Entry Type 11 Prior Notice FDA Requirements and Compliance Guidelines

1. Entry Type 11 Prior Notice FDA Requirements and Compliance Guidelines Entry Type 11 refers to a specific classification used in the FDA prior notice system for imported foods. This entry type is important because it helps identify how the import shipment will be processed and reviewed by customs and the FDA. For shipments requiring Entry Type 11, prior notice must be submitted to the FDA with detailed information about the food products before they arrive in the United States to ensure compliance and expedite entry clearance.Prior notice submission includes providing the correct entry type, product identity, packaging information, and a Customs and Border Protection (CBP) entry identifier when available. This process falls under strict regulatory requirements designed to protect the food supply chain and prevent potential risks. Understanding Entry Type 11 is essential for importers and brokers handling FDA- regulated products to avoid delays and penalties.By accurately completing the prior notice for Entry Type 11, importers enable smoother communication between customs and FDA, ensuring the shipment meets all health and safety standards. This reduces inspections, speeds up processing, and supports compliance with federal laws governing imported foods. Understanding Entry Type 11 and Prior Notice FDA Entry Type 11 refers to a specific customs entry category used in importing goods into the United States. Prior Notice is a required FDA notification submitted before food shipments arrive, ensuring regulatory compliance. Both play essential roles in the import process, focusing on proper documentation and timing. Definition of Entry Type 11 Entry Type 11 is an official customs classification for goods requiring formal entry processing. It is typically used for commercial shipments that need detailed customs examination and clearance.This entry type demands submission through authorized systems like ABI/ACS or the Prior Notice System Interface (PNSI). Unlike informal entries, Entry Type 11 supports submitting Prior Notice to the FDA electronically, ensuring timely updates on inbound food shipments.Entry Type 11 allows importers to accurately declare shipment details, ensuring regulatory agencies receive comprehensive information for risk assessment and clearance decisions. Purpose of Prior Notice FDA Prior Notice FDA is a mandatory alert submitted to the FDA before food products enter U.S. borders. Its purpose is to provide advance information on shipment contents, entry points, and expected arrival times.This process helps the FDA evaluate potential risks related to food safety, prevent contaminated or unauthorized food from entering the supply chain, and coordinate inspections efficiently.Importers or their agents must supply 1/3

2. details such as product identity, quantity, and shipment route. Timely submission of Prior Notice directly impacts customs clearance speed and helps avoid delays or refusals at the port of entry. Regulatory Background The FDA's Prior Notice requirement stems from the Bioterrorism Act of 2002, specifically codified under Title 21 CFR Part 1, Subpart I. This regulation mandates advance notification for all food imports, covering both human and animal food products.Entry Type 11's use is integrated into these regulations, providing a formal mechanism to submit Prior Notice documentation along with customs entries. The FDA collaborates with U.S. Customs and Border Protection to enforce these rules.Failure to submit Prior Notice properly can result in administrative penalties, shipment holds, or refusal of entry. Compliance with these regulations supports food safety objectives and ensures smoother import processes. Practical Guide to Filing Entry Type 11 with the FDA Entry Type 11 is used for formal entries involving merchandise valued over $2,500 that requires FDA prior notice. Filing this type correctly ensures smooth customs clearance and compliance with FDA regulations. Step-by-Step Filing Process The process begins by gathering all necessary shipment details, including product description, manufacturer, and anticipated arrival time. The filer must submit prior notice through the FDA’s Prior Notice System Interface (PNSI) before the goods reach U.S. ports.Entry Type 11 filings are typically done through the Automated Commercial Environment (ACE) or Automated Broker Interface (ABI). The broker or importer inputs the data, including the prior notice number and FDA product codes. Submission deadlines require prior notice to be sent at least two hours before arrival by land, four hours by air or rail, and eight hours by sea.Verification at the port follows, where FDA inspects documentation. Approval allows customs clearance, while rejections require prompt resolution or possible shipment rejection. Common Challenges and Solutions Timing is critical. Missing FDA prior notice deadlines often causes shipment delays or refusal. To prevent this, submit prior notice early and confirm receipt through the FDA system.Incorrect or incomplete data, especially on product description or quantities, commonly causes filing errors. Using checklists and validated product codes helps reduce mistakes. Importers can rely on customs brokers with FDA experience for accurate submissions.Communication gaps between brokers, importers, and carriers may cause missing or inaccurate updates. Setting up automated notifications and consistent follow- ups resolves these issues. 2/3

3. Required Documentation Key documents include the prior notice confirmation number, commercial invoice, bill of lading, and the FDA product code. Entry Type 11 also requires the Harmonized Tariff Schedule (HTS) codes and country of origin information.The prior notice must identify all FDA-regulated foods in the shipment. The submitter should gather data about manufacturer, shipper, and consignee, alongside details on the shipment’s point of origin and arrival.Maintaining these documents helps meet FDA requisites and avoids regulatory delays during customs processing. 3/3