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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

NIH is issuing this RFA in response to the declared public health emergency issued by the Secretary, HHS, for 2019 Novel Coronavirus (COVID-19). This emergency NOSI from the NIH provides an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Radical (RADx-rad) initiative. The goal of RADx-rad initiative is to encourage the development of novel, non-traditional approaches to identify the current SARS-CoV-2 virus or other markers of the COVID-19 disease that can be used in future outbreaks of COVID-19 and that could be applicable to other, as yet unknown, viruses. Specifically, the goal of this RFA is to solicit proposals to enhance the utility of chemosensory testing as a COVID-19 screening tool by using objective tests to examine the onset and prognostic value of chemosensory loss and to encourage the development and/or deployment of home-based and on-site chemosensory tests. The funding for this initiative is provided from the Paycheck Protection Program and Health Care Enhancement Act, 2020.

This funding opportunity announcement invites research on the mechanism(s) by which abnormal proteins spread throughout the nervous systems of patients with Frontotemporal Dementia and/or Lewy Body Dementia. Applications that move beyond a focus on one mechanisms of spread to consider how spreading might proceed in the context of multiple proteinopathies, multiple cell/circuit types, and multiple pathways are of particular interest.

Notice Special Interest NOSI): Platform Trials Thrombectomy Acute Stroke Treatment Notice Number: NOT-NS-20-095 Key Dates Release Date: August 5, 20 First Available Due Date: October 14, 2020 Expiration Date: July 15, 2021 Related Announcements PAR-20-285 - NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention UG3/UH3 Clinical Trial Optional) Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS issuing Notice Special Interest applications establish master protocol conduct platform trials treatments ischemic stroke due large vessel occlusion. Master protocols should incorporate advanced clinical trial methodologies such as, not limited to, Bayesian modeling, response adaptive randomization, shared controls, the ability treatment arms enter, leave, be combined. Master protocols must designed allow future addition trial questions. Strong representation expertise the neurology, neurosurgery, interventional communities required such multi-disciplinary approach will expected applicants. Research Objectives Recent pivotal interventional trials patients ischemic stroke due large vessel occlusion shown mechanical thrombectomy be highly beneficial certain groups patients to 24 hours after last known well. However, questions remain the potential benefit harm thrombectomy specific subgroups patients certain ischemic stroke phenotypes. Also interest considerations such pre-hospital care peri-procedural management strategies. Further, success mechanical thrombectomy raises possibility a new era neuroprotection patients large vessel ischemic stroke. Promising neuroprotectants failed trials predated successful reperfusion, well newer agents have potential remain untested, ripe consideration this new environment. NINDS interested master protocols enable platform trials answer above questions using seamless rolling approach. Trials further refine patient groups do do benefit mechanical thrombectomy, using management approaches, also open door testing neuroprotectant strategies an efficient, timely, cost-effective manner. Clinical study protocols consist acute short-term procedures are deemed Non-Significant Risk NSR) an Institutional Review Board IRB), Significant Risk SR) studies require Investigational Device Exemption IDE) the FDA. Evidence contact appropriate U.S. regulatory bodies e.g., IRB NSR studies and/or FDA the form either Pre-Submission meeting IDE submission SR studies recommended. Applicants must the resources ability do work without critically impacting high-priority, on-going NINDS research programs. Investigators planning submit application response the NOSI strongly encouraged contact program officer listed below discuss proposed project. Application Submission Information notice applies due dates or after October 14, 2020 subsequent receipt dates through July 14, 2021.  Applications this initiative must submitted using following funding opportunity announcement FOA) any reissues these announcement through expiration date this notice: PAR-20-285 - NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention UG3/UH3 Clinical Trial Optional) instructions the SF424 R&R) Application Guide the funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include “NOT-NS-20-095” 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 the NOSI initiative. Applications nonresponsive terms this NOSI will not considered the NOSI initiative. Inquiries Please direct inquiries the Scientific/Research, Peer Review, Financial/Grants Management contacts Section VII the listed funding opportunity announcements.

Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers

This FOA encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions; biomarker or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery; and ancillary studies designed to add scientific aims to active studies being conducted within StrokeNet. Successful applicants will collaborate and conduct the study within the NIH StrokeNet. Following peer review, NINDS will prioritize studies among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol.

The National Institute of Neurological Disorders and Stroke (NINDS) is soliciting applications for a Human Biospecimen and Data Repository for Biomarkers Research ("Biomarkers Repository") in Neurological Disorders. Collaborative teams combining expertise in neuroscience, biomarkers, biospecimen handling, and data management are encouraged. Experience in biomarker research, such as evaluation of batch effects, protocol development, and analyte quality control measures, is expected. Successful applications will include a detailed description of 1) Administrative Structure, 2) Research and Resource Plan, and 3) Data Management and Web-Based activities.

This Funding Opportunity Announcement (FOA) invites Research Project Grant (R01) applications that propose to study the ethical, legal and social implications (ELSI) of human genome research. Applications may propose studies using either single or mixed methods. Proposed approaches may include but are not limited to data-generating qualitative and quantitative approaches, legal, economic and normative analyses, and other types of analytical and conceptual research methodologies, such as those involving the direct engagement of stakeholders.

This Funding Opportunity Announcement (FOA) invites Exploratory/Developmental Research Grant (R21) applications that propose to study the ethical, legal and social implications (ELSI) of human genome research. These applications should propose single or mixed methods studies that break new ground, extend previous discoveries in new directions or develop preliminary data in preparation for larger studies. Of particular interest are studies that explore the implications of new or emerging genomic technologies or novel uses of genomic information.

The purpose of this FOA isto develop tools and technologies to conduct cientifically rigorous, ethical, efficient, and cost-effective research infrastructure that supports germline and somatic transgenic and gene editing studies in the common marmoset (Callithrix jacchus). These studies should to answer crucial scientific questions that require genetic perturbation in a non-human primate model organism with the aim of supporting BRAIN goals of understanding the brain in health an disease.