Notice Number: NOT-HG-19-021
Key Dates
Release Date: May 29, 2019
PAR-18-735: Investigator-Initiated Genomic Medicine Research (R01 Clinical Trial Optional)
PAR-18-736: Investigator-Initiated Genomic Medicine Research (R21 Clinical Trial Optional)Issued by
National Human Genome Research Institute (NHGRI)
Purpose
NHGRI seeks to encourage applications from small businesses conducting research, development, and implementation of genomic medicine through funding applications under the existing NIH SBIR and STTR omnibus/parent FOAs.
Background:
The National Human Genome Research Institute (NHGRI) is committed to using genomics to advance our understanding of human biology and improve the diagnosis, prevention and treatment of human disease in all populations. NHGRI's strategic vision extends from basic research to health applications, and projects an increasing level of research activity over time to (1) advance the science of medicine and (2) improve the effectiveness of health care. These latter activities constitute the genomic medicine research portfolio at NHGRI. Advancing the science of medicine includes studying how genomics can impact prevention, diagnosis and treatment; building an evidence base for genomic medicine; understanding how genomic information may contribute to the reduction of health disparities; and improving how we interpret genomic data to facilitate the return of information to clinicians and patients. Improving the effectiveness of health care includes developing innovative approaches to incorporate genomic data into electronic health records (EHRs); demonstrating effectiveness and clinical utility of genomic information across diverse populations; and increasing access to genomic information across different healthcare systems.
The Genomic Medicine Research FOAs cited above (R01, PAR-18-735; R21, PAR-18-736) were published to expand opportunities to include independent investigators to engage in genomic medicine research. As a companion effort to the Genomic Medicine Research FOAs, this notice is intended to encourage applications from small businesses conducting research, development, and implementation of genomic medicine through funding applications under the existing NIH SBIR and STTR omnibus/parent FOAs (see below). NHGRI has engaged with the community and shared a vision for genomic medicine in a series of workshops addressing key topics in genomic medicine of special interest. Summaries and materials from NHGRI Genomic Medicine workshops (https://www.genome.gov/27530164/dgm-meetings--workshops/) are available and can be explored as further targets of opportunity. NHGRI has also held a number of workshops that have provided recommendations for research in genomic medicine by consortia or independent investigators, including: NHGRI Roundtable on Inclusion of Underrepresented Populations in Genomics, IGNITE and Beyond, eMERGE and Beyond, CSER and Beyond, and eMERGE & CSER: The Convergence of Genomics and Medicine. This Notice is intended to expand NHGRI's portfolio of projects in genomic medicine from small businesses that complements ongoing consortia and investigator-initiated work at NIH Applications are encouraged from small business independently (SBIR) or with academic partners for technology transfer (STTR).
Definitions
In the context of this Notice, the following definitions apply:
- "Genomic medicine" is defined as a medical discipline that involves using genomic information about an individual as part of their clinical care (e.g., for diagnostic or therapeutic decision-making) and the health outcomes and policy implications of that clinical use.
- "Genomic data" is defined as single nucleotide polymorphism (SNP) array data, genome sequence data, transcriptomic data, epigenomic data, or other molecular data produced by array-based technologies or high-throughput sequencing technologies.
Areas of Research Interest
Topics identified as high priority for further research and development by small businesses include, but are not limited, to the following: - Polygenic risk prediction and use in healthcare and disease management.
- Systems for decision support that integrate genomics in clinical care and enhance reinterpretation of variants.
- Incorporation of pharmacogenomic information into clinical care
- Strategies for integrating genomic and clinical data through the development and implementation of biomedical ontologies
- Methods for expanding access to and transportability of genomic information across clinical systems
- Interoperability and data sharing innovations that make it feasible to share clinical knowledge across clinical systems.
- Integration of diverse data types, such as family history, transcriptomics, epigenomics, functional, model organism, or environmental data to improve utility of genomic information.
- New resources for variant interpretation or genetic disease studies.
- Applications of machine learning (ML) and artificial intelligence (AI) in genomic medicine research and healthcare.
- Innovative use of biobanks integrated in health systems to advance research and implementation of genomic medicine in populations.
- Methods and systems to lower barriers for access of underrepresented populations to genomic medicine.
Application and Submission Information
Applications for this Notice must submit an application through an SBIR and STTR Omnibus/Parent Grant Solicitation shown below.
All instructions for the Omnibus/Parent Announcement must be followed.
Submissions should indicate that they are in response to NOT-HG-19-XXX in Field 4.b on the SF 424 form.
Activity Code |
FOA |
First Available Due Date |
R43/R44 |
PA-19-272: PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) |
September 5, 2019 |
R41/R42 |
PA-19-270: PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) |
September 5, 2019 |
R43/R44 |
PA-19-273: PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) |
September 5, 2019 |
R41/R42 |
PA-19-271: PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required) |
September 5, 2019 |
Applications non-responsive to terms of this Notice will be withdrawn.
Inquiries
Please direct all inquiries to:
Scientific/Research Contact:
Heidi Sofia, Ph.D.
National Human Genome Research Institute
Telephone: 301-480-3424
Email: [email protected]
Financial/Grants Management Contact
Ms. Monika Christman
Phone: 301-435-7860
Fax: 301-451-5434
Email: [email protected]
and Human Services (HHS)
