NIH Funding Opportunities

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Weekly Funding Opportunities and Policy Notices from the National Institutes of Health.
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Regenerative Medicine Innovation Projects (RMIP) (U44 - Clinical Trial Not Allowed)

Wed, 08/01/2018 - 01:05
Funding Opportunity RFA-HL-18-035 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH), participating NIH Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U44) applications to support small business research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.
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Regenerative Medicine Innovation Projects (RMIP) (UT2 - Clinical Trial Not Allowed)

Wed, 08/01/2018 - 01:05
Funding Opportunity RFA-HL-18-033 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH), participating NIH Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (UT2) applications to support small business research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.
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Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)

Wed, 08/01/2018 - 01:04
Funding Opportunity RFA-HL-18-031 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH), participating NIH Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite exploratory/developmental phased award cooperative agreement (UG3/UH3) applications to support investigator-initiated clinical trials (Phase I or later phase) aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that use RM products with demonstrated readiness to be advanced into clinical trials through appropriate product development and pre-clinical studies. Trials for which this FOA applies must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). This FOA utilizes a bi-phasic, milestone-driven cooperative agreement mechanism of award. This FOA seeks applications that present a strong scientific rationale for the clinical trial and a comprehensive scientific and operational plan. It is anticipated that applications will consist of plans for project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, data sharing, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) application authorization or approval, respectively, to administer the product to humans. Due to the complex nature of conducting a clinical trial, applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. Staff will be able to assist applicants in meeting the objectives of this FOA.
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Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Studies (Collaborative U01 Clinical Trial Not Allowed)

Wed, 08/01/2018 - 01:04
Funding Opportunity RFA-HL-18-030 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U01) applications to support investigator-initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.
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Short-term Mentored Career Enhancement Awards in Mobile and Wireless Health Technology and Data Analytics: Cross-Training at the intersection of Behavioral and Social Sciences and STEM Disciplines (K18 Independent Clinical Trial Not Allowed)

Tue, 07/31/2018 - 09:57
Funding Opportunity PAR-18-881 from the NIH Guide for Grants and Contracts. The goal of the program is to support the development of research capability in mobile and wireless health technology (e.g., wearable devices, mobile applications, electronic health records, data analytics). Special emphasis will be given to independent behavioral and social sciences investigators who seek to train in a STEM discipline (e.g., big data analysis, computational modeling, engineering, computer science, and mathematics) or to STEM scientists who which to train in a behavioral and social science discipline
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Short-term Mentored Career Enhancement Awards in Mobile and Wireless Health Technology and Data Analytics: Cross-Training at the intersection of Behavioral and Social Sciences and STEM Disciplines (K18 Independent Clinical Trial Required)

Tue, 07/31/2018 - 09:57
Funding Opportunity PAR-18-882 from the NIH Guide for Grants and Contracts. The goal of the program is to support the development of research capability in mobile and wireless health technology (e.g., wearable devices, mobile applications, electronic health records, data analytics). Special emphasis will be given to independent behavioral and social sciences investigators who seek to train in a STEM discipline (e.g., big data analysis, computational modeling, engineering, computer science, and mathematics) or to STEM scientists who which to train in a behavioral and social science discipline.
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Genomic Innovator Award (R35 Clinical Trial Optional)

Tue, 07/31/2018 - 07:58
Funding Opportunity RFA-HG-18-006 from the NIH Guide for Grants and Contracts. This program aims to support researchers to do highly innovative work on important problems in genomics. The PIs should be creative investigators, early in their careers, who are part of consortia, large research groups, or other team science efforts. They should have shown the potential to make important contributions to the field of genomics. PIs will have some flexibility to pursue their new ideas and take advantage of opportunities that arise during the course of this award.
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FDA Standard Core Clinical Outcome Assessments and Endpoints

Tue, 07/31/2018 - 07:17
Notice NOT-FD-18-014 from the NIH Guide for Grants and Contracts
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Early Psychosis Intervention Network (EPINET): Data Coordinating Center (U24 Clinical Trial Not Allowed)

Mon, 07/30/2018 - 11:03
Funding Opportunity RFA-MH-19-151 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) invites applications for an Early Psychosis Intervention Network (EPINET) National Data Coordinating Center (ENDCC) to support and extend the work of regional scientific hubs described in companion announcement RFA-MH-19-150. The ENDCC will lead efforts to (a) harmonize early psychosis common data elements, standard measures, and uniform data collection procedures across multiple early psychosis Coordinated Specialty Care (CSC) clinics within regional networks; (b) build informatics infrastructure and pipelines necessary to gather and store de-identified, patient-level data collected across all regional clinics; (c) develop data analysis, presentation, and reporting tools to facilitate timely quality improvement and program evaluation efforts across regional networks; (d) identify innovative CSC assessment, intervention, and quality improvement practices for broad dissemination; and (e) and make national CSC data available for practice-based research to improve early identification, diagnosis, clinical assessment, intervention effectiveness, service delivery and health outcomes in early psychosis. The ENDCC will combine regional datasets into a national repository of early psychosis common data elements, clinical measures, assessment and intervention strategies, and de-identified person-level data from patients receiving CSC services. Data assembled by the ENDCC will facilitate large-scale, practice-based research to improve early identification, diagnosis, clinical assessment, intervention effectiveness, and health outcomes in clinics offering evidence-based care to persons in the early stages of psychotic illness.
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Early Psychosis Intervention Network (EPINET): Practice-Based Research to Improve Treatment Outcomes (R01 Clinical Trial Optional)

Mon, 07/30/2018 - 11:03
Funding Opportunity RFA-MH-19-150 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) invites applications for Early Psychosis Intervention Network (EPINET) regional scientific hubs to support practice-based research to improve diagnosis, clinical assessment, intervention effectiveness, service delivery, and health outcomes in clinics offering evidence-based specialty care to persons in the early stages of psychotic illness. Each EPINET regional scientific hub will link multiple early psychosis clinical service programs through (a) standard measures of early psychosis clinical features, services, and treatment outcomes; (b) informatics tools to collect de-identified, person-level data across sites; and (c) a unified approach for aggregating and analyzing pooled data. Large, integrated datasets are expected to facilitate rigorous quality improvement and program evaluation efforts within regional networks. In addition, each regional scientific hub will propose mental health services and intervention research to advance the learning health care goals of measurement-based treatment, continuous improvement and innovation in care delivery, and practice-based research to drive the process of scientific discovery. Regional scientific hubs selected for funding will collaborate closely with the EPINET National Data Coordinating Center, which is described in companion announcement RFA-MH-19-151.
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NCI Outstanding Investigator Award (R35 Clinical Trial Not Allowed)

Mon, 07/30/2018 - 10:28
Funding Opportunity PAR-18-880 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) invites grant applications for the Outstanding Investigator Award (R35) in any area of cancer research. The objective of the National Cancer Institute (NCI) Outstanding Investigator Award (OIA) is to provide long-term support to accomplished investigators with outstanding records of cancer research productivity who propose to conduct exceptional research. The OIA is intended to allow investigators the opportunity to take greater risks, be more adventurous in their lines of inquiry, or take the time to develop new techniques. The OIA would allow an Institution to submit applications nominating established Program Directors/Principal Investigators (PDs/PIs) for the NCI OIA. It is expected that the OIA would provide extended funding stability and encourage investigators to embark on projects of unusual potential in cancer research. The research projects should break new ground or extend previous discoveries toward new directions or applications that may lead to a breakthrough that will advance biomedical, behavioral, or clinical cancer research.
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Vet-LIRN Network Capacity-Building Projects (U18)

Mon, 07/30/2018 - 07:10
Notice NOT-FD-18-015 from the NIH Guide for Grants and Contracts
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