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Notice Correction PAR-14-295 NINDS CREATE Devices: Translational Clinical Studies the Path 510(k) UH2/UH3)" Notice Number: NOT-NS-14-047 Key Dates Release Date:   September 12, 2014 Related Announcements PAR-14-295 Issued National Institute Neurological Disorders Stroke NINDS) Purpose July 28, 2014, NINDS published Funding Opportunity Announcement PAR-14-295 quot;NINDS CREATE Devices: Translational Clinical Studies the Path 510(k) UH2/UH3)". purpose this Notice to correct information the eligibility foreign institutions. following sections PAR-14-295 modified this Notice allow applications foreign institutions: Part 2. Section III. Eligibility Information 1. Eligible Applicants Non-domestic non-U.S.) Entities Foreign Institutions) Foreign Institutions Non-domestic non-U.S.) Entities Foreign Institutions) eligible apply. Non-domestic non-U.S.) components U.S. Organizations eligible apply. Foreign components, defined the NIH Grants Policy Statement, allowed. Part 2. Section IV. Application Submission Information 2. Content Form Application Submission Foreign Institutions Foreign non-U.S.) institutions must follow policies described the NIH Grants Policy Statement, procedures foreign institutions described throughout SF424 R&R) Application Guide. other aspects this FOA remain same. Inquiries Please direct inquiries to: Stephanie Fertig National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov Kip Ludwig Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: kip.ludwig@nih.gov

Notice Correction PAR-14-298 NINDS CREATE Devices: Translational Early Feasibility Studies the Path Pre-Market Approval PMA) Humanitarian Device Exemption HDE) UH2/UH3)" Notice Number: NOT-NS-14-048 Key Dates Release Date:   September 12, 2014 Related Announcements PAR-14-298 Issued National Institute Neurological Disorders Stroke NINDS) Purpose July 28, 2014, NINDS published Funding Opportunity Announcement PAR-14-298 quot;NINDS CREATE Devices: Translational Early Feasibility Studies the Path Pre-Market Approval PMA) Humanitarian Device Exemption HDE) UH2/UH3)". purpose this Notice to correct information the eligibility foreign institutions. following sections PAR-14-298 modified this Notice allow applications foreign institutions: Part 2. Section III. Eligibility Information 1. Eligible Applicants Non-domestic non-U.S.) Entities Foreign Institutions) Foreign Institutions Non-domestic non-U.S.) Entities Foreign Institutions) eligible apply. Non-domestic non-U.S.) components U.S. Organizations eligible apply. Foreign components, defined the NIH Grants Policy Statement, allowed. Part 2. Section IV. Application Submission Information 2. Content Form Application Submission Foreign Institutions Foreign non-U.S.) institutions must follow policies described the NIH Grants Policy Statement, procedures foreign institutions described throughout SF424 R&R) Application Guide. other aspects this FOA remain same. Inquiries Please direct inquiries to: Stephanie Fertig National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov Kip Ludwig Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: kip.ludwig@nih.gov

Notice Inform Potential Applicants RFA-NS-14-006 High Impact Neuroscience Research Resource Grants R24)" NINDS Policies Induced Pluripotent Stem Cell Development Resource Sharing Notice Number: NOT-NS-14-044 Key Dates Release Date: September 5, 2014 Related Announcements RFA-NS-14-006 NOT-NS-14-032 Issued National Neurological Disorders Stroke NINDS) Purpose Notice directed potential applicants RFA-NS-14-006 quot;High Impact Neuroscience Research Resource Grants R24)." purpose to provide information clarification regarding recent update NINDS guidelines best practices developing distributing induced pluripotent stem cell iPSC) lines, described NOT-NS-14-032 quot;NINDS Requirements Induced Pluripotent Stem Cell Development Resource Sharing." indicated NOT-NS-14-032, NINDS expects investigators developing iPSC lines follow specific best practice guidelines quality control Freedom Operate conditions sharing cell lines. NINDS also expects investigators verify lines proposed development not already publicly available repositories such those maintained NINDS, NIMH, NIGMS, public collections. addition these requirements, Notice indicates NINDS not currently prioritizing applications are focused primarily developing iPSC lines resources. limited circumstances, applications proposing exceptional opportunities dissemination iPSCs related resources be appropriate, investigators expected provide strong justification to why unique circumstances warrant separate iPSC resource. general, expect iPSC development be proposed within context specific research project aims, that utility overall value the proposed lines be established the perspective anticipated research outcomes. Potential applicants RFA-NS-14-006 urged contact NINDS Program staff and/or Scientific/Research Contact the FOA also listed below this Notice) discuss potential relevance a particular resource the FOA. Inquiries Please direct inquiries to: Edmund Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email: TalleyE@mail.nih.gov

Notice Clarification NINDS Policy the Submission Multi-site Clinical Trials Stroke Treatment, Recovery, Prevention Notice Number: NOT-NS-14-043 Key Dates Release Date:   August 26, 2014 Related Announcements PAR-14-220 PAR-14-252 PAR-14-253 Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS established NIH Stroke Clinical Trials Research Network NIH StrokeNet) facilitate rapid initiation efficient implementation NINDS-funded stroke trials. network specifically designed harness multidisciplinary stroke expertise conduct exploratory i.e., phase 1 2) confirmatory i.e., phase 3) clinical trials acute stroke treatment, stroke recovery rehabilitation, primary secondary stroke prevention; may include so-called pragmatic trials performed large numbers patients minimal alteration clinical practice low per-patient costs.  Exploratory clinical trials must include clearly defined go/no-go pathway toward advancement a future phase 3 trial. addition, network support studies validate biomarkers demonstrated promise inform phase 2 clinical trials. While additional sites outside the StrokeNet network Regional Coordinating Centers be required, NINDS expects any phase 3 trial proposed and subsequently conducted within network utilize most all the Regional Coordinating Centers.  Exploratory trials biomarker validation studies expected use least 5 Regional Coordinating Centers should feasible within network the addition relatively few non-StrokeNet sites note the applicant institution, not StrokeNet site, be included a performance site the study). final number sites needed a proposed study be determined following feasibility assessment the StrokeNet. NINDS issued three companion Funding Opportunity Announcements PAR-14-220, PAR-14-252, PAR-14-253) which relevant applications should submitted. Only exceptional circumstances NINDS consider funding multi-site stroke clinical trials outside this program.  Individuals interested applying NINDS funding a clinical trial stroke treatment, recovery, prevention strongly advised contact NINDS least 3 months advance a planned submission determine appropriate funding mechanism their application. Inquiries Please direct inquiries to: Claudia Scala Moy, PhD National Institute Neurological Disorders amp; Stroke NINDS) Telephone: 301-496-9135 Email: moyc@ninds.nih.gov nbsp;

Notice Intent Publish Limited Competition Announcement Applications Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network U54) Notice Number: NOT-NS-14-042 Key Dates Release Date: August 8, 2014 Estimated Publication Date Announcement: October 2014   First Estimated Application Due Date: December 2014  Earliest Estimated Award Date: July 2015  Earliest Estimated Start Date: July 2015  Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Center Advancing Translational Sciences NCATS) Purpose National Institute Neurological Disorders Stroke NINDS), the Office Rare Diseases Research ORDR) the National Center Advancing Translational Sciences NCATS), intend publish Funding Opportunity Announcement FOA) solicit applications research rare diseases via Rare Diseases Clinical Research Network.  FOA be limited competition available only Program Directors/Principal Investigators received previous NINDS award under Rare Disease Clinical Research Network program who recently submitted renewal type 2) application response RFA-TR-13-002. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published the fall 2014 an anticipated application due date December 2014. FOA utilize U54 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights the area rare neurological disorders begin consider applying this limited competition FOA. objective to facilitate clinical research rare diseases through support for: 1) collaborative clinical research rare diseases, including longitudinal studies individuals rare diseases, clinical studies and/or phase and II trials; 2) training clinical investigators rare diseases research; 3) pilot demonstration projects; 4) access information related rare diseases basic clinical researchers, academic practicing physicians, patients, the lay public.  total project period an application submitted response this FOA not exceed 4 years. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Laura A. Mamounas, Ph.D. National Institute Neurological Disorders & Stroke NINDS) Telephone: 301-496-5745 Email: mamounas@ninds.nih.gov  

Notice NINDS's Participation RFA- AG-15-016 Paul B. Beeson Clinical Scientist Development Award Aging K08)" Notice Number: NOT-NS-14-040 Key Dates Release Date:  August 6,, 2014 Related Announcements RFA-AG-15-016 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participation, effective immediately, RFA-AG-15-016 quot;Paul B. Beeson Clinical Scientist Development Award Aging K08)" following sections RFA-AG-15-016 been updated reflect participation NINDS this FOA: Part 1. Overview Information Components Participating Organizations National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.866, 93.853 Part 2. Section II. Award Information Funds Available Anticipated Number Awards National Institute Aging the National Institute Neurological Disorders Stroke intend combination) commit approximately 1 million FY 2014 support 5 7 awards. number awards contingent upon NIH appropriations, the submission a sufficient number meritorious applications. Part 2. Section VII. Agency Contacts Scientific/Research Contact(s) Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov Financial/Grants Management Contact(s) Tijuana Decoster, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9231 Email: decostert@ninds.nih.gov other aspects this FOA remain unchanged. 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 NINDS's Participation RFA- AG-15-017 Paul B. Beeson Patient-Oriented Research Career Development Award Aging K23)" Notice Number: NOT-NS-14-041 Key Dates Release Date: August 6, 2014 Related Announcements RFA-AG-15-017 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participation, effective immediately, RFA-AG-15-017 quot;Paul B. Beeson Patient-Oriented Research Career Development Award Aging K23)" following sections RFA-AG-15-017 been updated reflect participation NINDS this FOA: Part 1. Overview Information Components Participating Organizations National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.866, 93.853 Part 2. Section II. Award Information Funds Available Anticipated Number Awards National Institute Aging the National Institute Neurological Disorders Stroke intend combination) commit approximately 1 million FY 2014 support 5 7 awards. number awards contingent upon NIH appropriations, the submission a sufficient number meritorious applications. Part 2. Section VII. Agency Contacts Scientific/Research Contact(s) Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov Financial/Grants Management Contact(s) Tijuana Decoster, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9231 Email: decostert@ninds.nih.gov other aspects this FOA remain unchanged. 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 the Change the Expiration Date PA-11-347 NINDS SBIR Technology Transfer SBIR-TT R43/R44])" Notice Number: NOT-NS-14-038 Key Dates Release Date: July 18, 2014 Related Announcements PA-11-347 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform applicants the change the expiration date PA-11-347 quot;NINDS SBIR Technology Transfer SBIR-TT R43/R44])" previous expiration date September 8, 2014. new expiration date be January 8, 2015. other aspects PA-11-347 remain unchanged. Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1997 Email: fertigs@ninds.nih.gov

Notice Intent Publish Funding Opportunity Announcement FOA) Senator Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers U54) Notice Number: NOT-AR-15-001 Key Dates Release Date: July 9, 2014 Estimated Publication Date Announcement: August 2014 First Estimated Application Due Date: November 2014 Earliest Estimated Award Date: June 2015 Earliest Estimated Start Date: July 2015 Related Announcements None Issued National Heart, Lung, Blood Institute NHLBI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Arthritis Musculoskeletal Skin Diseases NIAMS), the Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), National Heart, Lung Blood Institute NHLBI) the National Institute Neurological Disorders Stroke NINDS), intend promote ongoing initiative publishing Funding Opportunity Announcement FOA) solicit new renewal applications Wellstone Muscular Dystrophy Cooperative Research Centers. NIH expects make to three Center awards response this upcoming FOA, contingent upon scientific merit the applications availability funds. NIH established Centers Excellence program 2003 part an ongoing effort enhance intensify research the muscular dystrophies. Centers described the MD-CARE Act Public Law 107-84 2001 110-361 2008), were named honor the late Senator Paul D. Wellstone. theme each Center must focus one more the muscular dystrophies, include Duchenne, Becker, myotonic, facioscapulohumeral, limb-girdle, congenital, oculopharyngeal, Emery-Dreifuss others. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published the summer 2014 an expected due date fall 2014. FOA utilize U54 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights translational clinical muscular dystrophy research consider organizing collaborative groups prepare applications this FOA. Successful applicants foster translation new scientific findings technological developments novel treatments other strategies improving lives muscular dystrophy patients. Center should involve clinical research direct interactions between researchers muscular dystrophy patients. Appropriate clinical studies include natural history studies, biomarker development, early stage clinical trials, patient-oriented studies facilitate future trials, biopsychosocial studies, health services research, etc. Center also contain basic and/or preclinical translational research, long efforts directed toward steps required the development therapies, including therapeutic target identification, characterization validation; development pharmacodynamic biomarkers surrogate endpoints; animal model development characterization; candidate therapeutic screening, optimization FDA-required activities leading an investigational new drug IND) application. Applicants should propose multi-disciplinary collaborative studies will significantly accelerate progress toward effective treatments other improvements patients' lives. Research problems should require substantial collaborative efforts solve, thus best carried in center setting. Center should at least core facility shares services resources the national international muscular dystrophy research community, another core promotes career development junior researchers, well patient community outreach activities. Centers supported through FOA participate annual meetings the Centers the program promote communication collaborations. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries Glen H. Nuckolls, Ph.D. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-4974 Email: nuckollg@mail.nih.gov John D. Porter, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5739 Email: porterjo@ninds.nih.gov Tiina Urv, Ph.D. Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-402-7015 Email: tu36j@nih.gov Jonathan R. Kaltman, M.D. National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-0510 Email: kaltmanj@nhlbi.nih.gov nbsp;

Notice Intent Publish Funding Opportunity Announcement Institutional Center Core Grants Support Neuroscience Research P30) Notice Number: NOT-NS-14-037 Key Dates Release Date: June 19, 2014 Estimated Publication Date Announcement: August, 2014 First Estimated Application Due Date: October, 2014 Earliest Estimated Award Date: June, 2015 Earliest Estimated Start Date: July, 2015 Related Announcements PAR-13-116 Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS intends publish Funding Opportunity Announcement FOA) solicit applications Institutional Center Core Grants Support Neuroscience Research. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published summer 2014 an expected application due date fall 2014. FOA utilize P30 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages applicant organizations having minimum six NINDS R01-supported investigators, plus wider base neuroscience research labs, consider applying an upcoming FOA P30 Institutional Center Core Grants NINDS. applications should propose core resources facilities offering services expertise would difficult impractical support individual labs, should capitalize economies synergies associated resource sharing. Potential applicants encouraged consult PAR-13-116 NINDS Institutional Center Core Grants Support Neuroscience Research) general guidance core suitability eligibility. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Edmund Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email: TalleyE@ninds.nih.gov