A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) are soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward NIH or CDC mission needs and Small Business Innovation Research (SBIR) program objectives.

THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS), THE NATIONAL INSTITUTES OF HEALTH (NIH), AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) SMALL BUSINESS INNOVATIVE RESEARCH (SBIR) PROGRAM SOLICITATION PHS-2025-1 is anticipated to be made available on or around August 2, 2024, through both SAM.gov and the NIH Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) funding web page at https://sbir.nih.gov/funding. This solicitation is anticipated to have a closing date of October 18, 2024 for receipt of proposals.

The purposes of the SBIR program are to: (a) stimulate technological innovation; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and (d) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth. 

For purposes of the SBIR program, a small business concern is any business concern that, on the date of award, (1) is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; (2) is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; (3) more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; AND, (4) has, including its affiliates, no more than 500 employees.* 

* Note: This size standard is established by law for the SBIR program, regardless of the NAICS Code assigned. See 13 C.F.R. § 121.702. 

THE FOLLOWING RESEARCH TOPICS ARE ANTICIPATED TO BE INCLUDED IN SBIR CONTRACT SOLICITATION PHS-2025-1

NATIONAL INSTITUTES OF HEALTH (NIH)

NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS): 

Topic 025        Development of a versatile small footprint benchtop device to perform batch evaporation 

Topic 026        Scalable Generation of Liver and Brain Organoids Derived from Human iPS Cells. 

NATIONAL CANCER INSTITUTE (NCI): 

Topic 466        Novel Delivery Systems for RNA-based Cancer Vaccines

Topic 467        Development of Cancer Immunoprevention Agents

Topic 468        Synthetic Microbes (Excluding Oncolytic Viruses) for Immuno-Oncology Therapies

Topic 469        Development of Novel Therapeutics for HPV-related Precancer

Topic 470        Precision Nutrition Interventions to Reduce Cancer-Related Symptoms

Topic 471        Drug-Loaded Carrier Particles for Improved Oral Delivery for Colon Cancer Prevention

Topic 472        Antibody-Drug Conjugates as Radiopharmaceutical Theranostics for Cancer

Topic 473        Point of Care Detection of Antibodies Against HPV16/18 E6 and E7 Oncoproteins in                               Oropharyngeal Cancer

Topic 474        Point of Care Technologies for GI Cancer Prevention and Early Detection

Topic 475        Development of Digital Biomarkers and Endpoints for Clinical Cancer Care

Topic 476        Digital Twin Software for Optimization of Cancer Radiation Therapy 

Topic 477        Wearable Technologies to Facilitate Remote Monitoring of Cancer Patients Following Treatment

Topic 478        Advanced Biomaterials to Improve Cancer Modeling for Research

NATIONAL INSTITUTE ON AGING (NIA):  

Topic 011        Digital Technologies as Tools to Screen and Monitor Alzheimer’s Disease (AD)  and Related Dementias (ADRD)

Topic 012        Modeling Aging through Microphysiological Systems

Topic 013        Leveraging Multimodal and Generative Artificial Intelligence to Advance the  Application of Social Robotics in Caregiving

NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

Topic 020        Alcohol-activated locking systems for firearms and firearm storage units 

Topic 021        Data science tools for accelerating alcohol research 

Topic 022        Non-invasive Wearable Alcohol Sensor

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID): 

Topic 137        New Drug Classes with Novel Mechanisms of Action for HIV, Hepatitis B, and Tuberculosis

Topic 138        Devices and Materials-Based Platforms for the Delivery of Broadly Neutralizing Antibodies

Topic 139        Rapid Diagnostic Assays for Self-Monitoring of Acute or Rebound HIV-1 Infection

Topic 140        Adjuvant Discovery and Down-Selection for Vaccines against Infectious and Immune- Mediated Diseases

Topic 141        Reagents for Immunologic Analysis of Non-mammalian and Underrepresented Mammalian Models

Topic 142        Adjuvant Development for Vaccines and for Autoimmune and Allergic Diseases

Topic 143        Development of Diagnostics for Mycoplasma genitalium Infection

Topic 144        Development of Medical Interventions for Treating Non-Tuberculosis Mycobacterial (NTM)  Infections

Topic 145        Diagnostics to Detect Host Immunity to Coccidioidomycosis (Valley fever) or Histoplasmosis

Topic 146        Discovery and Development of Oral Small-molecule Direct-acting Antivirals Targeting Viruses of Pandemic Potential

Topic 147        Software or Web Services to Assess Quality and Reproducibility of Data and Information about Therapeutics and Vaccines

NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH):

Topic 001        Point-of-Care and Pharmacy-based Antiretroviral Drug Adherence Assays

Topic 002        Development of novel In-vitro and In-vivo Models to support NeuroHIV Research

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

NATIONAL CENTER FOR EMERGING ZOONOTIC AND INFECTIOUS DISEASE (NCEZID): 

Topic 032        Canine Vaccines to Prevent Tick Bites

Topic 033        Rapid, Portable, Point-of-Care Carbapenem Resistant Acinetobacter Colonization Screening                         Diagnostic

Topic 034        Improved Diagnostic Assays for Foodborne and Waterborne Bacterial Pathogens

Topic 035        Improved Diagnostic Assays for Parasitic Diseases

Topic 036        Developing an Over-the-Counter Diagnostic for Valley Fever

Topic 037        Enhancing the CDC Autocidal Gravid Ovitrap to    Control Dengue Vectors

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES (NCIRD):

Topic 038        Development of a Molecular Panel to Detect Febrile Rash Illnesses

Topic 039        Synthetic IgM Antibody Controls for Measles, Mumps, and Rubella Assays

NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL (NCIPC)

Topic 001        Data Science Solutions to Characterize Polysubstance Use Behavior from Online Sources

NOTE – SBIR / STTR GRANT OPPORTUNITIES

SBIR and STTR grant opportunities are also available for investigator-initiated ideas. Companies are encouraged to review omnibus SBIR/STTR grant solicitations of the National Institutes of Health, Centers for Disease Control and Prevention and Food and Drug Administration posted on the NIH SBIR/STTR funding web page located at https://seed.nih.gov/small-business-funding/find-funding/sbir-sttr-funding-opportunities#omnibus-solicitations. Standard due dates for SBIR/STTR grant applications are September 5th, January 5th, and April 5th. To understand better the differences between grants and contracts, see https://seed.nih.gov/apply.

For general information regarding the NIH/CDC SBIR Program, please refer to:

NIH SEED (Small business Education and Entrepreneurial Development)

Office of Extramural Research
National Institutes of Health
Phone: 301-827-8595 
Email: SEEDinfo@nih.gov

Full Topic Details are in the Attached Document

Amendment one (1) attached purpose is to:

- Provide slides, recording, and transcript of the pre-proposal conference; and,

- Respond to Questions received regarding the solicitation.

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) are soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward NIH or CDC mission needs and Small Business Innovation Research (SBIR) program objectives.

THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS), THE NATIONAL INSTITUTES OF HEALTH (NIH), AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) SMALL BUSINESS INNOVATIVE RESEARCH (SBIR) PROGRAM SOLICITATION PHS-2025-1 is anticipated to be made available on or around August 2, 2024, through both SAM.gov and the NIH Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) funding web page at https://sbir.nih.gov/funding. This solicitation is anticipated to have a closing date of October 18, 2024 for receipt of proposals.

The purposes of the SBIR program are to: (a) stimulate technological innovation; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and (d) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth. 

For purposes of the SBIR program, a small business concern is any business concern that, on the date of award, (1) is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor; (2) is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture; (3) more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; AND, (4) has, including its affiliates, no more than 500 employees.* 

* Note: This size standard is established by law for the SBIR program, regardless of the NAICS Code assigned. See 13 C.F.R. § 121.702. 

THE FOLLOWING RESEARCH TOPICS ARE ANTICIPATED TO BE INCLUDED IN SBIR CONTRACT SOLICITATION PHS-2025-1

NATIONAL INSTITUTES OF HEALTH (NIH)

NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS): 

Topic 025        Development of a versatile small footprint benchtop device to perform batch evaporation 

Topic 026        Scalable Generation of Liver and Brain Organoids Derived from Human iPS Cells. 

NATIONAL CANCER INSTITUTE (NCI): 

Topic 466        Novel Delivery Systems for RNA-based Cancer Vaccines

Topic 467        Development of Cancer Immunoprevention Agents

Topic 468        Synthetic Microbes (Excluding Oncolytic Viruses) for Immuno-Oncology Therapies

Topic 469        Development of Novel Therapeutics for HPV-related Precancer

Topic 470        Precision Nutrition Interventions to Reduce Cancer-Related Symptoms

Topic 471        Drug-Loaded Carrier Particles for Improved Oral Delivery for Colon Cancer Prevention

Topic 472        Antibody-Drug Conjugates as Radiopharmaceutical Theranostics for Cancer

Topic 473        Point of Care Detection of Antibodies Against HPV16/18 E6 and E7 Oncoproteins in                               Oropharyngeal Cancer

Topic 474        Point of Care Technologies for GI Cancer Prevention and Early Detection

Topic 475        Development of Digital Biomarkers and Endpoints for Clinical Cancer Care

Topic 476        Digital Twin Software for Optimization of Cancer Radiation Therapy 

Topic 477        Wearable Technologies to Facilitate Remote Monitoring of Cancer Patients Following Treatment

Topic 478        Advanced Biomaterials to Improve Cancer Modeling for Research

NATIONAL INSTITUTE ON AGING (NIA):  

Topic 011        Digital Technologies as Tools to Screen and Monitor Alzheimer’s Disease (AD)  and Related Dementias (ADRD)

Topic 012        Modeling Aging through Microphysiological Systems

Topic 013        Leveraging Multimodal and Generative Artificial Intelligence to Advance the  Application of Social Robotics in Caregiving

NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

Topic 020        Alcohol-activated locking systems for firearms and firearm storage units 

Topic 021        Data science tools for accelerating alcohol research 

Topic 022        Non-invasive Wearable Alcohol Sensor

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID): 

Topic 137        New Drug Classes with Novel Mechanisms of Action for HIV, Hepatitis B, and Tuberculosis

Topic 138        Devices and Materials-Based Platforms for the Delivery of Broadly Neutralizing Antibodies

Topic 139        Rapid Diagnostic Assays for Self-Monitoring of Acute or Rebound HIV-1 Infection

Topic 140        Adjuvant Discovery and Down-Selection for Vaccines against Infectious and Immune- Mediated Diseases

Topic 141        Reagents for Immunologic Analysis of Non-mammalian and Underrepresented Mammalian Models

Topic 142        Adjuvant Development for Vaccines and for Autoimmune and Allergic Diseases

Topic 143        Development of Diagnostics for Mycoplasma genitalium Infection

Topic 144        Development of Medical Interventions for Treating Non-Tuberculosis Mycobacterial (NTM)  Infections

Topic 145        Diagnostics to Detect Host Immunity to Coccidioidomycosis (Valley fever) or Histoplasmosis

Topic 146        Discovery and Development of Oral Small-molecule Direct-acting Antivirals Targeting Viruses of Pandemic Potential

Topic 147        Software or Web Services to Assess Quality and Reproducibility of Data and Information about Therapeutics and Vaccines

NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH):

Topic 001        Point-of-Care and Pharmacy-based Antiretroviral Drug Adherence Assays

Topic 002        Development of novel In-vitro and In-vivo Models to support NeuroHIV Research

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

NATIONAL CENTER FOR EMERGING ZOONOTIC AND INFECTIOUS DISEASE (NCEZID): 

Topic 032        Canine Vaccines to Prevent Tick Bites

Topic 033        Rapid, Portable, Point-of-Care Carbapenem Resistant Acinetobacter Colonization Screening                         Diagnostic

Topic 034        Improved Diagnostic Assays for Foodborne and Waterborne Bacterial Pathogens

Topic 035        Improved Diagnostic Assays for Parasitic Diseases

Topic 036        Developing an Over-the-Counter Diagnostic for Valley Fever

Topic 037        Enhancing the CDC Autocidal Gravid Ovitrap to    Control Dengue Vectors

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES (NCIRD):

Topic 038        Development of a Molecular Panel to Detect Febrile Rash Illnesses

Topic 039        Synthetic IgM Antibody Controls for Measles, Mumps, and Rubella Assays

NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL (NCIPC)

Topic 001        Data Science Solutions to Characterize Polysubstance Use Behavior from Online Sources

NOTE – SBIR / STTR GRANT OPPORTUNITIES

SBIR and STTR grant opportunities are also available for investigator-initiated ideas. Companies are encouraged to review omnibus SBIR/STTR grant solicitations of the National Institutes of Health, Centers for Disease Control and Prevention and Food and Drug Administration posted on the NIH SBIR/STTR funding web page located at https://seed.nih.gov/small-business-funding/find-funding/sbir-sttr-funding-opportunities#omnibus-solicitations. Standard due dates for SBIR/STTR grant applications are September 5th, January 5th, and April 5th. To understand better the differences between grants and contracts, see https://seed.nih.gov/apply.

For general information regarding the NIH/CDC SBIR Program, please refer to:

NIH SEED (Small business Education and Entrepreneurial Development)

Office of Extramural Research
National Institutes of Health
Phone: 301-827-8595 
Email: SEEDinfo@nih.gov

Full Topic Details are in the Attached Document