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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.

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.

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.

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.

The purpose of this initiative is to solicit applications for Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers. These Centers promote collaborative basic, translational, and clinical research, and provide important resources that can be used by the national muscular dystrophy research community. The Centers also provide outstanding environments for the training of new scientists electing to pursue careers conducting research in high priority areas of muscular dystrophy. Furthermore, Center investigators participate in community outreach efforts to increase awareness and convey the importance and implications of their research activities to the patient and advocacy communities.

This NOFO solicits applications for establishing a Center for Exposome Research Coordination (CERC) that will serve the broad biomedical research community by coordinating and advancing exposome research to accelerate precision environmental health. The CERC will engage existing and ongoing exposome initiatives around the globe to promote methodological advancement and best practices, provide training and education, and foster national and international collaborations.

This Notice of Funding Opportunity (NOFO) will support students at institutions without NIH-funded institutional predoctoral dual-degree training programs. The purpose of the Kirschstein-NRSA, dual-doctoral degree, predoctoral fellowship (F30) is to enhance the integrated research and clinical training of promising predoctoral students, who are matriculated in a combined MD/PhD or other dual-doctoral degree training program (e.g. DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), and who intend careers as physician/clinician-scientists. Candidates must propose an integrated research and clinical training plan and a dissertation research project in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The fellowship experience is expected to clearly enhance the individual's potential to develop into a productive, independent physician/clinician-scientist. This NOFO is designed specifically for candidates proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

To enable the development and validation of real-world remote digital endpoints from wearable devices for monitoring pain experience and progression, response to interventions, and impact on quality of life. In the context of this RFA, endpoints will include biosignatures derived from functional and physiological assessments detected from wearable devices. These biosignatures can be used to monitor the effects of therapeutics developed for the treatment of pain.

Reissue of RFA-MH-21-205 to comply with DMS Policy. This Notice of Funding Opportunity (NOFO), in support of the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, is one of several NOFOs aimed at supporting transformative discoveries that will lead to breakthroughs in understanding human brain function. Guided by the long-term scientific plan, BRAIN 2025: A Scientific Vision, this NOFO specifically seeks to support efforts addressing core ethical issues associated with research focused on the human brain and resulting from emerging technologies and advancements supported by the BRAIN Initiative. The hope is that efforts supported under this NOFO might be both complementary and integrative with the transformative, breakthrough neuroscience discoveries supported through the BRAIN Initiative.