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Notice Expiration PAR-17-277 NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention Infrastructure Resource Access X01)" Notice Number: NOT-NS-18-036 Key Dates Release Date:   January 12, 2018 Related Announcements PAR-17-277 Issued National Institute Neurological Disorders Stroke NINDS) Purpose notice announces expiration PAR-17-277 quot;NIH StrokeNet Clinical Trials Biomarker Studies Stroke Treatment, Recovery, Prevention Infrastructure Resource Access X01)" effective January 24, 2018. last date NINDS accept applications PAR-17-277 January 23, 2018. Part 1: Overview nbsp; Key Dates: Currently Reads: Application Due Date(s): Applications accepted continuous receipt. Council Round                   Receipt Window January                             June 11 – October 10 May      nbsp;                           October 11 – February 10 October                             New Date February 11 – June 10 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Modified Read: Application Due Date(s): Applications accepted continuous receipt. Council Round                   Receipt Window May      nbsp;                           nbsp;October 11 – January 23, 2018 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Currently Reads: Expiration Date: March 6, 2020 Modified Read: Expiration Date: January 24, 2018 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Claudia Scala Moy, PhD National Institute Neurological Disorders amp; Stroke NINDS) Telephone: 301-496-9135 Email: moyc@ninds.nih.gov

Notice Intent Publish Funding Opportunity Announcement Support New Applications Regenerative Medicine Innovation Projects RMIP) UG3/UH3 - Clinical Trial Required) Notice Number: NOT-HL-18-573 Key Dates Release Date: January 12, 2018 Estimated Publication Date Funding Opportunity Announcement: 02/15/2018 First Estimated Application Due Date:05/15/2018 Earliest Estimated Award Date:09/14/2018 Earliest Estimated Start Date: 10/15/2018 Related Announcements RFA-HL-18-031 NOT-HL-19-700 NOT-HL-18-574 NOT-HL-18-575 NOT-HL-18-576 NOT-HL-18-577 NOT-HL-18-578 Issued National Heart, Lung, Blood Institute ( NHLBI) National Eye Institute ( NEI) National Institute Aging ( NIA) National Institute Allergy Infectious Diseases ( NIAID) National Institute Arthritis Musculoskeletal Skin Diseases ( NIAMS) National Institute Biomedical Imaging Bioengineering ( NIBIB) National Institute Deafness Other Communication Disorders ( NIDCD) National Institute Dental Craniofacial Research ( NIDCR) National Institute Diabetes Digestive Kidney Diseases ( NIDDK) National Institute Mental Health ( NIMH) National Institute Neurological Disorders Stroke ( NINDS) National Center Advancing Translational Sciences ( NCATS) U.S. Food Drug Administration ( FDA)  Purpose National Institutes Health NIH) participating NIH Institutes Centers ICs) the U.S. Food Drug Administration FDA) intend publish Funding Opportunity Announcement FOA) new applications will support investigator-initiated clinical trials aimed furthering field regenerative medicine RM) using adult stem cells. Applicants must apply undergo peer review.   planned FOA, known the Regenerative Medicine Innovation Project RMIP), support new projects utilize rigorous science reproducible methods establish proof concept a robust evidence base clinical interventions. In order fulfill mandate advancing field RM broadly, applicants propose solutions widely recognized issues the development safe effective RM therapies. Emphasis be given projects use RM interventions and/or products demonstrated be ready advancing clinical trials. Applicants be encouraged include plans project management, subject recruitment retention, performance milestones, scientific conduct the trial, dissemination results.   Toward ends, NIH consider applications clinical trials involving adult stem cells the context generating supplementing necessary evidence clinical development, including support such research conducted under authorized IND IDE.  Potential applicants encouraged review additional information the RMIP answers frequently asked questions the RMIP website. Inquiries be sent RMIP@nih.gov.   FOA utilize UG3/UH3 activity code employs bi-phasic, milestone-driven cooperative agreement mechanism award is expected be published February 2018 an application due date May 2018.   Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds below). note, and five Notices being issued a total 28 million overall, 10 million which available award FY 2018 order solicit new projects for mechanisms listed herein under Related Announcements. Research Initiative Details RMIP FOA represents step fulfilling new statutory provision set forth the 21st Century Cures Act. Given potential RM enhance human health treat disease, Congress included provision an Innovation Project the Act authorizing total 30 million the funding clinical research further field RM using adult stem cells, including autologous cells. Act stipulates the NIH, coordination FDA, award funds contingent upon recipient making available non-Federal contributions an amount less 1 each 1 Federal funds provided the award i.e., matching funds requirement).   RMIP FOA intended support only research involves: 1) human subjects material human origin, such cells, tissues, specimens; 2) human stem cells are of embryonic fetal origin.  Applicable research adult human stem cells encompass, example, research biologics e.g., growth factors, cytokines) biomaterials e.g., ECM, scaffolds) stimulate host adult stem cell growth, differentiation, function otherwise directly act upon adult stem cells support innate host healing mechanisms, treat disease, and/or restore function. Funds not used research involving human cells embryonic fetal origin.    FOA support highly meritorious clinical trials proposing explore enable development safe effective RM interventions. Specifically, FY 2018 funds, addition being subject the standard NIH review criteria, clinical trials also assessed according the following criteria:   RM interventions and/or products demonstrating readiness advancing clinical trials under IND/IDE application; Matching funds available time award; Contributes breadth/diversity RM science; Addresses critical issues relevant clinical research regulatory submissions including those related improved evaluation product quality, clinical safety, effectiveness; Will help significantly build advance field RM contributing fundamental knowledge well addressing well-recognized challenge clinical development including development evaluation safe effective RM products.   Applications demonstrate potential catalyze sustained accelerated development the RM field through contributing the foundational knowledge critical clinical testing, data standards sharing, strongly encouraged. example, such projects may:   Promote enhance mechanisms data standardization, curation, integration, sharing; Utilize clinical trial network(s) leverage infrastructure facilitate subject recruitment follow as well data sharing; Contribute a better shared understanding current technical operational barriers well the regulatory science issues; and/or Monitor stem cell function integration vivo.   Matching Requirement Government requires least 1:1 recipient cost matching all federal funds awarded this program, required the 21st Century Cures Act. Government consider any non-federal funds, include state local funding originating Federal funds), well private-sector investment, in-kind contributions, donations foundations provided support the application qualifying the cost matching ratio requirement. information the RMIP matching requirement be found the RMIP website. Funding Information Estimated Total Funding 28 million Expected Number Awards 5 Estimated Award Ceiling 10 million Primary CFDA Numbers 93.837, 93.838, 93.839, 93.840, 93.233 Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Regional Organization Applications not being solicited this time. Inquiries Please direct inquiries to: Allan Shipp National Heart, Lung, Blood Institute ( NHLBI) 301-435-2152 RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support New Applications Regenerative Medicine Innovation Projects RMIP) U01 - Clinical Trial Allowed) Notice Number: NOT-HL-18-574 Key Dates Release Date:January 12, 2018 Estimated Publication Date Funding Opportunity Announcement: 02/15/2018 First Estimated Application Due Date: 05/15/2018 Earliest Estimated Award Date: 09/14/2018 Earliest Estimated Start Date: 10/15/2018 Related Announcements RFA-HL-18-030 NOT-HL-18-573 NOT-HL-18-575 NOT-HL-18-576 NOT-HL-18-577 NOT-HL-18-578 Issued National Heart, Lung, Blood Institute ( NHLBI) National Eye Institute ( NEI) National Institute Aging ( NIA) National Institute Allergy Infectious Diseases ( NIAID) National Institute Arthritis Musculoskeletal Skin Diseases ( NIAMS) National Institute Biomedical Imaging Bioengineering ( NIBIB) National Institute Deafness Other Communication Disorders ( NIDCD) National Institute Dental Craniofacial Research ( NIDCR) National Institute Diabetes Digestive Kidney Diseases ( NIDDK) National Institute Mental Health ( NIMH) National Institute Neurological Disorders Stroke ( NINDS) National Center Advancing Translational Sciences ( NCATS) U.S. Food Drug Administration ( FDA) Purpose National Institutes Health NIH) participating NIH Institutes Centers ICs) the U.S. Food Drug Administration FDA) intend publish Funding Opportunity Announcement FOA) new applications will support clinical research studies aimed furthering field regenerative medicine RM) using adult stem cells. Applicants must apply undergo peer review.   planned FOA, known the Regenerative Medicine Innovation Project RMIP), support new projects utilize rigorous science reproducible methods establish proof concept a robust evidence base clinical applications.  order fulfill mandate advancing field RM broadly, applicants propose solutions widely recognized issues the development safe effective RM therapies. Emphasis be given projects address critical issues product development relevant regulatory submissions. Areas focus include improved tools, methods, standards, applied science support better understanding improved evaluation product manufacturing, quality, safety, effectiveness.    Toward ends, NIH consider applications clinical research involving adult stem cells the context generating supplementing necessary evidence clinical development, including submission a pre-Investigational New Drug IND) pre-Investigational New Device Exemption IDE) package; submission an IND/IDE application; to support such research conducted under authorized IND IDE.  Potential applicants encouraged review additional information the RMIP answers frequently asked questions the RMIP website. Inquiries be sent to RMIP@nih.gov.   FOA utilize U01 activity code is expected be published February 2018 an application due date May 2018.   Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds below). note, and five Notices being issued a total 28 million overall, 10 million which available award FY 2018 order solicit new projects for mechanisms listed herein under Related Announcements. Research Initiative Details RMIP FOA represents step fulfilling new statutory provision set forth the 21st Century Cures Act. Given potential RM enhance human health treat disease, Congress included provision an Innovation Project the Act authorizing total 30 million the funding clinical research further field RM using adult stem cells, including autologous cells. Act stipulates the NIH, coordination FDA, award funds contingent upon recipient making available non-Federal contributions an amount less 1 each 1 Federal funds provided the award i.e., matching funds requirement).   RMIP FOA intended support only research involves: 1) human subjects material human origin, such cells, tissues, specimens; 2) human stem cells are of embryonic fetal origin. Applicable research adult human stem cells encompass, example, research biologics e.g., growth factors, cytokines) biomaterials e.g., ECM, scaffolds) stimulate host adult stem cell growth, differentiation, function otherwise directly act upon adult stems cells support innate host healing mechanisms, treat disease, and/or restore function. Funding be used, example, the appropriate chemistry, manufacturing, controls development support production such products clinical trials using good manufacturing practices GMP). Funds not used research involving human cells embryonic fetal origin.    FOA support highly meritorious clinical research projects proposing explore enable development safe effective RM interventions. Specifically, FY 2018 funds, addition being subject the standard NIH review criteria, clinical research projects also assessed according the following criteria:   Does include a clinical trial (for clinical trial applications see NOT-HL-18-573); Matching funds available time award; Contributes breadth/diversity RM science; Addresses critical issues relevant clinical research regulatory submissions including those related product development. Areas focus include improved tools, methods, standards, applied science support better understanding improved evaluation product manufacturing, quality, safety, effectiveness; Will help significantly build advance field RM contributing fundamental knowledge well addressing well-recognized challenge clinical development including development evaluation safe effective RM products.   Applications demonstrate potential catalyze sustained accelerated development the RM field through contributing the foundational knowledge critical product development, clinical testing, data standards sharing, strongly encouraged. example, such projects may:   Further development standards GMP adult stem cell-based RM products; Leverage extant cell production facilities product preparation qualification; Promote enhance mechanisms data standardization, curation, integration, sharing; Contribute a better shared understanding current technical operational barriers well the regulatory science issues; and/or Monitor stem cell function integration vivo.   Matching Requirement   Government requires least 1:1 recipient cost matching this program, required the 21st Century Cures Act. Government consider any non-federal funds, include state local funding originating Federal funds), well private-sector investment, in-kind contributions, donations foundations provided support the application qualifying the cost matching ratio requirement. information the RMIP matching requirement be found the RMIP website. Funding Information Estimated Total Funding 28 million Expected Number Awards 5 Estimated Award Ceiling 10 million Primary CFDA Numbers 93.837, 93.838, 93.839, 93.840, 93.233 Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Nonprofit without 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments City township governments Special district governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Regional Organization Applications not being solicited this time. Inquiries Please direct inquiries to: Allan Shipp National Heart, Lung, Blood Institute ( NHLBI) 301-435-2152 RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support New Applications Regenerative Medicine Innovation Projects RMIP) UT1/UT2 - Clinical Trial Required) Notice Number: NOT-HL-18-575 Key Dates Release Date:January 12, 2018 Estimated Publication Date Funding Opportunity Announcement: 02/15/2018 First Estimated Application Due Date: 05/15/2018 Earliest Estimated Award Date: 09/14/2018 Earliest Estimated Start Date: 10/15/2018 Related Announcements NOT-HL-18-573 NOT-HL-18-574 NOT-HL-18-576 NOT-HL-18-577 NOT-HL-18-578 Issued National Heart, Lung, Blood Institute NHLBI) National Eye Institute NEI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Advancing Translational Sciences NCATS) U.S. Food Drug Administration ( FDA)  Purpose National Institutes Health NIH) participating NIH Institutes Centers ICs) the U.S. Food Drug Administration FDA) intend publish Funding Opportunity Announcement FOA) new applications will support investigator-initiated clinical trials aimed furthering field regenerative medicine RM) using adult stem cells.  Applicants must apply undergo peer review.   planned FOA, known the Regenerative Medicine Innovation Project RMIP), support new projects utilize rigorous science reproducible methods establish proof concept a robust evidence base clinical interventions. In order fulfill mandate advancing field RM broadly, applicants propose solutions widely recognized issues the development safe effective RM therapies. Emphasis be given projects use RM interventions and/or products demonstrated be ready advancing clinical trials. Applicants be encouraged include plans project management, subject recruitment retention, performance milestones, scientific conduct the trial, dissemination results.   Toward ends, NIH consider applications clinical trials involving adult stem cells the context generating supplementing necessary evidence clinical development, including support such research conducted under authorized IND IDE. Potential applicants encouraged review additional information the RMIP answers frequently asked questions the RMIP website. Inquiries be sent RMIP@nih.gov.   FOA utilize UT1/UT2 activity code is expected be published February 2018 an application due date May 2018.   Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds below). note, and five Notices being issued a total 28 million overall, 10 million which available award FY 2018 order solicit new projects for mechanisms listed herein under Related Announcements. Research Initiative Details RMIP FOA represents step fulfilling new statutory provision set forth the 21st Century Cures Act. Given potential RM enhance human health treat disease, Congress included provision an Innovation Project the Act authorizing total 30 million the funding clinical research further field RM using adult stem cells, including autologous cells. Act stipulates the NIH, coordination FDA, award funds contingent upon recipient making available non-Federal contributions an amount less 1 each 1 Federal funds provided the award i.e., matching funds requirement).   RMIP FOA intended support only research involves: 1) human subjects material human origin, such cells, tissues, specimens; 2) human stem cells are of embryonic fetal origin.  Applicable research adult human stem cells encompass, example, research biologics e.g., growth factors, cytokines) biomaterials e.g., ECM, scaffolds) stimulate host adult stem cell growth, differentiation, function otherwise directly act upon adult stem cells support innate host healing mechanisms, treat disease, and/or restore function. Funds not used research involving human cells embryonic fetal origin.    FOA support highly meritorious clinical trials proposing explore enable development safe effective RM interventions. Specifically, FY 2018 funds, addition being subject the standard NIH review criteria, clinical trials also assessed according the following criteria:   RM interventions and/or products demonstrating readiness advancing clinical trials under IND/IDE application; Matching funds available time award; Contributes breadth/diversity RM science; Addresses critical issues relevant clinical research regulatory submissions including those related improved evaluation product quality, clinical safety, effectiveness; Will help significantly build advance field RM contributing fundamental knowledge well addressing well-recognized challenge clinical development including development evaluation safe effective RM products. Applications demonstrate potential catalyze sustained accelerated development the RM field through contributing the foundational knowledge critical clinical testing, data standards sharing, strongly encouraged. example, such projects may:   Promote enhance mechanisms data standardization, curation, integration, sharing; Utilize clinical trial network(s) leverage infrastructure facilitate subject recruitment follow as well data sharing; Contribute a better shared understanding current technical operational barriers well the regulatory science issues; and/or Monitor stem cell function integration vivo. Matching Requirement Government requires least 1:1 recipient cost matching all federal funds awarded this program, required the 21st Century Cures Act. Government consider any non-federal funds, include state local funding originating Federal funds), well private-sector investment, in-kind contributions, donations foundations provided support the application qualifying the cost matching ratio requirement. information the RMIP matching requirement be found the RMIP website. Funding Information Estimated Total Funding 28 million Expected Number Awards 5 Estimated Award Ceiling 10 million Primary CFDA Numbers 93.837, 93.838, 93.839, 93.840, 93.233 Anticipated Eligible Organizations Small Business Applications not being solicited this time. Inquiries Please direct inquiries to: Allan Shipp National Heart, Lung, Blood Institute ( NHLBI) 301-435-2152 RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support New Applications Regenerative Medicine Innovation Projects RMIP) UT1/UT2 - Clinical Trial Allowed) Notice Number: NOT-HL-18-576 Key Dates Release Date:January 12, 2018 Estimated Publication Date Funding Opportunity Announcement: 02/15/2018 First Estimated Application Due Date: 05/15/2018 Earliest Estimated Award Date: 09/14/2018 Earliest Estimated Start Date: 10/15/2018 Related Announcements RFA-HL-18-033 NOT-HL-18-573 NOT-HL-18-574 NOT-HL-18-575 NOT-HL-18-577 NOT-HL-18-578 Issued National Heart, Lung, Blood Institute NHLBI) National E?y?e Institute NEI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Advancing Translational Sciences NCATS) U.S. Food Drug Administration ( FDA)  Purpose National Institutes Health NIH) participating NIH Institutes Centers ICs) the U.S. Food Drug Administration FDA) intend publish Funding Opportunity Announcement FOA) new applications will support clinical research studies aimed furthering field regenerative medicine RM) using adult stem cells. Applicants must apply undergo peer review.   planned FOA, known the Regenerative Medicine Innovation Project RMIP), support new projects utilize rigorous science reproducible methods establish proof concept a robust evidence base clinical applications. In order fulfill mandate advancing field RM broadly, applicants propose solutions widely recognized issues the development safe effective RM therapies. Emphasis be given projects address critical issues product development relevant regulatory submissions. Areas focus include improved tools, methods, standards, applied science support better understanding improved evaluation product manufacturing, quality, safety, effectiveness.    Toward ends, NIH consider applications clinical research involving adult stem cells the context generating supplementing necessary evidence clinical development, including submission a pre-Investigational New Drug IND) pre-Investigational New Device Exemption IDE) package; submission an IND/IDE application; to support such research conducted under authorized IND IDE. Potential applicants encouraged review additional information the RMIP answers frequently asked questions the RMIP website. Inquiries be sent to RMIP@nih.gov.   FOA utilize UT1/UT2 activity code is expected be published February 2018 an application due date May 2018.   Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds below). note, and five Notices being issued a total 28 million overall, 10 million which available award FY 2018 order solicit new projects for mechanisms listed herein under Related Announcements. Research Initiative Details RMIP FOA represents step fulfilling new statutory provision set forth the 21st Century Cures Act. Given potential RM enhance human health treat disease, Congress included provision an Innovation Project the Act authorizing total 30 million the funding clinical research further field RM using adult stem cells, including autologous cells. Act stipulates the NIH, coordination FDA, award funds contingent upon recipient making available non-Federal contributions an amount less 1 each 1 Federal funds provided the award i.e., matching funds requirement). RMIP FOA intended support only research involves: 1) human subjects material human origin, such cells, tissues, specimens; 2) human stem cells are of embryonic fetal origin.  Applicable research adult human stem cells encompass, example, research biologics e.g., growth factors, cytokines) biomaterials e.g., ECM, scaffolds) stimulate host adult stem cell growth, differentiation, function otherwise directly act upon adult stems cells support innate host healing mechanisms, treat disease, and/or restore function. Funding be used, example, the appropriate chemistry, manufacturing, controls development support production such products clinical trials using good manufacturing practices GMP). Funds not used research involving human cells embryonic fetal origin.    FOA support highly meritorious clinical research projects proposing explore enable development safe effective RM interventions. Specifically, FY 2018 funds, addition being subject the standard NIH review criteria, clinical research projects also assessed according the following criteria:   Does include a clinical trial (for clinical trial applications see NOT-HL-18-575); Matching funds available time award; Contributes breadth/diversity RM science; Addresses critical issues relevant clinical research regulatory submissions including those related product development. Areas focus include improved tools, methods, standards, applied science support better understanding improved evaluation product manufacturing, quality, safety, effectiveness; Will help significantly build advance field RM contributing fundamental knowledge well addressing well-recognized challenge clinical development including development evaluation safe effective RM products.   Applications demonstrate potential catalyze sustained accelerated development the RM field through contributing the foundational knowledge critical product development, clinical testing, data standards sharing, strongly encouraged. example, such projects may:   Further development standards GMP adult stem cell-based RM products; Leverage extant cell production facilities product preparation qualification; Promote enhance mechanisms data standardization, curation, integration, sharing; Contribute a better shared understanding current technical operational barriers well the regulatory science issues; and/or Monitor stem cell function integration vivo.   Matching Requirement Government requires least 1:1 recipient cost matching this program, required the 21st Century Cures Act. Government consider any non-federal funds, include state local funding originating Federal funds), well private-sector investment, in-kind contributions, donations foundations provided support the application qualifying the cost matching ratio requirement. information the RMIP matching requirement be found the RMIP website. Funding Information Estimated Total Funding 28 million Expected Number Awards 5 Estimated Award Ceiling 10 million Primary CFDA Numbers 93.837, 93.838, 93.839, 93.940, 93.233 Anticipated Eligible Organizations Small Business Applications not being solicited this time. Inquiries Please direct inquiries to: Allan Shipp National Heart, Lung, Blood Institute NHLBI) 301-435-2152 RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support New Applications Regenerative Medicine Innovation Projects RMIP) U43/U44 - Clinical Trial Required) Notice Number: NOT-HL-18-577 Key Dates Release Date:January 12, 2018 Estimated Publication Date Funding Opportunity Announcement: 02/15/2018 First Estimated Application Due Date: 05/15/2018 Earliest Estimated Award Date: 09/14/2018 Earliest Estimated Start Date: 10/15/2018 Related Announcements NOT-HL-18-573 NOT-HL-18-574 NOT-HL-18-575 NOT-HL-18-576 NOT-HL-18-578 Issued National Heart, Lung, Blood Institute ( NHLBI) National Eye Institute ( NEI) National Institute Aging ( NIA) National Institute Allergy Infectious Diseases ( NIAID) National Institute Biomedical Imaging Bioengineering ( NIBIB) National Institute Deafness Other Communication Disorders ( NIDCD) National Institute Dental Craniofacial Research ( NIDCR) National Institute Diabetes Digestive Kidney Diseases ( NIDDK) National Institute Mental Health ( NIMH) National Institute Neurological Disorders Stroke ( NINDS) National Center Advancing Translational Sciences ( NCATS) U.S. Food Drug Administration ( FDA) Purpose National Institutes Health NIH) participating NIH Institutes Centers ICs) the U.S. Food Drug Administration FDA) intend publish Funding Opportunity Announcement FOA) new applications will support investigator-initiated clinical trials aimed furthering field regenerative medicine RM) using adult stem cells.  Applicants must apply undergo peer review.   planned FOA, known the Regenerative Medicine Innovation Project RMIP), support new projects utilize rigorous science reproducible methods establish proof concept a robust evidence base clinical interventions. In order fulfill mandate advancing field RM broadly, applicants propose solutions widely recognized issues the development safe effective RM therapies. Emphasis be given projects use RM interventions and/or products demonstrated be ready advancing clinical trials. Applicants be encouraged include plans project management, subject recruitment retention, performance milestones, scientific conduct the trial, dissemination results.   Toward ends, NIH consider applications clinical trials involving adult stem cells the context generating supplementing necessary evidence clinical development, including support such research conducted under authorized IND IDE. Potential applicants encouraged review additional information the RMIP answers frequently asked questions the RMIP website. Inquiries be sent RMIP@nih.gov.   FOA utilize U43/U44 activity code is expected be published February 2018 an application due date May 2018.   Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds below). note, and five Notices being issued a total 28 million overall, 10 million which available award FY 2018 order solicit new projects for mechanisms listed herein under Related Announcements. Research Initiative Details RMIP FOA represents step fulfilling new statutory provision set forth the 21st Century Cures Act. Given potential RM enhance human health treat disease, Congress included provision an Innovation Project the Act authorizing total 30 million the funding clinical research further field RM using adult stem cells, including autologous cells. Act stipulates the NIH, coordination FDA, award funds contingent upon recipient making available non-Federal contributions an amount less 1 each 1 Federal funds provided the award i.e., matching funds requirement).   RMIP FOA intended support only research involves: 1) human subjects material human origin, such cells, tissues, specimens; 2) human stem cells are of embryonic fetal origin. Applicable research adult human stem cells encompass, example, research biologics e.g., growth factors, cytokines) biomaterials e.g., ECM, scaffolds) stimulate host adult stem cell growth, differentiation, function otherwise directly act upon adult stem cells support innate host healing mechanisms, treat disease, and/or restore function. Funds not used research involving human cells embryonic fetal origin.    FOA support highly meritorious clinical trials proposing explore enable development safe effective RM interventions. Specifically, FY 2018 funds, addition being subject the standard NIH review criteria, clinical trials also assessed according the following criteria:   RM interventions and/or products demonstrating readiness advancing clinical trials under IND/IDE application; Matching funds available time award; Contributes breadth/diversity RM science; Addresses critical issues relevant clinical research regulatory submissions including those related improved evaluation product quality, clinical safety, effectiveness; Will help significantly build advance field RM contributing fundamental knowledge well addressing well-recognized challenge clinical development including development evaluation safe effective RM products.   Applications demonstrate potential catalyze sustained accelerated development the RM field through contributing the foundational knowledge critical clinical testing, data standards sharing, strongly encouraged. example, such projects may:   Promote enhance mechanisms data standardization, curation, integration, sharing; Utilize clinical trial network(s) leverage infrastructure facilitate subject recruitment follow as well data sharing; Contribute a better shared understanding current technical operational barriers well the regulatory science issues; and/or Monitor stem cell function integration vivo.   Matching Requirement Government requires least 1:1 recipient cost matching all federal funds awarded this program, required the 21st Century Cures Act. Government consider any non-federal funds, include state local funding originating Federal funds), well private-sector investment, in-kind contributions, donations foundations provided support the application qualifying the cost matching ratio requirement. information the RMIP matching requirement be found the RMIP website. Funding Information Estimated Total Funding 28 million Expected Number Awards 5 Estimated Award Ceiling 10 million Primary CFDA Numbers 93.837, 93.838, 93.839, 93.840, 93.233 Anticipated Eligible Organizations Small Business Applications not being solicited this time. Inquiries Please direct inquiries to: Allan Shipp National Heart, Lung, Blood Institute NHLBI) 301-435-2152 RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support New Applications Regenerative Medicine Innovation Projects RMIP) U43/U44 - Clinical Trial Allowed) Notice Number: NOT-HL-18-578 Key Dates Release Date:January 12, 2018 Estimated Publication Date Funding Opportunity Announcement: 02/15/2018 First Estimated Application Due Date: 05/15/2018 Earliest Estimated Award Date: 09/14/2018 Earliest Estimated Start Date: 10/15/2018 Related Announcements RFA-HL-18-035 NOT-HL-18-573 NOT-HL-18-574 NOT-HL-18-575 NOT-HL-18-576 NOT-HL-18-577 Issued National Heart, Lung, Blood Institute ( NHLBI) National Eye Institute ( NEI) National Institute Aging ( NIA) National Institute Allergy Infectious Diseases ( NIAID) National Institute Arthritis Musculoskeletal Skin Diseases ( NIAMS) National Institute Biomedical Imaging Bioengineering ( NIBIB) National Institute Deafness Other Communication Disorders ( NIDCD) National Institute Dental Craniofacial Research ( NIDCR) National Institute Diabetes Digestive Kidney Diseases ( NIDDK) National Institute Mental Health ( NIMH) National Institute Neurological Disorders Stroke ( NINDS) National Center Advancing Translational Sciences ( NCATS) U.S. Food Drug Administration ( FDA) Purpose National Institutes Health NIH) participating NIH Institutes Centers ICs) the U.S. Food Drug Administration FDA) intend publish Funding Opportunity Announcement FOA) new applications will support clinical research studies aimed furthering field regenerative medicine RM) using adult stem cells. Applicants must apply undergo peer review.   planned FOA, known the Regenerative Medicine Innovation Project RMIP), support new projects utilize rigorous science reproducible methods establish proof concept a robust evidence base clinical applications. In order fulfill mandate advancing field RM broadly, applicants propose solutions widely recognized issues the development safe effective RM therapies. Emphasis be given projects address critical issues product development relevant regulatory submissions. Areas focus include improved tools, methods, standards, applied science support better understanding improved evaluation product manufacturing, quality, safety, effectiveness.    Toward ends, NIH consider applications clinical research involving adult stem cells the context generating supplementing necessary evidence clinical development, including submission a pre-Investigational New Drug IND) pre-Investigational New Device Exemption IDE) package; submission an IND/IDE application; to support such research conducted under authorized IND IDE. Potential applicants encouraged review additional information the RMIP answers frequently asked questions the RMIP website. Inquiries be sent to RMIP@nih.gov.   FOA utilize U43/U44 activity code is expected be published February 2018 an application due date May 2018.   Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds below). Of note, and five Notices being issued a total 28 million overall, 10 million which available award FY 2018 order solicit new projects for mechanisms listed herein under Related Announcements. Research Initiative Details RMIP FOA represents step fulfilling new statutory provision set forth the 21st Century Cures Act. Given potential RM enhance human health treat disease, Congress included provision an Innovation Project the Act authorizing total 30 million the funding clinical research further field RM using adult stem cells, including autologous cells. Act stipulates the NIH, coordination FDA, award funds contingent upon recipient making available non-Federal contributions an amount less 1 each 1 Federal funds provided the award i.e., matching funds requirement).   RMIP FOA intended support only research involves: 1) human subjects material human origin, such cells, tissues, specimens; 2) human stem cells are of embryonic fetal origin.  Applicable research adult human stem cells encompass, example, research biologics e.g., growth factors, cytokines) biomaterials e.g., ECM, scaffolds) stimulate host adult stem cell growth, differentiation, function otherwise directly act upon adult stems cells support innate host healing mechanisms, treat disease, and/or restore function. Funding be used, example, the appropriate chemistry, manufacturing, controls development support production such products clinical trials using good manufacturing practices GMP). Funds not used research involving human cells embryonic fetal origin.    FOA support highly meritorious clinical research projects proposing explore enable development safe effective RM interventions. Specifically, FY 2018 funds, addition being subject the standard NIH review criteria, clinical research projects also assessed according the following criteria:   Does include a clinical trial (for clinical trial applications see NOT-HL-18-577); Matching funds available time award; Contributes breadth/diversity RM science; Addresses critical issues relevant clinical research regulatory submissions including those related product development. Areas focus include improved tools, methods, standards, applied science support better understanding improved evaluation product manufacturing, quality, safety, effectiveness; Will help significantly build advance field RM contributing fundamental knowledge well addressing well-recognized challenge clinical development including development evaluation safe effective RM products.   Applications demonstrate potential catalyze sustained accelerated development the RM field through contributing the foundational knowledge critical product development, clinical testing, data standards sharing, strongly encouraged. example, such projects may:   Further development standards GMP adult stem cell-based RM products; Leverage extant cell production facilities product preparation qualification; Promote enhance mechanisms data standardization, curation, integration, sharing; Contribute a better shared understanding current technical operational barriers well the regulatory science issues; and/or Monitor stem cell function integration vivo.   Matching Requirement Government requires least 1:1 recipient cost matching this program, required the 21st Century Cures Act. Government consider any non-federal funds, include state local funding originating Federal funds), well private-sector investment, in-kind contributions, donations foundations provided support the application qualifying the cost matching ratio requirement. information the RMIP matching requirement be found the RMIP website. Funding Information Estimated Total Funding 28 million Expected Number Awards 5 Estimated Award Ceiling 10 million Primary CFDA Numbers 93.837, 93.838, 93.839, 93.940, 93.233 Anticipated Eligible Organizations Small Business Applications not being solicited this time. Inquiries Please direct inquiries to: Allan Shipp National Heart, Lung, Blood Institute NHLBI) 301-435-2152 RMIP@nih.gov

Notice Corrected Expiration Date PA-15-354 SBIR Technology Transfer R43/R44)" Notice Number: NOT-NS-18-031 Key Dates Release Date: January 11, 2018 Related Announcements PA-15-354 Issued National Institute Neurological Disorders Stroke NINDS) National Cancer Institute NCI) National Eye Institute NEI) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Drug Abuse NIDA) National Institute Dental Craniofacial Research NIDCR) National Center Advancing Translational Sciences NCATS) National Institute Nursing Research NINR)) Purpose purpose this Notice inform applicants the new expiration date PA-15-354, SBIR Technology Transfer R43/R44)", January 6, 2018.  Applications still accepted the January 5, 2018 receipt date. Part 1. Overview Information Key Dates Currently reads: Application Due Date(s) Standard Dates January 5, 2016; April 5, 2016; September 5, 2016; January 5, 2017; April 5, 2017; September 5, 2017; January 5, 2018; April 5, 2018, September 5, 2018) Modified read: Application Due Date(s) Standard Dates January 5, 2016; April 5, 2016; September 5, 2016; January 5, 2017; April 5, 2017; September 5, 2017; January 5, 2018) Currently reads: Expiration Date: September 6, 2018 Corrected read: Expiration Date: January 11, 2018 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone 301-496-1779 Email: fertigs@ninds.nih.gov

Notice Corrected Expiration Date PAR-15-277 NINDS Exploratory Clinical Trials Small Business R44)" Notice Number: NOT-NS-18-032 Key Dates Release Date: January 11, 2018 Related Announcements PAR-15-277 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform applicants the new expiration date PA-15-277 NINDS Exploratory Clinical Trials Small Business R44)" January 6, 2018. Applications still accepted the January 5, 2018 receipt date.  notice also serves inform applicants NINDS plans reissue Funding Opportunity Announcement FOA) compliance FORMS-E. Part 1. Overview Key Dates Currently reads: Application Due Date(s) Standard Dates September 5, 2015; January 5, 2016; April 5, 2016; September 5, 2016; January 5, 2017; April 5, 2017; September 5, 2017; January 5, 2018; April 5, 2018) Modified read: Application Due Date(s) Standard Dates September 5, 2015; January 5, 2016; April 5, 2016; September 5, 2016; January 5, 2017; April 5, 2017; September 5, 2017; January 5, 2018) Currently reads: Expiration Date: April 6, 2018 Modified read: Expiration Date: January 11, 2018 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov

Notice Corrected Expiration Date PAR-15-278 NINDS Exploratory Clinical Trials Small Business R42)" Notice Number: NOT-NS-18-033 Key Dates Release Date: January 11, 2018 Related Announcements PAR-15-278 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform applicants the new expiration date PAR-15-278 NINDS Exploratory Clinical Trials Small Business R42)" January 6, 2018. Applications still accepted the January 5, 2018 receipt date.  NINDS plans reissue Funding Opportunity Announcement FOA) compliance FORMS-E. Part 1. Overview Key Dates Currently reads: Application Due Date(s) Standard Dates September 5, 2015; January 5, 2016; April 5, 2016; September 5, 2016; January 5, 2017; April 5, 2017; September 5, 2017; January 5, 2018; April 5, 2018) Modified read: Application Due Date(s) Standard Dates September 5, 2015; January 5, 2016; April 5, 2016; September 5, 2016; January 5, 2017; April 5, 2017; September 5, 2017; January 5, 2018) Currently reads: Expiration Date: April 6, 2018 Modified read: Expiration Date: January 11, 2018 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephanie Fertig, MBA Telephone 301-496-1779 Email: fertigs@ninds.nih.gov