Form FDA 3540 Form FDA 3540 Prior Notice of Imported Foods

Importing Food Products into the United States > OMB Burden Statement FDA Form 3540 Page 1 of 1

OMB Burden Statement FDA Form
3540
*Public reporting burden for this collection of information is estimated to take one hour each time
an import entry is submitted on form 3540. An import entry, on average, constitutes 2.6 different
articles of food; with a prior notice submitted for each article. Therefore we estimate that submitting
prior notice for each article of food will take 23 mintues to complete, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
Send comments regarding this burden estimate or another aspect of this collection of information,
including suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Paperwork Reduction Act Office
Director, JonnaLynn Capezutto
8455 Colesville Road, Room 14526
Silver Spring, MD 20910
[email protected] (mailto:[email protected])
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid Office of Management and Budget (OMB) control
number.

More in Importing Food Products into the United States
(/Food/GuidanceRegulation/ImportsExports/Importing/default.htm)
Prior Notice of Imported Foods
(/Food/GuidanceRegulation/ImportsExports/Importing/ucm2006836.htm)
Filing Prior Notice (/Food/GuidanceRegulation/ImportsExports/Importing/ucm2006837.htm)
Historical Information about Prior Notice
(/Food/GuidanceRegulation/ImportsExports/Importing/ucm153853.htm)

https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm151675.htm

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FDA Industry Systems

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¡ Check System Status (http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm161883.htm)

FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other
notifications. FIS has been available 24 hours a day, seven days a week, since October 16, 2003 6:00 p.m. EDT.

j Log-In (https://www.access.fda.gov/oaa/logonFlow.htm?execution=e2s1)

+ Create Account (https://www.access.fda.gov/oaa/createNewAccountflow.htm?execution=e2s1)

FIS was created, in part, in response to the Bioterrorism Act of 2002 (http://www.fda.gov/regulatoryinformation/legislation/ucm148797.htm), which gave high priority
to improved information management to help protect the food supply. The Act requires that FDA develop two systems: one to support the registration of facilities that
manufacture, process, pack, or hold food products intended for consumption in the United States and one to receive prior notice before food is imported or offered for import
into the United States. Under the law, facilities must be registered by December 12, 2003 when Prior Notice went into effect.

Systems Index
FURLS Acidified/Low Acid Canned Foods
(LACF)
Form 2541/2541d/2541e/2541f/2541g
OMB Approval Number 0910-0037
OMB Expiration Date 09/30/2017
See OMB Burden Statement
(http://www.fda.gov/Food/GuidanceRegulation
/FoodFacilityRegistration/AcidifiedLACFRegis
tration/ucm151742.htm)

FURLS Biologics Export Certification
Application & Tracking System (BECATS)
FDA 3613
OMB Approval Number 0910-0498
OMB Expiration Date 03/31/2018
See OMB Burden

FURLS Dairy Listing Module (DLM)
FDA 3972
OMB Approval Number 0910-0509
OMB Expiration Date 09/30/2017
See OMB Burden

Info (http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/BiologicsImport
Help (http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Complianc
Info (http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/E
Help (http://www.fda.gov/Food/GuidanceR

Info (http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/default.htm)
Help (http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/default.htm)

FURLS CDER Export Certification Application
& Tracking System (CDEReCATS)
FDA 3613
OMB Approval Number 0910-0498
OMB Expiration Date 03/31/2018
See OMB Burden

FURLS CDRH Export Certification Application
& Tracking System (CECATS)

FURLS CFSAN Certificate Application
Process (CAP)

FDA 3613
OMB Approval Number 0910-0498
OMB Expiration Date 03/31/2018
See OMB Burden

FDA 3613d/3613e
OMB Approval Number 0910-0793
OMB Expiration Date 05/31/2018
See OMB Burden

FURLS Device Registration & Listing Module
(DRLM)
Form 3673(03/08)
OMB Approval Number 0910-0625
OMB Expiration Date 06/30/2019
See OMB Burden Statement
(http://www.fda.gov/MedicalDevices/DeviceRe
gulationandGuidance/HowtoMarketYourDevic
e/RegistrationandListing/default.htm)

FURLS Food Facility Registration
Module (FFRM)
Form 3537/3537a
OMB Approval Number 0910-0502
OMB Expiration Date 08/31/2019
See OMB Burden Statement
(http://www.fda.gov/Food/GuidanceRegulation
/FoodFacilityRegistration/ucm151633.htm)

FURLS New Dietary Ingredient Notification
(NDIN) (Dietary Supplements)
Form 3880
OMB Approval Number 0910-0330
OMB Expiration Date 03/31/2018
See OMB Burden Statement

FURLS Shell Egg Producer Registration
Module (SEPRM)
Form 3733
OMB Approval Number 0910-0660
OMB Expiration Date 08/31/2016
See OMB Burden Statement
(http://www.fda.gov/Food/GuidanceRegulation
/FoodFacilityRegistration/ShellEggProducerR
egistration/ucm210764.htm)

FURLS Structure/Function Claims Notification
(SFCN) (Dietary Supplements)
FDA TBA
OMB Approval Number 0910-0331
OMB Expiration Date 06/30/2019
See OMB Burden

Info (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ImportsandExportsCompliance/ucm496247.htm)
Help (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ImportsandExportsCompliance/UCM498232.pdf)
Info (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ucm050521.htm)
Help (https://www.access.fda.gov/cecats/help/CreateApplication.html)
Info (http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/E
Help (http://www.fda.gov/Food/GuidanceR

Info (http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegi
Help (http://www.fda.gov/downloads/Food

Info (http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006831.htm)
Help (http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm)
Info (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm)
Help (http://www.access.fda.gov/drlm/help/index.html)

FURLS Tobacco Registration and Product
Listing (TRLM)
FDA 3741
OMB Approval Number 0910-0650
OMB Expiration Date 01/31/2019
See OMB Burden

Info (http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/StructureFunctionClaimsProcess/default.htm)
Help (http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/StructureFunctionClaimsPro
Info (http://www.fda.gov/TobaccoProducts/GuidanceComplianceReg
Help (http://www.fda.gov/TobaccoProduc

Info (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Eggs/ucm170615.htm)
Help (http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ShellEggProducerRegistration/default.htm)

Prior Notice System Interface (PNSI)
Form 3540
OMB Approval Number 0910-0502
OMB Expiration Date 06/30/2017
See OMB Burden Statement
(http://www.fda.gov/Food/GuidanceRegulation
/ImportsExports/Importing/ucm151675.htm)
Info (http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm114217.htm)
Help (http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm2006837.htm)

Help Desk

https://www.access.fda.gov/

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FDA Industry Systems

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FDA Industry Systems / FDA Unified Registration and Listing Systems (FURLS) /
Technical Help
Electronic Submissions Gateway Approved Production Transaction Partners, Food Facility Registration Module,
Prior Notice, Low Acid & Acidified Canned Foods, and Account Management.
Phone: 1-800-216-7331 or 240-247-8804 7:30 a.m.-11:00 p.m. Eastern Time
Fax: 301-436-2804 or 1-866-573-0846
To e-mail questions about the Bioterrorism Act use this form
(http://www.accessdata.fda.gov/scripts/email/cfsan/bioterrorismact/helpf2.cfm)

Phone: 1-866-521-2297
The Prior Notice Center staff can answer questions
about Prior Notice policies, procedures, and
interpretations 24 hours a day, 7 days a week.

Electronic Submissions Gateway / PreProduction Help

Account Management Help (http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm073725.htm)

Electronic Submissions Gateway Help (http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm)

Effective January 14, 2004: The FDA Industry System Help Desk is available for technical assistance with online
registration and listing systems, Prior Notice, and regulated electronic submissions on U.S. Government
business days (Monday to Friday, excluding U.S. government holidays) from 7:30 a.m. to 11:00 p.m. Eastern
Time (see Federal Holidays (https://www.opm.gov/policy-data-oversight/snow-dismissalprocedures/federal-holidays/) and Federal Government Operating Status
(http://www.opm.gov/Operating_Status_Schedules/)).
You may leave a message or send e-mail at other times. These will be addressed on the next business day.

Additional Information

Prior Notice / Policy Help

If you want to become a trading partner, or have a
question about becoming a trading partner, for the
Electronic Submissions Gateway, please visit the
FDA Electronic Submissions Gateway
(http://www.fda.gov/ForIndustry/ElectronicSubmi
ssionsGateway/default.htm)

FURLS Tobacco Registration and
Product Listing (TRLM) Help
Email: [email protected]
The Registration and Listing staff can assist with
answering your questions about Tobacco
Registration and Product Listing.

System Requirements

1. Internet Access Internet access is widely available, including at public
libraries and Internet cafes.
• Voluntary Cosmetic Registration Program
2. Web Browser The following web browsers are supported by FURLS/PNSI
(http://www.fda.gov/cosmetics/registrationprogram/ucm2005171.htm)
applications.
• Blood Establishment Registration and Product Listing
FURLS
(http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/default.htm)
• Microsoft Internet Explorer (Version 11)
• Human Cell and Tissue Establishment Registration and Product Listing
• Mozilla Firefox 43.0 or newer
(http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/default.htm)
• Google Chrome 49.0 or newer (except TRLM)
• Drug Registration and Listing
PNSI
(http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm)
• Microsoft Internet Explorer (Version 9.0)
• Medical Device Registration and Listing for Firms
• Mozilla Firefox 45.0.1
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm)

FDA Registration, Listing, or Notification Programs

• Google Chrome 49.0 or newer

Other FDA Industry Information
• Information for FDA-Regulated Industry
(http://www.fda.gov/ForIndustry/default.htm)
• Information Materials for the Food and Cosmetics Industries
(http://www.fda.gov/Food/ResourcesForYou/Industry/default.htm)
• ORA Industry Assistance
(http://www.fda.gov/food/guidanceregulation/retailfoodprotection/industryandregulatoryassistanceandtrainingresources/default.htm)
• Small Business Guide to FDA
(http://www.fda.gov/ForIndustry/SmallBusinessAssistance/SmallBusinessGuidetoFDA/default.htm)
• Cosmetics - Information for Industry
(http://www.fda.gov/Cosmetics/ResourcesForYou/Industry/default.htm)
• Food Ingredients and Packaging - Information for Industry
(http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm)
• Over the Counter Drug Products - Industry Information
(http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/default.htm)
• Medical Devices and Radiation-Emitting Electronic Products
(http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm)
• Food Labeling and Nutrition - Information for Industry
(http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/default.htm)

https://www.access.fda.gov/

6/2/2017