The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R and D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R and D throughout the award. Clinical Trials are not accepted under this FOA.

Notice Special Interest NOSI): Understanding Sudden Death the Young Through Research Notice Number: NOT-HL-20-787 Key Dates Release Date: June 29, 2020 First Available Due Date: October 05, 2020 Expiration Date: January 08, 2023 Related Announcements PA-20-185 - NIH Research Project Grant Parent R01 Clinical Trial Allowed) Issued National Heart, Lung, Blood Institute NHLBI) National Institute Neurological Disorders Stroke NINDS) Purpose Notice Special Interest NOSI) highlights interest receiving grant applications focused mechanistic, genetic, other studies evaluate causes consequences and risk factors sudden death the young. Studies required use data DNA samples, associated sequence data the NIH/CDC Sudden Death the Young SDY) Case Registry foundations their research. Results such studies expected be disseminated widely to provide evidence base advance discussions screening prevention SDY. sudden, unexpected loss a child a tragic event significant impact families communities. Sudden Death the Young SDY) Case Registry sdyregistry.org) a unique collaboration between National Institutes Health NHLBI NINDS) the Centers Disease Control Prevention CDC). was designed address critical knowledge gaps the epidemiology causes SDY to develop resource research will enhance evidence base inform prevention efforts. Fundamental gaps knowledge incidence, mechanisms, risk factors SDY limit identification effective prevention efforts. the majority SDY cases, after autopsy investigation, cause cannot identified. deaths where cause be identified, sudden, unexpected, non-injury-related infant child deaths often due cardiac causes myocarditis, cardiomyopathy, coronary artery anomalies, ion channelopathies), respiratory causes asthma, pneumonia), sudden unexpected death epilepsy SUDEP), various infections, neurological, hematologic, gastrointestinal catastrophes. Because the high number unexplained deaths the lack evidence regarding cause(s), is disagreement the best approach prevent SDY. SDY Case Registry the associated research efforts should help close knowledge gaps provide foundation data can used inform targeted prevention efforts. SDY Case Registry first funded 2013 address critical knowledge gaps the epidemiology etiologies SDY. CDC leading population-based surveillance efforts identify 100% cases SDY funded states/jurisdictions the SDY Case Registry. do this, provide technical assistance states/jurisdictions increase case ascertainment ensure consistent categorization cases. Support NHLBI NINDS focused developing resource research SDY ensuring collection a comprehensive battery phenotypic data elements collection DNA samples enable genomic analysis. Detailed phenotyping performed cases sudden cardiac death the young SCDY), unexplained infant child death, sudden unexpected death epilepsy SUDEP), limited data gathered other explained SDY cases. SDY Case Registry one the largest population-based cohorts children have died suddenly the US, including over 3000 SDY cases date. SDY Case Registry’s 13 states/jurisdictions include approximately 20% SDYs the US. population infants children the states/jurisdictions funded the SDY Case Registry 23% black. Ethnicity data not available all jurisdictions, the funded states include 14% Hispanic/Latino infants children. Data be used explore causes SCDY well SUDEP, sudden unexpected infant death SUID), other causes pediatric sudden death. Inclusion criteria infants children to age 20 die suddenly unexpectedly. Homicide, suicide, intentional overdose obvious injury-related deaths excluded. Data gathered symptoms, activity/exercise, previous diagnoses, medications, treatments, seizures, family history, resuscitation. Cases categorized cause state/local experts cardiology, neurology pathology, and, after informed consent surviving family members, blood/tissue collected DNA extraction stored the biorepository the University Michigan enable research. consent allows use the child’s DNA sample research, access the autopsy report, re-contact return results discussions future research opportunities. addition, families given option consent re-contact investigators the purposes obtaining additional information returning clinically actionable results. Consent been obtained research approximately 250 cases date, whole genome sequencing been performed 200 cases thus far. Sequence data be available investigators through NIH data repositories dbGAP). Controls not included the Registry must sought elsewhere. State public health agencies their bona fide agents) participating the SDY Case Registry proprietary rights over data enter the Registry; however, under specific agreement, data individual states combined a single de-identified dataset. SDY Case Registry’s Data Coordinating Center the Michigan Public Health Institute facilitate initiation data agreements between investigators state public health agencies access dataset. SDY Case Registry’s Data Coordinating Center DCC) the Michigan Public Health Institute funded separately via contract an Interagency Agreement between NIH CDC. DCC provides administrative support the SDY Case Registry, creates case report forms phenotypic data, develops consent forms participation the Registry, maintains SDY database, subcontracts a biorepository the University Michigan DNA extraction storage samples. DCC works closely research teams establish data agreements the SDY Case Registry data collection sites state public health agencies their bona fide agents) access phenotypic data DNA samples study. DCC does provide statistical support conduct data analysis each funded research project. Rather, facilitate access the data act liaisons between investigators the jurisdictions collect data. Selected Research Examples Research questions interest include, are limited the following: is prevalence ion channel mutations other candidate genes known be associated arrhythmias cases compared controls? is prevalence ion channel mutations other candidate genes known be associated the epilepsies cases compared controls, compared cases sudden cardiac death the young? do ion channel mutations differ between SUID cases cases sudden death older children? competitive athletics risk factor sudden cardiac death the young? there diurnal variations sudden cardiac death the young, is case some cardiovascular conditions adults? there risk factors SUDEP are associated the sleep setting and/or time death? there significant environmental contextual differences between cases controls, such socioeconomic status, history drug exposure, serum toxicology screens, family history, other factors? is yield molecular autopsy defined postmortem molecular, typically genetic diagnosis) autopsy-negative cases SDY? machine learning complex genetic models used identified novel SDY risk genes? Applications seek determine incidence SDY outside scope this NOSI, be considered non-responsive, will be considered under NOSI. CDC, NHLBI, NINDS SDY Case Registry Steering Committee be responsible evaluating incidence. Application Submission Information notice applies due dates or after October 5, 2020 subsequent receipt dates through January 8, 2023. Submit applications this initiative using following funding opportunity announcement FOA) any reissues this announcement through expiration date this notice PA-20-185 NIH Research Project Grant Parent R01 Clinical Trial Allowed) instructions the SF424 R&R) Application Guide the funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include “NOT-HL-20-787” 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 will not 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) Kristin M. Burns, MD National Heart, Lung, Blood Institute Telephone: 301-594-6859 Email: kristin.burns@nih.gov Vicky Whittemore, PhD National Institute Neurological Disorders Stroke Telephone: 301-594-8909 Email: vicky.whittemore@nih.gov Peer Review Contact(s) Examine eRA Commons account review assignment contact information information appears weeks after submission due date). Financial/Grants Management Contact(s) Judy Sint National Heart, Lung, Blood Institute Telephone: 301-480-1307 Email: sintj@mail.nih.gov

Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions Administrative Supplements Research Coronavirus Disease 2019 COVID-19) Individuals Down Syndrome the INCLUDE Project Notice Number: NOT-OD-20-129 Key Dates Release Date: June 25, 2020 First Available Due Date: July 13, 2020 Expiration Date: July 13, 2021 Related Announcements PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - 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-20-024 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 Nvestigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Clinical Trial Readiness R21 Clinical Trial Allowed) RFA-OD-20-005 Transformative 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 Human Genome Research Institute NHGRI) 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 Diabetes Digestive Kidney Diseases NIDDK) National Institute Environmental Health Sciences NIEHS) National Institute Neurological Disorders Stroke NINDS) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Division Program Coordination, Planning Strategic Initiatives, Office Research Infrastructure Programs ORIP) National Cancer Institute NCI) Purpose NIH issuing Notice Special Interest NOSI) highlight urgent need research Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV-2) Coronavirus Disease 2019 COVID-19) individuals Down syndrome conjunction the INCLUDE INvestigation Co-occurring conditions across Lifespan Understand Down syndromE) Project. Because people Down syndrome at increased risk having co-occurring medical conditions, such pulmonary disease, cardiac problems, obesity, diabetes, sleep apnea, altered immune function may predispose to severe infection SARS-CoV-2, may particularly vulnerable COVID-19 complications. Combined shared living situations, reduced access testing treatment services due disparities provision resources, impact COVID-19 infection people Down syndrome likely be elevated. overarching goal this NOSI to improve understanding treatment COVID-19 infection individuals Down syndrome reduce COVID-19 associated morbidity mortality this population, may disproportionately affected by, higher infection rates of, and/or at elevated risk adverse outcomes contracting virus. Background Investigation Co-occurring conditions across Lifespan Understand Down syndromE INCLUDE) Project developed response Fiscal Year 2018 2019 Consolidated Appropriations Acts, encouraged NIH expand current efforts Down syndrome common co-occurring conditions also seen the general population while increasing pipeline Down syndromeinvestigators. Information projects were funded 2018 2019, well the INCLUDE Project Research Plan, available the INCLUDE Project website. Individuals Down syndrome face significant changing health challenges have often excluded participation research could improve health outcomes quality life. population understudied even though Down syndrome the most common genetic cause intellectual developmental disabilities IDD) and, the past 25 years, average lifespan doubled 30 60 years. addition intellectual disability, Down syndrome associate an increased prevalence autism epilepsy. 75% individuals Down syndrome experience cognitive decline a syndrome resembles Alzheimer’s disease, with onset decade two earlier typical Alzheimer’s disease. Individuals Down syndrome also high rates congenital heart defects, sleep apnea, pulmonary hypertension, obesity, gastrointestinal malformations, thyroid disease, diabetes, leukemia, other autoimmune immune dysregulation disorders. leading causes mortality individuals Down syndrome pneumonias, respiratory failure, dementia. particular, given many interferon receptor genes map chromosome 21, people Down syndrome three copies chromosome 21, result a hyperactive immune system elevated levels inflammatory markers results a baseline cytokine storm” status may predispose to infection viruses such SARS-CoV-2, increasing risk severe respiratory tract involvement, respiratory failure mortality this virus. addition, may at increased risk contracting COVID-19 due residence congregate housing settings may experience severe illness death given increased mortality due the infection those IDD. also potential experience health disparities related access diagnostic testing, treatment, interventions. Understanding unique combination risk factors inform testing treatment those Down syndrome may contract COVID-19 infection. Research Objectives order rapidly improve our understanding SARS-CoV-2 COVID-19 infection, NIH encouraging submission applications administrative supplements urgent competitive revisions active NIH grants address pathology, prevention, diagnosis, sequelae, treatment COVID-19 people Down syndrome. funding opportunity intended support applications focus immediate needs help address COVID-19 pandemic a timely manner. Applications should address whether ongoing potential future public health restrictions e.g., closures, physical distancing) might affect research approach, if so, include plan prevent mitigate any effect the proposed study. General Objectives relevant more one Institute Center IC) NIH): Relationships individual factors, including co-existing conditions medications, resilient adverse outcomes SARS-CoV-2 exposure individuals Down syndrome. Studies pre-hospital, emergency, critical care settings improve screening, risk stratification, diagnostic testing, care delivery decisions, resource allocation, clinical outcomes those Down syndrome exposed SARS-CoV-2. Studies prevention practices hand washing, effectively covering cough, social distancing, etc.) factors influence adherence, including individual age differences social network effects populations cognitive impairment such Down syndrome. Evaluation pharmacological health care delivery intervention strategies those Down syndrome after exposure SARS-CoV-2 prevent mitigate morbidity and/or improve post-infection health function. Evaluating strategies used health systems reallocate resources, rapidly train practitioners, communicate preventative practices, maintain adherence public health clinical guidelines, a particular interest those serve high-risk groups e.g., group homes, nursing homes) resulting racial, ethnic, regional disparities access/care. Leveraging longitudinal studies elucidate COVID-19-related changes the social, economic, institutional, policy environments differentially impact health welfare people across life course in vulnerable social groups, such those Down syndrome; comparative studies regional national approaches encouraged. Areas specific interest participating Institutes, Centers, Offices include, are limited to, following: National Cancer Institute NCI): better understand impact SARS-CoV-2 infection its impact disease progression, response therapy, care delivery, survivorship infants children Down syndrome co-occurring cancer, such leukemia. particular interest studies take advantage unique cancer model systems analytical tools study consequences SARS-CoV-2 infection COVID-19 disease progression. Supported research expected inform future efforts diagnose, prevent, mitigate, treat viral infection children Down syndrome have leukemia transient myeloproliferative disorder pre-cancer), undergoing treatment cancer, are remission. National Heart, Lung, Blood Institute NHLBI): elucidate clinical trajectory cardio-respiratory illness, response therapy, outcomes individuals Down syndrome COVID-19, including, not limited to, sudden death, respiratory insufficiency progressing failure, arrhythmias, myocardial dysfunction, coagulation disorders including, not limited to, predisposition venous thromboembolism),and pulmonary hypertension; also individuals Down syndrome co-existing conditions such obstructive sleep apnea, obesity, congenital heart disease pre- post-surgery). assess refine approaches the management critically ill individuals Down syndrome COVID-19 including, not limited to, assessment optimization different ventilatory strategies acute respiratory distress syndrome ARDS), risks benefits prone positioning management these individuals considering habitus airways, their susceptibility and/ resilience end-organ damage a consequence profound hypoxemia. better understand pathogenesis pneumonia the basic mechanisms cytokine surge COVID-19 closely-coupled and/or specific Down syndrome, e.g., gamma-interferon mediated mechanisms, the goal identifying druggable biological pathways these mechanisms. understand effect COVID-19 central ventilatory control response hypoxemia individuals Down syndrome. assess clinical trajectory response therapies people Down Syndrome presenting the recently described Multisystem Inflammatory Syndrome Children MIS-C) left ventricular dysfunction and/or coronary artery aneurysms. National Human Genome Research Institute NHGRI): Develop novel methods using genomic techniques identify signatures infection, prognosis, and/or severity disease individuals Down syndrome a medical setting. of electronic health information, other relevant clinical, environmental, demographic social determinants health data, accompanying genomic data, aid tracking understanding genetic epidemiology SARS-CoV-2, the individual susceptibility resistance infection disease severity those Down syndrome. Studies addressing ethical, legal, social implications the of genetic genomic information technologies diagnose, track, monitor, treat, triage SARS-CoV-2 COVID-19 infected individuals populations Down syndrome clinical public health settings. National Institute Aging NIA): Studies the role inflammation immune senescence adults Down syndrome increased susceptibility SARS-CoV-2 infection subsequent progression more severe disease, including lung pathology ARDS. Studies how host factors, including existing co-occurring conditions such respiratory, cardiac, other conditions, predispose older individuals Down syndrome acquire SARS-CoV-2 infections and/or develop severe COVID-19 disease, such ARDS. Studies mechanisms underlying SARS-CoV-2 neurological symptoms pathology older individuals Down syndrome COVID-19; research the role brain barriers preventing SARS-CoV-2 gaining access the neural tissues mechanisms through SARS-CoV-2 compromises such barriers propagates the central nervous system CNS); neuropathological studies COVID-19 the contribution brain tissue damage SARS-CoV-2 the morbidity mortality COVID-19 those Down syndrome. Studies neurological neurocognitive symptoms COVID-19 sequelae SARS-CoV-2 infection related the development aggravation such symptoms adults Down syndrome, e.g., delirium early alterations sensory function; studies the susceptibility people Down syndrome Alzheimer's disease Alzheimer's disease-related dementias AD/ADRD) COVID-19. Evaluation strategies minimize spread COVID-19 among adults Down syndrome their care providers, particularly within congregate housing facilities those cognitive impairment such group homes, including telemedicine remote medicine strategies. Studies how social distancing requirements impact care well-being vulnerable adult Down syndrome populations cognitive impairment and/or AD/ADRD, may dependent care providers. National Institute Allergy Infectious Diseases NIAID): Studies understand critical aspects viral infection pathogenesis individuals Down syndrome. development SARS-CoV-2 infection Down syndrome animal models suitable therapeutic candidate and/or pathogenesis studies. Identification evaluation the innate, cellular, humoral immune responses SARS-CoV-2 infection and/or candidate vaccines, individuals Down syndrome. National Institute Arthritis Musculoskeletal Skin Diseases NIAMS): Research SARS-CoV-2 COVID-19 the Down syndrome population relevant the areas arthritic other rheumatic), musculoskeletal, skin anomalies disorders. Eunice Kennedy Shriver National Institute Child Health Human Development NICHD): Research whether children Down syndrome more susceptible Multisystem Inflammatory Syndrome Children MIS-C) associated COVID-19 infection. Studies understand whether infection SARS-CoV-2 more severe children Down syndrome underlying health conditions such congenital heart disease, pulmonary hypertension, frequent respiratory infections in those without such co-occurring conditions. Studies determine whether past infection vaccination, available, SARS-CoV-2 provides lasting immunity children Down syndrome. Research determine COVID-19 infection adolescents young adults impacts risk cognitive decline, behavioral mental health conditions, and/or regression. Incorporation COVID-19 elements existing registries the purpose tracking testing, diagnosis, and/or treatment the infection people Down syndrome. National Institute Deafness Other Communication Disorders NIDCD): Research SARS-CoV-2 COVID-19 the Down syndrome population relevant the areas hearing, balance, taste, smell, voice, speech, language. Specific impacts communication those Down syndrome the context a pandemic enforced social distancing, including impacts services interventions. National Institute Dental Craniofacial Research NIDCR): Topics would of immediate high impact protect ensure safety personnel dental practices their patients comprised individuals Down syndrome: Modifications dental practice and/or treatment space prevent aerosol droplet pathogen transmission Determination the extent which viral pathogens transmitted via aerosol droplet routes during treatment dental settings Design implementation strategies achieve Centers Disease Control Prevention CDC) second-tier Transmission-Based Precautions dental practice Implementation disinfection processes ensure treatment spaces equipment devoid transmissible viral pathogens Development interventions protect health care workers, front-line professionals, patients viral transmission Assessment the impact dental care delivery delays upon oral health needs access care, especially vulnerable Down syndrome populations those affected health disparities. Development implementation strategies triage manage those Down syndrome have oral care needs, including via remote virtual means. Examination the role oral/nasal microbiota ACE2 receptor SARS-CoV-2 infectivity carriage oral fluids nasal secretions the Down syndrome population, gateways the spread infection the respiratory tract via proof principle studies. Pilot testing existing therapeutic modulators oral microbiota may limit infectivity SARS-CoV-2 those Down syndrome. Performance research conducted within National Dental Practice-Based Research Network PBRN), supports clinical research studies dental practices dental practitioners their consenting patients well survey studies practitioners and/or patients include individuals Down syndrome. Potential applicants strongly encouraged review process potential grant applicants interact and utilize National Dental PBRN resources. Implementation FDA-approved detection screening tests SARS-CoV-2 virus antibodies improve triage early disease management strategies those Down syndrome. National Institute Minority Health Health Disparities NIMHD): Including individuals Down syndrome NIH-designated health disparity populations Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, sexual gender minorities) existing clinical community-based studies sufficient number study: Intersectional stigma discrimination their impact health healthcare utilization. Coping strategies, social support, other protective factors related chronic disease risk outcomes. Access and quality healthcare, including primary, specialty, behavioral health care. Evaluating transition child adult healthcare other service systems. National Institute Neurological Disorders Stroke NINDS): Studies understand biologic effects SARS-CoV-2 infection the brain, spinal cord, nerves individuals Down syndrome. includes acute neurological symptoms, symptoms ranging the relatively mild anosmia dysgeusia) the extreme encephalitis, ataxia, seizures, cerebrovascular events such stroke). also includes potential delayed effects COVID-19, such post-viral complications e.g., acute disseminated encephalomyelitis Guillain-Barre syndrome). Establishment maintenance a database designed collect clinical information the neurological manifestations SARS-CoV-2 individuals Down syndrome. Such database should address objectives outlined NOT-NS-20-046 align centralized NINDS data collection efforts. Studies using telemedicine the diagnosis treatment neurological symptoms individuals Down syndrome. National Center Complementary Integrative Health NCCIH): in vivo animal models Down syndrome, conduct assessments natural product therapeutic candidates repurposed existing candidate natural product therapeutics initially developed other indications against SARS-CoV-2, study mechanisms action the candidates treatment prevention COVID-19, such suppressing virus transmission, infection loading, entry, fusion), replication; and/or regulating innate, adaptive, cellular, humoral immune systems including immune-mediated pathologies host interactions molecular pathways, cytokine storms, free radicals, etc.). Office Research Infrastructure Programs ORIP): ORIP interested supporting projects aimed enhancing existing creating new animal models Down syndrome studying mechanisms underlying COVID-19 the context Down syndrome. Preference be given applications develop informative animal models demonstrate potential investigating multiple phenotypic features COVID-19 the context Down syndrome, rather focusing a specific phenotype the disease. Note ORIP only consider applications submitted under PA-18-591 subsequent reissued equivalents. Considerations maximize comparisons across datasets studies, facilitate data integration collaboration, researchers funded through NOSI strongly encouraged use following resources: Data Harmonization Social Determinants Health via PhenX Toolkit: Investigators involved human-subject studies strongly encouraged employ common set tools resources will promote collection comparable data social determinants health SDOH) across studies. particular, human-subject studies should incorporate SDOH measures the Core Specialty collections are available the Social Determinants Health Collection the PhenX Toolkit www.phenxtoolkit.org). NIH encouraging researchers explore use the HL7 FHIR Fast Healthcare Interoperability Resources) standard capture, integrate, exchange clinical data research purposes to enhance capabilities share research data NOT-OD-19-122). FHIR resources be particularly useful the development computational tools used COVID-19 research data sharing. Additional emerging data terminologies, ontologies, standards should considered describing semantic content data metadata COVID-19 research e.g., LOINC, SNOMED, ICD-10, others described here: https://covid.cd2h.org/forms_and_standards). trans-NIH working group making existing COVID-19 survey items investigator contact information publicly available through NIH-supported platforms: NIH Public Health Emergency Disaster Research Response DR2) https://dr2.nlm.nih.gov/] the PhenX Toolkit https://www.phenxtoolkit.org/index.php]. Researchers addressing COVID-19 questions, whether population-based for clinical research, strongly encouraged consider COVID-19 specific survey item repositories select existing survey items protocol modules currently being fielded. Additionally, researchers funding through NOSI be strongly encouraged share survey items make public other researchers consider submitting surveys NIHCOVID19Measures@nih.gov. 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. addition the review criteria described PA-18-591 PA-18-935, as applicable the project proposed, reviewers also evaluate: what extent does application address goals the INCLUDE Project? relevant the proposed research regard addressing key areas identified priorities COVID-19 research Down syndrome? likely it the investigators have immediate access the necessary resources e.g., patient samples, isolates, test kits, laboratory access, etc.) achieve aims the proposed research? strong the proposed plans the execution the proposed work laboratory access limited restricted due the COVID-19 pandemic? likely it the proposed research generate unique resources data could impact public health response? adequate the resource sharing plan? Review Selection Process: Applications both PA-18-591 PA-18-935 be evaluated scientific technical merit an appropriate internal review panel convened staff the NIH INCLUDE Project Team, accordance the stated review criteria any additional review criteria specified. Application Submission Information Application Due Dates: July 13, 2020, November 12, 2020, March 12, 2021, July 12, 2021 5:00 PM local time applicant organization. Applications this initiative must submitted electronically using of following target opportunities their subsequent reissued equivalents: PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional) NIH anticipates most applications response this NOSI be expanding scope the parent award will submitted response PA-18-935. definition scope be found the NIH Grants Policy Statement. funding instrument, activity code, be same the parent award. Applicants must follow instructions the SF424 R&R) Application Guide in selected target funding opportunity announcement PA-18-591 PA-18-935), the following additions: Budget: applications targeting PA-18-591 Administrative Supplement), application budgets limited no than amount the current parent award 1,000,000 direct costs, whichever less, must reflect actual needs the proposed project. applications targeting PA-18-935 Urgent Competitive Revision), application budgets limited no than 1,000,000 direct costs, must reflect actual needs the proposed project. Exceptions these budget limits be with NIH pre-approval will only approved under very rare circumstances where work immediately impact public health. Project Period: Applicants request budget period only year support that year must align the existing parent award. parent award must active the supplement application submitted e.g. within originally reviewed approved project period), regardless the time remaining the current project. Abstract: Abstract section should describe proposed supplement. Research Strategy: Research Strategy section should provide summary abstract the funded parent award project describe relevance the proposed project the funded parent award the INCLUDE project. Describe component(s) any IC-specific priorities the supplement addressing. Research Strategy limited 6 pages Applicants should address whether ongoing potential future public health restrictions e.g., closures, physical distancing) might affect research approach and, so, include plan prevent mitigate any effect the proposed study. Administrative supplement applications PA-18-591must the application form package theCompetition ID contains FORMS-F-ADMINSUPP." addition, process forStreamlined Submissions using eRA Commons cannot used this initiative. Competitive revision applications PA-18-935 must the application form package the Competition ID contains FORMS-F-COMP-REV." applications including those multi-project activity codes) must submitted electronically using single-project application form package. funding consideration, applicants must include NOT-OD-20-129 the Agency Routing Identifier field Box 4.b) the SF 424 R&R) Form. Applications without information Box 4b not considered this initiative. Pre-award costs be incurred January 20, 2020 through public health emergency period prior the date the federal award. process Streamlined Submissions using eRA Commons cannot used this initiative. INCLUDE Program Office not consider applications fail meet terms this NOSI. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. NOSI expires July 13, 2021. application submitted response this NOSI is received on/after expiration date be withdrawn. Inquiries Please direct inquiries the contact the Institute, Center Office supporting parent award indicated the funding page the INCLUDE Project website. Financial/Grants Management Contact(s) Ryan Talesnik Eunice Kennedy Shriver National Institute Child Health Human Development Telephone: 301-435-6976 Email: talesnikr@mail.nih.gov

The National Human Genome Research Institute (NHGRI) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development are coordinating efforts for establishing a Developmental Genotype-Tissue Expression (dGTEx) project, to catalog and analyze transcriptional profiles from a wide variety of tissues obtained from neonates, children, and adolescents in a post-mortem setting. The purpose of this FOA is to solicit applications to develop and implement a Laboratory, Data Analysis, and Coordinating Center (LDACC) for the Developmental Genotype-Tissue Expression (dGTEx) Project. The LDACC will perform 2 major functions: a molecular laboratory, and a data analysis and coordinating center. As a molecular laboratory, the LDACC will work with the Biospecimen Procurement Center (BPC) funded by NICHD to process tissue samples for sequencing and biobanking. Responsibilities as a data analysis and coordinating center include ensuring close coordination with the BPC, monitoring study progress and laboratory performance, performing basic analysis of data for gene expression analyses, and harmonizing and submitting datasets to be deposited in repositories such as the AnVIL ((Analysis, Visualization, and Informatics Lab-space) https://anvilproject.org/) or the GTEx portal (https://gtexportal.org/home/).