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