NIDCR Drug, Biologic, Device and/or Procedure Intervention Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

Purpose. This Funding Opportunity Announcement (FOA), issued by the National Institute on Deafness and Other Communication Disorders (NIDCD), is a companion FOA to PAR-09-057, Improving Interventions for Communication Disorders, which supports the development of new efficacious interventions for communication disorders. The goal of the present FOA is to identify and develop new methodologies and insights into the basic biology of the communication sciences that will have the future potential for clinical and translational application but which are still at the preliminary exploratory stage.The research design will be milestone-driven and basic science in nature but the research plan must be focused on some clinical or translational problem related to communication disorders. Projects will necessarily have an uncertain outcome but must have a realistic expectation to yield enhanced diagnostic, intervention and treatment tools, or paradigms with widespread, cost-effective application in the NIDCD mission areas of hearing, balance, smell, taste, voice, speech and language.Basic science studies intended to explore some aspect of the biology of the communication sciences with no focus on future interventions and translational research are not appropriate. This FOA uses the R21/R33 grant mechanism and requires a separate statement that describes anticipated milestones and justifies the future translational potential of the proposed studies. Clinical and patient-oriented research is not appropriate. Mechanism of Support. This FOA will utilize the R21/R33 grant mechanism.Applicants will submit a single application organized into two phases, beginning with discussion of the R21 phase followed by discussion of the R33 phase. Funds Available and Anticipated Number of Awards. Awards issued under this FOA are contingent upon the availability of funds. Budget and Project Period. The total project period for an application submitted in response to this FOA may not exceed five years. The R21 phase may not exceed two years or $275,000 in direct costs, with no more than $150,000 in direct costs in any single year of the R21 phase. The R33 phase may not exceed four years (assumes the R21 component is for one year) or $1.5M in direct costs with no more than $400,000 in direct costs in any single year of the R33 phase.A separate detailed (non-modular) budget must be submitted for the R21 and R33 phase.The modular budget format is not to be used. Application Research Plan Component Length. The R21/R33 Research Plan component of the PHS398 (Items 2-5) may not exceed 25 pages, The Milestones section will be included within the 25-page limit for the Research Plan. See also http://grants.nih.gov/grants/funding/funding_program.htm. Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply. Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Number of PDs/PIs. More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application. Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct Resubmissions.Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Renewals. Applicants may not submit a renewal application.