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NINDS Notice Clarify Types Clinical Trial Applications NINDS Support Under PA-18-141 Mechanisms, Models, Measurement, & Management Pain Research R01 Clinical Trial Optional)" Notice Number: NOT-NS-18-017 Key Dates Release Date: March 9, 2018 Related Announcements PA-18-141 Issued National Institute Neurological Disorders Stroke NINDS)   Purpose purpose this Notice to clarify types clinical trials NINDS support under Funding Opportunity Announcement PA-18-141, Mechanisms, Models, Measurement, Management Pain Research R01 Clinical Trial Optional)." applications submitted this FOA propose clinical trials, NINDS support applications propose human mechanistic trials/studies meet NIH's definition a clinical trial that fall within NINDS research priorities.    Resources Does human subjects research study meet definition a clinical trial?   Part 2. Full Text Announcement Section I. Funding Opportunity Description   Translational Research   Currently reads:   Specific NINDS: NINDS not accept clinical trials under FOA. Applicants submitting applications NINDS contain clinical trial must submit one the NINDS FOAs specifically designed clinical trials see:   http://www.ninds.nih.gov/research/clinical_research/index.htm ).   Modified read:   Specific NINDS: NINDS only support Clinical Trial applications under FOA propose human mechanistic trials/studies meet NIH's definition a clinical trial that fall within NINDS research priorities.    NIH defines clinical trial ldquo;A research study which or human subjects prospectively assigned one more interventions may include placebo other control) evaluate effects those interventions health-related biomedical behavioral outcomes.” NOT-OD-15-015)   NIH defines mechanistic clinical trial follows: mechanistic study designed understand biological behavioral process, pathophysiology a disease, the mechanism action an intervention.”   NINDS supports hypothesis-driven mechanistic clinical trial studies basic and/or translational discovery research healthy human subjects in pathobiology, pathophysiology, neuropathology neurological disorders. goal to address basic questions to interrogate concepts biology, behavior, pathophysiology will provide insight understanding neurological disorders.  Such studies seek understand biological behavioral process, the mechanism action an intervention. NINDS supports biomarker studies may provide information physiological function, target engagement novel therapeutics, and/or mechanisms therapeutic responses. submitted studies defined clinical trials noted above) do seek answer specific questions safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation pharmacologic, behavioral, biologic, surgical, device invasive non-invasive) interventions. preventive, therapeutic, services interventions.  Such designs should submitted an NINDS clinical trial-specific funding announcement listed the NINDS website at https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Clinic…). Applicants strongly advised consult NINDS program staff prior submitting application human subjects determine appropriate funding opportunity.   Examples types applications intended be supported NINDS under PA-18-141 include, are limited to:   Studies which manipulation physiological behavioral) used answer basic science questions normal brain function. Studies develop, validate, and/or apply novel measures brain signaling circuits healthy humans including, example, PET, SPECT, other neuroimaging approaches, well biomarkers physiological processes. Studies that an experimental manipulation e.g., CNS active drugs, direct neurostimulation cognitive task activating specific neural circuit) order understand normal functioning the pathophysiology a neurological disorder, do aim demonstrate clinical improvement. Studies involve prospective of efficacious interventions e.g., biomedical, behavioral, cognitive, therapeutic approaches), where intent to obtain biospecimens e.g., blood, patient-derived induced pluripotent stem cells) identify genetic risk associations, novel biomarkers, examine disease process, characterize mechanisms therapeutic response. Studies which intervention demonstrated efficacy that population being studied understand mechanisms response, non-response, risk adverse effects the efficacious intervention.   following types clinical trials not intended be supported NINDS under this FOA: Early-stage trials novel treatment approaches humans are prerequisite clinical efficacy trials pharmacological, device, behavioral intervention development. Studies develop conduct tests the clinical efficacy/effectiveness treatments. Studies have safety, clinical efficacy, clinical management, and/or implementation its principal aim. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Michael L. Oshinsky, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov

National Science Foundation - National Institutes Health NSF-NIH Interagency Initiative: Smart Connected Health Notice Number: NOT-OD-18-149 Key Dates Release Date: March 9, 2018 Related Announcements NOT-NS-18-052 NOT-AT-18-012 - April 13, 2018 Issued Office Behavioral Social Sciences Research OBSSR) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Library Medicine NLM) Purpose Institutes Centers the National Institutes Health NIH) the National Science Foundation NSF) identified Smart Connected Health a program focus.The purpose this interagency program solicitation the development technologies, analytics models supporting next generation health medical research through high-risk, high-reward advances computer information science, engineering technology, behavior, cognition, robotics imaging. Collaborations between academic, industry, other organizations strongly encouraged establish better linkages between fundamental science, medicine healthcare practice technology development, deployment use. solicitation aligned previous reports the President's Council Advisors Science Technology others calling new partnerships facilitate major changes health medicine, well healthcare delivery is aimed the fundamental research enable changes. Realizing promise disruptive transformation health, medicine healthcare require well-coordinated, multi-disciplinary approaches draw the computer information sciences, engineering, social, behavioral, economic sciences, medical health research biology. following be considered response NSF's solicitation NSF-18-541: Integrative Projects: Multi-disciplinary teams spanning 2 4 years may receive NIH support 300,000 total costs per year. Scientists engineers all disciplines encouraged participate. Application submission through National Science Foundation via solicitation NSF-18-541. Following jointly conducted initial peer review these applications, likely NIH awardees applications be forwarded NIH processing. general interests the participating NIH Institute organizations outlined below: National Cancer Institute NCI) NCI interested funding research centered the smart connected health technologies facilitate efficient effective collection, flow, use health information improve cancer outcomes. governing documents especially relevant guide research endeavors the area.First a report produced the Presidents Cancer Panel, legislatively mandated oversight committee, titled:Improving Cancer-Related Outcomes Connected Health: Report the President the United States the Presidents Cancer Panel. Second the NCIs Cancer Moonshot SM Blue Ribbon Panel Report priorities accomplishing five years might otherwise taken ten.From two reports, following priorities relevant the SCH initiative: Improve understanding how connected health technologies optimize team performance through better support distributed cognition between members the patients virtual care team inclusive the patient patients caregivers) co-producers positive health outcomes across continuum care prevention, early detection, treatment, survivorship, end-of-life. Identify strategies enhance individuals engagement their healthcare through smart connected support structures, including ability manage symptoms adverse events during treatment. Develop approaches using data connected devices including biosensors, home monitoring devices, smartphones, wearable technologies meaningful ways enhance clinical care to support faster cures. Create building blocks a national data ecosystem sharing analyzing cancer data that researchers, clinicians, patients be able contribute data benefit actionable data analytics. Develop intelligent data mining tools predicting patients responses treatment based a retrospective analysis patients clinical, specimen, genomic data. Utilize health information technologies enhance cancer surveillance the benefit local, regional, national efforts improve health outcomes equitably across populations. National Human Genome Research Institute NHGRI) NHGRI encourages research related genomic medicine. Such research include, not limited to: methods algorithms aggregation multi-scale clinical genomic data a patient electronic health records EHRs) personal health records PHRs) decision support tools facilitate optimized patient-centered, evidence-based decisions utilizing genomic data human-computer interfaces clinician, patient, family access genomic information EHRs PHRs. National Institute Aging NIA) NIA specifically interested applications improve quality life health individuals Alzheimer's Disease AD) Alzheimer's Disease Related Dementia ADRD) and/or family care providers, a special focus diverse underrepresented populations, including older adults living alone. Additionally, efforts address the SCH program might begin address prediction cognitive other decline everyday function may predict detect earliest indicators dementia be interest. National Institute Alcohol Abuse Alcoholism NIAAA) technology e.g. EMA, brain imaging, biosensors) innovative statistical methods e.g., machine learning, systems science dynamic models) appropriate analysis big data i.e., time intensive, multisource data) inform our understanding mechanisms underlying problematic alcohol use. Development improvement a portable, affordable, inconspicuous, user-friendly device/technique enhance medication adherence. Develop, improve, validate ecological momentary assessment EMA) methods capturing, integrating analyzing real-time multi-source data related alcohol including sensor integration modeling behavioral processes. Devise novel methods e.g., Web-mining software social networking sites) capture social network information among groups risk alcohol disorder high-risk drinking. National Institute Biomedical Imaging Bioengineering NIBIB) mission NIBIB to improve health leading development accelerating application biomedical technologies. NIBIB broad interests the development biomedical technologies improve human health address health disparities.Program areas particular relevance include: health information technologies, telehealth, mHealth, point-of-care technologies, rehabilitation engineering, robotics, next generation predictive models. Institute interested the development novel technologies in advances enable effective utilization new existing technologies. National Institute Neurological Disorders Stroke NINDS) Within goals this FOA, NINDS particularly interested research advances technologies systems the potential decrease burden neurological disorders stroke. Examples areas interest include development validation invasive non-invasive devices, diagnostic/monitoring tools, advanced imaging techniques, computational models, tissue engineering, other innovative methods. National Library Medicine NLM) NLM interested the development technologies, analytics models utilize novel informatics data science approaches help individuals gather, manage use data information their personal health. bring benefits big data research consumers patients, new biomedical informatics data science approaches needed, shaped meet needs consumers patients, whose health literacy, language skills, technical sophistication, education cultural traditions affect they find, understand use personal health information. Novel data science approaches needed help individuals every step, harvesting storing using data information a personal health library. approaches should support FAIR Findable, Accessible, Interoperable, Reusable) principles data management. National Institute Mental Health NIMH) NIMH interested supporting development novel technologies improve understanding treatment mental illness. NIMH encourages research consistent the NAMHC workgroup report Opportunities Challenges Developing Information Technologies Behavioral Social Science Clinical Research improve early detection mental illness improve access, continuity, quality, equity, value care. NIMH priorities include: Deep phenotyping through development technologies capture analyze fine-grained, multimodal data individuals mental disorders healthy controls, the purpose identifying novel biological behavioral patterns can 1) add our understanding specific mental health constructs domains function; 2) reveal causal links between environmental factors mental functions; 3) uncover developmental trajectories;(4) better predict outcomes; 5) improve specificity timeliness clinical interventions. Technologies interest NIMH include, are limited to: Sensors tailored infer subjective mental states e.g. mood, thought process, risk self-harm, abnormal perceptions) objectively observable behaviors e.g. speech, movement, social interactions). Sensors adapted monitor mental health related outcomes across lifespan, special populations, within diverse settings e.g. young children, geriatric populations, nonverbal individuals, assisted living environments). Platforms the delivery nonpharmacological interventions e.g. cognitive behavioral, psychosocial, stimulation-based) real-world settings. Technology allowing simultaneous, temporally synchronized neurophysiology measurements quantification behavior, high spatial temporal precision, using either invasive noninvasive methods, toward long-term goal closing loop between real-time behavioral measurements delivery targeted interventions real-world settings. Sensors measure outcomes mental health interventions, including demonstrations sensitivity change correspondence conventional clinical assessments. Technologies targeting improvements mental health care delivery systems, including: Methods harmonize analyze electronic health record EHR) data across multiple systems, especially low base-rate events/conditions are difficult identify, treat, and/or manage e.g., suicide). Application big data analytics and/or algorithm development EHRs inform real-time clinical decision making measurement-based care associated the delivery mental health services. Technology platforms include real-time of disease registries, measurement-based care, feedback systems, quality improvement processes part a continuously learning healthcare system. Research improve designs, measures, statistical approaches support testing system improvement efforts, including information communication technologies. Technology platforms can utilized across range systems e.g., primary care, schools, criminal justice system, child welfare agencies) optimize delivery effective mental health interventions. Development innovative technologies facilitate adoption, implementation, sustainability, scalability best practices, conversely, technologies de-implement low value mental health services. Inquiries Please direct inquiries to: Brad Hesse, PhD National Cancer Institute NCI) Telephone: 240-276-6721 Email: hesseb@mail.nih.gov Anastasia L. Wise, PhD National Human Genome Research Institute NHGRI) Telephone: 301-480-3517 Email: anastasia.wise@nih.gov Partha Bhattacharyya, PhD National Institute Aging NIA) Telephone: 301-496-3136 Email:bhattacharyyap@mail.nih.gov Anita Bechtholt, PhD National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-443-9334 Email: anita.bechtholt@nih.gov Tiffani Bailey Lash, Ph.D. National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4778 Email: baileylasht@mail.nih.gov Margaret Grabb, PhD National Institute Mental Health NIMH) Telephone: 301-443-3563 Email: mgrabb@mail.nih.gov Adam Haim, PhD National Institute Mental Health NIMH) Telephone: 301-435-3593 Email: haima@mail.nih.gov Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: nick.langhals@nih.gov Hua-Chuan Sim, MD National Library Medicine NLM) Telephone: 301-594-4882 Email: simh@mail.nih.gov

Notice NINDS Participation PA-18-688 Developmental Pharmacodynamics Models Drug Effects Pediatrics R01 Clinical Trial Optional) Notice Number: NOT-NS-18-049 Key Dates Release Date: March 6, 2018 Related Announcements PA-18-688 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participating PA-18-688 Developmental Pharmacodynamics Models Drug Effects Pediatrics R01 - Clinical Trial Optional)". following sections been updated reflect participation NINDS this FOA. Currently Reads: Part 1. Overview Information Components Participating Organizations Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Mental Health NIMH) Catalog Federal Domestic Assistance CFDA) Number(s) 93.865, 93.242 Part 2. Full Text Announcement Section I. Funding Opportunity Description Scope NIMH Area Interest: The NIMH specifically interested clinical studies supporting establishment pharmacodynamic PD) markers psychopharmacologic drugs pediatric populations.  instance, study using EEG measure would change proportion an administered drug dose CNS PD marker drug action) be interest.  is expected studies include dose ranging PK/PD measures.  Age-dependent effects be interest well the inclusion comparator drugs. Using EEG PD example, is likely the EEG measures reflecting drug action be different grade school children vs adults.  Modified Read: Part 1. Overview Information Components Participating Organizations Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.865, 93.242, 93.853 Part 2. Full Text Announcement Section I. Funding Opportunity Description Scope NIMH Area Interest:The NIMH specifically interested clinical studies supporting establishment pharmacodynamic PD) markers psychopharmacologic drugs pediatric populations.  instance, study using EEG measure would change proportion an administered drug dose CNS PD marker drug action) be interest.  is expected studies include dose ranging PK/PD measures.  Age-dependent effects be interest well the inclusion comparator drugs. Using EEG PD example, is likely the EEG measures reflecting drug action be different grade school children vs adults.  NINDS Area Interest: National Institute Neurological Disorders Stroke NINDS) encourages applications mission-relevant topics, particularly study pharmacodynamics treatments diseases affecting nervous system. Examples include are limited to) diseases conditions neonates e.g., seizures, hypoxic-ischemic injury, stroke, neuromuscular disorders) younger children e.g., headache, epilepsy, movement disorders, neuromuscular disorders, stroke, demyelinating disorders) where age-related PD not explored cannot extrapolated adult studies. Treatments rare diseases affecting CNS across pediatric age spectrum also interest. Only treatments have approved FDA use humans be considered. Pharmacodynamic studies experimental drugs seek support via PAR-15-071. Applications include clinical trials noted above); however, NINDS not accept applications seek answer specific questions safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation pharmacologic, behavioral, biologic, surgical, device invasive non-invasive) interventions, preventive, therapeutic, services interventions e.g., phase I, phase II, phase III clinical trials). Such designs should submitted a clinical trial-specific funding announcement PAR-18-420 or PAR-18-422). Applicants strongly advised consult NINDS Scientific/Research staff prior submitting application human subjects determine appropriate funding opportunity. following contacts been added: Section VII. Agency Contacts Scientific/Research Contact(s) Adam L. Hartman, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9135 E-mail: adam.hartman@nih.gov Financial/Grants Management Contact(s) Tijuanna Decoster, Ph.D.  National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-9231 E-mail: tijuanna.decoster@nih.gov other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Adam L. Hartman, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9135 E-mail: adam.hartman@nih.gov

Notice National Institute Neurological Disorders Stroke NINDS) IGNITE CREATE Bio Program Applications Directed Non-Addictive Pain Therapies Notice Number: NOT-NS-18-048 Key Dates Release Date: March 5, 2018 Related Announcements PAR-17-456 PAR-17-457 PAR-18-542 PAR-18-543 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) Innovation Grants Nurture Initial Translational Efforts  (IGNITE) Cooperative Research Enable Advance Translational Enterprises Biologics CREATE Bio) program Funding Opportunity Announcements an area special interest.  NINDS like accelerate development pain treatments little no potential misuse addiction. IGNITE program contains suite early-stage therapy development funding programs is meant serve a feeder program later-stage therapy development programs. three IGNITE programs in following areas:  Assay Development Neurotherapeutic Agent Identification, Neurotherapeutic Agent Characterization In vivo Efficacy Studies, Development Validation Model Systems and/or Pharmacodynamic Markers Facilitate Neurotherapeutic Discovery.  of IGNITE programs like encourage applications related non-addictive therapies the treatment pain. CREATE Bio program interested receiving applications biotechnology products biologics-based therapies, broadly include modalities such peptides, proteins, oligonucleotides, gene therapies, cell therapies, novel emerging therapies directed optimizing developing non-addictive therapies the treatment pain.  CREATE Bio program includes following tracks:  Optimization Track supports optimization agents obtain clinical candidate appropriate entry to the Development Track. Development Track supports IND-enabling studies a clinical candidate projects expected achieve filing an Investigational New Drug IND) application the U.S. Food Drug Administration FDA), the end the funding period.  more advanced projects, optional small delayed-onset first human Phase clinical trial also proposed follow filing the IND package. Additionally, IGNITE CREATE Bio programs hold informational webinar potential applicants. webinar recommended investigators meet entry criteria the programs interest. webinar optional not required submission applications.   WEBINAR INFORMATION Informational Webinar the IGNITE CREATE Bio Programs a focus Non-Addictive Pain Therapies April 16, 2018 1:30 p.m.- 2:30 Eastern Time Please visit following link register the webinar: Link webinar registration button available the bottom the page. Inquiries Please direct inquiries to: Chris Boshoff, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: chris.boshoff@nih.gov Rebecca Roof, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:  Rebecca.Roof@nih.gov   Michael Oshinsky, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov  

Notice Change Application Due Date RFA-NS-18-024 Lewy Body Dementia Center Without Walls CWOW) U54 Clinical Trial Allowed)" Notice Number: NOT-NS-18-047 Key Dates Release Date: February 28, 2018 Related Announcements RFA-NS-18-024 Issued National Institute Neurological Disorders Stroke NINDS) National Institute Aging NIA) Purpose purpose this notice to inform interested applicants the Key Dates RFA-NS-18-024 Lewy Body Dementia Center Without Walls CWOW) U54 Clinical Trial Allowed)" been changed.  new application due date is April 30, 2018.  new expiration date is May 1, 2018. Key Dates Currently Reads:    Open Date March 17, 2018 Application Due Date(s) April 17, 2018, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due this date. Late applications not permitted response this FOA. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date April 18, 2018   Modified Read:   Open Date March 30, 2018 Application Due Date(s) April 30, 2018, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due this date. Late applications not permitted response this FOA. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date 1, 2018 other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Debra Babcock, PhD, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: dbabcock@mail.nih.gov

Notice Intent Reissue Funding Opportunity Announcement PA-15-354, SBIR Technology Transfer R43/R44)" Notice Number: NOT-NS-18-046 Key Dates Release Date: February 23, 2018 Estimated Publication Date Funding Opportunity Announcement: 03/01/2018 First Estimated Application Due Date: 09/01/2018 Earliest Estimated Award Date: 04/01/2019 Earliest Estimated Start Date: 04/01/2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform applicants NINDS plans reissue PA-15-354, SBIR Technology Transfer R43/R44)for compliance FORMS-E. FOA not allow clinical trials.   Notice being provided allow potential applicants sufficient time develop meaningful collaborations appropriate projects.    FOA expected be published March 2018 the September 5th, 2018 due date. Research Initiative Details Funding Opportunity Announcement FOA) encourages Small Business Innovation Research SBIR) grant applications small business concerns SBCs) projects transfer technology of NIH intramural research labs the private sector. selected SBIR funding, SBC be granted royalty-free, non-exclusive patent license agreement internal research for term and within field use the SBIR award technologies held NIH the intent the SBC develop invention a commercial product benefit public. Funding Information Estimated Total Funding TBD Expected Number Awards TBD Estimated Award Ceiling TBD Primary CFDA Numbers TBD Anticipated Eligible Organizations Small Business Applications not being solicited this time. Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) 301-496-1779 fertigs@ninds.nih.gov

Notice National Institute Neurological Disorders Stroke NINDS) Interest Biomarkers Directed Pain Pain Therapies Notice Number: NOT-NS-18-043 Key Dates Release Date: February15, 2018 Related Announcements PAR-18-548 PAR-18-549 PAR-18-550 PAR-18-664 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) Neuroscience Biomarker Program Funding Opportunity Announcements PAR-18-548, PAR-18-549, PAR-18-550 an area special interest. NINDS like encourage applications directed the analytical and/or clinical validation biomarkers associated pain pain therapies. Candidate biomarkers particular interest those can used stratify patients clinical trials, predict response a therapeutic, indicate target engagement.   Moreover, applications directed developing biomarkers associated pain pain therapies permitted include aims related biomarker discovery identification addition aims related analytical and/or clinical validation.   NINDS hold informational webinar the Neuroscience Biomarker Program potential applicants. webinar recommended investigators have identified candidate biomarkers are interested learning the NINDS funding opportunities supporting rigorous validation biomarkers a manner is consistent FDA guidelines.   webinar optional not required submission applications. Webinar Information Informational Webinar the Neuroscience Biomarker Program February 14, 2018 2:30 p.m.- 3:30 p.m. Eastern Time Please visit following link register the webinar: Link webinar registration button available the bottom the page. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: mary.pelleymounter@nih.gov   Victoria Smith, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email: victoria.smith@ninds.nih.gov   Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov   Michael Oshinsky, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov

Notice Correction Application Instructions RFA-HL-19-007: Limited Competition: Data Analysis Coordination Center the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed) Notice Number: NOT-HL-18-591 Key Dates Release Date: February 13, 2018 Related Announcements RFA-HL-19-007 Issued National Heart, Lung, Blood Institute NHLBI) National Cancer Institute NCI) 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 Drug Abuse NIDA) National Institute Dental Craniofacial Research NIDCR) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) Purpose December 22, 2017, NHLBI Participating ICs issued RFA-HL-19-007 Limited Competition: Data Analysis Coordination Center the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed)." The purpose this Notice to alert scientific community an additional attachment required the application.  Part 2. Section IV. Application Submission Information Current Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. Revised Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. 5. Technical Details Specifications Assessments Procedures Technical details specifications assessments procedures, grouped listed component, must provided an attachment using filename Technical Specifications.pdf". other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Sean Altekruse National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-1290 Email: altekrusesf@mail.nih.gov

Notice Correction Application Instructions RFA-HL-19-008: Limited Competition: Clinical Research Sites the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed) Notice Number: NOT-HL-18-592 Key Dates Release Date: February 13, 2018  (Rescinded March 21, 2018) Related Announcements RFA-HL-19-008 Issued National Heart, Lung, Blood Institute NHLBI) National Cancer Institute NCI) 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 Drug Abuse NIDA) National Institute Dental Craniofacial Research NIDCR) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) Purpose December 22, 2017, NHLBI Participating ICs issued RFA-HL-19-008 Limited Competition: Clinical Research Sites the MACS/WIHS Combined Cohort Study MACS/WIHS-CCS) U01 Clinical Trial Allowed)". purpose this Notice to alert scientific community an additional attachment required the application. Part 2. Section IV. Application Submission Information Current Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. Revised Language: SF424 R&R) Project Information Attachments: attachments listed below must completed the application not peer reviewed. names be reflected the final image bookmarking easy access reviewers. 1. Collaboration Plan Collaboration Plan must provided an attachment using filename Collaboration.pdf" may exceed 6 pages. Collaboration Plan must clearly define interactions between integration the MACS/WIHS-CCS, information resources be exchanged, plans communication, processes making decisions scientific direction, procedures resolving conflicts. Describe plans enable scientific collaboration across CRS sites with external investigators. Without repeating information individual biosketches, describe plans achieve synergy interaction among key investigators ensure efficient cooperation, communication coordination across CRSs. Describe communication plans study leadership committees science work groups. 2. Data Management Plan Data Management Plan must provided an attachment using filename Data Management.pdf" may exceed 5 pages. Data Management Plan must describe internal external data sharing strategies appropriate consistent achieving goals the MACS/WIHS-CCS science interests. Where applicable, applicants expected describe plans data harmonization, metadata generation, adoption/use data standards common data elements, consortium-wide information technology infrastructure deployment. 3. Statistical Analysis Plan Statistical Analysis Plan must provided an attachment using filename Statistical Analysis Plan.pdf" may exceed 6 pages. Statistical Analysis Plan should describe statistical design, power overall study studies restricted subsets participants, list outcome measures be included the unified science agenda, describe innovative approaches statistical analysis prospective observational cohort data. 4. Biospecimen Plan Biospecimen Plan must provided an attachment using filename Biospecimen Plan.pdf" may exceed 5 pages. Biospecimen Plan must clearly describe facilitation biorepository access MACS/WIHS-CCS other investigators. Biospecimen Plan should also describe study biospecimens be collected, managed, analyzed, stored. Applicants must include plans maintenance organization existing future biospecimens. Describe plans adherence Good Laboratory Practices GLP). Opportunities leverage institutional resources should detailed, applicable. 5. Technical Details Specifications Assessments Procedures Technical details specifications assessments procedures, grouped listed component, must provided an attachment using filename Technical Specifications.pdf". other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Sean Altekruse National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-1290 Email: altekrusesf@mail.nih.gov

Notice Change Key Dates PAR-17-001 Emerging Global Leader Award K43)" Notice Number: NOT-TW-18-003 Key Dates Release Date: February 08, 2018 Related Announcements PAR-17-001 Issued Fogarty International Center FIC) National Cancer Institute NCI) National Human Genome Research Institute NHGRI) National Institute Dental Craniofacial Research NIDCR) National Institute Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Office Research Women’s Health ORWH) Purpose purpose this Notice to alert scientific community a change the Key Dates for PAR-17-001 "Emerging Global Leader Award K43)".    Part 1. Overview Information Key Dates Currently reads: Letter Intent Due Date: 30 days before application due date Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 AIDS Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 Scientific Merit Review: March 2017, March 2018, March 2019 Advisory Council Review: 2017, May 2018, 2019 Earliest Start Date: July 2017, July 2018, July 2019 Expiration Date: November 8, 2018 Modified read: Letter Intent Due Date: 30 days before application due date Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 AIDS Application Due Date(s): December 14, 2016; December 14, 2017; November 7, 2018 Scientific Merit Review: March 2017; May 2018; March 2019 Advisory Council Review: 2017; August 2018; May 2019 Earliest Start Date: July 2017; September 2018; July 2019 Expiration Date: November 8, 2018 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Christine Jessup Ph.D Fogarty International Center Telephone:301-496-1653 Email: Christine.Jessup@nih.gov