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Notice NINDS' Participation PA-18-403 Ruth L. Kirschstein National Research Service Award NRSA) Institutional Research Training Grant Parent T32)" Notice Number: NOT-NS-18-022 Key Dates Release Date:   December 14, 2017 Related Announcements PA-18-403 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participate, effective immediately, PA-18-403 quot;Ruth L. Kirschstein National Research Service Award NRSA) Institutional Research Training Grant Parent T32)" following italicized changes made indicate participation NINDS this FOA.  Part 1. Overview Information Components Participating Organizations National Cancer Institute NCI) National Eye Institute NEI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) 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 Deafness Other Communication Disorders NIDCD) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.242; 93.351; 93.846; 93.113; 93.847; 93.866; 93.173; 93.279; 93.361; 93.865; ; 93.855; 93.398; 93.859; 93.867; 93.213; 93.286; 93.853 nbsp;   other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-188 Email: korns@mail.nih.gov

Notice Clarification NINDS Statement interest Bioengineering Research Grants BRG) R01 Clinical Trial Optional)" Notice Number: NOT-NS-18-028 Key Dates Release Date:   December 14, 2017 Related Announcements PAR-18-206 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to revise NINDS interest statement PAR-18-206. current language reads: Part 2. Full Text Announcement Section I. Funding Opportunity Description IC-Specific Interests   NINDS: NINDS not accept applications under announcement include clinical trials https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html). clinical trial a prospective biomedical behavioral research study human subjects designed answer specific questions safety, tolerability, efficacy and/or effectiveness pharmacologic, behavioral, biologic, surgical, device invasive non-invasive) interventions. human subjects research be submitted NINDS decline funding any application includes human subjects programmatic administrative reasons. Applicants considering projects involving human subjects research strongly encouraged contact Scientific/Research staff. Applications proposing non-clinical studies concluding a clinical trial should submitted one the following NINDS CREATE Devices FOAs specifically designed pre-clinical pilot clinical studies therapeutic devices http://www.ninds.nih.gov/funding/areas/translational_research/CREATE-De…). Applications proposing clinical trial must submitted one the following NINDS FOAs specifically designed clinical trials http://www.ninds.nih.gov/research/clinical_research/index.htm#tab3-panel) language been modified now reads: Part 2. Full Text Announcement Section I. Funding Opportunity Description IC-Specific Interests NINDS: Within goals this FOA, NINDS particularly interested bioengineering research advances technologies the potential decrease burden neurological disorders stroke. Examples areas interest include development validation invasive non-invasive devices, diagnostic/monitoring tools, advanced imaging techniques, computational models, tissue engineering, other innovative methods. Applicants strongly encouraged contact NINDS Scientific Program staff prior submission. Applicants interested translational activities clinical studies therapeutic diagnostic devices disorders affect nervous neuromuscular systems be appropriate other NINDS bioengineering opportunities https://www.ninds.nih.gov/Current-Research/Focus-Research/Focus-Bioengi…). other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice National Institute Neurological Disorders Stroke NINDS) National Institute Drug Abuse NIDA) Interest Blueprint Neurotherapeutic Network Applications Directed Small Molecule Non-Addictive Pain Therapies Notice Number: NOT-NS-18-027 Key Dates Release Date: December 13, 2017 Related Announcements PAR-17-201 PAR-17-205   Issued National Institute Neurological Disorders Stroke NINDS) National Institute Drug Abuse NIDA) Purpose purpose this Notice to inform potential applicants concerned the NIH Blueprint Neurotherapeutics Network BPN) Funding Opportunity Announcements the areas special interest. National Institute Neurological Disorders Stroke NINDS) interested receiving applications directed identifying developing new small molecule pain therapies. National Institute Drug Abuse NIDA) specifically interested receiving highly innovative applications, entering BPN the discovery phase only, directed identifying new small molecules devoid addictive properties the treatment pain. Additionally, BPN hold informational webinar the program potential applicants. webinar recommended investigators have small molecule validated hit compounds the disease biology assays drive lead optimization are interested learning the BPN it virtual pharma model brings NIH investigators together NIH expertise, seasoned industry consultants BPN's contract resources. webinar optional not required submission applications. WEBINAR INFORMATION Informational Webinar the Blueprint Neurotherapeutic Network January 3, 2018 3:30 p.m.- 4:30 Eastern Time Please visit following link register the webinar: Link webinar registration button available the bottom the page. Inquiries Please direct inquiries to: Charles L. Cywin, Ph.D. Program Director, Blueprint Neurotherapeutics Network National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email: charles.cywin@nih.gov Stephanie Fertig National Institute Neurological Disorders Stroke NINDS) Telephone:301-496-1779 Email: fertigs@ninds.nih.gov Elena Koustova, PhD, MBA National Institute Drug Abuse NIDA) Telephone: 301-496-8768 Email: koustovae@mail.nih.gov Michael Oshinsky, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov Tanya Tatiana) Ramey, MD PhD National Institute Drug Abuse NIDA) Telephone: 301-827 5944 Email: tanya.ramey@nih.gov nbsp;

Collaborative Research Computational Neuroscience CRCNS) NSFInnovative Approaches Science Engineering Research Brain Function Notice Number: NOT-MH-18-012 Key Dates Release Date: December 11, 2017 Related Announcements NOT-MH-18-003 Issued National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Drug Abuse NIDA) National Institute Deafness Other Communication Disorders NIDCD) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) National Center Complementary Integrative Health NCCIH) Purpose Notice announces reissue a joint initiative, Collaborative Research Computational Neuroscience CRCNS), among six National Science Foundation NSF) Directorates Offices DOs), nine participating National Institutes Health NIH) Institutes Centers ICs).  Notice supplements NOT-MH-18-003 reiterates involvement all ICs listed above. CRCNS announcement released under NSF 18-501 https://www.nsf.gov/publications/pub_summ.jsp?ods_key=nsf18501). announcement supersedes NSF 16-607: Collaborative Research Computational Neuroscience CRCNS) – Innovative Approaches Science Engineering Research Brain Function. German Federal Ministry Education Research Bundesministerium für Bildung und Forschung, BMBF http://www.bmbf.de/), French National Research Agency Agence Nationale de la Recherche, ANR http://www.agence-nationale-recherche.fr), U.S.-Israel Binational Science Foundation BSF http://www.bsf.org.il) and National Institute Information Communications Technology NICT, https://www.nict.go.jp/en/) now formal partners this program, along NSF the NIH. NIH, CRCNS now affiliated the NIH Blueprint Neuroscience Research http://neuroscienceblueprint.nih.gov). Computational neuroscience provides theoretical foundation a rich set technical approaches understanding complex neurobiological systems, building the theory, methods, findings computer science, neuroscience, numerous disciplines. Through CRCNS program, NSF, NIH, BMBF, ANR, BSF, NICT support collaborative activities will advance understanding nervous system structure function, mechanisms underlying nervous system disorders, computational strategies used the nervous system. classes proposals be considered response this solicitation: Research Proposals describing collaborative research projects; Data Sharing Proposals to enable sharing data other resources. Domestic international projects be considered. detailed the solicitation, international components collaborative projects be funded parallel the participating agencies. Specific CRCNS opportunities parallel funding available bilateral US-German Research Proposals, US-German Data Sharing Proposals, US-French Research Proposals, US-French Data Sharing Proposals, US-Israeli Research Proposals, US-Israeli Data Sharing Proposals, US-Japanese Research Proposals, US-Japanese Data Sharing Proposals, multilateral proposals involving United States 2 more partnering countries Germany, France, Israel, and/or Japan; please Section VIII the solicitation country-specific instructions limitations). Appropriate scientific areas investigations be related the interests any the participating funding organizations. Questions concerning particular project’s focus, direction relevance a participating funding agency should addressed the appropriate person the list agency contacts the NSF Program Solicitation NSF 18-501, https://www.nsf.gov/publications/pub_summ.jsp?ods_key=nsf18501). computational research supported under program must impact on, relate biological processes, optimally generate hypotheses are testable biological studies. is expected that: 1) applications include collaborations among computational and/or modeling experts, theorists, experimental neuroscientists; 2) collaborations involve dynamic and, possibly, protracted period model theory development refinement, intense interaction among scientists engineers different disciplines; 3) development testing new models theories provide framework the design experiments the generation new hypotheses can help reveal mechanisms underlying normal disease states the nervous system, 4) development distribution professional quality software tools e.g., modeling algorithms analytic tools). NSF coordinate manage review proposals jointly participating domestic foreign funding organizations, through joint panel review process used all participating funders. Additional information available the NSF Program Solicitation NSF 18-501, https://www.nsf.gov/publications/pub_summ.jsp?ods_key=nsf18501). Applications submitted response this solicitation not duplicate be substantially similar other applications concurrently under consideration other programs study sections across agencies, including NIH investigator-initiated parent’ FOAs NIH BRAIN Initiative FOAs. Duplicate substantially similar applications be returned without review.  Award Information Award sizes research projects expected range approximately 100,000 250,000 per year direct costs, durations three five years. Many awards be the smaller end this range; award exceed 250,000 per year direct costs. Applicants strongly discouraged requesting greater budgets are necessary the activities being proposed. is estimated data sharing projects range approximately 25,000 100,000 cumulative award size a one- three-year project. Estimated program budget, number awards average award size duration subject the availability funds. Upon conclusion the review process, meritorious applications be recommended funding either participating NSF DOs NIH ICs, the option the agencies, the applicant. Subsequent grant administration procedures be accordance the individual policies the awarding agency. Eligibility Information Limit Number Proposals per PI Collaborator: 2 response this solicitation, investigator participate PI Collaborator no than proposals per review cycle. the event a PI Collaborator does appear either these roles more two proposals, proposals include person a PI Collaborator be returned without review. This limit applies all PIs Collaborators, based inside outside the United States. Proposal Preparation Submission Instructions Applications submitted response this announcement should prepared submitted accordance the general guidelines contained the NSF Proposal & Award Policies & Procedures Guide PAPPG). Applications must submitted the NSF, to NIH. complete text the PAPPG available electronically the NSF Web Site at: http://www.nsf.gov/publications/pub_summ.jsp?ods_key=pappg. Applicants reminded identify announcement number NSF 18-501) the program announcement block the NSF Cover Sheet Proposal the National Science Foundation. Compliance this announcement critical determining relevant proposal processing guidelines. Failure submit information delay processing. Budgetary Information Inclusion voluntary committed cost sharing prohibited proposals submitted NSF under solicitation. Budgets should include travel funds the PI team members attend annual CRCNS Principal Investigators' meeting. NIH Process those proposals are selected potential funding participating NIH ICs, PI be required resubmit proposal an NIH-approved format directly the Center Scientific Review http://www.csr.nih.gov/) the NIH. PIs invited resubmit NIH receive further information resubmission procedures the NIH. applicant not allowed increase proposed budget change scientific content the application the resubmission the NIH.  applicants be expected utilize Multiple Program Director/Principal Investigator option the NIH http://grants.nih.gov/grants/multi_PI/) appropriate. These NIH applications be entered the NIH IMPAC II system. The results the review be presented the involved IC's National Advisory Councils the second level review. Subsequent the Council reviews, NIH ICs make funding determinations selected awards be made. Subsequent grant administration procedures NIH awardees, including those related New Early Stage Investigators http://grants.nih.gov/grants/new_investigators/) be accordance the policies NIH. Applications selected NIH funding use NIH R01 funding mechanism. Inquiries Written telephone inquiries encouraged.  Please the NSF program announcement names contact information each the participating NSF DOs and/or NIH ICs at https://www.nsf.gov/publications/pub_summ.jsp?ods_key=nsf18501  

Notice NINDS' Participation PA-18-373 Mentored Clinical Scientist Research Career Development Award Parent K08 - Independent Clinical Trial Allowed)" Notice Number: NOT-NS-18-023 Key Dates Release Date: December 11, 2017 Related Announcements PA-18-373 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participate, effective immediately, PA-18-373 quot;Mentored Clinical Scientist Research Career Development Award Parent K08 - Independent Clinical Trial Allowed)". following italicized changes made indicate participation NINDS this FOA.  Part 1. Overview Information Components Participating Organizations National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) 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 Deafness Other Communication Disorders NIDCD) 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 General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.121; 93.307; 93.853; 93.286; 93.865; 93.242; 93.867; 93.398; 93.273; 93.233; 93.840; 93.839; 93.838; 93.837; 93.398; 93.213; 93.279; ; 93.173; 93.172; 93.866; 93.853 nbsp; other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-188 Email: korns@mail.nih.gov

Notice NINDS' Participation PA-18-371 Independent Scientist Award Parent K02 - Independent Clinical Trial Allowed)" Notice Number: NOT-NS-18-024 Key Dates Release Date: December 11, 2017 Related Announcements PA-18-371 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participate, effective immediately, PA-18-371 quot;Independent Scientist Award Parent K02 - Independent Clinical Trial Allowed)". following italicized changes made indicate participation NINDS this FOA.  Part 1. Overview Information Components Participating Organizations National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.113; 93.866; 93.273; 93.279; 93.121; 93.853 nbsp;  other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-188 Email: korns@mail.nih.gov

Notice NINDS' Participation PA-18-375 Mentored Patient-Oriented Research Career Development Award Parent K23 - Independent Clinical Trial Allowed)" Notice Number: NOT-NS-18-025 Key Dates Release Date: December 8, 2017 Related Announcements PA-18-375 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participate, effective immediately, PA-18-375 quot;Mentored Patient-Oriented Research Career Development Award Parent K23 - Independent Clinical Trial Allowed)". following italicized changes made indicate participation NINDS this FOA.  Part 1. Overview Information Components Participating Organizations National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) 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 Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.307; 93.286; 93.865; 93.859; 93.113; 93.242; 93.867; 93.855; 93.213; 93.361; 93.866; 93.273; 93.847; 93.233; 93.840; 93.839; 93.838; 93.837; 93.279; 93.121; 93.173; 93.853 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-188 Email: korns@mail.nih.gov nbsp;

Notice NINDS' Participation PA-18-398 NIH Pathway Independence Award Parent K99/R00 - Independent Clinical Trial Allowed)" Notice Number: NOT-NS-18-026 Key Dates Release Date: December 8, 2017 Related Announcements PA-18-398 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participate, effective immediately, PA-18-398 quot;NIH Pathway Independence Award Parent K99/R00 - Independent Clinical Trial Allowed)." following italicized changes made indicate participation NINDS this FOA.  Part 1. Overview Information Components Participating Organizations National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) 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 Deafness Other Communication Disorders NIDCD) 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 General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Library Medicine NLM) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.351; 93.121; 93.307; 93.286; 93.865; 93.859; 93.113; 93.242; 93.867; ? 93.879; 93.855; 93.213; 93.361; 93.866; 93.273; 93.847; 93.172; 93.233; 93.840; 93.839; 93.839; 93.838; 93.837; 93.279; ; 93.121; 93.398; 93.173, 93.846, 93.853 other aspects this FOA remain unchanged Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-188 Email: korns@mail.nih.gov

Notice Intent Publish Funding Opportunity Announcement Analytical Clinical Validation Candidate Biomarkers Neurological Diseases U01) Notice Number: NOT-NS-18-015 Key Dates Release Date: December 5, 2017 Estimated Publication Date Funding Opportunity Announcement: 11/29/2017 First Estimated Application Due Date: 06/10/2018 Earliest Estimated Award Date: 02/10/2019 Earliest Estimated Start Date: 02/11/2019   Related Announcements PAR-18-664 PAR-18-550 PAR-18-548 PAR-18-549 Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS intends launch new biomarker initiative publishing Funding Opportunity Announcements FOA) focused the analytical clinical validation candidate biomarkers neurological disorders conditions.  Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published April 2018 an expected application due date June 2018. FOA utilize U01 activity code.  Details the planned FOA provided below. Research Initiative Details Biomarkers become recognized critical the successful development effective therapeutics.  Despite active pace discovery novel biomarker candidates, few biomarkers progress through essential steps analytical clinical validation, robust, well-validated biomarkers use Phase II Phase III clinical trials remain scant. Thus, is critical need support clinical validation candidate biomarkers improve public health, particularly disorders the nervous system where failures advance therapeutics discovery the market notorious.  NINDS biomarker initiative consists four primary components:  1) Leverage existing NIH-funded tissue data repositories, 2) Efforts better understand gaps biomarker discovery through scientific workshops, 3) Milestone-driven funding opportunities focused analytical clinical validation candidate biomarkers, 4) development an online website will provide one-stop shop” investigators an interest using resources applying funding biomarker research. funding opportunity announcement be milestone driven. FOA support analytical validation identified candidate biomarkers.  degree validation depend upon context use the biomarker, using standards guidelines provided the FDA.  Applicants strongly encouraged consult NINDS program staff below) plans an application being developed. Funding Information Estimated Total Funding   Expected Number Awards TBD Estimated Award Ceiling   Primary CFDA Numbers 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) 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: Mary Ann Pelleymounter, Ph.D.  National Institute Neurological Disorders Stroke 301-451-4551 mary.pelleymounter@nih.gov  

Notice Intent Publish Funding Opportunity Announcement Analytical Clinical Validation Candidate Biomarkers Neurological Disease U01) Notice Number: NOT-NS-18-020 Key Dates Release Date: December 4, 2017 Estimated Publication Date Funding Opportunity Announcement: 11/29/2017 First Estimated Application Due Date: 06/10/2018 Earliest Estimated Award Date: 02/10/2019 Earliest Estimated Start Date: 02/11/2019 Related Announcements PAR-18-664 PAR-18-550 PAR-18-548 PAR-18-549 Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS intends launch second biomarker initiative publishing Funding Opportunity Announcement FOA) focused the analytical clinical validation candidate biomarkers neurological disorders conditions. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published April 2018 an expected application due date June 2018 FOA utilize U01 activity code. Details the planned FOA provided below. Research Initiative Details Biomarkers become recognized critical the successful development effective therapeutics.  Despite active pace discovery novel biomarker candidates, few biomarkers progress through essential steps analytical clinical validation, robust, well-validated biomarkers use Phase II Phase III clinical trials remain scant. Thus, is critical need support clinical validation candidate biomarkers improve public health, particularly disorders the nervous system where failures advance therapeutics discovery the market notorious.  NINDS biomarker initiative consists four primary components:  1) Leverage existing NIH-funded tissue data repositories, 2) Efforts better understand gaps biomarker discovery through scientific workshops, 3) Milestone-driven funding opportunities focused analytical clinical validation candidate biomarkers, 4) development an online website will provide one-stop shop” investigators an interest using resources applying funding biomarker research. funding opportunity announcement be milestone driven. FOA support clinical validation evaluation clinical utility candidate biomarkers.  degree validation depend upon context use the biomarker, using standards guidelines provided the FDA.  Applicants strongly encouraged consult NINDS program staff below) plans an application being developed. Funding Information Estimated Total Funding   Expected Number Awards TBD Estimated Award Ceiling   Primary CFDA Numbers 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) 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: Mary Ann Pelleymounter, Ph.D.  National Institute Neurological Disorders Stroke 301-451-4551 mary.pelleymounter@nih.gov