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Notice Removal Matching Requirement Instructions RFA-NS-19-016 HEAL Initiative: Translational Devices Treat Pain UG3/UH3 Clinical Trial Optional)". Notice Number: NOT-NS-19-030 Key Dates Release Date : February 05, 2019 Related Announcements RFA-NS-19-016 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants the removal the Cost Matching Requirement Instructions RFA-NS-19-016 HEAL Initiative: Translational Devices Treat Pain(UG3/UH3)". will longer a Cost Matching Requirement this Funding Opportunity Announcement FOA).  notice be effective the next application due date March 22, 2019 subsequent application due dates. Currently Reads: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH’s Helping End Addiction Long-term HEAL) Initiative speed scientific solutions the national opioid public health crisis.The NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. information the HEAL Initiative available at:https://heal.nih.gov/. 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 contributionof 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. 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 contributionsrequired under announcement. See45 CFR 75.306for additional details. estimated 20.4% 50 million) Americans suffer chronic pain 8% 19.6 million) Americans suffer high-impact chronic pain. is highly debilitating medical condition is complex lacks effective treatments. recent decades, has an overreliance opioids chronic pain despite poor ability improve function. contributed a significant alarming epidemic opioid overdose deaths addictions. Innovative solutions develop alternative treatment options pain thus critically needed. part the mission the HEAL Initiative, NINDS working other NIH Institutes Centers encourage translation basic research new non-addictive pain treatments. program announcement intended encourage translation diagnostic therapeutic devices treat pain catalyze development partnerships between academic industrial sectors that translational research pain flourish a cooperative, iterative process leading safe, effective, non-addictive treatments pain. Modified toRead: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH’s Helping End Addiction Long-term HEAL) Initiative speed scientific solutions the national opioid public health crisis.The NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. information the HEAL Initiative available at:https://heal.nih.gov/. estimated 20.4% 50 million) Americans suffer chronic pain 8% 19.6 million) Americans suffer high-impact chronic pain. is highly debilitating medical condition is complex lacks effective treatments. recent decades, has an overreliance opioids chronic pain despite poor ability improve function. contributed a significant alarming epidemic opioid overdose deaths addictions. Innovative solutions develop alternative treatment options pain thus critically needed. part the mission the HEAL Initiative, NINDS working other NIH Institutes Centers encourage translation basic research new non-addictive pain treatments. program announcement intended encourage translation diagnostic therapeutic devices treat pain catalyze development partnerships between academic industrial sectors that translational research pain flourish a cooperative, iterative process leading safe, effective, non-addictive treatments pain. Currently Reads: Section III. Eligibility Information 2. Cost Sharing 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. Modified Read: Section III. Eligibility Information 2. Cost Sharing FOA does require cost sharing defined the NIH Grants Policy Statement. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget: 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. See45 CFR 75.306for 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. 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. Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget: instructions the SF424 R&R) Application Guide must followed. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letter support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing IP associated this project. research be performed more one institution, include letter support each institution clarifying IP be shared otherwise managed across institutions appropriate consistent achieving goals the program. collaborating a private entity, state they agreeing provide device technology), whether are any limits the studies can performed that device technology) limitations sharing data, whether licensing agreements in place. 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.    Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letter support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing IP associated this project. research be performed more one institution, include letter support each institution clarifying IP be shared otherwise managed across institutions appropriate consistent achieving goals the program. collaborating a private entity, state they agreeing provide device technology), whether are any limits the studies can performed that device technology) limitations sharing data, whether licensing agreements in place. Currently Reads: Section VI. Award Administration Information 1. Award Notices Individual awards based the application submitted to, as approved by, NIH are subject the IC-specific terms conditions identified the NoA.  ClinicalTrials.gov: an award provides one more clinical trials. law Title VIII, Section 801 Public Law 110-85), responsible party" must register submit results information certain applicable clinical trials” the ClinicalTrials.gov Protocol Registration Results System Information Website https://register.clinicaltrials.gov). NIH expects registration all trials whether required under law not. more information, http://grants.nih.gov/ClinicalTrials_fdaaa/  Institutional Review Board Independent Ethics Committee Approval: Grantee institutions must ensure the application well all protocols reviewed their IRB IEC. help ensure safety participants enrolled NIH-funded studies, awardee must provide NIH copies documents related all major changes the status ongoing protocols.  Data Safety Monitoring Requirements: NIH policy data safety monitoring requires oversight monitoring all NIH-conducted supported human biomedical behavioral intervention studies clinical trials) ensure safety participants the validity integrity the data. Further information concerning requirements found http://grants.nih.gov/grants/policy/hs/data_safety.htm in application instructions SF424 R&R) PHS 398). Investigational New Drug Investigational Device Exemption Requirements: Consistent federal regulations, clinical research projects involving use investigational therapeutics, vaccines, other medical interventions including licensed products devices a purpose than for they licensed) humans under research protocol must performed under Food Drug Administration FDA) investigational new drug IND) investigational device exemption IDE).  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.   Modified Read: Section VI. Award Administration Information 1. Award Notices Individual awards based the application submitted to, as approved by, NIH are subject the IC-specific terms conditions identified the NoA.  ClinicalTrials.gov: an award provides one more clinical trials. law Title VIII, Section 801 Public Law 110-85), responsible party" must register submit results information certain applicable clinical trials” the ClinicalTrials.gov Protocol Registration Results System Information Website https://register.clinicaltrials.gov). NIH expects registration all trials whether required under law not. more information, http://grants.nih.gov/ClinicalTrials_fdaaa/  Institutional Review Board Independent Ethics Committee Approval: Grantee institutions must ensure the application well all protocols reviewed their IRB IEC. help ensure safety participants enrolled NIH-funded studies, awardee must provide NIH copies documents related all major changes the status ongoing protocols.  Data Safety Monitoring Requirements: NIH policy data safety monitoring requires oversight monitoring all NIH-conducted supported human biomedical behavioral intervention studies clinical trials) ensure safety participants the validity integrity the data. Further information concerning requirements found http://grants.nih.gov/grants/policy/hs/data_safety.htm in application instructions SF424 R&R) PHS 398). Investigational New Drug Investigational Device Exemption Requirements: Consistent federal regulations, clinical research projects involving use investigational therapeutics, vaccines, other medical interventions including licensed products devices a purpose than for they licensed) humans under research protocol must performed under Food Drug Administration FDA) investigational new drug IND) investigational device exemption IDE) other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email:nick.langhals@nih.gov

Notice Removal Matching Requirement Instructions RFA-NS-19-017 HEAL Initiative: Translational Devices Treat Pain U44 Clinical Trial Optional)". Notice Number: NOT-NS-19-031 Key Dates Release Date : February 05, 2019 Related Announcements RFA-NS-19-017 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants the removal the Cost Matching Requirement Instructions RFA-NS-19-017 HEAL Initiative: Translational Devices Treat Pain U44)". will longer a Cost Matching Requirement this Funding Opportunity Announcement FOA).  notice be effective the next application due date March 22, 2019 subsequent application due dates. Currently Reads: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH’s Helping End Addiction Long-term HEAL) Initiative speed scientific solutions the national opioid public health crisis.The NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. information the HEAL Initiative available at:https://heal.nih.gov/. 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. 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 contributionsrequired under announcement. See45 CFR 75.306for additional details. estimated 20.4% 50 million) Americans suffer chronic pain 8% 19.6 million) Americans suffer high-impact chronic pain. is highly debilitating medical condition is complex lacks effective treatments. recent decades, has an overreliance opioids chronic pain despite poor ability improve function. contributed a significant alarming epidemic opioid overdose deaths addictions. Innovative solutions develop alternative treatment options pain thus critically needed. part the mission the HEAL Initiative, NINDS working other NIH Institutes Centers encourage translation basic research new non-addictive pain treatments. program announcement intended encourage translation diagnostic therapeutic devices treat pain catalyze development partnerships between academic industrial sectors that translational research pain flourish a cooperative, iterative process leading safe, effective, non-addictive treatments pain. Modified toRead: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH’s Helping End Addiction Long-term HEAL) Initiative speed scientific solutions the national opioid public health crisis.The NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. information the HEAL Initiative available at:https://heal.nih.gov/. estimated 20.4% 50 million) Americans suffer chronic pain 8% 19.6 million) Americans suffer high-impact chronic pain. is highly debilitating medical condition is complex lacks effective treatments. recent decades, has an overreliance opioids chronic pain despite poor ability improve function. contributed a significant alarming epidemic opioid overdose deaths addictions. Innovative solutions develop alternative treatment options pain thus critically needed. part the mission the HEAL Initiative, NINDS working other NIH Institutes Centers encourage translation basic research new non-addictive pain treatments. program announcement intended encourage translation diagnostic therapeutic devices treat pain catalyze development partnerships between academic industrial sectors that translational research pain flourish a cooperative, iterative process leading safe, effective, non-addictive treatments pain. Currently Reads: Section III. Eligibility Information 2. Cost Sharing 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. Modified Read: Section III. Eligibility Information 2. Cost Sharing FOA does require cost sharing defined the NIH Grants Policy Statement. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget: 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. See45 CFR 75.306for 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. 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. Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget: instructions the SF424 R&R) Application Guide must followed. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letter support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing IP associated this project. research be performed more one institution, include letter support each institution clarifying IP be shared otherwise managed across institutions appropriate consistent achieving goals the program. collaborating a private entity, state they agreeing provide device technology), whether are any limits the studies can performed that device technology) limitations sharing data, whether licensing agreements in place. 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.    Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letter support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing IP associated this project. research be performed more one institution, include letter support each institution clarifying IP be shared otherwise managed across institutions appropriate consistent achieving goals the program. collaborating a private entity, state they agreeing provide device technology), whether are any limits the studies can performed that device technology) limitations sharing data, whether licensing agreements in place. Currently Reads: Section VI. Award Administration Information 1. Award Notices Individual awards based the application submitted to, as approved by, NIH are subject the IC-specific terms conditions identified the NoA.  ClinicalTrials.gov: an award provides one more clinical trials. law Title VIII, Section 801 Public Law 110-85), responsible party" must register submit results information certain applicable clinical trials” the ClinicalTrials.gov Protocol Registration Results System Information Website https://register.clinicaltrials.gov). NIH expects registration all trials whether required under law not. more information, http://grants.nih.gov/ClinicalTrials_fdaaa/  Institutional Review Board Independent Ethics Committee Approval: Grantee institutions must ensure the application well all protocols reviewed their IRB IEC. help ensure safety participants enrolled NIH-funded studies, awardee must provide NIH copies documents related all major changes the status ongoing protocols.  Data Safety Monitoring Requirements: NIH policy data safety monitoring requires oversight monitoring all NIH-conducted supported human biomedical behavioral intervention studies clinical trials) ensure safety participants the validity integrity the data. Further information concerning requirements found http://grants.nih.gov/grants/policy/hs/data_safety.htm in application instructions SF424 R&R) PHS 398). Investigational New Drug Investigational Device Exemption Requirements: Consistent federal regulations, clinical research projects involving use investigational therapeutics, vaccines, other medical interventions including licensed products devices a purpose than for they licensed) humans under research protocol must performed under Food Drug Administration FDA) investigational new drug IND) investigational device exemption IDE).  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.   Modified Read: Section VI. Award Administration Information 1. Award Notices Individual awards based the application submitted to, as approved by, NIH are subject the IC-specific terms conditions identified the NoA.  ClinicalTrials.gov: an award provides one more clinical trials. law Title VIII, Section 801 Public Law 110-85), responsible party" must register submit results information certain applicable clinical trials” the ClinicalTrials.gov Protocol Registration Results System Information Website https://register.clinicaltrials.gov). NIH expects registration all trials whether required under law not. more information, http://grants.nih.gov/ClinicalTrials_fdaaa/  Institutional Review Board Independent Ethics Committee Approval: Grantee institutions must ensure the application well all protocols reviewed their IRB IEC. help ensure safety participants enrolled NIH-funded studies, awardee must provide NIH copies documents related all major changes the status ongoing protocols.  Data Safety Monitoring Requirements: NIH policy data safety monitoring requires oversight monitoring all NIH-conducted supported human biomedical behavioral intervention studies clinical trials) ensure safety participants the validity integrity the data. Further information concerning requirements found http://grants.nih.gov/grants/policy/hs/data_safety.htm in application instructions SF424 R&R) PHS 398). Investigational New Drug Investigational Device Exemption Requirements: Consistent federal regulations, clinical research projects involving use investigational therapeutics, vaccines, other medical interventions including licensed products devices a purpose than for they licensed) humans under research protocol must performed under Food Drug Administration FDA) investigational new drug IND) investigational device exemption IDE) other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email:nick.langhals@nih.gov

Notice Removal Matching Requirement Instructions RFA-NS-19-018 HEAL Initiative: Clinical Devices Treat Pain UH3 Clinical Trial Optional)". Notice Number: NOT-NS-19-032 Key Dates Release Date : February 05, 2019 Related Announcements RFA-NS-19-018 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants the removal the Cost Matching Requirement Instructions RFA-NS-19-018 HEAL Initiative: Clinical Devices Treat Pain UH3 Clinical Trial Optional)". will longer a Cost Matching Requirement this Funding Opportunity Announcement FOA).  notice be effective the next application due date March 22, 2019 subsequent application due dates. Currently Reads: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH’s Helping End Addiction Long-term HEAL) Initiative speed scientific solutions the national opioid public health crisis.The NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. information the HEAL Initiative available at:https://heal.nih.gov/. 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 contributionof 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. 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 contributionsrequired under announcement. See45 CFR 75.306for additional details. estimated 20.4% 50 million) Americans suffer chronic pain 8% 19.6 million) Americans suffer high-impact chronic pain. is highly debilitating medical condition is complex lacks effective treatments. recent decades, has an overreliance opioids chronic pain despite poor ability improve function. contributed a significant alarming epidemic opioid overdose deaths addictions. Innovative solutions develop alternative treatment options pain thus critically needed. part the mission the HEAL Initiative, NINDS working other NIH Institutes Centers encourage translation basic research new non-addictive pain treatments. program announcement intended encourage translation diagnostic therapeutic devices treat pain catalyze development partnerships between academic industrial sectors that translational research pain flourish a cooperative, iterative process leading safe, effective, non-addictive treatments pain. Modified toRead: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH’s Helping End Addiction Long-term HEAL) Initiative speed scientific solutions the national opioid public health crisis.The NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. information the HEAL Initiative available at:https://heal.nih.gov/. estimated 20.4% 50 million) Americans suffer chronic pain 8% 19.6 million) Americans suffer high-impact chronic pain. is highly debilitating medical condition is complex lacks effective treatments. recent decades, has an overreliance opioids chronic pain despite poor ability improve function. contributed a significant alarming epidemic opioid overdose deaths addictions. Innovative solutions develop alternative treatment options pain thus critically needed. part the mission the HEAL Initiative, NINDS working other NIH Institutes Centers encourage translation basic research new non-addictive pain treatments. program announcement intended encourage translation diagnostic therapeutic devices treat pain catalyze development partnerships between academic industrial sectors that translational research pain flourish a cooperative, iterative process leading safe, effective, non-addictive treatments pain. Currently Reads: Section III. Eligibility Information 2. Cost Sharing 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. Modified Read: Section III. Eligibility Information 2. Cost Sharing FOA does require cost sharing defined the NIH Grants Policy Statement. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget: 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. See45 CFR 75.306for 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. 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. Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission R&R Budget: instructions the SF424 R&R) Application Guide must followed. Currently Reads: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letter support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing IP associated this project. research be performed more one institution, include letter support each institution clarifying IP be shared otherwise managed across institutions appropriate consistent achieving goals the program. collaborating a private entity, state they agreeing provide device technology), whether are any limits the studies can performed that device technology) limitations sharing data, whether licensing agreements in place. 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.    Modified Read: Section IV. Application Submission Information 2. Content Form Application Submission PHS 398 Research Plan Letters Support: Applicants should include letter support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing IP associated this project. research be performed more one institution, include letter support each institution clarifying IP be shared otherwise managed across institutions appropriate consistent achieving goals the program. collaborating a private entity, state they agreeing provide device technology), whether are any limits the studies can performed that device technology) limitations sharing data, whether licensing agreements in place. Currently Reads: Section VI. Award Administration Information 1. Award Notices Individual awards based the application submitted to, as approved by, NIH are subject the IC-specific terms conditions identified the NoA.  ClinicalTrials.gov: an award provides one more clinical trials. law Title VIII, Section 801 Public Law 110-85), responsible party" must register submit results information certain applicable clinical trials” the ClinicalTrials.gov Protocol Registration Results System Information Website https://register.clinicaltrials.gov). NIH expects registration all trials whether required under law not. more information, http://grants.nih.gov/ClinicalTrials_fdaaa/  Institutional Review Board Independent Ethics Committee Approval: Grantee institutions must ensure the application well all protocols reviewed their IRB IEC. help ensure safety participants enrolled NIH-funded studies, awardee must provide NIH copies documents related all major changes the status ongoing protocols.  Data Safety Monitoring Requirements: NIH policy data safety monitoring requires oversight monitoring all NIH-conducted supported human biomedical behavioral intervention studies clinical trials) ensure safety participants the validity integrity the data. Further information concerning requirements found http://grants.nih.gov/grants/policy/hs/data_safety.htm in application instructions SF424 R&R) PHS 398). Investigational New Drug Investigational Device Exemption Requirements: Consistent federal regulations, clinical research projects involving use investigational therapeutics, vaccines, other medical interventions including licensed products devices a purpose than for they licensed) humans under research protocol must performed under Food Drug Administration FDA) investigational new drug IND) investigational device exemption IDE).  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.   Modified Read: Section VI. Award Administration Information 1. Award Notices Individual awards based the application submitted to, as approved by, NIH are subject the IC-specific terms conditions identified the NoA.  ClinicalTrials.gov: an award provides one more clinical trials. law Title VIII, Section 801 Public Law 110-85), responsible party" must register submit results information certain applicable clinical trials” the ClinicalTrials.gov Protocol Registration Results System Information Website https://register.clinicaltrials.gov). NIH expects registration all trials whether required under law not. more information, http://grants.nih.gov/ClinicalTrials_fdaaa/  Institutional Review Board Independent Ethics Committee Approval: Grantee institutions must ensure the application well all protocols reviewed their IRB IEC. help ensure safety participants enrolled NIH-funded studies, awardee must provide NIH copies documents related all major changes the status ongoing protocols.  Data Safety Monitoring Requirements: NIH policy data safety monitoring requires oversight monitoring all NIH-conducted supported human biomedical behavioral intervention studies clinical trials) ensure safety participants the validity integrity the data. Further information concerning requirements found http://grants.nih.gov/grants/policy/hs/data_safety.htm in application instructions SF424 R&R) PHS 398). Investigational New Drug Investigational Device Exemption Requirements: Consistent federal regulations, clinical research projects involving use investigational therapeutics, vaccines, other medical interventions including licensed products devices a purpose than for they licensed) humans under research protocol must performed under Food Drug Administration FDA) investigational new drug IND) investigational device exemption IDE) other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email:nick.langhals@nih.gov

Notice Correction Cooperative Agreement Terms Conditions Award RFA-NS-19-020 HEAL Initiative: Optimization Non-addictive Therapies Small Molecules Biologics) Treat Pain U44 - Clinical Trial Allowed)". Notice Number: NOT-NS-19-033 Key Dates Release Date : February 05, 2019 Related Announcements RFA-NS-19-020 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to amend missing information under Cooperative Agreement Terms Conditions Award RFA-NS-19-020 HEAL Initiative: Optimization Non-addictive Therapies Small Molecules Biologics) Treat Pain U44 - Clinical Trial Allowed)".  Cooperative Agreement Terms Conditions Award been modified include information was erroneously omitted. Currently Reads: Section VI. Award Administration Information 2. Administrative National Policy Requirements Cooperative Agreement Terms Conditions Award Applicable Modified Read: Section VI. Award Administration Information 2. Administrative National Policy Requirements Cooperative Agreement Terms Conditions Award following special terms award in addition to, not lieu of, otherwise applicable U.S. Office Management Budget OMB) administrative guidelines, U.S. Department Health Human Services DHHS) grant administration regulations 45 CFR Part 75, other HHS, PHS, NIH grant administration policies. administrative funding instrument used this program be cooperative agreement, assistance" mechanism rather an acquisition" mechanism), which substantial NIH programmatic involvement the awardees anticipated during performance the activities. Under cooperative agreement, NIH purpose to support stimulate recipients' activities involvement and otherwise working jointly the award recipients a partnership role; is to assume direction, prime responsibility, a dominant role the activities. Consistent this concept, dominant role prime responsibility resides the awardees the project a whole, although specific tasks activities be shared among awardees the NIH defined below. PD(s)/PI(s) have primary responsibility for: Determining experimental approaches, designing protocols, conducting experiments, analyzing interpreting research data studies funded through UG3/UH3. Hosting face-to-face meeting the outset the project working NIH staff assist the development a project milestone plan. Presenting project updates including raw data, requested) regular conference calls other intermittent face-to-face meetings. Coordinating participating NIH staff all aspects scientific technical management the project. Implementing scientific policy decisions approved NIH staff an oversight committee. Submitting periodic milestone progress reports a standard format, agreed upon the initiation. Preparing annual administrative site visits NIH Program staff. Awardees agree participate the overall coordination NIH research efforts translational research pain. participation include collaboration consultation other translational research awardees, the sharing information, data, research materials. Awardees retain custody and primary rights the data software developed under awards, subject Government rights access consistent current DHHS, PHS, NIH policies. Working closely his/her institution's technology transfer officials ensure royalty agreements, patent filings, all necessary intellectual property arrangements completed a timely manner. Awardees responsible pursuing patent protection. NIH staff substantial programmatic involvement is above beyond normal stewardship role awards, described below: project have support one more Project Scientists NIH program staff are assigned administrative role the target pain condition being studied have expertise the implementation NINDS cooperative agreement programs. NIH Project Scientists have substantial scientific/programmatic involvement during conduct this activity, through technical assistance, advice, coordination above beyond normal program stewardship grants. NIH Project Scientists assist the development a finalized project milestone plan the outset the project approve final milestone language incorporation the award notice. NIH Project Scientists be responsible assessing progress the projects toward accomplishment specified milestones, for recommending further funds should released the project. NIH Project Scientists coordinate participate meetings discuss project status, planning, implementation. NIH Project scientists serve scientific liaisons among awardee other NIH program staff report periodically the progress the project NIH leadership. NIH Project Scientists facilitate establishment contacts collaborations between awardees other persons organizations whose participation assist the accomplishment project goals. persons organizations include FDA, disease voluntary organizations, pharmaceutical companies, research organizations can provide essential services contract. important part the NIH HEAL Initiative the coordination research efforts across different funding mechanisms research structures, coordination among efforts aimed different pain conditions. NIH Project Scientists have primary responsibility this overall coordination provide perspective the priorities the HEAL Initiative other NIH translational programs. Additionally, agency program official IC program director be responsible the normal scientific programmatic stewardship the award will named the award notice. assigned program director also serve an NIH Project Scientist. Leadership the Institute/Center funding project make decisions project continuation input NIH staff and/or any established oversight committee, based on: Successful achievement milestones overall feasibility project advancement, considering data may have captured milestones Based emerging published literature competition the disease indication drug target Program priorities Availability funds Areas Joint Responsibility include: None; responsibilities divided between awardees NIH staff described above. Dispute Resolution: Any disagreements may arise scientific programmatic matters within scope the award) between award recipients the NIH be brought Dispute Resolution. Dispute Resolution Panel composed three members be convened. will three members: designee the Steering Committee chosen without NIH staff voting, NIH designee, a third designee expertise the relevant area is chosen the two; the case individual disagreement, first member be chosen the individual awardee. special dispute resolution procedure does alter awardee's right appeal adverse action is otherwise appealable accordance PHS regulation 42 CFR Part 50, Subpart D DHHS regulation 45 CFR Part 16.  other aspects this FOA remain same. Inquiries Please direct inquiries to: Charles Cywin National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email: charles.cywin@nih.gov

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