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Notice Correction the Budget Instructions PAR-15-070 Innovation Grants Nurture Initial Translational Efforts IGNITE): Assay Development Therapeutic Agent Identification Characterization Support Therapeutic Discovery R21/R33)" Notice Number: NOT-NS-15-018 Key Dates Release Date:   March 24, 2015 Related Announcements PAR-15-070 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to correct budget instructions PAR-15-070 quot;Innovation Grants Nurture Initial Translational Efforts IGNITE): Assay Development Therapeutic Agent Identification Characterization Support Therapeutic Discovery R21/R33)". Part 2. Section IV. Application Submission Information instructions currently read: Modular R&R Budget instructions the SF424 R&R) Application Guide must followed. instructions modified read: R&R Budget instructions the SF424 R&R) Application Guide must followed. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Amir Tamiz, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: amir.tamiz@mail.nih.gov

Notice Correction the Budget Instructions PAR-15-071 " Innovation Grants Nurture Initial Translational Efforts IGNITE): Pharmacodynamics In vivo Efficacy Studies Small Molecules Biologics/Biotechnology Products R21/R33)" Notice Number: NOT-NS-15-019 Key Dates Release Date:   March 24, 2015 Related Announcements PAR-15-071 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to correct budget instructions PAR-15-071 quot; Innovation Grants Nurture Initial Translational Efforts IGNITE): Pharmacodynamics In vivo Efficacy Studies Small Molecules Biologics/Biotechnology Products R21/R33) quot;. Part 2. Section IV. Application Submission Information instructions currently read: Modular R&R Budget instructions the SF424 R&R) Application Guide must followed. instructions modified read: R&R Budget instructions the SF424 R&R) Application Guide must followed. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Amir Tamiz, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: amir.tamiz@mail.nih.gov

Request Information RFI) the Draft 2015 Action Plan the Muscular Dystrophies Notice Number: NOT-NS-15-014 Key Dates Release Date: February 13, 2015 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Heart, Lung, Blood Institute NHLBI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Purpose NIH, together the Muscular Dystrophy Coordinating Committee MDCC), leading effort update Action Plan the Muscular Dystrophies, was first released 2005.  have significant advances muscular dystrophy research an update the plan intended reflect progress new challenges opportunities. help inform planning process, NIH the MDCC welcome comments the public regarding draft the 2015 plan. Background NIH’s mission to seek fundamental knowledge the nature behavior living systems the application that knowledge enhance health, lengthen life, reduce illness disability. National Institute Neurological Disorders Stroke NINDS), National Institute Arthritis Musculoskeletal Skin Diseases NIAMS), Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), the National Heart, Lung, Blood Institute NHLBI) fund majority muscular dystrophy-related research NIH work together coordinate muscular dystrophy research activities across NIH.  muscular dystrophies a group hereditary, progressive degenerative disorders causing weakness the skeletal voluntary muscles.  are different forms muscular dystrophy, differ their age onset, severity, pattern muscles other body systems affected.  Among provisions, Muscular Dystrophy Community Assistance, Research, Education Amendments 2001 MD-CARE Act, Public Law 107-84) established MDCC prompted series activities leading the development the Action Plan the Muscular Dystrophies.  Action Plan, developed input an MDCC Scientific Working Group, includes research objectives five areas: Mechanisms Muscular Dystrophy, Diagnosis Screening Muscular Dystrophy, Therapy Muscular Dystrophy, Living Muscular Dystrophy, Research Infrastructure Needs Muscular Dystrophy.  Through individual collaborative activities researchers, clinicians, stakeholders in  muscular dystrophy community, driven, part, the Action Plan, have significant advances understanding disease mechanisms, development new diagnostic tools reduce diagnostic odyssey affected individuals their families, evolution drug discovery development partnerships have advanced candidate therapeutics, improvements the care quality life affected individuals.  While type muscular dystrophy distinctive, has required disease-appropriate activities, has benefited a shared focus the muscular dystrophy community.  this time, are new challenges gaps require revision the original Action Plan the Muscular Dystrophies. Information Requested NIH the MDCC invite muscular dystrophy research, advocacy, family communities provide comments suggestions regarding content organization the draft version the 2015 Action Plan.  collected comments be reviewed considered the MDCC finalizes revised 2015 Action Plan.  to Submit Response Responses this RFI must submitted electronically using web-based format at: http://mdcc.nih.gov/. Responses be accepted until March 10, 2015.  Responses this RFI voluntary.  Submitted information not considered confidential.  Any personal identifiers be removed responses compiled. request for information planning purposes only should be construed a solicitation as obligation the part the Federal Government. NIH does intend make any awards based responses this RFI to otherwise pay the preparation any information submitted for Government's of such information. NIH use information submitted response this RFI its discretion will provide comments any responder’s submission. However, responses the RFI be reflected future funding opportunity announcements. information provided be analyzed may appear reports. Respondents advised the Government under obligation acknowledge receipt the information received 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). Inquiries Please direct inquiries to: Glen H. Nuckolls, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5745 Email: glen.nuckolls@nih.gov

Notice the Change Application Due Dates PAR-13-240 NINDS Research Education Opportunities R25)" Notice Number: NOT-NS-15-013 Key Dates Release Date: January 30, 2015 Related Announcements PAR-13-240 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice changes application due dates PAR-13-240 NINDS Research Education Opportunities R25)". Key Dates section PAR-13-240 been revised follows: Current Key Dates: Part 1. Key Dates Posted Date June 7, 2013 Open Date Earliest Submission Date) August 25, 2013 Letter Intent Due Date(s) Applicable Application Due Date(s) Standard dates apply AIDS Application Due Date(s) Applicable Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date September 8, 2016 Due Dates E.O. 12372 Applicable   Modified Key Dates: Part 1. Key Dates Posted Date June 7, 2013 Open Date Earliest Submission Date) August 25, 2013 Letter Intent Due Date(s) Applicable Application Due Date(s) August 25, 2015, August 26, 2016 AIDS Application Due Date(s) Applicable Scientific Merit Review November 2015, November 2016 Advisory Council Review January 2016, January 2017 Earliest Start Date March 2016, March 2017 Expiration Date August 27, 2016 Due Dates E.O. 12372 Applicable other aspects this FOA remain same. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov

Notice the Extension the Expiration Date PAR-12-152 NINDS Faculty Development Award Promote Diversity Neuroscience Research K01)" Notice Number: NOT-NS-15-011 Key Dates Release Date: January 21, 2015 Related Announcements PAR-12-152 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice extends expiration date PAR-12-152 quot;NINDS Faculty Development Award Promote Diversity Neuroscience Research K01)" one receipt cycle. Current Expiration Date: 8, 2015 New Expiration Date: September 8, 2015 Inquiries Please direct inquiries to: Michelle Jones-London, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-451-7966 Email: jonesmiche@ninds.nih.gov

Notice the Extension the Expiration Date PAR-12-163 NINDS Advanced Postdoctoral Career Transition Award Promote Diversity Neuroscience Research K22)" Notice Number: NOT-NS-15-012 Key Dates Release Date: January 21, 2015 Related Announcements PAR-12-163 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice extends expiration date PAR-12-163 quot;NINDS Advanced Postdoctoral Career Transition Award Promote Diversity Neuroscience Research K22)" one receipt cycle. Current Expiration Date: 8, 2015 New Expiration Date: September 8, 2015 Inquiries Please direct inquiries to: Michelle Jones-London, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-451-7966 Email: jonesmiche@ninds.nih.gov nbsp;

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