DRAFT COPY-- DO NOT CITE OR CIRCULATE 1 Modeling Decisions for Digital Content

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中石油托福词汇频率

中石油托福词汇频率

Cast anchor; cast down; cast forth; cast off; Cast-off>n.adj.
To supply food ready to eat for parties Any large and important church A large cave or chamber in a cave Hole; dental caries = tooth decay; Stop; interrupt; N. = end . Of heaven or the spirit; of or relating to the sky. celestial body; celestial equator; Viola; the bass member of the violin family. A count of the population Serials of acts prescribed by ritual, protocol, or convention Irratate; warm by rubbing; wear caused by friction Bedroom; enclosed space or cavity A state of utter confusion <> cosmos A charcoal drawing A written instrument; hire, rent, lease; charter school Castle or fortress; mansion Moderately cold>depression; lacking warmth of feeling 黑<>大 gorilla Used to chip, carve; cheat gallant or distinguished gentlemen Chop-mark; rough with small waves Accord, harmonize ; seventh chord; A large noteworthy quantity

托福词汇

托福词汇

词汇解释a pivotal figure关键人物a premium price高价a range of一系列abandon抛弃 放纵abandonmentabbreviate缩写abrasion磨损abstractabsurd荒谬的abundanceabundantaccelerateaccessacclaimedaccompanimentaccommodateaccompanyaccordion手风琴accumulateaccustomedacquaintanceacronym首字母缩略词acute急性病adaptadaptableadaptationadditive食品添加剂 附加的adeptadjacentadjoiningadjustadjustmentadobeadopt采纳adorn v 装饰adornmentadventadverseadverselyadversityadvocate支持 拥护aesthetic美学的(a pron)aestheticallyaffectaffectedaffiliate withafflict使痛苦 折磨affluent富裕的 支流aggravating加重 恶化aggregateaggregationagitation鼓动 焦虑akin to有密切关系alchemy炼金术alderalgae水藻alienall butall-inclusiveallocate分派alloy合金alternativealtitudealuminumambience环境 氛围amenableamplifyancestorannihilateannualannuallyanomalyanonymous匿名的antibioticantiquateantiquatedantiquityapart fromappealappeal toapprenticeapproach方法aptly恰当地 得体地aquaticarcarchaeologicalarchipelagoarchitectarduous费力的 艰难的arena竞技场aridarmoraromatic芳香的array排列 队形 装扮arthritis关节炎artificialartisanas a ruleas a rule of thumb大概 差不多as far north as向北远到as suchascend攀登ascribe toaspiringassemble集合 装备 聚集assert断言 主张associateassorted混合的assortmentassumeassumptionassureastonishingastute机敏的 机灵的at intervals不时 相隔一定的间隔at one session一次性的at the cutting edge of在……关键时刻atomizationattachattached附加 附属attachmentattain达到 获得attainment成就attire穿着 装扮 衣服attribute toauditorium礼堂 大讲堂auger钻孔机aurora极光auroral lightautomatedavailableaviationavocational副业的 嗜好的awarenessawkwardly笨拙的backdropballetbalmy天气温和的 芳香的barb倒钩Barbed wire带倒刺的铁丝barge驳船bark树皮barnbarren贫瘠的barrierbarter以物易物basement地下室basin盆地be characterized bybe taken by被……所吓住be up tobeakbeam木结构的大梁/光线bequest遗产 遗赠besiege围攻 包围bestow把……赠与biasbitterness苦味 辛酸bizarre奇异的 古怪的blanket毯子blast爆破blazing燃烧的bleak荒凉的blendblessingblock阻止(v)blocksblossombluesbluff陡峭的悬崖 v吓唬bluntbolster枕垫 支持 鼓励boomboon恩惠boostboringboundarybow小提琴的弓breach毁坏 泄密 缺口break all ties withbreeze微风brilliancebriny海水的 咸的brisknessbrittle易碎的bronze青铜的bubblebucklebuggy两轮马车building blockbulk体积bundleburdensome繁重的burgeon雨后春笋般成长burrowbust半身像bustle喧闹by a factor of翻……倍by farcabcabinetcacticalibrationcampaigncannibalism同类相食canopy蚊帐 华盖 树荫canyon峡谷(宽而深的) capability能力capacity容量carapace甲壳carbohydratecardiaccargocarnivalcarnivorouscarvingcastcast off casting category cater cathedral cavern cavity cease celestial cellcellist census ceremonial ceremony chafe chamber chaos charcoal charter chateau checkchillchilly chimpanzee chisel chivalry chop choppy chord chunkcirculate circulation circumscribe citecivilian civility claim clamor clamclan classification classifyclaycliffcling to clockwise clumsy cluster code of laws coexist cohesion cohesive coil coincide coincident collaboration collective collide colossal combustiblecombustion comet commission v committed commodity commonsense communally community commuter compact companion comparable compatible compel compensation competing competitiveness compile complacence complement complementary complexes complicated comply with component composed of composition compound compress compriseconconceal concede conceive conception concerted concise concrete condensation condense condor conductivity cone confederacy configuration confine to confinement confirm conflict conflicting confront congenial congestion congregate conifer conjecture consecutive consequence conservative conserve consort with conspicuousconstant constantly constellation constituent constitute constitution constitutional constrain constraint constrict constricted construction consumption contact container contemporary context contours contraction contractor contribute to convention conventional conventionally converge convert converter convict convinced convincingcoral reef coralscore correlated corrosion corruption cosmic costume counteract counterbalance counterclockwise counterpart cowhandcrabcrackcraft craftspeople cratercrawlcrayon credence creditor crevice crippling crisscross crossbones crossbreeding crowcrudecrude oilcrumple crust crustacean crystalline crystallized cubismcue culminate cumbersome curator curriculum 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precipitation precursor predator predatory predecessor predominantly predominate preeminent prefabricated prehistoric preponderance prerequisite presencepreservation preservative preside over prestige pretension prevail prevailing prey primal primarily primate prime primitive priority privilege probe proceed process proclaim proclivity prod sb. into prodigious prodigy produce proficiency profile prohibitively proliferation prolific prominence prominentpromising promote pronounced proper property proponent proportion proprietorship propulsion prospect prosper prosperous protectionist protein prototype protruding provincialism provocative prudentpry open publicize pueblo punch puncture purification pyramid quaint qualification quarry quench questquiescent quiltradar radiation radiusraftragtimerally rampant rancher ranching rangerange from...to rarefyration rattlesnake raven readjust realmrear rebellion receptor receptacle recipe recipient recognize reconstruct reconstruction recreation 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HP Color LaserJet Enterprise MFP M776用户指南说明书

HP Color LaserJet Enterprise MFP M776用户指南说明书

Legal informationCopyright and License© Copyright 2019 HP Development Company, L.P.Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowedunder the copyright laws.The information contained herein is subject to change without notice.The only warranties for HP products and services are set forth in the express warranty statementsaccompanying such products and services. Nothing herein should be construed as constituting anadditional warranty. HP shall not be liable for technical or editorial errors or omissions contained herein.Edition 1, 10/2019Trademark CreditsAdobe®, Adobe Photoshop®, Acrobat®, and PostScript® are trademarks of Adobe Systems Incorporated.Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries.macOS is a trademark of Apple Inc., registered in the U.S. and other countries.AirPrint is a trademark of Apple Inc., registered in the U.S. and other countries.Google™ is a trademark of Google Inc.Microsoft®, Windows®, Windows® XP, and Windows Vista® are U.S. registered trademarks of MicrosoftCorporation.UNIX® is a registered trademark of The Open Group.iiiT able of contents1 Printer overview (1)Warning icons (1)Potential shock hazard (2)Printer views (2)Printer front view (2)Printer back view (4)Interface ports (4)Control-panel view (5)How to use the touchscreen control panel (7)Printer specifications (8)T echnical specifications (8)Supported operating systems (11)Mobile printing solutions (12)Printer dimensions (13)Power consumption, electrical specifications, and acoustic emissions (15)Operating-environment range (15)Printer hardware setup and software installation (16)2 Paper trays (17)Introduction (17)Load paper to Tray 1 (multipurpose tray) (17)Load Tray 1 (multipurpose tray) (18)Tray 1 paper orientation (19)Use alternative letterhead mode (24)Enable Alternative Letterhead Mode by using the printer control-panel menus (24)Load paper to Tray 2 (24)Load Tray 2 (24)Tray 2 paper orientation (26)Use alternative letterhead mode (29)Enable Alternative Letterhead Mode by using the printer control-panel menus (29)Load paper to the 550-sheet paper tray (30)Load paper to the 550-sheet paper tray (30)550-sheet paper tray paper orientation (32)Use alternative letterhead mode (35)Enable Alternative Letterhead Mode by using the printer control-panel menus (35)ivLoad paper to the 2 x 550-sheet paper trays (36)Load paper to the 2 x 550-sheet paper trays (36)2 x 550-sheet paper tray paper orientation (38)Use alternative letterhead mode (41)Enable Alternative Letterhead Mode by using the printer control-panel menus (41)Load paper to the 2,700-sheet high-capacity input paper trays (41)Load paper to the 2,700-sheet high-capacity input paper trays (41)2,700-sheet HCI paper tray paper orientation (43)Use alternative letterhead mode (45)Enable Alternative Letterhead Mode by using the printer control-panel menus (45)Load and print envelopes (46)Print envelopes (46)Envelope orientation (46)Load and print labels (47)Manually feed labels (47)Label orientation (48)3 Supplies, accessories, and parts (49)Order supplies, accessories, and parts (49)Ordering (49)Supplies and accessories (50)Maintenance/long-life consumables (51)Customer self-repair parts (51)Dynamic security (52)Configure the HP toner-cartridge-protection supply settings (53)Introduction (53)Enable or disable the Cartridge Policy feature (53)Use the printer control panel to enable the Cartridge Policy feature (54)Use the printer control panel to disable the Cartridge Policy feature (54)Use the HP Embedded Web Server (EWS) to enable the Cartridge Policy feature (54)Use the HP Embedded Web Server (EWS) to disable the Cartridge Policy feature (55)Troubleshoot Cartridge Policy control panel error messages (55)Enable or disable the Cartridge Protection feature (55)Use the printer control panel to enable the Cartridge Protection feature (56)Use the printer control panel to disable the Cartridge Protection feature (56)Use the HP Embedded Web Server (EWS) to enable the Cartridge Protection feature (56)Use the HP Embedded Web Server (EWS) to disable the Cartridge Protection feature (57)Troubleshoot Cartridge Protection control panel error messages (57)Replace the toner cartridges (58)T oner-cartridge information (58)Remove and replace the cartridges (59)Replace the imaging drums (62)Imaging drum information (62)Remove and replace the imaging drums (63)Replace the toner-collection unit (66)T oner-collection unit information (66)vRemove and replace the toner-collection unit (67)Replace the staple cartridge (M776zs model only) (70)Staple cartridge information (70)Remove and replace the staple cartridge (71)4 Print (73)Print tasks (Windows) (73)How to print (Windows) (73)Automatically print on both sides (Windows) (74)Manually print on both sides (Windows) (74)Print multiple pages per sheet (Windows) (75)Select the paper type (Windows) (75)Additional print tasks (76)Print tasks (macOS) (77)How to print (macOS) (77)Automatically print on both sides (macOS) (77)Manually print on both sides (macOS) (77)Print multiple pages per sheet (macOS) (78)Select the paper type (macOS) (78)Additional print tasks (79)Store print jobs on the printer to print later or print privately (79)Introduction (79)Create a stored job (Windows) (79)Create a stored job (macOS) (80)Print a stored job (81)Delete a stored job (81)Delete a job that is stored on the printer (81)Change the job storage limit (82)Information sent to printer for Job Accounting purposes (82)Mobile printing (82)Introduction (82)Wi-Fi, Wi-Fi Direct Print, NFC, and BLE printing (82)Enable wireless printing (83)Change the Wi-Fi Direct name (83)HP ePrint via email (83)AirPrint (84)Android embedded printing (85)Print from a USB flash drive (85)Enable the USB port for printing (85)Method one: Enable the USB port from the printer control panel (85)Method two: Enable the USB port from the HP Embedded Web Server (network-connectedprinters only) (85)Print USB documents (86)Print using high-speed USB 2.0 port (wired) (86)Method one: Enable the high-speed USB 2.0 port from the printer control panel menus (86)Method two: Enable the high-speed USB 2.0 port from the HP Embedded Web Server (network-connected printers only) (87)vi5 Copy (88)Make a copy (88)Copy on both sides (duplex) (90)Additional copy tasks (92)6 Scan (93)Set up Scan to Email (93)Introduction (93)Before you begin (93)Step one: Access the HP Embedded Web Server (EWS) (94)Step two: Configure the Network Identification settings (95)Step three: Configure the Send to Email feature (96)Method one: Basic configuration using the Email Setup Wizard (96)Method two: Advanced configuration using the Email Setup (100)Step four: Configure the Quick Sets (optional) (104)Step five: Set up Send to Email to use Office 365 Outlook (optional) (105)Introduction (105)Configure the outgoing email server (SMTP) to send an email from an Office 365 Outlookaccount (105)Set up Scan to Network Folder (108)Introduction (108)Before you begin (108)Step one: Access the HP Embedded Web Server (EWS) (108)Step two: Set up Scan to Network Folder (109)Method one: Use the Scan to Network Folder Wizard (109)Method two: Use Scan to Network Folder Setup (110)Step one: Begin the configuration (110)Step two: Configure the Scan to Network Folder settings (111)Step three: Complete the configuration (118)Set up Scan to SharePoint (118)Introduction (118)Before you begin (118)Step one: Access the HP Embedded Web Server (EWS) (118)Step two: Enable Scan to SharePoint and create a Scan to SharePoint Quick Set (119)Scan a file directly to a SharePoint site (121)Quick Set scan settings and options for Scan to SharePoint (122)Set up Scan to USB Drive (123)Introduction (124)Step one: Access the HP Embedded Web Server (EWS) (124)Step two: Enable Scan to USB Drive (124)Step three: Configure the Quick Sets (optional) (125)Default scan settings for Scan to USB Drive setup (126)Default file settings for Save to USB setup (126)Scan to email (127)Introduction (127)Scan to email (127)Scan to job storage (129)viiIntroduction (129)Scan to job storage on the printer (130)Print from job storage on the printer (132)Scan to network folder (132)Introduction (132)Scan to network folder (132)Scan to SharePoint (134)Introduction (134)Scan to SharePoint (134)Scan to USB drive (136)Introduction (136)Scan to USB drive (136)Use HP JetAdvantage business solutions (138)Additional scan tasks (138)7 Fax (140)Set up fax (140)Introduction (140)Set up fax by using the printer control panel (140)Change fax configurations (141)Fax dialing settings (141)General fax send settings (142)Fax receive settings (143)Send a fax (144)Additional fax tasks (146)8 Manage the printer (147)Advanced configuration with the HP Embedded Web Server (EWS) (147)Introduction (147)How to access the HP Embedded Web Server (EWS) (148)HP Embedded Web Server features (149)Information tab (149)General tab (149)Copy/Print tab (150)Scan/Digital Send tab (151)Fax tab (152)Supplies tab (153)Troubleshooting tab (153)Security tab (153)HP Web Services tab (154)Networking tab (154)Other Links list (156)Configure IP network settings (157)Printer sharing disclaimer (157)View or change network settings (157)Rename the printer on a network (157)viiiManually configure IPv4 TCP/IP parameters from the control panel (158)Manually configure IPv6 TCP/IP parameters from the control panel (158)Link speed and duplex settings (159)Printer security features (160)Introduction (160)Security statements (160)Assign an administrator password (160)Use the HP Embedded Web Server (EWS) to set the password (160)Provide user access credentials at the printer control panel (161)IP Security (161)Encryption support: HP High Performance Secure Hard Disks (161)Lock the formatter (161)Energy-conservation settings (161)Set the sleep timer and configure the printer to use 1 watt or less of power (161)Set the sleep schedule (162)Set the idle settings (162)HP Web Jetadmin (163)Software and firmware updates (163)9 Solve problems (164)Customer support (164)Control panel help system (165)Reset factory settings (165)Introduction (165)Method one: Reset factory settings from the printer control panel (165)Method two: Reset factory settings from the HP Embedded Web Server (network-connectedprinters only) (166)A “Cartridge is low” or “Cartridge is very low” message displays on the printer control panel (166)Change the “Very Low” settings (166)Change the “Very Low” settings at the control panel (166)For printers with fax capability (167)Order supplies (167)Printer does not pick up paper or misfeeds (167)Introduction (167)The printer does not pick up paper (167)The printer picks up multiple sheets of paper (171)The document feeder jams, skews, or picks up multiple sheets of paper (174)Clear paper jams (174)Introduction (174)Paper jam locations (174)Auto-navigation for clearing paper jams (175)Experiencing frequent or recurring paper jams? (175)Clear paper jams in the document feeder - 31.13.yz (176)Clear paper jams in Tray 1 (13.A1) (177)Clear paper jams in Tray 2 (13.A2) (182)Clear paper jams in the fuser (13.B9, 13.B2, 13.FF) (188)ixClear paper jams in the duplex area (13.D3) (194)Clear paper jams in the 550-sheet trays (13.A3, 13.A4) (199)Clear paper jams in the 2 x 550 paper trays (13.A4, 13.A5) (206)Clear paper jams in the 2,700-sheet high-capacity input paper trays (13.A3, 13.A4, 13.A5, 13.A7) (213)Resolving color print quality problems (220)Introduction (220)Troubleshoot print quality (221)Update the printer firmware (221)Print from a different software program (221)Check the paper-type setting for the print job (221)Check the paper type setting on the printer (221)Check the paper type setting (Windows) (221)Check the paper type setting (macOS) (222)Check toner-cartridge status (222)Step one: Print the Supplies Status Page (222)Step two: Check supplies status (222)Print a cleaning page (222)Visually inspect the toner cartridge or cartridges (223)Check paper and the printing environment (223)Step one: Use paper that meets HP specifications (223)Step two: Check the environment (223)Step three: Set the individual tray alignment (224)Try a different print driver (224)Troubleshoot color quality (225)Calibrate the printer to align the colors (225)Troubleshoot image defects (225)Improve copy image quality (233)Check the scanner glass for dirt and smudges (233)Calibrate the scanner (234)Check the paper settings (235)Check the paper selection options (235)Check the image-adjustment settings (235)Optimize copy quality for text or pictures (236)Edge-to-edge copying (236)Improve scan image quality (236)Check the scanner glass for dirt and smudges (237)Check the resolution settings (238)Check the color settings (238)Check the image-adjustment settings (239)Optimize scan quality for text or pictures (239)Check the output-quality settings (240)Improve fax image quality (240)Check the scanner glass for dirt and smudges (240)Check the send-fax resolution settings (242)Check the image-adjustment settings (242)Optimize fax quality for text or pictures (242)Check the error-correction setting (243)xSend to a different fax machine (243)Check the sender's fax machine (243)Solve wired network problems (244)Introduction (244)Poor physical connection (244)The computer is unable to communicate with the printer (244)The printer is using incorrect link and duplex settings for the network (245)New software programs might be causing compatibility problems (245)The computer or workstation might be set up incorrectly (245)The printer is disabled, or other network settings are incorrect (245)Solve wireless network problems (245)Introduction (245)Wireless connectivity checklist (245)The printer does not print after the wireless configuration completes (246)The printer does not print, and the computer has a third-party firewall installed (246)The wireless connection does not work after moving the wireless router or printer (247)Cannot connect more computers to the wireless printer (247)The wireless printer loses communication when connected to a VPN (247)The network does not appear in the wireless networks list (247)The wireless network is not functioning (247)Reduce interference on a wireless network (248)Solve fax problems (248)Checklist for solving fax problems (248)What type of phone line are you using? (249)Are you using a surge-protection device? (249)Are you using a phone company voice-messaging service or an answering machine? (249)Does your phone line have a call-waiting feature? (249)Check fax accessory status (249)General fax problems (250)The fax failed to send (250)No fax address book button displays (250)Not able to locate the Fax settings in HP Web Jetadmin (250)The header is appended to the top of the page when the overlay option is enabled (251)A mix of names and numbers is in the recipients box (251)A one-page fax prints as two pages (251)A document stops in the document feeder in the middle of faxing (251)The volume for sounds coming from the fax accessory is too high or too low (251)Index (252)xiPrinter overview1Review the location of features on the printer, the physical and technical specifications of the printer,and where to locate setup information.For video assistance, see /videos/LaserJet.The following information is correct at the time of publication. For current information, see /support/colorljM776MFP.For more information:HP's all-inclusive help for the printer includes the following information:●Install and configure●Learn and use●Solve problems●Download software and firmware updates●Join support forums●Find warranty and regulatory informationWarning iconsUse caution if you see a warning icon on your HP printer, as indicated in the icon definitions.●Caution: Electric shock●Caution: Hot surface●Caution: Keep body parts away from moving partsPrinter overview1●Caution: Sharp edge in close proximity●WarningPotential shock hazardReview this important safety information.●Read and understand these safety statements to avoid an electrical shock hazard.●Always follow basic safety precautions when using this product to reduce risk of injury from fire orelectric shock.●Read and understand all instructions in the user guide.●Observe all warnings and instructions marked on the product.●Use only a grounded electrical outlet when connecting the product to a power source. If you do notknow whether the outlet is grounded, check with a qualified electrician.●Do not touch the contacts on any of the sockets on the product. Replace damaged cordsimmediately.●Unplug this product from wall outlets before cleaning.●Do not install or use this product near water or when you are wet.●Install the product securely on a stable surface.●Install the product in a protected location where no one can step on or trip over the power cord.Printer viewsIdentify certain parts of the printer and the control panel.Printer front viewLocate features on the front of the printer.2Chapter 1 Printer overviewPrinter front view3Printer back viewLocate features on the back of the printer.Interface portsLocate the interface ports on the printer formatter. 4Chapter 1 Printer overviewControl-panel viewThe control panel provides access to the printer features and indicates the current status of the printer.NOTE:Tilt the control panel for easier viewing.The Home screen provides access to the printer features and indicates the current status of the printer.screens.NOTE:The features that appear on the Home screen can vary, depending on the printerconfiguration.Control-panel view5Figure 1-1Control-panel view?i 12:42 PM6Chapter 1 Printer overviewHow to use the touchscreen control panelPerform the following actions to use the printer touchscreen control panel.T ouchT ouch an item on the screen to select that item or open that menu. Also, when scrolling T ouch the Settings icon to open the Settings app.How to use the touchscreen control panel 7SwipeT ouch the screen and then move your finger horizontally to scroll the screen sideways.Swipe until the Settings app displays.Printer specificationsDetermine the specifications for your printer model.IMPORTANT:The following specifications are correct at the time of publication, but they are subject to change. For current information, see /support/colorljM776MFP .T echnical specificationsReview the printer technical specifications.Product numbers for each model ●M776dn - #T3U55A ●Flow M776z - #3WT91A ●Flow M776zs - #T3U56APaper handling specificationsPaper handling features Tray 1 (100-sheet capacity)Included Included Included Tray 2 (550-sheet capacity)IncludedIncludedIncluded8Chapter 1 Printer overview550-sheet paper trayOptional Included Not included NOTE:The M776dn models accept one optional550-sheet tray.Optional Included Included2 x 550-sheet paper tray and standNOTE:The M776dn models accept one optional550-sheet tray that may be installed on top of thestand.Optional Not included Not included2,700-sheet high-capacity input (HCI) paper trayand standNOTE:The M776dn models accept one optional550-sheet tray that may be installed on top of theoptional printer stand.Printer standOptional Not included Not included NOTE:The M776dn models accept one optional550-sheet tray that may be installed on top of theoptional printer stand.Inner finisher accessory Not included Not included Included Automatic duplex printing Included IncludedIncludedIncluded Included Included10/100/1000 Ethernet LAN connection with IPv4and IPv6Hi-Speed USB 2.0Included Included IncludedIncluded Included IncludedEasy-access USB port for printing from a USBflash drive or upgrading the firmwareIncluded Included Included Hardware Integration Pocket for connectingaccessory and third-party devicesHP Internal USB Ports Optional Optional OptionalOptional Optional OptionalHP Jetdirect 2900nw Print Server accessory forWi-Fi connectivity and an additional Ethernet portOptional IncludedIncludedHP Jetdirect 3100w accessory for Wi-Fi, BLE, NFC,and proximity badge readingPrints 45 pages per minute (ppm) on Letter-sizepaper and 46 ppm on A4-size paperEasy-access USB printing for printing from a USBIncluded Included Includedflash driveT echnical specifications9Included Included Included Store jobs in the printer memory to print later orprint privatelyScans 100 pages per minute (ppm) on A4 andIncluded Included Included letter-size paper one-sidedIncluded Included Included 200-page document feeder with dual-headscanning for single-pass duplex copying andscanningNot included Included Included HP EveryPage T echnologies including ultrasonicmulti-feed detectionNot included Included Included Embedded optical character recognition (OCR)provides the ability to convert printed pages intotext that can be edited or searched using acomputerIncluded Included Included SMART Label feature provides paper-edgedetection for automatic page croppingIncluded Included Included Automatic page orientation for pages that haveat least 100 characters of textIncluded Automatic tone adjustment sets contrast,Included Includedbrightness, and background removal for eachpageIncluded Included Includedfolders on a networkIncludedSend documents to SharePoint®Included IncludedIncluded Included Included NOTE:Memory reported on the configurationpage will change from 2.5 GB to 3 GB with theoptional 1 GB SODIMM installed.Mass storage: 500 GB hard disk drive Included Included IncludedSecurity: HP Trusted Platform Module (TPM)Included Included IncludedT ouchscreen control panel Included Included IncludedRetractable keyboard Not included Included Included 10Chapter 1 Printer overviewFax Optional Included IncludedSupported operating systemsUse the following information to ensure printer compatibility with your computer operating system.Linux: For information and print drivers for Linux, go to /go/linuxprinting.UNIX: For information and print drivers for UNIX®, go to /go/unixmodelscripts.The following information applies to the printer-specific Windows HP PCL 6 print drivers, HP print driversfor macOS, and to the software installer.Windows: Download HP Easy Start from /LaserJet to install the HP print driver. Or, go tothe printer-support website for this printer: /support/colorljM776MFP to download the printdriver or the software installer to install the HP print driver.macOS: Mac computers are supported with this printer. Download HP Easy Start either from /LaserJet or from the Printer Support page, and then use HP Easy Start to install the HP print driver.1.Go to /LaserJet.2.Follow the steps provided to download the printer software.Windows 7, 32-bit and 64-bit The “HP PCL 6” printer-specific print driver is installed for this operating system aspart of the software installation.Windows 8.1, 32-bit and 64-bit The “HP PCL-6” V4 printer-specific print driver is installed for this operating systemas part of the software installation.Windows 10, 32-bit and 64-bit The “HP PCL-6” V4 printer-specific print driver is installed for this operating systemas part of the software installation.Windows Server 2008 R2, SP 1, 64-bit The PCL 6 printer-specific print driver is available for download from the printer-support website. Download the driver, and then use the Microsoft Add Printer tool toinstall it.Windows Server 2012, 64-bit The PCL 6 printer-specific print driver is available for download from the printer-support website. Download the driver, and then use the Microsoft Add Printer tool toinstall it.Windows Server 2012 R2, 64-bit The PCL 6 printer-specific print driver is available for download from the printer-support website. Download the driver, and then use the Microsoft Add Printer tool toinstall it.Windows Server 2016, 64-bit The PCL 6 printer-specific print driver is available for download from the printer-support website. Download the driver, and then use the Microsoft Add Printer tool toinstall it.Windows Server 2019, 64-bit The PCL 6 printer-specific print driver is available for download from the printer-support website. Download the driver, and then use the Microsoft Add Printer tool toinstall it.Supported operating systems11macOS 10.13 High Sierra, macOS 10.14 MojaveDownload HP Easy Start from /LaserJet , and then use it to install the print driver.NOTE:Supported operating systems can change.NOTE:For a current list of supported operating systems and HP’s all-inclusive help for the printer, go to /support/colorljM776MFP .NOTE:For details on client and server operating systems and for HP UPD driver support for this printer, go to /go/upd . Under Additional information , click Specifications .●Internet connection●Dedicated USB 1.1 or 2.0 connection or a network connection● 2 GB of available hard-disk space ●1 GB RAM (32-bit) or2 GB RAM (64-bit)●Internet connection●Dedicated USB 1.1 or 2.0 connection or a network connection●1.5 GB of available hard-disk spaceNOTE:The Windows software installer installs the HP Smart Device Agent Base service. The file size is less than 100 kb. Its only function is to check for printers connected via USB hourly. No data is collected. If a USB printer is found, it then tries to locate a JetAdvantage Management Connector (JAMc) instance on the network. If a JAMc is found, the HP Smart Device Agent Base is securelyupgraded to a full Smart Device Agent from JAMc, which will then allow printed pages to be accounted for in a Managed Print Services (MPS) account. The driver-only web packs downloaded from for the printer and installed through the Add Printer wizard do not install this service.T o uninstall the service, open the Control Panel , select Programs or Programs and Features , and then select Add/Remove Programs or Uninstall a Programto remove the service. The file name isHPSmartDeviceAgentBase.Mobile printing solutionsHP offers multiple mobile printing solutions to enable easy printing to an HP printer from a laptop, tablet, smartphone, or other mobile device.T o see the full list and to determine the best choice, go to /go/MobilePrinting .NOTE:Update the printer firmware to ensure all mobile printing capabilities are supported.●Wi-Fi Direct (wireless models only, with HP Jetdirect 3100w BLE/NFC/Wireless accessory installed)●HP ePrint via email (Requires HP Web Services to be enabled and the printer to be registered with HP Connected)●HP Smart app ●Google Cloud Print12Chapter 1 Printer overview。

Angew. Chem. Int. Ed.德国应用化学(翻译)写作指导

Angew. Chem. Int. Ed.德国应用化学(翻译)写作指导

1. General Information(基本资料,总说明)Angewandte Chemie International Edition and its German version (德语版)Angewandte Chemie are owned(拥有)by the Gesellschaft Deutscher Chemiker (German Chemical Society) and are published by Wiley-VCH(出版社). This leading journal (重要期刊)for all fields of chemistry publishes a variety of articles (各种各样的文章)(see below). Both editions of the journal will have 52 issues(期号)in 2011 in print and online (in Wiley Online Library); all articles are available online weeks before the printed version appears (Early Views提前在线出版模式). Contributions (投稿)may be submitted in English or German(可以为英语或者德语递交). Angewandte Chemie does not publish manuscripts(手稿,原稿草稿)that have already appeared(出现,发表).The author must inform(通知,告知)the editor of manuscripts submitted(提交手稿的编辑), soon to be submitted(很快投稿), or in press at other journals that have a bearing on the manuscript being submitted(那些与投递原稿的相关信息). If the manuscript is, in fact, a revised/extended version (之前被拒手稿修改或者扩展版本)of a manuscript previously rejected by Angewandte Chemie, the author must inform the editor about the previous submission(提交<物>,意见)in the cover letter(投稿信,附信)and explain in detail which changes have been made. The Ethical Guidelines for Publication in Journals and Reviews(期刊和评论出版物道德准则)issued by the European Association for Chemical and Molecular Sciences (EuCheMS) are followed(遵循)and applied by Angewandte Chemie; these guidelines are similar to the Ethical Guidelines to Publication of Chemical Research of the American Chemical Society. Authors should declare any conflict of interest(声明任何利益冲突)in their letter to the editor, for example support of the research by companies who stand to profit from publication of the results. Authors submitting a manuscript to Angewandte Chemie for the first time are asked to characterize their main research interests with a maximum of five keywords (最多五个关键词)from the Keyword List for Authors and Reviewers.All Manuscripts should be submitted through manuscriptXpress. Please prepare a single file一个单一文件(allowed formats格式: Word, RTF, Postscript, PDF) containing all schemes(方案,图式), figures(图形,图表), and tables(表格)integrated in the text; this file should also contain the Supporting Information, when appropriate. Then follow the instructions(按照说明)on the submission website. In this file, please include a short text justifying(证明)why your article should appear in Angewandte Chemie. Please use the box "Cover letter" for your cover letter (no formatted text, for example italics, sub/superscript). Any information that is intended for(打算给)the editorial office only (e.g., suggested reviewers and conflicts of interest with potential reviewers) should be given in the box "Additional Upload Comment(上传评论)". If you experience any problems please make use of the contact form(接触方式)at this site. When your article has been accepted you will be informed of (接到)the procedure for submitting revised manuscripts.Should you wish to submit multimedia files that exceed 5 MB in size, please proceed (继续)as described on the homepage. Smaller files can simply be sent as ane-mail attachement(附件).MSword templates(模板)for Reviews(综述), Minireviews, Essays(随笔), Highlights(集锦), and Communications are available in the section "Author Guidelines".2. Types of ContributionAlthough Reviews, Minireviews, Essays, and Highlights are generally written upon invitation(邀请)of the editor, they can also be the result of an author's own initiative.(主动)However, the editor should be informed in advance about such an intended contribution(有意的投稿).We would like to emphasize that the number of characters mentioned in the following Sections always include spaces. (要强调的是包括空格在内的字符数)2.1. Review ArticlesReview articles should be written by leading experts(权威专家)and deal with(涉及)topics of high current interest in any area of chemistry. Rather than an assembly of detailed information with a complete literature survey, a critically selected treatment of the material is desired; unsolved problems and possible developments should also be discussed. (一个严格挑选材料处理是期望的,未解决的问题和可能的发展也应该讨论,而不是一组完整文献调查的详细信息)Reviews should be divided into numbered sections, as in this "Notice to Authors". Cross-references(相互参照,交叉引用)in the text should also use these section numbers. The Review starts with a lead-in(导入)(1000 characters, no references). This text should not be a mere summary(不仅有概要)but rather should—together with a round picture 18.5 cm in diameter (frontispiece(卷头插画))—arouse the readers' interest. The first section of the Review itself, the Introduction, should primarily introduce the nonspecialist(非专业人士)to the subject in as clear a way as possible. A Review should conclude with a section entitled Summary and Outlook (题为总结和展望), in which the achievements of and new challenges for the subject are presented succinctly(主题取得的成就和新挑战简洁的提出). In addition, biographical sketches(传记性概述)(maximum length 560 characters) and portrait-quality black-and-white photographs of the correspondence authors(通讯作者)should be submitted.Length: A Review should not be of more than 65000 characters, including footnotes (脚注,附注), literature citations, tables, and legends(文献引用,表格和说明,图例). If a longer article is planned, the agreement of the editor should be sought(寻求)as early as possible.2.2. MinireviewsA Minireview (up to (多达)25000 characters) should present(呈现)current topics in a concise review style(用简洁的评论风格). Minireviews offer the flexibility (灵活性)to treat topics at a time(在某时,每次)and in a suitable manner(方式,态度), when a Review would still be premature or inappropriate(过早或者不适当). The format is the same as that outlined(概述)for Reviews in Section 2.1; however, Minireviews do not have a frontispiece and the lead-in should be no longer than800 characters.2.3. EssaysIn Essays (up to 15000 characters) themes(主题)from every aspect of chemistry, including the philosophy or history of science(哲学和科学史), are addressed(处理)freely. Use of unpublished results from original research(原创性研究的未发表过的成果)should be extremely limited. Primarily, known topics should be discussed illuminatingly and critically from a new vantage point(讨论启发性,从新的角度评论), and they should be suitably illustrated(阐明,加插图). In addition, a biographical sketch (maximum length 560 characters) and a portrait-qualityblack-and-white photograph of the correspondence author should be submitted.2.4. HighlightsIn Highlights very important new results of original research should be described, in general by a third person, with a view to instruct and to highlight their significance(一般由第三者指点或者强调那些原创性成果的意义). The results should be presented clearly, but as succinctly as possible, without the comprehensive details required for an original article(没有原文全面细节的需要). Highlights should include only essential formulas(基本的公式)and figures as well as(以及)not more than 15 references. A Highlight should not be longer than two pages (up to 8500 characters). To ensure that your manuscript does not exceed this length, please use the template, which can be found in the section "Author Guidelines" of the homepage.2.5. CommunicationsCommunications are short notes on experimental and/or theoretical studies in all branches of chemistry(通讯是化学分支科学实验或理论研究的简短札记). The results must be of general interest (大众兴趣)or at least contribute to the development of an important area of research. The essential findings(重要的发现/成果)presented in a Communication or significant parts of them may not already have appeared in print or in electronic online systems (for example, in online resources, in reviews, proceedings(会议录), or preprints(预印本)). Contributions that are too specialized(专业)for the general readership of Angewandte Chemie will be returned to the authors without further external review(没有进一步的外审)(ca. 25%). All other Communications are sent to two independent referees(审查员). Authors are welcome to suggest referees. We ask referees to consult(参考)the "Guidelines for Referees for Communications" when judging the suitability of a Communication for Angewandte Chemie.Communications that are "very important" in the opinion of at least two referees are denoted(表示)as being a VIP (very important paper) upon publication. If a third referee’s report is however received that does note judge the work to be "very important" or "highly important", the communication does not receive this VIP status.Please be considerate(体谅的)to our many readers for whom English is a foreign language—use a simple, clear style and avoid jargon(避免术语). Communications submitted in English to Angewandte Chemie will be printed in German only when an author provides a translation, perhaps from a current or former postdoc(博士后), or gives specific reasons for wishing to have the article appear in German. In all other cases the Communication will appear in English in both editions of the journal.Length: The maximal length of a Communication, inclusive of all literature citations, footnotes, and tables, is 10000 characters; formulas and figures may be added. Longer Communications will be accepted only if their quality warrants(授权)special consideration and a written justification(书面辩护)of their length is provided. Details that are of importance to the referees and to specialists(专家), but not to most of the readers, should be submitted as Supporting Information (see Section 3.2), which will be made accessible on the Web. Copies of cited publications not yet available publicly should be submitted along with the manuscript. Unpublished results and lectures should only be cited for exceptional reasons(为出版的成果和报告因特殊原因只引用).The identity(身份,特性)and purity of all new compounds must be fully characterized by appropriate analytical methods (NMR spectroscopy, X-ray crystal structure analysis, elemental analysis, etc.). These data should be given in the Supporting Information in the event that(如果,万一)they exceed the scope of the Experimental Section.Computer-aided image enhancement is often unavoidable(计算机辅助增强图像不可避免). However, such manipulation(操作,处理)cannot result in data that are less relevant(相关的)or unrepresentative(非代表性的)being shown and/or genuine(真实的)and significant signals(信息)being lost. A clear relationship must remain between the original data and the images that result from those data. If an image has been electronically modified(修改), the form of the modification shall be given in the Figure caption(修改的方式应该在图标上说明). If computer-aided processing or modification of an image is a fundamental part of the experimental work, then the form that this processing takes must be clearly described in the Experimental Section.Manuscripts containing animal experiments must include a statement(声明)that permission was obtained from the relevant national or local authorities(有关国家或当地政府). The institutional committees(机构委员会)that have approved(批准)the experiments must be identified(认定)and the accreditation number(认证数)of the laboratory or of the investigator given where applicable(适当情况下). If no suchrules or permissions are in place in the country where the experiments were performed, then this must also be clearly stated. Manuscripts with experiments with human subjects or tissue samples(组织样本)from human subjects must contain a disclaimer(免责声明)in the Experimental Section to state that informed, signed consent was obtained from either the patient or next of kin(病人或者亲属知情、签字同意).A Communication returned to the author for revision(修改)should be returned to the editorial office within three weeks. If more time is needed the editor must be informed.Communications should not be divided into sections. However, experimental details or methods should be summarized concisely(简洁的概括)under the heading(标题)Experimental Section or Methods. The first paragraph of a Communication should be formulated(规划)as an introduction that provides the nonspecialist reader with a general idea of the state of the art of the field and allows the importance of the results to be put into perspective(清楚地认识). In the final paragraph the results should be summarized succinctly and one sentence should be devoted to(用于)their significance and—if appropriate(如果有的话)—to the next challenges.2.6. Correspondences(通信,一致,相当)Manuscripts that critically comment on publications(批判性的评论出版物)in Angewandte Chemie can be published as Correspondences if they make an important contribution to the scientific discussion(探讨). The author of the publication to which the Correspondence pertains(属于,关于)will have the opportunity to reply(回复).2.7. Book Reviews, Meeting Reviews, Obituaries(讣闻)Book and Meeting Reviews as well as Obituaries are written upon invitation. Suggestions for books to be reviewed as well as for meeting reviews and obituaries are welcome, as are suggestions for possible authors. Publishers(出版商)should send brochures(手册)or preferably books(较好的书)directly to the editorial office.An informative Book Review(资讯书评)should provide answers to the following questions: Has the area of research covered in the book been the focus of recent research efforts(研究工作), or does the book provide a fresh look at an already established area? Does the book have other merits(优点), or is it unnecessary? Are the many aspects of the book's topic appropriately weighted? What benefits does the book offer to different types of readers?A Meeting Review should deal with the following questions: Why is the presented field of research currently of particular interest?(为什么这个研究领域目前令人感兴趣)How has it developed over the past few years? What are the most important unanswered questions? Which contributions were the highlights of the conference?(哪些文稿是会议的集锦)Among the answers given to the most important questions of the field, is there one that represents the "biggest leap forward"(跃进)? Have any new research topics arisen?(新的研究课题诞生)Are there any (new) prospects in the application of developments in the field?2.8. Corrigenda(勘误表)Scientifically incorrect or incomplete information(科学上的错误和不完整的信息)in published articles should be corrected in a Corrigendum—which is as short as possible. Corrigenda are printed directly after the Table of Contents(目录). We request that authors submit the Corrigendum electronically like any other article through manuscriptXpress and that they cite the publication to be corrected as well as its "digital object identifier" (DOI). (数字对象标识符)3. General Remarks(总论,第一章,一般注解)3.1. Table of Contents and KeywordsFor all manuscripts (with the exception of<除了…以外>Book Reviews, Meeting Reviews, Obituaries, and Corrigenda) a short text for the Table of Contents of the issue(发行物)(up to 450 characters; templates(模板)available from the section "Author Guidelines" on the homepage) and a maximum of five keywords in alphabetical order(按字母排序)should be included as(作为)the last page of the manuscript. At least two of the keywords should be taken from the "Keyword Catalogue"(关键字目录)(see the complete Notice to Authors on the homepage). The text(正文)for the Table of Contents should (ideally<理想中>with the help of a graphic, color is free here) arouse curiosity(唤起好奇心). Repetition or a paraphrase of the title (重复或者题目的释义/改述)and presentation(描述,介绍)of experimental details should be avoided.3.2. Supporting InformationExperimental procedures, spectroscopic data, graphics(光谱数据,图像), etc. that are essential for understanding the main points(大意,重点)of the publication but could be considered supplementary(补充,附属)or cannot be included in the actual publication for space reasons or because of technical limitations (e.g. animated(动画,有生气的)multimedia applications and movies) should be provided online as Supporting Information (in English!). This material is available free of charge to authors and readers, and appears simultaneous(同时)to the publication of the article. In the relevant sections相关部分of the article, reference should be made to the Supporting Information. The scientific quality of the Supporting Information and the preparation of the text and graphics should be of the same standard as that in the actual publication. The Supporting Information should start with a Table of Contents, and the relationships between the sections of the main article and the Supporting Information should be apparent. To submit multimedia files, please proceed(进行)as described on the homepage.3.3. ColorThe publication of Schemes and Figures in color is expensive, and we request that part of the additional costs be carried by the author. If color is essential(基本的,必要的)and the author does not have access to(使用,接近)funds for publication costs, the editor can make an exception.3.4. Cover Picture and Other Eye-Catching Graphics(封面图片和其它引人注目的图像)Suggestions for the cover or the inside-cover(封面里)picture of the issue (with an explanatory text up to 500 characters) or for the frontispiece(卷头插画)of the Communications<说明文本> section are welcome (diameter of the circle 16.5 and 18.5 cm, respectively). Part of the additional cost for color must be paid by the author. Assistance(辅助设备)for the design of these pictures is available on the homepage. Animated graphics(动画图形,活动图像)can also be deposited(放置)for cover pictures.3.5. Correction Process(纠错过程)The correspondence author will receive page proofs(版面校样)(in most cases as compressed(压缩的)PDF files). They should be returned to the editorial office within three days. Corrections after "Early View"(提前在线出版模式)and before issue publication will be accepted only if formal aspects or misprints are concerned.(只有格式或者印刷错误)For all the other corrections a Corrigendum has to be submitted (see Section 2.8).3.6. ReprintsThe main correspondence author of a Review will receive a complementary PDF in one of the two languages which allows 50 printouts(印出)as well as complimentary copies (赠送本)of both editions. For all other types of articles, complimentary copies of both editions are provided. Reprints and high-resolution(转载和高分辨率)PDFs can be ordered for a reasonable price(合理价格)before an article has been published.3.7. Press Releases(新闻发布,新闻稿,通讯稿)Each week, the publisher issues a press release about at least one Communication. It goes without saying不言而喻that authors are welcome to enhance the visibility知名度of their article through a press release from their institution, but such a release, about which the editorial office should be informed, must not precede(不能先于)the online publication of the article (embargo date禁止期).3.8. Open Access(开架阅览)If authors have to or want to make their publications freely available at the moment they are published (open access), Angewandte Chemie offers such a service. Under the keyword OnlineOpen you can find all the information about this subject on our homepage. Angewandte Chemie also complies with(遵守,依照)the request ormandate(授权,命令)from research funding agencies(研究资助机构), for example the US National Institutes of Health (NIH)美国国立卫生研究院, to make manuscripts freely available online in the unedited(未刊行的,未编辑的)and not proof-read form after acceptance. In general we recommend that authors link on their homepage to their Angewandte Chemie publication through the "Digital Object Identifier" (DOI). Only in this way can Crossref function检索功能correctly and full-text downloads be tallied.4. Guidelines for the Preparation of ManuscriptsAuthors are requested to take special care with respect to the following points(对于以下几点特别注意)when preparing a manuscript for publication in Angewandte Chemie:a) Greek letters should be typed in the character font Symbol; special characters must be clearly recognizable; sub- or superscripts and italicized or boldface text should be clearly distinguishable. All pages, including those with the references, tables, and legends, must be numbered consecutively. 希腊字母应该以字符字体符号输入,特殊字符必须明确辨认;上下标以及斜体、加粗文本清晰可辨。

【世卫标准】美国FDA的食品添加剂使用卫生标准

【世卫标准】美国FDA的食品添加剂使用卫生标准

[Code of Federal Regulations][Title 21, Volume 3][Revised as of April 1, 2006][CITE: 21CFR171]TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED) PART 171 FOOD ADDITIVE PETITIONSSubpart A--General ProvisionsSec. 171.1 Petitions.(a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act) shall be submitted in triplicate (quadruplicate, if intended uses include use in meat, meat food product, or poultry product). If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state petitioner's post office address to which published notices or orders issued or objections filed pursuant to section 409 of the Act may be sent.(b) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of the Food and Drug Administration. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized in a written statement signed by the person who submitted it. Any reference to published information offered in support of a food additive petition should be accompanied by reprints or photostatic copies of such references.(c) Petitions shall include the following data and be submitted in the following form:(Date)Name of petitionerPost-office addressDateName of food additive and proposed use______________________________________________________________Petitions Control BranchFood and Drug AdministrationDepartment of Health and Human ServicesWashington, DC 20204.Dear Sirs:The undersigned, _____ submits this petition pursuant to section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act with respect to _____(Name of the food additive and proposed use)Attached hereto, in triplicate (quadruplicate, if intended uses include use in meat, meat food product, or poultry product), and constituting a part of this petition are the following: A. The name and all pertinent information concerning the food additive, including chemical identity and composition of the food additive, its physical, chemical, and biological properties, and specifications prescribing the minimum content of the desired component(s) and identifying and limiting the reaction byproducts and other impurities. Where such information is not available, a statement as to the reasons why it is not should be submitted.When the chemical identity and composition of the food additive is not known, the petition shall contain information in sufficient detail to permit evaluation regarding the method of manufacture and the analytical controls used during the various stages of manufacturing, processing, or packing of the food additive which are relied upon to establish that it is a substance of reproducible composition. Alternative methods and controls and variations in methods and controls within reasonable limits that do not affect the characteristics of the substance or the reliability of the controls may be specified.If the food additive is a mixture of chemicals, the petition shall supply a list of all substances used in the synthesis, extraction, or other method of preparation, regardless of whether they undergo chemical change in the process. Each substance should be identified by its common English name and complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation is used as a component, the proprietary name should be followed by a complete quantitative statement of composition. Reasonable alternatives for any listed substance may be specified.If the petitioner does not himself perform all the manufacturing, processing, and packing operations for a food additive, the petition shall identify each person who will perform a part of such operations and designate the part.The petition shall include stability data, and, if the data indicate that it is needed to insure the identity, strength, quality, or purity of the additive, the expiration date that will be employed.B. The amount of the food additive proposed for use and the purposes for which it is proposed, together with all directions, recommendations, and suggestions regarding the proposed use, as well as specimens of the labeling proposed for the food additive and any labeling that will be required by applicable provisions of the Federal Food, Drug, and Cosmetic Act on the finished food by reason of the use of the food additive. If the additive results or may reasonably be expected to result from the use of packaging material, the petitioner shall show how this may occur and what residues may reasonably be anticipated.(Typewritten or other draft-labeling copy will be accepted for consideration of the petition, provided a statement is made that final printed labeling identical in content to the draft copy will be submitted as soon as available and prior to the marketing of the food additive.)(If the food additive is one for which a tolerance limitation is required to assure its safety, the level of use proposed should be no higher than the amount reasonably required to accomplish the intended physical or other technical effect, even though the safety data may support a higher tolerance.)C. Data establishing that the food additive will have the intended physical or other technical effect or that it may reasonably be expected to become a component, or to affect the characteristics, directly or indirectly, of food and the amount necessary to accomplish this. These data should include information in sufficient detail to permit evaluation with control data.D. A description of practicable methods to determine the amount of the food additive in the raw, processed, and/or finished food and of any substance formed in or on such food because of its use. The test proposed shall be one that can be used for food-control purposes and that can be applied with consistent results by any properly equipped and trained laboratory personnel.E. Full reports of investigations made with respect to the safety of the food additive.(A petition may be regarded as incomplete unless it includes full reports of adequate tests reasonably applicable to show whether or not the food additive will be safe for its intended use. The reports ordinarily should include detailed data derived from appropriate animal and other biological experiments in which the methods used and the resultsobtained are clearly set forth. The petition shall not omit without explanation any reports of investigations that would bias an evaluation of the safety of the food additive.)F. Proposed tolerances for the food additive, if tolerances are required in order to insure its safety. A petitioner may include a proposed regulation.G. If submitting petition to modify an existing regulation issued pursuant to section409(c)(1)(A) of the Act, full information on each proposed change that is to be made in the original regulation must be submitted. The petition may omit statements made in the original petition concerning which no change is proposed. A supplemental petition must be submitted for any change beyond the variations provided for in the original petition and the regulation issued on the basis of the original petition.H. The petitioner is required to submit either a claim for categorical exclusion under25.30 or 25.32 of this chapter or an environmental assessment under 25.40 of this chapter. Yours very truly,PetitionerBy(Indicate authority)(d) The petitioner will be notified of the date on which his petition is filed; and an incomplete petition, or one that has not been submitted in triplicate, will usually be retained but not filed as a petition under section 409 of the Act. The petitioner will be notified in what respects his petition is incomplete.(e) The petition must be signed by the petitioner or by his attorney or agent, or (if a corporation) by an authorized official.(f) The data specified under the several lettered headings should be submitted on separate sheets or sets of sheets, suitably identified. If such data have already been submitted with an earlier application, the present petition may incorporate it by specific reference to the earlier. If part of the data have been submitted by the manufacturer of the food additive as a master file, the petitioner may refer to the master file if and to the extent he obtains the manufacturer's written permission to do so. The manufacturer may authorize specific reference to the data without disclosure to the petitioner. Nothing herein shall prevent reference to published data.(g) A petition shall be retained but shall not be filed if any of the data prescribed by section 409(b) of the Act are lacking or are not set forth so as to be readily understood. (h)(1) The following data and information in a food additive petition are available for public disclosure, unless extraordinary circumstances are shown, after the notice of filingof the petition is published in the Federal Register or, if the petition is not promptly filed because of deficiencies in it, after the petitioner is informed that it will not be filed because of the deficiencies involved:(i) All safety and functionality data and information submitted with or incorporated by reference in the petition.(ii) A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial information in 20.61 of this chapter.(iii) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of:(a) Names and any information that would identify the person using the product.(b) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution.(iv) A list of all ingredients contained in a food additive, whether or not it is in descending order of predominance. A particular ingredient or group of ingredients shall be deleted from any such list prior to public disclosure if it is shown to fall within the exemption established in 20.61 of this chapter, and a notation shall be made that any such ingredient list is incomplete.(v) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption established in 20.61 of this chapter.(2) The following data and information in a food additive petition are not available for public disclosure unless they have been previously disclosed to the public as defined in 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in 20.61 of this chapter:(i) Manufacturing methods or processes, including quality control procedures.(ii) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure.(iii) Quantitative or semiquantitative formulas.(3) All correspondence and written summaries of oral discussions relating to a food additive petition are available for public disclosure in accordance with the provisions ofpart 20 of this chapter when the food additive regulation is published in the Federal Register.(4) For purposes of this regulation, safety and functionality data include all studies and tests of a food additive on animals and humans and all studies and tests on a food additive for identity, stability, purity, potency, performance, and usefulness.(i)(1)(i) Within 15 days after receipt, the Food and Drug Administration will notify the petitioner of the acceptance or nonacceptance of a petition, and if not accepted, the reasons therefor. If accepted, the petitioner will be sent a letter stating this and the date of the letter shall become the date of filing for the purposes of section 409(b)(5) of the act. In cases in which the Food and Drug Administration agrees that a premarket notification for a food contact substance (Food Contact Notification (FCN)) submitted under section 409(h) of the act may be converted to a petition, the withdrawal date for the FCN will be deemed the date of receipt for the petition.(ii) If the petitioner desires, he may supplement a deficient petition after being notified regarding deficiencies. If the supplementary material or explanation of the petition is deemed acceptable, the petitioner shall be notified. The date of such notification becomes the date of filing. If the petitioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the petitioner so notified.(iii) Notwithstanding paragraph (i)(1)(ii) of this section, the petition shall not be filed if the Food and Drug Administration determines that the use identified in the petition should be the subject of an FCN under section 409(h) of the act rather than a petition. (2) The Commissioner will publish in the Federal Register within 30 days from the date of filing of such petition, a notice of the filing, the name of the petitioner, and a brief description of the proposal in general terms. In the case of a food additive which becomes a component of food by migration from packaging material, the notice shall include the name of the migratory substance, and where it is different from that of one of the original components, the name of the parent component, the maximum quantity of the migratory substance that is proposed for use in food, and the physical or other technical effect which the migratory substance or its parent component is intended to have in the packaging material. A copy of the notice will be mailed to the petitioner when the original is forwarded to the Federal Register for publication.(j) The Commissioner may request a full description of the methods used in, and the facilities and controls used for, the production of the food additive, or a sample of the food additive, articles used as components thereof, or of the food in which the additive is proposed to be used, at any time while a petition is under consideration. The Commissioner shall specify in the request for a sample of the food additive, or articles used as components thereof, or of the food in or on which the additive is proposed to be used, a quantity deemed adequate to permit tests of analytical methods to determine quantities of the food additive present in foods for which it is intended to be used oradequate for any study or investigation reasonably required with respect to the safety of the food additive or the physical or technical effect it produces. The date used for computing the 90-day limit for the purposes of section 409(c)(2) of the Act shall be moved forward 1 day for each day after the mailing date of the request taken by the petitioner to submit the sample. If the information or sample is requested a reasonable time in advance of the 180 days, but is not submitted within such 180 days after filing of the petition, the petition will be considered withdrawn without prejudice.(k) If nonclinical laboratory studies are involved, petitions filed with the Commissioner under section 409(b) of the act shall include, with respect to each nonclinical study contained in the petition, either a statement that the study has been, or will be, conducted in compliance with the good laboratory practice regulations as set forth in part 58 of this chapter, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.(l) [Reserved](m) If clinical investigations involving human subjects are involved, petitions filed with the Commissioner under section 409(b) of the Act shall include statements regarding each such clinical investigation relied upon in the petition that it either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in accordance with 56.104 or 56.105, and that it was conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter.(n)(1) If intended uses of the food additive include uses in meat, meat food product, or poultry product subject to regulation by the U.S. Department of Agriculture (USDA) under the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) or the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition, forward a copy of the petition or relevant portions thereof to the Food Safety and Inspection Service, USDA, for simultaneous review under the PPIA and FMIA.(2) FDA will ask USDA to advise whether the proposed meat and poultry uses comply with the FMIA and PPIA, or if not, whether use of the substance would be permitted in products under USDA jurisdiction under specified conditions or restrictions.[42 FR 14489, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26, 1985; 62 FR 40599, July 29, 1997; 65 FR 51763, Aug. 25, 2000; 67 FR 35731, May 21, 2002]Effective Date Note:At 65 FR 51763, Aug. 25, 2000, 171.1 was amended in paragraph (a) by revising the first sentence, in paragraph (c) in the petition by revising the introductory paragraph preceding paragraph A., and by adding paragraph (n). The revised and added text containsinformation collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.Sec. 171.6 Amendment of petition.After a petition has been filed, the petitioner may submit additional information or data in support thereof. In such cases, if the Commissioner determines that the additional information or data amount to a substantive amendment, the petition as amended will be given a new filing date, and the time limitation will begin to run anew. If nonclinical laboratory studies are involved, additional information and data submitted in support of filed petitions shall include, with respect to each nonclinical study, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.[50 FR 7492, Feb. 22, 1985, as amended at 50 16668, Apr. 26, 1985]Sec. 171.7 Withdrawal of petition without prejudice.(a) In some cases the Commissioner will notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or the regulation requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal will be without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew from the date of refiling.(b) At any time before the order provided for in 171.100(a) has been forwarded to the Federal Register for publication, the petitioner may withdraw the petition without prejudice to a future filing. Upon refiling the time limitation will begin to run anew. (c) Any petitioner who has a food additive petition pending before the agency and who subsequently submits a premarket notification for a food contact substance (FCN) for a use or uses described in such petition shall be deemed to have withdrawn the petition for such use or uses without prejudice to a future filing on the date the FCN is received by the Food and Drug Administration.[42 FR 14489, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002]Sec. 171.8 Threshold of regulation for substances used in food-contact articles. Substances used in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate or that may be expected to migrate into food at negligible levels may be reviewed under 170.39 of this chapter. The Food and Drug Administration will exempt substances whose uses it determines meet the criteria in 170.39 of this chapter from regulation as food additives and, therefore, a food additive petition will not be required for the exempted use.[60 FR 36596, July 17, 1995]Subpart B--Administrative Actions on ApplicationsSec. 171.100 Regulation based on petition.(a) The Commissioner will forward for publication in the Federal Register, within 90 days after filing of the petition (or within 180 days if the time is extended as provided for in section 409(c)(2) of the Act), a regulation prescribing the conditions under which the food additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or on which such additive may be used, the maximum quantity that may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use), and prior to the forwarding of the order to the Federal Register for publication shall notify the petitioner of such order and the reasons for such action; or by order deny the petition, and shall notify the petitioner of such order and of the reasons for such action.(b) The regulation shall describe the conditions under which the substance may be safely used in any meat product, meat food product, or poultry product subject to the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) or the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.).(c) If the Commissioner determines that additional time is needed to study and investigate the petition, he shall by written notice to the petitioner extend the 90-day period for not more than 180 days after the filing of the petition.[42 FR 14489, Mar. 15, 1977, as amended at 65 FR 51763, Aug. 25, 2000]Sec. 171.102 Effective date of regulation.A regulation published in accordance with 171.100(a) shall become effective upon publication in the Federal Register.Sec. 171.110 Procedure for objections and hearings.Objections and hearings relating to food additive regulations under section 409 (c), (d), or(h) of the Act shall be governed by part 12 of this chapter.[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977]Sec. 171.130 Procedure for amending and repealing tolerances or exemptions from tolerances.(a) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive or granting or repealing an exception for such additive.(b) Any such petition shall include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or repeal. New data shall be furnished in the form specified in 171.1 and 171.100 for submitting petitions.[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977] Authority: 21 U.S.C. 321, 342, 348, 371.Source: 42 FR 14489, Mar. 15, 1977, unless otherwise noted.。

Draft Guidance for Industry and Food and Drug Administration Staff

Draft Guidance for Industry and Food and Drug Administration Staff

Draft Guidance for Industry and 1 Food and Drug Administration2 Staff3 45 eCopy Program for Medical Device6 Submissions78 DRAFT GUIDANCE910 This guidance document is being distributed for comment purposes only.11 Document issued on: [use release date of FR Notice]1213 You should submit comments and suggestions regarding this draft document within 30 days of 14 publication in the Federal Register of the notice announcing the availability of the draft guidance. 15 Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug 16 Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic17 comments to . Identify all comments with the docket number listed in 18 the notice of availability that publishes in the Federal Register . 1920 For questions regarding this document, contact the Premarket Notification (510(k)) Section or 21 the Premarket Approval Section of CDRH at 301-796-5640 or CBER’s Office of 22 Communication, Outreach and Development at 1-800-835-4709 or 301-827-1800. 23 2425262728U.S. Department of Health and Human Services 29 Food and Drug Administration 30 Center for Devices and Radiological Health 31 Center for Biologics Evaluation and Research32Preface3334Additional Copies3536Additional copies are available from the Internet. You may also send an e-mail request to37dsmica@ to receive an electronic copy of the guidance or send a fax request to 301-38827-8149 to receive a hard copy. Please use the document number (1797) to identify the39guidance you are requesting.4041Additional copies of this guidance document are also available from the Center for Biologics42Evaluation and Research (CBER), Office of Communication, Training and Manufacturers43Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, or by44calling 1-800-835-4709 or 301-827-1800, or from the Internet at45/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/defau 46lt.htm.4748Table of Contents491.Introduction (1)502.What is an eCopy? (2)513.Are differences between the contents of an eCopy and paper submission acceptable? 2 524.For what submission types would an eCopy be required? (3)535.What submission types would FDA consider exempt from submission of an eCopy? .4 546.What submission types or applicants should be eligible for an eCopy waiver? (4)557.How many copies of a submission would be needed? (4)568.What are the processing steps for an eCopy? (5)57a. What are the standards for an eCopy? (5)58b. How do I know if my eCopy meets FDA’s standards for acceptance?? (6)59c. What if there is another processing party involved? (6)60d. How do you submit an eCopy to FDA? (6)61e. How does FDA process an eCopy? (7)629.What if your device is regulated by CBER? (7)63a. Will the new eCopy Program apply? (7)64b. Can you submit an electronic submission instead? (7)65c. How do you prepare and submit an electronic submission to CBER? (8)66Attachment 1 –Standards for eCopies (7)67A. Cover Letter that accompanies an eCopy (10)68B. Volume versus non-volume structure (11)69C. Folder naming convention for volume-based submissions that house PDF files (13)70D. Adobe Acrobat PDF file format (14)71E. Non-PDF file formats (15)72F. PDF file naming convention (16)73G. PDF file size limit (17)74H. Creating a PDF version from the source document (17)75I. Bookmarks and hypertext links within PDFs (20)76J. PDFs created from scanning paper documents (21)77K. Common mistakes in creating an eCopy (22)7879Guidance for Industry and Food and Drug 80Administration Staff8182eCopy Program for Medical Device83Submissions84851.Introduction86The purpose of this guidance is to explain the new electronic copy (eCopy) Program for medical 87device submissions. At this time, submission of an eCopy of a medical device submission is88voluntary. However, section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C89Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act90(FDASIA) (Pub. L. 112-144), requires the submission of eCopies after this guidance is finalized.91This draft guidance describes how the Food and Drug Administration (FDA) plans to implement 92the eCopy Program under section 745A(b) of the FD&C Act. The inclusion of an eCopy is93expected to improve the efficiency of the review process by allowing for the immediate94availability of an electronic version for review rather than relying solely on the paper version.9596This draft guidance provides, among other things, the standards for a valid eCopy under section 97745A(b)(2)(A) of the FD&C Act. In accordance with section 745A(b), following the issuance of98a final guidance on this topic, submission types identified in the final guidance must include an99eCopy in accordance with the standards provided by this guidance for the submission to be100processed and accepted for review by FDA. Submissions submitted without an eCopy and101eCopy submissions that do not meet the standards provided in this guidance will be placed on 102hold until a valid eCopy is submitted to FDA and verified to meet the standards, unless a waiver 103or exemption has been granted. While the submission is on hold, the review clock will not104begin.105106In Section 745A(b), Congress granted explicit statutory authorization to FDA to implement the 107statutory eCopy requirement by providing standards, criteria for waivers, and exemptions in108guidance. Accordingly, to the extent that this document provides such requirements under109section 745A(b) of the FD&C Act (i.e., standards, criteria for waivers, and exemptions),110indicated by the use of the words must or required,this document is not subject to the usual111restrictions in FDA’s good guidance practice (GGP) regulations, such as the requirement that 112guidances not establish legally enforceable responsibilities. See 21 CFR 10.115(d).113114However, this document also provides guidance on FDA’s interpretation of the statutory eCopy 115requirement and the Agency’s current thinking on the best means for implementing other aspects 116of the eCopy program. Therefore, to the extent that this document includes provisions that are 117not “standards,” “criteria for waivers,” or “exemptions” under section 745A(b)(2), this document 118does not create or confer any rights for or on any person and does not operate to bind FDA or the 119public, but will represent the Agency’s current thinking on this topic when finalized. The use of 120the word should in such parts of this guidance means that something is suggested or121recommended, but not required. You can use an alternative approach if the approach satisfies 122Draft – Not for Implementationthe requirements of the applicable statutes and regulations. If you want to discuss an alternative 123approach, contact the FDA staff responsible for implementing this guidance. If you cannot124identify the appropriate FDA staff, call the appropriate number listed on the title page of this125guidance.126127To comply with the GGP regulations and make sure that regulated entities and the public128understand that guidance documents are nonbinding, FDA guidances ordinarily contain standard 129language explaining that guidances should be viewed only as recommendations unless specific 130regulatory or statutory requirements are cited. FDA is not including this standard language in 131this draft guidance because it is not an accurate description of all of the effects of this guidance, 132when finalized. This guidance, when finalized, will contain both binding and nonbinding133provisions. Insofar as this guidance, when finalized, provides “standards,” “criteria for waivers,” 134and “exemptions” pursuant to section 745A(b) of the FD&C Act, it will have binding effect. For 135these reasons, FDA is not including the standard guidance language in this draft guidance.136137The eCopy Program is not intended to impact (reduce or increase) the type or amount of data the 138applicant1 includes in a submission to support clearance or approval. Please refer to other FDA 139device or program-specific guidance documents from CDRH140(/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/defau 141lt.htm) and CBER142/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida 143nces/General/ucm214106.htm) for the appropriate contents for submissions.1441452.What is an eCopy?146An electronic copy (eCopy) is defined as an exact duplicate of the paper submission, created and 147submitted on a compact disc (CD), digital video disc (DVD), or in another electronic media148format that FDA has agreed to accept, accompanied by a copy of the signed cover letter and the 149complete original paper submission.21501513.Are differences between the contents of an eCopy and152paper submission acceptable?153While an eCopy is defined as an exact duplicate of the paper copy, there are limited cases in154which differences between the eCopy and the paper copy may be justified because a paper copy 155is not practical or appropriate for analysis purposes (e.g., raw data and statistical analysis156programs,3 data line listings to facilitate a bioresearch monitoring review) or is not feasible (e.g., 157videos, x-rays). The critical attribute of an eCopy is that it must include in electronic form all 1581 For the purposes of this guidance, applicant includes “submitter,” “sponsor,” or “holder.”2 An eCopy is not considered to be an electronic submission. For information on eSubmissions, refer to “FDAeSubmitter” (/ForIndustry/FDAeSubmitter/default.htm) and “Regulatory Submissions inElectronic Format for Biologic Products”(/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm163685.htm).3 For information on electronically submitted data, refer to “Clinical Data for Premarket Submissions”(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissi ons/ucm136377.htm).Draft – Not for Implementationdata required for that submission type.4 In other words, the eCopy must include all of the159required information for FDA review, whereas the paper copy can include a page cross-160referencing the location of certain information in the eCopy.161162The cover letter must contain the eCopy statement described in Attachment 1 and describe any 163differences between the paper version and the eCopy. The paper version must also have a164placeholder (e.g., a piece of paper printed with the appropriate section title or a divider165appropriately cross-labeled to the table of contents) that cross-references the eCopy to indicate 166that there are additional data/information in the eCopy and where in the eCopy that information 167is located.168169FDA will consider the eCopy loaded into the appropriate Center’s official document repository 170to be the official record. Any undisclosed differences between the eCopy and the paper version 171may need to be rectified and could delay the review of the submission.1721734. For what submission types is an eCopy required?174Once FDA finalizes this guidance, section 745A(b) of the FD&C Act, as added by section 1136 175of FDASIA, will require an eCopy for the following submission types5:176•Premarket notification submissions (510(k)s), including third party 510(k)s;177•Evaluation of automatic class III designation petitions (de novos);178•Premarket approval applications (PMAs)6;179•Modular PMAs;180•Transitional PMAs;181•Product development protocols (PDPs);182•Investigational device exemptions (IDEs);183•Humanitarian device exemptions (HDEs), including Humanitarian Use Device184designation requests (HUDs);185•Certain investigational new drug applications (INDs)7;186•Certain biologics license applications (BLAs)8; and187•Pre-Submissions9.1884 For example, the content requirements for a 510(k) submission are found in 21 CFR 870.87 and 807.92; those fororiginal PMA submissions are found in 21 CFR 814.20.5 Although not subject to the eCopy legislation, FDA accepts and strongly encourages eCopies for Master AccessFiles (“MAF” submissions), 513(g) Requests for Classification (“C” submissions), and Clinical LaboratoryImprovement Act (CLIA) Categorization – Exempt Device submissions (“X” submissions). If you choose to submit an eCopy, it must meet the standards outlined in Attachment 1.6 This includes all PMA submission types, including, but not limited to, original PMAs, panel-track supplements,180-day supplements, manufacturing site change supplements, and post-approval study supplements.7 Applicable only to those devices regulated by CBER that are also biologics under section 351 of the Public HealthService (PHS) Act and that also require submission of an IND prior to submission of a BLA. Such devices aregenerally those intended for use in screening donated blood for transfusion transmissible diseases.8 Applicable only to those devices regulated by CBER that are also biologics under Section 351 of the PHS Act,including those that do not require submission of an IND prior to the submission of the BLA. Such devicesgenerally include those reagents used in determining donor/recipient compatibility in transfusion medicine inaddition to those for use in screening blood for transfusion transmissible diseases.9 Refer to the draft guidance entitled, “Medical Devices: The Pre-Submission Program and Meetings with FDAStaff” (/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm310375.htm).Draft – Not for Implementation189eCopies for all subsequent submissions to an original submission, including amendments,190supplements, and reports10 to the submission types identified above would also be required even 191if the original was submitted to FDA prior to implementation of the eCopy requirement.1921935.What submission types does FDA consider exempt from 194submission of an eCopy?195Due to the potential urgent nature of the following types of submissions, FDA considers these to 196be exempt from the requirement for an eCopy:197•Compassionate use IDE submissions;198•Emergency use IDE submissions11; and199•Emergency Use Authorizations (EUAs)12.200201However, we encourage you to submit eCopies of these submissions, when feasible, in order to 202facilitate the review process. In addition, this exemption would not preclude you from sending 203in pertinent electronic information, such as imaging data, as supporting information for these 204submission types when an eCopy is not submitted.2052066.What submission types or applicants are eligible for an207eCopy waiver?208FDA believes that, given the widespread availability of software to enable the creation of an209acceptable eCopy at little to no cost, all applicants should have the ability to provide an eCopy. 210Therefore, at this time, FDA does not anticipate the need for waivers, except as described in211Section 9.2122137.How many copies of a submission are needed?214The eCopy Program would not change the overall number of copies to submit to FDA. Upon 215finalization of this guidance document, an eCopy (with a signed cover letter) will serve as one of 216the required number of copies for the various submission types. (See Table 1 below.) FDA will 217accept additional eCopies (each with a signed cover letter) in lieu of additional paper copies as 218long as at least one paper copy is submitted along with the eCopy and the total number of219required copies remains the same.22022110 Reports include all reports submitted to an applicable submission type, including annual/periodic and post-approval reports. Section 745A(b) of the FD&C Act does not apply to Medical Device Reports submitted under 21 CFR Part 803 .11 Please refer to CDRH’s device advice page entitled “IDE Early/Expanded Access”(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDevi ceExemptionIDE/ucm051345.htm#compassionateuse) and FDA’s “Guidance on IDE Policies and Procedures”(/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080202.htm) for additional details on compassionate and emergency use IDE submissions.12 Refer to the guidance entitled, “Emergency Use Authorization of Medical Products”(/RegulatoryInformation/Guidances/ucm125127.htm) for more information on EUAs.Draft – Not for ImplementationFor submission types for which only two copies are required to be submitted, one must be an 222eCopy and the other must be a paper copy. For submission types requiring more than two223copies, this policy would allow additional flexibility in how the application is submitted. For 224example, for an original PMA, you would submit: (1) one eCopy and five paper copies; (2) five 225eCopies and one paper copy; or (3) any other combination that results in six total copies as long 226as there is at least one eCopy and one paper copy.227228Table 1, provides the total number of copies to be submitted to FDA. As explained above, you 229must submit at least one eCopy and one paper submission. The format for the remaining copies 230(i.e., eCopy or paper) is your choice.231232Table 1 – Number of Copies for Submission233Submission Type Total Number ofCopies510(k)s 213Third Party 510(k)s 213Original PMAs and Panel-Track Supplements 614Other PMA supplement types 315PMA reports 2Modular PMAs 3HDEs Same as PMAs,16except for HUDdesignationrequests, whichrequire two.17PDPs Same as PMAsIDEs 318INDs 319BLAs 3Pre-Submissions 32348.What are the processing steps for an eCopy?235Below are the processing steps for the submission and acceptance of an eCopy.236237a.What are the standards for an eCopy?238With regard to the standards for an eCopy submitted to FDA, please refer to Attachment 2391. Because an eCopy cannot be accepted by our eCopy loading system if it does not meet 240the standards, you should carefully review this information.24124213 See 21 CFR 807.90(a)(3)(c).14 See 21 CFR 814.20(b)(2).15 See 21 CFR 814.39(c).16 See 21 CFR 814.104(b)(4).17 See 21 CFR 814.102(d).18 See 21 CFR 812.20(a)(3).19 See 21 CFR 312.23(d).b.How do I know before submission whether my eCopy meets FDA’s243standards for acceptance?244To confirm that your eCopy will meet FDA’s standards, we strongly encourage you to 245use the new free eSubmitter-eCopies tool available on FDA’s website at246/ForIndustry/FDAeSubmitter/ucm317334.htm. One of the benefits of 247utilizing the eSubmitter-eCopies tool is that it creates an eCopy in real-time that is248consistent with the standards. Use of the eSubmitter-eCopies tool is intended to prevent 249delays in review of your submission due to the need to resolve technical issues.250Although it is highly encouraged, you will not be required to utilize the eSubmitter-251eCopies tool and may choose to skip the eSubmitter step.252253Should you have any technical questions when generating your eCopy, please contact 254cdrhesub@ prior to submission of the eCopy to FDA.255256c.What if there is another processing party involved?257In the case that another party (e.g., law firm, consultant) submits a submission on behalf 258of an applicant, the eCopy must still meet the standards for an eCopy in order to be259successfully processed whether accomplished by you (the applicant) or the submitting 260party. While the applicant may or may not include their own cover letter as part of the 261eCopy, our standards require that the submitting party include a signed cover letter with 262an eCopy statement, as described in Attachment 1.263264In the case of Third Party 510(k)s, two separate CDs comprise the eCopy. The first CD 265includes the applicant’s submission and should be clearly marked as such. The contents 266of the CD must include a cover letter with an eCopy statement, as described in267Attachment 1, that the applicant has provided. The second CD includes the Accredited 268Person’s review records and should be clearly marked as such. The Accredited Person is 269responsible for ensuring that the CDs meet the standards in Attachment 1 for an eCopy. 270In addition, the Accredited Person is responsible for providing a signed cover letter that 271includes an eCopy statement, as described in Attachment 1, that speaks to both: (1) the 272Accredited Person’s portion of the eCopy and (2) the presence of the eCopy statement 273provided by the applicant. It is not sufficient for the Accredited Person to address only 274one of these two eCopy statement issues in their cover letter.275276d.How do you submit an eCopy to FDA?277An eCopy is submitted simultaneously with the paper submission(s). First, attach the 278signed cover letter with the eCopy statement to your eCopy. Then attach this eCopy279package to the paper submission(s) and send them to CDRH’s or CBER’s Document280Control Center20 (DCC). An eCopy that is sent to the DCC without a cover letter and 281accompanying paper submission(s) will be placed on hold.282283If more than one eCopy is to be submitted, then you must attach a signed cover letter as 284described above to each additional eCopy.28528620 Refer to 21 CFR 807.90 for the DCC addresses for CDRH and CBER.e.How does FDA process an eCopy?287If an eCopy passes the validation check, the cover letter and eCopy contents will be288loaded into the appropriate Center’s official submission repository.289290If an eCopy fails the validation check (i.e., is rejected), we will notify you in writing291(e.g., by email or fax) of the reason(s). The notification will describe the logistics for 292submitting a replacement eCopy, including how to properly mark it as a replacement293eCopy, the address to which to send it, and the submission number to write on it. It is 294important that you follow these directions to avoid delays in processing the replacement 295eCopy. The submission will be placed on hold until a valid replacement eCopy is296submitted to FDA and verified to meet the standards.2972989.What if your device is regulated by CBER?299a.Will the new eCopy Requirement apply?300Yes, unless your submission is an entirely electronic submission exempted under this 301guidance, as described below. Upon implementation of the statutory requirement, all 302medical device submission types listed in Section 4 must be accompanied by an eCopy 303regardless of the Center in FDA in which the submission will be reviewed unless the304requirement is waived or exempted. Accordingly, submissions for devices subject to 305review under the FD&C Act and submitted by filing paper copies with CBER’s DCC 306must be accompanied by an eCopy, except where exempted as described below.307308While many submissions made to CBER are still in paper format and require submission 309of multiple copies, CBER is also currently able to receive and manage submissions that 310are entirely electronic.311312Submissions for devices that are subject to licensure under the Public Health Service313(PHS) Act, including biologics license applications and supplements, investigational new 314drug applications, and EUAs and pre-submissions for these devices, may be submitted as 315entirely electronic submissions as detailed in sections 9b and 9c below. FDA will316exempt such entirely electronic submissions from the eCopy requirement.317318FDA additionally waives the eCopy requirement to submit paper copies of any entirely 319electronic submission made to CBER. Accordingly, entirely electronic submissions that 320comply with CBER guidance identified in Section 9.c. below do not need to be321accompanied by paper copies.322323b.Can you submit an electronic submission instead?324Yes, and there are several advantages for both industry and for CBER staff when you 325choose to make submissions electronically.326327The main advantage to you is in the financial savings that will likely result. The costs 328associated with printing, binding, labeling, and shipping multiple paper copies can be 329significant, especially for submissions that contain a great deal of supporting330Draft – Not for Implementationdocumentation. Likewise, we anticipate that FDA will recognize financial savings in that 331FDA avoids the costs associated with tracking, routing, and storing large amounts of332paper when you choose to submit electronically.333334Another advantage with the use of the electronic submission process is that all parties 335involved in the submission and review are referencing the same document – the336electronic one. There is no question about whether the paper copy is an exact copy of the 337eCopy. Electronic submissions may also reduce the need for reviewers to request re-338submission of previously submitted information due to an inability to read or interpret the 339information on the paper copy, as sometimes occurs when documents are photocopied. 340341c.How do you prepare and submit an electronic submission to CBER?342CBER has several resources available to applicants who choose to submit electronic343submissions as outlined in the document “Regulatory Submissions in Electronic Format 344for Biologic Products.”345(/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm163685 346.htm). Thus, specific details are available in the cited references and will not be repeated 347in this guidance.348349For devices that are regulated under the PHS Act and require the submission of a BLA, 350consult the guidance document entitled “Providing Regulatory Submissions to the Center 351for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics352Marketing Applications”353(/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulator 354yInformation/Guidances/General/UCM192413.pdf) for details on preparing your355electronic submission. Note that certain sections of this guidance, for example, those on 356pharmacology and toxicology, are generally not pertinent to licensed devices.357358For guidance on preparing electronic submissions for other device submissions (e.g.,359510(k)s, PMAs) sent to CBER, please see “Guidance for Industry: Providing Regulatory 360Submissions in Electronic Format - General Considerations”361(/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances 362/UCM072390.pdf) and “CBER SOPP 8110: Submission of Paper Regulatory363Applications to CBER”364(/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformati 365on/ProceduresSOPPs/ucm079467.htm), which includes information about providing366electronic copies to CBER.367368We are currently developing additional, updated guidance for other electronic369submissions sent to CBER and have issued a revised, updated draft guidance document 370for comment entitled, “Draft Guidance for Industry: Providing Regulatory Submissions 371in Electronic Format-General Considerations”372(/RegulatoryInformation/Guidances/ucm124737.htm). When373finalized, this document will provide an additional resource for applicants preparing374electronic submissions.375376。

Applied Geochemistry主编教你如何撰写国际SCI论文

Applied Geochemistry主编教你如何撰写国际SCI论文

Journal Homepage style of Elsevier
5
Journal Insights
Choosing the right journal
6
Preparations before you start
– Read the Guide for Authors
• Stick to the Guide for Authors in your manuscript, even in the first draft (text layout, nomenclature, figures & tables, references etc.). In the end it will save you time, and also the editor‟s.
A clear abstract will strongly influence whether or not We tackle the general linearis instantaneous model (possibly your work further considered... underdetermined and noisy) where we model the source prior with a
Is it a commercial or scientific journal? Who is this journal‟s audience? What is the journal‟s Impact Factor?
• Decide on one journal. DO NOT submit to multiple journals!
“Modeling of Arsenic mobilization in Hetao basin aquifer sediments” groundwater, arsenate, arsenite, goethite, Phreeqc, …

从Elsevier的投稿指南可借鉴的东西

从Elsevier的投稿指南可借鉴的东西

从Elsevier的投稿指南可借鉴的东西(1)Elsevier杂志的投稿指南,有人对其进行了全文翻译,尽管有些地方翻译的不是很恰当,但从中我们可以借鉴很多东西,如版权问题,一稿多投问题,图片要求问题等等。

全文如下Guide for Authors 指南作者Submission of manuscripts 提交手稿Types of contribution 类型的贡献Original Research Papers should report the results of original research. 原始的研究论文,应在报告中说明结果的原始研究。

The material should not have been previously published elsewhere, except in a preliminary form.该材料不应此前已在其他地方发表,除在初步形成。

Review Articles can cover either narrow disciplinary subjects or broad issues requiring interdisciplinary discussion. 审查条款可以涵盖或是狭隘学科交叉或广泛性问题,需要跨学科的讨论。

They should provide objective critical uation of a defined subject.它们应当提供客观严谨的评价一项确定的主题。

Reviews should not consist solely of a summary of published data.评语不应当仅仅一个简要的公布数据。

uation of the quality of existing data, the status of knowledge, and the research required to advance knowledge of the subject are essential.质量评价现有的数据,地位,知识和研究所需的先进知识,主题是至关重要的。

美国DMF目录及要求

美国DMF目录及要求

Drug SubstanceChemistry, Manufacturing, and Controls InformationDRAFT GUIDANCEThis guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 180 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.For questions regarding this draft document contact (CDER) Stephen Miller (301) 827-2392, (CBER) Chris Joneckis (301) 435-5681, or (CVM) Dennis Bensley (301) 827-6956.U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Review (CBER)Center for Veterinary Medicine (CVM)January 2004CMCDrug Substance Chemistry, Manufacturing, and Controls InformationAdditional copies are available from:Office of Training and CommunicationDivision of Drug Information, HFD-240Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573/cder/guidance/index.htmorOffice of Communication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Rockville, MD 20852-1448/cber/guidelines.htm.(Tel) Voice Information System at 800-835-4709 or 301-827-1800orCommunications Staff, HFV-12Center for Veterinary MedicineFood and Drug Administration7519 Standish PlaceRockville, MD 20855(Tel) 301-827-3800/cvm/guidanc/published.htmU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Review (CBER)Center for Veterinary Medicine (CVM)January 2004CMCTABLE OF CONTENTS1I. INTRODUCTION (1)II. BACKGROUND (3)A. The Common Technical Document — Quality (CTD-Q) Format (3)B. Content of an Application (4)C. Additional Guidance (4)D. References to Other Applications or Master Files (MFs) (5)1. Other Applications (5)2. Master Files (MFs) (6)III. GENERAL INFORMATION (S.1) (8)A. Nomenclature (S.1.1) (8)B. Structure (S.1.2) (8)C. General Properties (S.1.3) (9)IV. MANUFACTURE (S.2) (10)A. Manufacturers (S.2.1) (10)B. Description of Manufacturing Process and Process Controls (S.2.2) (10)1. Flow Diagram (11)2. Description of the Manufacturing Process and Process Controls (12)3. Reprocessing, Reworking, Recycling, Regeneration, and Other Operations (15)C. Control of Materials (S.2.3) (18)1. Starting Materials (18)2. Reagents, Solvents, and Auxiliary Materials (19)3. Diluents (20)D. Controls of Critical Steps and Intermediates (S.2.4) (20)E. Process Validation and/or Evaluation (S.2.5) (23)F. Manufacturing Process Development (S.2.6) (23)V. CHARACTERIZATION (S.3) (24)A. Elucidation of Structure and Other Characteristics (S.3.1) (24)1. Elucidation of Structure (24)2. Physicochemical Characterization (25)3. Biological and Other Relevant Characteristics (26)B. Impurities (S.3.2) (27)VI. CONTROL OF DRUG SUBSTANCE (S.4) (29)1 Alphanumeric designations in parentheses that follow headings show where information should be placed in applications that are submitted in Common Technical Document (CTD) format.A. Specification (S.4.1) (29)B. Analytical Procedures (S.4.2) (34)C. Validation of Analytical Procedures (S.4.3) (35)D. Batch Analyses (S.4.4) (35)1. Batch Analysis Reports (36)2. Collated Batch Analyses Data (36)E. Justification of Specification (S.4.5) (37)VII. REFERENCE STANDARDS OR MATERIALS (S.5) (40)VIII. CONTAINER CLOSURE SYSTEM (S.6) (40)IX. STABILITY (S.7) (41)A. Stability Summary and Conclusions (S.7.1) (41)B. Postapproval Stability Protocol and Stability Commitment (S.7.2) (41)C. Stability Data (S.7.3) (41)1. Primary Stability Studies (41)2. Supporting Stability Studies (42)3. Stress Studies (42)X. APPENDICES (A) (43)A. Facilities and Equipment (A.1) (43)B. Adventitious Agents Safety Evaluation (A.2) (44)1. Nonviral Adventitious Agents (45)2. Viral Adventitious Agents (45)XI. REGIONAL INFORMATION (R) (46)A. Executed Production Records (R.1.S) (46)B. Comparability Protocols (R.2.S) (46)C. Methods Validation Package (R.3.S) (46)XII. LITERATURE REFERENCES (3.3) (47)ATTACHMENT 1: (48)STARTING MATERIALS FOR SYNTHETIC DRUG SUBSTANCES (48)ATTACHMENT 2: (56)STARTING MATERIALS OF PLANT OR ANIMAL ORIGIN (56)GLOSSARY (59)GUIDANCE FOR INDUSTRY2Drug SubstanceChemistry, Manufacturing, and Controls Information12345678910111213If you plan to submit comments on this draft guidance, to expedite FDA review of your14comments, please:15∙Clearly explain each issue/concern and, when appropriate, include a proposed revision and the rationale and/or justification for the proposed revision.1617∙Identify specific comments by line numbers; use the pdf version of the document whenever 18possible.19∙If possible, e-mail an electronic copy (Word) of the comments you have submitted to the20docket to cummingsd@.212223I. INTRODUCTION2425Information on the chemistry, manufacturing, and controls (CMC) for the drug substance must 26be submitted to support the approval of original new drug applications (NDAs), abbreviated new 27drug applications (ANDAs), new animal drug applications (NADAs), and abbreviated new28animal drug applications (ANADAs).3 This guidance provides recommendations on the CMC 29information for drug substances that should be submitted to support these applications. The30guidance is structured to facilitate the preparation of applications submitted in Common31Technical Document (CTD) format.3233This guidance addresses the information to be submitted for drug substances to ensure continued 34drug substance and drug product quality (i.e., the identity, strength, quality, purity, and potency).2 This guidance has been prepared by Drug Substance Technical Subcommittee of the Chemistry Manufacturing andControls Coordinating Committee (CMC CC) in the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluations and Research (CBER) and the Center for Veterinary Medicine (CVM) at the FDA.3 See 21 CFR 314.50(d)(1) and 514.1(b)This guidance provides recommendations on the information that should be included for the3536following topics:37∙Nomenclature, structure, and general drug substance properties3839∙Manufacture40∙Characterization41∙Control of drug substance42∙Reference standards or materials43∙Container closure system44∙Stability45The recommendations provided in this guidance apply to the following types of drug substances:464748∙Drug substances manufactured by chemical synthesis49∙Highly purified and well characterized drug substances derived from plants or animals 4 50∙Semisynthetic drug substances manufactured by the chemical modification of a highly 51purified and well characterized intermediate derived from plants or animals52∙The synthetic portion of the manufacturing process for semisynthetic drug substances53manufactured by the chemical modification of an intermediate produced by conventional 54fermentation.5556The guidance does not provide specific recommendations relating to the following:5758∙Monoclonal antibodies59∙Peptides60∙Oligonucleotides61∙Radiopharmaceuticals62∙Medical gases63∙Drug substances that are not well characterized (e.g., botanicals, some proteins) derived 64from plants or animals65∙Drug substances derived using transgenic technology66∙Drug substances derived directly from or manufacturing operations involving67fermentation (conventional fermentation or using rDNA technology) or tissue or cell68culture.6970More detailed guidance on the content of an application may be available in separate guidance 71documents for specific types of drug substances (see section II.C). Applicants with drug72substances not specifically covered by this (Drug Substance guidance) or another guidance can 73apply the content recommendations in this guidance, as scientifically appropriate, and/or can74contact the appropriate chemistry review teams for guidance.754 For purposes of this guidance, d rug substances derived from plants or animals does not include materials producedby plant cell fermentation, animal cell or tissue culture, or through use of transgenic technology (e.g.,biotechnology-derived protein drug products).FDA’s guidance docume nts, including this guidance, do not establish legally enforceable7677responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should 78be viewed only as recommendations, unless specific regulatory or statutory requirements arecited. The use of the word should in Agency guidances means that something is suggested or7980recommended, but not required.8182This guidance, when finalized, will replace the guidance entitled Submitting Supporting83Documentation in Drug Applications for the Manufacture of Drug Substances (February 1987).848586II. BACKGROUND8788A. The Common Technical Document — Quality (CTD-Q) Format89In November 2000, the International Conference on Harmonisation of Technical9091Requirements for Registration of Pharmaceuticals for Human Use (ICH) issued92harmonized guidance for the format of drug product applications (i.e., Common93Technical Document (CTD)). The CTD describes a format for applications that94(supplemented with regional information) can be used for submission to the regulatory 95authorities in the United States, European Union, and Japan. One focus of this effort was 96harmonizing the format for quality information (i.e., chemistry, manufacturing, and97controls) that will be submitted in an application. FDA’s guidance on M4Q: The CTD —98Quality describes the format for the quality information submitted in Module 3 of an99application and provides additional information on formatting aspects of an application. 100Applicants can submit NDAs, ANDAs, NADAs, and ANADAs using the CTD-Q101format.5Applicants should review FDA’s guidance on M4Q: The CTD — Quality and 102other related CTD guidance documents for detailed formatting recommendations on103preparing an application in CTD format.104105Module 3 of each NDA and ANDA should include the specified CTD sections: Drug 106Substance (3.2.S), Drug Product (3.2.P), Appendices (3.2.A), Regional Information107(3.2.R), and Literature References (3.3). In some cases, the majority of information to 108address the drug substance sections will be incorporated by reference from a master file 109(see section II.D.2). However, an applicant should still provide information to address 110some of the drug substance subsections. Recommendations on the content of the drug 111product section (3.2.P) of Module 3 will be the provided in the guidance Drug Product —112Chemistry, Manufacturing, and Controls Information (Drug Product guidance), when 113finalized.6 The Appendices, Regional Information, and Literature References sections 114include information for both drug substance and drug product, as appropriate.1155 The information in animal drug applications is commonly presented in the order of the required CMC informationspecified under section § 514.1(b)(4) and (5). Although the CTD-Q format was developed for human drugs, thedrug substance information to support NADAs and ANADAs can be formatted according to the CTD-Q format or any alternative format that provides the appropriate information to support the application.6 A draft version of this guidance published on January 28, 2003 (68 FR 4219).116This Drug Substance guidance has been organized in a format conforming to Module 3 of 117the CTD, and it provides CMC content recommendations specific to drug substance,118including recommendations for the Appendices, Regional Information, and Literature 119References sections. Alphanumeric designations in parentheses corresponding to the 120CTD format follow relevant headings and text to show where information is to be placed 121in the CTD.7 Recommendations specific to drug product, including recommendations for 122the Appendices, Regional Information and Literature References sections, will be123provided in the Drug Product guidance.124125Multiple Drug Substances in an Application126127When an application is submitted for a drug product involving two or more drug128substances (e.g., combination drug product, copackaged drug products), information for 129each drug substance should be presented separately in the application. Information130presented separately means one complete S section for one drug substance followed by 131other complete S sections for additional drug substances. All of the information pertinent 132to each one of the drug substances (general information, manufacture, characterization, 133control, standards, container closure system, and stability) should be provided in a single 134section.135136B. Content of an Application137The application should include information in every S subsection for each of the drug 138139substances and manufacturing schemes (e.g., alternative processes, manufacturing site) 140intended for approval under the application. Information should be provided in theAppendices, Regional Information, and Literature References sections for each of the 141142drug substances and manufacturing schemes, as appropriate. If an Appendices or143Regional Information subsection or the Literature References section is not applicable, 144this should be stated in the application.145146C. Additional Guidance147148This Drug Substance guidance and the Drug Product guidance, when finalized, will be 149the primary content guidances for NDA and ANDA applicants. For quality, the general 150format guidance is M4Q: The CTD — Quality. These are the first guidances an applicant 151should consider when preparing the quality section (i.e., chemistry, manufacturing, and 152controls) of an NDA or ANDA (Module 3).153This guidance references ICH guidance documents cited in the CTD-Q and FDA’s154155guidances on general technical topics (i.e., stability, container closure systems, analytical 156procedures and methods validation, sterilization process validation, drug master files, and7 Arabic numbers have been assigned to specific sections of the CTD. For example, the designation 3.2 before S, P,A, and R indicates Module 3, Body of Data section 2. Where this guidance discusses Module 3, Body of Datasection 2, for brevity, the initial designation 3.2 is not repeated throughout the rest of the guidance (e.g., 3.2.S.1.3reads S.1.3).157environmental assessments) rather than incorporating this detailed information. These 158guidances are referenced in the text and/or listed at the end of a section. An applicant159should refer to these guidances for recommendations on the detailed information that160should be included in the application to address the general technical topic.161162Finally, an applicant should consider guidances that are available for specific technical 163issues or type (e.g., synthetic peptides) of drug substance when preparing its application. 164These guidances provide additional recommendations on unique scientific and technical 165aspects of the topic. Some references to these types of guidances are included in this166guidance. However, the references are given only as examples, and the list is not meant 167to be all-inclusive. Some examples of these types of guidance include the following:168∙Submission of Chemistry, Manufacturing, and Controls Information for Synthetic 169170Peptide Substances171∙Submission of Chemistry, Manufacturing and Controls Information for a172Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody173Product for In Vivo Use, CBER/CDER (under development)174∙Botanical Drug Products (under development)∙Fermentation Derived Drug Substances and Intermediates and Associated Drug 175176Products (under development)177∙Synthetic Oligonucleotides; Submission of Chemistry, Manufacturing, and178Controls Information (under development)179∙Radiopharmaceutical Drug Products: Chemistry, Manufacturing and ControlsInformation (under development)180181182FDA continues to update existing and publish new guidance documents. An applicant 183should use current guidance when preparing an NDA, ANDA, NADA or ANADA184submission.8185186D. References to Other Applications or Master Files (MFs)1871881. Other Applications189190In some cases, chemistry, manufacturing, and controls information about drug substances 191is provided in one application by reference to pertinent information in another application. 192This situation is less common than inclusion of information by reference to a MF and193usually occurs when the same firm submits both applications.194An applicant must identify in the application all other referenced applications, and each 195reference to information submitted in another application must identify where the196information can be found in the referenced application (21 CFR 314.50(a)(1) and197514.1(a)). If the referenced application was submitted by a firm other than the applicant,the referencing application must contain a written statement that authorizes the reference, 1988Current guidance documents are available on the Internet at /cder/guidance/index.htm,/cber/guidelines.htm, and /cvm/guidance/published.htm.199signed by the holder of the referenced application (21 CFR 314.50(g)(1), 314.420(b). and 200514.1(a)).9 Copies of letters of authorization (LOAs) should be submitted in Module 1 of 201the NDA or ANDA or in the appropriate section of an NADA or ANADA.2022032. Master Files (MFs)204205This guidance describes chemistry, manufacturing, and controls information for drug206substances that should be submitted to the Agency as part of the process of seeking theapproval of an NDA, ANDA, NADA, or ANADA. When a drug substance is207208manufactured by a firm other than the applicant, much of this information is frequently 209provided by reference to one or more Type II MFs rather than directly in an application. 210The CMC information in a Type II MF can be organized in CTD-Q format. Under FDA's 211regulations, an application can incorporate by reference all or part of the contents of any 212MF to address particular drug substance issues if the MF holder provides written213authorization (i.e., LOA) to the applicant and the authorization is included in the214application (Module 1 for an NDA or ANDA or in the appropriate section of an NADAor ANADA). The authorization must specifically identify the material being215216incorporated by reference (21 CFR 314.420 and 514.1(a)). The incorporated material217should be identified by name, reference number, volume and page number of the MF, anddate of submission. See 21 CFR 314.420, CDER’s guidance on Drug Master Files, and 218219CVM’s guidance on Preparation and Submission of Veterinary Master Files for moreinformation.220221222Both the applicant and the drug substance manufacturer (MF holder) contribute to223establishing and maintaining the identity, strength, quality, purity, and potency of the224applicant's drug products by manufacturing and controlling the drug substance in225accordance with the information submitted in the application and, by reference, in the MF. 226The following recommendations pertain to location of information in the MF and/or227application when an applicant and Type II MF holder are different firms.228229∙General Information (S.110): Both the MF and the application should include this 230information. These sections should contain similar, though not necessarily identical, 231information. For example, if an applicant performed screening studies and232established the existence of multiple polymorphs, information concerning these233polymorphs might be present in the application but not in the MF.234235∙Manufacture (S.2): The application should identify in S.2.1 the manufacturers of 236each drug substance with appropriate administrative information (see section IV.A). 237The MF should include this information for its manufacturing operations and any9 CVM discourages the reference of NDAs or ANDAs for drug substance information. In these instances, CVMrecommends that the drug substance information be included in a master file or incorporated in the applicant’sNADA or ANADA.10 Alphanumeric designations in parentheses that follow headings show where information should be placed inapplications that are submitted in Common Technical Document (CTD) format.238contract facilities that are used (e.g., intermediate manufacturers, laboratories). In239general, a MF can be referenced for the information recommended in S.2.2 through240S.2.6. However, the information should be augmented by the applicant, as241appropriate. For example, if the applicant micronizes drug substance purchased from242a MF holder the information on the micronization process should be included in the243application.244245∙Characterization (S.3): In general, a MF can be referenced for this information.However, the information should be augmented by the applicant, as appropriate. For 246247example, characterization information on physical properties critical to the applicant’s248product, such as solid state form or particle size distribution, should be included in249S.3.1 by the applicant under certain circumstances (e.g., applicant manipulates the250physical property (micronizes), the MF holder has not characterized the physical251property). Furthermore, information on an applicant’s studies to characterizeimpurities (S.3.2) can be warranted to support the applicant’s drug substance controls. 252253254∙Control of Drug Substance (S.4): In general, information recommended in S.4 should be provided in both the MF and the application. However, reference to an MF 255256can be appropriate for some of the information in S.4.2 through S.4.5 if the MF257holder and applicant are working together to develop the drug substance controls.Both the MF and the application should include a drug substance specification (S.4.1). 258259The MF could include more than one drug substance specification if the holder sellsdifferent technical grades of the drug substance (e.g., micronized and nonmicronized). 260261262∙Reference Standards (S.5): In general, information should be provided in both the 263MF and the application. However, reference to a MF can be appropriate for some of264the information if the MF holder and applicant are working together to develop the265reference standard.266267∙Container Closure System (S.6): In general, MFs can be referenced for this268information. However, the information should be augmented by the applicant, as269appropriate.270271∙Stability (S.7): In general, MFs can be referenced for this information. However, the information should be augmented by the applicant, as appropriate. For example, 272273an applicant might perform stress studies to support the analytical procedures it used274to control the drug substance.275276∙Appendices (A): In general, MFs can be referenced for this information. However, 277the information should be augmented by the applicant, as appropriate.278279∙Regional Information (R): Comparability protocols can be included in both the MF 280and application (R.2.S). A methods validation package should be included in theapplication (R.3.S).281282∙Literature References (3.3): Both the MF and the application should include283284literature references as warranted.285Type II MFs for drug substance intermediates can also be submitted in the CTD-Q format. 286287However, not all sections of the CTD-Q format would apply (e.g., S.4). The CMC288information provided to support an intermediate should be appropriate for the particularsituation (e.g., process, complexity of the molecule).289290291III. GENERAL INFORMATION (S.1)292293294General information on the nomenclature, structure, and general properties of the drug substance, should be provided in S.1.295296297A. Nomenclature (S.1.1)298299All appropriate names or designations for the drug substance should be provided in S.1.1. 300Any codes, abbreviations, or nicknames used in the application to identify the drug301substance should also be listed, including the following, if they exist or have been302proposed. A name that has not yet been finalized should be identified as proposed in the 303list.304305∙United States Adopted Name (USAN)∙Compendial name11306307∙Chemical names (e.g., Chemical Abstracts Service (CAS), International Union of 308Pure and Applied Chemistry (IUPAC))∙Company names or laboratory codes309310∙Other nonproprietary names (e.g., International Nonproprietary Name (INN),311British Approved Name (BAN), Japanese Accepted Name (JAN))312∙Chemical Abstracts Service (CAS) Registry Number313314B. Structure (S.1.2)315316Information on the chemical structure of the drug substance should be provided in S.1.2. 317This information should include:318319∙one or more drawings to show the overall chemical structure of the drug substance, 320including stereochemistry321∙molecular formula322∙molecular weight323324For a naturally derived protein drug substance, the information should include:11 A compendial name is a name that appears in an official compendium as defined in the Federal Food, Drug, andCosmetic Act (e.g., United States Pharmacopeia (USP)) (§ 201(j) (21 U.S.C. 32(i)).325326∙the schematic amino acid sequence indicating glycosylation sites or other327posttranslational modifications∙ a general description of the molecule (e.g., shape, disulfide bonds, subunit328329composition)330∙number of amino acid residues331∙molecular weight332333C. General Properties (S.1.3)334A list should be provided of the general physicochemical properties of the drug substance. 335336Other relevant properties of the drug substance should also be listed. Relevant properties 337are those physical, chemical, biological and microbiological attributes relating to theidentity, strength, quality, purity, and/or potency of the drug substance and, as338339appropriate, drug product. The information should include, as appropriate:340341∙ A general description (e.g., appearance, color, physical state)342∙Melting or boiling points343∙Optical rotation344∙Solubility profile (aqueous and nonaqueous, as applicable)345∙Solution pH346∙Partition coefficients347∙Dissociation constants348∙Identification of the physical form (e.g., polymorph, solvate, or hydrate) that will 349be used in the manufacture of the drug product350∙Biological activities351352For a naturally derived protein drug substance, additional information should be included, 353such as:354355∙Isoelectric point356∙Extinction coefficient357∙Any unique spectral characteristics358359If the drug substance can exist in more than one physical form, the information included 360in S.1.3 should be for the form (or forms) of the drug substance that will be used in the 361manufacture of the drug product. Detailed information on the characterization (e.g., X-362ray powder diffraction data, thermal analysis curves) of these and other physical forms 363and conditions required to produce one form or another should be provided in S.3.1.364。

Adobe Acrobat SDK 开发者指南说明书

Adobe Acrobat SDK 开发者指南说明书
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美国FDA的食品添加剂使用卫生标准

美国FDA的食品添加剂使用卫生标准

[Code of Federal Regulations][Title 21, Volume 3][Revised as of April 1, 2006][CITE: 21CFR171]TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED) PART 171 FOOD ADDITIVE PETITIONSSubpart A--General ProvisionsSec. 171.1 Petitions.(a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the Federal Food, Drug, and Cosmetic Act (the act) shall be submitted in triplicate (quadruplicate, if intended uses include use in meat, meat food product, or poultry product). If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state petitioner's post office address to which published notices or orders issued or objections filed pursuant to section 409 of the Act may be sent.(b) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of the Food and Drug Administration. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized in a written statement signed by the person who submitted it. Any reference to published information offered in support of a food additive petition should be accompanied by reprints or photostatic copies of such references.(c) Petitions shall include the following data and be submitted in the following form:(Date)Name of petitionerPost-office addressDateName of food additive and proposed use______________________________________________________________Petitions Control BranchFood and Drug AdministrationDepartment of Health and Human ServicesWashington, DC 20204.Dear Sirs:The undersigned, _____ submits this petition pursuant to section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act with respect to _____(Name of the food additive and proposed use)Attached hereto, in triplicate (quadruplicate, if intended uses include use in meat, meat food product, or poultry product), and constituting a part of this petition are the following: A. The name and all pertinent information concerning the food additive, including chemical identity and composition of the food additive, its physical, chemical, and biological properties, and specifications prescribing the minimum content of the desired component(s) and identifying and limiting the reaction byproducts and other impurities. Where such information is not available, a statement as to the reasons why it is not should be submitted.When the chemical identity and composition of the food additive is not known, the petition shall contain information in sufficient detail to permit evaluation regarding the method of manufacture and the analytical controls used during the various stages of manufacturing, processing, or packing of the food additive which are relied upon to establish that it is a substance of reproducible composition. Alternative methods and controls and variations in methods and controls within reasonable limits that do not affect the characteristics of the substance or the reliability of the controls may be specified.If the food additive is a mixture of chemicals, the petition shall supply a list of all substances used in the synthesis, extraction, or other method of preparation, regardless of whether they undergo chemical change in the process. Each substance should be identified by its common English name and complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation is used as a component, the proprietary name should be followed by a complete quantitative statement of composition. Reasonable alternatives for any listed substance may be specified.If the petitioner does not himself perform all the manufacturing, processing, and packing operations for a food additive, the petition shall identify each person who will perform a part of such operations and designate the part.The petition shall include stability data, and, if the data indicate that it is needed to insure the identity, strength, quality, or purity of the additive, the expiration date that will be employed.B. The amount of the food additive proposed for use and the purposes for which it is proposed, together with all directions, recommendations, and suggestions regarding the proposed use, as well as specimens of the labeling proposed for the food additive and any labeling that will be required by applicable provisions of the Federal Food, Drug, and Cosmetic Act on the finished food by reason of the use of the food additive. If the additive results or may reasonably be expected to result from the use of packaging material, the petitioner shall show how this may occur and what residues may reasonably be anticipated.(Typewritten or other draft-labeling copy will be accepted for consideration of the petition, provided a statement is made that final printed labeling identical in content to the draft copy will be submitted as soon as available and prior to the marketing of the food additive.)(If the food additive is one for which a tolerance limitation is required to assure its safety, the level of use proposed should be no higher than the amount reasonably required to accomplish the intended physical or other technical effect, even though the safety data may support a higher tolerance.)C. Data establishing that the food additive will have the intended physical or other technical effect or that it may reasonably be expected to become a component, or to affect the characteristics, directly or indirectly, of food and the amount necessary to accomplish this. These data should include information in sufficient detail to permit evaluation with control data.D. A description of practicable methods to determine the amount of the food additive in the raw, processed, and/or finished food and of any substance formed in or on such food because of its use. The test proposed shall be one that can be used for food-control purposes and that can be applied with consistent results by any properly equipped and trained laboratory personnel.E. Full reports of investigations made with respect to the safety of the food additive.(A petition may be regarded as incomplete unless it includes full reports of adequate tests reasonably applicable to show whether or not the food additive will be safe for its intended use. The reports ordinarily should include detailed data derived from appropriate animal and other biological experiments in which the methods used and the resultsobtained are clearly set forth. The petition shall not omit without explanation any reports of investigations that would bias an evaluation of the safety of the food additive.)F. Proposed tolerances for the food additive, if tolerances are required in order to insure its safety. A petitioner may include a proposed regulation.G. If submitting petition to modify an existing regulation issued pursuant to section409(c)(1)(A) of the Act, full information on each proposed change that is to be made in the original regulation must be submitted. The petition may omit statements made in the original petition concerning which no change is proposed. A supplemental petition must be submitted for any change beyond the variations provided for in the original petition and the regulation issued on the basis of the original petition.H. The petitioner is required to submit either a claim for categorical exclusion under25.30 or 25.32 of this chapter or an environmental assessment under 25.40 of this chapter. Yours very truly,PetitionerBy(Indicate authority)(d) The petitioner will be notified of the date on which his petition is filed; and an incomplete petition, or one that has not been submitted in triplicate, will usually be retained but not filed as a petition under section 409 of the Act. The petitioner will be notified in what respects his petition is incomplete.(e) The petition must be signed by the petitioner or by his attorney or agent, or (if a corporation) by an authorized official.(f) The data specified under the several lettered headings should be submitted on separate sheets or sets of sheets, suitably identified. If such data have already been submitted with an earlier application, the present petition may incorporate it by specific reference to the earlier. If part of the data have been submitted by the manufacturer of the food additive as a master file, the petitioner may refer to the master file if and to the extent he obtains the manufacturer's written permission to do so. The manufacturer may authorize specific reference to the data without disclosure to the petitioner. Nothing herein shall prevent reference to published data.(g) A petition shall be retained but shall not be filed if any of the data prescribed by section 409(b) of the Act are lacking or are not set forth so as to be readily understood. (h)(1) The following data and information in a food additive petition are available for public disclosure, unless extraordinary circumstances are shown, after the notice of filingof the petition is published in the Federal Register or, if the petition is not promptly filed because of deficiencies in it, after the petitioner is informed that it will not be filed because of the deficiencies involved:(i) All safety and functionality data and information submitted with or incorporated by reference in the petition.(ii) A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial information in 20.61 of this chapter.(iii) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of:(a) Names and any information that would identify the person using the product.(b) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution.(iv) A list of all ingredients contained in a food additive, whether or not it is in descending order of predominance. A particular ingredient or group of ingredients shall be deleted from any such list prior to public disclosure if it is shown to fall within the exemption established in 20.61 of this chapter, and a notation shall be made that any such ingredient list is incomplete.(v) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption established in 20.61 of this chapter.(2) The following data and information in a food additive petition are not available for public disclosure unless they have been previously disclosed to the public as defined in 20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in 20.61 of this chapter:(i) Manufacturing methods or processes, including quality control procedures.(ii) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure.(iii) Quantitative or semiquantitative formulas.(3) All correspondence and written summaries of oral discussions relating to a food additive petition are available for public disclosure in accordance with the provisions ofpart 20 of this chapter when the food additive regulation is published in the Federal Register.(4) For purposes of this regulation, safety and functionality data include all studies and tests of a food additive on animals and humans and all studies and tests on a food additive for identity, stability, purity, potency, performance, and usefulness.(i)(1)(i) Within 15 days after receipt, the Food and Drug Administration will notify the petitioner of the acceptance or nonacceptance of a petition, and if not accepted, the reasons therefor. If accepted, the petitioner will be sent a letter stating this and the date of the letter shall become the date of filing for the purposes of section 409(b)(5) of the act. In cases in which the Food and Drug Administration agrees that a premarket notification for a food contact substance (Food Contact Notification (FCN)) submitted under section 409(h) of the act may be converted to a petition, the withdrawal date for the FCN will be deemed the date of receipt for the petition.(ii) If the petitioner desires, he may supplement a deficient petition after being notified regarding deficiencies. If the supplementary material or explanation of the petition is deemed acceptable, the petitioner shall be notified. The date of such notification becomes the date of filing. If the petitioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the petitioner so notified.(iii) Notwithstanding paragraph (i)(1)(ii) of this section, the petition shall not be filed if the Food and Drug Administration determines that the use identified in the petition should be the subject of an FCN under section 409(h) of the act rather than a petition. (2) The Commissioner will publish in the Federal Register within 30 days from the date of filing of such petition, a notice of the filing, the name of the petitioner, and a brief description of the proposal in general terms. In the case of a food additive which becomes a component of food by migration from packaging material, the notice shall include the name of the migratory substance, and where it is different from that of one of the original components, the name of the parent component, the maximum quantity of the migratory substance that is proposed for use in food, and the physical or other technical effect which the migratory substance or its parent component is intended to have in the packaging material. A copy of the notice will be mailed to the petitioner when the original is forwarded to the Federal Register for publication.(j) The Commissioner may request a full description of the methods used in, and the facilities and controls used for, the production of the food additive, or a sample of the food additive, articles used as components thereof, or of the food in which the additive is proposed to be used, at any time while a petition is under consideration. The Commissioner shall specify in the request for a sample of the food additive, or articles used as components thereof, or of the food in or on which the additive is proposed to be used, a quantity deemed adequate to permit tests of analytical methods to determine quantities of the food additive present in foods for which it is intended to be used oradequate for any study or investigation reasonably required with respect to the safety of the food additive or the physical or technical effect it produces. The date used for computing the 90-day limit for the purposes of section 409(c)(2) of the Act shall be moved forward 1 day for each day after the mailing date of the request taken by the petitioner to submit the sample. If the information or sample is requested a reasonable time in advance of the 180 days, but is not submitted within such 180 days after filing of the petition, the petition will be considered withdrawn without prejudice.(k) If nonclinical laboratory studies are involved, petitions filed with the Commissioner under section 409(b) of the act shall include, with respect to each nonclinical study contained in the petition, either a statement that the study has been, or will be, conducted in compliance with the good laboratory practice regulations as set forth in part 58 of this chapter, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.(l) [Reserved](m) If clinical investigations involving human subjects are involved, petitions filed with the Commissioner under section 409(b) of the Act shall include statements regarding each such clinical investigation relied upon in the petition that it either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or was not subject to such requirements in accordance with 56.104 or 56.105, and that it was conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter.(n)(1) If intended uses of the food additive include uses in meat, meat food product, or poultry product subject to regulation by the U.S. Department of Agriculture (USDA) under the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.) or the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), FDA shall, upon filing of the petition, forward a copy of the petition or relevant portions thereof to the Food Safety and Inspection Service, USDA, for simultaneous review under the PPIA and FMIA.(2) FDA will ask USDA to advise whether the proposed meat and poultry uses comply with the FMIA and PPIA, or if not, whether use of the substance would be permitted in products under USDA jurisdiction under specified conditions or restrictions.[42 FR 14489, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985; 50 16668, Apr. 26, 1985; 62 FR 40599, July 29, 1997; 65 FR 51763, Aug. 25, 2000; 67 FR 35731, May 21, 2002]Effective Date Note:At 65 FR 51763, Aug. 25, 2000, 171.1 was amended in paragraph (a) by revising the first sentence, in paragraph (c) in the petition by revising the introductory paragraph preceding paragraph A., and by adding paragraph (n). The revised and added text containsinformation collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.Sec. 171.6 Amendment of petition.After a petition has been filed, the petitioner may submit additional information or data in support thereof. In such cases, if the Commissioner determines that the additional information or data amount to a substantive amendment, the petition as amended will be given a new filing date, and the time limitation will begin to run anew. If nonclinical laboratory studies are involved, additional information and data submitted in support of filed petitions shall include, with respect to each nonclinical study, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.[50 FR 7492, Feb. 22, 1985, as amended at 50 16668, Apr. 26, 1985]Sec. 171.7 Withdrawal of petition without prejudice.(a) In some cases the Commissioner will notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or the regulation requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal will be without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew from the date of refiling.(b) At any time before the order provided for in 171.100(a) has been forwarded to the Federal Register for publication, the petitioner may withdraw the petition without prejudice to a future filing. Upon refiling the time limitation will begin to run anew. (c) Any petitioner who has a food additive petition pending before the agency and who subsequently submits a premarket notification for a food contact substance (FCN) for a use or uses described in such petition shall be deemed to have withdrawn the petition for such use or uses without prejudice to a future filing on the date the FCN is received by the Food and Drug Administration.[42 FR 14489, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002]Sec. 171.8 Threshold of regulation for substances used in food-contact articles. Substances used in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate or that may be expected to migrate into food at negligible levels may be reviewed under 170.39 of this chapter. The Food and Drug Administration will exempt substances whose uses it determines meet the criteria in 170.39 of this chapter from regulation as food additives and, therefore, a food additive petition will not be required for the exempted use.[60 FR 36596, July 17, 1995]Subpart B--Administrative Actions on ApplicationsSec. 171.100 Regulation based on petition.(a) The Commissioner will forward for publication in the Federal Register, within 90 days after filing of the petition (or within 180 days if the time is extended as provided for in section 409(c)(2) of the Act), a regulation prescribing the conditions under which the food additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or on which such additive may be used, the maximum quantity that may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him to assure the safety of such use), and prior to the forwarding of the order to the Federal Register for publication shall notify the petitioner of such order and the reasons for such action; or by order deny the petition, and shall notify the petitioner of such order and of the reasons for such action.(b) The regulation shall describe the conditions under which the substance may be safely used in any meat product, meat food product, or poultry product subject to the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) or the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.).(c) If the Commissioner determines that additional time is needed to study and investigate the petition, he shall by written notice to the petitioner extend the 90-day period for not more than 180 days after the filing of the petition.[42 FR 14489, Mar. 15, 1977, as amended at 65 FR 51763, Aug. 25, 2000]Sec. 171.102 Effective date of regulation.A regulation published in accordance with 171.100(a) shall become effective upon publication in the Federal Register.Sec. 171.110 Procedure for objections and hearings.Objections and hearings relating to food additive regulations under section 409 (c), (d), or(h) of the Act shall be governed by part 12 of this chapter.[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977]Sec. 171.130 Procedure for amending and repealing tolerances or exemptions from tolerances.(a) The Commissioner, on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive or granting or repealing an exception for such additive.(b) Any such petition shall include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or repeal. New data shall be furnished in the form specified in 171.1 and 171.100 for submitting petitions.[42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977] Authority: 21 U.S.C. 321, 342, 348, 371.Source: 42 FR 14489, Mar. 15, 1977, unless otherwise noted.。

哈工大博士学位论文模板

哈工大博士学位论文模板

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学 学博士学位论文
4.1
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4.1.1
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3.3
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第 4 章 图表 ............................................................................................ 9
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学 学博士学位论文
Abstract
This is a LATEX template for the master/doctor thesis/dissertation of Harbin Institute of Technology (due to personal interest, not an official template). Keywords: Master/Doctor thesis/dissertation, Harbin Institute of Technology, LATEX template
2.4
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Declaration of Independence(in APA style)

Declaration of Independence(in APA style)

will describe the necessity of Independence from
England by the 13 colonies.
Table of Contents…
The Declaration of Table of Contents Title Page Abstract Introduction Is It Legal Is It Moral/Ethical Is It Socially Responsible Conclusion References 1 2 3 4 5 6 7 8 3
The Title Page…
• • • • • • Pagination: The Title Page is page 1. Key Elements: Paper title, author(s), and affiliation(s) of author(s). Article Title: Uppercase and lowercase letters, centered and positioned in the upper half of the paper. Author(s): Uppercase and lowercase letters, centered on the line following the title. Institutional affiliation: Uppercase and lowercase letters, centered on the line following the author(s). Running head: The running head is typed flush left (all uppercase) following the words "Running head:" on the line below the manuscript page header. Do not exceed 50 characters, including punctuation and spaces. Running heads are only required if you intend to submit your paper for publication.

(5)Summary writing

(5)Summary writing

2. Also introduces the text to be summarized: (i) Gives the title of the source (following the citation guidelines of whatever style sheet you are using); (ii) Provides the name of the author of the source; (ii) Sometimes also provides pertinent background information about the author of the source or about the text to be summarized.
• Major ideas and thoughts should not be missed. • Must convey the message of the original statement fully and clearly. In brief: a. Omit the details. b. Reduce the examples c. Simplify the description
b. The body of a summary essay (one or more paragraphs): This paraphrases and condenses the original piece. In your summary, be sure that you 1. Include important data but omit minor points; 2. Include one or more of the author’s examples or illustrations;

整理好的LC英语

整理好的LC英语
2.bills of lading made out in negotiable form 作成可议付形式的提单
3.clean shipped on board ocean bills of lading to order and endorsed in blank marked "Freight Prepaid" notify: importer(openers,accountee) 洁净已装船的提单空白抬头并空白背书,注明“运费付讫”,通知进口人(开证人)
2.beneficiary 受益人
(1)beneficiary 受益人
(2)in favour of 以(某人)为受益人
(3)in one's favour 以……为受益人
(4)favouring yourselves 以你本人为受益人
3.drawee 付款人(或称受票人,指汇票)
11.back to back L/Creciprocal L/C 对背信用证/对开信用证
12.traveller's L/C(or:circular L/C) 旅行信用证----
Names of Parties Concerned
1. opener 开证人
(1)applicant 开证人(申请开证人)
(2)drafts are to be drawn in duplicate to our order bearing the clause “Drawn under United Malayan Banking Corp.Bhd.Irrevocable Letter of Credit No.…dated July 12, 1978” 汇票一式两份,以我行为抬头,并注明“根据马来西亚联合银行1978年7月12日第……号不可撤销信用证项下开立”

Learning with kernel

Learning with kernel

Training Data
Here, X is some nonempty set that the patterns xi (sometimes called cases or inputs ) are taken from, sometimes referred to as the domain ; the yi are called labels , targets , or outputs . Note that there are only two classes of patterns. For the sake of mathematical convenience, they are labeled by +1 and −1, respectively. This is a particularly simple situation, referred to as (binary) pattern recognition or (binary) classification.
2001/03/02 20:32
c 2000 Massachusetts Institute of Technology All rights reserved. No part of this book may be reproduced in any form by any electronic or mechanical means (including photocopying, recording, or information storage and retrieval) without permission in writing from the publisher. Printed and bound in the United States of America Library of Congress Cataloging-in-Publication Data Learning with Kernels / by Bernhard Sch¨ olkopf, Alexander J. Smola. p. cm. Includes bibliographical references and index. ISBN 0-xxx-xxxxx-x (alk. paper) 1. Machine learning. 2. Algorithms. 3. Kernel functions I. Sch¨ olkopf, Bernhard. II. Smola, Alexander J. xxxx.x.xxx 2000 xxx.x’x–xxxx 00.xxTutorial Introduction 1.1 Data Representation and Similarity . . . . . . . . 1.2 A Simple Pattern Recognition Algorithm . . . . 1.3 Some Insights From Statistical Learning Theory . 1.4 Hyperplane Classifiers . . . . . . . . . . . . . . . 1.5 Support Vector Classification . . . . . . . . . . . 1.6 Support Vector Regression . . . . . . . . . . . . . 1.7 Kernel Principal Component Analysis . . . . . . 1.8 Empirical Results and Implementations . . . . . References Index

协作文档可以复制吗英文

协作文档可以复制吗英文

协作文档可以复制吗英文Title: Can Collaboration Documents Be Duplicated?Collaboration documents are an essential tool intoday's interconnected digital world, facilitating teamwork, sharing of ideas, and collective creation. However, a common question arises: can collaboration documents be duplicated? In this article, we'll delve into this topic to explore the intricacies and considerations surrounding the duplication of collaboration documents.To begin with, it's crucial to define what we mean by "collaboration documents." These are typically digitalfiles stored on platforms like Google Docs, MicrosoftOffice Online, or other cloud-based services that enable multiple users to edit, comment, and contribute to the document simultaneously. Examples include shared documents for team projects, meeting minutes, or co-authored reports.Now, can these collaboration documents be duplicated?The short answer is yes, in most cases, they can be duplicated. However, several factors come into play, andit's essential to consider the implications and best practices associated with duplicating collaboration documents.One primary consideration is the ownership and permissions of the original document. When you create a collaboration document, whether it's a Google Doc, a shared spreadsheet, or a collaborative presentation, there are typically settings that determine who has access to the document and what actions they can perform. These settings may include options such as "view only," "comment," or "edit," and they dictate the level of access granted to different users.When you duplicate a collaboration document, you essentially create a copy of the original file. The permissions associated with the original document may or may not carry over to the duplicate, depending on the platform and settings. For example, if the original document allows anyone with the link to view and edit it,the duplicate may inherit the same permissions by default. However, if the original document restricts editing to specific users or requires authentication, the duplicate may not automatically grant the same level of access.Another consideration is the purpose and context of duplicating the collaboration document. Are you creating a backup copy for archival purposes? Are you intending to modify the duplicate independently of the original? Are you sharing the duplicate with a different group of collaborators? The answers to these questions can influence how you approach the duplication process and what precautions you should take to ensure data integrity and security.It's also essential to be mindful of intellectual property rights and confidentiality when duplicating collaboration documents, especially in professional or sensitive contexts. If the original document contains proprietary information, sensitive data, or copyrighted material, you must adhere to appropriate protocols and obtain necessary permissions before creating duplicates orsharing them with others.In conclusion, collaboration documents can generally be duplicated, but it's essential to consider various factors such as permissions, purpose, and security implications before doing so. By understanding the nuances ofduplication and adhering to best practices, you can effectively leverage collaboration tools while safeguarding data integrity and respecting privacy rights.。

laura's job interview高职国际英语原文

laura's job interview高职国际英语原文

laura's job interview高职国际英语原文U1How to Adapt to College Life QuicklyWhen you first enter your college,you will find that differences between high school life and college life are great.In high school,we always depended on our parents and teachers to solve all kinds of difficult problems.At college,however,we have to rely exclusively on ourselves.What's more,we have to learn how to get along with our classmates and roommates.Almost every college freshman experiences some level of nervousness and anxiety.But don’t worry,here are some tips to help you adapt to college life as quickly as possible.1.Remember you are not alone.Everyone in your dorm is in the same situation as you.Talk to them about your own fears and anxieties.Chances are,they are feeling the same way and will be glad to have someone to talk to about it.2.Step outside of your dorm.The beauty of college is that you can start over with new people.They don't know your past;they will only know what you want them to know about you.For this reason,try new things and don't be afraid to tryon new personalities.This is a great time to figure out not only who you are,but also who you want to be.3.Make detailed study plans.They should include your short-term goals,what books to read at a certain stage,what extra curriculum activities to participate in and your daily activities.This will help you make full use of your spare time.4.Don't forget to enjoy it!College is about having fun and making new friends as well as learning new things.Living in a dorm is a great way to do so.You will have friends to hang out with and study partners for finals.Do crazy things,take pictures,share funny stories---enjoy yourself.You are only young onceRemember that your friends and parents are just a phone call away and that every person's adjustment period is different.Take your time and above all,learn things.(345 words)U2About MyselfHi,everyone!Welcome to my blog.Let me make a short introduction to myself.I’m a boy aged 18.I come from a small village in South China.Though it is small,it is very beautiful.It lies by a small river.The air is fresh and thewater is so clear that you can see lots of fish swimming in the river.There’re many rice fields around.So it is known as the “land of rice and fish”.Now,I’m studying computer science at South China Vocational College.I wish to become a computer engineer after graduation.I like my college life.It’s so different from life in the high school.After class you are all on your own.There’s nobody to tell you what to do.So you need to plan your time well so that you don’t waste it.All my classmates study hard,for we know that“Time and tide wait for no man”.We must make good use of the time to learn more.I have an active attitude towards life.There are many things I’d like to do,to see,and to experience.I like to read;I like to write.I like to think;I like to dream.I like flowers in spring,rain in summer,leaves in autumn,and snow in winter.I like the skyscrapers in big cities;I like the green fields in the country.I like good books and romantic movies.I like delicious food and comfortable shoes…But I spend most of my spare time surfing the Internet to search for useful information.I also spend time writing and updating my blog.It’s like my second home,my dreamland.This is me,Liu Ming.Thanks very much for visiting my blog!Your remarks will be most welcome!(300 words)U3Career PlanningCareer planning is a lifelong process,which includes choosing an occupation,getting a job,growing in the job,possibly changing careers,and eventually retiring.This process is usually comprised of four steps:analysis,exploration,selection,and actionThe first step is to conduct a detailed self analysis.Not only will you have to consider your interests and skills,you'll also have to think about your personality and values.Besides,find out what you’re really good at by asking family and friends,and remember to take your preferred work environments and development needs into consideration.Once self analysis is complete,it's time to start exploring the career options that interest you the most.Would you rather be an engineer or a businessman?Are middle school teachers paid more than salesmen?What’s the difference between a software engineer and a software developer?Research the occupations and industries you’d like to work in and try to speak to people with professional experience in those fields.The career action plan lists all the steps you will need to take to reach them,for example,investigating sources ofrequired training and education;writing your resume;gathering company information;preparing for job interviews,etc.(316 words)U4How to Answer Questions in an InterviewAn interview is a question-and-answer process.Good answers will surely bring you an advantage and the possibility of getting your ideal job.Here are good answers to some of the tough questions asked in job interviews.1.What is important to you in a job?Mention specific rewards other than a paycheck,for example,challenge,the feeling of accomplishment,and knowing that you have made a contribution.2.Why do you want to work for this organization?Cite its reputation,the opportunities it offers,and the working conditions.Stress that you want to work for this organization,not just any organization.3.Why should we employ you?Point to your academic qualifications,job skills,and enthusiasm about working for the organization.Mention your performance in school or previous employment as evidence of your ability to learn.If the job involves managementresponsibilities,refer to past activities as proof of your ability to get along with others and to work as part of a team.4.What are your greatest strengths?Give a response like one of the following:"I can see what needs to be done and do it","I'm willing to make decisions","I can organize my time efficiently."5.What are your greatest weaknesses?Identify one or two,such as the following:"I tend to drive myself too hard","I expect others to perform beyond their capacities".Note these weaknesses could also be regarded as desirable qualities.The trick with this question is to describea weakness so that it could also be considered a virtue.6.What are your salary expectations?You must have a clear idea of the market price of a person like you and,moreover,what the organization usually pays for the position and someone like you.Never fight a battle without preparation.If your expectation sounds reasonable,they will probably try to meet your price.(320 words)U5A Quick Guide to Writing a Business Invitation LetterWriting and delivering invitations to customers,potential customers,or colleagues to attend your importantbusiness-related occasions requires careful attention.Though great opportunities lie in it,if done improperly,it can cause undesired results.The following guidelines will help you make your business invitation letters professional and effective:1)Pay personal attention–Although it requires a little more effort,it pays off.Start your invitation with the recipient’s first name,i.e.,"Dear George"is far more effective than"Dear Madam or Sir".We all like to read our names.2)Make it brief-People are busy;they prefer a short,effective invitation that quickly answers the following questions:What?Where?When?Tell them clearly and briefly.3)Be creative-Use humor or something related to your business that makes people smile.This may increase their interest in your event.4)Offer an incentive-It shows you understand that your invitees’time is valuable.Invite them to a free luncheon or enter them in a prize drawing.Incentives also serve to keep your guests there until the end.5)Set a convenient date-Plan your occasion as far ahead as possible and you give your invitees more opportunity to keep the date open.6)Add RSVP information-Include RSVP at the bottom of theinvite if you need to know who will be attending;for example,'RSVP'followed by your telephone number.7)Send reminders-Send an electronic copy of your invitation as a reminder seven and three days before the occasion,with the Subject line“Countdown to Bluesky luncheon-only three more days!”8)Determine the wording-Should the language be formal or informal?A formal invitation might say,'Dr.and Mrs.Stanley request the pleasure of your company,'whereas a more casual note might say,'Please join us.'(314 words)U6The Basics in Receiving Foreign GuestsA good interpersonal relationship is the basis of either personal or corporate success on many occasions.Receiving guests or visitors provides a good chance for bettering mutual understanding and building good relations.The following are the basics in receiving foreign guests.As a general rule,you should let the guest walk on your right,and it is polite for you to open the door for him or her and let the guest go through the door first.It is usually considered offending to call a young lady ‘Madam’,or to ask a female about her age,salary,and otherprivate matters.You are not supposed to smoke unless you are permitted.It is customary to dress clean and tidy when you meet a guest for the first time.On a formal occasion,it is best to dress in black or blue.Don’t be humble or pushy,but you are required to show respect for the guest and his or her custom.When keeping an appointment with the guest,you must bepunctual.When shaking hands,you can use a little strength,but not too tightly.You should always use‘please’,‘thanks’in your talks.In addition,you should get ready to help your guests whenever and wherever they are in trouble.The following elements should be considered when hostinga foreign delegation:●Be aware of your visitors’background and prepare to meet them as soon as they arrive;●Make sure you understand your visitors’objectives and their desired route of the journey;●Contact the departments to be visited;●Make suggestions to enable your visitors to best use their time;●Draft a reception proposal which covers the following:◆Meeting the visitors at the airport or station;◆Making the schedule for interviews,meetings and fieldvisits;◆Making arrangements for reception,dinners and ceremony;◆Confirming hotel,transportation,and communication in advance.In a word,do what you should to show your hospitality as a host and you will find it rewarding.(337words)。

【刺猬实习】Peperdine Resume Template

【刺猬实习】Peperdine Resume Template

RESUME TEMPLATE & RESOURCESYour resume is not your career life-story. It is a self-marketing tool that encourages potential employers to learn more about you. This means you must selectively present information that demonstrates how and why you are qualified for the job you are applying. It is important to keep in mind that a resume is designed to get you an interview – not a job. Your ability to tell your success story and market yourself is how you will land a job. Your resume is your opportunity to stand out, to show your unique contributions and accomplishments, and to entice the potential employer enough so they will have the desire to call you for an interview. In this fast-paced competitive job market, this is no small task.Use the required template to create your one-page resume:•Do not alter the format– keep items in the template that are in bold font bold, italicized font italicized, and indented items indented•Do not cut & paste contents and/or bullet points from another resume into the template– this may alter the format of the template•Do not alter the type of font (it needs to be in Times New Roman) or change the type of bullet point used in the template•Do not add, delete, or rename sections in the template– the EDUCATION, followed by EXPERIENCE, followed by ADDITIONAL section sequence in the template may not be alteredYour resume is a truthful representation of who you are. Do not falsify past experiences; do not copy contents and/or bullet points from another person’s resume; do not have someone else draft your resume for you! Some of you may not be able to provide all of the information outlined in the template and others will have difficulties fitting everything onto one page. The following are resources to assist you and get you started: •JSO Resume and Cover Letter Writing Workshops•The Career Management Library, , and other resources available to you on GTO•The University Writing Center(/seaver/writingcenter/)As you are working on your resume, remember these key points:•The five graduate business skill areas that should be reflected on your resume are:1.Analytical ability2.Creative thinking or problem solving ability3.Leadership experience or potential4.Achievement and value-added results5.Technical savvy or knowledge of relevant business toolsResume mistakes to avoid:•Including objectives – it is obvious your goal is to obtain the position of application•Including information that is too personal (age, sex, marital status, nationality, attaching your photo) •Listing references•Providing too many details and information – instead make sure you have key words or phrases, valued-added statements, and hard-hitting facts in your resume•Spelling and grammatical errors, typing errors, poor format, and other blatant errors*W HEN UPLOADING YOUR RESUME ONTO GTO, DO NOT UPLOAD THIS PAGE – UPLOAD ONLY YOUR RESUME!YOUR NAME HERE1234 Main St., Apt. #1, Malibu, CA 90045310-000-0000 | yourname@EDUCATIONPepperdine University, Graziadio School of Business and Management Malibu, CA Degree, Concentration <if applicable>: GPA: 3.70 <if over 3.7>Month & Year Grad •Club leadership roles; case/business plan competitions; awards/scholarships; international experience •Memberships, organizations, held and volunteer work <relevant work only>University of Wherever City, State Degree, Major: GPA: 3.50 <if over 3.5>Month & Year Grad •Club leadership roles; awards/scholarships; international experience•Memberships, organizations, held and volunteer work <relevant work only>EXPERIENCE <reverse chronological order>Company Name, City, State Dates A two-line overview of your essential role in this company, including the type of services, products, market share information about this company.Most Recent Job Title (Duration)•Start writing about your accomplishments (in phrases) by using powerful action verbs and identifying the skills you used that are most relevant to the target position•Do not focus on the tasks that you performed, but rather focus on what you accomplished by performing the tasks. Describe the action you took, state specifics about what you did, and quantify the size andscope of your projects•Prioritize your accomplishments relative to the target position, and do not duplicate informationFirst Job Title (Duration)•Dedicate more space to accomplishments that directly relate to the position you are seeking•Action you took, specifically what you did, resultsCompany Name, City, State Dates A two-line overview of your essential role in this company, including the type of services, products, market share information about this company.Job Title•Follow the same format as above starting with an accomplishment (show measurable results where possible) from THIS job, illustrating a skill needed in the NEW job/industry you are targeting •Another accomplishment from this job, key roles or contributions made while there•Another activity from this job, illustrating a skill needed in the new jobCompany Name, City, State Dates A two-line overview of your essential role in this company, including the type of services, products, market share information about this company.Job Title•Relevant actions taken, accomplishments, resultsADDITIONAL <only provide information that offers value relative to your target area>•Memberships & Affiliations/Volunteer Work <not academic in nature>•Languages you are fluent or knowledgeable in•Business software applications, hardware, that you are proficient in <not just MS Office>•Relevant, unique, special interest or achievements <this should not be a long list of hobbies>。

英语作文可以做的事和不可以做的事

英语作文可以做的事和不可以做的事

英语作文可以做的事和不可以做的事全文共3篇示例,供读者参考篇1Things you can do in an English essay and things you can’tWriting an English essay can be a challenging task, but it can also be a rewarding experience. There are many things you can do in an English essay to make it engaging and informative. However, there are also some things you should avoid doing in an English essay. In this article, we will discuss both the things you can do and the things you can’t do in an English essay.Things you can do in an English essay:1. Use a clear and concise writing style: When writing an English essay, it is important to use a clear and concise writing style. This will make your essay easier to read and understand.2. Use proper grammar and punctuation: It is important to use proper grammar and punctuation in your English essay. This will help you to communicate your ideas clearly and effectively.3. Use evidence to support your arguments: When writing an English essay, it is important to use evidence to support yourarguments. This will help you to make your case more persuasive and convincing.4. Use transitions to connect your ideas: Transitions are important in an English essay because they help to connect your ideas and make your essay more cohesive.Things you can’t do in an English essay:1. Plagiarize: Plagiarism is a serious offense in academic writing. It is important to always cite your sources and give credit to the original authors of the ideas you are using in your essay.2. Use slang or informal language: When writing an English essay, it is important to use formal language. Using slang or informal language can make your essay seem unprofessional and can detract from your credibility as a writer.3. Make unsupported claims: It is important to support your arguments with evidence in an English essay. Making unsupported claims can weaken your essay and make it less convincing.4. Ramble: It is important to stay focused and on topic in an English essay. Rambling can make your essay seem disorganized and can confuse your readers.In conclusion, there are many things you can do in an English essay to make it engaging and informative. It is important to use a clear and concise writing style, proper grammar and punctuation, evidence to support your arguments, and transitions to connect your ideas. However, it is also important to avoid plagiarism, the use of slang or informal language, making unsupported claims, and rambling in an English essay. By following these guidelines, you can write a successful English essay that will impress your readers.篇2Things You Can and Cannot Do in English CompositionAs students, we often find ourselves faced with various writing assignments, including English compositions. When working on these tasks, it's important to remember what you can and cannot do. In this article, we will discuss the dos and don'ts of English composition writing.Things You Can Do:1. Choose a captivating topic: When writing an English composition, you have the freedom to choose a topic that interests you. This will make the writing process more enjoyable and help you stay motivated throughout.2. Engage the reader: Make sure to write in a way that captivates the reader's attention. Use descriptive language, vivid imagery, and engaging storytelling techniques to keep your audience hooked.3. Follow the rules of grammar and punctuation: It's crucial to adhere to proper grammar and punctuation rules when writing an English composition. This will ensure that your writing is clear, concise, and easy to understand.4. Use a variety of vocabulary: Don't be afraid to showcase your vocabulary skills in your composition. Use different words and phrases to add depth and complexity to your writing.5. Revise and edit: After completing your composition, take the time to revise and edit it. Look for any spelling or grammar mistakes, check for coherence, and make sure your ideas flow smoothly.Things You Cannot Do:1. Plagiarize: It is not acceptable to copy someone else's work and pass it off as your own. Plagiarism is a serious offense and can have severe consequences.2. Use inappropriate language: Avoid using offensive or inappropriate language in your English composition. Make sureyour writing is respectful and appropriate for the intended audience.3. Ignore the assignment guidelines: Always make sure to read and follow the assignment guidelines provided by your teacher. Failure to do so can result in a lower grade.4. Write without a plan: Don't start writing your composition without a clear plan in mind. Create an outline or brainstorm your ideas before diving into the writing process.5. Rush through the writing process: Take your time when writing an English composition. Rushing through the process can lead to sloppy writing and lower quality work.In conclusion, English composition writing is an opportunity for students to showcase their creativity, language skills, and critical thinking abilities. By following the dos and don'ts outlined in this article, you can ensure that your compositions are well-written, engaging, and successful. Remember to stay true to yourself, express your unique voice, and enjoy the writing process. Happy writing!篇3Things You Can and Cannot Do in English CompositionEnglish composition is a form of writing that requires creativity, grammar skills, and critical thinking. When writing an English composition, there are certain things you can do to make your writing stand out and certain things you should avoid. In this article, we will discuss what you can and cannot do in English composition.Things You Can Do1. Be creative: English composition allows for creativity and imagination. You can experiment with different writing styles, use metaphors, and create vivid descriptions to make your writing more engaging.2. Use proper grammar: Good grammar is essential in English composition. Make sure to use correct punctuation, spelling, and sentence structure to convey your ideas clearly.3. Provide evidence: When making an argument in your composition, it is important to support your claims with evidence. Use examples, quotes, and statistics to back up your points.4. Revise and edit: Writing is a process, and it is important to revise and edit your composition before submitting it. Check for errors in grammar, spelling, and organization to ensure your writing is polished.5. Follow the prompt: If you are given a prompt for your composition, make sure to read it carefully and address all aspects of the prompt in your writing.Things You Cannot Do1. Plagiarism: Plagiarism is a serious offense in writing. Do not copy someone else's work and claim it as your own. Always give credit to the original source when using someone else's ideas or words.2. Use slang or informal language: English composition is a formal type of writing, so avoid using slang, colloquialisms, or casual language in your composition.3. Write without structure: A well-organized composition is easier to read and understand. Make sure your writing has a clear introduction, body paragraphs, and conclusion that flow logically.4. Ignore feedback: If you receive feedback on your composition, do not ignore it. Use feedback to improve your writing and make necessary revisions.5. Rush the writing process: Writing takes time and effort. Do not rush the writing process or wait until the last minute to startyour composition. Give yourself enough time to brainstorm, draft, revise, and edit your writing.In conclusion, English composition offers a lot of creative freedom, but it also comes with certain rules and guidelines. By following these tips on what you can and cannot do in English composition, you can improve your writing skills and create compelling compositions.。

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Modeling Decisions for Digital ContentNaomi Dushay and Carl LagozeCornell Digital Library Research GroupDepartment of Computer ScienceCornell UniversityIthaca, NY 14853-7501{naomi, lagoze}@AbstractThe organization of digital information poses unique challenges not only due to rapidly evolving data formats and software, but also because digital content may be dynamic, distributed, or executable. Managers of digital information need flexible, extensible architectures that facilitate maintainability as well as accessibility and long-term utility of content. However, the flexibility of these architectures requires difficult organizational, or modeling, decisions. To explore these modeling decisions and their consequences, we introduce four dimensions of digital content modeling: storage, interfaces, transformations and indirection. We discuss these dimensions individually and also examine their interaction; in essence, this paper examines general design patterns for digital content modeling.1 IntroductionOrganizing large quantities of information to promote accessibility and maintainability has always been challenging. With digital content, additional levels of complexity are present, not only because of rapidly evolving software, hardware and data formats, but also due to new management and organization challenges that result from the new technologies. For example, digital information can be remotely located, dynamic (today’s weather prediction for Lisbon) or executable (an interactive program, e.g. a backgammon game).While the Internet can deliver dynamic, distributed, and executable content, two difficult tasks for managers of digital information are 1) making complex digital content comprehensible to users and 2) managing the digital content and its complex interrelationships. Digital content stewards need a flexible, extensible architecture that enables maintainability as well as accessibility and utility of content. But with such an architecture comes myriad organizational, or modeling decisions. How should digital content be modeled to promote ease of maintenance? To ensure continued utility of the information? To promote easy access? What are the tradeoffs of choosing one organization scheme over another?To discuss such modeling decisions, we introduce four dimensions of digital content modeling:1. Storage: What information will be stored in a digital object? What bit streams will be stored, andwhich bit streams will be aggregated into a single digital object?2. Interfaces: How will information be made available and presented to users? Using object-oriented terms, what methods will be published for use by agents and users? What disseminations of bit streams will be delivered to users as a result of those methods? What methods should begrouped into a single interface, and which interfaces should be associated with a digital object?3. Transformations: How does the data stored in a digital object correspond to the disseminationsavailable through its interfaces? What mechanisms will be used to transform what is stored towhat is delivered to users? What aspects of transformations will be static, what aspectsparameterized?4. Indirection: What information will be stored within the digital object, and what will be accessedat a remote location? How will remote information be accessed?This paper will explore these dimensions and some of the ways they interact when considering different modeling choices. Our experience has shown that the nature and motivations for these decisions can have impact on digital library design and management. As new and powerful architectures evolve it is vital that information managers understand and consider these design decisions.The remainder of this paper is organized as follows. In section 2 we describe the features of an enabling architecture for digital content that sets the context for modeling decisions. In section 3 we explore two examples to begin understanding the dimensions of digital content modeling. We take a closer look at each of the modeling dimensions and how they interact in section 4 and we state our conclusions in section 5.2 A Flexible, Extensible Architecture for Digital ContentOur analysis presumes digital content architectures of considerably greater power than those currently available through the World Wide Web. In particular, we assume architectures that:• accommodate new types of digital content as they emerge, as well as mechanisms for transforming and manipulating that content,• support aggregation of heterogeneous, possibly distributed digital content into single entities, • support multiple, extensible disseminations of information from these aggregated entities,• have an open, well-defined protocol facilitating repository interoperability and confederation [1]. Within our digital library research at Cornell we have been experimenting with one such architecture, Fedora (Flexible and Extensible Digital Object and Repository Architecture)1, described in [2]. The Cornell Digital Library Research Group2 and the Corporation for National Research Initiatives (CNRI)3 have each implemented an interoperable version of the Fedora architecture in Java, using CORBA as a transport layer [3]. The University of Virginia Library has implemented an alternative version of Fedora using MYSQL and various scripts, which uses HTTP as a transport layer. There are similar architecture efforts in the digital library community, such as Smart Object, Dumb Archive (SODA)[4], Dienst4 [5], Multivalent Documents [6], and that proposed by the Making of America II project [7].Fedora, like SODA, builds on the concepts of the Kahn/Wilensky Framework [8] and the model presented in the Warwick Framework [9]; Fedora uses a container abstraction to aggregate distinct resources into a single abstract container, called a digital object. These resources may either be local to the digital object – i.e., physically contained within the object – or derived from external requests to other digital objects or other network resources. Fedora builds on the Distributed Active Relationship (DAR) abstraction [10] [11] to provide extensible disseminations from that digital object.Another key facet of the Fedora architecture is the segregation of digital object structure, interfaces and mechanisms. This segregation allows digital content storage, disseminations and transformations to be specified independently of each other. It is this independence that allows us to view the dimensions of digital information modeling as orthogonal.1 /cdlrg/FEDORA.html2 /cdlrg/3 /4 /cdlrg/dienst/architecture/architecture.htmThroughout this paper, we use visual metaphors to represent Fedora digital objects. We introduce these metaphors in Figure 1, and also present some fundamentals of the Fedora architecture.Digital Object “A” in Figure 1 physically contains two bit streams: a PDF file and a Dublin Core record. It has one interface, or set of behaviors, associated with it: a BOOK interface. The BOOK interface is defined by a set of behaviors called the Book Behavior Definition; the individual behaviors might include JHW3DJH SDJH1R , JHW7LWOH , JHW7DEOH2I&RQWHQWV , etc. Figure 1 shows only one interface attached to digital object “A”, but Fedora digital objects can have any number of attached interfaces.A digital object disseminating a Book Behavior Definition is shown in the upper right of the figure. Note that there is no interface associated with this digital object: Fedora provides a bootstrap mechanism for disseminations of Behavior Definitions. Similarly, the digital object in the lower right disseminates a Book Behavior Implementation via a bootstrap mechanism.The Book Behavior Implementation is executable code that transforms stored content into disseminations based on behavior requests. This transformation occurs when a user requests a dissemination from digital object “A”. In our example, a JHW7LWOH request on digital object “A” would cause the Book Behavior Implementation to parse the stored Dublin Core data and deliver the title to the user.Please note that the example digital content models in this paper are conceived within the Fedoraarchitecture, but the modeling concepts and issues are applicable to other architectures. In some sense, we are describing general design patterns for digital content modeling.3 Getting Started – A Comparison of Two ModelsWe begin exploring the digital content modeling dimensions by simplifying the problem. In the two examples below, we hold the interface dimension constant: in both cases, the user has access to the same set of behaviors (or methods) to request disseminations. However, we vary the three other dimensions: storage, transformations and indirection. What is stored in the digital objects is different, which in turn impacts the transformations from physical storage to available disseminations, and we introduce a form of indirection in the second example.The DOCUMENT interface is attached to digital objects “B” and “C” in the figures below. Because the interface is the same, it refers to the same Document Behavior Definition. Let’s assume the behavior definition has two methods: JHW%LEOLRJUDSKLF'DWD and JHW3RVW6FULSW5HQGLWLRQ.Figure 1 - three Fedora digital objectsIn Figure 2, the content stored in digital object “B” is 1) a Dublin Core bit stream containing bibliographic metadata for the document and 2) a PostScript representation of the document. The transformations to get from the stored content to the disseminations for digital object “B” are quite simple: JHW%LEOLRJUDSKLF'DWD will return the Dublin Core bit stream and JHW3RVW6FULSW5HQGLWLRQ the PostScript bit stream. Document Behavior Implementation 1, shown in the lower left, carries out these simple transformations.The content stored in digital object “C” in Figure 3 and the transformations performed on that content are completely different from that in digital object “B”, even though the interface is the same: JHW%LEOLRJUDSKLF'DWD and JHW3RVW6FULSW5HQGLWLRQ are still the dissemination request methods. Digital object “C” contains only a URI, which is used by Document Behavior Implementation 2 to make HTTP requests to an external server. When digital object “C” receives a JHW%LEOLRJUDSKLF'DWD request,Document Behavior Implementation 2 uses the stored URI to make an HTTP request to an external server, and then parses the dissemination from the HTTP server in order to pull out Dublin Core data to deliver to the user. Similarly, a JHW3RVW6FULSW5HQGLWLRQ request causes Document Behavior Implementation 2 to make an HTTP request and then parse the results for PostScript data to deliver to the user. These transformations are more complex than those carried out by Document Behavior Implementation 1 in Figure 2.Because the stored URI in digital object “C” is used to get information external to the digital object, a form of indirection is present. We could even say that digital object “C” is a Fedora wrapper for a particular document (indicated by the URI) in the HTTP server.Figure 2 - digital object “B”Figure 3 - digital object "C"Disseminations3.1 Why choose one model over another?In the previous two examples, we held the interface dimension constant while altering the storage, transformation and indirection dimensions: the user can get exactly the same information from these two digital objects, but what is stored and how it is transformed is different. So why choose one model over another?Let’s assume that the HTTP server in Figure 3 is storing the same Dublin Core and PostScript bit streams shown in Figure 2. This means digital object “B” in Figure 2 repeats the storage of files: Dublin Core and PostScript files are stored in the HTTP Server as well as in digital object “B”. Figure 3 avoids repetitious storage, but adds vulnerability due to indirection: it is dependent on URI reliability, the robustness of an external service as well as network stability. There may also be issues of maintainability: if changes are made to the external files, then the digital object in Figure 2 will need to be updated, while the digital object in Figure 3 requires no changes. But if we don’t believe the external repository will be maintained for the life of the digital object, then Figure 2’s model may be preferable to Figure 3 ‘s.Most digital object modeling decisions will require similar considerations -- anticipating not only future needs of users, but future maintenance of services outside the scope of the repository or even the owning institution, e.g. a remote service or connectivity to that service. We will further explore modeling decisions and their ramifications in the rest of this paper.4 A Closer Look at the Modeling DimensionsIn section 3, the interface for the digital objects was already known – we wanted our digital object to “speak” DOCUMENT. But the starting point for modeling decisions may vary. There may be situations where storage is the first dimension to be considered: digital content stewards could have lots of digital content which first needs to be organized for maintainability first and then have interfaces provided. Or there might be initial questions about indirection: what should be stored in the local repository, and what should be stored externally?In this section, we will analyze choices for each dimension and their ramifications. Since the dimensions aren’t truly orthogonal, we will also explore how decisions for one dimension affect the others. We begin with the interface dimension, and then we examine the storage dimension, including storage and maintenance of mechanisms. We next discuss transformations and finish with a discussion of indirection.4.1 InterfacesIn many cases, defining interfaces for a digital object is one of the most challenging modeling issues. It's not only a matter of anticipating what information a user will want to get out of a digital object, but also of understanding the appropriate granularity and grouping of behaviors. For example, Dublin Core5 behavior might be defined as JHW7LWOH , JHW&UHDWRUV , JHW'HVFULSWLRQ , etc. Or it might be defined asJHW'&(OHPHQW HOHPHQW1DPH , or even JHW'&5HFRUG , which would return the entire Dublin Core record to be parsed by a client application. This last option requires further decisions: in what format should the Dublin Core record be disseminated? XML? Plain text? RDF? Or should that be specified by the user via parameter, e.g. JHW'&5HFRUG IRUPDW ?Payette suggests that access rights and other policies will be enforced during the execution of behaviors [12]; in effect, the granularity of behavior definitions is closely coupled with policy enforceability. In our Dublin Core example, we must decide if we want to have policies pertaining to the entire Dublin Core record (JHW'&5HFRUG ) or to individual elements (JHW'&(OHPHQW HOHPHQW1DPH or JHW7LWOH , JHW&UHDWRU , ...). There may be security issues in providing data to users or agents: it may be okay to disseminate the title, but a security violation to send the whole Dublin Core record.5 /dc/Another facet of interface choices lies in the grouping of requests into behavior definitions. For example, should the LECTURE behavior definition include a JHW$VVLJQPHQW request or should there be a separate HOMEWORK behavior definition with JHW$VVLJQPHQW and JHW6ROXWLRQ requests?Stepping back further, we must determine which interfaces will be associated with any given digital object. In addition to DUBLIN CORE, we might want a given object to speak BOOK and PHOTO ALBUM or any number of other interfaces. We might create new interfaces for a digital object, or use existing ones. The Fedora architecture allows new interfaces to be associated with a digital object at any time, so all of these decisions need not be made at digital object creation time.Another question to consider is who defines interfaces? Who maintains them and makes them available? We envision digital content providers, either singly or in association, taking on these tasks.4.2 StorageIn some cases, digital content stewards need to decide what to store locally and what to access at a remote location, while in other cases, digital content stewards already have lots of digital content and need to decide how to organize it. We address the former situation in section 4.4 when we discuss indirection; the latter situation is the main focus of the storage dimension – which bit streams should be grouped together into single digital objects?Sensible aggregation choices may depend on anticipating the uses for and interfaces to be attached to the digital objects: should we package images of different resolutions and a thumbnail together into one object, or should each image be in a separate object? If we expect the group of images to be used together, then we want to package them together, but if we anticipate individual images being used in particular contexts, then we may want to package them separately.Preservation considerations such as maintainability and long-term utility of information may also impact storage decisions. Or we might want to apply policies such as access permissions at the package level, which would also impact aggregation choices.There’s a new wrinkle in the aggregation question when we consider the bit streams for mechanisms – the executable code containing behavior definitions or behavior implementations.4.2.1 Where should mechanisms be stored?The figures in sections 2 and 3 show each mechanism stored in a separate digital object. But the architecture may not require these to be stand-alone digital objects. In fact, Fedora digital objects can contain any number of behavior definitions and any number of behavior implementations, raising some interesting modeling questions.For example, a digital object can contain all behavior definitions and implementations it uses – the mechanisms can be stored in same container as the “content.” An example of such a “self-contained” digital object is shown in Figure 4. BOOK and DUBLIN CORE interfaces are attached to this digital object, and the bit streams for the mechanisms required for the interfaces’ behavior definitions and behavior implementations are all stored in this digital object, along with “content” bit streams of type XML, PostScript and GIF.Self-contained digital objects reduce dependency on external software and files: they do not need to locate or retrieve the mechanisms for their interfaces. One tradeoff for that reliability gain is the potentially repetitious storage of mechanism executables: the BOOK interface’s mechanisms will be duplicated in every self-contained digital object using that interface. There are also implications if the BOOK interface is updated – would the digital objects be updated, or would they continue using an older version? How would this versioning of be tracked? Moreover, would the enforcement of policies on this digital object allow the mechanisms to be used by other digital objects or by external users? How shareable are these mechanisms? The Fedora architecture allows mechanisms to be globally shareable from anywhere, depending on policy decisions.If we choose not to store the mechanisms with the content in self-contained digital objects, then we are still faced with aggregation choices for the mechanisms. Should mechanisms be in stand-alone digital objects, as shown in section 3 or should they be grouped? We have returned to the aggregation question for mechanisms.Mechanisms could be grouped by interface. For example, the behavior definition and the behavior implementation for the BOOK interface could both be packaged in a single digital object. If additional behavior implementations were created for the BOOK behavior definition, they might be added to this digital object. This avoids repetitious storage of mechanisms, and may make version handling ofmechanisms easier. But what if someone who doesn’t have write access to this digital object creates a new BOOK behavior implementation?Another possible organization of mechanisms would be to create a “BehaviorDefinition” digital object and a “BehaviorImplemenation” digital object. So, in our example, the BOOK and DUBLIN CORE behavior definitions would be in the former digital object, while the behavior implementations would be in the latter digital object. This might make maintenance easier if a repository contained lots of interface mechanisms. Any combination of the above aggregation schemes is possible in Fedora. For example, if animplementation of BOOK behaviors was likely to be used only by a particular digital object, it might make sense to store that BOOK behavior implementation in that digital object, even though the BOOK behavior definition would be accessed in another location. In another scenario, if Cornell’s BOOK behaviorimplementation was proprietary, it might be easiest to enforce rights management if it was in a stand-alone digital object.4.3 TransformationsTransformations by their very nature are constrained by what is stored in a digital object and the behaviors they are implementing. For instance, if we’re storing a Dublin Core record in plain text, and we have aninterface with behaviors JHW7LWOH and JHW$XWKRU , then it’s clear the transformation will involve parsing the Dublin Core record, finding the relevant tags, and disseminating the correct information to the user. But there are many cases where transformation choices must be made, even given storage and behavior constraints.As an example, let’s assume we’re storing a large, unsorted list of names, and we have a behavior request JHW6RUWHG1DPHV . There are multiple sorting algorithms that will all produce the correct results, but the different algorithms require different amounts of resources such as memory or processing time. These types of decisions have been in the bailiwick of programmers in the past and we expect them to remain there, not with digital content stewards. On the other hand, given multiple behavior implementations that are functionally equivalent, digital content stewards will have to choose which one to use.Figure 4 - self-contained digital objectDisseminationsThere are further interdependencies between storage, interfaces and transformations, especially concerning parameters in behavior requests. Consider the interface and storage scenarios for a digital object providing a dissemination of a document, as represented in Table 1. The interface could define the JHW'RFXPHQW behavior request with or without a format parameter, and the storage could include the document as a PostScript bit stream or as a LaTeX bit stream.Table 1 – behavior requests vs. storage renditionsWhen we set the format parameter to “PostScript” for the first line of the table, transformation A is trivial: it merely delivers the stored PostScript bit stream to the user. On the other hand, transformation B must take the LaTeX bit stream and convert it to PostScript before delivering it to the user. For this row of the table, the storage and interface dimensions are constraining the transformation dimension: if the transformation cannot produce the format specified by the parameter, the dissemination request produces an error.In the second line of the table, depending on the architecture constraints, it’s possible that transformation C will return a PostScript bit stream, while transformation D will return a LaTex bit stream. In essence, the storage provides the value of the absent format parameter. For this row of the table, the storage and the transformation dimensions are affecting the interface dimension.We can also see that the complexity of the transformation is affected by the interface definition if we view the first column of the table. Transformation A may need to produce multiple disseminations corresponding to different values of the format parameter, but transformation C may be trivial, merely delivering the stored PostScript bit stream to the user.Another interaction between parameters and storage can be illustrated by recalling Figure 3. In this figure, a URI is stored in the digital object. But what if the URI was specified as a parameter in a behavior request? We will explore this in the next section.4.4 IndirectionWe want to take full advantage of the networked environment of digital information and allow access to digital content that is stored remotely. Figure 3 showed one type of this indirection – stored URIs are used to access remote content. Architectures may enable other forms of indirection, providing ways to aggregate distributed content into digital objects.The Fedora architecture supports two forms of indirection for the storage dimension: it provides two ways to specify formal requests for remote content within its content container. Since indirect bit stream requests are directly supported by the architecture, problems such as invalid requests can be caught when these remote bit stream requests are stored. Figure 3, problems accessing the data via the URIs will not be caught until a dissemination is requested.Figure 5 shows an indirect PostScript bit stream that is a request for a specified PostScript dissemination from a specified Fedora digital object. Such indirection occurs entirely within the Fedora architecture, enabling multiple digital objects to use the same content while minimizing repetitious storage.specified HTTP server. The stored “service request” specifies the dissemination from an HTTP server via a behavior request from the HTTP Behavior Definition. The HTTP Behavior Implementation is the mechanism that extracts information from the stored service request, gets the requested dissemination from the specified HTTP server, and then, in this case, transforms the dissemination results into an XML bit stream, as shown in the figure.This form of indirection involves a service outside the Fedora architecture, and as with the URIs in Figure 3, the out-of-band communication limits policy enforcement capabilities and adds dependencies on external services and network reliability. However, since the service request itself is specified within the Fedora architecture, we have some degree of policy enforcement for out-of-band activity.Note that accessing an external service, such as HTTP in our example, requires service request mechanisms to support the indirection. These mechanisms must be stored and maintained just like any other mechanisms; the modeling choices described in section 4.2.1 apply here also.Both forms of indirection illustrated in Figure 5 may reduce duplication of storage, but add vulnerability due to dependence on content outside the digital object. Clearly, remote content within the same Fedora repository exposes fewer vulnerabilities than remote content in an out-of-band service in an external repository located far away. Deciding what to store locally and what to access remotely will require weighing repetitious storage and versioning issues against expected vulnerabilities.Indirect bit streams within the Fedora architecture raise interesting aggregation questions, as we now have a means to combine locally controlled content in unlimited ways. For example, what if a JPEG image of Cornell’s McGraw tower is used in a multimedia presentation on the chimes housed there, in a video presentation of the Cornell campus and in a treatise on architectural photography? The Fedora architecture allows us to store the JPEG image in one digital object and refer to it from other digital objects. Figure 6 shows a digital object comprised solely of references to other Fedora digital objects.The University of Virginia Library takes advantage of this indirection within the architecture in their modeling decisions. They create “building block” digital objects that contain a single entity such as an image (possibly multiple resolutions packaged together) or an EAD rendition of a manuscript, and then they create aggregate digital objects such as the one shown in Figure 6, which refer to the “building block” objects. This maximizes the utility, maintainability, and flexibility of their content for their purposes – they can easily aggregate bit streams in multiple ways without duplicating storage. Moreover, interfaces can be associated with any of the individual aggregate or “building block” digital objects at any time: the interface dimension is orthogonal to both the storage and the indirection dimensions.。

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