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 enable regional clinician-to-clinician genomic medicine eConsult services. Specifically, we seek products, such as technologies or services, that will allow for the development and sustainment of eConsult services.

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.

Regional eConsult Services

Non-regional eConsult services (i.e., those within a single organization or system) have been established by many institutions in non-genomic specialties. They’ve been shown to reduce specialty clinic appointment wait times, healthcare costs and utilization, and patient travel costs and burden, and to improve primary/specialty communication. Previous research has demonstrated the feasibility of eConsult services and identified factors promoting successful implementation including compatibility with existing workflows, clarity of communications, technologic simplicity, and protected time for consultants. In addition to the benefits seen in non-regional services, regional eConsult services have successfully provided specialty care in large, disadvantaged populations with historically poor access to specialty care. Regional eConsult services can promote equity of access by enabling patients to obtain the care that they need without referrals to other providers.

The use of genomic testing in primary and specialty care remains scant, in part due to lack of understanding and confidence with genomics among non-genetic clinicians and lack of access to genetic specialists. Yet, genomic medicine eConsult services are rare despite the potential support that these services could provide.

The August 2022 Genomic Medicine XIV Meeting on Genomic Learning Health Systems highlighted the need for consult services to support clinicians in providing genomic care, especially in lower-resourced settings that do not have genetic experts. The subsequent NHGRI Genomic Consultation Research Working Group explored the current status of genomic eConsult services at their institutions and research needed to successfully implement these services elsewhere.

First-year results from one genomic medicine eConsult service demonstrated rapid turnaround times and high rates of actionable recommendations and follow-through on those recommendations. More extensive experience in Ontario showed that genomic eConsults enabled many primary care providers (PCPs) to provide care without referring the patient and that most referring PCPs perceived the eConsult as valuable for patient management. Unfortunately, such services are currently targeted only to the clinicians within these institutions, so clinicians in locations without access to genomic specialists lack access to genomic medicine eConsults as well.

While regional genomic medicine eConsult services have been shown to be effective in Ontario, similar services are not available in the United States. Barriers such as inconsistent licensure laws, lack of consultants, and diverse Electronic Health Record systems have stymied efforts to create regional services. Solutions that can help eConsult services overcome barriers need to be developed.

Relationship to Prior Funding Opportunities

Applications previously submitted under NHGRI’s prior small business notices of funding opportunity for eConsults (PAR-24-106 and PAR-24-107) may be submitted under this opportunity as revisions.

Specific Objectives

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

• Technologies that allow diverse EHR systems to transmit and manage eConsult requests, associated clinical information, and/or information needed for reimbursement.
• Artificial intelligence and/or machine learning solutions that can triage, identify common questions, create responses, or otherwise enable eConsult services.
• Services or technologies that help manage the administration of eConsult services, such as the reimbursement or multi-state licensure of consultants.
• Services or products that can be used to educate providers on the need for and use of eConsult services.

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 eConsults for oncology or prenatal concerns.
• Solutions that do not enable regional services (i.e., work within a single healthcare system).

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.