Evaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (U01)

Quick Facts

Due DateJuly 15, 2014 (Tuesday)
Award AmountUp to $ 100,000
Category of Funding ActivityConsumer Protection
Food and Nutrition
Health
Eligible Applicants
  • 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 - 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.

Program Description

Earlier exploratory CDER research projects showed that dissolution and/or solubility of a poorly soluble drug (furosemide was studied as the model drug) was higher in medium containing milk and baby formula than that in standard buffer medium. This research project will explore in vivo performance of furosemide in vivo in an environment similar to that seen in pediatric patients Furosemide will be given with milk, baby formula and Ensure Plus? to healthy adults. The studies will be designed with emphasis on the absorption phase and the changes that may be detected during the first 4 to 6 hours after dosing.

General Information

Funding Opportunity NumberRFA-FD-14-081
Funding Opportunity TitleEvaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (U01)
Opportunity CategoryConsumer Protection
Food and Nutrition
Health
Funding Instrument TypeCooperative Agreement
Category ExplanationNot Available
Number of Awards1
Cost Sharing or Matching RequirementNo
Posted DateJune 10, 2014 (Tuesday)
Application Due DateJuly 15, 2014 (Tuesday)
Application Archive DateAugust 14, 2014 (Thursday)
Total Program Funding$ 100,000
Award AmountUp to $ 100,000
CFDA Number
  • 93.103 - Food and Drug Administration_Research

Eligible Applicants

  • 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 - 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.

Contact Information

Agency NameDepartment of Health and Human Services
Program Information WebsiteFull Announcement RFA-FD-14-081
ContactOffice: Food & Drug Administration
Lisa Ko
Grants Management Specialist

lisa.ko@fda.hhs.gov

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