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Notice Change Application Due Date Administrative Supplement the NINDS Research Education Program Residents Fellow Neurosurgery, Neuropathology, Neuroradiology Emergency Medicine Admin Supplement) Notice Number: NOT-NS-19-013 Key Dates Release Date: October 24, 2018 Related Announcements PA-17-442 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants there be change receipt dates the Funding Opportunity Announcement FOA) PA-17-442 "Administrative Supplement the NINDS Research Education Program Residents Fellows Neurology, Neurosurgery, Neuropathology, Neuroradiology, Emergency Medicine Admin Supp).  Specifically, October 15, 2018 receipt date been extended to November 2, 2018. Part 1. Overview Information Key Dates Currently Reads: Application Due Date(s) October 31, 2017, October 15, 2018 October 15, 2019 5:00PM local time applicant organization. Modified Read: Application Due Date(s) October 31, 2017, November 2, 2018, October 15, 2019 5:00PM local time applicant organization. other aspects this FOA remain same. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disease Stroke NINDS)) Telephone: 301-496-4188 Email: korns@ninds.nih.gov

Notice Intent Publish Funding Opportunity Announcement Translational Devices Treat Pain UG3/UH3 Clinical Trial Optional) Notice Number: NOT-NS-19-009 Key Dates Release Date:October 23, 2018 Estimated Publication Date Funding Opportunity Announcement: November 15, 2018 First Estimated Application Due Date: December 15, 2018 Earliest Estimated Award Date: 15, 2018 Earliest Estimated Start Date: July 01, 2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) other NIH Institutes Centers participating the HEAL Helping End Addiction Long-term) Initiative, intends publish Funding Opportunity Announcement FOA) support development therapeutic, diagnostic, rehabilitative technologies pain. focus this FOA be support preclinical development demonstration safe, effective, non-addictive device-based technologies approaches treat pain. goal the program be demonstrate treatment using credible neural targets device-based interventions and/or diagnostics pain, building upon latest mechanistic knowledge the anatomy physiology central, spinal, peripheral pathways involved pain. FOA facilitate translation new devices overcoming key challenges identified during preliminary proof-of-concept studies. scope the program includes technology optimization, regulatory activities enable IDE/IRB approvals, a subsequent clinical study. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published 2018 an expected application due date 2018. FOA utilize UG3/UH3 activity code. Details the planned FOA provided below. Research Initiative Details Translational research develop new medical devices the focus this FOA. Applications this FOA should be hypothesis-driven, should propose design-directed technology development. Applications be expected have rigorous mechanistic biological rationale, scientifically sound assays test system, a near final device design. is also expected applications include supporting data the mechanism therapy, rehabilitation, diagnosis been demonstrated humans bench top, ex vivo, in silico, in vitro, and/or in vivo models representative the intended patient population indication. is anticipated there be restrictions invasiveness i.e., devices be non-invasive, minimally invasive, invasive). Devices utilize any viable modality focally interact the nervous system, such optical, electrical, magnetic, acoustic, chemical/pharmaceutical, microfluidic, combinations thereof. FOA not specific any pain condition patient population. Funding Information Estimated Total Funding Issuing IC partner components intend issue 5-7 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: Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke NINDS) 301-496-1447 Nick.Langhals@nih.gov  

Notice Intent Publish Funding Opportunity Announcement Translational Devices Treat Pain U44 Clinical Trial Optional) Notice Number: NOT-NS-19-010 Key Dates Release Date: October 22, 2018 Estimated Publication Date Funding Opportunity Announcement: November 15, 2018 First Estimated Application Due Date: November 15, 2018 Earliest Estimated Award Date: 15, 2019 Earliest Estimated Start Date: July 01, 2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) other NIH Institutes Centers participating the HEAL Helping End Addiction Long-term) Initiative, intends publish Funding Opportunity Announcement FOA) support development therapeutic, diagnostic, rehabilitative technologies pain. focus this FOA be support preclinical development demonstration safe, effective, non-addictive device-based technologies approaches treat pain. goal the program be demonstrate treatment using credible neural targets device-based interventions and/or diagnostics pain, building upon latest mechanistic knowledge the anatomy physiology central, spinal, peripheral pathways involved pain. FOA facilitate translation new devices overcoming key challenges identified during preliminary proof-of-concept studies. scope the program includes technology optimization, regulatory activities enable IDE/IRB approvals, a subsequent clinical study. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published 2018 an expected application due date 2018. FOA utilize U44 activity code. Details the planned FOA provided below. Research Initiative Details Translational research develop new medical devices the focus this FOA. Applications this FOA should be hypothesis-driven, should propose design-directed technology development. Applications be expected have rigorous mechanistic biological rationale, scientifically sound assays test system, a near final device design. is also expected applications include supporting data the mechanism therapy, rehabilitation, diagnosis been demonstrated humans bench top, ex vivo, in silico, in vitro, and/or in vivo models representative the intended patient population indication. is anticipated there be restrictions invasiveness i.e., devices be non-invasive, minimally invasive, invasive). Devices utilize any viable modality focally interact the nervous system, such optical, electrical, magnetic, acoustic, chemical/pharmaceutical, microfluidic, combinations thereof. FOA not specific any pain condition patient population. Funding Information Estimated Total Funding Issuing IC partner components intend issue 5-7 awards 2019. Expected Number AwardsTBD Estimated Award Ceiling TBD Primary CFDA Numbers TBD Anticipated Eligible Organizations Small Business Applications not being solicited this time.  nbsp; Inquiries Please direct inquiries to: Nick Langhals, Ph.D.National Institute Neurological Disorders Stroke NINDS)301-496-1447 Nick.Langhals@nih.gov Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov  

Notice Intent Publish Funding Opportunity Announcement Development Translational Devices Treat Pain U18 Clinical Trial Allowed) Notice Number: NOT-EB-18-030 Key Dates Release Date: October 22, 2018 Estimated Publication Date Funding Opportunity Announcement: December 15, 2018 First Estimated Application Due Date: February 15, 2019 Earliest Estimated Award Date: September 15, 2019 Earliest Estimated Start Date: October 15, 2019 Related Announcements RFA-EB-18-003 Issued National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose National Institute Biomedical Imaging Bioengineering NIBIB) other NIH Institutes Centers participating the HEAL Helping End Addiction Long-term) Initiative, intends publish Funding Opportunity Announcement FOA) support development therapeutic, diagnostic, rehabilitative technologies pain through U18 activity code focus this FOA be support preclinical development demonstration safe, effective, non-addictive device-based technologies approaches treat pain. goal the program be demonstrate treatment using credible neural targets device-based interventions and/or diagnostics pain, building upon latest mechanistic knowledge the anatomy physiology central, spinal, peripheral pathways involved pain. FOA facilitate translation new devices to stage readiness first human FIH) clinical trials overcoming key challenges identified during preliminary proof-of-concept studies. scope the program includes technology development optimization, studies prepare approvals human use. Notice being provided allow potential applicants sufficient time develop responsive projects using systems engineering principles practices to form meaningful collaborations potential technology transition manufacturing partners. Applicants contact members the public private partnerships the BRAIN Initiative and theSPARC Initiative. Potential applicants strongly encouraged discuss proposed project NIBIB program staff. FOA expected be published December 2018 an expected application due date February 2019. Research Initiative Details Translational research develop new medical devices the focus this FOA. Applications this FOA should be hypothesis-driven, should propose design-directed technology development. Applications be expected have rigorous mechanistic biological rationale, scientifically sound assays test system. is also expected applications include supporting data the mechanism therapy, rehabilitation, diagnosis been demonstrated humans bench top, ex vivo, in silico, in vitro, and/or in vivo models representative the intended patient population indication. Early stage technologies be considered, long there a sufficiently credible research plan supporting data. is anticipated there be restrictions invasiveness i.e., devices be non-invasive, minimally invasive, invasive). Devices utilize any viable modality focally interact the nervous system, such optical, electrical, magnetic, acoustic, chemical/pharmaceutical, microfluidic, combinations thereof. FOA not specific any pain condition patient population. Clinical research, basic research, studies disease mechanism mechanism action not focus this FOA, may supported through FOAs within HEAL Initiative. Funding Information Estimated Total Funding TBD 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) Regional Organization Eligible Agencies the Federal Government, including NIH Intramural Program Applications not being solicited this time. Inquiries Please direct inquiries to: Michael Wolfson National Institute Biomedical Imaging Bioengineering NIBIB) 301-451-4778 Michael.Wolfson@NIH.gov

Expert Panel Meeting Discuss Study Design a Longitudinal Study the Impact Prenatal Opioid other Substance Exposure Brain Behavioral Development Notice Number: NOT-DA-18-047 Key Dates Release Date: October 19, 2018 Related Announcements None Issued National Institute Drug Abuse NIDA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Minority Health Health Disparities NIMHD) Purpose Problem Statement:  has a dramatic increase the number babies have prenatally exposed opioids due the opioid crisis. Between 2004 2014, number infants born neonatal opioid withdrawal syndrome NOWS; also known neonatal abstinence syndrome NAS]) increased 433% 1.5 8.0 per 1000 hospital births translates one neonate born NOWS every 15 minutes. the opioid crisis continues escalate, numbers also increase, we not know the long-term implications early exposure opioids to medications used treat opioid disorder) be. addition, drugs continue be used during pregnancy afterwards many women breastfeeding. National Survey Drug and Health indicates in 2016, 6.3% pregnant women used illicit drug Center Behavioral Health Statistics Quality, 2017), many used than drug. large growing body evidence indicates early exposure substances, including pre- perinatally, linked greater risk developing substance disorders. Prenatal exposure also associated other behavioral problems, including ADHD, conduct disorder, anxiety, etc. However, causal link difficult establish due confounding factors such socioeconomic, environmental, genetic influences. Thus, meeting being convened discuss research needs understand disentangle complex interrelated factors may impact long-term consequences pre- perinatal substance exposure.   Key research objectives include, are limited to: Understanding variability individual developmental trajectories e.g., brain, cognitive, emotional, social, academic) birth through childhood. Understanding impact pre- postnatal exposure opioids, opioid treatment medications, cannabis, alcohol, tobacco, prescription illicit substances alone in combination) developmental trajectories. Investigating role sex, genetic, epigenetic, social other environmental factors risk/resilience related structural functional brain development, social/behavioral/academic achievement, future substance and mental disorders.  goal this meeting to discuss study design related issues e.g., sampling strategy, recruitment retention high risk populations, bioethical social service implications) a longitudinal study the impact pre- postnatal substance exposure including opioids, opioid treatment medications, cannabis, alcohol, tobacco, prescription illicit substances, alone in combination) brain development, mental illness, substance use, social/behavioral/academic achievement. is envisioned successful execution a program this breadth depth require broad interdisciplinary team investigators collective expertise pregnancy, neonatal, early childhood affective, cognitive, social development; longitudinal cohort studies; developmental neuroimaging; social/legal environmental issues. Input advice the extramural community be actively encouraged through multiple mechanisms.  NIH hold workshop October 22, 2018 at 6001 Executive Blvd Bethesda MD 20892, is open the public, although seating limited.  meeting also webcast. more information see https://www.drugabuse.gov/news-events/meetings-events. will followed a formal Request Information potential issues such study.   Inquiries Please direct inquiries to: Gayathri J. Dowling, Ph.D. Director, Adolescent Brain Cognitive Development ABCD) Study National Institute Drug Abuse Telephone: 301-443-4877 Email: gayathri.dowling@nih.gov

Request Information RFI) the Proposed Funding Priorities Neuroscience Research, Input Cross-Cutting Opportunities NIH Neuroscience Blueprint) Notice Number: NOT-NS-19-002 Key Dates Release Date:October 17, 2018 Related Announcements None Issued NIH Blueprint Neuroscience Research ( http://neuroscienceblueprint.nih.gov) 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 Dental Craniofacial Research ( NIDCR) National Institute Drug Abuse ( NIDA) National Institute Environmental Health Sciences ( NIEHS) National Institute Mental Health ( NIMH) National Institute Nursing Research ( NINR) National Center Complementary Integrative Health ( NCCIH) Office Behavioral Social Sciences Research ( OBSSR)  Purpose National Institutes Health Blueprint Neuroscience Research Blueprint) a collaboration among 14 participating NIH Institutes, Centers Offices support cross-cutting funding programs advance research the nervous system. Request Information RFI) seeks input the scientific community future Blueprint activities. Responses this RFI should suggest best have broadest possible impact the neuroscience community, ideally, a value-added fashion over current activities the participating Institutes, Centers Offices. Recommendations should serve interests many the Blueprint Institutes listed above. Blueprint invites input all interested stakeholders. Organizations encouraged submit single representative response. Background Neuroscience research a unifying theme across NIH Institutes Centers. Sixteen participating Institutes Centers launched Blueprint 2004 provide framework coordinating research developing tools resources broadly advance neuroscience research. pooling resources expertise, NIH Blueprint taking advantage economies scale, confronting challenges too large any single NIH Institute Center IC), harmonizing related efforts across multiple ICs. following website provides overview previous current NIH Blueprint Activities: http://www.neuroscienceblueprint.nih.gov/. Information Requested Blueprint considering best advance neuroscience the future. the establishment funding the BRAIN Initiative, focuses development application innovative technologies interrogating circuit activity the nervous system, Blueprint hopes identify non-duplicative areas broad interest the neuroscience community will the highest potential advance neuroscience via investment cross-cutting research, training, infrastructure and/or workforce development. Keeping mind the Blueprint interested ideas are broadly relevant across multiple missions the 14 participating NIH Institutes Centers, comments the RFI include are limited the following areas: Please submit specific suggestions how NIH Blueprint enhance neuroscience training workforce diversity going forward. Please submit suggestions infrastructure research resources needs cut across NIH neuroscience Institutes Centers would best serviced a Blueprint program. addition to training diversity efforts, Blueprint previously supported programs address cross-cutting issues such as: computational neuroscience research, dissemination of neuroscience tools to advance science, supporting core facilities Please submit thoughts how efforts been useful.  Please submit suggestions specific ways which programs should expanded. Please identify specific scientific areas neuroscience research specific research topics are currently being supported the BP Institutes, Centers Offices would of broad interest impact. Please suggest level budgetary investment be needed make significant difference that research area over five-year period. Please identify specific impediments advancing our understanding neuroscience a Blueprint supported program solve. to Submit Response comments must submitted electronically to: NIH-Blueprint-Responses. Responses this RFI be accepted through November 26, 2018. will receive electronic confirmation acknowledging receipt your response will receive individualized feedback any suggestions. Disclaimer RFI is information planning purposes only should be construed a solicitation as obligation the part the Federal Government, National Institutes Health NIH), individual NIH Institutes Centers. NIH does intend make any awards based responses this RFI pay the preparation any information submitted for Government's of such information. basis claims against U.S. Government shall arise a result a response this request information from Government’s of such information. NIH use information submitted response this RFI its discretion will provide comments any responder’s submission. However, responses the RFI be reflected future planning activities funding opportunity announcements. information provided be analyzed may appear reports. Respondents advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted. proprietary, classified, confidential, sensitive information should included your response. Government reserves right use any non-proprietary technical information any resultant solicitation(s). Inquiries Please direct inquiries to: Meghan Mott, Ph.D. National Institute Neurological Disorders Stroke ( NINDS) Telephone: 301-596-4470 Email: nihblueprint@nih.gov

Notice Clarification: Research Strategy page limit RFA-NS-18-046 Analytical and/or Clinical Validation a Candidate Biomarker Pain R61/R33 Clinical Trial Optional) Notice Number: NOT-NS-19-004 Key Dates Release Date:October 15, 2018 Related Announcements PAR-18-550 PAR-18-664 PAR-18-548 PAR-18-549  RFA-NS-18-046 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to clarify Research Strategy page limit RFA-NS-18-046, Analytical and/or Clinical Validation a Candidate Biomarker Pain R61/R33 Clinical Trial Optional). Research Strategy section page limit been increased 12 20 pages allow additional space materials are disallowed the Appendix. Figures, tables, graphs, diagrams, data, charts are necessary support proposal should included the Research Strategy section, these not appropriate the Appendix. not the Appendix circumvent page limits. Allowable Appendix Materials, follow instructions the Appendix described the SF424 R&R) Application Guide. Allowable Appendix Materials restricted. Please the NIH Guide Notice on Allowable Appendix Materials and the FAQs the NIH Appendix Policy for information.  an application submitted disallowed materials the Appendix will withdrawn noncompliance. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email:  mary.pelleymounter@nih.gov

Notice Clarification: Research Strategy page limit PAR-18-548, Clinical Validation a Candidate Biomarker Neurological Disease U44 Clinical Trial Optional) Notice Number: NOT-NS-19-005 Key Dates Release Date:October 15, 2018 Related Announcements PAR-18-550 PAR-18-664 PAR-18-548 PAR-18-549 RFA-NS-18-046 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to clarify Research Strategy page limit PAR-18-548, Clinical Validation a Candidate Biomarker Neurological Disease U44 Clinical Trial Optional). Research Strategy section page limit been increased 12 20 pages allow additional space materials are disallowed the Appendix. Figures, tables, graphs, diagrams, data, charts are necessary support proposal should included the Research Strategy section, these not appropriate the Appendix. not the Appendix circumvent page limits. Allowable Appendix Materials, follow instructions the Appendix described the SF424 R&R) Application Guide. Allowable Appendix Materials restricted. Please the NIH Guide Notice on Allowable Appendix Materials and the FAQs the NIH Appendix Policy for information.  an application submitted disallowed materials the Appendix will withdrawn noncompliance. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email:  mary.pelleymounter@nih.gov

Notice Clarification: Research Strategy page limit PAR-18-664, Clinical Validation a Candidate Biomarker Neurological Disease U01 Clinical Trial Optional) Notice Number: NOT-NS-19-006 Key Dates Release Date:October 15, 2018 Related Announcements PAR-18-550 PAR-18-664 PAR-18-548 PAR-18-549 RFA-NS-18-046 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to clarify Research Strategy page limit PAR-18-664, Clinical Validation a Candidate Biomarker Neurological Disease U01 Clinical Trial Optional). Research Strategy section page limit been increased 12 20 pages allow additional space materials are disallowed the Appendix. Figures, tables, graphs, diagrams, data, charts are necessary support proposal should included the Research Strategy section, these not appropriate the Appendix. not the Appendix circumvent page limits. Allowable Appendix Materials, follow instructions the Appendix described the SF424 R&R) Application Guide. Allowable Appendix Materials restricted. Please the NIH Guide Notice on Allowable Appendix Materials and the FAQs the NIH Appendix Policy for information.  an application submitted disallowed materials the Appendix will withdrawn noncompliance. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email:  mary.pelleymounter@nih.gov

Notice Clarification: Research Strategy page limit PAR-18-550, Analytical Validation a Candidate Biomarker Neurological Disease U01) Clinical Trial Optional) Notice Number: NOT-NS-19-007 Key Dates Release Date:October 15, 2018 Related Announcements PAR-18-550 PAR-18-664 PAR-18-548 PAR-18-549 RFA-NS-18-046 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to clarify Research Strategy page limit PAR-18-550, Analytical Validation a Candidate Biomarker Neurological Disease U01) Clinical Trial Optional). Research Strategy section page limit been increased 12 20 pages allow additional space materials are disallowed the Appendix. Figures, tables, graphs, diagrams, data, charts are necessary support proposal should included the Research Strategy section, these not appropriate the Appendix. not the Appendix circumvent page limits. Allowable Appendix Materials, follow instructions the Appendix described the SF424 R&R) Application Guide. Allowable Appendix Materials restricted. Please the NIH Guide Notice on Allowable Appendix Materials and the FAQs the NIH Appendix Policy for information.  an application submitted disallowed materials the Appendix will withdrawn noncompliance. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email:  mary.pelleymounter@nih.gov