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The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome (DS). This Notice of Special Interest (NOSI) announces NIH support for the professional development of early career scientists aiming to establish a career in DS-related research. By providing these scientists with training, resources, and mentorship, the NIH intends to support the career development of investigators in DS and other intellectual disabilities who will lead future research to improve the understanding of the biology of DS and support development of new treatments for health conditions experienced by those with DS.

The All of Us Research Program (All of Us) within the Office of the Director (OD) encourages eligible grantees of the participating Institutes, Centers, and Offices (ICOs) to apply for administrative supplements to support analysis of currently available data within the All of Us Research Programs Researcher Workbench or to develop analysis tools for the available data within the general scope of the parent award.

This funding opportunity announcement (FOA) is designed to support integrated efforts of three or more (up to six) PDs/PIs to pursue bold, impactful, and challenging research in any area within the scope of the NINDS mission. The research approach should be interdisciplinary in nature, and the research teams are expected to establish a common goal that requires collaboration, synergy, and managed team interactions. Proposed research should not represent a collection of individual efforts or parallel projects. This program is distinct from the NINDS P01 in that it will support a cohesive, single, well-integrated research plan with a singular focus, one set of aims, and a budget without subprojects. Teams are encouraged to consider transformative objectives with defined 5-year outcomes.

The NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project seeks to improve health and quality-of-life for individuals with Down syndrome (DS). This Notice of Special Interest (NOSI) announces NIH support for the professional development of trainees aiming to establish a career in DS-related research. By providing these scientists with training, resources, and mentorship, the NIH intends to support the career development of junior investigators in DS who will lead future research to improve the understanding of the biology of DS and support development of new treatments for health conditions experienced by those with DS. Investigators early in their careers (e.g., predoctoral candidates) as well as those with advanced degrees (e.g., PhD, MD) may benefit from mentorship from established investigators and professionals in the DS research community in basic science fields as well as clinical and translational arenas.

This Funding Opportunity Announcement invites applications from experienced investigators seeking to conduct exploratory clinical trials designed to test new treatments for patients with Lewy Body Dementia (LBD). Applicants may propose to conduct either Phase I or Phase II clinical trials depending on the developmental stage of the potential therapeutic, but all trials must include patients with LBD. Proposed therapies may include novel medications or devices, or existing treatments that are potentially beneficial but not currently approved for use in patients with LBD. Treatments intended to prevent or delay disease progression in LBD patients, as well as therapies to alleviate existing motor or non-motor clinical symptoms, are of interest.

The purpose of this funding opportunity announcement (FOA) is to invite applications for research projects to test promising cerebrovascular interventions in the NINDS Stroke Preclinical Assessment Network (SPAN). SPAN will facilitate the testing of up to 8 promising cerebroprotective drugs or interventions to be given prior to or at the time of reperfusion in experimental models of ischemic stroke (e.g., transient middle cerebral artery occlusion, tMCAo). The PIs of the awarded interventions will become part of the network and will collaborate with the SPAN Coordinating Center (RFA-NS-22-004), testing laboratories (RFA-NS-22-003), and other intervention contributors (RFA-NS-22-066, RFA-NS-22-067) to facilitate the parallel testing of multiple cerebroprotective interventions in experimental models of ischemic stroke. Applicants must propose a promising cerebroprotective intervention, supported by rigorous and extensive preliminary data, to be tested in SPAN. If successful, this network will accelerate the identification of the most promising cerebroprotective therapies for future pivotal clinical trials and span the gap between small businesses, preclinical testing laboratories, and a pipeline to clinical testing, in a cost-and time-effective fashion.

Reissue PAR-19-220.

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.

The Office of Disease Prevention (ODP) and participating National Institutes of Health (NIH) Institutes, Centers, and Offices (ICs) are issuing this Notice of Special Interest (NOSI) to encourage applications proposing to test multilevel strategies and interventions to improve the uptake of evidence-based screening services across the lifespan and in diverse populations including, but not limited to, those experiencing health disparities and those that have been underserved.

The Office of Disease Prevention (ODP) and participating National Institutes of Health (NIH) Institutes, Centers, and Offices (ICs) are issuing this Notice of Special Interest (NOSI) to solicit applications proposing to strengthen the evidence base for preventive screening services where the evidence is lacking, of poor quality, conflicting, or the balance of benefits and harms cannot be determined.