Notices of Funding Opportunities

The purpose of this notice is to inform applicants of a change to the Key Dates for RFA-NS-18-022 "BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44 Clinical Trial Required)". This Funding Opportunity Announcement has been extended by one council round. The dates have been modified to add a New Application Due Date of February 22, 2021.

The purpose of this notice is to inform applicants of a change to the Key Dates 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 (UH3 Clinical Trial Required)". This Funding Opportunity Announcement has been extended by one council round. The dates have been modified to add a New Application Due Date of February 22, 2021.

Notice Clarification NIH BRAIN Initiative Institutional Letter RFA-NS-19-043 RFA-NS-19-044" K99/R00 - BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity" Notice Number: NOT-NS-20-094 Key Dates Release Date: August 5, 2020 Related Announcements RFA-NS-19-043 - BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00 Independent Clinical Trial Allowed) RFA-NS-19-044 - BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00 Independent Clinical Trial Required) 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) National Center Complementary Integrative Health NCCIH) Purpose Notice to clarify placement inclusion the Institutional Letter RFA-NS-19-043 BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00 Independent Clinical Trial Allowed) RFA-NS-19-044- BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00 Independent Clinical Trial Required). current language reads: Section IV. Application Submission Information Project Information Institutional Letter: Applicants required attach letter the institution explaining the candidate's participation further goals the BRAIN Initiative Postdoctoral Career Transition Award, consistent the Notice NIH's Interest Diversity NOT-OD-18-210). letter the institution must on institutional letterhead scanned that institutional official signature visible. Name PDF-formatted letter Institutional_Ltr.pdf". letter limited 1 page. Due Forms-F application package changes, language been removed. Applicants should refer the PHS 398 Career Development Award Supplement Form instructions this letter. Please updated instructions below. language been modified read: Section IV. Application Submission Information PHS 398 Career Development Award Supplemental Form Environment Institutional Commitment Candidate Section outlined the SF424 form instructions, applicants diversity-related FOAs must complete 12. Description Candidate’s Contribution Program Goals” attachment: sponsoring institution must provide document institutional letterhead explains the candidate’s participation further goals the career development program promote diversityin BRAIN Initiative research. Description Candidate’s Contribution Program Goals” attachment must dated signed an institutional official. most cases, will the dean the chairman the department. signature must appear over signer's name title the end the statement. Attach information a PDF file. other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Michelle Jones-London, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-451-7966 Email: BRAINDIVERSITYK99R00@nih.gov

Notice Intent Publish Funding Opportunity Announcement BRAIN Initiative Fellows: Ruth L. Kirschstein National Research Service Award NRSA) Individual Postdoctoral Fellowship F32)" Notice Number: NOT-MH-20-062 Key Dates Release Date: June 17, 2020 Estimated Publication Date Funding Opportunity Announcement: August 14, 2020 First Estimated Application Due Date: December 08, 2020 Earliest Estimated Award Date: July 01, 2021 Earliest Estimated Start Date: July 01, 2021 Related Announcements Reissue RFA-MH-18-510 - BRAIN Initiative Fellows: Ruth L. Kirschstein National Research Service Award NRSA) Individual Postdoctoral Fellowship F32) Issued National Institute Mental Health NIMH) 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 Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose NIMH, other NIH Institutes Centers participating theBrain Research through Advancing Innovative Neurotechnologies®(BRAIN) Initiative, intends reissue "BRAIN Initiative Fellows: Ruth L. Kirschstein National Research Service Award NRSA) Individual Postdoctoral Fellowship F32)." Notice being provided allow potential applicants sufficient time develop meaningful mentoring teams responsive projects. Funding Opportunity Annoucement FOA) expected be published Summer 2020 an initial expected application due date December 2020. FOA utilize F32 activity code. Details the planned FOA provided below. Research Initiative Details purpose the BRAIN Initiative Fellows F32) program to enhance research training promising postdoctorates, early their postdoctoral training period, have potential become productive investigators research areas will advance goals the BRAIN Initiative. Applications encouraged any research area is aligned one more the seven high-priority areas the BRAIN Initiative, including neuroethics. Applicants expected propose research training an area clearly complements predoctoral research. Formal training analytical tools appropriate the proposed research expected be integral component the research training plan. order maximize training potential the F32 award, program encourages applications individuals have yet completed terminal doctoral degree who expect do within 12 months the application due date. the application due date, candidates not completed than 12 months postdoctoral training. Funding Information Estimated Total Funding TBD Expected Number Awards TBD Estimated Award Ceiling TBD Primary CFDA Numbers 93.242, 93.173, 93.866, 93.853, 93.286, 93.213, 93.867, 93.865, 93.279, 93.273 Anticipated Eligible Organizations Public/State Controlled Institution Higher EducationPrivate Institution Higher EducationNonprofit 501(c)(3) IRS Status than Institution Higher Education)Small BusinessFor-Profit Organization than Small Business)Eligible Agencies the Federal GovernmentNon-domestic non-U.S.) Entity Foreign Organization) Applications not being solicited this time. Inquiries Please direct inquiries to: Ashlee Van’t Veer, PhD National Institute Mental Health NIMH) 301-443-3107 BRAIN.Initiative.Training@nih.gov

Notice Extend RFA-MH-20-120 BRAIN Initiative: Secondary Analysis Archiving BRAIN Initiative Data R01 Clinical Trial Allowed) Notice Number: NOT-MH-20-052 Key Dates Release Date: 11, 2020 Related Announcements RFA-MH-20-120 Issued National Institute Mental Health NIMH) 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 Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) Purpose purpose this Notice to extend RFA-MH-20-120, BRAIN Initiative: Non-Invasive Neuromodulation - New Tools Techniques Spatiotemporal Precision R01 Clinical Trial Optional) Part 1. Overview Information Key Dates Currently reads: Application Due Date(s) September 6, 2019 June 11, 2020, 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. late applications be accepted this Funding Opportunity Announcement. 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) Applicable Scientific Merit Review: March 2020 October 2020 Advisory Council: 2020, January 2021 Earliest Start Date: July 2020, April 2021 Expiration Date: June 12, 2020 Modified read: Application Due Date(s) September 6, 2019, June 11, 2020, February 26, 2021 5:00 PM local time applicant organization. types non-AIDS applications allowed this funding opportunity announcement due these dates. late applications be accepted this Funding Opportunity Announcement. 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) Applicable Scientific Merit Review March 2020 October 2020, June 2021 Advisory Council 2020, January 2021, August 2021 Earliest Start Date July 2020, April 2021, September 2021 Expiration Date February 27, 2021 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Ming Zhan, Ph.D. National Institute Mental Health NIMH) Telephone: 301-827-3678 Email: ming.zhan@nih.gov

Notice Correction Key Dates RFA-NS-20-029 BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP U01 Clinical Trials Optional)" Notice Number: NOT-NS-20-063 Key Dates Release Date: April 28, 2020 Related Announcements RFA-NS-20-029 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to notify potential applicants a correction the Key Dates RFA-NS-20-029 BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP U01 Clinical Trials Optional)". Advisory Council Review Earliest Start Dates been modified show correct dates. Changes show in bold italics below. changes effective immediately. Currently Reads: Part 1. Overview Information Key Dates Advisory Council Review January 2022 January 2023 Earliest Start Date February 2022 February 2023 Modified Read: Part 1. Overview Information Key Dates Advisory Council Review January 2021 January 2022 Earliest Start Date February 2021 February 2022 other aspects this FOA remain unchanged. Inquiries Please direct inquiries to: Karen K David, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email:BRAINCircuits@nih.gov

Notice Correction Open Date RFA-NS-19-043 BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00 Independent Clinical Trial Allowed)" Notice Number: NOT-NS-20-037 Key Dates Release Date: Janaury 16, 2020 Related Announcements RFA-NS-19-043 Issued National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to inform interested applicants a correction the Open Date Earliest Submission Date) RFA-NS-19-043 "BRAIN Initiative Advanced Postdoctoral Career Transition Award Promote Diversity K99/R00 Independent Clinical Trial Allowed)". Open Date Earliest Submission Date) January 9, 2020. Changes the FOA shown Bold Italics below. Currently Reads: Part 1. Overview Information Key Dates Open Date Earliest Submission Date) January 9, 2022 Modified Read: Part 1. Overview Information Key Dates Open Date Earliest Submission Date) January 9, 2020 other aspects this FOA remain same. Inquiries Please direct inquiries to: Michelle Jones-London, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-451-7966 Email: BRAINDIVERSITYK99R00@nih.gov

Notice Special Interest 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-MH-19-038 Key Dates Release Date: September 4, 2019 First Available Due Date: October 5, 2019 Expiration Date: September 8, 2021 Related Announcements PA-18-906, Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed) Issued National Institute Mental Health NIMH) National Eye Institute NEI) 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 Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) 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) encourages institutions diversify populations enhancing participation individuals groups identified underrepresented the biomedical, clinical, behavioral, social sciences. foundational BRAIN 2025 report states the BRAIN Initiative should a catalyst will drive outstanding young people enter area their most creative career stage." NIH diversity supplement offers opportunity 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 PDs/PIs) active BRAIN Initiative research program grants encouraged identify eligible individuals across career development pipeline high school students the faculty level) support scientific mentorship under auspices this administrative supplement. research activities proposed the supplement application must fall within scope the parent grant. Proposed career development activities should appropriate the career stage the supplement candidate should demonstrate both strong commitment the mentor a clear path forward the candidate. BRAIN Initiative PD/PIs strongly encouraged incorporate training activities will help prepare supplement candidate conduct 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 emphasis placed 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 emphasizes need leverage perspectives quantitative disciplines e.g., statistics, computer science, physics, mathematics, engineering) address neuroscience questions. Application Submission Information: Notice applies due dates or after October 5, 2019 expires September 8, 2021. Applications this initiative must submitted using following opportunity its subsequent reissued equivalent PA-18-906 - Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed). instructions the SF424 R&R) Application Guide PA-18-906 must followed, the following additions: the first sentence the Research Strategy, applicants requested state the parent grant awarded a BRAIN Initiative award to identify specific FOA the parent grant e.g., RFA-NS-18-030) facilitate processing the supplement application. funding consideration, applicants must include NOT-MH-19-038" without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Only existing awardees BRAIN program eligible apply. Supplement applications be evaluated the BRAIN Initiative research training committee. process Streamlined Submissions using eRA Commons cannot used this initiative. Diversity supplement applications a parent grant is multiple-PD/PI MPI) BRAIN Initiative award a foreign institution permitted. Specifically, diversity supplement be submitted the supplement candidate meets eligibility criteria specified in PA-18-906 and work a subaward MPI a U.S. domestic institution. Potential applicants encouraged confirm eligibility the Program contact listed below. BRAIN diversity supplement awardees strongly encouraged participate annual PD/PI meetings in activities their mentors. 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. Potential applicants strongly 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 highly recommended. Supplement applications be evaluated the BRAIN Initiative research training committee. Applications be considered according the following schedule: Application Due Date Funding Decision) October 5 – December 1 January) December 2 – February 15 March) February 16 – April 15 May) April 16 – June 15 July) tracking purposes, applicants encouraged inform Dr. James Churchill via email James.Churchill@nih.gov) a diversity supplement application submitted. Please include PD/PI name grant number the subject line this email. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. 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 Change the Cooperative Agreement RFA-MH-19-149, BRAIN Initiative Cell Census Network BICCN) – Specialized Collaboratory Human Non-Human Primate Brain Cell Atlases U01 Clinical Trial Allowed) Notice Number: NOT-MH-19-040 Key Dates Release Date: August 2, 2019 Related Announcements RFA-MH-19-149 Issued National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) Purpose purpose this notice to change cooperative agreement language in RFA-MH-19-149, " BRAIN Initiative Cell Census Network BICCN) Specialized Collaboratory Human Non-Human Primate Brain Cell Atlases U01 Clinical Trial Allowed). Currently Reads: Cooperative Agreement Terms Conditions Award following special terms award in addition to, not lieu of, otherwise applicable U.S. Office Management Budget OMB) administrative guidelines, U.S. Department Health Human Services DHHS) grant administration regulations 45 CFR Parts 75, other HHS, PHS, NIH grant administration policies. administrative funding instrument used this program be cooperative agreement, assistance" mechanism rather an acquisition" mechanism), which substantial NIH programmatic involvement the awardees anticipated during performance the activities. Under cooperative agreement, NIH purpose to support stimulate recipients' activities involvement and otherwise working jointly the award recipients a partnership role; is to assume direction, prime responsibility, a dominant role the activities. Consistent this concept, dominant role prime responsibility resides the awardees the project a whole, although specific tasks activities be shared among awardees the NIH defined below. PD(s)/PI(s) have primary responsibility for: PD(s)/PI(s) have primary authority responsibility define objectives approaches to plan conduct proposed research. She/he assume responsibility accountability the applicant organization to NIMH performance proper conduct all research, including NIH intramural component, applicable, accordance the Terms Conditions Award. Principal Investigator be member the Steering Committee will responsible scheduling Steering Committee meetings disseminating meeting notes all participants within 2 weeks each meeting below under Collaborative Responsibilities). Awardee Institution and/or Research Project Leader's Institution retain primary custody and primary rights data specified under NIMH approved Intellectual Property Patent Rights Agreements New Chemical Entities the data research resource sharing plans described below). PD/PI provide the NIMH Program Official Project Scientist(s) access data generated under cooperative agreement allow to periodically review data consistent current DHHS, PHS, NIH policies. Timely publication major findings the Steering Committee members encouraged. Publication oral presentation work done under agreement require appropriate acknowledgment NIMH support, including assigned cooperative agreement award number. NIH staff substantial programmatic involvement is above beyond normal stewardship role awards, described below: Project Scientist(s) interacts scientifically the funded PIs the collaborators their cooperative agreement grants, may provide appropriate assistance, including: 1) assisting research planning, 2) suggesting studies within scope the cooperative agreement objectives research activities, 3) presenting experimental findings published sources from relevant contract projects, 4) participating the design experiments, 5) participating the analysis results, 6) advising management technical performance. Project Scientist(s) be member(s) the Steering Committee. FIH, EFS, Phase Ib Phase II/PoC studies be reviewed an appropriate NIMH Data Safety Monitoring Board DSMB) ensure safety participants the validity integrity the data. study protocol(s) consent form(s) be reviewed the DSMB prior initiation the project. DSMB review study reports a regular basis monitor subject enrollment retention, safety, quality data collection, integrity the study. Applicants should refer NIH’s policy data safety monitoring https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html) well the NIMH Guidelines Data Safety Monitoring http://www.nimh.nih.gov/funding/grant-writing-and-application-process/n…. Additionally, NIMH Program Official be responsible the normal scientific programmatic stewardship the award, including monitoring implementation the data research resource sharing plans will named the award notice. noted previously, both NIMH Project Scientist Program Official be given access the data generated under cooperative agreement, will allow to periodically review data ensure consistency current DHHS, PHS, NIH Policies. Participation NIH Intramural Scientists: NIH intramural scientist not serve the PD(s)/PI(s) may participate a collaborator, consultant. However, Intramural scientist not receive salary, equipment, supplies, other remuneration awards resulting this FOA. Intramural scientist must obtain written approval his/her NIH Institute Scientific Director the amount resources may allocated the project. approval must also specify the conduct the project comply the DHHS regulations research involving human subjects applicable) with PHS policy vertebrate animal research. participation an intramural scientist independent and unrelated the role the NIMH Project Scientist. applications include NIH intramural components, intramural resource level be included the total cost the overall application. involvement Intramural scientists needs be consistent NIH Policy. http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/ethical-conduct-toc… Intramural research scientists participating collaborators the same rights responsibilities other researchers are participating investigators the funded cooperative agreement grants. Most often investigators be members the Steering Committee, since will likely considered key personnel. Areas Joint Responsibility include: governing Steering Committee composed the PD(s)/PI(s), CRO lead CTSA lead applicable), key personnel, NIMH Project Scientist(s), NIMH Program Official be established assist monitoring developing scientific content direction the program. total membership NIMH staff not exceed one-third 1/3) the membership the Steering Committee. all cases, role NIMH be assist, participate deliberations, facilitate discussion not direct activities. Steering Committee serve the governing board awardees. awardees under initiative program bound the policies procedures developed the Steering Committee; adoption such policies procedures requires majority vote. Awardees under FOA be required accept implement policies approved the Steering Committee. Membership the Steering Committee include PD(s)/PI(s) each U01 award, a designated representative the case Multiple PD/PI award. member have vote. NIMH Project Scientist be voting member the Steering Committee. chair be chosen a majority vote the Steering Committee, years service chair determined the committee. chair responsible preparing meeting agendas, scheduling chairing meetings, for preparing concise minutes will delivered Steering Committee members within 30 days the meeting. Virtual meetings appropriate. NIMH Project Scientist not serve the Chair the Steering Committee. Steering Committee members meet periodically review progress, plan design research activities, establish priorities. frequency meetings, fewer two per year, be determined the PD(s)/PI(s) will responsible scheduling time place generally one the performance sites) for preparing concise proceedings minutes action items one-two page summary) will delivered the members the Committee within 2 weeks the meeting. Dispute Resolution: Any disagreements may arise scientific programmatic matters within scope the award) between award recipients the NIH be brought Dispute Resolution. Dispute Resolution Panel composed three members be convened. will three members: designee the Steering Committee chosen without NIH staff voting, NIH designee, a third designee expertise the relevant area is chosen the two; the case individual disagreement, first member be chosen the individual awardee. special dispute resolution procedure does alter awardee's right appeal adverse action is otherwise appealable accordance PHS regulation 42 CFR Part 50, Subpart D DHHS regulation 45 CFR Part 16. Intellectual Property Patent Rights New Chemical Entities Devices Since development new pharmacological treatments psychiatric disorders a major objective this effort active involvement pharmaceutical laboratories encouraged would facilitated the existence appropriate patent coverage, is expected applicants provide plans address handling intellectual property new chemical entities devices under FOA. Under earlier National Cooperative Drug Discovery/Development Groups NCDDG) the Treatment Mental Disorders, Drug Alcohol Addiction program, successful applicants required supply following confidential materials the NIMH Program Official listed under Section VII. Agency Contacts. Similar the NCDDG, applicants expected address three items noted below under FOA, consistent achieving goals this program: 1. applicant expected provide detailed description the approach be used handling intellectual property for licensing where appropriate, particular where invention involve investigators more one institution. Procedures expected be described resolution legal problems should arise, consistent achieving goals the program. attention drawn the NIH Extramural Technology Transfer Policies Documents https://grants.nih.gov/grants/intell-property.htm]. 2. formal statement Intellectual Property among PD(s)/PI(s) their institutions well a detailed description procedures be followed resolution legal problems may develop, expected be signed dated the organizational official authorized enter intellectual property arrangements each PD(s)/PI(s) their institution(s). signed agreement expected be submitted prior award the appropriate NIMH staff the addresses provided under Section VII. Agency Contacts. 3. Prior the award, PD(s)/PI(s) expected provide signed statement acceptance the participation NIMH staff during performance the award outlined under NIH Staff Responsibilities" in Section VI.2 - Cooperative Agreement Terms Conditions Award. Note: NOT submit documents 1-3 above the application. However, awards not made until documents received approved NIMH. Progress Reviews Progress the project be reviewed annually the NIMH Project Officer the time each non-competing continuation application assure satisfactory progress being in achieving project objectives, especially respect enrollment quality data collection, timely data sharing appropriate consistent achieving goals the program, to ensure site following procedures recommended approved the project Steering Committee. acceptance these awards, awardees agree abide decisions policies the project Steering Committee the terms conditions listed above referenced the Notice Grant Award. Modified Read: Cooperative Agreement Terms Conditions Award following special terms award in addition to, not lieu of, otherwise applicable U.S. Office Management Budget OMB) administrative guidelines, U.S. Department Health Human Services DHHS) grant administration regulations 45 CFR Parts 74 92 Part 92 applicable State local Governments eligible apply) , other HHS, PHS, NIH grant administration policies. administrative funding instrument used this program be cooperative agreement, assistance" mechanism rather an acquisition" mechanism), which substantial NIH programmatic involvement the awardees anticipated during performance the activities. Under cooperative agreement, NIH purpose to support stimulate recipients' activities involvement and otherwise working jointly the award recipients a partnership role; is to assume direction, prime responsibility, a dominant role the activities. Consistent this concept, dominant role prime responsibility resides the awardees the project a whole, although specific tasks activities be shared among awardees the NIH defined below. PD(s)/PI(s) have primary responsibilities described below: Define details the project within guidelines this FOA. Oversee perform scientific activities. Administratively manage Collaboratory grant. Accept close coordination, cooperation, participation NIH BRAIN program staff the scientific, technical, administrative management the BICCN. Inform NIH program official all major interactions other members the Steering Group. Provide milestones cost the Collaboratory operation the NIH BRAIN program staff requested usually the outset the award annually thereafter, also other times requested the program staff). common brain samples, common coordinate systems, standard nomenclature generate integrate data, metadata, knowledge. Demonstrate capability flexibility modifying brain regions study, data formats metadata. Ensure the products the production effort meet quality standards. Share data resources according the data release resource sharing policies developed and this project appropriate consistent achieving goals the program. Share Specific Aims Research Strategy the project other members the BICCN the purpose collaboration coordination. Fully disclose algorithms, software source code the members the Network the purpose scientific evaluation. disclose confidential pre-public information confidential information obtained other members the Network. Submit data quality assessment and/or validation any manner specified the Steering Group, External Scientific Panel, and/or NIH BRAIN program ensure scientific rigor; Adhere NIH policies regarding intellectual property other policies might established during course this activity. Awardees retain custody and primary rights the data resources developed under awards, subject Government rights access consistent current DHHS, PHS, NIH policies. Participate BICCN activities, including periodic meetings report Collaboratory’s progress, coordinate publication research results. Coordinate collaborate other U.S. international groups may generating relevant cell census datasets; Serve a member the BICCN Steering Committee. Submit periodic progress reports agreed upon the Steering Committee. Accept implement common guidelines procedures approved the Steering Committee, External Scientific Panel, NIH. NIH staff substantial programmatic involvement is above beyond normal stewardship role awards, described below: Program Officer be assigned this award. Program Officer be responsible normal scientific programmatic stewardship guidance the overall project within NIMH will ensure the generation cell census datasets resources relevant the diverse research community served the NIH Institutes Centers. Program Officer be responsible milestone negotiations ensure the milestones achieved goals being met. addition, NIH Program Officer responsible monitoring implementing Data Sharing Plan http://grants.nih.gov/grants/policy/data_sharing/index.htm). NIH Program Officer attend Steering Group meetings a non-voting participant. NIH Program Officer be named the award notice. or extramural NIH program staff member be assigned the Project Scientist(s) this award. same person serve the Project Scientist multiple BRAIN Initiative awards. Project Scientist(s) interact scientifically the PDs/PIs other named personnel that award, a partner the research, including providing technical assistance, advice, coordination the BICCN its component parts. However, role NIH staff be facilitate not direct activities. is anticipated decisions all activities be reached consensus the BICCN Steering Committee that NIH staff be given opportunity offer input this process. NIH BRAIN Project Team be composed Program Officials other relevant extramural staff NIH Institutes Centers the Project Scientist(s). primary role to ensure the datasets resources generated represent diverse interests the participating NIH Institutes Centers, advise brain cell census activities relevant their individual Institute/Center mission, monitor overall progress, attend Steering Group meetings required, report back their Institute/Center. NIH BRAIN Project Team establish External Scientific Panel ESP) help evaluate progress the BICCN. NIH intramural scientists involved the BICCN have same rights responsibilities the comparable extramural Project Scientists involved the BICCN. intramural scientist not receive salary, equipment supplies, other remuneration awards resulting this FOA. intramural scientist must obtain written approval his/her NIH Institute Scientific Director the amount resources may allocated the project. approval must also specify the conduct the project comply the DHHS regulations research involving human subjects applicable) with PHS policy vertebrate animal research. participation an intramural scientist independent and unrelated the role the NIH Project Scientist(s). involvement intramural scientists needs be consistent NIH Policy. http://sourcebook.od.nih.gov/ethic-conduct/ethical-conduct-toc.htm Areas Joint Responsibility include: BRAIN Cell Census Network BICCN) Steering Committee: Steering Committee be composed the PD(s)/PI(s), NIH program staff member(s) External Scientific Panel members experts be named after award). Steering Committee be established help monitor progress, encourage improvements, coordinate production brain cell census datasets resources through BICCN. is anticipated additional coordination mechanisms be set with U.S. international groups may join effort. BICCN Steering Committee members meet periodically plan design activities, review discuss progress, establish priorities policies. chair a co-chair be designated a rotating basis needed. PD(s)/PI(s), external scientific advisor have vote and NIH have vote through participation the Project Scientist(s). Awardee members the Steering Committee be required accept implement policies approved the Steering Committee. BICCN Steering Committee will: Discuss progress meeting research community's need cell census datasets. Facilitate development uniform procedures policies, example data standards, quality measures assessment, nomenclature annotation conventions data depositions, so forth. Awardee members the Steering Group be required accept implement common guidelines procedures approved the Steering Group. Coordinate improve cell census data production, example reporting progress, disseminating best practices collectively evaluating new procedures, resources, technologies. Establish subcommittees needed address particular issues. Subcommittees include representatives the BICCN, NIH BRAIN Project Team, possibly experts. Subcommittees be formed to: 1) develop implement data production analysis standards including spatial semantic standards integrating heterogeneous data sets information; 2) address data submission, management, analysis issues; 3) develop quality standards methods quality control assurance; 4) develop common reagents informatics tools. these cases, common policies, uniform practices needed), data exchange be critical the success the effort will enable harmonization eliminate duplication/overlap. External Scientific Panel ESP): ESP provide recommendations the NIH BRAIN Project Team BICCN the progress scientific direction all components the program. ESP be composed four six senior scientists represent broad research community have relevant expertise, although membership be enlarged permanently on ad hoc basis needed. ESP meet twice year; meetings be conducted telephone conference. least once year, will a joint meeting the Steering Committee the members both ESP Steering Committees interact directly. ESP make recommendations regarding progress the BICCN present advice the NIH BRAIN Project Team changes, any, may necessary the BICCN program. Dispute Resolution: Any disagreements may arise scientific programmatic matters within scope the award) between award recipients the NIH be brought Dispute Resolution. Dispute Resolution Panel composed three members be convened. will three members: designee the Steering Committee chosen without NIH staff voting, NIH designee, a third designee expertise the relevant area is chosen the two; the case individual disagreement, first member be chosen the individual awardee. special dispute resolution procedure does alter awardee's right appeal adverse action is otherwise appealable accordance PHS regulation 42 CFR Part 50, Subpart D DHHS regulation 45 CFR Part 16. Inquiries Please direct inquiries to: Yong Yao, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-6102 Email: yyao@mail.nih.gov

Notice Change Application Types Allowed RFA-NS-18-022 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44 Clinical Trial Required)" Notice Number: NOT-NS-19-073 Key Dates Release Date: June 28, 2019 Related Announcements RFA-NS-18-022 Issued National Institute Neurological Disorders Stroke NINDS) National Institute Deafness Other Communication Disorders NIDCD) Purpose purpose this notice to inform applicants revision applications be accepted response RFA-NS-18-022 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System U44 Clinical Trial Required)". Changes listed below bold italics). notice be effective the October 21, 2019 due date subsequent due dates. Currently Reads: Section II. Award Information Application Types Allowed? New Resubmission Modified Read: Section II. Award Information Application Types Allowed New Resubmission Revision other aspects this FOA remain unchanged.? Inquiries Please direct inquiries to: Nick Langhals, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: nick.langhals@nih.gov