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Notice Change IC NIH Office Interest Areas Specific Requirements RFA-NS-19-009 Promoting Research Music Health: Fundamentals Applications R21 Clinical Trial Optional)" Notice Number: NOT-NS-19-035 Key Dates Release Date : February 05, 2019 Related Announcements RFA-NS-19-009 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) Purpose purpose this notice to inform interested applicants a change IC NIH Office Interest Areas Specific Requirements RFA-NS-19-009 Promoting Research Music Health: Fundamentals Applications R21 Clinical Trial Optional)".  IC NIH Office Interest Areas Specific Requirements been modified include information was erroneously omitted.  IC-specific Areas Interest Specific Requirements been added the National Eye Institute NEI), National Institute Alcohol Abuse NIAAA) the National Institute Aging NIA). Currently Reads: Part 2. Full Text Announcement Section I. Funding Opportunity Description IC NIH Office Interest Areas Specific Requirements Understanding basic science music exploring potential enhance health treat disease relevant the mission the NIH Institutes participating this FOA. Below a list areas are particular interest participating ICs: NCCIH: The National Center Complementary Integrative Health NCCIH) broadly interested supporting research aimed understanding mechanisms which music music interventions impact symptom management high-priority topics such pain, stress-related disorders, sleep disorders.  NICCH also interested how music music intervention be used address opioid misuse enhancement emotional well-being. addition basic animal model work, NCCIH supports mechanistic clinical trials under FOA.  However, NCCIH not support grant applications proposing efficacy effectiveness research primary clinical outcomes under FOA.  Investigators are ready propose fully powered efficacy effectiveness clinical trials apply PAR-18-662 a companion application PAR-18-663 an independent data coordinating center. Investigators strongly encouraged contact program staff discuss aims prior submission. Modified Read: Part 2. Full Text Announcement Section I. Funding Opportunity Description IC NIH Office Interest Areas Specific Requirements Understanding basic science music exploring potential enhance health treat disease relevant the mission the NIH Institutes participating this FOA. Below a list areas are particular interest participating ICs: NEI: The National Eye Institute NEI) supports research addresses blinding eye diseases, visual disorders, mechanisms visual function, preservation sight, the special health problems requirements the blind. Under FOA, NEI accept applications propose examine music affects fundamental mechanisms visual function loss vision, may inform development music-based interventions the visually impaired.  Topics interest include, are restricted to, role music neural reorganization plasticity the visually impaired; impact music sensory substitution, navigation/mobility, functional strategies the visually impaired; music integration low vision rehabilitation.   NIAAA: The National Institute Alcohol Abuse Alcoholism NIAAA) interested supporting research within mission NIAAA. Example research areas interest NIAAA include 1) does music modulate negative emotion states associated alcohol dependence withdrawal? are biological neurological underpinnings the modulation? 2) does alcohol exposure across life span, during early development, adolescent stage, adult, aging, impact music processing? 3) music facilitate cognitive recovery following heavy chronic alcohol use, what the underlying neurocircuit mechanisms? 4) does music impact recovery alcohol disorders? types music might promote sustained abstinence? NIA: The National Institute Aging NIA) interested research increase our basic understanding how music affects brain, body behavior aging. specific interest research investigate neural pathways circuits involved music processing how may altered aging, mechanisms which experience music affect brain structure function aging the potential music induce neural behavioral plasticity aging the underlying mechanisms. NIA also interested behavioral intervention development,  accordance the  NIH Stage Model please see https://www.nia.nih.gov/research/dbsr/stage-model-behavioral-interventi…) capitalizes and integrates basic research music inform development efficacious interventions individuals they age.   purpose the interventions be developed be, example, promote health well-being, promote behaviors associated health well-being e.g., exercise), cope stress e.g., dementia caregivers), improve emotional/behavioral status care providers individuals dementia, help individuals deal age-related disorders e.g., Parkinson’s), help older individuals declining memory improve memory.  Applications NIA proposing behavioral intervention development research encouraged use NIH Science Behavior Change experimental medicine methodology more information the SOBC program, please see: https://commonfund.nih.gov/behaviorchange).   NCCIH: The National Center Complementary Integrative Health NCCIH) broadly interested supporting research aimed understanding mechanisms which music music interventions impact symptom management high-priority topics such pain, stress-related disorders, sleep disorders.  NICCH also interested how music music intervention be used address opioid misuse enhancement emotional well-being. addition basic animal model work, NCCIH supports mechanistic clinical trials under FOA.  However, NCCIH not support grant applications proposing efficacy effectiveness research primary clinical outcomes under FOA.  Investigators are ready propose fully powered efficacy effectiveness clinical trials apply PAR-18-662 a companion application PAR-18-663 an independent data coordinating center. Investigators strongly encouraged contact program staff discuss aims prior submission. other aspects this FOA remain same. Inquiries Please direct inquiries to: Robert Riddle, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:301-496-5745 Email: riddler@ninds.nih.gov

Notice Data Sharing Policy the BRAIN Initiative Notice Number: NOT-MH-19-010 Key Dates Release Date:January 22, 2019 Related Announcements RFA-EY-18-001 RFA-MH-18-510 RFA-MH-19-135 RFA-MH-19-136 RFA-MH-19-147 RFA-MH-19-400 RFA-NS-18-018 RFA-NS-18-019 RFA-NS-18-020 RFA-NS-18-021 RFA-NS-18-022 RFA-NS-18-023 RFA-NS-18-030 RFA-NS-19-001 RFA-NS-19-002 RFA-NS-19-003 Issued National Institute Mental Health NIMH) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy ShriverNational 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 purpose this notice to inform prospective applicants current awardees a new policy concerning data collected support awards are funded the BRAIN Initiative. Specifically, Notice clarifies expectation applicants BRAIN Initiative funding opportunity announcements: 1) submit data one the BRAIN data archives sharing; 2) include specific required elements the Resource Sharing Plan further detailed below; 3) include costs attributed data preparation submission a data archive grant applications. BRAIN Initiative Overview Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative aimed revolutionizing our understanding the human brain. accelerating development application innovative technologies, researchers be able produce new dynamic picture the brain that, the first time, show individual cells complex neural circuits interact both time space. is expected the application these new tools technologies ultimately lead new ways treat prevent brain disorders. NIH one several federal agencies involved the BRAIN Initiative. Planning the NIH component the BRAIN initiative guided the long-term scientific plan, BRAIN 2025: Scientific Vision," details seven high-priority research areas calls a sustained federal commitment 4.5 billion over 12 years. Notice related FOAs issued part the BRAIN initiative based careful consideration the NIH the recommendations the BRAIN 2025 Report, input the NIH BRAIN Multi-Council Working Group. Videocasts the NIH BRAIN Multi-council Working Group available athttp://www.braininitiative.nih.gov/about/mcwg.htm. enable rapid progress development new technologies well in theory data analysis, BRAIN Initiative encourages collaborations between neurobiologists scientists statistics, physics, mathematics, engineering, computer information sciences. BRAIN Initiative Data Sharing BRAIN 2025 report calls establishing platforms sharing data related the BRAIN Initiative. response, NIH released RFAs related data archives RFA-MH-19-145andRFA-MH-17-255), data standards RFA-MH-19-146andRFA-MH-17-256), software integrate analyze data RFA-MH-19-147andRFA-MH-17-257). of those efforts focused data a sub-domain are usually defined the data collection methodology. Data archives have established include: 1) Neuroscience Multi-omic Data Archive https://nemoarchive.org/about/, R24MH114788) hold data omics experiments. 2) Brain Image Library http://www.brainimagelibrary.org/index.html, R24MH114793) hold microscopy data. 3) Data Archive the BRAIN Initiative https://dabi.loni.usc.edu, R24MH114796) hold data related human electrophysiology experiments. 4) OpenNeuro https://openneuro.org/, R24MH117179) hold magnetic resonance imaging data. 5) Block Object Storage Service https://bossdb.org/, R24MH114785) hold electron microscopy data. few additional data archives distinct sub-domains expected be funded. complete list BRAIN Initiative infrastructure awards be foundhere. awardees the RFAs listed above creating informatics infrastructure necessary BRAIN Initiative awardees others share data are collecting the research community. BRAIN Initiative applications both new resubmissions) submitted after March 1, 2020, applicants required share data collect using BRAIN Initiative informatics infrastructure both data archives relevant data standards),consistent authorities under 21st Century Cures Act these awards authorized under Act. . BRAIN Initiative fellowship applications using any the F activity codes) not required share data are collecting, they encouraged use informatics infrastructure part their training activities. general expectation that data BRAIN Initiative awards be submitted the archives every 6 months. Submitting data an archive distinct sharing data the research community. Submitted data generally held a private enclave until data shared the research community. Frequent submission allows those measuring data perform quality control checks the data deposited. Submitting data an ongoing basis often easier trying package data the end an award period. After data been submitted the appropriate data archive, will shared the research community papers using data been published at end the award period, whichever occurs sooner. calendar submitting data the relevant archive sharing data the research community depend the exact details the experiments are being conducted. applications BRAIN Initiative FOAs required include Resource Sharing Plan part the application. Consistent authorities under 21st Century Cures Act these awards authorized under Act, t portion that plan dealing data must include: 1) summary the data will shared 2) description the standard(s) will used describe data set 3) data archive(s) will house data 4) proposed timeline submitting data the archive sharing data the research community. applications involve human subjects, Resource Sharing Plan should a description whether how consents will used obtain data affect research can done that data. Consents would allow data be used General Research are appropriate all experiments, applicants should consents allow broad data sharing whenever possible. resource sharing plan required matter level funding requested. Costs associated preparing submitting data a data archive should included grant applications. BRAIN Initiative awardees have received awards prior the effective date this Notice encouraged share data. awards prior the effective date this Notice, administrative supplements be necessary prepare such data sets submission an appropriate repository. Investigators should discuss such supplements their assigned program officer. existing BRAIN Initiative awardees already data sharing expectations part their awards. Notice does alter existing data sharing expectations milestones. Inquiries Please direct inquiries to: technical assistance data submission, please contact relevant data archive. other inquiries please contact: Ming Zhan, Ph.D. National Institute Mental Health NIMH) Telephone: 301-827-3678 E-mail:ming.zhan@nih.gov

Notice Pre-Application Information Webinar RFA-DA-19-029, RFA-DA-19-036, HEALthy Brain Child Development HEALthy BCD) Study Notice Number: NOT-DA-19-020 Key Dates Release Date: January 16, 2019 Related Announcements RFA-DA-19-029 RFA-DA-19-036 Issued National Institutes Health NIH) National Institute Drug Abuse NIDA) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Mental Health NIMH) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Institute Minority Health Health Disparities NIMHD) Office Behavioral Social Sciences Research OBSSR) Office Research Women’s Health ORWH) Environmental Influences Child Health Outcomes Program ECHO) Purpose December 21, 2018, NIH issued following Funding Opportunity Announcements FOAs) RFA-DA-19-029 HEAL Initiative: HEALthy Brain Child Development Study HEALthy BCD) Collaborative R34 Clinical Trial Allowed) RFA-DA-19-036 HEAL Initiative: HEALthy Brain Child Development Study HEALthy BCD) R34 Clinical Trial Allowed) assist potential applicants the above referenced FOAs, Notice provides following information: pre-application information webinar potential HEALthy BCD applicants be provided February 6, 2019. HEALthy BCD Webinar Information Date: February 6, 2019 Time: 1:00-2:00 pm ET intent the pre-application webinar to provide overview the HEALthy BCD FOAs to address questions potential applicants. webinar optional not required application submission. webinar conclude before scheduled time depending the number questions. Additional information, including link register the webinar be posted at: https://www.drugabuse.gov/news-events/meetings-events/2019/02/pre-appli…. Following webinar, NIDA post slides presented during Webinar the same website.  Prospective applicants inquiries concerning FOA are unable participate the Webinar encouraged view summary questions answers after Webinar. FAQs FAQs be posted the same website a summary questions answers the webinar may updated additional questions answers without further notice.   Inquiries Please direct inquiries to: Gayathri J. Dowling, Ph.D. National Institute Drug Abuse NIDA) Email: babybrain@mail.nih.gov

Notice Intent Publish Funding Opportunity Announcement Biological Measures Prognosing Monitoring Persistent Concussive Symptoms Early Middle Adolescents: Center Without Walls CWOW) U54 Clinical Trial Optional) Notice Number: NOT-NS-19-027 Key Dates Release Date:January 07, 2019 Estimated Publication Date Funding Opportunity Announcement: February 10, 2019 First Estimated Application Due Date: April 12, 2019 Earliest Estimated Award Date: October 01, 2019 Earliest Estimated Start Date: October 01, 2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications research discovering validating biological measures be used assessing, prognosing, monitoring recovery adolescents either clinically present or at risk developing prolonged/persistent concussive symptoms following exposure repetitive head impacts and/or concussion. biological measures should be incorporated risk stratification algorithms inform clinical care patient stratification future clinical trials. A key component this FOA be broad sharing clinical, neuroimaging, physiological, biospecimen data to further advance research the area persistent concussive symptoms early middle adolescent EMA; ages 11-17 years old) populations. Notice being provided allow potential applicants sufficient time develop meaningful collaborations appropriate projects. FOA expected be published Winter 2019 an expected application due date Spring 2019. FOA utilize NIH Specialized Center Cooperative Agreement U54) activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights this area Traumatic Brain Injury TBI) begin consider applying this new FOA. addition, collaborative investigations combining expertise pediatrics, rehabilitation, biomarker development, proteomics, neuroimaging, risk assessment, clinical outcomes research be encouraged, these investigators should also begin considering applying this application. FOA utilize U54 Cooperative Agreement Center Without Walls CWOW) mechanism will included multi-site, multidisciplinary, research teams work synergistically discover, characterize, validate combination biological measures prognosis and/or monitoring recovery persistent concussive symptoms enrollment multiple points care e.g., Emergency Departments, urgent care clinics, primary care, concussion/sports medicine clinics, other specialty clinics) participants a variety injury mechanisms e.g., falls, sports, abusive head trauma, automobile accidents). Biological measures are responsive include, are limited neuroimaging, electroencephalography, oculomotor control, vestibular function, measures auditory processing speech production, autonomic responses, metabolomics, proteomics, other biofluid-based assays. Applications' analysis plans also expected include potential mediating factors such medication the type amount post-injury treatment rehabilitation provided participants. U54 should include following:(1) Administrative Core management reporting, establishing milestones, organizing communications among sites, resolving disputes; 2) Data Coordinating Core will responsible data curation, quality, submission the Federal Interagency Traumatic Brain Injury Research FITBIR) informatics platform be able coordinate the NINDS biomarker repository BioSEND; 3) least three research projects will used address list research areas interest. Scientific projects be expected include both 1) discovery / internal validation, 2) external validation stage their project. the discovery stage, research project should focus discovery biological measures persistent concussive symptoms. Where feasible, project's biological measures should collected across research projects sites. During internal validation stage, projects be expected determine selectivity sensitivity a unique individual set biological measures assessing, prognosing, / monitoring persistent concussive symptoms an EMA population. external validation, of research projects should collect full set biological measures be validated determine selectivity sensitivity these measures across multiple sites in multiple clinical contexts. Following validation, risk stratification algorithm prognosing monitoring recovery persistent concussive symptoms an EMA population should developed. is expected the FOA require incorporation the NINDS Core TBI pediatric common data elements CDEs) appropriate Core CDEs the NINDS Sports Concussion CDE set. Additionally, FOA expected require use the NINDS CDEs both outcome non-outcome measures including, not limited demographics, medical injury history, history abusive injury, family history, medications, neuroimaging, rehabilitation strategy, standardized outcome assessments) described theNINDS CDE Project. FOA require data sharing schedule is consistent NINDS's TBI data submission policy NOT-NS-17-029. Further, ensure maximal value the project, data sharing plan require sharing a limited" clinical data set e.g., clinical assessment amp; outcome measures, symptom lists, mechanism injury, demographics, etc.) be available FITBIR a limited access public” state more 1-year after collection. FOA also expect all biological specimens be banked the NINDS BioSEND Biomarkers Repository. Note costs collection NOT included a component the NINDS BioSEND Biomarkers Repository award. Therefore, most costs the biospecimen banking borne the grantees utilizing resource seeNOT-NS-15-046) should budgeted in application. Funding Information Estimated Total Funding 2,000,000 direct costs Expected Number Awards NINDS intends fund to 1 award. 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) Indian/Native American Tribal Government Federally Recognized) Applications not being solicited this time.  nbsp; Inquiries Please direct inquiries to: Patrick S. Frost Bellgowan, Ph.D. National Institute Neurological Disorders Stroke NINDS) 301-496-1447 psfb@mail.nih.gov

Notice Change Key Dates RFA-NS-19-021 HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning Implementation Cooperative Agreement UG3/UH3 Clinical Trial Required)" Notice Number: NOT-NS-19-028 Key Dates Release Date: January 2, 2019 Related Announcements RFA-NS-19-021 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants a change the Key Dates in RFA-NS-19-021 "HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning Implementation Cooperative Agreement UG3/UH3 Clinical Trial Required)". Specifically, first receipt date change February 1, 2019 to February 11, 2019. Currently Reads: Part 1. Overview Key Dates Open Date Earliest Submission Date) February 1, 2019 Application Due Date(s) February 1, 2019, 5:00 PM local time applicant organization. All types non-AIDS applicationsallowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) February 1, 2019, 5:00 PM local time applicant organization All types AIDS AIDS-related applicationsallowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date February 2, 2019 Modified Read: Part 1. Overview Key Dates Open Date Earliest Submission Date) January 11, 2019 Application Due Date(s) February 11, 2019, 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) February 11, 2019, 5:00 PM local time applicant organization All types AIDS AIDS-related applicationsallowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date February 12, 2019 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Linda L. Porter, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-435-7572 Email:porterl@ninds.nih.gov

Notice Interest Advancing Research Acute Flaccid Myelitis Guillain-Barre Syndrome Notice Number: NOT-NS-19-029 Key Dates Release Date: December 20, 2018 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Institute Allergy Infectious Diseases NIAID) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Purpose recent increase cases a polio-like illness children called Acute Flaccid Myelitis AFM) drawn attention gaps understanding its causes treatment. Both AFM Guillain-Barre Syndrome GBS) rare neurological conditions characterized acute onset muscle weakness paralysis believed be triggered an infectious agent. Affected individuals lose ability walk disrupted breathing be life threatening. currently available treatments, recovery often incomplete resulting long-term neurological deficits. purpose this Notice to announce the National Institute Neurological Disorders Stroke NINDS), National Institute Allergy Infectious Diseases NIAID), the Eunice Kennedy ShriverNational Institutes Child Health Human Development NICHD) encourage new applications request supplements existing grants competitive revisions administrative supplements) support basic, translational, and/or clinical research the causes, diagnosis, prevention treatment AFM, GBS other acute neurological conditions muscle weakness/paralysis triggered infectious agents related immune responses. Applications should submitted through ldquo;parent” funding opportunity announcements FOAs), through existing FOAs supported NINDS, NIAID, NICHD. Areas programmatic interest include, are limited to: Identifying etiology these neurological conditions, including infectious agents, immunological factors, other genetic environmental susceptibility factors Understanding pathogenesis these neurological conditions the central peripheral nervous systems musculoskeletal system. might include natural history studies cases study acute disease long-term sequelae Characterizing immunologic landscape e.g., immune profiling, genome sequencing) among AFM- GBS-affected individuals determining relationship related immune responses disease Developing model systems e.g. animal, cell organ culture) study pathogenesis serve screening platforms more reliable diagnosis, prevention therapy development Diagnosing conditions, including infectious agent detection, serology, genetics, imaging- electrophysiology-based techniques Developing biomarkers diagnostic, prognostic, predictive pharmacodynamic/response) use preclinical therapy development clinical studies these conditions Developing treatments, including potential novel therapies drug/biologic repurposing Testing strategies the rehabilitation patients affected these conditions, including conventional novel modalities, intense physiotherapies, and/or assistive technologies. variety Parent institute-specific FOAs available applicants, including Research R), Cooperative Agreement U), Career Development K), Fellowship F) awards which NINDS, NIAID, NICHD participate NINDS funding opportunities https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities; NICHD funding opportunities ((https://www.nichd.nih.gov/grants-contracts/FOAs-notices/active-FOAs/par… active FOAs https://www.nichd.nih.gov/grants-contracts/FOAs-notices/active-FOAs). Interested applicants encouraged contact program staff listed below guidance selecting appropriate FOA. Inquiries Please direct inquiries to: Adam L. Hartman, M.D. National Institute Neurological Disorders amp; Stroke Neuroscience Center Telephone: 301-496-9135 Email: adam.hartman@nih.gov Bill G. Kapogiannis, M.D. Eunice Kennedy Shriver National Institutes Child Health Human Development Telephone: 301-402-0698 Email: kapogiannisb@mail.nih.gov Walla Dempsey, Ph.D. National Institute Allergy Infectious Diseases Telephone: 240-292-4197 E-mail: wdempsey@niaid.nih.gov

Notice update Application Types Allowed PAR-18-763 Innovation Grants Nurture Initial Translational Efforts IGNITE): Development Validation Model Systems and/or Pharmacodynamic Markers Facilitate Neurotherapeutic Discovery R61/R33) Notice Number: NOT-NS-19-017 Key Dates Release Date: December 19, 2018 Related Announcements PAR-18-763 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to update Application Types Allowed PAR-18-763 Innovation Grants Nurture Initial Translational Efforts IGNITE): Development Validation Model Systems and/or Pharmacodynamic Markers Facilitate Neurotherapeutic Discovery R61/R33 Clinical Trial Allowed) ".  Specifically, NINDS accept resubmission applications response this Funding Opportunity Announcement FOA) from PAR-18-763 and RFA-NS-16-013. Section II. Award Information Application Types Allowed Currently Reads: New Resubmission Revision The OER Glossary and SF424 R&R) Application Guide provide details these application types. Modified Read: New Resubmission (PAR-18-763 RFA-NS-16-013) Revision The OER Glossary and SF424 R&R) Application Guide provide details these application types. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Rebecca Roof, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email:  Rebecca.Roof@nih.gov

Notice NINDS Participation NOT-AG-18-050 Notice Specify High-Priority Research Topic PAR-19-070" Notice Number: NOT-NS-19-025 Key Dates Release Date: December 13, 2018 Related Announcements NOT-AG-18-050 PAR-19-070 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participate effective immediately, NOT-AG-18-050 Notice Specify High-Priority Research Topic PAR-19-070". following sections been updated reflect participation NINDS this Notice. Currently Reads: Issued National Institute Aging NIA) Modified Read: Issued National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) following contacts been added: Inquiries: Roderick Corriveau, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: roderick.corriveau@nih.gov other aspects this notice remain unchanged. Inquiries Please direct inquiries to: Roderick Corriveau, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: roderick.corriveau@nih.gov

Reinstatement NIH SBIR Direct-to-Phase II Authority Associated Updates PA-18-705 Notice Number: NOT-NS-19-023 Key Dates Release Date: December 12, 2018 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) Purpose Section 5106 the SBIR/STTR Reauthorization Act 2011 authorized NIH lsquo;issue Phase II award a small business concern did receive Phase award that research/research amp; development'. phase flexbility' called lsquo;Direct-to-Phase II’ SBIR award. original authority this provision expired 9/30/2017. Recent legislation P.L. 115-232 re-instated SBIR Direct Phase II provision through Fiscal Year 2022. SBIR Direct-to-Phase II authority not available the STTR program not available the CDC, FDA, ACL SBIR progams. such, NIH re-implementing SBIR Direct-to-Phase II program. prior program specific SBIR Direct-to-Phase II funding opportunity announcements FOAs). transition FORMS-E earlier year allows NIH track SBIR Direct-to-Phase II applications the Application level, there a new check-box the SBIR/STTR Information Form Direct Phase II. a result this, NIH does need issue separate SBIR Direct-to-Phase II FOAs before, can offer Direct-to-Phase II an allowable Application Type any SBIR FOA. NINDS therefore amending following SBIR FOA allow SBIR Direct-to-Phase II submissions per below: PA-18-705 SBIR Technology Transfer R43/R44 Clinical Trial Allowed) NIH strongly encourages small businesses contact appropriate Institute Center early their application planning process ensure technology of priority the Institute/Center. updated SBIR/STTR Application Guide additional instructions SBIR Direct Phase II application preparation submission be posted November 26, 2018. following sections PA-18-705 changed follows: Part 2, Section I. Funding Opportunity Description following Components NOT accept SBIR Direct-to-Phase II submission: National Institute Nursing Research NINR) Part 2, Section II. Award Information Currently reads: Application Types Allowed New Phase I, Fast-Track) Renewal Phase II* Direct Phase IInotallowed) Resubmission phases) Phase IIB Competing Renewal Phase IIB) Revision The OER Glossary the SF424 R&R) SBIR/STTR Application Guide provide details these application types. Modified to: Application Types Allowed New Phase I, Fast-Track) New Phase II - Direct Phase II) Renewal Phase II) Resubmission phases) Phase IIB Competing Renewal Phase IIB) Revision OER Glossary the SF424 R&R) SBIR/STTR Application Guide provide details these application types. other aspects these FOAs remain unchanged.   Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone:301-496-1779 Email: fertigs@ninds.nih.gov

HEAL Initiative: Notice Interest Small Business Innovation Research SBIR) Small Business Technology Transfer STTR) Applications Directed Enhanced Pain Management Improved Treatments Opioid Misuse Addiction Notice Number: NOT-NS-19-014 Key Dates Release Date: December 10, 2018 Related Announcements PA-18- 573 PA-18-574 PA-1 8 -575 PA-18-576 PAR-18-617 PAR-18-618 Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Institute Alcohol Abuse Alcoholism NIAAA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Minority Health Health Disparities NIMHD) National Institute Nursing Research NINR) National Library Medicine NLM) National Center Advancing Translational Sciences NCATS) Purpose purpose this Notice to rescind NOT-NS-18-076 and inform potential SBIR STTR applicants areas special interest related the NIH Helping End Addiction Long-term HEAL) Initiative , effort speed scientific solutions stem national opioid public health crisis. NIH Institutes Centers listed this notice interested receiving applications directed improving pain treatment, including development new non-addictive medications devices objective pain measurement. addition, NIH interested new screening tools models focused specifically pain development pain therapies. National Institute Drug Abuse NIDA) specifically interested receiving applications develop new approaches the prevention treatment opioid misuse, overdose addiction will help people opioid disorder OUD) achieve maintain meaningful sustained recovery.   Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone:301-496-1779 Email:  fertigs@ninds.nih.gov Elena Koustova, PhD, MBA National Institute Drug Abuse NIDA) Telephone: 301-496-8768  Email:  koustovae@mail.nih.gov