Notice of Intent to Publish a Funding Opportunity Announcement for ClinGen Genomic Curation Expert Panels

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), with other NIH Institutes and Centers (ICs) - National Eye Institute, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute on Deafness and Other Communication Disorders, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Center for Advancing Translational Sciences, and National Cancer Institute - intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for the establishment and continuation of Genomic Curation Expert Panels that manually curate, review and define the clinical relevance of genes and variants as part of the NIH established and funded Clinical Genome Resource (ClinGen). Despite advances in genomic sequencing technology and increasing adoption in clinical practice, there are many genomic variants with unknown significance (VUS), and there is limited understanding of their function. This presents barriers to genomic and precision medicine. To address this need for better knowledge about the links between genes, variants, and disease, this NOFO will facilitate the development of Expert Panels to select genes and variants associated with diseases or conditions of high priority for participating NIH Institutes and Centers (ICs) and to systematically determine their clinical significance for diagnosis and treatment of these diseases or conditions. The Expert Panels funded through this NOFO are required to utilize the NHGRI ClinGen and the NCBI ClinVar procedures, interfaces, tools, and informatics infrastructure. Ultimately, these expert panels contribute to an authoritative, centralized, and public resource, through aggregation, evaluation, and sharing of expert-curated data about genetic conditions, and the variants that cause them.

The major elements in evaluating proposals include assessments of the significance of the proposed research; approach; innovation; investigators; and environment. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget...

Fiscal year 2025: The following is a tiny sample of fiscal year 2025 NICHD funded grants within the discretionary award class type. 1) Understanding the role of early life social determinants and sex-specific pubertal pathways in the development of adolescent chronic pain. 2) Improving In Vitro Fertilization Success through Multiplexed Optical Metabolic Imaging. 3) Genetic Studies of Large Palindromes. 4) A Safe, Fast, and Cost-Effective System for Tissue Removal in Laparoscopic Hysterectomy and Other Minimally Invasive Surgery. The following is a tiny sample of fiscal year 2025 NICHD funded grants within the cooperative agreement award class type. 1) Study of Treatment and Reproductive outcomes. 2) Pediatric HIV/AIDS Cohort Study (PHACS): Research on Immune Aging, Sexual and Reproductive Health, and Perinatal Acquisition: Elucidating Relationships in HIV (RISE). 3) Pelvic Floor Disorders Network Data Coordinating Center. 4) NICHD Maternal-Fetal Medicine Units (MFMU) Network: Data Coordinating Center. Fiscal year 2026: The following is a tiny sample of fiscal year 2026 NICHD funded grants within the discretionary award class type. 1) Placental Proteins and Prematurity. 2) In...