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April Center for Tobacco ProductsU.S. Food and Drug Administration
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April Center for Tobacco ProductsU.S. Food and Drug Administration ... - PDF document

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April Center for Tobacco ProductsU.S. Food and Drug Administration ... - PPT Presentation

Electronic Establishment Registration and Product Listing UpdateFURLS TRLMFURLS FDA Unified Registration and Listing SystemTRLM Tobacco Registration and Product Listing Module Topics CoveredBrief ID: 504796

Electronic Establishment Registration and Product

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April Center for Tobacco ProductsU.S. Food and Drug Administration Electronic Establishment Registration and Product Listing Update:FURLS TRLMFURLS = FDA Unified Registration and Listing SystemTRLM = Tobacco Registration and Product Listing Module Topics CoveredBrief overview of establishment and product listing requirementsWhat is the FDA Unified Registration and Listing System (FURLS)?Benefits of using FURLSTips for using FURLSResources if you need help Establishment Registration and Product Listing RequirementsAnnual registrationOn or before December 31of each yearBiannual product listing updates (if changes have been made)June and December Additional ResourcesSection 905 of the Federal Food, Drug, and Cosmetic ActGuidance for Industry is available at www.fda.gov by searching for “Tobacco Registration and Listing uidance” CTP held a webinar on December 8, 2011, which is also available at www.fda.govby searching for “2011 Archived Tobacco Compliance Training” 4 What is FURLS TRLM?FURLS is the FDA Unified Registration and Listing SystemFURLS is also used by other Centers within FDATRLM is the new Tobacco Registration and Product Listing Module of FURLS Why did CTP Transition from eSubmitter to FURLS?FURLS is a more userfriendly, online systemFURLS allows firms to view and edit their data at any time Note that establishment registration and product listing is the onlysubmission type transitioning from eSubmitterto FURLS 6 Additional Benefits of FURLSYou do not have to download an additional program to your computerYou no longer need to “package” files and use a separate system (ESG) to submitYou can reuse the same spreadsheet that was used to upload product listings in eSubmitter What Happened to Data Submitted through eSubmitter?CTP has migrated all current establishment registration and product listing data into FURLSAccounts were created for firms with existing registration and product listing dataIf you did not receive your account information, contact CTPRegList@fda.hhs.gov 8 Can I Still Use the Paper Form?Yes, paper form FDA 3741 is still available for submitting establishment registration and product listing informationHowever, CTP strongly encourages you to view and edit your data online using FURLS Do I Have to Submit Any New or Different Information?No you will provide the same establishment registration and product listing informationThe form questions have not changed; only the electronic method for submitting this information has changed��10 Adding Advertising, Labeling, and Consumer InformationThe system accepts the following file types: .pdf, .xpt, .xmldtd, .gif, ., .jpg, sgml, .xls, .xlsx, .csv, .wmv, .aviand .zip FURLS Streamlines the Submission of InformationFor example:If there are no changes to your establishment registration, you can now simply check a boxIf there is no advertising, labeling, or consumer information for a product, you can indicate this by checking a boxIf you have multiple establishments, you can indicate where listed products are made��12 Tips for Using FURLS��13 Logging into FURLS��14 View/Update Existing Data��15 Owner who is also the Operator��16 Annual Registration��17 View/Update Product Listings��18 View/Update Product Listings (cont��19 Where to Get HelpWhile logged into FURLS, you can click the “Get Help” icon in the upper right hand corner of each screen for a stepstep tutorial: You can send an email to AskCTP@fda.hhs.gov ; please include your FURLS account ID Small manufacturers can contact smallbiz.tobacco@fda.hhs.gov ; please include your FURLS account ID CTP will have staff available to assist you with your questions ��20 Where to Get Help While logged into FURLS, you can click the “Get elp” icon in the upper right hand corner of each screen for a stepstep tutorial: You can send an email to skCTP@fda.hhs.gov ; please include your FURLS account ID Small manufacturers can contact allbiz.tobacco@fda.hhs.gov ; please include your FURLS account ID CTP will have staff available to assist you with your ions ��20 View/Update Product Listings (cont��19 View/Update Product Listings��18 Annual Registration ��17 Owner who is also the Operator ��16 View/Update Existing Data��15 Logging into FURLS ��14 Tips for Using FURLS��13 FURLS Streamlines the Submission of InformationFor example:If there are no changes to your establishment stration, you can now simply check a boxIf there is no advertising, labeling, or er information for a product, you can indicate this by checking a boxIf you have multiple establishments, you can ndicate where listed products are made��12 Adding Advertising, Labeling, and Consumer InformationThe system accepts the following file pes: .pdf, .xpt, .xmldtd, .gif, ., .jpg, sgml, .xls, .xlsx, .csv, .wmv, .aviand .zip Do I Have to Submit Any New or Different Information? No you will provide the same establishment registration and product listing informationThe form questions have not changed; y the electronic method for submitting this information has changed��10 Can I Still Use the Paper Form? Yes, paper form FDA 3741 is still available or submitting establishment registration and product listing informationHowever, CTP strongly encourages you to iew and edit your data online using FURLS What Happened to Data Submitted through eSubmitter?CTP has migrated all current establishment egistration and product listing data into FURLSAccounts were created for firms with isting registration and product listing dataIf you did not receive your account nformation, contact CTPRegList@fda.hhs.gov 8 Additional Benefits of FURLSYou do not have to download an additional ogram to your computerYou no longer need to “package” files and e a separate system (ESG) to submitYou can reuse the same spreadsheet that as used to upload product listings in eSubmitter Why did CTP Transition from eSubmitter to FURLS?FURLS is a more userfriendly, online systemFURLS allows firms to view and edit their a at any time Note that establishment registration and product listing is the onlysubmission type transitioning from eSubmitterto FURLS 6 What is FURLS TRLM?FURLS is the FDA Unified Registration Listing SystemFURLS is also used by other Centers ithin FDATRLM is the new Tobacco Registration roduct Listing Module of FURLS Additional ResourcesSection 905 of the Federal Food, Drug, Cosmetic ActGuidance for Industry is available at ww.fda.gov by searching for “Tobacco Registration and Listing uidance” CTP held a webinar on December 8, 2011, which is also available at www.fda.govby searching for “2011 Archived Tobacco Compliance Training” 4 Establishment Registration and Product Listing RequirementsAnnual registrationOn or before December 31of each yearBiannual product listing updates (if hanges have been made)June and December Topics CoveredBrief overview of establishment and oduct listing requirementsWhat is the FDA Unified Registration and sting System (FURLS)?Benefits of using FURLSTips for using FURLSResources if you need help April Center for Tobacco ProductsU.S. Food and Drug Administration Electronic Establishment Registration and Product Listing Update:FURLS TRLMFURLS = FDA Unified Registration and Listing SystemTRLM = Tobacco Registration and Product Listing Module Where to Get HelpWhile logged into FURLS, you can click the “Get Help” icon in the upper right hand corner of each screen for a stepstep tutorial: ou can send an email to AskCTP@fda.hhs.govplease include your FURLS account ID Small manufacturers can contact smallbiz.tobacco@fda.hhs.gov; please include your FURLS account ID CTP will have staff available to assist you with your questions ��20 ��View/Update Product Listings (cont ��19 ��View/Update Product Listings��18 ��Annual Registration ��17 ��Owner who is also the Operator 16 �� &#x/Att;¬he; [/;&#xTop ;&#x]/BB;&#xox [;I 3;b 6;p 4;V ];&#x/MCI; 2 ;&#x/Typ; /P; gin; tio;&#xn 00;&#x/Att;¬he; [/;&#xTop ;&#x]/BB;&#xox [;I 3;b 6;p 4;V ];&#x/MCI; 2 ;&#x/Typ; /P; gin; tio;&#xn 00;View/Update Existing Data 15 ��Logging into FURLS��14 Tips for Using FURLS ��13 FURLS Streamlines the Submission of Informationor example: f there are no changes to your establishmentregistration, you can now simply check a boxIf there is no advertising, labeling, or consumer information for a product, you can indicate this by checking a box If you have multiple establishments, you can ndicate where listed products are made ��12 ��Adding Advertising, Labeling, and Consumer Informationhe system accepts the following file types: .pdf, .xpt, .xmldtd, .gif, ., .jpg, sgml, .xls, .xlsx, .csv, .wmv, .aviand .zip ��What Happened to Data Submitted through eSubmitter?TP has migrated all current establishment registration and product listing data into FURLS Accounts were created for firms with existing registration and product listing data If you did not receive your account information, contact CTPRegList@fda.hhs.gov ��Do I Have to Submit Any New or Different Information? o you will provide the same establishment registration and product listing information The form questions have not changed; only the electronic method for submitting this information has changed ��10 ��Can I Still Use the Paper Form?es, paper form FDA 3741 is still available for submitting establishment registration and product listing information However, CTP strongly encourages you to view and edit your data online using FURLS ��Additional Benefits of FURLSou do not have to download an additional program to your computer You no longer need to “package” files and use a separate system (ESG) to submitYou can reuse the same spreadsheet that was used to upload product listings in eSubmitter ��Why did CTP Transition fromeSubmitter to FURLS?URLS is a more userfriendly, online system FURLS allows firms to view and edit their data at any time Note that establishment registration and product listing is the only submission type transitioning from eSubmitter to FURLS Electronic Establishment Registration and Product Listing Update:FURLS TRLMFURLS = FDA Unified Registration and Listing SystemTRLM = Tobacco Registration and Product Listing ModuleApril Center for Tobacco ProductsU.S. Food and Drug Administration ��What is FURLS TRLM?URLS is the FDA Unified Registration and Listing System FURLS is also used by other Centers within FDA TRLM is the new Tobacco Registration and Product Listing Module of FURLS ��Additional Resourcesection 905 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry is available at www.fda.gov by searching for “Tobacco egistration and Listing uidance” CTP held a webinar on December 8, 2011, which is also available at www.fda.gov earching for “2011 Archived Tobacco Compliance Training” ��Establishment Registration and Product Listing Requirementsnnual registration On or before December 31of each year iannual product listing updates (if changes have been made) ecember ��Topics Coveredrief overview of establishment and product listing requirements What is the FDA Unified Registration and Listing System (FURLS)? Benefits of using FURLS Tips for using FURLS Resources if you need help ��Establishment Registration and Product Listing RequirementsAnnual registration On or before December 31of each year Biannual product listing updates (if hanges have been made) June and December ��Topics CoveredBrief overview of establishment and product listing requirements What is the FDA Unified Registration and Listing System (FURLS)? Benefits of using FURLS Tips for using FURLS Resources if you need help Where to Get HelpWhile logged into FURLS, you can click the “Get Help” icon in the upper right hand corner of each screen for a steptep tutorial: You can send an email to AskCTP@fda.hhs.govplease include your FURLS account ID Small manufacturers can contact smallbiz.tobacco@fda.hhs.gov; please include your FURLS account ID CTP will have staff available to assist you with your questions ��20 FURLS Streamlines the Submission of InformationFor example: If there are no changes to your establishmentregistration, you can now simply check a boxIf there is no advertising, labeling, or consumer information for a product, you can indicate this by checking a box If you have multiple establishments, you can ndicate where listed products are made ��12 ��Adding Advertising, Labeling, and Consumer InformationThe system accepts the following file types: .pdf, .xpt, .xmldtd, .gif, ., .jpg, sgml, .xls, .xlsx, .csv, .wmv, .aviand .zip ��What Happened to Data Submitted through eSubmitter?CTP has migrated all current establishment registration and product listing data into FURLS Accounts were created for firms with existing registration and product listing data If you did not receive your account information, contact CTPRegList@fda.hhs.gov ��Do I Have to Submit Any New or Different Information? No you will provide the same establishment registration and product listing information The form questions have not changed; only the electronic method for submitting this information has changed ��10 ��Can I Still Use the Paper Form?Yes, paper form FDA 3741 is still available for submitting establishment registration and product listing information However, CTP strongly encourages you to view and edit your data online using FURLS ��Additional Benefits of FURLSYou do not have to download an additional program to your computer You no longer need to “package” files and use a separate system (ESG) to submitYou can reuse the same spreadsheet that was used to upload product listings in eSubmitter ��Why did CTP Transition fromeSubmitter to FURLS?FURLS is a more userfriendly, online system FURLS allows firms to view and edit their data at any time Note that establishment registration and product listing is the only submission type transitioning from eSubmitter to FURLS ��Additional ResourcesSection 905 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry is available at www.fda.gov by searching for “Tobacco Registration and Listing uidance” CTP held a webinar on December 8, 2011, which is also available at www.fda.gov searching for “2011 Archived Tobacco Compliance Training” ��What is FURLS TRLM?FURLS is the FDA Unified Registration and Listing System FURLS is also used by other Centers within FDA TRLM is the new Tobacco Registration and Product Listing Module of FURLS ��Establishment Registration and Product Listing RequirementsAnnual registration On or before December 31of each year Biannual product listing updates (if changes have been made) June and December Where to Get HelpWhile logged into FURLS, you can click the “Get Help” icon in the upper right hand corner of each screen for a stepstep tutorial: ou can send an email to AskCTP@fda.hhs.govplease include your FURLS account ID Small manufacturers can contact smallbiz.tobacco@fda.hhs.gov; please include your FURLS account ID CTP will have staff available to assist you with your questions ��20 ��View/Update Product Listings��18 ��Logging into FURLS��14