Find Funding Opportunities

Notice Intent Publish Funding Opportunity Announcement Translational Neural Devices Program U44) Notice Number: NOT-NS-17-023 Key Dates Release Date: April 25, 2017 Estimated Publication Date Announcement: July 2017  First Estimated Application Due Date: October 2017  Earliest Estimated Award Date: February 2018  Earliest Estimated Start Date: June 2018  Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS), intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications milestone-driven projects involving translational activities small clinical studies advance development therapeutic diagnostic devices disorders affect nervous system. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published July 2017 an expected application due date October 2017. FOA utilize U44 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages SBIR-eligible small businesses expertise insights neurotherapeutic neurodiagnostic devices begin consider applying this new FOA. initiative a successor the prior NINDS Cooperative Research Enable Advance Translational Enterprises CREATE Devices) program ended early 2017. Fast-Track phased U44 cooperative agreement mechanism milestone-driven involves NIH program staff's participation developing project plan, monitoring research progress, appropriate go/no-go decision-making. projects have phases, Phase and Phase II. initial phase support translational device activities leading submission an Investigational Device Exemption IDE) the US Food Drug Administration FDA) Institutional Review Board IRB) application a Non-Significant Risk NSR) study. projects start Phase but duration Phase will depend the maturity the project entry. Only successful Phase projects have met milestones other requirements be eligible transition Phase II after NIH administrative review. Phase II support Early Feasibility Study a small clinical study. is expected devices within scope this program either: very close the final system' manufactured using very close the same manufacturing process the device be marketed studied a larger clinical trial following completion this project, or  require early feasibility clinical data inform final device design manufacturing processes. is also expected devices within scope this program either received Pre-Submission feedback the FDA will conduct Pre-Submission the FDA the first year Phase I. expectations the program in line those industry regards advancing devices through developmental pipeline. such inherent high rate attrition expected within program. Applicants strongly encouraged consult NINDS program staff plans an application being developed. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-1447 Email: nick.langhals@nih.gov nbsp;

Notice Extend Expiration Date PA-14-069 Neurobiology Migraine R21)" Notice Number: NOT-NS-17-026 Key Dates Release Date: April 25, 2017 Related Announcements PA-14-069 Issued National Institute Neurological Disorders Stroke NINDS) Purpose Part 1. Overview Information purpose this Notice to inform interested applicants the expiration date the Funding Opportunity Announcement FOA) PA-14-069 Neurobiology Migraine R21)" be extended one receipt cycle.  FOA expires September 8, 2017. Key Dates Table updated accordingly: Part 1. Overview Information Key Dates Application Due Date(s) Standard dates 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date September 8, 2017 other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Michael L. Oshinsky, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov

Notice Intent Publish Funding Opportunity Announcement Translational Neural Devices Program UG3/UH3) Notice Number: NOT-NS-17-024 Key Dates Release Date: April 25, 2017 Estimated Publication Date Announcement: July 2017  First Estimated Application Due Date: October 2017  Earliest Estimated Award Date: February 2018 Earliest Estimated Start Date: June 2018 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS), intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications milestone-driven projects involving translational activities small clinical studies advance development therapeutic diagnostic devices disorders affect nervous system. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects.  FOA expected be published July 2017 an expected application due date October 2017. FOA utilize UG3/UH3 activity code. Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights neurotherapeutic neurodiagnostic devices begin consider applying this new FOA. initiative a successor the prior NINDS Cooperative Research Enable Advance Translational Enterprises CREATE Devices) program ended early 2017. UG3/UH3 cooperative agreement mechanism milestone-driven involves NIH program staff's participation developing project plan, monitoring research progress, appropriate go/no-go decision-making. projects have phases. initial UG3 phase support translational device activities leading submission an Investigational Device Exemption IDE) the US Food Drug Administration FDA) Institutional Review Board IRB) application a Non-Significant Risk NSR) study. projects start the UG3 phase the duration UG3 depend the maturity the project entry. Only successful UG3 projects have met milestones other requirements be eligible transition the second UH3 phase after NIH administrative review. UH3 phase support Early Feasibility Study a small clinical study. is expected devices within scope this program either: very close the final system' manufactured using very close the same manufacturing process the device be marketed studied a larger clinical trial following completion this project, or  require early feasibility clinical data inform final device design manufacturing processes. is also expected devices within scope this program either received Pre-Submission feedback the FDA will conduct Pre-Submission the FDA the first year the UG3 phase. expectations the program in line those industry regards advancing devices through developmental pipeline. such inherent high rate attrition expected within program. Applicants strongly encouraged consult NINDS program staff plans an application being developed. Early contact provides opportunity NINDS program staff discuss program scope, entry criteria, goals, to provide information guidance how develop competitive application. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-1447 Email: nick.langhals@nih.gov Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov nbsp;

Extension Expiration Date PAR-15-070 Innovation Grants Nurture Initial Translational Efforts IGNITE): Assay Development Therapeutic Agent Identification Characterization Support Therapeutic Discovery R21/R33)" Notice Number: NOT-NS-17-020 Key Dates Release Date: April 24, 2017 Related Announcements PAR-15-070 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform interested applicants the expiration date the Funding Opportunity Announcement FOA) PAR-15-070 quot;Innovation Grants Nurture Initial Translational Efforts IGNITE): Assay Development Therapeutic Agent Identification Characterization Support Therapeutic Discovery R21/R33)" be extended one receipt cycle. FOA expires May 8, 2018. Key Dates table updated accordingly: Key Dates Application Due Date(s) Standard dates 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) Standard AIDS dates 5:00 PM local time applicant organization. types AIDS AIDS-related applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date 8, 2018 Due Dates E.O. 12372 Applicable other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: mary.pelleymounter@nih.gov

Extension Expiration Date PAR-15-071 Innovation Grants Nurture Initial Translational Efforts IGNITE): Pharmacodynamics In vivo Efficacy Studies Small Molecules Biologics/Biotechnology Products R21/R33)" Notice Number: NOT-NS-17-021 Key Dates Release Date: April 24, 2017 Related Announcements PAR-15-071 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform interested applicants the expiration date the Funding Opportunity Announcement FOA) PAR-15-071 quot;Innovation Grants Nurture Initial Translational Efforts IGNITE): Pharmacodynamics In vivo Efficacy Studies Small Molecules Biologics/Biotechnology Products R21/R33)" be extended one receipt cycle. FOA been modified expire May 8, 2018. Key Dates table updated accordingly: Key Dates Application Due Date(s) Standard dates 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) Standard AIDS dates 5:00 PM local time applicant organization. types AIDS AIDS-related applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review Standard dates apply Advisory Council Review Standard dates apply Earliest Start Date Standard dates apply Expiration Date 8, 2018 Due Dates E.O. 12372 Applicable other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: mary.pelleymounter@nih.gov

Extension Expiration Date RFA NS-16-013 Innovation Grants Nurture Initial Translational Efforts IGNITE): Development Validation Model Systems and/or Pharmacodynamic Markers Facilitate Discovery Neurotherapeutics R21/R33)" Notice Number: NOT-NS-17-022 Key Dates Release Date:   April 24, 2017 Related Announcements RFA-NS-16-013 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform interested applicants the expiration date the Funding Opportunity Announcement FOA) RFA NS-16-013 quot;Innovation Grants Nurture Initial Translational Efforts IGNITE): Development Validation Model Systems and/or Pharmacodynamic Markers Facilitate Discovery Neurotherapeutics R21/R33" be extended one receipt cycle. additional non-AIDS new resubmission application due date February 20, 2018 AIDS AIDS-related application due date May 7, 2018 been added this FOA. FOA expires May 8, 2018. Key Dates table updated accordingly: Key Dates nbsp; Application Due Date(s) February 18, 2016; June 21, 2016; October 18, 2016; February 21, 2017; June 21, 2017; October 18, 2017, February 20, 2018, 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) Standard AIDS dates beginning May 7, 2016) apply, 5:00 PM local time applicant organization. types AIDS AIDS-related applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Scientific Merit Review June 2016; October 2016; February 2017; June 2017; October 2017; February 2018; June 2018 Advisory Council Review October 2016; January 2017; 2017; October 2107; January 2018; 2018; October 2018 Earliest Start Date November, 2016 Expiration Date 8, 2018 Due Dates E.O. 12372 Applicable nbsp; other aspects the FOA remain unchanged. Inquiries Please direct inquiries to: Mary Ann Pelleymounter, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: mary.pelleymounter@nih.gov

Notice Intent Publish Funding Opportunity Announcement Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers Research Centers P50) Notice Number: NOT-AR-18-006 Key Dates Release Date: April 13, 2017 Estimated Publication Date Announcement: 2017  First Estimated Application Due Date: October 2017  Earliest Estimated Award Date: July 2018  Earliest Estimated Start Date:   July 2018 Related Announcements RFA-AR-18-001 Issued National Heart, Lung, Blood Institute NHLBI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Arthritis Musculoskeletal Skin Diseases NIAMS), the National Institute Neurological Disorders Stroke NINDS), Eunice Kennedy Shriver National Institute Child Health Human Development NICHD), the National Heart, Lung, Blood Institute NHLBI), intend promote the reissue an ongoing initiative publishing Funding Opportunity Announcement FOA) solicit new renewal applications Wellstone Muscular Dystrophy Research Centers. NIH expects make to three Center awards response this upcoming FOA, contingent upon scientific merit the applications availability funds. NIH established Centers Excellence program 2003 part an ongoing effort enhance intensify research the muscular dystrophies. Centers described the MD-CARE Act subsequent reauthorizations 2008 2014, were named honor the late Senator Paul D. Wellstone. theme each Center must focus one more the muscular dystrophies, include Duchenne, Becker, myotonic, facioscapulohumeral, limb-girdle, congenital, oculopharyngeal, Emery-Dreifuss, others. FOA expected be published Spring 2017 an expected application due date Fall 2017. FOA utilize P50 activity code instead the U54, was used prior awards. scope, funding level, programmatic requirements the Centers not change NIH Program Officers continue promote communication coordination across network Centers. Notice being provided allow potential applicants sufficient time develop meaningful collaborations responsive projects Details the planned FOA provided below. Research Initiative Details Notice encourages investigators expertise insights translational clinical muscular dystrophy research consider organizing collaborative groups prepare applications this FOA. Successful applicants foster translation new scientific findings technological developments novel treatments other strategies improving lives muscular dystrophy patients. Center should involve clinical research direct interactions between researchers muscular dystrophy patients. Appropriate clinical studies include natural history studies, biomarker development, early stage clinical trials, patient-oriented studies facilitate future trials, biopsychosocial studies, health services research, etc. Center also contain basic and/or preclinical translational research, long efforts directed toward steps required the development therapies, including therapeutic target identification, characterization validation; development pharmacodynamic biomarkers surrogate endpoints; animal model development characterization; candidate therapeutic screening, optimization FDA-required activities leading an investigational new drug IND) application. Applicants should propose multi-disciplinary collaborative studies will significantly accelerate progress toward effective treatments other improvements patients' lives. Research problems should require substantial collaborative efforts solve, thus best carried in center setting. Center should at least core facility shares services resources the national international muscular dystrophy research community, a training core promotes career development junior researchers. Centers should also an administrative core oversee activities the center well organize patient community outreach activities. Centers supported through FOA participate biennial meetings the Centers the program promote communication collaborations. APPLICATIONS NOT BEING SOLICITED THIS TIME. Inquiries Please direct inquiries to: Tom Cheever, Ph.D. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5019 Email: thomas.cheever@nih.gov Glen Nuckolls, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-5876 Email: nuckollg@ninds.nih.gov Danuta Krotoski, Ph.D. Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-495-5576 Email: tu36j@nih.gov Jonathan R. Kaltman, M.D. National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-0510 Email: kaltmaj@nhlbi.nih.gov

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) 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) 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