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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

Request Information: Phase 1 Clinical Trial Services Neurotherapeutics Notice Number: NOT-NS-14-035 Key Dates Release Date: June 16, 2014 Response Date: July 18, 2014 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS), NIH considering establishing Phase 1 clinical trials contract program support advancement neurotherapeutics. services provided under contract program support part NINDS's mission the development neurotherapeutics. design, study population procedures be performed vary project project; therefore NINDS like determine whether is possible a single vendor provide full range services potentially required. NINDS seeking feedback potential sources regarding interest, availability, costs the desired resources services. is Request Information RFI). is a solicitation proposals, proposal abstracts, quotations. purpose this RFI to obtain knowledge information project planning purposes. Background proposed clinical trial services contract envisioned offering mechanism support Phase 1 clinical trials neurotherapeutics, well other drugs direct interest NINDS. term neurotherapeutics includes therapies targeted indications due dysfunction the central and/or peripheral nervous system, fall within mission NINDS the Institutes Centers are part the NIH Blueprint Neurotherapeutics Network http://neuroscienceblueprint.nih.gov/bpdrugs/). Compounds be assessed include small molecules, peptides, proteins oligonucleotides provided Contributors e.g. NINDS grantees) the program. Phase 1 studies denote clinical trials performed characterization safety, pharmacokinetics PK) pharmacodynamics PD), although exploratory efficacy data be collected some instances. Pharmacodynamics PD) used here encompass measures assess target engagement, modulation biological processes subsequent target engagement, modulated processes relevant disease pathogenesis. is anticipated these all first-in-human clinical trials. Depending the project, study populations be healthy volunteers, demographic subsets healthy volunteers, patients conditions interest, typically mild forms the proposed disease indication. NINDS maintain frequent, close communication contact monitoring providing oversight the Phase 1 trials contract. addition, under such program NINDS provide Phase 1 clinical trial unit contractor(s) the following: detailed clinical trial synopsis full protocol; IND the project held NIH Contributor Institution); cGMP manufactured investigational therapeutic the clinical trial; Access design performance PK PD assays used preclinical development; Expertise the compound indication under study. extent services provided the Phase 1 clinical trial unit contractor(s) vary somewhat depending the specific requirement each project, though generally anticipated be full service finalization the clinical protocol through writing a complete study report. Technical Requirements following the requirements envisioned the Phase 1 clinical trial unit contractor(s): track record successful recruitment healthy volunteer patient populations, including capability creating recruitment plans; clinical research unit facilities equipment housing subjects, performing routine safety evaluations e.g., vital signs, ECG), precisely timed phlebotomy urine collection PK/PD studies processing PK PD samples ; On-site sample storage facilities room temperature, 4, 20 70 degrees Celsius; CLIA Clinical Laboratory Improvement Amendments) certified laboratory performance routine chemistry, hematology urine safety tests; Collection cerebrospinal fluid CSF) via lumbar puncture with temporary in-dwelling catheter; Performance and experience cognitive testing, using paper computer based systems; Performance PK specialty PD assays plasma, blood, CSF; Design validation PK PD assays; Regulatory support writing IND annual reports; Data management capabilities/facilities necessary the conduct/performance a Phase 1 clinical trial, such CRF design, data base compliant Good Clinical Practice GCP) guidelines; On-site resuscitation equipment a definitive plan management life-threatening adverse events; Access equipment required diagnosis special safety evaluations, including computerized tomography CT), magnetic resonance imaging MRI), proton emission tomography PET), electromyography EMG), electroencephalography EEG) electroretinography ERG); Note: Please describe access plan located off-site. Drug storage facility shipment capability study requires than site; On-site on-staff physicians established experience performance Phase 1 clinical trials; On-site study coordinators staff conduct study perform site regulatory tasks; Support required the following disciplines: Medical writing assist finalization protocol, investigators brochure composition complete study report; Statisticians programmers assist finalization protocol, statistical analysis plan data analysis; Clinical research associates study monitoring. investigational pharmacist established experience performance Phase 1 clinical trials an on-site investigational pharmacy double locked access storage capabilities room temperature, 4, 20 70 degrees Celsius; Limited cGMP capability the investigational pharmacy manipulations such over encapsulation; Pharmacovigilance capabilities composition serious adverse event reports narratives; clinical pharmacologist established experience analysis PK PD Phase 1 clinical trials writing pharmacology reports; Access clinical specialists additional safety assessments may required some studies, such ophthalmology exam detailed neurologic examination. Information Requested your organization be interested providing services under such contract program, please address interest, qualifications, experience, capabilities responding the following five areas outlined below. would appreciated responses limited no than ten pages. Any organization responding this notice should ensure its response complete sufficiently detailed. Generic marketing brochures not wanted nor they considered. information collection recordkeeping requirement associated publication the proposed RFI been approved OMB Control Number 9000-0037 Exp.Date 11/30/2014, codified FAR 1.106. Technical Requirements Please address of bulleted requirements above. Please identify requirements be performed your organization's facility which require subcontracting. Experience Provide total number Phase 1 studies conducted the last 3 years healthy volunteers in patient populations relevant neurotherapeutic development stratified small molecule, protein therapeutics oligonucleotides. Quality Please describe organization's internal quality control processes; many times the facility audited FDA? Please summarize any Form 483 citations remediation. Costs Please provide estimate the typical costs the of bulleted Technical Requirements described above. Please comment cost a typical healthy volunteer single ascending dose trial alone, multiple ascending dose trial alone, a combined single multiple ascending dose trial. Business Organization Information Government does intend provide liability insurance nor indemnify any contractor under program. Given that, would organization handle this, e.g., via obtaining own Clinical Trial Insurance, certificate insurance indemnification the Contributor IND holder), etc...? Please address. list current and/or prior federal contracts directly the Government as subcontractor another organization services called in notice; Type size your business organization, e.g., Large Business, Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College University/Minority Institution HBCU/MI), educational institution, profit/non-profit hospital, other nonprofit organization. Submitting Response RFI for information planning purposes only shall be construed a solicitation as obligation the part the Government. Government does intend award contract the basis responses nor otherwise pay the preparation any information submitted the Government's of such information.  Acknowledgement receipt responses not made, nor respondents notified the Government's evaluation the information received.  However, should such requirement materialize, basis claims against Government shall arise a result a response this request information the Government's of such information either part our evaluation process in developing specifications any subsequent requirement.  Responses be held a confidential manner.  proprietary, classified, confidential, sensitive information should included your response. Government reserves right use any non-proprietary technical information any resultant solicitation(s). Responses due 4:00 PM local time Friday July 18, 2014. Please submit responses to: Annette Carter Contracting Officer National Institutes Health NINDS R&D Contracts Management Branch 6001 Executive Boulevard, Room 3287 Bethesda, Maryland 20892-9531 FedEx courier, use: Rockville, MD 20852) Telephone: 301-496-1813 Fax: 301-402-4225 Email responses sent cartera@mail.nih.gov also accepted please format printing). Inquiries Please submit responses to: Annette Carter National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1813 Email:cartera@mail.nih.gov

Notice the Change the Expiration Date PAR-14-253 NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention Infrastructure Resource Access X01)" Notice Number: NOT-NS-14-036 Key Dates Release Date: Release Date: June 13, 2014 Related Announcements PAR-14-253 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform applicants the change the expiration date PAR-14-253 quot;NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention Infrastructure Resource Access X01)".  previous expiration date September 8, 2017. new expiration date be July 13, 2017. other aspects PAR-14-253 remain unchanged.  Inquiries Please direct inquiries to: Claudia Moy, PhD National Institute Neurological Disorders amp; Stroke NINDS) Telephone: 301-496-9135 Email: moyc@ninds.nih.gov nbsp;

Notice Intent Publish Funding Opportunity Announcement Detect, Define Measure Progression Chronic Traumatic Encephalopathy U01)" Notice Number: NOT-NS-14-031 Update: following update relating this announcement been issued: July 29, 2014 - Issuance RFA-NS-14-012. Key Dates Release Date: 29, 2014 Estimated Publication Date Announcement: July, 2014  First Estimated Application Due Date: November, 2014 Earliest Estimated Award Date: June, 2015 Earliest Estimated Start Date: June, 2015 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) support longitudinal clinical study detect define progression chronic traumatic encephalopathy CTE) using neuroimaging tools, such MRI PET, well genetics, cognitive behavioral tests, CSF blood biomarkers. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published the summer 2014 an expected application due date fall 2014. FOA utilize U01 activity code. Details the planned FOA provided below. Research Initiative Details purpose this initiative to detect, characterize measure progression neurodegeneration individuals a probable possible diagnosis chronic traumatic encephalopathy CTE) using brain imaging other biomarkers. overall goals increased knowledge concerning neurological mechanisms ways detect CTE it evolves over 3 - 5 year period the development a consensus diagnosis inform clinical trials aimed preventing slowing disease progression the future. research objectives are: 1) collect analyze high quality data such MRI PET, genetics, cognitive tests, CSF blood biomarkers detect characterize neurodegenerative changes progression CTE over 3 - 5 year period; 2) develop consensus criteria the clinical diagnosis staging CTE. study team should include expertise necessary recruit follow relevant study cohort would include individuals a probable" possible" diagnosis CTE appropriate controls. addition, multidisciplinary team should able collect analyze high quality data such MRI PET, genetics, cognitive tests, CSF blood biomarkers detect define CTE. study must include relevant TBI Common Data Elements comply the data sharing policies the FITBIR Informatics System. If new data elements needed CTE, investigators expected work the NINDS Common Data Elements CDE) Project develop see http://www.nindscommondataelements.org/). Specific Areas Research Interest Areas interest include are limited to: Advanced imaging studies, including high field MRI scans, tau-radioligand and/or metabolic PET studies aimed defining regional distribution other characteristic features CTE high-risk, symptomatic individuals possible" probable" CTE. qualitative quantitative assessment the progression the neurodegeneration symptomatic, individuals considered be high risk CTE over 3 - 5 year period Development and/or validation clinical tools make possible" probable" diagnosis CTE to develop sensitive specific biomarkers track progression over time may inform future therapeutic trials. Clinical studies advance knowledge the pathophysiological mechanisms CTE its progression. Identification risk factors CTE. Investigation the temporal correspondence between neurodegenerative changes the clinical signs symptoms CTE. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Ramona Hicks, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: hicksra@mail.nih.gov

Notice Delay Application Due Date RFA-NS-14-006 High Impact Neuroscience Research Resource Grants R24)" Notice Number: NOT-NS-14-034 Key Dates Release Date: 29, 2014 Related Announcements RFA-NS-14-006 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice being issued inform applicants the delay the application due date RFA-NS-14-006 quot;High Impact Neuroscience Research Resource Grants R24)". new Key Dates this FOA are: Key Dates Posted Date March 27, 2014 Open Date Earliest Submission Date) September 20, 2014 Letter Intent Due Date(s) September 20, 2014 Application Due Date(s) October 20, 2014, 5:00 PM local time applicant organization. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) Applicable Scientific Merit Review February, 2015 Advisory Council Review May, 2015 Earliest Start Date June, 2015 Expiration Date October 21, 2014 Due Dates E.O. 12372 Applicable 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 nbsp;

Notice Correct NOT-NS-13-040 Notice Intent Publish Funding Opportunity Announcement the NINDS Exploratory Grant Program Parkinson's Disease Research P20)" Notice Number: NOT-NS-14-033 Key Dates Release Date: 19, 2014 Related Announcements NOT-NS-13-040 NOT-NS-14-001 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice being issued update information provide NOT-NS-13-040 quot;Notice Intent Publish Funding Opportunity Announcement the NINDS Exploratory Grant Program Parkinson's Disease Research P20)" NOT-NS-14-001 quot;Notice Correct Anticipated Application Due Date NINDS Exploratory Grant Program Parkinson's Disease Research P20)". expected Key Dates this FOA now be: Estimated Publication Date Announcement: June 2014 First Estimated Application Due Date: September 2014 Earliest Estimated Award Date: March, 2015 Earliest Estimated Start Date: April, 2015 Applicants request maximum annual direct costs 250,000 per year, up two years. Applicants should address research recommendations the recent NINDS conference, quot;Parkinson's Disease 2014: Advancing Research, Improving Lives" their applications. other aspects NOT-NS-13-040 remain unchanged. Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sieberb@ninds.nih.gov nbsp;

NINDS Requirements Induced Pluripotent Stem Cell Development Resource Sharing Notice Number: NOT-NS-14-032 Update: following update relating this announcement been issued: September 5, 2014 - Notice Inform Potential Applicants RFA-NS-14-006. Notice NOT-NS-14-044. Key Dates Release Date: 13, 2014 Related Announcements NOT-NS-12-003 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to alert research community the current NINDS best practices guidelines development distribution human induced pluripotent stem cells iPSC) through NINDS Repository, also known the NINDS Human Genetics Resource Center. iPSC lines available through NINDS Repository primarily developed through American Recovery Reinvestment Act collaborations government California Institute Regenerative Medicine CIRM)) non-government organizations Amyotrophic Lateral Sclerosis Association, Association Frontotemporal Degeneration, CHDI, Hereditary Disease Foundation, Huntington's Disease Society America, Michael J. Fox Foundation, the Parkinson's Disease Foundation). further information NINDS Repository banking guidance NOT-NS-12-003.   iPSC lines available through NINDS Repository a Certificate Analysis CofA) provides quality control data sterility, cell recovery, karyotype, identity match applicable), surface antigen expression stem cell markers pluripotency analysis), well information the method derivation, passage method, passage number split ratio each line.  NINDS Repository catalog updated frequently, investigators encouraged visit website a regular basis access availability new human fibroblast iPSC lines. Based the availability these resources, NINDS no longer support development iPSC lines e.g. control lines and/or lines specific mutations) are already represented the NINDS Repository in similar resources such the NIMH NIGMS Repositories. Moreover, NINDS not presently seeking applications are focused primarily developing iPSC lines solely a resource. Investigators propose develop use iPSC lines represented the NINDS Repository similar resources, hypothesis-driven research, anticipate depositing lines the NINDS Repository, strongly encouraged consult NINDS program director prior submission a grant application.  Quality Control Freedom Operate Requirements iPSC lines be banked the NINDS Repository addition requiring compliance standard NIH resource sharing policies, NINDS request novel investigator-developed iPSC lines made available through NINDS Repository, consistent achieving goals this program. Such request deposition iPSC lines be prior the release a notice grant award, will specified the notice grant award.  the human iPSC lines be deposited the NINDS Repository, investigators need meet following requirements prior the release a notice grant award: Patient consent must allow de-identified broad data resource sharing academic industry investigators) including for genetic studies, wherein part all the genome be sequenced; IP applicable, institution/facility must all necessary legal authority sharing, document this, including any necessary licenses iPSC related e.g. genome editing, reporter use) technologies allow deposition broad distribution resulting iPSC lines through NINDS Repository; iPSC lines derived under NINDS funding mechanisms must characterized sterility be free mycoplasma contamination, normal karyotypes, normal growth rates colony morphology, demonstrated pluripotency through pluritest, scorecard test equivalent test, demonstrate surface antigen expression stem cell markers, demonstrated ability form embryoid bodies demonstrated transgene silencing the reprogramming factors used;  timeline must provided banking available iPSC lines the NINDS Repository.  Investigators strongly encouraged contact NINDS program director prior application submission determine broad applicability the iPSC lines be developed. Development isogenic iPSC Lines generation isogenic lines, are be deposited the NINDS Repository, where disease causing mutation represented NINDS Repository iPSC lines, investigators encouraged perform  gene editing the available NINDS Repository iPSC lines. Furthermore, such grant applications should budget and propose whole genome sequencing the parent edited clones. genetic data generated along available de-identified clinical data be deposited the NIH database Genotypes Phenotypes dbGaP). Inquiries Please direct inquiries to: Margaret Sutherland, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sutherlandm@ninds.nih.gov David Owens, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: OwensD@ninds.nih.gov Please direct NINDS Repository inquiries to: Roderick A. Corriveau, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: roderick.corriveau@nih.gov  

Notice Intent Publish Funding Opportunity Announcement the NINDS Epilepsy Centers without Walls Program Disease Modification Prevention U54) Notice Number: NOT-NS-14-028 Key Dates Release Date: 12, 2014 Estimated Publication Date Announcement: June 2014 First Estimated Application Due Date: Nov 2014 Earliest Estimated Award Date: 2015  Earliest Estimated Start Date: July 2015 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends publish Funding Opportunity Announcement FOA) solicit applications multidisciplinary, collaborative research conducted a team investigators an Epilepsy Center Without Walls CWOW) focused developing disease modifying prevention therapies epilepsy. Current treatments epilepsy control seizures do appear alter course the disease, do prevent epilepsy developing those individuals risk. ultimate goal this CWOW to support development rigorous evidence-based justification further translational activities a first-in-class disease modifying prevention therapy a defined population individuals with, at high risk developing, epilepsy. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published June 2014 an expected application due date November 2014. NINDS consider funding up two Epilepsy CWOWs development disease-modifying prevention therapies, depending the scientific merit the applications submitted availability funds. FOA utilize Cooperative Specialized Research Center Grant U54) activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights this area neurology neuroscience begin develop collaborative teams apply this new FOA. Such teams should include individuals expertise translational therapeutics development. Applications all qualified teams encouraged, including not limited teams supported a prior Center Without Walls P20 planning grant. Applications a Center without Walls should from multidisciplinary, collaborative team proposing synergistic research projects appropriate scientific administrative cores. goal a Center without Walls Disease Modification Prevention to develop rigorous evidence base needed justify investment further translational activities a first-in-class disease modifying prevention therapy a defined population individuals with, at risk developing, epilepsy. proposed administrative core should include detailed policies regarding publication assignment intellectual property rights, well plans sharing pre-competitive data, reagents methods the broader epilepsy research community. Center without Walls should at least core facility shares services resources the national international epilepsy research community another core promotes education outreach activities the patient community. Center without Walls application must include three more related, integrated, high-quality research projects provide multi-disciplinary, yet unified, approach the problem be investigated. Center without Walls application include preclinical studies and/or non-interventional clinical studies, necessary given state the field a particular indication. During review, CWOW applications be considered three different tracks: Preclinical studies track: track includes CWOW applications consist entirely projects involve studies preclinical model systems. studies include, are limited to, those seek develop vitro assays, establish rigorous preclinical proof efficacy, preliminary pharmacokinetics pharmacodynamics, effect repeated exposures, definition appropriate treatment windows, duration, dosing route administration paradigms. Clinical studies track: track includes CWOW applications consist entirely projects involve studies clinical populations healthy volunteers. studies include, are limited to, those seek establish validate 1) biomarkers risk, disease progression, treatment response, 2) tools determine target engagement therapeutic candidates, 3) clinical outcome measures study designs appropriate evaluating disease-modifying prevention treatments. Dual studies track: track includes CWOW applications consist projects involve studies both preclinical model systems clinical populations. CWOW applications should include description the key limitations our current knowledge prevent proposed interventions immediately entering translational development. projects cores included the CWOW application should designed directly address overcome limitations. Ideally, the completion the CWOW activities, rigorous evidence base be available enable further translational development the chosen therapeutic approach. Through cores, new CWOW resources collaborations also made available the larger epilepsy research community should help facilitate translational research other disease modifying prevention approaches. NINDS highlighted importance well-designed transparently reported studies the foundation translating basic research discoveries treatments. Investigators should aware the considerations described NOT-NS-11-023 these issues be considered the review applications. Interested prospective applicants strongly encouraged consult the NINDS Scientific/Research Staff identified the FOA prior preparing application. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Brandy Fureman, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1917 Email: furemanb@ninds.nih.gov nbsp;