Notices of Funding Opportunities

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 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

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 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

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 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 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 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 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

Notice Support Administrative Supplements Embed Ethicists BRAIN Initiative Supported Research Notice Number: NOT-MH-18-034 Key Dates Release Date: 01, 2018 Related Announcements None Issued National Institute Mental Health NIMH) National Eye Institute NEI) National Institute Aging NIA) 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 Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose Brain Research through Advancing Innovative Neurotechnologies BRAIN) Initiative aimed revolutionizing neuroscience through development application innovative technologies map neural circuits, monitor modulate activity, understand they contribute thoughts, sensations, emotions behavior. NIH issued variety Funding Opportunity Announcements FOAs) will support projects apply technologies understand neural circuit function the context specific circuits, resulting a diverse portfolio research the fundamental biology nervous system function.  purpose this announcement to notify research community NIH encouraging applications to PA-18-591 to integrate neuroethics perspectives approaches existing BRAIN Initiative awards. Supplement applications encouraged ongoing BRAIN Initiative projects can readily incorporate core ethical issues associated research focused the human brain resulting emerging technologies advancements research development supported the BRAIN Initiative. intent that efforts supported through administrative supplement be both complimentary integrative the transformative, breakthrough neuroscience discoveries supported through BRAIN Initiative.   an administrative supplement, work proposed needs be within scope the research is already supported. Research proposed supplement applications should clear relevance the BRAIN Initiative. proposed work cover pilot projects, resource development, personnel costs embedding neuroethics the research project. each case, work proposed should feasible complete within one-year timeframe with limited funds permitted. should also show promise becoming more substantial project might attract additional funding. Investigators should submit applications responses the parent active administrative supplement announcement https://grants.nih.gov/grants/guide/pa-files/PA-18-591.html) using electronic submission. Electronic applications strongly encouraged.. Individual requests be more 100,000 direct costs exclusive Facilities Administrative costs sub-contracts may for year only. Requests must received June 15 funding FY 2018. Inquiries Please direct inquiries to: James Churchill National Institute Mental Health NIMH) Telephone: 301-443-3621 Email: churchillj@mail.nih.gov