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Notice Extend Expiration Date RFA-NS-19-020 Optimization Non-addictive Therapies Small Molecules Biologics) Treat Pain U44 Clinical Trial Allowed)" Notice Number: NOT-NS-19-042 Key Dates Release Date: March 7, 2019 Related Announcements RFA-NS-19-020 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants the expiration Date RFA-NS-19-020 Optimization Non-addictive Therapies Small Molecules Biologics) Treat Pain U44 Clinical Trial Allowed)" be extended one council round changes shown in bold italics below). FOA been modified add additional due date of June 4, 2019. Currently Reads: Part 1. Overview Information Key Dates Application Due Date(s) January 9, 2019 March 6, 2019, 5:00PM local time applicant organization. Alltypes 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) January 9, 2019 March 6, 2019, 5:00PM 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. Scientific Merit Review March 2019 June 2019 Advisory Council Review 2010 August 2019 Earliest Start Date June 2019 September 2019 Expiration Date March 7, 2019 Modified Read: Part 1. Overview Information Key Dates Application Due Date(s) January 9, 2019, March 6, 2019, and June 4, 2019, 5:00PM 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 Apllication Due Date(s) January 9, 2019, March 6, 2019, and June 4, 2019, 5:00PM 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. Scientific Merit Review March 2019, June 2019, October 2019 Advisory Council Review 2010, August 2019, August 2019 Earliest Start Date June 2019, September 2019, February 2020 Expiration Date June 5, 2019 other aspects this FOA remain same.  Inquiries Please direct inquiries to: Charles Cywin, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email: charles.cywin@nih.gov

Notice Removal Matching Requirements RFA-NS-18-046 Analytical and/or Clinical Validation a Candidate Biomarker Pain R61/R33 Clinical Trial Optional)” Notice Number: NOT-NS-19-037 Key Dates Release Date: March 6, 2019 Related Announcements RFA-NS-18-046 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants the removal the Cost Matching Requirement Instructions for RFA-NS-18-046 “Analytical and/or Clinical Validation a Candidate Biomarker Pain R61/R33 Clinical Trial Optional)”. will longer a Cost Matching Requirement this Funding Opportunity Announcement FOA).  Notice only applies the November 25, 2019 application due date subsequent application due dates. Currently Reads: Section III. Eligibility Information 2. Cost Sharing FOA does require cost sharing defined the NIH Grants Policy Statement. 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. grantees a for-profit organization, FOA does not-require cost sharing. 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.  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. 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 letters support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing intellectual property associated this project. research be performed more one institution, include letter support each institution clarifying intellectual property be shared otherwise managed across institutions. collaborating a private entity, include letter support addresses any agreement provide agent(s), any limits the studies can performed said agent(s), any limitations sharing data including negative results), whether licensing agreement(s) be needed in place once project funded. letter should from designated official within private entity has authority speak these issues. an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration data sharing must included. utilization extant samples proposed a component the study, letters support approval use those samples should included. 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 letters support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing intellectual property associated this project. research be performed more one institution, include letter support each institution clarifying intellectual property be shared otherwise managed across institutions. collaborating a private entity, include letter support addresses any agreement provide agent(s), any limits the studies can performed said agent(s), any limitations sharing data including negative results), whether licensing agreement(s) be needed in place once project funded. letter should from designated official within private entity has authority speak these issues. an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration data sharing must included. utilization extant samples proposed a component the study, letters support approval use those samples should included. Currently Reads: Section V. Application Review Information 1. Criteria Additional Review Considerations Budget Period Support  Reviewers consider whether budget the requested period support fully justified reasonable relation the proposed research.  Specific this FOA: likely it the plans cost matching be adequate? Modified Read: Section V. Application Review Information 1. Criteria Additional Review Considerations Budget Period Support  Reviewers consider whether budget the requested period support fully justified reasonable relation the proposed research. Currently Reads: Section VI. Award Administration Information 3. Reporting multiple years involved, awardees be required submit the Research Performance Progress Report RPPR) annually financial statements required the NIH Grants Policy Statement. 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. 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. 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. final RPPR, invention statement, the expenditure data portion the Federal Financial Report required closeout an award, described the NIH Grants Policy Statement. Federal Funding Accountability Transparency Act 2006 Transparency Act), includes requirement awardees Federal grants report information first-tier subawards executive compensation under Federal assistance awards issued FY2011 later.  awardees applicable NIH grants cooperative agreements are required report the Federal Subaward Reporting System FSRS) available at www.fsrs.gov on subawards over 25,000.  the NIH Grants Policy Statement for additional information this reporting requirement. accordance the regulatory requirements provided 45 CFR 75.113 Appendix XII 45 CFR Part 75, recipients have currently active Federal grants, cooperative agreements, procurement contracts all Federal awarding agencies a cumulative total value greater 10,000,000 any period time during period performance a Federal award, must report maintain currency information reported the System Award Management SAM) about civil, criminal, administrative proceedings connection the award performance a Federal award reached final disposition within most recent five-year period.  recipient must also semiannual disclosures regarding such proceedings. Proceedings information be publicly available the designated integrity performance system currently FAPIIS).  is statutory requirement under section 872 Public Law 110-417, amended 41 U.S.C. 2313).  required section 3010 Public Law 111-212, information posted the designated integrity performance system or after April 15, 2011, except past performance reviews required Federal procurement contracts, be publicly available.  Full reporting requirements procedures found Appendix XII 45 CFR Part 75 – Award Term Conditions Recipient Integrity Performance Matters. Modified Read: Section VI. Award Administration Information 3. Reporting 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. Federal Funding Accountability Transparency Act 2006 Transparency Act), includes requirement awardees Federal grants report information first-tier subawards executive compensation under Federal assistance awards issued FY2011 later.  awardees applicable NIH grants cooperative agreements are required report the Federal Subaward Reporting System FSRS) available at www.fsrs.gov on subawards over 25,000.  the NIH Grants Policy Statement for additional information this reporting requirement. accordance the regulatory requirements provided 45 CFR 75.113 Appendix XII 45 CFR Part 75, recipients have currently active Federal grants, cooperative agreements, procurement contracts all Federal awarding agencies a cumulative total value greater 10,000,000 any period time during period performance a Federal award, must report maintain currency information reported the System Award Management SAM) about civil, criminal, administrative proceedings connection the award performance a Federal award reached final disposition within most recent five-year period.  recipient must also semiannual disclosures regarding such proceedings. Proceedings information be publicly available the designated integrity performance system currently FAPIIS).  is statutory requirement under section 872 Public Law 110-417, amended 41 U.S.C. 2313).  required section 3010 Public Law 111-212, information posted the designated integrity performance system or after April 15, 2011, except past performance reviews required Federal procurement contracts, be publicly available.  Full reporting requirements procedures found Appendix XII 45 CFR Part 75 – Award Term Conditions Recipient Integrity Performance Matters. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email: mary.pelleymounter@nih.gov

Notice Removal Matching Requirements RFA-NS-18-041 Discovery Biomarkers, Biomarker Signatures, Endpoints Pain R61/R33 Clinical Trial Optional)” Notice Number: NOT-NS-19-044 Key Dates Release Date: March 6, 2019 Related Announcements RFA-NS-18-041 NOT-NS-19-036 Rescinded Issued National Institute Neurological Disorders Stroke NINDS) Purpose notice updates, supercedes replaces previous notice: NOT-NS-19-036. Notice provides clarification indicate effective date this notice November 25, 2019). purpose this notice to inform applicants the removal the Cost Matching Requirement Instructions RFA-NS-18-041 ldquo;Discovery Biomarkers, Biomarker Signatures, Endpoints Pain R61/R33 Clinical Trial Optional)”. will longer a Cost Matching Requirement this Funding Opportunity Announcement FOA). Notice only applies the November 25, 2019 application due date subsequent application due dates. Currently Reads: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part theNIH HEAL Helping End Addiction Long-term) Initiative—an aggressive, trans-agency effort speed scientific solutions stem national opioid public health crisis. than 25 million Americans suffer chronic pain, 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 scientific solutions develop alternative treatment options thus critically needed. challenges facing development non-opioid alternative pain medications include: lack reliable measures pain biology perception, difficult regulatory path high safety labeling hurdles, poor predictive power preclinical models, a paucity validated targets. addition, patient populations heterogeneous across multiple pain conditions, high variability individual responses intervention. potential solution toward accelerating discovery development alternative pain therapies the of objective biomarkers endpoints could define pathophysiologic subsets pain, evaluate target engagement a therapeutic predict analgesic efficacy new therapeutics. Unfortunately, are very few validated biomarkers available provide information described above. Therefore, goal this FOA to promote discovery promising candidate biomarkers, biomarker signatures endpoints pain indications will withstand rigorous validation ultimately provide tools necessary the development non-opioid therapeutics the treatment pain conditions. 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. 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. 45 CFR 75.306 additional details. Modified Read: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part theNIH HEAL Helping End Addiction Long-term) Initiative—an aggressive, trans-agency effort speed scientific solutions stem national opioid public health crisis. than 25 million Americans suffer chronic pain, 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 scientific solutions develop alternative treatment options thus critically needed. challenges facing development non-opioid alternative pain medications include: lack reliable measures pain biology perception, difficult regulatory path high safety labeling hurdles, poor predictive power preclinical models, a paucity validated targets. addition, patient populations heterogeneous across multiple pain conditions, high variability individual responses intervention. potential solution toward accelerating discovery development alternative pain therapies the of objective biomarkers endpoints could define pathophysiologic subsets pain, evaluate target engagement a therapeutic predict analgesic efficacy new therapeutics. Unfortunately, are very few validated biomarkers available provide information described above. Therefore, goal this FOA to promote discovery promising candidate biomarkers, biomarker signatures endpoints pain indications will withstand rigorous validation ultimately provide tools necessary the development non-opioid therapeutics the treatment pain conditions. Currently Reads: Section II. Award Information Award Budget Application budgets not limited need reflect actual needs the proposed project. mentioned NOT-OD-18-181, any for-profit recipient funds shall subject a matching requirement funds documented in-kind contributions not less 50 percent the total funds awarded such entity. Modified Read: Section II. Award Information Award Budget Application budgets not limited need reflect actual needs the proposed project. 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. grantees a for-profit organization, FOA does not-require cost sharing. 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. 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. 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 letters support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing intellectual property associated this project. research be performed more one institution, include letter support each institution clarifying intellectual property be shared otherwise managed across institutions. collaborating a private entity, include letter support addresses any agreement provide agent(s), any limits the studies can performed said agent(s), any limitations sharing data including negative results), whether licensing agreement(s) be needed in place once project funded. letter should from designated official within private entity has authority speak these issues. an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration data sharing must included. utilization extant samples proposed a component the study, letters support approval use those samples should included. 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 letters support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing intellectual property associated this project. research be performed more one institution, include letter support each institution clarifying intellectual property be shared otherwise managed across institutions. collaborating a private entity, include letter support addresses any agreement provide agent(s), any limits the studies can performed said agent(s), any limitations sharing data including negative results), whether licensing agreement(s) be needed in place once project funded. letter should from designated official within private entity has authority speak these issues. an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration data sharing must included. utilization extant samples proposed a component the study, letters support approval use those samples should included. Currently Reads: Section V. Application Review Information 1. Criteria Additional Review Considerations Budget Period Support Reviewers consider whether budget the requested period support fully justified reasonable relation the proposed research. Specific this FOA: How likely it the plans cost matching be adequate? Modified Read: Section V. Application Review Information 1. Criteria Additional Review Considerations Budget Period Support Reviewers consider whether budget the requested period support fully justified reasonable relation the proposed research. Currently Reads: Section VI. Award Administration Information 2. Administrative National Policy Requirements NIH grant cooperative agreement awards include theNIH Grants Policy Statementas part the NoA. these terms award, theNIH Grants Policy Statement Part II: Terms Conditions NIH Grant Awards, Subpart A: General andPart II: Terms Conditions NIH Grant Awards, Subpart B: Terms Conditions Specific Types Grants, Grantees, Activities. information provided atAward Conditions Information NIH Grants. Recipients federal financial assistance FFA) HHS must administer programs compliance federal civil rights law. means recipients HHS funds must ensure equal access their programs without regard a person’s race, color, national origin, disability, age and, some circumstances, sex religion. includes ensuring programs accessible persons limited English proficiency. HHS recognizes research projects often limited scope many reasons are nondiscriminatory, such the principal investigator’s scientific interest, funding limitations, recruitment requirements, other considerations. Thus, criteria research protocols target exclude certain populations warranted where nondiscriminatory justifications establish such criteria appropriate respect the health safety the subjects, scientific study design, the purpose the research. accordance the statutory provisions contained Section 872 the Duncan Hunter National Defense Authorization Act Fiscal Year 2009 Public Law 110-417), NIH awards be subject the Federal Awardee Performance Integrity Information System FAPIIS) requirements. FAPIIS requires Federal award making officials review consider information an applicant the designated integrity performance system currently FAPIIS) prior making award. applicant, its option, review information the designated integrity performance systems accessible through FAPIIS comment any information itself a Federal agency previously entered is currently FAPIIS. Federal awarding agency consider any comments the applicant, addition other information FAPIIS, making judgement the applicant’s integrity, business ethics, record performance under Federal awards completing review risk posed applicants described 45 CFR Part 75.205 ldquo;Federal awarding agency review risk posed applicants.” provision apply all NIH grants cooperative agreements except fellowships. additional guidance regarding the provisions apply NIH grant programs, please contact Scientific/Research Contact is identified Section VII under Agency Contacts this FOA. HHS provides general guidance recipients FFA meeting legal obligation take reasonable steps provide meaningful access their programs persons limited English proficiency. Please https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited…. HHS Office Civil Rights also provides guidance complying civil rights laws enforced HHS. Please seehttp://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; andhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidanc…. Recipients FFA also specific legal obligations serving qualified individuals disabilities. Please seehttp://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact HHS Office Civil Rights more information obligations prohibitions under federal civil rights laws athttps://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 TDD 1-800-537-7697. Also note is HHS Departmental goal ensure access quality, culturally competent care, including long-term services supports, vulnerable populations. further guidance providing culturally linguistically appropriate services, recipients should review National Standards Culturally Linguistically Appropriate Services Health Health Care athttp://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53. Special award condition specific this FOA: A 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. 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. Modified Read: Section VI. Award Administration Information 2. Administrative National Policy Requirements NIH grant cooperative agreement awards include theNIH Grants Policy Statementas part the NoA. these terms award, theNIH Grants Policy Statement Part II: Terms Conditions NIH Grant Awards, Subpart A: General andPart II: Terms Conditions NIH Grant Awards, Subpart B: Terms Conditions Specific Types Grants, Grantees, Activities. information provided atAward Conditions Information NIH Grants. Recipients federal financial assistance FFA) HHS must administer programs compliance federal civil rights law. means recipients HHS funds must ensure equal access their programs without regard a person’s race, color, national origin, disability, age and, some circumstances, sex religion. includes ensuring programs accessible persons limited English proficiency. HHS recognizes research projects often limited scope many reasons are nondiscriminatory, such the principal investigator’s scientific interest, funding limitations, recruitment requirements, other considerations. Thus, criteria research protocols target exclude certain populations warranted where nondiscriminatory justifications establish such criteria appropriate respect the health safety the subjects, scientific study design, the purpose the research. accordance the statutory provisions contained Section 872 the Duncan Hunter National Defense Authorization Act Fiscal Year 2009 Public Law 110-417), NIH awards be subject the Federal Awardee Performance Integrity Information System FAPIIS) requirements. FAPIIS requires Federal award making officials review consider information an applicant the designated integrity performance system currently FAPIIS) prior making award. applicant, its option, review information the designated integrity performance systems accessible through FAPIIS comment any information itself a Federal agency previously entered is currently FAPIIS. Federal awarding agency consider any comments the applicant, addition other information FAPIIS, making judgement the applicant’s integrity, business ethics, record performance under Federal awards completing review risk posed applicants described 45 CFR Part 75.205 ldquo;Federal awarding agency review risk posed applicants.” provision apply all NIH grants cooperative agreements except fellowships. additional guidance regarding the provisions apply NIH grant programs, please contact Scientific/Research Contact is identified Section VII under Agency Contacts this FOA. HHS provides general guidance recipients FFA meeting legal obligation take reasonable steps provide meaningful access their programs persons limited English proficiency. Please https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited…. HHS Office Civil Rights also provides guidance complying civil rights laws enforced HHS. Please seehttp://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; andhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidanc…. Recipients FFA also specific legal obligations serving qualified individuals disabilities. Please seehttp://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact HHS Office Civil Rights more information obligations prohibitions under federal civil rights laws athttps://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 TDD 1-800-537-7697. Also note is HHS Departmental goal ensure access quality, culturally competent care, including long-term services supports, vulnerable populations. further guidance providing culturally linguistically appropriate services, recipients should review National Standards Culturally Linguistically Appropriate Services Health Health Care athttp://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53. Currently Reads: Section VI. Award Administration Information 3. Reporting 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. final RPPR, invention statement, the expenditure data portion the Federal Financial Report required closeout an award, described the NIH Grants Policy Statement. Federal Funding Accountability Transparency Act 2006 Transparency Act), includes requirement awardees Federal grants report information first-tier subawards executive compensation under Federal assistance awards issued FY2011 later. awardees applicable NIH grants cooperative agreementsare required report the Federal Subaward Reporting System FSRS) available at www.fsrs.gov on subawards over 25,000. the NIH Grants Policy Statement for additional information this reporting requirement. accordance the regulatory requirements provided 45 CFR 75.113 Appendix XII 45 CFR Part 75, recipients have currently active Federal grants, cooperative agreements, procurement contracts all Federal awarding agencies a cumulative total value greater 10,000,000 any period time during period performance a Federal award, must report maintain currency information reported the System Award Management SAM)about civil, criminal, administrative proceedings connection the award performance a Federal award reached final disposition within most recent five-year period. recipient must also semiannual disclosures regarding such proceedings.Proceedings information be publicly available the designated integrity performance system currently FAPIIS). is statutory requirement under section 872 Public Law 110-417, amended 41 U.S.C. 2313). required section 3010 Public Law 111-212, information posted the designated integrity performance system or after April 15, 2011, except past performance reviews required Federal procurement contracts, be publicly available. Full reporting requirements procedures found Appendix XII 45 CFR Part 75 – Award Term Conditions Recipient Integrity Performance Matters. Modified Read: Section VI. Award Administration Information 3. Reporting 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. Federal Funding Accountability Transparency Act 2006 Transparency Act), includes requirement awardees Federal grants report information first-tier subawards executive compensation under Federal assistance awards issued FY2011 later. awardees applicable NIH grants cooperative agreementsare required report the Federal Subaward Reporting System FSRS) available at www.fsrs.gov on subawards over 25,000. the NIH Grants Policy Statement for additional information this reporting requirement. accordance the regulatory requirements provided 45 CFR 75.113 Appendix XII 45 CFR Part 75, recipients have currently active Federal grants, cooperative agreements, procurement contracts all Federal awarding agencies a cumulative total value greater 10,000,000 any period time during period performance a Federal award, must report maintain currency information reported the System Award Management SAM)about civil, criminal, administrative proceedings connection the award performance a Federal award reached final disposition within most recent five-year period. recipient must also semiannual disclosures regarding such proceedings.Proceedings information be publicly available the designated integrity performance system currently FAPIIS). is statutory requirement under section 872 Public Law 110-417, amended 41 U.S.C. 2313). required section 3010 Public Law 111-212, information posted the designated integrity performance system or after April 15, 2011, except past performance reviews required Federal procurement contracts, be publicly available. Full reporting requirements procedures found Appendix XII 45 CFR Part 75 – Award Term Conditions Recipient Integrity Performance Matters. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email: mary.pelleymounter@nih.gov

Notice Pre-Application Webinar FAQs RFA-NS-19-022, Biological Measures Prognosing Monitoring Persistent Concussive Symptoms Early Middle Adolescents: Center Without Walls PCS-EMA CWOW) U54 Clinical Trial Allowed)” Notice Number: NOT-NS-19-038 Key Dates Release Date: March 4, 2019 Related Announcements RFA-NS-19-022 Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Neurological Disorders Stroke NINDS) Purpose February 7, 2019, NIH issued following Funding Opportunity Announcement FOA): RFA-NS-19-022,Biological Measures Prognosing Monitoring Persistent Concussive Symptoms Early Middle Adolescents: Center Without Walls PCS-EMA CWOW) U54 Clinical Trial Allowed) assist potential applicants the above-referenced FOA, Notice provides following information: Pre-Application Information Webinar potential applicants responding the Initiative ldquo;Biological Measures Prognosing Monitoring Persistent Concussive Symptoms Early Middle Adolescents: Center Without Walls PCS-EMA CWOW)” be provided March 6, 2019. PCS-EMA CWOW Webinar Information Date: March 6, 2019 Time: 3:00 – 4:00 pm ET intent the pre-application webinar to provide overview the PCS-EMA CWOW FOA 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, posted at: https://www.ninds.nih.gov/News-Events/Events-Proceedings/Events/Webinar…. Following webinar, NINDS 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: Patrick Bellgowan, Ph.D. National Institute Neurological Disorders Stroke NINDS)Telephone:  301-496-1447 Email: pcsema_cwow@mail.nih.gov

Notice Correction Award Budget RFA-NS-19-009 Promoting Research Music Health: Fundamentals Applications R21 Clinical Trials Optional) " Notice Number: NOT-NS-19-039 Key Dates Release Date: March 4, 2019 Related Announcements RFA-NS-19-009 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants a correction the Award Budget RFA-NS-19-009 Promoting Research Music Health: Fundamentals Applications R21 Clinical Trial Optional)." Award Budget been modified include information was erroneously stated. Award Budget states The R21 award not exceed 275,000.00 cumulative direct costs more 150,000.00 direct costs either the years." Indirect costs not considered this budget cap. Currently Reads: Section II Award Information Award Budget: R21 award not exceed 275,000.00 cumulative total costs more 150,000.00 either the years. Modified Read: Section II Award Information Award Budget: R21 award not exceed 275,000.00 cumulative direct costs more 150,000.00 in direct costs for either the years. others aspects this FOA remain same. Inquiries Please direct inquiries to: Robert Riddle, Ph.D.National Institute Neurological Disorders Stroke NINDS)Telephone: 301-496-5745E-mail: riddlerr@ninds.nih.gov

Notice Removal Matching Requirements RFA-NS-18-041 Discovery Biomarkers, Biomarker Signatures, Endpoints Pain R61/R33 Clinical Trial Optional)" Notice Number: NOT-NS-19-036 Key Dates Release Date : February 14, 2019 Rescinded March 6, 2019) Related Announcements RFA-NS-18-041 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform applicants the removal the Cost Matching Requirement Instructions RFA-NS-18-041 Discovery Biomarkers, Biomarker Signatures, Endpoints Pain R61/R33 Clinical Trial Optional)”. will longer a Cost Matching Requirement this Funding Opportunity Announcement FOA).  notice be effective the next application due date March 7, 2019 subsequent application due dates. Currently Reads: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH HEAL Helping End Addiction Long-term) Initiative—an aggressive, trans-agency effort speed scientific solutions stem national opioid public health crisis.  than 25 million Americans suffer chronic pain, 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 scientific solutions develop alternative treatment options thus critically needed. challenges facing development non-opioid alternative pain medications include: lack reliable measures pain biology perception, difficult regulatory path high safety labeling hurdles, poor predictive power preclinical models, a paucity validated targets.  addition, patient populations heterogeneous across multiple pain conditions, high variability individual responses intervention. potential solution toward accelerating discovery development alternative pain therapies the of objective biomarkers endpoints could define pathophysiologic subsets pain, evaluate target engagement a therapeutic predict analgesic efficacy new therapeutics. Unfortunately, are very few validated biomarkers available provide information described above. Therefore, goal this FOA to promote discovery promising candidate biomarkers, biomarker signatures endpoints pain indications will withstand rigorous validation ultimately provide tools necessary the development non-opioid therapeutics the treatment pain conditions. 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. 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.  45 CFR 75.306 additional details. Modified Read: Part 2. Full Announcement Text Announcement Section I. Funding Opportunity Description Background: FOA part the NIH HEAL Helping End Addiction Long-term) Initiative—an aggressive, trans-agency effort speed scientific solutions stem national opioid public health crisis.  than 25 million Americans suffer chronic pain, 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 scientific solutions develop alternative treatment options thus critically needed. challenges facing development non-opioid alternative pain medications include: lack reliable measures pain biology perception, difficult regulatory path high safety labeling hurdles, poor predictive power preclinical models, a paucity validated targets.  addition, patient populations heterogeneous across multiple pain conditions, high variability individual responses intervention. potential solution toward accelerating discovery development alternative pain therapies the of objective biomarkers endpoints could define pathophysiologic subsets pain, evaluate target engagement a therapeutic predict analgesic efficacy new therapeutics. Unfortunately, are very few validated biomarkers available provide information described above. Therefore, goal this FOA to promote discovery promising candidate biomarkers, biomarker signatures endpoints pain indications will withstand rigorous validation ultimately provide tools necessary the development non-opioid therapeutics the treatment pain conditions. Currently Reads: Section II. Award Information Award Budget Application budgets not limited need reflect actual needs the proposed project. mentioned NOT-OD-18-181, any for-profit recipient funds shall subject a matching requirement funds documented in-kind contributions not less 50 percent the total funds awarded such entity. Modified Read: Section II. Award Information Award Budget Application budgets not limited need reflect actual needs the proposed project. 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. grantees a for-profit organization, FOA does not-require cost sharing. 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.  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. 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 letters support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing intellectual property associated this project. research be performed more one institution, include letter support each institution clarifying intellectual property be shared otherwise managed across institutions. collaborating a private entity, include letter support addresses any agreement provide agent(s), any limits the studies can performed said agent(s), any limitations sharing data including negative results), whether licensing agreement(s) be needed in place once project funded. letter should from designated official within private entity has authority speak these issues. an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration data sharing must included. utilization extant samples proposed a component the study, letters support approval use those samples should included. 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 letters support consultants, contractors, collaborators. applying an academic institution, include letter support the technology transfer official will managing intellectual property associated this project. research be performed more one institution, include letter support each institution clarifying intellectual property be shared otherwise managed across institutions. collaborating a private entity, include letter support addresses any agreement provide agent(s), any limits the studies can performed said agent(s), any limitations sharing data including negative results), whether licensing agreement(s) be needed in place once project funded. letter should from designated official within private entity has authority speak these issues. an application plans utilize infrastructure resources existing projects, whether funded the NIH, governmental non-governmental entities, letters support detailing terms collaboration data sharing must included. utilization extant samples proposed a component the study, letters support approval use those samples should included. Currently Reads: Section V. Application Review Information 1. Criteria Additional Review Considerations Budget Period Support  Reviewers consider whether budget the requested period support fully justified reasonable relation the proposed research.  Specific this FOA: How likely it the plans cost matching be adequate? Modified Read: Section V. Application Review Information 1. Criteria Additional Review Considerations Budget Period Support  Reviewers consider whether budget the requested period support fully justified reasonable relation the proposed research. Currently Reads: Section VI. Award Administration Information 2. Administrative National Policy Requirements NIH grant cooperative agreement awards include the NIH Grants Policy Statement as part the NoA. these terms award, the NIH Grants Policy Statement Part II: Terms Conditions NIH Grant Awards, Subpart A: General  and Part II: Terms Conditions NIH Grant Awards, Subpart B: Terms Conditions Specific Types Grants, Grantees, Activities. information provided at Award Conditions Information NIH Grants. Recipients federal financial assistance FFA) HHS must administer programs compliance federal civil rights law. means recipients HHS funds must ensure equal access their programs without regard a person’s race, color, national origin, disability, age and, some circumstances, sex religion. includes ensuring programs accessible persons limited English proficiency.  HHS recognizes research projects often limited scope many reasons are nondiscriminatory, such the principal investigator’s scientific interest, funding limitations, recruitment requirements, other considerations. Thus, criteria research protocols target exclude certain populations warranted where nondiscriminatory justifications establish such criteria appropriate respect the health safety the subjects, scientific study design, the purpose the research. accordance the statutory provisions contained Section 872 the Duncan Hunter National Defense Authorization Act Fiscal Year 2009 Public Law 110-417), NIH awards be subject the Federal Awardee Performance Integrity Information System FAPIIS) requirements.  FAPIIS requires Federal award making officials review consider information an applicant the designated integrity performance system currently FAPIIS) prior making award.  applicant, its option, review information the designated integrity performance systems accessible through FAPIIS comment any information itself a Federal agency previously entered is currently FAPIIS.  Federal awarding agency consider any comments the applicant, addition other information FAPIIS, making judgement the applicant’s integrity, business ethics, record performance under Federal awards completing review risk posed applicants described 45 CFR Part 75.205 Federal awarding agency review risk posed applicants.”  provision apply all NIH grants cooperative agreements except fellowships. additional guidance regarding the provisions apply NIH grant programs, please contact Scientific/Research Contact is identified Section VII under Agency Contacts this FOA. HHS provides general guidance recipients FFA meeting legal obligation take reasonable steps provide meaningful access their programs persons limited English proficiency. Please https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited…. HHS Office Civil Rights also provides guidance complying civil rights laws enforced HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidanc…. Recipients FFA also specific legal obligations serving qualified individuals disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact HHS Office Civil Rights more information obligations prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 TDD 1-800-537-7697. Also note is HHS Departmental goal ensure access quality, culturally competent care, including long-term services supports, vulnerable populations. further guidance providing culturally linguistically appropriate services, recipients should review National Standards Culturally Linguistically Appropriate Services Health Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53. Special award condition specific this FOA: A 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. 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. Modified Read: Section VI. Award Administration Information 2. Administrative National Policy Requirements NIH grant cooperative agreement awards include the NIH Grants Policy Statement as part the NoA. these terms award, the NIH Grants Policy Statement Part II: Terms Conditions NIH Grant Awards, Subpart A: General  and Part II: Terms Conditions NIH Grant Awards, Subpart B: Terms Conditions Specific Types Grants, Grantees, Activities. information provided at Award Conditions Information NIH Grants. Recipients federal financial assistance FFA) HHS must administer programs compliance federal civil rights law. means recipients HHS funds must ensure equal access their programs without regard a person’s race, color, national origin, disability, age and, some circumstances, sex religion. includes ensuring programs accessible persons limited English proficiency.  HHS recognizes research projects often limited scope many reasons are nondiscriminatory, such the principal investigator’s scientific interest, funding limitations, recruitment requirements, other considerations. Thus, criteria research protocols target exclude certain populations warranted where nondiscriminatory justifications establish such criteria appropriate respect the health safety the subjects, scientific study design, the purpose the research. accordance the statutory provisions contained Section 872 the Duncan Hunter National Defense Authorization Act Fiscal Year 2009 Public Law 110-417), NIH awards be subject the Federal Awardee Performance Integrity Information System FAPIIS) requirements.  FAPIIS requires Federal award making officials review consider information an applicant the designated integrity performance system currently FAPIIS) prior making award.  applicant, its option, review information the designated integrity performance systems accessible through FAPIIS comment any information itself a Federal agency previously entered is currently FAPIIS.  Federal awarding agency consider any comments the applicant, addition other information FAPIIS, making judgement the applicant’s integrity, business ethics, record performance under Federal awards completing review risk posed applicants described 45 CFR Part 75.205 Federal awarding agency review risk posed applicants.”  provision apply all NIH grants cooperative agreements except fellowships. additional guidance regarding the provisions apply NIH grant programs, please contact Scientific/Research Contact is identified Section VII under Agency Contacts this FOA. HHS provides general guidance recipients FFA meeting legal obligation take reasonable steps provide meaningful access their programs persons limited English proficiency. Please https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited…. HHS Office Civil Rights also provides guidance complying civil rights laws enforced HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidanc…. Recipients FFA also specific legal obligations serving qualified individuals disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact HHS Office Civil Rights more information obligations prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 TDD 1-800-537-7697. Also note is HHS Departmental goal ensure access quality, culturally competent care, including long-term services supports, vulnerable populations. further guidance providing culturally linguistically appropriate services, recipients should review National Standards Culturally Linguistically Appropriate Services Health Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD  National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779  Email: mary.pelleymounter@nih.gov

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