HHS issues Four (4) PHS 2018-2 SBIR and STTR Omnibus/Parent Grant Solicitations with FORMS-E and Clinical Trials Policy Updates

Notice Number: NOT-OD-18-123

Key Dates
Release Date:  January 16, 2018

Related Announcements
PA-18-574      
PA-18-575
PA-18-573
PA-18-576

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

Purpose

The 2018 Omnibus (Parent) Grant Solicitations of the NIH, CDC, and FDA are now available for the SBIR and STTR (NIH only) programs.  This issuance also implements new NIH Clinical Trials Policy and FORMS-E transition, as detailed below.

FORMS-E

With this issuance, all SBIR/STTR applications for due dates on or after January 25, 2018 must use application packages with a competition id of FORMS-E

Additionally, with the transition to FORMS-E, applicants can no longer submit directly to www.grants.gov with a single, downloaded PDF form package.  Submission options are:

  1. NIH ASSIST (Application Submission System & Interface for Submission Tracking) - recommended
  2. www.grants.gov Workspace
  3. Your own System-to-System solution

           

FORMS-E introduces an updated SBIR/STTR Information Form, updated R&R Budget and associated R&R Subaward Attachment Form, new PHS Human Subjects and Clinical Trials Information Form and other changes listed here: https://grants.nih.gov/grants/funding/high-level_summary_of_form_changes-FORMS-E.pdf.

Clinical Trials

NIH is launching a series of initiatives that are rolling out in 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-18-574 PHS 2018-02 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-18-575 PHS 2018-02 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-18-573 PHS 2018-02 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 will accept SBIR applications that must propose a clinical trial as defined above.  This will not be all NIH Institutes/Centers.  CDC and FDA will not accept clinical trials for SBIR.

4. PA-18-576 PHS 2018-02 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 2018 Program Descriptions and Research Topics and Appendix A (SBA approved topics for budget waivers).

Additional resources for the HHS 2018 SBIR/STTR Omnibus/Parent solicitations can be found below:

 
Standard Application Due Dates: April 5, 2018; September 5, 2018; January 7, 2019 (January 5, 2019 is on a Saturday); and April 5, 2019.

These Omnibus/Parent FOAs are being issued with four (4) due dates.

Two informational webinars will be offered.  

The content of both webinars will be similar, but webinar 1 will provide specific information about clinical trials and using the New PHS Human Subjects and Clinical Trials Information Form. 

1. HHS SBIR/STTR PHS 2018-2 Grant Clinical Trial Parent Webinar

2. HHS SBIR/STTR PHS 2018-2 Grant Non-Clinical Trial Omnibus 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.

Inquiries

Please direct all inquiries to:

NIH SBIR/STTR Program Office
Telephone: (301) 435-2688
Fax: (301) 480-0146
Email: sbir@od.nih.gov
Website: http://sbir.nih.gov