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BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19 Clinical Trial Not Allowed)

RFA
Wednesday, August 29, 2018
Wednesday, October 31, 2018
U19
RFA-NS-19-003

Funding Opportunity Purpose

This FOA will support integrated, interdisciplinary research teams from prior BRAIN technology and/or integrated approaches teams, and/or new projects from the research community that focus on examining circuit functions related to behavior, using advanced and innovative technologies. The goal will be to support programs with a team science approach that can realize meaningful outcomes within 5-plus years. Awards will be made for 5 years, with a possibility of one competing renewal. Applications should will incorporate overarching principles of circuit function in the context of specific neural systems underlying sensation, perception, emotion, motivation, cognition, decision-making, motor control, communication, or homeostasis. Applications should incorporate theory-/model-driven experimental design and should offer predictive models as deliverables. Applications should seek to understand circuits of the central nervous system by systematically controlling stimuli and/or behavior while actively recording and/or manipulating relevant dynamic patterns of neural activity and by measuring the resulting behaviors and/or perceptions. Applications are expected to employ approaches guided by specified theoretical constructs, and are encouraged to employ quantitative, mechanistic models where appropriate. Applications will be required to manage their data and analysis methods in a prototype framework that will be developed and used in the proposed U19 project and exchanged with other BRAIN U19 awardees for further refinement and development. Model systems, including the possibility of multiple species ranging from invertebrates to humans, can be employed and should be appropriately justified. Programs should employ multi-component teams of research expertise including neurobiologists, statisticians, physicists, mathematicians, engineers, computer scientists, and data scientists, as appropriate - that seek to cross boundaries of interdisciplinar

Regenerative Medicine Innovation Projects (RMIP) (U44 - Clinical Trial Not Allowed)

RFA
Wednesday, August 1, 2018
Saturday, October 20, 2018
U44
RFA-HL-18-035

Funding Opportunity Purpose

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.

Regenerative Medicine Innovation Projects (RMIP) (UT2 - Clinical Trial Not Allowed)

RFA
Wednesday, August 1, 2018
Saturday, October 20, 2018
UT2
RFA-HL-18-033

Funding Opportunity Purpose

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.

Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)

RFA
Wednesday, August 1, 2018
Saturday, October 20, 2018
UG3/UH3
RFA-HL-18-031

Funding Opportunity Purpose

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.

Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Studies (Collaborative U01 Clinical Trial Not Allowed)

RFA
Wednesday, August 1, 2018
Saturday, October 20, 2018
U01
RFA-HL-18-030

Funding Opportunity Purpose

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.

Data Management and Coordinating Center (DMCC) for Rare Diseases Clinical Research Network (RDCRN) (U2C Clinical Trial Not Allowed)

RFA
Friday, June 8, 2018
Wednesday, October 10, 2018
U2C
RFA-TR-18-021

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is to invite applications for new applications for the Data Management and Coordinating Center (DMCC) for the Rare Diseases Clinical Research Network (RDCRN). Each consortium within the RDCRN is intended to advance the diagnosis, management, and treatment of rare diseases. The DMCC will facilitate and support the activities of each Rare Diseases Clinical Research Consortium (RDCRC) along with trans-network activities that broadly facilitate the advancement of rare disease research via four Cores; 1) Administrative; 2) Data Management; 3) Clinical Research and; 4) Engagement and Dissemination.

Rare Diseases Clinical Research Consortia (RDCRC) for Rare Diseases Clinical Research Network (U54 Clinical Trials Optional)

RFA
Friday, June 8, 2018
Wednesday, October 10, 2018
U54
RFA-TR-18-020

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to invite new and re-competing applications to apply to the Rare Diseases Clinical Research Consortia (RDCRC) that comprise the Rare Diseases Clinical Research Network (RDCRN). The RDCRCs are intended to advance the diagnosis, management, and treatment of rare diseases with a focus on clinical trial readiness. Each RDCRC will promote highly collaborative, multi-site, patient-centric, translational and clinical research with the intent of addressing unmet clinical trial readiness needs.

Biomarkers Discovery In Parkinsonism (U01 Clinical Trial Optional)

PAR
Wednesday, May 23, 2018
Clinical Trials Research
Friday, September 7, 2018
U01
PAR-18-800

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to support hypothesis-driven research to discover human biomarkers in Parkinsons disease and other Parkinsonian syndromes, as a component of the NINDS Parkinsons Disease Biomarkers Program (PDBP). This FOA encourages biomarkers discovery projects in 1) genetically causal Parkinson's disease, especially for particular sub-types of Parkinson's Disease (PD), including genetic cohorts, biologically defined cohorts of idiopathic PD, or ethnic subgroups of idiopathic PD; 2) The differentiation of synucleinopathies (such as PD and Multiple System Atrophy (MSA) from tauopathies (such as Progressive Supranuclear Palsy and Corticobasal degeneration); or 3) to improve diagnostic differentiation between idiopathic/subtypes of PD and these disorders, as well as from Essential tremor. In order to further advance research in this area, broad sharing of biospecimens and associated data is a critical feature of the PDBP generally and of this FOA specifically. A timeline including milestones, which will be used to evaluate the application not only in peer review but also in consideration of the awarded project for funding of non-competing award years, is required for all studies.

Research Program Award (R35 Clinical Trial Optional)

RFA
Friday, May 11, 2018
Clinical Trials Research
Saturday, July 14, 2018
R35
RFA-NS-18-032

Funding Opportunity Purpose

The purpose of the NINDS Research Program Award (RPA) is to provide longer-term support and increased flexibility to Program Directors (PDs) /Principal Investigators (PIs) whose records of research achievement demonstrate their ability to make major contributions to neuroscience. RPAs will support the overall research programs of NINDS-funded investigators for up to 8 years, at a level commensurate with a PD/PIs recent NINDS support (Part 2, Section II) This greater funding stability will provide eligible investigators at nearly all career stages increased freedom and flexibility, allowing them to be more adventurous in their research, take greater risks, embark upon research that breaks new ground, undertake research projects that require a longer timeframe, and/or extend previous discoveries in new directions. Research supported through the RPA must be within the scope of the NINDS mission (http://www.ninds.nih.gov/about_ninds/mission.htm). Research activities outside of the NINDS mission, or traditionally supported by another NIH Institute or Center will not be considered through this program. Other anticipated benefits of the RPA include: A more stable funding environment, facilitating the pursuit of longer term research goals; Flexible funding, enabling investigators to pursue research opportunities as they arise, not tied to specific aims; Reduced time spent writing grant applications and managing multiple grant awards, thereby allowing investigators to spend more time conducting and overseeing research; and More time for PDs/PIs to mentor junior scientists. Eligibility to apply through this FOA is limited to investigators who currently have at least one active NINDS R01 or R01 equivalent grant (defined as R01, R37, R56, DP1 or DP2 awards) due to expire in FY18 or FY19. Applicants must also have received R01, R00, or R01 equivalent grant support from NINDS in each of the past 5 years), with no more than one of those years in a no cost ext

Small Research Grant Program for the Next Generation of Clinical Researchers in Alzheimer's Disease (AD) and Alzheimers Disease Related Dementias (ADRD) Research (R03 Clinical Trial Optional)

RFA
Wednesday, April 25, 2018
Clinical Trials Research
Wednesday, July 4, 2018
R03
RFA-AG-19-002

Funding Opportunity Purpose

This Small Research Grant Program supports important and innovative research in areas in which more scientific investigation is needed to improve the prevention, diagnosis, treatment and care for Alzheimer's disease and related dementias. The program seeks to stimulate the next generation of researchers in the United States to pursue research and academic careers in neurosciences, Alzheimer's disease and healthy brain aging.

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