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

Synopsis: 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-2024-1 is anticipated to be made available on or around August 25, 2023, 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 November 14, 2023 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-2024-1 NATIONAL INSTITUTES OF HEALTH (NIH) NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS): Topic 024 - Small Manufacturing Systems to Produce Research Grade Pharmaceutical Intermediates NATIONAL CANCER INSTITUTE (NCI): Topic 455 - Point-of-Care Detection of Prostate Specific Antigen Topic 456 - Rapid and Affordable Point-of-Care HPV Diagnostics for Cervical Cancer Control Topic 457 - Technologies for Detecting Tumor-Derived Cell Clusters Topic 458 - Microbiome-Based Tests for Cancer Research, Diagnosis, Prognosis and/or Patient Management Topic 459 - Automated Software for Point-of-Care Testing to Identify Cancer-Associated Malnutrition Topic 460 - Evaluation Datasets as Medical Device Development Tools for Testing Cancer Technologies Topic 461 - Ultra-Fast Dose Rate (FLASH) Radiation Detectors and Safety Systems for Cancer Treatment Topic 462 - Organ-on-Chip for Preclinical and Translational Radiobiological Studies Topic 463 - Translation of Novel Cancer-specific Imaging Agents and Techniques to Mediate Successful Image-guided Cancer Interventions Topic 464 - Cloud-Based Multimodal Data Analysis Software for the Cancer Research Data Commons Topic 465 - Cancer Prevention and Treatment Clinical Trials Tools for Recruitment and Retention of Diverse Populations NATIONAL INSTITUTE ON AGING (NIA): Topic 010 - Technology to facilitate characterization of the exposome in under - resourced populations for AD/ADRD Studies NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID): Topic 124 - Development of Next-Generation Devices and Materials-Based Platforms for the Administration of HIV-1 Broadly Neutralizing Antibodies Topic 125 - Development of Long-Acting Treatments for HCV Cure Topic 126 - Rapid Diagnostic Assays for Self-Monitoring of Acute or Rebound HIV-1 Infection Topic 127 - Multiplexed Patient Administered Diagnostics for Hepatitis B, Hepatitis C, and HIV Topic 128 - Adjuvant Development for Vaccines for Infectious and Immune-Mediated Diseases Topic 129 - Reagents for Immunologic Analysis of Non-mammalian and Underrepresented Mammalian Models Topic 130 - Adjuvant Discovery and Down-Selection for Vaccines against Infectious and Immune-Mediated Diseases Topic 131 - Development of Bacteriophage for Treatment of Mycobacterial Infections Topic 132 - Novel Diagnostic Biomarker Discovery and Validation for Malaria and Select Neglected Tropical Diseases (NTDs) Topic 133 - Development of a Serological Test for Herpes Simplex Types 1 and 2 Infections Topic 134 - Alternatives to Benzathine Penicillin for Treatment of Syphilis Topic 135 - Software or Web Services to Automate Metadata Enrichment and Standardization for Data on Infectious and Immune - Mediated Diseases Topic 136 - Software or Web Services to Re-Represent Existing Scientific Data and Knowledge into a Knowledge Graph Format NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI): Topic 115 - Clinical Instrument for Para-Hydrogen (pH2) Based Signal Amplification by Reversible Exchange (SABRE) for Hyperpolarizing 13C-Pyruvate and Other Probes for MRI Imaging NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH): Topic 001 - Point-of-Care HIV Viral Load and 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 03 - Development of SHERLOCK Assay for Detection of High Threat Orthopoxviruses NATIONAL CENTER FOR HIV/AIDS, VIRAL HEPATITIS, STD, AND TB PREVENTION (NCHHSTP): Topic 055 - Software Solutions: Bridging the Gap between Public Health and Pharmacies Topic 056 - EHR Algorithm to Identify Persons with HIV Not in Care Topic 057 - Device for point-of-care nucleic acid purification and detection of HCV NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES (NCIRD): Topic 036 - Improved Diagnostic Assays for Measles, Mumps, Rubella, and Varicella Topic 037 - Rapid Diagnostic Tests for Measles, Mumps, Rubella, and Varicella 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://sbir.nih.gov/funding#omni-sbir. 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://sbir.nih.gov/apply. For general information regarding the NIH/CDC SBIR Program, please refer to: Office of Extramural Programs, Office of Extramural Research National Institutes of Health Phone 301-435-2688 seedinfo@nih.gov