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Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32)

Funding Opportunity PA-18-670 from the NIH Guide for Grants and Contracts. The purpose of the Kirschstein-NRSA postdoctoral fellowship is to support research training of highly promising postdoctoral candidates who have the potential to become productive, independent investigators in scientific health-related research fields relevant to the missions of the participating NIH Institutes and Centers. Applications are expected to incorporate exceptional mentorship. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial, but does allow applicants to propose research experience in a clinical trial led by a sponsor or co-sponsor.

Broad Agency Announcement: Vaccine Adjuvant Discovery Program NIAID-DAIT-NIHAI201700100

Notice NOT-AI-18-018 from the NIH Guide for Grants and Contracts

Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (T1D) (R01 Clinical Trial Optional)

Funding Opportunity RFA-DK-18-004 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing original research addressing barriers that limit progress toward effective cell replacement therapies for type 1 diabetes (T1D). The purpose is to support research leading to the development and testing of novel and supportive technologies for the improvement of cell replacement interventions using novel biomaterials and devices for T1D treatment.

National Laboratory Curriculum Framework Development

Funding Opportunity RFA-FD-18-005 from the NIH Guide for Grants and Contracts. The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Training Education and Development (OTED) is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement Grant. The goals of this Cooperative Agreement Grant are to continue the development of the Integrated Food Safety System (IFSS) National Curriculum Standard (NCS) for the laboratory competency and curriculum frameworks, further work on the development and validation of competency statements. As the NCS is completed at each level, then training content can be developed to meet the standard, post web courses and deliver classroom courses to IFSS laboratorians nationwide. Under FSMA Section 209, FDA is directed to improve the training of state, local, territorial and tribal food safety officials and set standards and administer training and education programs to ensure a competent work force doing comparable work.

NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional)

Funding Opportunity PAR-18-665 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support clinical trials for projects that were previously funded by NIH SBIR and STTR Phase II awards. The projects must focus on products related to the mission and goals of the National Institute of Neurological Disorders and Stroke (NINDS) and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Since conducting the clinical trials needed for commercialization may be capital-intensive, the FOA aims to facilitate the transition of SBIR Phase II projects to the commercialization stage by promoting partnerships between NIHs SBIR/STTR awardees and third-party investors and/or strategic partners. Consistent with the goals of this funding initiative and as required by the SF424 instructions for all SBIR Phase II applications, applicants must submit a Commercialization Plan, which should include details on any independent third-party investor funding that has already been secured or is anticipated during the project period. It is expected that the level of this independent third-party funding will equal or exceed the NINDS funds being requested throughout the SBIR Phase IIB project period.

Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31)

Funding Opportunity PA-18-666 from the NIH Guide for Grants and Contracts. The purpose of this Kirschstein-NRSA predoctoral fellowship (F31) award is to enhance the diversity of the health-related research workforce by supporting the research training of predoctoral students from population groups that have been shown to be underrepresented in the biomedical, behavioral, or clinical research workforce, including underrepresented racial and ethnic groups and those with disabilities. Through this award program, promising predoctoral students will obtain individualized, mentored research training from outstanding faculty sponsors while conducting well-defined research projects in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The proposed mentored research training is expected to clearly enhance the individuals potential to develop into a productive, independent research scientist

Impact of the Use of Glucose Monitoring and Control Technologies on Health Outcomes and Quality of Life in Older Adults with Type 1 Diabetes (T1D) (R01 Clinical Trial Required)

Funding Opportunity RFA-DK-17-024 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing clinical studies of the use of current and emerging technologies for monitoring of blood glucose and insulin administration in older adults. (aged 65 years or older) Older adults may have increased vulnerability to hypoglycemia, cognitive impairment and/or multiple co-morbidities which may affect the risks and benefits of these technologies in this population. This research is intended to improve health, glucose control and quality of life of older patients with type 1 diabetes Only human studies will be considered responsive to this FOA; applications involving animal or invitro studies are not responsive to this FOA.

Clinical, Behavioral and Physiological Research Testing Current and Novel Closed Loop Systems (R01- Clinical Trial Required)

Funding Opportunity RFA-DK-17-023 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing clinical trials to test a highly reliable, wearable/implantable, portable, and easy to operate system linking continuous glucose monitoring and pancreatic hormone delivery in a closed loop system. This research is also intended to study behavioral and physiological aspects of relevance to the use and adoption of these systems. The main goal of this FOA is to improve glucose control and quality of life of patients with type 1 diabetes. Only human studies will be considered responsive to this FOA, applications involving animal or in vitro studies are not responsive to this FOA.

Development and Integration of Novel Components for Open and Closed Loop Hormone Replacement Platforms for T1D Therapy (R01- Clinical Trial Optional)

Funding Opportunity RFA-DK-17-025 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing original research addressing barriers that limit progress toward effective open- and closed-loop glucose control systems. Proposed research should tackle important obstacles at the level of sensing, hormone formulation and delivery, self-management decision support systems, and/or design of automated controllers/algorithms able to manage an integrated platform. This research may contribute to development of affordable and user friendly technologies to improve glucose control in patients with type 1 diabetes.

Extending Deadline for RFA-FD-18-004

Notice NOT-FD-18-005 from the NIH Guide for Grants and Contracts

Exploiting Omics Assays to Investigate Molecular Regulation of Persistent HIV in Individuals with Substance Use Disorder (R61/R33 Clinical Trial Optional)

Funding Opportunity RFA-DA-19-003 from the NIH Guide for Grants and Contracts. This initiative will support projects that exploit Omics assays to address outstanding questions regarding molecular regulation of persistent HIV (e.g. latency or reservoirs) in the context of chronic substance use or substance use disorder (SUD).

The Characterization and Discovery of Novel Autoantigens and Epitopes in Type 1 Diabetes (R01 Clinical Trial Optional)

Funding Opportunity RFA-DK-17-031 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing original research aimed at the characterization and discovery of neoantigens and neoepitopes in type 1 diabetes. These include the characterization of the humoral and cell mediated autoimmune responses elicited by these neoepitopes and neoantigens and their role in the etiology and pathophysiology of type 1 diabetes. These studies should be integrated with the present knowledge of established epitopes and antigens (e.g. autoantibodies for insulin, GAD65, IA-2, and ZnT8T).

Elucidating the Effect of Glycemic Excursions on Patient Well-being and Cognitive Status in People with Type 1 Diabetes (T1D) (R01 Clinical Trial Optional)

Funding Opportunity RFA-DK-18-003 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages applications from institutions/organizations proposing research on the use of current and emerging technologies for monitoring of blood glucose levels to capture the relationship between blood glucose excursions, perception of wellbeing, and cognitive status in people with type 1 diabetes (T1D). This information will inform the design of more effective interventions that may improve patient reported outcomes (PROs), including quality of life measures, and validate glycemic measures that may serve as outcomes in clinical trials to improve glucose management in T1D.

Discovery of Early Type 1 Diabetes Disease Biomarkers in the Human Pancreas [HIRN Consortium on Beta Cell Death and Survival (CBDS)] (U01 - Clinical Trial Not Allowed)

Funding Opportunity RFA-DK-17-021 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) requests applications to explore human pancreatic tissues for the discovery of early biomarkers of T1D pathogenesis, the description of specific signaling or processing pathways that may contribute to the asymptomatic phase of T1D, the development of clinical diagnostic tools for the detection and staging of early T1D in at-risk or recently-diagnosed individuals, and/or the identification of therapeutic targets for the development of preventative or early treatment strategies. Successful applicants will join the Consortium on Beta Cell Death and Survival (CBDS), whose mission is to better define and detect the mechanisms of beta cell stress and destruction central to the development of T1D in humans, with the long-term goal of detecting beta cell destruction and protecting the residual beta cell mass in T1D patients as early as possible in the disease process, and of preventing the progression to autoimmunity. The CBDS is part of a collaborative research framework, the Human Islet Research Network (HIRN, https://hirnetwork.org), whose overall mission is to support innovative and collaborative translational research to understand how human beta cells are lost in T1D, and to find innovative strategies to protect and replace functional beta cell mass in humans. This FOA will only support studies with a primary focus on increasing our understanding of human disease biology (as opposed to rodent or other animal models). This FOA will not accept applications proposing a clinical trial.

High-Resolution Exploration of the Human Islet Tissue Environment [HIRN Human Pancreas Analysis Consortium (HPAC)] (U01 Clinical Trial Not Allowed)

Funding Opportunity RFA-DK-17-022 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) invites cooperative agreement applications that will contribute to a higher resolution understanding of the physical and functional organization of the human islet tissue environment by describing the composition (cellular and molecular) and function of important components of the pancreatic islet and peri-islet tissue architecture, the cell-cell relationships and means of communications used by cell types and cell subtypes within the pancreatic tissue ecosystem, and/or the contribution of adjacent (including acinar, ductal, lymphatic) and neighboring (intestinal, mesenteric and adipose) tissues to islet cell function and dysfunction. Successful projects will integrate the Human Pancreas Analysis Consortium (HPAC), that will consist of the research teams funded in response to this FOA with the Human Pancreas Analysis Program (HPAP), a resource-generation program that was funded in 2016 in response to RFA-DK-15-027. HPAC will become the fifth consortium of the Human Islet Research Network (HIRN, https://hirnetwork.org/ ). HIRN's overall mission is to support innovative and collaborative translational research to understand how human beta cells are lost in T1D, and to find innovative strategies to protect and replace functional beta cell mass in humans. This FOA will only support studies with a primary focus on increasing our understanding of human tissue structure and function, and human disease biology (as opposed to rodent or other animal models). This FOA is not intended to support the conduct of a clinical trial.

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