Notices of Funding Opportunities

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;