Notices of Funding Opportunities

National Institutes of Health (NIH) BRAIN Initiative notices of funding opportunities (NOFOs), requests for applications (RFAs), program announcements (PAs), and other NIH Guide announcements are listed below. Search this page to find all notices of special interest (NOSI). Search the Closed Opportunities page to find expired opportunities.  

Learn more about NIH’s grant mechanisms.  

Learn about the Plan for Enhancing Diverse Perspectives (PEDP), a required component in most BRAIN applications.  

Learn about the NIH Data Management and Sharing Policy, which all NIH applications must follow.  

To see more NIH-funded awards, please visit NIH Grants and Funding.

For more about NIH BRAIN Initiative research and associated funding opportunities, visit the Research Overview.

Title
Release Date
Expiration Date
Funding Opportunity #
Notice to Encourage Eligible NIH BRAIN Initiative Awardees to Apply for PA-18-906 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
January 01 , 2027
Notice Encourage Eligible NIH BRAIN Initiative Awardees Apply PA-18-906 Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed) Notice Number: NOT-DA-18-038 Key Dates Release Date: September 18, 2018 Related Announcements PAR-18-501 PAR-18-515 RFA-DA-18-018 RFA-EB-15-006 RFA-EB-17-001 RFA-EB-17-002 RFA-EB-17-003 RFA-EB-17-004 RFA-EB-17-005 RFA-EY-17-001 RFA-EY-18-001 RFA-MH-16-750 RFA-MH-16-775 RFA-MH-16-810 RFA-MH-16-815 RFA-MH-17-210 RFA-MH-17-215 RFA-MH-17-220 RFA-MH-17-230 RFA-MH-17-235 RFA-MH-17-240 RFA-MH-17-245   RFA-MH-17-255 RFA-MH-17-256 RFA-MH-17-257 RFA-MH-17-260 RFA-MH-18-505 RFA-MH-19-136 RFA-NS-15-008 RFA-NS-16-006 RFA-NS-16-007 RFA-NS-16-008 RFA-NS-16-009 RFA-NS-16-010 RFA-NS-17-003 RFA-NS-17-004 RFA-NS-17-006 RFA-NS-17-014 RFA-NS-17-015   RFA-NS-17-019 RFA-NS-18-014 RFA-NS-18-018 RFA-NS-18-019 RFA-NS-18-020 RFA-NS-18-021 RFA-NS-18-022 RFA-NS-18-023 RFA-NS-18-029 RFA-NS-18-030 Issued National Eye Institute NEI) National Institute Biomedical Imaging Bioengineering NIBIB) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Purpose Notice encourages eligible awardees the BRAIN Initiative community apply administrative supplements response to PA-18-906 Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed). NIH a strong interest the diversity the NIH-funded workforce see NOT-OD-18-210 for details) encourages institutions diversify student populations enhancing participation individuals groups identified underrepresented the biomedical, clinical, behavioral, social sciences. BRAIN Initiative 2025 report stated the BRAIN Initiative should a catalyst will drive outstanding young people enter area their most creative career stage." NIH diversity supplement offers opportunity existing BRAIN awardees request additional funds train mentor next generation researchers, including those underrepresented groups, will contribute advancing goals the BRAIN Initiative. Program Directors/Principal Investigators PD/PI) active BRAIN Initiative research program grants thus encouraged identify eligible individuals throughout continuum high school the faculty level support scientific mentorship under auspices this administrative supplement. activities proposed the supplement application must fall within scope the parent grant, both advance objectives the parent grant support research training professional development the supplement candidate. BRAIN Initiative PIs strongly encouraged incorporate training activities will help prepare supplement candidate conduct rigorous research relevant the goals the BRAIN Initiative 2025 Report. Educational goals the NIH component the BRAIN Initiative see BRAIN 2025: Scientific Vision) include acquisition quantitative skills; appropriate and integration newly developed tools, technologies methods developed under BRAIN Initiative; consideration the ethical implications neuroscience research. special focus training quantitative neuroscience, i.e., theory statistics biologists, exposing physicists, engineers statisticians experimental neuroscience. BRAIN 2025 Report strongly encourages scientists cross traditional areas expertise conduct interdisciplinary research, acknowledges need attract investigators faculty recruits neuroscience quantitative disciplines, e.g., statistics, computer science, physics, mathematics, engineering.   Applicants requested state, the first sentence the Research Strategy, the parent grant awarded a BRAIN Initiative award, to state specific FOA the parent grant e.g., RFA-NS-18-030) facilitate processing the supplement application. some cases, diversity supplement be submitted a multiple-PD/PI MPI) BRAIN Initiative award is awarded a foreign institution. Specifically, diversity supplement be submitted the supplement candidate meets eligibility criteria specified in PA-18-906 and work a subaward MPI a domestic institution. Potential applicants encouraged confirm eligibility the Program contact listed below.  BRAIN diversity supplement awardees, appropriate the duration their support career stage, strongly encouraged participate annual PD/PI meetings in activities. Applicants request funds, addition the research costs specified in PA-18-906, to enable supplement candidate attend annual BRAIN Initiative PD/PI meeting the Washington, DC area. request additional funds should reasonable well justified the application.  Before submitting application, applicants encouraged review the supplemental guidance for BRAIN Initiative diversity supplement applications   the NIH BRAIN Initiative web site. Consultation the Program Official the qualifying BRAIN award the individual named under Inquiries below also strongly encouraged. Supplement applications be evaluated the BRAIN Initiative research training committee, committee Program staff the Institutes Centers participating the NIH BRAIN Initiative.  Applications be considered according the following schedule: Application Due Date                                    Funding Decision October 1, 2018 December 1, 2018              January 30, 2019 December 2, 2018 February 15, 2019          March 31, 2019 February 16, 2019 April 15, 2019                 30, 2019 April 16, 2019 June 15, 2019                       July 30, 2019 tracking purposes, applicants encouraged inform Dr. James Churchill via email BRAIN.Initiative.Training@nih.gov) a diversity supplement application submitted. Please include PD/PI name grant number the subject line this email. Inquiries Please direct inquiries to: James Churchill, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-3621 Email: BRAIN.Initiative.Training@nih.gov
Notice of Correction of PA-18-871, "BRAIN Initiative: Development Optimization, and Validation of Novel Tools and Technologies for Neuroscience Research (SBIR) (R43/R44 Clinical Trial Not Allowed) "
January 01 , 2027
Notice Correction PA-18-871, BRAIN Initiative: Development Optimization, Validation Novel Tools Technologies Neuroscience Research SBIR) R43/R44 Clinical Trial Allowed) " Notice Number: NOT-MH-18-051 Key Dates Release Date: September 04, 2018 Related Announcements PA-18-871 Issued National Institute Mental Health NIMH) Purpose purpose this Notice clarify Application Types allowed in PA-18-871, BRAIN Initiative: Development Optimization, Validation Novel Tools Technologies Neuroscience Research SBIR) R43/R44 Clinical Trial Allowed). Currently reads Section II. Award Information  Application Types Allowed New Phase I) Renewal Phase II* Direct Phase II not allowed) Resubmission phases) Revision The OER Glossary and SF424 R&R) SBIR/STTR Application Guide provide details these application types. Modified read  Section II. Award Information    Application Types Allowed  New Phase I, Fast Track) Renewal Phase II* Direct Phase II not allowed) Resubmission phases) Revision The OER Glossary and SF424 R&R) SBIR/STTR Application Guide provide details these application types. other aspects this FOA remain unchanged.  Inquiries Please direct inquiries to: Margaret Grabb, PhD National Institute Mental Health NIMH) Telephone:  301-443-3563 Email:  mgrabb@mail.nih.gov
Notice of Change of Receipt Date for RFA-NS-18-019 "BRAIN Initiative: Optimization of Transformative Technologies for Large Scale Recording and Modulation in the Nervous System (U01 Clinical Trials Not Allowed)"
January 01 , 2027
Notice Change Receipt Date RFA-NS-18-019 BRAIN Initiative: Optimization Transformative Technologies Large Scale Recording Modulation the Nervous System U01 Clinical Trials Allowed)" Notice Number: NOT-NS-18-086 Key Dates Release Date: August 10, 2018 Related Announcements RFA-NS-18-019 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) Purpose purpose this notice to inform interested applicants there be change receipt dates the Funding Opportunity Announcement FOA) RFA-NS-18-019 BRAIN Initiative: Optimization Transformative Technologies Large Scale Recording Modulation the Nervous System U01 Clinical Trials Allowed).  Specifically, next receipt date change October 29, 2018 to November 27, 2018. Part 1. Overview Information Key Dates Currently Reads: Application Due Date(s) 15, 2018, October 29, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All 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) 15, 2018, November 27, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All 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. other aspects this FOA remain same. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: BRAIN-FOAs@nih.gov
Notice of Change of Receipt Date for RFA-NS-18-020 "BRAIN Initiative: New Technologies and Novel Approaches for Large-Scale Recording and Modulation in the Nervous System (R01 Clinical Trial Not Allowed)"
January 01 , 2027
Notice Change Receipt Date RFA-NS-18-020 BRAIN Initiative: New Technologies Novel Approaches Large-Scale Recording Modulation the Nervous System R01 Clinical Trial Allowed)" Notice Number: NOT-NS-18-087 Key Dates Release Date: August 10, 2018 Related Announcements RFA-NS-18-020 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) Purpose purpose this notice to inform interested applicants there be change receipt dates the Funding Opportunity Announcement FOA) RFA-NS-18-020 BRAIN Initiative: New Technologies Novel Approaches Large-Scale Recording Modulation the Nervous System R01 Clinical Trial Allowed)".  Specifically, next receipt date change October 29, 2018 to November 27, 2018. Part 1. Overview Information Key Dates Currently Reads: Application Due Date(s) 15, 2018, October 29, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All 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) 15, 2018, November 27, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All 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.   other aspects this FOA remain same. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: BRAIN-FOAs@nih.gov
Notice of Change of Receipt Date for RFA-EY-18-001 "BRAIN Initiative: New Concepts and Early - Stage Research for Large - Scale Recording and Modulation in the Nervous System (R21 Clinical Trial Not Allowed)"
January 01 , 2027
Notice Change Receipt Date RFA-EY-18-001 BRAIN Initiative: New Concepts Early - Stage Research Large - Scale Recording Modulation the Nervous System R21 Clinical Trial Allowed)" Notice Number: NOT-NS-18-088 Key Dates Release Date: August 10, 2018 Related Announcements RFA-EY-18-001 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) Purpose purpose this notice to inform interested applicants there be change receipt dates the Funding Opportunity Announcement FOA) RFA-EY-18-001 BRAIN Initiative: New Concepts Early - Stage Research Large - Scale Recording Modulation the Nervous System R21 Clinical Trial Allowed)".  Specifically, next receipt date change October 29, 2018 to November 27, 2018. Part 1. Overview Information Key Dates Currently Reads: Application Due Date(s) 1, 2018, October 29, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All 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) 1, 2018, November 27, 2018, 1, 2019, October 29, 2019, 1, 2020, October 29, 2020 , 5:00 PM local time applicant organization. All 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.   other aspects this FOA remain same. Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1447 Email: BRAIN-FOAs@nih.gov
Soliciting Feedback on the BRAIN Initiative
January 01 , 2027
Soliciting Feedback the BRAIN Initiative Notice Number: NOT-NS-18-075 Key Dates Release Date: July 23, 2018 Response Date: November 15, 2018 Related Announcements NOT-NS-19-041 Issued National Eye Institute NEI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose purpose this Request Information RFI) to solicit input how best accomplish ambitious vision the Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative® set forth BRAIN 2025: Scientific Vision. NIH soliciting input all interested stakeholders, including members the scientific community, trainees, academic institutions, private sector, health professionals, professional societies, advocacy groups, patient communities, well other interested members the public. Background BRAIN Initiative aims develop new tools technologies understand manipulate networks cells the brain. BRAIN 2025: Scientific Vision serves the strategic plan the BRAIN Initiative NIH outlines overarching vision, seven high level scientific priorities, many specific goals. Designed be achieved over least decade, first five years BRAIN 2025 emphasizes development tools technology, the next five years shifts emphasis using tools make fundamental discoveries how brain circuits work what goes wrong disease. BRAIN Initiative well underway see  http://www.braininitiative.nih.gov ), we now approaching midpoint. this time, NIH seeking feedback the BRAIN Initiative's progress on opportunities moving forward given current state the science. NIH established new BRAIN Initiative Advisory Committee the NIH Director ACD) Working Group will provide scientific guidance the ACD how best continue accelerate ambitious vision the BRAIN Initiative. ACD-WG use responses this RFI, along information gathered through series public workshops, help inform discussions the BRAIN Initiative's progress potential updates the plan moving forward. Information Requested Please submit: Ideas new tools technologies have potential transform brain circuit research. Suggestions fundamental questions brain circuit function humans animal models could addressed new technologies. Considerations data sharing infrastructure policies. Areas topics research the ethical implications BRAIN Initiative-supported emerging neurotechnologies advancements their applications. Approaches disseminating new tools technologies well training broader neuroscience research community. Any topic relevant the strategic plan the BRAIN Initiative. to Submit Response assure consideration, responses must received November 15, 2018. Responses this RFI must submitted electronically using web-based form https://www.braininitiative.nih.gov/rfi.aspx via email BRAINFeedback@nih.gov  BRAIN RFI" the subject line. Responses this RFI voluntary. Any personal identifiers be removed responses compiled.  Individual feedback not provided any responder. Proprietary, classified, confidential, sensitive information should be included your response. This Request Information RFI) for planning purposes only is a solicitation applications an obligation the part the United States U.S.) Government provide support any ideas identified response it. Please note the U.S. Government not pay the preparation any comment submitted for use that comment. Inquiries Please direct inquiries to: Email: BRAINFeedback@nih.gov
Notice of Clarification for Submission of Materials Related to Communications with FDA for RFA-NS-18-021 "BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3)"
January 01 , 2027
Notice Clarification Submission Materials Related Communications FDA RFA-NS-18-021 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UG3/UH3)" Notice Number: NOT-NS-18-065 Key Dates Release Date:   June 22, 2018 Related Announcements RFA-NS-18-021 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify submission materials related Communications the FDA RFA-NS-18-021 BRAIN Initiative:  Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UG3/UH3 Clinical Trial Required)". current language reads   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award   language been modified now reads:   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Applicants should include minutes all pre-submission meetings, notice IDE, risk determination, email communications, other relevant documentation. material should only submitted section 4.6.a the application as post-submission material.   Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award. other aspects this FOA remain same. Inquiries Please direct inquiries to: Kari Ashmont, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: kari.ashmont@nih.gov   Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov
Notice of Clarification for Submission of Materials Related to Communications with FDA for RFA-NS-18-022 "BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)"
January 01 , 2027
Notice Clarification Submission Materials Related Communications FDA RFA-NS-18-022 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44)" Notice Number: NOT-NS-18-066 Key Dates Release Date:   June 22, 2018 Related Announcements RFA-NS-18-022 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify submission materials related Communications the FDA RFA-NS-18-022 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44 Clinical Trial Required)". current language reads   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award   language been modified now reads:   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Applicants should include minutes all pre-submission meetings, notice IDE, risk determination, email communications, other relevant documentation. material should only submitted section 4.6.a the application as post-submission material.   Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award. other aspects this FOA remain same. Inquiries Please direct inquiries to: Kari Ashmont, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: kari.ashmont@nih.gov   Stephanie Fertig, M.B.A. National Institute Neurological Disorders Stroke Telephone: 301-496-1779 Email: fertigs@ninds.nih.gov   Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov
Notice of Clarification for Submission of Materials Related to Communications with FDA for RFA-NS-18-023 "BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System"
January 01 , 2027
Notice Clarification Submission Materials Related Communications FDA RFA-NS-18-023 BRAIN Initiative: Clinical Studies Advance Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System" Notice Number: NOT-NS-18-067 Key Dates Release Date:   June 22, 2018 Related Announcements RFA-NS-18-023 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this Notice to clarify submission materials related Communications the FDA RFA-NS-18-023 BRAIN Initiative: Clinical Studies Advance Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UH3 Clinical Trial Required)". current language reads   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award   language been modified now reads:   Section 4 Protocol Synopsis   4.6 the study an FDA-regulated intervention?   4.6.a. yes, describe availability Investigational Product IP) Investigational New Drug IND)/Investigational Device Exemption IDE) status:   Communications FDA: Applicants should include minutes all pre-submission meetings, notice IDE, risk determination, email communications, other relevant documentation. material should only submitted section 4.6.a the application as post-submission material.   Large animal safety studies often required the FDA support IDE. Applicants should include large animal GLP safety study conducted the full-final device system using final manufacturing process intended support IDE. a large animal safety study not required the FDA an IDE, a test the full final system using final design manufacturing processes not required, applicants should include communication the FDA clearly stating is case the form a response a Pre-Submission. If studies proposed, ultimately needed, program staff work the investigators remove relevant milestones associated costs these activities the award. other aspects this FOA remain same.   Inquiries Please direct inquiries to: Kari Ashmont, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: kari.ashmont@nih.gov Nick Langhals, Ph.D. National Institute Neurological Disorders Stroke Telephone: 301-496-1447 Email: nick.langhals@nih.gov
Notice of Correction to Key Dates in RFA-NS-18-029 "BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP (U01 Clinical Trial Not Allowed)
January 01 , 2027
Notice Correction Key Dates RFA-NS-18-029 BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP U01 Clinical Trial Allowed) Notice Number: NOT-NS-18-070 Key Dates Release Date: 23, 2018 Related Announcements RFA-NS-18-029 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants a correction the Key Dates RFA-NS-18-029 BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP U01 Clinical Trial Allowed)".  Specifically, Advisory Council Review dates January 2019 and January 2020 and Earliest Start Dates February 2019 and February 2020. Part 1. Overview Information Key Dates Currently Reads: Advisory Council Review January 2019 Earliest Start Date February 2019 Modified Read: Advisory Council Review January 2019 and January 2020 Earliest Start Date February 2019 and February 2020 other aspects this FOA remain same. Inquiries Please direct inquiries to: James Gnadt, PhD  National Institute Neurological Disorders Stroke NINDS)  Telephone: 301-496-9964  Email: BRAINCircuits@nih.gov
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