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Notice Intent Publish Funding Opportunity Announcement Support Competitive Revision Applications Regenerative Medicine Innovation Projects RMIP) UM2) Notice Number: NOT-HL-17-501 Key Dates Release Date:   March 31, 2017 Estimated Publication Date Announcement: April/May 2017 First Estimated Application Due Date: May/June 2017 Earliest Estimated Award Date: September 2017 Earliest Estimated Start Date: October 2017 Related Announcements RFA-HL-17-031 NOT-HL-17-507NOT-HL-17-496 NOT-HL-17-497 NOT-HL-17-498 NOT-HL-17-499 NOT-HL-17-500 NOT-HL-17-502 NOT-HL-17-503 NOT-HL-17-504 NOT-HL-17-505 NOT-HL-17-506 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) competitive revisions will support clinical research studies aimed furthering field regenerative medicine RM) using adult stem cells. competing revision a request an increase support a current budget period expansion the project's approved scope research protocol. Applicants must apply undergo peer review. planned FOA, known the Regenerative Medicine Innovation Project RMIP), support revision 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 regenerative medicine 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. FOA utilize UM2 activity code is expected be published April/May 2017 an application due date May/June 2017.  Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds. note, and 10 notices being issued 2 million available FY 2017 order solicit revision projects the 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, 2 million available FY 2017 the funding clinical research further field regenerative medicine 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 2017 funds, addition being subject the standard NIH review criteria, clinical research projects also assessed according the following criteria: Represents unfunded opportunities put funds new immediate use); Underlying project well along/already underway e.g., the pre-IND/IDE stage 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 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; Utilize clinical trial network(s) leverage infrastructure facilitate subject recruitment follow as well data sharing; and/or Contribute a better shared understanding current technical operational barriers well the regulatory science issues. 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 donations foundations provided support the application qualifying the cost matching ratio requirement. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Megan Mitchell, MPH National Heart, Lung, Blood Institute NHLBI) Telephone: 301-827-7950 Email: RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support Competitive Revision Applications Regenerative Medicine Innovation Projects RMIP) U54) Notice Number: NOT-HL-17-502 Key Dates Release Date:   March 31, 2017 Estimated Publication Date Announcement: April/May 2017 First Estimated Application Due Date: May/June 2017 Earliest Estimated Award Date: September 2017 Earliest Estimated Start Date: October 2017 Related Announcements NOT-TR-17-016 RFA-HL-17-025 NOT-HL-17-507NOT-HL-17-496 NOT-HL-17-497 NOT-HL-17-498 NOT-HL-17-499 NOT-HL-17-500 NOT-HL-17-501 NOT-HL-17-503 NOT-HL-17-504 NOT-HL-17-505 NOT-HL-17-506 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) competitive revisions will support clinical research studies aimed furthering field regenerative medicine RM) using adult stem cells. competing revision a request an increase support a current budget period expansion the project's approved scope research protocol. Applicants must apply undergo peer review. planned FOA, known the Regenerative Medicine Innovation Project RMIP), support revision 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 regenerative medicine 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. FOA utilize U54 activity code is expected be published April/May 2017 an application due date May/June 2017.  Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds. note, and 10 notices being issued 2 million available FY 2017 order solicit revision projects the 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, 2 million available FY 2017 the funding clinical research further field regenerative medicine 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 2017 funds, addition being subject the standard NIH review criteria, clinical research projects also assessed according the following criteria: Represents unfunded opportunities put funds new immediate use); Underlying project well along/already underway e.g., the pre-IND/IDE stage 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 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; Utilize clinical trial network(s) leverage infrastructure facilitate subject recruitment follow as well data sharing; and/or Contribute a better shared understanding current technical operational barriers well the regulatory science issues. 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 donations foundations provided support the application qualifying the cost matching ratio requirement. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Megan Mitchell, MPH National Heart, Lung, Blood Institute NHLBI) Telephone: 301-827-7950 Email: RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support Competitive Revision Applications Regenerative Medicine Innovation Projects RMIP) UM1) Notice Number: NOT-HL-17-503 Key Dates Release Date:   March 31, 2017 Estimated Publication Date Announcement: April/May 2017 First Estimated Application Due Date: May/June 2017 Earliest Estimated Award Date: September 2017 Earliest Estimated Start Date: October 2017 Related Announcements RFA-HL-17-026 NOT-HL-17-507NOT-HL-17-496 NOT-HL-17-497 NOT-HL-17-498 NOT-HL-17-499 NOT-HL-17-500 NOT-HL-17-501 NOT-HL-17-502 NOT-HL-17-504 NOT-HL-17-505 NOT-HL-17-506 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) competitive revisions will support clinical research studies aimed furthering field regenerative medicine RM) using adult stem cells. competing revision a request an increase support a current budget period expansion the project's approved scope research protocol. Applicants must apply undergo peer review. planned FOA, known the Regenerative Medicine Innovation Project RMIP), support revision 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 regenerative medicine 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. FOA utilize UM1 activity code is expected be published April/May 2017 an application due date May/June 2017.  Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds. note, and 10 notices being issued 2 million available FY 2017 order solicit revision projects the 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, 2 million available FY 2017 the funding clinical research further field regenerative medicine 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 2017 funds, addition being subject the standard NIH review criteria, clinical research projects also assessed according the following criteria: Represents unfunded opportunities put funds new immediate use); Underlying project well along/already underway e.g., the pre-IND/IDE stage 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 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; Utilize clinical trial network(s) leverage infrastructure facilitate subject recruitment follow as well data sharing; and/or Contribute a better shared understanding current technical operational barriers well the regulatory science issues. 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 donations foundations provided support the application qualifying the cost matching ratio requirement. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Megan Mitchell, MPH National Heart, Lung, Blood Institute NHLBI) Telephone: 301-827-7950 Email: RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support Competitive Revision Applications Regenerative Medicine Innovation Projects RMIP) R01) Notice Number: NOT-HL-17-504 Key Dates Release Date:   March 31, 2017 Estimated Publication Date Announcement: April/May 2017 First Estimated Application Due Date: May/June 2017 Earliest Estimated Award Date: September 2017 Earliest Estimated Start Date: October 2017 Related Announcements RFA-HL-17-029 NOT-HL-17-507NOT-HL-17-496 NOT-HL-17-497 NOT-HL-17-498 NOT-HL-17-499 NOT-HL-17-500 NOT-HL-17-501 NOT-HL-17-502 NOT-HL-17-503 NOT-HL-17-505 NOT-HL-17-506 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) competitive revisions will support clinical research studies aimed furthering field regenerative medicine RM) using adult stem cells. competing revision a request an increase support a current budget period expansion the project's approved scope research protocol. Applicants must apply undergo peer review. planned FOA, known the Regenerative Medicine Innovation Project RMIP), support revision 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 regenerative medicine 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. FOA utilize R01 activity code is expected be published April/May 2017 an application due date May/June 2017.  Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds. note, and 10 notices being issued 2 million available FY 2017 order solicit revision projects the 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, 2 million available FY 2017 the funding clinical research further field regenerative medicine 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 2017 funds, addition being subject the standard NIH review criteria, clinical research projects also assessed according the following criteria: Represents unfunded opportunities put funds new immediate use); Underlying project well along/already underway e.g., the pre-IND/IDE stage 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 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; Utilize clinical trial network(s) leverage infrastructure facilitate subject recruitment follow as well data sharing; and/or Contribute a better shared understanding current technical operational barriers well the regulatory science issues. 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 donations foundations provided support the application qualifying the cost matching ratio requirement. Inquiries Please direct inquiries to: Megan Mitchell, MPH National Heart, Lung, Blood Institute NHLBI) Telephone: 301-827-7950 Email: RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support Competitive Revision Applications Regenerative Medicine Innovation Projects RMIP) P50) Notice Number: NOT-HL-17-505 Key Dates Release Date:   March 31, 2017 Estimated Publication Date Announcement: April/May 2017 First Estimated Application Due Date: May/June 2017 Earliest Estimated Award Date: September 2017 Earliest Estimated Start Date: October 2017 Related Announcements RFA-HL-17-032 NOT-HL-17-507NOT-HL-17-496 NOT-HL-17-497 NOT-HL-17-498 NOT-HL-17-499 NOT-HL-17-500 NOT-HL-17-501 NOT-HL-17-502 NOT-HL-17-503 NOT-HL-17-504 NOT-HL-17-506 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) competitive revisions will support clinical research studies aimed furthering field regenerative medicine RM) using adult stem cells. competing revision a request an increase support a current budget period expansion the project's approved scope research protocol. Applicants must apply undergo peer review. planned FOA, known the Regenerative Medicine Innovation Project RMIP), support revision 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 regenerative medicine 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. FOA utilize P50 Specialized Center activity code is expected be published April/May 2017 an application due date May/June 2017.  Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds. note, and 10 notices being issued 2 million available FY 2017 order solicit revision projects the 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, 2 million available FY 2017 the funding clinical research further field regenerative medicine 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 2017 funds, addition being subject the standard NIH review criteria, clinical research projects also assessed according the following criteria: Represents unfunded opportunities put funds new immediate use); Underlying project well along/already underway e.g., the pre-IND/IDE stage 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 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; Utilize clinical trial network(s) leverage infrastructure facilitate subject recruitment follow as well data sharing; and/or Contribute a better shared understanding current technical operational barriers well the regulatory science issues. 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 donations foundations provided support the application qualifying the cost matching ratio requirement. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Megan Mitchell, MPH National Heart, Lung, Blood Institute NHLBI) Telephone: 301-827-7950 Email: RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement Support Competitive Revision Applications Regenerative Medicine Innovation Projects RMIP) R24) Notice Number: NOT-HL-17-506 Key Dates Release Date:   March 31, 2017 Estimated Publication Date Announcement: April/May 2017 First Estimated Application Due Date: May/June 2017 Earliest Estimated Award Date: September 2017 Earliest Estimated Start Date: October 2017 Related Announcements RFA-HL-17-030 NOT-HL-17-507NOT-HL-17-496 NOT-HL-17-497 NOT-HL-17-498 NOT-HL-17-499 NOT-HL-17-500 NOT-HL-17-501 NOT-HL-17-502 NOT-HL-17-503 NOT-HL-17-504 NOT-HL-17-505 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) competitive revisions will support clinical research studies aimed furthering field regenerative medicine RM) using adult stem cells. competing revision a request an increase support a current budget period expansion the project's approved scope research protocol. Applicants must apply undergo peer review. planned FOA, known the Regenerative Medicine Innovation Project RMIP), support revision 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 regenerative medicine 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. FOA utilize R24 activity code is expected be published April/May 2017 an application due date May/June 2017.  Notice being provided allow potential applicants sufficient time develop responsive proposals, consider requirements are integral this initiative, obtain necessary matching funds. note, and 10 notices being issued 2 million available FY 2017 order solicit revision projects the 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, 2 million available FY 2017 the funding clinical research further field regenerative medicine 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 2017 funds, addition being subject the standard NIH review criteria, clinical research projects also assessed according the following criteria: Represents unfunded opportunities put funds new immediate use); Underlying project well along/already underway e.g., the pre-IND/IDE stage 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 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; Utilize clinical trial network(s) leverage infrastructure facilitate subject recruitment follow as well data sharing; and/or Contribute a better shared understanding current technical operational barriers well the regulatory science issues. 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 donations foundations provided support the application qualifying the cost matching ratio requirement. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Megan Mitchell, MPH National Heart, Lung, Blood Institute NHLBI) Telephone: 301-827-7950 Email: RMIP@nih.gov

Notice Intent Publish Funding Opportunity Announcement NINDS StrokeNet Regional Coordinating Stroke Centers U24) Notice Number: NOT-NS-17-019 Key Dates Release Date: March 20, 2017 Estimated Publication Date Announcement: 2017   First Estimated Application Due Date: September 2017 Earliest Estimated Award Date: July 2018 Earliest Estimated Start Date: September 2018 Related Announcements PAR-17-276 Issued National Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS), intends issue Funding Announcement FOA) solicit applications NINDS StrokeNet Regional Coordinating Centers U24) participate StrokeNet clinical recruitment centers during next 5 years the program. goal this existing network www.nihstrokenet.org) to maximize efficiencies develop, promote conduct high-quality, multi-site clinical trials focused key interventions stroke prevention, treatment, recovery the objective have balanced portfolio between three approaches.  Exploratory phase 1/2 confirmatory phase 3 clinical trials well biomarker-validation studies are immediately preparatory trials be coordinated through separate National Clinical Coordinating Data Management Centers.  Efficiency fostered through use master trial agreements a central IRB.  Leaders drawn both clinical basic stroke science communities the sites contribute the development network clinical trial proposals peer review, well planning execution proposals coming outside the network, including trials result a Collaborative Research Development Agreement CRADA) between NINDS an Industry partner.  Network also uniquely poised rapidly collaborate other existing networks International Consortia conduct larger, definitive trials promising interventions the treatment stroke. Notice being provided allow potential applicants sufficient time develop meaningful collaborations competitive research programs.  FOA expected be published Summer 2017 an expected receipt date October 2017. FOA utilize U24 activity code. Details the planned FOA provided below. Research Initiative Details NINDS Stroke Trials Network utilize Cooperative Agreements U24) support clinical recruiting sites the Stroke Trials Network up 5 years.  funded site the network have access stroke patients have demonstrated ability enroll patients stroke trials.  site also strong collaborative relationships between Vascular Neurology, Emergency Medicine, Interventional Neuroradiology, Neurosurgery, NeuroIntensive care, Neuroimaging, Stroke Rehabilitation, Pediatric Neurology order ensure commitment offer every eligible patient opportunity participate a trial conducted through Network.  addition, network sites include stroke research training program.  network sites be committed increase value clinical research data through aggressive data sharing plan. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Scott Janis, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301) 496-9135 Email: janiss@ninds.nih.gov  

Notice Requirement Predoctoral T32 Training Programs Formerly Supported NIGMS Intend apply the Jointly Sponsored Predoctoral Training Program the Neurosciences JSPTPN) Notice Number: NOT-NS-17-018 Key Dates Release Date: March 8, 2017 Related Announcements NOT-GM-14-104 Issued National Institute Neurological Disorders Stroke NINDS) National Institute General Medical Sciences NIGMS) Purpose described NOT-GM-14-104 NIGMS no longer accepting applications the neurosciences research area under Systems Integrated Biology SIB) Predoctoral Training Program.  Early stage neuroscience training programs are currently supported NIGMS encouraged apply the Jointly Sponsored Predoctoral Training Program the Neurosciences JSPTPN, PAR-17-096) NIH funding.  purpose this Notice to inform institutions neuroscience training programs were previously are currently supported the SIB Program they must submit new Type 1) applications response PAR-17-096. Applications submitted renewal applications Type 2) any program currently formerly supported the JSPTPN FOA not accepted review. Inquiries Please direct inquiries to: Letitia Weigand, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: letitia.weigand@nih.gov nbsp;

Notice Date Informational Webinar PAR-16-219 NINDS Faculty Development Award Promote Diversity Neuroscience Research K01)" Notice Number: NOT-NS-17-017 Key Dates Release Date:   February 10, 2017 Related Announcements PAR-16-219 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Notice to inform potential applicants mentors to the NINDS Faculty Development Award Promote Diversity Neuroscience Research K01) the date an upcoming webinar preparing applications this mechanism. webinar optional not required submission PAR-16-219. Webinar Information nbsp; You Need Know the NINDS Diversity Faculty Development K01 Award: Tips Preparing Application March 22, 2017, 2:00 - 3:00 p.m. Eastern Time Learn the NINDS K01 diversity faculty development award successful applicants a reviewer these mechanisms. webinar take through process putting together application the NINDS Faculty Development Award Promote Diversity Neuroscience Research K01) the from writing application anticipating responding reviewer's comments. Hear two K01 awardees how crafted applications, learn a reviewer common mistakes helpful tips. webinar intended potential applicants mentors NINDS diversity K01 grants. register the webinar, please to: https://nih.webex.com/nih/onstage/g.php?MTID=eb57f85ff7f36b4aa3334f4b98…. registration link available the bottom the page. Inquiries Please direct inquiries to: Michelle Jones-London, PhD National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-4188 Email: NINDSDiversityTraining@ninds.nih.gov nbsp;

Notice Extend Expiration Date PAR-14-209 NINDS Renewal Awards SBIR Phase II Grants Phase IIB) Pre-Clinical Research R44)" Notice Number: NOT-NS-17-016 Key Dates Release Date: February 6, 2017 Related Announcements PAR-14-209 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform interested applicants the expiration date the Funding Opportunity Announcement FOA) PAR-14-209 quot;NINDS Renewal Awards SBIR Phase II Grants Phase IIB) Pre-Clinical Research R44)" be extended one receipt cycle.  additional application due date, September 5, 2017, been added this FOA.  FOA expires September 6, 2017. Key Dates Table updated accordingly: Part 1. Overview Information Key Dates Application Due Date(s) Standard dates apply, 5:00 PM local time applicant organization. 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) Standard AIDS dates apply, 5:00 PM local time applicant organization. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date September 6, 2017 nbsp; other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov nbsp;