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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.

This FOA encourages applications for the Lasker Clinical Research Scholars Program for the purpose of supporting the research activities during the early stage careers of independent clinical researchers. The program offers the opportunity for a unique bridge between the NIH intramural and extramural research communities and contains two phases. In the first phase, Lasker scholars will receive appointments for up to 5-7 years as tenure-track investigators within the NIH Intramural Research Program with independent research budgets. In the second phase, successful scholars will receive up to 3 years of NIH support for their research at an extramural research facility; or, the scholar can be considered to remain as an investigator within the intramural program.

This Funding Opportunity Announcement (FOA) encourages investigator(s)-initiated applications that propose to examine the etiology, diagnosis, pathophysiology and manifestations of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in diverse groups and across the lifespan. Applications that address gaps in the understanding of the environmental and biological risk factors, the determinants of heterogeneity among individuals with ME/CFS, and the common mechanisms influencing the multiple affected body systems in ME/CFS are encouraged. The NIH is particularly interested in funding interdisciplinary research that will enhance our knowledge of disease processes and provide evidence-based solutions to improve the diagnosis, treatment, and quality of life of all persons with ME/CFS. This interdisciplinary research may include the building of scientific teams to study and develop biomarkers and/or characterize the pathophysiological response of organ systems in individuals with ME/CFS. Applicants are encouraged to propose novel and innovative research that will break new ground or extend previous discoveries toward new directions.

This Funding Opportunity Announcement (FOA) encourages investigator(s)-initiated applications that propose to examine the etiology, diagnosis, pathophysiology and manifestations of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in diverse groups and across the lifespan. Applications that address gaps in the understanding of the environmental and biological risk factors, the determinants of heterogeneity among individuals with ME/CFS, and the common mechanisms influencing the multiple affected body systems in ME/CFS are encouraged. The NIH is particularly interested in funding interdisciplinary research that will enhance our knowledge of disease processes and provide evidence-based solutions to improve the diagnosis, treatment, and quality of life of all persons with ME/CFS. This interdisciplinary research may include the building of scientific teams to study and develop biomarkers and/or characterize the pathophysiological response of organ systems in individuals with ME/CFS. The R21 Grant mechanism is intended to support innovative, high impact research projects. Such projects would either 1) generate pilot data to assess the feasibility of a novel avenue of investigation; 2) involve high risk experiments that could lead to a breakthrough in ME/CFS; 3) demonstrate the feasibility of new technologies that could have a major impact on ME/CFS research. Proposals submitted under this mechanism should be limited to those with the potential for truly ground-breaking impact.

Notice Special Interest Encourage Eligible NIH HEAL Initiative Awardees Apply Administrative Supplements Promote Training Clinical Research Pain Admin Supp – Clinical Trial Allowed) Notice Number: NOT-NS-20-044 Key Dates Release Date: April 10, 2020 First Available Due Date: 15, 2020 xpiration Date: July 31, 2020 Related Announcements PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued National Institute Neurological Disorders Stroke NINDS) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Center Complementary Integrative Health NCCIH) Office Strategic Coordination Common Fund) National Cancer Institute NCI) Purpose NIH Helping End Addiction Long TermSM (HEAL) Initiative aims improve our understanding, management treatment pain funding high quality scientific research this relatively understudied area medicine. the HEAL Initiative NIH meet long-term goals providing effective non-opioid options the treatment pain conditions innovative approaches treating opioid disorders, will necessary train new generation clinical pain researchers. Leveraging HEAL Initiative clinical research programs train novice researchers investigators new pain research the mechanics, techniques, best practices clinical pain research maximize impact HEAL funding both current future research endeavors. Increasing number individuals trained high quality clinical pain research a critical step toward ensuring highest impact HEAL, studies encompass broad range pain conditions have potential include, address needs of, positively impact diverse traditionally underserved patient populations. supplement existing HEAL clinical research awards intended allow exceptional graduate, post-doctoral e.g., MD, DO, DDS, PhD), early career individuals hereafter ldquo;candidates”) expand clinical pain research experience gain access the tools skills needed prepare for career clinical pain research. 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) – 15, 2020 July 1, 2020 5:00 PM local time applicant organization. funding consideration, applicants must include ldquo;NOT-NS-20-044” 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 two years support only. Only existing awardees active HEAL Initiative Clinical Research Pain Management awards including EPPIC-Net, BACPAC, ERN, PRISM, HOPE programs) the HEAL associated Common Fund A2CPS program eligible apply. Applications supplement parent grants sites performing clinical studies be prioritized. project budget periods this supplement must within currently approved project period the parent award parent award must active not a cost extension the entire extent a supplement). A?dministrative 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. Research Strategy section the application limited 5 pages two additional sections/attachments, PD/PI statement a candidate statement required descriptions below). Research Strategy Research Experience Plan; 5 pages) Describe plan the candidate’s research under supplement is within scope the funded parent HEAL Initiative research project. Identify research-related experiences be new the candidate how experiences contribute the candidate’s development a clinical pain researcher enhance ability contribute a meaningful to both current future clinical pain research projects. Describe goals will achieved during supplement award period. Examples goals include gaining experience new methodologies, assessment pain management pain management techniques the research setting, recruiting study participants, acquiring and/or analyzing data, preparing manuscripts publication, applying independent research funding. the first sentence the Research Strategy, applicants requested state the parent grant awarded a HEAL Initiative award to identify specific FOA the parent grant e.g., RFA-NS-19-016) facilitate processing the supplement application. additional sections/attachments required should attached PDF documents the ldquo;Other Attachments” field. PD/PI Statement 1 page) Describe qualifications track record the PD/PI the parent grant supporting co-investigators, applicable) mentoring graduate post-doctoral trainees clinical pain research. addition, describe specific plans mentorship this candidate during proposed research experience. Candidate Statement 3 pages) candidate should describe prior research experience, clinical experience the assessment, management, treatment pain, their accomplishments. candidate should also describe short- long-term research-related goals the ways which additional research experiences outlined this supplemental application help to achieve goals. Award Budget HEAL Initiative provide support up 50,000K per year a maximum 2 years up eight awards FY2020 FY2021. Awards be used provide salary support the candidate and/or funding relevant travel coursework. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. Applications non-responsive terms this NOSI be be considered the NOSI initiative nbsp; Inquiries Please direct inquiries to: Rebecca Hommer, MDNational Institute Neurological Disorders amp; StrokeTelephone: 301-827-2257 Email: rebecca.hommer@nih.gov

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

The purpose of this Funding Opportunity Announcement (FOA) is to promote research to understand the underlying mechanisms of sleep deficiencies among health disparity populations and how sleep deficiencies may lead to disparities in health outcomes.

set to be a reissue of: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-18-029.html

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_P… 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 Special Interest NOSI): Research Improve Interpretation Patient-Reported Outcomes the Individual Patient Level Use Clinical Practice Notice Number: NOT-OD-20-079 Key Dates Release Date: March 24, 2020 First Available Due Date: June 05, 2020 Expiration Date: January 08, 2022 Related Announcements None Issued Office Behavioral Social Sciences Research OBSSR) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Deafness Other Communication Disorders NIDCD) National Institute Mental Health NIMH) 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 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 patient-reported outcome PRO) defined any report a persons health status including symptoms, function well-being, is gathered directly a patient, without interpretation that report a clinician, observer, anyone else. PROs critical the support patient-centered care, they provide information the patients perspective, offer important information improve patient-clinician communication, decision-making, care delivery. PROs increasingly being used clinical stakeholders e.g., providers, care delivery systems, payers regulators) characterize individual patients symptoms functional status the change outcomes over time. Thus, PROs becoming important piece information clinical decision-making, including shared decision-making. purpose this Notice Special Interest NOSI) to stimulate research contributes the evidence base precise accurate PRO score interpretation the individual patient level use clinical practice. Background National Institutes Health NIH) made considerable investments the development testing PROs provide research community robust tools monitor evaluate patient health. validity, reliability, utility PRO measures been studied extensively a variety clinical conditions among diverse populations use interpretation group level differences. Given efficiency greater accessibility PROs via electronic health record EHR) systems, clinicians increasingly interested using well-validated PROs inform individual treatment care decisions their patients. are existing PRO systems widely use clinical settings. few examples include are certainly limited to: HealthMeasures is comprised the Patient Reported Outcomes Measurement Information System(R) PROMIS(R)), NIH Toolbox Assessment Neurological Behavioral Function NIH Toolbox); Neurology Quality Life Measurement System Neuro-QoL), The Adult Sickle Cell Quality Life Measurement Information System ASCQ-Me); EQ-5D EQ-5D-Y; SF-36; QuoLO. Research support use these measures interpreting individual level differences within between individuals various clinical contexts, sparse. some assessment tools, interpretive thresholds, reference values, minimally important differences informing clinical care been developed. However, thresholds empirically derived group-level data. Thus, value interpreting scores making clinical decisions predictions individual patients unclear. Furthermore, measurement error, along intra-individual variability, confound interpretation scores the individual patient level. Sensitivity specificity critical PRO measures employed clinical decision-making. Given both underdiagnosis overdiagnosis result adverse outcomes, research needed better understand appropriate clinical interpretation PRO scores individual patients a variety disease healthcare contexts. Thus, is vital the of PROs guide clinical decision-makingat individual levelbe supported a robust evidence base. NIH NOSI encourages grant applications research develops evidence needed support interpretation existing, well-validated PROs use clinical care settings. focus this NOSI on self-report PRO) measures that: a) already developed andvalidated use clinical researchand strong, demonstrated psychometric properties, b) currently being used, could utility, clinical practice. Specifically, Notice calls methodological studies provide meaningful interpretation PRO scores collected acted upon the individual patient level use clinical decision-making. NOSI isnotintended encourage development, testing, validation new PRO measures to study methods electronic PRO data capture the presentation PRO summaries clinicians patients. Research questions responsive this NOSI include are limited to: Improving Understanding Interpretation PRO Scores Individual Patients score level, combination score levels, signal need clinical action individual patients? score differences over time indicate worsening vs. improvement, onset resolution health problems an individual patient? what clinical contexts ecological momentary assessment EMA) methods interpretable surveillance, diagnosis, determination individual treatment benefit? should PROs interpreted differently individuals specific clinical conditions, those multiple conditions, other high-risk contextual factors? these interpretations dependent different disease phases treatment trajectories? should PRO scores interpreted individuals within specific healthcare settings e.g., acute, outpatient, primary, specialty, community, rehabilitation settings) where PRO scores be used inform actions e.g., hospital discharge, additional assessments, referral services)? group-level information such current reference values) used accurately inform individual-level care? any modifications transformations needed apply information validly individual e.g., covariate adjustment, precise score range reference values define worsening improvement)? might clinically relevant information e.g., comorbidity, age, sex, social support, self-management, social determinants health, minority population status) affect interpretation individual PROs clinical practice, how should clinically relevant information incorporated the interpretation PROs clinical practice? is relationship between PROs other clinical indicators such laboratory tests, biomarkers, imaging? should PRO data integrated these clinical indicators improve sensitivity specificity PROs individual decision-making diverse patient populations clinical settings? using PRO measures routine surveillance, are relationships between frequency assessment, intra-individual variability, measure precision individual-level reliability? Understanding Bias, Variance, Error can ceiling floor effects sub-populations accounted when applying scores specific individuals? are sources bias error are introduced amplified interpreting individual scores based co-calibrations crosswalks PROs measuring same construct e.g., cutoffs scores one PRO used the cutoffs a co-calibrated cross-walked PRO)? are effects measurement invariance interpreting scores individual patients, how these effects accounted for? levels validity, reliability, responsiveness needed interpretation the individual level? Does recall period influence such interpretations? is relationship between scaling, precision, accuracy a measure its suitability a specific purpose e.g. screening versus responder definition) specific clinical settings serving diverse patient populations? Example Study Questions might include, are limited to: can individual PRO scores e.g., pain, fatigue, physical function) used screen for, diagnose conditions, diseases treatment-related symptoms functional impairments, order identify need specific care? PRO score threshold slope change over time indicates need immediate triage clinical intervention? example, threshold slope increased symptom severity e.g., pain severity, nausea/vomiting, diarrhea) an individual patient diagnosed a particular medical condition disease indicate need phone in-person follow-up)? are sensitivity specificity such PRO indicators? the sensitivity specificity vary based the treatment regimen individual patients, particularly patients high risk populations? what contexts PRO measures sensitive specific are performance-based measures capturing worsening/improvement physical functioning over time? Recovery: PRO score improvement physical functioning pain over time indicates achievement clinical benefit the individual patient level after major surgery medical treatment? Worsening: score reduction physical functioning the first 2 weeks after surgery represents decline an individual patient requires clinical intervention? these thresholds clinical deterioration moderated baseline age functional status? do individual PRO scores predict short-term 3-6 month) longer-term 1-2 year) worsening improvement chronic disease management indicators risk factors, functional outcomes e.g., work, school, family, leisure)? magnitude slope change individual PRO scores predicts improvement chronic disease management? does clinically relevant information e.g., age, preoperative functional status, comorbid conditions such depression, of multiple medications, social determinants health) affect interpretation PROs determine appropriate treatment options any given diagnosis? should information incorporated the interpretation PROs making clinical decisions individual patients? can individuals PRO score/s e.g., diabetes distress, depression, fear hypoglycemia) guide treatment decisions such referral behavioral health, medication intensification, regimen simplification, engagement chronic disease management education support? do ldquo;action prompting scores vary based other individual characteristics, type chronic condition, and/or comorbidities? PRO-based values e.g., continuous score, categorical value such above below age-matched cut point, slope change over time) best predict functional outcomes the individual patient level 1 year following particularly intensive invasive disease treatments e.g., cancer-directed therapies such stem cell transplantation, combined modality treatment)? might PRO data integrated clinical indicators inform individual prevention treatment recommendations. an example, individual A1C data used along PRO data help tailor improve diabetes prevention treatment recommendations shared decision-making processes? Does vary individual characteristics, high risk social determinants variables, type diabetes, and/or comorbidities? should PROs interpreted individuals more one chronic medical condition? Should PRO scores thresholds interpreted same for different populations? example, threshold scores developed age overall health status inform care specific populations e.g., older adults, children complex medical needs, pregnant women, women severe maternal morbidity at high risk maternal mortality) stages care e.g., prevention post-surgical complications, post-partum care)? Application Submission Information IC Specific Application Submission Information: submissions should indicate they in response NOT-OD-20-079 Field 4.b the SF 424 form. Prior submission, investigators strongly encouraged contact IC scientific contacts listed this Notice advice alignment program priorities polices. following funding opportunity announcements FOAs) their reissued equivalents must used submissions this initiative.Although NCI NINDS not listed a Participating Organization all FOAs listed below, applications this initiative be accepted provided the NOSI listed Field 4.b the SF 424. Applications nonresponsive terms this NOSI be withdrawn consideration this initiative. Activity Code FOA R01 PA-19-056- NIH Research Project Grant Parent R01 Clinical Trial Allowed) R21 PA-19-053- NIH Exploratory/Developmental Research Grant Program Parent R21 Clinical Trial Allowed) Although NCI NINDS not listed a Participating Organization all FOAs listed above, applications this initiative be accepted. Applications nonresponsive terms this NOSI be withdrawn consideration this initiative. nbsp; Inquiries Please direct inquiries to: Scientific/Research Contact(s) Ashley Wilder-Smith, Ph.D., MPH National Cancer Institute NCI) Telephone: 240-276-6714 Email:smithas@mail.nih.gov Dave Kaufman, Ph.D. National Human Genome Research Institute NHGRI) Telephone: 301-594-6907 Email:dave.kaufman@nih.gov Molly Wagster, Ph.D.National Institute Aging NIA) Telephone: 301-496-9350 Email:wagsterm@nia.nih.gov Jonathan King, Ph.D.National Institute Aging NIA)Telephone: 301-402-4156Email:kingjo@mail.nih.gov Mariela C. Shirley, Ph.D.National Institute Alcohol Abuse Alcoholism NIAAA) Telephone: 301-402-9389 Email:shirleym@mail.nih.gov Stephanie M. George, PhD, MPH, MANational Institute Arthritis Musculoskeletal Skin Diseases NIAMS)Telephone: 301-594-4974Email:stephanie.george@nih.gov Lana Shekim, Ph.D.National Institute Deafness Other Communication Disorders NIDCD) Telephone: 301-496-5061Email:shekiml@nidcd.nih.gov Claudia Moy, Ph.D. National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-9135 Email:cm384s@nih.gov Jenni Pacheco, Ph.D. National Institute Mental Health NIMH) Telephone: 301-443-3645 Email:jenni.pacheco@nih.gov Martha Matocha, Ph.D. National Institute Nursing Research NINR) Telephone: 301-594-2775 Email:matocham@mail.nih.gov Larissa Avils-Santa, M.D., M.P.H. National Institute Minority Health Health Disparities NIMHD)Telephone: 301-827-6924 Email:avilessantal@nih.gov Lanay M. Mudd, Ph.D. National Center Complementary Integrative Health NCCIH) Telephone: 301-594-9346 Email:lanay.mudd@nih.gov Elizabeth Ginexi, Ph.D. NIH Office Behavioral Social Sciences Research OBSSR) Telephone: 301-594-4574 Email:LGinexi@mail.nih.gov Margaret Bevans, PhD, RN, FAANNIH Office Research Womens Health ORWH) Telephone: 301-496-3934 Email:Margaret.Bevans@nih.gov Kay L. Wanke, PhD, MPHNIH Office Disease Prevention ODP)Telephone: 301-451-1856Email: kay.wanke@nih.gov