PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)


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), and the Food and Drug Administration (FDA) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase I, Phase II, Direct to Phase II (NIH Only) Fast-Track (NIH only), and Phase IIB (NIH only) grant applications.

The PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA 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, or FDA 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 on the Assignment Request Form. Staff within the NIH’s Center for Scientific Review (CSR) office, the single receiving point for all NIH, CDC, and FDA 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 (second, sequential) 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 2019-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA, 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% (FY2019) for small companies to conduct innovative R/R&D that has potential for commercialization and public benefit.

The SBIR and STTR programs were reauthorized and extended through 2022 under Public Law 114-328, Section 1834 and Public Law 115-232.

All applications submitted to this Parent Funding Opportunity Announcement must propose clinical trial(s).

For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website.

Applicants should note that some ICs (please see the Related Notices section above) only accept applications proposing mechanistic studies through this funding opportunity announcement. A mechanistic study is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. If the proposed research project includes clinical trial other than a mechanistic study that would be assigned to one of these ICs, applicants are advised to contact relevant Scientific/Research staff to discuss alternative mechanisms of support of these studies.

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

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.

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

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