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Notice of Correction to application forms package for PA-17-326 "Administrative Supplements for the U.S.-Japan Brain Research Cooperative Program (BRCP) - U.S. Entity (Admin Supplement)"

NOT
Tuesday, September 11, 2018
Friday, January 1, 2021
NOT-NS-18-093

Funding Opportunity Purpose

Notice Correction application forms package PA-17-326 Administrative Supplements the U.S.-Japan Brain Research Cooperative Program BRCP) - U.S. Entity Admin Supplement)" Notice Number: NOT-NS-18-093 Key Dates Release Date: September 11, 2018 Related Announcements PA-17-326 Issued National Institute Neurological Disorders Stroke NINDS) National Institute Aging NIA) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Center Complementary Integrative Health (NCCIH) National Center Advancing Translational Sciences NCATS) Purpose Notice informs community an application form issue with  PA-17-326 - Administrative Supplements the U.S.-Japan Brain Research Cooperative Program BRCP) - U.S. Entity Admin Supp). application forms package originally posted this Funding Opportunity Announcement FOA) included inappropriate forms. address issue, new application forms package been posted in Grants.gov identified a Competition ID lsquo;FORMS-E-ADMINSUPP-RESEARCH-REVISED’.  If initiated application using original (FORMS-E-ADMINSUPP-RESEARCH) package, must move application information the revised application package successfully submit. you not sure application package are using, please see this  resource. Note: ASSIST, Workspace many institutional system-to-system solutions allow application data be easily copied one application package another. Contact appropriate support team assistance ASSIST –  eRA Service Desk ; Workspace –  Grants.gov Contact Center ). Inquiries Please direct inquiries to: Stacey D. Chambers National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-0690 Email: chambers@ninds.nih.gov

Notice of Intent to Publish a Funding Opportunity Announcement for NINDS Exploratory Grant for Morris K. Udall Center without Walls for Parkinsons Disease Research (P20)

NOT
Tuesday, September 11, 2018
Friday, January 1, 2021
NOT-NS-18-083

Funding Opportunity Purpose

Notice Intent Publish Funding Opportunity Announcement NINDS Exploratory Grant Morris K. Udall Center without Walls Parkinson's Disease Research P20) Notice Number: NOT-NS-18-083 Key Dates Release Date: September 11, 2018 Estimated Publication Date Funding Opportunity Announcement: October 01, 2018 First Estimated Application Due Date: December 14, 2018 Earliest Estimated Award Date: July 01, 2019 Earliest Estimated Start Date: July 01, 2019 Related Announcements NOT-NS-18-084 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications Exploratory Grants NINDS Morris K. Udall Parkinson's Disease Research Center Without Walls. purpose this FOA Exploratory Grant P20) applications to support formation new, highly skilled research consortia address urgent emergent challenges posed the inherent complexity Parkinson's Disease PD). Resolution some particularly difficult challenges requires transdisciplinary Center without Walls CWOW)" approach, which specialized research consortium works seamlessly across institutional, geographic research boundaries using goal-driven approach resolve essential question controversy PD. Development an effective research consortium, identification an optimal strategy planning comprehensive efforts address fundamental challenges PD research require dedicated time resources. Therefore, NINDS initiative provide to years support new collaborative teams initiate planning, develop organizational structure, perform research feasibility studies obtain preliminary data will lead directly the submission a competitive NINDS Morris K. Udall Center without Walls PD Research Udall PD CWOW) application. Exploratory Grant mechanism provides applicant consortium flexibility choice PD research challenge project design. stated, consortium select justify timely, relatively implementation-ready challenge, such the team effectively mobilize required data, skills resources within two-year period. Because goal this initiative to establish new research consortia, preliminary data not required proposed research feasibility projects. components required form effective partnerships develop rigorous evidence base involve range research expertise, multiple sites institutional resources. activities be directed toward development submission a subsequent NINDS Udall PD CWOW application. Udall PD CWOW applications expected transform PD research treatment through transdisciplinary, synergistic timely resolution an identified critical challenge PD research. anticipated scope the ensuing Udall PD CWOW applications include optimal combination preclinical clinical reseaserch necessary address identified challenge to meet stated goals within five-year project period. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published Autumn 2018 an expected application due date Winter 2018. FOA utilize P20 Exploratory Grant activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights Parkinson's Disease begin consider applying this new FOA. Among areas research encouraged this initiative transdisciplinary, consortium-based exploratory research efforts resolve critical challenge Parkinson's Disease PD) research. goal this FOA to convene new transdisciplinary research consortia formalize multi-institutional organizational investigational structure necessary resolve essential challenge Parkinson's disease PD) through subsequent NINDS Udall PD Center without Walls CWOW) approach. most compelling applications will: i) identify fundamental PD research priority; ii) build exemplary research consortium; iii) gather supportive preliminary data; iv) demonstrate exceptional potential pursue targeted strategy remove critical impediment blocking advancement the understanding treatment PD. stated challenge related research feasibility projects inform etiology, pathogenesis treatment PD; investigations related synucleinopathies be included such studies directly address central PD research challenge.  foster development innovative research collaborations, FOA provide support new research consortia only; continuation established projects teams not supported. be considered new," consortium must represent novel collaboration among independent investigators have co-authored primary research publications within past years. consortium must also include transdiciplinary expertise demonstrated primary training, professional affiliation research expertise its members. Consortium novelty also defined the combination research methodologies, expertise significance the challenge selected the optimal combination specialized expertise required resolve stated challenge using goal-driven approach. Program Director/Principal Investigator PD/PI) must eminently qualified provide visionary scientific leadership effective oversight consortium administrative activities. Participating investigators should recognized world-class experts their fields. Teams must anchored at least PD researcher. maximize potential new insights incorporation cutting-edge approaches,  consortia actively integrate least investigator primary expertise another, complementary research area. applicant institution must demonstrate ability lead coordinate research administrative activities the consortium. Participating sites must demonstrate leadership their area scientific expertise, well propensity leverage existing resources technologies meet stated goals. Proposals include established consortia, interventional clinical trials that seek establish research infrastructure not responsive this opportunity. Applications should highlight expected end products exploratory activities well significance a subsequent PD CWOW effort. Successful exploratory efforts lead directly an application support an NINDS Morris K. Udall Center without Walls Parkinson’s Disease Research Udall PD CWOW; U54). Synergistic Udall PD CWOW efforts expected transform PD research treatment through transdisciplinary, goal-driven timely resolution an identified essential challenge PD research. PD CWOW FOA anticipated fiscal year FY) 2021 will utilize NIH Specialized Center Cooperative Agreement U54) mechanism. U54 a milestone-driven mechanism, continuation which dependent upon achievement quantifiable steps within clearly defined timeframe. Udall PD CWOW milestones describe research goal well provide objective quantitative outcomes which justify advancing project, i.e. measures would recognizable appropriate endpoints the specific scientific area. Synergy must evident among PD CWOW research projects cores such successful completion proposed milestones not accomplished without CWOW consortium structure. Interventional clinical trials advanced therapeutic development approaches be beyond scope NINDS Udall PD CWOW efforts; addition, applications proposing incremental expansion rather transformative advancement) knowledge, data, resources technologies not considered responsive.   following information provided facilitate development an Exploratory Grant application.  Required components a future Udall PD CWOW application expected include: Overall Section, including not limited to: Statement and justification the selected PD challenge. Expected impact the proposed solution. Description synergistic research activities, including: Transdisciplinary pursuit the defined research challenge.      Harmonization methodologies, technologies, approaches. Standardization data biospecimen collection. Justification the proposed consortium, including unique investigative skills, emergent methodologies, cutting-edge technologies readily available resources. Well-defined milestones.   timeline key CWOW events. minimum three milestone-driven Research Projects. Administrative Core. minimum one Scientific Core; Core must support least Research Projects. Clinical Core support human subjects-focused research proposed). Resource Sharing Core. Scientific Governance structure, including not limited to: Internal Executive Committee. External Steering Committee be assembled only subsequent a successful U54 application). coordinating committees required optimal Udall PD CWOW function, e.g. Data coordination/access. Resource coordination/access. Clinical research oversight. dedicated website provide information the research community. Proposed consortia must include optimal combination specialized expertise required resolve stated challenge using goal-driven approach. Program Director/Principal Investigator PD/PI) must eminently qualified provide visionary scientific leadership effective oversight consortium administrative activities. PD/PI must lead Administrative Core may lead more one component. Participating investigators should recognized world-class experts their fields, excellent research productivity and/or stewardship multi-site clinical research studies. Teams must anchored at least PD researcher/clinician. maximize potential new insights incorporation cutting-edge approaches, consortia actively integrate least investigator primary expertise another, complementary research area. Inclusion international collaborators critical expertise reaching proposed goals encouraged. team structure intended enrich perspectives methodologies brought bear resolution key issues PD research. Effort dedicated the PD/PI investigators must commensurate the goals timeline the PD CWOW. applicant institution must demonstrate ability lead coordinate research administrative activities the consortium. Participating sites must demonstrate leadership their area scientific expertise, well propensity leverage existing resources technologies meet stated goals. projects should supported a timeline yearly milestones completion. Milestones goals that create go/no-go decision points in project must include clear quantitative criteria success. Achievement milestones be evaluated NINDS, funding non-competing award years depend milestone accomplishment. Note the NINDS Udall PD CWOW awards be managed cooperative agreements; therefore, projects do comply terms, conditions, established milestones the award of program be terminated. design, Udall PD CWOW expected include larger-scale research collaborations, terms numbers investigators research projects, geographic institutional diversity multiple (= 3) research site locations, dedicated resources, current Udall Centers P50). Udall PD CWOW consortia also focused resolution the identified PD research challenge within 5-year project period. Due the goal-driven focus the planned U54 FOA inherent differences aims-driven investigative approach the P50 Udall Centers, Udall PD CWOW not include career development/research training formal community outreach activities. However, Udall PD CWOW consortia be encouraged include person Parkinson's a caregiver the Steering Committee provide important perspective. Based common goals advancement PD research, Udall PD CWOW Program Directors/Principal Investigators become part the overall NINDS Udall Centers program will required participate annual meetings exchange information ideas. NINDS PD CWOW be expected leverage existing infrastructure share developed resources, including knowledge, data reagents, broadly the research community, consistent achieving goals the Udall Centers program. P20 Exploratory Grant Award not prerequisite submission a Udall PD CWOW U54 application. Funding Information Estimated Total Funding 1,000,000 direct costs Expected Number Awards NINDS intends fund to 4 awards. Estimated Award Ceiling 250,000 direct costs Primary CFDA Numbers 93.853 Anticipated Eligible Organizations 93.853 Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Indian/Native American Tribal Government Federally Recognized) Applications not being solicited this time.    Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD National Institute Neurological Disorders Stroke NINDS) 301-496-5680 Beth-Anne.Sieber@nih.gov

Notice of Intent to Publish a Funding Opportunity Announcement for NINDS Morris K. Udall Centers of Excellence for Parkinsons Disease Research (P50)

NOT
Tuesday, September 11, 2018
Friday, January 1, 2021
NOT-NS-18-084

Funding Opportunity Purpose

Notice Intent Publish Funding Opportunity Announcement NINDS Morris K. Udall Centers Excellence Parkinson's Disease Research P50) Notice Number: NOT-NS-18-084 Key Dates Release Date:September 11, 2018 Estimated Publication Date Funding Opportunity Announcement: October 01, 2018 First Estimated Application Due Date: December 14, 2018 Earliest Estimated Award Date: July 01, 2019 Earliest Estimated Start Date: July 01, 2019 Related Announcements NOT-NS-18-083 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends publish Funding Opportunity Announcement FOA) solicit applications Morris K. Udall Centers Excellence Parkinson's Disease Research. overarching goal the NINDS Udall Centers Excellence program to establish network Centers work collaboratively well independently define causes and discover improved treatments PD. Udall Centers pursue high-impact, synergistic research projects while serving national leaders PD research, local resources research career enhancement outreach the PD patient/advocacy community. Another important goal to further advance PD research through broad sharing data research resources developed through Centers program. NINDS Udall Centers program prioritizes innovative integrative research significant potential discovery. Udall Center applications expected identify address overall research theme defines critical challenge PD research, emphasize novel ideas approaches, well to utilize state-of-the-art technologies a team-based approach achieve stated goals. overall theme each Center, proposed research projects, cores inform etiology, pathogenesis treatment PD; investigations related synucleinopathies be included such studies directly address identified PD research challenge. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published Autumn 2018 an expected application due date Winter 2018. FOA utilize Specialized Center P50) activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights this area Parkinson's Disease PD) begin consider applying this new FOA. Among areas research encouraged this initiative the examination the mechanisms underlie effects PD well research designed improve translation existing knowledge strategies the prevention treatment PD. overarching goal the specialized Udall Centers program to establish network Centers work collaboratively well independently define causes and discover improved treatments Parkinson’s disease PD). more immediate goal each Center to rapidly advance synergistic, interdisciplinary research programs while serving national leaders PD research. Udall Centers also serve local resources organizing research career enhancement activities Center investigators periodic outreach the PD patient/advocacy community. Applicants expected identify address overall research theme defines critical challenge PD research. stated theme, proposed research projects, associated cores inform etiology, pathogenesis treatment PD; investigations related synucleinopathies be included such studies directly address identified PD research challenge. Requirements include 1) minimum three research projects; 2) research cores are essential accomplish aims at least proposed research projects, plus Administrative Core; 3) mission statement plan career enhancement Center researchers; 4) plan effective outreach the local patient community. NINDS Udall Centers program prioritizes innovative integrative research significant potential discovery. considerable degree synergy must evident among Center research projects cores, such successful completion the aims not accomplished without Center structure. Udall Center Director PD/PI) must an established leader scientific research visionary leadership skills proven expertise the stewardship large-scale research programs; participating investigators must lead independent research programs. Eligible institutions must demonstrate commitment and support the establishment and/or continuation the proposed Udall Center. Funding decisions focus those applications most likely make significant contributions PD research, well those greatest potential collaborate effectively across Centers program. Funding Information Estimated Total Funding 2,500,000 direct costs Expected Number AwardsThe NINDS support to 2 awards, pending receipt meritorious applications NIH appropriations. Estimated Award Ceiling 825,000 direct costs DC); 1,250,00 DC applications proposing clinical and/or translational components. Primary CFDA Numbers 93.853 Anticipated Eligible Organizations Public/State Controlled Institution Higher Education For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments Regional Organization Applications not being solicited this time.  Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD National Institute Neurological Disorders Stroke NINDS) 301-496-5680 Beth-Anne.Sieber@nih.gov

Notice of Intent to Publish a Funding Opportunity Announcement for Promoting Research on Music and Health: Fundamentals and Applications (R01 Clinical Trials Optional)

NOT
Friday, August 31, 2018
Friday, January 1, 2021
NOT-NS-18-090

Funding Opportunity Purpose

Notice Intent Publish Funding Opportunity Announcement Promoting Research Music Health: Fundamentals Applications R01 Clinical Trials Optional) Notice Number: NOT-NS-18-090 Key Dates Release Date: August 31, 2018 Estimated Publication Date Funding Opportunity Announcement: November 01, 2018 First Estimated Application Due Date: February 28, 2019 Earliest Estimated Award Date: September 01, 2019 Earliest Estimated Start Date: September 01, 2019 Related Announcements NOT-NS-18-091 NOT-AT-18-015 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institutes Health intends publish three related Funding Opportunity Announcements FOA) promote ground-breaking research better utilize music’s ability improve human health.  This FOA use R01 mechanism, support fundamental studies aimed understanding effects music healthy individuals, and/or its best usage improving specific health conditions. related FOA use R21 mechanism encourage exploratory proposals. Applications proposing phased musical interventional studies encouraged read NOT-AT-18-015. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published the fall 2018 an expected application due date the winter 2019. Details the planned FOA provided below. Research Initiative Details Music the remarkable ability enhance child development, improve adult function well-being, optimize quality life during aging.  studies shown music also ameliorate symptoms a broad range diseases disorders occur throughout lifespan. Recent scientific breakthroughs, including development new technologies, providing community opportunities understand mechanisms through music acts, to develop new music interventions a variety human conditions. capitalize these opportunities, NIH issuing three related initiatives intended to: i) promote our understanding the basic mechanisms through music processed the brain body; ii) explore music impacts health physiology, iii) facilitate rigorous music intervention studies treat disease symptoms. 2016, NIH, John F. Kennedy Center the Performing Arts KC), National Endowment the Arts NEA)  formed collaborative partnership Sound Health) organized workshop evaluate state basic applied music research Music the Brain). this meeting, diverse panel experts discussed three overlapping periods life childhood, adulthood, aging) made recommendations enhancing research each these domains NIH report). group developed set recommendations intended highlight research opportunities promote rigor future research. recommendations centered around four broad areas: 1) Basic Mechanistic Research, 2) Translational Clinical Research, 3) Methods Outcomes 4) Capacity Building Infrastructure. 2017, trans-NIH Music Health working group formed capitalize these recommendations promote implementation. achieve this, NIH be issuing three related FOAs fall two categories. first FOAs support R01 R21 awards are intended broadly support any research areas related the fundamentals application music health. third FOA utilize phased R61/R33 mechanism support research music health geared towards music intervention. the announcement further details contact scientific contacts listed prior preparing application determine most suitable FOA a given proposal. Notice encourages investigators expertise insights areas of relevant music research begin consider applying this new FOA. Studies aimed examining benefits music healthy individuals those medical conditions permissible. Among areas research encouraged this initiative those promoting music research examining mechanisms underlie fundamentals applications health, well as, research designed improve translation existing knowledge strategies the prevention treatment a variety diseases disorders. Funding Information Estimated Total Funding NIH its participating institutes, centers, offices, intend commit to 5,000,000 FY2019 promote research music health via intended FOA well the related FOAs. Expected Number Awards 9-12 awards expected be across three related FOAs. Estimated Award Ceiling R01 FOA be limited 250,000.00 direct costs any given year. Primary CFDA Numbers TBD Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Applications not being solicited this time. Inquiries Please direct inquiries to: Robert Riddle, PhD NINDS 301-496-5745 riddler@nih.gov Dr. Robert Finkelstein, PhD Division Extramural Administration National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9248 Email: rf45c@nih.gov

Notice of Intent to Publish a Funding Opportunity Announcement for Promoting Research on Music and Health: Fundamentals and Applications (R21 Clinical Trials Optional)

NOT
Friday, August 31, 2018
Friday, January 1, 2021
NOT-NS-18-091

Funding Opportunity Purpose

Notice Intent Publish Funding Opportunity Announcement Promoting Research Music Health: Fundamentals Applications R21 Clinical Trials Optional) Notice Number: NOT-NS-18-091 Key Dates Release Date: August 31, 2018 Estimated Publication Date Funding Opportunity Announcement: November 01, 2018 First Estimated Application Due Date: February 28, 2019 Earliest Estimated Award Date: September 01, 2019 Earliest Estimated Start Date: September 01, 2019 Related Announcements NOT-NS-18-090 NOT-AT-18-015 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institutes Health, intends publish three related Funding Opportunity Announcements FOA) promote ground-breaking research better utilize music’s ability improve human health.  FOA use R21 mechanism, support exploratory studies aimed at shedding new light the effects music healthy individuals, and/or best usage improving specific health conditions. related FOA use R01 mechanism encourage proposals a larger scope. Applications proposing phased musical interventional studies encouraged read NOT-AT-18-015. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published the fall 2018 an expected application due date the winter 2019. Details the planned FOA provided below. Research Initiative Details Music the remarkable ability enhance child development, improve adult function well-being, optimize quality life during aging.  studies shown music also ameliorate symptoms a broad range diseases disorders occur throughout lifespan. Recent scientific breakthroughs, including development new technologies, providing community opportunities understand mechanisms through music acts, to develop new music interventions a variety human conditions.  capitalize these opportunities, NIH issuing three related initiatives intended to: i) promote our understanding the basic mechanisms through music processed the brain body; ii) explore music impacts health physiology, iii) facilitate rigorous music intervention studies treat disease symptoms. 2016, NIH, John F. Kennedy Center the Performing Arts KC), National Endowment the Arts NEA) formed collaborative partnership Sound Health) organized workshop evaluate state basic applied music research Music the Brain). this meeting, diverse panel experts discussed three overlapping periods life childhood, adulthood, aging) made recommendations enhancing research each these domains NIH report). group developed set recommendations intended highlight research opportunities promote rigor future research. recommendations centered around four broad areas: 1) Basic Mechanistic Research, 2) Translational Clinical Research, 3) Methods Outcomes 4) Capacity Building Infrastructure. 2017, trans-NIH Music Health working group formed capitalize these recommendations promote implementation. achieve this, NIH be issuing three related FOAs fall two categories. first FOAs support R01 R21 awards are intended broadly support any research areas related the fundamentals application music health. third FOA utilize phased R61/R33 mechanism support research music health geared towards music intervention. the announcement further details contact scientific contacts listed prior preparing application determine most suitable FOA a given proposal. Notice encourages investigators expertise insights areas relevant music research begin consider applying this new FOA. Studies aimed examining benefits music healthy individuals those medical conditions permissible. R21 mechanism encourages potentially high-risk/high reward studies would the greatest impact the field. Among areas research encouraged this initiative those promoting music research examining mechanisms underlie fundamentals applications health, well as, research designed improve translation existing knowledge strategies the prevention treatment a variety diseases disorders. Funding Information Estimated Total Funding NIH its participating institutes, centers, offices, intend commit to 5,000,000 FY2019 promote research music health via intended FOA well the related FOAs. NIH its participating institutes, centers, offices, intend commit to 5,000,000 FY2019 promote research music health via intended FOA well the related FOAs. Expected Number Awards 9-12 awards anticipated be across related FOAs. Estimated Award Ceiling R21 FOA be limited 275,000 direct costs both years. single year greater 150,000. Primary CFDA Numbers TBD Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Applications not being solicited this time. Inquiries Please direct inquiries to: Robert Riddle, PhD NINDS 301-496-5745 riddler@nih.gov Dr. Robert Finkelstein, PhD Division Extramural Administration National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9248

Administrative Supplements for Validation of Novel Non-Addictive Pain Targets (Clinical Trials Not Allowed)

NOT
Thursday, August 23, 2018
Friday, January 1, 2021
NOT-NS-18-073

Funding Opportunity Purpose

Administrative Supplements Validation Novel Non-Addictive Pain Targets Clinical Trials Allowed) Notice Number: NOT-NS-18-073 Key Dates Release Date: August 23, 2018 Related Announcements PA-18-591 Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Library Medicine NLM) National Center Complementary Integrative Health NCCIH) Office Research Infrastructure Programs ORIP) Office Research Women's Health ORWH) Purpose Notice part the NIH Helping End Addiction Long-Term HEAL) Initiative, aggressive, trans-agency effort speed scientific solutions stem national opioid public health crisis. validation a biological target the treatment pain, i.e. proof its suitability treating specific group pain disorders, critical the development new nonaddictive therapeutics. Therefore, NINDS other participating Institutes Centers ICs) inviting investigators submit administrative supplements PA-18-591 expand existing ongoing pain target discovery research add rigorous multimethod validation studies, ultimately provide validation the pain therapeutic target necessary accelerate development non-addictive treatments.  Background Chronic pain one the most prevalent, costly, disabling health conditions the United States, among most complex manage. Currently available drugs acute chronic pain considerable limitations such undesirable side effects, lack data long-term usefulness, significant addiction overdose potential. Notice part the NIH Helping End Addiction Long-Term HEAL) Initiative, aggressive, trans-agency effort speed scientific solutions stem national opioid public health crisis. Novel non-addictive targets urgently needed could used the development small molecule drugs, biologics, natural products.  The NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. Once identified, pain treatment targets require rigorous validation justify significant investment therapeutic development. Rigorous approaches target validation include use multiple approaches, such the validation targets animal models, unidentifiable human tissue, and/or validation key experiments other laboratories. Applicants ongoing NIH funded research identify novel pain targets encouraged submit administrative supplement application add rigorous target validation studies. studies should the goal definitively determining utility a potential target future therapeutic development. Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contribution of federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment.  Due Date: Supplement requests must received by November 1, 2018.  Eligibility: Active R01s equivalents R21s an end date through March 30, 2020 1-year requests) March 30, 2021 2-year requests), including cost extensions. administrative supplements, work proposed needs be within scope the research is already supported. Entry Criteria: Projects should aim validate novel targets can lead significant improvements over existing therapeutics pain have limited abuse liability. Projects funded through opportunity must a strong biological rationale acute chronic pain conditions. Applicants must include strong rationale the intended approach validation, including preliminary data literature-based evidence supporting feasibility the approach. Applicants encouraged use least 2 different techniques validation their experimental design validate target. Preliminary data should from well-designed experiments include appropriate controls statistical analyses. Applicants should discuss druggability" the target, is based part the structure accessibility the target; consideration target distribution specificity, may contribute undesirable on-or off- target effects. Relevance therapy development: Projects should aim validate targets will address pain condition(s) human patients. Applicants must discuss where target fits the larger pain landscape which patients likely benefit. Examples target validation activities intended be supported through Notice include following, are limited to: Target validation using animal models Validation the target human tissue, i.e. human DRGs, human iPSCs Testing reproducibility the validation assay another laboratory will also support activities order prepare validation: Preparation design genetic probes RNAi, CRISPR/Cas9 etc.) Creation and/or verification genetically modified animals cells necessary purposes validation: Execution small scale screening possible probe compounds be used interrogate target. Preparation PET ligands use animal pain models a genetic animal cell model, ensuring the target successfully up/down regulated Rigorous evaluation the effects genetically pharmacologically manipulating target a cellular assays primary neurons human iPSCs example) animal models. Examples activities are appropriate this FOA include, are limited to: Validation targets are anticipated have abuse liability Development assays probes support basic understanding disease other basic research doesn't a clearly articulated path toward development a therapeutic Development devices, surgical procedures, diagnostics, rehabilitation strategies Clinical testing candidate therapeutics, any clinical studies fit NIH definition clinical trials. this link a description: https://grants.nih.gov/policy/clinical-trials/definition.htm Identification new targets  Application Instructions: Investigators should submit applications responses the parent active administrative supplement PA: https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html and include reference this notice NOT-18-073 the cover letter. part the application, investigators should submit detailed description to 3 pages) the proposed research plan validate novel non-addictive target the development pain treatments. first page should a summary goals rationale the validation experiments proposed the supplement, similar the format a Specific Aims page other NIH funding applications. addition this 3-page research plan description, applicants should also include detailed budget explains the supplement funding be used to 3 pages). Sufficient detail the budget should included give rationale the funds are requested. Individual requests be more 250,000 direct costs per year exclusive Facilities Administrative costs sub-contracts. Requests be up two years support, a total 500,000 direct costs. addition the research plan budget, price quotations vendors, letters support biosketches new key personnel be included. Though supplement requests not limited one per parent grant, will consider substantial additional funding an award beyond scope. Before submitting supplement request, principal investigators strongly encouraged contact program officers the Institute, Center Office supporting award discuss whether proposed supplement within scope. mentioned in NOT-OD-18-181,Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contribution of federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Matching Requirement: A grantee a for-profit organization funded under funding opportunity announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.The applicant be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applications must identify source amount funds proposed meet matching requirement how value in-kind contributions determined. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement. See 45 CFR 75.306 for additional details.  instructions the SF424 R&R) Application Guide must followed. Cost Matching Requirement For-profit Applicants Cost matching documented in-kind contributions required for-profit organizations responding this FOA.  for-profit awardee required match funds provide least 50% matching funds documented in-kind contributions a rate not less 50% the the total-Federally awarded amount direct costs, well facilities administrative costs), stipulated Public Law 115-141, Consolidated Appropriations Act 2018.    Federal funds not used a source matching funds. Generally, cost matching requirements not met the following sources: a) Costs borne another Federal grant sub award; b) Costs contributions toward cost sharing another Federal grant, Federal procurement contract, any award Federal funds; c) Cost services property financed income earned contractors under contract the recipient sub recipient); d) Program income; e) Patient incentives. for-profit organization be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applicants must submit budgets clearly document total costs, source amount matching funds, how valuation determined the case in-kind contributions, well the Federal Institutional non-Federal) components the budget. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement.  See 45 CFR 75.306 for additional details .  Budget Justification:  All for-profit applicants must document matching non-Federal) component the federal non-matching) component the total project budget. is, requested budget plus cost-matching budget must detailed tabular format document cost-matching non-Federal) component the federal non-cost matching) component. amount matching subject adjustment based total allowable costs incurred.  costs contributions used satisfy matching requirement must documented the recipient, including the value in-kind contributions determined, are subject audit. cost matching requirement not negotiable for-profit organizations. Rigor Sex a Biological Variable: There a crucial need address sex influences pain research since pain disorders disproportionately affect women. Inclusion the description sex a biological variable all validation experiments encouraged. Successful projects be well-designed meet NINDS RIGOR guidelines Landis et. al. Nature 2012, 490:187-91; NOT-NS-11-023 and the NIH Rigor website).   Letters Support For-profit applicants must include letter(s) support confirming the required secured cost matching cash; in-kind commitments such salary, consultant costs, equipment) available confirm the essential personnel the authority within organization allocate resources.  Review Process: NINDS review supplement application conjunction representatives other ICs. NINDS make funds available up 8 awards.  Criteria: the work proposed within scope the active award? there strong biological rationale the target? the premise validation experiments strong? the validation experiments rigorous? consideration biological variables, such sex, demonstrated? the target therapeutically relevant does have low addiction liability? the target novel? it likely lead significant improvements over existing therapeutics pain? thought given the feasibility druggability’ the target?   Inquiries Please direct inquiries to: Michael Oshinsky, PhD. National Institute Neurological Disorders Stroke Telephone:301-496-9964 Email: michael.oshinsky@nih.gov Ann O'Mara, PHD, RN National Cancer Institute NCI) Telephone: 240.276.7050 E-mail: omaraa@mail.nih.gov Houmam Araj, PhD National Eye Institute NEI) Telephone: 301.451.2020 E-mail: arajh@nei.nih.gov Coryse St. Hillaire-Clarke, PhD National Institute Aging NIA) Telephone: 301.827.6944 E-mail: sthillaireclacn@mail.nih.gov Abraham Bautista National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301.443.9737 E-mail: bautista@mail.nih.gov Soundar Regunathan, PhD National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301.443.1192 E-mail: regunathans@mail.nih.gov Charles Washabaugh, PhD National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301.594.5055 E-mail: washabac@mail.nih.gov Susan Marden, PhD, RN Eunice Kennedy Shriver National Institute Child Health Human Development Telephone: 301-435-6838 E-mail: mardens@mail.nih.gov Kristopher Bough, PhD National Institute Drug Abuse NIDA) Telephone: 301-443-9800 Email: Boughk@nih.gov Yolanda F. Vallejo, PhD National Institute Dental Craniofacial Research NIDCR) Telephone: 301.827.4655 E-mail: yolanda.vallejo@nih.gov Teresa L.Z. Jones, MD National Institute Diabetes Digestive Kidney Diseases NIDDK) Telephone: 301.435.2996 E-mail: teresa.jones@nih.gov Martha Matocha, Ph.D. National Institute Nursing Research NINR) Telephone: 301.594.2775 E-mail: matocham@mail.nih.gov Ron Wertz National Institute Nursing Research NINR) Telephone: 301-594-2807  Email: wertzr@mail.nih.gov Yisong Wang, PhD National Center Complementary Integrative Health NCCIH) Telephone: 301.480.9483 E-mail: yisong.wang@nih.gov Hua-Chuan Sim, MD National Library Medicine NLM) Telephone: 301.594.4882 E-mail: simh@mail.nih.gov Ronald Adkins, PhD Division Comparative Medicine, Office Research Infrastructure Programs ORIP) Telephone: 301.435.4511 E-mail: Ronald.adkins@nih.gov Tatjana Atanasijevic, PhD National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301.451.6873 E-mail: atanasijevict@mail.nih.gov

Notice of Intent to Publish a Funding Opportunity Announcement for Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)

NOT
Thursday, August 23, 2018
Friday, January 1, 2021
NOT-NS-18-080

Funding Opportunity Purpose

Notice Intent Publish Funding Opportunity Announcement Discovery Validation Novel Targets Safe Effective Pain Treatment R01 Clinical Trial Allowed) Notice Number: NOT-NS-18-080 Key Dates Release Date: August 23, 2018 Estimated Publication Date Funding Opportunity Announcement: October 27, 2018 First Estimated Application Due Date: November 27, 2018 Earliest Estimated Award Date: 27, 2019 Earliest Estimated Start Date: 27, 2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS, other NIH Institutes Centers participating the HEAL Helping End Addiction Long-term) Initiative, intends publish Funding Opportunity Announcement FOA) solicit applications discover validate novel nonaddictive pain targets. focus this FOA be the basic science discovery targets the peripheral nervous system, central nervous system, immune system other tissues the body can used develop pain therapeutics have minimal side effects little no abuse/addiction liability. Research will supported this FOA must include rigorous validation studies demonstrate robustness the target a pain treatment target.  studies should the goal definitively determining utility a potential target future therapeutic and/or device development. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published October 2018 an expected application due date November 2018. Please note: Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contribution of federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Matching Requirement: A grantee a for-profit organization funded under funding opportunity announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.The applicant be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applications must identify source amount funds proposed meet matching requirement how value in-kind contributions determined. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement. See 45 CFR 75.306 for additional details. Research Initiative Details Notice encourages investigators expertise insights targets specific pain indications begin consider applying this new FOA. Investigators encouraged form collaborations individuals knowledgeable bioinformatics, statistical analysis, pain biology physiology, clinical experience appropriate the type pain treatment discovery, well those familiar the ultimate goal a successful project this FOA, is have robust candidate target nonaddictive therapeutics development. Translational research develop new therapeutics medical devices not focus this FOA. Basic science studies the pain related systems the body responsive this FOA are encouraged the context novel pain therapeutic target discovery validation. Projects should supported a cogent biological rationale. FOA not specific any or group pain conditions. Projects identify novel targets acute pain, chronic pain, migraine, headache disorders, osteoarthritis, diabetic neuropathy, chemotherapy-induced neuropathy, sickle-cell pain, post stroke pain, etc. be considered. Projects identify novel targets a combination chronic overlapping pain conditions for specific pathological conditions be considered. Projects seek identify novel targets specific patient populations such women children also responsive this FOA. Funding Information Estimated Total Funding Issuing IC partner components intend issue 8-10 awards 2019. Awards issued under FOA part funds set aside support HEAL Helping End Addiction Long-term) initiative. Expected Number Awards TBD Estimated Award Ceiling TBD Primary CFDA Numbers TBD Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Non-domestic non-U.S.) Entity Foreign Organization) Regional Organization Applications not being solicited this time.  Inquiries Please direct inquiries to: Michael L. Oshinsky, PhD National Institute Neurological Disorders Stroke NINDS) 301-496-9964 michael.oshinsky@nih.gov

Notice of Change of Receipt Date for RFA-EY-18-001 "BRAIN Initiative: New Concepts and Early - Stage Research for Large - Scale Recording and Modulation in the Nervous System (R21 Clinical Trial Not Allowed)"

NOT
Friday, August 10, 2018
Friday, January 1, 2021
NOT-NS-18-088

Funding Opportunity Purpose

Notice Change Receipt Date RFA-EY-18-001 BRAIN Initiative: New Concepts Early - Stage Research Large - Scale Recording Modulation the Nervous System R21 Clinical Trial Allowed)" Notice Number: NOT-NS-18-088 Key Dates Release Date: August 10, 2018 Related Announcements RFA-EY-18-001 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) Purpose purpose this notice to inform interested applicants there be change receipt dates the Funding Opportunity Announcement FOA) RFA-EY-18-001 BRAIN Initiative: New Concepts Early - Stage Research Large - Scale Recording Modulation the Nervous System R21 Clinical Trial Allowed)".  Specifically, next receipt date change October 29, 2018 to November 27, 2018. Part 1. Overview Information Key Dates Currently Reads: Application Due Date(s) 1, 2018, October 29, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date.   Modified Read: Application Due Date(s) 1, 2018, November 27, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date.   other aspects this FOA remain same. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: BRAIN-FOAs@nih.gov

Notice of Change of Receipt Date for RFA-NS-18-019 "BRAIN Initiative: Optimization of Transformative Technologies for Large Scale Recording and Modulation in the Nervous System (U01 Clinical Trials Not Allowed)"

NOT
Friday, August 10, 2018
Friday, January 1, 2021
NOT-NS-18-086

Funding Opportunity Purpose

Notice Change Receipt Date RFA-NS-18-019 BRAIN Initiative: Optimization Transformative Technologies Large Scale Recording Modulation the Nervous System U01 Clinical Trials Allowed)" Notice Number: NOT-NS-18-086 Key Dates Release Date: August 10, 2018 Related Announcements RFA-NS-18-019 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) Purpose purpose this notice to inform interested applicants there be change receipt dates the Funding Opportunity Announcement FOA) RFA-NS-18-019 BRAIN Initiative: Optimization Transformative Technologies Large Scale Recording Modulation the Nervous System U01 Clinical Trials Allowed).  Specifically, next receipt date change October 29, 2018 to November 27, 2018. Part 1. Overview Information Key Dates Currently Reads: Application Due Date(s) 15, 2018, October 29, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Modified Read: Application Due Date(s) 15, 2018, November 27, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. other aspects this FOA remain same. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: BRAIN-FOAs@nih.gov

Notice of Change of Receipt Date for RFA-NS-18-020 "BRAIN Initiative: New Technologies and Novel Approaches for Large-Scale Recording and Modulation in the Nervous System (R01 Clinical Trial Not Allowed)"

NOT
Friday, August 10, 2018
Friday, January 1, 2021
NOT-NS-18-087

Funding Opportunity Purpose

Notice Change Receipt Date RFA-NS-18-020 BRAIN Initiative: New Technologies Novel Approaches Large-Scale Recording Modulation the Nervous System R01 Clinical Trial Allowed)" Notice Number: NOT-NS-18-087 Key Dates Release Date: August 10, 2018 Related Announcements RFA-NS-18-020 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) Purpose purpose this notice to inform interested applicants there be change receipt dates the Funding Opportunity Announcement FOA) RFA-NS-18-020 BRAIN Initiative: New Technologies Novel Approaches Large-Scale Recording Modulation the Nervous System R01 Clinical Trial Allowed)".  Specifically, next receipt date change October 29, 2018 to November 27, 2018. Part 1. Overview Information Key Dates Currently Reads: Application Due Date(s) 15, 2018, October 29, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date.   Modified Read: Application Due Date(s) 15, 2018, November 27, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date.   other aspects this FOA remain same. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: BRAIN-FOAs@nih.gov

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