A Solicitation of the Advanced Research Projects Agency for Health (ARPA-H) for Small Business Innovation Research (SBIR) Contract Proposals
ID: 75N91023R00041Type: BOTH
Overview

Topic

A Solicitation of the Advanced Research Projects Agency for Health (ARPA-H) for Small Business Innovation Research (SBIR) Contract Proposals

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2023

Topic Link

https://www.sbir.gov/node/2414267

Additional Information

https://sam.gov/opp/28f2dc47695f4091ab1aa6d7e02f6c03/view
Timeline
  1. 1
    Release Jun 2, 2023 12:00 AM
  2. 2
    Open Jun 2, 2023 12:00 AM
  3. 3
    Next Submission Due Jul 3, 2023 12:00 AM
  4. 4
    Close Jul 18, 2023 12:00 AM
Description

The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for Small Business Innovation Research (SBIR) contract proposals. The solicitation is from the Advanced Research Projects Agency for Health (ARPA-H). The ARPA-H SBIR program aims to encourage scientific and technical innovation in areas relevant to health outcomes for all Americans. The program is looking for proposals that can catalyze health breakthroughs that cannot be easily achieved through traditional research or commercial activity. The solicitation allows for Direct to Phase II and Fast-Track proposals. Phase I focuses on determining the feasibility and commercial merit of the proposed research, while Phase II aims to further develop the research efforts. Phase III refers to work that extends or completes prior SBIR/STTR funding agreements but is funded by sources other than the SBIR/STTR programs. Direct to Phase II proposals are accepted for projects that have already demonstrated feasibility, while Fast Track proposals allow for streamlined processes and potential funding continuity between Phase I and Phase II. The solicitation is closed, and more information can be found on the grants.gov website.

Files
No associated files provided.
Similar Opportunities
SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1, Clinical Trial Not Allowed)
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 SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development. This program aims to provide additional support for later stage research and development (R&D) and product development not typically supported through Phase II or Phase IIB grants or contracts. The program is designed to bridge the funding gap between the end of the SBIR/STTR Phase II award and the commercialization stage, often referred to as the "Valley of Death." The program supports new "Type 1" applications from recipients with Phase II or IIB SBIR/STTR awards that have been active within the last 36 months. The program focuses on providing technical assistance and late stage R&D activities, such as regulatory strategy development, intellectual property strategy development, manufacturing assistance, and market research. The program also supports activities related to late stage development, including replication of key studies, optimization of manufacturing processes, animal studies, and development of clinical trial supplies. The program allows for outsourcing of work to third-party technical assistance providers, but the small business should play a substantive role in the oversight and management of the R&D activities. The program does not support clinical trials and cannot be used to pay filing fees for patents or FDA submissions. The program is open for applications until April 6, 2025, and more information can be found on the grants.gov website.
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.
Late-Stage Translation of Biomedical and Behavioral Research Results in Arthritis and Musculoskeletal and Skin Diseases from Academic/Non-profit Lab to Marketplace (SBIR [R43/R44] Clinical Trial Not Allowed)
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 late-stage translation of biomedical and behavioral research results in arthritis and musculoskeletal and skin diseases from academic/non-profit labs to the marketplace. This Small Business Innovation Research (SBIR) grant opportunity aims to support the development of diagnostic tools, prevention tools, and treatments for these diseases. The focus is on moving lab technologies towards commercial dissemination through partnerships and close collaboration between small businesses and the original developers of the technologies. The research objectives include late-stage pre-clinical studies on technology or therapy feasibility and studies required for regulatory approval. Clinical trials are excluded from this opportunity. The funding is available for multiple years, with application due dates throughout the year. For more information, visit the solicitation agency URL: [link](https://grants.nih.gov/grants/guide/PA-files/PAR-23-032.html).
SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 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 SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development. This program aims to provide additional support for later stage research and development (R&D) and product development not typically supported through Phase II or Phase IIB grants or contracts. The program is designed to bridge the funding gap between the end of the SBIR/STTR Phase II award and the commercialization stage, often referred to as the "Valley of Death." The program supports projects that require technical assistance and R&D studies that are typically outsourced to contract research organizations (CROs), such as regulatory assistance, IND/IDE enabling studies, toxicology, manufacturing, and clinical trials. The program also supports activities important for commercialization, such as product development, market planning, market research, and costs related to license agreements and partnerships. The program is open to companies that have received Phase II or Phase IIB funding from NIH within the last 36 months. The funding specifics, project duration, and performance goals can be found in the solicitation notice on grants.nih.gov.
Late-Stage Translation of Biomedical and Behavioral Research Results in Arthritis and Musculoskeletal and Skin Diseases from Academic/Non-profit Lab to Marketplace (SBIR [R43/R44] Clinical Trial Not Allowed)
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 late-stage translation of biomedical and behavioral research results in arthritis and musculoskeletal and skin diseases from academic/non-profit labs to the marketplace. This Small Business Innovation Research (SBIR) grant opportunity aims to support the development of diagnostic tools, prevention tools, and treatments for these diseases. The focus is on moving lab technologies towards commercial dissemination through partnerships and close collaboration between small businesses and the original developers of the technologies. The research objectives include late-stage pre-clinical studies on technology or therapy feasibility, as well as studies required for regulatory approval before clinical testing. Clinical trials are excluded from this opportunity. The research topics of interest include the development of therapies, innovative drug delivery strategies, biomarker studies, outcome measures and methodologies, and 3D human tissue models. Collaboration between academic/non-profit labs and small businesses is encouraged, with the academic/non-profit labs performing a portion of the project. The proposal should include milestones with quantitative success criteria to measure the progress and efficacy of the project. Applications that do not originate from academic/non-profit labs or propose intervention studies are not responsive to this opportunity. The grant is open for applications until September 6, 2025. For more information, visit the solicitation agency URL: [link](https://grants.nih.gov/grants/guide/PA-files/PAR-23-032.html).