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Notice Intent Publish Funding Opportunity Announcement The NINDS Human Cell Resource Repository U42) Notice Number: NOT-NS-14-052 Key Dates Release Date:   September 25, 2014 Estimated Publication Date Announcement: January 2015   First Estimated Application Due Date: March 2015       Earliest Estimated Award Date: October 2015      Earliest Estimated Start Date: October 2015      Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications will support development a human cell resource repository focused derivation, standardized quality assessment, biobanking, data management distribution human iPSC fibroblast lines identified unique high value resources the neuroscience community for study neurological disorders Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published the winter 2015 an expected application due date spring 2015.   FOA utilize U42 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights the areas human iPSC derivation multiple human biospecimen sources including not limited fibroblasts peripheral blood mononucleated cells PBMCs), fibroblast derivation skin biopsies, iPSC genomic modification/editing, biobanking begin consider applying this new FOA. addition, collaborative investigations combining expertise iPSC derivation data patent/ licensing management around technologies related iPSC derivation genome editing be encouraged these investigators should also begin consider applying this application. Among areas research encouraged this initiative stem cell biology, biobanking, data management, genome editing, quality assessment standards iPSC fibroblasts lines, community outreach.  Knowledge application new technologies iPSC line generation, modification quality assessment contribute best practice paradigms this rapidly evolving field encouraged. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Margaret Sutherland, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sutherlandm@ninds.nih.gov

Notice Intent Publish Funding Opportunity Announcement NINDS Morris K. Udall Centers Excellence Parkinson's Disease Research P50) Notice Number: NOT-NS-14-053 Key Dates Release Date: nbsp;September 25, 2014 Estimated Publication Date Announcement: nbsp;November 2014  First Estimated Application Due Date: nbsp;January 2015 Earliest Estimated Award Date: nbsp;July 2015  Earliest Estimated Start Date: nbsp;July 2015  Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) continue Morris K. Udall Centers Excellence Parkinson's Disease Research program publishing Funding Opportunity Announcement FOA) new renewal applications. purpose this Notice to alert potential applicants to provide sufficient lead time the development responsive projects. FOA utilize Specialized Center P50) activity code, will support spectrum basic, translational clinical research activities utilizing integrated, multidisciplinary approach a specific disease entity, Parkinson's Disease PD). is anticipated this FOA be published autumn 2014 an expected application due date winter 2015. Research Initiative Details NINDS intends solicit new renewal applications the Morris K. Udall Centers Excellence Parkinson’s Disease Research program, consortium specialized Centers work collaboratively well independently define causes and discover improved treatments this disease. Individual Centers establish unique, interdisciplinary programs optimize available expertise basic, translational clinical research required advance PD research. overall theme, proposed research projects integral cores each Center relate directly the etiology, pathogenesis treatment PD. considerable degree collaboration among investigators required achieve overarching objectives each Center. application must address relevance the research recommendations the NINDS conference quot;Parkinson's Disease 2014: Advancing Research, Improving Lives." Notably, Centers Excellence, Udall Centers serve regional national resources PD research. Successful applicants participate the network existing Udall Centers foster translation scientific findings novel treatments PD. Applicants request maximum annual direct costs 1,500,000. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sieberb@ninds.nih.gov

Notice Extend Expiration Date PAR-12-072 quot;NINDS Exploratory Clinical Trials Small Business STTR R42])" Notice Number: NOT-NS-14-049 Key Dates Release Date: nbsp; September 18, 2014 Related Announcements PAR-12-072 Issued National Institute Neurological Disorders Stroke NINDS) nbsp;  Purpose Notice extends expiration date PAR-12-072 quot;NINDS Exploratory Clinical Trials Small Business STTR R42])", one funding cycle. Current Expiration Date: January 8, 2015 New Expiration Date: 8, 2015 Inquiries Please direct inquiries to: Stephanie Fertig National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov

Notice Extend Expiration Date PAR-12-073 quot;NINDS Exploratory Clinical Trials Small Business SBIR R44])" Notice Number: NOT-NS-14-050 Key Dates Release Date: September 18, 2014 nbsp; Related Announcements PAR-12-073 Issued National Institute Neurological Disorders Stroke NINDS) nbsp;  Purpose Notice extends expiration date PAR-12-073 quot;NINDS Exploratory Clinical Trials Small Business SBIR R44])", one funding cycle. Current Expiration Date: January 8, 2015 New Expiration Date: 8, 2015 Inquiries Please direct inquiries to: Stephanie Fertig National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov

Notice NINDS's Participation RFA-MH-15-800 Consortium Biomarker Outcome Measures Social Impairment Use Clinical Trials Autism Spectrum Disorder U19)" Notice Number: NOT-NS-14-045 Key Dates Release Date:   September 16, 2014 Related Announcements RFA-MH-15-800 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the participation the National Institute Neurological Disorders Stroke NINDS) RFA-MH-15-800 quot;Consortium Biomarker Outcome Measures Social Impairment Use Clinical Trials Autism Spectrum Disorder U19)". following sections RFA-MH-15-800 been updated reflect participation NINDS this FOA: Part 1. Overview Information Components Participating Organizations National Institute Mental Health NIMH) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.242, 93.865, 93.853 Part 2. Section II. Award Information Funds Available Anticipated Number Awards NIMH, NICHD NINDS intend commit 4,050,000 direct costs FY 2015 fund award. Part 2. Section VII. Agency Contacts Scientific/Research Contact(s) Deborah G Hirtz, M.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5821 Email: hirtzd@ninds.nih.gov Financial/Grants Management Contact(s) Tijuanna 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: Deborah G Hirtz, M.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5821 Email: hirtzd@ninds.nih.gov

Notice Correction PAR-14-297 NINDS CREATE Devices: Translational Clinical Studies Inform Final Device Design UH2/UH3)" Notice Number: NOT-NS-14-046 Key Dates Release Date: September 12, 2014 Related Announcements PAR-14-297 Issued National Institute Neurological Disorders Stroke NINDS) Purpose July 28, 2014, NINDS published Funding Opportunity Announcement PAR-14-297 quot;NINDS CREATE Devices: Translational Clinical Studies Inform Final Device Design UH2/UH3)". purpose this Notice to correct information the eligibility foreign institutions. following sections PAR-14-297 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-14-295 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;