Notices of Funding Opportunities

Notice Change the Application Due Date to Allow Foreign Components Applications RFA-NS-16-008 BRAIN Initiative: Research Opportunities Using Invasive Neural Recording Stimulating Technologies the Human Brain U01)" Notice Number: NOT-NS-15-044 Key Dates Release Date:   November 5, 2015 Related Announcements RFA-NS-16-008       Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Center Complementary Integrative Health NCCIH)  Purpose Notice to change application due date, to correct information eligible organizations RFA-NS-16-008 BRAIN Initiative:  Research Opportunities Using Invasive Neural Recording Stimulating Technologies the Human Brain U01).”  new due date be January 13, 2016.  Also changed Funding Opportunity Announcement FOA) allow applications include foreign components, such sub-contracts foreign organizations and/or activities performed foreign organizations.  Currently FOA reads: Key Dates Open Date Earliest Submission Date) November 15, 2015 Letter Intent Due Date(s) November 15, 2015 Application Due Date(s) December 15, 2015, 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due this date. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. late applications be accepted this Funding Opportunity Announcement. AIDS Application Due Date(s) Not  Applicable Scientific Merit Review February 2016 Advisory Council Review 2016 Earliest Start Date June 2016 Expiration Date December 16, 2015  Foreign Institutions Non-domestic non-U.S.) Entities Foreign Institutions) not eligible apply. Non-domestic non-U.S.) components U.S. Organizations not eligible apply. Foreign components, defined the NIH Grants Policy Statement, not allowed. FOA now changed read: Key Dates Open Date Earliest Submission Date) December 13, 2015 Letter Intent Due Date(s) December 13, 2015 Application Due Date(s) January 13, 2016, 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due this date. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. late applications be accepted this Funding Opportunity Announcement. AIDS Application Due Date(s) Not  Applicable Scientific Merit Review April 2016 Advisory Council Review August 2016 Earliest Start Date September 2016 Expiration Date January 14, 2016  Foreign Institutions Non-domestic non-U.S.) Entities Foreign Institutions) not eligible apply. Non-domestic non-U.S.) components U.S. Organizations not eligible apply. Foreign components, defined the NIH Grants Policy Statement,are allowed. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: James Gnadt, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: BRAIN_ResOppHu@mail.nih.gov

Notice Informational Webinar PAR-15-345 BRAIN Initiative: Pre-Applications Industry Partnerships Provide Early Access Devices Stimulation Recording the Human Central Nervous System X02)" Notice Number: NOT-NS-15-043 Key Dates Release Date:   October 15, 2015   Related Announcements PAR-15-345 RFA-NS-16-009 RFA-NS-16-010     Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to inform potential applicants Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative Funding Opportunity Announcement Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System RFA-NS-16-009 RFA-NS-16-010) a webinar provide technical assistance the optional pre-application, PAR-NS-15-345 BRAIN Initiative:  Pre-Applications Industry Partnerships Provide Early Access Devices Stimulation Recording the Human Central Nervous System X02). webinar optional not required submission PAR-NS-15-345, RFA-NS-16-009, RFA-NS-16-010. Webinar Information Date: Friday, October 30, 2015 Time: 3:30 PM EDT Duration: 1 hour register the webinar, to submit questions, please email BRAIN-FOAs@nih.gov Wednesday, October 28, 2015. Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: BRAIN-FOAs@nih.gov

Participation Canadian Researchers the NIH BRAIN Initiative Notice Number: NOT-MH-15-020 Key Dates Release Date:   August 6, 2015 Related Announcements None     Issued National Institute Mental Health NIMH) National Eye Institute NEI)National Institute Aging NIA) National Inistitute Alcohol 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) Brain Canada Foundation Brain Canada) Purpose 10 NIH Institutes are part the NIH BRAIN Initiative announce new partnership, formalized a letter agreement, the Brain Canada Foundation Brain Canada) support involvement Canadian researchers the NIH BRAIN Initiative.  Both NIH the Brain Canada Foundation believe the ambitious goals the BRAIN Initiative best attained collaboration across disciplinary boundaries well geographic boundaries.  Brain Canada seek partners provide grant support Canadian researchers through Canada Brain Research Fund provides 1:1 match funds raised other sources. Supplemental Funding NIH a number BRAIN Initiative awards FY14 http://braininitiative.nih.gov/nih-brain-awards.htm) many are expected be in FY15.  Canadian researchers are interested participating funded awards advised contact Program Director/Principal Investigator the NIH award inquire there mutual interest collaboration.  there interest, Canadian researcher apply directly the Brain Canada Foundation funding the work be performed Canada. each approved project an added Canadian collaboration, funding administration the work performed Canada shall managed Brain Canada. Matching Funding most the NIH BRAIN Initiative Funding Opportunity Announcements, foreign institutions been permitted participate either submitting applications directly as subcontractors an application a domestic institution.  Canadian researchers submit applications either role BRAIN Initiative awards should contact Brain Canada will seek partners provide grant support through Canada Brain Research Fund. addition providing funds, representatives the Brain Canada Foundation join those the National Science Foundation, Food Drug Administration, Defense Advanced Research Projects Agency, Australian National Health Medical Research Council, the Intelligence Advanced Research Projects Agency meetings the BRAIN Multi-Council Working Group http://braininitiative.nih.gov/Brain_multi_council_working_group.htm). Inquiries Please direct inquiries to: Gregory K. Farber, Ph.D. National Institute Mental Health NIMH) Telephone:  301-435-0778 Email:  farberg@mail.nih.gov Ned Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:  301-496-1917 Email:  talleye@mail.nih.gov Inez Jabalpurwala Brain Canada Foundation Telephone: 514-989-2989 Email:  programs@braincanada.ca

Notice Intent Publish Funding Opportunity Announcement BRAIN Initiative: Foundations Non-Invasive Human Brain Imaging Neuro-Recording Techniques R01) Participation the Australian National Health Medical Research Council Notice Number: NOT-MH-15-022 Key Dates Release Date:   July 21, 2015 Estimated Publication Date Announcement: October 2015   First Estimated Application Due Date: December 2015  Earliest Estimated Award Date: June 2016  Earliest Estimated Start Date: June 2016 Related Announcements RFA-MH-16-750     Issued National Institutes Health NIH) National Institute Mental Health NIMH) National Eye Institute NEI) National Institute Aging NIA) 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) Australian National Health Medical Research Council NHMRC) Purpose NIMH, other NIH Institutes Centers ICs) are part the BRAIN Initiative, intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications research the foundations non-invasive human brain imaging neuro-recording techniques.  goal this FOA be support integrative, multidisciplinary efforts will revolutionize our understanding the meaning the data collected non-invasive human brain imaging functional evaluation techniques.   Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published fall 2015 an expected application due date winter 2015. FOA utilize R01 activity code. Research Initiative Details Notice encourages investigators expertise insights this area non-invasive human brain imaging neuro-recording begin consider applying this new FOA.  Studies supported this new FOA move beyond simply observing signal collected using non-invasive imaging recording techniques a level more directly informs our understanding the cellular- circuit-bases these signals. Such studies greatly improve our knowledge dynamic brain function both normal pathological conditions. addition, collaborative investigations combining expertise physics, computational information science, engineering, biology, neuroscience, clinical science, behavioral science be encouraged investigators such expertise should also begin considering applying this application. NIH Institutes Centers are part the NIH BRAIN Initiative announce new partnership, formalized a letter agreement, the Australian National Health Medical Research Council NHMRC) support involvement Australian researchers specific NIH BRAIN Initiative programs.  Both NIH the NHMRC believe the ambitious goals the BRAIN Initiative best attained collaborating across disciplinary boundaries well geographic boundaries.  Details NHMRC application procedures, funding rules, eligibility requirements be available the NHMRC website. Foreign institutions be permitted submit applications the FOA described this Notice either submitting applications directly as subcontractors an application a domestic institution.  addition providing funds, representatives the NHMRC join those the National Science Foundation, Food Drug Administration, Defense Advanced Research Projects Agency, the Intelligence Advanced Research Projects Agency meetings the BRAIN Multi-Council Working Group http://braininitiative.nih.gov/Brain_multi_council_working_group.htm). APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Gregory K. Farber, Ph.D. National Institute Mental Health NIMH) Telephone: 301-435-0778 Email: farberg@mail.nih.gov Ned Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:  301-496-1917 Email:  talleye@mail.nih.gov National Health Medical Research Council NHMRC) Telephone: 61 2 6217 9450 Email: brain@nhmrc.gov.au

Request Information RFI): BRAIN Initiative Industry Partnerships Early Access Neuromodulation Recording Devices Human Clinical Studies Notice Number: NOT-NS-15-032 Key Dates Release Date: July 9, 2015 Response Date: August 7, 2015    Related Announcements None     Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Center Complementary Integrative Health NCCIH) Purpose Background BRAIN InitiativeSM Brain Research through Advancing Innovative Neurotechnologies BRAIN) InitiativeSM a multi-agency federal effort aimed revolutionizing understanding the human brain.  NIH guided its contributions this effort scientific strategic recommendations laid in landmark report, quot;BRAIN 2025: Scientific Vision," by input the NIH BRAIN Multi-Council Working Group MCWG, Roster).  Information meetings the MCWG available http://www.braininitiative.nih.gov/index.htm.  central focus the BRAIN Initiative development technologies recording modulating neural circuits.  bring technologies bear human brain disorders, BRAIN 2025 report recommended new quot;streamlined path developing, implementing integrating new technologies human neuroscience research, through cooperation clinical academic research teams private companies a pre-competitive space." Towards end, NIH initiated efforts facilitate public-private partnerships manufacturers devices stimulating and/or recording neural activity humans, make devices available NIH-funded research studies.  NIH BRAIN Public-Private Partnership Program NIH intends release Funding Opportunity Announcement FOA) Fiscal Year 2016 fund research partnerships between clinical investigators manufacturers latest-generation stimulating and/or recording devices are FDA-designated Class III invasive, posing significant risk harm), conduct clinical research the CNS.  goal to spur human research mitigate cost effort required translate pre-clinical research these devices therapeutic outcomes.  types research NIH plans support IRB-approved Non Significant-Risk NSR) clinical research studies, new Significant Risk SR) clinical studies requiring amendments existing Investigational Devices Exemptions IDEs) the FDA, or SR clinical studies which new IDE require or minimal additional non-clinical testing. nbsp;Envisioned studies include exploratory research obtain proof concept new therapeutic indications, identification neural signals relevant closed loop control device therapies, research fundamental human neuroscience questions.  the RFA Fiscal Year 2016, NIH specifically interested devices existing pre-clinical safety technical data can readily leveraged enable new NSR IDE clinical research studies without need significant additional pre-clinical testing.  preparation this FOA, NIH released previous Request Information the overall goals the planned effort NOT-NS-14-054), held Workshop featuring representatives industry, clinical researchers, government regulatory funding agencies, academic technology-transfer contracting offices.  nbsp;The agenda a summary this workshop, plus links the videocast workshop proceedings, available the NIH BRAIN website http://braininitiative.nih.gov/meetings/June-2015-PPP.htm).  Template Agreements Research Partnerships facilitate research partnerships between academic institutions commercial device manufacturers, NIH drafted following template documents, were focus specific discussions the aforementioned workshop.  1.  Template Memorandum Understanding agreements between NIH specific device manufacturers.  purpose this document to describe nature the Public-Private Partnership program the signatory company's agreement participate the program.  document goes over process under Collaborative Research Agreements be reached academic researchers wishing use company's device(s) prior their submission NIH grant applications.  company signing agreement NIH expected provide description the materials devices, software, surgical tools, etc.) support company willing make available this purpose, will included exhibits the agreement will posted publicly serve a guide investigators wishing pursue agreements manufacturers specific research projects.  companies already provisional draft descriptions available, links these drafts included the webpage linked below.  Note draft descriptions tentative subject revision, have only provided the purpose giving context responses this RFI.  2.  Template Collaborative Research Agreement, be used a starting point negotiating agreements between device manufacturers academic research institutions clinical research studies. goal this document to provide standardized terms covering essential components such agreements e.g., intellectual property, data publications, reporting requirements, etc.) using language has deemed acceptable many the commercial academic parties expect negotiate agreements.  3.  Template Confidential Disclosure Agreement, be signed academic researchers discuss specific details companies regarding device capabilities their research.  Draft versions each these template documents available review http://braininitiative.nih.gov/draft_template_agreements.htm.  NIH Goals the Template Agreement Documents drafting template documents seeking feedback major stakeholders their formulation, NIH hopes accomplish following: Reduce barriers time required successful negotiation research partnerships between academic research institutions corporate manufacturers.  anticipate the template Collaborative Research Agreement speed negotiations providing common language terms serve an acceptable baseline multiple parties.  NIH recognizes different devices projects need specific terms determined a case-by-case basis, these templates not intended endorsement specific terms any particular project.  goal for terms the template be useable quot;as is" some cases, while expediting process arrive final terms other cases providing community-vetted transparent starting point negotiations.        Provide transparent access latest-generation devices their associated capabilities new clinical studies.  Such devices be available exploratory research under controlled conditions ensure safety, are market approved therapeutic indications therefore might otherwise known the research community.  addition, devices available market often expanded capabilities can quot;unlocked" use controlled research settings, subject appropriate regulatory approval.  Leverage manufacturers’ existing data demonstrating safety utility these devices, are very costly obtain, the purpose regulatory approval new clinical studies.  expect framework allow academic researchers test innovative ideas new therapies, to address scientific unknowns regarding mechanisms disease consequences device action, will advance goals the BRAIN Initiative understanding human brain circuits progressing towards therapies brain disorders.  addition, expect resulting research have benefits device manufacturers insofar it serves facilitate creation solid business cases larger clinical trials required take specific therapies market.  Information Requested time-sensitive RFI, issued the Institutes Centers the NIH BRAIN Initiative listed above, for feedback the general goals the specific terms the template documents described above, will serve a basis collaborative partnerships the intended RFA Fiscal Year 2016.  NIH invites input stakeholders including not limited researchers academia industry, healthcare professionals, patient advocates advocacy organizations, scientific professional organizations, federal agencies other interested members the public.  Small businesses appropriate technologies especially encouraged provide input.  feedback include is limited perspectives the following topics: Intellectual property Confidentiality Data ownership, sharing, access, privacy considerations Publications other presentations arising data generated under collaboration Liability Reporting requirements necessary patient protection regulatory oversight Potential future opportunities capitalizing this Pilot Public-Private Partnership Program   to Submit Response ensure consideration, responses must received August 7, 2015 must submitted electronically using web-based format http://braininitiative.nih.gov/rfi2-brain-initiative.htm. web format provide confirmation response submission, respondents not receive individualized feedback. Responses this RFI voluntary may submitted anonymously. Please not include any personally identifiable other information you not wish make public. Proprietary, classified, confidential sensitive information should be included your response. Comments be compiled discussion may appear related reports. Any personal identifiers names, e-mail addresses, etc.) be removed responses compiled. RFI for informational planning purposes only should be construed a solicitation as obligation the part the United States US) Government, NIH the NINDS provide support any ideas submitted response it. Please note the US Government, NIH NINDS not pay the preparation any information submitted, for use that information. Inquiries Kip Ludwig, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: brain-devices-rfi@mail.nih.gov

Notice Correction the First Advisory Council Review Date the Earliest Start Date PAR-15-121 BRAIN Initiative: Optimization Novel Tools Technologies Neuroscience Research R44)" Notice Number: NOT-NS-15-017 Key Dates Release Date:   March 26, 2015 Related Announcements PAR-15-121 Issued National Institute Neurological Disorders Stroke NINDS)  Purpose purpose this Notice to correct First Advisory Council Review Date the Earliest Start Date PAR-15-121 quot;BRAIN Initiative: Optimization Novel Tools Technologies Neuroscience Research R44)". corrections as follows: Part 1. Key Dates Currently reads: Advisory Council Review August, 2015 the first receipt date, then standard dates apply nbsp; Earliest Start Date September, 2015 the first receipt date, standard dates apply nbsp; nbsp; Modified read: Advisory Council Review October 2015 the first due date, then standard dates apply nbsp; Earliest Start Date November 2015 the first due date, standard dates apply nbsp; nbsp; other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov

Notice Intent Publish Funding Opportunity Announcement the BRAIN Initiative: Clinical Studies Advance Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UH3) Notice Number: NOT-NS-15-007 Key Dates Release Date: December 17, 2014 Estimated Publication Date Announcement: January 2015 First Estimated Application Due Date: March 2015 Earliest Estimated Award Date: September, 2015 Earliest Estimated Start Date: September 2015 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Center Complementary Alternative Medicine NCCAM) Purpose NIH BRAIN Brain Research through Advancing Innovative Neurotechnologies) Initiative intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications Clinical Studies Advance Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published January 2015 an expected application due date Spring 2015. FOA utilize UH3 mechanism support small clinical studies will advance next generation recording and/or stimulating devices treat central nervous system disorders better understand human brain. Projects appropriate this FOA must completed non-clinical testing necessary obtain Investigational Device Exemption IDE) a Significant Risk SR) clinical study obtained Institutional Review Board IRB) approval a Non-Significant Risk NSR) clinical study prior entry. addition, projects must obtain necessary approval conduct clinical study prior entry within first year the award. total duration the award not exceed 5 years. companion FOA also expected be published January 2015, will support non-clinical testing required obtain necessary approvals conduct clinical study, addition a singular clinical study. summary the planned FOA provided below. Research Initiative Details FOA related Section III the BRAIN 2025 Report, addresses goal developing innovative technologies understand human brain treat disorders'. NIH recognizes initial first-in-man studies a key point the development innovative new clinical technologies. leap animal studies humans large, initial clinical studies often necessary address critical scientific questions the function a device human subjects and/or inform final device design suitable eventual FDA market approval. Initial demonstrations novel device function humans become increasingly required encourage industry venture capital investment necessary develop final safe, reliable, efficacious device can manufactured a scale suitable regulatory approval, yet a price point sufficient sustainable commercial market given insurance reimbursement. purpose this FOA to encourage applications pursue small clinical study obtain critical information necessary advance recording and/or stimulating devices treat central nervous system disorders better understand human brain e.g., Early Feasibility Study). Clinical studies supported consist acute short-term procedures are deemed Non-Significant Risk NSR) an Institutional Review Board, Significant Risk SR) studies require Investigational Device Exemption IDE) the FDA, such chronic implants. clinical study should provide data answer key questions the function final design a device. final device design require most, not all, the non-clinical testing the path more advanced clinical trials market approval. clinical study expected provide information cannot practically obtained through additional nonclinical assessments e.g., bench top animal studies) due the novelty the device its intended use. Examples the types clinical studies can proposed include, are limited to: Optimization the device design respect the human functional anatomy Identification the most simple, reliable, cost effective device configuration more advanced clinical trials eventual market approval Basic proof-of-concept testing human subjects Studies the key physiological variables may impact function the device humans Initial assessments device safety, only conjunction obtaining enabling data device design function. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Kip Ludwig, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: brain-initiative-FY15-FOA@mail.nih.gov

Notice Intent Publish Funding Opportunity Announcement the BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UH2/UH3) Notice Number: NOT-NS-15-008 Key Dates Release Date: December 17, 2014 Estimated Publication Date Announcement: January 2015 First Estimated Application Due Date: March 2015 Earliest Estimated Award Date: September 2015 Earliest Estimated Start Date: September 2015 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Center Complementary Alternative Medicine NCCAM) Purpose NIH BRAIN Brain Research through Advancing Innovative Neurotechnologies) Initiative intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published January 2015 an expected application due date Spring 2015. FOA utilize UH2/UH3 mechanism support non-clinical testing a singular clinical study advance next generation recording and/or stimulation devices treat central nervous system disorders better understand human brain. UH2 phase support non-clinical testing necessary obtain necessary approvals a small clinical study, the UH3 phase support subsequent clinical study. companion stand-alone UH3 FOA also expected be published January, will support projects do require additional non-clinical testing obtain approval the clinical study. total duration the UH2 UH3 Phases combined not exceed 5 years. summary the planned FOA provided below. Research Initiative Details FOA related Section III the BRAIN 2025 Report, addresses goal developing innovative technologies understand human brain treat disorders'. NIH recognizes initial first-in-man studies a key point the development innovative new clinical technologies. leap animal studies humans large, initial clinical studies often necessary address critical scientific questions the function a device human subjects and/or inform final device design suitable eventual FDA market approval. Initial demonstrations novel device function humans become increasingly required encourage industry venture capital investment necessary develop final safe, reliable, efficacious device can manufactured scale suitable regulatory approval, yet a price point sufficient sustainable commercial market given insurance reimbursement. purpose this FOA to encourage applications pursue translational clinical studies obtain critical information necessary advance recording and/or stimulating devices treat central nervous system disorders better understand human brain. program utilize cooperative agreement mechanism support non-clinical testing necessary enable successful submission an Investigational Device Exemption IDE) a Significant Risk SR) study obtain Institutional Review Board IRB) approval a Non-Significant Risk NSR) study, the subsequent small clinical study e.g., Early Feasibility Study). clinical study should provide data answer key questions the function final design a device. final device design require most, not all, the non-clinical testing the path more advanced clinical trials market approval. clinical study expected provide information cannot practically obtained through additional nonclinical assessments e.g., bench top animal studies) due the novelty the device its intended use. Activities supported this program include implementation clinical prototype devices, non-clinical safety efficacy testing, design verification validation activities, pursuit regulatory approval for, implementation of, single small clinical study. projects have phases, UH2 an UH3 phase. initial UH2 phase support nonclinical testing support the submission an IDE an SR study to obtain IRB approval an NSR clinical study. projects start the UH2 phase, the length UH2 phase depend the maturity the project entry. Only those UH2 projects have met specific criteria outlined the FOA be eligible transition the second UH3 phase after NIH administrative review. UH3 phase support small clinical study. Clinical studies supported consist acute short-term NSR studies, SR studies such chronic implants. Examples the types clinical studies can proposed include, are limited to: Optimization the device design respect the human functional anatomy Identification the most simple, reliable, cost effective device configuration more advanced clinical trials eventual market approval Basic proof-of-concept testing human subjects Studies the key physiological variables may impact function the device humans Initial assessments device safety, only conjunction obtaining enabling data device design function. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Kip Ludwig, PhD, National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: brain-initiative-FY15-FOA@mail.nih.gov

Notice Extend Due Date Expiration Date RFA-MH-14-217 BRAIN Initiative: Planning Next Generation Human Brain Imaging R24)" Notice Number: NOT-MH-14-010 Key Dates Release Date: March 5, 2014 Related Announcements RFA-MH-14-217 Issued NIH Blueprint Neuroscience Research http://neuroscienceblueprint.nih.gov) 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 Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Complementary Alternative Medicine NCCAM) National Center Advancing Translational Sciences NCATS) Office Behavioral Social Sciences Research OBSSR) Purpose purpose this Notice to inform interested applicants the Application Due Date RFA-MH-14-217 quot;BRAIN Initiative:  Planning Next Generation Human Brain Imaging R24)" being extended March 13, 2014, March 27, 2014. Accordingly, expiration date RFA-MH-14-217 now March 28, 2014. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Greg Farber, Ph.D. National Institute Mental Health NIMH) Telephone: 301-435-0778 Email: faberg@mail.nih.gov nbsp;

Notice Informational Conference Calls Prospective Applicants NIH BRAIN Initiative Funding Opportunity Announcements Notice Number: NOT-NS-14-005 Key Dates Release Date: January 6, 2014 Related Announcements RFA-NS-14-007 RFA-NS-14-008 RFA-NS-14-009 RFA-MH-14-215 RFA-MH-14-216 RFA-MH-14-217 Issued NIH Blueprint Neuroscience Research http://neuroscienceblueprint.nih.gov) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Purpose Background Information Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative a new Presidential project 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, shows individual cells complex neural circuits interact both time space. is expected the application these new tools technologies ultimately lead new ways treat, cure, even prevent brain disorders. general information inquiries regarding NIH support the BRAIN Initiative, please consult following website: http://www.nih.gov/science/brain/index.htm.  December 17, 2013, NIH released six Funding Opportunity Announcements FOAs) the inaugural set projects under BRAIN Initiative links the Related Announcements section this Notice), an expected initial investment 40M be considered NIH funding Fiscal Year 2014.  Summaries the FOAs other information prospective applicants available the following website: http://www.nih.gov/science/brain/funding.htm.  Informational Conference Calls purpose this Notice to inform prospective applications the FOAs NIH be hosting series informational conference calls address technical questions regarding applications each the FOAs.  Information dates contacts each the conference calls as follows: January 10, 2014, 2:00-3:00 PM EST: RFA-MH-14-215, Transformative Approaches Cell-Type Classification the Brain call-in information, contact Andrea Beckel-Mitchener BRAIN-info-NIMH@mail.nih.gov.  January 13, 2014, 2:00-3:00 PM EST: RFA-MH-14-216, Development Validation Novel Tools Analyze Cell-Specific Circuit-Specific Processes the Brain call-in information, contact Michelle Freund BRAIN-info-NIMH@mail.nih.gov.  January 15, 2014, 1:00-2:00 PM EST: RFA-MH-14-217, Planning Next Generation Human Brain Imaging call-in information, contact Greg Farber BRAIN-info-NIMH@mail.nih.gov.  February 4, 2014, 1:00-2:30 PM EST: RFA-NS-14-007, New Technologies Novel Approaches Large-Scale Recording Modulation the Nervous System RFA-NS-14-008, Optimization Transformative Technologies Large Scale Recording Modulation the Nervous System RFA-NS-14-009, Integrated Approaches Understanding Circuit Function the Nervous System call-in information, contact Karen David NINDS-Brain-Initiative@nih.gov.  addition accessing information provided the upcoming conference calls, applicants strongly encouraged consult the Scientific/Research Contacts listed each the FOAs discuss alignment their proposed work the goals the FOA which intend apply. Inquiries Inquiries specifically regarding Notice be directed to: Edmund Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301- 496-1917 Email: NINDS-Brain-Initiative@nih.gov nbsp;