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Notice Correction Regarding Institution Eligibility Requirements RFA-NS-14-013 quot;NINDS Institutional Center Core Grants Support Neuroscience Research P30)" Notice Number: NOT-NS-15-001 Key Dates Release Date: nbsp;October 22, 2014 Related Announcements RFA-NS-14-013 Issued National Institute Neurological Disorders Stroke NINDS)  Purpose Notice clarifies number P30 grants allowed per Institution provides supplemental instructions Section III.3 quot;Additional Information Eligibility" RFA-NS-14-013. Part 2. Section III. Eligibility Information 3. Additional Information Eligibility Currently reads: Number Applications Only application per institution normally identified having unique DUNS number NIH IPF number) allowed. Modified read: Number Applications: Only application per institution normally identified having unique DUNS number NIH IPF number) allowed.  Additionally, institution eligible a maximum one NINDS Center Core Grant. other aspects this FOA remain unchanged. 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 Intent Publish Funding Opportunity Announcement The NINDS Human Biomarkers Biospecimen Repository U2C) Notice Number: NOT-NS-14-051 Key Dates Release Date: October 10, 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 biospecimen banking associated data management biomarkers neurological disorders. Notice intended allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published early 2015 an expected application due date late spring/early summer 2015. FOA utilize U2C activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise biomarkers biospecimen handling data management begin consider applying this new FOA. Collaborative investigations combining expertise data management biospecimen handling be encouraged. Applicants should expertise biospecimen laboratory processes, banking, data management. Experience biomarker research, such evaluation batch effects, protocol development, analyte quality control measures, expected. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Katrina Gwinn, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5745 Email: gwinnk@ninds.nih.gov

Request Information RFI):  B.R.A.I.N. Initiative Public/Private Partnership Accelerate Clinical Access Next-Generation Stimulating/Recording Devices Notice Number: NOT-NS-14-054 Key Dates Release Date: September 26, 2014 Response Date: November 21, 2014 nbsp;  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 Drug Abuse NIDA) National Institute Deafness Other Communication Disorders NIDCD) National Institute Mental Health NIMH) National Center Complementary Alternative Medicine NCCAM) Purpose Brain Research through Advancing Innovative Neurotechnologies BRAIN) Working Group recommended new quot;streamlined path developing, implementing integrating new technologies human neuroscience research, through cooperation clinical academic research teams private companies a pre-competitive space" their landmark report the Advisory Committee the National Institutes Health NIH) Director titled quot;BRAIN 2025: Scientific Vision".  Towards end, NIH interested developing public/private partnerships manufacturers novel significant risk' stimulating and/or recording devices facilitate broad access these devices conduct clinical research. Investigational Device Exemptions IDE) regulation 21 CFR 812) describes three types devices studies: significant risk SR), non-significant risk NSR), exempt studies. Clinical research utilizing SR devices a new indication to answer scientific questions require Investigational Device Exemption IDE) the FDA. Moreover, devices available sale often expanded research capabilities could used accelerate additional clinical research studies, enabling those features require new IDE ensure appropriate in controlled research setting. Due the complexity the manufacturing requirements the statutory requirements market medical devices the U.S., may a period time between initial first-in-human demonstrations a novel technology the market approval clearance required legally market device widespread use.  Although first-in-human studies be sufficient demonstrate safety utility the technology answer clinical research questions a highly controlled environment, additional time before market approval clearance primarily needed conduct Feasibility Pivotal trial demonstrate safety effectiveness a device a specific intended use, typically a statistically justified number subjects.  studies also necessary further understand potential safety risks implanted scale under typical usage conditions adequately evaluate benefit/risk profile the device.      nbsp;  NIH recognizes opportunity work leading academics, clinical researchers, industry the FDA develop streamlined path provide clinical researchers widespread access next-generation technologies have already demonstrated safety Early Feasibility/Proof-of-Concept clinical studies, well enabling capability answer impactful research questions.  particular, NIH interested identifying manufacturers willing share pre-clinical safety technical data support new IDEs clinical research these devices.  is anticipated enabled studies include fundamental human neuroscience research, studies better understand mechanisms action existing therapies, well exploratory studies demonstrate therapeutic potential these existing devices small market indications.        purpose this time-sensitive RFI, issued the Institutes the NIH BRAIN Initiative http://www.nih.gov/science/brain/funding.htm), to seek input interested academic/clinical researchers, regulatory other government agencies, potential industry partners identify key barriers potential opportunities grant earlier broad access significant risk recording and/or stimulating medical devices clinical research.  the intent to address unique manufacturing regulatory burden SR implantable medical devices, scope the RFI limited invasive technologies can stimulate and/or record the brain, for first IDEs already obtained could obtained the very near term.  RFI intended gather relevant information identify interested parties inform follow-on workshop.  RFI workshop lead a subsequent funding opportunity announcement FOA); however, RFI should be construed a funding opportunity. Information Requested NIH invites input stakeholders including not limited researchers academia industry, healthcare professionals, patient advocates advocacy organizations, scientific professional organizations, federal agencies other interested members the public.  Small businesses appropriate technologies especially encouraged provide input.  NIH interested human neuroscience research, novel therapeutic approaches, further understanding the mechanisms action existing therapies, well interdisciplinary approaches span areas. input include is limited the following topics: New and/or ongoing challenges opportunities conducting clinical research utilizing significant risk medical devices either pre-market approval, using expanded research platforms existing market approved devices) Opportunities concerns utilizing public/private partnership structure including intellectual property, common data standards access annotation Extent industry contribution, potentially include free devices technical support, access pre-clinical data support new IDEs, cost-sharing, construction maintenance publically accessible data repositories Additional sources data could obtained supplement limited opportunities available utilize invasive recording/stimulating devices maximize value these studies the wider community to Submit Response ensure consideration, responses must received November 21, 2014, must submitted electronically using web-based format http://braininitiative.nih.gov/rfi-brain-initiative.htm. web format provide confirmation response submission, respondents not receive individualized feedback. Responses this RFI voluntary may submitted anonymously. Please not include any personally identifiable other information you not wish make public. Proprietary, classified, confidential sensitive information should be included your response. Comments be compiled discussion may appear related reports. Any personal identifiers names, e-mail addresses, etc.) be removed responses compiled. RFI for informational planning purposes only should be construed a solicitation as obligation the part the United States US) Government, NIH the NINDS provide support any ideas submitted response it. Please note the US Government, NIH NINDS not pay the preparation any information submitted, for use that information. Inquiries Please direct inquiries to: Kip Ludwig, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: kip.ludwig@nih.gov

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