Catalyzing Innovation in Pediatric Pharmacology Clinical Trial Design and Resource Access (X01 Clinical Trial Not Allowed)

The purpose of this funding opportunity announcement (FOA) is to provide investigators with access to a consultative resource for planning activities and concept development for single or multi-site investigator initiated clinical trials that address gaps in pediatric drug development and that align with priorities identified in the Best Pharmaceuticals for Children Act (BPCA) Program. The FOA will support the development of clinical trials concepts of future well-designed clinical trials that require non-traditional designs in pediatric therapeutics with the opportunity to expand novelty and/or innovation. Investigators will have access to the expertise in pediatric drug development trial designs by utilizing the consultative services provided by the Pediatric Trials Network (PTN) and the BPCA Data Coordinating Center.

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.