NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required)

The NIDCD is committed to identifying effective interventions for the treatment or prevention of communication disorders by supporting welldesigned and wellexecuted clinical trials. This funding opportunity announcement (FOA) supports a cooperative agreement between an NIDCD Project Scientist and an investigator to support a clinical trial that meets ANY of the following criteria: requires FDA oversight, has annual direct costs equal to or greater than $500,000, that is intended to formally establish efficacy, or has a higher risk to potentially cause physical or psychological harm. Clinical trial applications exceeding the annual direct costs of $700,000 or more may also be a criteria for this FOA. These investigator-initiated clinical trials are perceived to benefit from close interaction, oversight, and guidance resulting from a cooperative agreement. Only one clinical trial may be proposed in each NIDCD Clinical Trials in Communication Disorders U01 application.

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.