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The Therapeutic Development Award supports research ranging from validation of therapeutic leads to U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited ALS experience are strongly encouraged to collaborate with those having substantial expertise in ALS research and/or ALS model systems. Examples of activities that will be supported by this award include: * Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds * Validation of early pilot studies, including the use of multiple ALS model systems and/or replicating preliminary data with more time points or additional doses * Studies on formulation and stability leading to Good Manufacturing Practice (GMP) production methods * IND-enabling studies, to include compound characterization, absorption, distribution, metabolism, and excretion (ADME) studies, and dose/response and toxicology studies in relevant model systems Validation of treatment approaches in appropriately powered and controlled studies using biological correlates of disease activity and progression in pre-existing, de-identified human specimens from well-characterized patient cohorts is encouraged. Examples of acceptable cohorts for study include controlled clinical trials, observational studies, and registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://wwwn.cdc.gov/als/).

ntiretroviral therapy has been recommended for all persons living with HIV since 2012. However, in 2014, among persons with diagnosed HIV infection, 57.9% of all persons were virally suppressed and 48.1% of youth were virally suppressed (https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-22-2.pdf ). Insurers have information on clinical encounters which provide them with diagnoses codes. They also have information on pharmacy claims data and can assess if persons with a diagnosis of HIV are receiving antiretroviral (ARV) drugs.

This FOA will support exploratory/developmental research programs of interest to the NIBIB (https://www.nibib.nih.gov/research-funding). These studies are expected to lead to breakthroughs in development of innovative techniques, agents, methodologies, models, or their applications. These studies may involve considerable risk that should be balanced by the potential high impact on human-health and related research. Applicants are expected to propose novel biomedical research approaches for which there is no preliminary data to demonstrate the feasibility of the proposed project. A project may be exploratory, developmental, proof of concept, or high risk-high impact, and may be technology design-directed, discovery-driven, or hypothesis-driven.

The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available on GPO Access at: http://www.access.gpo.gov/nara/index.html. Please review the official application notice for pre-application and application requirements, application submission information, performance measures, priorities and program contact information. Purpose of Program: The Research Networks Focused on Critical Problems of Education Policy and Practice Program is designed to direct resources and attention to education problems or issues that are a high priority for the Nation, and to create a structure and process for researchers who are working on these issues to share ideas, build new knowledge, and strengthen their research and dissemination capacity. Under this announcement, the Institute of Education Sciences (Institute) intends to award one grant under this program to fund the Lead of a CTE Network, which is to carry out the requirements under section 114(d)(4) of the Carl D. Perkins Career and Technical Education Act to establish a national research center to carry out scientifically based research on career and technical education programs.

The NIDDK Central Repositories house valuable biological samples and data from numerous major clinical studies. This initiative allows investigators to apply for access to non-renewable samples from one or more of these studies. Information about the samples available can be found at https://repository.niddk.nih.gov. Applicants must provide a report from the NIDDK Central Repositories documenting sample availability.

The National Institute of Environmental Health Sciences (NIEHS) invites qualified investigators from domestic institutions of higher education to apply to the Superfund Research Program (SRP) R01 Individual Research Project grant program. The mission of the NIEHS is to discover how the environment affects people in order to promote healthier lives. The NIEHS Superfund Research Program (SRP) (http://www.niehs.nih.gov/research/supported/srp/) was established under the Superfund Amendment Reauthorization Act (SARA) Section 311(a), which authorizes NIEHS to implement a university-based program of basic research for the development of: 1) advanced techniques for the detection, assessment, and evaluation of the effect of hazardous substances on human health; 2) methods to assess the risks to human health presented by hazardous substances; 3) methods and technologies to detect hazardous substances in the environment; and 4) basic biological, chemical, and physical methods to reduce the amount and/or toxicity of hazardous substances. SRP's broad scope, as dictated by the SARA mandates, allows NIEHS to support scientific research to address the wide array of scientific uncertainties facing the national Superfund program utilizing biomedical as well as environmental science and engineering approaches. Research supported by the SRP uses mechanistic science as a foundation and, in keeping with the broad research themes of the program mandates, the SRP promotes an interdisciplinary approach to develop solutions for the safe management of hazardous substances with the ultimate goal of improving public health.

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nations biomedical, behavioral and clinical research needs. Information on current SEPA projects can be found at: https://www.nigms.nih.gov/Research/crcb/sepa/Pages/default.aspx ?and http://nihsepa.org. Applicants are strongly encouraged to consult with the SEPA Scientific/Research Contact to be advised on the appropriateness of the intended project for SEPA program objectives and the priorities of the NIGMS.

With this solicitation, NIJ seeks proposals for basic or applied research and development projects. An NIJ forensic science research and development grant supports a discrete, specified, circumscribed project that will: (1) increase the body of knowledge to guide and inform forensic science policy and practice, or (2) lead to the production of useful material(s), device(s), system(s), or method(s) that have the potential for forensic application. The intent of this program is to direct the findings of basic scientific research; research and development in broader scientific fields applicable to forensic science; and ongoing forensic science research toward the development of highly-discriminating, accurate, reliable, cost-effective, and rapid methods for the identification, analysis, and interpretation of physical evidence for criminal justice purposes. Projects should address the challenges and needs of the forensic science community. The operational needs discussed at NIJ's FY 2016 Forensic Science TWG meeting may be found on NIJ.gov. Additional research needs of the forensic science community can be found at the Organization of Scientific Area Committees website. While the goals and deliverables of proposed projects do not necessarily need to result in immediate solutions to the posted challenges or needs, they should speak to them and produce knowledge that adds to work towards eventual resolutions.

The over-arching goal of this NIDCD R25 program is to support educational activities that foster a better understanding of biomedical research and its implications in the areas of auditory and vestibular research. The complexity of auditory and vestibular biology processes provide our hearing and balance function. Interruption of these processes may occur from a variety of factors, including genetic, environmental and pathogenic agents, and often results in the loss of hearing and balance function. While loss or impairment of these functions are most often non-life-threatening, the disruption to quality of life is substantial. Since August of 2007, the National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/) has supported a special topics course in auditory and vestibular biology. The two to three week course, Biology of the Inner Ear, has been held at the Marine Biological Laboratory in Woods Hole, MA, and has brought together outstanding faculty to provide hands-on instruction to participants. It is the continued intent of the NIDCD to foster the advancement of research methodologies and technologies to improve, hasten and implement new treatments for these disorders and impairments. It is based on this template of excellence that the NIDCD invites R25 applications for support of a special topics course in the auditory and vestibular sciences. The purpose of this five-year initiative is to support three courses to be offered each in years 2021, 2023, and 2025. This will allow for a sustained specialized topics course that provides lecture and hands-on research exposure to the auditory and vestibular sciences. The target audience envisioned for this course consists of advanced graduate students, post-doctoral fellows and established early stage research investigators.

The purpose of the notice is to inform all NIAAA grant applicants of the revised Data and Safety Monitoring Plan (DSMP) requirements for all extramural NIAAA-funded clinical trials. The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes (https://grants.nih.gov/grants/glossary.htm#ClinicalTrial.) The revised DSMP guidelines provide better alignment with local Institutional Review Board (IRB) requirements and provide NIAAA with enhanced oversight of NIAAA-funded clinical trials.

This Funding Opportunity Announcement (FOA) invites applications for support of pre-clinical studies to repurpose existing experimental or FDA approved drugs or biologics (existing therapeutics) that have already begun or completed at least a Phase l trial. The hypothesis for proposed studies must be developed using innovative processes to identify the therapeutic/indication pair. Examples include independent crowdsourcing strategies (e.g., http://www.ncats.nih.gov/ntu/assets/current, http://openinnovation.astrazeneca.com/, or any website that lists experimental therapies), or use of computational algorithms. The initial UG3 award will support the development of milestone-driven rigorous, pre-clinical target engagement and/or efficacy studies. Once UG3 pre-clinical milestones have been met, the UH3 award may be made to support clinical trial planning: this includes complete planning, design, and preparation of the documentation necessary for implementation of Phase I and/or Phase II clinical trials for a new therapeutic use.

This Funding Opportunity Announcement (FOA) invites submission of investigator-initiated program project applications. The proposed programs should address scientific areas relevant to the NIDDK mission including diabetes, selected endocrine and metabolic diseases, obesity, digestive diseases and nutrition, and kidney, urologic and hematologic diseases, as well as new approaches to prevent, treat and cure these diseases, including clinical research. A description of NIDDK scientific program areas can be found at http://www.niddk.nih.gov/about-niddk/research-areas/pages/research-areas.aspx .

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications to support institutional career development programs in urological research that will assist MDs, PhDs, and MD/PhDs with an interest in benign urological disease or urological research to develop the skills necessary to initiate and sustain an independent research career in urological research. Research areas supported by this initiative must be related to the mission of the NIDDK (http://www2.niddk.nih.gov/Research/ScientificAreas/Urology/)

This Funding Opportunity Announcement (FOA) encourages applications for short-term mentored career development (K18) awards that improve synergies among researchers in basic and applied behavioral-social sciences, human subjects and model animals settings; and biomedical and behavioral-social sciences. Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-17-486.html

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The over-arching goal of this NIGMS R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation's biomedical, behavioral and clinical research needs. To this end, this funding opportunity announcement (FOA) encourages the development of innovative educational activities for pre-kindergarten to grade 12 (P-12), pre-service and in-service teachers (Teachers) and students from underserved communities with a focus on Courses for Skills Development, Research Experiences, Mentoring Activities, Curriculum or Methods Development and Outreach. Information on current SEPA projects can be found at: https://www.nigms.nih.gov/Research/crcb/sepa/Pages/default.aspx and http://nihsepa.org. Applicants are strongly encouraged to consult with the SEPA Scientific/Research Contact to be advised on the appropriateness of the intended P-12 STEM or ISE project for SEPA program objectives and the priorities of the NIGMS.

The NIDA Avant-Garde Award Program for HIV/AIDS Research supports individual scientists of exceptional creativity who propose high-impact research that will open new areas of HIV/AIDS research relevant to drug abuse and/or lead to new avenues for prevention and treatment of HIV/AIDS among drug abusers. The term "avant-garde" is used to describe highly innovative approaches that have the potential to be transformative. The proposed research should reflect approaches and ideas that are substantially different from those already being pursued by the investigator or others and should support the NIH HIV/AIDS Research Priorities https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html. The NIDA Avant-Garde award supports innovative, basic research that may lead to improved preventive interventions or therapies; creative, new strategies to prevent disease transmission; novel approaches to improve disease outcomes; and creative approaches to eradicating HIV or improving the lives of those living with HIV.

 Cutting-edge research in the biomedical, behavioral, clinical sciences and technologies requires new ideas, techniques, and points of view. Such ideas may differ substantially from current thinking or practice. The NIBIB seeks to foster these new scientific bioengineering and imaging ideas, model systems, tools, agents, targets, and technologies through the Exploratory/Developmental Research Grant Program.  More detail on our program areas can be found at https://www.nibib.nih.gov/research-funding.

This FOA encourages applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing a future trial, for biomarker validation studies, or for proof of mechanism clinical studies. Diseases chosen for study should be based on the NINDS' strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

The Division of Integrative Organismal Systems (IOS) continues to support the Enabling Discovery through GEnomic Tools (EDGE) program, previously a component of the IOS Core Programs solicitation (NSF 16-505). EDGE is designed to provide support for research addressing current impediments to research progress in organismal biology. In particular, the ability to directly test gene function is essential to improve understanding of the genomes-to-phenomes relationship, an area relevant to Understanding the Rules of Life, one of 10 Big Ideas for future NSF investment (www.nsf.gov/about/congress/reports/nsf_big_ideas.pdf). EDGE projects should focus on development of functional genomic tools, approaches, and associated infrastructure to enable direct tests of hypotheses about gene function in diverse organisms for which such tools and infrastructure are presently unavailable

This Funding Opportunity Announcement (FOA) issued by the Fogarty International Center (FIC) seeks to stimulate innovative ideas and impactful research to better understand the complexities around developing appropriate approaches for effective diagnosis, prevention, therapeutic interventions and integrated clinical care for HIV-associated non-communicable diseases (NCDs) in Low and Middle-Income Countries (LMICs). Specifically, this initiative will support research in the following areas: a) Basic sciences to address etiopathogenesis of NCDs in Persons Living with HIV (PLWH); b) Aging process in PLWH; c) Diagnostics tools for early detection of NCDs in PLWH; d) Therapeutic interventions to explore optimal drug regimens for PLWH with NCDs; e) Behavioral studies for better quality of life of PLWH with NCDs; and f) Clinical studies for better patient centered care for PLWH with NCDs. The R21 grant mechanism is intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development and assessing feasibility of the proposed studies (https://grants.nih.gov/grants/funding/r21.htm ). It is hoped that this preliminary research will lay the foundation for larger studies that can lead to applications to other organizations or NIH institutes that support HIV-associated NCD research.