Notice Number: NOT-OD-19-105
Release Date: May 7, 2019
The 2019 Omnibus (Parent) Grant Solicitations of the NIH, CDC, and FDA are now available for the SBIR and STTR (NIH only) programs.
Submission options are:
1. NIH ASSIST (Application Submission System & Interface for Submission Tracking) - recommended
3. Your own System-to-System solution
NIH launched a series of initiatives 2017-2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to results reporting. Learn more about these changes and how they will affect your research. Information can be found here: https://grants.nih.gov/policy/clinical-trials.htm.
The NIH definition of a clinical trial can be found here: https://grants.nih.gov/policy/clinical-trials/definition.htm, including a decision tree to assist applicants in determining if their project is a clinical trial here: https://grants.nih.gov/ct-decision/index.htm.
As a result of these initiatives, ALL applications, including SBIR/STTR, proposing any specific aims that meet NIH's definition of a clinical trial must now be submitted to a Funding Opportunity Announcement (FOA) that specifically states it accepts clinical trials.
NIH has implemented this requirement for the SBIR/STTR by offering four (4) Omnibus parents.
1. PA-19-272 PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
2. PA-19-270 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
3. PA-19-273 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
4. PA-19-271 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
NIH Institutes/Centers that do not accept SBIR or STTR clinical trial applications under these Omnibus/Parent solicitations may possibly accept clinical trial applications under a specific FOA issued by them. Those NIH Institutes/Centers will provide information to applicants about which FOAs small businesses can use to apply for clinical trials in their section of the 2019 Program Descriptions and Research Topics and Appendix A (SBA approved topics for budget waivers).
Additional resources for the HHS 2019 SBIR/STTR Omnibus/Parent solicitations can be found below:
Additionally, updated budget guidance is provided in all FOAs following recent SBA budget inflationary adjustments. Each participating component may also set their own budget limit (higher or lower than the amount listed) in the “Limited Amount of Award Section” of their respective topics section. Applicants are strongly encouraged to contact program officials prior to submitting any application in excess of the hard caps and early in the application planning process.
Standard Application Due Dates: September 5, 2019; January 6, 2020; and April 6, 2020 (January 5 and April 5, 2020 are on a Sunday).
HHS SBIR/STTR PHS 2019-2 Grant Omnibus/Parent Webinar
After registering, you will receive a confirmation email containing information about joining the webinar.
Frequently asked questions are available to assist applicants and can answer many basic questions about the program.
Please direct all inquiries to: