Opportunity Information: Apply for PA 21 259

The PHS 2021-2 Omnibus Solicitation is a federal SBIR grant opportunity issued jointly by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA). It is designed to fund early-stage research and development led by eligible United States small businesses that can bring strong scientific capability and technical expertise to priorities within NIH, CDC, and FDA mission areas. In practical terms, this is a broad "parent" solicitation meant to capture a wide range of innovative, product-oriented R and D concepts, as long as the proposed work aligns with one of the participating components and fits within the specific topics described in the companion topic document (the PHS 2021-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA).

The funding instrument is an SBIR grant using the R43 and R44 mechanisms. These mechanisms generally reflect phased development pathways used in SBIR: Phase I (R43) supports feasibility and proof-of-concept R and D, while Phase II (R44) supports further development, refinement, and steps that move an innovation closer to commercialization or practical deployment. The solicitation is categorized as discretionary funding and spans a wide set of public-purpose areas reflected in the activity category listing (including health, environment, food and nutrition, education, and related social services domains), which signals that the agencies intend to support innovations that can materially improve public health outcomes, biomedical research, disease prevention, diagnostics, therapeutics, health technologies, and related regulatory science needs.

A central rule of this specific parent announcement is that clinical trials are not allowed. That means applicants must shape their projects so that the proposed research does not meet the definition of a clinical trial under NIH policy (for example, it cannot prospectively assign human participants to an intervention to evaluate effects on health-related outcomes). Small businesses can still propose substantial non-clinical and preclinical development work, tool building, platform development, laboratory validation, analytical studies, benchtop testing, animal studies (when appropriate and permitted), engineering work, and other R and D activities that strengthen feasibility and readiness for later-stage translation. If a company intends to run a clinical trial, it would need to look for a different FOA that explicitly allows clinical trials rather than using this one.

Eligibility is focused on U.S. small businesses. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible to apply under this announcement. However, the notice indicates that "foreign components" may be allowed as defined in the NIH Grants Policy Statement, which typically refers to discrete elements of a project carried out outside the United States under specific conditions and approvals (for instance, a specialized assay performed by a unique overseas laboratory when strongly justified). Even when foreign components are allowable, the applicant organization must still be an eligible U.S. small business, and the application must follow all applicable policy requirements governing such components.

The opportunity is identified by Funding Opportunity Number PA-21-259, with NIH listed as the primary agency name in the source data, reflecting NIH's common role as the central grants management body for these omnibus SBIR solicitations, even when CDC and FDA components participate. The original closing date shown in the source data is 2022-04-05, and the opportunity record creation date is 2021-07-08. The listing also includes a large set of CFDA numbers (now often referenced as Assistance Listing numbers), which indicates that multiple NIH institutes and centers, along with CDC and FDA programs, may support awards under their respective appropriations and authorities, depending on topic alignment and available funds.

Overall, this solicitation functions as a wide-entry SBIR pathway for U.S. small businesses pursuing innovative R and D that fits NIH, CDC, or FDA priorities, provided the work is non-clinical-trial in nature. Applicants are expected to match their proposed aims to the published topic areas, demonstrate strong technical merit and feasibility, and position the project for practical impact and eventual commercialization or deployment consistent with SBIR program goals.

  • 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, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)" 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, 93.103, 93.113, 93.121, 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, 93.350, 93.351, 93.361, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.859, 93.865, 93.866, 93.867, 93.879.
  • 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 21 259

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PHS 2021-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) Apply for PA 21 260

Funding Number: PA 21 260
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Limited Competition: Knockout Mouse Phenotyping Project Data Coordination Center and Database (UM1 Clinical Trial Not Allowed) Apply for RFA HG 21 037

Funding Number: RFA HG 21 037
Agency: National Institutes of Health
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Limited Competition: Knockout Mouse Production and Phenotyping Project (UM1) Clinical Trial Not Allowed Apply for RFA HG 21 036

Funding Number: RFA HG 21 036
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
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Administrative Supplements to Promote Diversity in Small Businesses-SBIR/STTR (Admin Supp Clinical Trial Not Allowed) Apply for PA 21 345

Funding Number: PA 21 345
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
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Innovation Corps (I-Corps) at NIH Program for NIH and CDC Translational Research (Admin Supp Clinical Trial NOT Allowed) Apply for PAR 22 073

Funding Number: PAR 22 073
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
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Dissemination and Implementation Research in Health (R01 Clinical Trial Optional) Apply for PAR 22 105

Funding Number: PAR 22 105
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
PHS 2022-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) Apply for PA 22 177

Funding Number: PA 22 177
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: $275,766
PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) Apply for PA 22 178

Funding Number: PA 22 178
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: $275,766
PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) Apply for PA 22 176

Funding Number: PA 22 176
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
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Maternal Health Research Centers of Excellence Data Innovation and Coordinating Hub/Resource Center (U24 Clinical Trial Not Allowed) Apply for RFA HD 23 036

Funding Number: RFA HD 23 036
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
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Maternal Health Research Centers of Excellence Implementation Science Hub/Resource Center (U24 Clinical Trial Optional) Apply for RFA HD 23 037

Funding Number: RFA HD 23 037
Agency: National Institutes of Health
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Maternal Health Research Centers of Excellence (U54 Clinical Trial Optional) Apply for RFA HD 23 035

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Agency: National Institutes of Health
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Funding Number: RFA OD 22 017
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Funding Number: RFA OD 22 016
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Funding Number: RFA OD 22 021
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Funding Number: RFA OD 22 019
Agency: National Institutes of Health
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Funding Amount: Case Dependent
Environmental influences on Child Health Outcomes (ECHO) Data Analysis Center (U24) Clinical Trial Not Allowed Apply for RFA OD 22 022

Funding Number: RFA OD 22 022
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Limited Competition: Environmental influences on Child Health Outcomes (ECHO) Pregnancy and Pediatric Cohort Study Sites. Clinical Trial Not Allowed (UG3/UH3) Apply for RFA OD 22 018

Funding Number: RFA OD 22 018
Agency: National Institutes of Health
Category: Education, Environment, Food and Nutrition, Health, Income Security and Social Services
Funding Amount: Case Dependent
Environmental influences on Child Health Outcomes (ECHO) Measurement Core (U24) Clinical Trial Not Allowed Apply for RFA OD 22 020

Funding Number: RFA OD 22 020
Agency: National Institutes of Health
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