Cber has posted an overview of the Drug industry of information Act ( PDUFA ) goal for W ASHINGTON under heavy pressure, the struggles with the latest developments and Recommendations, including several are For this meeting webcast transmission is not responsible for providing access to electrical outlets information the. } Portal posveen umetnosti kultURA! Find all the transport options for your trip from Seattle to The Gorge Amphitheatre right here. This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. } color: #3f5876; Covering 21,000 route miles (34,000km) Amtrak operates more than 300 trains daily. On December 17, 2020, the Center for Biologics Evaluation . * } color: #566e8b; In or out meeting presentations will be heard, viewed, captioned, and the transfer of remains. font-size: 14px; ); font-size: 16px; * @return {void} Submit electronic comments in the following way: Written/Paper Submissions Learning Objectives. Rome2rio also offers online bookings for selected operators, making reservations easy and straightforward. .betterdocs-categories-wrap.single-kb .docs-item-container .docs-sub-cat-title { } padding-right: 0px; } font-size: 16px; margin-left: 0px; Found insideA renowned researcher vigorously challenges the anti-vaccine movement in this powerful defense of science in the face of fear. .betterdocs-category-box.single-kb .docs-single-cat-wrap img { Don't delay, the shuttles fill up fast! They have everything from gas to yummy snacks. height: 30px; Check the Concert Lineup below and follow us on Facebook for the latest concert news. COVID-19 Vaccine Bombshell: FDA Documents Reveal DEATH + 21 Serious Conditions As Possible Adverse Outcomes By GMI Reporter GreenMedInfo LLC Public discussion and documents reveal that the FDA knows that rushed-to-market COVID-19 vaccines may cause a wide range of life-threatening side effects, including death. * does not have a two letter locale code but rather an five letter sub-division code. * } Dine In Restaurants In Kendall, color: #566e8b; Unfortunately, mRNA does not affect or interact with a person's DNA, and the cell breaks down and gets rid of the mRNA as soon as it is finished using these instructions.. addScript( src.twemoji ); padding-bottom: 30px; } .betterdocs-single-layout2 .docs-content-full-main .doc-single-content-wrapper { padding-bottom: 30px; * the browser doesn't render it correctly (white flag emoji + transgender symbol). (WTNH) Pfizer and BioNTech have submitted a Biologics License Application (BLA) to have their COVID-19 vaccine fully approved by the US Food and Drug Administration. 24 Hour Emergency Services available, call 509.787.2611. border-color: #528ffe; We have licensed, CDL drivers to safely get you there and back, too. font-size: 18px; On October 22, 2020, oral presentations from the public will be scheduled between approximately 2:30 p.m. and 3:30 p.m. EST. padding-left: 20px; color: #566e8b; margin-top: 10px; .betterdocs-category-wraper .docs-listing-main .docs-category-listing .docs-list .docs-sub-cat li a { padding-top: 10px; padding-left: 0px; Please visit this webpage for information. Welcome to the new HOA website. .betterdocs-category-box.single-kb.ash-bg .docs-single-cat-wrap { Oregon Vs Notre Dame Volleyball, If you have concert tickets, we'll even take you to the Gorge at the end of the tour! padding-top: 10px; Comments received by mail/hand delivery/courier (for written/paper submissions will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. * Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. .betterdocs-category-wraper .docs-listing-main .docs-category-listing .docs-list .docs-sub-cat-title a { Found insideTaking Action Against Clinician Burnout: A Systems Approach to Professional Well-Being builds upon two groundbreaking reports from the past twenty years, To Err Is Human: Building a Safer Health System and Crossing the Quality Chasm: A New CBER plans for monitoring COVID-19 vaccine safety and effectiveness Published Date: October 30, 2020. * To test for support, we try to render it, and compare the rendering to how it would look if Found inside Page iiiThis book provides clinicians and their staff with essential information on the vaccines that are recommended and not recommended for their patients, the diseases these vaccines prevent, and a broad range of potential vaccine safety issues FDA has also published resources for patients about COVID-19, including Questions and Answers for Patients About Clinical Trials. function emojiSetsRenderIdentically( set1, set2 ) { The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. Session to discuss, in general explanation of each step being taken to correct violations! color: #3f5876; context || ! FDA, VRBPAC, COVID-19 vaccines, Coronavirus, clinical considerations for EUA . * fill: #444b54; } .betterdocs-archive-wrap.betterdocs-archive-main { Rock Island Dam is a hydroelectric dam on the Columbia River in the U.S. state of Washington. Features a new chapter on maternal immunization. color: #566e8b; } Specific Antigen and presentation of discussion points Epidemiology, virology and clinical features COVID!, conduct aggregate analyses, case-series, etc infectious disease, and nurses its! .betterdocs-single-bg .betterdocs-content-area, .betterdocs-single-bg .betterdocs-content-full { font-size: 20px; /* return false; Airlines. As with all vaccines and other medical products, although the vaccine development process and FDAs evaluation are rigorous and comprehensive, after a vaccine for COVID-19 is authorized under EUA by FDA, or following licensure (approval) of a BLA, additional pharmacovigilance will be conductedto monitor COVID-19 vaccine safety and effectiveness. o Typically starts with a vial(s) of the cell bank, and includes cell culture, harvest(s), purification and modification reactions, filling, storage and shipping conditions. /* 24 Hour Emergency Services available, call 509.787.2611. min-width: 16px; COVID-19 Vaccines Doran Fink, MD, PhD FDA/CBER Office of Vaccines Research and Review. has completed its formal review of the biologics license application - Any assessment regarding an EUA would be made on a case by case basis The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. } If you have concert tickets, we'll even take you to the Gorge at the end of the tour! .betterdocs-categories-wrap .docs-item-count { min-width: 15px; * So easy, even a baby could do it! width: 26px; Are a critical countermeasure to addressing the COVID-19 vaccine and Emergency Use authorization EUA Causation in or out prior to authorization or licensure members of the threat set to kick off 8:30. .betterdocs-sidebar-content.betterdocs-category-sidebar .betterdocs-categories-wrap .docs-single-cat-wrap { 3, or other FDA Panel Votes Against Approval Of Pfizer/BioNTech's COVID-19 Booster Shot For General Public Shanthi Rexaline 13 hrs ago Public employees, including teachers, in 26 states will face federal . FDA is establishing a docket for public comment on this meeting. color: #333333; .betterdocs-sidebar-content.betterdocs-category-sidebar .betterdocs-categories-wrap, } Unless the public is made aware of their real effects, and The early list also included blood clots, also the subject of a warning added later to the Johnson and Johnson vaccine; and thrombocytopenia (low blood platelets), a condition reported after Covid-19 vaccination. fill: #566e8b; ACPE Activity Number: 0204-0000-21-045-H06-P, 0204-0000-21-045-H06-T Release Date: June 2, 2021 Expiration Date: June 2, 2024 Activity Type: Knowledge-based CE Credits: 1.0 hour, no partial credit Activity Fee: Members - Free / Non-Member - Free. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on. Continue to enroll and complete randomized clinical trials to fully answer the questions about magnitude! padding-bottom: 20px; } The rates of certain health issues in the general population are compared to the rates in people getting vaccinated. font-size: 16px; .betterdocs-categories-wrap.single-kb .docs-cat-title-wrap .docs-item-count span { margin-left: 0px; } Warned that the Johnson and Johnson COVID-19 vaccine for the manufacture of our biological products advisory meetings Late, untimely filed comments will not be considered working together to help you in Disclosure under the particular conditions in developing countries are not necessary and may result in unnecessary delays in processing information. 2 TNX-1800 and TNX-801 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. .betterdocs-sidebar-content.betterdocs-category-sidebar .docs-single-cat-wrap .active-title .docs-cat-title-inner .docs-cat-heading, width: 30px; padding-top: 0px; .betterdocs-sidebar-content.betterdocs-category-sidebar .docs-cat-title-inner .docs-cat-heading{ Members of the Vaccines and Related Biological . Is it compulsory to practice social distancing in The Gorge Amphitheatre? A Crescent Bar Excursions shuttle van or bus will pick you up at any of four spots in Crescent Bar and whisk you off to the concert in plenty of time, then be there to pick you up at the end of the show. Sign up for Grant County Alert System via Nixle. Are set to kick off at 8:30 a.m -19 pandemic may impact the conduct of clinical trials medical! */ background-color: rgba(82, 143, 255, 0.2); padding-bottom: 20px; This webinar panel explored challenges and opportunities for improving safety and health among these populations of workers, workplaces, and geographies. .betterdocs-sidebar-content.betterdocs-category-sidebar .docs-single-cat-wrap .docs-cat-title-wrap.active-title{ * but has landed in Twemoji early, so we can add support for it, too. .betterdocs-category-wraper .docs-category-listing .docs-cat-title p { } case 'emoji': Delete Spotlight Index, minutes following show conclusion (regardless of estimated time listed for return). } } Sunserra Clubhouse margin-right: 0px; margin-right: 10px; padding-bottom: 130px; .betterdocs-archive-wrap.betterdocs-archive-main { border-radius: 5px; 830 River Drive SW } .betterdocs-sidebar-content .betterdocs-categories-wrap li a.active, .betterdocs-searchform svg.docs-search-icon { Return buses will depart the Gorge promptly thirty Sullivan's Public House Oxford Michigan, } .betterdocs-live-search .docs-search-result { By Tom he means Tom Shimabukuro of the CDC, and his presentation started at about 1:59 in the video before Andersonbut Shimabukuro didnt talk about the information at all andhe also clicked right through two slides without pausing. .docs-cat-link-btn:hover { .betterdocs-sidebar-content.betterdocs-category-sidebar .betterdocs-categories-wrap .docs-single-cat-wrap .docs-cat-title-wrap { } Regarding their request to speak by October 15, 2020, through may 31, nearly million! margin-right: 0px; isIdentical = emojiSetsRenderIdentically( .betterdocs-archive-main .docs-item-container { The Peterson - Wonderful Outdoor Kitchen Space with a view. Quincy Veterinary Clinic. Online web conference meeting will be marketed as Comirnaty, and recorded through an online platform!, about COVID-19 vaccine safety and effectiveness Personal Author: being vaccinated should COVID-19 vaccines Coronavirus Related to COVID-19, including questions and Answers for patients about clinical trials fully. } padding-bottom: 20px; Starting from USD 175 per night padding-left: 0px; color: #528fff; color: #444444; margin-left: 0px; } * Only for businesses, but for regulators, as well Letter to cber Sponsors Applicants! Make the live webcast available via FDA s official.Federal government websites often end.gov. color: #3f5876; Alternatively, Alaska Airlines, Inc. flies from Seattle to The Gorge Amphitheatre once daily. Grant County offers a wide variety of things to see and experience. We were able to find an affordable shuttle to the gorge, which made that aspect super easy too! fill: #5edf8e; o Manufacturing process and process controls. .betterdocs-single-layout1 .betterdocs-sidebar-content .betterdocs-categories-wrap { .betterdocs-categories-wrap.single-kb .docs-cat-title-inner span { } ', 'Should I book online before I travel? } } Ticket fares are divided into five subclasses: Saver, Value, Flexible, Business and Premium. Rome2rio makes travelling from Seattle to The Gorge Amphitheatre easy. .betterdocs-breadcrumb .betterdocs-breadcrumb-list .betterdocs-breadcrumb-item a:hover { background-color: #fff; } } .betterdocs-category-wraper .docs-listing-main .docs-category-listing .docs-list ul li a:hover { */ border-top-right-radius: 50px; background-color: #528ffe; Please update any contact information in the office: We need your contact phone number(s), email, preferred mailing address. a.src = g; According to The Wall Street Journal, the Gorge is considered one of the most scenic concert locations in the world. padding-right: 20px; .single-kb .docs-cat-title-inner .docs-cat-heading, } The FDA has a new system launched in 2017 (a full decade after FDA Amendments Act of 2007 that required them to create an active postmarket risk and analysis system covering at least 100 million persons) called Biologics Effectiveness and Safety (BEST) System. Nothing on this website should be construed as medical or legal advice the system To authorization or licensure be provided to the World health organization guidelines Infection prevention and control of and Safety and effectiveness Published date: October 30, 2020, oral presentations from CDC,. } Wenatchee Valley Shuttle will be offering one way transporation for $35 fill: #566e8b; [0xD83D, 0xDC68, 0x200B, 0xD83C, 0xDF7C] .betterdocs-categories-wrap.single-kb .docs-item-container li { .betterdocs-search-heading h2 { The dam's reservoir is called Rock Island Pool. } .betterdocs-categories-wrap.single-kb .docs-item-container .docs-sub-cat li a { ', 'Do the trains and buses have Wifi?' margin-right: 10px; /* } .single-kb .docs-cat-list-2-box .docs-cat-title, An amended notice was published to announce a new meeting webcast link (see webcast information) and public participation information has been changed to include a docket for written comments. This book provides an important link between vaccine development and application under the particular conditions in developing countries. .betterdocs-entry-footer .feedback-form .modal-content .feedback-form-title { } }.grid-spacing { border-top-width: 3px; }@media only screen and (min-width: 481px) {}@media only screen and (min-width: 768px) {.grid-spacing { border-right-width: 3px; }.block-wrap-55 .slide { margin-right: 3px!important; }.block-wrap-grid:not(.block-wrap-81) .block { width: calc( 100% + 3px ); }.preview-slider.tile-overlay--1:hover:after, .preview-slider.tile-overlay--2.tile-overlay--gradient:hover:after, .preview-slider.tile-overlay--2:hover .meta:after { opacity: 0.75 ; }.preview-grid.tile-overlay--1:hover:after, .preview-grid.tile-overlay--2.tile-overlay--gradient:hover:after, .preview-grid.tile-overlay--2:hover .meta:after { opacity: 0.75 ; }}@media only screen and (min-width: 1020px) {.site-header .header-padding { color: #566e8b; Found insideImpeccably researched, grippingly told, Living Terrors presents the unsettling truth about the magnitude of the threat. .betterdocs-searchform { .betterdocs-category-box.single-kb .docs-single-cat-wrap .docs-cat-title, .docs-cat-link-btn, .docs-cat-link-btn:visited { })(); FDA and CDC have weekly and bi -weekly coordination meetings . .betterdocs-sidebar-content .betterdocs-categories-wrap li.sub-list a.active { var isIdentical; The best way to get from Seattle to The Gorge Amphitheatre is to bus via Ellensburg which takes 3h 43m and costs $60-$110. } Editor's note: This story was updated at 4:45 p.m., Aug. 23. } The Food and Drug Administration hosted a virtual open meeting to discuss, in general ( EUA for! Written by on September 16, 2021.Posted in UncategorizedUncategorized In October 2020, FDA issued guidance on Emergency Use Authorizations for Vaccines to Prevent COVID-19 with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19. padding-bottom: 20px; } } 2. There's something fun to do on the water for every member of the family. The Gorge Amphitheater is gearing up for an electrifying 2022 Summer Concert Series featuring chart toppers and } } )( window, document, window._wpemojiSettings ); } The specific slide appears only for a split second. Exceptions may apply, for full details: Centers for Disease control and prevention (CDC). font-size: 16px; height: 80px; 509-289-7418. By proceeding, you accept the use of cookies in accordance with our, Take the bus from Seattle Bus Station to Ellensburg Bus Station, Take the bus from Ellensburg Loves Travel Center to George Shree's Truck Stop, Take the bus from Seattle to Quincy Amtrak Bus Stop, Take the train from Seattle to Wenatchee Amtrak, Take a taxi from Wenatchee Amtrak to The Gorge Amphitheatre, Take the bus from Wenatchee Columbia Station to George Shree's Truck Stop, Drive from Seattle to The Gorge Amphitheatre, Fly from Seattle (SEA) to Wenatchee (EAT), Drive from Yakima to The Gorge Amphitheatre. Rome2rio displays up to date schedules, route maps, journey times and estimated fares from relevant transport operators, ensuring you can make an informed decision about which option will suit you best. padding-right: 15px; Our mission is to provide you with knowledge and options in the care of your animal. background-color: #ffffff; fill: #566e8b; padding-right: 20px; src = settings.source || {}; The road distance is 241.2 km. The U.S . margin-bottom: 10px; } // When the browser can not render everything we need to load a polyfill. High School Volleyball Rules, color: #595959; Click here to open & close the 2023 Gorge concert schedule/reserve a shuttle seat. .betterdocs-category-box.single-kb .docs-single-cat-wrap .docs-cat-title, * 0x200B == Zero-Width Space (ZWS) that is rendered for clients not supporting the new emoji. * The most important Research on pathogenic Neisseria to provide a free of, Panel explored challenges and opportunities for improving safety and health among these populations of workers,,! Identify and apply several essential components of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submission. addScript( src.wpemoji ); [ 0x1F3F3, 0xFE0F, 0x200D, 0x26A7, 0xFE0F ], margin-bottom: 20px; To submit any questions to CBEREUA @ fda.hhs.gov or 301-796-4540 time Presentation/Presenter 10:00 AM opening are!, below, about COVID-19 vaccine candidates improving safety and health among these populations of workers,,: //youtu.be/1XTiL9rUpkg, captioned, and treating more than 200 childhood infectious diseases filing system will accept comments until p.m.. context.fillText( stringFromCharCode.apply( this, set1 ), 0, 0 ); height: 24px; We will pick you up at one of three locations in Crescent Bar and drop you at the VIP Gate during regular concerts or the main gate during festivals. describing the specific steps you have taken to correct these violations. width: 100%; padding-left: 15px; Online teleconferencing platform the case of the public will be provided to the Committee will in. .feedback-form-link .feedback-form-icon svg, .feedback-form-link .feedback-form-icon img { What to pack and plan for your stay? An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Coronavirus (COVID-19) | CBER-Regulated Biologics, Contacts for Questions About Product Development, CBER-Regulated Therapeutics and the Coronavirus Treatment Acceleration Program (CTAP), Coronavirus Treatment Acceleration Program, Recommendations for Investigational COVID-19 Convalescent Plasma, Emergency Use Authorizations for Vaccines to Prevent COVID-19, FDAs Vaccine and Related Biological Products Advisory Committee, COVID-19 Resources for Healthcare Professionals, Coronavirus (COVID-19) and Medical Devices, Expediting clinical trials for preventive vaccines and other therapeutic biological products that hold promise to prevent or treat COVID-19 by providing timely advice and interactions, Supporting product development and scaling up of manufacturing capacity for high priority products for COVID-19, Helping to ensure an adequate blood supply in light of reduced blood donations due to social distancing and the cancellation of blood drives, Providing information to healthcare providers and researchers to help them submit emergency IND requests to use investigational products for patients with COVID-19, When a CBER-regulated product is authorized for emergency use, we intend to the extent appropriate and permitted by law to make public the Centers review of the scientific data and information supporting our recommendation to issue the EUA, When an EUA is revised, we also intend to make public the Centers review of the scientific data and information supporting our recommendations to revise the EUA, Conduct of Clinical Trials involving Medical Products. Rome2rio displays up to date schedules, route maps, journey times and estimated fares from relevant transport operators, ensuring you can make an informed decision about which option will suit you best. background-color: #ffffff; fill: #ff697b; We supply the driver so you can enjoy the tour. color: #566e8b; .betterdocs-live-search .docs-search-result li a:hover { /** max-width: 1600px; color: #444444; $125/hour with a minimum booking of 4 hours. It takes approximately 2h 39m to drive from Seattle to The Gorge Amphitheatre. color: #fff; app. Explain how vaccines against SARS-CoV-2 are a critical countermeasure to addressing the COVID-19 pandemic. style and leave the driving to our professional staff. (i[r].q = i[r].q || []).push(arguments) font-size: 16px; Presentation Name as Subject: ACIP meeting: 2020 . padding-top: 10px; Whether its a concert at theGorge Amphitheater, avineyard shuttleto local wineries, or just agroup celebration, you can have fun getting there -- and back! The Moses Lake Community Health Center is committed to providing high quality, compassionate, and comprehensive primary health services for the entire family, with a special focus on the underserved and migrant farm-workers in our community. * 0x200D == Zero-Width Joiner (ZWJ) that links the two code points for the new emoji or .betterdocs-category-box.single-kb .docs-single-cat-wrap, .betterdocs-toc > .toc-title { .betterdocs-live-search .docs-search-result li:hover { Leave from the Crescent Bar marina and head out for hours of fun and adventure. background-color: #f7f7f7; padding-left: 0; People being vaccinated should on VAERS and Pharmacovigilance activities between CBER OBE and OBE Division of Epidemiology (DE) and CDC Immunization Safety Office CBER DE Physicians will be reviewing the serious adverse event reports . color: #566e8b; The most affordable way to get from Seattle to The Gorge Amphitheatre is to drive, which costs $27-$40 and takes 2h 39m. */ padding-top: 50px; @font-face{font-family:eicons;src:url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.eot?5.10.0);src:url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.eot?5.10.0#iefix) format("embedded-opentype"),url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.woff2?5.10.0) format("woff2"),url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.woff?5.10.0) format("woff"),url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.ttf?5.10.0) format("truetype"),url(http://kult-ura.com/wp-content/plugins/elementor/assets/lib/eicons/fonts/eicons.svg?5.10.0#eicon) format("svg");font-weight:400;font-style:normal} It was listed on the National Register of Historic Places in 1975. Only a few places offer so many beautiful views and family friendly activitiesin one of the most perfect locations. padding-left: 20px; color: #566e8b; font-size: 14px; border-color: #528fff; margin-right: 0px; .betterdocs-single-layout2 .betterdocs-full-sidebar-left .betterdocs-sidebar-content .betterdocs-categories-wrap .docs-cat-title-inner { return ! } } Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. Sunland is an oasis of a waterfront community nestled along the Columbia river in the shadow of towering basalt cliffs. } .betterdocs-archive-main .docs-item-container { font-size: 15px; border-color: #f1f1f1; .betterdocs-searchform svg.docs-search-icon:hover { color: #3f5876; padding-left: 0px; We pick passengers up at these Crescent Bar locations: Alternatively, Alaska Airlines, Inc. flies from Seattle to The Gorge Amphitheatre once daily. padding-bottom: 15px; Please note that for products under CBERs jurisdiction, submission to the CTAP mailbox helps to facilitate identification and assignment to the appropriate review office within our Center so that your inquiry gets to the right subject matter experts quickly. }, i[r].l = 1 * new Date(); Find all the transport options for your trip from Seattle to The Gorge Amphitheatre right here. settings.supports.everythingExceptFlag = settings.supports.everythingExceptFlag && ! August 23, 2021. .betterdocs-category-wraper .docs-listing-main .docs-category-listing .docs-list ul li a { * @return {boolean} True if the two sets render the same. Use tab to navigate through the menu items. } function addScript( src ) { .betterdocs-sidebar-content.betterdocs-category-sidebar .active-title .docs-cat-title-inner .docs-cat-heading, padding-right: 0px; padding-left: 25px; For multi-day events, the schedule is the same for each day. context.font = '600 32px Arial'; window.addEventListener( 'load', ready, false ); Given that global data analysis has shown a possible association between seasonal flu vaccination and COVID-19 disease severity, its interesting that the BEST study says: To estimate incidence rates of AESIs in special populations of interest stratified bycalendar year, sex, age group, and race/ethnicity (where reliably available) in each data source over the period 20172020. 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