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The purpose of this Funding Opportunity Announcement (FOA) is to encourage grant applications for investigator-initiated efficacy clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The trials must address questions within the mission and research interests of the NINDS and may evaluate drugs, biologics, and devices, as well as surgical, behavioral and rehabilitation therapies. Information about the mission and research interests of the NINDS can be found at the NINDS website (http://www.ninds.nih.gov/)

Reissue of RFA-NS-18-020: Understanding the dynamic activity of brain circuits is central to the NIH BRAIN Initiative. This FOA seeks applications for proof-of-concept testing and development of new technologies and novel approaches for recording and modulation (including various modalities for stimulation/activation, inhibition and manipulation) of cells (i.e., neuronal and non-neuronal) and networks to enable transformative understanding of dynamic signaling in the central nervous system (CNS). This FOA seeks exceptionally creative approaches to address major challenges associated with recording and modulating CNS activity, at or near cellular resolution, at multiple spatial and/or temporal scales, in any region and throughout the entire depth of the brain. It is expected that the proposed research may be high-risk, but if successful, could profoundly change the course of neuroscience research. Proposed technologies should be compatible with experiments in behaving animals, validated under in vivo experimental conditions, and capable of reducing major barriers to conducting neurobiological experiments and making new discoveries about the CNS. Technologies may engage diverse types of signaling beyond neuronal electrical activity such as optical, magnetic, acoustic and/or genetic recording/manipulation. Applications that seek to integrate multiple approaches are encouraged. If suitable, applications are expected to integrate appropriate domains of expertise, including biological, chemical and physical sciences, engineering, computational modeling and statistical analysis.

The Joint NINDS/NIMH Exploratory Neuroscience Research Grant program supports exploratory and innovative research projects, which fall within the missions of the NINDS and the NIMH. Awards will provide support for the early and conceptual stages of projects. These studies often assess the feasibility of a novel avenue of investigation and involve considerable risk, but have the potential to bring about breakthroughs in the understanding of important areas of neuroscience, or to the development of novel techniques, agents, methodologies, or models, of high value to the neuroscience community.

This notice informs applicants of a change to the Key Dates for RFA-NS-20-006 "BRAIN Initiative: Biology and Biophysics of Neural Stimulation and Recording Technologies (R01 Clinical Trials Optional)". Two of the receipt dates, the October 1, 2021 and June 1, 2022 receipt dates have been cancelled from this Funding Opportunity Announcement (FOA).

The purpose of this notice is to inform potential applicants of a correction for PAR-21-057 "Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)". This notice removes the STTR eligibility language that was erroneously publishedin this Funding Opportunity Announcement (FOA) and clarifies the Fast-Track (Phase I and II) eligibility languagethat was erroneously omitted in this FOA. This notice is effective for the June 22, 2021 receipt date and subsequent due dates.

The purpose of this notice is to inform potential applicants of a correction for PAR-21-059 "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)". This notice removes the STTR eligibility language that was erroneously publishedin this Funding Opportunity Announcement (FOA) and clarifies the Fast-Track (Phase I and II) eligibility languagethat was erroneously omitted in this FOA. This notice is effective for the June 22, 2021 receipt date and subsequent due dates.

The purpose of this funding opportunity announcement (FOA) is to invite applications to continue support of a national program of mentored research career development for junior neurosurgeon faculty at institutions nationwide that support neurosurgical research. The goal of the program is to expand the cadre of neurosurgeon investigators trained to conduct research into neurological disorders, making use of their neurosurgical training.

The NIH Blueprint for Neuroscience Research is a collaborative framework through which 14 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.nih.gov/). To facilitate biotherapeutic discovery and development by the neuroscience community, the NIH Blueprint for Neuroscience Research has established the Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics), a collection of contract service providers and consultants with extensive industry experience in the areas of pharmacokinetics, toxicology, manufacturing, and Phase I clinical safety testing. A planned Funding Opportunity Announcement (FOA) will solicit applications from investigators seeking funding through a UG3/UH3 phased cooperative agreement mechanism to help advance their biologic drug discovery and development projects into the clinic. This FOA will support preclinical discovery and development of potential therapeutic biologics and biotechnology products including, but not limited to, large biologic macromolecules, (e.g., proteins, antibodies, and peptides), gene-based therapies (i.e., oligonucleotide- and viral-based), cell therapies, and novel emerging therapies (e.g., microbial and microbiome therapies). Applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in manufacturing, pharmacokinetics, toxicology, and Phase I clinical testing. BPN-Biologics awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN-Biologics contractors (and thereby control the patent prosecution and licensing negotiations) for biotherapeutic candidates developed in this program. To be eligible for the BPN-Biologics program, an applicant must have identified one or more lead biologic agent(s) with e

The NIH Blueprint for Neuroscience Research announces its intention to publish a Funding Opportunity Announcement (FOA) for investigators seeking support from the Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics). Applicants will be encouraged to utilize a customized set of contract resources and consultants from the BPN-Biologics Network to help advance their neuroscience-focused biotherapeutic discovery and development projects into the clinic. This Notice is provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Details of the planned FOA are provided below. The FOA is expected to be published in the spring of 2021 with an expected application due date in the summer of 2021.

The NIH Countermeasures Against Chemical Threats (CounterACT) program intends to publish a Funding Opportunity Announcement (FOA) to solicit applications to recruit Early Stage Investigators (ESI) to pursue exploratory/developmental, applied, proof of concept, or high risk-high impact research to discover safe and effective therapeutics to mitigate toxicities resulting from exposures to highly toxic chemicals.