Step 1: Determine target Institute(s) and Communicate with a Program Director (Not required, but recommended):The first step in the NIH SBIR/STTR process is to determine the target Institute(s) within NIH where your project aligns best. While not required, it is highly recommended to communicate with a Program Director at the relevant NIH Institute(s). They can provide valuable insights into the suitability of your project for funding and offer guidance on navigating the application process. Consulting with experienced NIH consultants, such as those provided by BBCetc, can also help in determining the best fit for your project and approaching the Program Director effectively.

Step 2: Full Proposal:Once you have identified the target Institute(s) and received guidance from the Program Director or NIH consultants, you can proceed to prepare a full proposal. The full proposal includes a comprehensive Research Plan and other components, such as Biosketches, Facilities and Other Resources, Vertebrate Animals Section, PHS Human Subjects and Clinical Trials Information, and detailed budgets. It is crucial to submit all required components and adhere to the instructions provided in the solicitation, including rules regarding page limits and format.

Step 3: Prepare and submit application:NIH SBIR/STTR proposals are prepared and submitted through the agency's online portal, known as ASSIST. Utilizing ASSIST streamlines the application process and ensures compliance with NIH requirements. Applicants must follow the instructions provided in the application portal carefully and submit their proposals before the designated deadline.

Step 4: Proposal Review and Decision:Once submitted, proposals undergo a rigorous review process by members of a Study Section. These reviewers assess the proposal's scientific and technical merit, evaluating it based on five key criteria: Significance, Innovation, Investigators, Approach, and Environment. Applicants receive feedback in a Summary Statement approximately 2-3 months after submission. Notification regarding the funding decision is typically provided 6-9 months after submission.

By following these steps and leveraging available resources, applicants can enhance their chances of securing funding for innovative projects aimed at addressing health-related challenges.