Opportunity Information: Apply for RFA FD 21 013
This funding opportunity, titled "Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional" (RFA FD 21 013), is a cooperative agreement grant from the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It sits in the broader category of consumer protection, health, and research and development, and is cataloged under CFDA 93.103. The core focus is on building and improving mechanistic PBPK models specifically designed to represent how active pharmaceutical ingredients move into and through the skin when delivered by dermatological drug products.
The project aim is very targeted: develop enhanced, physiologically realistic PBPK modeling frameworks that can describe dermal absorption in a way that is useful for regulatory science. In practice, that means creating models that better capture the biological and physical processes involved in topical delivery, such as transport across skin layers and factors that influence uptake after application to the skin. The FDA is looking for models that are not just theoretical, but usable for decision-making around generic drug development, including "virtual bioequivalence" evaluations. Virtual bioequivalence generally refers to using scientifically credible computer simulations to compare how a proposed generic product performs relative to a reference product, potentially reducing reliance on certain in vivo studies and helping address long-standing challenges in proving bioequivalence for topical dermatological products.
The intended impact is to support more efficient and reliable development pathways for generic dermatology products and to strengthen the evidence base used in regulatory decisions. By improving PBPK models that can simulate dermal absorption, the work is meant to help identify what product characteristics matter most for performance, guide formulation development, and provide a scientifically defensible approach for comparing products through modeling and simulation. The "Clinical Trials Optional" label indicates that clinical trials are not required for all projects under this announcement, although applicants may include clinical components if they are justified and aligned with the project goals.
In terms of who can apply, eligibility is broad and includes many types of organizations: federal recognized tribal governments and other tribal organizations, state and local governments (including counties, cities, townships, and special districts), independent school districts, public housing authorities/Indian housing authorities, public and state-controlled institutions of higher education, private universities, nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education), for-profit organizations other than small businesses, and small businesses. The funding instrument is a U01 cooperative agreement, which typically implies substantial programmatic involvement from the funding agency compared to a standard research grant, with closer coordination between the awardee and FDA during the project.
Operational details provided in the notice include an opportunity creation date of December 10, 2020, and an original application closing date of February 15, 2021. The maximum award amount (award ceiling) is listed as $500,000, and the FDA anticipated making about three awards. Overall, the opportunity is best understood as an FDA regulatory science investment aimed at advancing mechanistic modeling capabilities for topical drug absorption so that generic dermatological products can be developed and evaluated more effectively, including through simulation-based bioequivalence approaches that can inform regulatory determinations.Apply for RFA FD 21 013
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, health, science and technology and other research and development sector is offering a public funding opportunity titled "Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional" 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 Dec 10, 2020.
- Applicants must submit their applications by Feb 15, 2021. (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 3 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.
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Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional" (RFA FD 21 013).
Which agency is offering this grant?
This is offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA).
What type of funding mechanism is used?
The funding instrument is a U01 cooperative agreement.
What does a U01 cooperative agreement generally imply for applicants and awardees?
A U01 cooperative agreement typically indicates substantial programmatic involvement from the funding agency compared to a standard research grant. In this opportunity, it suggests closer coordination between the awardee and the FDA during the project.
What is the main goal of the project?
The core goal is to build and improve mechanistic, physiologically realistic PBPK modeling frameworks that represent how active pharmaceutical ingredients move into and through the skin when delivered by dermatological drug products, in a way that is useful for regulatory science.
What kinds of models are being sought?
The FDA is seeking enhanced, physiologically based pharmacokinetic (PBPK) models that can describe dermal absorption and better capture biological and physical processes involved in topical delivery, such as transport across skin layers and factors that influence uptake after application.
What is meant by "mechanistic" PBPK models in this context?
In this notice, "mechanistic" refers to models designed to represent biological and physical processes involved in dermal absorption (for example, movement across skin layers and factors influencing uptake), rather than being purely empirical or theoretical without physiological grounding.
How does this funding relate to generic dermatological products?
The work is intended to support more efficient and reliable development pathways for generic dermatology products by improving modeling tools used to evaluate topical drug absorption and product performance.
What is "virtual bioequivalence" and why is it mentioned?
Virtual bioequivalence refers to using scientifically credible computer simulations to compare how a proposed generic product performs relative to a reference product. The models developed under this opportunity are expected to be usable for decision-making in generic drug development, including virtual bioequivalence evaluations.
What problem is the FDA trying to address with this opportunity?
The opportunity targets long-standing challenges in proving bioequivalence for topical dermatological products by strengthening mechanistic modeling capabilities that can support comparison of products through modeling and simulation.
What kinds of real-world uses does the FDA expect from the models?
The FDA is looking for models that are usable for regulatory science decision-making. The intended uses include helping identify which product characteristics matter most for performance, guiding formulation development, and supporting scientifically defensible product comparisons through modeling and simulation.
Is this opportunity specifically about dermatological (topical) delivery?
Yes. The core focus is on PBPK models that represent dermal absorption for active pharmaceutical ingredients delivered by dermatological drug products.
What does "Clinical Trials Optional" mean for this announcement?
Clinical trials are not required for all projects under this announcement. Applicants may include clinical components if they are justified and aligned with the project goals.
Are clinical trials required to apply?
No. Based on the "Clinical Trials Optional" designation, clinical trials are not required for all projects, although they may be included if justified and aligned with the project goals.
Which category does this opportunity fall under?
It is described as sitting in the broader category of consumer protection, health, and research and development.
What is the CFDA number for this opportunity?
The opportunity is cataloged under CFDA 93.103.
Who is eligible to apply?
Eligibility is broad and includes: federally recognized tribal governments and other tribal organizations; state and local governments (including counties, cities, townships, and special districts); independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private universities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations other than small businesses; and small businesses.
Can small businesses apply?
Yes. Small businesses are listed as eligible applicants.
Can for-profit organizations apply?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed separately as eligible.
Can universities apply?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private universities.
Can nonprofit organizations apply?
Yes. Nonprofits with or without 501(c)(3) status are eligible as long as they are not institutions of higher education.
Can government entities apply?
Yes. Eligible applicants include state and local governments and tribal governments and tribal organizations. Independent school districts and public housing authorities/Indian housing authorities are also included.
What is the maximum award amount?
The award ceiling is listed as $500,000.
How many awards did the FDA anticipate making?
The FDA anticipated making about three awards.
When was this funding opportunity created?
The opportunity creation date is December 10, 2020.
What was the original application closing date?
The original application closing date was February 15, 2021.
What does the FDA ultimately hope to achieve through this investment?
The intended impact is to improve the evidence base used in regulatory decisions and enable more efficient and reliable development and evaluation of generic dermatological products by advancing mechanistic PBPK models for dermal absorption, including simulation-based bioequivalence approaches.
Is the focus on purely theoretical modeling or practical regulatory application?
The notice emphasizes that the models should not be just theoretical. They should be usable for regulatory science decision-making, including virtual bioequivalence evaluations and other modeling-and-simulation approaches that can inform regulatory determinations.
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Applicants also applied for:
Applicants who have applied for this opportunity (RFA FD 21 013) also looked into and applied for these:
| Funding Opportunity |
|---|
| Development of Methods to Evaluate the Impact of Design Differences to the User Interface of Generic Drug-Device Combination Products in Comparison to their Reference Listed Drugs (U01) Clinical Trials Optional Apply for RFA FD 21 014 Funding Number: RFA FD 21 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Cutaneous pharamcokinetic-based approaches to establish bioequivalence of topically applied drug products Apply for RFA FD 22 017 Funding Number: RFA FD 22 017 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $1,500,000 |
| Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products Apply for RFA FD 22 018 Funding Number: RFA FD 22 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial Optional Apply for RFA FD 22 016 Funding Number: RFA FD 22 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $600,000 |
| In Vitro Based Approaches to Evaluate the Bioequivalence of Generic Rectal and Vaginal Products Apply for RFA FD 22 014 Funding Number: RFA FD 22 014 Agency: Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Development of advanced analytical methods for the characterization of complex generics Apply for RFA FD 22 013 Funding Number: RFA FD 22 013 Agency: Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $300,000 |
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