opportunity was created on February 7, 2019.
6) What was the original application deadline?
The original application deadline listed is April 11, 2019.
7) What is the CFDA number associated with this program?
The CFDA listing provided is 93.103.
8) What is the main purpose of this funding opportunity?
The primary goal is to fund targeted research to clarify how bioequivalence (BE) should be evaluated for certain topical drug products that present unique scientific and regulatory challenges.
9) Which dosage form sites are specifically targeted?
The opportunity focuses on topical dosage forms intended for use on the nail (ungual), scalp, vaginal, anal, or rectal sites.
10) Why are these topical sites treated differently for bioequivalence purposes?
They are not interchangeable from a BE perspective because they differ in anatomy and barrier properties, local environment (including moisture, pH, microbiome, and secretions), dosing conditions, and practical limitations around sampling drug levels at the site of action.
11) Why might traditional pharmacokinetic (blood-based) methods be insufficient here?
Many topical products act locally rather than systemically, so measuring drug levels in blood may be insensitive or not relevant enough to show that a generic performs the same as the reference product at the local site of action.
12) What research approach does the FDA emphasize in this announcement?
A central emphasis is developing in vitro or ex vivo approaches for establishing bioequivalence using comparative product characterization.
13) What does "comparative product characterization" mean in this context?
It refers to methods that compare a proposed generic product to a reference listed drug by measuring and matching critical attributes and performance-related characteristics, potentially avoiding reliance on human clinical endpoint trials.
14) What is meant by in vitro and ex vivo in this funding context?
In vitro generally means laboratory-based testing. Ex vivo refers to studies using excised tissues or biologically relevant models intended to better mimic real-world barrier properties (for example, nail tissue, scalp skin, vaginal mucosa, or rectal tissue models).
15) Are clinical trials allowed under this opportunity?
No. The announcement explicitly states "Clinical Trial Not Allowed," indicating proposed work should not include clinical intervention studies in human subjects designed to evaluate outcomes.
16) If clinical trials are not allowed, what kind of work is expected instead?
Projects are expected to focus on method development, validation, and comparative characterization strategies that can be translated into practical bioequivalence recommendations for these specialized topical dosage forms.
17) What is the broader regulatory or public health intent behind this research?
The larger intent is to strengthen the scientific foundation for alternative BE pathways that are more efficient, reproducible, and ethically and logistically simpler than clinical endpoint trials, while still being rigorous enough to support regulatory confidence in therapeutic equivalence.
18) How does this opportunity relate to generic drug development?
It aims to address a specific bottleneck: demonstrating that two products are truly equivalent in local drug delivery when direct measurement at the site of action is difficult and when clinical endpoint trials are expensive, variable, and time-consuming.
19) What is the award ceiling for this opportunity?
The listed funding cap (award ceiling) is $500,000.
20) How many awards were anticipated?
The announcement anticipated making one award.
21) What kinds of organizations are eligible to apply?
Eligibility is broad and includes: federally 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; and for-profit organizations (including small businesses and other-than-small businesses), along with additional entities as clarified in the full announcement.
22) Why is eligibility so broad for this funding opportunity?
The work is applied and may be advanced by academic labs, contract research and development groups, small businesses creating testing platforms, or collaborations combining formulation science, analytical chemistry, and physiologically relevant tissue modeling.
23) What topic areas or categories is this opportunity associated with?
It is described as a discretionary funding opportunity tied to areas such as consumer protection and food and nutrition, reflecting the FDA's broader role in regulating medical products and supporting science that strengthens regulatory decision-making.
24) What would a strong project generally aim to produce?
Based on the announcement's emphasis, a strong project would aim to produce in vitro and/or ex vivo bioequivalence methods and comparative characterization approaches that are practical, reproducible, and informative for BE determinations for ungual, scalp, vaginal, anal, or rectal topical products.
Browse more opportunities from the same category: Agriculture, Consumer Protection, Food and Nutrition
Next opportunity: Opioid Workforce Expansion Program (OWEP) Paraprofessionals
Previous opportunity: FY 19 USA For You
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA FD 19 008
Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 19 008) also looked into and applied for these:
| 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 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA FD 19 008", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.