[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR1.281]



[Page 28-32]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents

 

                 Subpart I_Prior Notice of Imported Food

 

Sec.  1.281  What information must be in a prior notice?



    (a) General. For each article of food that is imported or offered 

for import into the United States, except by international mail, you 

must submit the information for the article that is required in this 

paragraph.

    (1) The name of the individual submitting the prior notice and his/

her business address, and phone number, fax number, and e-mail address, 

and the name and address of the submitting firm, if applicable. If a 

registration number is provided, city and country may be provided 

instead of the full address;

    (2) If different from the submitter, the name of the individual and 

firm, if applicable, transmitting the prior notice on behalf of the 

submitter and his/her business address, and phone number, fax number, 

and e-mail address. If a registration number is provided, city and 

country may be provided instead of the full address;

    (3) The entry type;

    (4) The CBP entry identifier (e.g., CBP entry number or in-bond 

number), if available;

    (5) The identity of the article of food being imported or offered 

for import, as follows:

    (i) The complete FDA product code;

    (ii) The common or usual name or market name;

    (iii) The estimated quantity of food that will be shipped, described 

from largest container to smallest package size; and

    (iv) The lot or code numbers or other identifier of the food if 

required by the act or FDA regulations, e.g., low acid canned foods, by 

21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant 

formula, by 21 CFR 106.90;

    (6) For an article of food that is no longer in its natural state, 

the name and address of the manufacturer and the registration number 

assigned to the facility that is associated with the article of food. A 

registration number is not required for a facility associated with an 

article of food if the article is imported or offered for import for 

transshipment, storage and export, or further manipulation and export. 

If the article of food is sent by an individual as a personal gift 

(i.e., for nonbusiness



[[Page 29]]



reasons) to an individual in the United States, you may provide the name 

and address of the firm that appears on the label under 21 CFR 101.5 

instead of the name, address, and registration number of the 

manufacturer. If a registration number is provided, city and country may 

be provided instead of the full address;

    (7) For an article of food that is in its natural state, the name 

and growing location address of the grower, if known. If the submitter 

does not know the identity of the grower or, if the article has been 

consolidated and the submitter does not know the identity of any of the 

growers, you may provide the name and address of the firm that has 

consolidated the articles of food from different growers or different 

growing locations;

    (8) The FDA Country of Production;

    (9) The name and address of the shipper and, if the shipper is 

required to register under 21 CFR part 1, subpart H, the registration 

number assigned to the shipper's facility that is associated with the 

article of food. A registration number is not required for a facility 

associated with an article of food if the article is imported or offered 

for import for transshipment, storage and export, or further 

manipulation and export. If a registration number is provided, city and 

country may be provided instead of the full address;

    (10) The country from which the article is shipped;

    (11) Anticipated arrival information about the article of food being 

imported or offered for import, as follows:

    (i) The anticipated port of arrival and, if the anticipated port of 

arrival has more than one border crossing, the specific anticipated 

border crossing where the food will be brought into the United States;

    (ii) The anticipated date on which the article of food will arrive 

at the anticipated port of arrival; and

    (iii) The anticipated time of that arrival;

    (12) The name and address of the importer. If a registration number 

is provided, city and country may be provided instead of the full 

address. The identity of the importer is not required for an article of 

food that is imported or offered for import for transshipment through 

the United States under a Transportation and Exportation entry;

    (13) The name and address of the owner if different from the 

importer or ultimate consignee. If a registration number is provided, 

city and country may be provided instead of the full address. The 

identity of the owner is not required for an article of food that is 

imported or offered for import for transshipment through the United 

States under a Transportation and Exportation entry;

    (14) The name and address of the ultimate consignee. If a 

registration number is provided, city and country may be provided 

instead of the full address. The identity of the ultimate consignee is 

not required for an article of food that is imported or offered for 

import for transshipment through the United States under a 

Transportation and Exportation entry;

    (15) The mode of transportation;

    (16) The Standard Carrier Abbreviation Code (SCAC) or International 

Air Transportation Association (IATA) code of the carrier which is, or 

will be, carrying the article of food from the country from which the 

article is shipped to the United States, or if codes are not applicable, 

then the name and country of the carrier;

    (17) Planned shipment information, as applicable:

    (i) The Airway Bill number(s) or Bill of Lading number(s). This 

information is not required for an article of food when carried by or 

otherwise accompanying an individual when entering the United States;

    (ii) For food arriving by ocean vessel, the vessel name and voyage 

number;

    (iii) For food arriving by air carrier, the flight number;

    (iv) For food arriving by truck, bus, or rail, the trip number;

    (v) For food arriving as containerized cargo by water, air, or land, 

the container number(s). This information is not required for an article 

of food when carried by or otherwise accompanying an individual when 

entering the United States;

    (vi) For food arriving by rail, the car number. This information is 

not required for an article of food when carried by or otherwise 

accompanying an individual;



[[Page 30]]



    (vii) For food arriving by privately owned vehicle, the license 

plate number and State or province; and

    (viii) The 6-digit Harmonized Tariff Schedule (HTS) code.

    (b) Articles arriving by international mail. For each article of 

food that is imported or offered for import into the United States by 

international mail, you must submit the information for the article that 

is required in this paragraph.

    (1) The name of the individual submitting the prior notice and his/

her business address, and phone number, fax number, and e-mail address, 

and the name and address of the submitting firm, if applicable. If a 

registration number is provided, city and country may be provided 

instead of the full address;

    (2) If different from the submitter, the name of the individual and 

firm, if applicable, transmitting the prior notice on behalf of the 

submitter and his/her business address and phone number, fax number, and 

e-mail address. If a registration number is provided, city and country 

may be provided instead of the full address;

    (3) The entry type (which will be a mail entry);

    (4) The identity of the article of food being imported or offered 

for import, as follows:

    (i) The complete FDA product code;

    (ii) The common or usual name or market name;

    (iii) The estimated quantity of food that will be shipped, described 

from largest container to smallest package size; and

    (iv) The lot or code numbers or other identifier of the food if 

required by the act or FDA regulations, e.g., low acid canned foods, by 

21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant 

formula, 21 CFR 106.90;

    (5) For an article of food that is no longer in its natural state, 

the name and address of the manufacturer and the registration number 

assigned to the facility that is associated with the article of food. A 

registration number is not required for a facility associated with an 

article of food if the article is imported or offered for import for 

transshipment, storage and export, or further manipulation and export. 

If the article of food is sent by an individual as a personal gift 

(i.e., for non-business reasons) to an individual in the United States, 

you may provide the name and address of the firm that appears on the 

label under 21 CFR 101.5 instead of the name, address, and registration 

number of the manufacturer. If a registration number is provided, city 

and country may be provided instead of the full address;

    (6) For an article of food that is in its natural state, the name 

and growing location address of the grower, if known. If the submitter 

does not know the identity of the grower or, if the article has been 

consolidated and the submitter does not know the identity of any of the 

growers, you may provide the name and address of the firm that has 

consolidated the articles of food from different growers or different 

growing locations;

    (7) The FDA Country of Production;

    (8) The name and address of the shipper and, if the shipper is 

required to register under 21 CFR part 1, subpart H, the registration 

number assigned to the shipper's facility that is associated with the 

article of food. A registration number is not required for a facility 

associated with an article of food if the article is imported or offered 

for import for transshipment, storage and export, or further 

manipulation and export. If a registration number is provided, city and 

country may be provided instead of the full address;

    (9) The country from which the article is shipped (i.e., mailed);

    (10) The anticipated date of mailing; and

    (11) The name and address of the U.S. recipient.

    (c) Refused articles. If the article of food has been refused under 

section 801(m)(1) of the act and this subpart, you must submit the 

information for the article that is required in this paragraph. However, 

if the refusal is based on Sec.  1.283(a)(1)(iii) (Untimely Prior 

Notice), you do not have to re-submit any information previously 

submitted unless it has changed or the article has been exported and the 

original prior notice was submitted through ABI/ACS. If the refusal is 

based on Sec.  1.283(a)(1)(ii), you should cancel the



[[Page 31]]



previous submission per Sec.  1.282(b) and (c).

    (1) The name of the individual submitting the prior notice and his/

her business address, and phone number, fax number, and e-mail address, 

and the name and address of the submitting firm, if applicable. If a 

registration number is provided, city and country may be provided 

instead of the full address;

    (2) If different from the submitter, the name of the individual and 

firm, if applicable, transmitting the prior notice on behalf of the 

submitter and his/her business address, and phone number, fax number, 

and e-mail address. If the registration number is provided, city and 

country may be provided instead of the full address;

    (3) The entry type;

    (4) The CBP entry identifier (e.g., CBP entry number or in-bond 

number), if available;

    (5) The identity of the article of food being imported or offered 

for import, as follows:

    (i) The complete FDA product code;

    (ii) The common or usual name or market name;

    (iii) The quantity of food that was shipped, described from largest 

container to smallest package size; and

    (iv) The lot or code numbers or other identifier of the food if 

required by the act or FDA regulations, e.g., low acid canned foods, by 

21 CFR 113.60(c); acidified foods, by 21 CFR 114.80(b); and infant 

formula, by 21 CFR 106.90;

    (6) For an article of food that is no longer in its natural state, 

the name and address of the manufacturer and the registration number 

assigned to the facility that is associated with the article of food. A 

registration number is not required for a facility associated with an 

article of food if the article is imported or offered for import for 

transshipment, storage and export, or further manipulation and export. 

If the article of food is sent by an individual as a personal gift 

(i.e., for non-business reasons) to an individual in the United States, 

you may provide the name and address of the firm that appears on the 

label under 21 CFR 101.5 instead of the name, address, and registration 

number of the manufacturer. If a registration number is provided, city 

and country may be provided instead of the full address;

    (7) For an article of food that is in its natural state, the name 

and growing location address of the grower, if known. If the submitter 

does not know the identity of the grower or, if the article has been 

consolidated and the submitter does not know any of the growers, you may 

provide the name and address of the firm that has consolidated the 

articles of food from different growers or different growing locations;

    (8) The FDA Country of Production;

    (9) The name and address of the shipper and, if the shipper is 

required to register under 21 CFR part 1, subpart H, the registration 

number assigned to the shipper's facility that is associated with the 

article of food. A registration number is not required for a facility 

associated with an article of food if the article is imported or offered 

for import for transshipment, storage and export, or further 

manipulation and export. If a registration number is provided, city and 

country may be provided instead of the full address;

    (10) The country from which the article is shipped;

    (11) The port of arrival;

    (12) The name and address of the importer. If a registration number 

is provided, city and country may be provided instead of the full 

address. The identity of the importer is not required for an article of 

food that is imported or offered for import for transshipment through 

the United States under a Transportation and Exportation entry;

    (13) The name and address of the owner, if different from the 

importer or ultimate consignee. If a registration number is provided, 

city and country may be provided instead of the full address. The 

identity of the importer is not required for an article of food that is 

imported or offered for import for transshipment through the United 

States under a Transportation and Exportation entry;

    (14) The name and address of the ultimate consignee. If a 

registration number is provided, city and country may be provided 

instead of the full address. The identity of the ultimate consignee is 

not required for an article of food that is imported or offered for 

import



[[Page 32]]



for transshipment through the United States under a Transportation and 

Exportation entry;

    (15) The mode of transportation;

    (16) The Standard Carrier Abbreviation Code (SCAC) or International 

Air Transportation Association (IATA) code of the carrier which carried 

the article of food from the country from which the article is shipped 

to the United States, or if codes are not applicable, then the name and 

country of the carrier;

    (17) Shipment information, as applicable:

    (i) The Airway Bill number(s) or Bill of Lading number(s); however, 

this information is not required for an article of food when carried by 

or otherwise accompanying an individual when entering the United States;

    (ii) For food that arrived by ocean vessel, the vessel name and 

voyage number;

    (iii) For food that arrived by air carrier, the flight number;

    (iv) For food that arrived by truck, bus, or rail, the trip number;

    (v) For food that arrived as containerized cargo by water, air, or 

land, the container number(s); however, this information is not required 

for an article of food when carried by or otherwise accompanying an 

individual when entering the United States;

    (vi) For food that arrived by rail, the car number; however, this 

information is not required for an article of food when carried by or 

otherwise accompanying an individual;

    (vii) For food that arrived by privately owned vehicle, the license 

plate number and State or province;

    (viii) The 6-digit HTS code; and

    (18) The location and address where the article of refused food will 

be or is being held, the date the article has arrived or will arrive at 

that location, and identification of a contact at that location.



[68 FR 59070, Oct. 10, 2003; 69 FR 4851, Feb. 2, 2004]