OpportunityTitle: Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required)  Activity Code
AdditionalInformationOnEligibility: Higher Education Institutions&#8226; Public/State Controlled Institutions of Higher Education &#8226; Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher Education&#8226; Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) &#8226; Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations&#8226; Small Businesses&#8226; For-Profit Organizations (Other than Small Businesses)Governments&#8226; State Governments &#8226; County Governments&#8226; City or Township Governments&#8226; Special District Governments&#8226; Indian/Native American Tribal Governments (Federally Recognized) &#8226; Indian/Native American Tribal Governments (Other than Federally Recognized)&#8226; U.S. Territory or PossessionOther&#8226; Independent School Districts&#8226; Public Housing Authorities/Indian Housing Authorities&#8226; Native American Tribal Organizations (other than Federally recognized tribal governments)&#8226; Faith-based or Community-based Organizations&#8226; Regional Organizations
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&#8217;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&#8217;sresearch area of interest to &#8220;stimulate innovation in clinical evaluations andpersonalized medicine to improve product performance and patient outcomes.
GrantorContactEmailDescription: Work Email
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592