Notice Number: NOT-OD-13-027

Key Dates
Release Date: January 24, 2013

Related Announcements
PA-13-088
PA-13-089

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

Purpose

The PHS 2013-2 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for SBIR/STTR Grant Applications and SF 424 (R&R) Application Guide for SBIR/STTR Grant Applications are now available. The solicitation consists of: (1) parent funding opportunity announcement (FOA) for SBIR, (2) a parent FOA for STTR, and (3) narrative descriptions of the programs and research topics (in PDF - 1 MB and MS Word - 1 MB formats). The due dates for CY 2013 are April 5, August 5, and December 5, 2013. AIDS and AIDS-related applications are due May 7, September 7, 2013, and January 7, 2014.

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 new 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. The Small Business Administration (SBA) released the revised, final size rule on December 27, 2012, with a 30-day implementation window effective January 28, 2013. The new Omnibus FOAs (and all HHS- and NIH-issued FOAs) must also be published to allow sufficient time for the small business community to prepare applications for the first application due date of April 5, 2013. Given this and, furthermore, due to the complexities of implementing certain provisions, the issuance of the PHS 2013-2 Omnibus FOAs implements some, but not all, of the provisions of the SBIR/STTR Reauthorization Act.

HHS intends to revise, amend or re-issue the Omnibus FOAs in the middle of 2013 to implement additional reauthorization provisions as guidance from the SBA is received and electronic system and form updates at NIH and SBA are implemented.

Provisions implemented with current Omnibus issuances include:
New award budget language implementing new award guidelines, maximum award size and a waiver process to exceed (see the FOAs for details).
Allow applicants to sub-contract with a federal laboratory without the need for an SBA waiver (required previously).
Allow applicants to request up to $5,000 to obtain their own Technical Assistance vendor if they wish. In doing so, applicants cannot qualify for the NIH-provided Technical Assistance Programs.

HHS will implement the provisions below as guidance from the SBA is received and electronic system and form updates at NIH and SBA are realized; however at this time, the Omnibus FOAs DO NOT currently allow the following:

• Applicants cannot apply for Phase II SBIR funding based on a Phase I STTR award or conversely a Phase II STTR based on a Phase I SBIR award. Similarly, applicants cannot apply for a Phase IIB SBIR or STTR based on a Phase II STTR or SBIR award, respectively. This refers to the "switching mechanisms at Phase II" provision of the Act.

NIH is currently updating its electronic systems and forms to allow applicants to switch programs at Phase II. Only NIH participates in the STTR program; CDC, FDA, and ACF do not.

• Applicants cannot skip Phase I and apply directly for a Phase II SBIR award. This refers to the "Direct to Phase II" provision of the Act.

Per the reauthorization, this provision will only be available to NIH SBIR applicants once implemented. NIH is currently updating its electronic systems and forms to allow applicants to apply for a Direct Phase II SBIR award. Additionally, this provision will be piloted by NIH by issuing targeted FOAs and will not be available on the Omnibus FOAs. When issued, Direct to Phase II FOAs may be found here.

• Small business concerns that are majority-owned by multiple venture capital operating companies (VCOCs), hedge funds and/or private equity firms cannot apply to the HHS SBIR program at this time.

While SBA issued its final size rule pertaining to SBIR/STTR company eligibility (including VCOCs, etc. for the SBIR program) on December 27, 2012, the implementation date is January 28, 2013. Implementing the 'VCOC provision' first required SBA issuing the final rule and now entails updating the NIH electronic systems, forms, and application instructions. Additionally, all SBIR/STTR applicants will be required to register at the SBA registration database (in late stage development) prior to applying to an agency for an SBIR or STTR award. It was not feasible to include all of the requirements in our current Omnibus FOAs given the above and the requirement to issue the FOAs with sufficient time prior to the first application due date of April 5, 2013.

HHS has, therefore, decided that it is in the best interest of the small business community to issue new Omnibus FOAs with some reauthorization provisions implemented rather than removing the April 5 due date and inadvertenly risk delaying funding of meritorious projects . HHS intends to revise, amend or re-issue the Omnibus FOAs in the middle of 2013 to implement additional reauthorization provisions as guidance from SBA is received and electronic system and form updates at NIH and SBA are implemented. This ultimately allows HHS to retain the April 5, 2013 application due date and award cycle.

HHS will issue guidance to the community as it implements various provisions from the reauthorization through the NIH SBIR website and via NIH Guide Notices.

Applicants are required to follow the guidance and instructions in the Omnibus FOAs as issued.

Inquiries

Please direct all inquiries to:

NIH SBIR/STTR Program Office
Phone:  301-435-2688
Fax: 301-480-0146
Email:  [email protected]
Website: http://sbir.nih.gov