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Notice Clarification Eligibility Details Administrative Supplement the NINDS Research Education Program Residents Fellows Neurology, Neurosurgery, Neuropathology, Neuroradiology Emergency Medicine Admin Supp)" Notice Number: NOT-NS-15-009 Key Dates Release Date: January 13, 2015 Related Announcements PA-14-322 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice modifies eligibility criterion participants, described Part 2. Full Text Announcement, Section I. Funding Opportunity Description PA-14-322. Specifically describes under circumstances participants eligible support even they in faculty position. nbsp; Part 2. Full Text Announcement Section I. Funding Opportunity Description Paragraph 4 currently reads: one two year gap time between support during residency support during fellowship acceptable the gap required obtain clinical fellowship training. Research activity between second third period support must continuous. Funds not used those faculty positions. Paragraph 4 modified read: one two year gap time between support during residency support during fellowship acceptable the gap required obtain clinical fellowship training. Research activity between second third period support must continuous. general, funds not used those faculty positions. some unusual circumstances, however, participants obtain temporary, junior faculty appointments e.g. quot;Instructor," etc.] before completion the 2 years fellowship eligibility. these circumstances, individuals eligible continued R25 support long there no gap their participation the R25 program between fellowship the temporary, junior faculty position. Moreover, be eligible support, requirement remains the participant must devote 80% effort the R25 research education program. salary component the award, regardless professional position, be capped 80% the chronologically appropriate PGY salary, will no greater 80% the PGY salary the applicant institution. Salary supplementation other sources, required retain 80% effort requirement, allowable, long it does require duties different from, in addition to, those directly associated the R25 research education program. other aspects this FOA remain unchanged. nbsp; Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov nbsp;

Notice Pre-application Informational Webinar RFA-NS-15-002 NINDS Morris K. Udall Centers Excellence Parkinson's Disease Research Program P50)" Notice Number: NOT-NS-15-010 Key Dates Release Date: January 9, 2015 Related Announcements RFA-NS-15-002 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to inform potential applicants RFA-NS-15-002 a pre-application webinar provide submission information the NINDS Morris K. Udall Centers Excellence Parkinson's Disease Research Program. intent the webinar to provide overview the initiative to address questions pertinent preparing applications. webinar optional not required application submission. Webinar Information Date: Thursday, January 15, 2015 Time: 2:00pm ET Meeting URL: https://global.gotomeeting.com/join/414962901 Call-in number: 213-493-0622 Participant passcode: 414-962-901 Questions be submitted email Udall2015@mail.nih.gov before during webinar; Please include Udall Webinar Question" the subject line. While every effort be to answer questions during webinar itself, due time constraints responses be sent afterwards. Space limited, the webinar directed specifically applicants the February 18, 2015 due date. Please one phone line per applicant institution. applicants strongly encouraged discuss applications the Scientific/Research contact early the application development process. complete text the FOA available http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-15-002.html. Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sieberb@ninds.nih.gov Birgit Neuhuber, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-3562 Email: neuhuber@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 Frequently Asked Questions Webinar RFA-HL-15-021 Testing Multi-Level Interventions Improve Blood Pressure Control Minority Racial/Ethnic, Low Socioeconomic Status, and/or Rural Populations UH2/UH3)" Notice Number: NOT-HL-14-243 Key Dates Release Date: December 16, 2014 Related Announcements RFA-HL-15-021 Issued National Heart, Lung, Blood Institute NHLBI) National Institute Neurological Disorders Stroke NINDS) PCORI Addressing Disparities Program Addressing Disparities) Purpose purpose this Notice to inform potential applicants NHLBI hold webinar January 9, 2015, 10:30AM EST has posted set answers Frequently Asked Questions FAQs) regarding applications RFA-HL-15-021"Testing Multi-Level Interventions Improve Blood Pressure Control Minority Racial/Ethnic, Low Socioeconomic Status, and/or Rural Populations UH2/UH3)". webinar be available the following access information: Friday, January 9, 10:30AM-12:00PM EST https://webmeeting.nih.gov/r52wnlxf525/ Conference Number 1-877-701-3416 Participant Code: 567394 Frequently Asked Questions available this site: http://www.nhlbi.nih.gov/research/funding/opportunities/faq-foa-HL-15-0… applicants encouraged attend webinar view FAQs prior submitting application. Inquiries Please direct inquiries to: Larry Fine, M.D. National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-0305 Email:  finel@nhlbi.nih.gov Regina Hogle National Heart, Lung, Blood Institute NHLBI) Telephone: 301-451-6325 Email: regina.hogle@nih.gov

Notice Intent Publish Funding Opportunity Announcement BRAIN: Research Opportunities Using Invasive Neural Recording Stimulating Technologies the Human Brain U01) Notice Number: NOT-NS-15-002 Key Dates Release Date: December 8, 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 RFA-NS-15-005 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 initiative Brain Research through Advancing Innovative Neurotechnologies) intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications research Research Opportunities Using Invasive Neural Recording Stimulating Technologies the Human Brain. 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 U01 activity code an award a 3 year project period. Details the planned FOA provided below. Research Initiative Details Human studies using invasive technology record modulate neural circuits require extensive planning expense. a result, studies often constrained a limited number patients resources available implement complex experimental protocols are rarely aggregated a matter sufficient address high-impact neuroscience questions appropriate power. Furthermore, small scale projects rarely identify retain additional sources data beyond primary endpoints, could of high value the wider scientific community. this FOA, NIH seeks address fundamental barriers supporting planning efforts exploratory research studies investigating high-impact questions human neuroscience disorders the human nervous system. Projects should develop multidisciplinary teams maximize opportunities conduct neuroscience research arising invasive surgical procedures provide unique ability record stimulate neurons within precisely localized brain structures humans. Integrated teams should consist clinicians, scientists, device engineers, mathematicians, statisticians, data scientists, regulatory specialists and/or ethics specialists. teams be assembled within single institution, may integrated across multiple institutions answer essential neuroscience questions appropriate statistical power. Awardees also join consortium, coordinated the NIH, identify consensus standards practice well supplemental opportunities collect data ancillary studies, to aggregate standardize data dissemination among wider scientific community. Applications span spectrum experimental studies mechanisms human sensory-motor, perceptual, cognitive, mnemonic, affective, motivational processes, disorders the human nervous system, studies mechanisms action device neuromodulation therapies. Applications should seek understand circuits the brain systematically controlling stimuli while actively recording manipulating relevant dynamic patterns neural activity by measuring resulting behaviors and/or perceptions. Novel innovative approaches theory analysis frameworks expected identify gaps knowledge, build testable hypothesis drive design experiments. Applications expected employ approaches guided specified theoretical constructs, are encouraged employ quantitative, mechanistic models where appropriate. Applications must propose appropriately-regulated, invasive studies humans, including intra-operative procedures during therapeutic/diagnostic implantation devices, short- long-term device implantation procedures. complementary animal component conduct reverse translation mechanistic questions, to perform forward translation tools techniques can only done animal models, be allowed. addition the proposed primary study endpoints, applications should propose solicit input the larger community identify prioritize additional sources data could obtained maximize value these limited opportunities, well generate consensus best practices common data standards data access data sharing including collection, curation, analysis sharing). APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: James Gnadt, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: brain-initiative-FY15-FOA@mail.nih.gov

Notice Correction Regarding Companion Funding Opportunity Information PAR-14-286 quot;NINDS CREATE Bio Discovery Track: Optimization Preparation Development Biotechnology Products Biologics U01)" Notice Number: NOT-NS-15-003 Key Dates Release Date: December 8, 2014 Related Announcements PAR-14-286 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice clarifies information regarding companion funding opportunities PAR-14-286 quot;NINDS CREATE Bio Discovery Track: Optimization Preparation Development Biotechnology Products Biologics U01)". Part 1. Overview Information FOA currently reads: Companion Funding Opportunity PAR-14-288, UH2/UH3 Phase Innovation Awards Cooperative Agreement PAR-14-287, U44 Small Business Innovation Research SBIR) Cooperative Agreement ndash; Fast-Track PAR-14-289, U44 Small Business Innovation Research SBIR) Cooperative Agreement ndash; Fast-Track FOA modified read: Companion Funding Opportunity PAR-14-288, UH2/UH3 Phase Innovation Awards Cooperative Agreement PAR-14-287, U44 Small Business Innovation Research SBIR) Cooperative Agreement ndash; Phase II, Fast-Track PAR-14-289, U44 Small Business Innovation Research SBIR) Cooperative Agreement ndash; Fast-Track other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Hao Wang, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: CREATEinquiries@mail.nih.gov

Notice Correction Regarding Application Types Allowed PAR-14-287 quot;NINDS CREATE Bio Discovery Track: Optimization Preparation Development Biotechnology Products Biologics U44)" Notice Number: NOT-NS-15-004 Key Dates Release Date: December 8, 2014 Related Announcements PAR-14-287 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice clarifies application types allowed PAR-14-287. Part 2. Section II. Award Information FOA currently reads: Application Types Allowed New Fast-Track) Renewal Fast-Track) Resubmission Fast-Track) Revision Fast-Track) FOA modified read: Application Types Allowed New Fast-Track) Renewal Phase II) Resubmission Fast-Track Phase II) Revision Fast-Track Phase II) other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Hao Wang, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: CREATEinquiries@mail.nih.gov

Notice Correction Regarding Companion Funding Opportunity Information PAR-14-288 quot;NINDS CREATE Bio Development Track: Preclinical Early-phase Clinical Development Biotechnology Products Biologics UH2/UH3)" Notice Number: NOT-NS-15-005 Key Dates Release Date: December 8, 2014 Related Announcements PAR-14-288 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice clarifies information regarding companion funding opportunities PAR-14-288 quot;NINDS CREATE Bio Development Track: Preclinical Early-phase Clinical Development Biotechnology Products Biologics UH2/UH3)". Part 1. Overview Information FOA currently reads: Companion Funding Opportunity PAR-14-286, U01 Research Project ndash; Cooperative Agreements PAR-14-287, U44 Small Business Innovation Research SBIR) Cooperative Agreement ndash; Fast-Track PAR-14-289, U44 Small Business Innovation Research SBIR) Cooperative Agreement ndash; Fast-Track FOA modified read: Companion Funding Opportunity PAR-14-286, U01 Research Project ndash; Cooperative Agreements PAR-14-287, U44 Small Business Innovation Research SBIR) Cooperative Agreement ndash; Phase II, Fast-Track PAR-14-289, U44 Small Business Innovation Research SBIR) Cooperative Agreement ndash; Fast-Track other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Hao Wang, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: CREATEinquiries@mail.nih.gov

Notice Correction Regarding Companion Funding Opportunity Information PAR-14-289 quot;NINDS CREATE Bio Development Track: Preclinical Early-phase Clinical Development Biotechnology Products Biologics U44)" Notice Number: NOT-NS-15-006 Key Dates Release Date: December 8, 2014 Related Announcements PAR-14-289 Issued National Institute Neurological Disorders Stroke NINDS)) Purpose Notice clarifies information regarding companion funding opportunities PAR-14-289 quot;NINDS CREATE Bio Development Track: Preclinical Early-phase Clinical Development Biotechnology Products Biologics U44)". Part 1. Overview Information FOA currently reads: Companion Funding Opportunity PAR-14-288, UH2/UH3) Exploratory/Developmental Cooperative Agreement Phase I/ Phase II PAR-14-286, U01) Research Projects - Cooperative Agreements PAR-14-287, U44) Small Business Innovation Research SBIR) Cooperative Agreement ndash; Fast-track only FOA modified read: Companion Funding Opportunity PAR-14-288, UH2/UH3) Exploratory/Developmental Cooperative Agreement Phase I/ Phase II PAR-14-286, U01) Research Projects - Cooperative Agreements PAR-14-287, U44) Small Business Innovation Research SBIR) Cooperative Agreement ndash; Phase II, Fast-Track other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Hao Wang, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: CREATEinquiries@mail.nih.gov