Opportunity Information: Apply for RFA FD 14 081
Apply for RFA FD 14 081
- The Food Drug Administration in the consumer protection food and nutrition 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 Food and Drug AdministrationResearch.
- This funding opportunity was created on Jun 10, 2014 and posted on Jun 10, 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: Private institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education State governments Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses City or township governments Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities County 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 "Evaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study Furosemide (U01)" (Funding Opportunity Number RFA-FD-14-081) is an FDA cooperative agreement aimed at improving how drug performance is predicted for pediatric use by testing conditions that better reflect what children actually ingest with medicines. The scientific motivation comes from earlier exploratory research within FDA's Center for Drug Evaluation and Research (CDER), which found that for a poorly soluble drug used as a model (furosemide), dissolution and/or solubility increased in media containing milk and infant formula compared with standard buffer media typically used in lab testing. In practical terms, that earlier work raised an important question: if food-like liquids such as milk or baby formula change how much of a drug dissolves, do they also change how much drug is absorbed in the body, and how quickly, especially in ways that could matter for pediatric dosing and product performance?
The proposed project focuses on generating in vivo evidence by studying furosemide administration in healthy adult volunteers under conditions designed to mimic aspects of pediatric administration. Rather than enrolling children, the study uses adults as a controlled, lower-risk way to probe the same core mechanism: co-administration with common pediatric vehicles. Specifically, furosemide would be given with milk, baby formula, and Ensure Plus, and the resulting drug absorption patterns would be measured. The design emphasis is on the early absorption window, with particular attention to changes detectable within the first 4 to 6 hours after dosing. That time frame points to intensive early pharmacokinetic sampling and analysis, because shifts in dissolution, gastric emptying, intestinal solubilization, or interactions with fats and proteins in these liquids are most likely to show up as differences in early exposure metrics such as rate of absorption, early area-under-the-curve, or peak concentration timing.
From a public health and regulatory science perspective, the opportunity sits at the intersection of consumer protection, food and nutrition, and health. The core deliverable is evidence that helps evaluate whether current predictive methods (for example, standard in vitro dissolution tests using buffer media) adequately represent real-world administration conditions relevant to pediatrics, where medicines are frequently taken with milk, formula, or nutrient drinks. If the adult in vivo data show meaningful shifts in absorption when furosemide is taken with these vehicles, it would support the idea that more biorelevant test conditions or updated predictive approaches are needed to assess product performance and potentially inform labeling, formulation development, or bioequivalence considerations for pediatric contexts. If the differences are small or inconsistent, the work would still be valuable because it helps define boundaries on when food-like media matter and when standard methods are sufficient.
Administratively, the award mechanism is a U01 cooperative agreement, meaning the FDA is expected to have substantial scientific or programmatic involvement during the project rather than acting only as a pass-through funder. The opportunity was categorized as discretionary funding, with an estimated total funding amount of $100,000 and an award ceiling of $100,000, with the expectation of making one award. There is no cost-sharing or matching requirement listed. The program is associated with CFDA number 93.103 (Food and Drug Administration Research). The opportunity was posted on June 10, 2014, with an original and current closing date of July 15, 2014, and an archive date of August 14, 2014.
Eligibility is broad and includes a range of U.S. entities such as public and private institutions of higher education, state and local governments (including counties, cities/townships, special district governments, and independent school districts), small businesses, for-profit organizations other than small businesses, and nonprofits with or without 501(c)(3) status, as well as Native American tribal governments and tribal organizations. Notably, non-U.S. entities are eligible: foreign institutions may apply, non-U.S. components of U.S. organizations are eligible, and foreign components (as defined by HHS grants policy) are allowed. This wide eligibility suggests the FDA was primarily focused on finding a capable clinical pharmacology or biopharmaceutics team with the facilities and experience to run controlled administration studies and analyze early absorption outcomes with high-quality methods.
For applicants seeking further details, the announcement referenced a full solicitation document ("Full Announcement RFA FD 14 081"). The grants management contact listed for access issues was Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "Evaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study Furosemide (U01)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-14-081.
Which federal agency is offering this funding?
This is an FDA funding opportunity. The work is tied to the FDA Center for Drug Evaluation and Research (CDER) as the scientific motivation comes from earlier CDER exploratory research.
What type of award mechanism is used?
The mechanism is a U01 cooperative agreement, which means FDA is expected to have substantial scientific or programmatic involvement during the project (not just provide funding).
What is the main scientific goal of the project?
The project aims to improve how drug performance is predicted for pediatric use by testing conditions that better reflect what children actually ingest with medicines, particularly when drugs are given with milk, infant formula, or nutrient drinks.
Why is furosemide used in this opportunity?
Furosemide is used as the case-study (model) drug because earlier FDA/CDER exploratory work with a poorly soluble model drug found dissolution and/or solubility increased in media containing milk and infant formula compared with standard buffer media used in typical lab testing.
What earlier findings motivated this study?
Earlier exploratory research found that dissolution and/or solubility for the model drug increased in milk and infant formula media compared with standard buffer media. This raised the question of whether those in vitro differences translate into meaningful in vivo differences in absorption (how much drug gets into the body and how quickly).
Does the study enroll pediatric participants?
No. The project is designed to generate in vivo evidence using healthy adult volunteers under conditions meant to mimic aspects of pediatric administration, rather than enrolling children.
Why use healthy adults instead of children?
Based on the description, adults are used as a controlled, lower-risk way to probe the same core mechanism: co-administration of a drug with common pediatric vehicles and measuring changes in absorption patterns.
What administration conditions are being tested?
Furosemide would be administered with milk, baby formula, and Ensure Plus, and the resulting absorption patterns would be measured in healthy adult volunteers.
What is meant by "pediatric vehicles" in this opportunity?
In this context, "vehicles" refers to food-like liquids that are commonly used when giving medicines in pediatric settings, specifically milk, infant formula, and nutrient drinks such as Ensure Plus.
What outcomes or measurements are emphasized?
The emphasis is on early absorption, with particular attention to changes detectable within the first 4 to 6 hours after dosing. This implies intensive early pharmacokinetic sampling and analysis focused on early exposure metrics (for example, rate of absorption, early area-under-the-curve, and peak concentration timing).
Why is the first 4 to 6 hours after dosing highlighted?
The opportunity indicates that differences driven by dissolution changes, gastric emptying, intestinal solubilization, or interactions with fats and proteins in these liquids are most likely to show up as differences in early exposure during the first several hours after administration.
What practical question is the FDA trying to answer through this work?
The practical question is whether food-like liquids (milk, infant formula, nutrient drinks) that increase dissolution/solubility in lab media also change in-body absorption in ways that could matter for pediatric dosing and product performance.
How does this relate to predictive methods like in vitro dissolution testing?
A central purpose is to evaluate whether standard in vitro dissolution tests using buffer media adequately represent real-world pediatric-relevant administration conditions. The study generates in vivo evidence that can support or challenge current predictive approaches.
What is the intended public health or regulatory science value?
The deliverable is evidence that helps assess whether more biorelevant test conditions or updated predictive approaches are needed for pediatric contexts. Depending on results, it could inform considerations around labeling, formulation development, or bioequivalence in pediatric-relevant administration scenarios.
What if the study finds large differences in absorption with milk or formula?
If meaningful shifts in absorption are observed when furosemide is taken with these vehicles, the results would support the idea that more biorelevant test conditions or updated predictive approaches may be needed to assess product performance for pediatric-relevant use.
What if the study finds small or inconsistent differences?
If differences are small or inconsistent, the work is still described as valuable because it helps define boundaries on when food-like media matter and when standard methods are sufficient.
What is the total expected funding amount?
The estimated total funding amount is $100,000.
What is the maximum (ceiling) award amount?
The award ceiling is $100,000.
How many awards were expected?
The opportunity stated an expectation of making one award.
Is cost sharing or matching required?
No cost-sharing or matching requirement is listed.
Is this opportunity discretionary funding?
Yes. The opportunity was categorized as discretionary funding.
What is the CFDA number associated with this program?
The program is associated with CFDA number 93.103 (Food and Drug Administration Research).
When was the opportunity posted?
The opportunity was posted on June 10, 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 is August 14, 2014.
Who is eligible to apply?
Eligibility is broad and includes many U.S. entity types: public and private institutions of higher education; state and local governments (including counties, cities/townships, special district governments, and independent school districts); small businesses; for-profit organizations other than small businesses; and nonprofit organizations with or without 501(c)(3) status. Native American tribal governments and tribal organizations are also eligible.
Are non-U.S. (foreign) organizations eligible?
Yes. Foreign institutions may apply. In addition, non-U.S. components of U.S. organizations are eligible, and foreign components (as defined by HHS grants policy) are allowed.
Where should applicants look for the full details of the solicitation?
The announcement referenced a full solicitation document titled "Full Announcement RFA FD 14 081."
Who is the listed grants management contact for access issues?
The grants management contact listed for access issues is Lisa Ko, Grants Management Specialist, reachable at lisa.ko@fda.hhs.gov.
What kind of team or capability does this opportunity appear to target?
Based on the description, the FDA appears focused on identifying applicants with the facilities and experience to run controlled administration studies in healthy adult volunteers and to analyze early absorption outcomes with high-quality pharmacokinetic methods.
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| Funding Opportunity |
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| Kidney Health Initiative (R18) Apply for RFA FD 14 018 Funding Number: RFA FD 14 018 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
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| Program Expansion for Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas to add a Medical Device Module for Secure Regulatory Information Exchange (U01) Apply for RFA FD 15 040 Funding Number: RFA FD 15 040 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01) Apply for RFA FD 15 036 Funding Number: RFA FD 15 036 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
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| Building towards Statistically Based Pharmaceutical Quality Standards (U01) Apply for RFA FD 16 003 Funding Number: RFA FD 16 003 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $1,000,000 |
| Evaluating Quality Metrics for Risk Based Surveillance of Drug Manufacturing Operations and Facilities (U01) Apply for RFA FD 16 004 Funding Number: RFA FD 16 004 Agency: Food Drug Administration Category: Consumer Protection Food and Nutrition Health Funding Amount: $500,000 |
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