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Notice of Correction to Award Budget for RFA-DA-19-019 " HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)"

NOT
Thursday, August 8, 2019
Saturday, January 1, 2022
NOT-DA-19-057

Funding Opportunity Purpose

This Notice is to inform potential applicants that the NIDA is revising the award budget language in RFA-DA-19-019 "HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)."

Notice of Correction to Award Budget for RFA-DA-19-020 "HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R41/R42 - Clinical Trial Optional)"

NOT
Thursday, August 8, 2019
Saturday, January 1, 2022
NOT-DA-19-067

Funding Opportunity Purpose

This Notice is to inform potential applicants that the NIDA is revising the award budget language in RFA-DA-19-020 "HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R41/R42 - Clinical Trial Optional)."

Notice of Change to Key Dates for PAS-19-210 "Progression Markers for Cognitive Impairment in Parkinson's Disease Dementia (R01 Clinical Trial Not Allowed)"

NOT
Tuesday, August 6, 2019
Saturday, January 1, 2022
NOT-NS-19-081

Funding Opportunity Purpose

Notice Change Key Dates PAS-19-210 Progression Markers Cognitive Impairment Parkinson's Disease Dementia R01 Clinical Trial Allowed)" Notice Number: NOT-NS-19-081 Key Dates Release Date: August 6, 2019 Related Announcements PAS-19-210 Issued National Institute Neurological Disorders Stroke NINDS)National Institute Aging NIA) Purpose purpose this notice to inform potential applicants a change the key dates PAS-19-210 Progression Markers Cognitive Impairment Parkinson's Disease Dementia". Specifically, the February 5, 2020, June 5, 2020, October 5, 2020, February 5, 2021, June 5, 2021, October 5, 2021, and February 5, 2022 receipt dates, corresponding AIDS receipt dates been cancelled. new expiration date this Funding Opportunity Announcement now be November 6, 2019. Changes highlighted in bold italics below. Currently Reads: Part 1. Overview Information Key Dates Application Due Date(s) Standard dates apply 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. first standard application due date this FOA June 5, 2019. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) Standard AIDS dates apply 5:00 PM local time applicant organization. All types AIDS AIDS-related applications allowed this funding opportunity announcement due these dates. first AIDS application due date this FOA September 7, 2019. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. Expiration Date 08, 2022 Modified Read: Part 1. Overview Information Key Dates Application Due Date(s) Standard dates apply 5:00 PM local time applicant organization. All types non-AIDS applications allowed this funding opportunity announcement due these dates. first standard application due date this FOA June 5, 2019. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date. AIDS Application Due Date(s) Standard AIDS dates apply 5:00 PM local time applicant organization. All types AIDS AIDS-related applications allowed this funding opportunity announcement due these dates. first AIDS application due date this FOA September 7, 2019. Applicants encouraged apply early allow adequate time make any corrections errors found the application during submission process the due date Expiration Date November 6, 2019 other aspects this FOA remain same. Inquiries Please direct inquiries to: Debra Babcock, PhD, MD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: dbabcock@mail.nih.gov

Notice of Change to the Cooperative Agreement in RFA-MH-19-149, BRAIN Initiative Cell Census Network (BICCN) Specialized Collaboratory on Human and Non-Human Primate Brain Cell Atlases (U01 Clinical Trial Not Allowed)

NOT
Friday, August 2, 2019
Saturday, January 1, 2022
NOT-MH-19-040

Funding Opportunity Purpose

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/nimh-policy-on-data-and-safety-monitoring-in-extramural-investigator-initiated-clinical-trials.shtml. 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.htm 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

Request for Information: Input into the National Institute of Neurological Disorders and Stroke Strategic Planning Process

NOT
Wednesday, July 31, 2019
Saturday, January 1, 2022
NOT-NS-19-079

Funding Opportunity Purpose

Request Information: Input the National Institute Neurological Disorders Stroke Strategic Planning Process Notice Number: NOT-NS-19-079 Key Dates Release Date: July 31, 2019 Response Date: October 01, 2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose National Institute Neurological Disorders Stroke NINDS) embarking an institute-wide strategic planning process. goal the process to tune our practices policies our vision mission, order better serve anticipate needs the research patient communities the public. mission NINDS to seek fundamental knowledge the brain nervous system to that knowledge reduce burden neurological disease. Based this mission, NINDS formulated broad Strategic Goals a starting point the planning process: Strategic Goals a model excellence supporting performing paradigm-changing, innovative, rigorous neuroscience research. a model excellence funding conducting neuroscience research training career development programs ensuring vibrant, talented, diverse neuroscience work force. Promote timely dissemination accurate rigorous information scientific discoveries their implications neurological health. Create sustain supportive work culture the NINDS work force facilitate reward analogous efforts the outside neuroscience community. purpose this time-sensitive RFI to solicit input concrete means accomplish strategic goals over next 5-10 years. NINDS use responses collected part this RFI inform planning process, help identify relevant experts stakeholders, to formulate prioritize objectives action plans achieving Strategic Goal. resulting NINDS-wide Strategic Plan be posted draft form additional public comment before implementation. Information Requested: NINDS invites input stakeholders, experts, communities, members the public, including not limited researchers trainees across academia, industry, government; health care providers health advocacy organizations; nongovernmental, scientific professional organizations; federal agencies. any all the Strategic Goals stated above, please provide perspective expertise any the following points: Opportunities for, challenges facing, progress neuroscience research neurological health Emerging scientific organizational trends, advances, techniques, perspectives NINDS should account in planning process Recommendations steps, actions, activities, opportunities will enable NINDS make rapid progress toward achieving goal recommendations make, please consider indicating appropriate objective success criteria, including quantitative qualitative benchmarks milestones gauging progress the corresponding domain Successes, shortcomings, impacts existing NINDS policies, practices, partnerships, strategies, activities Stakeholders experts NINDS should consult the process strategic planning strategy implementation High-priority objectives you not reflected among four stated strategic planning goals Any topic you find relevant the development the NINDS institute-wide strategic plan input provide be available the committees taskforces charged carrying the planning implementation processes NINDS. Optional: Please indicate you a primary investigator, trainee, researcher, health care provider, patient advocate, science administrator, other interested party. you submitting response behalf an organization membership a whole, please indicate name your organization. Organizations strongly encouraged submit single response reflects views their organization membership a whole. to Submit Response Responses this RFI must submitted electronically using web-based form found here: https://www.ninds.nih.gov/NOT-NS-19-079. ensure full consideration, responses must received 10/1/2019. Responses this RFI voluntary. not include any proprietary, classified, confidential, trade secret, sensitive information your response. responses be reviewed NIH staff, individual feedback not provided any responder. U.S. Government use information submitted response this RFI its discretion. RFI for information planning purposes only shall be construed a solicitation, grant, cooperative agreement, as obligation the part the Federal Government, NIH, individual NIH Institutes Centers provide support any ideas identified response it. Government not pay the preparation any information submitted for U.S. Government’s of such information. basis claims against U.S. Government shall arise a result a response this request information from Government’s of such information. provided information be analyzed may appear, summary form, removing personally identifying sensitive information, reports other publicly accessible resources. Inquiries Please direct inquiries to: NINDS Strategic Planning Email: NINDSStrategicPlan@nih.gov

Notice of Special Interest: Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Applications Directed at the Adoption of the Fast Healthcare Interoperability Resources (FHIR) Standard

NOT
Tuesday, July 30, 2019
Saturday, January 1, 2022
NOT-OD-19-127

Funding Opportunity Purpose

Notice Special Interest: Small Business Innovation Research SBIR) Small Business Technology Transfer STTR) Applications Directed the Adoption the Fast Healthcare Interoperability Resources FHIR®) Standard Notice Number: NOT-OD-19-127 Key Dates Release Date: July 30, 2019 First Available Due Date: September 5, 2019 Expiration Date:April 7, 2020 Related Announcements PA-19-270 PHS 2019-02 Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42] Clinical Trial Allowed) PA-19-271 PHS 2019-02 Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42] Clinical Trial Required) PA-19-272 PHS 2019-02 Omnibus Solicitation the NIH, CDC, FDA Small Business Innovation Research Grant Applications Parent SBIR R43/R44] Clinical Trial Allowed) PA-19-273 PHS 2019-02 Omnibus Solicitation the NIH, CDC, FDA Small Business Innovation Research Grant Applications Parent SBIR R43/R44] Clinical Trial Required) PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued OFFICE THE DIRECTOR, NATIONAL INSTITUTES HEALTH OD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Library Medicine NLM) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Purpose purpose this Notice to inform SBIR STTR applicants awardees areas special interest related the of Fast Healthcare Interoperability Resources FHIR®) standard the development health information technology health IT) products services. Health can improve health care quality outcomes enabling health care providers effectively share information apply evidence support care decisions. NIH seeking innovative health solutions, implementing FHIR standard, enable effective patient-centered care coordination, population health management, data science research support. FHIR a standardized of transmitting health data one health information system another through API. API a specified set protocols data standards establish ground rules which information system directly communicates another. Software developers seamlessly connect program another computer through FHIR API transmit electronic health data. FHIR enables exchange many different health data types such clinical information, demographics, billing claims data. special relevance, complementary specification, Substitutable Medical Applications, Reusable Technologies SMART) FHIR, enables third party applications apps) access data electronic health record EHR) systems approved purposes, including research. FHIR also specifies of specific coding systems required interoperability health data. Several Federal health agencies promoting use FHIR EHR systems. 21st Century Cures Act requires a health information technology developer entity allow health information…to accessed, exchanged, used without special effort through use application programming interfaces APIs)… including providing access all data elements a patient's electronic health record.”[1] To implement provision, Department Health Human Services, Office the National Coordinator Health Information Technology ONC) proposed new rule support seamless secure access, exchange, use electronic health information.[2] Specifically, proposed rule calls the health care industry adopt standardized APIs using FHIR standard share patient data. NIH issuing Notice highlight interest receiving grant administrative supplement applications focused implementation the FHIR standard health applications including, not limited to, following area(s): Integration patient- population-level data EHR systems Access and management electronic health information Development clinical decision support systems Exchange EHR data health documentation Enhancement privacy security electronic health information Inclusion common data elements CDEs) clinical terminologies improve interoperability EHR data research clinical care Support a common structure sharing clinical research data Integration EHR patient-originated data clinical research data Design monitoring clinical trial protocols Enhancement patient recruitment, enrollment, consent clinical trials Application Submission Information Submit applications this initiative using of following funding opportunity announcements FOAs) any reissues these announcement through expiration date this notice. Activity Code FOA First Available Due Date R43/R44 PA-19-272: PHS 2019-02 Omnibus Solicitation the NIH, CDC, FDA Small Business Innovation Research Grant Applications Parent SBIR R43/R44] Clinical Trial Allowed) September 5, 2019 R41/R42 PA-19-270: PHS 2019-02 Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42] Clinical Trial Allowed) September 5, 2019 R43/R44 PA-19-273: PHS 2019-02 Omnibus Solicitation the NIH Small Business Innovation Research Grant Applications Parent SBIR R43/R44] Clinical Trial Required) September 5, 2019 R41/R42 PA-19-271: PHS 2019-02 Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42] Clinical Trial Required) September 5, 2019 R41/R42 R43/R44 PA-18-591: Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) September 5, 2019 Competing grant applications submitted response PA-19-270, PA-19-271, PA-19-272, PA-19-273: Applications be submitted due dates or after September 5, 2019 subsequent receipt dates through April 7, 2020. instructions the SF424 R&R) Application Guide and funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include NOT-OD-19-127” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications nonresponsive the terms this notice the FOA used submission be withdrawn Non-competing administrative supplement applications submitted response PA-18-591: Applications be submitted September 5, 2019 through expiration date this notice, April 7, 2020. instructions the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: Applications due 5:00 PM local time applicant organization. process Streamlined Submissions using eRA Commons cannot used this initiative. funding consideration, applicants must include NOT-OD-19-127” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. 1] Section 4002(D)(iv) the 21st Century Cures Act (P.L. 114 – 255) 2] https://www.federalregister.gov/documents/2019/03/04/2019-02224/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification Inquiries Please direct inquiries to: Scientific/Research, Peer Review, Financial/Grants Management contacts Section VII the listed funding opportunity announcements.

Solicitation of Nominations for the 2020 National Institute of Neurological Disorders and Stroke (NINDS) Landis Award for Outstanding Mentorship

NOT
Monday, July 29, 2019
Saturday, January 1, 2022
NOT-NS-19-080

Funding Opportunity Purpose

Solicitation Nominations the 2020 National Institute Neurological Disorders Stroke NINDS) Landis Award Outstanding Mentorship Notice Number: NOT-NS-19-080 Key Dates Release Date: July 29, 2019 Related Announcements None Issued National Institute Neurological Disorders Stroke NINDS) Purpose Excellent mentorship superior training critical the development exceptional future scientists. recognize crucial role great mentors play the development future leaders neuroscience, National Institute Neurological Disorders Stroke NINDS) created Landis Award Outstanding Membership. award provides 100,000.00 direct costs) up five 5) faculty members are considered be outstanding mentors trainers help foster research career development additional students post-doctorates. NINDS hopes this tangible award impress upon scientific community a whole, faculty institutional leaders particular, high value NINDS places outstanding training mentorship the need faculty institutions emphasize dedication mentorship addition outstanding research accomplishments. Selection this award based nomination those have first-hand knowledge an individual's outstanding mentorship. Current former trainees nominate faculty members have served their mentors. Faculty members nominated two more mentees then invited submit additional information needed the selection process. Eligible individuals this award must in tenure-track equivalent faculty position hold active NINDS R01, R35, U01, U54, P01 DP1 at least year left their grant June 2020. full details the award, the selection process be found at Landis Mentor Award. Because outstanding mentors exist each career stage, have different levels mentorship accomplishments, NINDS rotates eligibility requirements year. 2018, NINDS awards junior faculty mentors the 5th - 12th year the start their first tenure track equivalent position). 2019, NINDS awards mid-career faculty mentors the 13th - 20th year the start their first tenure track equivalent position). two cohorts Landis Awardees be found at Landis Mentor Award. this notice, NINDS invites nominations outstanding mentors are 21 years more the start their first tenure-track equivalent faculty position i.e., start date their first tenure-track equivalent faculty position in calendar year 1998 earlier). Nomination Nominations the NINDS Landis Mentor Award be accepted ONLY current former trainees the nominated individual. nominate current former mentor, individuals should click on Landis Mentor Award and complete a nomination form by December 1, 2019. following information be requested: Nominator's name current position Name individual being nominated nominee) Current institution email address nominee Start date nominee's first tenure-track equivalent position Relationship nominator nominee dates mentorship, position nominator mentored nominee e.g. Former Current Graduate Student, Postdoctoral Fellow, etc.]) Statement describing basis the nomination. description should include: made/makes nominated individual exceptional mentor/trainer; are specific examples extraordinary dedication mentorship personally experienced witnessed; does individual to ensure trainees conduct highest quality research respect scientific premise, experimental design analysis; were specific nominee activities influenced nominator's growth a neuroscientist. a nomination be considered, of above information must provided via nomination form found at Landis Mentor Award. Inquiries Please direct inquiries to: Stephen Korn National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-4188 Email: korns@ninds.nih.gov

Notice of Change to HEAL Initiative: Announcement of Collaboration Opportunities for Developing Drugs and Human Cell-Based Testing Platforms for Pain, Addiction and Overdose (NOT-TR-19-018)

NOT
Friday, July 5, 2019
Monday, July 5, 2021
NOT-TR-19-025

Funding Opportunity Purpose

The purpose of this Notice is to change the Eligible Organizations and Information for Foreign Institutions for HEAL Initiative: Announcement of Collaboration Opportunities for Developing Drugs and Human Cell-Based Testing Platforms for Pain, Addiction and Overdose NOT-TR-19-018.

Request for Information (RFI): Guidance on Current Education Curricula for Health Care Professionals Regarding Pain and Opioid Misuse and Use Disorder

NOT
Friday, July 5, 2019
Saturday, January 1, 2022
NOT-DA-19-054

Funding Opportunity Purpose

Request Information RFI): Guidance Current Education Curricula Health Care Professionals Regarding Pain Opioid Misuse Use Disorder Notice Number: NOT-DA-19-054 Key Dates Release Date: July 05, 2019 Response Date: September 01, 2019 Related Announcements None Issued National Institute Drug Abuse NIDA)National Institute Aging NIA) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Complementary Integrative Health NCCIH)National Institute Biomedical Imaging Bioengineering NIBIB) Purpose RFI seeks input stakeholders throughout scientific research medical education community the general public regarding CoEPEs program, general pain education, opioid misuse use disorder education curriculum. Stakeholders interest include are limited to: health care professionals providing pain treatment, students medical, dental nursing schools, residents, fellows, teaching faculty, medical dental associations, education accrediting agencies. Background Chronic pain affects 100 million American adults costs nation to 635 billion year medical treatment lost productivity. response this public health concern the 2011 Institute Medicine report Relieving Pain America,” Department Health Human Services DHHS) created National Pain Strategy NPS). Among priorities recommendations outlined the NPS, plan identified need educate health care professionals pain, pain treatment, its interaction opioid misuse use disorder. Specifically, NPS recommended steps improve discipline-specific core competencies, including basic knowledge, assessment, effective team-based care, empathy, cultural competency. plan encouraged educational program accreditation bodies professional licensure boards require pain teaching clinician learning the undergraduate, graduate, residency continuous education levels. NPS also endorsed development a web-based pain education portal would contain up-to-date, comprehensive, easily accessed educational materials. training efforts should made coordination current DHHS efforts develop tools providers recognize risk factors symptoms opioid disorders. National Institute Health NIH) Pain Consortium established enhance pain research promote collaboration among researchers across many NIH Institutes Centers have programs activities addressing pain. line the education recommendations outlined the NPS, Pain Consortium created supports Centers Excellence Pain Education CoEPEs; https://painconsortium.nih.gov/Funding_Research/CoEPEs). CoEPEs act hubs the development, evaluation, distribution pain management curriculum resources medical, dental, nursing, pharmacy other schools enhance improve health care professionals taught pain its treatment. modules intended educate health care professionals the different types pain resulting various forms surgery, pain conditions, comorbidities, acute chronic pain treatment, opioid disorder. Information Requested RFI seeks input stakeholders throughout scientific research medical education community the general public regarding CoEPEs program, general pain, opioid misuse opioid disorder education curriculum. Stakeholders interest include are limited to: health care professionals providing pain treatment, students medical, dental, pharmacy, physical therapy nursing schools, residents, fellows, teaching faculty, medical associations, physical therapy occupational therapy associations education accrediting agencies. NIH seeks information response any all the following topics interest: nature your institution’s current curriculum pain conditions, pain treatment, opioid misuse/use disorder, overdose. Include details topics covered these categories, this training content delivered, intended audience, general goals, the particular Learning Management System LMS; e.g., Moodle), any, your institution uses manage any related training content. Information the highest priority needs training resources infrastructure needs related pain conditions, pain treatment, opioid misuse/use disorder, overdose. Topics training resources needs include are limited to: multidisciplinary approach pain assessment/management and/or empathy cultural competency content related pain conditions, pain treatment, opioid misuses/use disorder. Input the current CoEPEs education content, including whether modules being using your institution, whether fit curricular needs your institution, recommended content future development, suggestions the format e.g., explicit didactic goals, video duration, etc), any comments may enhance accessibility utilization these CoEPEs modules. Comments the importance endorsement educational program accreditation bodies professional licensure incorporate training pain OUD CoEPEs utilization your institution’s education curricula. to Submit Response: Responses this RFI be accepted through September 1, 2019. Responses this RFI must submitted electronically via email to: paineducation@nih.gov Responses this RFI voluntary. not include any proprietary, classified, confidential, trade secret, sensitive information your response. responses be reviewed NIH staff, individual feedback not provided any responder. Government use information submitted response this RFI its discretion. Government reserves right use any submitted information public NIH websites, reports, summaries the state the science, any possible resultant solicitation(s), grant(s), cooperative agreement(s), in development future funding opportunity announcements. RFI for information planning purposes only shall be construed a solicitation, grant, cooperative agreement, as obligation the part the Federal Government, NIH, individual NIH Institutes Centers provide support any ideas identified response it. Government not pay the preparation any information submitted for Government’s of such information. basis claims against U.S. Government shall arise because a response this request information from Government’s of such information. NIH looks forward your input we hope you share RFI document your colleagues. Inquiries Please direct inquiries to: Shelley Su, PhD National Institute Drug Abuse Telephone: 301-402-3869 Email:paineducation@nih.gov

Notice of Change to Application Types Allowed for RFA-NS-18-021 "BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3 Clinical Trial Required)"

NOT
Friday, June 28, 2019
Saturday, January 1, 2022
NOT-NS-19-072

Funding Opportunity Purpose

Notice Change Application Types Allowed RFA-NS-18-021 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UG3/UH3 Clinical Trial Required)" Notice Number: NOT-NS-19-072 Key Dates Release Date: June 28, 2019 Related Announcements RFA-NS-18-021 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-18-021 BRAIN Initiative: Next-Generation Invasive Devices Recording Modulation the Human Central Nervous System UG3/UH3 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

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