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Extension Expiration Dates PA-08-246 R01) PA-08-247 R21):  Chronic Fatigue Syndrome: Pathophysiology Treatment Notice Number: NOT-OD-11-083 Key Dates Release Date: June 10, 2011 Issued Office Research Women’s Health ORWH) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Complementary Alternative Medicine NCCAM) National Center Research Resources NCRR) Office Dietary Supplements ODS) Purpose Notice extends expiration dates the Funding Opportunity Announcements FOA) PA-08-246 R01) PA-08-247 R21), Chronic Fatigue Syndrome: Pathophysiology Treatment.   new expiration date both FOAs January 8, 2012.  updated list Institute Center Science/Research contacts be posted the Trans-NIH ME/CFS Research Working Group website http://orwh.od.nih.gov/CSF%202011/resources.htm).  other aspects these FOAs remain unchanged. Inquiries Please direct inquiries to: Dennis F. Mangan, Ph.D. Chair, Trans-NIH ME/CFS Research Working Group Senior Research Advisor Office Research Women's Health, OD National Institutes Health 6707 Democracy Blvd., Suite 400 Bethesda, MD  20892-5484 Telephone:  301 496-9006 FAX:  301 402-1798 Email:  dennis.mangan@nih.gov

Notice Intent Publish Request Applications Stroke Prevention/Intervention Research Program SPIRP) U54) Notice Number: NOT-NS-11-017 Key Dates Release Date: June 7, 2011 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 Stroke Prevention/Intervention Research Programs SPIRP); goal be develop interventions research have potential reduce stroke disparities minority communities through effective and culturally appropriate stroke prevention/intervention programs. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published Fall 2011 an expected receipt date Winter 2012. FOA utilize U54 activity code. U54 mechanism a solicited, multi-component award mechanism which substantial NIH scientific and/or programmatic involvement anticipated project completion.  Details the planned FOA provided below. Research Initiative Details Stroke the fourth leading cause death a leading cause long-term disability.  Stroke disparities a major public health problem the United States due the excess burden disease, excess mortality, worse outcome minority populations.  address these, innovative effective strategies directly reduce incidence, morbidity, mortality stroke racial/ethnic minority communities are within programmatic priority NINDS of interest. initiative directly responds the recommendations the NINDS Advisory Panel Health Disparities http://www.ninds.nih.gov/about_ninds/plans/NINDS_health_disparities_rpt…(pdf, 196 KB)) the Health Human Services plan addressing health disparities http://www.minorityhealth.hhs.gov/npa/files/Plans/HHS/HHS_Plan_complete…).  the purposes this announcement, stroke defined broadly may address ischemic hemorrhagic stroke disparities minority communities.  SPIRP application program) must contain least stroke prevention/intervention project up 3 additional projects directly related stroke disparities. additional projects range basic science through outcomes research.  projects should aim identify, monitor target biologic, environmental, social, healthcare system factors confer stroke its treatment disproportionately adversely underserved minority populations. nbsp;We anticipate trans-disciplinary multi-disciplinary teams be used implement SPIRP projects.  Projects also tools such community engagement, decision analysis, economic analysis, patient-centered outcomes enhance overall SPIRP. nbsp;Applications have cores are directly related the administration, training, scientific function the program. overall aims this initiative are: 1) develop effective evidence-based interventions prevention strategies designed decrease identified disparities stroke the potential be scaled-up regional national implementation; 2) support stroke disparities research projects are most likely targets next generation prevention/intervention programs that significantly further knowledge the research gaps stroke disparities; 3) provide formal, quality training junior investigators key stakeholders the implementation the prevention/intervention project.  Importantly, only prevention/intervention projects are culturally appropriate be considered.  Therefore, applicant should discuss methodology used address important element may include theoretical constructs population group specific socio-cultural bio-behavioral variables including health beliefs practices.    APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Salina Waddy, MD Program Director National Institute Neurological Disorders Stroke NINDS) 6001 Executive Boulevard, Room 2153  Bethesda, Maryland 20892 Phone: 301- 496-9135 FAX: 301) 402-1501 Email: waddysp@mail.nih.gov Website: http://www.ninds.nih.gov

Extension Expiration Date NIAID Funding Opportunity Announcement: Investigations Primary Immunodeficiency Diseases R01) PAR-08-206 Notice Number: NOT-AI-11-047 Key Dates Release Date: 25, 2011 Issued National Institute Allergy Infectious Diseases NIAID) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Neurological Disorders Stroke NINDS) Purpose Notice extends expiration date the Funding Opportunity Announcement:  Investigations Primary Immunodeficiency Diseases R01) PAR-08-206 http://grants.nih.gov/grants/guide/pa-files/PAR-08-206.html) one receipt date.  a result, FOA being extended September 8, 2011 January 8, 2012. other aspects this FOA remain unchanged. Inquiries contacts FOA any inquires.

Request Information: Whole Genome Sequencing, Data Analysis, Storage Annotation Notice Number:  NOT- NS-11-015   Key Dates Release Date:     11, 2011 Response Date:  30, 2011    Issued National Institute Neurological Disorders Stroke NINDS) Purpose is time sensitive Request Information RFI) issued the National Institute Neurological Disorders Stroke NINDS).  purpose the RFI to solicit information the research needs the NINDS community whole genome sequencing services accompanying data storage, analysis annotation services.  responses the RFI be collected evaluated Institute staff assess best meet current future needs whole genome sequencing it relates neurologic disease. Background Rapid significant changes technology continue advance our understanding human biology disease technological applications ranging single molecule whole genome approaches.  of technologies, massively parallel sequencing Next Generation Sequencing NGS) revolutionized our ability identify rare variants as yet unidentified Mendelian mutations related disease.  Although is clear NGS technology eventually dominate genomic research field, technological developments resulting reductions cost rapid increases sequencing speed improved accuracy.  reality these advancements sequencing technology enables re-sequencing the whole human genome be achieved within weeks instead months years unprecedented accuracy.  NGS technologies leading new strategies the understanding monogenic Mendelian diseases allowing identification causative mutations disorders were amenable linkage-based positional cloning Lupski J.R. et al., 2010]. Although cost availability services play role determining NGS approach exome verses whole genome), understanding underlying complexity the disease phenotype a key selection eventual success identifying causative mutation.  Since technologic advancements NGS been rapid, volume complexity the information captured through NGS challenges storage processing capabilities many laboratories institutions.  all roadblocks accessing NGS services processing NGS data removed, perhaps greatest challenge be analysis annotation data effectively differentiate between many rare benign variants detected novel genomic techniques disease causing mutations. RFI meant solicit information extramural research investigators regarding type availability projects can advanced through whole genome sequencing services.  RFI also solicits information institutional capabilities sequence storage, data analysis annotation.  Responses this RFI be reviewed NINDS staff will help inform complement assessment current future whole genome sequencing needs. RFI for planning purposes only, should be construed a solicitation applications proposals and/or an obligation any on part the United States Federal Government. Sequencing Services 1.  Describe whole genome sequencing services available planned your institution. 2.  Describe composition your research cohort e.g. small large families, population based) will utilize whole genome sequencing. 3.  Indicate you anticipate whole genome sequencing contribute your field research. 4.  Provide rationale choosing whole genome sequencing over whole exome sequencing. 5.  you plan utilize whole genome sequencing, many samples you sequence within next 12 months? will samples chosen? 6.  Outline plans your laboratory institution regarding storage capacity raw data generated whole genome sequencing. 7.  are plans your laboratory institution regarding analytical support sequence assembly, variant identification annotation? 8. Provide perspective the constraints regarding public sharing genomic sequences associated phenotype your research cohort. General Information 1.  Please identify nature your interest the area whole genome sequencing services i.e. you biomedical clinical researcher, member an advocacy community group, other?). 2.  you a member a particular advocacy professional organization, please indicate name the organization. 3.  Please indicate main area research interest. 4.  name 5.  email address * Note: of preceding fields optional. Proprietary, classified, confidential, sensitive information should be included your response.  Responses Responses must submitted electronically using web-based form http://www.ninds.nih.gov/funding/areas/neurodegeneration/RFI-for-Whole-… will accepted through 30, 2011.  Replies individual questions optional, the site permit anonymous responses. information provided be analyzed may appear various reports. Inquiries Please direct inquiries to: Margaret Sutherland, PhD Program Director, Neurodegeneration Cluster NINDS / NIH 6001 Executive Blvd., Rm 2222 Bethesda, MD 20892 Phone: 301-496-5680 Fax: 301-480-1080 E-mail: sutherlandm@ninds.nih.gov 

NINDS no longer utilize Mentored Research Scientist Development Award Parent K01; PA-11-190) support scientists re-entering research Notice Number: NOT-NS-11-013 Key Dates Release Date: April 11, 2011   Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to notify potential applicants for PA-11-190 formerly PA-10-056, is expiring 8, 2011), NINDS no longer accept new ReEntry K01 submissions.  NINDS accept resubmission applications only cycles II July 12) III November 12) 2011.  the future, NINDS use K01 support mechanism exclusively the purpose promoting diversity neuroscience research through PAR-09-065, is still active. Candidates interested support re-entry Neurological research should the NINDS Re-Entry supplement program an alternate opportunity: http://www.ninds.nih.gov/funding/areas/office_of_minority_health_and_re…. Inquiries Please direct inquiries to: Michelle Jones-London, Ph.D. Program Director Office Minority Health Research National Institute Neurological Disorders Stroke 6001 Executive Blvd NSC, Suite 2149, MSC 9535 Bethesda, MD 20892-9535 301-451-7966; Fax 301-594-5929 jonesmiche@ninds.nih.gov

Notice Intent Publish Request Applications a Spinal Muscular Atrophy SMA) Biomarker Study U01) Convene Related Workshop Notice Number: NOT-NS-11-012 Key Dates Release Date: April 8, 2011 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 clinical research studies will accelerate augment validation biomarkers Spinal Muscular Atrophy SMA). Notice being provided allow potential applicants sufficient time develop responsive protocols necessary collaborations. FOA expected be published the NIH Guide Grants Contracts late spring/early summer 2011, an anticipated receipt date late summer 2011. FOA use U01 cooperative agreement mechanism. Details the planned FOA provided below. Research Initiative Details December 2010, FOAs RFA-NS-11-009, RFA-NS-11-010, RFA-NS-11-008 released a Clinical Coordinating Center CCC), Data Coordinating Center DCC) a group clinical sites, combined form Network Excellence Neuroscience Clinical Trials NEXT). study selected response the planned FOA be conducted through NEXT infrastructure using NEXT clinical sites well ad hoc clinical sites appropriate. Notice encourages investigators expertise insights the area SMA research biomarker discovery begin consider applying this new FOA.  nbsp; addition, collaborative investigations combining expertise neuromuscular disease be encouraged these investigators should also begin considering applying this application. addition scientific discovery, biomarker qualification hoped lead use pivotal clinical trials marketing application. collaboration Food Drug Administration FDA), NIH hold public workshop May 13, 2011 during academics/industry researchers non-government organizations invited present state-of-the-science SMA biomarkers http://www.ninds.nih.gov/news_and_events/proceedings/sma_workshop.htm). workshop include panel discussions. summary the workshop be publicly available the NINDS website. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: D. Elizabeth McNeil, MD MSc 6001 Executive Boulevard, MSC 9520 Rockville, MD 20852 Phone: 301-496-9135 Fax: 301-480-1080 Email: mcneilde@ninds.nih.gov

Withdrawal NINDS Participation PAR-10-266, Support NIGMS Program Project Grants P01) Notice Number: NOT-NS-11-014 Key Dates Release Date:   March 25, 2011 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice informs potential applicants that, effective immediately, National Institute Neurological Disorders Stroke NINDS) no longer participate PAR-10-266, Support NIGMS Program Project Grants P01)."  NINDS recently released PAR-11-172, NINDS Program Project Grant P01)," potential applicants should use NINDS-directed P01 submissions.  following Institutes continue participate PAR-10-266: National Institute General Medical Sciences NIGMS) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Diabetes Digestive Kidney Diseases NIDDK) other aspects PAR-10-266 remain unchanged. Inquiries Please direct inquiries to: Alan L. Willard, Ph.D. Deputy Director Extramural Research, NINDS 6001 Executive Blvd, Room 3305 Rockville, MD 20852 couriers) Bethesda, MD 20892-9531 US Mail) Voice: 301-496-9248 Fax: 301-402-4370 Email: AW135Y@NIH.GOV

Clarification, Institutional Clinical Translational Science Award U54), RFA-RM-10-020 Notice Number: NOT-RM-11-012 Key Dates Release Date:   March 23, 2011 Issued National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Library Medicine NLM) Fogarty International Center FIC) National Center Complementary Alternative Medicine NCCAM) National Center Research Resources NCRR) Office Behavioral Social Sciences Research OBSSR) Office Dietary Supplements ODS) Office Rare Diseases ORD) Office Research Women’s Health ORWH) Common Fund Roadmap) Purpose Notice issued make 3 amendments the current funding opportunity announcement Clinical Translational Science Awards, RFA-RM-10-020 under following headings: Mentored Research Career Development Component K12) Notice amends current CTSA RFA-RM-10-020 change minimum 9 person-months equivalent 75%) full-time professional effort conducting research scholars select clinical specialty appointments. original version RFA-RM-10-020, Section III 1. Eligible Research Education, Research Training Research Career Development Trainees, Scholars Mentors, reads: KL2 scholars must a research health-professional doctoral degree its equivalent. Candidates must able commit minimum 9 person-months equivalent 75%) conducting research career development research activities associated the program. remaining 3 person-months equivalent 25 %) be divided among research, clinical teaching activities only these activities consistent the proposed goals the KL2 program. is amended read: KL2 scholars must a research health-professional doctoral degree its equivalent. Candidates must able commit minimum 9 person-months equivalent 75%) full-time professional effort conducting research career development research activities associated the program. remaining 3 person-months equivalent 25 % be divided among research, clinical teaching activities only these activities consistent the proposed goals the KL2 program. KL2 scholars appointments certain clinical specialties have less 9 person-months, no less 6 person-months equivalent 50 %) protected time this Program sufficiently justified programmatically approved example, surgical specialties requiring 50 percent direct patient care time maintain surgical skills board eligibility). Review criteria Review Criteria currently include statement: Environment: a program awarding higher degrees clinical research place? the academic scientific environments contribute the probability success establishing maintaining home clinical translational science? there strong training record both institutional faculty levels? Does proposal provide strong evidence the CTSA provide resources would otherwise possible? applicable, there adequate cooperative arrangements between affiliated institutions ensure the CTSA program performs effectively one activity across institutional boundaries? there unique features the scientific environment in available human subject populations collaborative arrangements? infrastructure place indicating likelihood success the proposed C/D/I? is modified read: Environment: a program awarding higher degrees clinical research place? the academic scientific environments contribute the probability success establishing maintaining home clinical translational science? there strong training record both institutional faculty levels? Does proposal provide strong evidence the CTSA provide resources would otherwise possible? the applicants described effective administration governance structure will promote discipline clinical translational science? applications designating multiple PD/PIs, the leadership approach, including designated roles responsibilities, governance organizational structure consistent and justified the aims the CTSA the expertise each the PD/PIs? the governance structure designed ensure both accountability multiple PD/PIs, integration the components the C/D/I a coherent program? the organization the External Advisory Committee within structure the CTSA conducive providing critical, stimulating, thoughtful advice the overall CTSA performance CTSA key functions? applicable, there adequate cooperative arrangements between affiliated institutions ensure the CTSA program performs effectively one activity across institutional boundaries? there unique features the scientific environment in available human subject populations collaborative arrangements? infrastructure place indicating likelihood success the proposed C/D/I? Format the Application Section G Format the Application” currently reads: G. Literature cited a) Bibliography References Cited – Provide bibliography any references cited the Research Plan. reference must include names all authors the same sequence which appear the publication), article journal title, book title, volume number, page numbers, year publication. Include only bibliographic citations. Follow scholarly practices providing citations source materials relied upon preparing any section the application. references should limited relevant current literature. While is a page limitation, is important be concise select only those literature references pertinent the proposed research. b) Progress Report Publication List – Renewal applications list titles complete references all appropriate publications, manuscripts accepted publication, patents, other printed materials have resulted the project since was last reviewed competitively. is amended read: G. Literature cited a) Bibliography References Cited – Provide bibliography any references cited the Research Plan. reference must include names all authors the same sequence which appear the publication), article journal title, book title, volume number, page numbers, year publication. Include only bibliographic citations. Follow scholarly practices providing citations source materials relied upon preparing any section the application. references should limited the relevant current literature. While is a page limitation, is important be concise select only those literature references pertinent the proposed research. b) Progress Report Publication List – Renewal applications list titles complete references all appropriate publications, manuscripts accepted publication, patents, other printed materials have resulted the project since was last reviewed competitively.  Applicable papers directly supported CTSAs subject the Public Access Policy http://publicaccess.nih.gov/determine_applicability.htm criteria), awardees required ensure papers submitted PMCIDs included citations these papers renewal applications. Inquiries Please direct inquiries to: Dr. Anthony Hayward Division Clinical Research Resources, NCRR 6701 Democracy Blvd. Room 906, MCS 4874 Bethesda, MD 20892 Telephone: 301-435-0790 FAX: 301-480-3661 Email: haywarda@mail.nih.gov

Request Information RFI) NIH CTSA Neuroscience Research Notice Number: NOT-NS-11-007 Key Dates Release Date: March 18, 2011 Responses Due By:  assure consideration, comments must received May 20, 2011 Issued National Institute Neurological Disorders Stroke NINDS) National Center Research Resources NCRR) NIH Blueprint Neuroscience Research http://neuroscienceblueprint.nih.gov Purpose NIH Clinical Translational Science Award program CTSA) Neuroscience Research Trans-NIH Workgroup seeking public comment potential programs facilitate neuroscience research using existing new research resources. CTSA program supports national consortium medical research institutions committed speeding translation laboratory discoveries treatments patients, engaging communities clinical research efforts, training new generation clinical translational researchers http://www.ctsaweb.org/). this RFI, neuroscience research defined broadly the conduct basic, clinical, translational research relevant conditions diseases the nervous system. Neuroscience research employ interdisciplinary research teams include neuroscience researchers areas such as, not limited to, addiction, anatomy, behavioral health, biostatistics, economics, engineering, epidemiology, ethics, information systems technology, minority health, mental health, molecular developmental neurobiology, neurogenetics, neuroimaging, physics, substance disorders neuro-related fields clinical medicine.  this RFI, neuro-related fields clinical medicine generate neuroscience researchers include, are limited to, anesthesia, behavioral mental health, cardiovascular medicine, cognitive neuroscience, complementary alternative medicine, developmental disorders the nervous system, emergency medicine, geriatrics, internal medicine, military medicine, neurocritical care, neuroendocrinology, neurology, neurooncology, neuroradiology, neurosurgery, occupational environmental health, ophthalmology, otolaryngology, pediatrics/child neurology, physical medicine rehabilitation, psychiatry, sleep medicine, substance disorders. RFI aims gather information critical gaps, challenges, potential strategies close gaps resolve challenges order develop coordinate resources neuroscience research using CTSA infrastructure. Resources research include--but not limited to--team science, clinical trials infrastructure, collaborative networks, education training, biomedical informatics, clinical research units/centers, community engagement research, ethics, evaluation, novel clinical translational methodologies, pilot collaborative translational clinical studies, public-private partnerships, regulatory knowledge support, translational technologies. Background CTSA program complements programs the NIH Institutes works cooperation other NIH activities other relevant trans-NIH activities. goal the institutional Clinical Translational Science Award CTSA) program to transform local, regional national environment clinical translational science, thereby increasing efficiency speed clinical translational research. transformation be achieved creating academic home, can a center, department, institute, comprising faculty programs integrate clinical translational science across multiple departments, schools, clinical research institutes hospitals. CTSA expected include faculty able conduct original research, develop graduate postgraduate training curricula lead programs integrate clinical translational science across multiple departments, schools, clinical research institutes hospitals. more information, please http://www.ctsaweb.org. Definitions:  the purpose this initiative, clinical research comprises studies trials human subjects meeting NIH definition the PHS 398 instructions see: http://grants.nih.gov/grants/funding/phs398/phs398.pdf). Translational research includes areas translation. is process applying discoveries generated during research the laboratory, in preclinical studies, the development trials studies humans. second area translation concerns research aimed clinical trials other prospective studies, retrospective studies, observational studies, dissemination implementation enhance adoption best practices the community. Cost-effectiveness prevention treatment strategies also an important part translational science. Bidirectional communication work processes integral each these areas translational research. comparative effectiveness research prevention treatment strategies also important part translational science. Information Requested RFI seeks information critical gaps challenges potential approaches resolve in order enhance resources neuroscience research using infrastructure available through CTSA institutional, regional, the national consortium. Ideas both short-term 6 months-1 year) long-term 2-5 years) approaches develop coordinate neuroscience research research resources welcome. Members the scientific community, scientific organizations, healthcare professionals, patient advocates, the public invited respond any, all the following: Challenges — Describe critical gaps other challenges neuroscience research the CTSAs might address. Challenges be the level clinical translational research, clinical trials, participant recruitment amp; retention, special populations, team science collaborative networking, infrastructure, workforce resources, information systems technology, methodology, interventions, the execution, implementation, evaluation programs. Potential Solutions — Describe you believe be most innovative approaches address challenges.  NIH seeking input advice the following items.  Please consider commenting any the items are relevant your work and/or research. Challenges:  1.  are critical gaps in, other challenges to, advancing neuroscience research through team science your perspective may include or of following: 1) researcher, 2) patients/consumer individual advocacy group, 3) health care provider, 4) type health care professional, 5) administrator, 6) information systems technology worker, 7) health care payer, 8) research funding organization, 9) private organization, 10) regulatory agency? 2.  Identify critical gaps other challenges CTSAs address facilitate clinical and/or translational neuroscience research the CTSAs’ institutional, regional, and/or national consortium level. 3.  Aspects neuroscience research you think been impacted the NIH’s investment CTSAs.   Please consider commenting  any the CTSA functions resources devoted education training, biomedical informatics, clinical research units/centers, community engagement  research, ethics, evaluation, novel clinical translational methodologies, pilot collaborative translational clinical studies, public-private partnerships, regulatory knowledge support, translational technologies. 3a. have any these functions resources utilized advance neuroscience research? Feel free give particular examples might serve models others. 3b. have any these functions resources contributed the dissemination the outcomes neuroscience research researchers, clinical practice, patients community groups, policymakers? 4.  Drivers the decisions researchers, new treatment developers, drug, device diagnostic manufacturers participate multicenter neuroscience clinical trials conducted within CTSA Consortium infrastructure. 5.  are critical gaps other challenges constrain neuroscience clinical trials within CTSAs? are unique challenges highly impact participant recruitment retention especially among participants special populations with rare diseases these clinical trials? 6.  are barriers conducting assessing outcomes comparative effectiveness research neuroscience the CTSA institutional, regional, and/or national consortium level? 7.  your perspective, please describe interactions between CTSAs basic clinical researchers are neuroscientists, clinicians, nurses, allied health professionals, complementary alternative medicine experts, economists, engineers, epidemiologists, informaticians, methodologists, statisticians interests translational neuroscience research addressing: 7a. Communication, partnership, participation research teams related planned / ongoing studies examining development novel treatments diagnostics, rehabilitation, quality life, symptom identification/symptom management, palliative care, end life, behavioral mental health illness such but limited addiction, depression, post-traumatic stress disorders cognitive impairments such but limited mild cognitive impairments MCI), memory impairments resulting but limited brain injury, Alzheimer’s vascular diseases, autism, pain, mobility impairments resulting but limited arthritis, bone muscular diseases, spinal cord injury, stroke. 7b. Early career mid-career research training needs. 8.  Comment the most challenging barriers engaging private sector including for-profit non-for-profit organizations interact the CTSA Consortium. 9.  are critical gaps challenges the execution, implementation, evaluation CTSA programs advance neuroscience research? 10.  there issues NIH should consider the development team science advance neuroscience research? Potential Solutions:  1.  are potential approaches close critical gaps resolve challenges you described under Challenges Section” advance neuroscience  research through team science your perspective may include or of following: 1) researcher, 2) patients/consumer individual advocacy group, 3) health care provider, 4) type health care professional, 5) administrator, 6) information systems technology, 7) health care payers, 8) research funding organization, 9) private organization, 10) regulatory agency? 2.  CTSAs be utilized conduct preclinical studies early phase clinical trials phase 0/phase I/phase II) CNS drug development. Please comment the level target identification developmental methods. 3.  CTSAs might effectively contribute basic, clinical, and/or translational neuroscience research the CTSA institutional, regional, and/or national consortium level. 4.  the various neuroscience institutes other funding organizations might leverage value productivity their own investments interacting the CTSAs. 5.  can CTSAs better conduct assess outcomes comparative effectiveness research neuroscience the CTSA institutional, regional, and/or national consortium level? 6.  most effective approaches ensure continued dissemination the outcomes neuroscience research collection review multistakeholder input the CTSA institutional, regional, and/or national consortium level. 7.  can infrastructure the CTSAs best leveraged take advantage advances neuroscientific tools such as, not limited to, neuroimaging, neurogenomics, proteomics, metabolomics biomarker development, early phase studies assess proof biologic activity novel treatments?   8.  CTSAs more effectively contribute developing sustaining translational neuroscience research education, training, workforce. 9.  can infrastructure the CTSAs leveraged advance neuroscience translational discoveries the development evidence-based medicine  any the following research areas: a)      Autism b)      Behavioral health c)      Cancer d)      Cardiovascular and/or autonomic system e)      Cerebrovascular conditions events f)       Complementary Alternative Medicine CAM) g)      Concussions, Traumatic Brain Injury TBI), and/or Blast Injury h)      Genomics i)        Implementation science j)       Information dissemination k)       Mental health l)        Minority underserved populations m)     Neurocritical care n)      Neurodegenerative disorders o)      Neurodevelopmental disorders normative brain development p)      Neuroimaging q)      Neurological disorders Infant, adolescent, adult, and/or elderly r)       Neuroplasiticity s)      Neuro-related devices, information systems technology, other technologies t)       Neuro- related physical medicine rehabilitation u)      Neurotherapeutics v)       Neuro-related disorders occupational environmental health w)      Nursing x)       Pain y)       Patient centered outcomes comparative effectiveness research CER) z)       Peripheral nerve disorders aa)    Post Traumatic Stress Disorder PTSD) bb)    Sensory impairments disorders cc)     Sleep dd)    Spinal cord injury SCI) ee)    Substance disorders ff)      research areas listed 10.  can investigators working translational neuroscience relevant infants, children, adolescents, and/or adults, including elderly, CTSA resources infrastructure? 11.  CTSAs encourage developmental perspective, across lifespan, ongoing translational neuroscience research, applicable. 12.  can infrastructure the CTSAs best leveraged facilitate translation findings basic research behavioral social neuroscience effective interventions – pharmacological, behavioral devices – improve health? 13.  Given recent decline pharmaceutical company funding nervous system research development, can CTSAs re-invigorate neuroscience drug development? 14.  what purpose(s) you utilize CTSA Consortium Neuroscience Thematic Special Interest Group support research career development efforts? RESPONSES assure consideration, comments must received May 20, 2011. Individuals, groups, organizations interested commenting how Clinical Translational Science Awards CTSAs) advance neuroscience research, outlined this RFI, submit comments this RFI. Responses this RFI must submitted electronically using wed-based format http://www.ninds.nih.gov/funding/rfi-nihctsa-neuroscience.htm. Comments be publicly available, including any personally identifiable confidential business information they contain.  Trade secrets should be submitted.  Inquiries further information contact: Walter Koroshetz: koroshetzw@mail.nih.gov Rosemarie Filart:  filartr@mail.nih.gov Jerry Doyle:  doylejj@mail.nih.gov Request Information RFI) for planning purposes only is a solicitation applications an obligation the part the United States U.S.) Government provide support any ideas identified response it.  Please note the U.S. Government not pay the preparation any information submitted for use that information. Footnotes: the purposes this RFI, definition comparative effectiveness research CER) adhere that adopted the Federal Coordinating Council given http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf: Comparative effectiveness research the conduct synthesis research comparing benefits harms different interventions strategies prevent, diagnose, treat monitor health conditions real world” settings. purpose this research to improve health outcomes developing disseminating evidence-based information patients, clinicians, other decision-makers, responding their expressed needs, which interventions most effective which patients under specific circumstances. provide information, comparative effectiveness research must assess comprehensive array health-related outcomes diverse patient populations subgroups. Defined interventions compared include medications, procedures, medical assistive devices technologies, diagnostic testing, behavioral change, delivery system strategies. research necessitates development, expansion, use a variety data sources methods assess comparative effectiveness actively disseminate results.

Notice Intent Publish Funding Opportunity Announcement Induced Pluripotent Stem Cell iPSC) Resources promoting Translational Research Advancements Neurodegenerative Diseases U24) Notice Number: NOT-NS-11-011 Key Dates Release Date: February 15, 2011 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends publish Funding Opportunity Announcement FOA) nbsp;to promote continued development publically available, well characterized induced pluripotent stem cell iPSC) research resources will enable encourage collaborative research among academic industry investigators ultimately accelerate basic science discoveries therapeutic development late-onset neurodegenerative diseases. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published spring 2011 an expected receipt date early summer 2011. FOA utilize Research-related Resource cooperative agreement U24) activity code. Details the planned Funding Opportunity Announcement FOA) provided below. Research Initiative Details Notice encourages investigators have expertise somatic cell reprogramming, neurodegenerative disease biology, translational research, drug discovery the creation publically available, well characterized iPSC resources neurodegenerative diseases consider applying this new Funding Opportunity Announcement FOA).  December 2010, Workshop convened NINDS review technologies resources developed iPSC consortia investigators funded NINDS through American Recovery Reinvestment Act ARRA). http://www.ninds.nih.gov/funding/areas/neurodegeneration/2nd_iPSC_Conso… )  nbsp; Given insights recommendations provided the workshop, the challenges still be addressed applying iPSC resources the pre-clinical drug discovery process, NINDS recognizes unique opportunity bring academic industry researchers together share expertise drug development, stem cell biology neurodegenerative disease biology. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Margaret Sutherland, PhD Program Director, Neurodegeneration Cluster Division Extramural Research National Institute Neurological Disorders Stroke 6001 Executive Boulevard, Room 2222 Bethesda, MD 20892-9531 Phone: 301) 496-5680 Email: sutherlandm@ninds.nih.gov nbsp;