Key Dates

Related Announcements

• July 3, 2024 - PHS 2024-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) See NOFO PA-24-245.
• July 3, 2024 - PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required). See NOFO PA-24-246.
• July 3, 2024 - PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) See NOFO PA-24-247.
• July 3, 2024 - PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required) See NOFO PA-24-248.

Issued by

National Human Genome Research Institute (NHGRI)

Purpose

The National Human Genome Research Institute (NHGRI) is issuing this Notice of Special Interest (NOSI) to seek Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant applications to develop solutions for commercialization that can be used to assist Genomics-Enabled Learning Health Systems (gLHS). Specifically, we seek products, such as technologies or services, that will allow for the development and sustainment of gLHS.

Background

NHGRI Small Business Program

The NHGRI Small Business Program participates in the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. In general, the NHGRI Small Business Program is interested in supporting small businesses that engage in the research and development of innovative technologies that improve health through work in the field of genomics and have a strong potential for commercialization.

Genomics-Enabled Learning Health Systems (gLHS)

A learning health system (LHS), also called a rapid-learning health system, is one in which an infrastructure supports complete learning cycles that encompass both the analysis of data to produce results and the use of those results to develop changes in clinical practices in a system that will allow for optimal learning (NAM 2015). In an effective LHS, generalizable knowledge can potentially be captured from every patient encounter, used to generate evidence of impact on outcomes, and delivered to clinicians to modify their practice. The LHS concept has gained significant momentum in health systems in recent years due in part to advances in electronic health records (EHRs) and information technology, as well as increased emphasis on rapid translation of new knowledge to improve care. Data are collected on adopted strategies and analyzed to assess impact and identify areas for improvement, and those insights are then used to inform and optimize clinical practice in a virtuous cycle of continuous quality improvement.

Genomic information can be integrated at any step in this process to produce genomic-enabled learning health systems (gLHS). gLHS can facilitate rapid incorporation and evaluation of genomic-informed care, particularly if multiple gLHS collaborate to increase the adoption of evidence-based genomic interventions and assess their impact on delivery of care. Genomic-enabled LHS have begun to adopt the full cycle of implementation, evaluation, refinement, and re-implementation of genomic medicine in true gLHS fashion. Other systems may be considered gLHS-capable, with LHS infrastructure in place and utilized for non-genomic care delivery, but structured genomic data not yet incorporated. Still others may be considered potential LHS, with multiple components of LHS infrastructure in place (such as a system-wide EHR, implementable clinical decision support, computable outcomes) and having incorporated structured genomic data and implemented some genomic medicine interventions, but not having fully adopted other steps of the gLHS virtuous cycle such as evaluation, refinement, and re-implementation.

Leveraging individual health systems data and best practices in collaborative efforts to identify and implement effective genomic interventions requires adoption of common data standards and systems. Fostering interoperability of integrated genomic data across health systems to facilitate genomic medicine implementation was a key recommendation of the 2015 National Academies Genomic-Enabled Learning Health Care Roundtable report. Significant strides in improving genomic data exchange and interoperability have since been made through adoption of standards such as those developed by the Global Alliance for Genomics and Health (GA4GH). Expansion of such efforts through wider adoption of standardized genomic data elements, access procedures, and consent provisions provides an opportunity to expand upon and enable integration of genomic data into health information exchanges (HIE) that share individual-level EHR information among providers, across clinical facilities, and with patients to coordinate and improve clinical care. Expansion to under-resourced settings is also needed to address current barriers to accessing genomic testing and expert consultation and increase the availability of such approaches to all.

Specific Objectives

A variety of solutions that can assist gLHS are needed. NHGRI will consider applications that address barriers, which include but are not limited to, setting up gLHS; conducting outreach, promotion, and education about gLHS; and/or running gLHS. Eligible small businesses can submit applications focusing on solutions that reduce costs, time, and/or increase access to gLHS. Solutions of interest include, but are not limited to, those that address the following barriers:

• Technologies that allow diverse EHR systems to harmonize gLHS data and associated clinical information.
• Artificial intelligence and/or machine learning solutions that can identify and extract data.
• Services or technologies that help manage the administration of gLHS data.
• Services or products that can be used to educate providers on the need for and use of gLHS.

Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed:

• Solutions that focus on specific areas specialties of genomic medicine, such as those only providing solutions for oncology or prenatal concerns.

Application and Submission Information

This notice applies to due dates on or after January 5, 2025 and subsequent receipt dates through September 6, 2027. 

Submit applications for this initiative using one of the following notice of funding opportunity (NOFO) or any reissues of these announcement through the expiration date of this notice.

• PA-24-245 - PHS 2024-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PA-24-246 - PHS 2024-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
• PA-24-247 - PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-24-248 - PHS 2024-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

All instructions in the How to Apply - Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-HG-24-040” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed notice of funding opportunity.