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HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Reduce Stigma in Pain Management and Opioid Use Disorder (OUD) and Treatment

Notice of Special Interest
Thursday, April 23, 2020
Saturday, May 30, 2020
333
NOT-OD-20-101

Funding Opportunity Purpose

HEAL Initiative: Notice Special Interest NOSI) regarding Availability Administrative Supplements Support Strategies Reduce Stigma Pain Management Opioid Disorder OUD) Treatment Notice Number: NOT-OD-20-101 Key Dates Release Date: April 23, 2020 First Available Due Date: 29, 2020 Expiration Date: 30, 2020 Related Announcements PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued Office Behavioral Social Sciences Research OBSSR) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) 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. Division Program Coordination, Planning Strategic Initiatives, Office Disease Prevention ODP) Office Research Women's Health ORWH) Purpose Notice Special Interest NOSI) calls research stigma the context chronic pain management opioid or opioid disorder OUD). part NIH’s Helping End Addiction Long Term HEAL) Initiative, NIH support supplements current HEAL awards address challenges people affected the opioid crisis stigma, discrimination prejudice related chronic pain management the context opioid and/or opioid disorder its treatment. NOSI calls applications integrate incorporate stigma research ongoing HEAL funded chronic pain OUD studies order address stigma is occurring the context chronic pain and/or OUD. Because stigma research require large clinical community networks, supplement program designed leverage many networks already being developed through HEAL awards. supplement program not intended support research basic processes e.g. cultural attitudes) rather result strategies enable rapid implementation changes. total up 3.5 million available supplement existing HEAL grants cooperative agreements, up 1 year, evaluate strategies reduce stigma improve treatment, management services people chronic pain and/or OUD. Supplement requests not need address possible aspects stigma the context chronic pain or OUD, it encouraged appropriate consider piloting multi-layer, multicomponent interventions address stigma these contexts. Background 50 million adults the United States chronic daily pain. 19.6 million adults experience chronic pain interferes daily life work activities. Misuse addiction opioids, including prescription pain relievers, synthetic opioids such fentanyl, heroin become serious national health crisis. than130 people die every day an opioid-related drug overdose. Stigma be barrier treatment both people chronic pain the context being treated opioids also people OUD related painful conditions. Appropriate care needed address suffering people pain and/or OUD it critical address challenges associated stigma living these conditions, seeking care support pain management and/or recovery OUD. Stigma be barrier treatment both painful conditions substance abuse. Studies suggest people chronic pain are receiving who previously received opioid treatment face stigma their healthcare providers, family, friends, coworkers, health care system, society general. Stigma also major barrier implementation programs treatments chronic pain opioid disorder, such medication assisted treatment naloxone. People chronic pain problematic opioid report significant perceived stigma associated methadone buprenorphine treatment. Stigma also lead severe consequences people chronic pain long term opioid face acute opioid withdrawal due stigma. Chronic pain often stigmatized itself some approaches address opioid crisis led stigma related addictions be also applied people chronic pain. Stigma be challenge people pain and/or substance disorders, families, caregivers, clinicians. Reducing barriers care exist because stigma crucial care people for treatment effectiveness both chronic pain management and/or OUD. Research Objectives order effectively reduce stigma related the treatment chronic pain the context the opioid crisis and/or stigma related OUD, NIH encouraging submission applications supplements active grants provide evidence-based data inform strategies reduce stigma build resilience discrimination those chronic pain and/or OUD. High priority supplements will: Analyze strategies reduce stigma, discrimination prejudice related chronic pain management and/or OUD impact areas such prevention, management treatment access effectiveness recovery; existing psychometrically validated tools measure stigma only very compelling rationales, support development any new measurement tool. Research areas interest include: Prejudice care providers undermine treatment health QOL Strategies address stigma a variety contexts includes: among healthcare providers, workplace colleagues, emergency responders, family friends others; impact internalized anticipated stigma prevention, management, treatment recovery; adaption application existing theories health related stigma chronic pain and/or OUD reducing stigma; Rather the creation new measurement tools, use psychometrically validated measures stigma other populations e.g. HIV, mental illness) their application these populations. Analyses combinations approaches are known reduce discrimination prejudice a variety situations workplace- supervisors, colleagues; family friends, healthcare providers, emergency responders, community); Strategies address internalized stigma; Approaches build resilience discrimination prejudice these populations First stage development multicomponent approaches could expanded implemented large scale multicomponent research projects. Researchers find materials related the 2017 meeting: The Science Stigma Reduction that sponsored the National Institutes Health NIH) helpful. Description circumstances which administrative supplements available. 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 and PA-18-591 must followed, the following additions: Application Due Date(s) – Applications be accepted through 29 , 2020 , 5:00 PM local time applicant organization. NOSI expires May 30 , 2020 funding consideration, applicants must include ldquo;NOT-OD-20 101” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Requests be one year support only. Research Strategy section the application limited 6 pages. parent award must active the application submitted. project budget periods must within currently approved project period the existing parent award. Applications non-responsive the terms this Notice be be considered this initiative. Review criteria, addition those described PA-18-591, include following: Does PI(s)/PD(s) expertise stigma, pain management and/or addiction appropriate the study stigma chronic pain opioid use? Does application propose engage people chronic pain and/or those OUD, providers, relevant stakeholders identifying key questions regarding stigma chronic pain management opioid and treatment? successful, does application the potential be implemented broadly Administrative supplement applications to PA-18-591 must the application form package the Competition ID contains ldquo;FORMS-F-ADMINSUPP”. addition, process Streamlined Submissions using eRA Commons cannot used this initiative. Investigators planning submit application response the NOSI strongly encouraged contact appropriate Institute Center contact listed the NOSI discuss proposed project the context the parent award. Questions specific this NOSI should sent the contact listed the NOSI. nbsp; Inquiries Please direct inquiries to: Wendy B. Smith, MA, PhD, BCBAssociate DirectorOffice Behavioral Social Sciences Research OBSSR)Tel: 301-435-3718Email: smithwe@mail.nih.gov Wendy Weber, N.D., PhD., MPHNational Center Complementary Integrative Health NCCIH)Tel: 301-402-1272Email: mailto:weberwj@mail.nih.gov Alexis Bakos, PhD., MPH., RN National Cancer Institute NCI)Tel: 240-276-6609Email: alexis.bakos@nih.gov Leslie K. Derr, Ph.D.National Institute Arthritis Musculoskeletal Skin Diseases NIAMS)Tel: 301-402-4735 Email: derrl@mail.nih.gov M. Aklin, Ph.D.National Institute Drug Abuse NIDA)Tel: 301-827-5909Email: aklinwm@nida.nih.gov Shelley Su, Ph.D.National Institute Drug Abuse NIDA)Tel: 301-402-3869Email: shelley.su@nih.gov Yolanda Vallejo, PhD.National Institute Dental Craniofacial Research NIDCR)Tel: 301-827-4655Email: Yolanda.Vallejo@nih.gov Paul L. Kimmel, MDNational Institute Diabetes Digestive Kidney Diseases NIDDK)Tel: 301-594-1409Email:  Kimmelp@mail.nih.gov Durga Mohapatra, Ph.D.National Institute Neurological Disorders Stroke NINDS)Tel: 301-827-7403Email: dp.mohapatra@nih.gov Jacqueline Lloyd, PhD, MSWOffice Disease Prevention ODP)Tel: 301-827-5559Email: lloydj2@nih.gov

Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)

PA
Monday, April 20, 2020
Workforce Diversity, Training, Career Development
Friday, May 29, 2020
333
PA-20-166

Funding Opportunity Purpose

The National Institutes of Health (NIH) and the Center for Disease Control and Prevention hereby notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for administrative supplements to enhance the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

Notice of Special Interestregarding the Availability of Administrative Supplements and Urgent Competitive Revisions for the Establishment and Maintenance of a Research Database for Neurological Manifestations of the SARS-CoV-2

Notice of Special Interest
Friday, April 10, 2020
Saturday, May 9, 2020
NOT-NS-20-046

Funding Opportunity Purpose

Notice Special Interest regarding Availability Administrative Supplements Urgent Competitive Revisions the Establishment Maintenance a Research Database Neurological Manifestations the SARS-CoV-2 Notice Number: NOT-NS-20-046 Key Dates Release Date: April 14, 2020 First Available Due Date: April 06, 2020 Expiration Date: 09, 2020 Related Announcements PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional) PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued National Institute Neurological Disorders Stroke NINDS) Purpose NINDS issuing Notice Special Interest NOSI) highlight urgent need research the novel coronavirus SARS-CoV-2 previously termed 2019-nCoV) its associated illness, COVID-19. NINDS especially interested developing systems collect data the neurologic effects COVID-19 infection patients requiring intensive care less severely affected individuals seen health care practitioners people across U.S. the rest the world confront pandemic due SARS-CoV-2, research community should alert the possibility COVID-19 neurologic complications addition non-specific symptoms such headache dizziness. ICU patients, neurologic symptoms COVID-19 be secondary and overshadowed the severe pulmonary, cardiovascular hepatorenal dysfunction associated change level consciousness. However, are emerging reports neurologic symptomatology ranging the relatively mild anosmia dysgeusia) the extreme encephalitis, ataxia, seizures, cerebrovascular events). are also concerns possible post-viral complications acute disseminated encephalomyelitis Guillain-Barre syndrome, seen SARS MERS. is important collect, aggregate analyze data neurologic signs symptoms COVID-19 patients across spectrum disease severity across life-span, neonates/infants through elderly. Such data help us understand virus effects the brain, spinal cord nerves, including acute symptomatology potential delayed effects affected individuals. Research Objectives order rapidly improve our understanding the prevalence symptomatology SARS-CoV-2 neurologic involvement, NINDS encouraging submission applications Competitive Revisions Administrative Supplements active grants establish maintain database collects clinical information the neurological manifestations SARS-CoV-2 addresses following: Rapid establishment deployment a web-based portal individual practitioners institutions enter de-identified data neurological complications COVID-19 patients. Data must collected using established standards Common Data Elements CDEs). protocol should include implementation a set CDEs related neurologic disorders patients infected SARS-CoV-2 incorporates complements current NINDS CDEs other international standards. core CDEs should incorporate data dictionaries using NINDS CDE format https://www.commondataelements.ninds.nih.gov/), additional relevant CDEs generated a variety neurospecialty organizations, the ability capture, additional relevant patient characteristics data captured the core CDEs, submitted a computable format. addition study data IPD=individual participant data), data dictionary the study must provided. data dictionary must in computable format e.g., tab-separated-value file). CONSIDER statement provides additional guidance sharing data see https://w3id.org/CONSIDER ). portal should permit physicians update information over course the illness. Establishment a Global Unique Identifier GUID) patients entered a COVID-19 NeuroDatabase enable linkage other GUID-enabled clinical research the same individual. Establishment maintenance a COVID-19 NeuroDatabase harmonize, aggregate make collected data widely available useful analysis, following FAIR Findable, Accessible, Interoperable, Reusable) Guiding Principles. ensure maximal value the project, applicants expected use open-source tools harmonization curation whenever possible. Description circumstances which administrative supplements available. Application Submission Information Applications this initiative must submitted using of following opportunities: PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional) is intended provide funds NIH grantees applying to expand scope of active grant. PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) is intended provide funds NIH grantees where work proposed the supplement fully within scope of ongoing grant. funding instrument, activity code, be same the parent award. instructions the SF424 R&R) Application Guide and PA-18-935 or PA-18-591 must followed, the following additions: Applications encouraged be submitted soon possible will accepted a rolling basis April 6, 2020 until 8, 2020 5:00 PM local time applicant organization. NOSI expires May 9, 2020. funding consideration, applicants must include ldquo;NOT-NS-20-046” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applicants must hold active U01 U24NINDS data center award. Eligible Funding Opportunity Announcements include, are limited to: RFA-NS-19-024 RFA-NS-17-02 RFA-NS-16-015 RFA-NS-13-016 RFA-NS-11-010 supplements awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) must submitted the awardee institution the original award. Applicants must the resources ability do work under supplement without critically impacting high-priority, on-going NINDS research programs. project award budget periods this revision/supplement must within currently approved project period the original/parent award original award must active not a cost extension the entire extent the supplement). Administrative supplement applications to PA-18-591 must the application form package the Competition ID contains ldquo;FORMS-E-ADMINSUPP”. addition, process Streamlined Submissions using eRA Commons cannot used this initiative. Competitive revision applications to PA-18-935 must the application form package the Competition ID contains ldquo;NOT-NS-20-046" Research Strategy section the application limited 6 pages. Investigators planning submit application response the NOSI strongly encouraged contact program officers listed below discuss proposed project the context the original award. Applications non-responsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries to: Rebecca Hommer, MDNational Institute Neurological Disorders amp; StrokeTelephone: 301-827-2257 Email: rebecca.hommer@nih.gov

Notice of Special Interest (NOSI): Availability of Administrative Supplements to Advance Safe and Effective Therapeutics in Pregnant and Lactating Women and Children

Notice of Special Interest
Wednesday, March 25, 2020
Tuesday, June 2, 2020
333
NOT-HD-20-003

Funding Opportunity Purpose

Notice Special Interest NOSI): Availability Administrative Supplements Advance Safe Effective Therapeutics Pregnant Lactating Women Children Notice Number: NOT-HD-20-003 Key Dates Release Date: March 25, 2020 First Available Due Date: June 01, 2020 Expiration Date: June 02, 2020 Related Announcements PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Human Genome Research Institute NHGRI) National Institute General Medical Sciences NIGMS) National Institute Neurological Disorders Stroke NINDS) National Institute Minority Health Health Disparities NIMHD) Purpose Notice Special Interest NOSI) calls research can ultimately advance safe effective therapeutics pregnant lactating women, neonates, infants. purpose this NOSI to provide seed funds support current prospective investigators generate preliminary data, collect samples, develop robust models analytic tools future novel research the NICHD's Obstetric Pediatric Pharmacology Therapeutics Branch's program priorities https://www.nichd.nih.gov/about/org/der/branches/opptb). Background Physiological changes during pregnancy resulting altered maternal drug metabolism impacted efficacy safety therapeutics pregnant women. Pregnancy induced hormonal, immunologic, metabolic changes also influence alter drug disposition. Despite research efforts have focusing pharmacokinetics medications used pregnant women the past decade, knowledge gaps exist understanding pregnancy influences drug disposition the underlying mechanisms well roles placental drug transporters. Moreover, is dearth research understanding safety effectiveness therapeutics lactating women. Administrative supplements primarily provide support stimulate scientific community conducting research pregnant lactating women. knowledge gaps also exist the understanding pediatric ontogeny influencing pharmacokinetics, pharmacodynamics dosing, funds be also available research addressing gaps knowledge specifically neonates infants. Research Objectives NOSI informs current NIH awardees NICHD interested administrative supplement applications currently funded projects supported NICHD investigators are currently funded other participating NIH ICs interested expanding moving obstetric pediatric pharmacology therapeutics research. Interested applicants encouraged expand efforts their parent grants address research topics relevant NICHD’s strategic plan Theme Five advancing safe effective therapeutics pregnant lactating women children is outlined the link: https://www.nichd.nih.gov/sites/default/files/2019-09/NICHD_Strategic_Plan.pdf Example topics include, are limited to, following: Leveraging existing resources integrative data analyses e.g., biobanks, EHRs, etc.) assess safety, effects, clinical outcomes therapeutics pregnant lactating women discover/identify novel therapeutic potentials diseases conditions these populations; Biomarkers detect/predict adverse pregnancy outcomes preventing reducing maternal morbidity mortality; Pharmacogenomic, metabolomic, microbiome approaches precision therapeutics pregnant lactating women neonates; Innovative strategies accelerate ongoing studies e.g., incorporate new analytical technical approaches, add additional study sites augment patient enrollments, etc.); Studies ontogeny drug metabolizing enzymes, transporters, and/or receptors neonates infants; silico models assess potential targets toxicities novel therapeutic strategies pregnant lactating women; Collection banking biospecimens humans i.e., cord blood, placenta, breast milk) future therapeutics research. While a research area per se, inclusion underserved understudied populations research studies encouraged. populations include racial ethnic minority groups, underserved rural populations, people less privileged socioeconomic status, along groups subject discrimination have poorer health outcomes often attributed being socially disadvantage IC-Specific Information National Institute General Medical Sciences: NIGMS support studies focused drug disposition. Work proposed supplements must fall within scope the aims the NIGMS grant be supplemented. Investigators encouraged contact NIGMS Scientific Program Officer the grant be supplemented before preparing application, discuss relevance the proposed research the parent grant to Institute's research priorities. NIGMS grantees must hold active R01 Maximizing Investigators' Research Award MIRA) R35) award the time the award. National Human Genome Research Institute: NHGRI shares interest expresses support any the current NHGRI awardees qualifies submit administrative supplement requests under NOT-HD-20-003. National Institute Minority Health Health Disparities: NIMHD welcomes applications focus clinical translational research studies pregnant lactating women infants/children minority health disparity populations African Americans, Hispanics, American Indians, Alaska Natives, Asian Americans, Native Hawaiians other Pacific Islanders, socioeconomically disadvantaged populations, rural populations). Studies not limited early detection, prevention, treatment reduce maternal infant morbidity mortality, may include identification genetic ancestral markers, pharmacokinetic pharmacodynamic biomarkers drug efficacy, drug-drug interactions drug-diet interactions, microbial profiling validation studies. National Institute Neurological Disorders Stroke: NINDS interested research 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 advancing safe effective therapeutics neurological disorders pregnant lactating women, neonates, infants. Human subjects research either newly enrolled participants experiments using newly-acquired specimens the purposes this NOSI considered be of scope. Award Budget Supplement budget requests limited no than amount the current parent award cannot exceed 200,000 direct costs, exclusive Facilities Administrative costs sub-awards. Requests must reflect actual needs the proposed project. Requests for year support only. is anticipated 10-12 awards be made, subject availability funds NICHD. earliest anticipated start date August 1, 2020. Eligible Individuals Program Director/Principal Investigator) be eligible, individual(s) must hold active NIH grant the time the award. Awards No-Cost Extension NCE) not eligible. 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 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 and PA-18-591 must followed, the following additions: Application Due Date – June 1, 2020, 5:00 PM local time applicant organization. funding consideration, applicants must include ldquo;NOT-HD-20-003” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Requests be one year support only. Research Strategy section the application limited 6 pages. process Streamlined Submissions using eRA Commons cannot used this initiative. is strongly recommended the applicants contact both (1) their respective program officer(s) the Institute supporting parent award confirm ahead time the supplement falls within scope the parent award and (2) Dr. Aaron Pawlyk pawlykac@mail.nih.gov) confirm proposed request fits within scientific scope this Notice. Further, applicants strongly encouraged notify program contact the Institute supporting parent award See Table IC-Specific Information, Requirements Staff Contacts) that request been submitted response this FOA order facilitate efficient processing the request. Administrative Review Process NICHD conduct administrative reviews submitted applications will support most meritorious applications submitted consideration, pending availability funds. Criteria: the work proposed within scope the active award? the work proposed focused activities will ultimately lead advancing safe effective therapeutics pregnant lactating women, neonates, infants? the work likely stimulate additional activity leading progress towards safe effective therapeutics pregnant lactating women, neonates, infants? nbsp; Inquiries Please direct inquiries to: Aaron C. Pawlyk, Ph.D. Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) E-mail: pawlykac@mail.nih.gov

Notice of Special Interest for HEAL Initiative: Request for Administrative Supplements to Existing Grants for Identification and Validation of New Pain and Opioid Use Disorder Targets within the Understudied Druggable Genome

Notice of Special Interest
Tuesday, March 10, 2020
Tuesday, June 2, 2020
333
NOT-TR-20-008

Funding Opportunity Purpose

This Notice is part of the NIH Helping to End Addiction Long-Term (HEAL) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. NCATS and other participating institutes and Centers (ICs) are inviting investigators with relevant active research project grants and cooperative agreements to submit administrative supplements, according to PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional), for funded projects to identify and validate new pain and opioid use disorder (OUD) targets from within the understudied Druggable Genome.

Notice of Special Interest (NOSI): Administrative Supplements to Support Enhancement of Software Tools for Open Science

Notice of Special Interest
Tuesday, March 3, 2020
Saturday, May 16, 2020
333
NOT-OD-20-073

Funding Opportunity Purpose

Notice Special Interest NOSI): Administrative Supplements Support Enhancement Software Tools Open Science Notice Number: NOT-OD-20-073 Key Dates Release Date: March 3, 2020 First Available Due Date: 15, 2020 Expiration Date: 16, 2020 Related Announcements PA-18-591Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Administrative SupplementClinical Trial Optional) Issued Office The Director, National Institutes Health OD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Library Medicine NLM) Fogarty International Center FIC) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) National Cancer Institute NCI) Purpose Notice announces availability administrative supplements active grants focus biomedical software development have significant software development component. goal these supplements to invest research software tools recognized value a scientific community enhance impact leveraging best practices software development advances cloud computing. initiative part a plan implementing the NIH Strategic Plan Data Science, describes actions aimed modernizing biomedical research data ecosystem making data FAIR findable, accessible, interoperable, reusable) high impact open science. supplements intended support collaborations between biomedical scientists software engineers enhance design, implementation, cloud-readiness” research software. Through awards, NIH Office Data Science Strategy ODSS) intends help researchers have developed scientifically valuable software make tools sustainable, contribute open science, take advantage new data science computing paradigms. Background part their research projects, investigators often produce innovative, scientifically valuable software tools. tools enabled scientists efficiently process manage data, mine, analyze, visualize, interpret results. However, much this valuable software been built supported under conditions are longer optimal a rapidly changing landscape. Additionally, investigators lack resources adapt revise software take advantage new computing paradigms to robust, sustainable, accessible a broader community. opportunity intended help researchers redeploy research software tools be robust sustainable a shared data ecosystem envisioned the NIH ODSS. challenges considerable. example, tools developed customized data held on-premises, often optimized local computing platforms including supporting libraries) cannot readily scaled applied open science data, such those stored a cloud environment. Software tools most often developed academic settings absence input research software engineers can aid this transition operational efficiency sustainability. have few practical ways support joint efforts between researchers software engineers skills develop revise research tools robust design, accessibility scalability modern computing platforms. traditional grant funding process emphasized innovation research progress over use software engineering best-practices design principles, are essential reliability sustainability an era large-scale, integrated data. is NIH vision establish modernized integrated biomedical data ecosystem adopts latest data science technologies, including cloud computing, best practice guidelines arising community consensus, such the FAIR principles open-source development. effort described the NIH Data Science Strategic Plan led the newly established ODSS. addition major efforts IT infrastructure, data resources, workforce development, policy considerations, data science strategic plan includes goals enhance software workflows the modern data ecosystem. Research Objective goal this Notice Special Interest NOSI) to encourage researchers engage new types collaborations focus research software. Supplements support efforts address robustness, sustainability, reusability, scalability existing biomedical research software tools workflows recognized scientific value. efforts expected adhere software engineering best practices design principles take significant steps toward sustainability open source cloud-based environments. broad range projects have significant biomedical research software workflow development components eligible, regardless the scientific area emphasis. scope each proposed project defined and limited the aims the funded project which supplement being sought. Significant software engineering skills expected be needed develop robust implementations to adapt software changing computing paradigms. Thus, supplements primarily intended provide support software engineering staff storage computing costs are required test software revisions. Delivering reliable, sustainable, reusable software across multiple platforms a whole-lifecycle effort, illustrated the following examples. Software development be improved enhancements the development environment, including resources building, testing, community contribution. Engaging community improve robustness making code available appropriate open source licensing. Compliance open interfaces data formats be added enhance interoperability reusability. Refactoring be performed take advantage new hardware compute environments e.g., parallelizing process using standard workflow language can run cloud environments). Reusability be enhanced improving dissemination channels important algorithms tools e.g., inclusion package distribution channels), publication tools shared container registries, by refinement operating manuals. Projects propose test cloud-readiness a local, commercial, public cloud environment. Working the NIH STRIDES initiative https://datascience.nih.gov/strides) strongly encouraged. Cloud readiness a blanket term can encompass range activities. this announcement cloud readiness refers adapting cloud architecture extending usefulness software. Examples produce robust, sustainable cloud-ready research software include, are limited to: Adding APIs services reducing coupling complex shared state Decomposing decoupling services explicitly encoded data sources Employing standard security relies cloud Identity Access Management IAM) models Improving architecture reduce chattiness over network to minimize data ingress/egress charges cloud environments Adopting standard input output data formats Factoring configuration services environment variables configuration properties deployment Implementing standard logging models Converting tools provide clean input, output, configuration make more usable composition via workflow languages such CWL WDL Enhancing source code build/test tools support community open source development, developing standard build packaging tools manage dependencies produce containerized runtimes formatting packages sharing via common package management tools appropriate the language environment Enhancing standard unit functional testing support sample data sets testing patches upgrades supplement application must demonstrate use best software engineering practices design principles. Examples relevant projects address or of challenges toward becoming ready open science cloud environment include, are limited to: Provisioning standard source code structure, documentation, version management, build test support codebases promotes community open source enhancement. Refactoring software incorporate standard interfaces data formats, replacement built-in dependencies standard hardened libraries. Adding APIs services software, especially compliant community standards Refactoring software scale efficiently the cloud. Containerization software entry a tool registry. Enhancing usability, interoperability scalability under increasing load, including making of enhanced hardware clustering technology. Enhancing data security privacy protection. Projects involving significant new scientific features opposed software engineering NOT appropriate this NOSI. Possible exceptions include enhanced data security privacy functions. Projects no active software development components would to add are eligible this NOSI. Application Submission Information Budget be eligible, parent award must able receive funds FY2020 Oct. 1, 2019 - Sept. 30, 2020) not in final year in no-cost extension period the time the award. One-time supplement budget requests cannot exceed 150,000 direct costs. number awards be contingent availability funds receipt meritorious applications. is currently anticipated 6-10 awards be made. Eligible Activity Codes: Administrative supplement requests be submitted the following activity codes: R01, U01, R03, R00, R21, R33, R35, R37, R61 Centers multi-project grant mechanisms not eligible. Additional Information Applications this initiative must submitted using PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) its subsequent reissued equivalent. instructions the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: Application Due Date(s) – May 15, 2020 5:00 PM local time applicant organization. funding consideration, applicants must include NOT-OD-20-073" without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B will be considered for initiative. Requests be one year support only. Research Strategy section the application is limited 3 pages. Research Strategy should include justification significant user base cloud readiness’, timelines activities proposed, indication how supplement uses best software engineering practices design principles. Electronic submissions are required for funding opportunity. process Streamlined Submissions using eRA Commons cannot used this initiative. Administrative Evaluation Process Submitted applications must follow guidelines the IC funds parent grant. Administrative Supplements not receive peer review. IC conduct administrative reviews applications submitted their IC separately. most meritorious applications be evaluated a trans-NIH panel NIH staff supported based upon availability funds. criteria described below be considered the administrative evaluation process: the work proposed within scope the active award? the active award be supplemented focused software tool/workflow development, is a significant component the award? Does user base justify additional support? the proposed project technically feasible within supplement's funding period? the proposed timelines adequate realistic? the proposed supplement project focused software engineering robust, sustainable software is cloud ready” opposed enhancing scientific value)? Does project demonstrate sound software development practices, improve performance, interoperability, portability reliability, community engagement, sustainability, adoption? Information: is strongly recommended the applicants contact respective program officers the Institute supporting parent award advance to: Confirm the supplement falls within scope the parent award; Request requirements the IC submitting applications administrative supplements Investigators planning submit application response this NOSI also strongly encouraged contact discuss proposed research/aims the scientific contact listed this NOSI advance the application receipt date. Following submission, applicants strongly encouraged notify program contact the IC supporting parent award a request been submitted response this FOA order facilitate efficient processing the request.   Inquiries Please direct inquiries to: Jessica Mazerik, Ph.D.Office Data Science StrategyDivision Program Coordination, Planning, Strategic InitiativesOffice the DirectorJessica.mazerik@nih.gov  

Accelerating Medicine Partnership in Parkinsons disease (AMP PD) data use and analysis (U01 Clinical trials not allowed)

RFA
Thursday, January 16, 2020
Thursday, March 19, 2020
U01
RFA-NS-20-027

Funding Opportunity Purpose

The FOA invites applications that will apply computational approaches to the integration and analysis of clinical, genomic and transcriptomic data from the Accelerating Medicine Partnership in Parkinsons disease (AMP PD) to advance the identification of algorithms, biomarkers, and disease pathways related to the diagnosis, prognosis and progression of Parkinsons disease. Development of tools and workflows for data visualization and integration across data modalities and their application to AMP PD data are also supported.

HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Notice of Special Interest (NOSI) regarding the Availability of Urgent Competitive Revisions.

NOT
Wednesday, January 15, 2020
Saturday, March 14, 2020
NOT-AR-20-016

Funding Opportunity Purpose

HEAL Initiative: Back Pain Consortium BACPAC) Research Program Notice Special Interest NOSI) regarding Availability Urgent Competitive Revisions. Notice Number: NOT-AR-20-016 Key Dates Release Date: January 15, 2020 First Available Due Date: March 13, 2020 Expiration Date: March 14, 2020 Related Announcements PA-18-935NOT-AR-20-015 Issued National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) applications this funding opportunity announcement should fall within mission the Institutes/Centers. following NIH Offices co-fund applications assigned those Institutes/Centers. Office Behavioral Social Sciences Research OBSSR) Office Research Women's Health ORWH) Purpose Notice Special Interest NOSI) calls research pain management the context opioid or opioid disorder OUD). particular, NIAMS interested providing data-driven evidence regarding effective mechanisms reducing reliance opioids while maintaining quality life. Funds Competitive Revisions active grants available part the NIH HEAL Helping End Addiction Long-termSM) Initiative awardees operate within Back Pain Consortium BACPAC) Research Program, part the NIH HEAL InitiativeSM. Investigators active grants the area chronic pain and/or addiction encouraged apply. award two phases, one-year Planning Phase a to three year Research Project Phase. Background Back Pain the major form chronic pain among adults worldwide the most common, non-cancer reason opioid prescription the US. NIH HEAL InitiativeSM is trans-NIH initiative the aims improving treatments opioid misuse addiction; enhancing pain management, understanding biological underpinnings chronic pain accelerating discovery development non-addictive treatments pain. Back Pain Consortium BACPAC) Research Program, part the NIH HEAL InitiativeSM, provides platform research the intersection pain management opioid or opioid disorder OUD). BACPAC a patient-centric translational research initiative, is taking biopsychosocial approach the study chronic low back pain cLBP) the need more effective personalized treatments. Research Objectives order effectively reduce reliance opioids the treatment chronic low back pain while maintaining quality life, NIAMS encouraging submission applications Competitive Revisions active grants provide evidence-based data inform clinical practice guidelines. Research areas interest include: Project Planning Phase - are key questions providers patients with respect opioid for managing chronic pain? Questions interest might patient-centric and/or provider-focused, e.g., is appropriate prescribe opioids chronic pain; someone already taking opioids pain management are most effective means reducing dependence; alternatives exist? Research Project Phase - Investigators should propose strategies test most effective means managing pain while reducing dependence opioids the intent informing clinical practice. Award Information NIAMS intends commit 320,000 FY2020, Planning Phase, 800,000 year the Research Project Phase, FY2021 through FY2023, fund to awards. Budget research project length should reflect project needs, the parent grant must active throughout duration the Competitive Revision. Awardees expected share data resources consistent the guidelines policies the NIH, NIH HEAL InitiativeSM, as developed the Steering Committee the BACPAC Research Program. Adherence these guidelines policies be required the terms conditions award. Application Submission Information Applications response this NOSI must submitted using following target funding opportunity: PA-18-935 Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement - Clinical Trial Optional) Eligible activity codes applications to PA-18-935 are dependent upon target Institute, Center, Office ICO). Table 1 lists activity codes will accepted each participating ICO. Table 1: Eligible Activity Codes Participating ICO Activity Code NIAMS NIBIB NINR NIMHD NICHD NIAAA NCATS NCCIH NIDA NINDS DP1 NIH Director’s Pioneer Award Yes Yes No No Yes Yes Yes P01 Research Program Projects No No No Yes Yes P41 Research Program Projects Centers Yes No No No No P50 Specialized Center Yes No No Yes Yes Yes R01 Research Project Grant Yes Yes Yes Yes Yes Yes Yes Yes Yes R35 Outstanding Investigator Award No No No No Yes R61 Phase 1 Exploratory/Developmental Grant Yes No No No Yes Yes Yes U01 Research Project – Cooperative Agreements Yes Yes Yes No Yes Yes Yes Yes Yes U18 Research Demonstration- Cooperative Agreements Yes Yes No No No Yes Yes U19 Research Program Cooperative Agreement Yes No Yes No Yes Yes U24 Resource-Related Research Projects – Cooperative Agreements Yes Yes No Yes Yes Yes Yes U54 Specialized Center- Cooperative Agreements Yes Yes Yes No Yes Yes Yes U2C Resource-Related Research Multi-Component Projects Centers Cooperative Agreements No No No No Yes UF1 Multi-Year Funded Research Project Cooperative Agreement No No No No Yes UG1 Clinical Research Cooperative Agreements-Single Project Yes No No No Yes Yes UH3 Exploratory/Developmental Phased Award Cooperative Agreement Yes Yes No No Yes Yes Yes Yes UM1 Multi-Component Research Project Cooperative Agreements No No No No Yes All instructions the SF424 R&R) Application Guide and PA-18-935 must followed, the following additions: Research Strategy section the application limited 12 pages. award project period the Competitive Revision must three four years, one year the Planning Phase two three years the Research Project Phase. deadline applications is March 13, 2020 5:00 PM local time of applicant organization. NOSI expires March 14, 2020. application submitted response this NOSI is received March 14, 2020 later, be withdrawn. Applications should must submitted PA-18-935, ldquo;Urgent Competitive Revision Existing NIH Grants Cooperative Agreements Urgent Supplement – Clinical Trial Optional)" using application forms package the Competition ID ldquo;NOT-AR-20-016-FORMS-E” IMPORTANT: funding consideration, applicants must designate NOT-AR-20-016 in Agency Routing Identifier field Box 4b) the SF424 R&R) Form. Applications without information Box 4b not considered this initiative. Applications non-responsive the terms this Notice be be considered this initiative. Review criteria, addition those described PA-18-935, include following: Does PI(s)/PD(s) expertise pain management and/or addiction appropriate the study low back pain opioid use? Does application propose engage patients, providers, relevant stakeholders identifying key questions regarding pain management opioid use, curtailment, alternatives opioids? successful, does application the potential inform clinical decision making? the PI(s)/PD(s) considered their work might interface or avail the BACPAC research program? Investigators planning submit application response the NOSI strongly encouraged contact appropriate Institute Center contact listed the NOSI discuss proposed project the context the parent award. Questions specific this NOSI should sent to bacpac-nih@mail.nih.gov. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. nbsp; Inquiries Please direct inquiries to: Scientific/Research Contact(s) Leslie K. Derr, Ph.D National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Telephone: 301-402-4735 Email: derrl@mail.nih.gov Laura Kwako, PhDNational Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-451-8507 Email: laura.kwako@nih.gov Michael B. Wolfson, PhD National Institute Biomedical Imaging Bioengineering NIBIB) Telephone: 301-451-4778 Email: Michael.Wolfson@nih.gov Susan Marden PhD RN Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) Telephone: 301-435-6838 Email: mardens@mail.nih.gov Shelley Su, PhD National Institute Drug Abuse NIDA) Telephone: 301-402-3869 Email: shelley.su@nih.gov Benyam Hailu, MD, MPH National Institute Minority Health Health Disparities NIMHD) Telephone: 301-594-8696 Email: Benyam.Hailu@nih.gov Michael L. Oshinsky, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: michael.oshinsky@nih.gov D.P. Mohapatra, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9964 Email: dp.mohapatra@nih.gov Lois A. Tully, PhD National Institute Nursing Research NINR) Telephone: 301-594-5968 Email: tullyla@mail.nih.gov Lanay M. Mudd, PhD National Center Complementary Integrative Health NCCIH) Telephone: 301-594-9346 Email: Lanay.mudd@nih.gov Jane Atkinson, DDS National Center Advancing Translational Sciences NCATS) Telephone: 301-827-6031 Email: jatkinso@mail.nih.gov Lisa Begg, Dr.P.H., R.N.Office Research Women’s Health ORWH) Telephone: 301/496-3975 E-mail: beggl@od.nih.gov

Notice of Special Interest: Administrative Supplement for Research on Bioethical Issues (Admin Supp Clinical Trial Optional)

NOT
Monday, December 30, 2019
Friday, March 20, 2020
333
NOT-OD-20-038

Funding Opportunity Purpose

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 Women’s 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 NIH’s 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 NIH’s 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.html. Office Research Women’s Health Office Research Women’s 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 Women’s Health Research https://orwh.od.nih.gov/about/trans-nih-strategic-plan-womens-health-research). 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 women’s 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 award’s 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 Women’s 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. 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Novel Imaging Approaches for detection of Persistent HIV and Neuroimmune dysfunction associated with HIV In the Central Nervous System (CNS) (R01 Clinical Trial Optional)

RFA
Monday, December 16, 2019
Thursday, March 12, 2020
R01
RFA-MH-20-330

Funding Opportunity Purpose

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.

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