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Notice Intent Publish Funding Opportunity Announcement the Blueprint Neurotherapeutics Network BPN): SBIR Small Molecule Drug Discovery Development Disorders the Nervous System U44)" Notice Number: NOT-NS-14-021 Key Dates Release Date: Release Date: April 9, 2014 Estimated Publication Date Announcement: July 2014 First Estimated Application Due Date: October 2014 Earliest Estimated Award Date: July 2015 Earliest Estimated Start Date: July 2015 Related Announcements NOT-NS-14-020 Issued National Institute Neurological Disorders Stroke NINDS) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Center Complementary Alternative Medicine NCCAM) Purpose NIH announces intention publish Funding Opportunity Announcement FOA) SBIR-eligible small businesses seeking support the Blueprint Neurotherapeutics Network BPN). Applicants encouraged utilize customized set contract resources, consultants the Blueprint Neurotherapeutics Network BPN) help advance neuroscience-focused drug discovery development projects the clinic. Notice provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  Details the planned FOA provided below. Research Initiative Details facilitate drug discovery development the neuroscience community, NIH Blueprint Neuroscience Research http://neuroscienceblueprint.nih.gov/) established Blueprint Neurotherapeutics Network BPN), collection contract service providers consultants extensive industry experience the areas pharmacology, medicinal chemistry, pharmacokinetics, toxicology, GMP synthesis, formulation development, Phase clinical safety testing. list consultants contract service providers be viewed http://neuroscienceblueprint.nih.gov/bpdrugs/bpn.htm. planned Funding Opportunity Announcement FOA) solicit applications SBIR-eligible small businesses seeking funding through fast-track phased U44 cooperative agreement mechanism help advance drug discovery development projects the clinic.  Applicants be encouraged build customized utilization BPN services their applications. be eligible the BPN, applicant must well-validated bioactive compound(s) hand; BPN does support screening hit compounds. Projects enter BPN during Discovery Development may seek support through phase I/first-in-human testing. Discovery involves iterative medicinal chemistry improve potency ADMET properties compounds, toward goal identifying clinical candidate. During Development, clinical candidate undergoes preclinical toxicology testing required an IND manufacturing, ultimately advancing phase I/first-in-human testing. BPN Development activities include chemical manufacturing controls CMC), formulation development, toxicology studies, regulatory support, phase I/first-in-human testing. NIH assemble customized Lead Development Team each project accepted the program. Lead Development Team typically be co-chaired the Program Director/Principal Investigator PD/PI) a consultant extensive industry expertise identified supported the NIH. Lead Development Team also include members the PD/PI's team, NIH-hired consultants additional expertise, NIH staff. Lead Development Team plan coordinate work supported the cooperative agreement award conducted BPN contractors. projects enter BPN begin a preparatory phase up one year, can used complete any studies required meet Discovery Development entry criteria to engage Lead Development Team establishing detailed research plan, go/no-go milestones, all subsequent work. Applicants strongly encouraged consult NIH program staff plans an application being developed. Consultations include conference calls NIH program staff. Early contact provides opportunity NIH program staff discuss program scope, entry criteria, goals, to provide information guidance how develop competitive application. It's recommended applicants contact NIH staff least 8 weeks before receipt date. additional information the BPN, please http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Rebecca Farkas, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: farkasr@ninds.nih.gov nbsp;

Request Information RFI): Neurological Disorders Biorepository Needs, Practices Sources Notice Number: NOT-NS-14-023 Key Dates Release Date: April 3, 2014 Response Date: 23, 2014 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) committed reducing burden neurological disorders human lives. is time sensitive Request Information RFI) issued the NINDS. purpose the RFI to solicit information biorepository resource needs, practices sources the neuroscience research community. responses the RFI be collected evaluated Institute staff assess best meet current future biorepository resource needs fall within mission the NINDS. Background mission the NINDS Repository, also known the NINDS Human Genetics DNA Cell Line Repository, to accelerate discovery causes, risks mechanisms neurological disease sharing samples data. NINDS Repository, founded 2002 cited almost 300 publications, samples clinical data 45,000 subjects, more 32,000 these presently available researchers academia industry. Samples include genomic DNA de-identified clinical data individuals dystonia, epilepsy, motor neuron disease including ALS), Parkinson’s disease, stroke, Tourette syndrome, neurologically normal controls. NINDS Repository also includes resources sharing fibroblasts, induced pluripotent stem cells, biomarker discovery samples. http://ccr.coriell.org/Sections/Collections/NINDS/?SsId=10 detailed information regarding NINDS Repository collections, clinical data forms, de-identified clinical data, publications citing resource, policies. Information Requested NINDS seeks information the following areas: 1. Sources business practices. NINDS requests information regarding biorepository business practices. particular NINDS seeks identify sources to gather information regarding repository business practices for, not limited to, biomarkers collections. Comments also include information regarding sample types, timeline throughput capabilities, storage capacity, infrastructure management, including interfacing large external databases, distribution infrastructure, repository project management strategy practices, cost/pricing structure practices. NINDS Repository biomarkers collections presently include: Parkinson's Disease Biomarkers Program, https://pdbp.ninds.nih.gov/jsp/how-pdbp-works.jsp), BioFIND http://ccr.coriell.org/Sections/Collections/NINDS/BioFIND.aspx?coll=ND&…), Predict-HD http://ccr.coriell.org/Sections/Collections/NINDS/BioFIND.aspx?coll=ND&…), emerging collections frontotemporal dementia traumatic brain injury. 2. Repository science innovation. NINDS Repository presently includes DNA limited de-identified clinical data virtually samples accepted, and, a subset, includes: cryopreserved lymphocytes, lymphoblastoid cell lines, fibroblasts, induced pluripotent stem cells, cerebrospinal fluid, plasma, RNA, serum. NINDS seeks information regarding innovative approaches repository science, example, regarding sample types, IT, business practices, consider planning future the resource. 3. Best practices. NINDS Repository contributed a number protocols sample handing, preparation, shipping, including, example, PDBP biomarkers Laboratory Manual https://pdbp.ninds.nih.gov/assets/policy/PDBP%20Research%20Biomarkers%2…), the NINDS Repository Submitter's Guide http://ccr.coriell.org/PDF/NINDS/submitter_guide.pdf). NINDS seeks information regarding additional authoritative best practices can further inform future NINDS Repository activities. to Submit Responses Responses must submitted electronically using web-based form www.ninds.nih.gov/funding/RFI-Biorepository.htm will accepted through 23, 2014. Replies individual questions optional, the site permit anonymous responses.   information provided be kept confidential, will used assist NINDS its strategic planning efforts only. NINDS not provide comments any responder’s submission. However, responses the RFI inform future funding opportunity announcements. Respondents further advised the Government under obligation acknowledge receipt the information received provide feedback respondents respect any information submitted. proprietary, classified, confidential, sensitive information should included your response. Government reserves right use any non-proprietary technical information any resultant solicitation(s). request for information planning purposes only should be construed a solicitation as obligation the part the Federal Government. NIH does intend make any awards based responses this RFI to otherwise pay the preparation any information submitted for Government's of such information. Inquiries Please direct inquiries to: Roderick A. Corriveau, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: roderick.corriveau@nih.gov nbsp;

Notice Modification the Data Sharing Policy the Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System Notice Number: NOT-NS-14-022 Key Dates Release Date: March 27, 2014 Related Announcements NOT-NS-17-029 NOT-NS-12-016 NOT-NS-12-017 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Data Sharing Policy the Federal Interagency Traumatic Brain Injury Research FITBIR) Informatics System modified accelerate access data to promote collaboration.  modifications below. FITBIR Data Sharing Schedule Six months after submission the data, the Core (required) and Basic recommended) TBI common data elements CDEs) are used the study are expected be available all qualified approved researchers Recipients) determined the Data Access Quality Committee DAQC).  data fields also made available the submitting program director/principal investigator’s PD/PI's), i.e. Submitter’s, discretion.   Outcomes data other data elements needed the PD/PI test his/her hypotheses research questions, referred as Experimental Data, be available a staged manner.  Six months after award period ends, Experimental Data be open other researchers have submitted data FITBIR Submitters). Twelve months after award period ends, Experimental Data be open all qualified approved researchers Recipients).   Table.  Summary the FITBIR Data Sharing Schedule Core Basic CDEs Data uploaded quarterly after subject enrollment begins data available six months after submission all approved FITBIR Data Recipients. Specific CDEs be exempted pending approval the DAQC they needed test primary study hypothesis research question. Experimental Data approved FITBIR Data Recipients gain access either: Six months after award period ends they a FITBIR Submitter; or  Twelve months after award period ends those are FITBIR Submitters. Access also granted earlier agreed by Submitters ongoing study(s) in rare cases the DAQC over rules Submitters’ denial the grounds the request does compromise completion the ongoing study. Investigators also strongly encouraged collaborate share data throughout study accelerate research advance knowledge TBI.  facilitate collaboration, data access request forms be submitted before award period ends the DAQC initial review then forwarded to relevant Submitters.  Submitters choose collaborate and/or provide access all some their Experimental Data, which case data be available the data Recipients.  Alternatively, Submitters choose deny early access, which case request be reviewed the DAQC in consultation with Submitters.  this case, approvals early access only granted the DACQ it clear the data request does negatively impact completion the original study. example, prospective data collection projects are powered answer specific questions be jeopardized premature analysis these same questions. However, important research be accomplished without jeopardizing study, value the FITBIR data be greatly enhanced data sharing advances science TBI. Inquiries Please direct inquiries to: FITBIR Operations Team Email: FITBIR-ops@mail.nih.gov Website: https://fitbir.nih.gov/  

Discontinuation PAR-13-127 NINDS Ruth L. Kirschstein National Research Service Awards Individual Predoctoral Fellows MD-PhD Programs F31)" Notice Number: NOT-NS-14-018 Key Dates Release Date: March 14, 2014 Related Announcements PAR-13-127 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to inform potential applicants NINDS discontinue PAR-13-127 NINDS Ruth L. Kirschstein National Research Service Awards Individual Predoctoral Fellows MD-PhD Programs F31)".   New applications be accepted NINDS this Funding Opportunity Announcement FOA) through April 8, 2014, due date 7, 2014, AIDS AIDS-related applications).  order accommodate applicants need revise resubmit fellowship applications, NINDS accept resubmission applications A1) through December 8, 2014, due date January 7, 2015, AIDS AIDS-related applications). Starting the April 8, 2014, fellowship application due date, applicants submit F30 applications NINDS support dual-degree training using Ruth L. Kirschstein National Research Service Award NRSA) Individual Predoctoral MD/PhD Other Dual-Doctoral Degree Fellowship Parent F30). Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: Korns@ninds.nih.gov  

Notice Clarify Intellectual Property Requirements PAR-11-344 NeuroNEXT Infrastructure Resource Access X01)" Notice Number: NOT-NS-14-019 Key Dates Release Date: March 13, 2014 Related Announcements PAR-11-344 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice modifies language NINDS PAR-11-344 quot;NeuroNEXT Infrastructure Resource Access X01)" regarding intellectual property requirements. Part 2. Section I. Funding Opportunity Description Purpose Currently reads: Applicants should note the following: 1) applicant must hold intellectual property rights IP) the investigational agent/device proposed study. Modified read: Applicants should note the following: 1) applicants industry must hold intellectual property IP) rights the investigational agent/device proposed study. However, applicants non-profits not need hold IP rights the investigational agent/device under study. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Amanda Sibley, DPhil, MPH National Institute Neurological Disorders Stroke NINDS) Telephone: 301-451-1449 Email: amanda.sibley@nih.gov nbsp;

Notice Extension the Expiration Date PA-11-345 NeuroNEXT Small Business Innovation Clinical Trials U44)" Notice Number: NOT-NS-14-012 Key Dates Release Date: March 12, 2014 Related Announcements PAR-11-345 Issued National Institute Neurological Disorders Stroke NINDS)  Purpose Notice extends expiration date PAR-11-345, quot;NeuroNEXT Small Business Innovation Clinical Trials U44)" one receipt date. Due the extension, following application due date be added, December 2, 2014. Current Expiration Date: August 2, 2014. New Expiration Date: December 3, 2014. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Amanda Sibley, DPhil, MPH National Institute Neurological Disorders Stroke NINDS) Phone: 301-451-1449 Email: amanda.sibley@nih.gov nbsp;

Notice the Extension the Expiration Date PAR-11-344 NeuroNEXT Infrastructure Resource Access X01)" Notice Number: NOT-NS-14-011 Key Dates Release Date: March 12, 2014 Related Announcements PAR-11-344 Issued National Institute Neurological Disorders Stroke NINDS)  Purpose Notice extends expiration date PAR-11-344 quot;NeuroNEXT Infrastructure Resource Access X01)" one receipt cycle. Current Expiration Date: October 22, 2014 New Expiration Date: December 31, 2014 Inquiries Please direct inquiries to: Amanda Sibley, DPhil, MPH National Institute Neurological Disorders Stroke NINDS) Phone: 301-451-1449 Email: amanda.sibley@nih.gov nbsp;

Notice the Transition New Application Forms NeuroNEXT Infrastructure Resource Access X01)” Notice Number: NOT-NS-14-015 Key Dates Release Date: March 7, 2014 Related Announcements PAR-11-344 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform applicants new application forms now available Funding Opportunity Announcement FOA) PAR-11-344 ldquo;NeuroNEXT Infrastructure Resource Access X01)”. new application forms be identified the Grants.gov Download Application Package screen the Competition ID lsquo;FORMS-C’. older application forms a Competition ID lsquo;ADOBE-FORMS-B1’. Although FORMS-C application forms available immediate use, National Institute Neurological Disorders Stroke NINDS) allow transition period through March 28, 2014 during time applications using ADOBE-FORMS-B1 forms still accepted. application submissions PAR-11-344 on after March 29, 2014 must FORMS-C application forms NOT-OD-13-074). other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: D. Elizabeth McNeil, MD MSc National Institute Neurological Disorders amp; Stroke NINDS) Telephone: 301-496-9135 Email: mcneilde@ninds.nih.gov nbsp;

Notice Extend Due Date Expiration Date RFA-MH-14-217 BRAIN Initiative: Planning Next Generation Human Brain Imaging R24)" Notice Number: NOT-MH-14-010 Key Dates Release Date: March 5, 2014 Related Announcements RFA-MH-14-217 Issued NIH Blueprint Neuroscience Research http://neuroscienceblueprint.nih.gov) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) 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 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 Complementary Alternative Medicine NCCAM) National Center Advancing Translational Sciences NCATS) Office Behavioral Social Sciences Research OBSSR) Purpose purpose this Notice to inform interested applicants the Application Due Date RFA-MH-14-217 quot;BRAIN Initiative:  Planning Next Generation Human Brain Imaging R24)" being extended March 13, 2014, March 27, 2014. Accordingly, expiration date RFA-MH-14-217 now March 28, 2014. other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Greg Farber, Ph.D. National Institute Mental Health NIMH) Telephone: 301-435-0778 Email: faberg@mail.nih.gov nbsp;

Notice Correct NINDS CFDA Number Associated PAR-13-278 NINDS Phase III Investigator-Initiated Efficacy Clinical Trials U01)" Notice Number: NOT-NS-14-017 Key Dates Release Date: March 4, 2014 Related Announcements PAR-13-278 NOT-NS-14-008 Issued National Institute Neurological Disorders Stroke NINDS) Purpose January 16, 2014 National Institute Neurological Disorders Stroke NINDS) issued Notice NOT-NS-14-008) informing applicants the CFDA number for  PAR-13-278 quot;NINDS Phase III Investigator-Initiated Efficacy Clinical Trials U01)" should 93.853. Unfortunately, application packages available Grants.gov still reflected old CFDA number. Although is standard practice NIH staff verify correct CFDA numbers after submission, applicants raised concerns regarding display the incorrect CFDA their applications. address concerns, have posted new application package Grants.gov identified a Competition ID lsquo;FORMS-C-REVISED’ a Competition Title lsquo;Includes CFDA correction – must used due dates or after 8, 2014'. you already started prepare application the March 5, 2014 due date renewal, resubmission revision applications the 7, 2014 due date AIDS AIDS-Related applications, you two options: 1. Submit using old application package. Although application image eRA Commons show old CFDA, NIH staff adjust CFDA number our system process application correctly. 2. Revisit PAR-13-278, download new application package, transfer application data submission. After May 7, 2014 AIDS due date, old application package be closed application submissions using old package no longer accepted. Inquiries Please direct inquiries to: Wendy Galpern, MD, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9135 Email: Phase3Trial@ninds.nih.gov