Food and Drug Administration

Description

The purpose of this funding opportunity announcement (FOA)is to support research to develop and qualify a Patient Reported Outcome (PRO)for Non-Cystic Fibrosis Bronchiectasis (NCFB) under FDA’s Drug DevelopmentTools Qualification Program. This would include the qualitative phase ofdeveloping the instrument, quantitative phase of testing the instrument, andqualification of the instrument. It is expected that thisqualified PRO would help improve upon the current design, conduct, andinterpretation of anti-infective clinical trials in NCFB patients, for whichoptimal endpoints are currently lacking. This work directly aligns with FDA’sresearch area of interest to “stimulate innovation in clinical evaluations andpersonalized medicine to improve product performance and patient outcomes.

Who can apply

• 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)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Shashi Malhotra <br/>Grants Management Specialist <br/>Phone 2404027592
shashi.malhotra@fda.hhs.gov