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.

Questions?

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.

Prior Notice Help Desk
Phone: 1-800-216-7331 or 301-575-0156
Fax: 301-210-0247
E-mail: [email protected]

---

Related Information

• Food Defense Guidance Documents & Regulatory Information