Find Funding Opportunities

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.

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

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 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.

Notice Special Interest NOSI): Development Animal Models Down Syndrome Related Biological Materials Part the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project Notice Number: NOT-OD-20-017 Key Dates Release Date: December 18, 2019 First Available Due Date: January 27, 2020 Expiration Date: September 09, 2022 Related Announcements NOT-OD-20-024 NOT-OD-20-023 RFA-OD-19-027,Resource-Related Research Projects Development Animal Models Related Materials R24 Clinical Trials Not-Allowed)NOT-OD-20-025 PAR-19-369, Development Animal Models Related Biological Materials Research R21 Clinical Trial Allowed) NOT-OD-20-012, Notice Intent Publish Funding Opportunity Announcements Fiscal Year 2020 the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) ProjectNOT-OD-20-022 NOT-OD-20-129 - Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Administrative Supplements Research Coronavirus Disease 2019 COVID-19) Individuals Down Syndrome the INCLUDE Project/p NOT-OD-20-129 - Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Administrative Supplements Research Coronavirus Disease 2019 COVID-19) Individuals Down Syndrome the INCLUDE Project Issued National Institutes Health NIH) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) Purpose Background INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project developed response Fiscal Year 2018 2019 Omnibus Appropriations Reports, encouraged NIH expand current efforts Down syndrome common co-occurring conditions also seen the general population while increasing pipeline Down syndrome investigators. Information projects werefundedin 2018 2019, well the INCLUDE ProjectResearch Plan, available theINCLUDE Project website. Individuals DS face significant changing health challenges have often excluded participation research could improve health outcomes quality life. population understudied even though DS the most common genetic cause intellectual developmental disabilities IDD) and, the past 25 years, average lifespan doubled 30 60 years. addition intellectual disability, DS associated an increased prevalence autism epilepsy. 75% individuals DS experience cognitive decline a syndrome resembles Alzheimers disease, with onset decade two earlier typical Alzheimers disease. Individuals DS also high rates hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, other autoimmune immune dysregulation disorders including celiac disease. However, people DS infrequently develop solid tumors such breast prostate cancer. Despite multiple risk factors coronary artery disease high rates obesity, sleep apnea, type 1 diabetes, people DS rarely develop atherosclerosis have myocardial infarctions. Understanding unique combination risk resiliencies inform medical advances individuals DS for individuals do have DS who share co-occurring conditions. Research Objectives purpose this Notice Special Interest NOSI) to foster development and improve access animal models Down syndrome related materials information will advance preclinical basic science studies related Down syndrome. Sharing resources effective communication outputs broader communities a high priority theINCLUDE Project. Applicants responding this NOSI strongly encouraged describe plans rapid sharing data results well innovative data analytics approaches Goal 3,NIH Strategic Plan Data Science). Examples animal models related materials may developed include, are limited to: Animal models studying fundamental biological mechanisms underlying Down syndrome; Genetic resources, antibodies other reagents quantifying characterizing macromolecules cells animal models Down syndrome, systems biology approaches, informatics tools resources, including artificial intelligence, machine learning deep phenotyping tools, generating novel hypotheses improving value animal models Down syndrome research; Complementary approaches the of animals, such animal-tissue-on-chip models, can simulate physiological pathophysiological processes capture complex dynamics interacting molecules, cells, tissues organs outside the whole organism Down syndrome research. Comparison existing Down syndrome animal models best understand health conditions individuals Down Syndrome. While multiple useful animal models available the community, careful comparison their distinct phenotypes critical. example, the mouse strains presently use, penetrance particular phenotypes benefit qualitative quantitative validation. important comparisons include effect background strain colony maintenance the genotype phenotype over time. Development rat, non-rodent vertebrate, nonhuman primate models Down syndrome are better suited answer specific questions concerning complex neurological, behavioral, other phenotypes occur humans Down Syndrome currently available mouse models. INCLUDE project particularly interested development animal models relevance the multiple organ systems affected individuals Down syndrome co-occurring conditions, such neurodevelopment, immune system dysregulation, Alzheimers disease, cancer, cardiovascular disease, autism. Applications supporting R21 exploratory research projects R24 resource-related research projects should directly submitted response this NOSI. Applications R21 awards should describe projects distinct those supported through traditional R01 mechanism. Long-term projects, projects designed increase knowledge a well-established area, not appropriate R21 awards. R21 grant activity intended encourage exploratory research projects foster constant infusion new ideas, techniques, points view Down syndrome-related research. Such projects assess new experimental system propose innovative of existing methodology, system model enhance Down syndrome-related research. studies involve considerable risk may lead a breakthrough Down syndrome research through development novel techniques, reagents, methodologies models. Applications R24 awards should propose development animal models related resources would serve broad areas Down syndrome-related research. R24 grant activity intended encourage resource-related research projects support basic preclinical research providing substantial amount readily available animal-related resources. Animal-related resources include mutant transgenic animals; related biological materials, such nucleic acids, proteins, cell lines, tissues; knowledge an animals genome, life cycle, molecular, cellular physiological phenotypes, behaviors. Program Directors/Principal Investigators PD/PIs) planning submit applications response this NOSI strongly encouraged contact scientific contacts this NOSI prior submission be advised appropriateness the intended resource research plans this program, competitiveness a potential application, alignment program priorities the INCLUDE initiative. Application Submission Information Notice applies due dates or after January 27, 2020 expires September 9, 2022. following funding opportunity announcements FOAs) their reissued equivalents must used submissions this initiative. Activity Code FOA Number Title First Available Due Date R24 RFA-OD-19-027, Resource-Related Research Projects Development Animal Models Related Materials R24 Clinical Trials Not-Allowed) January 27, 2020 R21 PAR-19-369, Development Animal Models Related Biological Materials Research R21 Clinical Trial Allowed) February 16, 2020 instructions theSF424 R&R) Application Guideand funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must includeNOT-OD-20-017in Agency Routing Identifier field Box 4.b) the SF 424 R&R) Form. Applications without information Box 4.b not considered this initiative. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries to: Please direct inquiries the contacts Section VII the listed funding opportunity announcements the following additions/substitutions: Scientific/Research Contact(s) Charlene Schramm, PhD National Heart, Lung, Blood Institute NHLBI) Telephone: 301) 401-3793 Email:schrammc@nih.gov Sige Zou, PhD Office Research Infrastructure Programs ORIP) Telephone: 301) 435-0749 Email:zous@mail.nih.gov

Notice Special Interest NOSI): Competitive Supplements/Revisions R01) Available INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) Notice Number: NOT-OD-20-023 Key Dates Release Date: December 18, 2019 First Available Due Date: March 05, 2020 Expiration Date: September 08, 2022 Related Announcements NOT-OD-20-129 - Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Administrative Supplements Research Coronavirus Disease 2019 COVID-19) Individuals Down Syndrome the INCLUDE Project NOT-OD-20-022 NOT-OD-20-012Notice Intent Publish Funding Opportunity Announcements Fiscal Year 2020 the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project PA-19-055 Research Project Grant Parent R01 Clinical Trial Required) PA-19-056 NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-19-091 NIH Research Project Grant Parent R01 Basic Experimental Studies Humans Required) NOT-OD-20-017Notice Special Interest Encourage Development Animal Models Related Biological Materials Research Related Down Syndrome NOT-OD-20-020 Notice Special Interest NOSI): Ruth L. Kirschstein National Research Service Award NRSA) Fellowship Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-021 Notice Special Interest NOSI): Mentored Career Development Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-022 Notice Special Interest: Administrative Supplements the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project NIH-funded K12 KL2 Institutional Career Development Awards NOT-OD-20-023 Notice Special Interest: Availability Competitive Supplements/Revisions the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) NOT-OD-20-024 Notice Special Interest: Availability Administrative Supplements the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project NOT-OD-20-025 Notice Special Interest: NIH Research Project Grants Down Syndrome R01) RFA-OD-20-003 Clinical Trials Development Co-Occurring Conditions Individuals Down syndrome: Phased Awards INCLUDE R61/R33 Clinical Trial Required) RFA-OD-20-004 INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-005Transformative Research Award the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project R01 Clinical Trial Allowed) RFA-OD-20-006 Small Research Grants Analyses Down Syndrome-related Research Data the INCLUDE Project R03 Clinical Trial Allowed) RFA-OD-20-007 Development the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Data Coordinating Center U2C) Issued Office The Director, National Institutes Health OD) National Heart, Lung, Blood Institute NHLBI) National Institute Aging NIA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) 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 Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Minority Health Health Disparities NIMHD) National Cancer Institute NCI) Purpose Background INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project developed response Fiscal Year 2018 2019 Omnibus Appropriations Reports, encouraged NIH expand current efforts Down syndrome DS) common co-occurring conditions also seen the general population while increasing pipeline DS investigators. Information projects werefundedin 2018 2019, well the INCLUDE ProjectResearch Plan, available theINCLUDE Project website. Individuals Down syndrome DS) face significant changing health challenges have often excluded participation research could improve health outcomes quality life. population understudied even though DS the most common genetic cause intellectual developmental disabilities IDD) and, the past 25 years, average lifespan doubled 30 60 years. addition intellectual disability, DS associated an increased prevalence autism epilepsy. 75% individuals DS experience cognitive decline a syndrome resembles Alzheimers disease, with onset decade two earlier typical Alzheimers disease. Individuals DS also high rates hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, other autoimmune immune dysregulation disorders including celiac disease. However, people DS infrequently develop solid tumors such breast prostate cancer. Despite multiple risk factors coronary artery disease high rates obesity, sleep apnea, type 1 diabetes, people DS rarely develop atherosclerosis have myocardial infarctions. Understanding unique combination risk resiliencies inform medical advances individuals DS for individuals do have DS who share co-occurring conditions. Research Objectives Notice Special Interest NOSI) announces availability competitive revision formerly known competitive supplement) applications grantees active Research Project Grants R01) wish either expand scope their grant project focused DS to expand scope a non-DS grant incorporate DS-related research. Sharing resources effective communication outputs the broader communities a high priority the INCLUDE Project. Applicants responding this NOSI strongly encouraged describe plans rapid sharing data results well innovative data analytics approaches Goal 3,NIH Strategic Plan Data Science). list ofFunding Priorities Institute Centeris available theINCLUDE website. Applications response this NOSI should aligned the overall INCLUDE ProjectResearch Plan, consists three components: Component 1: Targeted, high risk-high reward, basic science studies areas highly relevant Down syndrome Component 2: Cohort Study connect existing resources expand inclusion individuals Down syndrome Component 3: Inclusive clinical trials research co-occurring conditions individuals Down syndrome Projects propose recruit subjects Down syndrome encouraged promote enrollment research subjects the Down syndrome patient registry supported NIH,DS-Connect. other data biospecimens human genetic non-genetic studies, awardees encouraged use biorepositories designated INCLUDE staff meet requirements broad sharing. NIH resource describingCommon Data Elementsmay helpful during planning phases a project considering ways optimize data collection order facilitate broad data sharing. further information INCLUDE priorities, resource sharing expectations, participating NIH Institutes Centers, seeFrequently Asked Questions. Application Submission Information Notice applies due dates or after March 5, 2020 subsequent receipt dates through September 7, 2022. Applications this initiative must submitted using of following funding opportunity announcements FOAs) their reissued equivalents.Although all NIH components indicated above listed Participating Organizations all FOAs listed below, applications this initiative be accepted the participating Institutes Centers NIH. PA-19-055- NIH Research Project Grant Parent R01 Clinical Trial Required) PA-19-056 - NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-19-091 NIH Research Project Grant Parent R01 Basic Experimental Studies Humans Required) instructions theSF424 R&R) Application Guideand funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must includeNOT-OD-20-023in Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. Revision applications must submitted the same project director/principal investigator PD/PI), Contact PD/PI multi-PI grants, listed the current award. Select Revision option Box 8 the SF424 R&R form indicate TYPE APPLICATION, option Increase Award. the Project Summary/Abstract field provide succinct accurate description the work proposedfor revision. not the abstract the parent grant. Applicants must the same budget format i.e. R&R Budget Form PHS 398 Modular Budget Form) thecurrent award. the Introduction Application field the PHS 398 Research Plan form attach one-page Introduction describes nature the revision how will influence specific aims, research design, methods the current grant. body the application should contain sufficient information the original grant application allow evaluation the proposed revision relation the goals the original application. Any budgetary changes the remainder the project period the current grant should discussed the Budget Justification. Revisions not extend beyond term the current award period.Grants their final year the project period the time application receipt not eligible under Notice. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries the contacts Section VII the listed funding opportunity announcements the following additions/substitutions: Scientific/Research Contact(s) list ofcontacts each participating NIH Institute Center available theINCLUDE website.

Notice Special Interest NOSI): Availability Administrative Supplements the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project Notice Number: NOT-OD-20-024 Key Dates Release Date: December 18, 2019 First Available Due Date: March 23, 2020 Expiration Date: March 24, 2022 Related AnnouncementsNOT-OD-20-129 - Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Administrative Supplements Research Coronavirus Disease 2019 COVID-19) Individuals Down Syndrome the INCLUDE Project NOT-OD-20-022 NOT-OD-20-012, Notice Intent Publish Funding Opportunity Announcements Fiscal Year 2020 the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project PA-18-591,Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) NOT-OD-20-017,Notice Special Interest Encourage Development Animal Models Related Biological Materials Research Related Down Syndrome NOT-OD-20-020 Notice Special Interest NOSI): Ruth L. Kirschstein National Research Service Award NRSA) Fellowship Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-021 Notice Special Interest NOSI): Mentored Career Development Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-022 Notice Special Interest: Administrative Supplements the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project NIH-funded K12 KL2 Institutional Career Development Awards NOT-OD-20-023 Notice Special Interest: Availability Competitive Supplements/Revisions the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) NOT-OD-20-025 Notice Special Interest: NIH Research Project Grants Down Syndrome R01) RFA-OD-20-003 Clinical Trials Development Co-Occurring Conditions Individuals Down syndrome: Phased Awards INCLUDE R61/R33 Clinical Trial Required) RFA-OD-20-004INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-005Transformative Research Award the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project R01 Clinical Trial Allowed) RFA-OD-20-006 Small Research Grants Analyses Down Syndrome-related Research Data the INCLUDE Project R03 Clinical Trial Allowed) RFA-OD-20-007 Development the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Data Coordinating Center U2C) Issued Office The Director, National Institutes Health OD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Institute Aging NIA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) 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 Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Center Advancing Translational Sciences NCATS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Cancer Institute NCI) Purpose Office the Director the National Institutes Health NIH) announces opportunity investigators relevant active NIH-supported grants the participating Institutes listed above submit administrative supplement applications funded projects meet new NIH Down syndrome research objectives related the NIH INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project. Notice soliciting administrative supplements the following mechanismsONLY:R03,R21,R24,P01,P30,P40,P50,P51,U01,U10,U19,U24,U42,U54,UG1,UG3,UL1,U2C,K12, andT32. Background INCLUDE Project developed response Fiscal Year 2018 2019 Omnibus Appropriations Reports, encouraged NIH expand current efforts Down syndrome DS) common co-occurring conditions also seen the general population while increasing pipeline DS investigators. Information projects were funded 2018 2019, well the INCLUDE ProjectResearch Plan, available theINCLUDE Project website. Individuals DS face significant changing health challenges have often excluded participation research could improve health outcomes quality life. population understudied even though DS the most common genetic cause intellectual developmental disabilities IDD) and, the past 25 years, average lifespan doubled 30 60 years. addition intellectual disability, DS associated an increased prevalence autism epilepsy. 75% individuals DS experience cognitive decline a syndrome resembles Alzheimers disease, with onset decade two earlier typical Alzheimers disease. Individuals DS also high rates hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, other autoimmune immune dysregulation disorders including celiac disease. However, people DS infrequently develop solid tumors such breast prostate cancer. Despite multiple risk factors coronary artery disease high rates obesity, sleep apnea, type 1 diabetes, people DS rarely develop atherosclerosis have myocardial infarctions. Understanding unique combination risk resiliencies inform medical advances individuals DS for individuals do have DS who share co-occurring conditions. Research Objectives Notice Special Interest NOSI) announces NIH support the professional development early career scientists aiming establish career DS-related research. providing scientists training, resources, mentorship, NIH intends foster pipeline investigators DS other intellectual disabilities will lead future research improve understanding the biology DS support development new treatments health conditions experienced those DS. Sharing resources effective communication outputs the broader communities a high priority theINCLUDE Project. Applicants responding this NOSI strongly encouraged describe plans rapid sharing data results well innovative data analytics approaches Goal 3,NIH Strategic Plan Data Science). Supplement applications be eligible funding they address or of following components related the INCLUDE Project research objectives: Component 1: Targeted, high risk-high reward, basic science studies areas highly relevant Down syndrome Component 2: Cohort Study connect existing resources expand inclusion individuals Down Syndrome Component 3: Inclusive clinical trials research co-occurring conditions individuals Down syndrome Applications be considered eligible funding they: within scope the active parent award focused DS Propose address of three components listed above likely stimulate additional activity leading progress DS Address priority the IC issued parent award below more information) Supplements existing clinical trials allowed. proposed research must within scope the parent clinical trial the parent clinical trial award must two more budget years remaining the current project period. addition a new clinical trial was a part the parent award not allowed. Supplement requests addressing INCLUDE Components 2 3 should encourage participants DS their caregivers register inDS-Connect: Down Syndrome Registry. INCLUDE website a list ofFunding Priorities Institute Center, well list ofcontactsfor participating NIH Institute Center. Before submitting supplement request, applicants strongly encouraged contact program officer the program contact the Institute Center IC) supporting parent award any questions to discuss whether proposed supplement within scope the parent award, focused the goals the INCLUDE Project consistent IC priorities. Award Project Period be eligible, parent award must active the current fiscal year i.e., parent award received funds the current fiscal year is in extension period), the research proposed the supplement should requested one year. awarding institute consider no-cost extension up an additional year the conclusion the first year. earliest anticipated start date August 2020, August 2021, August 2022. Budget Requests must reflect actual needs the proposed project. Supplement budget requests exceed 500,000 direct costs 50% the direct costs the current year the parent award exclusive Facilities Administrative costs sub-contracts) must receive permission the project officer IC Contact prior submission. Eligible Individuals Program Director/Principal Investigator) Individual(s) must hold active grant cooperative agreement. supplements parent awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) submitted the awardee institution the parent award. Application Submission Information: Applications response this NOSI must submitted toPA-18-591Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) its subsequent reissued equivalent. instructions theSF424 R&R) Application GuideandPA-18-591must followed, the following additions: order ensure identification, tracking, appropriate review their applications, applicants MUST follow special instructions: Application Due Date(s) March 23, 2020, March 23, 2021, March 23, 2022 5:00 PM local time applicant organization. Applications must include NOT-OD-20-024 the Agency Routing Identifier field Box 4b) the SF424 R&R form. Applications without identifier NOT-OD-20-024) Box 4b not considered this initiative. process Streamlined Submissions using eRA Commons cannot used forPA-18-591. the form package theexistingNIH Grants and/or Cooperative Agreements. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response toNOT-OD-20-024in order facilitate efficient processing the request. Applicant organizations submit than application this NOSI. unique project titles each application ensure our systems treat application a distinct submission. Application budgets must reflect actual needs the proposed project. Supplement budget requests exceed 500,000 direct costs 50% the direct costs the current year the parent award exclusive Facilities Administrative costs sub-contracts) must receive permission the project officer IC Contact prior submission. application Abstract section should describe proposed supplement, the Research Strategy section should include summary abstract the funded parent award project. Research Strategy should state relevance the parent award the INCLUDE project, articulate component(s) any IC-specific priorities the supplement addressing. Page Limits:NIH consider supplements a Research Strategy ofno than 6 pages, addition the abstract. part the application investigators should submit abstract the proposed research shows relevance DS. Place abstract the Project Summary/Abstract section the SF424 R&R) Form. work include pilot projects resource development. Review Process:Each IC conduct administrative reviews applications their IC separately. Inquiries Please direct inquiries to: Investigators planning submit application response this NOSI strongly encouraged contact discuss proposed research/aims a Program Officer the appropriate Institute Center listed this NOSI well advance the grant receipt date better determine appropriateness interest the awarding ICO. Please direct inquiries the contact the Institute, Center Office supporting parent award indicated the funding page theINCLUDE Project website.

Notice Special Interest NOSI): NIH Research Project Grants Down Syndrome R01) the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project Notice Number: NOT-OD-20-025 Key Dates Release Date: December 18, 2019 First Available Due Date: February 05, 2020 Expiration Date: January 08, 2022 Related Announcements NOT-OD-20-129 - Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Administrative Supplements Research Coronavirus Disease 2019 COVID-19) Individuals Down Syndrome the INCLUDE ProjectNOT-OD-20-022 NOT-OD-20-012Notice Intent Publish Funding Opportunity Announcements Fiscal Year 2020 the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project PA-19-055Research Project Grant Parent R01 Clinical Trial Required) PA-19-056NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-19-091NIH Research Project Grant Parent R01 Basic Experimental Studies Humans Required NOT-OD-20-017Notice Special Interest NOSI) Encourage Development Animal Models Related Biological Materials Research Related Down Syndrome NOT-OD-20-020Notice Special Interest NOSI): Ruth L. Kirschstein National Research Service Award NRSA) Fellowship Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-021Notice Special Interest NOSI): Mentored Career Development Awards Support Training Research Related Down Syndrome Part the INCLUDE Project NOT-OD-20-022Notice Special Interest: Administrative Supplements the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project NIH-funded K12 KL2 Institutional Career Development Awards NOT-OD-20-023Notice Special Interest: Availability Competitive Supplements/Revisions the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Competitive Supplement/Revision Clinical Trial Optional) NOT-OD-20-024Notice Special Interest: Availability Administrative Supplements the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project NOT-OD-20-025Notice Special Interest: NIH Research Project Grants Down Syndrome R01) RFA-OD-20-003Clinical Trials Development Co-Occurring Conditions Individuals Down syndrome: Phased Awards INCLUDE R61/R33 Clinical Trial Required) RFA-OD-20-004INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-005Transformative Research Award the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndrome) Project R01 Clinical Trial Allowed) RFA-OD-20-006Small Research Grants Analyses Down Syndrome-related Research Data the INCLUDE Project R03 Clinical Trial Allowed) RFA-OD-20-007Development the INCLUDE Investigation Co-occurring Conditions across Lifespan Understand Down syndromE) Project Data Coordinating Center U2C) Issued Office The Director, National Institutes Health OD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Institute Aging NIA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) 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 Environmental Health Sciences NIEHS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Minority Health Health Disparities NIMHD) Purpose Background INvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project developed response Fiscal Year 2018 2019 Omnibus Appropriations Reports, encouraged NIH expand current efforts Down syndrome DS) common co-occurring conditions also seen the general population while increasing pipeline DS investigators. Information projects werefundedin 2018 2019, well the INCLUDE ProjectResearch Plan, available theINCLUDE Project website. Individuals DS face significant changing health challenges have often excluded participation research could improve health outcomes quality life. population understudied even though DS the most common genetic cause intellectual developmental disabilities IDD) and, the past 25 years, average lifespan doubled 30 60 years. addition intellectual disability, DS associated an increased prevalence autism epilepsy. 75% individuals DS experience cognitive decline a syndrome resembles Alzheimers disease, with onset decade two earlier typical Alzheimers disease. Individuals DS also high rates hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, other autoimmune immune dysregulation disorders including celiac disease. However, people DS infrequently develop solid tumors such breast prostate cancer. Despite multiple risk factors coronary artery disease high rates obesity, sleep apnea, type 1 diabetes, people DS rarely develop atherosclerosis have myocardial infarctions. Understanding unique combination risk resiliencies inform medical advances individuals DS for individuals do have DS who share co-occurring conditions. Research Objectives purpose this Notice Special Interest NOSI) to support research project grant R01) applications are focused Down syndrome that meet programmatic objectives the INCLUDE Project. Sharing resources effective communication outputs appropriate interest broader communities a high priority theINCLUDE Project. Applicants responding this NOSI strongly encouraged describe plans rapid sharing data results well innovative data analytics approaches Goal 3,NIH Strategic Plan Data Science). list ofFunding Priorities Institute Centeris available theINCLUDEwebsite. Applications response this NOSI should aligned the overall INCLUDE ProjectResearch Plan, consists three components: Component 1: Targeted, high risk-high reward, basic science studies areas highly relevant Down syndrome Component 2: Cohort Study connect existing resources expand inclusion individuals Down syndrome Component 3: Inclusive clinical trials research co-occurring conditions individuals Down syndrome Projects propose recruit subjects Down syndrome encouraged promote enrollment research subjects the Down syndrome patient registry supported NIH,DS-Connect. other data biospecimens human genetic non-genetic studies, awardees encouraged use biorepositories designated INCLUDE staff meet requirements broad sharing. NIH resource describingCommon Data Elementsmay helpful during planning phases a project considering ways optimize data collection order facilitate broad data sharing. INCLUDE website a list ofFunding Priorities Institute Centerfor project, well list ofcontactsfor participating NIH Institute Center. Program Directors/Principal Investigators PD/PIs) planning submit applications response this NOSI strongly encouraged contact scientific contacts this NOSI prior submission be advised appropriateness the intended resource research plans this program, competitiveness a potential application, alignment program priorities the INCLUDE initiative. Application Submission Information Notice applies due dates or after February 5, 2020 subsequent receipt dates through September 7, 2022. following Funding Opportunity Announcements FOAs) their reissued equivalents must used submissions this initiative.Although all NIH components indicated above listed Participating Organizations all FOAs listed below, applications this initiative be accepted the participating Institutes Centers NIH. PA-19-055- NIH Research Project Grant Parent R01 Clinical Trial Required) PA-19-056- NIH Research Project Grant Parent R01 Clinical Trial Allowed) PA-19-091- NIH Research Project Grant Parent R01 Basic Experimental Studies Humans Required) instructions theSF424 R&R) Application Guideand funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include NOT-OD-20-025 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 withdrawn consideration this initiative. Inquiries Please direct inquiries to: Please direct inquiries the contacts Section VII the listed funding opportunity announcements the following additions/substitutions: list ofcontactsfor participating NIH Institute Center available theINCLUDEwebsite.

This Funding Opportunity Announcement (FOA) invites research applications to elucidate mechanisms of neuroimmune dysfunction caused by HIV-1 and to detect persistent/latent/reactivated HIV using novel imaging/neuroimaging approaches in the central nervous system from anti-retroviral therapy (ART) suppressed individuals. Applications testing a fully conceptualized and hypothesis-based solid premise founded with adequate preliminary data should consider applying to the companion R21 announcement, RFA MH-20-331 . Basic and preclinical research in domestic and international settings are of interest. Multidisciplinary research teams and collaborative alliances are encouraged but not required.