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The purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery of strong candidate biomarkers or biomarker signatures for pain that can be used to facilitate the testing of non-opioid pain therapeutics in Phase II clinical trials.The biomarkers or biomarker signature will be developed through clinical research specifically focused on the identification of pain biomarkers or biosignatures that predict and/or monitor response to pain therapeutics. The resulting biomarkers or biomarker signatures may be focused on a single pain condition or on several pain conditions with common underlying pathophysiology. Applications to identify biomarkers or biomarker signatures that predict or monitor a therapeutic response across several related pain conditions should feature Multiple Principal Investigator (MPI)-led teams that represent each of the related pain conditions and associated clinical networks. The MPI-led teams are expected to decide upon a single set of measures or biomarker modalities (i.e., combination of omics, QST, actigraphy, EEG, digital measures, etc.) as components of the biosignature for all pain conditions represented in the application. Applications should feature centralized resource groups that will coordinate clinical trials and standardize all sample or data collection methods, technology development, statistical analysis and algorithm development across the pain conditions under investigation. Applications seeking to develop biomarkers or biomarker signatures that will be used to predict and/or monitor a therapeutic response for a single pain condition must also feature MPI-led teams that represent the cross functional expertise necessary for biomarker and/or signature development, along with the same types of centralized resource groups that coordinate clinical trials and standardize sample or data collection methods, technology development and statistical analysis.

The goal of this Notice of Special Interest (NOSI) is to explore and test potential opportunities for leveraging cloud solutions to enhance existing NIH activities. Projects already using cloud may apply to explore and test cloud capabilities not yet leveraged.

The purpose of this funding opportunity is to enable multi-site clinical validation of a multimodal set of neuroimaging and biospecimen biomarkers to differentially diagnosis three or more similarly presenting neurodegenerative diseases, including at least one of the Alzheimers Disease and Related Dementias (ADRDs). As part of the program deliverables, investigators will be required to work towards qualifying the candidate biomarkers as therapeutic/drug development tools through the FDAs Biomarker Qualification Program. *Note this FOA has changed Council. ICs that previously joined are already in Shared Interest.

Notice of Change to Key Dates for RFA-NS-23-012 "Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)".

This FOA invites applications from multidisciplinary teams to perform secondary data analysis, using existing datasets from two or more multi-site clinical research projects, to address scientific and clinical hypotheses relevant to neurological disorders and conditions within the NINDS mission. In this phased funding mechanism, applications are required to systematically and comprehensively perform cross-project data harmonization and curation, assessed using Go/No-go data-quality metrics, prior to funding of the second phase of data analyses. Consistent with the FAIR (findable, accessible, interoperable and reusable) data principles, this funding opportunity expects open-source cataloging of the processes and tools used for harmonization, curation, and analysis, as well as controlled access to the curated datasets.

This effort aims support pilot projects that harmonize and jointly analyze datasets from both neurotypical and diseased brains. To this end, the NIH BP is soliciting supplement applications that support the integration of disease-focused single-cell/nucleus omics datasets with BRAIN Initiative-generated neurotypical or normative datasets from human brain tissue. Projects that are currently funded to analyze single-cell/nucleus datasets from human pre- or post-mortem brain tissue are eligible to apply. Projects that do not have an active analysis component or are not eligible. This supplement program strongly encourages direct collaborations between investigators funded by the BRAIN Initiative and investigators funded by participating NIH IC.

This Funding Opportunity Announcement (FOA) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) grant applications that propose to develop a product, process or service for commercialization with the aim of improving minority health and/or reducing and ultimately eliminating health disparities in one or more NIH-defined populations experiencing health disparities. Appropriate technologies should be effective, affordable, and culturally acceptable.

This Funding Opportunity Announcement (FOA) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications that propose to develop a product, process or service for commercialization with the aim of improving minority health and/or reducing and ultimately eliminating health disparities in one or more NIH-defined population groups who experience health disparities. Appropriate technologies should be effective, affordable, and culturally acceptable.

To support planning Grant applications that conceptualize the design and implementation of a future national, interdisciplinary, patient-centered research collaborative that will advance Temporomandibular Disorders (TMDs) basic and clinical research, research training, and translation to evidence-based treatments and improved clinical care. These planning grants are intended to enable the institutions to develop the necessary partnerships, infrastructure, and capabilities needed to address the major goals of the future collaborative, develop collaborative -wide research framework and strategies, and coordinate among studies, research projects, and sites, and thereby enhance competitiveness for future participation in TMD Collaborative for Improving Patient-Centered Translational Research (TMD IMPACT).

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.