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Change NIH Resources Available the NIH Clinical Center Research Projects Submitted Response PAR-15-286 Pre-application: Opportunities Collaborative Research the NIH Clinical Center X02)" Notice Number: NOT-HD-16-017 Key Dates Release Date:   July 11, 2016 Related Announcements PAR-15-286 Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) 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) 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 Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Office Dietary Supplements ODS) Office Research Women’s Health ORWH) Purpose purpose this Notice to inform potential applicants changes the resources available the NIH Clinical Center research projects submitted response PAR-15-286.  Specifically, good manufacturing practices GMP) pharmacy facility biological clinical products no longer available the Clinical Center, a clinical biomechanics laboratory been added the list available resources. Part 2 Section I. Funding Opportunity Description Purpose reflect changes, following list resources deleted: Examples the special resources the Clinical Center include: Large cohorts patients, including studies 500 rare diseases; good manufacturing practices GMP) pharmacy facility new biological clinical products; Specialized clinical phenotyping facilities including metabolic other units); manufacturing use newly designed PET ligands imaging studies; availability blood products special research studies; Collaborative opportunities clinical protocols unique pharmaceutical agents and/or modes therapy, extraordinarily rare diseases investigators are known experts; robust training curriculum clinical research; ability support long-term clinical studies minimal cost patients their families. On-campus amenities e.g., Family Lodge Children’s Inn) assist patients families supportive, home-like environments they leave own homes participate clinical research; A number other resources. section replaced an updated list resources, follows: Examples the special resources the Clinical Center include: Large cohorts patients, including studies 500 rare diseases; Specialized clinical phenotyping facilities including metabolic unit, clinical biomechanics laboratory, other units); manufacturing use PET ligands research imaging studies; availability blood products special research studies; Collaborative opportunities clinical protocols first-in-human early phase agents and/or modes therapy, deleted extraordinarily) rare diseases investigators are known experts; robust training curriculum clinical research; ability support long-term clinical studies minimal cost patients their families. On-campus amenities e.g., Family Lodge Children’s Inn) assist patients families supportive, home-like environments they leave own homes participate clinical research; A number other resources.” other provisions this Funding Opportunity Announcement unchanged.        Inquiries Please direct inquiries to: Julie Orlando, MA NIH Clinical Center CC) Telephone: 301-496-4121 Email: ClinicalCtrPartner@mail.nih.gov Pat Piringer, RN, MSN NIH Clinical Center CC) Telephone: 301-496-4121 Email: ClinicalCtrPartner@mail.nih.gov Eugene G. Hayunga, PhD Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6856 Email: ehayunga@mail.nih.gov

Change NIH Resources Available the NIH Clinical Center Research Projects Submitted Response PAR-15-287 Opportunities Collaborative Research the NIH Clinical Center U01)" Notice Number: NOT-HD-16-018 Key Dates Release Date: July 11, 2016 Related Announcements PAR-15-287      Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) 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) 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 Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Office Dietary Supplements ODS) Office Research Women’s Health ORWH) Purpose purpose this Notice to inform potential applicants changes the resources available the NIH Clinical Center research projects submitted response PAR-15-287.  Specifically, good manufacturing practices GMP) pharmacy facility biological clinical products no longer available the Clinical Center, a clinical biomechanics laboratory been added the list available resources. Part 2 Section I. Funding Opportunity Description Purpose reflect changes, following list resources deleted: Examples the special resources the Clinical Center include: Large cohorts patients, including studies 500 rare diseases; good manufacturing practices GMP) pharmacy facility new biological clinical products; Specialized clinical phenotyping facilities including metabolic other units); manufacturing use newly designed PET ligands imaging studies; availability blood products special research studies; Collaborative opportunities clinical protocols unique pharmaceutical agents and/or modes therapy, extraordinarily rare diseases investigators are known experts; robust training curriculum clinical research; ability support long-term clinical studies minimal cost patients their families. On-campus amenities e.g., Family Lodge Children’s Inn) assist patients families supportive, home-like environments they leave own homes participate clinical research; A number other resources. section replaced an updated list resources, follows: Examples the special resources the Clinical Center include: Large cohorts patients, including studies 500 rare diseases; Specialized clinical phenotyping facilities including metabolic unit, clinical biomechanics laboratory, other units); manufacturing use PET ligands research imaging studies; availability blood products special research studies; Collaborative opportunities clinical protocols first-in-human early phase agents and/or modes therapy, deleted extraordinarily) rare diseases investigators are known experts; robust training curriculum clinical research; ability support long-term clinical studies minimal cost patients their families. On-campus amenities e.g., Family Lodge Children’s Inn) assist patients families supportive, home-like environments they leave own homes participate clinical research; A number other resources.” other provisions this Funding Opportunity Announcement unchanged. Inquiries Please direct inquiries to: Julie Orlando, MA NIH Clinical Center CC) Telephone: 301-496-4121 Email: ClinicalCtrPartner@mail.nih.gov Pat Piringer, RN, MSN NIH Clinical Center CC) Telephone: 301-496-4121 Email: ClinicalCtrPartner@mail.nih.gov Eugene G. Hayunga, PhD Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6856 Email: ehayunga@mail.nih.gov

Notice NIH/BD2K Participation the Joint NSF/NIH Initiative Quantitative Approaches Biomedical Big Data QuBBD) Notice Number: NOT-EB-16-008 Key Dates Release Date: July 5, 2016 Related Announcements NOT-RM-17-012 NOT-AI-16-070 Issued National Institutes Health NIH) 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 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 Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) 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) Office Strategic Coordination Common Fund) Purpose Biomedical research rapidly becoming data-intensive investigators generating using increasingly large, complex, multidimensional, diverse datasets. era big data biomedical research taxes ability many researchers release, locate, analyze, interact these data associated software due the lack tools, accessibility, training. response these new challenges biomedical research, in response the recommendations the Data Informatics Working Group DIWG) the Advisory Committee the NIH Director http://acd.od.nih.gov/diwg.htm), NIH launched trans-NIH Big Data Knowledge Initiative https://datascience.nih.gov/bd2k). purpose this Notice to announce the NIH, through Big Data Knowledge BD2K) Initiative, collaborating a multi-agency funding opportunity, Quantitative Approaches Biomedical Big Data QuBBD) initiative http://nsf.gov/funding/pgm_summ.jsp?pims_id=505292] Recent advances medical healthcare technologies creating paradigm shift how medical practitioners biomedical researchers approach diagnosis, prevention, treatment diseases.  New imaging technologies, advances genetic testing, innovations wearable and/or ambient sensors allowing researchers predict health outcomes develop personalized treatments interventions. Coupled the rapid growth computing infrastructure, researchers have ability collect, store, analyze vast amounts health- disease-related data biological, biomedical, behavioral, social, environmental, clinical studies.  explosion the availability biomedical big data disparate sources, the complex data structures including images, networks, graphs, pose significant challenges terms visualization, modeling, analysis. While have some encouraging developments related foundational mathematical, statistical, computational approaches big data challenges over past decade, have relatively few opportunities collaboration challenges related biomedical data science.  National Science Foundation NSF) the National Institutes Health NIH) recognize fundamental questions basic, clinical, translational research benefit greatly multidisciplinary approaches involve experts quantitative disciplines such mathematics, statistics, computer science. Quantitative Approaches Biomedical Big Data Program designed support research addresses important application areas the intersection the biomedical data sciences encouraging inter- multi-disciplinary collaborations focus innovative transformative approaches address challenges. Award Information NIH expects fund projects durations up 3 years. Award sizes expected be less 200,000 direct costs) per year.  awards under Funding Opportunity Announcement FOA) NIH be grants cooperative agreements, determined the supporting agency. Application Preparation Submission Instructions Applications submitted response this FOA) should prepared submitted accordance the general guidelines contained the NSF Grant Proposal Guide GPG). Applications must submitted the NSF, to NIH. complete text the GPG available electronically the NSF website http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gpg. Applicants reminded identify NSF program announcement number the program announcement block the NSF Cover Sheet Proposal the National Science Foundation. Compliance this announcement critical determining relevant application processing guidelines. Failure submit information delay processing. Budgetary Information Inclusion voluntary committed cost sharing prohibited. NIH, indirect costs foreign subawards/subcontracts be limited 8 percent. NIH Process those applications are selected potential funding the Big Data Knowledge BD2K) Program, PD/PI be required submit application an NIH-approved format. PD/PIs invited submit NIH receive further information submission procedures NIH. applicant not allowed increase proposed total budget change scientific content the application the submission the NIH an NIH application. NIH applications be entered the NIH IMPAC II system. results the review be presented the involved Institutes' National Advisory Councils the second level review. Subsequent the Council reviews, NIH make final funding determinations selected awards be made. Subsequent grant administration procedures NIH awardees, including those related New Early Stage Investigators http://www.niaid.nih.gov/researchfunding/grant/Pages/aag.aspx), be accordance the policies NIH. Applications selected NIH funding use NIH funding mechanisms. information purposes, NIH PD/PIs wish consult NIAID web site, about Grants," provides excellent generic information all aspects NIH grantsmanship http://www.niaid.nih.gov/researchfunding/grant/Pages/aag.aspx). Inquiries Please direct inquiries to: Vinay M. Pai National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4781 Email: BD2K_QuBBD@mail.nih.gov  

Notice Increase Phase II Salary Level PAR-16-220 NINDS Advanced Postdoctoral Career Transition Award Promote Diversity Neuroscience Research K22)" Notice Number: NOT-NS-16-033 Key Dates Release Date: June 21, 2016 Related Announcements PAR-16-220   Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform applicants an increase the Phase II salary level PAR-16-220 quot;NINDS Advanced Postdoctoral Career Transition Award Promote Diversity Neuroscience Research K22)". Part 2. Section II. Award Budget Information Salary Currently reads: NINDS contribute to 95,000 commensurate salary effort, well fringe benefits during phase II. Phase I, NIH contribute salary commensurate the applicant institution's salary structure persons equivalent qualifications, experience, rank, to 50,000 plus fringe benefits per year. nbsp; Further guidance budgeting career development salaries provided the SF424 R&R) Application Guide. FOA now modified read: NINDS contribute to 100,000 commensurate salary effort, well fringe benefits during phase II. Phase I, NIH contribute salary commensurate the applicant institution's salary structure persons equivalent qualifications, experience, rank, to 50,000 plus fringe benefits per year. nbsp; Further guidance budgeting career development salaries provided the SF424 R&R) Application Guide. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Michelle Jones-London, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-451-7966 Email: jonesmiche@ninds.nih.gov

Clarification NIH Policy Post-Submission Application Materials PAR-16-106 Rapid Assessment Zika Virus ZIKV) Complications R21)" Notice Number: NOT-HD-16-015 Key Dates Release Date:   June 15, 2016 Related Announcements NOT-OD-13-030 PAR-16-106   nbsp;       Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Institute Allergy Infectious Diseases NIAID) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Dental Craniofacial Research NIDCR) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) Purpose purpose this Notice to clarify NIH Policy Post-Submission Application Materials PAR-16-106 quot;Rapid Assessment Zika Virus ZIKV) Complications R21)”. NOT-OD-13-030 ldquo;Reminders Updates: NIH Policy Post-Submission Application Materials“ provides policy guidance post-submission application materials.  Post-submission application materials those submitted after submission the grant application prior the initial peer review.  NIH policy post-submission application materials specifies that, the majority applications, only post-submission materials the NIH accept those resulting unforeseen administrative issues.  described NOT-OD-13-030, such materials must received the Scientific Review Officer month 30 calendar days) prior the peer review meeting, demonstrate concurrence the Authorized Organization Representative AOR) the applicant organization. Funding Opportunity Announcement FOA) PAR-16-106 quot;Rapid Assessment Zika Virus ZIKV) Complications R21)" set to accept applications a continuous basis March 20, 2016 until February 28, 2019 rather specifying exact due dates. Therefore, typical timelines receipt, review, council, award not apply applications submitted this FOA. Specifically, R21 applications PAR-16-106 be handled an expedited external peer review award basis meet goals this program. nbsp;Because this accelerated review schedule, 30-day timeframe submitting post-submission materials not always possible.  Therefore, applications submitted PAR-16-106, post-submission materials must received the Scientific Review Officer SRO) later 15 calendar days prior the review meeting must meet the requirements described NOT-OD-13-030.  Applicants strongly encouraged contact respective Scientific Review Officer SRO) before submitting any additional materials. Inquiries Please direct inquiries the Peer Review Contact(s) PAR-16-106: Sherry Dupere, PhD Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-451-3415 Email: duperes@mail.nih.gov Anne Schaffner, PhD National Eye Institute NEI) Telephone: 301-451-2020 Email: schaffnera@mail.nih.gov Director, Office Scientific Review National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-0270 Email: nhlbichiefreviewbranch@nhlbi.nih.gov nbsp; Raymond Richard Schleef, PhD, MBA National Institute Allergy Infectious Diseases NIAID) Telephone: 240-669-5019 Email: raymond.schleef@nih.gov  David George, PhD National Institute Biomedical Imaging Bioengineering NIBIB) Phone: 301-496-9474 Email: david.George@nih.hhs.gov Yasaman Shirazi, PhD National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-5593 Email: yasaman.shirazi@nih.gov David Armstrong, PhD National Institute Mental Health NIMH) Telephone: 301-443-3534 Email: armstrda@mail.nih.gov Ernest Lyons, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9223 Email: ernest.Lyons@nih.gov

Notice Participation NINDS PAR-16-245 Neural Regulation Cancer R01)" Notice Number: NOT-NS-16-031 Key Dates Release Date: June 14, 2016 Related Announcements PAR-16-245 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this announcement to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participate, effective immediately, PAR-16-245 quot;Neural Regulation Cancer R01)" following changes updates made PAR-16-245 reflect participation NINDS this FOA: Part 1. Overview Information Components Participating Organizations National Cancer Institute NCI) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s)  93.396, 93.853 Funding Opportunity Purpose Central nervous system CNS) tumor studies also encouraged, addition non-central nervous system activities.  Language the rest the FOA inclusive CNS-related tumor studies.  Part 2. Section I.  Funding Opportunity Description Research Scope NINDS National Institute Neurological Disorders Stroke NINDS) a shared interest NCI studies involve primary non-metastatic) brain spinal cord tumors their interactions nerves, neuropeptides, neurotransmitters, axon guidance molecules within Central Nervous System CNS).  NINDS supportive applications focused the Specific Challenges outlined the PAR long the proposed activity focused a primary brain and/or spinal cord tumor(s).  overall goal to encourage applications the intersection between cancer biology neuroscience, involving investigators transdisciplinary expertise, further our understanding how nerves influence tumor development, growth, invasion within CNS.  Applications propose look the impact tumors normal neuronal function also encouraged.  Lastly, NINDS also supports involvement neuroscientists peripheral nervous system expertise applications involving non-CNS cancers although applications be assigned NCI noted the current PAR.  NINDS not consider funding research activities the following areas under FOA: Chemobrain, cognitive, psycho-behavioral outcomes related cancer treatment Chemotherapy-induced peripheral neuropathy CIPN) Neuroendocrine cancers  Note:  NINDS does support conduct clinical trials under FOA. Part 2.  Section VII.  Agency Contacts participation NINDS, following contacts added the FOA. Scientific Research Contact(s) Jane W. Fountain, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone 301-496-1431 Email: fountai@ninds.nih.gov questions NINDS submissions related primary non-metastatic) brain tumors) Financial/Grants Management Contact(s) Tijuana Decoster, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone 301-496-9531 Email: decostert@mail.nih.gov other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Jane W. Fountain, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301 496-1431 Email: fountai@ninds.nih.gov

Notice Participation NINDS PAR-16-246 Neural Regulation Cancer R21)" Notice Number: NOT-NS-16-032 Key Dates Release Date: June 14, 2016 Related Announcements PAR-16-246 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this announcement to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participate, effective immediately, PAR-16-246 quot;Neural Regulation Cancer R21)" following changes updates made PAR-16-246 reflect participation NINDS this FOA: Part 1. Overview Information Components Participating Organizations National Cancer Institute NCI) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s)  93.396, 93.853 Funding Opportunity Purpose Central nervous system CNS) tumor studies also encouraged, addition non-central nervous system activities.  Language the rest the FOA inclusive CNS-related tumor studies.  Part 2. Section I.  Funding Opportunity Description Research Scope NINDS National Institute Neurological Disorders Stroke NINDS) a shared interest NCI studies involve primary non-metastatic) brain spinal cord tumors their interactions nerves, neuropeptides, neurotransmitters, axon guidance molecules within Central Nervous System CNS).  NINDS supportive applications focused the Specific Challenges outlined the PAR long the proposed activity focused a primary brain and/or spinal cord tumor(s).  overall goal to encourage applications the intersection between cancer biology neuroscience, involving investigators transdisciplinary expertise, further our understanding how nerves influence tumor development, growth, invasion within CNS.  Applications propose look the impact tumors normal neuronal function also encouraged.  Lastly, NINDS also supports involvement neuroscientists peripheral nervous system expertise applications involving non-CNS cancers although applications be assigned NCI noted the current PAR.  NINDS not consider funding research activities the following areas under FOA: Chemobrain, cognitive, psycho-behavioral outcomes related cancer treatment Chemotherapy-induced peripheral neuropathy CIPN) Neuroendocrine cancers  Note:  NINDS does support conduct clinical trials under FOA. Part 2.  Section VII.  Agency Contacts participation NINDS, following contacts added the FOA. Scientific Research Contact(s) Jane W. Fountain, Ph.D. National Institute Neurological Disorders Stroke NINDS), NIH Telephone 301-496-1431 Email: fountai@ninds.nih.gov questions NINDS submissions related primary non-metastatic) brain tumors) Financial/Grants Management Contact(s) Tijuana Decoster, Ph.D. National Institute Neurological Disorders Stroke NINDS), NIH Telephone 301-496-9531 Email: decostert@mail.nih.gov other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Jane W. Fountain, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301 496-1431 Email: fountai@ninds.nih.gov

Notice NINDS' Participation PA-16-183 Limited Competition: Rare Diseases Clinical Research Network RDCRN) Project Supplements Clinical Trials Repurpose Drugs Collaboration E-Rare Awardees Admin Supp)" Notice Number: NOT-NS-16-030 Key Dates Release Date: June 1, 2016 Related Announcements PA-16-183     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, PAR-16-183, ldquo;Limited Competition: Rare Diseases Clinical Research Network RDCRN) Project Supplements Clinical Trials Repurpose Drugs Collaboration E-RARE Awardees Admin Supp)".  following sections been updated reflect participation NINDS this PAR: nbsp; Part 1. Overview Information Components Participating Organizations National Heart, Lung, Blood Institute NHLBI) National Center Advancing Translational Sciences NCATS) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Allergy Infectious Diseases NIAID)  National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.350, 93.855, 93.856, 93.847, 93.846, 93.837, 93.838, 93.839, 93.233, 93.840, 93.853 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Jill Morris Program Director, NINDS Telephone: 301-496-5745 Email: jill.morris@nih.gov  

Notice Clarification Research Areas Included PAR-16-106 Rapid Assessment Zika Virus ZIKV) Complications R21)” Notice Number: NOT-NS-16-027 Key Dates Release Date: 27, 2016 Related Announcements PAR-16-106  Issued National Institute Neurological Disorders Stroke NINDS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Allergy Infectious Diseases NIAID) National Institute Dental Craniofacial Research NIDCR) National Eye Institute NEI) National Institute Biomedical Imaging NIBIB) National Heart, Lung, Blood Institute NHLBI) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) Purpose purpose this Notice to clarify areas high priority research are included the focus the funding opportunity announcement PAR-16-106, quot;Rapid Assessment Zika Virus ZIKV) Complications R21)".  the time publication this funding opportunity announcement, data not yet available the association ZIKV Guillain-Barré Syndrome GBS) other neurological complications adults.  that such data emerging, Notice intended amend list possible areas high priority include: Studies Guillain-Barré Syndrome GBS), encephalitis encephalomyelitis associated ZIKV infection determine disease course outcomes, causality, disease mechanisms, effectiveness current treatments to develop novel treatments. Notice also intended encourage immunologists apply expertise understanding treating immune mechanisms ZIKV-associated GBS other neurological complications. other aspects the FOA remain same. Inquiries Please direct inquiries to: Wong, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:  301-496-1431 Email:  wongm@ninds.nih.gov

Request Information RFI): Guidance Opportunities Neuroethics NIH BRAIN Initiative) Notice Number: NOT-MH-16-014 Key Dates Release Date: 27, 2016 Response Date: July 29, 2016 Related Announcements None     Issued NIH BRAIN Initiative braininitiative.nih.gov) National Institute Mental Health NIMH) 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 Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose is Request Information RFI) soliciting input identify set core ethical issues associated research involving human brain resulting advancements neurotechnology research development. Background BRAIN Initiative: Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative® aimed revolutionizing our understanding the human brain. accelerating development application innovative technologies, researchers be able produce new dynamic picture the brain that, the first time, show individual cells complex neural circuits interact both time space. work well underway http://www.braininitiative.nih.gov) the application the innovative tools technologies ultimately lead new ways treat prevent brain disorders. NIH one several federal agencies involved the BRAIN Initiative. Planning the NIH component the BRAIN initiative guided the long-term scientific plan, ldquo;BRAIN 2025: Scientific Vision,” details seven high-priority research areas calls a sustained federal commitment 4.5 billion over 12 years. address current challenges lay more stable foundation future generations researchers, NIH seeking input the community opportunities areas/topics where ethical issues related neuroscience research might considered. overall aim to integrate ethical insight progress under BRAIN Initiative, proactively consider ethical implications the research. Information Requested NIH strives maximize impact the taxpayers’ investments biomedical research. Specific this RFI, input researchers, academic institutions, professional societies other stakeholders solicited potential topics explore where BRAIN Initiative might invest resources the area neuroethics, particularly pertaining emerging neurotechnologies. While welcome input the community any areas germane neuroethics, are particularly interested feedback the following topics: Areas policy guidance might useful Principal Investigators Institutional Review Boards regarding emerging neuroethics issues associated neurotechnology research development. welcome responses point specific strengths weaknesses current policies suggestions how can expand and/or improve policies. evolving breadth neural data associated issues such as: should own data research participant, investigator, institution, public)? Storage data the cloud, via federated databases?) security concerns should access these data whom, quickly, how long, types data)? Privacy concerns protection discrimination those whose neural data shared Unintended uses data Special considerations associated novel neuromodulation neuroimaging technologies: Activation monitoring devices does it, is done) Responsibility the long-term maintenance such devices Security regarding telemetry data remote storage devices Potential culpability concerns regarding predictions neural data Informed consent issues, specifically pertaining studies using novel neurotechnologies Establishing greater uniformity the informed consent process participant perspective the consent process consent permits/hinders is possible technological advances Issues special populations such pregnant women, children, those physical and/or intellectual disabilities cognitive impairment to best integrate neuroethics, appropriate, workshops training opportunities when communicating neuroscience research findings to: Press Lay public Political leaders Scientific Community Translation new tools technologies neuroscience research contexts beyond clinic/bench: Ethics commercialization, public-private partnerships, wider application imaging technologies commercial purposes, conflicts interest use ex vivo human brain tissue; including ownership privacy issues Specific neuroethics questions could addressed using focused research approach Any issues respondents feel relevant to Submit Response Responses must submitted electronically through BRAIN-info-nimh@mail.nih.gov July 29, 2016. RFI for planning purposes only should be construed a solicitation applications an obligation the part the government. The government not pay the preparation any information submitted for government’s of information. NIH use information submitted response this RFI its discretion will provide comments any responder's submission. Responses the RFI be reflected future funding opportunity announcements. information provided be analyzed, appear reports, may shared publicly an NIH website. Respondents advised the government under obligation acknowledge receipt the information 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), policies procedures. Inquiries Please direct inquiries to: Email: BRAIN-info-nimh@mail.nih.gov