Anticipated Publication of the PHS 2024-2 Omnibus Solicitations of the NIH, CDC and FDA for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications (2024)

This Notice is to inform eligible United States small business concerns of the reissuance of the Omnibus Solicitations of the NIH, CDC and FDA for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant applications.

When reissued, these notices of funding opportunities (NOFOs) will continue to utilize the R41/R42 and R43/44 grant mechanisms. Modifications to these NOFOs will include new and revised research priorities. This Notice is provided to allow potential applicants sufficient time to develop meaningful collaborations and appropriate projects.

These NOFOs are expected to be published in Late Spring 2024 with an expected first application due date in September 2024.

NIH, CDC, and FDA Institutes and Centers likely to participate in one or more of the NOFOs include the following:

National Institutes of Health (NIH)

• National Cancer Institute (NCI)
• National Eye Institute (NEI)
• National Heart, Lung, and Blood Institute (NHLBI)
• National Human Genome Research Institute (NHGRI)
• National Institute on Aging (NIA)
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• National Institute of Allergy and Infectious Diseases (NIAID)
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• National Institute of Biomedical Imaging and Bioengineering (NIBIB)
• Eunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD)
• National Institute on Deafness and Other Communication Disorders (NIDCD)
• National Institute of Dental and Craniofacial Research (NIDCR)
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• National Institute on Drug Abuse (NIDA)
• National Institute of Environmental Health Sciences (NIEHS)
• National Institute of General Medical Sciences (NIGMS)
• National Institute of Mental Health (NIMH)
• National Institute of Neurological Disorders and Stroke (NINDS)
• National Institute of Nursing Research (NINR)
• National Institute on Minority Health and Health Disparities (NIMHD)
• National Library of Medicine (NLM)
• National Center for Complementary and Integrative Health (NCCIH)
• National Center for Advancing Translational Sciences (NCATS)
• Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Centers for Disease Control (CDC)

• Center for Forecasting Analytics (CFA)
• Global Health Center (CGH/CDC)
• National Center on Birth Defects and Developmental Disabilities (NCBDDD/CDC)
• National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP/CDC)
• National Center for Emerging and Zoonotic Infectious Diseases (NCEZID/CDC)
• National Center for Environmental Health (NCEH/CDC)
• National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP/CDC)
• National Center for Immunization and Respiratory Diseases (NCIRD/CDC)
• National Center for Injury Prevention and Control (NCIPC/CDC)
• National Institute for Occupational Safety and Health (NIOSH/CDC)

Food and Drug Administration (FDA)

• Center for Biologics Evaluation and Research (CBER/FDA)
• Center for Drug Evaluation and Research (CDER/FDA)
• Center for Food Safety and Applied Nutrition (CFSAN/FDA)
• Center for Devices and Radiological Health (CDRH/FDA)
• Center for Veterinary Medicine (CVM/FDA)
• Office of Critical Path Programs (CPI/FDA)
• Office of Orphan Products Development (OOPD/FDA)

SBIR/STTR Program Details

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 bysocially 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 STTR program is intended to stimulate a partnership of ideas and technologies between innovative small business concerns and non-profit research institutions through federally-funded research or research and development (R/R&D). By providing awards to small businesses for cooperative R/R&D efforts with non-profit research institutions, the STTR program assists the small business and research communities by commercializing innovative technologies.

SBIR/STTR are phased programs. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts, whereas in SBIR/STTR Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization.

An objective of the SBIR and STTR programs is to increase private sector commercialization of innovations derived from federally supported research and development. At the conclusion of an SBIR/STTR Phase II, it is expected that the small business will fully commercialize their product or technology using non-SBIR/STTR funds (either federal or non-federal).

NIH is committed to supporting a sustainable and diverse biomedical research workforce (see Notice of NIH's Interest in Diversity, NOT-OD-20-031).Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform hom*ogeneous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of research, advancing the likelihood that underserved populations and those that experience health disparities and inequities participate in and benefit from health research, and enhancing public trust. Fostering and encouraging participation by socially and economically disadvantaged and women-owned small businesses in technological innovation is one of the goals of the SBIR and STTR programs. (https://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf).

NIH anticipates re-issue of the four Notices of Funding Opportunities (NOFOs):

• Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
• Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)