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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  

Notice the Extension the Expiration Date PAR-13-281 NINDS Exploratory Clinical Trials R01)" Notice Number: NOT-NS-16-029 Key Dates Release Date: 25, 2016 Related Announcements PAR-13-281  Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice inform interested applicants the expiration date PAR-13-281 NINDS Exploratory Clinical Trials R01)" be extended one funding cycle. Key Dates table updated accordingly: Part 2. Key Dates Posted Date July 22, 2013 Open Date Earliest Submission Date) September 5, 2013 Letter Intent Due Date(s) Applicable Application Due Date(s) Standard dates apply, 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) Standard AIDS dates apply, 5:00 PM local time applicant organization. types AIDS AIDS-related applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date January 8, 2017 Due Dates E.O. 12372 Applicable Inquiries Please direct inquiries to: Peter Gilbert National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-0870 Email: gilbertp@ninds.nih.gov  

Request Information: Soliciting Input New Research Strategies Myalgic Encephalomyelitis/Chronic Fatigue Syndrome ME/CFS) Notice Number: NOT-NS-16-024 Key Dates Release Date: 24, 2016 Response Date: June 24, 2016   Related Announcements None     Issued National Institute Neurological Disorders Stroke NINDS) National Heart, Lung, Blood Institute NHLBI) 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 Dental Craniofacial Research NIDCR) 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 Nursing Research NINR) National Library Medicine NLM) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS)  Purpose Trans-National Institutes Health NIH) ME/CFS Working Group developing new strategies guide NIH's research efforts priority setting research ME/CFS.  Seeking input the planning process through Request Information RFI) critical identification consideration research areas topics be included future efforts.  members the Trans-NIH ME/CFS Working Group review consider comments received under RFI regard current future needs direction ME/CFS research research training. Information Requested Through RFI, Trans-NIH ME/CFS Working Group invites input researchers, health care providers, patient advocates health advocacy organizations, scientific professional organizations, Federal agencies, other interested parties.  Organizations strongly encouraged submit single response reflects views their organization membership a whole. Please provide perspective the following issues they relate the Working Group's planning efforts: Emerging needs opportunities should considered new ME/CFS research strategies developed. Challenges barriers progress research ME/CFS. Gaps opportunities across research continuum basic through clinical studies. commenting a research need scientific opportunity, Working Group suggests your comments contain following our full consideration: Description the need opportunity Scientific rationale potential public health impact Anticipated challenges will need be addressed Appropriate benchmarks evaluating progress. this RFI, NIBIB interested the ideas the development new imaging bioengineering technologies could the potential a significant impact ME/CFS research. Trans-NIH ME/CFS Working Group also welcomes general comments. Responses Responses this RFI must submitted via email MECFSRFI@mail.nih.gov  Responses be accepted through June 24, 2016. Responses voluntary may submitted anonymously.  Respondents advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted.  Please not include any personally identifiable other information you not wish make public.  proprietary, classified, confidential, sensitive information should included your response. request for information planning purposes only should be construed a solicitation as obligation the part the United States Government.  Trans-NIH ME/CFS Working Group not any awards based responses this RFI pay the preparation any information submitted for Government's of such information. Inquiries Please direct inquiries to: Vicky Whittemore, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email: vicky.whittemore@nih.gov

Notice the Extension the Expiration Date PAR-13-278 NINDS Phase III Investigator-Initiated Efficacy Clinical Trials U01)" Notice Number: NOT-NS-16-028 Key Dates Release Date: 24, 2016 Related Announcements PAR-13-278     Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice inform interested applicants the expiration date PAR-13-278 quot;NINDS Phase III Investigator-Initiated Efficacy Clinical Trials U01)" be extended one funding cycle. Key Dates table updated accordingly: Part 1. Key Dates Posted Date July 22, 2013 Open Date Earliest Submission Date) September 5, 2013 Letter Intent Due Date(s) Applicable Application Due Date(s) Standard dates apply, 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) Standard AIDS dates apply, 5:00 PM local time applicant organization. types AIDS AIDS-related applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date January 8, 2017 Due Dates E.O. 12372 Applicable nbsp; Inquiries Please direct inquiries to: Peter Gilbert National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-0870 Email: gilbertp@ninds.nih.gov  

Notice Travel Support PDs/PIs NINDS-Funded Institutional Training T32) Programs Attend NINDS T32 Regional Meetings Notice Number: NOT-NS-16-025 Key Dates Release Date:   May 10, 2016 Related Announcements NOT-NS-14-026 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice supersedes NOT-14-NS-026, establishes maximum travel support NINDS award T32 PDs/PIs cover costs associated attending T32 Regional Meetings. NINDS supports institutional training programs T32s) both predoctoral postdoctoral fellows are intended develop strong next generation neuroscientists engaged research NINDS-mission relevant research-associated occupations. programs expected facilitate development a highly qualified, diverse workforce. purpose this Notice to inform awardees NINDS T32 training programs it continue holding periodic meetings among PDs/PIs, to offset costs associated attendance these meetings, NINDS provide to 700 direct cost directly the T32 grants grant PDs/PIs their designees attend meetings.  meetings scheduled, Director, NINDS Office Training, Career Development Workforce Diversity notify PDs/PIs additional information, including instructions requesting funds. Inquiries Please direct inquiries to: Letitia Weigand, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:  301-496-4188 Email: letitia.weigand@nih.gov