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U.S. Department of Health and Human Services

Food

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Guidance for Industry: Entry Types and Entry Identifiers; Prior Notice of Imported Food

Contains Nonbinding Recommendations

April 7, 2005

Comments and suggestions regarding this guidance may be submitted at any time. For questions regarding this document, contact:

Ted Poplawski, Office of Regulatory Affairs (HFC-170), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-6553.

For single copies of this guidance, please contact
Prior Notice Help Desk
Phone: 1-800-216-7331 or 301-575-0156
Fax: 301-210-0247
E-mail: furls@fda.gov at
http://www.cfsan.fda.gov/guidance.html

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Office of Regulatory Affairs
April 7, 2005


Contains Nonbinding Recommendations

Guidance for Industry
Entry Types and Entry Identifier

This guidance document represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternate approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, please contact:
Ted Poplawski, Office of Regulatory Affairs (HFC-170), Office of Regional Operations, FDA, 5600 Fishers Lane, Rockville, MD 20857, 301-443-6553

 I. INTRODUCTION

On October 10, 2003, the Food and Drug Administration (FDA) published an interim final rule (IFR) in the Federal Register requiring submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States (68 FR 58974). This guidance is being issued to help the food industry comply with the legal requirements established by the prior notice IFR. The entry types and entry identifiers listed in the chart below apply to prior notice submitted via the U.S. Customs and Border Protection's (CBP's) Automated Broker Interface of the Automated Commercial System (ABI/ACS) and via FDA's Prior Notice System Interface (PNSI). This information is required in §§ 1.281(a)(b) & (c) (3) and §§ 1.281(a) & (c) (4) of the IFR. FDA is providing this guidance to assist those submitting prior notice of imported food shipments in determining which entry types are associated with which entry identifiers

II. GUIDANCE

This chart provides the acceptable relationships between Entry Types and Entry Identifiers. In those instances where "not applicable" is listed, prior notice can not be submitted through that system. For example, prior notice covered by an Informal Entry Type can be submitted through ABI/ACS or PNSI but not the mini-ABI (WP) system.

ENTRY TYPEENTRY IDENTIFIERS
ACS/ABImini-ABI (WP)PNSI
ConsumptionEntry NumberEntry NumberEntry number or system-generated number
Mail (Commercial)Entry numbernot applicableSystem generated number
Mail (Non-commercial Sender)not applicablenot applicableSystem generated number
InformalEntry Numbernot applicableEntry number or system generated number
Express Couriernot applicablenot applicableCourier-assigned tracking number
BaggageEntry numbernot applicableSystem generated number
WarehouseEntry numbernot applicableEntry number or system generated number
Foreign Trade Zonenot applicableFTZ NumberFTZ number or system generated number
Immediate Transportationnot applicableIn-Bond NumberIn-Bond number or system generated number
Temporary Importation Bondnot applicableIn-Bond NumberIn-Bond number or system generated number
Transportation & Exportationnot applicableIn-Bond NumberIn-Bond number or system generated number