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HEAL Initiative: Back Pain Consortium BACPAC) Research Program Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Notice Number: NOT-AR-20-012 Key Dates Release Date: January 9, 2020 First Available Due Date: March 13, 2020 Expiration Date: New date: January 15, 2020 - per notice NOT-AR-20-015 Related Announcements PA-18-935 Issued National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers. Office Behavioral Social Sciences Research OBSSR) Office Research Women's Health ORWH) Purpose Purpose Notice Special Interest NOSI) calls research pain management the context opioid or opioid disorder OUD). particular, NIAMS interested providing data-driven evidence regarding effective mechanisms reducing reliance opioids while maintaining quality life. Funds Competitive Revisions active grants available part the NIH HEAL Helping End Addiction Long-termSM) Initiative awardees operate within Back Pain Consortium BACPAC) Research Program, part the NIH HEAL InitiativeSM. Investigators active grants the area chronic pain and/or addiction encouraged apply. award two phases, one-year Planning Phase a to three year Research Project Phase. Background Back Pain the major form chronic pain among adults worldwide the most common, non-cancer reason opioid prescription the US. NIH HEAL InitiativeSM is trans-NIH initiative the aims improving treatments opioid misuse addiction; enhancing pain management, understanding biological underpinnings chronic pain accelerating discovery development non-addictive treatments pain. Back Pain Consortium BACPAC) Research Program, part the NIH HEAL InitiativeSM, provides platform research the intersection pain management opioid or opioid disorder OUD). BACPAC a patient-centric translational research initiative, is taking biopsychosocial approach the study chronic low back pain cLBP) the need more effective personalized treatments. Research Objectives order effectively reduce reliance opioids the treatment chronic low back pain while maintaining quality life, NIAMS encouraging submission applications Competitive Revisions active grants provide evidence-based data inform clinical practice guidelines. Research areas interest include: Project Planning Phase - are key questions providers patients with respect opioid for managing chronic pain? Questions interest might patient-centric and/or provider-focused, e.g., is appropriate prescribe opioids chronic pain; someone already taking opioids pain management are most effective means reducing dependence; alternatives exist? Research Project Phase - Investigators should propose strategies test most effective means managing pain while reducing dependence opioids the intent informing clinical practice. Award Information NIAMS intends commit 320,000 FY2020, Planning Phase, 800,000 year the Research Project Phase, FY2021 through FY2023, fund to awards. Budget research project length should reflect project needs, the parent grant must active throughout duration the Competitive Revision. Awardees expected share data resources consistent the guidelines policies the NIH, NIH HEAL InitiativeSM, as developed the Steering Committee the BACPAC Research Program. Adherence these guidelines policies be required the terms conditions award. Application Submission Information Applications response this NOSI must submitted using following target funding opportunity: PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional) Eligible activity codes applications to PA-18-935 are dependent upon target Institute, Center, Office ICO). Table 1 lists activity codes will accepted each participating ICO. Table 1: Eligible Activity Codes Participating ICO Activity Code NIAMS NIBIB NINR NIMHD NICHD NIAAA NCATS NCCIH NIDA NINDS DP1 NIH Director’s Pioneer Award Yes Yes No No Yes Yes Yes P01 Research Program Projects No No No Yes Yes P41 Research Program Projects Centers Yes No No No No P50 Specialized Center Yes No No Yes Yes Yes R01 Research Project Grant Yes Yes Yes Yes Yes Yes Yes Yes Yes R35 Outstanding Investigator Award No No No No Yes R61 Phase 1 Exploratory/Developmental Grant Yes No No No Yes Yes Yes U01 Research Project – Cooperative Agreements Yes Yes Yes No Yes Yes Yes Yes Yes U18 Research Demonstration- Cooperative Agreements Yes Yes No No No Yes Yes U19 Research Program Cooperative Agreement Yes No Yes No Yes Yes U24 Resource-Related Research Projects – Cooperative Agreements Yes Yes No Yes Yes Yes Yes U54 Specialized Center- Cooperative Agreements Yes Yes Yes No Yes Yes Yes U2C Resource-Related Research Multi-Component Projects Centers Cooperative Agreements No No No No Yes UF1 Multi-Year Funded Research Project Cooperative Agreement No No No No Yes UG1 Clinical Research Cooperative Agreements-Single Project Yes No No No Yes Yes UH3 Exploratory/Developmental Phased Award Cooperative Agreement Yes Yes No No Yes Yes Yes Yes UM1 Multi-Component Research Project Cooperative Agreements No No No No Yes All instructions the SF424 R&R) Application Guide and PA-18-935 must followed, the following additions: Research Strategy section the application limited 12 pages. award project period the Competitive Revision must three four years, one year the Planning Phase two three years the Research Project Phase. deadline applications is March 13, 2020 5:00 PM local time of applicant organization. NOSI expires March 14, 2020. application submitted response this NOSI is received March 14, 2020 later, be withdrawn. Applications should must submitted PA-18-935, Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement – Clinical Trial Optional)" using application forms package the Competition ID NOT-AR-20-012-FORMS-E” IMPORTANT: funding consideration, applicants must designate NOT-AR-20-012 in Agency Routing Identifier field Box 4b) the SF424 R&R) Form. Applications without information Box 4b not considered this initiative. Applications non-responsive the terms this Notice be be considered this initiative. Review criteria, addition those described PA-18-935, include following: Does PI(s)/PD(s) expertise pain management and/or addiction appropriate the study low back pain opioid use? Does application propose engage patients, providers, relevant stakeholders identifying key questions regarding pain management opioid use, curtailment, alternatives opioids? successful. does application the potential inform clinical decision making? the PI(s)/PD(s) considered their work might interface or avail the BACPAC research program? Investigators planning submit application response the NOSI strongly encouraged contact appropriate Institute Center contact listed the NOSI discuss proposed project the context the parent award. Questions specific this NOSI should sent to bacpac-nih@mail.nih.gov.   Inquiries Please direct inquiries to: Leslie K. Derr, Ph.D National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-402-4735 Email: derrl@mail.nih.gov Laura Kwako, PhD National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-451-8507 Email: laura.kwako@nih.gov Michael B. Wolfson, PhD National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4778 Email: Michael.Wolfson@nih.gov Susan Marden PhD RN Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6838 Email: mardens@mail.nih.gov Shelley Su, PhD National Institute Drug Abuse NIDA) Telephone: 301-402-3869 Email: shelley.su@nih.gov Benyam Hailu, MD, MPH National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-8696 Email: Benyam.Hailu@nih.gov Michael L. Oshinsky, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov D.P. Mohapatra, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: dp.mohapatra@nih.gov Lois A. Tully, PhD National Institute Nursing Research NINR) Telephone: 301-594-5968 Email: tullyla@mail.nih.gov Lanay M. Mudd, PhD National Center Complementary Integrative Health NCCIH) Telephone: 301-594-9346 Email: Lanay.mudd@nih.gov Jane Atkinson, DDS National Center Advancing Translational Sciences NCATS) Telephone: 301-827-6031 Email: jatkinso@mail.nih.gov Lisa Begg, Dr.P.H., R.N. Office Research Women’s Health ORWH) Telephone: 301/496-3975 E-mail: beggl@od.nih.gov

Notice Special Interest: Administrative Supplements Existing NIH Countermeasures Against Chemical Threats CounterACT) Program Research Grants Cooperative Agreement Awards Notice Number: NOT-NS-20-029 Key Dates Release Date: January 6, 2020 First Available Due Date: August 03, 2020 Expiration Date: August 04, 2020 Related Announcements PA-18-591 NOT-NS-20-030 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose NIH inviting administrative supplement applications provide additional funds active CounterACT research grants cooperative agreement projects support activities such new collaborations pilot studies were unanticipated the time the new competing continuation application submitted. proposed activities must within original research scope the parent award. Supplemental funding includes direct costs well associated facilities administrative costs. supplement project start any time during budget period must end the last day the budget period. parent award not in terminal no-cost extension going a no-cost extension FY2020. Application budgets limited 75,000 total costs must reflect actual needs the proposed project. Only parent CounterACT research grant cooperative agreement awards funded through following FOAs any reissues these announcements) eligible request supplemental funding under NOSI: PAR-13-208: Countermeasures Against Chemical Threats CounterACT) Cooperative Research Projects U01) PAR-15-146; PAR-16-329; PAR-18-657: Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54 Clinical Trial Optional) PAR-16-330: Countermeasures Against Chemical Threats CounterACT): Identification Therapeutic Lead Compounds U01 Clinical Trial Allowed) PAR-16-331: Countermeasures Against Chemical Threats CounterACT): Optimization Therapeutic Lead Compounds U01 Clinical Trial Optional) PAR-18-721: Countermeasures Against Chemical Threats CounterACT) Exploratory/Developmental Projects Translational Research R21 Clinical Trial Allowed) Scope Interest overall goal the NIH Countermeasures Against Chemical Threats CounterACT) program to support research development therapeutics can reduce mortality morbidity the event the release chemical threat agents. Chemical threat agents toxic compounds could released a deliberate terrorist attack against civilians, by accidental natural disaster causing mass casualties. include chemical warfare agents e.g., sarin, chlorine, sulfur mustard), toxic industrial chemicals e.g., cyanide, hydrogen sulfide, phosgene), pesticides e.g., parathion, brodifacoum), pharmaceutical-based agents e.g., opioids) other chemicals. Applications proposing research chemical threats are of interest the program not considered funding. research related opioid threats being proposed, NOT-NS-18-019 a description research supported the NIH CounterACT program. Examples topics interest include, are limited to: Facilitating collaborations fellow awardees within CounterACT community Identify and/or recruit new resources such investigators additional expertise, industry partner, research tools, systems, assays enhance outcomes the parent award Limited, pilot studies establish proof-of-principle approaches Investigators planning submit application response this NOSI strongly advised contact discuss proposed research/aims the Program Officer their parent CounterACT award well advance the receipt deadline better determine appropriateness relevance the supplement project Application Submission Information Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide PA-18-591 must followed, the following additions Research Strategy part the application, summarize scope the parent supplemental projects describe proposed aims research strategy the new study. Clearly state the supplemental efforts fit the scope the parent award. research strategy should clearly demonstrate the new collaboration(s), resource(s), and/or studies benefit parent award why those otherwise be feasible either within currently funded efforts by rebudgeting funds. Applicants the program urged consider directly address elements rigor reproducibility described NOT-OD-15-103 their experimental design. Administrative Evaluation Criteria the proposed supplemental project outcomes relevant the NIH CounterACT program mission goals? the work proposed within scope the active parent award? Does proposed research/scientific team possess expertise conduct achieve goals the supplemental study? Does supplemental proposal include well-described, rigorous scientific approach? the project yield significant preliminary data support more advanced drug discovery development efforts? the scope budget reasonable the proposed studies? Letters Support Applicants must include letter appropriate institutional biosafety officials indicating studies deemed safe research personnel the environment. formal letter support must provided all newly proposed collaborative, consultative, and/or contract arrangements. Application Due Date(s) – August 3,2020, 5:00 PM local time applicant organization. funding consideration, applicants must include “NOT-NS-20-029” without quotation marks) the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. Requests be one year support only. Research Strategy section the application limited 6 pages. Only existing awardees CounterACT program eligible apply. process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify CounterACT Program Officer the parent award a request been submitted response this FOA order facilitate efficient processing the request. application budget cannot exceed 75,000 total costs must reflect actual needs the project. Inquiries Please direct inquiries related the overall NIH CounterACT Program and/or parent awards managed the National Institutes Neurological Disorders Stroke NINDS) to: David A. Jett, PhD Telephone: 301-496-6035 Email: jettd@nih.gov Shardell M. Spriggs, PhD Telephone: 301-443-8189 Email: shardell.spriggs@nih.gov parent awards managed the National Institute Arthritis Musculoskeletal Skin Diseases NIAMS): Hung Tseng, Ph.D. Telephone: 301-594-5032 Email: tsengh@mail.nih.gov parent awards managed the National Eye Institute NEI): Houmam Araj, Ph.D. Telephone: 301-451-2020 Email: arajh@nei.nih.gov parent awards managed the National Institute Environmental Health Sciences NIEHS): Srikanth S. Nadadur, Ph.D. Telephone: 984-287-3296 Email: nadadurs@niehs.nih.gov parent awards managed the National Institute Drug Abuse NIDA): Kristopher Bough, Ph.D. Telephone: 301-443-9800 Email: boughk@nih.gov

Notice Special Interest: Administrative Supplements Promote Expand the Research Development Medical Countermeasures Against Chemical Threats Notice Number: NOT-NS-20-030 Key Dates Release Date: January 6, 2020 First Available Due Date: February 03, 2020 Expiration Date: August 04, 2020 Related Announcements PA-18-591 NOT-NS-20-029 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose NIH inviting administrative supplement applications existing awards are currently focused developing medical countermeasures MCMs) against chemical threats allow to expand research focus this critical field. Supplemental funding includes direct costs well associated facilities administrative costs. supplement project start any time during budget period must end the last day the budget period. parent award not in terminal no-cost extension. Application budgets limited no than amount the current award 125,000 total costs whichever lower) must reflect actual needs the proposed project. Scope Interest overall goal the NIH Countermeasures Against Chemical Threats CounterACT) program to support research development therapeutics can reduce mortality morbidity the event the release chemical threat agents. Chemical threat agents toxic compounds could released a deliberate terrorist attack against civilians, by accidental natural disaster causing mass casualties. include chemical warfare agents e.g., sarin, chlorine, sulfur mustard), toxic industrial chemicals e.g., cyanide, hydrogen sulfide, phosgene), pesticides e.g., parathion, brodifacoum), pharmaceutical-based agents e.g., opioids) other chemicals. research related opioid threats being proposed, NOT-NS-18-019 a description research supported the NIH CounterACT program. scope research will supported this NOSI should consistent the following currently published funding opportunity announcements, PAR-18-721, PAR-19-030, PAR-19-040, including basic translational research through preclinical studies. view list currently funded projects, please visit our webpage, CounterACT Research Network Funded Investigators. Examples topics chemical agents interest include, are limited to: Pulmonary Agents Chlorine Phosgene): Development MCMs prevent treat lung damage including pulmonary edema fibrosis) resulting after exposure Pharmaceutical-based Agents Synthetic Opioids): Development MCMs treat life-threatening respiratory depression caused opioid intoxication. post-exposure treatments should quick-acting effective against variety opioids, e.g., fentanyl, carfentanil. NOT-NS-18-019 more details Vesicants Sulfur Mustard Lewisite): Development MCMs mitigate acute and/or long-term injuries resulting exposure the skin, eyes, mucous membranes vesicating agents. Specific areas interest include treating corneal neovascularization, fibrosis, mustard gas keratopathy. Cellular Respiration/Blood Agents Cyanide): Development MCMs treat acute poisoning. Antidotes should rapidly effective easily administered first responders Nerve Agents Organophosphorus OP) Pesticides: Development MCMs treat seizures either before after become refractory treatment benzodiazepines therapeutics promote neuronal survival other persistent effects after seizure termination. the federal monograph, Sarin: Potential Long-term Neurological Effects. are chemicals interest addition those listed above, Investigators planning submit application response this NOSI strongly advised contact discuss proposed research/aims the Program Officer their parent award the CounterACT Program Officer listed below) most relevant the supplement project well advance the receipt deadline determine responsiveness, programmatic interest, relevance. Applications propose research chemical threats are of interest the program not considered funding. Application Submission Information Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide PA-18-591 must followed, the following additions Research Strategy part the application, include abstract the proposed research shows relevance developing chemical medical countermeasures. Summarize scope the parent supplemental projects describe proposed aims research strategy the new study. Clearly state the supplemental efforts fit the scope the parent grant. Applicants the program urged consider directly address elements rigor reproducibility described NOT-OD-15-103 their experimental design. Administrative Evaluation Criteria the proposed supplemental project outcomes relevant the NIH CounterACT program mission goals? the work proposed within scope the active parent award? Does proposed research/scientific team possess expertise conduct achieve goals the supplemental study? Does supplemental proposal include well-described, rigorous scientific approach? the project yield significant preliminary data support more advanced drug discovery development efforts? the scope budget reasonable the proposed studies Letters Support Applicants must include letter appropriate institutional biosafety officials indicating studies deemed safe research personnel the environment. formal letter support must also provided all newly proposed collaborative, consultative, and/or contract arrangements. Application Due Date(s) – February 3, 2020, April 1, 2020, June 1, 2020, August 3, 2020, 5:00 PM local time applicant organization. funding consideration, applicants must include NOT-NS-20-030” without quotation marks) the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. Requests be one year support only. Research Strategy section the application limited 6 pages. process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify program contact the Institute supporting parent award the CounterACT Program Officer listed below) most relevant the supplemental project a request been submitted response this FOA order facilitate efficient processing the request. application budget cannot exceed 125,000 total costs. Inquiries Please direct inquiries related the overall NIH CounterACT Program, neurological injury metabolic/blood research to: David A. Jett, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-6035 Email: jettd@nih.gov Shardell M. Spriggs, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-443-8189 Email: shardell.spriggs@nih.gov questions related dermal/vesicant-induced injuries: Hung Tseng, Ph.D. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5032 Email: tsengh@mail.nih.gov questions related ocular injury research: Houmam Araj, Ph.D. National Eye Institute NEI) Telephone: 301-451-2020 Email: arajh@nei.nih.gov questions related pulmonary injury research: Srikanth S. Nadadur, Ph.D. National Institute Environmental Health Sciences NIEHS) Telephone: 919-541-5327 Email: nadadurs@niehs.nih.gov questions related pharmaceutical based agents: Kristopher Bough, Ph.D. National Institute Drug Abuse NIDA) Telephone: 301-443-9800 Email: boughk@nih.gov

Notice Special Interest: Countermeasures Against Chemical Threats CounterACT) U54 Centers Excellence only support targeted chemical threats interest Notice Number: NOT-NS-20-031 Key Dates Release Date: 01/06/2020 First Available Due Date: September 09, 2020 Expiration Date: September 10, 2020 Related Announcements PAR-18-657 Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54 Clinical Trial Optional) Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose NIH Countermeasures Against Chemical Threats CounterACT) program supports research development therapeutics can reduce mortality morbidity the event the release chemical threat agents. important component the CounterACT research network the U54 Research Centers Excellence. U54 Centers designed support three more projects scientific cores having unifying well-defined goal problem area research synergistically produce rigorous interdisciplinary research the highest quality. is expectation support interrelated projects collaborating investigators yield results beyond those achievable each project pursued separately without formal interaction among participating investigators. more information the CounterACT Program, please visit our website. view list currently funded projects, please visit our webpage, CounterACT Research Network Funded Investigators. NIH CounterACT program issuing NOSI provide chemical threat agents will supported grant applications the September 9, 2020 receipt date PAR-18-657 U54 Centers Excellence. only chemical agents will supported the U54 program are: Blood/Metabolic Agents: hydrogen cyanide, potassium cyanide sodium cyanide Organophosphorus OP) Chemical Warfare Agents Pesticides Opioids: carfentanil, fentanyl related analogs, NOT-NS-18-019 Pulmonary Agents: chlorine phosgene Vesicants: sulfur mustard lewisite Applicants strongly encouraged contact CounterACT Program Staff listed the parent funding opportunity announcement PAR-18-657) determine their proposed threat agent(s) of interest the NIH CounterACT program. Applications propose research chemical threats are listed above not considered funding. research related opioid threats being proposed, NOT-NS-18-019 a description research supported the NIH CounterACT program. Application Submission Information Submit applications this initiative using following funding opportunity announcement through expiration date this notice. PAR-18-657 - Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54 Clinical Trial Optional) notice applies the September 9, 2020 due date PAR-18-657. instructions the SF424 R&R) Application Guide the funding opportunity announcement used submissionmust followed, the following additions funding consideration, applicants must include NOT-NS-20-031” 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 terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries the Scientific/Research, Peer Review, Financial/Grants Management contacts Section VII the listed funding opportunity announcements.

This Funding Opportunity Announcement (FOA) encourages research grant applications directed toward developing next-generation human cell-derived microphysiological systems (MPS) and related assays that replicate complex nervous system architectures and physiology with improved fidelity over current capabilities. Supported projects will be expected to enable future studies of complex nervous system development, function and aging in healthy and disease states.

This Funding Opportunity Announcement (FOA) encourages research grant applications directed toward developing next-generation human cell-derived microphysiological systems (MPS) and related assays that replicate complex nervous system architectures and physiology with improved fidelity over current capabilities. Supported projects will be expected to enable future studies of complex nervous system development, function and aging in healthy and disease states.

A central goal of the BRAIN Initiative is to develop new and improved technologies suitable for recording from as well as controlling specified cell types and circuits to modulate and understand function in the central nervous system. In order to accomplish these goals, further information is needed to understand the function of current technologies used for recording or stimulating the nervous system. This RFA accepts grant applications in two related but distinct areas. The first is to systematically characterize, model, and validate the membrane, cellular, circuit, and adaptive-biological responses of neuronal and non-neuronal cells to various types of stimulation technologies. The second is to understand the biological and bioinformatic content of signals recorded from neuronal and non-neuronal cells and circuits. Development of new technologies, therapies and disease models, are outside the scope of this FOA. Activities related to enabling the simultaneous use of multiple recording or stimulation technologies are allowed.

Notice Special Interest: Administrative Supplements Promote Research Continuity Retention NIH Mentored Career Development K) Award Recipients Scholars Notice Number: NOT-OD-20-054 Key Dates Release Date: January 2, 2020 First Available Due Date: March 05, 2020 Expiration Date: March 06, 2023 Related Announcements PA-18-591 RFA-AG-21-020 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) 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) Fogarty International Center FIC) National Center Complementary Integrative Health NCCIH) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Cancer Institute NCI) Purpose overarching goal this program to support transition retention investigators mentored career development research independence to minimize departures biomedical research workforce this critical juncture. supplement program intended ensure continuity research among recipients mentored career development K) awards providing supplemental research support help sustain investigators research during critical life events. supplement be used support additional personnel, computational services, supplies, equipment will promote continuity the career development research project during period which PD/PI experiences critical life events have potential impact research progress potential productivity. Administrative supplements must support work within scope the original project. the purposes this program, childbirth, adoption, primary caregiving responsibilities an ailing spouse, child, partner, a member the immediate family during project period critical life events would qualify consideration. Evidence the circumstance affect advancement the mentored career development award productivity must provided. circumstances which critical life event pending is expected occur during project period, supplement request be submitted advance the event. K awardees are late stage postdoctoral scientists, instructors, early stage faculty recipients the K awards referenced above encouraged apply. retention supplements support first-time NIH R01-Equivalent Awards, companion FOA Budget be eligible, parent award must able receive funds the time the award. administrative supplement budget limited 1 year. application budget cannot exceed maximum direct cost 50,000, applicable F & indirect) cost also requested. Flexible of supplemental funds highly encouraged support successful research within scope the parent project, including supported effort additional personnel, computational services, supplies equipment sustain research the PD/PI the individual K award during critical life event. Eligible Individuals Program Director/Principal Investigator) PD/PIs the following activity codes eligible the award: K01, K07, K08, K22, K23, K25, K38, K43, K76, K99/R00 the mentored K99 portion the K99/R00). Individual(s) must hold active grant, the research proposed the supplement must accomplished within competitive segment the active award. Individuals encouraged work their organizations develop applications support. Application Submission Information Supplement requests must submitted accordance the parent program announcement: Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-591or subsequent reissued equivalent. Supplement requests should submitted electronically. process Streamlined Submissions using eRA Commons cannot used this initiative. instructions the SF424 R&R) Application Guide PA-18-591 must followed, the following additions: Application Due Date(s) Submission dates vary awarding IC. Table IC-Specific Information Requirements more details. funding consideration, applicants must include NOT-OD-20-054 without quotation marks) the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4bwill be considered this initiative. PHS 398 Career Development Award Supplemental Form Candidate Information Goals Career Development attachment: Personal Statement the applicant, including long-term research objectives career goals, justification the supplemental support, a plan return full productivity the end the supplement period. Institutional Commitment Candidates Research Career Development attachment: Institutional letter commitment includes details resources mentoring be available the applicant ensure strong productivity the parent grant. letter should also detail institutional commitment the applicants return full productivity research career trajectory the end the supplement period. is strongly recommended the applicants contact respective program officers the NIH Institute/Center IC) supporting parent award confirm ahead time the supplement falls within scope the parent award. Further, applicants strongly encouraged notify program contact the IC supporting parent award Table IC-Specific Information Requirements)that request been submitted response this FOA order facilitate efficient processing the request. Administrative Review Process: IC conduct administrative reviews applications submitted their IC separately, will support most meritorious applications submitted consideration, based upon availability funds. Criteria: the work proposed within scope the parent mentored career development award? is progress date the parent mentored career development award? the administrative supplement increase preserve likelihood the project succeed assist K awardee appointee completing research project, transitioning the next career stage? there plan the PD/PI return full productivity the end the supplement period? there strong institutional commitment e.g., protected time, policies, programs, other strategies) ensure the PD/PI maintains his/her research project independent research trajectory? Inquiries Please direct inquiries to: Division Biomedical Research Workforce Office Extramural Research Website: https://researchtraining.nih.gov Email: NIHTrain@mail.nih.gov

Notice Special Interest: Administrative Supplement Research Bioethical Issues Admin Supp Clinical Trial Optional) Notice Number: NOT-OD-20-038 Key Dates Release Date: December 30, 2019 First Available Due Date: January 24, 2020 Expiration Date: March 20, 2020 Related Announcements PA-19-217 PA-18-591 Issued Office The Director, National Institutes Health OD) 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 Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) Fogarty International Center FIC) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Sexual Gender Minority Research Office SGMRO) National Cancer Institute NCI) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers. Office Behavioral Social Sciences Research OBSSR) Office Research Women's Health ORWH) Tribal Health Research Office THRO) National Library Medicine NLM) - New participating organization of 03/06/2020 due dates on/after 03/06/2020 National Eye Institute ( NEI ) - New participating organization of 03/09/2020 due dates on/after 03/09/2020 Purpose NIH Office Science Policy OSP) within Office the Director OD) announces availability administrative supplements support research bioethical issues develop evidence base may inform future policy directions. Applicants propose supplement parent awards focused bioethics to add component related bioethics a parent award which bioethics not focus. Note applications must within general scope the parent award. applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers: Office Behavioral Social Sciences Research OBSSR), Office Research Womens Health ORWH), Sexual Gender Minority Research Office SGMRO), the Tribal Health Research Office THRO). Background Ethical considerations intrinsic the responsible conduct biomedical research the translation scientific technological advances practice. Research bioethical issues provide evidentiary basis guide conduct, content, and/or application the biomedical behavioral sciences their associated policies, becomes increasing importance science societal views continue evolve. Ethical questions challenges interlinked many NIHs general areas scientific priority, such responding public health needs e.g., opioid crisis, desire precision medicine interventions) emerging scientific opportunities e.g., new data sharing infrastructure, innovative technologies). investment and integration bioethics-related research policy demonstrates NIHs commitment safeguarding integrity the research it conducts supports, which, turn, facilitates public participation trust the research enterprise. administrative supplement funding opportunity announcement provide opportunity NIH-supported researchers support research bioethical issues develop evidence base may inform future policy directions. Applicants propose supplement parent awards focused bioethics to add component related bioethics a parent award which bioethics not focus. Specific Areas Research Interest NIH seeks fund research ethical considerations related biomedical research. Applications projects do propose research question research aim specific a bioethical issue may inform future policy directions e.g. applications propose only support training educational activities do involve investigation a research question) not considered. Issues interest fall within scope research supported the NIH may beyond focus any Institute Center. Applications should propose research topics can provide evidence base may inform future policy directions, includes current future NIH-issued policies, federal policies, laws, regulations, well policies governing practice research medicine. Overarching areas research interest include are limited to: New emerging technology development use, such as: gene editing; organoids; artificial intelligence; machine learning; brain implants modulation; digital health; consumer-generated data; synthetic biology Clinical non-clinical data sharing; big data data science analytics; integration data research, including clinical, research, environment, social media, participant/patient provided, other data types; biases datasets algorithms Precision personalized medicine Personal, institutional, research privacy security Learning Healthcare System; interface clinical research clinical care; pragmatic trials; real-world data Crowdsourcing, citizen science, DIY biomedical research Participant driven, directed, sponsored clinical research Patient/participant representation research oversight study design, including appropriate return research results incidental findings Special vulnerable population research, including pediatric, palliative care, emergency, disaster, pandemic research Individual community health, treatment, and/or research disparities; accessing sharing benefits research; post-study obligations Issues related the inclusion Tribal American Indian/Alaska Native populations Issues related the inclusion populations underrepresented research, including issues related inclusion and research sexual gender minorities Current emerging regulatory policy environments, including NIH policy Innovative study design, conduct, management, oversight, including methods obtaining documenting informed consent; virtual clinical trials International research including research resource-constrained settings, transnational research, research low middle income countries Research stigmatized conditions Historical analyses bioethics issues Novel approaches developing, enhancing, measuring effectiveness of, bioethics infrastructure training New means enhancing assessing scientific workforce, including policies promote scientific workforce diversity inclusion promote safe inclusive research environment addition overarching areas interest, individual NIH Institutes, Centers, Offices indicated following specific areas research interest: FIC Fogarty International Center FIC) interested research ethical issues relevant low- middle-income countries, particular, studies conducted investigators these countries. of Us Research Program All Us Research Program interested applications address topics relevant its core mission. Please note at time, recontact All Us Research Program participants not possible. program in process developing requisite policies technical infrastructure support ancillary studies, including ELSI research, will notify researchers these capabilities become available. NCI National Cancer Institute NCI) interested bioethics issues relevant cancer research care, such issues raised cancer clinical trials, cohort studies, cancer prevention studies, cancer centers, prospective biobanking, projects using existing samples/tissues. Bioethical issues interest include are limited issues raised new therapies/technologies; issues raised the of ancestry markers vs. ethnicity/race research treatment; innovative methods recruitment retention participants are underserved, hard reach, otherwise underrepresented research; participant, community, patient engagement; return research results; participant patient perception comprehension; effective communication including patient-provider to/within families); increasing access care populations cancer disparities. Additional issues be found here: https://epi.grants.cancer.gov/bioethics-cancer-research.html. NCI encourages investigators contact parent grant program officer address any budgetary issues prior submitting supplement application NHGRI National Human Genome Research Institute NHGRI) interested applications investigate address bioethical issues related the of genetics genomics research, clinical medicine healthcare, society. NHGRI supports studies specific conditions diseases only the proposed work produce knowledge is generalizable transferable other genetic conditions. Research the implications new emerging genomic technologies novel uses existing technologies particularly encouraged. Examples include, are limited to: use polygenic risk scores diverse ancestral populations, synthetic biology the application artificial intelligence and/or machine learning genomic data. NHLBI National Heart, Lung, Blood Institute NHLBI) interested research bioethics issues relevant its Strategic Vision https://www.nhlbi.nih.gov/about/strategic-vision), its focus heart, lung, blood, sleep conditions. Specific examples include, are limited The return research results e.g., genomic, omic, environmental) context participants communities, such environmental toxins may impact community health, handoff between research clinical care, providing genetic counseling large scales Issues related clinical trials, including adaptive clinical trial designs, usual care arms, other novel designs Bioethical questions related implementation science research Waivers informed consent, exceptions informed consent, obtaining consent surrogates Ethics cardiopulmonary support Novel emerging technologies, such machine learning bias algorithm overreach physician autonomy Privacy confidentiality especially large datasets), such artificial intelligence applied imaging data concerns may arise multi-omics profiles impact NIH policy changes, such updates the management genomic summary results Issues related working understudied vulnerable populations creating culturally-appropriate messaging Investigators encouraged contact NHLBI staff discuss ideas NCATS National Center Advancing Translational Sciences NCATS) interested research ethical issues cross disease domains span translational research spectrum. NCATS encourages collaboration between translational researchers bioethics researchers projects addressing ethical challenges moving discoveries laboratory, clinic, community interventions improve health. Note concerning Award Project Period: Supplement project budget periods limited the remaining active budget period started FY20 the existing parent award. be eligible, parent award must active i.e. be an extension period), the activities proposed the supplement must accomplished within remaining active budget period started FY20 the existing parent award. earliest anticipated start date July 1, 2020. NIMHD National Institute Minority Health Health Disparities NIMHD) interested supporting research projects the ethical, legal, social implications research participation and/or health care racial/ethnic minority other health disparity populations. Areas interest NIMHD include are limited studies seek understand address cultural preferences; values norms ensure ethical equitable conduct research delivery health care; ethical integration social biomedical sciences e.g., social epigenomics incorporation social determinants the health care system); mitigating stigmatization, group harms, unintended social implications research. NIAAA National Institute Alcohol Abuse Alcoholism NIAAA) interested bioethics applications address topics relevant its mission research priorities provided its strategic plan. information, please see: https://www.niaaa.nih.gov/strategic-plan NIAID NIAID interested supporting supplemental projects focus ethical issues relevant domestic international collaborative research HIV/AIDS its co-morbidities TB, malaria, hepatitis, sexually transmitted infections), infectious diseases, immunologic allergic diseases; ethics clinical trials implementation science; ethical issues relevant NIAID's scientific mission. Applications include conceptual work bioethics, empirical work gathering analyzing data relevant ethical issues research, a combination the two. empirical projects, data collection include quantitative qualitative methods, both. Although intended be exhaustive list, particular interest projects Ethical issues research involving adolescents young adults Ethical issues research preventing, treating, curing HIV Ethical, legal policy issues the intersections public health surveillance, care delivery, research Ethics research involving child-bearing age pregnant women Applications addressing empirical research informed consent not interest NIAMS mission The National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) to support research the causes, treatment, prevention arthritis musculoskeletal skin diseases; training basic clinical scientists carry this research; the dissemination information research progress these diseases. NIAMS also conducts supports basic research the normal structure function bones, joints, muscles, skin. Clinical research areas include rheumatology, orthopedics, dermatology, metabolic bone diseases, heritable disorders bone cartilage, inherited inflammatory muscle diseases, sports rehabilitation medicine. NIAMS interested bioethics topics relevant its core mission. NIBIB National Institute Biomedical Imaging Bioengineering NIBIB) interested bioethics research relevant its mission support development innovative technologies bioimaging bioengineering. Areas particular interest NIBIB include, are limited to, ethical issues related to: artificial intelligence machine learning; digital health wearable/implantable technologies; clinical decision support systems healthcare professionals, caregivers, and/or patients); data sharing, privacy, security; synthetic biological systems; neuromodulation technologies; health disparities inclusion biomedical research. Investigators strongly encouraged contact NIBIB staff discuss ideas. more information areas interest the NIBIB, please visit: https://www.nibib.nih.gov/research-funding NIDDK National Institute Diabetes Digestive Kidney Diseases NIDDK) interested applications address topics relevant its core mission. more information, please see: NIDDK Research Areas NCCIH National Center Complementary Integrative Health NCCIH) interested bioethics applications address topics relevant its mission research priorities provided its strategic plan. information, please see: https://nccih.nih.gov/about/plans NICHD Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) interested bioethical issues relevant research involving children, pregnant women, people disabilities. Research the fields developmental biology, reproductive health, pediatrics, population health, medical rehabilitation, research addresses health disparities improves prevention efforts among populations served NICHD, well areas identified high-priority research areas the institute of particular interest. https://www.nichd.nih.gov/grants-contracts/research-areas/priorities the current research priorities the institute in https://www.nichd.nih.gov/about/org/strategicplan regarding future themes the Institute. NIDCD National Institute Deafness Other Communications Disorders NIDCD) interested applications address topics the areas hearing, balance, taste, smell, voice, speech, language. more information, please see: NIDCD Strategic Plan NIDCR National Institute Dental Craniofacial Research NIDCR) interested applications propose bioethics research relevant dental, oral, craniofacial health. more information, please see: https://www.nidcr.nih.gov/about-us/mission. addition the overarching priority areas this notice related dental, oral, craniofacial health, NIDCR also interested in: Return incidental findings overall health clinical non-clinical data e.g., genome-wide omics data) produced studies focus dental, oral craniofacial phenotypes Privacy, confidentiality, data re-use other ethical issues clinical non-clinical data, particularly large scale facial image data omics data NIDA National Institute Drug Abuse NIDA) interested bioethics applications address topics relevant its mission research priorities provided its strategic plan, including research involving pregnant women using substances. more information, please see: https://www.drugabuse.gov/about-nida/2016-2020-nida-strategic-plan NINDS National Institute Neurological Disorders Stroke NINDS) interested research bioethical neuroethical questions relevant its mission seek fundamental knowledge the brain nervous system to that knowledge reduce burden neurological disease. addition the general areas interest listed above, areas interest specific NINDS include are limited the ethical implications of: aspects neuroscience research human participants, such differing stakeholder views trial design, return research results participants, patient consent-related issues, therapeutic misconception including rare diseases); research brain organoids ex vivo human brain tissue; collecting sharing human brain data, such de-identification, privacy, re-use practices; development use neuromodulation neuroimaging technologies, such device maintenance, data security, intended unintended uses these technologies; predictive/diagnostic research related brain disorders; advances neural recording and/or neuromodulation specifically use children. Additional information the NINDS mission be found here: http://www.ninds.nih.gov/about_ninds/mission.htm. Note applications must consider bioethical and/or neuroethical questions be within general scope the parent award. Also, NINDS not consider supplement applications include basic research activities research vertebrate animals. NINR NINR interested studies examining bioethical issues related end life palliative care EOLPC) research consider including not limited to): EOLPC needs individuals serious, advanced illness, particularly vulnerable populations such as: children, frail elderly, individuals limited decision-making capacity. Prioritization patient preferences, beliefs, values respect treatment and/or end life decision making. needs/challenges families, caregivers, proxy decision makers individuals serious, advanced illness. Disparities access EOLPC individuals across settings urban, rural, remote), including differences among socioeconomic, racial/ethnic geographic sub-populations. Because the complex, multi-factorial nature this issue, multi-disciplinary teams highly encouraged NIEHS National Institute Environmental Health Sciences NIEHS)is interested bioethics applications address topics relevant its mission research priorities provided its strategic plan. information, please see:https://www.niehs.nih.gov/about/strategicplan/index.cfm NIA National Institute Aging NIA) interested applications address topics relevant its core mission. more information, please see:https://www.nia.nih.gov/about/mission NIMH National Institute Mental Health NIMH) interested bioethics applications address topics relevant its mission research priorities provided its strategic plan. information, please see:https://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml NLM National Library Medicine NLM) interested bioethics applications address topics relevant its mission research priorities provided its strategic plan. information, please see: https://www.nlm.nih.gov/pubs/plan/lrp17/NLM_StrategicReport2017_2027.ht…. Office Research Womens Health Office Research Womens Health ORWH) focuses research is relevant the health women is interested research bioethics issues intersect the goals, objectives, guiding principles the trans-NIH Strategic Plan Womens Health Research https://orwh.od.nih.gov/about/trans-nih-strategic-plan-womens-health-re…). Specific examples include, are limited to: Ethical, legal, social implications sex and/or gender differences research across lifespan; the ethics the consideration sex/gender intersectionality basic, translational, clinical research inclusion and/or exclusion understudied, underrepresented, underreported populations women research i.e. pregnant lactating women, incarcerated women, young girls, women color, women health disparities, sex gender minority women, women disabilities, women living rural areas); their retention research Ethical issues governing retainment advancement women biomedical careers i.e. power dynamics and/or differentials, gender harassment, hiring, promotion tenure); issues related women participating team science conducting interdisciplinary and/or trans-disciplinary research. Bioethical issues derived data generated research development R&D) drugs, medical devices, emerging technologies, along health screenings i.e. mammograms, Pap-smears, newborn screening, EKG) Societal implications, such stigma based gender, related sex and/or gender bias considerations the development use novel emerging technologies i.e. artificial intelligence, machine learning, multi-accuracy auditing, digital/mobile health, social media tools) Sex/gender neuroethics ethics related sex gender considerations genomic research precision medicine Ethical issues around provider-patient interactions/relationships family caregiving related its impact womens health well-being Scope Support number awards contingent upon NIH appropriations the submission a sufficient number meritorious applications. Office the Director intends commit least 2,000,000 FY 2020 fund approximately 10 awards Application Submission Information Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide PA-18-591 must followed, the following additions: Application Due Date(s) March 20, 2020, 5:00 PM local time applicant organization. funding consideration, applicants must include NOT-OD-20-038 without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Application budget cannot exceed maximum direct cost 100,000. addition the direct cost, applicable F&A indirect) costs also requested. Requests be one year support only. Research Strategy section the application limited 6 pages. criteria review Section V. Application Review Criteria PA-18-591 be followed, except the following criteria be used instead the criteria provided Overall Impact: NIH staff consider ability the proposed supplement activities increase preserve parent awards overall impact within original scope award appropriate: the administrative supplement increase preserve likelihood the project exert influence the bioethics-related policy the research field(s) involved? the administrative supplement provide evidence base may inform future policy directions? Does administrative supplement address bioethical issue is pressing, recurring, and/or emerging biomedical research? the overall strategy, methodology, analyses proposed the supplement application well-reasoned appropriate accomplish proposed research a one-year period? process Streamlined Submissions using eRA Commons cannot used this initiative. Applicant organizations submit than application, provided each sufficiently distinct any administrative supplement currently under consideration the awarding NIH Institute Center. Only application per parent award be submitted. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. Inquiries Please direct inquiries to: Scientific/Research Contact(s) Wendy Weber, N.D., Ph.D., M.P.H. National Center Complementary Integrative Health NCCIH) Telephone: 301-402-1272 Email:weberwj@mail.nih.gov Kristina McLinden, PhD National Institute Aging Telephone: 301-827-2563 Email:mclindenka@nih.gov Shari Feirman, Ph.D. Office Science Policy/Office the Director OSP/OD) Telephone: 301-435-6350 Email: shari.feirman@nih.gov Nicole Lockhart, Ph.D. National Human Genome Research Institute NHGRI) Telephone: 301-480-2493 Email: lockhani@mail.nih.go Tammara Jenkins, MSN, RN, PCNS-BC Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6837 Email: tjenkins@mail.nih.gov Khara Ramos, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-594-2614 Email: khara.ramos@nih.gov Mollie Minear, Ph.D. National Heart, Lung, Blood Institute NHLBI) Telephone: 301-435-0448 Email: mollie.minear@nih.gov Barbara Sina, Ph.D. Fogarty International Center FIC) Telephone: 301-402-9467 Email: sinab@mail.nih.gov Elaine Collier, M.D. National Center Advancing Translational Sciences NCATS) Telephone: 301-435-0794 Email: colliere@mail.nih.gov Charlisse Caga-anan, J.D. National Cancer Institute NCI) Telephone: 240-276-6738 Email: charlisse.caga-anan@nih.gov Pamela Wernett, Ph.D. National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-827-5391 Email: wernettpj@mail.nih.gov Joana Roe National Institute Allergies Infectious Disease NIAID) Telephone: 240-627-3213 Email: Joana.Roe@nih.gov Marisol Espinoza-Pintucci, Ph.D. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-827-6959 Email: marisol.espinoza-pintucci@nih.gov Todd Merchak National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-496-8592 Email: merchakt@mail.nih.gov Trinh Ly, M.D. National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-435-4085 Email: trinh.ly@nih.gov Leslie Frieden, Ph.D. National Institute Dental Craniofacial Research NIDCR) Telephone: 301-496-4263 Email: leslie.frieden@nih.go Aynur Unalp-Arida, MD, MSc, PhD National Institute Diabetes Digestive Kidney Diseases NIDDK) Telephone: 301-594-8879 Email: aynur.unalp-arida@nih.go Ruben Baler, Ph.D. National Institute Drug Abuse NIDA) Telephone: 301-480-2733 Email: baler@nida.nih.gov Nancy Jones, Ph.D., M.A. National Institute Minority Health Disparities NIMHD) Telephone: 301-594-8945 Email: jonesna@nimhd.nih.gov Lynn Adams, Ph.D. National Institute Nursing Research NINR) Telephone: 301-594-8911 Email: adamsls@mail.nih.gov Jamie White, M.S. Office Research Womens Health/Office the Director ORWH/OD) Telephone: 301-496-9200 Email: Jamie.white@nih.gov Subhashini Chandrasekharan, Ph.D. of Us Research Program/Office the Director AoURP/OD) Email: subhashini.chandrasekharan@nih.go Lindsey Martin, PhD National Institute Environmental Health Sciences Telephone: 984.287.4036 Email:lindsey.martin@nih.gov James Churchill, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-3621 Email: churchillj@mail.nih.gov Wendy Weber, ND, PhD, MPH National Center Complementary Integrative Health NCCIH) Telephone: 301-402-1272 Email: weberwj@mail.nih.gov Peer Review Contact(s) Applicable Financial/Grants Management Contact(s) Shelley Carow National Center Complementary Integrative Health NCCIH) Telephone: 301-594-3788 Email:carows@mail.nih.gov Jeff Ball National Institute Aging Telephone: 301-403-7736 Email:ballj@nia.nih.gov Bryan Clark, MBA Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6975 Email: clarkb1@mail.nih.gov Tijuana Decoster, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone 301-496-9531 Email: decostert@mail.nih.gov Monique Day, Ph.D. National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4797 Email: Monique.day@nih.gov Bruce Butrum Fogarty International Center FIC) Telephone: 301-496-2075 Email: butrumb@mail.nih.gov Tawana McKeither National Heart, Lung, Blood Institute NHLBI) Telephone: 301-827-9238 Email: tawana.mckeither@nih.gov Harvey Kincaid National Center Advancing Translational Sciences NCATS) Telephone: 301-435-0850 Email: harvey.kincaid@nih.gov Crystal Wolfrey National Cancer Institute NCI) Telephone: 240-276-6277 Email: wolfreyc@gab.nci.nih.gov Deanna Ingersoll National Human Genome Research Institute NHGRI) Telephone: 301-435-7858 Email: Deanna.Ingersoll@nih.gov Judy Fox National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-443-4704 Email: jfox@mail.nih.gov Dhana Khurana National Institute Allergies Infectious Disease NIAID) Telephone: 240-669-2966 Email: Vandhana.Khurana@nih.gov Leslie Littlejohn National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-594-5055 Email: Leslie.Littlejohn@nih.gov Christopher Myers National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-435-0713 Email: myersc@mail.nih.gov Diana Rutberg, M.B.A. National Institute Dental Craniofacial Research NIDCR) Telephone: 301-594-4798 Email: rutbergd@mail.nih.gov Pamela G. Fleming National Institute Drug Abuse NIDA) Telephone: 301-480-1159 Email: pfleming@nida.nih.gov Priscilla Grant, JD National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-8412 Email: pg38h@nih.gov Ronald Wertz National Institute Nursing Research NINR) Telephone: 301) 594-2807 Email: wertzr@mail.nih.gov Elizabeth Spencer Office Research Womens Health/Office the Director ORWH/OD) Telephone: 301-435-1057 Email: Elizabeth.spencer@nih.gov Kim Stanton National Health Lung Blood Institute NHLBI) of Us Research Program/Office the Director AoURP/OD)) Telephone: 301-827-8054 Email: stantonk@mail.nih.gov Thuthuy Nguyen National Institute Diabetes Digestive Kidney Diseases NIDDK) 301-594-8825 thuthuynguyen@niddk.nih.gov Theresa Jarosik National Institute Mental Health NIMH) Telephone: 301-443-3858 Email: Theresa.Jarosik@nih.gov Shelley Carow National Center Complementary Integrative Health NCCIH) Telephone: 301-594-3788 Email: CarowS@mail.nih.gov

Despite established associations between white matter lesions and cognitive impairment including dementia, the volume, anatomical location, and other key cellular and molecular characteristics of white matter lesions that are both necessary and sufficient are unknown, as are the comorbid clinical factors that may modify (including protect from) these effects. Therefore, this initiative will support one large prospective clinical research study in the U.S. studying individuals with white matter lesions at risk for cognitive decline to determine the magnitude and anatomical locations that are both necessary and sufficient to cause cognitive impairment and dementia. The study will include health disparities populations, and will examine additional clinical factors and comorbidities that may be effect modifiers of the relationship between white matter lesions and cognitive impairment, including dementia. Clinical trial-ready VCID biomarkers should be utilized, further developed, and/or subject to implementation research in this study. Secondary goals include: identifying clinical and mechanistic targets for future VCID interventional trials; determining interrelationships (cross-sectional and longitudinal) among white matter lesions, cerebro- and cardio-vascular disease and risk factors including dementia-relevant genes. Applicants are encouraged, when scientifically advantageous, to utilize existing resources for VCID and stroke research, e.g. MarkVCID, StrokeNet, Alzheimers Centers, and large NIH funded prospective cohort studies (e.g. Framingham, ARIC, CHS, NOMAS, etc.) as well as other dementia resources.