Opportunity Information: Apply for PA 21 260

The PHS 2021-2 Omnibus Solicitation from the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) is a Small Business Innovation Research (SBIR) funding opportunity designed to support U.S. small businesses that can advance biomedical, behavioral, clinical, and public health-related research and development priorities. Issued as a Parent SBIR announcement using the R43 (Phase I) and R44 (Phase II) mechanisms, it is meant to serve as a broad entry point for many different technology areas rather than being limited to a single disease or product category. Applicants are expected to align their proposed work with the missions and program interests of one or more participating NIH Institutes and Centers (and CDC components where applicable), and to select a topic area from the PHS 2021-2 SBIR/STTR Program Descriptions and Research Topics list that corresponds to those interests.

A defining feature of this specific Parent announcement is that it is “Clinical Trial Required,” meaning the application must include at least one clinical trial as part of the proposed project. In practical terms, the project should be structured around human subjects research that meets the NIH definition of a clinical trial, with clear plans for protocol-driven evaluation of an intervention or strategy and measurement of health-related or behavioral outcomes. Because clinical trials carry additional regulatory, ethical, and operational expectations, applicants should be prepared to address clinical trial planning elements such as study design, participant eligibility, recruitment and retention, data management, safety monitoring, and compliance requirements. The intent is to move beyond preclinical or purely technical development and into human testing that directly supports translation, feasibility, validation, or early evidence of effectiveness, depending on the project stage and the participating component’s priorities.

Eligibility is limited to U.S. small businesses that meet SBIR program requirements, reflecting the program’s purpose of stimulating technological innovation and commercialization capacity within the domestic small business sector. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. That said, “foreign components” as defined under the NIH Grants Policy Statement may be permitted in some circumstances, which generally means a portion of the project may be performed outside the United States if it is justified as necessary, adds unique value, and is allowable under NIH policy and the specific awarding component’s rules. Even when foreign components are allowed, the applicant organization itself must still be a qualifying U.S. small business, and the overall project must remain consistent with SBIR eligibility and performance requirements.

Administratively, the opportunity is categorized as a discretionary grant program and spans a wide range of public health and biomedical domains, which is reflected in the many listed CFDA numbers associated with NIH and CDC activities. The funding instrument is a grant, with no award ceiling stated in the provided listing (SBIR budgets are often guided by program policies and topic-specific expectations rather than a single universal ceiling in the summary record). The opportunity was created on July 8, 2021, and the original closing date shown is April 5, 2022. Applications submitted under this Parent SBIR solicitation are expected to propose R and D that is scientifically sound, relevant to an identified NIH/CDC topic area, and appropriate for SBIR support, typically emphasizing a pathway toward product development and commercialization such as diagnostics, therapeutics, devices, digital health tools, vaccines, or other health-related technologies, while also meeting the additional bar of including at least one clinical trial within the proposed scope.

  • The National Institutes of Health in the education, environment, food and nutrition, health, income security and social services sector is offering a public funding opportunity titled "PHS 2021-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.068, 93.070, 93.073, 93.083, 93.084, 93.113, 93.136, 93.172, 93.173, 93.213, 93.233, 93.242, 93.262, 93.273, 93.279, 93.286, 93.307, 93.316, 93.326, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.847, 93.859, 93.865, 93.866, 93.867.
  • This funding opportunity was created on 2021-07-08.
  • Applicants must submit their applications by 2022-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Small businesses.
Apply for PA 21 260

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