National Institutes of Health

Description

The purpose of this funding opportunity announcement is to support the development of Clinical Outcome Assessments (COAs) for Substance Use Disorders (SUDs) aiming to be qualified by the Food and Drug Administration (FDA) as Drug Development Tools (DDTs).The FDA qualification of a COA is based on a review of the evidence to support the conclusion that the COA is a "well-defined and reliable assessment of a targeted concept(s) in a specified context of use in adequate and well-controlled investigations". Once qualified as a DDT, the COA will become a publicly available instrument and can be deployed within a specified context of use (COU) as a sensitive, reliable and validated instrument. COA can be a patient-reported outcome (PRO), a clinician-reported outcome (ClinRO), an observer-reported outcome (ObsRO) or a performance outcome (PerfO). Applications may focus on the creation and development of a new COA, or on modification/optimization of an existing COA. The final goal is to have FDA-qualified COA(s) measure(s) that would be acceptable to regulatory authorities when used in SUDs clinical trials. It is expected that such FDA-qualified COAs will have a potential to catalyze the regulatory approval path for new treatments.

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

NIH OER Webmaster<br/>FBOWebmaster@OD.NIH.GOV
FBOWebmaster@OD.NIH.GOV