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The purpose of this funding opportunity announcement (FOA) is to support preclinical optimization and development of safe, effective, and non-addictive small molecule and biologic therapeutics to treat pain. The goal of the program is to accelerate the optimization and development of promising small molecule and biologic hits/leads to Phase I clinical trials and readiness for the Early Phase Pain Investigation Clinical Network (EPPIC-Net) or other Phase II clinical studies. Applicants must have a promising biologic or small molecule hit/lead, robust biological rationale for the intended approach, and identified assays for optimization of the agent. The scope of this program includes optimization and early development activities, IND-enabling studies, development of a pharmacodynamic/target engagement biomarker, assembly and filing of an Investigational New Drug (IND) application and Phase I clinical testing. This is a milestone-driven phased cooperative agreement program involving participation of NIH program staff in the development of the project plan and monitoring of research progress.

This Notice of Special Interest encourages administrative supplements for the NINDS Research Education Program for Residents and Fellows in Neurology, Neurosurgery, Neuropathology, Neuroradiology and Emergency Medicine (R25, PAR-13-384 and subsequent reissuances)

The participating Institutes and Centers (ICs) are inviting applications to expand existing awards that are not currently focused on Alzheimers disease and its related dementias - Frontotemporal dementia, Lewy Body dementia, Vascular Cognitive Impairment with Dementia and multiple etiology dementias - to allow the research to develop such a focus.

Purpose The purpose of this Notice is to announce an interest in research addressing patients with emergency medical conditions, including trauma. Background Over 145 million people are seen in emergency departments across the US. Emergency departments are the source of twelve million admissions, or 35% of all hospital admissions and 14% of all outpatient visits. This includes over 27 million children under the age of 15, 23 million adults over the age of 65 and over 42 million visits for injuries and major trauma. When they learn of a patient's new symptoms, primary care providers often use the emergency department to obtain rapid diagnostic tests and a treatment plan. Emergency Departments are the only component of the country's healthcare system that is accessible at any time of the day or night, and by law they provide treatment regardless of the ability to pay. Rapid assessment and treatment within the first minutes or hours after the onset of illness plays a major role in determining both the trajectory of recovery and future healthcare costs. Research in the emergency setting offers a unique opportunity to improve not only the treatment of acute life-threatening disorders, but also a spectrum of common disorders that encompass a considerable burden of illness and account for a major component of health care costs.

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 https://neuroscienceblueprint.nih.gov/). The goal of this FOA is to enhance our fundamental understanding of interoception with a specific focus on dissecting neural circuits connecting peripheral organs/tissues with the central nervous system via peripheral ganglia. For this FOA, interoception science includes studies of the processes by which an organism senses, interprets, integrates, and regulates signals originating from within itself. The FOA encourages projects that combine diverse expertise and use innovative approaches to delineate interoceptive mechanisms at the molecular, cellular, circuitry, functional, and/or behavioral levels. Outcomes of this research will lay a critical foundation for future translational and clinical research on interoception as well as its roles in nervous system disorders. Studies of interoceptive neural circuits exclusively within the central nervous system may consider seeking for BRAIN INITIATIVE funding opportunities.

The Lewy Body Dementias (LBD) are frequently misdiagnosed or underdiagnosed during life, and despite the development of diagnostic criteria at multiple expert consensus conferences, the gold standard for diagnosis remains post-mortem brain analysis. Improvement in diagnostic accuracy during life, and the development of good quality diagnostic biomarkers, would be greatly facilitated if comprehensive, longitudinal clinical and biological data obtained on patients during life were regularly linked with detailed post-mortem brain examination. In response to recommendations from the Alzheimer's Disease Related Dementias (ADRD) Summits convened by the NINDS in 2013, 2016, and 2019, longitudinal clinical data and biospecimens are being collected from patients with LBD and shared with the research community through the Parkinsons Disease Biomarker Program (PDBP). The PDBP is an NINDS-funded resource that collects standardized clinical data and biospecimens longitudinally on patients with Parkinson's Disease (PD) and PD-related disorders (including LBD) with the goal of accelerating the pace of biomarkers research. The PDBP currently has data and biospecimens on about 1900 subjects, some of whom have gone to autopsy, though relatively little post-mortem data on these subjects is available in PDBP at this time. This NOSI encourages researchers with extensive pre- and post-mortem data on patients with LBD to apply for supplemental funds to be used for the purpose of adding this data to the existing NINDSPDBP repository. Supplements may be requested by: Researchers who have previously contributed clinical and biospecimen data to the PDBP on patients with LBD while alive, and who wish to add the post-mortem autopsy data they have collected on the same patient(s) after their death.

The goal of the Frontotemporal Dementia (FTD) Centers Without Walls (CWOW) is to improve our understanding of the mechanisms underlying neurodegeneration in FTD through multi-disciplinary, team-based science to address a specific challenge or challenges in the field that could not be achieved through individual research projects.

Accumulation of abnormal proteins such as alpha-synuclein or tau in the brains of patients with dementia tends to occur in specific brain structures (cells/circuits/regions), resulting in the unique clinical presentations that are characteristic of the different types of dementia. This funding opportunity announcement invites applications that seek to identify mechanisms responsible for this selective regional vulnerability to abnormal protein deposition in the brains of patients with Lewy Body Dementia or Frontotemporal Dementia.

This Funding Opportunity Announcement (FOA) solicits applications to develop web-accessible data archives to capture, store, and curate data related to BRAIN Initiative activities. The data archives will work with the research community to incorporate tools that allow users to analyze and visualize the data, but the creation of such tools is not part of this FOA. The data archives will use appropriate standards to describe the data, but the creation of such standards is not part of this FOA. A goal of this program is to advance research by creating a community resource data archive with appropriate standards and summary information that is broadly available and accessible to the research community for furthering research.

Notice Special Interest NOSI): Availability Emergency Competitive Revisions Chemosensory Testing a COVID-19 Screening Tool Notice Number: NOT-OD-20-152 Key Dates Release Date: August 6, 2020 First Available Due Date: September 01, 2020 Expiration Date: September 16, 2020 Related Announcements PA-20-135 - Emergency Competitive Revision Existing NIH Awards Emergency Supplement - Clinical Trial Optional) NOT-OD-20-144 - Notice Intent Publish Funding Opportunity Announcements the RADx-rad Initiative RFA-OD-20-022 - Chemosensory Testing a COVID-19 Screening Tool U01 Clinical Trial Optional) RFA-OD-20-019 - Emergency Awards: RADx-rad Data Coordination Center DCC) U24 Clinical Trial Allowed) Issued Office The Director, National Institutes Health OD) National Institute Aging NIA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers. Office Research Women's Health ORWH) Purpose Purpose NIH issuing NOSI response the declared public health emergency issued the Secretary, HHS, 2019 Novel Coronavirus COVID-19). emergency NOSI the National Institutes Health NIH) provides expedited funding mechanism part the Rapid Acceleration Diagnostics-Radical RADx-rad) initiative. goal the RADx-rad initiative to encourage development novel, non-traditional approaches identify current SARS-CoV-2 virus other markers the COVID-19 disease can used future outbreaks COVID-19 that be applicable other, yet unknown, viruses. Specifically, goal this NOSI to solicit proposals enhance utility chemosensory testing a COVID-19 screening tool using objective tests examine onset prognostic value chemosensory loss to encourage development and/or deployment home-based on-site chemosensory tests. funding this initiative provided the Paycheck Protection Program Health Care Enhancement Act, 2020. Background SARS-CoV-2 a novel coronavirus has recently identified the causative agent COVID-19, respiratory disease exhibits wide range clinical outcomes asymptomatic mild disease severe viral pneumonia, Acute Respiratory Distress Syndrome ARDS), Multisystem Inflammatory Syndrome Children MIS-C), acute kidney injury, thrombotic disorders, chemosensory dysfunction, serious cardiac, cerebrovascular vascular complications. March 11, SARS-CoV-2 outbreak classified a pandemic the WHO. Research an important component the public health emergency response before, during after emergency. United States Food Drug Administration FDA)-authorized COVID-19 diagnostic testing critical slowing spread the virus preventing future outbreaks. Given this, is urgent public health need the National Institutes Health NIH) support development a variety approaches testing. Expanding capacity, throughput, regional placement existing technologies accelerating development new technologies contribute significantly the current national efforts curb COVID-19 pandemic. help meet need, NIH launched Rapid Acceleration Diagnostics RADx) initiative speed innovation the development, commercialization, implementation technologies COVID-19 testing. RADx initiative a national call scientists organizations bring innovative ideas new COVID-19 testing approaches strategies. a part this initiative, NIH developed RADx Radical RADx-rad) project. RADx-rad support new, non-traditional approaches, including unconventional screening, biological physiological markers, new platforms, point-of-care devices, address current gaps COVID-19 testing. program also support new non-traditional applications existing approaches enhance usability, accessibility, and/or accuracy. Despite variety activities included, overall RADx-rad effort be centrally aligned coordinated harmonize data collection, storage, management, providing opportunity further explore identify additional approaches understand novel virus. Beyond current crisis, is anticipated the technologies advanced through RADx-rad also applicable other, yet unknown, infectious agents. Sudden loss smell taste formally recognized one the hallmarks COVID-19 the CDC has emerged the main neurological manifestation the disease as as 80% patients infected SARS-CoV-2 reporting chemosensory dysfunction. fact, recent observational studies indicate the loss smell taste one the most common symptoms COVID-19 more predictive all symptoms, including fatigue, fever, cough. Most studies date used self-report rather objective chemosensory testing, leading the possibility the prevalence chemosensory loss be even higher among patients COVID-19 previously reported. findings highlight need objective chemosensory tests COVID-19 screening, yield immediate results are validated across lifespan, easy self-administer, quantitative graded allow determination diminished well profound sensory loss. initiative aims support further development, commercialization, implementation technologies chemosensory testing screen patients COVID-19 to complement current temperature screening procedures. Research Objectives NOSI fund competitive revisions existing NIH awards support chemosensory testing a COVID-19 screening tool using objective tests examine onset prognostic value chemosensory loss to encourage development and/or deployment home-based on-site chemosensory tests. Areas interest include: Development deployment standardized validated over counter testing kits tests utilize common household items remote, home-based screening through telemedicine mild moderately affected individuals. Modification existing test platforms e.g. NIH Toolbox) improve efficiency administration, data collection evaluation using mobile phone apps telemedicine. Development innovative chemosensory platforms can implemented testing large, risk populations, example, health care workers, pregnant women, older adults caretakers residing/working nursing homes long-term care facilities. Establishment appropriate odorants, optimal odorant concentrations, standardized delivery systems protocols the development onsite, group testing stations those working living high-density, high risks environments. Analysis test results determine specificity chemosensory testing respect COVID-19 versus influenza, onset chemosensory dysfunction, the prognostic value chemosensory testing predicting neurological other manifestations. maximize research rapidly implement approaches address COVID-19 pandemic, comparisons across datasets studies data integration essential collaboration. Projects funded through FOA strongly encouraged use following resources applicable: Data Harmonization Social Determinants Health via PhenX Toolkit: Investigators involved human-subject studies strongly encouraged employ common set tools resources will promote collection comparable data social determinants health SDOH) across studies. particular, studies human participants should incorporate SDOH measures the Core Specialty collections are available the Social Determinants Health Collection the PhenX Toolkit www.phenxtoolkit.org). trans-NIH working group making existing COVID-19 survey items investigator contact information publicly available through NIH-supported platforms: NIH Public Health Emergency Disaster Research Response DR2) https://dr2.nlm.nih.gov/] the PhenX Toolkit https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based for clinical research, strongly encouraged consider COVID-19 specific survey item repositories select existing survey items protocol modules currently being fielded. Additional Requirements NIH requiring data sharing all COVID-19 projects, where is prohibited i.e., Tribal data sovereignty). NIH expects supports timely release sharing final research data NIH-supported studies use other researchers expedite translation research results knowledge, products, procedures improve human health. Recipients expected work the RADx-rad Data Coordinating Center DCC) submit common evaluation metrics COVID-19 testing-related outcomes implementation the DCC. Recipientsshould identify dedicated unit responsible these data reporting activities. NIH expects all projects funded under NOSI actively coordinate, collaborate, share data the RADx-rad Data Coordinating Center, allowed, with considerations under tribal IRB processes, appropriate. Researchers applying this funding opportunity strongly encouraged review Data Coordinating Center DCC) funding opportunity. NIH Expects, data acquisition, collection, curation strategies be coordinated the DCC guidance annotation benchmarking data, including obtaining appropriate consent data sharing implementation the schemas proposed under ABOUT ML effort (Annotation benchmarking understanding transparency machine learning lifecycles; available https://www.partnershiponai.org/about-ml/). order maximize progress successful outcomes, recipientsare expected participate DCC-organized activities, including regular e.g., monthly) progress meetings individual subsets awardees, twice annual meetings all RADx-rad awardees. Applications must include timeline completion. timeline must include plans regular reports progress be submitted the DCC. Projects must include evaluation plan demonstrating the proposed COVID-19 diagnostic strategies/activities be assessed effectiveness impact. Recipientsare expected obtain retain personal identifiers all research participants where is prohibited i.e., Tribal data sovereignty) future longitudinal follow-up to leveraged intervention research. Data collected this program be protected a Certificate Confidentiality. Recipients must include measures reporting relevant testing implementation outcomes, inform future community, local, state, federal policies. with NIH supported research, details regarding human subjects research expected, including data safety monitoring plans and, needed, plans a Data Safety Monitoring Board DSMB). Studies have DSMB expected coordinate DCC DSMB activities. Recipients expected disaggregate study results sex gender; race ethnicity; age other relevant demographic factors, to consider intersectionality appropriate Accuracy, sensitivity, specificity, accessibility affordability key considerations chemosensory tests. Odor taste assessment delivery tools should follow FDA guidelines including performance testing demonstrate reliability detection loss chemosensory function be considered Generally Recognized Safe GRAS). Non-responsive Projects do have infrastructure rapidly report study findings impact the DCC. Projects have limited testing capacity, do include FDA-authorized/approved testing strategies present plan incorporate approved testing strategies Review Process Applications be evaluated scientific technical merit an appropriate internal review panel convened NIH staff, accordance the review criteria specified PA-20-135 well these additional review criteria: Urgency significance research: will successful completion the aims contribute or complement public health efforts the control detection SARS-CoV-2 COVID-19) infection related pathogenic processes? Research strategy: the overall strategy, methodology, analyses well-reasoned appropriate accomplish specific aims the project? feasible appropriate the overall research design elements including power calculations) demonstrating effectiveness impact the proposed COVID-19 diagnostic testing? the emergency time frame appropriate feasible support aims goals the study? Investigators: the PD/PIs, collaborators, other researchers well suited appropriate carry the project? Outcomes: outcomes products proposed impact improve acceptability, accessibility, effectiveness COVID-19 testing? Testing: feasible appropriate the plans access FDA-authorized/approved test kits related activities i.e., ability process tests a timely manner return test results quickly possible)? Data Sharing Plan: the proposed research generate unique resources data may impact public health response medical countermeasure development, does resource sharing plan adequately address rapid dissemination data, results, analyses the broader scientific community, using existing public repositories whenever possible not limited Tribal data sharing policy, a foundation further study? Coordination plans:How feasible appropriate the plans submit data, data collection instruments, outcomes/products the DCC? Pre-Award costs Pre-award costs be incurred January 20, 2020 through public health emergency period prior the date the federal award. Reporting Funds awarded using appropriations provided the Paycheck Protection Program Health Care Enhancement Act, Public Law 116-139 be issued unique subaccounts the HHS Payment Management System will require separate financial reporting any funds awarded. Application Submission Information Application due date: September 15, 2020 5:00 PM local time applicant organization. Submit applications this initiative response the following funding opportunity announcement FOA) the subsequent reissued equivalent through expiration date this notice: PA-20-135- Emergency Competitive Revision Existing NIH Awards Emergency Supplement - Clinical Trial Optional) Eligibility Active research resource grants, cooperative agreements small business grants SBIR STTRs). NRSA training fellowship grants not eligible apply funding. Product development, validation, scale-up activities supporting commercialization all within scope this NOSI. be eligible a competing revision award under NOSI, parent award which revision application based must an active award including those a no-cost-extension period) managed one the participating institutes centers. Grants currently a no-cost extension eligible apply. instructions the SF424 R&R) Application Guide the parent funding opportunity announcement must followed, the following additions: funding consideration, applicants must include NOT-OD-20-152 without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications non-responsive terms this NOSI be be considered. Requests expected to exceed 250,000 total direct costs. Total direct costs requested not exceed direct cost amount the current years award. Maximum direct costs exclusive consortium/contractual Facilities Administrative F&A) costs. Requests limited one year support. Regardless the grant mechanism the parent award, Research Strategy section the application limited 6 pages. Where applicable, provide details appropriate biohazard management plans commensurate the level risk https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines…). Applications conducting research the SARS-CoV-2 virus specimens possible SARS-CoV-2 infection must address protections against potential biohazards, including details access special facilities, e.g., Biosafety Level 3/4 BSL3/4) laboratories. Potential applicants strongly encouraged contact Program Official listed the Notice Grant Award the parent project discuss responsiveness appropriate mechanism before submission to facilitate efficient processing the request. Inquiries Please direct inquiries one the following contacts: Susan Sullivan, Ph.D. National Institute Deafness Other Communication Disorders NIDCD): 301-451-3841 sullivas@nidcd.nih.gov Amanda Melillo, Ph.D. National Institute Dental Craniofacial Research NIDCR 301-312-9037 amanda.melillo@nih.gov Coryse St. Hillaire-Clarke, Ph.D. National Institute Aging NIA) 301-827-6944 sthillaireclacn@mail.nih.gov Nahida Chakhtoura, Ph.D. Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) 301-435-6872 nahida.chakhtoura@nih.gov Jim Gnadt, Ph.D. National Institute Neurological Disorders Stroke NINDS) 301-496-9964 gnadtjw@ninds.nih.gov Michelle Hamlet National Institute Nursing Research NINR) 301-496-9623 hamletm@mail.nih.gov Rajasri Roy Office Research Women's Health ORWH) 301-451-0993 rajasri.roy@nih.gov