Notices of Funding Opportunities

Notice Extend RFA-MH-17-235 BRAIN Initiative: Foundations Non-Invasive Functional Human Brain Imaging Recording-Bridging Scales Modalities R01)" Notice Number: NOT-MH-16-025 Key Dates Release Date: September 16, 2016 Related Announcements RFA-MH-17-235 Issued 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 purpose this Notice to extend RFA-MH-17-235 ldquo;BRAIN Initiative: Foundations Non-Invasive Functional Human Brain Imaging Recording - Bridging Scales Modalities R01)" invites application support effort will revolutionize our understanding the biological activity underlying, bioinformatic content data collected using contemporary non-invasive functional brain imaging techniques.  Part 1. Key Dates Currently reads:   Application Due Date(s): November 23, 2016 Scientific Merit Review: March 2017 Advisory Council Review: 2017 Earliest Start Date: September 2017 Expiration Date: November 24, 2016 Modified read: Application Due Date(s): November 23, 2016 October 13, 2017 Scientific Merit Review: March 2017 March 2018 Advisory Council Review: 2017 May 2018 Earliest Start Date: September 2017 September 2018 Expiration Date: October 14, 2017 other aspects this FOA remain same. Inquiries Please direct inquiries to: Jay Churchill, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-3621 Email: churchillj@mail.nih.gov

BRAIN Initiative Multi-Council Working Group Clearance Initiative Concepts FY2017 Notice Number: NOT-NS-16-041 Key Dates Release Date: September 6, 2016 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 Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative an ambitious multi-agency effort announced President Obama April 2013. Specific goals NIH contributions the Initiative formulated over year-long planning process culminated the release BRAIN 2025: Scientific Vision, seminal planning document produced a working committee the Advisory Council the NIH Director. NIH continues be guided this document by input the BRAIN Multi-Council Working Group MCWG), committee includes Advisory Council members each the ten NIH Institutes Centers ICs) contributing the BRAIN Initiative.  upcoming fiscal year represents transition point the BRAIN Initiative, goals scaling efforts a number specific areas: 1.  Census Brain Cell Types 2.  Tools Cells Circuits 3.  Technologies Neural Recording Modulation 4.  Human Imaging Neuromodulation 6.  Technology Dissemination Training 7.  Small Business Awards 8.  Data Coordination 9.  Neuroethics fund ambitious goals this transition, President’s budget calls a total appropriation 195 million, has matched exceeded proposals House Senate appropriations subcommittees.  its most recent meeting August 2, 2016, MCWG provided clearance BRAIN FY 2017 initiatives.  Investigators interested particular research areas encouraged review listing cleared initiatives, includes contact information NIH Program staff each area.  Links this information be found the following url:  Multi-Council Working Group.   Interested parties also encouraged subscribe the BRAIN Update post https://brainupdate.nih.gov/), issues periodic announcements including new funding opportunities.  Inquiries Please direct inquiries to: Edmund Ned) Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email: Edmund.Talley@nih.gov email strongly preferred) Gregory K. Farber, Ph.D. National Institute Mental Health NIMH) Telephone:  301-435-0778 Email: farberg@mail.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  

Participation Danish Researchers the NIH BRAIN Initiative Notice Number: NOT-MH-16-004 Key Dates Release Date:   February 22, 2016 Related Announcements None     Issued National Institutes Health NIH) 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) Lundbeckfonden http://www.lundbeckfoundation.com/) Purpose Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative a multi-agency effort, a coordinated contribution 10 NIH Institutes Centers http://braininitiative.nih.gov/).  part the NIH BRAIN Initiative, NIH announces new partnership, formalized a letter agreement, Lundbeckfonden http://www.lundbeckfoundation.com/) support involvement researchers Danish institutions the BRAIN Initiative.  Both NIH Lundbeckfonden believe the ambitious goals the BRAIN Initiative best attained collaboration across disciplinary boundaries well geographic boundaries.  Supplemental Funding NIH a number BRAIN Initiative awards FY14 FY15 http://www.braininitiative.nih.gov/nih-brain-awards.htm).  Researchers Danish institutions are interested participating funded awards advised contact Program Director/Principal Investigator the NIH award inquire there mutual interest collaboration.  there interest, researcher a Danish institution apply directly Lundbeckfonden funding the work be performed Denmark.  each approved project an added Danish collaboration, funding administration the work performed Denmark shall managed the foundation the Danish host institution.  NIH consider administrative supplements support such collaborations. Matching Funding most the NIH BRAIN Initiative Funding Opportunity Announcements, foreign institutions permitted participate either submitting applications directly as subcontractors an application a domestic institution.  Researchers Danish institutions submit applications either role BRAIN Initiative awards should contact Lundbeckfonden the award submitted they interested having award potentially co-funded NIH the Lundbeckfonden.  NIH evaluate i.e., peer review) application, will a funding decision.  the project receives NIH award, Lundbeckfonden decide whether will fund – fully in part – Danish based elements the project.  NIH not share application materials summary statements directly the Lundbeckfonden, the applicant must those materials available Lundbeckfonden they want be considered co-funding.    addition providing funds, representatives the foundation join those the National Science Foundation, Food Drug Administration, Defense Advanced Research Projects Agency, Brain Canada, 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 Lundbeckfonden Telephone: 45 39 12 80 15 Email:  application@lundbeckfonden.com

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