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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. Details of the planned FOA are provided below.

This Notice reflects the participation of multiple other NIH Offices, Institutes and Centers (OICs) in the NIH Science Education Partnership Awards (PAR-20-153). The SEPA program supports Pre-K to grade 12 (P-12) and informal science education (ISE) activities that: (1) enhance the diversity of the biomedical, behavioral and clinical research workforce and (2) foster a better understanding of NIH-funded biomedical, behavioral and clinical research and its public health implications. The SEPA program targets two primary audiences: (1) SEPA formal or classroom-based projects that provide STEM content, pedagogical expertise, and problem solving skills to teachers, students, and families in communities not generally supported by advanced and innovative educational practices: (2) SEPA informal science education (ISE) activities that are conducted in outside-the-classroom venues as well as in science centers and museums, target both workforce diversity and improved public health literacy.

This Notice announces the participation of additional NIH Institutes and Centers in the NIH Science Education Partnership Awards (PAR-20-153). The SEPA program supports P-12 and informal science education (ISE) activities that: (1) enhance the diversity of the biomedical, behavioral and clinical research workforce and (2) foster a better understanding of NIH-funded biomedical, behavioral and clinical research and its public health implications. The SEPA program targets two primary audiences: (1) SEPA formal or classroom-based projects that provide STEM content, pedagogical expertise, and problem solving skills to teachers, students, and families in communities not generally supported by advanced and innovative educational practices: (2) SEPA informal science education (ISE) activities that are conducted in outside-the-classroom venues as well as in science centers and museums, target both workforce diversity and improved public health literacy. Applications that target pre-kindergarten to grade 12 (P-12) or ISE topics that cannot be addressed by existing school, community, or ISE-based activities are encouraged.

The purpose of this notice is to rescind NOT-NS-22-053 "Notice of Special Interest (NOSI): Pain-Focused Administrative Supplements for NINDS Grants that are Not Focused on Pain Research". Due to budgetary constraints in FY22, it has become necessary to rescind this notice.

The National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute on Aging (NIA) intend to publish a Funding Opportunity Announcement (FOA) to solicit applications for basic and translational research on the impact of the microbiome gut-brain axis on Alzheimers Disease Related Dementias (ADRD). While there is growing evidence that the microbiome is an important factor that contributes to overall health and a variety of diseases and disorders, the role of intestinal microbiota dysfunction in specific ADRDs has not been adequately addressed. Furthermore, there is a need for more engagement of the ADRD research community to better understand the mechanistic relationship between the gut-brain axis and dementia-related diseases. This FOA will support mechanistic and early translational research focused on a more rigorous in-depth examination of the potential interactions between the gut microbiome and genetic and non-genetic molecular targets that influence ADRD. It is expected that these studies will address the clinical relevance of the gut microbiome on disease initiation, progression, or modification that will lead ultimately to better therapeutic interventions. This Notice is being provided to allow potential applicants sufficient time to develop integrated multidisciplinary collaborations and responsive projects. The FOA is expected to be published in Summer 2022 with an expected application due date in Fall 2022. This FOA will utilize the R01 (Clinical Trials Not Allowed) activity code.

The NIH Countermeasures Against Chemical Threats (CounterACT) program intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for the discovery and early-stage development of safe and effective new and repurposed drug candidates to mitigate the health effects resulting from exposure to highly toxic chemical threats. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The purpose of this notice is to inform applicants of a change to the IC specific interests for NINDS in PAR-21-357 "Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Required)". Changes to the FOA are shown below.

This Request for Information (RFI) seeks input on challenges and opportunities for interdisciplinary research that brings together neuroscientists, environmental health scientists, and scientists from other related disciplines to form new teams to advance understanding of the contribution of environmental toxicants to impaired function of the nervous system across the life span. For the purpose of this RFI, environmental toxicants of primary interest include industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, plastics, fungal exposures, and bacterial or biologically derived toxins. Expression of toxicity can take many forms across different ages and developmental stages, ranging from neurodevelopmental to neurodegenerative disorders, and encompassing alterations in cognition and behavior that range from subtle to severe. The full range of nervous system outcomes is relevant to this RFI.

The purpose of this notice is to inform applicants of a change to the Award Budget for RFA-NS-22-021 "HEAL Initiative: Human Pain-associated Genes & Cells Data Coordination and Integration Center (U24 Clinical Trial Not Allowed)".

Purpose This Notice informs the research community that NINDS and NCATS intend to reissue its funding opportunity announcement (FOA) for Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases. Through this FOA, researchers will be invited to submit applications for support of clinical studies that address critical needs for clinical trial readiness in rare neurological and neuromuscular diseases. These studies should result in clinically validated biomarkers and clinical outcome assessment measures appropriate for use in upcoming clinical trials. Through the support of trial readiness studies, NINDS and NCATS expect to enhance the quality and increase the likelihood of success of clinical trials in these rare diseases.