NOT-OD-19-105: HHS issues Four (4) PHS 2019-2 SBIR and STTR Omnibus/Parent Grant Solicitations

HHS issues Four (4) PHS 2019-2 SBIR and STTR Omnibus/Parent Grant Solicitations

Notice Number: NOT-OD-19-105

Key Dates
Release Date: May 7, 2019

Related Announcements

Issued by
National Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)
U.S. Food and Drug Administration (FDA)

Purpose

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

Learn more about preparing your application using ASSIST

2. www.grants.gov Workspace

3. Your own System-to-System solution

Clinical Trials

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)

This is the 'main', regular Omnibus SBIR FOA. ALL listed NIH Institutes/Centers and CDC and FDA will accept SBIR applications that do NOT propose clinical trials, within the mission of the Institute/Agency.

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)

This is the 'main', regular Omnibus STTR FOA. ALL listed NIH Institutes/Centers (but not CDC and FDA as is the case every year) will accept STTR applications that do NOT propose clinical trials, within the mission of the Institute/Agency.

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)

This is the SBIR Omnibus/Parent Clinical Trials Required solicitation. Only the listed, participating NIH Institutes/Centers and CDC will accept SBIR applications that must propose a clinical trial as defined above. This will not be all NIH Institutes/Centers. FDA will not accept clinical trials for SBIR.

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)

This is the STTR Omnibus/Parent Clinical Trials Required solicitation. Only the listed, participating NIH Institutes/Centers will accept STTR applications that must propose a clinical trial as defined above. This will not be all NIH Institutes/Centers. CDC and FDA do not participate in STTR.

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:

2019 Program Descriptions and Research Topics and Appendix A (SBA approved topics for budget waivers)
SF 424 (R&R) Online HTML Application Guide
SF 424 (R&R) PDF Guide Application Guide for SBIR/STTR Grant Applications
Annotated SF424 SBIR/STTR Form Set

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).

One informational webinar will be offered that will cover all 4 Omnibus/Parent solicitations and Clinical Trials.

HHS SBIR/STTR PHS 2019-2 Grant Omnibus/Parent Webinar

Wednesday May 29, 2019, 1-3PM EDT
Please register for HHS SBIR/STTR PHS 2019-2 Grant Omnibus/Parent Webinar on Wednesday 29, 2019, 1-3PM EDT at:

https://attendee.gotowebinar.com/register/483596398390515457

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.

Inquiries

Please direct all inquiries to:

NIH SBIR/STTR Program Office
Telephone: (301) 435-2688
Email: sbir@od.nih.gov
Website: http://sbir.nih.gov