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Request Information RFI): Expansion sharing standardization NIH-funded human brain imaging data Notice Number: NOT-DA-11-021 Key Dates Release Date:     August 26, 2011 Response Date:  Received October 14, 2011 Issued NIH Blueprint Neuroscience Research http://neuroscienceblueprint.nih.gov) National Institute Mental Health NIMH) National Eye Institute NEI) National Center Complementary Alternative Medicine NCCAM) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) Office Behavioral Social Sciences Research OBSSR) Purpose Request Information RFI) for information planning purposes only, should be construed a solicitation as obligation the part the Federal Government, National Institutes Health NIH), NIH Blueprint Neuroscience Research Blueprint), and/or National Institute Drug Abuse NIDA). NIH does intend make any awards based responses this RFI to otherwise pay the preparation any information submitted for Government's of such information. Blueprint Workgroup Neuromaging Data-Sharing the Blueprint Lifespan Human Connectome Project Team seeking input the scientific community, health professionals, patient advocates, community-based organizations, students, the general public the administrative technical issues involved removing barriers the sharing human brain imaging data collected using NIH support.  input include is limited to) issues potential solutions related image hosting, well the adoption standardized scanning procedures, imaging protocols, phenotypic characterization, data formats.  particular interest input regarding human-subjects protection confidentiality issues.  Definitions: Standardization, the purpose this Notice, defined the joint adoption across multiple laboratories institutions) either: a) specific neuro-image acquisition parameters, b) image processing processes after image collection reconstruction, c) specific instruments collateral phenotypic characterization, d) data formats definitions, e) data de-identification, f) potential post-facto algorithms schemes harmonizing data collected under different parameters data definitions.  Sharing, the purpose this Notice, defined either actual transfer brain image data the laboratory infrastructure initial data collection simply enabling dynamic access image data remains stored the institution its collection.  either case, image data be annotated demographic other phenotypic information sufficient detail secondary data analysis.  Transferred data be sent directly a particular laboratory either through centralized referral hub, bilaterally request), alternatively furnished one more common repository infrastructures. Background NIH Blueprint Neuroscience Research endorses principle standardization open-access brain imaging data.  example, Blueprint-funded Human Connectome Project HCP) promises provide neuroscience community easy access well-annotated raw processed data secondary analyses potential federation other datasets.  Alternatively, 1000 Functional Connectomes Project FC1000) a consortium-based dataset comprised primarily resting-state functional connectivity data obtained healthy human subjects dozens individual laboratories Biswal et al.  Proc Natl Acad Sci 2010);107(10):4734-9).  consortium provided evidence federated brain image datasets successfully compiled secondary analysis, especially exploratory investigations. developing distribution/sharing infrastructure the HCP, well success the FC1000, fostered only nascent grass-roots efforts pool donated image data secondary analysis, has also increased interest the NIH Blueprint fostering expansion open-access neuroimage data NIH-funded grants, contracts, cooperative agreements, where standardization across labs significantly facilitate ease federation.  Expanded sharing image data be further enhanced increased standardization across laboratories repositories, holds potential significant value-added investigations the human brain relatively minimal expense.  example, assembly data across different research projects allow investigations genetic behavioral associations require sample sizes statistical power too large any laboratory collect.  Alternatively, assembly image data collected across multiple laboratories enable investigations comparing brain metrics across disease states span programmatic foci different NIH institutes centers.  Despite potential, however, few laboratories institutions currently provide easy access stored neuroimage related meta-data. Information Requested NIH Blueprint interested removing barriers sharing order expand access NIH-funded neuroimage data secondary data analysis meta-analysis.  RFI seeks information will help NIH Blueprint: a) identify interest, utility, preferences, potential technical administrative challenges overcoming barriers data-sharing, b) expand standardization brain image data, c) facilitate sharing brain image data.  Individual members the scientific community, scientific organizations, healthcare professionals, patient advocates, the public invited provide commentary the following items: 1. Describe current barriers the standardization sharing neuroimaging data secondary analysis.   Responses include comments suggestions strategies incentivize data sharing. a. Mandatory condition award mandated journals) b. Incentives promote voluntary sharing adoption standard procedures c. Technical infrastructure/IT barriers 2.  Considerations human-subjects protections a. Issues experiences related informed consent subjects their data be: stored indefinitely stored a repository than the laboratory data collection available third parties secondary analysis b. Issues related subject confidentiality, respect de-identification brain image data potential identification subjects based brain images such gyrus sulcus morphology) extent access secondary analysis HIPAA compliance 3.  Suitability different image data modalities donation federation across labs, utility different image modalities secondary analysis a. Resting-state task-evoked functional MRI b. Structural MRI e.g. diffusion volumetric) c. image modalities MRS PET d. Reconciling need standardization versus value methods innovation 4.  Conditions qualifications under data should shared a. Applicant eligibility qualifications; composition data access committee b. Data quality sample size c. Embargo collecting lab duration) before furnishing data d. Financial considerations e.g. fee-for-access, current NIH funding status) 5. Existing including international) efforts, large scale databases, clearing houses, tools, resources facilitate sharing imaging data a. Lessons learned b. Features suitability up-scaling accommodate data- especially different modalities, with different linked phenotypic data c. Methods harmonizing data different extant emerging extramural repositories 6. Issues standardization, sharing, maintenance image data linked phenotypic genetic data a. Advantages, disadvantages, costs centralized repositories versus distributed hosting b. Computational infrastructure, database management, data processing software/algorithms c. Data meta-data formats, common data elements d. Challenges, costs, sources, other issues long-term data storage curation) e. Linking image data genetic genomic data f. Interface centralized referral  hubs, HCP, similar NIH-initiated infrastructures 7. Issues phenotypic harmonization definitions respect to: a. Developmentally-sensitive measures suitability different life stages) b. Objective behavioral metrics c. Psychometric measures d. Psychiatric disorders, brain disorders, histories substance e. Family history, environmental other psychosocial factors f. Expansion use a mandate) adopt consensus phenotypic measures NIH Blueprint also welcomes any additional comments suggestions regard considerations mentioned above. Note: Responses NOT-DA-11-008 Request Information RFI): Creation A Consortium-Based Repository fMRI-Based Connectivity Brain Scans Substance-Using Abusing Clinical Research Participants be collated responses this RFI. Responses be accepted until October 14, 2011 via email to: James Bjork, Ph.D. jbjork@mail.nih.gov. Please mark responses this RFI identifier NOT-DA-11-021.  Reponses expected be longer approximately 2000 words. Respondents receive automated email confirmation acknowledging receipt their response, will receive individualized feedback. Any identifiers e.g., names, institutions, e-mail addresses, etc) be removed responses compiled. Only processed, anonymized results be shared internally the NIH Blueprint program staff leadership, appropriate. Nonetheless, proprietary information should submitted. Inquiries Please direct inquiries to: James M. Bjork, Ph.D. Clinical Neuroscience Branch Division Clinical Neuroscience Behavioral Research National Institute Drug Abuse National Institutes Health 6001 Executive Boulevard, Room 3172 Bethesda, MD  20892 Phone: 301) 443-3209 Email: jbjork@mail.nih.gov

Notice Correction the Eligibility Applying Limited Competition the Global Research Initiative Program, Basic/Biomedical Sciences R01) PAR-10-278) Notice Number: NOT-TW-11-027 Key Dates Release Date: August 26, 2011   Related Notices NOT-TW-11-028 Issued Fogarty International Center FIC) National Cancer Institute NCI) National Eye Institute NEI) National Institute Aging NIA) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Office Dietary Supplements ODS) Purpose Notice redefines Eligible PD/PIs” allow increased opportunities NIH supported Low- Middle-Income Countries LMIC) trainees apply this program, clarifies the intent Global Initiative Research Program GRIP) to support independent research. Background John E. Fogarty International Center FIC) the National Institutes Health NIH) published Funding Opportunity Announcement Limited Competition the Global Research Initiative Program, Basic/Biomedical Sciences R01)” PAR-10-278), September 2010. order improve access this program scientists LMIC, eligible PD/PIs redefined this notice. Currently Defined Eligible PD/PIs PAR-10-278 Section III. Eligibility Information 1.B. Eligible Individuals Any individual(s) the skills, knowledge, resources necessary carry the proposed research the PD/PI invited work his/her organization develop application support. Individuals underrepresented racial ethnic groups well individuals disabilities always encouraged apply NIH support. Only PD/PI be designated the application responding this FOA. PD/PI must registered the NIH electronic Research Administration eRA) Commons prior the submission the application seehttp://grants.nih.gov/grants/ElectronicReceipt/preparing.htm instructions). Only applicants institutions eligible countries apply. FIC strongly encourages applications women individuals underrepresented racial, ethnic socially disadvantaged groups.  order be eligible, applicants must meet the following three requirements: LMIC scientists, completed research training within 4 years prior the receipt date this GRIP announcement who have completed research training the start date the proposed project; research training must supported under following NIH funded research research training grant/award: NIH Intramural Visiting Fellow Programs; FIC supported training programs D43, U2R, R24); NIDA INVEST Humphrey Fellowship; International Research Fellowship Program F05 equivalent); NIEHS supported LMIC trainees under R01; NIA supported LMIC trainees under R01, R37, P01; LMIC trainees the TOBAC program R01); NICHD supported LMIC trainees the Global Partnerships Social Science AIDS Research R24), the Global Network Women’s Children’s Health Research U01); least years research training experience, at least year training experience plus additional year well documented mentored research. Notice redefines eligible PD/PIs making trainees under FIC research training research programs eligible GRIP. eligibility statements rewritten follows: Redefined Eligible PD/PIs PAR-10-278 Section III. Eligibility Information 1.B. Eligible Individuals Any individual(s) the skills, knowledge, resources necessary carry the proposed research the PD/PI invited work his/her organization develop application support. Only PD/PI be designated the application responding this FOA. PD/PI must registered the NIH electronic Research Administration eRA) Commons prior the submission the application seehttp://grants.nih.gov/grants/ElectronicReceipt/preparing.htm instructions). GRIP PIs must meet following three requirements be eligible: 1) LMIC scientists, have completed research training no than 4 years prior the application submission deadline this GRIP announcement who have completed research training the start date the proposed project. 2) PIs must at least years research training experience one year training plus additional year well-documented mentored research following training. 3) training must supported under following NIH funded research research training grants/awards: FIC research training research programs NIH Institutes Centers Intramural Visiting Fellow Programs Specified extramural research training research programs the GRIP participating ICs: NIDA INVEST Humphrey Fellowship; NIEHS supported LMIC trainees under R01; NIA supported LMIC trainees under R01, R37, P01; NICHD supported LMIC trainees the Global Partnerships Social Science AIDS Research R24); NIMH supported LMIC trainees under Collaborative Hubs International Research Mental Health U19). the Global Network Women’s Children’s Health Research U01). Notice also clarifies the GRIP funding supports independent research, should be used PI’s mentored research, such thesis research a Ph.D. Inquiries Please direct inquiries to: Dr. Xingzhu Liu Fogarty International Center National Institutes Health 31 Center Dr., Bldg 31, Room B2C39 Bethesda, MD 20892-2220 Tel:  301-402-6681 Fax:  301-402-0779 Email:  Xingzhu.Liu@nih.gov

Correction Instructions RFA-NS-12-003, quot;NINDS Research Education Programs Residents Fellows Neurology, Neurosurgery, Neuropathology Neuroradiology R25) Notice Number:  NOT-NS-11-026 Key Dates Release Date: August 25, 2011 Related Notices RFA-NS-12-003  Issued National Institute Neurological Disorders Stroke NINDS) Purpose page 12 Funding Opportunity Announcement RFA-NS-12-003, the section entitled, quot;PHS 398 Research Plan Component," the end the 4th paragraph, applicants instructed upload PDF attachment a list table trainee outcomes.  currently published instruction reads follows: list table) should uploaded a PDF attachment Item 12 Attachment” Section 2. Research Plan Attachments the PHS 398 Research Plan Component. instruction above erroneous.  instruction should read: list table) should uploaded a PDF attachment Item 12 quot;Other Attachment" the RESEARCH amp; RELATED Project Information page. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. Director Office Training, Career Development Workforce Diversity National Institute Neurological Disorders Stroke NINDS) 6001 Executive Boulevard, Room 2153  Bethesda, Maryland 20892 Phone: 301- 496-4188 Email: korns@ninds.nih.gov Website: http://www.ninds.nih.gov/funding/areas/training_and_career_development/…

Notice Intent Publish Request Applications the Morris K. Udall Centers Excellence Parkinson's Disease Research P50) Notice Number: NOT-NS-11-024 Key Dates Release Date: August 19, 2011   Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS intends issue Funding Opportunity Announcement FOA) continue Morris K. Udall Centers Excellence Parkinson's Disease Research program http://www.ninds.nih.gov/research/parkinsonsweb/udall_centers/). Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published the autumn 2011 an expected receipt date January 2012. FOA utilize Specialized Center P50) activity code. Details the planned FOA provided below. Research Initiative Details goal this NINDS program to fund multidisciplinary research Centers Excellence will rapidly advance innovative research our 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 integral resource Cores should relate directly the etiology, pathogenesis treatment PD related parkinsonian disorders. Notice encourages established investigators proven expertise and/or novel insights PD related disorders consider applying through upcoming FOA. Applications Principal Investigators currently pursuing PD research welcome their specific expertise, together proof project feasibility relevance, provide novel approaches the identification disease mechanisms therapeutic targets PD related disorders. Centers be expected contribute unique knowledge the ongoing network Udall Centers programs to collaborate within network. While basic research PD and continue serve the foundation discovery the Udall Centers program, proposed Center must include least one, small-scale, early translational research project. this context, translational research defined investigations focusing the development therapeutics, diagnostics, devices clinical criteria would ultimately lead new approaches the treatment PD. NINDS policy Udall Centers establishes following budget limits new competing renewal applications: applicants request maximum annual direct costs 1,000,000; requested budget 1,500,000 permitted inclusion a clinical component including research project plus supportive core). clinical component accompanying budget should clearly described specified. Full details be available the FOA. 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 2223 Bethesda, MD 20892-9525 Phone: 301) 496-5680 Email: sieberb@ninds.nih.gov

Improving Quality NINDS-Supported Preclinical Clinical Research through Rigorous Study Design Transparent Reporting Notice Number: NOT-NS-11-023 Key Dates Release Date: August 10, 2011 Related Announcements June 9, 2015 - Enhancing Reproducibility through Rigor Transparency. Notice NOT-OD-15-103. Issued National Institute Neurological Disorders Stroke NINDS) Purpose Developing effective treatments neurological disorders central the mission NINDS.  Notice highlights importance well-designed preclinical studies the foundation translating basic research discoveries such treatments. Before being evaluated the clinic, candidate therapeutics often tested animal cell culture models specific diseases.  recent years, is increasing awareness among neurological disease communities the predictive value preclinical research improved information made available study design, execution, analysis interpretation.  Examples the most critical elements a well-designed study summarized the NINDS website http://www.ninds.nih.gov/funding/grant_policy.htm). NINDS believes applications propose preclinical research, that based previous preclinical data, be greatly strengthened the design, execution, interpretation the proposed studies supporting data adequately described.  NINDS encourages investigators, whenever possible, address elements directly their applications. Investigators urged discuss issues program staff prior submission applications, especially applications will requesting 500,000 more direct costs any year, which applicants must seek agreement accept assignment NINDS least 6 weeks prior the anticipated submission NOT-OD-02-004). Inquiries Please direct inquiries to: Shai Silberberg, Ph.D. Program Director NINDS 6001 Executive Blvd., NSC Rm 2131 Bethesda, MD 20892 Phone: 301-496-1917 Email: SilberbS@ninds.nih.gov

Notice Intent Publish Funding Opportunity Announcement NINDS Accelerated Awards Program Supporting Ancillary Studies PREDICT-HD U01) Notice Number: NOT-NS-11-022 Key Dates Release Date: August 5, 2011 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends publish Funding Opportunity Announcement FOA) solicit applications ancillary studies will further our understanding the unique clinical biomarker signatures premanifest Huntington's disease HD) through coordination the NINDS-funded Neurobiological Predictors Huntington's Disease PREDICT-HD) study. PREDICT-HD study an international 32-site observational study persons at-risk HD, includes clinical biospecimen resources 800 premanifest HD participants 200 healthy control subjects.  Extensive clinical data including UHDRS motor examination, cognitive neuropsychiatric assessments, structural MRI imaging been collected over ten-year time frame, a subset these data accessible through dbGaP website http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs… .  Biospecimen samples including plasma blood collected yearly stored the Coriell Institute Medical Research biorepository.  PREDICT-HD study cohort database offer unprecedented opportunity further examine distinct aspects premanifest HD.  During current final period funding the PREDICT-HD study, specific goals this FOA will: Coordinate pilot studies within existing infrastructure the PREDICT-HD study Facilitate standardized collection management biospecimen resources across sites funded projects Accelerate discovery validation HD biomarkers Promote development new clinical assessments clinical trial design premanifest HD Foster expand collaborative opportunities all stakeholders FOA encourage collaborative investigations combining expertise imaging, proteomics, assay development, clinical trial design, genetic variant modifier analysis, motor, neuropsychological cognitive assessments neurological disease.   Among areas research encouraged this initiative innovative informative clinical biomarker assessments designed improve translation existing knowledge towards efficient effective clinical trials the prevention treatment Huntington's disease. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  Investigators within outside the PREDICT-HD study be eligible apply.  Applications proposing additional clinical assessments must complete studies within remaining 3 year time frame September 1, 2011-August 31, 2014) PREDICT-HD.  Based the infrastructure available through PREDICT-HD, is anticipated responsive applications have direct costs 500k less per year. FOA expected be published October 2011 an initial application receipt date December, 2011. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Margaret Sutherland, PhD Program Director, Neurodegeneration Cluster NINDS 6001 Executive Blvd, NSC 2222 Bethesda, MD 20892 Phone: 301-496-5680 EMAIL : sutherlandm@ninds.nih.gov

Notice Correction PA-11-148  Nanoscience Nanotechnology Biology Medicine R01) Notice Number: NOT-EB-11-007 nbsp; Key Dates Release Date: August 1, 2011   Issued National Institute Biomedical Imaging Bioengineering NIBIB) 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) 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 Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) Purpose purpose this Notice to correct Funding Opportunity Announcement PA-11-148, Nanoscience Nanotechnology Biology Medicine R01) http://grants.nih.gov/grants/guide/pa-files/PA-11-148.html ), published the NIH Guide March 14, 2011, indicate foreign institutions not eligible apply. Section III. Eligibility Information 1. Eligible Applicants Eligible Organizations Non-domestic non-U.S.) Entities Foreign Organizations) not eligible apply. Foreign non-U.S.) components U.S. Organizations not allowed. other aspects this FOA remain same. Inquiries Please direct inquiries to: Steven Zullo, Ph.D. National Institute Biomedical Imaging Bioengineering NIBIB) Phone: 301) 451-4774 Email: zullo@helix.nih.gov

Notice Intent Publish Request Applications Neurosurgeon  Research Career Development Program NRCDP) K12) Notice Number: NOT-NS-11-019 Key Dates Release Date: July 29, 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 a Neurosurgeon Research Career Development Program NRCDP). goal the program to expand cadre neurosurgeon-researchers will combine clinical research expertise conduct research neurological disorders neurosurgeons uniquely qualified conduct. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published Fall 2011 an expected receipt date November 2011. FOA utilize K12 activity code. K12 be housed the PD/PI's institution, will support national program, overseen the PD/PI a national advisory committee. maximum one national K12 program be supported. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators appropriate expertise stature begin consider applying this new FOA. Potential PD/PIs should nationally acknowledged leaders the neurosurgery community, should a history active, funded research, should a track record successfully training clinician-scientists. the application process, PD/PIs have recruit approximately 9 members the national advisory committee, of whom should acknowledged leaders their communities. advisory committee should consist primarily neurosurgeon-researchers, should also include leading researchers other communities, such neurology, clinical communities relevant neurosurgical research PhD neuroscientists an understanding disease-related research. goals the NRCDP program to provide support a period mentored training following residency, build networking collaborative infrastructure, to facilitate transition neurosurgeons mentored independent research positions. NRCDP provide neurosurgeons the experience, research support funding necessary initiate vigorous, sustainable research program. K12 program provide support mentored training neurosurgeon-researchers have moved a new institution following residency, beginning their first year a faculty position. Training occur the scholar's home institution, may anywhere the U.S.. scholar be supported the institution sponsors K12, the sponsoring institution not intended be unique training location. Training occur two phases, two year phase which scholar financially supported this K12 award a three year phase which scholar supported an individual NIH K award other source funding. entire 5 year period be overseen the NRCDP, will include yearly meeting those supported NRCDP scholars other junior neurosurgeon investigators, will focus career development, grant writing networking. Investigators interested applying response this FOA encouraged contact Dr. Stephen Korn, Director the NINDS Office Training, Career Development Workforce Diversity. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. Director Office Training, Career Development Workforce Diversity National Institute Neurological Disorders Stroke NINDS) 6001 Executive Boulevard, Room 2153  Bethesda, Maryland 20892 Phone: 301- 496-4188 Email: korns@ninds.nih.gov Website: http://www.ninds.nih.gov/funding/areas/training_and_career_development/…

Request Information RFI): Proposed Funding Priorities Neuroscience Research, Resources Tools NIH Neuroscience Blueprint) Notice Number: NOT-MH-11-016 Key Dates Release Date: July 21, 2011 Response Date: September 9, 2011 Issued NIH Blueprint Neuroscience Research http://neuroscienceblueprint.nih.gov) National Institute Mental Health NIMH) National Eye Institute NEI) National Center Complementary Alternative Medicine NCCAM) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) Office Behavioral Social Sciences Research OBSSR) Background is time-sensitive Request Information RFI) soliciting ideas the neuroscience research community how best support accelerate neuroscience research. Responses this RFI should pertinent the interests more one the NIH Neuroscience Blueprint Institutes listed above. Neuroscience research a unifying theme across NIH Institutes Centers. NIH Blueprint Neuroscience Research NIH Blueprint) launched 2004 16 participating Institutes Centers provide framework coordinating research, developing tools resources are broadly useful advancing neuroscience research http://neuroscienceblueprint.nih.gov/). pooling resources expertise, NIH Blueprint taking advantage economies scale confronting challenges too large any single NIH Institute Center. NIH Blueprint Resources Currently Available the Neuroscience Community NIH Blueprint presently its seventh year, has funded variety tools resources available the neuroscience community are broadly relevant across diseases participating NIH ICs. following website gives overview the NIH Blueprint activities underway resources available neuroscientists: http://www.neuroscienceblueprint.nih.gov/ Information Requested NIH Blueprint considering best invest funds future fiscal years. FY2012 FY2013, is anticipated limited funding be available year more 4 million) while FY2014 provide greater flexibility several NIH Blueprint projects to end. Keeping mind the NIH Blueprint interested ideas are broadly relevant across diseases participating ICs, responses requested the questions below: Identify areas neuroscience research could accelerated the development specific research resources tools. are major opportunities for, impediments to, advancing neuroscience research? are 2-3 highest priority tools resources needed capitalize the scientific opportunities overcome obstacles progress neuroscience research? Describe NIH Blueprint might best facilitate development these tools/resources. Confidentiality Responses this RFI voluntary will kept anonymous.  Any identifiers e.g., names, institutions, e-mail addresses, etc.) be removed responses compiled. Only processed, anonymized results be shared internally working groups convened the NIH Blueprint, appropriate. Proprietary, classified, confidential, sensitive information should be included your response. The Government reserves right use any non-proprietary technical information any resultant solicitation(s). NIH use information gathered develop grant, contract, other funding initiatives. RFI for information planning purposes only should be construed a solicitation as obligation the part the Federal Government, National Institutes Health NIH), individual NIH Institutes Centers. NIH does intend make any awards based responses this RFI pay the preparation any information submitted for Government's of such information. to Submit Response   comments must submitted electronically to:  nihblueprint@nih.gov. Responses this RFI be accepted through September 9, 2011. will receive electronic confirmation acknowledging receipt your response, will receive individualized feedback any suggestions.  basis claims against U.S. Government shall arise a result a response this request information from Government’s of such information. Inquiries Inquiries regarding Notice be directed to: Susan Marino, Ph.D. NIH Blueprint Executive Secretariat National Institute Neurological Diseases Stroke 31 Center Dr, Room 8A/52 MSC 2540 Bethesda, MD 20892-9641 Telephone:  (301) 596-4470 Email: nihblueprint@nih.gov

NINDS Policy the Requirement Authorization the Food Drug Administration FDA) use Investigational Drug, Biologic Product Device a Clinical Trial Prior Submission an Application Notice Number: NOT-NS-11-018 Update: following update relating this announcement been issued: July 22, 2013 - Issuance PAR-13-278, NINDS Phase III Investigator-Initiated Efficacy Clinical Trials U01). March 13, 2012 - Notice NOT-NS-12-007. NINDS Policy Submission Applications Containing Clinical Trials. Key Dates Release Date: July 15, 2011 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform NINDS grant applicants that, beginning applications intended the September 25, 2011 due date beyond, following conditions related FDA regulations must met before NINDS allow submission an application involving clinical trial scientific technical review. Notice applies grant applications submitted under Exploratory Clinical Trials FOA PAR-10-199 http://grants.nih.gov/grants/guide/pa-files/PAR-10-199.html) the Phase III Clinical Trials FOA PAR-11-173 http://grants.nih.gov/grants/guide/pa-files/PAR-11-173.html) all subsequent NINDS FOAs where clinical trials FDA regulated interventions be proposed”. the time grant submission, applicants must provide documentation the FDA providing information one the following three scenarios: A)  protocol been submitted under open IND/IDE the IND/IDE not under full partial hold.  Under scenario, applicants must provide documentation such a proceed” email letter the FDA. B)  protocol been submitted under IND/IDE is full partial hold.  Under scenario applicants must provide full documentation the FDA the reasons hold the FDA recommendations. C)  protocol exempt an IND/IDE.  Under scenario applicants must provide copy the exemption letter the FDA. Applications do include information described under scenarios A), B), C) be withdrawn not reviewed.  Prior grant award NINDS require awardees do have previously documented study exemption provide documentation their IND/IDE remains open that has been placed under full partial hold. purposes this policy, clinical trial defined NIH policy http://grants.nih.gov/grants/policy/nihgps_2010/index. htm) a biomedical research study human subjects is designed answer specific questions biomedical interventions drugs, treatments, devices, new ways using known drugs, treatments, devices). Clinical trials used determine whether new interventions safe effective”. Inquiries Inquiries concerning policy should sent to: Scott Janis, Ph.D. Office Clinical Research National Institute Neurological Disorders Stroke Room 2170, MSC 9525 6001 Executive Blvd. Bethesda, MD 20892-9525 Telephone: 301) 496-9135 Fax: 301) 410-1080 Email: janiss@ninds.nih.gov D Elizabeth McNeil, M.D. MSc Office Clinical Research National Institute Neurological Disorders Stroke Room 2215, MSC 9520 6001 Executive Blvd. Bethesda, MD 20892-9520 Telephone: 301) 496-9135 Fax: 301) 410-1080 Email: mcneilde@ninds.nih.gov inquiries review issues contact: Chief, Scientific Review Branch National Institute Neurological Disorders Stroke Room 3201, MSC 9529 6001 Executive Blvd. Bethesda, MD 20892-9529 Telephone: 301) 496-9223 Fax: 301) 402-0182 Email: nindsreview@ninds.nih.gov