Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed)

Drug development tools (DDTs) are methods, materials, or measures that can potentially facilitate drug development. To support DDT development efforts, FDA established qualification programs for animal models for use under the Animal Rule, biomarkers, and clinical outcome assessments. Examples of DDTs may include but are not limited to: a biomarker used for clinical trial enrichment, a clinical outcome assessment (COA) used to evaluate clinical benefit, or an animal model used for efficacy testing of medical countermeasures under the regulations commonly referred to as the Animal Rule. Qualification is a conclusion that within the stated context of use, the DDT can be relied upon to have a specific interpretation and application in drug development and regulatory review under the FD&C Act. Qualification does not encompass the use of a DDT outside the COU specified through the qualification process. Once qualified, a DDT may be used within the qualified Context of Use (COU) as part of any relevant drug or biologic Investigational New Drug Application (IND), New Drug Application (NDA) or Biologic Licensing Application (BLA) without submission of additional information to justify the use of the DDT. Qualification of a DDT is voluntary and the use of a qualified DDT is not required for drug or biologic development. However, having qualified DDTs that can be used by multiple sponsors helps optimize drug development and evaluation. Increased public availability of qualified DDTs for specific contexts of use is anticipated to benefit the public health through (1) increased availability of effective drugs, (2) earlier access to medical therapies and (3) an enhanced knowledge of the drug under development. The qualification process allows for greater efficiency of development of DDTs by promoting DDT development in the precompetitive arena through collaborative efforts such as public-private partnerships and consortia. These grants will be used to provide funding to developers of drug development tools that have an accepted letter of intent within CDER's Drug Development Tool Qualification Program and working towards their qualification plan or full qualification package as described here: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm378219.htm . The grants will be used to further the development of tools that, once qualified, will be made publicly available to fill unmet needs in drug development. Applicants should use the outline of the qualification plan or full qualification package of the respective DDT program they are in, to assist in developing their grant application. Funding will only support grantee's work towards either their qualification plan or full qualification package.