Step #1: Request a Technical Assistance Meeting with NIDA
The first step in the process is to request and complete a Technical Assistance meeting with the Office of Translational Initiatives and Program Innovations (OTIPI) team. The Technical Assistance meeting ensures the OTIPI team understands the problem you are solving and offers the opportunity to receive guidance on the grant application process.
Steps to request and complete a Technical Assistance Meeting:
- Review the eligibility requirements and confirm that your small business meets the requirements. If you have questions about your company’s eligibility, continue to schedule the Technical Assistance Meeting, where the OTIPI team can provide further guidance.
- Contact the OTIPI team to schedule your Technical Assistance Meeting.
- Once the meeting is complete and the OTIPI team has confirmed your small business is eligible, continue to Step #2.
Step #2: Complete the five required registrations
The next step in the process is completing the five required registrations. Typically, the registration process can take 6-8 weeks, so it is important to begin registration as early as possible. All registrations must be completed prior to the submission of an application.
- DUNS – required to obtain a unique organization identifier
- SAM (System for Award Management) – required to do business with the U.S. government
- eRA Commons – required to submit grant applications through the federal-wide portal
- Grants.gov – required to submit grant applications through the federal-wide grant portal
- SBA (Small Business Administration) – required to participate in SBIR and STTR federal funding programs
Additional details about each registration, can be found on the NIH SEED site.
Step #3: Submit your SBIR/STTR grant application to NIH
Most small business applicants will submit their SBIR or STTR application for the omnibus or Targeted Funding Opportunity Announcement via a web-based application software called ASSIST. An error-free application must be submitted via ASSIST by the due date with a time stamp on or before 5 p.m. in the submitting organization’s time zone. Detailed instructions on using ASSIST to submit your application can be found at the NIH ERA site.
Step #4: Receive Proposal Evaluation from the NIH Center for Scientific Review
NIH uses a rigorous dual peer review system to ensure that only the most meritorious scientific proposals are funded. For SBIR/STTR applications, the technology’s commercialization potential is also evaluated during the review process. The review occurs approximately 2-3 months after the application submission date. Once the review is complete, applicants will receive a summary statement of the reviewers’ feedback.
Step #5: Obtain a Notice of Award
If the application is funded, the small business will receive a Notice of Award (approximately 3 months after review).
If the application is not funded, please discuss your summary statement with the assigned Program Officer. The Program Officer will provide guidance and assistance on the next steps, including a possible resubmission.
Step #6: Conduct Research
NIDA’s grants management will outline the necessary steps to take prior to beginning the grant-funded research.
Grant recipients have 6 to 12 months to complete the research for a Phase I award and up to 2 years to complete the research for a Phase II award. In addition to the research work, Phase I recipients are strongly encouraged to complete business-related activities such as building out the team, identifying strategic partners, and raising capital in parallel to Phase I technical work. Completing business-related activities will ensure that a Phase II submission is competitive. Grantees should start planning a Phase II submission 3 months before the application due date.
In rare circumstances, if an active project requires additional funding, grantees can request an administrative supplement. Consistent with existing NIDA and NIH policies (PA-20-272), the request must be strongly justified and must address the criteria in the parent announcement for administrative supplement under Section V., Application Review Information.
Step #7: Submit Research Performance Progress Report
As the research grant comes to an end, grantees will be required to submit a Research Performance Progress Report (RPPR) one month prior to the grant’s end date. The report outlines the project’s accomplishments and compliance with terms of award. The progress report must be submitted electronically using the RPPR module in eRA Commons (See OER’s RPPR webpage for details).
If additional time is required to complete the project, the grantee may submit a No-Cost Extension (NCE). However this must be completed before the project period ends and must meet the following conditions:
- No additional funds are required from the NIH awarding office
- No change in the project’s originally approved scope
- No term of award specifically prohibits the extension
Submitting an NCE does not require prior authorization (See: No Cost Extension for NIH Grants), however, grantees are encouraged to contact their program officer to explain the request. Once an NCE is submitted, an email is automatically sent to the Grants Management specialist. No further action is required by the recipient.
How to Write a Commercialization Plan
A commercialization plan is a critical component in the application process. This document offers suggestions for writing a good commercialization plan.
Applicants also are encouraged to work with business development consultants with the Office of Translational Initiatives and Program Innovations (OTIPI) who can provide concrete feedback on the draft of the commercialization plan and the company’s pitch deck
Requests for feedback on the commercialization plan or pitch deck can be made during a Technical Assistance meeting with the program (Contact). For companies that have active grants with NIDA, the request also can be made directly to the Program Officer.