Opportunity Information: Apply for RFA FD 13 035
Apply for RFA FD 13 035
- The Food Drug Administration in the consumer protection food and nutrition sector is offering a public funding opportunity titled "Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study Furosemide" 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 Jul 19, 2013 and posted on Jul 19, 2013.
- Applicants must submit their applications by Aug 15, 2013 The application receipt/due date is August 15, 2013 by 1159PM Eastern time.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $250,000.00 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 3 candidate(s).
- Eligible applicants include: Public and State controlled institutions of higher education.
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Opportunity Summary:
The FDA grant opportunity titled "Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study Furosemide" (Funding Opportunity Number RFA-FD-13-035) supports research aimed at improving how well laboratory (in vitro) testing predicts real-world drug performance (in vivo), with a specific emphasis on situations relevant to pediatric dosing. The project centers on furosemide as a model compound because it presents a challenging biopharmaceutic profile: it is considered a BCS Class IV drug, meaning it is both poorly soluble and poorly permeable. Drugs in this class often show variable absorption and are harder to model accurately using standard dissolution and solubility tests, which makes them useful for studying and improving predictive methods.
The scientific motivation for the project comes from earlier CDER research where furosemide dissolution and/or solubility were measured across different dissolution media, including simulated gastric and intestinal fluids. Across two separate studies that used different testing approaches and dissolution apparatus, a consistent pattern was observed: furosemide dissolved more when the test medium contained milk and baby formula than when it was tested in standard buffer media. This suggests that components in milk or formula (such as fats, proteins, and emulsifying structures) may enhance the apparent dissolution of furosemide compared with traditional, simpler laboratory buffers. Since pediatric patients commonly receive medications with milk or formula, these findings raise an important question about whether standard in vitro tests are missing clinically relevant effects of real feeding conditions.
To address that gap, the funded work is designed to generate in vivo data by administering furosemide to healthy adult volunteers together with milk, baby formula, and Ensure Plus. Although the long-term goal is tied to pediatric relevance, using healthy adults is a practical and ethical way to collect controlled pharmacokinetic data while still testing the food-matrix effects that mimic pediatric co-administration scenarios. The core objective is to determine whether in vitro dissolution methods that incorporate milk, baby formula, and Ensure Plus as components of the dissolution media can reliably predict what happens in vivo when furosemide is taken with these products. In other words, the project is about evaluating and validating the predictive value of these more biorelevant in vitro methods, using measured in vivo performance as the benchmark.
From a program and administrative standpoint, this is a discretionary grant opportunity in the FDA research portfolio, listed under the activity category "Consumer Protection - Food and Nutrition" with CFDA number 93.103. The announcement was posted July 19, 2013, with an application deadline of August 15, 2013 (11:59 PM Eastern), and an archive date of September 14, 2013. The FDA anticipated making up to three awards, with an estimated total funding amount of $250,000 and an award ceiling of $100,000 per award; there was no stated award floor. Cost sharing or matching was not required. Eligible applicants were limited to public and state-controlled institutions of higher education, indicating the program was aimed at academic or similarly structured public research institutions capable of conducting controlled dissolution testing and human pharmacokinetic studies.
Overall, the opportunity is essentially a targeted methods-development and validation effort: it links earlier laboratory observations (enhanced furosemide dissolution in milk/formula-containing media) to planned human data collection, then uses those results to judge whether modified in vitro dissolution approaches can better predict in vivo drug behavior. If successful, the work would strengthen the scientific basis for designing dissolution tests and performance predictions that reflect real administration conditions, particularly those common in pediatric care where drugs are frequently given with milk, formula, or nutritional supplements.
For applicants needing help accessing the full announcement, the listed grants management contact was Oluyemisi (Yemisi) Akinneye, Grants Management Specialist, reachable at 301-827-0079 or Oluyemisi.Akinneye@fda.hhs.gov, with the NIH Guide for Grants and Contracts provided as an additional information resource.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this FDA grant?
The opportunity is titled "Predictive Methods for Characterizing Product Performance in Pediatric Patients, Case Study Furosemide" and the Funding Opportunity Number is RFA-FD-13-035.
What is the main purpose of this grant opportunity?
The grant supports research aimed at improving how well laboratory (in vitro) testing predicts real-world drug performance (in vivo). The emphasis is on situations relevant to pediatric dosing, especially when medicines are administered with milk, baby formula, or nutritional supplements.
Which drug does the project focus on?
The project centers on furosemide as a model compound.
Why was furosemide selected as the model compound?
Furosemide presents a challenging biopharmaceutic profile and is considered a BCS Class IV drug (poorly soluble and poorly permeable). Drugs in this class often have variable absorption and are harder to model accurately using standard dissolution and solubility tests, making them useful for studying and improving predictive methods.
What issue in standard lab testing is this project trying to address?
Earlier CDER research observed that furosemide dissolved more in test media containing milk and baby formula than in standard buffer media. This suggests standard in vitro tests using simple buffers may miss clinically relevant effects that occur under real feeding conditions common in pediatric care.
What prior findings motivated this research?
Across two separate studies (using different testing approaches and dissolution apparatus), a consistent pattern was observed: furosemide showed greater dissolution when milk or baby formula was included in the dissolution media compared with standard buffer media.
What does the increased dissolution in milk or formula suggest?
It suggests that components in milk or formula (such as fats, proteins, and emulsifying structures) may enhance the apparent dissolution of furosemide compared with traditional laboratory buffers.
How is the project designed to generate real-world (in vivo) data?
The funded work is designed to administer furosemide to healthy adult volunteers together with milk, baby formula, and Ensure Plus, and then collect controlled pharmacokinetic data.
Why does the study use healthy adult volunteers if the emphasis is pediatric relevance?
Using healthy adults is described as a practical and ethical way to collect controlled pharmacokinetic data while still testing food-matrix effects that mimic pediatric co-administration scenarios (milk and formula).
Which co-administered products are specifically mentioned for the in vivo study?
The in vivo portion specifically mentions milk, baby formula, and Ensure Plus.
What is the core research objective of the funded work?
The core objective is to determine whether in vitro dissolution methods that incorporate milk, baby formula, and Ensure Plus into the dissolution media can reliably predict what happens in vivo when furosemide is taken with these products.
What does the grant mean by evaluating "predictive value" of in vitro methods?
In this context, it means comparing results from modified, more biorelevant in vitro dissolution testing (including milk/formula/Ensure Plus) against measured in vivo performance, using the in vivo data as the benchmark.
How does this project connect lab observations to human data?
It starts from prior lab observations (enhanced furosemide dissolution in milk/formula-containing media), then collects human pharmacokinetic data under comparable co-administration conditions, and finally uses those human results to judge whether the modified in vitro approaches predict in vivo behavior more accurately.
What is the program or activity category listed for this opportunity?
The opportunity is listed under the activity category "Consumer Protection - Food and Nutrition."
What CFDA number is associated with this FDA grant?
The CFDA number provided is 93.103.
Is this a discretionary grant?
Yes. It is described as a discretionary grant opportunity in the FDA research portfolio.
When was the announcement posted?
The announcement was posted on July 19, 2013.
What was the application deadline?
The application deadline was August 15, 2013 at 11:59 PM Eastern.
When was the archive date for this opportunity?
The archive date listed was September 14, 2013.
How many awards did FDA anticipate making under this opportunity?
FDA anticipated making up to three awards.
What was the estimated total funding amount?
The estimated total funding amount was $250,000.
What was the maximum award amount (award ceiling)?
The award ceiling was $100,000 per award.
Was there a minimum award amount (award floor)?
No award floor was stated.
Was cost sharing or matching required?
No. Cost sharing or matching was not required.
Who was eligible to apply?
Eligible applicants were limited to public and state-controlled institutions of higher education.
What types of capabilities would an applicant likely need for this project?
Based on the project description, applicants would need the capability to conduct controlled dissolution/solubility testing (including media containing milk, baby formula, and Ensure Plus) and to conduct human pharmacokinetic studies in healthy adult volunteers.
What is the long-term significance of the research if successful?
If successful, the work would strengthen the scientific basis for designing dissolution tests and performance predictions that better reflect real administration conditions, particularly those common in pediatric care where medications are often given with milk, formula, or nutritional supplements.
Who was the listed grants management contact for accessing the full announcement?
The listed grants management contact was Oluyemisi (Yemisi) Akinneye, Grants Management Specialist.
How can the grants management contact be reached?
Oluyemisi (Yemisi) Akinneye could be reached by phone at 301-827-0079 or by email at Oluyemisi.Akinneye@fda.hhs.gov.
What additional information resource was mentioned?
The NIH Guide for Grants and Contracts was provided as an additional information resource.
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