NIH Implements Option for Applicants to Switch between the SBIR/STTR programs and the SBIR Direct to Phase II pilot of the SBIR/STTR Reauthorization Act of 2011

Notice Number: NOT-OD-14-048

Key Dates
Release Date: February 5, 2014

Related Announcements
PA-14-071 (SBIR Omnibus Solicitation)
PA-14-072 (STTR Omnibus Solicitaion)
PAR-14-088 (SBIR Direct to Phase II pilot solicitation)

Issued by
National Institutes of Health (NIH)

Purpose

The 2014 Omnibus Grant Solicitations of the NIH, CDC, FDA and ACF are now available for the SBIR and STTR programs (NIH only).

The 2014 SBIR/STTR Omnibus solicitations and accompanying resources can be found below:

Standard Application Due Dates: April 5, August 5, and December 5, 2014. AIDS and AIDS-related Application Due Dates: May 7 2014, September 7 2014, January 7, 2015.

HHS is committed to implementing all the provisions of the SBIR/STTR Reauthorization Act of 2011 (P.L. 112-81).  NIH has set up a website to keep the small business research community abreast of its implementation plan for the many changes resulting from the reauthorization. The site will be updated as the implementation process moves forward. 

This issuance implements an additional provision of the Reauthorization Act.

1. NIH SBIR/STTR applicants may now ‘switch’ programs at Phase II or Phase IIB.

Under Section 5104 of the Reauthiorization Act, a Federal agency may issue an SBIR Phase II award to an STTR Phase I awardee to further develop the work performed under the STTR Phase I award.  NIH has extended this to include the transition from Phase II to Phase IIB.  Therefore Effective 2/1/2014:

  • Phase I STTR Awardees may apply for NIH SBIR or STTR Phase II.
  • Phase I SBIR Awardees may apply for NIH SBIR or STTR Phase II.
  • Phase II STTR Awardees may apply for NIH SBIR or STTR Phase IIB.
  • Phase II SBIR Awardees may apply for NIH SBIR or STTR Phase IIB.

Applicants may ‘switch’ programs to any active and open NIH SBIR or STTR solication, including the Omnibus and any targeted funding opportunity.

Note that not all NIH Institutes and Centers accept Phase IIB applications.  For those ICs that included these opportunities in the PHS 2014-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, FDA, and ACF, applications will be accepted through this Parent SBIR FOA. All others must be submitted in response to the specific FOA released by the IC. See the NIH Special Announcements for Small Business Research Opportunities for a list of these unique SBIR funding opportunities.

Applicants must follow the all the rules and policies for the program and solicitation they are applying for.  The employment status of the PI, sub-contracting rules, etc, must be adhered to for the Phase II or IIB application to the opposite program. 

For example, a Phase I STTR awardee where the Principal Investator (PI) is at the non-profit research instituton (RI) and where the RI is performing a minimum of 30%, but up to 60% of the work intends to apply for SBIR Phase II.  For the SBIR program, the PI must have primary employment at the small business concern and the small business must perform at least 50% of the work in Phase II; these eligibility rules and all applicable regulations must be met for the SBIR program.

Applicants are strongly advised to discuss this option with their program officer well in advance of any due date.

2. NIH has issued a pilot SBIR Direct to Phase II soliciation, PAR-14-088.

Under Section 5106 of the Reauthiorization Act, NIH may ‘issue a Phase II award to a small business concern that did not receive a Phase I award for that research/research & development'.  This is a so-called ‘Direct-to-Phase II’ SBIR award. This authority would permit small businesses to submit Direct-to-Phase-II SBIR applications, if the small business had performed the Phase I stage-type of research through other funding sources.  The legislative rationale for permitting the Direct-to-Phase II  award is to allow a SBC that has already built a technology prototype  and tested its feasibility (i.e. completed Phase-I-type R&D) to move directly into a Phase-II-type R&D that tests the functional viability of the prototype according to scientific methods and potential for commercial development The Direct-to-Phase-II SBIR mechanism eliminates the need for the SBCs  to propose additional small feasibility studies, if the technology is ready for the Phase II stage of development.  The Direct-to-Phase II authority is not available to the STTR program and not available for the CDC, FDA, and ACF SBIR progams.

To implement this provision, NIH has issued a pilot SBIR Direct to Phase II solicitation PAR-14-088Only the NIH Institutes and Centers listed in Components of Participating Organizations within the solicitation will accept Direct-to-Phase II SBIR submissions.  The solicitation will also not accept ‘regular’ Phase II submissions from SBCs that have received a Phase I SBIR or STTR award from NIH or any other agency that participates in the SBIR/STTR programs for projects which applicants are now seeking  follow-on research and development funding.

Please read the soliciation carefully, paying particular attention to instructions specific to this program.  Applicants are strongly advised to discuss this option with their program officer well in advance of any due date.

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

 

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.