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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

Notice Correction Regarding Application Instructions PAR-13-116 NINDS Institutional Center Core Grants Support Neuroscience Research P30)" Notice Number:  NOT-NS-13-017 Key Dates Release Date: February 21, 2013 Related Announcements RFA-NS-14-013 PAR-13-116 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice provides supplemental instructions Section IV.2 Application Submission Information) PAR-13-116. Part 2. Section IV.2. Application Submission Information Budget Allowable Costs: Salary support the PD(s)/PI(s) not exceed 0.6 calendar months.  Support secretarial administrative staff be requested the extent it contributes substantially the management the Center.  Costs PD(s)/PI(s) salary support secretarial administrative staff not exceed 10% the total direct costs a Center any year. Salary not requested PD(s)/PI(s) qualifying projects directors individual cores within Center. Salary be requested technical support personnel consultants. Requests shared equipment allowed. Consumable supplies be requested the extent directly contribute the operation the cores are project specific.  Unique research reagents supplies are specific the support individual projects, including experimental animals, not requested. Costs animal purchase care only allowed limited circumstances required core operations, are allowed furtherance specific projects. Travel costs not allowed. Patient care recruitment costs not allowed. Costs seminars workshops not allowed. Alteration renovation costs not allowed. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Edmund Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) 6001 Executive Blvd, Bethesda, MD 20892 Telephone: 301-496-1917 Email strongly preferred): TalleyE@mail.nih.gov

Notice Correction Application Submission Instructions RFA-NS-13-009 quot;High Impact Neuroscience Research Resource Grants R24)" Notice Number:  NOT-NS-13-016 Key Dates Release Date: February 20, 2013 Related Notices RFA-NS-13-009 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to correct application submission instructions the Budget form RFA-NS-13-009 quot;High Impact Neuroscience Research Resource Grants R24)". Funding Opportunity Announcement FOA) currently states: Part II. Section IV.2 Application Submission Information Budget applications must the R&R Budget forms regardless the direct costs each budget year. Applicants ignore following warning during submission process: direct cost requests 250K less year the 424 R&R Budget page section F-K) must in modules 25K, using PHS 398 Modular Budget Form not R&R Budget Form. Incorrect applications be delayed the peer review process rejected.”  FOA modified state: Part II. Section IV.2 Application Submission Information Budget applications must contain detailed budget. 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 strongly preferred): TalleyE@mail.nih.gov

Notice Intent Publish Funding Opportunity Announcement the NINDS Research Education Program Residents Fellows Neurology, Neurosurgery, Neuropathology Neuroradiology R25) Notice Number: NOT-NS-13-012 Key Dates Release Date:   February 13, 2013 Estimated Publication Date Announcement: Summer 2013  First Estimated Application Due Date: Fall 2013  Earliest Estimated Award Date: Spring 2014  Earliest Estimated Start Date: Spring 2014  Related Announcements RFA-NS-12-003 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends release new Funding Opportunity Announcement FOA) receipt new renewal applications its research education program residents fellows Neurology, Neurosurgery, Neuropathology Neuroradiology. Notice being provided allow potential applicants sufficient time plan and prepare applications.  FOA expected be published the summer 2013, an expected receipt date the fall 2013. programmatic details expected be largely similar those described the previously issued Funding Opportunity Announcement RFA-NS-12-003 used solicit applications this program. FOA utilize R25 activity code. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. Chief, Office Training, Career Development Workforce Diversity National Institute Neurological Disorders Stroke, NIH Email: korns@ninds.nih.gov

Notice Correction the Instructions the Submission the Eligibility Certification Letter PAR-12-152 quot;NINDS Faculty Development Award Promote Diversity Neuroscience K01)" Notice Number: NOT-NS-13-014 Key Dates Release Date: February 11, 2013    Related Notices PAR-12-152 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice corrects application instruction regarding submission a required letter certifying eligibility the K01 applicant this program. Specifically, applicant institution must submit letter certifying the applicant belongs one the diversity groups currently underrepresented the neuroscience research workforce a national basis further defined PAR-12-152 Section III.1 Eligible Individuals). instructions currently state: Information must submitted the applicant Institution a letter certifying the applicant belongs one the above groups. letter should inserted the application immediately before Checklist a PDF file. instructions SHOULD state: certification letter titled: Diversity_Eligibility_Ltr) must attached via quot;Other Attachments" the SF424 Project Information form.  letter must on institutional letterhead scanned that institutional official signature visible. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Michelle Jones-London, Ph.D. National Institute Neurological Disorders Stroke Phone: 301) 451-7966 Email: jonesmiche@ninds.nih.gov

NINDS Policy Submission Applications Containing Clinical Trials Notice Number: NOT-NS-13-006 Update: following update relating this announcement been issued: July 20, 2016 - Notice been replaced NINDS Policy Submission Applications Containing Clinical Trials. Notice NOT-NS-16-034. July 22, 2013 - Issuance PAR-13-278, NINDS Phase III Investigator-Initiated Efficacy Clinical Trials U01). Key Dates Release Date:  February 6, 2013 Related Notices Notice replaces NOT-NS-12-007 PA-11-260 PAR-10-199 PAR-11-173 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to define types clinical studies may submitted NINDS response the NIH parent R01 Funding Opportunity Announcement FOA) PA-11-260 subsequent revisions this FOA.  NINDS not accept investigator initiated R01 applications include clinical trials under PA-11-260.  clinical trial a prospective biomedical behavioral research study human subjects designed answer specific questions the safety, tolerability, efficacy and/or effectiveness pharmacologic, behavioral, biologic, surgical, device invasive non-invasive) interventions.  policy applies only clinical trials submitted PA-11-260 investigator initiated R01 applications subsequent revisions.  policy does apply 1) NINDS-specific announcements specifically solicit clinical trials, 2) exploratory IND studies defined the FDA http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformat…) 3) early feasibility studies devices defined the FDA http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance…).  Applicants submitting investigator initiated applications NINDS contain clinical trial must submit one the following NINDS FOAs specifically designed clinical trials: NINDS Exploratory Clinical Trials R01) PAR-10-199 NINDS PHASE III Investigator-Initiated Multi-Site Clinical Trials U01) PAR-11-173 Inquiries Please direct inquiries to: Crina Frincu, PhD Office Clinical Research National Institute Neurological Disorders Stroke Neuroscience Center, Room 2210 6001 Executive Boulevard Bethesda, MD 20892 Telephone: 301) 496-9135 Fax: 301) 410-1080 Email:  CRLiaison@ninds.nih.gov

Notice Correction the Instructions the Submission the Eligibility Certification Letter PAR-12-163 quot;NINDS Advanced Postdoctoral Career Transition Award Promote Diversity Neuroscience Research K22)" Notice Number: NOT-NS-13-013 Key Dates Release Date:   February 6, 2013 Related Notices PAR-12-163 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice corrects application instruction regarding submission a required letter certifying eligibility the K22 applicant this program. Specifically, applicant institution must submit letter certifying the applicant belongs one the diversity groups currently underrepresented neuroscience research workforce a national basis further defined PAR-12-163 Section III.1 Eligible Individuals). instructions currently state: Information must submitted the applicant institution a letter certifying the applicant belongs one the above groups. letter should inserted the application immediately before Checklist a PDF file. instructions SHOULD state: certification letter titled: Diversity_Eligibility_Ltr) must attached via quot;Other Attachments" the SF424 Project Information form.  letter must on institutional letterhead scanned that institutional official signature visible.  other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Michelle Jones-London, Ph.D. National Institute Neurological Disorders Stroke Phone: 301) 451-7966 Email: jonesmiche@ninds.nih.gov 

Notice Intent Publish Funding Opportunity Announcement Clinical Sites the NINDS Stroke Trials Network U10) Notice Number: NOT-NS-13-007 Key Dates Release Date: February 1, 2013    Estimated Publication Date Announcement: March 1, 2013  First Estimated Application Due Date: 15, 2013    Earliest Estimated Award Date: September 30, 2013     Earliest Estimated Start Date: September 30, 2013     Related Announcements NOT-NS-13-008 NOT-NS-13-009  Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS), intends issue Funding Opportunity Announcement FOA) solicit applications Clinical Sites the NINDS Stroke Trials Network U10)”. goal this initiative to harness multidisciplinary stroke expertise work together an efficient manner conduct exploratory NINDS-sponsored phase 2 clinical trials the treatment stroke the goal quickly move potential treatments larger, confirmatory phase 3 trials.  initiative provide support develop, promote conduct high quality, multi-site clinical trials stroke focused key interventions prevention, treatment, recovery the objective have balanced portfolio between three approaches.  Exploratory phase 2 confirmatory phase 3 clinical trials, well biomarker-validation studies are immediately preparatory trials, be coordinated through separate Data Clinical Coordinating Centers DCC CCC).  Efficiency be encouraged through use master trial agreements a central IRB.  Leaders drawn both clinical basic stroke science communities the sites contribute the development network clinical trial applications peer review, well planning execution of  applications coming outside the network, including trials result a Collaborative Research Development Agreement CRADA) between NINDS an Industry partner.  Network also uniquely poised rapidly collaborate other existing networks, such the NINDS Neurological Treatment Trials Network NETT), International Consortia conduct larger, definitive trials promising interventions the treatment stroke. http://www.ninds.nih.gov/find_people/ninds/OSPP/Stroke-Research-Priorit… a description the Stroke Priorities this network. Notice being provided allow potential applicants sufficient time develop meaningful collaborations competitive research programs.  FOA expected be published Spring 2013 an expected application due date May 2013. FOA utilize U10 activity code. Details the planned FOA provided below. Research Initiative Details NINDS Stroke Trials Network utilize Cooperative Agreements U10) support clinical recruiting sites the Stroke Trials Network up 5 years.  funded site the network have access stroke patients have demonstrated ability enroll patients stroke trials.  site also strong collaborative relationships between Vascular Neurology, Emergency Medicine, Interventional Neuroradiology, Neurosurgery, NeuroIntensive care, Neuroimaging, Stroke Rehabilitation, Pediatric Neurology order ensure commitment offer every eligible patient opportunity participate a trial conducted through Network.  addition, network sites include stroke research training program.  network sites be committed increase value clinical research data through aggressive data sharing plan.  APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Scott Janis, Ph.D. Program Director Office Clinical Research National Institute Neurological Disorders Stroke Room 2170, MSC 9525 6001 Executive Blvd. Bethesda, MD 20892-9525 Telephone: 301) 496-9135 Fax: 301) 410-1080 Email: janiss@ninds.nih.gov

Notice Intent Publish Funding Opportunity Announcement a Clinical Coordinating Center the NINDS Stroke Trials Network U01) Notice Number: NOT-NS-13-008 Key Dates Release Date: February 1, 2013 Estimated Publication Date Announcement: March 1, 2013 First Estimated Application Due Date: June 4, 2013 Earliest Estimated Award Date: September 30, 2013 Earliest Estimated Start Date: September 30, 2013 Related Announcements NOT-NS-13-007 NOT-NS-13-009 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS), intends issue Funding Opportunity Announcement FOA) solicit applications Clinical Coordinating Center the ldquo;NINDS Stroke Trials Network U01)”. goal this initiative to harness multidisciplinary stroke expertise work together an efficient manner conduct exploratory NINDS-sponsored phase 2 clinical trials the treatment stroke the goal quickly move potential treatments larger, confirmatory phase 3 trials.  initiative provide support develop, promote conduct high quality, multi-site clinical trials stroke focused key interventions prevention, treatment, recovery the objective have balanced portfolio between three approaches.  Exploratory phase 2 confirmatory phase 3 clinical trials well biomarker-validation studies are immediately preparatory trials be coordinated through separate Data Clinical Coordinating Centers DCC CCC).  Efficiency be encouraged through use master trial agreements a central IRB.  Leaders drawn both clinical basic stroke science communities the sites contribute the development network clinical trial applications peer review, well planning execution applications coming outside the network, including trials result a Collaborative Research Development Agreement CRADA) between NINDS an Industry partner.  Network also uniquely poised rapidly collaborate other existing networks, such the NINDS Neurological Treatment Trials Network NETT), International Consortia conduct larger, definitive trials promising interventions the treatment stroke. http://www.ninds.nih.gov/find_people/ninds/OSPP/Stroke-Research-Priorit… a description the Stroke Priorities this network.  Notice being provided allow potential applicants sufficient time develop meaningful collaborations competitive research programs.  FOA expected be published Spring 2013 an expected application due date May 2013. FOA utilize U01 activity code. Details the planned FOA provided below. Research Initiative Details NINDS Stroke Trials Network utilize Cooperative Agreements U01) support Clinical Coordinating Center the Stroke Trials Network up 5 years.  Clinical Coordinating Center CCC) provides overall study coordination, working closely the DCC the clinical sites. CCC coordinate activities the SC, develop implement investigator staff training programs meetings, oversee drug acquisition distribution needed, work closely the project-specific lead protocol teams, support project investigators IND submission reporting the Food Drug Administration FDA), establish maintain standardized master trial agreements the network sites distribute funding network trial projects, maintain regulatory documents coordinate central IRB process, monitor eligibility participants, assure compliance regulations monitor informed consent process, prepare blinded reports adverse events, monitor study execution sites, support outreach patients inclusion patients protocol recruitment plan development, supervise encourage recruitment, editorial meeting coordination manuscript preparation, development operational publication guidelines within framework outlined the network CCC FOA. CCC also coordinate development clinical trial protocols be submitted the NINDS peer review future execution the Stroke Trials Network.  addition, Clinical Coordinating Center collaborate the Statistical Data Management Center developing implementing data management procedures. Clinical Coordinating Center be responsible quarterly progress reports the NINDS, NINDS-appointed Network Advisory Group, one more Data Safety Monitoring Boards DSMBs). APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Scott Janis, Ph.D. Program Director Office Clinical Research National Institute Neurological Disorders Stroke Room 2170, MSC 9525 6001 Executive Blvd. Bethesda, MD 20892-9525 Telephone: 301) 496-9135 Fax: 301) 410-1080 Email: janiss@ninds.nih.gov