PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])

The SBIR program, as established by law, is intended to meet the following goals: stimulate technological innovation in the private sector; strengthen the role of small business in meeting Federal research or research and development (R/R&D) needs; increase the commercial application of Federally-supported research results; foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns in the SBIR program; and improve the return on investment from Federally-funded research for economic and social benefits to the Nation.

The SBIR program is structured in three phases, the first two of which are supported using SBIR funds. The objective of Phase I is to establish the technical/scientific merit and feasibility of the proposed R/R&D efforts. The objective of Phase II is to continue the research or R&D efforts initiated in Phase I. An objective of the SBIR program is to increase private sector commercialization of innovations derived from Federal R/R&D. The objective of Phase III, where appropriate, is for the SBC to pursue with non-SBIR funds (either Federal or non-Federal) the commercialization objectives resulting from the results of the R/R&D funded in Phases I and II.  In some Federal agencies, Phase III may involve follow-on, non-SBIR funded R&D, or production contracts for products or processes intended for use by the U.S. Government.

The competition for SBIR Phase I and Phase II awards satisfies the competition requirement of the Armed Services Procurement Act, the Federal Property and Administrative Services Act, and the Competition in Contracting Act. Therefore, an agency that wishes to fund an SBIR Phase III project is not required to conduct another competition in order to satisfy those statutory provisions. As a result, in conducting actions relative to a Phase III SBIR award, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5 that the project is a SBIR Phase III award that is derived from, extends, or logically concludes efforts performed under prior SBIR funding agreements and is authorized under 10 U.S.C. 2304(b)(2) or 41 U.S.C. 253(b)(2).

This Funding Opportunity Announcement (FOA) issued by the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Administration for Children and Families (ACF) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase I, Phase II, Fast-Track (NIH only), and Phase IIB Competing Renewal (NIH only) grant applications.

The PHS 2016-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, FDA, and ACF represent scientific program areas that may be of interest to applicant SBCs in the development of projects that have potential for commercialization. Small business concerns that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH, CDC, FDA, or ACF awarding components identified in this FOA are encouraged to submit SBIR grant applications in these areas. SBIR grant applications will also be accepted and considered in any area within the mission of the Components of Participating Organizations listed for this FOA. In addition to the general research areas described above some NIH awarding components have identified additional, specific SBIR funding opportunities of potential interest to SBCs. See the NIH Special Announcements for Small Business Research Opportunities. Applicants are not required to identify a potential awarding component prior to submission of the application, but may request one in a cover letter. Staff within the NIH’s Center for Scientific Review (CSR) office, the single receiving point for all NIH, FDA, CDC, and ACF grant applications, will assign all applications to the most appropriate Agency and Institute/Center (IC) based on their mission and the science proposed.

Some of the NIH ICs offer the opportunity to submit Phase IIB Competing Renewal applications that will provide additional funding for Phase II SBIR projects. These renewals are typically offered for those projects that require regulatory approval for the product or service being developed or to support complex instrumentation, clinical research tools, and behavioral interventions/treatments. For those ICs that included these opportunities in the PHS 2016-2 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.

Government-wide SBIR policy is provided by the Small Business Administration (SBA) through its SBIR Program Policy Directive. Federal agencies with extramural research and development budgets over $100 million annually are required to administer SBIR programs using a set-aside of 3.2% (FY2017) for small companies to conduct innovative R/R&D that has potential for commercialization and public benefit.

The SBIR/STTR Reauthorization Act of 2011 (P.L. 112-81) provides for new provisions for the SBIR program.  NIH implemented the provisions in the reauthorization and an information website is available.

• NIH and CDC will accept applications from small businesses that are majority-owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these.
• This FOA can accept a Phase II or Phase IIB SBIR submission, where the previous award was an STTR Phase I or II respectively.   Please contact a program official to discuss this option.
• This FOA cannot accept a "Direct Phase II" SBIR submission.  This option is only available in specific FOAs posted at the NIH Special Announcements for Small Business Research Opportunities (NIH SBIR Direct to Phase II Pilot Solicitation/s) website.

Applicants should note that the following NIH Institutes/Centers will NOT accept applications proposing a clinical trial through this funding opportunity announcement:

• National Institute of Allergy and Infectious Diseases (NIAID)
• National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS)
• National Institute of Neurological Disorders and Stroke (NINDS)
• National Center for Advancing Translational Sciences (NCATS)

If your proposed work includes an NIH-defined clinical trial that would be assigned to one of these NIH Institutes/Centers, you should contact relevant program staff to discuss alternatives for support of those studies.

Frequently asked questions are available to assist applicants and can answer many basic questions about the program.

See Section VIII. Other Information for award authorities and regulations.