Key Dates

Related Announcements

• July 12, 2023 - 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). See NOFO PA-23-230.
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed). See NOFO PA-23-232.

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 in the field of genomic medicine. Specifically, NHGRI seeks applications to research and develop innovative solutions with commercial potential, such as new clinical services, computer software, mobile apps, and other products, that enable the use of genomic information in clinical care for individuals of all racial/ethnic backgrounds and socioeconomic statuses. Applications should focus on genomic medicine, defined as the utilization of an individual’s genomic information as an integral part of their clinical care (e.g., for screening, diagnostic, or therapeutic decision-making) while improving health outcomes and addressing policy implications of that clinical use.

NHGRI supports small businesses that develop services and products that can be used across a broad spectrum of diseases. Applications may focus on a particular disease or organ system as an exemplar if the generalizability to multiple diseases is explained. Applications that are not generalizable should be directed to the appropriate Institute or Center. Similarly, projects that focus only on a gene or limited set of genes will not be appropriate for NHGRI funding unless broad applicability is clearly explained, potential for the approach to eventually scale to be genome-wide is demonstrated, and use of a single gene or limited set of genes is well justified. All applications, regardless of focus, should explain how generalizable, broadly useful, and transformative their approaches will be to the field of genomic medicine.

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.

Genomic Medicine Research

The past decade has seen a significant growth in the implementation of genomics in clinical practice. NHGRI has primarily funded genomic medicine research through multi-disciplinary consortia and investigator-initiated research. This funding opportunity is intended to stimulate technological innovation and encourage small businesses to engage in research and development in the field of genomic medicine.

Scope and Objectives

This NOSI centers on stimulating the research and development of promising technologies and products necessary to use genomic information in clinical care. The following are examples of topics on which small businesses could focus, but are not exclusive, grouped by category:

Implementing genomic medicine

• Technological solutions or clinical services that improve health outcomes through the use of genomic information
• Tools, services, or other solutions that for implementation of genomic medicine and pharmacogenomics in diverse clinical settings
• Software or other tools that can be used to study genomic medicine in academic clinical settings, non-academic clinical settings, or both
• Computational, health-economic, or other analytical approaches and associated tools that identify characteristics of participants likely to derive the greatest (or conversely, the least) value from incorporating various types of genomic data into clinical care
• Clinical decision support tools for genomics
• Novel, scalable clinical services or other solutions that address the need for more healthcare professionals trained in genetic counseling

Facilitating analysis of clinical genomic data

The pace and volume of genomic data being generated presents challenges and opportunities for solutions and tools that facilitate clinical analysis.

• Solutions to automate or otherwise improve the efficiency of clinical annotation and interpretation of genomic variants, especially those that allow for dynamic interpretation as knowledge of variants and clinical recommendations evolve
• Tools or other technologies that integrate genomic data with other data types such as environmental data, family history, social determinants of health, transcriptomics, functional data, or model organism data for clinical predictive value, clinical validity, and/or clinical utility

Improving clinical access and sharing of genomic data

Clinical access and sharing of genomic data is critical to promoting genomic medicine.

• Solutions to integrate genomic data throughout health systems or make genomic information available to healthcare providers, payers, and regulators.
• Technologies that enhance portability of genomic data that uses standards for genomic information and allows for iterative use (e.g., integration with EHR apps, transporting to other care systems).

Meetings

Small businesses funded though this NOSI will be considered to be part of the Advancing Genomic Medicine Research (AGMR) Program. Thus, awardees will be encouraged to attend an annual AGMR grantee meeting hosted by NHGRI. These annual meetings serve as venues to facilitate sharing of research findings; promote the exchange of ideas; enable discussion of opportunities, challenges, and emerging needs; develop expertise and abilities among collaborators newer to genomic medicine; and accelerate progress in genomic medicine. Other investigators in the field may be invited to participate in these grantee meetings. Applicants may include travel costs to attend the meeting in-person in their budget. Alternatively, small business grantees may attend virtually.

Application and Submission Information

This notice applies to due dates on or after January 5, 2024 and subsequent receipt dates through September 6, 2026. 

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-23-230 - 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)
• PA-23-232 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) 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-24-002” (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 contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:

Scientific/Research Contact(s)

Renee Rider, JD, MS, CGC
National Human Genome Research Institute (NHGRI)
Telephone: 301-443-4336
Email: Renee.Rider@nih.gov 

Christine Chang, MPH
National Human Genome Research Institute (NHGRI)
Telephone: 240-552-1208
Email: changcq@mail.nih.gov