The "PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)" invites United States small businesses with innovative research capabilities and technological expertise to submit proposals for Small Business Innovation Research (SBIR) grants. Issued by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), this funding opportunity supports early-stage research and development that has potential for commercialization and aligns with the missions of participating NIH and CDC Institutes and Centers (ICs). Applications must propose at least one clinical trial and are evaluated on their scientific merit, feasibility, and commercialization potential.

The purpose of this funding is to stimulate private-sector technological innovation, strengthen the role of small businesses in meeting federal research needs, and foster the commercialization of federally supported R&D. Eligible applicants can propose projects for Phase I, Phase II, Fast-Track, Direct to Phase II (NIH only), and Phase IIB (NIH only). NIH Fast-Track applications allow simultaneous review of Phases I and II to avoid funding gaps, while Direct to Phase II supports businesses that have already demonstrated project feasibility. Phase IIB targets projects requiring extended development efforts post-Phase II and emphasizes the need for third-party investment.

Funding may cover research and development costs up to $306,872 for Phase I and $2,045,816 for Phase II. Budgets exceeding these limits are possible with prior approval based on designated topics. The project duration typically does not exceed six months for Phase I and two years for Phase II. Applications should demonstrate a clear commercialization path and address review criteria including scientific significance, innovation, technical approach, and the applicant’s capacity to execute the project.

Applicants must be U.S.-based small business concerns (SBCs) that are majority-owned by U.S. citizens or residents, venture capital operating companies, or other eligible combinations. All SBCs must employ fewer than 500 employees. Eligibility benchmarks related to prior SBIR/STTR participation, such as transition and commercialization rates, also apply. The opportunity is open to for-profit entities that meet these criteria. Non-domestic entities are ineligible, and foreign components are only allowed under specific circumstances.

Applications must be submitted electronically via Grants.gov, NIH ASSIST, or institutional S2S systems. Key due dates are September 5, 2024, January 5, 2025, April 5, 2025, and September 5, 2025. The earliest project start dates range from April 2025 to April 2026 depending on the review cycle. The expiration date for this solicitation is September 6, 2025. Required components include various forms, a commercialization plan (for Phase II), and compliance with NIH policies on human subjects, data management, and foreign disclosures.

Review criteria include the project's significance, innovation, technical approach, environment, and investigators’ qualifications. Phase II and Fast-Track applications must also demonstrate commercialization potential. Applicants are evaluated by NIH peer review panels and funding decisions consider merit, available funds, program priorities, and national security risks. The Notice of Award is the formal funding notification, and funded projects must comply with NIH policy and federal regulations.