CREATE Bio Program Pre-Application Process & Background

To be able to advise you better and know who in the NINDS team will be the best to give advice, we would like to know some basic background information and what objectives you want to achieve. Please provide the following brief information, as you would plan to describe in further detail in your grant application and as instructed in PAR-17-456, PAR-17-457 (SBIR), PAR-18-542, or  PAR-18-543 SBIR depending on the stage of your project. The information you provide during this pre-application process is voluntary but will help us to determine your eligibility for the appropriate track and to provide further guidance on program scope, goals, and developing appropriate milestones.

Title of the proposal

PI name, institution


Type of Therapy (Gene, oligo, peptide, protein, cell, other)

Specific Aims: Briefly list the aims.

Research Strategy: The Research Strategy section should include the following subsections:

  1. Significance: Clinical Impact and Feasibility [A target product profile (TPP)]
  2. Supporting Data for Entry [with a focus to explain how the data meet the entry criteria for the PAR you are interested in applying. You may include key data or key references.]
  3. Research Strategy [Only need Milestones and which year the proposed milestones will be completed]
  4. Team Management [only list major collaborators at this stage]


Please also let us know if the requested project budget will exceed $500K in direct costs in any year.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks (at least 12 weeks is strongly encouraged) before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide. Budget justification will be needed in order to proceed to a discussion with senior leadership for Acceptance for Review of Unsolicited Applications.