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Notice Change Receipt Date RFA-EY-18-001 BRAIN Initiative: New Concepts Early - Stage Research Large - Scale Recording Modulation the Nervous System R21 Clinical Trial Allowed)" Notice Number: NOT-NS-18-088 Key Dates Release Date: August 10, 2018 Related Announcements RFA-EY-18-001 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) Purpose purpose this notice to inform interested applicants there be change receipt dates the Funding Opportunity Announcement FOA) RFA-EY-18-001 BRAIN Initiative: New Concepts Early - Stage Research Large - Scale Recording Modulation the Nervous System R21 Clinical Trial Allowed)".  Specifically, next receipt date change October 29, 2018 to November 27, 2018. Part 1. Overview Information Key Dates Currently Reads: Application Due Date(s) 1, 2018, October 29, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 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.   Modified Read: Application Due Date(s) 1, 2018, November 27, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 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.   other aspects this FOA remain same. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: BRAIN-FOAs@nih.gov

Notice Change Receipt Date RFA-NS-18-019 BRAIN Initiative: Optimization Transformative Technologies Large Scale Recording Modulation the Nervous System U01 Clinical Trials Allowed)" Notice Number: NOT-NS-18-086 Key Dates Release Date: August 10, 2018 Related Announcements RFA-NS-18-019 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) Purpose purpose this notice to inform interested applicants there be change receipt dates the Funding Opportunity Announcement FOA) RFA-NS-18-019 BRAIN Initiative: Optimization Transformative Technologies Large Scale Recording Modulation the Nervous System U01 Clinical Trials Allowed).  Specifically, next receipt date change October 29, 2018 to November 27, 2018. Part 1. Overview Information Key Dates Currently Reads: Application Due Date(s) 15, 2018, October 29, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 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. Modified Read: Application Due Date(s) 15, 2018, November 27, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 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. other aspects this FOA remain same. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: BRAIN-FOAs@nih.gov

Solicitation Nominations the 2019 National Institute Neurological Disorders Stroke NINDS) Landis Award Outstanding Mentorship Notice Number: NOT-NS-18-089 Key Dates Release Date: August 10, 2018 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose Excellent mentorship superior training critical the development exceptional future scientists. recognize crucial role great mentors play the development future leaders neuroscience, National Institute Neurological Disorders Stroke NINDS) created Landis Award Outstanding Mentorship. award provides 100,000 direct costs) up five 5) faculty members are considered be outstanding mentors trainers help foster research career development additional students postdoctorates. NINDS hopes this tangible award impress upon scientific community a whole, faculty institutional leaders particular, high value NINDS places outstanding training mentorship the need faculty institutions emphasize dedication mentorship addition outstanding research accomplishments. Selection this award based nomination those have first-hand knowledge an individual’s outstanding mentorship. Current former trainees nominate faculty members have served their mentors. Faculty members nominated two more mentees then invited submit additional information needed the selection process. Eligible individuals this award must in tenure-track equivalent faculty position hold active NINDS R01, R35, U01, U54, P01 DP1 at least year left the time the award June 2019). full details the award, the selection process, be found at Landis Mentor Award. Because outstanding mentors exist each career stage, have different levels mentorship accomplishments, NINDS rotates eligibility requirements year. 2018, NINDS awards junior faculty mentors the 5th – 12th year the start their first tenure track equivalent position).  FY2018 Landis Awardees be found at Landis Mentor Award. this notice, NINDS invites nominations outstanding mentors are 13 20 years the start their first tenure-track equivalent faculty positions i.e., start date their first tenure-track equivalent faculty position in calendar year 1999 2006).  Nomination Nominations the NINDS Landis Mentor Award be accepted ONLY current former trainees the nominated individual. nominate current former mentor, individuals should click on Landis Mentor Award and complete nomination form by December 1, 2018. The following information be requested: Nominator's name current position Name individual being nominated nominee) Current institution email address nominee Start date nominee’s first tenure-track equivalent position Relationship nominator nominee dates mentorship, position nominator mentored nominee e.g. Former Current Graduate Student, Postdoctoral Fellow, etc.]) Statement describing basis the nomination. description should include: made/makes nominated individual exceptional mentor/trainer; are specific examples extraordinary dedication mentorship personally experienced witnessed; does individual to ensure trainees conduct highest quality research respect scientific premise, experimental design analysis; were specific nominee activities influenced nominator’s growth a neuroscientist. a nomination be considered, of above information must provided via nomination form found at Landis Mentor Award. Inquiries Please direct inquiries to: Stephen Korn National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov

Notice Change Expiration Date Application Due Dates PAR-18-534 Clinical Trial Readiness Rare Neurological Neuromuscular Diseases U01 Clinical Trial Optional)" Notice Number: NOT-NS-18-081 Key Dates Release Date: August 8, 2018 Related Announcements PAR-18-534 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform interested applicants the expiration date the Funding Opportunity Announcement FOA) PAR-18-534 Clinical Trial Readiness Rare Neurological Neuromuscular Diseases U01 Clinical Trial Optional)" been extended 1 receipt cycle.  new receipt date be February 15, 2019.  new expiration date be May 8, 2019. Par 1. Overview Information Key Dates Currently Reads: Application Due Date(s) February 15, 2018; August 17, 2018, 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. Scientific Merit Review June 2018, November 2018 Advisory Council Review October 2018, January 2019 Earliest Start Date December 2018, April 2019 Expiration Date August 18, 2018 Modified Read: Application Due Date(s) February 15, 2018; August 17, 2018, February 15, 2019, by 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. Scientific Merit Review June 2018, November 2018, June 2019 Advisory Council Review October 2018, January 2019, October 2019 Earliest Start Date December 2018, April 2019, December 2019 Expiration Date 8, 2019   other aspects this FOA remain same. Inquiries Please direct inquiries to: Glen H. Nuckolls, Ph.D.  National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-5745  Email: glen.nuckolls@nih.gov

Notice the NINDS' Participation PAR-18-296 interest Clinical Trial readiness applications Frontotemporal Degeneration FTD) the National Institute Aging the National Institute Neurological Disorders Stroke. Notice Number: NOT-NS-18-082 Key Dates Release Date: August 8, 2018 Related Announcements PAR-18-296 Issued National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants the National Institute Neurological Disorders Stroke NINDS) participate, effective immediately, PAR-18-296 Complex Integrated Multi-component Projects Aging Research U19 Clinical Trial Optional)" and that studies focused Alzheimer's disease Related Dementia ADRD) research supporting natural history studies will contribute clinical trial readiness Frontotemporal Degeneration FTD) of interest both National Institute Aging NIA) the National Institute Neurological Disorders Stroke NINDS). Applications addressing area FTD research should include large cohorts both genetically defined sporadic forms the FTD disease spectrum.  It anticipated these cohorts contribute early late stage clinical trials FTD providing genetic resources, harmonized clinical imaging data collection standardized biosample collection current future clinical diagnostic, prognostic progression biomarker development.  Research this area in response the Alzheimer's Disease-Related Dementias ADRD) milestones the 2017 update the National Plan Address Alzheimer's Disease. To address complexity infrastructure required these studies, applicants advised apply under PAR-18-296, " Complex Integrated Multi-Component Projects Aging Research U19 Clinical Trial Optional)". following sections PAR-18-296 been updated shown italics) reflect participation NINDS this Funding Opportunity Announcement FOA). Part 1. Overview Information Components Participating Organizations National Institute Aging NIA) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.866, 93.853 Part 2. Full Text Announcement Section I. Funding Opportunity Description following text been added: National Institute Neurological Disorders Stroke the National Institute Aging interested Alzheimer’s disease Related Dementia ADRD) research supporting natural history studies will contribute clinical trial readiness Frontotemporal Degeneration FTD). Applications addressing area FTD research should include large cohorts both genetically defined sporadic forms the FTD disease spectrum support cohorts will enable early late stage clinical trials FTD.  Research this area in response the Alzheimer's Disease Related Dementias ADRD) challenges outlined the 2017 update the National Plan Address Alzheimer's Disease. Scientific/Research Contact(s): John Hsiao, M.D. National Institute Aging NIA) Telephone: 301-496-9322 Email:  hsiaoj@mail.nih.gov Margaret Sutherland, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sutherlandm@ninds.nih.gov other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: John Hsiao, M.D. National Institute Aging NIA) Telephone: 301-496-9322 Email:  hsiaoj@mail.nih.gov Margaret Sutherland, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5680 Email: sutherlandm@ninds.nih.gov

Notice Availability Administrative Supplements Tissue Chip Consortium Awardees: Development Tissue Chips Model Nociception, Opioid Addiction Overdose Notice Number: NOT-TR-18-027 Key Dates Release Date: July 27, 2018   Related Announcements RFA-TR-16-017 RFA-TR-16-019 PA-18-591     NOT-EB-18-023 NOT-TR-19-001 Issued National Institutes Health NIH) National Heart, Lung, Blood Institute NHLBI) National Institute Dental Craniofacial Research NIDCR) National Institute Neurological Disorders Stroke NINDS) Purpose Notice announces investigators institutions funded through: NIH Microphysiological Systems MPS) Program: Microphysiological Systems MPS) Disease Modeling Efficacy Testing UG3/UH3) RFA-TR-16-017) the NIH-CASIS Coordinated Microphysiological Systems Program Translational Research Space UG3/UH3) RFA-TR-16-019) or; Associated SBIR/STTR-supported investigators Omnibus Solicitation the NIH, CDC, FDA ACF Small Business Innovation Research Grant Applications Parent SBIR R43/R44]: PA-14-071, PA-15-269, PA-16-302, PA-17-302, PA-18-573 PA-18-574; Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42]): PA-14-072, PA-15-270, PA-16-303, PA-15-270, PA-17-303, PA-18-575 or PA-18-576) grantees request supplemental funding will used create test tissue chip devices that model mechanisms effects nociception/pain-relevant signaling, addiction opioid overdose using human tissues an vitro microphysiological system MPS). should a clear utility the of physiologically-relevant MPS investigate novel pain-related mechanism(s), discover novel therapeutic targets pathways, develop evaluate drugs therapeutics pain-related processing physiological responses pain/opioids. Integrated models peripheral central nervous tissue encouraged. particular interest models may include following: development tissue chips trigeminal ganglia, dorsal root ganglia and/or dorsal horn the spinal cord is integrated crucial brain regions, including blood-brain barrier BBB), better understand local pain circuitry, barrier function therapeutic testing. Dopaminergic opioidergic areas the brain e.g. rostral ventromedial medulla, prefrontal cortex, basal ganglia) could inform therapeutic/intervention development, interruption addictive circuitry. Adaptation existing non-nervous tissues are involved nociceptive responses, pain sensation, and/or drug addiction overdose mechanisms. Targets related mitigating overdose, such respiratory suppression. addition being within scope the awards, administrative supplement requests intended support: Development activities can maintained after period supplemental support. Depending the success these administrative supplement projects, consideration be given establishment a new program Tissue Chips Nociception, Opioid Disorder OUD) Opioid Overdose Sharing any information, methods, resources, products developed using funds widely without charge other institutions, via publications, presentations, workshops. the purpose this consideration, Tissue Chip program-funded investigator defined the recipient an active Tissue Chip award UG3/UH3) under following funding opportunities: RFA-TR-16-017 Microphysiological Systems MPS) Disease Modeling Efficacy Testing UG3/UH3)", RFA-TR-16-019 NIH-CASIS Coordinated Microphysiological Systems Program Translational Research Space UG3/UH3)", well any Omnibus Solicitation the NIH, CDC, FDA ACF Small Business Innovation Research Grant Applications Parent SBIR R43/R44]: PA-14-071, PA-15-269, PA-16-302, PA-17-302, PA-18-573 PA-18-574; Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42]): PA-14-072, PA-15-270, PA-16-303, PA-15-270, PA-17-303, PA-18-575 or PA-18-576). Recipients supplemental funds under announcement be expected provide monthly updates NIH program staff funded projects. Those under RFA-TR-016-017 RFA-TR-16-019 also expected attend Tissue Chip Consortium meetings the Washington D.C. area, per Terms Conditions the parent award. Funds travel Tissue Chip Consortium meetings should be included this supplemental request. Submissions Requested NIH encouraging requests administrative supplements MPS program-funded investigators projects within currently approved budget period the parent award.  supplemental support for development adaptation existing MPS platforms model key aspects pain-related processing physiological responses pain/opioids, can used investigate novel pain/addiction/overdose-related mechanism(s) to discover novel therapeutic targets pathways pain-related processing opioid addiction/overdose. Applicant organizations submit application per parent grant. Budget Available Funds Budgets limited no than 25% total costs the amount the current parent award must reflect actual needs the proposed projects be reasonable respect the activities proposed. program-related expenses must justified specifically required the proposed activities must duplicate items generally available other sources the applicant collaborating institutions. Supplement project budget periods limited the remaining active budget period started FY18 the existing parent award.  be eligible, parent award must active i.e. be an extension period), the research proposed the supplement must accomplished within remaining active budget period started FY18 the existing parent award. earliest anticipated start date September 1, 2018. Examples: parent awards FY18 budget periods started March 1, 2018, supplement applicants request project period September 1, 2018, through February 28, 2019. parent awards FY18 budget periods start July 1, 2018, supplement applicants request project period September 1, 2018, through June 30, 2019. Supplemental funds awarded under Notice subject the requirements Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018), includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contribution all federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Notice details this matching requirement applies for-profit organizations apply PA-18-591 cite Notice. Requests from for-profit organizations do comply the budget requirements provide required letter(s) support documenting cost-sharing be withdrawn non-compliant. NCATS intends commit approximately 2,000,000 FY 2018 fund 10-12 awards. Highest priority funding consideration be given applications entail collaboration investigators outside current Tissue Chip Consortium, example, pain/nociception/addiction/overdose researchers clinicians other programs their institutions with outside institutions. Submitting Application Applicants should begin applications stating: application being submitted response NOT-TR-18-027".  Through Notice, NCATS only consider submissions which the Research Strategy does exceed 6 pages that include summary abstract the funded parent award. Projects should: Appropriately model nociception/addiction/overdose-relevant organ system fit objectives the funding opportunity. Utilize MPS can demonstrated provide better model currently existing tissue models other model systems. Build key resources components future development better platforms model pain-relevant pathways/outcomes, including selection appropriate cell sources induced pluripotent stem cell iPSC) sources commercially available cell lines. Include endpoints molecular, electrophysiological, imaging, etc.) can demonstrated correlate clinical measures nociception/addiction/overdose. Adhere milestones an overall timeline ensure completion the project within first phase a parent biphasic grant within remaining timeframe a monophasic grant. Applications due 5:00 PM local time August 24, 2018 should submitted per instructions Part 2, Section IV. Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional)" PA-18-591, the following modifications: Part 2, Section I, Funding Opportunity Description Background Additional language: Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contribution of federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Matching Requirement: grantee a for-profit organization funded under funding opportunity announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.The applicant be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applications must identify source amount funds proposed meet matching requirement how value in-kind contributions determined. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement. See 45 CFR 75.306 for additional details. Part 2, Section III, Cost Sharing Current language: FOA does require cost sharing defined the NIH Grants Policy Statement. Revised language: grantees a for-profit organization, FOA does require cost sharing, defined the NIH Grants Policy Statement.  information cost matching requirements in Section IV.2 R&R Modular Budget Part 2, Section IV, R&R Budget Current language: instructions the SF424 R&R) Application Guide must followed. Revised language: instructions the SF424 R&R) Application Guide must followed. Cost Matching Requirement For-profit Applicants Cost matching documented in-kind contributions required for-profit organizations responding this FOA.  for-profit awardee required match funds provide least 50% matching funds documented in-kind contributions a rate not less 50% the the total-Federally awarded amount direct costs, well facilities administrative costs), stipulated Public Law 115-141, Consolidated Appropriations Act 2018.    Federal funds not used a source matching funds. Generally, cost matching requirements not met the following sources: a) Costs borne another Federal grant sub award; b) Costs contributions toward cost sharing another Federal grant, Federal procurement contract, any award Federal funds; c) Cost services property financed income earned contractors under contract the recipient sub recipient); d) Program income; e) Patient incentives. for-profit organization be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applicants must submit budgets clearly document total costs, source amount matching funds, how valuation determined the case in-kind contributions, well the Federal Institutional non-Federal) components the budget. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement.  See 45 CFR 75.306 for additional details. Budget Justification: All for-profit applicants must document matching non-Federal) component the federal non-matching) component the total project budget. is, requested budget plus cost-matching budget must detailed tabular format document cost-matching non-Federal) component the federal non-cost matching) component. amount matching subject adjustment based total allowable costs incurred.  costs contributions used satisfy matching requirement must documented the recipient, including the value in-kind contributions determined, are subject audit. cost matching requirement not negotiable for-profit organizations. Part 2, Section IV, Letters Support Additional language: Letters Support For-profit applicants must include letter(s) support confirming the required secured cost matching cash; in-kind commitments such salary, consultant costs, equipment) available confirm the essential personnel the authority within organization allocate resources.  Part 2, Section V, Budget Period Support Budget Period Support Additional language: Specific this FOA: likely it the plans cost matching be adequate? Part 2, Section VI, Award Administration Information, Award Notices Additional language: Special award condition specific this FOA: grantee a for-profit organization funded under announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.  See 45 CFR 75.306 for additional details.   Matching funds must non-Federal funds set aside this project are available the source(s) identified the application, committed by recipient. Cost matching be evaluated the awarding office ensure this requirement being met. Compliance the matching requirement must verified an annual basis must documented the annual final FFR.If IS cooperative agreement, fill the template Cooperative Agreement Terms Conditions Award” appropriate.  THEN, copy paste the text that template this section, replacing Applicable” below) your text. Part 2, Section VI, Reporting Current language: multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement final RPPR, invention statement, the expenditure data portion the Federal Financial Report required closeout an award, described the NIH Grants Policy Statement. Revised language: multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. final Research Performance Progress Report F-RPPR), invention statement, the expenditure data portion the Federal Financial Report, including Federal non-Federal share cost matching, required closeout an award, described the NIH Grants Policy Statement. Application Review Requests be reviewed described Section V. PA-18-591: Administrative Supplements Existing NIH Grants Cooperative Agreements. Inquiries Please direct inquiries to: Danilo Tagle, Ph.D. National Center Advancing Translational Sciences NCATS) Telephone: 301-594-8064 Email: danilo.tagle@nih.gov Lucie Low, Ph.D. National Center Advancing Translational Sciences NCATS) Telephone: 301-594-7609 Email: lucie.low@nih.gov Lili Portilla, M.P.A. National Center Advancing Translational Sciences NCATS) Telephone: 301-827-7170 Email: lili.portilla@nih.gov Shannon Oden National Center Advancing Translational Sciences NCATS) Telephone: 301-594-3028 Email: shannon.oden@nih.gov

Notification NINDS Accept Postdoctoral Fellowship Applications F32; PAR-16-458) October 2018 all Potential Applicants Meet Eligibility Requirements the August 2018 Due Date Notice Number: NOT-NS-18-079 Key Dates Release Date: July 25, 2018 Related Announcements PAR-16-458 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform potential applicants that, because due dates Funding Opportunity Announcement PAR-16-458 "NINDS Ruth L. Kirschstein National Research Service Award NRSA) Training Postdoctoral Fellows F32)" changed short notice see NOT-NS-18-061), individuals would been eligible the August 8, 2018 due date be eligible submit applications the October 18, 2018 due date. This policy effective both new (-01) resubmission (-A1) applications.  other requirements provisions of PAR-16-458 remain same. Note:  exception only made the October 18, 2018 old August 8, 2018) due date. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone:  301-496-4188 Email:  korns@ninds.nih.gov

Notice Intent Publish Funding Opportunity Announcement Analytical Clinical Validation Biomarkers, Biomarker Signatures, Endpoints Pain Indications R61/R33) Notice Number:NOT-NS-18-074 Key Dates Release Date: July 23, 2018 Estimated Publication Date Funding Opportunity Announcement: 09/12/2018 First Estimated Application Due Date: 11/14/2018 Earliest Estimated Award Date: 06/01/2019 Earliest Estimated Start Date: 07/01/2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS, other NIH Institutes Centers participating the HEAL Helping End Addiction Long-term) Initiative, intends publish Funding Opportunity Announcement FOA) solicit applications research the analytical clinical validation biomarkers, biomarker signatures, endpoints pain indications. goal this FOA be support analytical clinical validation candidate biomarkers use the discovery development non-opiate alternatives the treatment pain conditions using retrospective and/or prospective methods. FOA assumes that: 1) candidate biomarker already identified, 2) assay technology already developed, 3) working hypothesis regarding context use in place. Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contribution of federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Matching Requirement: A grantee a for-profit organization funded under funding opportunity announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.The applicant be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applications must identify source amount funds proposed meet matching requirement how value in-kind contributions determined. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement. See 45 CFR 75.306 for additional details. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects. FOA expected be published September 2018 an expected application due date November 2018. FOA utilize bi-phasic, milestone driven R61/R33 mechanism. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights biomarkers endpoints specific pain indications begin consider applying this new FOA. FOA support rigorous analytical clinical validation promising candidate biomarkers pain indications provide tools necessary the development non-opiate therapeutics the treatment pain conditions. biomarker a defined characteristic is measured an indicator normal biological processes, pathogenic processes responses an exposure intervention, including therapeutic interventions.  Biomarker modalities diverse, can include genetic, protein, cellular, metabolomic, imaging physiologic endpoints. endpoint an outcome event used objectively measure effect a therapeutic other intervention being studied.  precise definition an endpoint typically specifies type assessments made, timing those assessments, assessment tools used, possibly details, applicable, such how multiple assessments within individual to combined. scope this FOA does include discovery, will supported through another funding opportunity announcement supporting Discovery Biomarkers, Biomarker Signatures, Endpoints Pain Indications, will published shortly.   Rather, FOA supports Validation Phase biomarker endpoint development, where analytical validation the assay detection technology completed, along increasingly rigorous clinical validation. degree evidence required provide necessary confidence biomarker endpoint validation depends upon context use the biomarker endpoint. the context use moves research accepted utility clinical practice i.e., a diagnostic predictor therapeutic response), required degree validation evidence increased must include prospective, multi-site validation data. Multidisciplinary collaboration among scientific investigators, assay developers, clinicians, bioinformatics statistical experts, consultants, clinical laboratory staff must an integral part the application, investigators such expertise should also begin considering applying this FOA. Projects proposed this FOA also utilize multi-site design applicable, standardized data stewardship ensure data reusable accessible. Funding Information Estimated Total Funding TBD Expected Number Awards TBD 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) Non-domestic non-U.S.) Entity Foreign Organization) Regional Organization Applications not being solicited this time. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD. National Institute Neurological Disorders Stroke 301-451-4551 mary.pelleymounter@nih.gov

Soliciting Feedback the BRAIN Initiative Notice Number: NOT-NS-18-075 Key Dates Release Date: July 23, 2018 Response Date: November 15, 2018 Related Announcements NOT-NS-19-041 Issued National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose purpose this Request Information RFI) to solicit input how best accomplish ambitious vision the Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative® set forth BRAIN 2025: Scientific Vision. NIH soliciting input all interested stakeholders, including members the scientific community, trainees, academic institutions, private sector, health professionals, professional societies, advocacy groups, patient communities, well other interested members the public. Background BRAIN Initiative aims develop new tools technologies understand manipulate networks cells the brain. BRAIN 2025: Scientific Vision serves the strategic plan the BRAIN Initiative NIH outlines overarching vision, seven high level scientific priorities, many specific goals. Designed be achieved over least decade, first five years BRAIN 2025 emphasizes development tools technology, the next five years shifts emphasis using tools make fundamental discoveries how brain circuits work what goes wrong disease. BRAIN Initiative well underway see  http://www.braininitiative.nih.gov ), we now approaching midpoint. this time, NIH seeking feedback the BRAIN Initiative's progress on opportunities moving forward given current state the science. NIH established new BRAIN Initiative Advisory Committee the NIH Director ACD) Working Group will provide scientific guidance the ACD how best continue accelerate ambitious vision the BRAIN Initiative. ACD-WG use responses this RFI, along information gathered through series public workshops, help inform discussions the BRAIN Initiative's progress potential updates the plan moving forward. Information Requested Please submit: Ideas new tools technologies have potential transform brain circuit research. Suggestions fundamental questions brain circuit function humans animal models could addressed new technologies. Considerations data sharing infrastructure policies. Areas topics research the ethical implications BRAIN Initiative-supported emerging neurotechnologies advancements their applications. Approaches disseminating new tools technologies well training broader neuroscience research community. Any topic relevant the strategic plan the BRAIN Initiative. to Submit Response assure consideration, responses must received November 15, 2018. Responses this RFI must submitted electronically using web-based form https://www.braininitiative.nih.gov/rfi.aspx via email BRAINFeedback@nih.gov  BRAIN RFI" the subject line. Responses this RFI voluntary. Any personal identifiers be removed responses compiled.  Individual feedback not provided any responder. Proprietary, classified, confidential, sensitive information should be included your response. This Request Information RFI) for planning purposes only is a solicitation applications an obligation the part the United States U.S.) Government provide support any ideas identified response it. Please note the U.S. Government not pay the preparation any comment submitted for use that comment. Inquiries Please direct inquiries to: Email: BRAINFeedback@nih.gov

Notice Change Requirements 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-18-076 Key Dates Release Date: July 23, 2018 Related Announcements PA-18-573 PA-18-574 PA-18-575 PA-18-576 PAR-18-617 PAR-18-618 Issued National Institute Neurological Disorders Stroke NINDS) National Institute Drug Abuse NIDA) Purpose purpose this Notice to 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. National Institute Neurological Disorders Stroke NINDS) interested receiving applications directed improving pain treatment, including development new non-addictive medications devices objective pain measurement. addition, NINDS 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. Notice also informs small business community a new requirement matching funds awarding grants through HEAL Initiative to for-profit applicant organizations. Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contribution of federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Notice details matching/in-kind contribution requirement the HEAL Initiative how applies for-profit organizations apply to PA-18-573, PA-18-574, PA-18-575, PA-18-576, PAR-18-617, and PAR-18-618, amends following sections of PA-18-573, PA-18-574, PA-18-575, PA-18-576, PAR-18-617, and PAR-18-618 listed below. Part 2, Section I, Funding Opportunity Description Additional language: NIH Helping End Addiction Long-term HEAL) Initiative: The HEAL Initiative an NIH wide effort speed scientific solutions stem national opioid public health crisis. NIH interested receiving research related opioid addition, development opioid alternatives, pain management addiction treatment. Public Law 115-141, Consolidated Appropriations Act 2018 signed March 23, 2018) includes requirement grantees for-profit applicant organizations must provide 50% match and/or in-kind contribution of federally awarded dollars under grant award direct costs, well facilities administrative costs) research related opioid addiction, development opioid alternatives, pain management addiction treatment. Matching Requirement: A grantee a for-profit organization funded through HEAL Initiative under PA-18-573, PA-18-574, PA-18-575, PA-18-576, PAR-18-617, and PAR-18-618 must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.The applicant be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applications must identify source amount funds proposed meet matching requirement how value in-kind contributions determined. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement. See 45 CFR 75.306 for additional details. Part 2, Section III, Cost Sharing Current language: FOA does require cost sharing defined the NIH Grants Policy Statement. Revised language: grantees a for-profit organization, FOA does require cost sharing research through HEAL Initiative related opioid addition, development opioid alternatives, pain management addiction treatment defined the NIH Grants Policy Statement.  information cost matching requirements in Section IV.2 R&R Modular Budget.  Part 2, Section IV, R&R Budget Current language: instructions the SF424 R&R) Application Guide must followed. Revised language: instructions the SF424 R&R) Application Guide must followed. Cost Matching Requirement For-profit Applicants funded through HEAL Initiative: Cost matching documented in-kind contributions required for-profit organizations funded through HEAL Initiative research related opioid addition, development opioid alternatives, pain management addiction treatment.  for-profit awardee required match funds provide least 50% matching funds documented in-kind contributions a rate not less 50% the the total-Federally awarded amount direct costs, well facilities administrative costs), stipulated Public Law 115-141, Consolidated Appropriations Act 2018.    Federal funds not used a source matching funds. Generally, cost matching requirements not met the following sources: a) Costs borne another Federal grant sub award; b) Costs contributions toward cost sharing another Federal grant, Federal procurement contract, any award Federal funds; c) Cost services property financed income earned contractors under contract the recipient sub recipient); d) Program income; e) Patient incentives. for-profit organization be required demonstrate matching funds and/or in-kind contributions committed available the time of, for duration of, award. Applicants must submit budgets clearly document total costs, source amount matching funds, how valuation determined the case in-kind contributions, well the Federal Institutional non-Federal) components the budget. matching funds and/or in-kind contributions must used the portion allowable project costs paid Federal funds under grant award.  NIH not the recipient, nor serve a pass-through entity, any such matching funds and/or in-kind contributions required under announcement.  45 CFR 75.306 additional details. Budget Justification: All for-profit applicants must document matching non-Federal) component the federal non-matching) component the total project budget. is, requested budget plus cost-matching budget must detailed tabular format document cost-matching non-Federal) component the federal non-cost matching) component. amount matching subject adjustment based total allowable costs incurred.  costs contributions used satisfy matching requirement must documented the recipient, including the value in-kind contributions determined, are subject audit. cost matching requirement not negotiable for-profit organizations. Part 2, Section IV, Letters Support Additional language: Letters Support: HEAL Initiative For-profit applicants research related opioid addition, development opioid alternatives, pain management addiction treatment seeking funding through HEAL Initiative must include letter(s) support confirming the required secured cost matching cash; in-kind commitments such salary, consultant costs, equipment) available confirm the essential personnel the authority within organization allocate resources.  Part 2, Section V, Budget Period Support Budget Period Support Additional language: Specific this FOA: research related opioid addition, development opioid alternatives, pain management addiction treatment seeking funding through HEAL Initiative: likely it the plans cost matching be adequate? Part 2, Section VI, Award Administration Information, Award Notices Additional language: Special award condition specific this FOA: grantee a for-profit organization funded through HEAL Initiative research related opioid addiction, development opioid alternatives, pain management addiction treatment under announcement must match funds provide documented in-kind contributions a rate not less 50% the total-Federally awarded amount, stipulated Public Law 115-141, Consolidated Appropriations Act 2018.  45 CFR 75.306 additional details.   Matching funds must non-Federal funds set aside this project are available the source(s) identified the application, committed by recipient. Cost matching be evaluated the awarding office ensure this requirement being met. Compliance the matching requirement must verified an annual basis must documented the annual final FFR. Part 2, Section VI, Reporting Current language: NIH requires SBIR/STTR grantees submit following reports within 90 days the end the grant budget period unless grantee under extension. multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. Final RPPR (requirements recently changed - please the NOT-OD-17-085 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-085.html) Final Invention Statement Certification HHS 568) Annual Invention Utilization Reports Federal Financial Report FFR) – replaced Final Cash Transaction Report PSC 272) Phase II Data Collection Requirement Government Tech-Net Database Revised language: NIH requires SBIR/STTR grantees submit following reports within 90 days the end the grant budget period unless grantee under extension. multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. Final RPPR (requirements recently changed - please the NOT-OD-17-085 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-085.html) Final Invention Statement Certification HHS 568) Annual Invention Utilization Reports Federal Financial Report FFR) (including Federal non-Federal share cost matching applicable) – replaced Final Cash Transaction Report PSC 272) Phase II Data Collection Requirement Government Tech-Net Database other aspects the FOA 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 Elena Koustova, PhD, MBA National Institute Drug Abuse NIDA) Telephone: 301-496-8768  Email: koustovae@mail.nih.gov