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This notice of funding opportunity (NOFO) seeks applications proposing a set of planning activities that will lay the groundwork for a scientific project aimed at integrating complementary theories and methods to 1) develop, validate, and apply cutting-edge tools and methods for minimally invasive, multi-dimensional, high-resolution measurement of behavior at the level of the organism, with synchronous capture of changes in the organisms social or physical environment; and 2) develop data science and computational methods that allow for integration of multidimensional behavioral and environmental datarepresenting multiple timescales, and that will establish of a conceptual and/or computational model of behavior as a complex dynamic system. Prospective projects are expected to be designed with the potential to integrate synchronously recorded neural data and/or inform existing models of neurobehavioral function, such as those developed with the support of the NIH BRAIN Initiative. The purpose of this R34 planning grant opportunity is to support planning and development of the research framework, design, and approach, including activities that will establish feasibility, validity, and/or other technically qualifying results that, if successful, would support a competitive application for a U01, or equivalent, NIH research award. This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material.

The common marmoset (Callithrix jacchus) has emerged as a promising nonhuman primate model system to understand the primate brain. This has come about both from the realization that the behavior of the common marmoset is similar in some ways to human behavior and from recent demonstration of germline transmission of exogenous genetic information. This Notice of Funding Opportunity (NOFO) solicits applications to expand existing colonies of the common marmoset for neuroscience research in the United States, and to support the care, breeding and distribution of genetically modified marmosets, and cryopreserved embryos and gametes created by NIH-funded research programs such as the NIH BRAIN Initiative Tools for Germline Gene Editing in Marmosets research consortium. Recipients s under this NOFO are expected to expand their current marmoset colonies to provide healthy, well-characterized animals that will be made available to the neuroscience research community, and to include a plan to accept genetically modified marmosets, and cryopreserved embryos and gametes for distribution to the research community. Recipients are also expected to participate in and provide health and genetic information to an NIH-Funded Marmoset Coordination Center to help the community understand the pedigree of individuals in the captive marmoset population and improve the genetic diversity of that population across multiple colonies.

This Notice of Funding Opportunity (NOFO) solicits applications to create a Marmoset Coordination Center. The awardee will be responsible for two separate but related activities. The first activity will be to become the repository for genomic, pedigree, and event records (date of birth, medical, reproductive history) for captive marmosets. The awardee is expected to use that information to help make breeding recommendations to maximize the health and genetic diversity of the marmosets in primate colonies. Applicants are encouraged to adopt the model used by the Association of Zoos and Aquariums.

(Reissue of PAR-21-266) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only SBIR Phase II and Fast-Track applications are supported under this program. SBIR Phase I applications are only accepted as part of a Fast-track application.

(Reissue of PAR-18-617) The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Technology Transfer (STTR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only STTR Phase II and Fast-Track applications are supported under this program. STTR Phase I applications are only accepted as part of a Fast-track application.

The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical trials for the diagnosis, mitigation, treatment, or cure of ALS ("intermediate EA protocol for ALS"). Providing the investigational drug or biological product under an intermediate EA protocol for ALS must not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval, or otherwise compromise the potential development of medical products for the diagnosis, mitigation, treatment, or cure of ALS. Eligible applicants are clinical trial sites that participate in a phase 3 clinical trial supported by a United States (U.S.) small business concern (as defined in section 3(a) of the Small Business Act (15 U.S. C. 623(a)) that is also the U.S. Food and Drug Administration (FDA) designated sponsor of a drug or biological product for ALS that is the subject of an Investigational New Drug Application (IND). This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in May 2022 with an expected application due date in June 2022. This FOA will utilize the U01 activity code.

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.

This Notice of Funding Opportunity (NOFO) solicits applications for one or more Data Coordinating Centers (DCCs) to support BRAIN CONNECTS, a networked consortium of Comprehensive Centers and Specialized Projects funded under RFA-NS-22-047, RFA-NS-22-048, and RFA-NS-22-049. The goals of these awards are to develop the research capacity and technical capabilities for comprehensive brain-wide connectivity mapping in mouse, human, and non-human primate (NHP). BRAIN CONNECTS projects will collect and process unprecedented volumes of anatomical data by scaling up cutting-edge acquisition modalities and analysis methods, to demonstrate the feasibility of collecting, reconstructing, analyzing, integrating, disseminating, and interpreting connectivity maps from entire brains. The resulting feasibility data from these awards are expected to inform NIH decisions on program continuation in a potential subsequent five-year funding period for production of brain-wide wiring diagrams. NIH expects to fund one or more BRAIN CONNECTS DCCs, which will collaborate with CONNECTS data generating projects to (1) coordinate activities of the BRAIN CONNECTS Network, (2) develop and harmonize common data processing pipelines, (3) integrate and disseminate data analytic tools and capabilities, (4) establish a unified knowledge base for connectivity data of diverse modalities, and (5) organize and implement outreach and engagement to the wider research community and the general public. Awards will be integrated into the BRAIN CONNECTS Network as a coordinated effort aimed at developing the ability to generate wiring diagrams spanning entire brains across multiple scales and species.

Reissue of PAR-18-541. The Blueprint Neurotherapeutics Network (BPN) encourages applications from small businesses 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. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. 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.

This RFA will solicit applications for a pivotal phase 3 clinical trial to determine the efficacy of FDA approved monoclonal antibody therapy compared to placebo in diverse "mixed dementia" populations with a focus on vascular contributions. Mixed dementia refers to dementia cases positive for 1) Alzheimer biomarkers, such as amyloid positron emission tomography and/or low cerebrospinal fluid amyloid beta 42 combined with elevated phosphorylated tau; and 2) evidence of vascular contributions based on imaging (white matter disease and/or subclinical infarction). Bayesian approaches with response adaptive randomization to examine specific subgroups are engouraged. Successful applications will be well-powered to determine efficacy in diverse populations representative of the effect of the disease in the United States by sex, race/ethnicity, and geographic distribution. Applications must include patient and community engagement cores that are incorporated into all stages of program development and at all levels of the organizational structure.