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Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (R01 Clinical Trials Not Allowed)

PAR
Monday, April 13, 2020
Monday, March 6, 2023
R01
PAR-20-165
Vicky Whittemore

Funding Opportunity Purpose

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.

Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) (R21 Clinical Trials Not Allowed)

PAR
Monday, April 13, 2020
Monday, May 8, 2023
R21
PAR-20-168
Vicky Whittemore

Funding Opportunity Purpose

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 of Special Interest (NOSI): Research to Improve the Interpretation of Patient-Reported Outcomes at the Individual Patient Level for Use in Clinical Practice

Notice of Special Interest
Tuesday, March 24, 2020
Saturday, January 8, 2022
NOT-OD-20-079

Funding Opportunity Purpose

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

Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)

PAR
Tuesday, March 3, 2020
Monday, May 8, 2023
U44
PAR-20-111
Charles Cywin

Funding Opportunity Purpose

Reissue of PAR-18-541. The Blueprint Neurotherapeutics Network (BPN) encourages applications from small businesses seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to IND enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development of Disorders of the Nervous System (UG3/UH3 Clinical Trial Optional)

PAR
Tuesday, March 3, 2020
Monday, May 8, 2023
UG3/UH3
PAR-20-122
Charles Cywin

Funding Opportunity Purpose

Reissue of PAR-18-546. The Blueprint Neurotherapeutics Network (BPN) invites applications from neuroscience investigators seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry to the Development stage, to advance a single development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Alternatively, projects can enter at the Development stage and progress in a shorter period to IND enabling toxicology studies and phase I clinical testing. BPN awardee Institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

Notice of Special Interest (NOSI): Availability of Administrative Supplements for the Rare Disease Clinical Research Network (RDCRN)

Notice of Special Interest
Friday, February 28, 2020
Monday, April 4, 2022
333
NOT-TR-20-006

Funding Opportunity Purpose

Notice Special Interest NOSI): Availability Administrative Supplements the Rare Disease Clinical Research Network RDCRN) Notice Number: NOT-TR-20-006 Key Dates Release Date: February 27, 2020 First Available Due Date: April 01, 2020 Expiration Date: April 04, 2022 Related Announcements RFA-TR-18-020 Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network RDCRN) U54 Clinical Trial Optional) PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) Issued National Center Advancing Translational Sciences ( NCATS) National Heart, Lung, Blood Institute NHLBI) 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 Neurological Disorders Stroke NINDS) Purpose National Center Advancing Translational Sciences NCATS) informs Program Directors/Principal Investigators PDs/PIs) holding active Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network RDCRN) U54) awards the opportunity submit administrative supplement requests through NIH Parent Funding Opportunity Announcement FOA), PA-18-591, ldquo;Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional)”. supplements provide short-term and/or catalytic support projects a significant unmet needs. Applicants the administrative supplements encouraged form new collaborations enhance reach impact the activity. Administrative supplements must add value the science proposed the aims the original project; such, they must within scientific scope the parent grant. Enthusiasm be higher requests describe clear outcome that the potential greatest impact across RDCRN these outcomes be subsequently distributed shared throughout consortium. RDCRN Program also identified specific areas interest accordance its aim to advance diagnosis, management, treatment rare diseases a focus clinical trial readiness. The RDCRN priority research areas would appropriate requests supplemental funding include, are limited to, topics listed here: Methods accelerate diagnosis Genomic analysis/characterization, interpretation e.g., Gene Curation leveraging ClinGen resources) Novel precision personalized approaches treatment Outreach increase research participant diversity Addressing health disparities Expanding focus women’s health Expanding focus mental health issues Expanding age range research participants Evolving technologies e.g., remote data capture, augmented reality) facilitate assessment, management treatment rare diseases. Trans-network research common interests e.g., shared molecular etiologies, research data collections approaches) Administrative supplement requests support clinical trials not accepted and/or considered response this funding opportunity announcement. Applications should demonstrate the supplement be completed within project period. applicable, proposed research effort should supported a strong rationale should contribute advancing translational sciences. Applicants strongly encouraged discuss potential requests their Program Official listed the Notice Grant Award the parent grant. Award Project Period Administrative supplements limited 12 months. Budget Available Funds Supplement budget requests not exceed 150,000 per year direct costs must reflect actual needs the proposed project. is guarantee funds available NCATS for any specific grant. Application Submission Information Eligible Individuals Program Director/Principal Investigator) Applicants must hold active RDCRN award: only parent RDCRN cooperative agreement awards funded through following FOA any reissues this announcement) eligible request supplemental funding under NOSI: RFA-TR-18-020: Rare Diseases Clinical Research Consortia RDCRC) the Rare Diseases Clinical Research Network RDCRN) U54 Clinical Trial Optional) supplements parent awards include multiple PDs/PIs, supplement be requested any all the PDs/PIs accordance the existing leadership plan) must submitted the awardee institution the parent award. Submitting Application 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: funding consideration, applicants must include ldquo;NOT-TR-20-006” without quotation marks) the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. facilitate efficient processing the request, applicants strongly encouraged notify Tiina Urv urvtiin@mail.nih.gov), well the assigned IC program officer IC grants management specialist the parent award a request been submitted response this NOSI. Research Strategy section the application limited to 6 pages. Applicant organizations submit only application per fiscal year this NOSI. process Streamlined Submissions using eRA Commons cannot used this initiative. applications must submitted electronically using single-project application form package. Please note, for single multi-project applications applicants must the form package the Competition ID ldquo;FORMS-E-ADMINSUPP-RESEARCH". one the methods described PA-18-591. Paper submissions applications submitted attachments be returned. Application Due Date – April 1, 2020; April 1, 2021; April 1, 2022, 5:00 PM local time applicant organization. Inquiries Please direct inquiries to: Tiina K. Urv, Ph.D. National Center Advancing Translational Sciences NCATS) Telephone: 301-827-2746 Email: urvtiin@mail.nih.gov

Non-Viral Technologies for in vivo Delivery of Genome Editors (R41/R42 Clinical Trial Not Allowed)

PAR
Thursday, February 6, 2020
Thursday, January 6, 2022
R41/R42
PAR-20-109
Emily Caporello

Funding Opportunity Purpose

The purpose of this PAR is to support the development and evaluation of non-viral technologies to deliver genome editors to disease relevant somatic cells and tissues in vivo. The ultimate goal of these technologies is translation into clinical trials of genome editing to treat human disease.

Non-Viral Technologies for in vivo Delivery of Genome Editors (R43/R44 Clinical Trial Not Allowed)

PAR
Thursday, February 6, 2020
Thursday, January 6, 2022
R43/R44
PAR-20-098
Emily Caporello

Funding Opportunity Purpose

The purpose of this PAR is to support the development and evaluation of non-viral technologies to deliver genome editors to disease relevant somatic cells and tissues in vivo. The ultimate goal of these technologies is translation into clinical trials of genome editing to treat human disease.

Genomic Expert Curation Panels (U24 Clinical Trial Not Allowed)

PAR
Thursday, January 23, 2020
Friday, May 27, 2022
U24
PAR-20-101
Vicky Whittemore

Funding Opportunity Purpose

The purpose of this FOA is to establish expert panels that will select genes and genomic variants associated with diseases or conditions of high priority to participating NIH Institutes and Centers (ICs) and systematically determine their clinical significance for diagnosis and treatment of these diseases or conditions. The Genomic Expert Curation Panels funded through this FOA are r?e?q?u?i?r?e?d to utilize the NHGRI Clinical Genomics Resource (ClinGen) and the NCBI ClinVar procedures, interfaces, tools and informatics infrastructure to determine the strength of evidence supporting the clinical significance of the selected genes and variants that will support development of clinical practice guidelines.

Notice of Special Interest (NOSI): Administrative Supplement for Continuity of Biomedical and Behavioral Research Among First-Time Recipients of NIH Research Project Grant Awards

Notice of Special Interest
Friday, January 17, 2020
Monday, March 6, 2023
333
NOT-OD-20-055

Funding Opportunity Purpose

Notice Special Interest NOSI): Administrative Supplement Continuity Biomedical Behavioral Research Among First-Time Recipients NIH Research Project Grant Awards Notice Number: NOT-OD-20-055 Key Dates Release Date: January 17, 2020 First Available Due Date: March 05, 2020 Expiration Date: March 06, 2023 Related Announcements PA-18-591 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 Insrtitute Arthritis Musculoskeletal Skin Diseases NIAMS)National Institute Biomedical Imaging Bioengineering NIBIB)National Institute Deafness Other Cormmunication 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)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. Office Behavioral Social Sciences Research OBSSR) Purpose overarching goal this pilot program to enhance retention investigators facing critical life events are transitioning the first renewal their first independent research project grant award to second new NIH research project grant award. Retention the first renewal continuous NIH research project grant support crucial sustaining both ongoing research NIH made investment and retaining diversity the biomedical research workforce. program supports at-risk investigators identified the NIH Next Generation Researchers Initiative seehttps://grants.nih.gov/ngri.htm). retention program seeks maintain productivity current first-time recipients eligible independent NIH research project grant awards are dealing a critical life event(s), such they remain competitive the first renewal their award for second research project grant award. retention supplements support transition K award independence, the companion NOSI. Background Investigators, especially women, leave science critical transition stages branching points their career for NIH-supported scientific workforce include transitions post-doctoral training faculty positions Heggeness et al., 2016,Acad Med,doi:10.1097/ACM.0000000000001209and Nikaj et al., 2019, FASEB Journal,doi:10.1096/fj.201800639) prior obtaining first R01 renewal Hechtman et al., 2018, PNAS,doi:10.1073/pnas.1800615115). rate R01/R01-equiv renewals potential impact the longevity an investigators research career Pohlhaus et al., 2011,Acad Med,doi:10.1097/ACM.0b013e31821836ff) remains gender disparity NIH funding should addressed. vulnerable career stages often parallel critical life events commonly contribute faculty attrition. Data NSF demonstrates among racial ethnic groups both biomedical scientists engineers, women far likely men cite family responsibilities a reason leaving work force https://www.nsf.gov/statistics/2017/nsf17310/, especially chart 6B). Pregnancy childbirth particular, appear be significant contributors the underemployment women scientists engineers given pregnancy impact research productivity Cech Blair-Loy 2018, Changing career trajectories new parents STEM;https://www.nsf.gov/statistics/2017/nsf17310/, especially chart 6B). demands childbirth subsequent primary caregiving responsibilities necessitate changes career goals alter researchers career trajectories, depriving scientific workforce an important source talent undermining NIHs investment promising avenues new research. Retaining investigators this critical transition point protect research investment already via parent NIH award enhance diversity the investigator pool. Budget be eligible, parent award must able receive funds the time the award. administrative supplement budget request limited 1 year. Supplement budget requests cannot exceed 50,000/year direct costs, applicable F&A indirect) cost also requested. Budgets not exceed total direct costs the current parent award. Requests must reflect actual needs the proposed project. Categorical budgets permitted. Awards subject availability funds. Flexible of supplemental funds highly encouraged, may include all inclusive)computational services, supplies, equipment, supported effort additional scientific staff sustain PD/PIs research during critical life event. Eligible Individuals Program Director/Principal Investigator) PD/PIs the following activity codes eligible the program:DP1,DP2,DP5,R01,R00,R15,R21,R35,RF1, andU01and have qualifying critical life event. PD/PIs more one independent research project grant award ineligible this supplement. Qualifying Critical Life Events: PD/PI must demonstrate critical life event such childbirth adoption during parent grant project period; primary caregiving responsibilities an ailing spouse, partner, a member the immediate family. circumstances which critical life event pending is expected occur during project period, supplement period be submitted advance the event. supplements parent awards include multiple PDs/PIs, supplement be requested any the PDs/PIs accordance the existing leadership plan on behalf the PD/PI meets eligibility criteria) submitted the grantee institution the parent award. should noted for parent grant for administrative supplement, grantee the institution, the PD/PI. Application Submission Information Supplement requests must submitted accordance the parent program announcement: Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional)PA-18-591or subsequent reissued equivalent. Supplement requests must submitted electronically. process Streamlined Submissions using eRA Commons cannot used this initiative. . instructions theSF424 R&R) Application GuideandPA-18-591must followed, the following additions: Application Due Date(s) Submission dates vary awarding IC.SeeTable IC-Specific Information, Requirements Staff Contactsfor details. funding consideration, applicants must include NOT-OD-20-055 without quotation marks) the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. Research Strategy section the application limited 6 pages. R&R Project Information form, the Attachments" field: Attach Personal Statement the applicant, including long-term research objectives career goals, justification the supplemental support, a plan return full productivity the end the supplement period. Attach Institutional letter commitment includes details resources mentoring be available the applicant ensure strong productivity the parent grant. letter should also detail institutional commitment the applicants return full productivity research career trajectory the end the supplement period. is strongly recommended the applicants contact respective program officers the Institute supporting parent award confirm ahead time the supplement falls within scope the parent award. Further, applicants strongly encouraged notify program contact the Institute supporting parent award SeeTable IC-Specific Information, Requirements Staff Contacts)that request been submitted response this FOA order facilitate efficient processing the request. Administrative Review Process IC conduct administrative reviews applications submitted their IC. ICs the parent grants support most meritorious applications submitted consideration, pending availability funds. Criteria: the work/activities proposed within scope the parent award? the progress the project prior the life event adequate? the administrative supplement increase preserve likelihood the project succeed, assist candidate complete research project submit timely renewal new research project grant application? there plan the PD/PI return full productivity the end the supplement period? there strong institutional commitment e.g., protected time, policies, programs, other strategies) ensure the PD/PI maintains his/her research project independent research trajectory? Inquiries Please direct inquiries to: Melissa Ghim, PhD Office Research Womens Health ORWH) Division Program Coordination, Planning, Strategic Initiatives DPCPSI) Telephone: 301-496-7853 Email:melissa.ghim@nih.gov

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