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Notice Intent Publish Funding Opportunity Announcement Support Competitive Revision Applications Regenerative Medicine Innovation Projects RMIP) P41) Notice Number: NOT-HL-17-507 Key Dates Release Date:   April 7, 2017 Estimated Publication Date Announcement: April/May 2017 First Estimated Application Due Date: June 2017 Earliest Estimated Award Date: September 2017 Earliest Estimated Start Date: October 2017 Related Announcements NOT-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 NOT-HL-17-506 RFA-HL-17-033 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 P41 activity code is expected be published April/May 2017 an application due date 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) U01) Notice Number: NOT-HL-17-496 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-HL-17-507 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 NOT-HL-17-506 RFA-HL-17-034 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 U01 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) R43/R44) Notice Number: NOT-HL-17-497 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-17-023 NOT-HL-17-507NOT-HL-17-496 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 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 R43/R44 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) U24) Notice Number: NOT-HL-17-498 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-17-028 NOT-HL-17-507NOT-HL-17-496 NOT-HL-17-497 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 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 U24 Resource-Related Research Projects – Cooperative Agreements 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) R41/R42) Notice Number: NOT-HL-17-499 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-17-024 NOT-HL-17-507NOT-HL-17-496 NOT-HL-17-497 NOT-HL-17-498 NOT-HL-17-500 NOT-HL-17-501 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 R41/R42 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) UC4) Notice Number: NOT-HL-17-500 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-17-027 NOT-HL-17-507NOT-HL-17-496 NOT-HL-17-497 NOT-HL-17-498 NOT-HL-17-499 NOT-HL-17-501 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 UC4 High Impact Research Research Infrastructure - Cooperative Agreement Programs 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) 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