Key Dates

PA-21-259 - 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)

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

PA-21-262 - PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA-21-261- PHS 2021-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

Office of The Director, National Institutes of Health (OD)

This Notice is to inform the 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 FOAs will continue to utilize the R41/R42 and R43/44 grant mechanisms. Modifications to these FOAs will be the inclusion of new and revised research priorities.

NIH, CDC, and FDA Institutes and Centers likely to participate in one or more of the FOAs 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 Shriver National 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 Global Health (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 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)
• National Center for Environmental Health (NCEH/CDC)
• Center for Preparedness and Response (CPR/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)

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and appropriate projects.

The FOA is expected to be published in Summer 2022 with an expected application due date in September 2022.

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 by socially 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).

Diversity within the NIH-supported scientific workforce fosters innovation, enhances global competitiveness, improves the quality of research and research outcomes. NIH has a commitment to supporting a sustainable and diverse biomedical research workforce. (Notice of NIH's Interest in Diversity, NOT-OD-20-031). Scientists and trainees from underrepresented backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. 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/SBIR-STTR_Policy_Directive_2019.pdf)

NIH intends to re-issue the four Funding Opportunity Announcements (FOAs):

• 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)

Applications are not being solicited at this time. 

Please direct all inquiries to:

SEED (Small business Education and Entrepreneurial Development)

Office of Extramural Research

301-435-2688

SEEDinfo@nih.gov