PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
ID: PA-23-230Type: BOTH
Overview

Topic

PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2023
Timeline
  1. 1
    Release Jul 12, 2023 12:00 AM
  2. 2
    Open Aug 7, 2023 12:00 AM
  3. 3
    Next Submission Due Sep 5, 2023 12:00 AM
  4. 4
    Close Apr 6, 2024 12:00 AM
Description

The Department of Health and Human Services, specifically the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), is seeking proposals for Small Business Innovation Research (SBIR) grants. The SBIR program aims to stimulate technological innovation in the private sector and increase the commercialization of innovations developed through federal research and development funding. The program supports US-owned and operated small businesses in conducting research and development with strong potential for commercialization. The grants are intended to develop promising technologies and products that align with the mission of improving health and saving lives. The solicitation is open for Phase I, Phase II, Direct to Phase II, Fast-Track, and Phase IIB grant applications. The SBIR and STTR programs are phased, with Phase I establishing technical merit and feasibility, and Phase II advancing technology towards commercialization. The NIH also offers Fast-Track and Direct to Phase II options. Phase IIB grants provide additional funding for projects requiring considerable financing beyond Phase II. The grants are open to small businesses that have been awarded a Phase II SBIR or STTR. The application deadline is April 6, 2024. For more information and to apply, visit the NIH, CDC, and FDA SBIR solicitation page on grants.gov.

Files
No associated files provided.
Similar Opportunities
NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
Active
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required). This solicitation aims to support small business concerns (SBCs) in conducting exploratory clinical trials that contribute to the justification for future trials to establish definitive efficacy. The trials can include Phase 1 and 2 studies of drugs and biologics, feasibility and preliminary efficacy studies of devices, as well as early studies of surgical, behavioral, or rehabilitation therapies. The trials can be single-site or multi-site with up to three clinical sites. The applications must generate data that inform further clinical development of the proposed intervention or diagnostic, and FDA approval is required for FDA-regulated clinical trials. The goal is to advance products/technologies that require federal regulatory approval or bring complex research tools to market. The funding opportunity is open until September 6, 2026. For more information and to apply, visit the solicitation agency URL: [link](https://grants.nih.gov/grants/guide/pa-files/PAR-24-044.html).
NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)
Active
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required). This solicitation aims to support small business concerns (SBCs) in conducting exploratory clinical trials that contribute to the justification for future trials to establish definitive efficacy. The trials can include Phase 1 and 2 studies of drugs and biologics, feasibility and preliminary efficacy studies of devices, as well as early studies of surgical, behavioral, or rehabilitation therapies. The trials can be single-site or multi-site with up to three clinical sites. The applications must generate data that inform further clinical development of the proposed intervention or diagnostic, and FDA approval is required for FDA-regulated clinical trials. The goal is to advance products/technologies that require federal regulatory approval or bring complex research tools to market. The funding opportunity is open until September 6, 2026. For more information and to apply, visit the solicitation agency URL: [link](https://grants.nih.gov/grants/guide/pa-files/PAR-24-044.html).
Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Required)
Active
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the Small Business Transition Grant for New Entrepreneurs (R43/R44 Clinical Trial Required). This grant aims to support early-career scientists and health professionals interested in transitioning to a small business to gain industry experience, receive entrepreneurial training and mentorship, and advance biomedical or public health technology with commercial potential. The grant utilizes the R43/R44 SBIR Award mechanism and supports research and development efforts, as well as the employment and salaries of researchers as Program Directors/Principal Investigators overseeing the project. The grant requires the inclusion of at least one mentor and a career development plan for the PD/PI, which may include entrepreneurship training. The eligibility of the contact PD/PI is limited to scientists, engineers, and health professionals who are new to research entrepreneurship and have not independently led significant research programs. The proposed projects must pertain to the mission space of one of the participating Institutes and Centers and fall within the scope of the traditional SBIR/STTR grant mechanisms. The grant supports Phase I and Fast-Track applications and encourages diversity in the biomedical entrepreneurial workforce. The specific research priorities and areas of interest vary among the participating Institutes and Centers, such as the National Center for Complementary and Integrative Health, National Eye Institute, National Human Genome Research Institute, National Heart, Lung, and Blood Institute, and others. The grant is currently open for applications, with multiple application due dates throughout the year. More information and the full solicitation can be found at the provided links.
NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)
Active
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required). This solicitation encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials, including mechanistic studies associated with clinical trials. The program supports milestone-driven, hypothesis-driven clinical trials related to the research mission of the NIAID that address high-priority research areas. The solicitation encourages high-risk clinical studies, which involve non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged. The funding supports the conduct, completion, and analysis of a single clinical trial, including activities such as training of study personnel, enrollment and recruitment of study subjects, data collection and management, laboratory work, safety monitoring, and regulatory activities. The project duration is not specified, but the application due dates are provided. More information can be found on the grants.gov website.
SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer-Relevant Technologies Toward Commercialization (R44 Clinical Trial Optional)
Active
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for SBIR Phase IIB Bridge Awards to accelerate the development of cancer-relevant technologies toward commercialization. This funding opportunity aims to support small business concerns (SBCs) that have previously received SBIR or STTR Phase II awards from any Federal agency. The goal is to assist applicants in pursuing the next milestone necessary to advance a promising product or service along a commercialization pathway. The focus is on cancer therapeutics, imaging technologies, diagnostics, prevention and control tools, and model systems for cancer research. The funding will prioritize projects that have secured substantial independent third-party investor funds and those that require approval from a Federal regulatory agency. The application due date is August 21, 2024, and more information can be found at the solicitation agency URL: [link](https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-24-022.html).