Opportunity Information: Apply for RFA FD 16 025
Apply for RFA FD 16 025
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Integrating Supersaturation-precipitation Mechanisms in Mechanistic Oral Absorption Models for Predicting In- vivo Performance of Associated Formulations (U01)" 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 Apr 01, 2016 and posted on Apr 01, 2016.
- Applicants must submit their applications by Jun 03, 2016. (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 $250,000.00 in funding.
- The number of recipients for this funding is limited to 2 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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Opportunity Summary:
This funding opportunity, titled "Integrating Supersaturation-precipitation Mechanisms in Mechanistic Oral Absorption Models for Predicting In-vivo Performance of Associated Formulations (U01)," is a U.S. government cooperative agreement program administered by the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS). It was released under Funding Opportunity Number RFA FD 16 025 and falls under the broader activity area of consumer protection, food and nutrition, and health (CFDA 93.103). The agency posted it on April 1, 2016, with an application deadline of June 3, 2016. The FDA anticipated making about two awards, with a maximum budget (award ceiling) of $250,000 per award.
The scientific focus is on improving the prediction of how certain oral drug formulations behave inside the human body, specifically for poorly water-soluble drugs that are formulated into "supersaturable" systems. In practical terms, many modern drug candidates dissolve poorly in water, which can limit how much of the drug dissolves in gastrointestinal (GI) fluids and ultimately gets absorbed. Supersaturable formulations are designed to temporarily create drug concentrations in the GI tract that exceed the drug's normal equilibrium solubility (a supersaturated state), which can increase the amount available for absorption. However, supersaturation is often unstable, and the drug can precipitate (come out of solution as solid particles) before it is absorbed, reducing exposure and creating variability. Because of this dynamic balance between supersaturation and precipitation, traditional models and simple dissolution tests often struggle to accurately forecast real in vivo performance.
The opportunity lays out two main objectives. First, it aims to integrate in vivo supersaturation-precipitation mechanisms into mechanistic, physiology-based oral absorption models. Mechanistic oral absorption models attempt to represent the underlying processes that govern drug dissolution, precipitation, transit, permeability, and absorption throughout the GI tract, rather than relying only on empirical correlations. Here, the emphasis is on explicitly capturing the formation and loss of supersaturation and the kinetics and triggers of precipitation in the in vivo environment, so that model predictions better reflect what actually happens after a patient takes a supersaturable formulation.
Second, the opportunity seeks to establish a mechanism-based in vitro-in vivo correlation (IVIVC) for these drug products. An IVIVC is a structured relationship between in vitro measurements (for example, dissolution or precipitation behavior measured in laboratory systems) and in vivo outcomes (such as plasma concentration-time profiles or measures of bioavailability). The key point in this announcement is that the desired IVIVC should be mechanism-based, meaning it should connect lab tests to clinical performance through a scientific understanding of the causative processes (supersaturation generation, precipitation kinetics, GI conditions, and absorption), rather than being a purely statistical fit. If successful, such correlations can support better formulation design, more informative quality testing, and more reliable prediction of clinical performance across batches or formulation variants, particularly for challenging poorly soluble compounds.
The award mechanism is a cooperative agreement (U01), which typically indicates that the FDA expects to have substantial scientific or programmatic involvement during the project compared to a standard grant. Eligibility was broad and included many categories of applicants: various levels of government (state, county, city/township, special districts), public and private institutions of higher education, federally recognized Native American tribal governments and certain tribal organizations, public housing authorities/Indian housing authorities, nonprofit organizations (including both 501(c)(3) and non-501(c)(3)), for-profit organizations (including those other than small businesses), and small businesses, along with other entities as described in the full eligibility clarification. Overall, the program is aimed at advancing regulatory-relevant science for oral drug product development, with a very specific emphasis on supersaturable formulations and the modeling and in vitro methods needed to predict their in vivo absorption performance more confidently.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Integrating Supersaturation-precipitation Mechanisms in Mechanistic Oral Absorption Models for Predicting In-vivo Performance of Associated Formulations (U01)."
Which federal agency is administering this program?
This program is administered by the U.S. Food and Drug Administration (FDA), within the U.S. Department of Health and Human Services (HHS).
What type of award is being offered?
The award mechanism is a cooperative agreement (U01), which generally means the FDA expects to have substantial scientific or programmatic involvement in the project compared with a typical grant.
What is the Funding Opportunity Number for this announcement?
The Funding Opportunity Number is RFA FD 16 025.
What is the CFDA number and activity area associated with this opportunity?
This opportunity is listed under CFDA 93.103 and falls within the broader activity area of consumer protection, food and nutrition, and health.
When was the opportunity posted, and when were applications due?
The FDA posted the opportunity on April 1, 2016. The application deadline was June 3, 2016.
How many awards did the FDA expect to make?
The FDA anticipated making about two awards.
What is the maximum budget per award?
The award ceiling was $250,000 per award.
What scientific problem is this program trying to address?
The program focuses on improving predictions of in vivo (in-human-body) performance for certain oral drug formulations, especially for poorly water-soluble drugs formulated as "supersaturable" systems. These systems can temporarily increase drug concentration in gastrointestinal (GI) fluids above equilibrium solubility, but the supersaturated state can be unstable and the drug may precipitate before absorption.
What are "supersaturable" oral formulations in the context of this opportunity?
Supersaturable formulations are designed to create drug concentrations in the GI tract that exceed the drug's normal equilibrium solubility (a supersaturated state), potentially increasing the amount of drug available for absorption. A key challenge is that supersaturation can be short-lived because the drug can precipitate out of solution as solid particles.
Why is precipitation important for predicting oral absorption of poorly soluble drugs?
Precipitation can reduce drug exposure and increase variability because drug that precipitates may no longer be available in dissolved form for absorption. The shifting balance between supersaturation and precipitation makes it hard for traditional models and simple dissolution tests to reliably predict real in vivo performance.
What is the first main objective described in the opportunity?
The first main objective is to integrate in vivo supersaturation-precipitation mechanisms into mechanistic, physiology-based oral absorption models. The goal is to more explicitly capture how supersaturation forms and dissipates in vivo and how precipitation is triggered and proceeds in the GI environment.
What is meant by a "mechanistic, physiology-based oral absorption model" here?
In this announcement, mechanistic oral absorption models are described as models that represent underlying processes governing dissolution, precipitation, transit, permeability, and absorption across the GI tract, rather than relying only on empirical correlations. The emphasis is on representing the causal processes that determine absorption outcomes.
What is the second main objective described in the opportunity?
The second main objective is to establish a mechanism-based in vitro-in vivo correlation (IVIVC) for these drug products, linking in vitro measurements (such as dissolution or precipitation behavior in lab systems) to in vivo outcomes (such as plasma concentration-time profiles or bioavailability) through scientifically grounded mechanisms.
How is a "mechanism-based" IVIVC different from a purely statistical correlation?
In this opportunity, a mechanism-based IVIVC is described as one that connects laboratory tests to clinical performance through a scientific understanding of the underlying causative processes (supersaturation generation, precipitation kinetics, GI conditions, and absorption), rather than being only a statistical fit to observed data.
What kinds of in vitro measurements are mentioned as relevant to the IVIVC goal?
The opportunity references in vitro measurements such as dissolution behavior and precipitation behavior measured in laboratory systems as examples of in vitro data that could be related to in vivo outcomes.
What kinds of in vivo outcomes are mentioned as targets for prediction or correlation?
The announcement mentions in vivo outcomes such as plasma concentration-time profiles and measures of bioavailability as examples of clinical performance metrics that could be linked to in vitro behavior.
Why does the announcement emphasize poorly water-soluble drugs?
Many modern drug candidates dissolve poorly in water, limiting how much drug dissolves in GI fluids and therefore limiting absorption. Supersaturable formulations can help by temporarily increasing dissolved concentrations, but precipitation can undermine this benefit and complicate prediction of in vivo performance.
Why might traditional dissolution tests or simple models be insufficient for these products?
The opportunity explains that the dynamic balance between supersaturation and precipitation can be difficult to capture with traditional models and simple dissolution tests, leading to inaccurate forecasts of real in vivo performance for supersaturable formulations.
How could successful results from this project be used, according to the opportunity description?
If successful, the mechanism-based correlations and improved models could support better formulation design, more informative quality testing, and more reliable prediction of clinical performance across batches or formulation variants, especially for challenging poorly soluble compounds.
Who was eligible to apply for this funding opportunity?
Eligibility was broad and included many categories of applicants, such as state, county, city/township, and special district governments; public and private institutions of higher education; federally recognized Native American tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (including 501(c)(3) and non-501(c)(3)); for-profit organizations (including those other than small businesses); small businesses; and other entities as described in the full eligibility clarification.
Is this opportunity focused on regulatory-relevant science?
Yes. The program is described as aimed at advancing regulatory-relevant science for oral drug product development, with a specific emphasis on supersaturable formulations and the modeling and in vitro methods needed to predict in vivo absorption performance more confidently.
What formulation types are the primary focus of this announcement?
The specific emphasis is on "supersaturable" oral formulations for poorly water-soluble drugs, particularly where supersaturation and precipitation in the GI tract strongly influence absorption and variability.
What is the core technical theme connecting the modeling and IVIVC objectives?
The unifying theme is integrating supersaturation-precipitation mechanisms (how supersaturation forms and how precipitation occurs in vivo) into both mechanistic oral absorption modeling and mechanism-based in vitro testing approaches that can be linked to in vivo performance.
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