Ape

AIDS CLINICAL TRIALS GROUP NETWORK

APP FOR PAD 936-8300

MEASURE PHASE III-MONITORING AND ASSESSMENT FOR RESULTS

CANCER CENTER CORE SUPPORT GRANT

INDIAN HSG BLOCK GR

APPLICATION PURPOSE: THIS A CAPE COD REGIONAL TRANSIT AUTHORITY (CCRTA) REQUEST FOR $74151753 IN AMERICAN RESCUE PLAN ACT 5307 FUNDS (ARP) APPROPRIATION FOR THE BARNSTABLE-UZA FOR OPERATING ASSISTANCE AND PREVENTIVE MAINTENANCE WHICH WILL FACILITATE MAINTAINING SERVICE IN THE AFTERMATH OF THE COVID-19 PANDEMIC.IN ACCORDANCE WITH FTA CIRCULARS 9040.1G AND 9030.1E PREVENTIVE MAINTENANCE ACTIVITIES ARE CONSIDERED OPERATING COSTS.; ACTIVITIES PERFORMED: OPERATING AND PREVENTIVE MAINTENANCE ACTIVITIES FOR THE PERIOD OF JULY 1 2023 - DECEMBER 31 2027.; EXPECTED OUTCOMES: FUNDING WILL PERMIT CONTINUOUS UNINTERRUPTED SERVICE FOR RIDERS WHILE ENSURING THAT TRANSIT ASSETS ARE MAINTAINED IN A STATE OF GOOD REPAIR.; INTENDED BENEFICIARIES: THE BENEFICIARIES OF THIS EFFORT ARE THE RIDERS OF OUR SERVICE WITHIN THE 15 TOWNS OF CAPE COD.; SUBRECIPIENT ACTIVITIES: NONE

UNIVERSITY OF NORTH CAROLINA AIDS CLINICAL TRIALS UNIT (UNC ACTU)

RAPIDLY EMERGING ANTIVIRAL DRUG DEVELOPMENT INITIATIVE- AVIDD CENTER (READDI-AC) - PROGRAM SUMMARY/ABSTRACT EMERGING VIRUSES ARISE SUDDENLY AND CAUSE CONSIDERABLE MORBIDITY AND MORTALITY WORLDWIDE. TO PREPARE FOR CURRENT AND FUTURE THREATS, PUBLIC-PRIVATE PARTNERSHIPS ARE NEEDED TO CHANGE THE CURRENT REACTIVE RESPONSE PLATFORM INTO ONE THAT IS PROACTIVE. IN RESPONSE TO RFA-AI-21-050, THE RAPIDLY EMERGING ANTIVIRAL DRUG DEVELOPMENT INITIATIVES AVIDD CENTER (READDI-AC) IS AN INTEGRATED PUBLIC-PRIVATE PARTNERSHIP WITH A RENOWNED, INTERDISCIPLINARY RESEARCH TEAM OF EXPERTS, WHO APPLY CUTTING EDGE INNOVATIVE TECHNOLOGIES IN VIROLOGY, BIOCHEMISTRY, STRUCTURAL BIOLOGY, MEDICINAL CHEMISTRY, COMPUTATIONAL BIOLOGY, STRUCTURE-GUIDED DRUG DESIGN AND GENOMICS TO DEVELOP ORAL, POTENT, BROAD-SPECTRUM FAMILY-SPECIFIC ANTIVIRALS FOR CORONAVIRUSES, FLAVIVIRUSES, ALPHAVIRUSES AND FILOVIRUSES. TO ACHIEVE THESE GOALS, THE READDI-AC PROGRAM INCLUDES ACADEMIC LEADERS IN BASIC AND APPLIED ANTIVIRAL RESEARCH AND CHEMISTRY AS WELL AS INDUSTRY LEADERS JANSSEN PHARMACEUTICALS N.V.(JPNV), TAKEDA, CHIMERIX INC. AND PARDES BIOSCIENCES. OUR COMMERCIAL PARTNERS PROVIDE AN ENVIABLE TRACK RECORDS IN DRUG DISCOVERY AND PRODUCT DEVELOPMENT, AND LEADERSHIP IN MEDICINAL CHEMISTRY, PHARMACOLOGY, DRUG FORMULATION, TOXICITY STUDIES AND PHARMACOKINETICS, ESPECIALLY CRITICAL FOR DRIVING OPTIMIZED LEADS THROUGH PREIND ENABLING STUDIES TOWARD THE CLINIC. IMPORTANTLY, OUR INDUSTRY PARTNERS ALSO PROVIDE IN KIND MATCHING CONTRIBUTIONS, ACCESS TO HIGH QUALITY COMMERCIAL CHEMICAL LIBRARIES, EARLY HITS, OPTIMIZED LEADS, AND STATE OF THE ART HIGH- THROUGHPUT SCREENS. THE IMMEDIATE AND LONG-TERM GOALS OF READDI-AC ARE TO: A) VALIDATE DRUGGABLE TARGETS IN CONSERVED VIRAL PROTEINS, B) IDENTIFY HITS AND LEADS USING SAR AND STATE OF THE ART BIOCHEMICAL AND ENZYMATIC ASSAYS, C) OPTIMIZE/FORMULATE CHEMICAL PROBES AND LEAD COMPOUNDS AS BROADLY ACTING ORAL COMPOUNDS WITH ACTIVITY AGAINST MULTIPLE RELEVANT MEMBERS OF EACH EMERGING VIRUS FAMILY; D) PROVIDE CRITICAL LATE-STAGE PRECLINICAL DEVELOPMENT AND IND-ENABLING IN VIVO STUDIES FOR TWO BROADLY ACTIVE, ORAL DRUG CANDIDATES; E) PROMOTE OPEN SCIENCE SHARING OF UNUSED CHEMICAL ASSETS, CHEMICAL PROBES, METHODS, REAGENTS AND ASSAYS FOR INNOVATIONS BY CROWDSOURCING; F) BUILD CAPACITY AND TRAINING IN 21ST CENTURY VIRAL DRUG DISCOVERY AND DEVELOPMENT BY COUPLING INNOVATIVE APPROACHES IN TARGET DISCOVERY AND VALIDATION WITH STATE OF THE ART TECHNIQUES, INTEGRATED WORKFLOWS AND NOVEL DISCOVERY PLATFORMS FOR HIT TO LEAD PROGRESSION AND SAR OPTIMIZATION. READDI-AC HAS FIVE RESEARCH PROJECTS AND FOUR HIGHLY INTERACTIVE CORES THAT ESTABLISH A COOPERATIVE LANDSCAPE THAT BUILDS LEADERSHIP, EXPERTISE, RESPONSE CAPACITY AND PARTNERSHIPS THAT INVIGORATE 21ST CENTURY DRUG DEVELOPMENT.

RANDOMIZED DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CT1812 IN EARLY ALZHEIMER'S DISEASE OVER 18 MONTHS

BACK PAIN CONSORTIUM (BACPAC) RESEARCH PROGRAM DATA INTEGRATION, ALGORITHM DEVELOPMENT AND OPERATIONS MANAGEMENT CENTER

UNC CENTER FOR AIDS RESEARCH

SERCEB SOUTHEAST REGIONAL CENTERS OF EXCELLENCE FOR BIO*

DATA FOR IMPACT

THE NATIONAL LONGITUDINAL STUDY OF ADOLESCENT HEALTH

NORTH CAROLINA TRANSLATIONAL AND CLINICAL SCIENCE INSTITUTE (NC TRACS)

CARES ACT HIGHER EDUCATION EMERGENCY RELIEF FUND - INSTITUTIONAL AID

TAS::89 0227::TAS RECOVERY; NEW: RECOVERY ACT - SOLAR FUELS AND NEXT GENERATION PHOTOVOLTAICS -- EFRC; PI THOMAS MEYER

A LONGITUDINAL MRI STUDY OF INFANTS AT RISK FOR AUTISM

UNC CLINICAL AND TRANSLATIONAL SCIENCE AWARD

DATA, MODELING,AND COORDINATION CENTER FOR PRECISE NETWORK

NORTH CAROLINA TRANSLATIONAL & CLINICAL SCIENCES INSTITUTE (NC TRACS)

ADOLESCENT MEDICINE TRIALS NETWORK FOR HIV/AIDS INTERVENTIONS (ATN) COORDINATING CENTER

USAID FOREIGN ASSISTANCE FOR PROGRAMS OVERSEAS

CARES ACT HIGHER EDUCATION EMERGENCY RELIEF FUND

MARTIN DELANEY COLLABORATORY TO ERADICATE HIV-1 INFECTION

SYSTEMS IMMUNOGENETICS OF BIODEFENSE PATHOGENS IN THE COLLABORATIVE CROSS

CAPE TOWN CLINICAL TRIALS UNIT (CT-CTU) FOR HIV/AIDS PREVENTION & TREATMENT

HEALTH CENTER CLUSTER

TB DATA, IMPACT ASSESSMENT AND COMMUNICATIONS HUB (TB DIAH)

THE UNC/EMORY CENTER FOR INNOVATIVE TECHNOLOGY (ITECH) ACROSS THE PREVENTION AND CARE CONTINUUM

MOLECULAR AND CELLULAR PATHOGENESIS IN ALCOHOLISM

CENTER FOR HYBRID APPROACHES IN SOLAR ENERGY TO LIQUID FUELS (CHASE)

SPORE IN BREAST CANCER

RECOVERY ACT - OPENCAPE CORPORATION MIDDLE MILE PROJECT

NATIONAL LONGITUDINAL STUDY OF ADOLESCENT TO ADULT HEALTH (ADD HEALTH): WAVE VI CORE PROJECT - PROJECT SUMMARY THIS PROJECT, DEVELOPED IN RESPONSE TO RFA-AG-21-008, DESCRIBES CORE PLANS FOR DATA COLLECTION AND DISSEMINATION OF THE SIXTH WAVE (WAVE VI) OF THE NATIONAL LONGITUDINAL STUDY OF ADOLESCENT TO ADULT HEALTH (ADD HEALTH), WHEN COHORT MEMBERS WILL BE 39-48 YEARS OF AGE (MEAN 44). ADD HEALTH IS A LONGITUDINAL STUDY OF A NATIONALLY REPRESENTATIVE SAMPLE OF OVER 20,000 ADOLESCENTS WHO WERE IN GRADES 7-12 DURING THE 1994-95 SCHOOL YEAR AND HAVE BEEN FOLLOWED FOR FIVE WAVES TO DATE. OVER 25 YEARS, ADD HEALTH HAS COLLECTED RICH DEMOGRAPHIC, SOCIAL, FAMILIAL, SOCIOECONOMIC, BEHAVIORAL, PSYCHOSOCIAL, COGNITIVE, AND HEALTH SURVEY DATA FROM PARTICIPANTS AND THEIR PARENTS; A VAST ARRAY OF CONTEXTUAL DATA FROM PARTICIPANTS' SCHOOLS, NEIGHBORHOODS, AND GEOGRAPHIES OF RESIDENCE; ADMINISTRATIVE DATA LINKED TO PARTICIPANTS, INCLUDING BIRTH AND DEATH CERTIFICATES; AND IN-HOME PHYSICAL AND BIOLOGICAL DATA FROM PARTICIPANTS, INCLUDING ANTHROPOMETRIC MEASURES, GENETIC MARKERS, BLOOD-BASED ASSAYS, AND MEDICATIONS. ANCILLARY STUDIES HAVE ADDED MORE INFORMATION, INCLUDING EPIGENETIC, GENE EXPRESSION, AND MICROBIOME DATA. THUS, ADD HEALTH IS EXCEPTIONALLY UNIQUE BECAUSE IT HAS A RICH, MULTI- LEVEL, LONGITUDINAL ARRAY OF DATA FOR A LARGE NATIONALLY REPRESENTATIVE COHORT OF AMERICANS WHO ARE ENTERING MIDLIFE. IMPORTANTLY, THE OVERALL HEALTH PROFILE OF THE COHORT AS THEY MAKE THE TRANSITION TO MIDLIFE IS PROBLEMATIC ACROSS MANY DIMENSIONS. MOREOVER, HEALTH DISPARITIES BY RACE, ETHNICITY, GENDER, SOCIOECONOMIC STATUS, SEXUAL MINORITY STATUS, AND RURAL-URBAN RESIDENCE IN THIS COHORT ARE WIDE AND, IN SOME CASES, WIDENING. AS SUCH, RICH LONGITUDINAL, MULTI-LEVEL, AND NATIONALLY REPRESENTATIVE DATA ARE URGENTLY NEEDED TO BEST UNDERSTAND THE LIFE COURSE DETERMINANTS OF HEALTH TRAJECTORIES AND HEALTH DISPARITIES OF US ADULTS AS THEY ENTER MIDLIFE. WAVE VI OF ADD HEALTH WILL FILL THIS CRITICAL NEED. THE OVERALL GOAL OF WAVE VI OF ADD HEALTH IS TO COLLECT AND DISSEMINATE THE COMPREHENSIVE DATA NEEDED TO BEST UNDERSTAND THE SOCIAL, ECONOMIC, PSYCHOSOCIAL, CONTEXTUAL, AND BIOLOGICAL DETERMINANTS OF HEALTH TRAJECTORIES AND DISPARITIES AMONG THIS NATIONALLY REPRESENTATIVE COHORT OF AMERICANS AS THEY AGE INTO MIDLIFE. THE PROJECT IS FOCUSED AROUND FIVE AIMS: 1) RE-INTERVIEWING COHORT MEMBERS USING PREDOMINANTLY WEB-BASED AND IN-PERSON MODES, WITH EXPLICIT ATTENTION TO SECURING HIGH RESPONSE RATES FROM RACIAL/ETHNIC MINORITY AND LOW SOCIOECONOMIC STATUS PARTICIPANTS; 2) ENRICHING STUDY CONTENT IN KEY DOMAINS THAT WILL ELUCIDATE MID- AND LATER-LIFE HEALTH TRAJECTORIES AND DISPARITIES; 3) RE-VISITING COHORT MEMBERS WHO CONSENT FOR AN IN-HOME HEALTH EXAM THAT INCLUDES VENOUS BLOOD COLLECTION AND OTHER IMPORTANT COMPONENTS OF HEALTH; 4) ASSAYING BIOLOGICAL SPECIMENS FOR IMPORTANT PRE-DISEASE AND DISEASE BIOMARKERS; AND 5) CLEANING, DOCUMENTING, DISSEMINATING, ARCHIVING, PROMOTING, AND SUPPORTING WAVE VI DATA FOR THE SCIENTIFIC COMMUNITY. THIS PROJECT HAS EXTRAORDINARY POTENTIAL TO CONTRIBUTE TO THE SCIENCE OF AGING, HEALTH, AND HEALTH DISPARITIES FOR DECADES TO COME, AS THE ADD HEALTH COHORT AGES INTO THE MIDDLE ADULT YEARS AND BEYOND. SUCCESSFUL CARRYOUT OF THIS PROJECT WILL SUPPLY ESSENTIAL DATA FOR THOUSANDS OF RESEARCHERS WORKING ON THESE CRITICAL ISSUES.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CT1812 IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE

HEALTH CENTER CLUSTER

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CT1812 IN SUBJECTS WITH DEMENTIA WITH LEWY BODIES - ABSTRACT: COGNITION THERAPEUTICS, INC. (COGRX) IS DEVELOPING CT1812 FOR NEURODEGENERATIVE CONDITIONS, INCLUDING DEMENTIA WITH LEWY BODIES (DLB). THIS FIRST-IN-CLASS SMALL MOLECULE DRUG CANDIDATE SELECTIVELY DISPLACES ASS OLIGOMERS BOUND TO NEURONAL RECEPTORS AT SYNAPSES AND PROTECTS SYNAPSES FROM TOXIC OLIGOMER EFFECTS, CLEARING THEM FROM THE BRAIN INTO THE CEREBROSPINAL FLUID (CSF). CT1812 ALSO DISPLACES A-SYNUCLEIN OLIGOMER BINDING TO NEURONS IN VITRO. CT1812 IS CURRENTLY IN A PHASE 2 TRIAL IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE (AD), WHERE IT HAS BEEN FOUND TO BE SAFE AND GENERALLY WELL-TOLERATED. WHEN ADMINISTERED ONCE DAILY FOR 28 DAYS TO AD PATIENTS, CT1812 SIGNIFICANTLY REDUCED CONCENTRATIONS OF SYNAPTIC DEGENERATION MARKERS IN CSF. SIMILAR TO ASS OLIGOMERS, A-SYNUCLEIN OLIGOMERS BIND TO NEURONS AND CAUSE SYNAPTIC DYSFUNCTION AND LOSS, SPREADING THROUGHOUT THE BRAIN AS DISEASE PROGRESSION IS OBSERVED IN DLB. EIGHTY PERCENT OF PATIENTS WITH DLB REFLECT BOTH ASS AND A-SYNUCLEIN PATHOLOGY AT AUTOPSY. PATIENTS WITH DLB LIKELY HAVE BOTH TYPES OF OLIGOMERS AND SHOULD BENEFIT FROM TREATMENT WITH CT1812. THIS CLINICAL TRIAL PROJECT PROPOSES TO CONDUCT A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SIX-MONTH STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EXPLORATORY EFFICACY OF CT1812 AT 100 MG AND 300 MG DAILY DOSES IN MILD TO MODERATE DLB PATIENTS (N=40/GROUP). TRIAL ENDPOINTS WILL INCLUDE SAFETY AS WELL AS EXPLORATORY EFFICACY MEASURES (MONTREAL COGNITIVE ASSESSMENT [MOCA], COGNITIVE DRUG RESEARCH BATTERY [CDR], CLINICIAN ASSESSMENT OF FLUCTUATION [CAF], EPWORTH SLEEPINESS SCALE [ESS], MOVEMENT DISORDER SOCIETY – UNIFIED PARKINSON'S DISEASE RATING SCALE – PART III [MDS-UPDRS3], THE ALZHEIMER'S DISEASE COOPERATIVE STUDY – CLINICAL GLOBAL IMPRESSION OF CHANGE [ADCS-CGIC], ADCS-ACTIVITIES OF DAILY LIVING [ADL], AND NEUROPSYCHIATRIC INVENTORY [NPI]) AT BASELINE, 3 MONTHS, AND 6 MONTHS. ADDITIONAL MEASUREMENTS OF PLASMA AND CSF CONCENTRATIONS OF DRUG, TARGET ENGAGEMENT BIOMARKERS (INCLUDING ASS AND A-SYNUCLEIN OLIGOMERS), DISEASE PROGRESSION PROTEIN MARKERS (ASS AND A-SYNUCLEIN MONOMER, TOTAL AND PHOSPHORYLATED TAU PROTEIN) AND SYNAPTIC DAMAGE/NEURODEGENERATION BIOMARKERS (NEUROGRANIN, SYNAPTOTAGMIN, SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 [SNAP-25], AND NEUROFILAMENT LIGHT [NFL]) AT BASELINE AND AT 6 MONTHS WILL ALLOW CORRELATION OF DRUG CONCENTRATIONS WITH MEASURES OF SYNAPTIC DAMAGE AND COGNITIVE PERFORMANCE. CONDUCTING A STUDY WITH THIS PATIENT POPULATION WILL LEVERAGE THE ONGOING CT1812 DEVELOPMENT EFFORTS FOR AD AND WILL PROVIDE A NEAR-TERM OPPORTUNITY TO INVESTIGATE A CLINICAL CANDIDATE THERAPEUTIC IN DLB, AN INDICATION FOR WHICH NO DISEASE-MODIFYING TREATMENTS EXIST. COMPLETION OF THIS STUDY WILL PROVIDE AN INITIAL ASSESSMENT OF CT1812 EFFICACY IN DLB PATIENTS THAT WILL INFORM DESIGN OF SUBSEQUENT PIVOTAL TRIALS NECESSARY FOR FURTHER CLINICAL DEVELOPMENT OF CT1812.

HERPESVIRAL ONCOGENESIS, LATENCY AND REACTIVATION

NORTH CAROLINA TRANSLATIONAL AND CLINICAL SCIENCES INSTITUTE (NC TRACS) - PROJECT SUMMARY THE NORTH CAROLINA TRANSLATIONAL AND CLINICAL SCIENCES INSTITUTE (TRACS) IS A DYNAMIC REGIONAL NETWORK OF UNIVERSITIES, RESEARCH INSTITUTES, HEALTHCARE PROVIDERS, AND >250 COMMUNITY COLLABORATORS ACROSS OUR STATE. BASED AT UNC CHAPEL HILL, TRACS HAS STRATEGICALLY FOSTERED PARTNERSHIPS WITH NC A&T, THE LARGEST HBCU IN THE U.S., WHICH BRINGS EXPERTISE IN HEALTH EQUITY RESEARCH, WORKFORCE DEVELOPMENT, ENGINEERING, AND DATA SCIENCE, AND NC STATE, WITH A NATIONALLY RANKED SCHOOL OF VETERINARY MEDICINE AND ADDITIONAL EXPERTISE IN ENGINEERING AND COMPUTER SCIENCE. OVER THE NEXT SEVEN YEARS, WE WILL CATALYZE DEVELOPMENT, TESTING, IMPLEMENTATION, AND DISSEMINATION OF TRANSLATIONAL SCIENCE AND RESEARCH TO IMPROVE HUMAN HEALTH, WITH AN EXPLICIT FOCUS ON ADVANCING HEALTH EQUITY BY COMPLETING OUR OVERALL AIMS. AIM 1: PERFORM AND SUPPORT RESEARCH THAT ADVANCES THE SCIENCE OF TRANSLATION WITH THE GOAL OF CLEARING BARRIERS TO RAPID TRANSLATION OF RESEARCH TOWARDS IMPLEMENTATION OF BEST EVIDENCE TO OUR PATIENTS AND THEIR COMMUNITIES. AIM 2: MAXIMIZE THE INFORMATIVENESS OF TRANSLATIONAL RESEARCH, TO DRIVE ITS IMPACT TO IMPROVE CLINICAL BENEFITS AND REDUCE HARMS WITH PARTICULAR ATTENTION TO POPULATIONS IMPACTED BY HEALTH INEQUITIES. AIM 3: TRAIN AND MAINTAIN A DIVERSE, EXPERT, MULTIDISCIPLINARY TRANSLATIONAL RESEARCH WORKFORCE AT ALL PROFESSIONAL LEVELS, PREPARED TO MEET THE CHALLENGES OF CURRENT AND FUTURE HEALTH CRISES. AIM 4: IMPLEMENT EVIDENCE-BASED STRATEGIES TO IMPROVE HUMAN HEALTH USING OUR LEARNING HEALTH CARE SYSTEM AS OUR LABORATORY. WE HAVE INTENSIFIED OUR EFFORTS IN HEALTH EQUITY AS WELL AS DISSEMINATION AND IMPLEMENTATION, RECOGNIZING THAT THESE ARE THE CRITICAL BARRIERS TO EFFECTIVE TRANSLATION OF INNOVATION TO HEALTH. WE WILL CAPITALIZE ON (I) THE SUBSTANTIAL RESOURCES OF OUR LEARNING HEALTH CARE SYSTEM AND (II) THE COLLECTIVE EXPERTISE OF TRACS, HONED OVER 14 YEARS OF SUPPORTING WORLD-CLASS TRANSLATIONAL RESEARCH, TO INTEGRATE THE PRINCIPLES OF SOCIAL JUSTICE IN ALL OUR SERVICES AND TRAININGS AND TO REALIZE OUR VISION OF “A HEALTHIER NORTH CAROLINA THROUGH INNOVATION”. WE WILL INNOVATE INCLUSIVE METHODS AND PROCESSES, ENGENDER TRUST, AND RECRUIT RESEARCH PARTICIPANTS WHO REFLECT THE DIVERSITY OF OUR STATE. WE WILL IMPLEMENT OUR ADVANCES TO ENSURE BENEFITS FOR OUR PARTICIPANTS, THEIR COMMUNITIES AND PATIENTS EVERYWHERE. WITH BROAD STAKEHOLDER ENGAGEMENT AND RIGOROUS EVALUATION OF OUR EFFORTS, WE WILL MAXIMIZE THE RELEVANCE OF OUR RESEARCH TO THOSE WE SERVE. TRACS WILL LEAD AND SUPPORT EFFORTS ACROSS THE CTSA CONSORTIUM TO CREATE A MORE EFFICIENT, INCLUSIVE RESEARCH ENVIRONMENT TO MITIGATE HEALTH DISPARITIES.

RISK FACTORS FOR ONSET AND PERSISTENCE OF TMD

TAS::89 0331::TAS RECOVERY ACT EERE - NEW COMBINED HEAT AND POWER (CHP) AWARD ENTITLED RECOVERY ACT: IMMEDIATE DEPLOYMENT OF WASTE ENERGY RECOVERY TE

APPLICATION PURPOSE: THE WOODS HOLE MARTHAS VINEYARD AND NANTUCKET STEAMSHIP AUTHORITY (SSA) PROVIDES FERRY SERVICE TO THE ISLANDS OF NANTUCKET AND MARTHAS VINEYARD AND HAS UNDERTAKEN THE PURCHASE OF USED VESSELS WHICH REQUIRE CONVERSION FOR USE AS PASSENGER VESSELS. THIS GRANT WILL PROVIDE FUNDS FOR THE REBUILD AND OVERHAUL NECESSARY FOR THE CONVERSION OF THE VESSELS. THE GOAL OF THE PROJECT IS TO REPLACE UP TO FOUR EXISTING VESSELS WHICH HAVE REACHED AND EXCEEDED THEIR PLANNED LIFE WHICH HAVE BECOME UNRELIABLE IN SERVICE. THESE VESSELS ARE PLANNED TO BE PUT INTO SERVICE AS SOON AS THE SUMMER OF 2023.; ACTIVITIES PERFORMED: PREVENTIVE MAINTENANCE REBUILD AND OVERHAUL SERVICES AS REQUIRED TO CONVERT UP TO FOUR OFFSHORE SUPPLY VESSELS TO PASSENGER SERVICE. DURING THE COURSE OF THIS CONVERSION ALL CHANGES REQUIRED TO MAKE THE VESSELS FULLY HANDICAPPED ACCESSIBLE AS REQUIRED TO MEET ADA REQUIREMENTS WILL BE COMPLETED. THE VESSELS CURRENTLY HAVE ELEVATORS TO MANAGE ON-BOARD MOVEMENT FROM DECK TO DECK AND ACCESS TO THE VESSELS IS VIA RAMP SYSTEMS THAT ARE PART OF DOCK-SIDE SERVICES WHICH ALREADY EXIST AT ALL STEAMSHIP AUTHORITY TERMINALS.; EXPECTED OUTCOMES: THE EXPECTED OUTCOME OF THIS PROJECT IS TO REPLACE OLDER VESSELS WHICH HAVE BECOME UNRELIABLE WITH REBUILT VESSELS CONVERTED SPECIFICALLY FOR THE PURPOSE OF PROVIDING PASSENGER AND FREIGHT SERVICE RESULTING IN A MORE RELIABLE SERVICE FOR THE PASSENGERS TO THE ISLANDS.; INTENDED BENEFICIARIES: COMMUTER PASSENGERS ISLAND RESIDENTS AND TOURISTS WHO VISIT THE ISLANDS OR USE THE FERRY SERVICE AS A LIFE-LINE BACK AND FORTH TO THE ISLANDS.; SUBRECIPIENT ACTIVITIES: THE WOODS HOLE MARTHAS VINEYARD AND NANTUCKET STEAMSHIP AUTHORITY (SSA) IS A SUBRECIPIENT OF THE CAPE COD REGIONAL TRANSIT AUTHORITY AND WILL BE THE ONLY SUBRECIPIENT FOR THIS PROJECT. A LARGE PERCENTAGE OF THE PROJECT FUNDS WILL BE SPENT ON WORK SUBCONTRACTED TO SHIPYARDS EQUIPPED TO MANAGE VESSELS OF THIS SIZE HOWEVER NONE OF THESE WILL BE CONSIDERED SUBRECIPIENTS. THE WORK BEING PERFORMED WILL INCLUDE CONVERSION MODIFICATION REACTIVATION AND PREVENTIVE MAINTENANCE ACTIVITIES TO EXTEND THE USEFUL LIFE OF THESE VESSELS.

COASTAL RESILIENCE

THE PURPOSE OF THIS AGREEMENT IS TO FUND RESEARCH SUPPORTING THE DEFENSE ADVANCED RESEARCH PROJECTS AGENCY DARPA BIOLOGICAL TECHNOLOGIES OFFICES BTO FOCUSED PHARMA PROGRAM.

COLORECTAL CHEMOPREVENTION WITH CALCIUM AND VITAMIN D

ASSOCIATE AWARD FOR MEASURE EVALUATION PROJECT.

COLLABORATORY OF AIDS RESEARCHERS FOR ERADICATION (CARE) - ABSTRACT SINCE ITS INCEPTION IN 2011, THE MARTIN DELANEY COLLABORATORY PROGRAM HAS MADE IMPORTANT ADVANCES TOWARDS A CURE FOR HIV. IN RESPONSE TO THE MARTIN DELANEY COLLABORATORIES (MDC) FOR HIV CURE RESEARCH RFA, WE SEEK TO CONTINUE TO ADVANCE THE FIELD BY DISCOVERY OF SUCCESSFUL MODALITIES TO CURE HIV INFECTION. WE WILL EXPAND OUR EXPERTISE AND WORK TOWARD A BETTER UNDERSTANDING OF PERSISTENT HIV INFECTION, THE DISCOVERY OF NOVEL APPROACHES TO DISRUPT LATENCY, METHODS TO CLEAR THE HIV RESERVOIR, AND IDENTIFICATION OF STRATEGIES TO CONTROL VIRAL REBOUND. BY BUILDING ON THE SIGNIFICANT ADVANCES THAT WE HAVE MADE TO DEVELOP, IMPLEMENT, AND EXECUTE A SUITE OF PRE-CLINICAL EXPERIMENTS THAT REPRESENT THE MOST ADVANCED AND NOVEL CONCEPTS, WE WILL CONTINUE TO PURSUE OUR CENTRAL UNIFYING HYPOTHESIS THAT REVERSING HIV LATENCY SUCH THAT VIRAL PROTEINS ARE EXPRESSED, IN PARALLEL WITH INTERVENTIONS THAT SPEED THE CLEARANCE OF CELLS EMERGING FROM LATENT INFECTION, WILL ULTIMATELY LEAD TO ERADICATION OF PERSISTENT HIV INFECTION. IN PARALLEL TO THE EFFORTS TO CLEAR THE INFECTION, WE WILL PURSUE INTERVENTIONS TO PREVENT REBOUND OF VIREMIA AFTER ART INTERRUPTION. WE WILL LEVERAGE A BROAD PORTFOLIO OF TOOLS FROM BOTH ACADEMIC AND INDUSTRY PARTNERS, AND APPLY NEW DISCOVERIES, DEMONSTRATING PROOF-OF-CONCEPT FOR CLINICAL INITIATIVES. WE WILL ENGAGE ACADEMIC SCIENTISTS AND CLINICIANS, INDUSTRY INVESTIGATORS, AND THE COMMUNITY TO A) DEFINE NOVEL TARGETS TO DESTABILIZE PROVIRAL GENOMES THAT PERSIST DESPITE ANTIRETROVIRAL THERAPY (ART) B) DEFINE NOVEL APPROACHES TO BLOCK PROVIRAL ESTABLISHMENT C) DEVELOP AND DEPLOY NOVEL EFFECTORS TO CLEAR VIRAL RESERVOIRS, D) DELINEATE EFFECTIVE STRATEGIES TO PREVENT REBOUND VIREMIA THAT MIGHT EMANATE FROM SUCH RESERVOIRS AFTER ART IS DISCONTINUED AND E) CREATE BRIDGES TO THE COMMUNITY TO IMPROVE THE UNDERSTANDING OF AND ACCESS TO HIV CURE RESEARCH AND CLINICAL TRIALS. OUR INITIAL EFFORTS WILL FOCUS ON BIOLOGY DISCOVERY TO ILLUMINATE NEW HOST TARGETS FOR LATENCY REVERSAL, AND THE VALIDATION OF THE NOVEL BIOLOGICAL CONCEPT OF LATENCY PREVENTION. UNIVERSAL STRATEGIES FOR PROVIRAL CONTROL OR CLEARANCE WILL BE DEVELOPED AND TESTED, INCLUDING THOSE BASED ON HLA-E TARGETING, ECD4, AND CD4 MIMETICS. OUR MAJOR RECENT ADVANCE IN LATENCY REVERSAL VIA NF-KB SIGNALING WILL BE FURTHER DEVELOPED IN BOTH NON-HUMAN PRIMATE AND HUMANIZE MICE MODELS, IN COMBINATION WITH CANDIDATES TO CLEAR INFECTED CELLS. WE ENVISION AN ITERATIVE PROCESS WITH INSIGHTS GAINED IN EX VIVO AND PRE-CLINICAL STUDIES, CARRIED FORWARD TO ENHANCE THE NEXT STEP IN CLINICAL DEVELOPMENT AND, IMPORTANTLY, FED BACK TO SCIENTISTS TO VALIDATE ASSAYS OR HYPOTHESES, AND EXPLORE NEW DIRECTIONS. AS WE HAVE DONE IN THE PAST, WE WILL DEVELOP HUMAN CLINICAL TRIALS TO ADDRESS QUESTIONS AND TEST CONCEPTS DEVELOPED IN OUR WORK THROUGH FUNDING MECHANISMS DISTINCT FROM CARE. WE ARE DEDICATED TO WORKING TOGETHER IN A NIMBLE PROGRAM, WITH OUR RESEARCH DIRECTION FOLLOWING OUR DISCOVERIES. TOGETHER WE WILL CATALYZE ADVANCES THAT WILL ULTIMATELY LEAD TO THE ERADICATION OF HIV INFECTION.

HEAD START AND EARLY HEAD START

NORTH CAROLINA OCCUPATIONAL SAFETY AND HEALTH EDUCATION AND RESEARCH CENTER

THE CLINICAL GENOME RESOURCE ? ADVANCING GENOMIC MEDICINE THROUGH BIOCURATION AND EXPERT ASSESSMENT OF GENES AND VARIANTS AT SCALE - PROJECT SUMMARY/ABSTRACT HIGH-QUALITY EVIDENCE ABOUT CLINICALLY RELEVANT GENES AND VARIANTS IS A FUNDAMENTAL CORNERSTONE OF GENOMIC MEDICINE. ALL ASPECTS OF CLINICAL CARE DERIVE FROM ACCURATE INFORMATION ABOUT THE ETIOLOGY, NATURAL HISTORY, AND MANAGEMENT OF DISEASE. WITH GENOMIC ANALYSIS BECOMING MORE ROUTINE FOR PATIENT CARE, THE PUBLIC AVAILABILITY OF WELL-CURATED AND EXPERTLY ADJUDICATED KNOWLEDGE ABOUT GENES AND VARIANTS IS CRITICAL. THE CLINGEN RESOURCE REPRESENTS A HIGHLY COLLABORATIVE EFFORT OF THE GENETICS COMMUNITY TO ESTABLISH AN EVIDENCE-BASED RESOURCE FOR THE ASSESSMENT OF THE CLINICAL RELEVANCE OF GENES AND VARIANTS THAT IS READILY ACCESSIBLE TO (AND TRUSTED BY) DIAGNOSTIC LABORATORIES, PROVIDERS, AND PATIENTS. OUR OBJECTIVE IS TO IMPROVE PATIENT CARE THROUGH ENHANCED AND ACCELERATED CURATION OF THE CLINICAL GENOME USING INNOVATIVE APPROACHES TO OVERCOME CHALLENGES AND ADDRESS NEW TOPICS. WE WILL ACCOMPLISH THIS OBJECTIVE THROUGH THE CONCERTED PURSUIT OF THE FOLLOWING AIMS: AGGREGATION OF STRUCTURED EVIDENCE REGARDING GENETIC CONDITIONS AND THE GENES AND VARIANTS THAT CAUSE THEM; APPLICATION OF FRAMEWORKS FOR EXPERT CURATION OF CLINICAL VALIDITY, VARIANT PATHOGENICITY, AND CLINICAL ACTIONABILITY OF GENETIC CONDITIONS; BROAD DISSEMINATION OF TOOLS, STANDARDS, KNOWLEDGE BASES, AND ASSERTIONS ABOUT CLINICALLY RELEVANT GENES AND VARIANTS; AND EVALUATION OF ALL ASPECTS OF THIS WORK, SO THAT WE CAN IMPROVE THE QUALITY AND IMPACT OF THE RESOURCE FOR IMPLEMENTATION OF TRANSPARENT, REPRODUCIBLE, AND EVIDENCE-BASED GENOMIC MEDICINE. THE PROPOSAL IS INNOVATIVE IN SEVERAL WAYS. IT WILL AGGREGATE DATA PRODUCED BY CUTTING EDGE TECHNOLOGIES, ADAPT ANNOTATION TOOLS TO ENABLE CROWDSOURCING THROUGH COMMUNITY CURATION, AND APPLY ADVANCED NATURAL LANGUAGE PROCESSING FOR ANNOTATION SO THAT HUMAN CURATORS CAN FUNCTION AT THE TOP OF THEIR SKILL LEVEL. IT WILL LEVERAGE THE PARTICIPATION OF A LARGE AND ENTHUSIASTIC COMMUNITY OF VOLUNTEERS, THUS ACTING AS A FORCE MULTIPLIER FOR THE NIH FUNDED TEAMS. IT WILL ENGAGE ADVOCATES WHO CAN CONDUCT OUTREACH WITHIN THEIR AREAS OF SPECIALTY, TO FURTHER EXTEND THE REACH OF CLINGEN PRODUCTS INTO GENOMIC MEDICINE RESEARCH AND CLINICAL CARE. IT WILL TRANSFORM A WIDE RANGE OF CLINICAL AND BASIC SCIENCE DATA INTO WELL-STRUCTURED, TRANSPARENTLY REFERENCED EXPERT ASSERTIONS WITH DOCUMENTATION OF PROVENANCE AND ATTENTION TO ENSURING THE INTEROPERABILITY OF THE RESOURCE WITH DIVERSE END- USERS, INCLUDING ELECTRONIC HEALTH RECORDS. THE PROPOSED RESOURCE PROJECT IS SIGNIFICANT BECAUSE IN ITS ENTIRETY IT WILL IMPROVE, SCALE, AND DISSEMINATE THE FREELY AVAILABLE EXPERT CURATION AND INTERPRETATION OF THE HUMAN GENOME TO THE GLOBAL GENOMICS COMMUNITY WITH THE GOAL OF IMPROVING HEALTH CARE FOR ALL PEOPLE.

UNC-CH CENTER FOR ENVIRONMENTAL HEALTH & SUSCEPTIBILITY

LONGITUDINAL ASSESSMENT OF POST-TRAUMATIC SYNDROMES

THE PURPOSE OF THIS ACTIVITY IS TO STRENGTHEN EFFECTIVE GENERATION AND USE OF HIGH-QUALITY DATA AND EVIDENCE TO STRENGTHEN POLICIES AND PROGRAM IMPLEMENTATION IN LOW- AND MIDDLE-INCOME COUNTRIES. GH PEARL HAS BEEN DESIGNED TO SERVE AS A RESOURCE FOR MONITORING, EVALUATION, RESEARCH AND LEARNING (MERL) RELATED TO IMPROVEMENTS IN THE QUALITY, COVERAGE AND EQUITY OF FAMILY PLANNING (FP) AND REPRODUCTIVE, MATERNAL, NEWBORN, CHILD HEALTH AND NUTRITION (RMNCH+N) INTERVENTIONS.

NOVEL THERAPIES FOR MUCO-OBSTRUCTIVE LUNG DISEASES

ENVIRONMENTAL EXPOSURE AND EFFECT OF HAZARDOUS CHEMICALS

TAS::97 X0360 TAS:: 3D MICROELECTRONICS FOR INFORMATION PROTECTION PROJECT

STUDIES OF NUCLEAR PROCESSES

COLLABORATORY OF AIDS RESEARCHERS FOR ERADICATION (CARE)

EARLY CHILDHOOD SYSTEMS TECHNICAL ASSISTANCE CENTER

A CAROLINA CENTER TO CHARACTERIZE AND MAINTAIN MUTANT MICE

BIOSTATISTICS FOR RESEARCH IN ENVIRONMENTAL HEALTH

MONITORING SOCIAL CHANGE: HEALTH, REPRODUCTION, AGING

APPLICATION PURPOSE: THIS IS A CAPE COD REGIONAL TRANSIT AUTHORITY (CCRTA) REQUEST FOR $22637064 IN AMERICAN RESCUE PLAN 5307 FUNDS (ARP) ACT APPROPRIATION FOR THE BARNSTABLE-MA UZA FOR A PROGRAM OF OPERATING AND CAPITAL PROJECTS WHICH WILL FACILITATE MAINTAINING SERVICE IN THE MIDST AND AFTERMATH OF THE COVID-19 PANDEMIC AS WELL AS ACCELERATE THE CONVERSION OF THE CCRTA FLEET TO ZERO-EMISSIONS VEHICLES.IN ACCORDANCE WITH FTA CIRCULARS 9040.1G AND 9030.1E PREVENTIVE MAINTENANCE ACTIVITIES ARE CONSIDERED OPERATING COSTS.; ACTIVITIES PERFORMED: - OPERATING ASSISTANCE NON-FIXED ROUTE ADA PARATRANSIT SERVICE PREVENTIVE MAINTENANCE AND MOBILITY MANAGEMENT ACTIVITIES FOR THE PERIOD OF JAN 1 2023 - DEC 31 2023- ACQUISITION AND INSTALLATION OF MISCELLANEOUS SUPPORT EQUIPMENT AT THE SOUTH DENNIS OPERATIONS CENTER- PURCHASE OF THREE (3) ELECTRIC CARAVANS- PURCHASE OF SEVEN (7) EIGHT PASSENGER ELECTRIC CUTAWAY BUSES- PURCHASE OF TWO (2) TEN TO TWELVE PASSENGER ELECTRIC CUTAWAY BUSES- PURCHASE OF THREE (3) ELECTRIC ADMINISTRATIVE VEHICLES- EMPLOYEE TRAINING ACTIVITIES FOR FLEET ELECTRIFICATION- ACQUISITION AND INSTALLATION OF REAL-TIME INFORMATION SYSTEMS AT BUS SHELTERS- DEVELOPMENT AND INSTALLATION OF SMARTDART SCHEDULING SOFTWARE; EXPECTED OUTCOMES: THE PRIMARY FOCUS OF THIS EFFORT WILL BE TO CONTINUE TO BRING BACK RIDERSHIP LOST DURING THE COVID PANDEMIC AND MODERNIZE THE FLEET WITH ZERO-EMISSION VEHICLES WHICH ARE IN DEMAND IN AN AREA AS ENVIRONMENTALLY CONSCIOUS AS CAPE COD. BOTH EFFICIENCY AND EMISSION REDUCTION ARE OBVIOUS ADVANTAGES BUT WE WOULD EXPECT FURTHER TO BE A LEADER AMONG TRANSPORTATION PROVIDERS IN THE AREA BY PROVIDING SUPPORT TO OTHERS IN THEIR EFFORTS TO ELECTRIFY THEIR FLEETS.; INTENDED BENEFICIARIES: THE BENEFICIARIES OF THIS EFFORT WILL BE THE RIDERS WHO USE OUR SERVICE BUT THE REDUCED EMISSIONS WE EXPECT TO DELIVER WILL BENEFIT ALL CITIZENS IN OUR AREA AND BEYOND.; SUBRECIPIENT ACTIVITIES: THERE ARE NO SUBRECIPIENT ACTIVITIES DIRECTLY RELATED TO THIS EFFORT.

NC GENES: NORTH CAROLINA CLINICAL GENOMIC EVALUATION BY NEXTGEN EXOME SEQUENCING

UNC CLINICAL NUTRITION RESEARCH UNIT

ADD HEALTH PARENT STUDY: A BIOSOCIAL RESOURCE FOR THE STUDY OF MULTIGENERATIONAL RACIAL/ETHNIC DISPARITIES IN ALZHEIMER'S DISEASE AND ALZHEIMER'S DISEASE-RELATED DEMENTIAS (AD/ADRD) - ABSTRACT SIGNIFICANT KNOWLEDGE GAPS EXIST REGARDING INTERGENERATIONAL DIMENSIONS OF COGNITIVE AGING AND RISK FOR ALZ- HEIMER’S DISEASE AND ALZHEIMER’S DISEASE RELATED DEMENTIAS (AD/ADRD), AND HOW THESE PROCESSES DIFFER ACROSS RACE AND ETHNIC GROUPS. THE PROPOSED ADD HEALTH PARENT STUDY (AHPS) PHASE 2 IS DESIGNED TO AD- DRESS THESE GAPS. AHPS IS AN ONGOING STUDY OF SOCIAL, BEHAVIORAL, AND BIOLOGICAL FACTORS INFLUENCING HEALTHY AGING AND THE DEVELOPMENT OF AD/ADRD IN A NATIONAL SAMPLE OF ADULTS CURRENTLY AGED 58-90. SAMPLE MEMBERS ARE PARENTS OF THE NATIONAL LONGITUDINAL STUDY OF ADOLESCENT TO ADULT HEALTH (ADD HEALTH) COHORT, INITIALLY INTER- VIEWED IN ADD HEALTH IN EARLY MIDLIFE (1994-95) BEFORE DIFFERENTIAL SURVIVAL COULD CONTRIBUTE BIAS TO SAMPLE REP- RESENTATION. PHASE 1 OF AHPS (2015-17) COLLECTED LONGITUDINAL DATA ON A RANDOM SUBSAMPLE OF PARENTS AND THEIR SPOUSE/PARTNERS (S/P, N= 3001), THE MAJORITY (73%) OF WHOM WERE NON-HISPANIC (NH) WHITE. PHASE 2 OF AHPS WILL COLLECT SOCIAL, BEHAVIORAL, AND HEALTH DATA ON ALL AVAILABLE NH BLACK AND HISPANIC PARENTS (BHS SUP- PLEMENT, N= 2,505), AND COGNITIVE ASSESSMENTS AND DNA DATA ON ALL AHPS PHASE 1 AND BHS SAMPLE PARENTS AND THEIR CURRENT S/P (TOTAL N= 5,506). BY ADDING NH BLACK AND HISPANIC PARENTS, AHPS WILL BE SUFFICIENTLY STA- TISTICALLY POWERED TO ADDRESS, FOR THE FIRST TIME, MEASUREMENT OF HEALTH, SOCIAL, AND BEHAVIORAL DIFFERENCES IN AD/ADRD RISK AND PROTECTIVE FACTORS ACROSS RACE/ETHNIC GROUPS AND SOCIOECONOMIC STRATA. COMBINED DATA FROM AHPS PHASES 1 AND 2 WILL BE LINKED WITH RICH LONGITUDINAL DATA ON ORIGINAL ADD HEALTH RE- SPONDENTS TO CREATE AND DISSEMINATE THE FIRST NATIONALLY REPRESENTATIVE MULTIGENERATIONAL BIOSOCIAL RESOURCE WITH COGNITIVE, GENOMIC, BEHAVIORAL, AND SOCIAL DATA FOR THE STUDY OF RACIAL/ETHNIC DISPARITIES IN COGNITIVE AGING AND AD/ADRD RISK. COGNITION AND GENOMIC DATA WILL BE HARMONIZED ACROSS THE TWO GENERATIONS OF PARENTS AND CHILDREN FOR INNOVATIVE ANALYSIS OF INTERGENERATIONAL PREDICTORS OF AD/ADRD; THE ROLE OF GENETIC PROCESSES IN AD/ADRD ETIOLOGY; AND INTERGENERATIONAL AND LATERAL CAREGIVING. PROJECT SPECIFIC AIMS ARE: 1A. RECRUIT AND INTERVIEW ADDITIONAL SAMPLE OF 2,505 NH BLACK AND HISPANIC PARENTS WITH THE AHPS SURVEY. 1B. CONSENT ALL 5,506 AHPS MEMBERS FOR PARTICIPATION IN AD/ADRD ASSESSMENT AND DNA DATA COLLECTION. 2A. COLLECT DNA AND CONDUCT SNP GENOTYPING AND DNA METHYLATION ANALYSIS ON AHPS SAMPLE. 2B. DEVELOP AN INTERGENERATIONAL GENOMIC DATABASE TO ADVANCE AN UNDERSTANDING OF THE GENE-ENVIRONMENT INTERPLAY IN THE ETIOLOGY OF AD/ADRD. 3A. EXAMINE NOVEL LONGITUDINAL AND INTERGENERATIONAL SOCIAL, HEALTH, AND BEHAVIORAL RISK AND PREVENTIVE FACTORS FOR AD/ADRD ACROSS RACIAL/ETHNIC GROUPS AND SOCIAL STRATA. 3B. EXAMINE AHPS MEMBERS’ CAREGIVING EXPERIENCES AND THE SOCIOECONOMIC CONSEQUENCES OF CAREGIVING EX- PERIENCES RELATED TO AD/ADRD CONDITIONS OR RISKS. 4. DOCUMENT, DISSEMINATE, AND PROMOTE USE OF AHPS DATA TO THE GLOBAL SCIENTIFIC COMMUNITY.

TAS::89 0328::TAS RECOVERY

MID-SCALE RI-1 (M1:IP): FABRIC: ADAPTIVE PROGRAMMABLE RESEARCH INFRASTRUCTURE FOR COMPUTER SCIENCE AND SCIENCE APPLICATIONS

EARLY CHILDHOOD TECHNICAL ASSISTANCE CENTER (ECTA)

STATISTICAL METHODS FOR CANCER CLINICAL TRIALS

THE IMPACT OF TOBACCO EXPOSURE ON THE LUNGS INNATE DEFENSE SYSTEM

GENE EXPRESSION PATTERNS IN HUMAN TUMORS IDENTIFIED USING TRANSCRIPT SEQUENCING

NOVEL NANOPARTICLE PLATFORM FOR THE DELIVERY OF VACCINES AND ADJUVANTS

ENVIRONMENT, EPIGENETICS, NEURODEVELOPMENT & HEALTH OF EXTREMELY PRETERM CHILDREN

PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL OF T3D-959 IN MILD TO MODERATE ALZHEIMER'S DISEASE SUBJECTS

HEALTH CENTER CLUSTER

UNC MACS/WIHS COMBINED COHORT STUDY CLINICAL RESEARCH SITE

EFFECTIVE COMMUNICATION ON TOBACCO PRODUCT RISK AND FDA AUTHORITY

MOLECULAR THERAPY CORE CENTER

CENTER FOR GASTROINTESTINAL BIOLOGY AND DISEASE

GENETIC DISORDER OF MUCOCILARY CLEARANCE

HEALTH CENTER PROGRAM

APPLICATION PURPOSE: ACTIVITIES IN THIS GRANT WILL ENABLE CCRTA TO KEEP ITS FLEET AND FACILITIES IN A STATE OF GOOD REPAIR AND CONTINUE PROVIDING A RELIABLE RESPONSIVE AND SAFE SERVICE TO THE PUBLIC THAT WILL HELP KEEP EXISTING RIDERS AND ATTRACT NEW RIDERS.; ACTIVITIES PERFORMED: IMPROVEMENTS TO BUS STATION AND MAINTENANCE FACILITY PROPERTIES AND PURCHASE OF VEHICLES.; EXPECTED OUTCOMES: ACTIVITIES IN THIS GRANT AMENDMENT WILL ENABLE CCRTA TO KEEP ITS FACILITIES IN A STATE OF GOOD REPAIR AND CONTINUE PROVIDING A RELIABLE RESPONSIVE AND SAFE SERVICE TO THE PUBLIC; INTENDED BENEFICIARIES: THE RESIDENTS AND VISITORS OF ALL 15 TOWNS ON CAPE COD.; SUBRECIPIENT ACTIVITIES: NONE

THE UNC CHAPEL HILL SUPERFUND RESEARCH PROGRAM (UNC-SRP)

SEEDING POSTDOCTORAL INNOCATORS IN RESEARCH AND EDUCATION (SPIRE)

ADEPT: DXOD - POC

UNIVERSITY OF NORTH CAROLINA AIDS CLINICAL TRIALS UNIT (UNC ACTU)

EVALUATION AND RESEARCH CAPACITY OF THE COMMUNITY HEALTH AND SOCIAL SERVICE PROGRAMS IN THE UNITED REPUBLIC OF TANZANIA

HOST INNATE IMMUNE-MICROBIAL INTERACTIONS AND INTESTINAL INFLAMMATION

INSTITUTIONAL PORTION OF THE HIGHER EDUCATION EMERGENCY RELIEF FUND FORMULA GRANTS AUTHORIZED BY SECTION 1800 (A) (1) OF THE CARES ACT

STATISTICAL AND APPLIED MATHEMATICAL SCIENCES INSTITUTE

ANCA GLOMERULONEPHRITIS: FROM MOLECULES TO MAN

HEAD START FULL YEAR/PART DAY

STRATEGIC INFORMATION CAPACITY BUILDING ACTIVITY WITH LWA-

HEAD START

MODIFICATION OF COOPERATIVE AGREEMENT TO ADD STANDARD PROVISIONS.

INFLATION REDUCTION ACT MARYLAND MID ATLANTIC ENVIRONMENTAL JUSTICE FUND URBAN AND COMMUNITY FORESTRY

GRADUATE RESEARCH FELLOWSHIP PROGRAM (GRFP)

UNIVERSITY TRANSPORTATION CENTERS

PA-22 FYPD, PA-20 T/TA & CDA

DEEP SEQUENCING STUDIES FOR CANNABIS AND STIMULANT DEPENDENCE

NORTH CAROLINA BIO-PREPAREDNESS COLLABORATIVE (NCB-PREPARED)

TA CENTER ON EARLY CHILDHOOD

STATE MATERNAL HEALTH INNOVATION SUPPORT AND IMPLEMENTATION PROGRAM

NATIONAL LONGITUDINAL STUDY OF ADOLESCENT TO ADULT HEALTH (ADD HEALTH): WAVE VI COGNITION AND EARLY RISK FACTORS FOR DEMENTIA PROJECT - PROJECT SUMMARY ALZHEIMER'S DISEASE AND RELATED DEMENTIAS (ADRD) ARE PROJECTED TO AFFECT 14 MILLION AMERICANS BY 2050. TO DATE, THOUGH, RESEARCH ON THE SIGNS AND SYMPTOMS OF ADRD HAS BEEN SPARSE IN EARLY MIDLIFE POPULATIONS, ESPECIALLY AT THE NATIONAL LEVEL. IT IS CRUCIAL TO CONDUCT SUCH RESEARCH BECAUSE EARLY CHANGES IN COGNITIVE FUNCTIONING AND THE ACCUMULATION OF RISK FACTORS FOR ADRD CAN BEGIN DECADES BEFORE CONCRETE SIGNS AND SYMPTOMS EMERGE. THE CHALLENGING SEARCH FOR THE CAUSES OF ADRD HAS MADE IT CLEAR THAT PROSPECTIVE AND COMPREHENSIVE DATA—INCLUDING DETAILED SOCIAL, BIOLOGICAL, AND HEALTH MEASUREMENTS ACROSS THE LIFE COURSE— ARE NEEDED TO IDENTIFY KEY PREDICTORS OF ADRD. AS SUCH, THE NATIONAL LONGITUDINAL STUDY OF ADOLESCENT TO ADULT HEALTH (ADD HEALTH) PROVIDES AN EXTRAORDINARY OPPORTUNITY TO STUDY THE EARLY ORIGINS OF COGNITIVE FUNCTIONING/CHANGE AND ADRD RISK IN A NATIONALLY REPRESENTATIVE COHORT THAT HAS BEEN FOLLOWED SINCE ADOLESCENCE AND WILL BE IN THEIR MID-40S IN THE NEXT WAVE OF DATA COLLECTION (WAVE VI). THE OVERALL GOAL OF THIS PROJECT IS TO COLLECT AND DISSEMINATE CRITICAL DATA RELATED TO COGNITIVE, PHYSICAL, AND SENSORY FUNCTIONING IN CONJUNCTION WITH THE ADD HEALTH WAVE VI CORE PROJECT TO FACILITATE IDENTIFICATION OF EARLY RISK FACTORS FOR LATER LIFE ADRD. ADDING SUCH RICH MEASURES TO WAVE VI OF ADD HEALTH WILL MAKE POSSIBLE TRACKING OF COGNITIVE, SENSORY, AND PHYSICAL FUNCTIONING ACROSS THE LIFE COURSE; COUPLED WITH THE TESTING OF BIOLOGICAL RISK MARKERS, IT WILL ALSO LAY THE FOUNDATION FOR DETECTING SIGNS OF COGNITIVE IMPAIRMENT AND ADRD RISK IN EARLY MIDLIFE. THESE NEW DATA, WHEN COMBINED WITH ADD HEALTH'S EXISTING 25-YEAR COLLECTION OF EXTRAORDINARILY RICH MULTI-LEVEL AND LONGITUDINAL MEASURES AND ITS NEW WAVE VI DATA, WILL ALSO AID IN THE SCIENTIFIC COMMUNITY'S UNDERSTANDING OF THE INTERPLAY OF SOCIAL, BEHAVIORAL, AND BIOLOGICAL FACTORS LEADING TO ADRD IN LATER LIFE. MOREOVER, BECAUSE ADD HEALTH IS A VERY DIVERSE SAMPLE, ADDING THESE DATA TO WAVE VI WILL GREATLY INCREASE UNDERSTANDING OF COGNITIVE, PHYSICAL, AND SENSORY FUNCTIONING WITHIN HEALTH DISPARITY POPULATIONS. THE PROJECT'S SPECIFIC AIMS ARE TO: 1) COLLECT NEW IN- DEPTH, IN-PERSON ASSESSMENTS OF COGNITIVE FUNCTIONING IN EARLY MIDLIFE FOR A NATIONALLY REPRESENTATIVE AND RACIALLY/ETHNICALLY DIVERSE SUBSAMPLE OF PARTICIPANTS IN WAVE VI; 2) COLLECT AUTOMATED, (LARGELY) WEB-BASED MEASURES OF COGNITION IN EARLY MIDLIFE FOR ALL PARTICIPANTS IN WAVE VI AND COMPARE THEM WITH OUR IN-PERSON MEASURES OF COGNITION TO ASSESS THEIR FEASIBILITY AND VALUE; 3) INCLUDE ASSESSMENTS OF PHYSICAL AND SENSORY FUNCTIONING IN EARLY MIDLIFE FOR WAVE VI PARTICIPANTS OF ADD HEALTH; 4) TEST FOR BIOLOGICAL MARKERS OF ADRD RISK AND COGNITIVE FUNCTION IN EARLY MIDLIFE; 5) CLEAN, DOCUMENT, DISSEMINATE, PROMOTE, AND SUPPORT THE DATA COLLECTED IN THIS PROJECT FOR THE SCIENTIFIC COMMUNITY. ALL TOLD, THIS PROJECT WILL COLLECT AND DISSEMINATE INNOVATIVE DATA TO THOUSANDS OF RESEARCHERS THAT WILL FACILITATE THE RIGOROUS STUDY OF COGNITION AND RISK FACTORS FOR LATER LIFE ADRD AMONG A DIVERSE NATIONALLY REPRESENTATIVE SAMPLE OF EARLY MIDLIFE AMERICANS.

HEAD START AND EARLY HEAD START

HEALTH CENTER CLUSTER

H3ABIONET: INFORMATICS SOLUTIONS FOR H3AFRICA

SEMANTIC LAMHDI: LINKING DISEASES TO MODEL ORGANISM RESOURCES

CATEGORY 1: UNC CENTER FOR HEALTH PROMOTION AND DISEASE PREVENTION

GRADUATE RESEARCH FELLOWSHIP PROGRAM (GRFP)

PURPOSE: THE ASSOCIATION TO PRESERVE CAPE COD WILL WORK WITH AN ARRAY OF PARTNERS TO LEAD THE COLLABORATIVE PLANNING, DESIGN, AND IMPLEMENTATION OF PROJECTS TO RESTORE RIVERS, RETIRED CRANBERRY BOGS, AND SALT MARSHES ON CAPE COD IN MASSACHUSETTS. THESE EFFORTS WILL SUPPORT IMPORTANT SPECIES LIKE RIVER HERRING AND AMERICAN EEL. THEY WILL ALSO PROVIDE BENEFITS TO COMMUNITIES SUCH AS INCREASED CLIMATE RESILIENCE AND PROTECTION FROM FLOODING.

METABOLOMICS AND CLINICAL ASSAYS CENTER - ABSTRACT (METABOLOMICS AND CLINICAL ASSAY CENTER, MCAC) DETERMINING HOW INDIVIDUALS DIFFER IN THEIR METABOLISM, AND IN THEIR RESPONSE TO DIETARY INTAKE, IS CRITICAL TO DEVELOPING PERSONALIZED INTERVENTION STRATEGIES FOR PREVENTING AND DELAYING THE ONSET OF CHRONIC DISEASES SUCH AS OBESITY, DIABETES, CARDIOVASCULAR DISEASE, AND CANCER. THE MCAC WILL A) ACQUIRE AND PROCESS HIGH QUALITY TARGETED AND UNTARGETED METABOLOMICS DATA, B) PRIORITIZE, PREDICT, AND CONFIRM THE IDENTITY OF UNKNOWN PEAKS, C) PROVIDE CLIA CERTIFIED CLINICAL ASSAYS, D) COLLABORATE WITH THE COMMON FUND DATA ECOSYSTEM, E) CONSTRUCT A DATA INFRASTRUCTURE WHICH ENSURES FAIRNESS AND ENABLES INTEROPERABILITY OF THE DATA WITH OTHER COMMON FUND DATA SETS, AND F) COLLABORATIVELY WORK WITH THE NIH COMMON FUND NUTRITION FOR PRECISION HEALTH (NPH) CONSORTIUM. THE MCAC BRINGS AN OUTSTANDING TEAM OF INVESTIGATORS FROM 3 UNC SYSTEMS UNIVERSITIES THAT ARE CO-LOCATED ON THE NORTH CAROLINA RESEARCH CAMPUS (NCRC) AND DUKE UNIVERSITY. DR. SUSAN SUMNER (UNC CHAPEL HILL, NUTRITION RESEARCH INSTITUTE, NCRC, UNTARGETED METABOLOMICS) WILL SERVE AS THE PI WITH SUPPORT FROM EXPERT SCIENTISTS WHO SPECIALIZE IN NUTRITION AND TARGETED METABOLOMICS OF HOST METABOLISM (DR. CHRISTOPHER NEWGARD, DIRECTOR, SARAH W. STEDMAN NUTRITION AND METABOLISM CENTER AND DUKE MOLECULAR PHYSIOLOGY INSTITUTE), DIETARY INTERVENTIONS AND TARGETED PHYTOCHEMICAL ANALYSIS (DR. COLIN KAY, NORTH CAROLINA STATE UNIVERSITY, NCRC), CLIA CERTIFIED CLINICAL ASSAYS (DR. STEVEN COTTEN, UNCCH), AND COMPUTATIONAL METABOLOMICS (DR. XIUXIA DU, UNC CHARLOTTE, NCRC). OUR TEAM PROVIDES A UNIQUE COMBINATION OF LONG-STANDING EXPERTISE IN METABOLOMICS TECHNOLOGIES, COUPLED WITH DEEP KNOWLEDGE OF NUTRITION, METABOLIC PHYSIOLOGY, AND CHRONIC DISEASE MECHANISMS. WE ARE EXPERIENCED WITH THE APPLICATION OF TARGETED AND UNTARGETED METABOLOMICS IN LARGE-SCALE CLINICAL AND EPIDEMIOLOGY STUDIES, INCLUDING IN OTHER NIH CONSORTIA. WE HAVE USED METABOLOMICS TO DEFINE METABOLIC SIGNATURES AND PATHWAYS ASSOCIATED WITH DIETARY INTAKE, NUTRITION ASSESSMENTS, DEMOGRAPHICS, LIFESTYLE FACTORS, MICROBIAL POPULATIONS, GENETICS, TRANSCRIPTOMICS, CLINICAL ASSAYS, AND CLINICAL PHENOTYPES OF HEALTH AND WELLNESS. WE HAVE DEVELOPED COMPREHENSIVE INFORMATICS CAPABILITIES FOR TARGETED AND UNTARGETED METABOLOMICS AND EXPOSOME RESEARCH. WE HAVE DEVELOPED AN ONLINE MASS SPECTRAL KNOWLEDGE BASE RESOURCE FOR PRIORITIZING AND PREDICTING UNKNOWN METABOLITES BY LEVERAGING PUBLICLY AVAILABLE DATA. OUR HIGH QUALITY MCAC DATASETS PRODUCED UNDER FINE-TUNED PROTOCOLS WITH QUALITY CONTROL AND QUALITY ASSURANCE METRICS, WILL BE ESSENTIAL FOR SUCCESS OF THE NPH CONSORTIUM. THE MCAC WILL PROVIDE DATA AND EXPERT BIOLOGICAL INTERPRETATION IN EXPLORATION OF THE HETEROGENEITY IN METABOLISM AMONG STUDY SUBJECTS, PROVIDING A ROADMAP THAT WILL HELP EXPLAIN WHY INDIVIDUALS DIFFER IN THEIR METABOLIC RESPONSES TO DIETARY INTERVENTIONS, AND WHAT THIS PORTENDS FOR FUTURE DISEASE RISK. THE MCAC WILL PROVIDE A ROBUST DATA SET TO THE ARTIFICIAL INTELLIGENCE FOR MULTIMODAL DATA MODELING AND BIOINFORMATICS CENTER FOR USE IN DEVELOPMENT OF ALGORITHMS TO PREDICT INDIVIDUAL DIETARY RESPONSES THAT CAN ULTIMATELY BE TRANSLATED FOR DESIGN OF TARGETED DIETARY INTERVENTIONS TO IMPROVE HEALTH AND QUALITY OF LIFE.

APPLICATION PURPOSE: THIS IS A CAPE COD REGIONAL TRANSIT AUTHORITY (CCRTA) REQUEST FOR $14613149 IN SECTION 5339 LOW OR NO EMISSIONS PROGRAMS FUNDS FOR THE BARNSTABLE-MA UZA FOR THE PURCHASE OF 13- 35 DIESEL-ELECTRIC HYBRID BUSES TO REPLACE 13 - 29 AND 30 DIESEL BUSES RELATED TOOLS EQUIPMENT AND WORKFORCE DEVELOPMENT.; ACTIVITIES PERFORMED: CCRTA RECEIVED LOW EMISSIONS GRANT FUNDING TO ACQUIRE 13 - 35 DIESEL-ELECTRIC HYBRID VEHICLES WHICH WILL ALLOW US TO DIVERSIFY OUR AGENCYS VEHICLE PROFILE (2) PURCHASE TOOLS AND EQUIPMENT NECESSARY FOR THE TRANSITION. CCRTA IS SEEKING FUNDING FOR TOOLS AND EQUIPMENT INCLUDING GANTRY CRANES AND LIFTS TO ALLOW OUR MAINTENANCE TEAM TO KEEP THE VEHICLES IN SERVICE AND (3) WORK FORCE DEVELOPMENT. CCRTA IS WORKING WITH CAPE TECHNICAL SCHOOLS AND CAPE COD COMMUNITY COLLEGE TO DEVELOP CURRICULUM AND WORK FORCE OPPORTUNITIES TO SUPPORT LOW EMISSIONS VEHICLE OPERATIONS MAINTENANCE AND SUPPORT TO PREPARE INDIVIDUALS FOR JOBS. CCRTA IS ALSO WORKING WITH OUR OPERATING COMPANY TO PROVIDE EXTENSIVE TRAINING FOR THE IMPLEMENTATION OPERATION STORAGE AND MAINTENANCE FOR THE HYBRID VEHICLES.- THE EV TRAINING PROGRAM IS CURRENTLY UNDERWAY AND INCLUDES BOTH HANDS ON AND DIDACTIC INSTRUCTION FOR EACH EMPLOYEE CRAFT INCLUDING DRIVERS MECHANICS SUPERVISORS TRAINERS DISPATCHERS ADMINISTRATIVE STAFF AND MANAGERS. - EACH TEAM MEMBERS IS REQUIRED TO ATTEND MULTIPLE CLASSES OVER THE COURSE OF TWO MONTHS.- DRIVERS AND MECHANICS WILL RECEIVE CONTINUED MONTHLY EV TRAINING INSTRUCTION THEREAFTER IN ADDITION TO TRADITIONAL SAFETY TRAINING.; EXPECTED OUTCOMES: CCRTA WILL IMPROVE AIR QUALITY THROUGHOUT CAPE COD. THE BUSES IDENTIFIED IN THIS GRANT WILL TRAVERSE THROUGHOUT ALL OF THESE COMMUNITIES AND WILL REDUCE HARMFUL NOX VOC CO2 AND PM THROUGHOUT THE REGION. THESE EMISSIONS HAVE BEEN LINKED TO HARMFUL HEALTH IMPACTS SUCH AS INCREASED RATES OF ASTHMA AND OTHER DISEASES. THE AGENCY ALSO WILL TARGET RECRUITMENT IN THESE AREAS TO IDENTIFY INDIVIDUALS TO BRING INTO THE WORKFORCE FOR GOOD PAYING JOBS.; INTENDED BENEFICIARIES: THE BENEFICIARIES OF THIS EFFORT WILL BE THE RIDERS WHO USE OUR SERVICE BUT THE IMPROVED AIR QUALITY WILL BENEFIT ALL CITIZENS IN OUR AREA AND BEYOND.; SUBRECIPIENT ACTIVITIES: NOT APPLICABLE

RESEARCH INFRASTRUCTURE: FABRIC OPERATIONS - ACCELERATING INNOVATION AND RESEARCH -THE FABRIC PROJECT HAS DEPLOYED A STATE-OF-THE-ART PROGRAMMABLE WORLD-WIDE NETWORK INFRASTRUCTURE DURING THE COMMISSIONING PHASE FUNDED THROUGH THE NSF MIDSCALE RESEARCH INFRASTRUCTURE-1 PROGRAM. THIS INFRASTRUCTURE CONNECTS RESEARCH FACILITIES GLOBALLY, ENABLING GROUNDBREAKING DISTRIBUTED APPLICATIONS AND SERVICES USING WHILE MORE THAN 30 INTERCONNECTED FABRIC SITES ALREADY DEPLOYED. FABRIC ENHANCES RESEARCH CAPABILITIES IN WIDE-AREA NETWORKING PROTOCOLS, INTERNET-OF-THINGS (IOT), BIG DATA, MACHINE LEARNING, MOBILE TECHNOLOGIES AND HIGH-PERFORMANCE COMPUTING, FOSTERING SCIENTIFIC DISCOVERIES AND CROSS-DISCIPLINARY COLLABORATIONS. THE FABRIC PROJECT, NOW IN ITS OPERATIONS PHASE, AIMS TO FURTHER GROW USER COMMUNITIES, FOSTER OPERATIONAL EXCELLENCE, DEVELOP NEW FEATURES, AND DEMONSTRATE SUCCESS TO ITS STAKEHOLDER COMMUNITIES. EXPANDING THE USER BASE AMPLIFIES THE IMPACT OF FABRIC AND OTHER NSF TESTBEDS ON SCIENCE. BY PROVIDING RELIABLE SERVICES, FABRIC ENSURES REPRODUCIBILITY OF COMPLEX EXPERIMENTS. THE DEVELOPMENT OF NEW FEATURES ATTRACTS USERS FROM VARIOUS COMMUNITIES, HELPING ADDRESS THEIR SPECIFIC NEEDS. DEMONSTRATING SUCCESS THROUGH MEASURED OUTCOMES INFORMS THE FUNDERS AND REINFORCES FABRIC'S IMPACT ON STAKEHOLDER COMMUNITIES. ITS INTELLECTUAL MERITS LIE IN INFRASTRUCTURE PROGRAMMABILITY AND INTERCONNECTIVITY, ENABLING EXPERIMENTATION WITH DISTRIBUTED SYSTEMS AT UNPRECEDENTED SCALES. IT SUPPORTS SCIENTIFIC REPRODUCIBILITY AND IS A CRUCIAL COMPONENT OF THE SCIENTIFIC CYBERINFRASTRUCTURE ECOSYSTEM. ITS IMPACT SPANS DIVERSE DOMAINS, SUCH AS HIGH-ENERGY PHYSICS, ASTROPHYSICS, CYBERSECURITY, AND SCIENTIFIC INSTRUMENT STREAMING SERVICES, EMPOWERING RESEARCHERS TO ACHIEVE BREAKTHROUGH DISCOVERIES. FABRIC'S BROADER IMPACTS EXTEND TO RESEARCHERS IN COMPUTER SCIENCE, ENGINEERING, AND DOMAIN SCIENCES SUCH AS GENOMICS, ASTRONOMY AND CLIMATE RESEARCH. IT ACTIVELY ENGAGES THE RESEARCH COMMUNITY THROUGH KNIT WORKSHOPS AND THE AMBASSADOR PROGRAM DESIGNED TO EXPAND FABRIC?S REACH TO RESEARCHERS FROM ALL DISCIPLINES AND INSTITUTIONS, REGARDLESS OF BACKGROUND. FABRIC PROVIDES EDUCATIONAL RESOURCES TO FACULTY, AND DEVELOPS COLLABORATIONS WITH MINORITY-SERVING INSTITUTIONS, SIMPLIFYING ACCESS TO ADVANCED RESEARCH TOOLS AND INFRASTRUCTURE FOR MANY COMMUNITIES. THE PROJECT WEBSITE, [HTTPS://WWW.FABRIC-TESTBED.NET], SERVES AS A CENTRAL REPOSITORY FOR PROJECT UPDATES, DATA, CODE, AND RESOURCES, FOSTERING COLLABORATION AND ACCESSIBILITY WORLDWIDE. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.- SUBAWARDS ARE PLANNED FOR THIS AWARD.

DISCOVERY OF NEW INNATE IMMUNE PATHWAYS IN VIRAL RECOGNITION

NORTH CAROLINA STI/TM COOPERATIVE RESEARCH CENTER

AMERICAN RECOVERY AND REINVESTMENT ACT OF 2009, HEALTH INFORMATION TECHNOLOGY EXTENSION PROGRAM: REGIONAL CENTERS

NUTRITION FOR PRECISION HEALTH: THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL CLINICAL CENTER - PROJECT SUMMARY/ABSTRACT – THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL CLINICAL CENTER THE NEED FOR MORE PRECISE NUTRITION ADVICE IS WIDELY RECOGNIZED, YET SPECIFIC DIFFERENCES IN GENETIC, EPIGENETIC, MICROBIOME AND PHENOTYPIC DRIVERS OF INDIVIDUAL VARIABILITY TO DIET ARE NOT WELL KNOWN. THE NATIONAL INSTITUTES OF HEALTH INITIATIVE TO FUND NUTRITION FOR PRECISION HEALTH (NPH), POWERED BY THE ALL OF US RESEARCH PROGRAM, WILL ENABLE MAJOR PROGRESS IN THE FIELD OF PRECISION NUTRITION. HERE WE PROPOSE NUTRITION FOR PRECISION HEALTH: THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL CLINICAL CENTER (UNC-CC). BECAUSE CHRONIC INFLAMMATION PROMOTES THE PATHOGENESIS OF A WIDE RANGE OF DISEASES, INCLUDING OBESITY, TYPE 2 DIABETES, AND CARDIOVASCULAR, NEOPLASTIC, AND NEURODEGENERATIVE DISORDERS, WE DRAW UPON THE ANTI-INFLAMMATORY MEDITERRANEAN DIET AS A VIABLE STRATEGY TO IMPROVE SYSTEMIC INFLAMMATION AND REDUCE RISK FOR MANY CHRONIC DISEASES AND THEIR COMPLICATIONS. A BODY OF LITERATURE HAS EMERGED THAT DEMONSTRATES BOTH GENOTYPICALLY- AND PHENOTYPICALLY-DRIVEN DIFFERENTIAL RESPONSES TO THE MEDITERRANEAN DIET RELATIVE TO A RANGE OF OUTCOMES. OUR PROPOSAL WILL ADDRESS THE CRITICAL NEED TO UNDERSTAND VARIABILITY IN PHYSIOLOGIC RESPONSES TO DIET, ANCHORED BY THE THEME OF INFLAMMATION. WE EMPHASIZE INCLUSION OF A HIGHLY DIVERSE SAMPLE FACILITATED BY TWO CLINICAL LOCATIONS WITH METABOLIC KITCHENS: THE UNC NUTRITION RESEARCH INSTITUTE (UNC-NRI) IN KANNAPOLIS, NC, AND THE CHAPEL HILL CAMPUS OF UNC (UNC-CH). THE UNC-NRI DRAWS FROM RELATIVELY RURAL COMMUNITIES, AND UNC-CH DRAWS FROM RELATIVELY URBAN COMMUNITIES, BOTH WITH A SUBSTANTIAL PROPORTION OF PEOPLE OF COLOR. SPECIFIC AIMS ARE: AIM 1. TO PARTICIPATE ACTIVELY IN THE YEAR 1 PLANNING PROCESS AND BEYOND, ENGAGING ACROSS THE NPH CONSORTIUM TO COLLABORATIVELY DEVELOP AND EXECUTE THE FINAL STUDY PROTOCOL. AIM 2. TO EXECUTE NPH MODULE 1. FOLLOWING PARTICIPANT ENROLLMENT INTO ALL OF US, WE WILL ENROLL AND COMPLETE THE MODULE 1 PROTOCOL FOR A TOTAL OF 2,000 NPH PARTICIPANTS (25% AT UNC-NRI; 75% AT UNC-CH), INCLUDING TWO STUDY VISITS WITH A 2-WEEK REMOTE DATA CAPTURE PERIOD AND A MIXED MEAL CHALLENGE TEST. AIM 3. TO EXECUTE NPH MODULE 2. A SUBSET OF 500 MODULE 1 PARTICIPANTS WILL COMPLETE A FREE-LIVING, CONTROLLED FEEDING STUDY OF THREE 2-WEEK DIET INTERVENTION PERIODS, SEPARATED BY 3-WEEK WASHOUT PERIODS. DIETS INCLUDE: THE MEDITERRANEAN DIET ADAPTED FOR THE US (MED-USA; 40% FAT CALORIES, 40% CARBOHYDRATE), THE MED-USA MODIFIED FOR HIGH HEALTHY FAT CONTENT (60% FAT CALORIES, 20% CARBOHYDRATE), AND MED-USA MODIFIED FOR HIGH HEALTHY CARBOHYDRATE CONTENT (20% FAT CALORIES, 60% CARBOHYDRATE). DIFFERENTIAL EFFECTS OF THE DIETS ON OUTCOMES COMPRISING INFLAMMATORY MARKERS AND METABOLIC PARAMETERS FROM THE MIXED MEAL CHALLENGE WILL BE TESTED ACROSS GENOTYPIC AND PHENOTYPIC SUBGROUPS, FOCUSING ON WEIGHT STATUS, AGE, AND DIABETES STATUS. THE UNC-CC TEAM BRINGS IMPRESSIVE INTERDISCIPLINARY STRENGTH IN NUTRITION (BASIC SCIENCE TO PUBLIC HEALTH) AND HAS THE CAPACITY AND EXPERIENCE IN COMPLEX, MULTI-SITE TRIALS TO ENSURE THE SCIENTIFIC RIGOR NEEDED TO EXECUTE THIS STUDY. RESULTS WILL GENERATE PREDICTIVE ALGORITHMS TO INFORM INDIVIDUALIZED DIETARY GUIDANCE TO IMPROVE HEALTH.

ILLUMINATING THE DRUGGABLE GPCR-OME

HEALTH CENTER CLUSTER

FACILITATION, SPREAD AND TRANSLATION OF PATIENT-CENTERED EVIDENCE IN NC PRACTICES

MCH WORKFORCE CENTERS

GRADUATE RESERACH FELLOWSHIP PROGRAM (GRFP)

FUNCTIONAL SELECTIVITY: A NOVEL APPROACH FOR CNS DRUG DISCOVERY

HEALTH CENTER CLUSTER

ILLUMINATING FUNCTION OF THE UNDERSTUDIED DRUGGABLE KINOME

UNC DEVELOPMENTAL DISABILITIES RESEARCH CENTER

THE CAPE COD REGIONAL TRANSIT AUTHORITY REQUESTS $8775138 IN CRRSAA FUNDS IS TO PROVIDE FUNDS FOR OPERATING ASSISTANCE AND PREVENTATIVE MAINTENANCE ACTIVITIES. CCRTA WILL UTILIZE AT LEAST 1% OF THESE FUNDS FOR PUBLIC TRANSPORTATION SECURITY OPERATING EXPENSES. CCRTA IS CURRENTLY DEVELOPING AN ACTION PLAN TO OBLIGATE THE REMAINING $2770535 OF UNOBLIGATED FUNDS FROM CRRSAA FOR CAPITAL EXPENSES AND WILL APPLY FOR A GRANT IN THE NEAR FUTURE.PURPOSE:THE PURPOSE OF THIS GRANT IS TO PROVIDE APPROXIMATELY 2 YEARS OF OPERATING ASSISTANCE AND PREVENTIVE MAINTENANCE FUNDS TO THE CAPE COD REGIONAL TRANSIT AUTHORITY TO ASSIST IT IN RECOVERING FROM THE EFFECTS OF THE COVID-19 PANDEMIC DURING THE PERIOD OF JULY 1 2022 TO SEPTEMBER 27 2024.ACTIVITIES TO BE PERFORMED:FUNDS WILL BE USED TO COVER ALL ELIGIBLE OPERATING EXPENSES SUCH AS DRIVER SALARIES FUEL ITEMS HAVING A USEFUL LIFE OF LESS THAN ONE YEAR PREVENTIVE MAINTENANCE ETC. IN ORDER TO CONTINUE TRANSIT OPERATIONS.EXPECTED OUTCOMES:FUNDING WILL PERMIT CONTINUOUS UNINTERRUPTED SERVICE FOR RIDERS WHILE ENSURING THAT TRANSIT ASSETS ARE MAINTAINED IN A STATE OF GOOD REPAIR.INTENDED BENEFICIARIES:RIDERS IN ALL 15 TOWNS ON CAPE COD.SUBRECIPIENT ACTIVITIES:THERE ARE NO SUBRECIPIENTS WHO WILL RECEIVE FUNDS FROM THIS AWARD.CCRTA AGREES THAT IF IT RECEIVES FEDERAL FUNDING FROM THE FEDERAL EMERGENCY MANAGEMENT AGENCY (FEMA) OR THROUGH A PASS-THROUGH ENTITY THROUGH THE ROBERT T. STAFFORD DISASTER RELIEF AND EMERGENCY ASSISTANCE ACT A DIFFERENT FEDERAL AGENCY OR INSURANCE PROCEEDS FOR ANY PORTION OF A PROJECT ACTIVITY APPROVED FOR FTA FUNDING UNDER THIS GRANT AGREEMENT IT WILL PROVIDE WRITTEN NOTIFICATION TO FTA AND REIMBURSE FTA FOR ANY FEDERAL SHARE THAT DUPLICATES FUNDING PROVIDED BY FEMA ANOTHER FEDERAL AGENCY OR AN INSURANCE COMPANY.CCRTA IS BARNSTABLE COUNTYS REGIONAL TRANSIT AUTHORITY SERVING THE 15 TOWNS ON CAPE COD (BARNSTABLE BOURNE BREWSTER CHATHAM DENNIS ORLEANS EASTHAM SANDWICH TRURO WELLFLEET FALMOUTH HARWICH MASHPEE PROVINCETOWN AND YARMOUTH). CCRTA PROVIDES FIXED ROUTE FLEX ROUTE PARATRANSIT (ADA AND GENERAL DIAL-A RIDE) AND FULLY FUNDED HUMAN SERVICE TRANSPORTATION SERVICES TO MEMBER TOWNS. CCRTA IS A MEMBER OF THE CAPE COD JOINT TRANSPORTATION COMMITTEE (CCJTC) OF THE CAPE COD COMMISSION (CCC REGIONAL PLANNING AGENCY) AND A VOTING MEMBER OF THE METROPOLITAN PLANNING ORGANIZATION.

ATLANTIC COAST CENTER FOR INFECTIOUS DISEASE DYNAMICS AND ANALYTICS

HIGHER EDUCATION EMERGENCY RELIEF PROJECT

IND-ENABLING STUDIES IN SUPPORT OF FIRST IN HUMAN SAFETY STUDIES OF A NOVEL ANTI-NICOTINE HUMAN MONOCLONAL ANTIBODY - ENTER THE TEXT HERE THAT IS THE NEW ABSTRACT INFORMATION FOR YOUR APPLICATION. THIS SECTION MUST BE NO LONGER THAN 30 LINES OF TEXT.

THE CLINICAL GENOME RESOURCE - EXPERT CURATION AND EHR INTEGRATION

COMPUTER INTEGRATED SYSTEMS FOR MICROSCOPY&MANIPULATION

RESEARCH TRIANGLE CENTER OF EXCELLENCE IN REGULATORY SCIENCE AND INNOVATION - ABSTRACT THE RAPID EMERGENCE OF INNOVATIVE TECHNOLOGIES, THERAPEUTICS, AND OTHER FDA-REGULATED PRODUCTS HAVE OUTPACED THE ABILITY TO EFFECTIVELY APPROPRIATE THEM FOR PUBLIC BENEFIT. DOING SO HINGES ON THE CAPABILITY TO EXPEDITIOUSLY EVALUATE THESE PRODUCTS AND EFFECTIVELY MONITOR THEM ONCE ON THE MARKET. HOWEVER, METHODOLOGIES FOR PRE- MARKET EVALUATION THROUGH LABORATORY TESTING AND CLINICAL TRIALS FOR DRUGS, DEVICES, AND BIOLOGICS AND FOR POST- MARKETING SURVEILLANCE OF ALL FDA-REGULATED PRODUCTS HAVE NOT KEPT PACE, AND KEY GAPS IN KNOWLEDGE EXIST THAT WOULD INFORM REGULATORY DECISION MAKING IN MANY AREAS. IN THE FACE OF THESE PRESSING NEEDS, THE RESEARCH TRIANGLE CENTER OF EXCELLENCE IN REGULATORY SCIENCE AND INNOVATION (TRIANGLE CERSI) WILL PROVIDE A ONE-STOP- SHOP ACCELERATOR TO MEET FDA’S CURRENT AND EVOLVING NEEDS IN REGULATORY SCIENCE AND A GENERATIVE COMMUNITY FOR REGULATORS, ACADEMIA, INDUSTRY, AND OTHER STAKEHOLDERS. A COLLABORATION OF THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL, DUKE UNIVERSITY, NORTH CAROLINA STATE UNIVERSITY, AND NORTH CAROLINA CENTRAL UNIVERSITY, ALL IN CLOSE PROXIMITY, THE TRIANGLE CERSI REPRESENTS A BROAD NETWORK OF INVESTIGATORS AND NATIONAL AND INTERNATIONAL COLLABORATORS THAT BRING UNIQUE AND DIVERSE EXPERTISE AND RESOURCES FOR REGULATORY SCIENCE, INCLUDING BUT NOT LIMITED TO NOVEL APPROACHES IN STATISTICAL METHODOLOGIES, MACHINE LEARNING AND ARTIFICIAL INTELLIGENCE, IMAGING, IN SILICO TRIALS, PEDIATRIC PHARMACOLOGY, PATIENT REPORTED OUTCOMES (PRO), POPULATION SCIENCE, AND SAFETY ASSESSMENT ACROSS THE LIFESPAN, AND OTHER AREAS. THE TRIANGLE CERSI INCLUDES TWO SCHOOLS OF MEDICINE, A SCHOOL OF PHARMACY, TWO SCHOOLS OF NURSING, A SCHOOL OF PUBLIC HEALTH, A COLLEGE OF VETERINARY MEDICINE, A LEADING HISTORICALLY BLACK UNIVERSITY, A NATIONAL CENTER FOR VIRTUAL IMAGING TRIALS, AND THE DUKE CLINICAL RESEARCH INSTITUTE, AND LEVERAGES RELATIONSHIPS WITH NEARBY COMPANIES AND ORGANIZATIONS IN THE RESEARCH TRIANGLE PARK. THE TRIANGLE CERSI HAS THREE SPECIFIC AIMS: 1. CONDUCT REGULATORY SCIENCE PROJECTS IN COLLABORATION WITH FDA TO DELIVER MAJOR ADVANCES IN REGULATORY SCIENCE AND RAPIDLY ADDRESS A BROAD RANGE OF MAJOR, SPECIFIC, AND EMERGING CHALLENGES IN RESPONSE TO FDA NEEDS. 2. ESTABLISH ROBUST CERSI CORE INFRASTRUCTURE TO DEVELOP, PROPOSE, SUPPORT, ENABLE, AND MONITOR EXECUTION OF CERSI RESEARCH PROJECTS TO FACILITATE RAPID ACHIEVEMENT OF PROJECT DELIVERABLES; PARTNER OAK RIDGE NATIONAL LABORATORY PROVIDES SUPPORT FOR DATA ACCESS, COMPUTATION, AND RESOURCE SHARING. 3. EXPAND SUPPORT OF THE TRIANGLE CERSI AND EXTEND ITS IMPACT THROUGH REGULATORY SCIENCE INFORMATION SHARING ACTIVITIES, INCLUDING EFFORTS TO DIVERSIFY THE REGULATORY SCIENCE WORKFORCE. THE TRIANGLE CERSI WILL ACTIVELY SHARE RESULTS AND NEWLY DEVELOPED TOOLS AND RESOURCES WITH THE FDA, RESEARCH COMMUNITY, STAKEHOLDERS, AND OUR INSTITUTIONS’ STUDENTS AND TRAINEES. TOGETHER, OUR OVERARCHING GOAL IS TO PROVIDE AN ABUNDANCE OF ESSENTIAL NEW INFORMATION, INFRASTRUCTURE, AND TOOLS TO SHORTEN THE DRUG AND DEVICE DEVELOPMENT PROCESS, TO ADVANCE PUBLIC HEALTH, AND TO INFORM FDA ACTIVITIES IN WAYS THAT COMPLEMENT OTHER CERSIS AND CONTRIBUTE TO ACHIEVING THE GOALS OF THE NATIONAL CERSI PROGRAM.

THE UPMC SEXUALLY TRANSMITTED INFECTIONS COOPERATIVE RESEARCH CENTER

THE UJMT GLOBAL CONSORTIUM: BUILDING RESEARCH CAPACITY THROUGH MENTORED TRAINING

PACT-PRODVIDING AIDS CARE & TREATMENT IN THE DEMOCRATICS REPUBLIC OF CONGO UNDER

ANIMAL MODELS FOR STUDYING THE GENETICS OF HYPERTENSION

BRIDGE INVESTMENT PROGRAM

NANO APPROACHES TO MODULATE HOST CELL RESPONSE FOR CANCER THERAPY

BASIC MECHANISMS OF VIRAL AND CHEMICAL CARCINOGENESIS

CAROLINA CENTER OF CANCER NANOTECHNOLOGY EXCELLENCE

THIS AGREEMENT SHALL BE PERFORMED IN ACCORDANCE WITH THE PROPOSAL ENTITLED, RESEARCH IN AERODYNAMIC AND FLOW CONTROL TECHNOLOGY, AND ALL REVISIONS

PROGRAM PROJECT ? IMPROVING PROVIDER ANNOUNCEMENT COMMUNICATION TRAINING (IMPACT) - ABSTRACT – OVERALL WIDESPREAD HPV VACCINATION IN THE US COULD PREVENT 32,100 CANCERS EVERY YEAR. DESPITE THIS TREMENDOUS POTENTIAL, HPV VACCINATION COVERAGE IS FAR SHORT OF THE NATION'S GOAL OF 80%. PROVIDER RECOMMENDATIONS ARE UNIQUELY POWERFUL IN INCREASING HPV VACCINE UPTAKE. HOWEVER, PRIMARY CARE TEAMS AND HEALTHCARE SYSTEMS FACE BARRIERS TO EFFECTIVE HPV VACCINE COMMUNICATION, AND MANY QUESTIONS REMAIN UNANSWERED ABOUT HOW TO INCREASE THE POTENCY OF PROVIDER RECOMMENDATIONS. WE PROPOSE THE P01 PROGRAM PROJECT, “IMPROVING PROVIDER ANNOUNCEMENT COMMUNICATION TRAINING (IMPACT).” THE GOAL OF IMPACT IS TO IMPROVE HPV VACCINE COMMUNICATION AND UPTAKE AMONG ADOLESCENTS. IMPACT'S SPECIFIC AIMS ARE TO 1) IDENTIFY OPPORTUNITIES TO IMPROVE HPV VACCINE COMMUNICATION; 2) EVALUATE THE IMPACT AND COST OF HPV VACCINE COMMUNICATION INTERVENTIONS IN CLUSTER RANDOMIZED CLINICAL TRIALS; AND 3) SUPPORT IMPLEMENTATION OF HPV VACCINE COMMUNICATION INTERVENTIONS IN HEALTHCARE SYSTEMS. THE IMPACT PROGRAM PROJECT'S SHARED THEME IS AMPLIFYING THE IMPACT OF A RESEARCH-TESTED INTERVENTION PROGRAM TO IMPROVE HPV VACCINE COMMUNICATION IN HEALTHCARE SYSTEMS. THE PROJECTS WILL WORK TOGETHER TO ENHANCE THE IMPACT OF THE ANNOUNCEMENT APPROACH TRAINING (AAT), AN HPV VACCINE COMMUNICATION TRAINING FOR PRIMARY CARE PROFESSIONALS, WHICH RECEIVED DESIGNATION AS A RESEARCH-TESTED INTERVENTION PROGRAM (RTIP) FROM THE NATIONAL CANCER INSTITUTE. PROJECT 1 WILL ESTABLISH HOW TO INVOLVE THE WHOLE PRIMARY CARE TEAM IN HPV VACCINE RECOMMENDATIONS. THE PROJECT WILL EXAMINE WHETHER OPTIMIZING THE USE OF STANDING ORDERS SUPPORT INCREASES HPV VACCINE UPTAKE IN CLINICS RECEIVING THE AAT. PROJECT 2 WILL EXAMINE WHAT MOTIVATES PROVIDERS TO RECOMMEND HPV VACCINATION. THE PROJECT WILL ESTABLISH WHETHER CLINIC-LEVEL FINANCIAL INCENTIVES INCREASE VACCINE UPTAKE IN CLINICS RECEIVING THE AAT. PROJECT 3 WILL EXAMINE WHO SHOULD FACILITATE THE TRAININGS. THE PROJECT WILL ESTABLISH WHETHER ENGAGING CLINICAL CHAMPIONS IN HEALTHCARE SYSTEMS TO IMPLEMENT THE AAT WITHIN THEIR OWN SYSTEMS INCREASES VACCINE UPTAKE. PROJECT 4 WILL EXAMINE WHICH INTERVENTIONS FIT SYSTEMS' RESOURCES. THE PROJECT WILL EXAMINE THE BUDGET IMPACT, COST-EFFECTIVENESS, AND POPULATION HEALTH IMPACT OF HPV VACCINE INTERVENTIONS IN RURAL AND NONRURAL COMMUNITIES AND AID DECISION MAKERS WITH A DECISION SUPPORT TOOL TO FACILITATE THE ADOPTION OF PROMISING INTERVENTIONS. THE RESEARCH PROJECTS WILL RECEIVE SUPPORT FROM 3 CORES: ADMINISTRATIVE, DATA, AND INTERVENTION. IMPACT'S ACTIVITIES WILL CULMINATE WITH THE CREATION OF THE AAT INTERVENTION PACKAGE TO SUPPORT IMPROVING HPV VACCINE UPTAKE IN HEALTHCARE SYSTEMS. THROUGHOUT THE PROPOSED PROGRAM PROJECT, THE SHARED THEME AND AAT FOCUS WILL CREATE SYNERGIES AMONG THE PROJECTS AND CORES THAT GENERATES SIGNIFICANT AND NOVEL SCIENTIFIC INSIGHTS INTO HOW TO IMPROVE HPV VACCINE COMMUNICATION AND UPTAKE. OUR APPROACH WILL ALSO ACCELERATE THE EVOLUTION OF COMMUNICATION TRAININGS FOR PRIMARY CARE PROFESSIONALS, ACCOMPLISHING IN 5 YEARS WHAT MIGHT OTHERWISE TAKE TWO DECADES.

UNC CLINICAL AND TRANSLATIONAL SCIENCE AWARD

MEDICAL SCIENTIST TRAINING PROGRAM

APPLICATION PURPOSE: N/A; ACTIVITIES PERFORMED: N/A; EXPECTED OUTCOMES: N/A; INTENDED BENEFICIARIES: N/A; SUBRECIPIENT ACTIVITIES: N/A

ADVANCING TOBACCO REGULATORY SCIENCE TO REDUCE HEALTH DISPARITIES - ABSTRACT: OVERALL THE US HAS MADE DECADES OF PROGRESS IN REDUCING CIGARETTE SMOKING, BUT NOTABLE DISPARITIES PERSIST IN MENTHOL FLAVORED PRODUCT USE AND IN THE USE OF NON-CIGARETTE TOBACCO PRODUCTS, INCLUDING LITTLE CIGARS, CIGARILLOS, AND E- CIGARETTES. WE PROPOSE THE U54 PROGRAM PROJECT, “ADVANCING TOBACCO REGULATORY SCIENCE TO REDUCE HEALTH DISPARITIES” TO ADDRESS THIS GAP. THE INTEGRATIVE THEME OF OUR UNC TCORS IS BUILDING THE SCIENCE FOR EFFECTIVE REGULATION OF AND COMMUNICATION ABOUT TOBACCO PRODUCTS DISPROPORTIONATELY USED BY PRIORITY POPULATIONS – FLAVORED TOBACCO PRODUCTS AND E-CIGARETTES. OUR INTEGRATED SET OF FOUR RESEARCH PROJECTS SEEK TO UNDERSTAND THE IMPACT OF REGULATIONS AND COMMUNICATION CAMPAIGNS ON THOSE DISADVANTAGED BY TOBACCO USE DISPARITIES, INCLUDING BLACK; LOWER-SOCIOECONOMIC STATUS (SES); AND LESBIAN, GAY, OR BISEXUAL (LGB) POPULATIONS; AND YOUTH AND YOUNG ADULTS. OUR ULTIMATE GOAL IS TO FURTHER FDA AND NIH EFFORTS TO PROTECT PUBLIC HEALTH THROUGH REGULATION OF TOBACCO PRODUCTS. UNC TCORS’ RESEARCH WILL PROVIDE ESSENTIAL EVIDENCE TO GUIDE THE FDA AS IT IMPLEMENTS BANS ON MENTHOL CIGARETTES AND FLAVORED CIGARS, DEVELOPS COMMUNICATION CAMPAIGNS, AND ADDRESSES THE YOUTH VAPING EPIDEMIC. WE PROPOSE FOUR SPECIFIC AIMS: 1) DEVELOP AND EVALUATE THE IMPACT OF COMMUNICATION CAMPAIGNS TO DISCOURAGE TOBACCO PRODUCT USE IN DIVERSE POPULATIONS (PROJECTS 1, 2, 4); 2) UNDERSTAND THE PUBLIC HEALTH IMPACT OF FLAVORED TOBACCO PRODUCT BANS IN DIVERSE POPULATIONS AND THE CONDITIONS UNDER WHICH THEY ARE MOST LIKELY TO BE MOST EFFECTIVE (PROJECTS 2 AND 3); 3) BUILD TRAINEES’ CAPACITY TO CONTRIBUTE TO THE FIELD OF TOBACCO REGULATORY SCIENCE THROUGH TRAINING, MENTORSHIP, AND PILOT FUNDING FOR A DIVERSE AND MULTIDISCIPLINARY GROUP OF PRE-DOCTORAL FELLOWS, POST-DOCTORAL FELLOWS, AND EARLY-STAGE INVESTIGATORS (PROJECTS 1-4, CAREER ENHANCEMENT CORE); 4) INFORM FDA REGULATION OF MENTHOL CIGARETTE AND FLAVORED CIGAR BANS AND COMMUNICATION CAMPAIGNS THROUGH ACTIVE DISSEMINATION OF TCORS SCIENTIFIC FINDINGS (PROJECTS 1-4, ADMINISTRATIVE CORE). PROJECT 1 WILL DEVELOP A NOVEL COMMUNICATION CAMPAIGN TO DISCOURAGE YOUNG ADULT LITTLE CIGAR AND CIGARILLO USE. PROJECT 2 WILL EVALUATE WHETHER A MENTHOL CIGARETTE BAN COULD BE AMPLIFIED BY A QUIT SMOKING CAMPAIGN TO HELP MENTHOL SMOKERS QUIT, INCLUDING BLACK AND LGB SMOKERS. PROJECT 3 WILL BUILD A MICROSIMULATION MODEL TO ESTIMATE THE PUBLIC HEALTH IMPACT OF A FEDERAL FLAVORED CIGAR BAN ON TOBACCO USE, MORTALITY, AND HEALTH DISPARITIES. PROJECT 4 WILL TEST THE ABILITY OF VAPING PREVENTION VIDEO ADS WITH PROMISING FEATURES TO REDUCE SUSCEPTIBILITY TO VAPING AMONG YOUTH AND YOUNG ADULTS. THE RESEARCH PROJECTS WILL RECEIVE SUPPORT FROM TWO CORES: ADMINISTRATIVE AND CAREER ENHANCEMENT (WHICH INCLUDES PILOT RESEARCH PROJECTS). OUR MULTIDISCIPLINARY GROUP OF SEASONED REGULATORY SCIENCE RESEARCHERS WILL PROVIDE ACTIONABLE INFORMATION TO INFORM FDA REGULATIONS AND COMMUNICATION CAMPAIGNS.

CENTER FOR GENOMICS AND SOCIETY

ASPIRE: ADVANCING SCIENCE & PRACTICE IN THE RETAIL ENVIRONMENT

H3ABIONET: A SUSTAINABLE AFRICAN BIOINFORMATICS NETWORK FOR H3AFRICA

NEUTRALIZING ANTIBODY & AAV FIX GENE THERAPY

EMB-001: A NOVEL COMBINATION THERAPY FOR THE TREATMENT OF COCAINE-USE DISORDER

ELWAZI OPEN DATA SCIENCE PLATFORM AND COORDINATING CENTER - PROJECT SUMMARY/ABSTRACT THE OPEN DATA SCIENCE PLATFORM (ODSP) AND COORDINATING CENTER (CC) FOR DS-I AFRICA IS LED BY A WELL-ESTABLISHED PARTNERSHIP BETWEEN PROF MULDER (CURRENT PI H3ABIONET) AND DR MICHELLE SKELTON (CURRENT COORDINATOR, H3AFRICA CC) HOSTED WITHIN THE COMPUTATIONAL BIOLOGY DIVISION AND IDM AT THE UNIVERSITY OF CAPE TOWN (UCT). USING 8 YEARS OF EXPERIENCE IN LEADING A PAN AFRICAN INFORMATICS CONSORTIUM AIMED AT DATA AND INFORMATICS RESOURCE AND CAPACITY DEVELOPMENT, MULDER WILL ESTABLISH THE ODSP GATEWAY AND ITS ELWAZI PLATFORM, A FLEXIBLE, SCALABLE AFRICAN OPEN DATA SCIENCE PLATFORM FOR DEPOSITING, SHARING AND ACCESSING DATA, SELECTING DATA-SPECIFIC TOOLS AND DATA SCIENCE METHODS, AND DEPLOYING TOOLS AND WORKFLOWS ON A CHOICE OF COMPUTING ENVIRONMENTS SUITED TO THE AFRICAN CONTEXT, FACILITATING NOVEL DISCOVERIES FOR HEALTH. SKELTON WILL USE HER 7 YEARS OF EXPERIENCE IN COORDINATING THE LARGE H3AFRICA CONSORTIUM TO DEVELOP AN EFFICIENT CC ADDRESSING ALL THE JOINT ADMINISTRATIVE, COLLABORATIVE AND LOGISTICAL NEEDS OF THE CONSORTIUM. TOGETHER, THIS FORMIDABLE PAIR WILL TRANSITION THEIR CURRENT TEAMS AND ACTIVITIES FROM H3AFRICA TO DS-I AFRICA, WRAPPING UP ONE AND STARTING THE NEW, COMPLEMENTARY ENDEAVOUR WITH HIGHLY EXPERIENCED TEAMS READY TO PROVIDE IMMEDIATE IMPACT. THEY WILL SUPPORT EACH OTHER’S ACTIVITIES, TECHNICALLY FROM THE ODSP AND OPERATIONALLY/LOGISTICALLY FROM THE CC AND CO-DEVELOP AN EFFECTIVE DATA SCIENCE AND PROFESSIONAL DEVELOPMENT TRAINING PROGRAM. ODSP WILL SUPPORT THE CC ON WEBSITE AND TOOL DEVELOPMENT, WHILE THE CC WILL SUPPORT ODSP IN EVENTS PLANNING, MANAGING DATA DEPOSITION, ACCESS POLICIES AND AGREEMENTS AND INTEGRATION WITH THE DS-I AFRICA CONSORTIUM. THE OUTCOMES WILL BE: 1) AN OPEN, TRANSPARENT AND SUSTAINABLE ODSP DEVELOPED WITH USER INPUT TO ENSURE THEIR NEEDS ARE MET, ACCOMPANIED BY ADEQUATE USER AND ADMINISTRATIVE SUPPORT; 2) ACCESS TO A CHOICE OF PUBLIC AND PRIVATE CLOUD AND LOCAL AFRICAN COMPUTING FACILITIES FOR DATA STORAGE AND ANALYSIS; 3) ACCESS TO A COMPREHENSIVE SET OF AFRICAN AND OTHER RELEVANT DATASETS, TOOLS/WORKFLOWS AND RESOURCES REQUIRED FOR THE IMPLEMENTATION OF DATA SCIENCE TECHNIQUES TO BIOMEDICAL DATA; 4) A COMPREHENSIVE DATA SCIENCE AND PROFESSIONAL DEVELOPMENT TRAINING PROGRAM; 5) CONSOLIDATED CONSORTIUM POLICIES, DOCUMENTS AND RESOURCES; 6) EFFICIENTLY ORGANIZED CONSORTIUM ACTIVITIES, WORKSHOPS AND EVENTS; 7) AVENUES FOR EXPLORATION OF NEW COLLABORATIVE AND TRANSLATIONAL IDEAS AND PARTNERSHIPS WITH INDUSTRY AND OTHER STAKEHOLDERS. COLLECTIVELY THESE PROVIDE THE ELEMENTS REQUIRED FOR A FULLY SUPPORTED COHESIVE CONSORTIUM FACILITATING THE APPLICATION OF DATA SCIENCE TO HEALTH. THE ODSP AND CC ARE AFRICAN LED, DEVELOPED IN AFRICA BY AFRICANS AND FOR THE BENEFIT OF AFRICAN SCIENTISTS AND RESEARCH PARTICIPANTS.

MULTI-SCALE INVESTIGATIONS OF RESPIRATORY MUCUS/MUCIN STRUCTURE AND FUNCTION IN HEALTH AND DISEASE - OVERALL ABSTRACT THE MUCUS CLEARANCE SYSTEM CONSTITUTES THE PRIMARY AIRWAY HOST DEFENSE SYSTEM AGAINST INHALED INFECTIOUS AGENTS AND TOXINS. HOWEVER, DESPITE MORE THAN TWO CENTURIES OF RESEARCH INTO THE NATURE OF THE MUCUS CLEARANCE SYSTEM, SURPRISING GAPS IN OUR KNOWLEDGE OF FUNDAMENTAL ASPECTS OF THIS SYSTEM PERSIST. FILLING IN THESE GAPS IS IMPORTANT FOR IMPROVING PUBLIC HEALTH STRATEGIES TO COMBAT RESPIRATORY INFECTIOUS DISEASES. FILLING IN THESE GAPS IS ALSO IMPORTANT FOR ELUCIDATING THE PATHOGENESIS OF AND DEVELOPING THERAPIES FOR CHRONIC PULMONARY DISEASES, INCLUDING COPD, ASTHMA, NCFB, AND RARE GENETIC DISEASES (CF, PCD), WHICH ARE BY DEFINITION CHARACTERIZED BY MUCUS ACCUMULATION IN THE LUNG. THIS PPG PROPOSES TO INVESTIGATE FUNDAMENTAL, BUT POORLY UNDERSTOOD, ASPECTS OF THE MUCUS CLEARANCE SYSTEM THAT MUST BE QUANTITATED TO UNDERSTAND MUCUS FUNCTION IN HEALTH AND DYSFUNCTION IN DISEASE. EACH PPG PROJECT HAS TWO SPECIFIC AIMS FOCUSED ON BASIC MUCIN FUNCTION AND ONE FOCUSED ON TRANSLATIONAL ASPECTS OF MUCIN PATHOBIOLOGY. PROJECT 1 (“MUCIN STRUCTURE AND ASSOCIATIONS IN RESPIRATORY MUCUS”, MICHAEL RUBINSTEIN, PHD, PI) WILL INVESTIGATE FUNDAMENTAL ASPECTS OF THE ORGANIZATION OF MUCINS IN SOLUTION AND WITHIN THE MUCUS LAYER. THESE STUDIES WILL BE COMPLEMENTED BY STUDIES OF THE ADDITION OF “ABNORMAL POLYMERS”, E.G., DNA, TO MUCUS SOLUTIONS. PROJECT 2 (“WHY ARE MUCINS SO GIGANTIC AND IS IT SAFE/EFFECTIVE TO SEVER THEM THERAPEUTICALLY?”, RICHARD C. BOUCHER, MD, PI) WILL FOCUS ON THE FUNDAMENTAL QUESTION AS TO WHY HUMAN AIRWAY MUCIN POLYMERS ARE OF SUCH ENORMOUS SIZE (300 MDA, RG 250 NM) AND CHARACTERIZE THE RATIO OF EFFICACY (CHAIN LENGTH REDUCTION) VS RISK (OFF-TARGET CHAIN UNWINDING) REQUIRED FOR THE DEVELOPMENT OF MUCOLYTICS FOR LUNG DISEASE. PROJECT 3 (“MEMBRANE-BOUND MUCINS ON THE AIRWAY SURFACE ENSURE EFFICIENT MUCUS CLEARANCE AND LUNG HEALTH”, BRIAN BUTTON, PHD, PI) WILL STUDY THE RELATIONSHIPS BETWEEN CILIA, PCL, AND THE MUCUS LAYER REQUIRED FOR TRANSPORT, FOCUSING ON A NOVEL HYDRAULIC “PUSHING” VS CLASSIC “CLAWING” MECHANISMS. IN ADDITION, BARRIER FUNCTIONS OF PCL AND REGULATION THEREOF WILL BE STUDIED. PROJECT 4 (“BIOPHYSICAL AND STRUCTURAL CHARACTERIZATION OF AIRWAY SUBMUCOSAL GLAND MUCUS IN HEALTH AND CYSTIC FIBROSIS”, RONIT FREEMAN, PHD, PI) WILL FOCUS ON A NOVEL ATTRIBUTE OF SUBMUCOSAL GLAND (SMG) MUCUS, A STRAND/BUNDLE INSOLUBLE COMPONENT, AND HOW STRANDS/BUNDLES CONTRIBUTE TO SMG MUCUS FUNCTION IN HEALTH AND DISEASE. THREE CORES SUPPORT THE PPG: 1) CORE A, THE ADMINISTRATIVE/BIOSTATISTICAL CORE, MULTI-PIS RICHARD C. BOUCHER, MD, AND MICHAEL RUBINSTEIN, PHD, SUPPLIES PROJECT MANAGEMENT AND STATISTICAL SUPPORT FOR THE PPG; 2) CORE B, THE MUCUS/MUCIN ANALYTICS CORE, PI MEHMET KESIMER, PHD, PROVIDES QUALITY CONTROL OF ALL MUCIN REAGENTS FOR THE PPG AND NOVEL BIOCHEMICAL/BIOPHYSICAL MEASUREMENTS; AND 3) CORE C, THE IMAGING CORE, PI CAMILLE EHRE, PHD, PROVIDES ELECTRON MICROSCOPIC, MOLECULAR, AND MORPHOLOGIC ANALYSES TO THE PROJECTS. THE OVERALL GOALS OF THE PPG ARE TO ELUCIDATE THE STRUCTURE AND FUNCTION OF MUCUS IN HEALTH, HOW THESE CHARACTERISTICS ARE DEGRADED IN DISEASE, AND IDENTIFY STRATEGIES FOR DEVELOPMENT OF NOVEL THERAPEUTIC AGENTS TO TREAT MUCO-OBSTRUCTIVE DISEASES.

5/6 HBCD PRENATAL EXPERIENCES AND LONGITUDINAL DEVELOPMENT (PRELUDE) CONSORTIUM - PROJECT SUMMARY/ABSTRACT BRAIN DEVELOPMENT OCCURS AT A RAPID PACE PRENATALLY AND THROUGHOUT CHILDHOOD, IMPACTED BY DYNAMIC GENETIC AND ENVIRONMENTAL INFLUENCES. STUDIES USING ADVANCED NEUROIMAGING HAVE PROVIDED SIGNIFICANT INSIGHTS INTO BRAIN DEVELOPMENT BUT HAVE BEEN LIMITED BY SMALL SAMPLE SIZE, ESPECIALLY FOR HIGH-RISK POPULATIONS. SUBSTANCE- EXPOSED INFANTS ARE AT PARTICULARLY HIGH RISK FOR ADVERSE OUTCOMES; HOWEVER, FINDINGS ARE INCONSISTENT, MAKING IT DIFFICULT TO DISENTANGLE PRENATAL EXPOSURE EFFECTS FROM OTHER ADVERSE INFLUENCES. THE OBJECTIVES OF OUR HEALTHY BRAIN AND CHILD DEVELOPMENT (HBCD) PRENATAL EXPERIENCES AND LONGITUDINAL DEVELOPMENT (PRELUDE) CONSORTIUM ARE TO CHARACTERIZE TYPICAL TRAJECTORIES OF BRAIN DEVELOPMENT FROM BIRTH THROUGH CHILDHOOD, MEASURING THE INFLUENCE OF KEY BIOLOGIC AND ENVIRONMENTAL FACTORS AND THEIR INTERACTIONS ON CHILD SOCIAL, COGNITIVE, AND EMOTIONAL DEVELOPMENT. WE WILL ASSESS HOW CHILDREN PRENATALLY EXPOSED TO OPIOIDS AND OTHER SUBSTANCES, AS WELL AS ENVIRONMENTAL ADVERSITY, DIFFER IN THOSE BRAIN TRAJECTORIES AND OUTCOMES. OUR CONSORTIUM CONSISTS OF SIX CENTERS (ARKANSAS CHILDREN’S RESEARCH INSTITUTE, CASE WESTERN RESERVE UNIVERSITY, CINCINNATI CHILDREN’S HOSPITAL, CHILDREN’S NATIONAL MEDICAL CENTER, UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL, AND VANDERBILT UNIVERSITY) WHICH HAVE COLLABORATED PREVIOUSLY AND HAVE COMPLEMENTARY EXPERTISE IN NEUROIMAGING, NEUROPHYSIOLOGY, LONGITUDINAL CLINICAL RESEARCH, CHILD DEVELOPMENT, SUBSTANCE EXPOSURE AND ADDICTION, ETHICAL/LEGAL ISSUES, AND CLINICAL CARE OF HIGH-RISK INFANTS/CHILDREN. THE PRELUDE CONSORTIUM WILL RECRUIT 680 PREGNANT WOMEN WITH SUBSTANCE USE, 680 AT-RISK PREGNANT WOMEN WITHOUT SUBSTANCE USE, AND 1360 COMPARISON PREGNANT WOMEN REPRESENTATIVE OF THE GENERAL POPULATION TO CONTRIBUTE TO THE OVERALL HBCD STUDY. WE WILL WORK CLOSELY WITH THE OTHER SITES, THE HBCD CONSORTIUM ADMINISTRATIVE CORE, AND THE HBCD DATA COORDINATING CENTER TO DEVELOP A COMPREHENSIVE STUDY PROTOCOL AND ENSURE COMPLIANCE OF STUDY WORKFLOW AND DATA TRANSFER. OUR CONSORTIUM HAS AN OPTIMIZED RESEARCH PROTOCOL AND 4 SPECIFIC AIMS: 1) EMPLOY ETHICAL AND EVIDENCE-BASED BEST PRACTICES TO ENROLL AND RETAIN A DIVERSE COHORT OF PREGNANT WOMEN INTO A LONGITUDINAL STUDY OF INFANT/CHILD BRAIN DEVELOPMENT, OVERSAMPLING MOTHERS FROM HIGH-RISK BACKGROUNDS AND THOSE USING SUBSTANCES DURING PREGNANCY; 2) ENGAGE A COMPREHENSIVE ARRAY OF MATERNAL- AND CHILD-ORIENTED COMMUNITY STAKEHOLDERS TO IDENTIFY COMMUNITY CONCERNS AND PRIORITIES REGARDING THIS RESEARCH, MINIMIZE RISKS, AND PROMOTE LONG-TERM ENGAGEMENT OF THE RECRUITED CHILD-MOTHER DYADS; 3) COLLECT RICH DATA TO EXAMINE HOW MATERNAL HEALTH CONTEXT AND BROADER ENVIRONMENTAL FACTORS MAY AFFECT THE MATERNAL-FETAL DYAD AND NEURODEVELOPMENT OF CHILDREN; 4) CAPTURE KEY DEVELOPMENTAL WINDOWS DURING WHICH MATERNAL AND ENVIRONMENTAL FACTORS MAY INTERACT WITH BRAIN AND BEHAVIORAL DEVELOPMENT OF CHILDREN. THE INSIGHTS FROM THESE DATA WILL PROVIDE GREATER UNDERSTANDING OF FACTORS AFFECTING EARLY CHILDHOOD BRAIN DEVELOPMENT, ALLOWING TARGETED INTERVENTIONS AND IMPROVED OUTCOMES FOR MOTHER-CHILD DYADS.

UNIVERSITY OF NORTH CAROLINA WOMENS INTERAGENCY HIV STUDY UNC WIHS

APPLICATION PURPOSE: ACTIVITIES IN THIS GRANT WILL ENABLE OUR SUBRECIPIENT THE WOODS HOLE MARTHAS VINEYARD AND NANTUCKET STEAMSHIP AUTHORITY (SSA) TO KEEP ITS FERRY FLEET IN A STATE OF GOOD REPAIR AND CONTINUE PROVIDING A RELIABLE RESPONSIVE AND SAFE SERVICE TO THE PUBLIC THAT WILL HELP KEEP EXISTING RIDERS AND ATTRACT NEW RIDERS.; ACTIVITIES PERFORMED: ANNUAL PREVENTIVE MAINTENANCE ACTIVITIES FOR THE SSA FLEET OF FERRIES.; EXPECTED OUTCOMES: ACTIVITIES IN THIS GRANT AMENDMENT WILL ENABLE SSA TO KEEP ITS FERRY FLEET IN A STATE OF GOOD REPAIR AND CONTINUE PROVIDING A RELIABLE RESPONSIVE AND SAFE SERVICE TO THE PUBLIC.; INTENDED BENEFICIARIES: THE RESIDENTS AND VISITORS OF WOODS HOLE MARTHAS VINEYARD AND NANTUCKET.; SUBRECIPIENT ACTIVITIES: ANNUAL PREVENTIVE MAINTENANCE ACTIVITIES FOR THE WOODS HOLE MARTHAS VINEYARD AND NANTUCKET STEAMSHIP AUTHORITY (SSA) FLEET OF FERRIES.

NORTH CAROLINA TRANSLATIONAL AND CLINICAL SCIENCE INSTITUTE (NC TRACS) KL2

CENTER FOR HEALTH PROMOTION AND DISEASE PREVENTION

UNIVERSITY OF NORTH CAROLINA - CHLAMYDIA VACCINE INITIATIVE (UNC-CVI)

MCH WORKFORCE CENTERS

APPLICATION PURPOSE: ACTIVITIES IN THIS GRANT WILL ENABLE CCRTA TO KEEP ITS FLEET AND FACILITIES IN A STATE OF GOOD REPAIR AND CONTINUE PROVIDING A RELIABLE RESPONSIVE AND SAFE SERVICE TO THE PUBLIC THAT WILL HELP KEEP EXISTING RIDERS AND ATTRACT NEW RIDERS.; ACTIVITIES PERFORMED: IMPROVEMENTS TO BUS STATION PROPERTY.; EXPECTED OUTCOMES: ACTIVITIES IN THIS GRANT AMENDMENT WILL ENABLE CCRTA TO KEEP ITS FACILITIES IN A STATE OF GOOD REPAIR AND CONTINUE PROVIDING A RELIABLE RESPONSIVE AND SAFE SERVICE TO THE PUBLIC.; INTENDED BENEFICIARIES: THE RESIDENTS AND VISITORS OF ALL 15 TOWNS ON CAPE COD.; SUBRECIPIENT ACTIVITIES: NONE

PURPOSE: CORONAVIRUS AID, RELIEF, AND ECONOMIC SECURITY ACT FUNDS AWARDED AS ECONOMIC RELIEF U.S. AIRPORTS AFFECTED BY THE PREVENTION OF, PREPARATION FOR, AND RESPONSE TO THE COVID-19 PANDEMIC. ACTIVITIES TO BE PERFORMED/EXPECTED OUTCOMES: THIS PROJECT CONSTRUCTS A NEW 18,300 SQUARE FOOT TERMINAL BUILDING TO INCREASE PASSENGER THROUGHPUT. INTENDED BENEFICIARY: THIS GRANT WILL PROVIDE FEDERAL FUNDING FOR AIRPORTS ASSOCIATED WITH CAPE GIRARDEAU, MISSOURI.

PULMONARY SURFACE LIQUID HOMEOSTASIS

PROGRAM OF PROJECTS: OPERATIONS VEHICLES FACILITIES EQUIPMENT AND PLANNING

EXPANSION OF ART, TB AND VCT PROGRAMS IN ZAMBIA

CHARACTERIZATION OF NOVEL GENES ENCODED TY RNA AND DNA VIRUSES

POLYMERASE THETA, GENOME INSTABILITY, AND CANCER

CHILDREN LIVING IN RURAL POVERTY: THE CONTINUATION OF THE FAMILY LIFE PROJECT

NEUROBIOLOGICAL AND BEHAVIORAL CONSEQUENCES OF COCAINE USE IN MOTHER/INFANT DYADS

THE PROJECT WILL ELIMINATE AN AT GRADE CROSSING IN THE CITY OF CHESAPEAKE, VA BY CONSTRUCTING A ROADWAY OVERPASS AT FREEMANAVENUE OVER THE NORFOLK AND PORTSMOUTH BELT LINE RAILROAD THE PROJECT WILL IMPROVE OVERALL RELIABILITY AND SAFETY OF THETRANSPORTATION SYSTEM AND CREATE A CONTINUOUS, UNIMPAIRED FLOW OF TRAFFIC ALONG FREEMAN AVENUE TO REDUCE VEHICULAR DELAYS TO AND FROM THE MONEY POINT INDUSTRIAL AREA WHILE THE RAILROAD IS IN USE ELIMINATE CONFLICTS BETWEEN ROADWAY AND RAIL TRAFFIC AND ENHANCE EMERGENCY RESPONSE FREEMAN AVENUE IS THE ONLY ROADWAY ACCESS TO THE MONEY POINT INDUSTRIAL AREA IMPROVE THE CONDITION OF THE EXISTING RAILWAY SYSTEM AND FACILITIES IN THE REGION DECREASE TRANSPORTATION COSTS BY REDUCING VEHICULAR AND TRAIN AND DELAY IMPROVE LONG TERM EFFICIENCY, RELIABILITY AND COSTS IN THE MOVEMENT OF WORKERS AND GOODS BOTH BY PROVIDING RELIABLE, UNIMPAIREDVEHICULAR ACCESS TO AND FROM THE INDUSTRIES AND BUSINESSES AS WELL AS TRAIN ACCESS TO THE REGION INCREASE THE ECONOMIC PRODUCTIVITY OF THE MONEY POINT INDUSTRIAL AREA BY MAKING IT MORE ACCESSIBLE FOR EXISTING BUSINESSES, ANDMORE ATTRACTIVE TO FUTURE TENANTS

CENTER FOR REDUCE CVD DISPARITIES: GENES, CLINICS, AND COMMUNITIES

POPULATION RESEARCH TRAINING

NATIONAL CENTER FOR SPECIAL RESEARCH (NCSER)

MAINTENANCE OF ANIMAL MODELS OF HUMAN HEMOPHILIA AND VWD

CENTER FOR ENVIRONMENTALLY RESPONSIBLE SOLVENTS AND PROCESSES

BRONCHITIS IN THE MILITARY: DIAGNOSIS, RISK MITIGATION, AND TREATMENT

TARGETED GENETIC ANALYSIS OF T2D AND QUANTITATIVE TRAITS

MOLECULAR MECHANISM OF MAMMALIAN DNA EXCISION REPAIR, DNA DAMAGE CHECKPOINTS AND THE CIRCADIAN CLOCK

MODEL STATE-SUPPORTED AHEC PROGRAM

CARES ACT: WOODS HOLE MARTHAS VINEYARD AND NANTUCKET STEAMSHIP AUTHORITY OPERATING ASSISTANCE

UNC REGIONAL EMERGING SPECIAL PATHOGEN TREATMENT CENTER (RESPTC) - THE UNIVERSITY OF NORTH CAROLINA MEDICAL CENTER (UNCMC) IN PARTNERSHIP WITH THE UNC INSTITUTE OF GLOBAL HEALTH AND INFECTIOUS DISEASES (IGHID) PROPOSES TO ESTABLISH A REGIONAL EMERGING SPECIAL PATHOGEN TREATMENT CENTER (RESPTC) IN US DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) REGION 4, COVERING MOST OF THE US SOUTH. THE GOAL OF THIS PROJECT IS TO BUILD ON THE STRONG FOUNDATION OF CURRENT CAPABILITIES AT UNCMC AND THE UNC HEALTH SYSTEM OF HOSPITALS AND CLINICS TO ESTABLISH A RESPTC THAT WILL ENHANCE SPECIAL PATHOGEN READINESS FOR THIS REGION AND THE NATION. THE OBJECTIVES OF THE UNC RESPTC ARE TO: A) DEVELOP A STATE-OF-THE-ART, RESPONSIVE, AND ACCESSIBLE FACILITY STAFFED BY A HIGHLY-TRAINED WORKFORCE TO CARE FOR AND MANAGE PATIENTS ACROSS THE LIFE SPAN INFECTED WITH A SPECIAL PATHOGEN INCLUDING CAPACITY TO SURGE, IF NECESSARY, B) ENHANCE PREPAREDNESS OF REGIONAL HEALTHCARE PARTNERS BY COLLABORATING WITH THE EMORY RESPTC AND THE NATIONAL EMERGING SPECIAL PATHOGENS TRAINING AND EDUCATION CENTER (NETEC) TO PROVIDE BEST PRACTICES TRAINING FOR EMERGING PATHOGEN PREPAREDNESS AND RESPONSE INCLUDING THE ABILITY TO IDENTIFY, ISOLATE, AND INFORM (3I) AND PROVIDE HIGH-QUALITY CARE TO SPECIAL PATHOGENS PATIENTS, AND C) SUPPORT REGIONAL SPECIAL PATHOGEN READINESS AND RESPONSE BY PLAYING A COORDINATING ROLE DURING EVENTS AND PROVIDING TECHNICAL ASSISTANCE AND CRITICAL SUPPLIES SUCH AS PERSONAL PROTECTIVE EQUIPMENT (PPE) ON REQUEST. COLLECTIVELY, THE OUTCOMES OF THIS PROJECT WILL ESTABLISH UNC RESPTC AS A VALUABLE RESOURCE FOR CLINICAL CARE, TRAINING, AND MATERIAL SUPPORT TO MEET FUTURE MAJOR INFECTIOUS DISEASES CHALLENGES.

RTI'S REGIONAL COMPREHENSIVE METABOLOMICS RESOURCE CENTER

OUTLAST - A FIRST MULTIPLE-DOSE EFFICACY STUDY OF IXT-M200, AN ANTI-METH MONOCLONAL ANTIBODY, IN PATIENTS WITH METH USE DISORDER - PROJECT ABSTRACT METHAMPHETAMINE USE DISORDER (MUD) IS A SIGNIFICANT HEALTH CONCERN IN THE US WITH NO APPROVED MEDICATIONS FOR TREATMENT. THIS APPLICATION AIMS TO TEST IXT-M200, AN ANTI-METHAMPHETAMINE MONOCLONAL ANTIBODY, IN A 6- MONTH MULTIPLE-DOSE STUDY FOR EFFICACY IN REDUCING RELAPSE TO METHAMPHETAMINE USE. PREVIOUS HUMAN STUDIES OF IXT-M200 HAVE SHOWN THAT SINGLE DOSES ARE SAFE AND THE ANTIBODY ALTERS METHAMPHETAMINE PHARMACOKINETICS BY REDUCING ITS VOLUME OF DISTRIBUTION TO APPROXIMATELY THE VASCULAR SPACE. THIS SEQUESTERS METHAMPHETAMINE IN THE BLOOD AND REDUCES ITS ABILITY TO FREELY ENTER OTHER TISSUES SUCH AS THE BRAIN WHERE IT IS MOST ACTIVE. THE MAIN GOAL OF THIS PROPOSAL IS TO COMPLETE THE OUTLAST STUDY WHICH WILL BE THE FIRST TIME A MEDICATION THAT SPECIFICALLY ACTS ON METHAMPHETAMINE WILL BE TESTED IN PEOPLE WITH MUD. THE SPECIFIC AIMS ARE TO FULFILL ALL REGULATORY REQUIREMENTS TO MAINTAIN THE IXT-M200 IND AND PREPARE FOR APPROVAL, COMPLETE THE OUTLAST STUDY, AND SUPPORT THE CLINICAL TRIAL WITH SAMPLE ANALYSIS AND MANUFACTURING. THE OUTLAST STUDY WILL ENROLL APPROXIMATELY 120 PARTICIPANTS WITH MUD IN TWO CONSECUTIVE COHORTS. THE FIRST COHORT WILL RECEIVE EITHER 1.5 G IXT-M200 OR PLACEBO IN A 2:1 RATIO. FOLLOWING AN INTERIM ANALYSIS, THE SECOND COHORT WILL RECEIVE 3 G IXT-M200 OR PLACEBO, UNLESS THE INTERIM ANALYSIS SUPPORTS A DOSE ADJUSTMENT. EACH PARTICIPANT WILL RECEIVE 6 DOSES SPACED 4 WEEKS APART. FOLLOW-UP VISITS WILL CONTINUE FOR 3 MONTHS AFTER THE LAST DOSE. EACH PARTICIPANT WILL COMPLETE THE COMPUTER-BASED TRAINING FOR COGNITIVE BEHAVIORAL THERAPY (CBT4CBT) MODULES DURING THE FIRST TWO MONTHS OF THE TRIAL. PARTICIPANTS WILL ALSO HAVE ACCESS TO A DEDICATED RECOVERY COACH FOR WEEKLY PHONE/VIDEO CALLS AND TEXTING DURING BUSINESS HOURS. AFTER RANDOMIZATION AND INITIAL DOSING, SUBJECTS WILL REPORT THEIR PREVIOUS DAY’S DRUG USE THROUGH A SURVEY CONDUCTED VIA SMARTPHONE APP. THE APP WILL ALSO NOTIFY SUBJECTS WHEN THEY ARE RANDOMLY SELECTED FOR A TWICE- WEEKLY SALIVA DRUG TEST. EACH SUBJECT WILL BE SHIPPED SALIVA TESTING KITS WHICH THEY WILL USE WHILE RECORDING THEMSELVES ON VIDEO WHEN SELECTED. VIDEOS WILL BE REVIEWED FOR VALIDITY AND THE RESULTS RECORDED BY TRAINED PERSONNEL. THESE DRUG USE DATA, BOTH SELF-REPORT AND RANDOM TESTING, WILL BE USED TO ASSESS THE PRIMARY EFFICACY ENDPOINT WHICH IS PERCENT OF 20 WEEKS ABSTINENT FROM STIMULANTS FOLLOWING A 4-WEEK GRACE PERIOD DURING WHICH RELAPSES ARE ALLOWED. THE PRIMARY ANALYSIS WILL BE A TEST OF THE MEAN DIFFERENCES BETWEEN EACH IXT-M200 GROUP AND THE PLACEBO GROUP, AS ESTIMATED USING AN ANALYSIS OF COVARIANCE. SECONDARY ENDPOINTS INCLUDE COMPLETE ABSTINENCE DURING THE LAST MONTH OF STUDY DRUG TREATMENT, CHANGE FROM SCREENING IN THE TREATMENT EFFICACY ASSESSMENT PERFORMED AT WEEKS 13, 25 AND 33, AND SAFETY AS MEASURED BY PHYSICAL EXAMS, VITAL SIGNS, CLINICAL LABORATORY TESTING, AND ADVERSE EVENT ASSESSMENTS. IMMUNOGENICITY WILL ALSO BE DETERMINED.

CLINICAL CENTER FOR THE STUDY OF DEV LEARNING UAP

INITIATIVE FOR MINORITY STUDENT DEVELOPMENT AT UNC-CHAPEL HILL

NCCU-LCCC PARTNERSHIP IN CANCER RESEARCH (2 OF 2)

SCCOR IN HOST FACTORS IN CHRONIC LUNG DISEASE

NORTH CAROLINA SERONET CENTER FOR EXCELLENCE

MODEL STATE-SUPPORTED AHEC PROGRAM

STAMPOUT: A PHASE 2A STUDY OF ANTIBODY FOR METHAMPHETAMINE OUTPATIENT THERAPY

BRIDGING THE GAP BETWEEN TYPE 2 DIABETES GWAS AND THERAPEUTIC TARGETS

DESCRIPTION:THIS COOPERATIVE AGREEMENT APPROVES FEDERAL FUNDS OF $13 MILLION WHILE AWARDING FEDERAL FUNDS OF $6,000,000 FOR ADMINISTRATION OF THE COMMUNITY CAPACITY BUILDING - SMALL WATERSHED GRANTS PROGRAM, WHICH AIMS TO BUILD THE CAPACITY OF FRONTLINE ORGANIZATIONS WORKING COLLABORATIVELY ON COMMUNITY AND WATERSHED HEALTH GOALS. FEDERAL FUNDS OF $7,000,000 ARE CONTINGENT UPON AVAILABILITY. ACTIVITIES:THE CHESAPEAKE BAY TRUST WILL WORK CLOSELY WITH THE CHESAPEAKE BAY PROGRAM PARTNERSHIP AND STAKEHOLDERS TO ADVANCE REGIONAL, ORGANIZATIONAL, AND LOCAL GOVERNMENT COLLABORATIVE CAPACITY TO ACCELERATE CLEAN WATER ACTIONS THROUGH ADMINISTRATION OF A COMPETITIVE SUBAWARD PROGRAM, TRAINING AND TECHNICAL ASSISTANCE, CONVENING AND STORYTELLING TO SHARE INFORMATION ON THE OUTCOMES AND LESSONS LEARNED, AND COORDINATION WITH OTHER PARTNERS TO ALIGN EFFORTS. SUBRECIPIENT:THE CHESAPEAKE BAY TRUST WILL ISSUE SUBAWARDS TO LOCAL GOVERNMENTS AND NONPROFIT ORGANIZATIONS TO BUILD INDIVIDUAL ORGANIZATION AND COLLABORATIVE CAPACITY TO ADVANCE ENVIRONMENTAL AND COMMUNITY GOALS. SUBAWARDS WILL SUPPORT DISCRETE ORGANIZATIONAL CAPACITY AND TECHNICAL ASSISTANCE ACTIVITIES IN ANY AREA THAT MAKES AN ORGANIZATION STRONGER, INCLUDING BUT NOT LIMITED TO FINANCE AND FUNDRAISING, STRATEGIC PLANNING, DIVERSITY, EQUITY, INCLUSION AND JUSTICE, GRANT MANAGEMENT, PROGRAM EVALUATION, COLLABORATION, COMMUNICATIONS, AND TECHNOLOGY.OUTCOMES:THE COMMUNITY CAPACITY BUILDING INITIATIVE WILL IMPROVE THE ABILITY OF COMMUNITY AND FRONTLINE ORGANIZATIONS TO ACCOMPLISH WATERSHED RESTORATION WORK AND SUPPORTS ACHIEVEMENT OF THE GOALS AND OUTCOMES OF THE CHESAPEAKE BAY WATERSHED AGREEMENT, IN PARTICULAR THE VITAL HABITATS, WATER QUALITY, CLIMATE RESILIENCY, HEALTHY WATERSHEDS, AND STEWARDSHIP GOALS. BENEFICIARIES INCLUDE THE CHESAPEAKE BAY PROGRAM PARTNERSHIP, LOCAL GOVERNMENTS, AND COMMUNITY AND ENVIRONMENTAL ORGANIZATIONS IN THE CHESAPEAKE BAY WATERSHED.

HISTONE MRNA REGULATION IN DEVELOPMENT

HEAD START

STATISTICAL AND APPLIED MATHEMATICAL SCIENCES INSTITUTE

A ONCE-WEEKLY ORAL METHADONE FOR MAINTENANCE THERAPY FOR OPIOID USE DISORDER - METHADONE IS AN FDA-APPROVED MEDICATION-ASSISTED THERAPY (MAT) FOR OPIOID USE DISORDER (OUD). METHADONE MAINTENANCE THERAPY HAS BEEN SHOWN TO FACILITATE RECOVERY AND PREVENT DEATHS. IN THE US METHADONE MAINTENANCE THERAPY CURRENTLY INVOLVES ONCE-DAILY DRUG ADMINISTRATION AT SPECIALLY DESIGNATED TREATMENT SITES (“METHADONE CLINICS”) UNDER DIRECT OBSERVATION. ONCE-DAILY DIRECTLY OBSERVED THERAPY PRESENTS DIFFICULTIES FOR MANY PATIENTS AND PROVIDERS AND CONTRIBUTES TO THE CURRENT TREATMENT GAP WHEREIN ONLY APPROXIMATELY 20% OF PATIENTS WITH OUD ARE RECEIVING MATS. RECENT INNOVATIONS IN DRUG DELIVERY TECHNOLOGY, SUCH AS LONG-ACTING INJECTABLES, HAVE NOT BEEN APPLIED TO METHADONE DELIVERY AND METHADONE DRUG PRODUCTS ARE ESSENTIALLY IDENTICAL TO THE IMMEDIATE RELEASE PRODUCTS INTRODUCED SEVERAL DECADES AGO. NIDA HAS EXPRESSED A NEED FOR NEW TREATMENT STRATEGIES FOR OUD TO HELP ADDRESS THE CURRENT OPIOID CRISIS, INCLUDING NEW FORMULATIONS OF EXISTING MEDICATIONS SUCH AS METHADONE TO IMPROVE TREATMENT ACCESS AND COMPLIANCE AND REDUCE DIVERSION. THIS PROPOSAL IS FOR DEVELOPMENT OF A ONCE-WEEKLY ORAL METHADONE FOR MAINTENANCE THERAPY FOR OUD. LYNDRA HAS DEVELOPED AN ORAL GASTRIC RESIDENCE DOSAGE FORM THAT HAS BEEN DEMONSTRATED TO PROVIDE AT LEAST SEVEN DAYS OF CONTINUOUS DELIVERY OF MANY DIFFERENT THERAPEUTIC AGENTS, INCLUDING DRUGS FOR TREATMENT OF ALZHEIMER’S DISEASE, HIV AND MALARIA. LYNDRA’S TECHNOLOGY HAS BEEN VALIDATED IN MULTIPLE LARGE ANIMAL MODELS AND IS CURRENTLY IN CLINICAL TRIALS. A ONCE-WEEKLY ORAL METHADONE PRODUCT COULD (1) LOWER A MAJOR BARRIER TO TREATMENT FOR MANY PATIENTS, (2) REDUCE THE STIGMA AND SOCIOECONOMIC IMPACT OF MMT, AND (3) INCREASE THE CAPACITY OF METHADONE TREATMENT CENTERS BY REDUCING THE NUMBER OF PATIENT VISITS. THE UG3 PHASE OF THIS PROPOSAL IS FOR TWO YEARS OF PHARMACEUTICAL DEVELOPMENT AND PHARMACOLOGICAL CHARACTERIZATION OF A ONCE-WEEKLY ORAL METHADONE DOSAGE FORM, LEADING TO THE SELECTION OF A CLINICAL CANDIDATE FOR A FIRST-IN-HUMAN TRIAL AND SUBMISSION OF AN IND. IN AIM 1, DOSAGE FORM DEVELOPMENT AND OPTIMIZATION WILL BE PURSUED TO ACHIEVE TARGET VALUES FOR DRUG LOAD, RELEASE KINETICS AND PK PROFILE. AIM 2 WILL FOCUS ON IND- ENABLING ACTIVITIES LEADING TO SUBMISSION OF AN IND FOR A FIRST-IN-HUMAN CLINICAL TRIAL. ONCE-WEEKLY METHADONE DOSAGE FORM PROCESS DEVELOPMENT AND SCALE-UP, SHELF LIFE STUDIES, CLINICAL MANUFACTURING AND GLP TOXICITY STUDIES WILL BE PERFORMED. THE UH3 PHASE OF THE PROPOSAL INCLUDES CLINICAL TRIALS TO EVALUATE THE SAFETY AND PK OF THE ONCE-WEEKLY ORAL METHADONE DOSAGE FORM IN SUBJECTS WITH OUD WHO ARE CURRENTLY MAINTAINED ON ONCE- DAILY METHADONE. THE GATING MILESTONE FOR TRANSITION TO THE UH3 PHASE IS ACCEPTANCE OF THE IND BY THE FDA. LYNDRA INC CONFIDENTIAL PAGE 1