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The purpose of this Notice of Funding Opportunity is to solicit applications for clinical sites that will provide expert diagnostic services for undiagnosed diseases across the nation. The clinical sites known as Diagnostic Centers of Excellence (DCoEs) will partner with the Undiagnosed Diseases Network (UDN) to sustain some of the key research activities currently performed by the Phase II UDN Clinical sites (see:RFA-RM-17-019) and facilitate its transition to a larger network that serves diverse undiagnosed patient populations. The DCoEs will establish collaborations and efficient processes with the Data Management and Coordinating Center (DMCC; see: RFA-NS-22-051); enroll and evaluate new participants; and foster scientific discovery. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material.

The purpose of this notice is to notify applicants of a correction to the table of page limits and Instructions for Submission of Multicomponent Applications for RFA-NS-24-011 "Center without Walls for PET Ligand Development for Alzheimer's disease-related dementias (ADRDs) (U19 - Clinical Trial Optional)".

HIV associated CNS complications are a significant problem for people living with HIV despite suppressive anti-retroviral therapy. HIV enters the CNS as early as 8 days after infection and can cause several complications including cognitive, neurological and mental health related issues. Although experts have gathered much data on underlying HIV-induced CNS pathophysiology, specific targeted causality remains elusive, and no effective therapies exist to slow, stop, or reverse these adverse outcomes. This initiative is to comprehend the actionable biotypes of CNS complications in people living with HIV based on underlying mechanisms to help capture the heterogeneity of outcomes. Identifying biotypes can inform the development of precision treatment strategies for CNS complications seen in people living with HIV.

As part of the NIH's Helping to End Addiction Long-term (HEAL) Initiative, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and participating NIH Institutes and Centers invite applications for a single HEAL KIDS Pain Resource and Data Center (RDC) to provide the following: leadership in data collection and management, data curation, data harmonization, and the development of data standards; administrative and logistical support including oversight of NIH HEAL-related requirements; and coordination of shared research-related resources all for the HEAL KIDS Pain research activities. This Notice of Funding Opportunity (NOFO) runs in parallel with a companion NOFO (RFA-HD-24-011) that invites applications to support innovative, multi-site, large-scale clinical trials to advance the understanding, assessment, measurement, treatment, and prevention of acute pain in infants, children, and adolescents, including those with disabilities and/or experiencing health disparities.

As part of the NIH's Helping to End Addiction Long-term (HEAL) Initiative, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and participating NIH Institutes and Centers invite applications to this U01 Cooperative Agreement funding opportunity to support innovative, multi-site, large-scale investigator-initiated clinical trials to advance the understanding, assessment, measurement, treatment, and prevention of acute pain in infants, children, and adolescents, including those with disabilities and/or experiencing health disparities. Clinical trials testing behavioral interventions to manage pain as the primary outcome(s) will not be considered as high priority projects. This Notice of Funding Opportunity (NOFO) runs in parallel with a companion NOFO (RFA-HD-24-012) that invites applications for a single HEAL KIDS Pain Resource and Data Center (RDC) to provide the following: leadership in data management, data curation, data harmonization, and the development of data standards; administrative and logistical support including oversight of NIH HEAL-related requirements; and coordination of shared research-related resources for all of the HEAL KIDS Pain research activities.

The purpose of the Clinical Trial Methods in Clinical Neurological Disorders Course" Notice of Funding Opportunity Announcement (NOFO) is to increase the reliability and effectiveness of clinical trials and to enhance the training of investigators new to clinical trials.

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This NOFO solicits applications for planning grants to assess feasibility and/or determine best practices to conduct community-engaged health equity research in neurological disorders with populations that experience health disparities (HDPs). If successful, these planning grants would support, enable and/or lay the groundwork for future clinical studies or trials.In addition to posing a research question related to addressing health disparities in neurological disorders, applicants must also be filling a gap in 1) Engagement with one or more HDP communities; and/or 2) Multidisciplinary research team expertise in neurological disorders, health disparities research and/or community-engaged research.Expected outcomes would advance understanding of drivers of health disparities and barriers to neurological health equity and establish collaborative research teams, including community partners, with appropriate expertise in community engagement with HDPs, health disparities research and neurological disorders.

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The goal of this RFA is to enable partnerships between academics and companies that make wearable devices to validate their digital health technologies (DHTs) as digital monitoring biomarkers in ADRD populations. Applications will be required to optimize their DHTs in diverse patient populations from two or more early stage clinically diagnosed ADRD. Studies must demonstrate the accuracy of the digital markers to differentiate clinically meaningful features (such as sleep stage) and establish the longitudinal relationship between the features measured with quality-of-life metrics. Studies should also establish the relationship with one or more analytically validated ADRD biomarker(s) and standard cognitive assessments to validate the relationship between the features measured by the DHTs with the underlying pathophysiology or cognitive concept it reflects. An ideal outcome would be evidence for incorporating these DHT measures as monitoring biomarkers in future ADRD clinical trials. A 5-year phased mechanism is requested with a 2-year start-up phase (R61) to ensure adequate community engagement and recruitment of diverse patient populations, and to conduct pilot studies to optimize the algorithms; this will be followed by a 3-year R33 validation phase.