Opportunity Information: Apply for RFA FD 16 048
Apply for RFA FD 16 048
- The HHS-FDA in the consumer protection, health sector is offering a public funding opportunity titled "Evaluating predictive methods and product performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (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 Jun 14, 2016 and posted on Jun 14, 2016.
- Applicants must submit their applications by Aug 12, 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 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).
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Opportunity Summary:
This FDA (HHS-FDA) cooperative agreement opportunity, RFA-FD-16-048, focuses on improving how well researchers and regulators can predict how an oral drug product will behave in very young pediatric patients by testing a practical case study in healthy adults. The specific drug used as the model is furosemide, a poorly soluble drug where earlier exploratory research from CDER suggested an important food and formulation interaction: furosemide appeared to dissolve and/or become more soluble in media that contain milk or infant formula compared with standard buffer media typically used in laboratory dissolution testing. Because dissolution and solubility can strongly influence how much drug is absorbed after an oral dose, the grant is aimed at connecting those lab observations to real-world, in vivo drug exposure patterns.
The core of the proposed work is a clinical pharmacokinetic study in healthy adult volunteers. Participants would take furosemide tablets by mouth using different dosing liquids: water, milk, baby formula, and Ensure Plus. These liquids are chosen to simulate common dosing and feeding conditions for pediatric patients two years old and younger, where medications are often given with milk, formula, or nutritional supplements rather than plain water. The intent is not to study children directly, but to use a controlled adult study to understand how these pediatric-relevant liquids may change early drug absorption and overall exposure, and to provide data that can help evaluate and refine predictive methods used for pediatric product performance.
A major design feature highlighted in the announcement is the emphasis on the absorption phase, with careful characterization of the furosemide concentration-time profile during the first 6 hours after dosing. In practical terms, this means dense early blood sampling and analysis to capture the onset and rate of absorption, detect any shifts in peak concentration (Cmax), time to peak (Tmax), and early partial exposure (for example, early AUC metrics). The first several hours after dosing are typically the most sensitive window for observing food or liquid effects on dissolution and gastric emptying, so the grant places particular weight on getting high-resolution pharmacokinetic data in that timeframe rather than focusing only on later elimination.
From a broader program perspective, the project sits at the intersection of consumer protection and health (CFDA 93.103) and supports FDA/CDER’s interest in better tools for anticipating when pediatric administration practices could meaningfully alter drug performance. If milk, formula, or nutrition shakes measurably increase furosemide dissolution and change systemic exposure compared with water, that could have implications for dosing recommendations, labeling considerations, and the design of in vitro tests meant to mirror real-use conditions. Even if the findings show minimal differences, that result would still be valuable because it would help validate (or challenge) current assumptions about how predictive in vitro methods translate to in vivo behavior when pediatric-like coadministration liquids are used.
Administratively, the opportunity was offered as a U01 cooperative agreement, meaning FDA would expect substantial scientific involvement during the project rather than a hands-off grant. The award ceiling was $250,000 total, with one expected award. The opportunity was posted June 14, 2016, with a closing date of August 12, 2016. Eligibility was broad and included governmental entities, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), tribal governments and organizations, and other applicants as allowed by the solicitation.
Grant Opportunity FAQs (RFA-FD-16-048)
What is the goal of this FDA cooperative agreement (RFA-FD-16-048)?
The goal is to improve how well researchers and regulators can predict how an oral drug product will behave in very young pediatric patients by testing a practical case study in healthy adults. The project is designed to connect laboratory (in vitro) findings about dissolution/solubility to real-world (in vivo) drug exposure patterns.
Which FDA organization is associated with this opportunity?
The opportunity is associated with FDA (HHS-FDA), specifically reflecting FDA/CDER interests in improving predictive tools for pediatric product performance.
What funding mechanism is being used?
This was offered as a U01 cooperative agreement, which generally means FDA expects substantial scientific involvement during the project rather than a hands-off grant relationship.
What drug is being used as the model in this project?
Furosemide is the model drug for the case study.
Why was furosemide selected for this study?
Furosemide is described as a poorly soluble drug, and earlier exploratory research from CDER suggested an important food and formulation interaction. Specifically, furosemide appeared to dissolve and/or become more soluble in media containing milk or infant formula compared with standard buffer media typically used in lab dissolution testing.
What problem is the grant trying to address regarding dissolution and solubility?
The opportunity is aimed at understanding whether lab observations about increased dissolution/solubility in milk- or formula-containing media translate into meaningful differences in how much drug is absorbed after an oral dose (systemic exposure) under real-use conditions relevant to very young pediatric patients.
Is the study being conducted in children?
No. The intent is not to study children directly. The core work is a controlled clinical pharmacokinetic study in healthy adult volunteers, used to simulate pediatric-relevant dosing liquids and feeding conditions.
What type of study is at the core of the proposed work?
A clinical pharmacokinetic study in healthy adult volunteers focused on measuring furosemide concentration over time after oral dosing under different dosing-liquid conditions.
How will furosemide be administered in the study?
Participants would take furosemide tablets by mouth using different dosing liquids.
What dosing liquids are being compared?
The dosing liquids listed are water, milk, baby formula, and Ensure Plus.
Why were water, milk, baby formula, and Ensure Plus chosen?
They were chosen to simulate common dosing and feeding conditions for pediatric patients two years old and younger, where medications are often given with milk, formula, or nutritional supplements rather than plain water.
What age group is the study trying to better predict outcomes for?
The case study is intended to support prediction for very young pediatric patients, specifically referencing pediatric patients two years old and younger.
What is the main pharmacokinetic focus of the study design?
A major design feature is emphasis on the absorption phase, with careful characterization of the concentration-time profile during the first 6 hours after dosing.
Why is the first 6 hours after dosing emphasized?
The first several hours after dosing are described as the most sensitive window for observing food or liquid effects on dissolution and gastric emptying. The grant therefore places particular weight on high-resolution pharmacokinetic data in that timeframe.
What kind of sampling approach is implied for the absorption-phase focus?
The announcement describes dense early blood sampling and analysis during the first 6 hours to capture the onset and rate of absorption.
Which pharmacokinetic outcomes are specifically mentioned?
The description mentions detecting shifts in peak concentration (Cmax), time to peak (Tmax), and early partial exposure (for example, early AUC metrics), along with overall characterization of the concentration-time profile during early absorption.
Is the study focused only on later elimination-phase pharmacokinetics?
No. The emphasis is on the early absorption window rather than focusing only on later elimination.
How does this project relate to pediatric administration practices?
It is designed to generate evidence about whether pediatric-relevant coadministration liquids (milk, formula, nutritional supplements) can meaningfully alter drug performance compared with water, which could matter because these liquids are commonly used when administering medications to very young children.
What kinds of implications are mentioned if meaningful differences are found?
If milk, formula, or nutrition shakes measurably increase furosemide dissolution and change systemic exposure compared with water, the opportunity notes possible implications for dosing recommendations, labeling considerations, and the design of in vitro tests meant to mirror real-use conditions.
Would a finding of minimal differences still be useful?
Yes. The opportunity states that even if findings show minimal differences, the result would still be valuable because it would help validate (or challenge) current assumptions about how predictive in vitro methods translate to in vivo behavior when pediatric-like coadministration liquids are used.
What broader program area is this project associated with?
The project is described as sitting at the intersection of consumer protection and health (CFDA 93.103).
What is the award ceiling for this opportunity?
The award ceiling was $250,000 total.
How many awards were expected?
One expected award was indicated.
When was the opportunity posted?
The opportunity was posted on June 14, 2016.
What was the closing date for applications?
The closing date was August 12, 2016.
Who was eligible to apply based on the announcement?
Eligibility was broad and included governmental entities, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), tribal governments and organizations, and other applicants as allowed by the solicitation.
Does the opportunity describe FDA involvement during the project?
Yes. Because it was a U01 cooperative agreement, FDA would expect substantial scientific involvement during the project.
What is the key real-world question this study is trying to answer?
Whether using pediatric-relevant dosing liquids (milk, baby formula, and nutritional supplements like Ensure Plus) changes early absorption and overall systemic exposure of a poorly soluble drug (furosemide) compared with dosing with water, and how those findings can inform predictive methods used for pediatric product performance.
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