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Reissue of PAR-18-546. The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to IND enabling toxicology studies and phase I clinical testing. BPN awardee Institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

Notice Special Interest NOSI): Availability Administrative Supplements the Rare Disease Clinical Research Network RDCRN) Notice Number: NOT-TR-20-006 Key Dates Release Date: February 27, 2020 First Available Due Date: April 01, 2020 Expiration Date: April 04, 2022 Related Announcements RFA-TR-18-020 Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network RDCRN) U54 Clinical Trial Optional) PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued National Center Advancing Translational Sciences ( NCATS) National Heart, Lung, Blood Institute NHLBI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Neurological Disorders Stroke NINDS) Purpose National Center Advancing Translational Sciences NCATS) informs Program Directors/Principal Investigators PDs/PIs) holding active Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network RDCRN) U54) awards the opportunity submit administrative supplement requests through NIH Parent Funding Opportunity Announcement FOA), PA-18-591, ldquo;Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional)”. supplements provide short-term and/or catalytic support projects a significant unmet needs. Applicants the administrative supplements encouraged form new collaborations enhance reach impact the activity. Administrative supplements must add value the science proposed the aims the original project; such, they must within scientific scope the parent grant. Enthusiasm be higher requests describe clear outcome that the potential greatest impact across RDCRN these outcomes be subsequently distributed shared throughout consortium. RDCRN Program also identified specific areas interest accordance its aim to advance diagnosis, management, treatment rare diseases a focus clinical trial readiness. The RDCRN priority research areas would appropriate requests supplemental funding include, are limited to, topics listed here: Methods accelerate diagnosis Genomic analysis/characterization, interpretation e.g., Gene Curation leveraging ClinGen resources) Novel precision personalized approaches treatment Outreach increase research participant diversity Addressing health disparities Expanding focus women’s health Expanding focus mental health issues Expanding age range research participants Evolving technologies e.g., remote data capture, augmented reality) facilitate assessment, management treatment rare diseases. Trans-network research common interests e.g., shared molecular etiologies, research data collections approaches) Administrative supplement requests support clinical trials not accepted and/or considered response this funding opportunity announcement. Applications should demonstrate the supplement be completed within project period. applicable, proposed research effort should supported a strong rationale should contribute advancing translational sciences. Applicants strongly encouraged discuss potential requests their Program Official listed the Notice Grant Award the parent grant. Award Project Period Administrative supplements limited 12 months. Budget Available Funds Supplement budget requests not exceed 150,000 per year direct costs must reflect actual needs the proposed project. is guarantee funds available NCATS for any specific grant. Application Submission Information Eligible Individuals Program Director/Principal Investigator) Applicants must hold active RDCRN award: only parent RDCRN cooperative agreement awards funded through following FOA any reissues this announcement) eligible request supplemental funding under NOSI: RFA-TR-18-020: Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network RDCRN) U54 Clinical Trial Optional) supplements parent awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) must submitted the awardee institution the parent award. Submitting Application Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: funding consideration, applicants must include ldquo;NOT-TR-20-006” without quotation marks) the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. facilitate efficient processing the request, applicants strongly encouraged notify Tiina Urv urvtiin@mail.nih.gov), well the assigned IC program officer IC grants management specialist the parent award a request been submitted response this NOSI. Research Strategy section the application limited to 6 pages. Applicant organizations submit only application per fiscal year this NOSI. process Streamlined Submissions using eRA Commons cannot used this initiative. applications must submitted electronically using single-project application form package. Please note, for single multi-project applications applicants must the form package the Competition ID ldquo;FORMS-E-ADMINSUPP-RESEARCH". one the methods described PA-18-591. Paper submissions applications submitted attachments be returned. Application Due Date – April 1, 2020; April 1, 2021; April 1, 2022, 5:00 PM local time applicant organization. Inquiries Please direct inquiries to: Tiina K. Urv, Ph.D. National Center Advancing Translational Sciences NCATS) Telephone: 301-827-2746 Email: urvtiin@mail.nih.gov

This Funding Opportunity Announcement (FOA) solicits applications to develop standards that describe experimental protocols that are being conducted as part of the BRAIN Initiative. It is expected that applications will solicit community input at all stages of the process. It is recommended that the first step of standard development will involve sharing data between different key groups in the experimental community in order to ensure that the developing standard will cover the way that all of those groups are collecting data. The developed standard is expected to be made widely available.

This funding opportunity announcement (FOA) invites applications to develop a multisite, longitudinal, prospective study of idiopathic REM sleep behavior disorder (iRBD) as a prodromal phase of ?-synuclein neurodegenerative disorders.

This Funding Opportunity Announcement (FOA) is aimed at discovering, characterizing the selectivity and sensitivity, and externally validating biological measures to be used for assessing, prognosing, and monitoring recovery of adolescents who either clinically present with or are at risk for developing prolonged/persistent concussive symptoms following exposure to repetitive head impacts and/or concussion. Resultant biological measures should be incorporated into risk stratification algorithms to inform clinical care and patient stratification for future clinical trials. A critical feature of this FOA includes the broad sharing of clinical, neuroimaging, physiological, and biospecimen data to further advance research in the area of persistent concussive symptoms in early and middle adolescent (EMA; ages 11-17 years old) populations.

The purpose of this PAR is to support the development and evaluation of non-viral technologies to deliver genome editors to disease relevant somatic cells and tissues in vivo. The ultimate goal of these technologies is translation into clinical trials of genome editing to treat human disease.

The purpose of this PAR is to support the development and evaluation of non-viral technologies to deliver genome editors to disease relevant somatic cells and tissues in vivo. The ultimate goal of these technologies is translation into clinical trials of genome editing to treat human disease.

The purpose of this FOA is to establish expert panels that will select genes and genomic variants associated with diseases or conditions of high priority to participating NIH Institutes and Centers (ICs) and systematically determine their clinical significance for diagnosis and treatment of these diseases or conditions. The Genomic Expert Curation Panels funded through this FOA are r?e?q?u?i?r?e?d to utilize the NHGRI Clinical Genomics Resource (ClinGen) and the NCBI ClinVar procedures, interfaces, tools and informatics infrastructure to determine the strength of evidence supporting the clinical significance of the selected genes and variants that will support development of clinical practice guidelines.

This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct efficient, large-scale pragmatic trial or implementation science study designs to improve pain management and reduce the use of opioid medications. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The overall goal of this initiative is to identify effective methods to improve the management of pain and reduce the need for opioid medications at the health care system level. This FOA requires that the intervention under study be embedded into health care delivery system, real world settings. Studies can propose to integrate interventions that have demonstrated efficacy into health care system; or implement health care system changes to improve adherence to evidence-based guidelines. Trials must be conducted across two or more health care systems (HCS) and must be conducted as part of the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory). The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. After awards are made by NIH, the CCC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) and the NIH will work with successful awardees from this FOA to facilitate the planning and rapid execution of high impact trials that conduct research studies in partnerships with health care delivery systems.

The purpose of this Funding Opportunity Announcement (FOA) is to solicit cooperative agreement applications that propose clinical trials to test the comparative effectiveness of existing pharmacological therapies or devices for prevention or management of pain while reducing risk of addiction. The studies must evaluate methods to manage specific pain conditions that are within the mission and research interests of participating NIH Institutes and Centers, and evaluate interventions including medications, biologics, medical and assistive devices or delivery system strategies in controlled trials. This FOA does not include testing behavioral interventions for management of pain. The overall goal is to inform clinicians about the effectiveness of pharmacological or device interventions or management strategies concerning use of these interventions that reduce opioid use, improve functional outcomes and reduce pain for diseases or conditions of interest. Clinical trials will be conducted within the infrastructure of the HEAL Pain Effectiveness Research Network.