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Pre-application Meeting RFA-NS-11-005 - Clinical Data Coordinating Center(s) Parkinson's Disease Biomarkers Identification Network PD-BIN) U01) Notice Number:  NOT-NS-11-003 Key Dates Release Date:   November 24, 2010 Pre-Application Meeting Date: December 17, 2010 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) hold pre-application meeting regarding RFA-NS-11-005 http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-11-005.html), Clinical Data Coordinating Center(s) Parkinson’s Disease Biomarkers Identification Network PD-BIN) U01), which prospective applicants invited. is intended explain goals objectives this initiative answer questions prospective applicants. Participation this meeting neither required nor necessary a successful application. Details Meeting: Title: Pre-application Meeting RFA-NS-11-005 When: Friday, December 17th, 2010; 3:00pm-4:00pm Time Zone: GMT - 05:00) Eastern Time US Canada) Website: https://webmeeting.nih.gov/pdbinccc-dccrfa/ Telephone information audio): Conference number US Participants): 1-866-692-4538 Participant Code: 2145501 Non-US participants, please email contact listed below call-in information your specific location be provided. Please email questions advance, wished, the below contact. While effort be to include questions, is possible not will addressed during meeting due time constraints. Inquiries questions further information, contact: Katrina Gwinn MD National Institute Neurological Disorders Stroke 6001 Executive Blvd Room 2143 Bethesda MD 20892 Telephone: 301-496-5745 Fax: 301-502-1501 Email: gwinnk@ninds.nih.gov

Notice Intent Publish Limited Competition Program Announcement Applications Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network U54) Notice Number:  NOT-NS-11-004 Key Dates Release Date:   November 24, 2010 Issued National Institute Neurological Disorders Stroke NINDS) Office Rare Diseases Research ORD) Purpose National Institute Neurological Disorders Stroke NINDS), the NIH Office Rare Diseases Research ORDR), intend publish Funding Opportunity Announcement FOA) solicit applications research rare diseases via Rare Diseases Clinical Research Network.  FOA be limited competition available only the current American Recovery Reinvestment Act ARRA)-supported Rare Disease Clinical Research Consortia awardees.  Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published the winter 2011 a receipt date the spring 2011. 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 I, II II/III 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 3 years. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Randall R. Stewart, PhD Program Director National Institute Neurological Disorders Stroke 6001 Executive Blvd., Room 2135 Bethesda, MD 20892 Telephone: 301-496-1917 Fax:  301-402-1501 stewartr@ninds.nih.gov

Correction RFA-CA-10-017, quot;Scientific Meetings Creating Interdisciplinary Research Teams Basic Behavioral Social Science Research R13)," Order Simplify Submission Requirements Notice Number:  NOT-CA-11-001 Key Dates Release Date: November 18, 2010 Related Notices None Issued NIH Basic Behavioral Social Science Opportunity Network OppNet; http://oppnet.nih.gov/) and, member institutes, centers, offices) National Cancer Institute NCI) National Center Minority Health Health Disparities NCMHD) nbsp; 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 Library Medicine NLM) Fogarty International Center FIC) National Center Complementary Alternative Medicine NCCAM) National Center Research Resources NCRR) Office AIDS Research OAR) Office Behavioral Social Sciences Research OBSSR) Office Dietary Supplements ODS) Office Disease Prevention ODP)  Office Research Women’s Health ORWH) Purpose purpose this Notice to correct RFA-CA-10-017, quot;Scientific Meetings Creating Interdisciplinary Research Teams Basic Behavioral Social Science Research R13)," eliminating requirement a quot;Permission-to-Submit Letter" the appropriate NIH Institute Center IC) Conference Grant Contact. such quot;Permission-to-Submit Letter" required order submit application.  Thus, Section IV.2 Content Form Application Submission RFA-CA-10-017, last item the block subtitled quot;Required Components" changed from: quot;PHS398 Cover Letter File, including Permission-to-Submit Letter appropriate IC Conference Grant Contact" quot;PHS398 Cover Letter File." other aspects RFA-CA-10-017 remain unchanged. Inquiries Please direct inquiries to: Kara L. Hall, Ph.D. Behavioral Research Program Division Cancer Control Population Sciences National Cancer Institute NCI) 6130 Executive Boulevard, EPN Room 4078, MSC 7326 Bethesda, MD 20892-7326 U.S. Postal Service express regular mail) Rockville, MD 20852 non-USPS delivery) Telephone: 301-594-9056 Fax: 301-480-2087 Email: hallka@mail.nih.gov Lis Nielsen, Ph.D. Division Behavioral Social Research National Institute Aging NIA) 7201 Wisconsin Avenue, 533 Bethesda, MD 20892-9205 Telephone: 301-402-4156 Fax: 301-402-0051 Email: nielsenli@nia.nih.gov Mariela C. Shirley, Ph.D. Division Epidemiology Prevention Research DEPR) National Institute Alcohol Abuse Alcoholism NIAAA) 5635 Fishers Lane, Room 2086, MSC 9304 Bethesda, MD 20892-9304 U.S. Postal Service express regular mail) Rockville, MD 20852-1705 non-USPS delivery) Telephone:  301-443-9787 Fax: 301-443-8614 Email:  shirleym@mail.nih.gov

Notice Intent Publish Request Applications Core Cohort Discovery Validation Studies the Parkinson's Disease Biomarkers Identification Network PD-BIN) U01) Notice Number:  NOT-NS-11-001 Key Dates Release Date:   November 10, 2010 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications hypothesis-driven clinical research studies will accelerate augment discovery biomarkers a component the NINDS Parkinson's Disease Biomarkers Identification Network PD-BIN). Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.   FOA expected be published late spring, 2011 an expected receipt date fall, 2011. FOA utilize U01 activity code. Details the FOA provided below. Research Initiative Details Notice encourages investigators expertise insights the area clinical Parkinson's disease research biomarker discovery begin consider applying this new Funding Opportunity Announcement FOA).  May 2010, Workshop convened the National Institute Neurological Disorders Stroke NINDS) http://www.ninds.nih.gov/research/parkinsonsweb/PD_meeting_schedule.htm) discuss current state biomarker development PD how discovery, standardization validation biomarkers most effectively facilitate therapy development PD.  Given insights recommendations provided the workshop, Parkinson's Disease Biomarkers Identification Network PD-BIN) being developed part the NINDS response the critical need biomarker development PD. September 2010, RFA NS-11-005; http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-11-005.html) released linked U01s a Clinical Coordinating Center CCC) Data Coordinating Center DCC) the initial step the Parkinson's Disease Biomarker Identification Network PD-BIN). CCC under intended award include sites will recruit characterize core cohort de novo subjects Parkinson's disease control subjects be evaluated a longitudinal manner.  FOA not allow hypothesis driven research. purpose this Notice to inform potential applicants the intention develop initiative will enable hypothesis-driven studies validate promising biomarkers require active participation the core cohort may include clinical imaging studies).  timing this intended FOA be such measures be integrated the longitudinal planning efforts the CCC DCC.  projects under PD-BIN program expected fully cooperate and utilize core resources the PD-BIN CCC-DCC biorepository order allow full sharing future cross sectional well longitudinal studies members the Network. FOA not include cohort studies, animal studies, assay design, other laboratory based studies, are expected be solicited via different mechanisms the future. 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

Notice Change Anticipated Start Date RFA-NR-11-002, NIH Basic Behavioral Social Science Opportunity Network OppNet) Short-term Interdisciplinary Research Education Program New Investigators R25) Notice Number: NOT-NR-11-005 Key Dates Release Date:  November 9, 2010 Related Notices RFA-NR-11-002 Issued NIH Basic Behavioral Social Science Opportunity Network OppNet http://oppnet.nih.gov) its member institutes, centers offices: Fogarty International Center FIC) 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) National Center Complementary Alternative Medicine NCCAM) National Center Research Resources NCRR) Office Behavioral Social Sciences Research OBSSR) Office Dietary Supplements ODS) Office Disease Prevention http://prevention.nih.gov/) Office Research Women’s Health ORWH) Purpose funding opportunity announcement FOA), RFA-NR-11-002, issued the National Institute Nursing Research NINR) part the NIH Basic Behavioral Social Science Opportunity Network OppNet) solicits short-term R25 Research Education Project applications will focus providing creative innovative education research experiences new scientists basic behavioral social science research b-BSSR). goal this initiative to support growth a cohort scientists research expertise b-BSSR further understanding fundamental mechanisms patterns behavioral social functioning relevant the health well-being individuals populations. notice being provided change anticipated start date December 30, 2011 September 30, 2011 applications submitted response this announcement. change Key Dates appear follows: Key Dates: Release/Posted Date:  September 14, 2010 Opening Date:  December 6, 2010 Earliest date application be submitted Grants.gov) Letters Intent Receipt Date(s): December 6, 2010 Application Due Date(s):  January 6, 2011 Peer Review Date(s): June/July 2011 Council Review Date(s): August 2011 Earliest Anticipated Start Date(s): September 30, 2011 Expiration Date: January 7, 2011 Applicants encouraged consider key date submitting application response this announcement. date change meant reflect fact OppNet funding this FOA come of FY 2011 dollars. other aspects this Funding Opportunity Announcement remain unchanged. Inquiries Please direct inquiries to: Scientific/Research Contact(s): David Banks, Ph.D., M.P.H., M.S.S.W., RN Research Training Officer, Program Director National Institute Nursing Research, NIH 6701 Democracy Blvd, Rm. 710 Democracy Plaza Bethesda, MD 20892-4870  Telephone: 301) 496.9558 Fax: 301.480.8260 Email: banksdh@mail.nih.gov Marcia S. Scott, Ph.D. Division Epidemiology Prevention Research National Institute Alcohol Abuse Alcoholism National Institutes Health, DHHS 5635 Fishers Lane Room 2083, MSC 9304 Bethesda, MD 20892-9304 Telephone: 301) 402-6328 FAX: 301-443-8614 Email: mscott@mail.nih.gov

Request Information RFI): Acquisition, Processing, Storage, Distribution Human Brain Tissues Advance Understanding Treatment Addiction; Neurological, Psychiatric, Developmental, Mental Disorders; Neurological Diseases; Normal Brain Development; Aging Notice Number: NOT-MH-10-034 Key Dates Release Date: October 27, 2010 Response Date: nbsp;December 3, 2010 Issued National Institute Mental Health NIMH) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Mental Health NIMH), Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), National Institute Drug Abuse NIDA), National Institute Aging NIA), National Institute Neurological Disorders Stroke NINDS) recognize human Brain Tissue Repositories BTR) contribute the advancement many aspects research addiction, developmental disorders, mental illness, neurological diseases, aging.  facilitate collaborative research enhance ability BTR serve diverse set constituents, institutes evaluating existing collections the possibility new approaches acquiring, storing, distributing important tissues, through collaborations partnerships other organizations, foundations and/or groups. nbsp;The participating Institutes also anticipate discussions those maintain similar human tissue repositories develop common collection protocols, QA/QC standards, processing, storage, distribution policies procedures specimens associated data.  Request Information RFI) serves gather information these topics the research, advocacy, other stakeholder communities. Background NIMH, NICHD, NIDA, NIA, NINDS evaluating approaches synergize collection human brain tissues important research diseases the central nervous system.  objective most existing biorepositories to systematically collect, store, catalog, preserve, distribute human brain tissues qualified scientific investigators. However, has little standardization the approach these activities, practices policies vary widely repository repository. Research utilizing human tissue poised novel clinically relevant discoveries a result the rapidly expanding spectrum sophisticated techniques approaches tissue analysis are currently available. nbsp;In order facilitate collaborative research increase ability Brain Tissue Repositories serve diverse set constituents, participating Institutes exploring approaches extend enhance resources, including collaborations partnerships other governmental non-governmental organizations groups. Information Requested participating Institutes invite public input several areas; feel free respond as as wish: I. nbsp;The NIH seeking information best practices the recruitment subjects future brain donation including patients addiction, developmental disorders, mental disorders, neurological diseases, normal brain development, aging. Interested parties wish comment strategies for: Recruitment relevant subjects, including methods outreach education encourage tissue donation. example, organizations have unique expertise access patient groups will facilitate goals a BTR Collection information including clinical data phenotyping) tissue genotyping provision advisory functions a BTR Collection, processing, genotyping, storage tissue associated data may facilitated other organizations Outreach communities the importance brain tissue donation, particularly underserved populations those may difficult recruit Clinical phenotyping subjects a BTR either through registry prior donation after donation Suggestions best practices identify or whom) tissue should allocated research, especially those tissues limited availability those high demand II. nbsp;The NIH also seeking information individuals, groups, organizations best practices develop manage coordinated network and/or centralized Brain Tissue Repository. NIH invites interested parties submit following: General specific comments regarding nature, activities, and/or organization a networked centralized BTR, either existing repository one might developed the future Suggestions best practices collecting, storing, sharing tissue specimens including fetal tissues); and/or obstacles creating managing, deploying successful BTR Suggestions how investigators should submit share newly collected and/or existing collections a coordinated network centralized BTR III.  NIH seeking information the existence availability so-called ldquo;legacy” pre-existing collections human brain tissues. NIH invites interested parties comment the following: legacy collections exist; where they located; phenotypes quality metrics included Whether collection be transferred a networked centralized BTR facilitate use other scientists would encourage individuals institutions brain tissues alreadycollected contribute to networked centralized BTR. could include tissues investigators are retiring, moving, otherwise transition to Submit Response Responses be accepted until December 3, 2010.  responses must submitted via email to: nbsp;BTRRFI@mail.nih.gov. nbsp;Please include notice number NOT-MH-10-034 the subject line include complete contact information your response. nbsp;You receive email confirmation acknowledging receipt your response. nbsp;The submitted information be reviewed the Brain Biospecimen Repository workgroup. nbsp;Submitted information not considered confidential. Inquiries Inquiries regarding notice be directed to: Roger Little, Ph.D. Office Science Policy, Planning Communications National Institute Mental Health 6001 Executive Boulevard, Room 8211, MSC 9667 Bethesda, MD  20892-9667 Telephone:  301) 402-5844 FAX:  301) 443-1328 Email:  BTRRFI@mail.nih.gov

Notice Intent Publish Request Applications the Morris K. Udall Centers Excellence Parkinson’s Disease Research P50) Notice Number: NOT-NS-10-028 Key Dates Release Date:   September 22, 2010   Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends publish Request Applications RFA) continue Morris K. Udall Centers Excellence Parkinson’s Disease Research program. Notice being provided allow potential applicants, including existing Centers approaching competing renewal, sufficient time develop meaningful collaborations responsive projects.  RFA expected be published the fall 2010 an expected receipt date January 2011. RFA utilize Specialized Center P50) activity code. Details the planned Funding Opportunity Announcement FOA) provided below. Research Initiative Details goal this NINDS program to fund multidisciplinary Centers Excellence can rapidly advance innovative research improve understanding treatment Parkinson’s disease PD) related disorders. Udall Centers perform state-of-the-art research PD, including examination underlying neurobiological neuropathological mechanisms, identification characterization candidate disease-associated genes, establishment improved PD models development testing potential therapeutics, the initiation novel avenues clinical research. Centers Excellence, Udall Centers should serve regional national resources the study PD related parkinsonian disorders. Udall Centers program utilizes Specialized Center P50) grant mechanism, is designed support spectrum basic, translational clinical research activities utilizing integrated, multidisciplinary approach a specific disease entity biomedical problem area. overall theme the Center, proposed research projects associated resource Cores should relate directly the etiology, pathogenesis treatment PD parkinsonian disorders. Notice encourages established investigators proven expertise and/or novel insights PD related disorders consider applying through upcoming RFA. Applications Principal Investigators outside the PD field welcome their specific expertise be readily applied novel approaches the identification disease mechanisms therapeutic targets PD. Successful Centers be expected both collaborate effectively within contribute unique knowledge the ongoing Udall Centers program. While basic research PD and continue serve the foundation discovery, proposed Center must include least one, small-scale, early stage preclinical clinical translational project. this purpose, preclinical translation defined early stage, pre-IND/IDE Investigational New Drug/Investigational Device Exemption) proof-of-concept research potential therapeutic diagnostic candidates.  Clinical translational projects, while intended assess therapeutic effect, should designed provide early proof-of-principle advancement research results clinical trials. NINDS policy Udall Centers establishes following budget limits: new competing renewal applications request maximum annual direct costs 1,000,000; requested budget 1,500,000 permitted inclusion a clinical component. clinical component accompanying budget should clearly described specified. Full details be available the RFA. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Beth-Anne Sieber, PhD Program Director, Neurodegeneration Cluster Division Extramural Research National Institute Neurological Disorders Stroke 6001 Executive Boulevard, Room 2192 Bethesda, MD 20892-9531 Phone: 301) 496-5680 Email: sieberb@ninds.nih.gov

Participation NINDS PAR-10-266, Support NIGMS Program Project Grants P01) Notice Number: NOT-NS-10-029 Key Dates Release Date:   September 16, 2010 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to inform potential applicants the National Institute Neurological Disorders Stroke announces participation, effective immediately, the Program Announcement PAR-10-266, titled quot;Support NIGMS Program Project Grants P01)." Components Participating Organizations section PAR-10-266 been revised include NINDS: Components Participating Organizations National Institute General Medical Sciences NIGMS), http://www.nigms.nih.gov/) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS), http://www.niams.nih.gov/   National Institute Diabetes Digestive Kidney Diseases NIDDK), http://www2.niddk.nih.gov/ National Institute Neurological Disorders Stroke NINDS), http://www.ninds.nih.gov/   NINDS supports biomedical behavioral research the causes, treatment, prevention neurological disorders stroke. nbsp;The NINDS Program Project Center Grant Guidelines, including direct cost limitations, apply http://www.ninds.nih.gov/funding/ppg_guidelines.htm). Applications assigned the NINDS receive second level review the National Advisory Neurological Disorders Stroke Council NANDSC). CFDA number NINDS is: 93.853. other aspects this FOA remain same. Inquiries Please direct inquiries to: Chief, Scientific Review Branch National Institute Neurological Disorders Stroke Room 3201, MSC 9529 6001 Executive Blvd. Bethesda, MD 20892-9529 Rockville, MD 20852 express/courier service) Telephone: 301) 496-9223 Fax: 301) 402-0182 Email: nindsreview.nih.gov@mail.nih.gov

Notice Correction RFA-AG-11-010, Basic Research Self-Regulation R21) Notice Number:  NOT-AG-10-011 Key Dates: Release Date: September 7, 2010    Issued National Institutes Health NIH) Basic Behavioral Social Science Opportunity Network OppNet http://oppnet.nih.gov/) its member institutes, centers offices: 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 Center Minority Health Health Disparities NCMHD) National Library Medicine NLM) Fogarty International Center FIC) National Center Complementary Alternative Medicine NCCAM) National Center Research Resources NCRR) Office AIDS Research OAR) http://www.oar.nih.gov/) Office Behavioral Social Sciences Research OBSSR) Office Dietary Supplements ODS) Office Disease Prevention ODP) http://prevention.nih.gov/) Office Research Women’s Health ORWH) Purpose purpose this Notice to correct Opening Date RFA-AG-11-010, Basic Research Self-Regulation R21) http://grants.nih.gov/grants/guide/rfa-files/RFA-AG-11-010.html issued the National Institute Aging behalf the NIH Behavioral Social Science Opportunity Network OppNet http://oppnet.nih.gov/) its member institutes, centers offices. Correction Under” Key Dates,” Opening Date Earliest date application be submitted Grants.gov) this FOA incorrectly listed December 6, 2011.  correct opening date December 6, 2010. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Lis Nielsen, Ph.D. Division Behavioral Social Research National Institute Aging 7201 Wisconsin Ave., 533 Bethesda, MD 20892-9205 Telephone: 301) 402-4156 Fax: 301) 402-0051 Email: nielsenli@nia.nih.gov

Notice Intent Publish Request Applications Clinical Research Centers establish Network Excellence Neuroscience Clinical Trials NEXT Sites - U10) Notice Number:  NOT-NS-10-025 Key Dates Release Date:   September 7, 2010 Related Notices NOT-NS-10-026 NOT-NS-10-027 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends issue Request Applications RFA) U10 grant applications support clinical research sites establish Network Excellence Neuroscience Clinical Trials NEXT). clinical research network develop conduct multiple early stage clinical trials research studies enable efficient testing the most promising therapies academia industry.  Examples include proof-of concept trials preparatory studies aimed validating biomarkers clinical outcomes neurological disorders including pediatric patients rare diseases. network provide robust, standardized, accessible infrastructure rapidly develop protocols will coordinate cadre specialist investigators implement studies efficiently. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  companion RFAs be concomitantly released, requesting U01 grant applications support a data coordinating center DCC) NOT-NS-10-027] U01 grant applications support a clinical coordinating center CCC) NOT-NS-10-026].  Note the currently planned RFAs establish collaborating Coordinating Centers Clinical Research Sites.  Separate FOAs be published the future invite applications Phase II clinical trials preparatory research studies will conducted within network. RFA expected be published fall 2010 an expected receipt date winter 2011. Clinical Research Sites RFA utilize U10 mechanism. Details the planned Funding Opportunity Announcement FOA) provided below. Research Initiative Details Notice encourages investigators expertise clinical trials consider applying this new RFA. Successful applicants the Clinical Sites RFA U10) have track record collaborative experienced neuroscience clinical trialists well institutional support.  APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Petra Kaufmann, MD National Institute Neurological Disorders Stroke National Institutes Health 6001 Executive Blvd., Room 2116 Bethesda, MD 20892-9520 Express/Courier:  Rockville, MD 20852 Telephone: 301) 496-9135 Fax: 301) 401-5301 Email: Petra.Kaufman@nih.gov http://www.ninds.nih.gov/