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

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

Funding Opportunity Purpose

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

Notice of Special Interest (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

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

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

Funding Opportunity Purpose

Notice Special Interest HEAL Initiative: Request Administrative Supplements Existing Grants Identification Validation New Pain Opioid Disorder Targets within Understudied Druggable Genome Notice Number: NOT-TR-20-008 Key Dates Release Date: March 9, 2020 First Available Due Date: March 17, 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 National Center Advancing Translational Sciences NCATS) National Institute Dental Craniofacial Research NIDCR) National Institute Drug Abuse NIDA) National Institute Neurological Disorders Stroke NINDS) National Center Complementary Integrative Health NCCIH) National Institute Arthritis Musculoskeletal Skin Diseases ( NIAMS ) - New participating organization of March 26, 2020 due dates on/after June 01, 2020 Purpose Notice part the NIH Helping End Addiction Long-Term HEAL) Initiative, aggressive, trans-agency effort speed scientific solutions stem national opioid public health crisis. NCATS other participating institutes Centers ICs) inviting investigators relevant active research project grants cooperative agreements submit administrative supplements, according to PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional), funded projects identify validate new pain opioid disorder OUD) targets within understudied Druggable Genome. Background: human genome revealed great deal the human proteome, though significant portions the genome remain understudied. Only subset expressed proteins demonstrate requisite properties serve targets the development therapeutics. bona fide drug targets likely remain be discovered the Druggable Genome” DG), can defined a subset the 20,000 protein-coding genes the human genome have potential bind drug-like molecules. term drug-like" refers the physical, biochemical, pharmacological attributes small molecule compounds are generally recognized be required efficacious clinical drugs humans. While number proteins the DG upwards 4,500, existing clinical pharmacopeia represented only few hundred targets, leaving huge swath biology remains unexploited. announcement for one-year administrative supplements ongoing funded projects support research will identify validate new targets pain OUD among understudied proteins the Druggable Genome. Kinases such ERK1/2, p38 JNK been shown counteract opioid analgesia precede desensitization the opioid receptors. addition, opioid receptors belong the well-known Gi/o class GPCRs, GPCRs been shown mediate pain neurogenic inflammation. Finally, ion channels been identified critical elements pain signaling transmission. these families contain adequate numbers understudied members are well established druggable families shown be critical pathways associated pain OUD, experimental focus be placed understudied members the families non-olfactory GPCRs, ion channels protein kinases. Eligible understudied proteins listed below considered understudied, they meet following criteria: protein 1) a low number publications/citations, a Jensen Pubmed score Understudied proteins eligible research support under notice: Kinases ADCK1, ADCK2, ADCK5, ALPK2, ALPK3, BCKDK, BRSK1, CAMK1D, CAMK1G, CAMKK1, CAMKV, CDC42BPA, CDC42BPB, CDC42BPG, CDK10, CDK11A, CDK11B, CDK12, CDK13, CDK14, CDK15, CDK16, CDK17, CDK18, CDK19, CDK20, CDKL1, CDKL2, CDKL3, CDKL4, CLK3, CLK4, COQ8A, COQ8B, CSNK1A1L, CSNK1G1, CSNK1G2, CSNK1G3, CSNK2A3, DCLK3, DSTYK, DYRK1B, DYRK2, DYRK3, DYRK4, EEF2K, ERN2, HIPK1, HIPK3, HIPK4, ICK, LMTK2, LMTK3, LRRK1, LTK, MAP3K10, MAP3K14, MAP3K15, MAP3K21, MAPK15, MAPK4, MARK1, MARK3, MARK4, MAST2, MAST3, MAST4, MKNK2, NEK1, NEK10, NEK11, NEK3, NEK4, NEK5, NEK6, NEK7, NEK9, NIM1K, NRBP2, NRK, NUAK2, PAK3, PAK5, PAK6, PAN3, PDIK1L, PHKG1, PHKG2, PI4KA, PIK3C2B, PIK3C2G, PIP4K2C, PIP5K1A, PIP5K1B, PIP5K1C, PKMYT1, PKN3, PNCK, POMK, PRKACB, PRKACG, PRPF4B, PSKH1, PSKH2, PXK, RIOK1, RIOK2, RIOK3, RPS6KC1, RPS6KL1, SBK2, SBK3, SCYL2, SCYL3, SGK494, SRPK3, STK17A, STK17B, STK19, STK3, STK31, STK32A, STK32B, STK32C, STK33, STK36, STK38L, STK40, STKLD1, TAOK1, TAOK2, TBCK, TESK1, TESK2, TLK1, TLK2, TP53RK, TSSK1B, TSSK2, TSSK3, TSSK4, TSSK6, TTBK1, TTBK2, ULK4, VRK2, VRK3, WEE2, WNK2, WNK3 Ion Channels ASIC4, BEST4, CACNA2D2, CACNA2D3, CACNA2D4, CACNG1, CACNG3, CACNG4, CACNG5, CACNG6, CACNG7, CACNG8, CALHM4, CALHM5, CALHM6, CATSPER2, CHRNA10, CHRNB1, CLCA4, CLCC1, CLCN6, CLIC6, GABRP, GPR89A, GPR89B, GRID1, KCNA6, KCNA7, KCNAB2, KCNAB3, KCND1, KCNG2, KCNG3, KCNG4, KCNH4, KCNH6, KCNH8, KCNJ15, KCNJ18, KCNK12, KCNK7, KCNMB3, KCNN1, KCNS1, KCNS2, LRRC38, LRRC55, PKD1L2, PKD1L3, PKD2L2, PLLP, SCN7A, SLC26A1, TMC3, TMC4, TMC5, TMC7, TMEM38B, TMEM63A, TMEM63B, TTYH1, TTYH2 G-Protein Coupled Receptors GPCRs) ADGRA1, ADGRA3, ADGRB2, ADGRB3, ADGRD1, ADGRD2, ADGRE1, ADGRE3, ADGRF1, ADGRF2, ADGRF3, ADGRF4, ADGRF5, ADGRG2, ADGRG3, ADGRG4, ADGRG5, ADGRG7, FZD10, GNRHR2, GPR101, GPR12, GPR135, GPR137, GPR139, GPR141, GPR142, GPR146, GPR149, GPR150, GPR151, GPR152, GPR153, GPR156, GPR157, GPR160, GPR162, GPR171, GPR173, GPR174, GPR18, GPR19, GPR20, GPR21, GPR22, GPR25, GPR26, GPR27, GPR3, GPR31, GPR32, GPR34, GPR37L1, GPR4, GPR45, GPR52, GPR6, GPR61, GPR62, GPR63, GPR65, GPR68, GPR75, GPR78, GPR82, GPR85, GPR87, GPR88, GPRC5A, GPRC5B, GPRC5C, GPRC5D, HCAR1, HCAR3, LPAR6, MRGPRE, MRGPRF, MRGPRG, MRGPRX1, MRGPRX2, MRGPRX3, MRGPRX4, NPBWR1, NPBWR2, OXER1, OXGR1, P2RY10, PROKR1, QRFPR, RXFP4, TAAR2, TAAR3P, TAAR8, TAAR9, TAS2R1, TAS2R10, TAS2R13, TAS2R14, TAS2R16, TAS2R19, TAS2R20, TAS2R3, TAS2R30, TAS2R31, TAS2R39, TAS2R4, TAS2R40, TAS2R41, TAS2R42, TAS2R43, TAS2R46, TAS2R5, TAS2R50, TAS2R60, TAS2R7, TAS2R8, TAS2R9 Examples potential research areas include would be limited to: Isolation purification understudied proteins and in vitro/in vivo characterization the intent developing novel therapeutics; Validation placement understudied protein(s) signaling cascades, including upstream signals downstream activities order better understand pain OUD targets; Pre-clinical animal studies understudied Druggable Genome candidate proteins focused therapeutic development development candidate therapeutics; Characterization cell- tissue-specific protein expression, localization, function understudied protein(s) native environments they pertain pain OUD; of novel tools validate preliminary disease physiological associations understudied proteins animal models, biomimetic systems, or ex vivo human samples; Studies establish preliminary structure-activity-relationships SAR) between functions an understudied protein its ligands e.g., small molecules, macrocycles, synthetic peptides) future drug discovery projects. work proposed must within scope the existing award. Before submitting supplement request, principal investigators strongly encouraged contact appropriate IC contact listed the end this notice any questions to discuss whether proposed supplement within scope the parent award consistent the priorities the IC supporting parent award. Applications must include detailed description the proposed activities a justification the proposed work within scope the existing award. Sufficient justification should provided indicate why particular protein(s) chosen study. Those projects employing methods identify multiple proteins study the above lists acceptable require justification to why those proteins chosen, beyond fact they on eligible protein lists provided. Applications must also demonstrate adequate progress date the parent study. activities proposed the supplement must able be accomplished within current competitive segment. Award Project Period be eligible, parent award must active FY20 i.e., parent award received funds FY20 is in extension period), the research proposed the supplement should requested 1 year. earliest anticipated start date June 1, 2020. Budget Supplement budget requests cannot exceed 99,999 direct costs excluding subcontract F&A). Requests must reflect actual needs the proposed project. Requests be one year support only. Modular categorical budgets permitted. Eligible Individuals Program Director/Principal Investigator) Individual(s) must hold active grant cooperative agreement. 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: Requests must received 5:00 PM local time applicant organization June 1, 2020 funding FY 2020. Application Due Date(s) – June 1, 2020, 5:00 PM local time applicant organization. funding consideration, applicants must include NOT-TR-20-008” 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. be eligible, parent award must active FY20 i.e. applications a no-cost extension not eligible apply.). earliest anticipated start date June 1, 2020. Research Strategy section the application limited 6 pages. process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. Supplement budget requests cannot exceed 99,999 direct costs excluding subcontract F&A) one year. Requests must reflect actual needs the proposed project. Modular categorical budgets permitted Individual(s) must hold active grant cooperative agreement. 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. Inquiries Please direct inquiries to: Karlie Sharma, Ph.D. National Center Advancing Translational Sciences NCATS) Telephone: 301-451-4965 Email: Karlie.Sharma@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): Administrative Supplements to Support Enhancement of Software Tools for Open Science

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

Funding Opportunity Purpose

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

Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-18-906 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)

Notice of Special Interest
Tuesday, March 3, 2020
Tuesday, June 30, 2020
333
NOT-NS-20-023

Funding Opportunity Purpose

Notice Special Interest Encourage Eligible NIH HEAL Initiative Awardees Apply PA-18-906 Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed) Notice Number: NOT-NS-20-023 Key Dates Release Date: March 3, 2020 First Available Due Date: April 15, 2020 Expiration Date: June 30, 2020 Related Announcements PA-18-906 - Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed) Issued National Institute Neurological Disorders Stroke NINDS) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Mental Health NIMH) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) 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 NIH a strong interest the diversity the NIH-funded research enterprise the recently funded NIH notice NOT-OD-20-031) encourages institutions diversify scientific workforce enhancing participation individuals groups identified underrepresented the biomedical, clinical, behavioral, social sciences. Participating institutes continue support efforts through ongoing programs supplement funding opportunities. specific notice reiterates interest encourages eligible grant cooperative agreement awardees the HEAL Initiative community apply administrative supplements response to PA-18-906, Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed). notice part the NIH’s Helping End Addiction Long-term HEAL) Initiative speed scientific solutions the national opioid public health crisis. NIH HEAL Initiative bolster research across NIH 1) improve treatment opioid misuse addiction 2) enhance pain management. information the HEAL Initiative available at: https://heal.nih.gov/ Application Submission Information Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-906 - Research Supplements Promote Diversity Health-Related Research Admin Supp - Clinical Trial Allowed) instructions the SF424 R&R) Application Guide and PA-18-906 must followed, the following additions: Application Due Date(s) – April 15, 2020 June 1, 2020 5:00 PM local time applicant organization. funding consideration, applicants must include ldquo;NOT-NS-20-023” 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. Only existing awardees the HEAL Initiative program eligible apply. process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify program contact the Institute supporting parent award well as Alex.Tuttle@nih.gov that request been submitted response this FOA order facilitate efficient processing the request. 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. HEAL diversity supplement awardees strongly encouraged participate annual PD/PI meetings in activities their mentors. Applicants request funds, addition the research costs specified in PA-18-906, enable supplement candidate attend annual HEAL Initiative PD/PI meeting the Washington, DC area. request additional funds should reasonable well justified the application. Potential applicants strongly encouraged review the supplemental guidance for diversity supplement applications the NINDS web site. Consultation the Program Official the qualifying HEAL award the individual named under Inquiries below highly recommended. Supplement applications be evaluated the HEAL Initiative diversity committee. Applications non-responsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries to: Eric Hudak, PhD National Institute Neurological Disorders Stroke NINDS) Telephone: 301-496-1779 Email: Eric.Hudak@nih.gov

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.

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