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Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Promote Training in Clinical Research on Pain (Admin Supp Clinical Trial Not Allowed)

Notice of Special Interest
Friday, April 10, 2020
Friday, July 31, 2020
333
NOT-NS-20-044

Funding Opportunity Purpose

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

Mechanisms and Consequences of Sleep Disparities in the U.S. (R01 - Clinical Trial Not Allowed)

PAR
Friday, April 3, 2020
Friday, July 15, 2022
R01
PAR-20-164

Funding Opportunity Purpose

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.

BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP (U01 Clinical Trials Optional)

RFA
Wednesday, April 1, 2020
Wednesday, June 16, 2021
U01
RFA-NS-20-029

Funding Opportunity Purpose

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

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 person’s 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 patient’s 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-making at individual level be 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 and validated use clinical research and 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 is not intended 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 individual’s 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 Avilés-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 Women’s 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

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

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

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

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

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.

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