FDA Prior Notice Submission Form PDF Details

The U.S. Food and Drug Administration (FDA) places significant emphasis on the safety and regulation of food products entering the United States, imposing specific requirements on foreign facilities that manage food for human or animal consumption. A crucial component of these regulations is the FDA Prior Notice Submission form, a requisite step for all applicable food shipments. This form serves as a notification to the FDA, detailing critical information about food products being shipped to the U.S. It is mandatory for foreign manufacturers, processors, packagers, or holders of food intended for consumption in the U.S. to register with the FDA and submit prior notice for their shipments. Additionally, the form is required for certain food shipments that transit through the U.S. The submission includes comprehensive data elements like the FedEx Airway Bill Number, shipment date, detailed submitter and shipper information, importer or ultimate consignee details, and extensive commodity information for each food item in the shipment. Notably, the form requires identification numbers, product codes (if applicable), and specific details about the food item's country of production, manufacturer, and packaging types. FedEx offers a service to transmit the Prior Notice on behalf of shippers, simplifying the process. Important to note, all food shipments, irrespective of their value, must be accompanied by a commercial invoice, ensuring compliance with FDA regulations.

QuestionAnswer
Form Name FDA Prior Notice Submission Form
Form Length 2 pages
Fillable? No
Fillable fields 0
Avg. time to fill out 30 sec
Other names fedex fda notice form, fedex fda prior notice form, fda prior notice fedex, required prior

Form Preview Example

Data Elements Required for FDA Prior Notice Submission

The U.S. Food and Drug Administration (FDA) regulations require that:

1.All foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States register with the FDA.

2.Prior notice is submitted to FDA for shipments of food for human or animal consumption in the United States, and for certain shipments transiting the U.S.A.

If you would like FedEx to transmit the Prior Notice on your behalf, please provide the following data elements, on your shipment documentation or on this form. If you have already filed the FDA Prior Notice, provide the Prior Notice Confirmation No(s) for each food product on your shipment documentation.

FedEx AWB No.

Date of Shipment

 

 

Submitter/Shipper – person providing this information

Company Name

Name

 

 

Address

Title

 

 

 

Email

 

 

Country of Export

Phone No.

 

 

*Registration Number

Fax No.

 

 

Importer/Ultimate Consignee

Company Name

Name

 

 

Address

Title

 

 

 

Phone No.

 

 

 

Fax No.

 

 

Commodity Information – provide the following for EACH food item in the shipment

Item

Description (Food Item Common, Usual or Market Name)

HTS Code (if available)

 

Lot/Code # (if applicable)

 

 

 

Quantity

 

Unit of Measure

 

 

 

Product Code (if available)

 

Country of Production

 

 

 

Type

 

*Manufacturer Registration Number (if applicable)

Grower

Manufacturer

 

Name

 

Type of packaging

 

 

 

Address

 

 

 

 

 

*Not required for shipments transiting the U.S.A.

All food shipments, regardless of value, require a commercial invoice.

FDA Prior Notice Submission, Continuation Page

FedEx AWB No.

Date of Shipment

 

 

Item

Description (Food Item Common, Usual or Market Name)

HTS Code (if available)

 

Lot/Code # (if applicable)

 

 

 

Quantity

 

Unit of Measure

 

 

 

Product Code (if available)

 

Country of Production

 

 

 

Type

 

*Manufacturer Registration Number (if applicable)

Grower

Manufacturer

 

Name

 

Type of packaging

 

 

 

Address

 

 

 

 

 

Item

Description (Food Item Common, Usual or Market Name)

HTS Code (if available)

 

Lot/Code # (if applicable)

 

 

 

Quantity

 

Unit of Measure

 

 

 

Product Code (if available)

 

Country of Production

 

 

 

Type

 

*Manufacturer Registration Number (if applicable)

Grower

Manufacturer

 

Name

 

Type of packaging

 

 

 

Address

 

 

 

 

 

Item

Description (Food Item Common, Usual or Market Name)

HTS Code (if available)

 

Lot/Code # (if applicable)

 

 

 

Quantity

 

Unit of Measure

 

 

 

Product Code (if available)

 

Country of Production

 

 

 

Type

 

*Manufacturer Registration Number (if applicable)

Grower

Manufacturer

 

Name

 

Type of packaging

 

 

 

Address

 

 

 

 

 

*Not required for shipments transiting the U.S.A.

All food shipments, regardless of value, require a commercial invoice.

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This document will require particular data to be typed in, so ensure that you take the time to provide what's required:

1. To start with, when filling out the prior notice form, beging with the part that includes the next blank fields:

Step number 1 for filling out prior notice submission

2. Just after this part is completed, go on to enter the relevant information in all these - Commodity Information cid provide, LotCode if applicable Unit of, Grower, Manufacturer, Name Address, Not required for shipments, and All food shipments regardless of.

Part number 2 of filling in prior notice submission

3. This stage is normally easy - complete all the blanks in FedEx AWB No Item Description Food, Grower, Manufacturer, Name Address Item Description Food, Date of Shipment, LotCode if applicable Unit of, and LotCode if applicable Unit of to conclude this part.

prior notice submission completion process described (part 3)

When it comes to FedEx AWB No Item Description Food and Date of Shipment, make sure you get them right in this current part. Both these are the most significant ones in this file.

4. This next section requires some additional information. Ensure you complete all the necessary fields - Name Address Item Description Food, Grower, Manufacturer, Name Address Item Description Food, Grower, Manufacturer, Name Address, LotCode if applicable Unit of, and LotCode if applicable Unit of - to proceed further in your process!

Part no. 4 of filling in prior notice submission

Step 3: Right after rereading your fields you have filled in, hit "Done" and you're good to go! After registering a7-day free trial account with us, you will be able to download prior notice form or send it via email immediately. The form will also be readily available through your personal account page with your every edit. When you work with FormsPal, you can certainly fill out forms without worrying about database breaches or entries being distributed. Our protected software helps to ensure that your personal details are kept safely.

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