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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;

Notice Intent Publish Funding Opportunity Announcement Biomarker Discovery through Use Data Resources Developed the NINDS Parkinson's Disease Biomarker Program PDBP) U01) Notice Number: NOT-NS-14-027 Key Dates Release Date: Release Date:   May 8, 2014 Estimated Publication Date Announcement: June, 2014  First Estimated Application Due Date: October, 2014  Earliest Estimated Award Date: March, 2015  Earliest Estimated Start Date: March, 2015  Related Announcements NOT-NS-12-003 NOT-NS-13-020 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications research support discovery, assay optimization, replication stages required the development biological biomarkers Parkinson’s disease PD).  is expected studies funded under FOA integrate and enhance NINDS Parkinson's Disease Biomarker Program PDBP). Discovery pilot projects use samples either PDBP other extant collections biospecimens data, long consent the extant biospecimens data enables deposition all data the PDBP Data Management Resource DMR). examples extant biospecimen collections, summary contact information available https://pdbp.ninds.nih.gov/jsp/funding.jsp. is expected the replication stage study use PDBP biospecimens data. 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 September 2014. FOA utilize U01 activity code. Details the planned FOA provided below. Research Initiative Details National Institute Neurological Disorders Stroke NINDS Parkinson's Disease Biomarkers Program PDBP) established advance discovery biomarkers will improve efficiency outcome Phase II clinical trials Parkinson's Disease PD) advance therapeutic development PD. PDBP covers spectrum Parkinson's disease first diagnosis more advance stages the disease includes longitudinal collection clinical data biospecimens.  Since program began November 2012, six clinical sites enrolled than 900 participants the study, over 12,000 clinical forms available through PDBP data management resource DMR).  participating clinical site follows standardized schedule patient visits clinical data collection.  Also, through standardized set procedures, biospecimens collected stored the NINDS Repository.  are currently over 250 cerebrospinal fluid samples CSF) collectively than 3800 RNA, DNA, plasma serum samples available analysis.  biospecimens associated quality control data the biospecimens available through NINDS Repository catalog the PDBP DMR requests biospecimens handled through PDBP Biospecimen Resource Access Committee BRAC).  Investigators are interested Parkinson's Disease Biomarker development request access PDBP biospecimens data any time. learn about NINDS Parkinson's Disease Biomarker Program PDBP) the PDBP Data Management Resource please visit PDBP website. view data biospecimens available through PDBP, researchers must first gain access the PDBP DMR requesting account Request PDBP DMR account). Once signed Data Certification DUC) received, access be available the PDBP data Query tool, NINDS Biorepository catalog Order Manager. Investigators are given access either PDBP data both data biospecimens expected acknowledge PDBP Consortium all resulting publications according the PDBP publication policy.  outlined NOT-NS-13-020, NINDS funded PD biomarker projects follow data resource sharing guidelines standards established the NINDS PDBP including deposition clinical biospecimen assessment data the PDBP DMR. Notice encourages investigators expertise insights areas Parkinson's Disease basic translational research, target validation, biomarker platform development biomarker discovery begin consider applying this new FOA. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Katrina Gwinn, M.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5745 Email: gwinnk@ninds.nih.gov Margaret Sutherland, Ph. D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sutherlandm@ninds.nih.gov nbsp;

Notice Correct Advisory Council Review Date Start Date RFA-NS-14-003 Morris K. Udall Centers Excellence Parkinson's Disease Research P50)" Notice Number: NOT-NS-14-030 Key Dates Release Date: 5, 2014 Related Announcements RFA-NS-14-003 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice being issued correct Advisory Council Review Date the Earliest Start Date RFA-NS-14-003.  Part 1. Overview Information Key Dates Currently reads: Advisory Council Review January, 2014 Earliest Start Date March, 2014 Modified read: Advisory Council Review January, 2015 Earliest Start Date March, 2015 other aspects this FOA 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

Notice NINDS Participation NOT-HL-14-222 Request Information RFI): Opportunities Advance Clinical Epidemiologic Research Facilitate Aging Place utilizing In-Home Monitoring" Notice Number: NOT-NS-14-029 Key Dates Release Date: April 29, 2014 Related Announcements NOT-HL-14-222 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to inform potential participants the National Institute Neurological Disorders Stroke NINDS) participate NOT-HL-14-222 Request Information RFI): Opportunities Advance Clinical Epidemiological Research Facilitate Aging Place utilizing In-Home Monitoring." following sections NOT-HL-14-222 been updated reflect participation NINDS this RFI: Issued By: National Heart, Lung, Blood Institute NHLBI) National Cancer Institute NCI) National Institute Aging NIA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Neurological Disorders Stroke NINDS) National Institute Disability Rehabilitation Research NIDRR) Office Behavioral Social Sciences Research OBSSR) Administration Community Living ACL) Office Women's Health OWH) U.S. Department Veterans Affairs VA) Inquiries Please direct inquiries to: Jamie Roberts, MA National Institute Neurological Disorders Stroke Telephone: 301-496-9135 Email: jamie.roberts@nih.gov

Request Information RFI): Opportunities Advance Clinical Epidemiologic Research Facilitate Aging Place utilizing In-Home Monitoring Notice Number: NOT-HL-14-222 Update: following update relating this announcement been issued: April 29, 2014 - Notice to inform potential participants the National Institute Neurological Disorders Stroke NINDS) participate NOT-HL-14-222. Notice NOT-NS-14-029. Key Dates Release Date: April 24, 2014 Response Date: June 25, 2014 Related Announcements None Issued National Heart, Lung, Blood Institute NHLBI) National Cancer Institute NCI) National Institute Aging NIA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Disability Rehabilitation Research NIDRR) National Institute Neurological Disorders Stroke NINDS) Office Behavioral Social Sciences Research OBSSR) Administration Community Living ACL) Office Women's Health OWH) U.S. Department Veterans Affairs VA) Purpose Request Information RFI) seeks input opportunities, appropriate infrastructure, critical needs key questions will advance research order optimize care treatment, independence community living the aging population individuals chronic disabilities e.g., physical, developmental, and/or intellectual disabilities) aimed supporting aging place reducing hospitalization admissions a nursing facility. NHLBI invites comments researchers, patient advocacy groups, patients, device companies, healthcare providers. Background understanding the current status future directions Aging Systems Technology AST) aging, chronic disabilities, community living independence needed order examine critical gaps knowledge, standards, infrastructure supports.  potential and benefits these technologies of great interest since population aging people living longer multiple chronic conditions. background information be found the following link: http://aspe.hhs.gov/daltcp/reports/2012/astsrptcong.shtml Information Requested RFI intended solicit perspectives comments the broad community scientific opportunities, critical needs optimal configurations conducting research the area unobtrusive in-home monitoring the aging population individuals chronic disabilities.  comments include are limited to: 1.  most important questions challenges over next 5-10 years regarding technology facilitate independent aging. 2. Programs, investments, and/or grant mechanisms NIH ought consider order foster clinical epidemiologic research the of in-home monitoring devices, including tele-health, assist elderly individuals chronic disabilities remain home. 3. Recommendations programs, infrastructure investments best address important questions this field focused research questions. 4. Optimal configurations allowing innovation autonomy private companies interact academic research provide information improving health care reducing transitions care facilities. 5.  Scale-up evaluations deployment technology transfer considerations validation algorithms sensed data home healthcare uses. you choose to identify yourself replying, please identify role the field help us better understand thoughts particular groups.  example, please indicate you a care provider, patient, patient advocate, researcher, device company, etc. Responses ensure consideration, responses should submitted June 25, 2014. Respond email to: iturriae@mail.nih.gov.  Please include text RFI Reply” your subject line. RFI for planning purposes only should be construed a solicitation as obligation the part the Federal Government generally the NIH specifically.  NIH does intend make any awards based responses this RFI to otherwise pay the preparation any information submitted for Government's of such information NIH use information submitted response this RFI its discretion will provide comments any responder's submission.  However, responses the RFI be reflected future solicitation(s).  information provided be analyzed may appear reports.  Respondents advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted.  proprietary, classified, confidential, sensitive information should included your response.  Government reserves right use any non-proprietary technical information any resultant solicitation(s). Inquiries Please direct inquiries to: Erin Iturriaga National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-0403 Email: iturriae@mail.nih.gov