A Solicitation of the Advanced Research Projects Agency for Health (ARPA-H) for Small Business Innovation Research (SBIR) Contract Proposals

PROGRAM DESCRIPTION Background The basic design of the ARPA-H SBIR program is in accordance with the Small Business Administration (SBA) SBIR Program Policy Directive dated October 1, 2020. This SBIR contract solicitation strives to encourage scientific and technical innovation in areas specifically identified by ARPA-H. The potential contributions of the proposed effort are relevant to health outcomes for all Americans. Specifically, ARPAH's mission is to benefit the health of all Americans by catalyzing health breakthroughs that cannot readily be accomplished through traditional research or commercial activity. The guidelines presented in this solicitation reflect the flexibility provided in the Policy Directive to encourage proposals based on scientific and technical approaches most likely to yield results important to ARPA-H and to the private sector. Phased Program The SBIR program consists of separate phases. Note: At this time, ARPA-H is only accepting Direct to Phase II and Fast-Track proposals for this solicitation. Please refer to the individual topics above for more information. Phase I: Feasibility The objective of Phase I is to determine the scientific or technical feasibility and commercial merit of the proposed research or R&D efforts. Phase II: Full R/R&D Effort The objective of Phase II is to further develop the research or R&D efforts initiated in Phase I. If your project has already demonstrated feasibility, you may prepare a Direct-to-Phase II proposal and begin your Federal SBIR award at Phase II. Phase III: Commercialization stage without SBIR funds (Not Accepting Proposals) Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR/STTR Funding Agreements, but is funded by sources other than the SBIR/STTR programs. Each of the following types of activity constitutes SBIR/STTR Phase III work: (i) Commercial application of SBIR/STTR funded R/R&D that is financed by non-Federal sources of capital. (ii) SBIR/STTR derived products or services intended for use by the Federal Government, funded by non- Page 15 SBIR/STTR sources of Federal funding. (iii) Continuation of SBIR/STTR work, funded by non-SBIR/STTR sources of Federal funding including R/R&D. For HHS SBIR/STTR projects, Phase III is primary financed by non-Federal sources of capital. The competition for SBIR Phase I and Phase II awards satisfies the competition requirements of the Competition in Contracting Act. Therefore, for an agency that wishes to fund an SBIR project beyond the Phase II, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5 that the project 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). Direct to Phase II Proposals If your project has already demonstrated feasibility, but you have not received a Phase I SBIR or STTR award, you can apply for a Direct to Phase II award and bypass Phase I. Small business concerns applying for Direct to Phase II awards must have already built a technology prototype and tested its technical feasibility (i.e., completed Phase I type R&D or another effort). Phase II type R&D tests the functional viability of the prototype according to scientific methods and potential for commercial development. Refer to Section 1.1 List of Topics for notation of Topics allowing Direct to Phase II proposals. Fast Track Proposals A Fast Track submission may result in an initial award for Phase I with a contractual option that the Government may exercise to continue the award on to Phase II. The Government is not obligated to fund the Phase II portion unless and until ARPA-H exercises that option. This mechanism allows for streamlined processes that have the potential to significantly minimize the funding gap between Phase I and Phase II. If a Topic notes that Fast Track proposals will be accepted, a Phase I proposal and a Phase II proposal may be submitted simultaneously. As described in Section 4.2 Proposal Instructions, a Fast Track submission consists of one complete Phase I proposal and one complete Phase II proposal, separately paginated. The Phase I proposal and Phase II proposal will be separately evaluated as set forth in Section 3.3 Technical Evaluation Criteria.