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Notice Intent Publish Limited Competition Announcement Applications Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network U54) Notice Number: NOT-NS-14-042 Key Dates Release Date: August 8, 2014 Estimated Publication Date Announcement: October 2014   First Estimated Application Due Date: December 2014  Earliest Estimated Award Date: July 2015  Earliest Estimated Start Date: July 2015  Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Center Advancing Translational Sciences NCATS) Purpose National Institute Neurological Disorders Stroke NINDS), the Office Rare Diseases Research ORDR) the National Center Advancing Translational Sciences NCATS), intend publish Funding Opportunity Announcement FOA) solicit applications research rare diseases via Rare Diseases Clinical Research Network.  FOA be limited competition available only Program Directors/Principal Investigators received previous NINDS award under Rare Disease Clinical Research Network program who recently submitted renewal type 2) application response RFA-TR-13-002. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published the fall 2014 an anticipated application due date December 2014. FOA utilize U54 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights the area rare neurological disorders begin consider applying this limited competition FOA. objective to facilitate clinical research rare diseases through support for: 1) collaborative clinical research rare diseases, including longitudinal studies individuals rare diseases, clinical studies and/or phase and II trials; 2) training clinical investigators rare diseases research; 3) pilot demonstration projects; 4) access information related rare diseases basic clinical researchers, academic practicing physicians, patients, the lay public.  total project period an application submitted response this FOA not exceed 4 years. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Laura A. Mamounas, Ph.D. National Institute Neurological Disorders & Stroke NINDS) Telephone: 301-496-5745 Email: mamounas@ninds.nih.gov  

Notice NINDS's Participation RFA- AG-15-016 Paul B. Beeson Clinical Scientist Development Award Aging K08)" Notice Number: NOT-NS-14-040 Key Dates Release Date:  August 6,, 2014 Related Announcements RFA-AG-15-016 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participation, effective immediately, RFA-AG-15-016 quot;Paul B. Beeson Clinical Scientist Development Award Aging K08)" following sections RFA-AG-15-016 been updated reflect participation NINDS this FOA: Part 1. Overview Information Components Participating Organizations National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.866, 93.853 Part 2. Section II. Award Information Funds Available Anticipated Number Awards National Institute Aging the National Institute Neurological Disorders Stroke intend combination) commit approximately 1 million FY 2014 support 5 7 awards. number awards contingent upon NIH appropriations, the submission a sufficient number meritorious applications. Part 2. Section VII. Agency Contacts Scientific/Research Contact(s) Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov Financial/Grants Management Contact(s) Tijuana 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: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov nbsp;

Notice NINDS's Participation RFA- AG-15-017 Paul B. Beeson Patient-Oriented Research Career Development Award Aging K23)" Notice Number: NOT-NS-14-041 Key Dates Release Date: August 6, 2014 Related Announcements RFA-AG-15-017 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participation, effective immediately, RFA-AG-15-017 quot;Paul B. Beeson Patient-Oriented Research Career Development Award Aging K23)" following sections RFA-AG-15-017 been updated reflect participation NINDS this FOA: Part 1. Overview Information Components Participating Organizations National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.866, 93.853 Part 2. Section II. Award Information Funds Available Anticipated Number Awards National Institute Aging the National Institute Neurological Disorders Stroke intend combination) commit approximately 1 million FY 2014 support 5 7 awards. number awards contingent upon NIH appropriations, the submission a sufficient number meritorious applications. Part 2. Section VII. Agency Contacts Scientific/Research Contact(s) Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov Financial/Grants Management Contact(s) Tijuana 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: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov nbsp;

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;