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Notice Intent Publish Funding Opportunity Announcement Dissemination Implementation Research Health R03) Notice Number: NOT-CA-16-027 Key Dates Release Date:   March 7, 2016 Estimated Publication Date Announcement: 2016  First Estimated Application Due Date: June 2016  Earliest Estimated Award Date: April 2017  Earliest Estimated Start Date: April 2017 Related Announcements NOT-CA-16-025 NOT-CA-16-026 Issued National Institutes Health NIH) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Fogarty International Center FIC) Office Disease Prevention ODP) Agency Healthcare Research Quality AHRQ) Purpose National Cancer Institute NCI), other participating NIH Institutes Centers ICs) the Agency Healthcare Research Quality AHRQ), intends reissue Funding Opportunity Announcement FOA) solicit applications dissemination implementation D&I) research health. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published May 2016 an expected application due date June 2016. FOA utilize R03 activity code. Details the planned FOA provided below. Research Initiative Details purpose this Funding Opportunity Announcement FOA) to support innovative approaches identifying, developing, testing, evaluating and/or refining strategies disseminate implement evidence-based practices e.g. behavioral interventions; prevention, early detection, diagnostic, treatment disease management interventions; quality improvement programs) public health, clinical practice, community settings. Conversely, is benefit understanding circumstances create need ldquo;de-implement” reduce use strategies interventions are evidence-based, been prematurely widely adopted, yield sub-optimal benefits patients, are harmful wasteful. addition, studies advance dissemination implementation research methods measures encouraged. Examples relevant research directions include are limited to: Studies strategies implement health promotion, prevention, screening, early detection, diagnostic interventions, well effective treatments, clinical procedures guidelines existing care systems. Studies the implementation multiple evidence-based practices within community clinical settings meet needs complex patients diverse systems care. Studies the local adaptation evidence-based practices the context implementation systematically identify intervention components surpass fall short expected intervention effects. Longitudinal follow-up studies the factors contribute the sustainability evidence-based interventions public health clinical practice. Studies testing effectiveness cost-effectiveness dissemination implementation strategies reduce health disparities improve quality care among rural, minority, low literacy numeracy, other underserved populations. Studies the de-implementation clinical community practices are evidence-based, been prematurely widely adopted, yield sub-optimal benefits patients, are harmful wasteful. Studies the relationship context local capacity clinical community settings adoption, implementation sustainability evidence-based practices. Prospective retrospective studies the adoption, implementation sustainability health policies their interaction programs contextual factors. Studies influences the creation, packaging, transmission reception valid health research knowledge. Studies systems interventions impact organizational structure, climate, culture, processes enable dissemination implementation clinical/public health information effective clinical/public health interventions. Studies focus the development testing theoretical evaluation models D&I processes. Development D&I relevant outcome process measures suitable methodologies dissemination implementation approaches.  Studies the dissemination varied strategies promote effective patient caregiver communication, leading improved healthcare delivery outcomes. Studies the dissemination implementation effective cost-effective strategies incorporating genomic medicine, sequence-based diagnostics therapeutics clinical care. Studies testing implementation use genomic information, family history risk information, and/or pharmacogenetic information improved diagnosis treatment. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: David Chambers, D.Phil. National Cancer Institute NCI) Telephone: 240-276-5090 Email:  dchamber@mail.nih.gov

Participation Danish Researchers the NIH BRAIN Initiative Notice Number: NOT-MH-16-004 Key Dates Release Date:   February 22, 2016 Related Announcements None     Issued National Institutes Health NIH) National Institute Mental Health NIMH) 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 Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Lundbeckfonden http://www.lundbeckfoundation.com/) Purpose Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative a multi-agency effort, a coordinated contribution 10 NIH Institutes Centers http://braininitiative.nih.gov/).  part the NIH BRAIN Initiative, NIH announces new partnership, formalized a letter agreement, Lundbeckfonden http://www.lundbeckfoundation.com/) support involvement researchers Danish institutions the BRAIN Initiative.  Both NIH Lundbeckfonden believe the ambitious goals the BRAIN Initiative best attained collaboration across disciplinary boundaries well geographic boundaries.  Supplemental Funding NIH a number BRAIN Initiative awards FY14 FY15 http://www.braininitiative.nih.gov/nih-brain-awards.htm).  Researchers Danish institutions are interested participating funded awards advised contact Program Director/Principal Investigator the NIH award inquire there mutual interest collaboration.  there interest, researcher a Danish institution apply directly Lundbeckfonden funding the work be performed Denmark.  each approved project an added Danish collaboration, funding administration the work performed Denmark shall managed the foundation the Danish host institution.  NIH consider administrative supplements support such collaborations. Matching Funding most the NIH BRAIN Initiative Funding Opportunity Announcements, foreign institutions permitted participate either submitting applications directly as subcontractors an application a domestic institution.  Researchers Danish institutions submit applications either role BRAIN Initiative awards should contact Lundbeckfonden the award submitted they interested having award potentially co-funded NIH the Lundbeckfonden.  NIH evaluate i.e., peer review) application, will a funding decision.  the project receives NIH award, Lundbeckfonden decide whether will fund – fully in part – Danish based elements the project.  NIH not share application materials summary statements directly the Lundbeckfonden, the applicant must those materials available Lundbeckfonden they want be considered co-funding.    addition providing funds, representatives the foundation join those the National Science Foundation, Food Drug Administration, Defense Advanced Research Projects Agency, Brain Canada, Australian National Health Medical Research Council, the Intelligence Advanced Research Projects Agency meetings the BRAIN Multi-Council Working Group http://braininitiative.nih.gov/Brain_multi_council_working_group.htm). Inquiries Please direct inquiries to: Gregory K. Farber, Ph.D. National Institute Mental Health NIMH) Telephone:  301-435-0778 Email:  farberg@mail.nih.gov Ned Talley, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:  301-496-1917 Email:  talleye@mail.nih.gov Lundbeckfonden Telephone: 45 39 12 80 15 Email:  application@lundbeckfonden.com

Notice Increased Registration Budget PA-16-019 Innovation Corps I-Corps™) NIH Program NIH CDC Phase Small Business Innovation Research SBIR) Small Business Technology Transfer STTR) Grantees Admin Supp)" Notice Number: NOT-CA-16-029 Key Dates Release Date:   February 18, 2016 Related Announcements PA-16-019       Issued National Cancer Institute NCI) National Heart, Lung, Blood Institute NHLBI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) 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 Center Advancing Translational Sciences NCATS) National Center Injury Prevention Control NCIPC/CDC) National Institute Occupational Safety Health NIOSH/CDC)  Purpose purpose this Notice to inform small business research community a change the award amounts under PA-16-019 ldquo;Innovation Corps I-Corps™) NIH Program NIH CDC Phase Small Business Innovation Research SBIR) Small Business Technology Transfer STTR) Grantees Admin Supp)". following sections the FOA revised indicated below: Part 2. Section II. Award Information Award Budget Currently reads: Application budgets limited no than 40,000 direct costs, must reflect actual needs the proposed project. Modified read: Application budgets limited no than 55,000 direct costs, must reflect actual needs the proposed project. Part 2. Section IV. 2. Content Form Application Submission Instructions Electronic Application Submission through Grants.gov Modified text marked italics: Budget forms e.g., R&R Budget, PHS 398 Training Budget): Only costs associated participation the I-Corps™ Program be requested under FOA.  recovery indirect costs F&A) be allowed under FOA.  Proposed budgets not exceed total 55,000 per team. Funds must set aside three persons C-Level Corporate Officer, Industry Expert, PI) mandatory attendance at: A) kick-off evening reception plus 3-day grantee entrepreneurial immersion workshop exact location be announced, first cohort planned the DC/Maryland/Virginia region the second the San Francisco Bay Area region), followed, approximately six weeks later, B) 2-day course Close Out/Lessons Learned workshop the end the course the same regional area the kick-off workshop). intent these workshops to establish foundation the formal technology disposition the project. Applicants should estimate travel expenses these trips all 3 team members. addition, proposed budgets should include 35,000 per team cover workshop registration fees. ($35,000  of total budget allowed 55,000) Remaining budget should allocated appropriate) cover personnel time the I-Corps™ team members, well travel costs conduct on-site customer development interviews the appropriate geographical regions within U.S. nbsp; Special Instructions Streamlined Submissions using eRA Commons electronic-based submissions Modified text marked italics: Budget information should entered the grantee institution the tabs provided each selected budget period. Only costs associated participation the I-Corps™ Program be requested under FOA.  recovery indirect costs F&A) be allowed under FOA.  Proposed budgets not exceed total 55,000 per team. Funds must set aside three persons C-Level Corporate Officer, Industry Expert, PI) mandatory attendance at: A) kick-off evening reception plus 3-day grantee entrepreneurial immersion workshop exact location be announced, first cohort planned the DC/Maryland/Virginia region the second the San Francisco Bay Area region), followed, approximately six weeks later, B) 2-day course Close Out/Lessons Learned workshop the end the course the same regional area the kick-off workshop). intent these workshops to establish foundation the formal technology disposition the project. Applicants should estimate travel expenses these trips all 3 team members. addition, proposed budgets should include 35,000 per team cover workshop registration fees. ($35,000  of total budget allowed 55,000) Remaining budget should allocated appropriate) cover personnel time the I-Corps™ team members, well travel costs conduct on-site customer development interviews the appropriate geographical regions within U.S. nbsp; other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Christie A. Canaria, PhD National Cancer Institute NCI) Telephone: 240-276-5300 Email: christie.canaria@nih.gov

Notice Intent Publish Funding Opportunity Announcement Bioengineering Research Grants BRG) R01) Notice Number: NOT-EB-16-001 Key Dates Release Date: February 17, 2016 Estimated Publication Date Announcement: 8, 2016 First Estimated Application Due Date: June 5, 2016 Earliest Estimated Award Date: January 2016 Earliest Estimated Start Date: April 2016 Related Announcements PAR-13-137, R01 Bioengineering Research Grants BRG)       Issued National Institute Biomedical Imaging Bioengineering NIBIB) National Cancer Institute NCI) National Eye Institute NEI) National Human Genome Research Institute NHGRI) 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 Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) Purpose NIBIB participating Institutes intend reissue current Funding Opportunity Announcement FOA), PAR-13-137, solicit applications biomedical research to foster development an innovative technology, model, technique, design, method has potential significant impact biomedical research infusing principles concepts the quantitative sciences. Notice being provided allow submission AIDS applications well continuous submission applications PAR-13-137 till reissue. reissued FOA expected be published May 8, 2016 an expected application due date June 5, 2016. Research Initiative Details purpose this upcoming reissuance FOA to encourage collaborations between life physical sciences that: 1) apply multidisciplinary bioengineering approach the solution a biomedical problem; 2) integrate, optimize, validate, translate otherwise accelerate adoption promising tools, methods techniques a specific research clinical problem basic, translational, clinical science practice. application propose design-directed, developmental, discovery-driven, hypothesis-driven research is appropriate small teams applying integrative approach increase our understanding and solve problems biological, clinical translational science. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Karen P. Peterson, Ph.D. National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-0707 Email: kpeterso@mail.nih.gov Houston Baker, Ph.D. National Cancer Institute NCI) Telephone: 240-276-5908 Email: bakerhou@mail.nih.gov Jerome Wujek, Ph.D. National Eye Institute NEI) Telephone: 301-451-2020 Email: wujekjer@mail.nih.gov Michael W. Smith, Ph.D. National Human Genome Research Institute NHGRI) Telephone: 301-402-1114 Email: Michael.Smith@nih.gov Maria Y Giovanni, Ph.D. National Institute Allergy Infectious Diseases NIAID) Telephone: 301-496-1884 Email: mgiovanni@niaid.nih.gov Gayle E. Lester, Ph.D. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301 594-3511 Email: lester1@mail.nih.gov Louis Quatrano, Ph.D. Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-402-4221 Email: quatranol@mail.nih.gov nbsp; Nadya Lumelsky, Ph.D. National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-7703 Email: nadyal@nidcr.nih.gov nbsp; Thomas Radman, Ph.D. National Institute Drug Abuse NIDA) Telephone: 301-435-1305 Email thomas.radman@nih.gov David M. Balshaw, Ph.D. National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-2448 Email: balshaw@niehs.nih.gov Jim Gnadt, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: gnadtjw@ninds.nih.gov

Notice Clarification PA-15-354 SBIR Technology Transfer R43/R44)" Notice Number: NOT- NS-16-007 Key Dates Release Date:   February 11, 2016 Related Announcements PA-15-354     Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Drug Abuse NIDA) National Institute Dental Craniofacial Research NIDCR) National Center Advancing Translational Sciences NCATS) National Institute Nursing Research NINR)    Purpose purpose this notice to clarify Technology Transfer contact information PA-15-354, quot;SBIR Technology Transfer R43/R44)". current language reads: Part 2. Full Text Announcement Section I. Funding Opportunity Description SBCs encouraged submit license application the NIH Office Technology Transfer OTT) before submitting SBIR application. SBIR application be reviewed the NIH Center Scientific Review CSR), while license applications be reviewed the NIH Office Technology Transfer. Under NIH SBIR-TT program, SBIR grant review process be conducted parallel with, distinct from, review any application a license. list relevant technical, invention, licensing-related answers be found online the NINDS Technology Transfer Office: http://www.ott.nih.gov/. language been modified now reads: Part 2. Full Text Announcement Section I. Funding Opportunity Description selected SBIR funding, SBC be granted royalty-free, non-exclusive, internal research-use license the United States Government’s intellectual property the eligible inventions the intramural programs the appropriate Institute, the intent the SBC advance development the technology toward commercial product benefit public, consistent the missions that Institute. internal license be the term award for performance work under SBIR award. SBC be required have commercial license executed the appropriate Institute prior award an SBIR Phase II grant. commercial license be applied at any time, will be reviewed until Phase is awarded. SBIR application be reviewed the NIH Center Scientific Review CSR), while license applications be reviewed the appropriate NIH IC Technology Transfer Office. Under NIH SBIR-TT program, SBIR grant review process be conducted parallel with, distinct from, review any application a license. list relevant technical, invention, licensing-related answers be found online http://www.ott.nih.gov/ at technology transfer office website the appropriate NIH Institute Center IC) IC technology transfer offices, quot;Quick Links" the NIH IC Technology Development Coordinators page http://www.ott.nih.gov/technology-development-coordinators). other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephanie Fertig, M.B.A. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov

Notice Cancellation PAR-15-178 Jointly Sponsored Ruth L. Kirschstein National Research Service Award Institutional Predoctoral Training Program the Neurosciences T32)" Notice Number: NOT-NS-16-008 Key Dates Release Date:   February 9, 2016 Related Announcements PAR-15-178     Issued National Institute Neurological Disorders Stroke NINDS) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH)  Purpose purpose this Notice to inform extramural community the cancellation PAR-15-178 quot;Jointly Sponsored Ruth L. Kirschstein National Research Service Award Institutional Predoctoral Training Program the Neurosciences T32)".  Applications not accepted the 25, 2016 application due date. new Institutional Training FOA support early-stage, predoctoral training the neurosciences be issued time preparation applications a 2017 due date. nbsp;  Inquiries Please direct inquiries to: Stephen J. Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Phone: 301-496-4188 Email: korns@ninds.nih.gov

Notice NICHD, NINDS, NIDCR NIAID's Interest Prioritize Zika Virus ZIKV) Research Areas Notice Number: NOT-HD-16-004 Key Dates Release Date:   February 5, 2016 Related Announcements NOT-AI-16-026       Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Neurological Disorders Stroke NINDS) National Institute Dental Craniofacial Research NIDCR) National Institute Allergy Infectious Diseases NIAID) Purpose NICHD, NINDS, NIDCR NIAID issuing Notice highlight interest research Zika virus ZIKV) it relates the mother-infant dyad sequelae infection.   Areas high priority include, are limited to, following: Demonstrate causative role infection pregnancy Zika virus ZIKV) the etiology fetal microcephaly Basic research understand ZIKV infection pathogenesis transmission the fetus, whether in-utero, postpartum, breastfeedingPopulation-based studies characterize epidemiology ZIKV infection the mother-infant dyadClinical studies improve understanding the mechanisms risks maternal child transmission ZIKV Determine timeline when how women transmit ZIKV the fetusStrategies prevent transmission ZIKV the fetus after infection the mother Studies determine optimal screening and management ZIKV infection pregnant women in exposed fetusesStudies understand mechanisms which ZIKV affects developing nervous system other organ systemsResearch develop lab-based point-of-care diagnosis ZIKV using saliva a biofluidStudies characterize outcome viral infection craniofacial skeletal dental phenotype or without microcephalyStudies understand pregnancy outcomes women infected ZIKVStudies identify sequelae infants infected ZIKV well potential sequelae exposed uninfected infantsStrategies identify neurologic other manifestations infants and without microcephaly such developmental delays other neurologic physical disordersStudies assess characterize natural history long-term neurodevelopmental consequences ZIKV infection childrenStrategies identify effective treatments exposed infants and without microcephaly they develop childhood.  Such strategies must take account cultural acceptance resourcesInvestigations mediating moderating factors affecting variability neurodevelopmental, behavioral, socio-emotional impact ZIKV exposure infants prenatally postnatallyDevelop novel, simple, feasible cost-effective testing methods and/or strategies infection screening during pregnancy Develop novel, simple, rapid, feasible cost effective testing methods and/or strategies infection screening the infant Research develop lab-based point-of-care diagnosis ZIKV using saliva a biofluid Develop culturally sensitive strategies increase knowledge the relative efficacy contraceptive methods, use knowledge plan pregnancy Strategies integrate discussion risk ZIKV infection contraceptive counseling pre-pregnancy prenatal care medical facilities ZIKV endemic areas Determine long-term implications ZIKV infection non-pregnant women men including impact fertility subsequent pregnancy Studies ascertain ZIKV present reproductive fluids such semen, cervical mucus, vaginal secretions and/or follicular fluid; persistence ZIKV these fluids; the mechanisms which ZIKV enters reproductive tract Studies effects ZIKV in vitro fertilization Studies whether ZIKV be transmitted direct sexual contact artificial reproductive technology procedures Once causality demonstrated, studies vaccine development pregnant women children Once causality demonstrated, development methods explain risk ZIKV infection risk harm the fetus pregnant women women are planning become pregnant Possible funding opportunities can used pursue research activities include: PA-16-031, Advancing Understanding, prevention, management Infections Transmitted Women their Infants R21) PA-16-032, Advancing Understanding, prevention, management Infections Transmitted Women their Infants R01) NOT-TW-16-001, Parallel Funding Initiative Collaborative Research Between Investigators the USA in State Sao Paulo, Brazil PAR-16-061, Natural History Disorders Identifiable Screening Newborns R01) PAR-14-331, Global Brain Nervous System Disorders Research Across Lifespan R21) PAR-14-332, Global Brain Nervous System Disorders Research Across Lifespan R01) PAR-15-192 , Immune System Plasticity the Pathogenesis Treatment Complex Dental, Oral, Craniofacial Diseases R01) PAR-15-193, Immune System Plasticity the Pathogenesis Treatment Complex Dental, Oral, Craniofacial Diseases R21) PA-13-302,  R01 Research Project Grant nbsp; PA-13-303, R21 Exploratory/Developmental Research Grant   Inquiries Please direct inquiries to: Nahida Chakhtoura MD, MsGH Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6872 Email: nahida.chakhtoura@nih.gov Wong, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:  301) 496-1431 Email:  wongm@ninds.nih.gov Lillian Shum, Ph.D. National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-0618 Email:  ShumL@mail.nih.gov Walla Dempsey, Ph.D. National Institute Allergy Infectious Diseases NIAID) Telephone:  240-292-4197 Email: wdempsey@niaid.nih.gov

Request Information RFI): NIH Countermeasures Against Chemical Threats CounterACT) Investigator-Industry Partnerships Notice Number: NOT-NS-16-005 Key Dates Release Date: February 3, 2016 Response Date: February 29, 2016 Related Announcements None     Issued National Institute Neurological Disorders Stroke NINDS) Purpose is time sensitive Request Information RFI) solicit feedback pharmaceutical biotechnology companies regarding potential convening a meeting facilitate partnerships between active NIH CounterACT investigators entities the commercial industrial sectors. Background mission the NIH Countermeasures Against Chemical Threats CounterACT) program to develop new improved therapeutics treat and/or prevent injuries resulting exposure chemical threats. Chemical threats toxic chemicals could used a terrorist attack accidentally released industrial production, storage shipping. include traditional chemical warfare agents toxic industrial chemicals materials.  chemical threats a variety effects.  Classes chemicals encompass cholinesterase GABA-inhibitors can induce prolonged uncontrolled excitation the nervous system, metabolic/cellular poisons prevent cellular respiration, vesicating agents cause moderate debilitating ocular, dermal, mucosal injuries, pulmonary compounds corrosively injure, irritate, react the lining the respiratory tract.  NIH CounterACT projects developing candidate therapeutics are poised more advanced development activities, including pre-Investigational New Drug pre-IND)-enabling clinical studies could supported other federal agencies fund advanced development, FDA approval licensure, well procurement activities under Project BioShield medical countermeasures.gov). majority projects supported NIH in academic labs often not possess resources expertise these types advanced studies. address need, is critical the NIH facilitate partnerships between academic laboratories pharmaceutical biotechnology companies typically more experience drug development regulatory approval. Please CounterACT Projects a list active projects.  Note not of projects mature enough engaging industry.  there general interest an Investigator-Industry Partnership meeting, information specific projects are ready engagement industry be provided a method be determined.  Information Requested NIH especially interested identifying facilitating establishment partnerships between funded researchers industrial entities. partnerships aid the successful development approved medical countermeasure products the sustainability the overall research enterprise. NIH seeks input specifically industry stakeholders potential interest attending meeting specific NIH CounterACT investigators ready partnerships. achieve goal this time-sensitive RFI, invite comments any all the following areas: 1.  Interest  attending presentations NIH CounterACT investigators regarding lead candidate therapeutics 2.   The most important characteristics a project would influence interest a product under development. example, is type product, market beyond biodefense, available non-dilutive funding including federal, etc.? 3.  Please provide any comments specific features the meeting would most useful. 4. Please provide any comments this proposed initiative respondents feel relevant. meeting also include presentations federal government officials the various funding programs available support advanced development medical products within mission. to Submit Response Responses this RFI must submitted electronically Dr. Shardell Spriggs shardell.spriggs@nih.gov later February 29, 2016.  Reference Notice number NOT-NS-16-005) the subject line the email. Responses this RFI voluntary. RFI for planning purposes only should be construed a solicitation as obligation the part the Federal Government, National Institutes Health, individual NIH institutes Centers. NIH does intend make any type award based responses this RFI to pay either preparation information submitted the Government’s of such information. NIH use information submitted response the RFI its discretion. Respondents advised the Government under obligation acknowledge receipt the information provided will provide feedback respondents. information submitted be analyzed may shared internally used NIH CounterACT staff planning future Investigator-Industry Partnership meetings, appropriate at Government’s discretion. Proprietary, classified, confidential, sensitive information should be included your response.   Inquiries Please direct inquiries to: David A. Jett, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-6035 Email: david.jett@nih.gov

Notice NIH/FDA Informational Webinar - Common Misunderstandings the Investigational Device Exemption Process Invasive Neuromodulation Devices Notice Number: NOT-NS-16-006 Key Dates Release Date:   January 29, 2016 Related Announcements RFA-NS-16-009 RFA-NS-16-010 RFA-NS-16-011 RFA-NS-16-018     Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to inform potential applicants Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative FOAs Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System RFA-NS-16-009, RFA-NS-16-010, RFA-NS-16-011 RFA-NS-16-018) a webinar both FDA NIH staff provide assistance the Investigational Device Exemption IDE) process neuromodulation devices. webinar optional is required submission RFA-NS-16-009, RFA-NS-16-010, RFA-NS-16-011 RFA-NS-16-018. register the webinar, to submit questions, please email BRAIN-FOAs@nih.gov Tuesday, February 23, 2016. Webinar Information Date: Thursday, February 25, 2016 Time: 3:00PM EDT Duration: 1 hour Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: BRAIN-FOAs@nih.gov

Notice Announcing Creation a Dedicated NINDS Human Cell Data Repository supporting Reprogramming, Gene Editing, Banking Distribution Fibroblasts Induced Pluripotent Stem Cells iPSCs) Neurological Disorders. Notice Number: NOT-NS-16-003 Key Dates Release Date:   January 14, 2016 Related Announcements None     Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) announcing creation a dedicated Human Cell Data Repository.  repository be housed curated RUCDR Infinite Biologics Rutgers University under direction Dr. Jay Tischfield.  purpose this Notice to: 1) describe timeline access existing NINDS fibroblast induced pluripotent stem cell iPSC) lines currently housed the Coriell Institute Medical Research; 2) outline plans the development new fibroblast iPSC lines including isogenic iPSC lines neurological disorders. Background September 2015, NINDS issued U24 award RUCDR Infinite Biologics RUCDR) Rutgers University support development new resources services will advance our knowledge disease mechanisms promote therapeutic discovery neurological diseases through creation a dedicated NINDS Human Cell Data Repository NHCDR).  new NHCDR support goals NINDS making human cell lines the highest quality, including iPSC lines source cells such fibroblasts, available the global research community. Access existing iPSC fibroblast lines previously distributed through Coriell Institute Medical Research NHCDR continue support access distribution the 177 fibroblast lines 67 iPSC lines have developed over last 5 years through American Recovery Reinvestment ARRA) 2009 collaborations government non-government organizations.  fibroblast iPSC lines previously distributed through Coriell Institute Medical Research. transition existing lines between Coriell Institute Medical Research the RUCDR expected take five months, the first transfer iPSC lines occurring January 2016 the final transfer all cell lines occurring May 2016.  During transfer period, investigators interested accessing cell lines encourage visit new NHCDR website.  NHCDR website provides to date information the lines available through NHCDR catalog, description the NHCDR services available, frequently asked questions, information new lines under development.  Beginning January 2016, investigators place orders NHCDR cell lines through NHCDR catalog.  orders be fulfilled soon the cell lines become available. New services human cell lines available through NHCDR support rapid advancement research tools basic biology therapeutic discovery, NHCDR continue support fibroblast, iPSC peripheral blood mononuclear cell PBMC) expansion, quality assessment distribution.  New services offered the NHCDR include: 1) iPSC derivation comprehensive quality control assessments: 2) generation stem cell derivatives, such neural stem cells; 3) genome editing repair introduce, iPSC lines, specific mutations are implicated human neurological diseases.  iPSC lines developed under NeuroLINCS Data Signature Generation Center, part  the National Institutes Health NIH) Library Integrated Network-based Cellular Signatures LINCS) program be available through NHCDR 2016.  Extensive analysis these iPSC lines differentiated cell derivatives including transcriptomics RNAseq), proteomics SWATH-MS), epigenomics ATAC-Seq) imaging data available the NeuroLINCS website.  find more new existing fibroblast iPSC lines available through NHCDR, well services available cellular reprogramming genetic modification please send email inquiries NINDS@dls.rutgers.edu contact NINDS program official the NINDS NHCDR contact personnel listed below. Inquiries Please direct inquiries to: Michael Sheldon, PhD Director, RUCDR Stem Cell Center Telephone: 848-445-7096 Email: sheldon@biology.rutgers.edu Margaret Sutherland, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sutherlandm@ninds.nih.gov