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Notice Availability Administrative Supplements NIH Grants are Focused Down Syndrome Address Specific Down Syndrome Research Objectives Notice Number: NOT-OD-18-194 Key Dates Release Date: June 20, 2018 Related Announcements NOT-OD-18-203 NOT-OD-18-204 PA-18-591 NOT-OD-18-195 Issued National Institutes Health NIH) 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 Allergy Infectious Diseases NIAID) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Purpose purpose this Notice to solicit administrative supplement applications existing awards are currently focused Down syndrome research order accelerate scientific progress meet new NIH Down syndrome research objectives, described below. Please NOT-OD-18-195 a companion notice applications are currently focused Down syndrome. Down syndrome the most common genetic cause intellectual disability, most common autosomal trisomy, one the most visible universally recognized genetic syndromes. year are approximately 5300 babies born the United States Down syndrome. Within past 25 years, average lifespan a person Down syndrome doubled, 30 60 years. While people Down syndrome connected the common feature a complete partial copy chromosome 21 trisomy 21), are significant physical cognitive differences among them, indicating inter-individual variability exists. notice initiates new trans-NIH program support research commonly co-occurring conditions individuals Down syndrome are also seen the general population, such Alzheimer’s disease/dementia, autism, cataracts, celiac disease, congenital heart disease, immune system dysregulation, diabetes. is known the INCLUDE Project INvestigation Co-occurring conditions across Lifespan Understand Down syndromE). Information learned studying people Down syndrome also help us learn these conditions people without Down syndrome. Likewise, common complications aging, such coronary heart disease solid cancers, rarely seen individuals Down syndrome; warrants additional study. new research initiative expands of research objectives opportunities previously highlighted the 2014 Down Syndrome Directions: NIH Research Plan Down Syndrome. recent discoveries enhanced our understanding chromosome segregation chromosome silencing, identified certain proteins neurotropic factors involved brain development using mouse models, uncovered role interferons immune dysregulation, of have potential lead development novel therapies individuals Down syndrome, well broader applications. People Down syndrome often excluded clinical research, such trials potentially beneficial drugs therapeutics are used treat same condition the general population. is great value connecting people Down syndrome therapies could improve overall health quality life. there great interest the Down syndrome community participating clinical research, based experience NICHD’s DS-Connect®: Down Syndrome Registry,” https://DSConnect.nih.gov ), online survey tool introduces individuals Down syndrome their families research opportunities. Opportunities engage Down syndrome community research also facilitated the members the Down Syndrome Consortium, public-private partnership involving NIH Institutes Centers, advocacy groups, private foundations professional organizations, self-advocates families, sharing passion promoting research will benefit people Down syndrome. comprehensive clinical cohort study deep phenotyping exploration pan-‘omics permit identification biomarkers outcomes the co-occurring conditions Down syndrome. Coupled development a clinical trials readiness program, informed basic science discoveries, combination resources have great impact addressing health disparities exist people Down syndrome could also lead the development therapies improve outcomes those and without condition. Supplement applications be considered eligible funding they address or of following components related the INCLUDE Project research objectives: Component 1: Targeted, high risk-high reward, basic science studies areas highly relevant Down syndrome: basic science studies, supplements should target areas science highest impact that likely translate new therapeutic approaches Down syndrome, even the parent award not focused Down syndrome. Topics emphasis include: chromosome silencing, immune system dysregulation, epigenetic/metabolomic/transcriptomic profiling model organisms/iPSCs/brain organoids, development novel model systems, development a molecular atlas cardiac other specimens. Supplements also support projects will inform other components, namely cohort study a clinical trials network. Component 2: Molecular snapshot Down syndrome through cohort study: goal to add Down syndrome cohort an existing cohort focused a condition commonly co-occurs Down syndrome, data collected a shared database using common data elements building the DS-Connect® patient registry. Supplements add comprehensive molecular i.e. pan-‘omics) analyses support existing infrastructure sample neuroimaging collection the Down syndrome population. Component 3: Inclusive clinical research individuals Down syndrome: Supplement requests leverage existing clinical trials infrastructure add new Down syndrome cohort an existing trial, start building Down syndrome-specific modules a future study, to test drugs therapies co-occurring conditions the Down syndrome population. particular interest ongoing clinical trials testing therapies common conditions such asthma sleep apnea occur people and without Down syndrome. encourage projects that: within scope the active parent award not currently focused Down syndrome could add Down syndrome cohort, module, model system great relevance Down syndrome Propose address of components listed under Down syndrome research objectives likely stimulate additional activity leading progress Down syndrome Address priority the IC issued parent award applicable--see below) Investigators should submit applications responses the parent active administrative supplement PA, Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional)”: https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html Supplements existing clinical trials allowed, addition a new clinical trial was a part the parent award not allowed. Supplement requests addressing components 2 3 should encourage participants Down syndrome their caregivers register DS-Connect®: Down Syndrome Registry https://DSConnect.nih.gov). the parent award focused Down syndrome, NOT-OD-18-195 Before submitting supplement request, principal investigators strongly encouraged contact program officer the program contact the Institute, Center Office supporting parent award discuss whether proposed supplement within scope the INCLUDE Project the priorities the IC supporting parent award with any questions. Award Project Period be eligible, parent award must receive funds FY18 Oct. 1, 2017-Sept. 30, 2018) not in extension period. request for year funding, the research proposed the supplement must accomplished within 1-2 years. earliest anticipated start date August 1, 2018. Budget Supplement budget requests cannot exceed 500,000 direct costs exclusive Facilities Administrative costs sub-contracts, 50% the direct costs the current parent award, whichever less. Requests must reflect actual needs the proposed project. Requests be one year support only. Modular categorical budgets permitted. Eligible Individuals Program Director/Principal Investigator) Individual(s) must hold active grant cooperative agreement. supplements parent awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) submitted the awardee institution the parent award. Submitting Application additional information, the parent program announcement Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-591. part the application investigators should submit no than one-page abstract the proposed research shows relevance the INCLUDE project articulates component(s) any IC-specific priorities the supplement addressing. Applicants should begin supplement application abstract stating: application being submitted PA-18-591 accordance NOT-OD-18-194." Page Limits: NIH consider supplements a Research Strategy no than 6 pages, addition the abstract. Supplements should submitted electronically allowed parent mechanism. addition, applicants strongly encouraged notify program contact the institute is supporting parent award list below) an application been submitted response this FOA order facilitate efficient processing the request. Requests must received 5:00 PM Pacific Daylight Time P.D.T.) July 23, 2018 funding FY 2018. Institute, Center IC) Office-specific Instructions National Cancer Institute NCI): NCI priorities include following: Evaluation the genetic, epigenetic, epidemiologic factors associated trisomy 21 lead greatly increased risk childhood leukemias that lead the distinctive biological clinical behavior these leukemias. Evaluation the genetic, epigenetic, epidemiologic factors associated trisomy 21 lead reduced risk selected childhood adult solid tumors. Characterization the biological clinical factors drive development transient abnormal myelopoiesis TAM) its progression acute myeloid leukemia AML) children trisomy 21. Mining and/or generation omics datasets clinically annotated specimens Down syndrome acute lymphoblastic leukemia ALL) AML. Translational research associated completed/ongoing clinical trials identify prognostic factors e.g., minimal residual disease) can used reliably guide treatment children leukemia associated Down syndrome. National Eye Institute NEI): NEI interested supplementing existing grants have potential further understanding ocular pathologies frequently seen Down syndrome manifestations include, are limited to, cataract, amblyopia, strabismus refractive errors). Applications examining regulation dysregulation eye development Down syndrome also encouraged. Interested applicants advised contact NEI program officer prior submitting supplement application. National Heart, Lung, Blood Institute NHLBI): NHLBI priorities include following: Incorporation individuals Down syndrome existing disease cohorts clinical trials directed toward sleep apnea, congenital heart disease, pediatric pulmonary hypertension, adult cardiovascular disease. This include collection tissue blood specimens omics data generation analysis genomics, transcriptomics, metabolomics, etc.), imaging, computational modeling, expansion a clinical trial include number Down syndrome cases necessary provide sufficient statistical power stratification.  Studies encouraged leverage DS-Connect registry identify potential participants. Mining and/or generation omics datasets heart, lung, blood, sleep disorders functions genes chromosome 21 downstream genes chromosome 21. Characterization animal models the morphological events occurring early heart development give rise the specific forms congenital heart disease are primary cause death during first year life infants born Down syndrome. Characterization differentiation disease-related tissue types induced pluripotent stem cells derived cells individuals Down syndrome compared euploid iPSC cells. Identification potential risk resilience factors make individuals Down syndrome susceptible transient persistent blood disorders congenital heart disease protected adult cardiovascular disease. National Human Genome Research Institute NHGRI): NHGRI interested the following: Ethical, legal social implications ELSI) related preimplantation prenatal screening testing trisomy 21. Research how Down syndrome understood individuals, families, specific subgroups within society. National Institute Aging NIA): NIA interested the following: Epidemiologic, genomic, mechanistic research studies aiming understand molecular mechanism underlying interplay between aging neurodegeneration Down syndrome. Mechanisms resilience Down syndrome individuals remain free dementia the face Alzheimer's pathology. Understanding aspects brain aging individuals Down syndrome. Identification sensitive neuropsychological measures cognitive decline, imaging, blood-based, genetic biomarkers associated transition normal aging mild cognitive impairment clinical dementia adults Down syndrome. particular interest studies will generate make available high quality omics data can used downstream systems biology other predictive modeling efforts. National Institute Allergy Infectious Diseases NIAID): Addition research focused immune system dysregulation Down syndrome; molecular basis, impact health, including infections autoimmunity, intervention strategies. Eunice Kennedy Shriver National Institute Child Health Human Development NICHD): NICHD priorities include: Basic science studies focused chromosome silencing; white matter brain development; gene therapy prenatal therapy animal models can include component significant relevance Down syndrome; studies rodent models understand cognition, behavior, other aspects the phenotype across different stages development; development novel tools understanding basic biology Down syndrome, such well-characterized induced pluripotent cell lines, cell tissue repositories, new murine other rodent models can better replicate chromosome regions syntenic human chromosome 21 well reproduce complex neurobehavioral other phenotypic features Down syndrome, mechanisms link current model organism databases resources. Supplements will increase pool individuals Down syndrome cohort studies, deep phenotyping, biospecimen collection, omics studies, ultimately, clinical trials, such through enhancements recruitment, phenotyping services, biobanks supplements perform pan-'omics approaches readily available cohorts; supplements will recruit individuals IDeA states limited NIH funding ensure representation rural underserved areas; approaches capture priorities parents individuals Down syndrome; supplements facilitate linkages between pan-'omics data sets, patient-reported outcomes, electronic medical records, DS-Connect® facilitate data sharing, data mining, secondary uses; development validation sensitive, robust, reproducible outcome measures complex phenotypes such cognition behavior using tools such the NIH ToolBox; studies expand extend available biomarkers studies regression, aging, dementia adolescents adults Down syndrome; studies risk resilience co-occurring conditions Down syndrome. Studies add Down syndrome component an existing pharmacologic clinical trial a condition common Down syndrome for dosage efficacy not established this population; supplements existing clinical trial networks establish infrastructure necessary clinical trials those Down syndrome, including efforts link existing datasets add participants DS-Connect®; studies develop new therapeutics interventions people Down syndrome; supplements explore ethical, legal, social implications research populations reduced decisional capacity optimal methods obtaining informed consent those Down syndrome. National Institute Deafness Other Communication Disorders NIDCD): NIDCD priorities include: Better understanding the natural history communication disorders hearing, balance/vestibular, voice, speech, language, taste smell) throughout lifespan Down syndrome. Early identification clinical management communication disorders throughout lifespan individuals Down syndrome. National Institute Dental Craniofacial Research NIDCR): Oral health problems experienced individuals Down syndrome: malocclusion, increased caries, periodontal diseases advanced pain. Evidence-based evaluation treatment approaches individuals Down syndrome: orthodontic treatment warranted? are best approaches the treatment sleep apnea individuals Down syndrome? National Institute Diabetes Digestive Kidney Diseases NIDDK): NIDDK interested research focused Down syndrome obesity, urologic conditions, type 1 diabetes, autoimmune thyroid disease, other autoimmune diseases within purview NIDDK.   National Institute Environmental Health Sciences NIEHS): PD/PI must propose project has focus environmental exposures within NIEHS mission.  Environmental agents are considered primary interest NIEHS include:  industrial chemicals manufacturing byproducts, metals, pesticides, herbicides, air pollutants other inhaled toxicants, particulates fibers, fungal, bacterial biologically derived toxins. Investigators propose studies a primary focus NIEHS mission-relevant exposures encouraged consider inclusion other relevant environmental exposures e.g., periconceptional smoking) order assess role(s) cofactors/modifiers the risk protection associated the primary exposure(s). Applications propose laboratory-based studies using only model compounds i.e., those without potential human exposure) must provide clear, reasonable specific description to research the model compound lead a better understanding the mechanisms involved responses specific environmental agents are included the mission responsibility the NIEHS.  NIEHS priorities include following: Characterization how environmental exposures linked cognitive/dementia phenotypic variations observed individuals Down syndrome. Incorporation animal models explore toxicity environmental agents impact oxidative stress pathways can exacerbate Down syndrome symptomology. Exploration the genetic susceptibility environmental exposures influencing progression, onset, and/or severity the complex clinical outcomes individuals Down syndrome. Epidemiologic mechanistic research studies aiming understand contribution environmental exposures subsequent co-morbidities and/or health factors individuals Down syndrome. National Institute General Medical Sciences NIGMS): the NIGMS MIRA Maximizing Investigators’ Research Award) program provides support an investigator's overall program research within Institute’s mission, MIRA awardees not eligible this supplement program. National Institute Mental Health NIMH): NIMH supports translational research examining neurodevelopmental underpinnings psychopathology, well the onset, developmental trajectories, outcomes mental health conditions across lifespan, including depression, anxiety, psychosis. Research a dimensional perspective supported identify fundamental components span multiple disorders, such attention, executive function affective regulation, may involve developing and/or validating biological markers, developing and/or validating methods measures assess domains psychopathology, testing integrative models within longitudinal frameworks track trajectories risk protection. interest supplements add specific Down syndrome cohorts develop validated measures psychopathology these individuals, to elucidate onset, course functional outcomes, including risk resilience, individuals Down syndrome have comorbid psychopathology. NIMH also supports studies investigating whether various mental disorders such schizophrenia, bipolar disorder, major depressive disorder, PTSD) increase risks developing dementia excessive cognitive decline, speed rate the biological aging process.  of studies follow aging adults prospectively, most include protocols neuroimaging changes brain structure and/or function, for assessing molecular, cellular, neuroinflammatory, other factors important the biological aging process.  interest supplements include persons Down syndrome, thereby contribute usefully an understanding how Down syndrome often leads early-onset, Alzheimer-type dementia to accelerated biological aging.  Finally, NIMH interest discovery specific genetic variants within chromosome 21 critical region have specific effects comorbid diseases mental health outcomes. National Institute Neurological Disorders Stroke NINDS): NINDS priorities include following: Addition a Down syndrome component a basic research study related cognitive decline Alzheimer's disease; Understanding role aberrant neurotrophin signaling the cognitive behavioral characteristics Down syndrome; Development characterization animal models developmental delays, cognitive, dysfunction cognitive decline Down syndrome; Determine role white matter individuals Down syndrome. National Institute Nursing Research NINR): NINR priorities research co-occurring conditions across lifespan individuals Down syndrome include health promotion, disease prevention, health disparities, caregiving, management symptoms, self-management, genetics, epigenetics, palliative care needs care the end life. Topics special interest include integration biological behavioral sciences, application new technologies research questions, improving quality effectiveness interventions. National Institute Minority Health Health Disparities NIMHD): NIMHD priorities include inclusion individuals Down syndrome NIH-designated health disparity populations Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, sexual gender minorities) existing clinical community-based studies sufficient number conduct meaningful subgroup analysis. Topics particular interest related individuals Down syndrome health disparity populations include are limited the following: Intersectional stigma discrimination their impact health healthcare utilization Coping strategies, social support, other protective factors related chronic disease risk outcomes Access and quality healthcare, including primary, specialty, behavioral health care transition child adult healthcare other service systems National Center Complementary Integrative Health NCCIH): NCCIH priorities include following: Understand use mind body approaches improve cognitive function for managing Down syndrome-associated health conditions e.g., chronic pain, anxiety disorders, etc.) Review process IC conduct administrative reviews applications submitted their IC separately. NIH Office the Director make funds available the top applications submitted consideration this cross-IC program. Criteria: 1. the work proposed within scope the active award? 2. the work relevant Down syndrome even though parent award not focused Down syndrome research? 3. Does work proposed address of components listed under Down syndrome research objectives? 4. Does work proposed scientific merit? 5. the work likely stimulate additional activity leading progress Down syndrome? 6. Does work address priority the IC issued parent award applicable)? Inquiries Please direct inquiries the contact the Institute, Center Office supporting parent award: Melissa A. Parisi, MD, PhD Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6880 Email: parisima@mail.nih.gov Anna E. Mazzucco, PhD National Institutes Health NIH) Telephone: 301-451-1220 Email: anna.mazzucco@nih.gov Malcolm A. Smith, MD, PhD National Cancer Institute NCI) Telephone: 240-276-6087 Email: Malcolm.Smith@nih.gov Houmam Araj, PhD National Eye Institute NEI) Telephone: 301-451-2020 Email: arajh@nei.nih.gov Charlene Schramm, PhD National Heart, Lung, Blood Institute NHLBI) Telephone: 301-402-3793 Email: SchrammC@nhlbi.nih.gov Joy T. Boyer, BA National Human Genome Research Institute NHGRI) Telephone: 301-480-2247 Email: jb40m@nih.gov Laurie M. Ryan, PhD National Institute Aging NIA) Telephone: 301-496-9350 Email: ryanl@mail.nih.gov Frosso Voulgaropoulou, PhD National Institute Allergy Infectious Diseases NIAID) Telephone: 240-627-3205 Email: fvoulgaropoulou@niaid.nih.gov Lana Shekim, PhD National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-496-5061 Email: shekiml@nidcd.nih.gov Jason Wan, PhD National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-9898 Email: JasonWan@nidcr.nih.gov Ellen Leschek, PhD National Institute Diabetes Digestive Kidney Diseases NIDDK ) Telephone: 301-402-8291 Email: LeschekE@EXTRA.NIDDK.NIH.GOV Jonathan A. Hollander, PhD National Institute Environmental Health Sciences NIEHS) Telephone: 984-287-3269 Email: jonathan.hollander@nih.gov Donna Krasnewich, MD, PhD National Institute General Medical Sciences NIGMS) Telephone: 301-594-0943 Email: dkras@nigms.nih.gov Lisa Gilotty, PhD National Institute Mental Health NIMH) Telephone: 301-443-3825 Email: gilottyl@mail.nih.gov Robert Riddle, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5745 Email: rr260c@nih.gov National Institute Nursing Research NINR) Rebekah S. Rasooly, PhD Telephone: 301-827-2599 Email: rr185i@nih.gov Nathan Stinson, Jr., PhD, MD National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-8704 Email: stinsonn@mail.nih.gov Robin Elizabeth Boineau, MD National Center Complementary Integrative Health NCCIH) Telephone: 301-435-6286 Email: Robin.Boineau@nih.gov    Erica K. Rosemond, PhD National Center Advancing Translational Sciences NCATS) Telephone: 301-594-8927 Email: Erica.Rosemond@nih.gov  

Notice Intent Publish Funding Opportunity Announcement Clinical Trials Network Pain - Data Coordinating Center U24 Clinical Trial Allowed) Notice Number: NOT-NS-18-057 Key Dates Release Date:June 14, 2018 Estimated Publication Date Funding Opportunity Announcement: 07/16/2018 First Estimated Application Due Date: 09/14/2018 Earliest Estimated Award Date: 12/04/2018 Earliest Estimated Start Date: 12/04/2018 Related Announcements NOT-NS-18-058 NOT-NS-18-069 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends publish Funding Opportunity Announcement FOA) solicit applications a Data Coordinating Center DCC) a new Clinical Trials Network Pain Research CTNPR). CTNPR part the NIH Helping End Addiction Long-Term HEAL) Initiative. The CTNPR enable exploratory clinical trials investigational drugs biologics, investigational devices, natural products, surgical procedures the treatment pain.  These trials validate biomarkers, provide proof mechanism, otherwise contribute the justification for and provide data required for designing future Phase 3 trial.  specific pain conditions include well-defined ones high unmet needs more common, chronic neuropathic, inflammatory nociceptive pain disorders adult pediatric populations. network also implement clinical studies biomarker discovery validation, will store biomarker data samples future biomarker discovery.  is anticipated the CTNPR be able run many five Phase 2 trials concurrently addition biomarker validation studies. Further, is anticipated a number the investigational drugs, biologics, devices tested come private companies academics.    DCC have responsibility web-based data collection, data management and quality assurance, statistical design analysis, reporting the Data Safety Monitoring Boards regulatory oversight groups.  importantly, DCC be expected provide innovative statistical leadership the CTNPR the goal accelerating discovery evaluation treatments pain. DCC also house data repository biosample repository. is envisioned the DCC also serve the convener an Expert Panel consists objective subject matter experts experience developing therapeutics. Expert Panel serve the liaison private companies may contribute therapeutics the CTNPR testing. analyses be submitted an NIH Scientific Review committee prioritization. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published Summer 2018 an expected application due date Fall 2018. FOA utilize U24 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise biostatistics data management multicenter clinical trials begin consider applying this new FOA.  Experience novel, efficient study designs including response-adaptive randomization basket platform designs, designs using biomarkers endpoints, be especially important.  Expertise risk-based site monitoring be valuable, will experience in use digital/mobile/sensor technologies web-based systems facilitate data collection including data collection a continual, contextual, real-world setting rather through traditional milestone-based approach) to enhance protocol adherence. is envisioned the network be scaled run five concurrent Phase 2 trials over 5-year project, addition biomarker validation studies. Applications the Clinical Coordinating Center CCC) be solicited a separate FOA issued the same time the DCC FOA.  Awards a CCC a DCC not made the same PD/PI institution ensure data analyses performed independently. Funding individual studies be provided through individual study grants   Applications Hubs for clinical trials studies themselves be solicited future FOAs. mentioned NOT-OD-18-181, any for-profit recipient funds shall subject a matching requirement funds documented in-kind contributions not less 50 percent the total funds awarded such entity. Funding Information Estimated Total Funding TBD Expected Number Awards 1 Estimated Award Ceiling TBD Primary CFDA Numbers 93.853 Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Applications not being solicited this time. Inquiries Please direct inquiries to: Jeremy Brown, MD National Institute Neurological Disorders Stroke NINDS) 301-827-8375 Jeremy.Brown@nih.gov

Notice Intent Publish Funding Opportunity Announcement Clinical Trials Network Pain - Clinical Coordinating Center U24 Clinical Trial Optional) Notice Number: NOT-NS-18-058 Key Dates Release Date:June 14, 2018 Estimated Publication Date Funding Opportunity Announcement: 07/16/2018 First Estimated Application Due Date: 09/14/2018 Earliest Estimated Award Date: 12/04/2018 Earliest Estimated Start Date: 12/04/2018 Related Announcements NOT-NS-18-057 NOT-NS-18-069 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends publish Funding Opportunity Announcement FOA) solicit applications a Clinical Coordinating Center CCC) a new Clinical Trials Network Pain Research CTNPR).  CTNPR part the NIH Helping End Addiction Long-Term HEAL) Initiative. network be charged testing novel, non-addictive treatments patients suffering acute chronic pain conditions. CTNPR harness multidisciplinary expertise pain science clinical research collaboratively design conduct Phase 2 multicenter clinical trials testing novel pain treatments. will also perform validation studies biomarkers promise inform target engagement proof principle Phase 2 clinical trials.  CTNPR develop deeply phenotyped cohorts specific acute chronic pain conditions adults children. The emphasis the CTNPR be pain conditions high unmet needs. Interventions be studied include drugs, biologics, devices, natural products surgical procedures.  CTNPR be composed one CCC, Data Coordinating Center DCC), approximately 10 clinical centers Hubs).  Hubs be Centers Excellence physicians pain expertise neurology, anesthesiology, rheumatology, physical medicine, obstetrics/gynecology, pediatrics, orthopedics, gastroenterology, other subspecialties providing care patients pain.  Hub envisioned as regional medical center will enroll patients along its network 2-10 satellite sites Spokes).    CCC the leaders the Clinical sites play critical role designing clinical trial protocols be conducted the CTNPR. Interventions be solicited a variety sources including pharmaceutical industry, medical device companies, academics.  will prioritized a separate NIH scientific review committee.  most promising interventions be assigned the CCC the CTNPR leadership will work outside investigators—including those the HEAL Public-Private Partnership—to develop innovative Phase 2 clinical trial protocols test highest priority tailored interventions patients specific pain conditions. CCC will provide scientific organizational leadership the CTNPR.  CCC the administrative center the CTNPR, responsibilities contracts sites performance clinical trials studies (master trial agreements the clinical centers, entities), planning budgets proposed clinical trials, disbursing payments sites. CCC leads manages key CTNPR governance committees. CCC primary responsibility identifying the central IRB.  The CCC responsible oversight all aspects trial enrollment recruitment, feasibility assessment, planning, tracking and, necessary, improvement plans.  CCC also responsible quality assurance related clinical trials to overall performance the CTNPR. CCC collaborate closely the DCC, clinical research sites, the clinical trial PDs/PIs with goal accelerating discovery evaluation treatments pain. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published July 2018 an expected application due date September 2018. FOA utilize U24 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators appropriate expertise begin consider applying this new FOA. PD/PI the Clinical Coordinating Center CCC) must a clinical trials expert has successfully coordinated implemented multicenter clinical trials. Experience neurology pain clinical trials especially relevant.  Since CCC PD/PI the chair several CTNPR governance committees, is important he she sufficient time attend actively contribute the committee meetings. Members the CCC research team might include: Experienced study coordinators and/or project managers, potentially areas subspecialty such recruitment interactions IRBs;   Experienced financial coordinator manager; Site Support Manager comparable staff training all Hubs, Spokes ad hoc clinical sites; Components the central IRB, such IRB chair, members, director; Liaisons the IRB clinical sites. Applications the CCC be solicited a separate FOA issued the same time the DCC FOA.  Awards a CCC a DCC not made the same PD/PI institution ensure data analyses performed independently. Funding individual studies be provided through individual study grants. Industry partnerships be encouraged.  Applications Hubs for clinical trials studies themselves be solicited future FOAs. Investigators the CCC institution apply a Hub award.  CCC a Hub the same institution should led separate PDs/PIs ensure the CCC activities the local Hub activities receive full attention to preserve needed firewalls. mentioned NOT-OD-18-181, any for-profit recipient funds shall subject a matching requirement funds documented in-kind contributions not less 50 percent the total funds awarded such entity. Funding Information Estimated Total Funding TBD Expected Number Awards 1 Estimated Award Ceiling TBD Primary CFDA Numbers 93.853 Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Regional Organization Applications not being solicited this time. Inquiries Please direct inquiries to: Jeremy Brown, MD National Institute Neurological Disorders Stroke NINDS) 301-827-8375 Jeremy.Brown@nih.gov

Notice Intent Publish Funding Opportunity Announcement Clinical Centers the Clinical Trials Network Pain Research CTNPR) U24 Clinical Trial Allowed) Notice Number: NOT-NS-18-069 Key Dates Release Date:June 14, 2018 Estimated Publication Date Funding Opportunity Announcement: 07/16/2018 First Estimated Application Due Date: 09/14/2018 Earliest Estimated Award Date: 12/04/2018 Earliest Estimated Start Date: 12/04/2018 Related Announcements NOT-NS-18-057 NOT-NS-18-058 Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke intends publish Funding Opportunity Announcement FOA) solicit applications a Clinical Trials Network Pain Research CTNPR). network be charged executing trials high impact the treatment patients acute chronic pain. CTNPR part the NIH Helping End Addiction Long-Term HEAL) Initiative. network be composed a Clinical Coordinating Center CCC), Data Coordinating Center DCC), ten Regional Clinical Centers together their linked clinical sites. purpose this notice to allow potential applicants sufficient time develop meaningful collaborations projects the clinical centers ("Hubs") CTNPR.  The CTNPR enable exploratory clinical trials investigational drugs biologics, investigational devices, natural products, surgical procedures the treatment pain.  These trials validate biomarkers, provide proof mechanism, otherwise contribute the justification proceeding not proceeding a future Phase 3 trial e.g., informing go/n-go decisions).  specific pain conditions include well-defined ones high unmet needs more common, chronic neuropathic, inflammatory nociceptive pain disorders adult pediatric populations. network focus multi-site Phase 2 trials.  The network also implement clinical studies biomarker discovery validation, will store biomarker data samples future biomarker discovery.  is anticipated the CTNPR be able run many five Phase 2 trials concurrently addition biomarker validation studies. The CTNPR consist one Clinical Coordinating Center CCC), Data Coordinating DCC), 10 clinical centers Hubs).   Hub be center excellence physician expertise neurology, anesthesiology, rheumatology, obstetrics/gynecology, pediatrics, orthopedics, physical medicine, gastroenterology, other subspecialties providing care patients pain.  Hub envisioned as regional medical center will enroll patients along its network 2-10 satellite sites Spokes). A Hub additionally provide scientific leadership administrative oversight its multiple satellite sites ("Spokes").  notice solicits applications the CTNPR Clinical Centers. Separate notices been issued the Clinical Coordinating Center the Data Coordinating Center NOT-NS-18-058 NOT-NS-18-057). Interventions trials within CTNPR be solicited the national scientific community.  CTNPR design execute trials investigational drugs, devices biologics provided companies academics. FOA expected be published July 2018 an expected application due date September 2018. FOA utilize U24 activity code. Research Initiative Details Hub must a flexible network Spokes.  principal function the Spokes to provide access a larger patient population trial enrollment. Spokes also increase access patients a particular disease syndrome, patients underserved communities, complement Hub providing access specific research clinical expertise.  each clinical trial, Hub be expected construct network 2-10 Spokes specifically tailored the needs that particular trial. Since requirements each clinical trial be somewhat different, identity configuration Spokes be unique each trial.  Therefore, Hub should relationships a number potential Spokes, the ability add Spokes appropriate.  demonstrate ability attract Spokes, applicant requested identify the grant submission five Spokes committed participation at least clinical trial.   Since five Spokes unlikely meet possible clinical trial requirements, Hub need have plans mechanisms recruiting adding Spokes, needed. mentioned NOT-OD-18-181, any for-profit recipient funds shall subject a matching requirement funds documented in-kind contributions not less 50 percent the total funds awarded such entity. Funding Information Estimated Total Funding TBD Expected Number Awards TBD Estimated Award Ceiling TBD Primary CFDA Numbers TBD Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) Indian/Native American Tribal Government than Federally Recognized) Regional Organization Applications not being solicited this time. Inquiries Please direct inquiries to: Jeremy Brown MD National Institute Neurological Disorders Stroke NINDS) 301-827-8375 jeremy.brown@nih.gov

Notice New Budget Limitation PAR-18-657 Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54 Clinical Trial Optional). Notice Number: NOT-NS-18-072 Key Dates Release Date: June 14, 2018 Related Announcements NOT-NS-20-085 PAR-18-657 Issued National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to amend award budget PAR-18-657 Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54 Clinical Trial Optional)." Section II. Award Information Currently Reads: Award Budget Application budgets not exceed 2.5 million direct costs per year. applications not need request maximum budget the size duration the awards vary because nature scope research programs vary. Modified Read: Award Budget Application budgets not exceed $2.0 million in direct costs per year. applications not need request maximum budget the size duration the awards vary because nature scope research programs vary. other aspects this FOA remain same. Inquiries Please direct inquiries to: David A. Jett, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:  301-496-6035 Email: jettd@ninds.nih.gov

Notice New Budget Limitation PAR-16-331 Countermeasures Against Chemical Threats CounterACT): Optimization Therapeutic Lead Compounds U01) Notice Number: NOT-NS-18-071 Key Dates Release Date: June 12, 2018 Related Announcements PAR-16-331 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose purpose this notice to amend award budget PAR-16-331 Countermeasures Against Chemical Threats CounterACT): Optimization Therapeutic Lead Compounds U01)." Section II. Award Information Currently Reads: Award Budget Application budgets not limited, need reflect actual needs the proposed project. most applications within scope this FOA, expected direct cost individual awards 300,000-$500,000 per year. applications not need request maximum budget the size duration the awards vary depending upon nature scope research programs. Modified Read: Award Budget Application Budget not exceed $500,000 in direct costs per year. applications not need request maximum budget the size duration the awards vary because nature scope research programs vary. other aspects this FOA remain same. Inquiries Please direct inquiries to: David A. Jett, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:  301-496-6035 Email:  jettd@ninds.nih.gov nbsp;

Notice Correction Key Dates RFA-NS-18-029 BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP U01 Clinical Trial Allowed) Notice Number: NOT-NS-18-070 Key Dates Release Date: 23, 2018 Related Announcements RFA-NS-18-029 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants a correction the Key Dates RFA-NS-18-029 BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP U01 Clinical Trial Allowed)".  Specifically, Advisory Council Review dates January 2019 and January 2020 and Earliest Start Dates February 2019 and February 2020. Part 1. Overview Information Key Dates Currently Reads: Advisory Council Review January 2019 Earliest Start Date February 2019 Modified Read: Advisory Council Review January 2019 and January 2020 Earliest Start Date February 2019 and February 2020 other aspects this FOA remain same. Inquiries Please direct inquiries to: James Gnadt, PhD  National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-9964  Email: BRAINCircuits@nih.gov

Second Round the NIH Applicant Assistance Program AAP) New Previously Unawarded Small Businesses Notice Number: NOT-CA-18-072 Key Dates Release Date: 14, 2018 Related Announcements NOT-CA-18-031 Issued National Cancer Institute NCI) National Heart, Lung, Blood Institute NHLBI) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to announce second round a pilot program assist eligible small businesses understanding completing Small Business Innovation Research SBIR) Small Business Technology Transfer STTR) application process. program, NIH Applicant Assistance Program AAP), intended help new and/or previously unsuccessful small businesses submit competitive SBIR STTR application one the participating institutes NCI, NINDS, NHLBI).   AAP designed to: Provide support small businesses preparing Phase SBIR STTR application Assist identifying appropriate market research an SBIR/STTR application Guide applicants through application process, including required registrations Help applicants the electronic system apply an SBIR/STTR award   NIH particularly interested assisting small businesses are owned operated individuals are underrepresented the biomedical sciences, including: Black African Americans Hispanics Latinos American Indians Alaska Natives Native Hawaiians other Pacific Islanders Individuals disabilities Women underrepresented biomedical industry ownership high-level leadership)   service provided through third-party federal contractor. Small businesses must apply be accepted the NIH AAP. After acceptance, program offered no charge the small business. Participation this program optional does guarantee successful SBIR STTR award. Small businesses interested the program apply here: https://www.dawnbreaker.com/aap/   second round the NIH AAP the final round the pilot program. deadline apply the NIH AAP Friday, June 1, 2018. Applicants applied the first round the pilot program were selected need apply the second round their application be considered. Inquiries Please direct inquiries to: Kory Hallett, PhD National Cancer Institute NCI) Telephone: 240-276-5882 Email: kory.hallett@nih.gov   Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone 301-496-1779 Email: fertigs@ninds.nih.gov   Eric Padmore, MHSA National Heart, Lung, Blood Institute NHLBI) Telephone: 301-496-2149 Email: NHLBI_SBIR@mail.nih.gov

Notice Support Administrative Supplements Embed Ethicists BRAIN Initiative Supported Research Notice Number: NOT-MH-18-034 Key Dates Release Date: 01, 2018 Related Announcements None Issued National Institute Mental Health NIMH) National Eye Institute NEI) National Institute Aging NIA) 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) Purpose Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative aimed revolutionizing neuroscience through development application innovative technologies map neural circuits, monitor modulate activity, understand they contribute thoughts, sensations, emotions behavior. NIH issued variety Funding Opportunity Announcements FOAs) will support projects apply technologies understand neural circuit function the context specific circuits, resulting a diverse portfolio research the fundamental biology nervous system function.  purpose this announcement to notify research community NIH encouraging applications to PA-18-591 to integrate neuroethics perspectives approaches existing BRAIN Initiative awards. Supplement applications encouraged ongoing BRAIN Initiative projects can readily incorporate core ethical issues associated research focused the human brain resulting emerging technologies advancements research development supported the BRAIN Initiative. intent that efforts supported through administrative supplement be both complimentary integrative the transformative, breakthrough neuroscience discoveries supported through BRAIN Initiative.   an administrative supplement, work proposed needs be within scope the research is already supported. Research proposed supplement applications should clear relevance the BRAIN Initiative. proposed work cover pilot projects, resource development, personnel costs embedding neuroethics the research project. each case, work proposed should feasible complete within one-year timeframe with limited funds permitted. should also show promise becoming more substantial project might attract additional funding. Investigators should submit applications responses the parent active administrative supplement announcement https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html) using electronic submission. Electronic applications strongly encouraged.. Individual requests be more 100,000 direct costs exclusive Facilities Administrative costs sub-contracts may for year only. Requests must received June 15 funding FY 2018. Inquiries Please direct inquiries to: James Churchill National Institute Mental Health NIMH) Telephone: 301-443-3621 Email: churchillj@mail.nih.gov 

NINDS Announces Modifications Special Council Review Policy Notice Number: NOT-NS-18-060 Key Dates Release Date: April 27, 2018 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice announces modifications the Special Council Review SCR) policy, pertains well-funded Program Director(s)/Principal Investigator(s) PD(s)/PI(s)] submitting applications NINDS.  new policy: 1) lowers funding threshold requires special review a pending application the National Advisory Neurological Disorders Stroke NANDS) Council and; 2) sets more stringent payline pending applications cause PD/PI exceed threshold. Background September 2012, NIH implemented SCR policy, whereby Advisory Councils instructed provide additional scrutiny new renewal applications investigators already receiving 1.0M more direct cost NIH Research Project Grant RPG) funding.  2012 NIH policy recognized institute-specific variations the general policy be developed consultation individual Councils.   NANDS Council discussed NIH policy its September 2017 February 2018 meetings, approved modified policy described here.  goals this policy are: 1) permit Institute fund larger, diverse pool researchers 2) ensure PIs sufficient bandwidth oversee rigorous research effective mentorship their laboratories.   Policy Effective applications under funding consideration the January 2019 meeting the NANDS Council, NINDS refine Special Council Review policy procedures support research well-funded investigators.  Under new policy, well-funded investigator defined an individual NIH research support exceeding 1M direct costs the time the Council meeting, including pending application.  the purposes this policy, only research support which investigator the PI Co-PI be considered.  competing applications well-funded investigators primary assignment NINDS exceptions noted below) be subject a percentile payline is ½ the NINDS payline the Council round question https://www.ninds.nih.gov/Funding/About-Funding/NINDS-Funding-Strategy; the payline an odd number, SCR payline be rounded down the next integer. questions applications are percentiled, applicants should contact individual noted below further information.  Exceptions this policy be rare, will determined after review NINDS staff, NANDS Council, NINDS leadership. contrast the existing SCR policy, competing applications P01s, Centers, other Multi-Component RPGs be included this policy.  Multi-PD/PI projects also subject the policy one more the PD/PIs NIH research support exceeding 1.0M inclusive the pending application.  Applications will excluded this policy include those intended support training, conferences, core facilities, research resources.  Applications submitted response SBIR/STTR solicitations to small number specially designated Funding Opportunity Announcements also excluded. identifying well-funded investigators, active NIH research support be considered except awards support training, conferences, core facilities, research resources, SBIR/STTR activities.  individual PD/PI’s financial allocation Multi-PD/PI multi-component projects be used determine individual’s level support. Grants are a no-cost extension single year competitive administrative supplements not included this determination. Factors may contribute a funding recommendation beyond SCR payline include conducting types research are inherently costly, PD/PI’s available bandwidth commit time effort commensurate the application’s complexity scope, the type, source end dates the PD/PI’s NIH support.  PDs/PIs be permitted temporarily exceed 1M threshold a period no than 90 days ensure continuity funding support. PDs/PIs also discontinue previously funded grants begin work the new project. Please visit NINDS website additional details a list Frequently Asked Questions. NINDS recognizes this policy change research plans some laboratories, the intent to advance mission the Institute supporting larger, diverse group investigators. Inquiries Please direct inquiries to: Anna Taylor, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-827-3565 Email: taylorann@mail.nih.gov