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Notice Participation Additional NIH Institutes Centers PAR-13-208 Countermeasures Against Chemical Threats CounterACT) Cooperative Research Projects U01) Notice Number: NOT-NS-13-029 Key Dates Release Date: 14, 2013 Related Announcements PAR-13-208 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the participation additional NIH Institutes, effective immediately, Funding Opportunity Announcement FOA) PAR-13-208. following sections PAR-13-208 been updated reflect participation NEI, NIAID, NIAMS, NIEHS this FOA. Part 1. Overview Information Components Participating Organizations National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.853; 93.867; 93.855; 93.856; 93.846; 93.113; 93.859  Part 2. Section VII. Agency Contacts Scientific/Research Contact(s)       Houman Araj, Ph.D. National Eye Institute NEI) Telephone: 301-451-2020 Email: arajh@nei.nih.gov Gennady E. Platoff Jr., Ph.D. National Institute Allergy amp; Infectious Diseases NIAID) Telephone: 301-451-4418 Email: platoffg@niaid.nih.gov Hung Tseng, Ph.D. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5032 Email: tsengh@mail.nih.gov Srikanth S. Nadadur, Ph.D. National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-5327 Email: nadadurs@niehs.nih.gov Financial/Grants Management Contact(s) William W. Darby Grants Management Branch National Eye Institute NEI) Telephone: 301-451-2020 Email: darbyw@mail.nih.gov Victoria Connors Grants Management Branch National Institute Allergy amp; Infectious Diseases NIAID) Telephone: 301-402-5065 Email: connorssv@niaid.nih.gov Melinda B. Nelson Grants Management Branch National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-435-5278 Email: nelson@mail.nih.gov Lisa Archer Edwards, MBA Grants Management Branch National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-0751  Email:  archer@niehs.nih.gov Inquiries Please direct inquiries to: David A. Jett, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-6035  Email: jettd@ninds.nih.gov

Notice Correction the Review Selection Process RFA-NS-13-014 quot;Pilot Projects Sports-Related Brain Spinal Cord Injury R21)" Notice Number: NOT-NS-13-025 Key Dates Release Date:  April 19, 2013   Related Announcements RFA-NS-13-014    Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) correcting process the selection grants fund RFA-NS-13-014 quot;Pilot Projects Sports-Related Brain Spinal Cord Injury R21)" include review the NIH Institute's Advisory Council which grant been given primary assignment. CURRENTLY READS: Review Selection Process Following initial peer review, recommended applications receive second level review the National Advisory Neurological Disorders Stroke NANDS) Council. CHANGED READ: Review Selection Process Following initial peer review, recommended applications receive second level review the NIH Institute's Advisory Council which grant been given primary assignment. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Ramona Hicks, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: hicksra@mail.nih.gov

Notice Correction the Review Selection Process RFA-NS-13-015 quot;Pilot Projects Sports-Related Brain Spinal Cord Injury R03)" Notice Number: NOT-NS-13-026 Key Dates Release Date:   April 19, 2013 Related Announcements RFA-NS-13-015     Issued National Institute Neurological Disorders Stroke NINDS)) Purpose National Institute Neurological Disorders Stroke NINDS) correcting process the selection grants fund RFA-NS-13-015 quot;Pilot Projects Sports-Related Brain Spinal Cord Injury R03)" include review the NIH Institute's Advisory Council which grant been given primary assignment. CURRENTLY READS: Review Selection Process Following initial peer review, recommended applications receive second level review the National Advisory Neurological Disorders Stroke NANDS) Council. CHANGED READ: Review Selection Process  Following initial peer review, recommended applications receive second level review the NIH Institute's Advisory Council which grant been given primary assignment. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Ramona Hicks, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: hicksra@mail.nih.gov

Notice Clarification Responsive Projects RFA-NS-13-009 quot;High Impact Neuroscience Research Resource Grants R24)" Notice Number: NOT-NS-13-024 Key Dates Release Date: April 12, 2013 Related Announcements RFA-NS-13-009 NOT-MH-12-020 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify project eligibility for RFA-NS-13-009 "High Impact Neuroscience Research Resource Grants R24)".   accordance a recent change funding support repositories brain related bio-specimens NOT-MH-12-020), NINDS not accept applications proposing activities submitted response RFA-NS-13-009 . Inquiries Please direct inquiries to: Edmund Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email strongly preferred): TalleyE@mail.nih.gov

Notice Extend Expiration Date PAR-10-199 quot;NINDS Exploratory Clinical Trials R01)" Notice Number:  NOT-NS-13-022 Key Dates Release Date: March 25, 2013 Related Announcements PAR-10-199 Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS gives notice the extension the expiration date PAR-10-199 quot;NINDS Exploratory Clinical Trials R01)" until September 8, 2013. Current Expiration Date: 8, 2013 New Expiration Date: September 8, 2013 other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Peter R. Gilbert, Sc.M. National Institute Neurological Disorders Stroke Telephone: 301) 496-0870 Email: Peter.Gilbert@nih.gov

Notice Extend Expiration Date PAR-11-173 quot;NINDS PHASE III Investigator-Initiated Multi-Site Clinical Trials U01)" Notice Number: NOT-NS-13-023 Key Dates Release Date:   March 25, 2013   Related Announcements PAR-11-173 Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS gives notice the extension the expiration date PAR-11-173 quot;NINDS PHASE III Investigator-Initiated Multi-Site Clinical Trials U01)" until September 8, 2013. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Scott Janis, PhD National Institute Neurological Disorders Stroke Telephone: 301) 496-9135 Email: Scott.Janis@nih.gov

Pre-application Information Webinars the NINDS Stroke Trials Network Notice Number: NOT-NS-13-021 Key Dates Release Date: March 22, 2013 Related Announcements RFA-NS-13-011 RFA-NS-13-012 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants pre-application webinars provide submission information the NINDS Stroke Trials Network. new network designed develop conduct high-quality, multi-site clinical trials focused key interventions stroke prevention, treatment, recovery the objective have balanced portfolio between three approaches.  Exploratory phase 1, 2 confirmatory phase 3 clinical trials well biomarker-validation studies are immediately preparatory trials be coordinated through separate National Clinical Coordinating Data Management Centers. intent the webinars to provide overview the initiative to address questions pertinent preparing applications.  webinars optional not required application submission. Webinars Information Date: Monday, April 1, 2013 Time: 12:00 PM - 1:00 PM EDT Meeting URL: https://www2.gotomeeting.com/join/407718530 Call-in number: 800-779-5339 Participant passcode: 53789 Date: Friday, April 5, 2013 Time: 12:00 PM - 1:00 PM EDT Meeting URL: https://www2.gotomeeting.com/join/521813330 Call-in number: 800-779-5339 Participant passcode: 53789 Space limited. Questions be submitted email either beforehand during webinar.  Please put Webinar question” the subject line, send the following email address: Stroke_Network@mail.nih.gov. While every effort be to answer questions during webinar, is possible not will addressed during meeting due time constraints. applicants strongly encouraged discuss applications the appropriate NIH Scientific/Research Contact Financial/Grants Management Contact listed the FOA early possible. complete text the FOAs available http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-13-011.html http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-13-012.html. Inquiries Please direct inquiries to: Scott Janis, PhD Program Director NINDS Office Clinical Research Telephone: 301-496-9135 Email: Scott.Janis@nih.gov

Notice Modification the Data Sharing Policy the Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System Notice Number: NOT-NS-13-018 Key Dates Release Date:  March 21, 2013 Related Announcements NOT-NS-12-016 NOT-NS-12-017    Issued National Institute Neurological Disorders Stroke NINDS) Purpose Data Sharing Policy the Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System modified. overall document been shortened reorganized make clearer more concise.  Also, Data Submission Data Sharing Schedules been modified greater clarity feasibility follows:   Data Submission Schedule Data include research clinical assessments information obtained via interviews, direct observations, laboratory tasks procedures, records reviews, genetic genomic data, neuroimaging data, neuropsychological assessments, data physical examinations, etc. addition, supporting documentation is needed enable investigator unfamiliar the dataset understand use data also required.  example, supporting documentation include non-copyrighted data collection forms, study procedures protocols, data dictionary rationale, exclusion criteria, website references, listing major study publications, the definition a genomic analysis protocol.  following not included data:  laboratory notebooks, preliminary analyses, drafts scientific papers, plans future research, peer review reports, communications colleagues, physical objects, such gels laboratory specimens. data be submitted FITBIR a quarterly basis according the following schedule: Data collection period Quarterly upload due: January 1 – March 31 June 30 April 1 – June 30 September 30 July 1 – September 30 December 31 October 1 – December 31 March 31 Data Sharing Schedule Six months after end the performance period the grant, data be available other researchers have submitted data FITBIR Submitters). Twelve months after end the grant contract, data be open all qualified approved researchers Recipients). Performance Period Research Study Ends Data Available FITBIR Submitters” Data Available All Approved FITBIR Data Recipients” Time 0   6 months 12 months Investigators also strongly encouraged collaborate share data throughout study accelerate research advance knowledge TBI. Inquiries Please direct inquiries to: FITBIR Operations Team Email: FITBIR-ops@mail.nih.gov Website: https://fitbir.nih.gov/ 

Notice Change Eligibility Foreign Institutions NINDS RFA-NS-13-013 quot;Collaborative Research Chronic Traumatic Encephalopathy Delayed Effects Traumatic Brain Injury: Neuropathology Neuroimaging Correlation U01)" Notice Number:  NOT-NS-13-019 Key Dates Release Date:  March 21, 2013 Related Announcements RFA-NS-13-013    Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) expanding institutional eligibility RFA-NS-13-013 quot;Collaborative Research Chronic Traumatic Encephalopathy Delayed Effects Traumatic Brain Injury: Neuropathology Neuroimaging Correlation U01)" include foreign components within applications US entities. Part II. Section III.1 Eligible Applicants CURRENTLY READS: Foreign Institutions Non-domestic non-U.S.) Entities Foreign Institutions) not eligible apply. Non-domestic non-U.S.) components U.S. Organizations not eligible apply. Foreign components, defined the NIH Grants Policy Statement, not allowed CHANGED READ: Foreign Institutions Non-domestic non-U.S.) Entities Foreign Institutions) not eligible apply. Non-domestic non-U.S.) components U.S. Organizations not eligible apply. Foreign components, defined the NIH Grants Policy Statement, allowed. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Ramona Hicks, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: hicksra@mail.nih.gov

Plan Include Parkinson's Disease Biomarkers Projects the NINDS Parkinson's Disease Biomarkers Program PDBP) Notice Number: NOT-NS-13-020 Update: following update relating this announcement been issued: 8, 2014 - Notice NOT-NS-14-027. Notice Intent Publish Funding Opportunity Announcement Biomarker Discovery through Use Data Resources Developed the NINDS Parkinson's Disease Biomarker Program PDBP) U01). Key Dates Release Date: March 20, 2013 Issued National Institute Neurological Disorders Stroke NINDS) Purpose creation the NINDS Parkinson’s Disease Biomarkers Program PDBP) resulted an opportunity a common platform exchanging data, protocols, biospecimens Parkinson’s Disease PD) Biomarkers Research. NINDS expects projects studying Parkinson’s Disease biomarkers utilize PDBP Data Management Resource DMR), NINDS created order accelerate progress this field. Background overall goal the NINDS Parkinson’s Disease Biomarkers Program PDBP)  to allow rapid identification development potential biomarkers improve efficiency outcome Phase II III clinical trials neuroprotective agents Parkinson’s Disease.  order accomplish goal, is essential there a concerted effort collect biospecimens, imaging, clinical data using standardized approaches.  Furthermore, collaborative environment be essential success this program; therefore sharing standards policies been established. Brief Summary PDBP Policies Details regarding PDBP structure policies be found https://pdbp.ninds.nih.gov/index.jsp.  brief selection policy highlights includes: Clinical laboratory data expected be entered and shared via PDBP Data Management Resource DMR). Costs related utilization this resource, any costs associated the inclusion legacy data, should included the application budget. Clinical studies expected use core set defined NINDS Clinical Data Elements CDEs), https://pdbp.ninds.nih.gov/jsp/healthcare-professionals.jsp. Note clinical trials interventional studies) not included the PDBP. studies have both interventional a biomarkers component, latter component be expected participate per specifications this notice the PDBP. Consent forms clinical studies should consistent those listed https://pdbp.ninds.nih.gov/assets/PDBP%20DMR%20Consent%20Elements.pdf. eligible biological specimens expected be banked the NINDS Repository. Sharing data biospecimens qualified researchers both academics industry expected.    Selected NINDS grantees be invited attend meetings per year discuss PDBP progress policy, be included the PDBP Steering Committee, a part the consortium. Plans the costs attending to PDBP organizational meetings per year should included the application budget. Implementation policy apply all NINDS projects PD Biomarkers research including R01, U01, P50, P01, other mechanisms). Because extensive programmatic input coordination required NINDS PDBP projects, successful applications be converted cooperative agreements U mechanism). Applicants are proposing PD biomarker studies urged contact NINDS program director prior submission order allow ample planning coordination the PDBP with PDBP policies. Inquiries Please direct inquiries to: Katrina Gwinn, MD Program Director Division Extramural Research National Institute Neurological Disorders Stroke Telephone: 301-496-5745 Email: gwinnk@ninds.nih.gov Website: Pdbp.ninds.nih.gov