Opportunity Information: Apply for RFA FD 22 015
This grant opportunity, titled "In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (U01) Clinical Trial Required," is a Food and Drug Administration (FDA) cooperative agreement aimed at improving how adhesion performance is tested for transdermal and topical delivery systems. These products, often patches or topical systems that rely on sticking properly to the skin, can fail if they lift, peel, shift, or fall off, which can reduce dosing reliability and create safety or effectiveness concerns. The central goal of the program is to fund research that develops laboratory-based (in vitro) test methods that meaningfully correlate with, and can help predict, real-world (in vivo) adhesion performance on patients.
A major driver behind the opportunity is the challenge of comparing prospective generic TDS products to their reference listed drugs. Even when two products are intended to be equivalent, differences in product design, formulation, manufacturing processes, or key quality attributes can change how well the product adheres to skin. The FDA is specifically interested in methods that can detect and explain those differences in a way that is relevant to clinical use. In practical terms, the funded work is expected to produce standardized or at least well-justified in vitro approaches that can evaluate adhesion quality, identify potential adhesion-related failure modes during development, and help anticipate when a generic product might behave differently from the reference product once worn under real conditions.
The expected impact is twofold. For industry, better in vitro adhesion tests could become development tools to troubleshoot problems early, reduce costly iteration, and support stronger evidence packages when pursuing generic approvals. For the FDA, these methods could support regulatory assessment by providing more predictive, mechanistic, and reproducible data when evaluating whether observed differences between a test and reference TDS are likely to matter for adhesion performance in actual use. The emphasis on correlation to in vivo performance signals that simple bench measurements are not enough; the work should connect laboratory results to clinically meaningful adhesion outcomes.
Administratively, this is a discretionary funding opportunity issued by the U.S. Department of Health and Human Services (HHS), FDA, using a cooperative agreement mechanism (U01). A cooperative agreement generally means there is substantial federal scientific or programmatic involvement during the project, so awardees should expect active engagement with the FDA as the research progresses. The program is categorized under science and technology and other research and development, with CFDA number 93.103. The opportunity number is RFA-FD-22-015. It was created on January 12, 2022, with an original closing date of March 31, 2022.
The funding profile indicates a single anticipated award (ExpectedAwards: 1) with an award ceiling of $1,250,000. Eligibility is broad and includes a wide range of organizations: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; and small businesses. The listing also labels the opportunity as "Clinical Trial Required," which signals that applicants needed to account for the possibility that human-subject or clinical components could be involved, even though the scientific focus described is on developing in vitro methods that relate to in vivo outcomes.
Overall, the opportunity is designed to strengthen the scientific foundation for evaluating adhesion in transdermal and topical delivery systems, particularly to support rigorous comparison of generic products to reference products. By funding development of predictive in vitro tools, the FDA is seeking methods that can better forecast real-world adhesion behavior, improve product development decision-making, and enhance regulatory confidence when determining whether differences in design or formulation translate into meaningful differences in performance on the skin.Apply for RFA FD 22 015
- The Department of Health and Human Services, Food and Drug Administration in the science and technology and other research and development sector is offering a public funding opportunity titled "In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (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 Jan 12, 2022.
- Applicants must submit their applications by Mar 31, 2022. (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 $1,250,000.00 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Frequently Asked Questions (FAQs)
What is the official title of this grant opportunity?
The opportunity is titled "In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (U01) Clinical Trial Required."
Which federal agency is offering this funding?
This is a Food and Drug Administration (FDA) funding opportunity under the U.S. Department of Health and Human Services (HHS).
What type of funding mechanism is being used?
The mechanism is a cooperative agreement (U01). This structure typically involves substantial federal scientific or programmatic involvement during the project, so recipients should expect active engagement from FDA as the work progresses.
What is the main purpose of the program?
The central goal is to support research that develops laboratory-based (in vitro) test methods for adhesion that meaningfully correlate with, and can help predict, real-world (in vivo) adhesion performance when transdermal and topical delivery systems are used on patients.
What kinds of products are the focus of this research?
The focus is on transdermal and topical delivery systems (TDS), such as patches or topical systems that must adhere properly to skin to deliver a reliable dose.
Why is adhesion performance a critical issue for TDS products?
If a product lifts, peels, shifts, or falls off, dosing reliability can be reduced and safety or effectiveness concerns can arise. Adhesion failures can directly affect how the product performs under real-world conditions.
What problem is FDA trying to solve with this grant?
FDA is addressing the difficulty of evaluating and comparing adhesion performance, especially when comparing a prospective generic TDS to its reference listed drug. Even small differences in design, formulation, manufacturing processes, or key quality attributes can change adhesion behavior in ways that matter clinically.
How does the opportunity relate to generic drug development?
A major driver is the need to compare prospective generic TDS products to reference listed drugs. The FDA is interested in in vitro methods that can detect and explain clinically relevant adhesion differences between a test product and a reference product.
What kinds of research outputs does FDA appear to be looking for?
Based on the description, FDA expects work that produces standardized, or at least well-justified, in vitro approaches that can (1) evaluate adhesion quality, (2) identify potential adhesion-related failure modes during development, and (3) help anticipate when a generic product might behave differently than the reference product under real use conditions.
Is FDA interested in simple bench measurements of adhesion?
The emphasis on correlation to in vivo performance indicates that simple bench measurements alone are not enough. The work is expected to connect laboratory results to clinically meaningful adhesion outcomes.
What does "in vitro" mean in the context of this opportunity?
Here, "in vitro" refers to laboratory-based testing approaches designed to evaluate adhesion performance without relying solely on real-world wear in patients, while still aiming to predict or correlate with in vivo outcomes.
What does "in vivo" mean in the context of this opportunity?
"In vivo" refers to real-world adhesion performance on patients during actual use, such as whether a patch or topical system stays properly adhered during wear.
Why is correlating in vitro results to in vivo performance emphasized?
The program is aimed at methods that are predictive of real use. FDA highlights the need for test methods that meaningfully correlate with clinical adhesion outcomes, rather than producing results that are difficult to interpret in terms of patient use.
How could successful projects impact industry?
Better in vitro adhesion tests could serve as development tools to troubleshoot adhesion issues earlier, reduce costly design or formulation iteration, and support stronger evidence packages when pursuing generic approvals.
How could successful projects impact FDA regulatory assessment?
FDA could use more predictive, mechanistic, and reproducible data to assess whether observed differences between a test and reference TDS are likely to matter for real-world adhesion performance.
What is the opportunity number?
The opportunity number is RFA-FD-22-015.
What is the CFDA number associated with this program?
The CFDA number listed is 93.103.
How many awards are expected to be made?
The funding profile indicates a single anticipated award (ExpectedAwards: 1).
What is the maximum award amount (ceiling) for this opportunity?
The award ceiling listed is $1,250,000.
When was the opportunity created?
The opportunity was created on January 12, 2022.
What was the original closing date?
The original closing date was March 31, 2022.
What is the general program category or field?
The opportunity is categorized under science and technology and other research and development.
Who is eligible to apply?
Eligibility is broad and includes: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (501(c)(3) and non-501(c)(3)); for-profit organizations other than small businesses; and small businesses.
Are small businesses eligible?
Yes. Small businesses are included in the eligibility list.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are explicitly listed as eligible, and small businesses are also listed as eligible.
Are universities and colleges eligible?
Yes. Both public/state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are nonprofit organizations eligible?
Yes. Nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status are both listed as eligible.
Are tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other tribal organizations are included in the eligibility list.
Are government entities eligible?
Yes. State, county, and local governments, as well as special district governments and independent school districts, are listed as eligible.
What does "Clinical Trial Required" mean for this opportunity?
The listing labels the opportunity as "Clinical Trial Required," which signals that applicants needed to account for the possibility that human-subject or clinical components could be involved, even though the scientific focus described is on developing in vitro methods that relate to in vivo outcomes.
Is the research strictly in vitro, or does it involve patient-related outcomes too?
The scientific focus described is on in vitro test method development, but the program explicitly emphasizes correlation to in vivo performance. The "Clinical Trial Required" label also indicates that clinical or human-subject components could be relevant depending on the proposed approach.
What kinds of adhesion failures are specifically mentioned?
The description mentions lifting, peeling, shifting, and falling off as examples of adhesion failures that can reduce dosing reliability and raise safety or effectiveness concerns.
What kinds of differences between products might affect adhesion?
The opportunity highlights that differences in product design, formulation, manufacturing processes, or key quality attributes can change adhesion performance, even when two products are intended to be equivalent.
What is meant by "meaningfully correlate" in this context?
Based on the description, it means the in vitro test results should be connected to clinically meaningful adhesion outcomes observed in actual use, supporting prediction of real-world performance rather than providing purely abstract measurements.
What does "mechanistic" data imply for FDA's interest?
The description indicates FDA is looking for data that helps explain why adhesion differences occur (not just whether they occur), supporting more informative and reproducible comparisons between test and reference products.
What is the overall intended outcome of the funded research?
Overall, the program aims to strengthen the scientific foundation for evaluating adhesion in transdermal and topical delivery systems by developing predictive in vitro tools that forecast real-world adhesion behavior and improve both product development decision-making and regulatory confidence.
Browse more opportunities from the same category: Science and Technology and other Research and Development
Next opportunity: Tribal Management Grant Program
Previous opportunity: PDS Belgrade Democracy Commission Small Grants Program
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 22 015
Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 22 015) also looked into and applied for these:
| Funding Opportunity |
|---|
| Opportunities in Frontier Plasma Science Apply for DE FOA 0002635 Funding Number: DE FOA 0002635 Agency: Department of Energy - Office of Science, Office of Science Category: Science and Technology and other Research and Development Funding Amount: $120,000 |
| Findable Accessible Interoperable Reusable Open Science Research Coordination Networks Apply for 22 553 Funding Number: 22 553 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| RESEARCH INITIATIVES AT THE NAVAL POST GRADUATE SCHOOL Apply for N00244 22 S NPS F001 Funding Number: N00244 22 S NPS F001 Agency: Department of Defense, Naval Supply Systems Command Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| QUANTUM COMPUTING in the SOLID STATE with SPIN and SUPERCONDUCTING SYSTEMS (QC-S5) Apply for W911NF 22 S 0006 Funding Number: W911NF 22 S 0006 Agency: Department of Defense, Dept of the Army -- Materiel Command Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Disability and Rehabilitation Research Projects (DRRP) Program: Americans With Disabilities Act (ADA) National Network Collaborative Research Project Apply for HHS 2022 ACL NIDILRR DPAD 0036 Funding Number: HHS 2022 ACL NIDILRR DPAD 0036 Agency: Department of Health and Human Services, Administration for Community Living Category: Science and Technology and other Research and Development Funding Amount: $500,000 |
| Semiconductor Synthetic Biology Circuits and Communications for Information Storage Apply for 22 557 Funding Number: 22 557 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Rehabilitation Engineering Research Centers (RERC) Program: RERC on Rehabilitation Strategies, Techniques, and Interventions Apply for HHS 2022 ACL NIDILRR REGE 0024 Funding Number: HHS 2022 ACL NIDILRR REGE 0024 Agency: Department of Health and Human Services, Administration for Community Living Category: Science and Technology and other Research and Development Funding Amount: $925,000 |
| Petrology and Geochemistry Apply for 22 560 Funding Number: 22 560 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Award Competition for Hollings Manufacturing Extension Partnership (MEP) Centers in the States of Kentucky, Nebraska, Rhode Island, and South Dakota Apply for 2022 NIST MEP 01 Funding Number: 2022 NIST MEP 01 Agency: Department of Commerce, National Institute of Standards and Technology Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Expanding Capacity in Quantum Information Science and Engineering Apply for 22 561 Funding Number: 22 561 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Molecular Tools for Management of Threatened and Endangered Species Apply for W81EWF 22 SOI 0009 Funding Number: W81EWF 22 SOI 0009 Agency: Department of Defense, Dept. of the Army -- Corps of Engineers Category: Science and Technology and other Research and Development Funding Amount: $64,300 |
| Avian Monitoring and Analysis in Upper Mississippi River Floodplain Apply for W81EWF 22 SOI 0004 Funding Number: W81EWF 22 SOI 0004 Agency: Department of Defense, Engineer Research and Development Center Category: Science and Technology and other Research and Development Funding Amount: $100,000 |
| Specially Adapted Housing Assistive Technology (SAHAT) Grant Program Apply for VA SAHAT 22 07 Funding Number: VA SAHAT 22 07 Agency: Department of Veterans Affairs, VA Loan Guaranty Service Category: Science and Technology and other Research and Development Funding Amount: $200,000 |
| Bat Diet Characterization at Arnold Air Force Base, Tennessee Apply for W9126G 22 2 SOI 1683 Funding Number: W9126G 22 2 SOI 1683 Agency: Department of Defense, Fort Worth District Category: Science and Technology and other Research and Development Funding Amount: $223,000 |
| U.S. Nuclear Regulatory Commission Notice of Funding Opportunity (NOFO), Research and Development Grant, Fiscal Year (FY) 2022 Apply for 31310022K0001 Funding Number: 31310022K0001 Agency: Nuclear Regulatory Commission Category: Science and Technology and other Research and Development Funding Amount: $500,000 |
| Early Career Faculty Apply for 80HQTR22NOA01 22ECF B1 Funding Number: 80HQTR22NOA01 22ECF B1 Agency: National Aeronautics and Space Administration, NASA Headquarters Category: Science and Technology and other Research and Development Funding Amount: $600,000 |
| Disability and Rehabilitation Research Projects (DRRP) Program: Community Living and Participation (Development) Apply for HHS 2022 ACL NIDILRR DPCP 0021 Funding Number: HHS 2022 ACL NIDILRR DPCP 0021 Agency: Department of Health and Human Services, Administration for Community Living Category: Science and Technology and other Research and Development Funding Amount: $500,000 |
| Disability and Rehabilitation Research Projects (DRRP) Program: Community Living and Participation (Research) Apply for HHS 2022 ACL NIDILRR DPCP 0022 Funding Number: HHS 2022 ACL NIDILRR DPCP 0022 Agency: Department of Health and Human Services, Administration for Community Living Category: Science and Technology and other Research and Development Funding Amount: $500,000 |
| Geophysics Apply for 22 563 Funding Number: 22 563 Agency: National Science Foundation Category: Science and Technology and other Research and Development Funding Amount: $1,500,000 |
| Fiscal Year 2022 Defense University Research Instrumentation Program – Lending Library (DURIP-LL) Apply for FOA AFRL AFOSR 2022 0002 Funding Number: FOA AFRL AFOSR 2022 0002 Agency: Department of Defense, Air Force Office of Scientific Research Category: Science and Technology and other Research and Development Funding Amount: $50,000 |
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 22 015", 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.