Opportunity Information: Apply for RFA FD 14 080
Apply for RFA FD 14 080
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Predictive in vitro Methods for Characterizing Product Performance, 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 Food and Drug AdministrationResearch.
- This funding opportunity was created on Jun 9, 2014 and posted on Jun 9, 2014.
- Applicants must submit their applications by Jul 15, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $100,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $100,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Special district governments Native American tribal governments (Federally recognized) State governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses County governments Independent school districts Small businesses Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments).
- Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
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Opportunity Summary:
The grant opportunity titled "Predictive in vitro Methods for Characterizing Product Performance, Case Study Furosemide (U01)" is an FDA cooperative agreement focused on improving laboratory (in vitro) methods that can better predict how a drug product performs in people (in vivo). The project builds directly on earlier Center for Drug Evaluation and Research (CDER) work where researchers measured furosemide dissolution and solubility in a range of test media, including simulated gastric and intestinal fluids. Those prior studies, using different experimental approaches and dissolution apparatus, produced a notable and consistent finding: furosemide dissolved more when the dissolution medium included milk or baby formula than when standard buffer media were used. That observation raises an important scientific and regulatory question about whether conventional dissolution tests, which often rely on simpler buffer systems, may miss clinically relevant behavior that occurs when patients take medicines with food or nutritional liquids.
The core purpose of this funding is to expand and refine dissolution methodology for furosemide by systematically examining dissolution behavior in media that contain milk, baby formula, and Ensure Plus. These are practical, real-world nutritional matrices that can meaningfully change the chemical environment around a dosage form by altering factors such as pH, ionic strength, viscosity, fat content, protein binding, and micellar solubilization. Because these factors can affect how quickly and how much drug dissolves, testing in such media could reveal performance differences that standard aqueous buffers do not capture. The project is framed as a case study using furosemide as a model drug, with the broader implication that successful methods could inform future approaches for other challenging compounds or formulations.
A key scientific driver is the nature of furosemide itself. The opportunity highlights that furosemide is considered a poorly soluble and poorly permeable compound and is classified as a Biopharmaceutics Classification System (BCS) Class IV drug. Drugs in this category are often the hardest to assess with simple surrogate tests because both dissolution (how much drug becomes available in solution) and permeability (how much can cross biological membranes) can limit absorption. As a result, predicting in vivo performance from in vitro tests is particularly difficult, and improved test conditions that better mimic realistic administration scenarios may be necessary. This project aims to determine whether dissolution methods using milk, baby formula, and Ensure Plus are suitable and predictive for understanding and forecasting furosemide performance in the body, rather than merely describing dissolution under idealized laboratory conditions.
From an operational standpoint, this was a discretionary FDA funding opportunity using a U01 cooperative agreement mechanism, which typically means substantial scientific involvement from the FDA during the project rather than a fully investigator-directed grant. The funding activity area is categorized under consumer protection, food and nutrition, and health, reflecting the intersection between drug performance and nutritional co-administration. The opportunity anticipated a single award with an estimated total funding amount of $100,000 and an award ceiling of $100,000, with no cost-sharing or matching requirement.
Eligibility was broad and included many U.S.-based entities such as state and local governments, tribal governments and organizations, public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), public housing authorities, and for-profit organizations including small businesses. Importantly, the announcement also allowed foreign participation: non-U.S. entities were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components as defined by HHS policy were permitted. The opportunity was posted June 9, 2014, with an original and current closing date of July 15, 2014, and an archive date of August 14, 2014. The listing references CFDA number 93.103 (Food and Drug Administration, Research). For administrative questions or access issues, the grant management contact provided was Lisa Ko (lisa.ko@fda.hhs.gov).
Overall, the grant is centered on a practical regulatory science problem: standard dissolution tests may not always reflect real-use conditions, especially for difficult drugs like BCS Class IV compounds. By investigating dissolution testing in nutritionally relevant media (milk, infant formula, Ensure Plus) and evaluating whether these methods better anticipate in vivo outcomes, the project aims to strengthen the scientific basis for assessing product performance and, ultimately, support better-informed decisions about drug quality and therapeutic equivalence.
Frequently Asked Questions (FAQs)
What is the title of this grant opportunity?
The opportunity is titled "Predictive in vitro Methods for Characterizing Product Performance, Case Study Furosemide (U01)."
Which agency is offering this funding?
This is a U.S. Food and Drug Administration (FDA) funding opportunity, associated with the Center for Drug Evaluation and Research (CDER) work described in the notice.
What type of funding mechanism is being used?
The opportunity uses a U01 cooperative agreement mechanism, which typically indicates substantial scientific involvement from the FDA during the project rather than a fully investigator-directed award.
What is the main purpose of the project?
The purpose is to improve and refine laboratory (in vitro) dissolution methods so they can better predict how a drug product performs in people (in vivo), using furosemide as the case study drug.
Why is furosemide being used as the case study drug?
Furosemide is described as a poorly soluble and poorly permeable compound and is classified as a Biopharmaceutics Classification System (BCS) Class IV drug. For BCS Class IV drugs, predicting in vivo performance from standard in vitro tests can be especially difficult, making it a useful model for exploring improved test methods.
What earlier FDA/CDER finding is motivating this project?
Earlier CDER work measured furosemide dissolution and solubility in various test media (including simulated gastric and intestinal fluids) and found a notable, consistent result: furosemide dissolved more when the dissolution medium included milk or baby formula than when standard buffer media were used.
What scientific question is this funding trying to address?
The project is aimed at addressing whether conventional dissolution tests that rely on simpler buffer systems may miss clinically relevant drug behavior that occurs when patients take medicines with food or nutritional liquids.
Which dissolution media are specifically emphasized in this opportunity?
The opportunity specifically calls for systematic examination of furosemide dissolution behavior in media containing milk, baby formula, and Ensure Plus.
Why test dissolution in milk, baby formula, and Ensure Plus?
These nutritional matrices can change the chemical and physical environment around a dosage form in ways that may influence dissolution, including changes in pH, ionic strength, viscosity, fat content, protein binding, and micellar solubilization. Testing in these media could reveal performance differences not captured by standard aqueous buffer tests.
Is the project intended to be broader than furosemide?
Yes. While furosemide is the model drug for the case study, the broader implication is that methods found to be successful could help inform future approaches for other challenging compounds or formulations.
What does the opportunity mean by "predictive" in vitro methods?
Within the context provided, "predictive" refers to in vitro dissolution methods that help forecast in vivo product performance, rather than only describing dissolution behavior under idealized or simplified laboratory conditions.
What funding amount is anticipated for this award?
The opportunity anticipated a single award with an estimated total funding amount of $100,000.
What is the award ceiling?
The award ceiling is $100,000.
Is there a cost-sharing or matching requirement?
No. The opportunity states there is no cost-sharing or matching requirement.
How many awards were anticipated?
The opportunity anticipated a single award.
What is the funding activity area or category for this opportunity?
The funding activity area is categorized under consumer protection, food and nutrition, and health, reflecting the intersection between drug product performance and nutritional co-administration.
Who is eligible to apply?
Eligibility is broad and includes U.S.-based entities such as state and local governments, tribal governments and organizations, public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), public housing authorities, and for-profit organizations including small businesses.
Are non-U.S. or foreign organizations eligible to apply?
Yes. The announcement allows foreign participation: non-U.S. entities were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components (as defined by HHS policy) were permitted.
What is the CFDA number associated with this opportunity?
The listing references CFDA number 93.103 (Food and Drug Administration, Research).
When was the opportunity posted?
The opportunity was posted on June 9, 2014.
What was the application closing date?
The original and current closing date listed is July 15, 2014.
When was the opportunity archived?
The archive date listed is August 14, 2014.
Who is the contact for administrative questions or access issues?
The grant management contact listed for administrative questions or access issues is Lisa Ko at lisa.ko@fda.hhs.gov.
What larger regulatory science issue does this grant aim to support?
The grant is centered on the concern that standard dissolution tests may not reflect real-use conditions, especially for difficult drugs such as BCS Class IV compounds. By evaluating dissolution testing in nutritionally relevant media (milk, infant formula, Ensure Plus) and assessing whether these methods better anticipate in vivo outcomes, the project aims to strengthen the scientific basis for assessing product performance and supporting better-informed decisions about drug quality and therapeutic equivalence.
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