Multiplexed Nucleic Acid Self-Test for Reproducible and Sensitive HIV Detection

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. Amendment two (2) attached purpose is to:

- Respond to Questions received regarding the solicitation.