Find Funding Opportunities

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

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

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

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

Notice Expiration PAR-16-340 Career Transition Award NINDS Intramural Clinician-Scientists K22)" Notice Number: NOT-NS-18-035 Key Dates Release Date:   January 11, 2018 Related Announcements PAR-16-340 Issued National Institute Neurological Disorders Stroke NINDS) Purpose notice announces expiration PAR-16-340 quot;Career Transition Award NINDS Intramural Clinician-Scientists K22)" effective January 24, 2018. notice also serves inform applicants NINDS plans reissue Funding Opportunity Announcement FOA) compliance FORMS-E. nbsp; Part 1. Overview Key Dates Currently Reads: Application Due Date(s): Standard dates October 12, 2016; February 12, 2017; June 12, 2017; October 12, 2017; February 12, 2018; June 12, 2018; October 12, 2018; February 12, 2019; June 12, 2019) Modified Read: Application Due Date(s): Standard dates October 12, 2016; February 12, 2017; June 12, 2017; October 12, 2017) Currently Reads: Expiration Date: 8, 2019 Modified Read: Expiration Date: January 24, 2018 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Stephen Korn, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-4188 Email: korns@mail.nih.gov

Notice Expiration PAR-15-195 NeuroNEXT Infrastructure Resource Access X01)" Notice Number: NOT-NS-18-037 Key Dates Release Date: January 11, 2018 Related Announcements PAR-15-195 Issued National Institute Neurological Disorders Stroke NINDS) Purpose notice announces expiration PAR-15-195 quot;NeuroNEXT Infrastructure Resource Access X01)" effective January 24, 2018.  last date NINDS accept applications PAR-15-195 January 23, 2018. Part 1: Overview nbsp; Key Dates: Currently Reads: Application Due Date(s): Applications accepted continuous receipt. Council Round: Receipt Window: November 13 - March 12 Council Round: October Receipt Window: March 13 - July 12 Council Round: January Receipt Window: July 13 - November 12 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Modified Read: Application Due Date(s): Applications accepted continuous receipt. Council Round: Receipt Window: November 13 - January 23, 2018 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Currently Reads: Expiration Date: March 13, 2018 Modified Read: Expiration Date: January 24, 2018 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Codrin Lungu, MD National Institute Neurological Disorders amp; Stroke NINDS) Telephone: 301-496-9135 Email: mcneilde@ninds.nih.gov

NIH Applicant Assistance Program AAP) New Previously Unawarded Small Businesses Notice Number: NOT-CA-18-031 Key Dates Release Date: December 21, 2017 Related Announcements NOT-CA-18-072 Issued National Cancer Institute NCI) National Heart, Lung, Blood Institute NHLBI) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to announce pilot program assist eligible small businesses understanding completing Small Business Innovation Research SBIR) Small Business Technology Transfer STTR) application process. program, NIH Applicant Assistance Program AAP), intended help new and/or previously unsuccessful small businesses submit competitive SBIR STTR application one the participating institutes NCI, NINDS, NHLBI). AAP designed to: Provide support small businesses preparing Phase SBIR STTR application Assist identifying appropriate market research an SBIR/STTR application Guide applicants through application process, including required registrations Help applicants the electronic system apply an SBIR/STTR award NIH particularly interested assisting small businesses are owned operated individuals are underrepresented the biomedical sciences, including: Black African Americans   Hispanics Latinos American Indians Alaska Natives Native Hawaiians other Pacific Islanders Individuals disabilities Women underrepresented biomedical industry ownership high-level leadership) service provided through third-party federal contractor. Small businesses must apply be accepted the NIH AAP. After acceptance, program offered no charge the small business. Participation this program optional does guarantee successful SBIR STTR award. Small businesses interested the program apply here: https://www.dawnbreaker.com/aap/ Inquiries Please direct inquiries to: Kory Hallett, PhD National Cancer Institute NCI) Telephone: 240-276-5882 Email: kory.hallett@nih.gov Stephanie Fertig, MBA National Institute Neurological Disorders Stroke NINDS) Telephone 301-496-1779 Email: fertigs@ninds.nih.gov Eric Padmore, MHSA National Heart, Lung, Blood Institute NHLBI) Telephone: 301-496-2149 Email: NHLBI_SBIR@mail.nih.gov

Notice Clarification NINDS Statement interest PAR-18-208 Bioengineering Research Partnerships BRP) U01 Clinical Trial Optional)" Notice Number: NOT-NS-18-029 Key Dates Release Date:   December 18, 2017 Related Announcements PAR-18-208 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to revise NINDS interest statement PAR-18-208. current language reads: Part 2. Full Text Announcement Section I. Funding Opportunity Description Institute statements interest:   applications relevant the mission http://www.ninds.nih.gov/about_ninds/mission.htm) the National Institute Neurological Disorders Stroke NINDS) under FOA: Applications should milestone-driven, translational engineering development regulatory approval targeted, diagnostic devices excluding neuro-imaging). nbsp;Specific go/no-go milestones be negotiated NINDS Program staff the time award inclusion the notice award.  Applications proposing translational studies designed pre-clinical pilot clinical studies therapeutic devices, specifically, should submitted one the following NINDS CREATE Devices FOAs http://www.ninds.nih.gov/funding/areas/translational_research/CREATE-De…).  Applications NINDS proposing pre-translational, pre-clinical, investigative research projects deliberative optimization development devices impacts neurology neuroscience should apply through Bioengineering Research Grants R01) Exploratory Bioengineering Research Grants R21) refer 2018 FOAs].  NINDS not accept applications under announcement include clinical trials https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html). clinical trial a prospective biomedical behavioral research study human subjects designed answer specific questions safety, tolerability, efficacy and/or effectiveness pharmacologic, behavioral, biologic, surgical, device invasive non-invasive) interventions. human subjects research be submitted NINDS decline funding any application includes human subjects programmatic administrative reasons. Applicants considering projects involving human subjects research strongly encouraged contact Scientific/Research staff.  Applications NINDS proposing clinical trial must submitted one the following NINDS FOAs specifically designed clinical trials http://www.ninds.nih.gov/research/clinical_research/index.htm#tab3-panel) language been modified now reads: Part 2. Full Text Announcement Section I. Funding Opportunity Description Institute statements interest: NINDS: Within goals this FOA, NINDS particularly interested bioengineering research advances technologies the potential decrease burden neurological disorders stroke. Examples areas interest include development validation invasive non-invasive devices, diagnostic/monitoring tools, advanced imaging techniques, computational models, tissue engineering, other innovative methods. Applicants strongly encouraged contact NINDS Scientific Program staff prior submission. Applicants interested translational activities clinical studies therapeutic diagnostic devices disorders affect nervous neuromuscular systems be appropriate other NINDS bioengineering opportunities https://www.ninds.nih.gov/Current-Research/Focus-Research/Focus-Bioengi…). Inquiries Please direct inquiries to: Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice NINDS Withdrawal Participation PA-18-286 Exploratory/Developmental Bioengineering Research Grants EBRG) R21 Clinical Trial Optional)" Notice Number: NOT-NS-18-030 Key Dates Release Date:   December 18, 2017 Related Announcements PA-18-286 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to inform applications as the February 16, 2018, standard due date, NINDS no longer participate the Exploratory/Developmental Bioengineering Research Grants EBRG) R21 Clinical Trial Optional) PA-18-286), will accept any applications  the Funding Opportunity Announcement FOA) PA18-286. Currently reads: Components Participating Organizations National Cancer Institute NCI) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.865; 93.853; 93.399; 93.396; 93.395; 93.394; 93.393; 93.279; 93.846 Part 2. Full Text Announcement Section I. Funding Opportunity Description IC Specific Guidelines following text been removed: NINDS: applications relevant the mission http://www.ninds.nih.gov/about_ninds/mission.htm) the National Institute Neurological Disorders Stroke NINDS): NINDS not accept applications under announcement include clinical trials https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html). clinical trial a prospective biomedical behavioral research study human subjects designed answer specific questions safety, tolerability, efficacy and/or effectiveness pharmacologic, behavioral, biologic, surgical, device invasive non-invasive) interventions. human subjects research be submitted NINDS decline funding any application includes human subjects programmatic administrative reasons. Applicants considering projects involving human subjects research strongly encouraged contact Scientific/Research staff. Modified read: Components Participating Organizations National Cancer Institute NCI) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.865; 93.399; 93.396; 93.395; 93.394; 93.393; 93.279; 93.846 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov

Notice NINDS Policy Submission Applications Participation PA-18-345 NIH Research Project Grant Parent R01) - Clinical Trial Required". NINDS Only accepts Clinical Trial Applications Proposing Mechanistic Studies Clinical Trial Parent R01 Notice Number: NOT-NS-18-011 Key Dates Release Date: December 18, 2017 Related Announcements PA-18-345 NOT-NS-18-054 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to announce NINDSs participation the NIH Research Project Grant Parent R01 Clinical Trial Required) Funding Opportunity Announcement FOA) subsequent reissuances these FOAs. applications submitted or after January 25, 2018, NINDS only accept applications this FOA propose human mechanistic trials/studies meet NIH's definition a clinical trial that fall within NINDS research priorities. NIH defines clinical trial A research study which or human subjects prospectively assigned one more interventions may include placebo other control) evaluate effects those interventions health-related biomedical behavioral outcomes. NOT-OD-15-015) NIH defines mechanistic clinical trial follows: mechanistic study designed understand biological behavioral process, pathophysiology a disease, the mechanism action an intervention. NINDS supports hypothesis-driven mechanistic clinical trial studies basic and/or translational discovery research healthy human subjects in pathobiology, pathophysiology, neuropathology neurological disorders. goal to address basic questions to interrogate concepts biology, behavior, pathophysiology will provide insight understanding neurological disorders. Such studies seek understand biological behavioral process, the mechanism action an intervention. NINDS supports biomarker studies may provide information physiological function, target engagement novel therapeutics, and/or mechanisms therapeutic responses. submitted studies defined clinical trials noted above) do seek answer specific questions safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation pharmacologic, behavioral, biologic, surgical, device invasive non-invasive) interventions. preventive, therapeutic, services interventions. Such designs should submitted an NINDS clinical trial-specific funding announcement listed the NINDS website https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Clinic…). Applicants strongly advised consult NINDS program staff prior submitting application human subjects determine appropriate funding opportunity. Examples types applications intended be supported NINDS under NIH Parent Clinical Trial R01 FOA include, are limited to: Studies which manipulation physiological behavioral) used answer basic science questions normal brain function. Studies develop, validate, and/or apply novel measures brain signaling circuits healthy humans including, example, PET, SPECT, other neuroimaging approaches, well biomarkers physiological processes. Studies use experimental manipulation e.g., CNS active drugs, direct neurostimulation cognitive task activating specific neural circuit) order understand normal functioning the pathophysiology a neurological disorder, do aim demonstrate clinical improvement. Studies involve prospective of efficacious interventions e.g., biomedical, behavioral, cognitive, therapeutic approaches), where intent to obtain biospecimens e.g., blood, patient-derived induced pluripotent stem cells) identify genetic risk associations, novel biomarkers, examine disease process, characterize mechanisms therapeutic response. Studies which intervention demonstrated efficacy that population being studied understand mechanisms response, non-response, risk adverse effects the efficacious intervention. following types clinical trials not intended be supported NINDS under NIH Parent Clinical Trials R01 FOA: Studies do meet NIH definition clinical trial. Early-stage trials novel treatment approaches humans are prerequisite clinical efficacy trials pharmacological, device, behavioral intervention development. Studies develop conduct tests the clinical efficacy/effectiveness treatments. Studies have safety, clinical efficacy, clinical management, and/or implementation its principal aim. Resource Does human subjects research study meet definition a clinical trial? Part 1. Overview Information Components Participating Organizations National Center Complementary Integrative Health NCCIH) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Drug Abuse NIDA) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Minority Health Health Disparities NIMHD) National Institute Nursing Research NINR) National Institute Neurological Disorders Stroke NINDS) Catalog Federal Domestic Assistance CFDA) Number(s) 93.853 Inquiries Please direct inquiries to: Claudia Moy, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9135 Email: moyc@ninds.nih.gov