21 CFR 1.279 - When must prior notice be submitted to FDA?

Status message

There are 2 Updates appearing in the Federal Register for 21 CFR 1. View below or at eCFR (GPOAccess)
§ 1.279 When must prior notice be submitted to FDA?
(a) Except as provided in paragraph (c) of this section, you must submit the prior notice to FDA and the prior notice submission must be confirmed by FDA for review as follows:
(1) If the article of food is arriving by land by road, no less than 2 hours before arriving at the port of arrival;
(2) If the article of food is arriving by land by rail, no less than 4 hours before arriving at the port of arrival;
(3) If the article of food is arriving by air, no less than 4 hours before arriving at the port of arrival; or
(4) If the article of food is arriving by water, no less than 8 hours before arriving at the port of arrival.
(b) Except in the case of an article of food imported or offered for import by international mail:
(1) If prior notice is submitted via Automated Broker Interface/Automated Commercial System (ABI/ACS), you may not submit prior notice more than 30-calendar days before the anticipated date of arrival.
(2) If prior notice is submitted via the FDA Prior Notice System Interface (FDA PNSI), you may not submit prior notice more than 15-calendar days before the anticipated date of arrival.
(c) Notwithstanding paragraphs (a) and (b) of this section, if the article of food is arriving by international mail, you must submit the prior notice before the article of food is sent to the United States.
(d) FDA will notify you that your prior notice has been confirmed for review with a reply message that contains a Prior Notice (PN) Confirmation Number. Your prior notice will be considered submitted and the prior notice time will start when FDA has confirmed your prior notice for review.
(e) The PN Confirmation Number must accompany any article of food arriving by international mail. The PN Confirmation Number must appear on the Customs Declaration (e.g., CN22 or CN23 or U.S. equivalent) that accompanies the package.
(f) A copy of the confirmation, including the PN Confirmation Number, must accompany any article of food that is subject to this subpart when it is carried by or otherwise accompanies an individual when arriving in the United States. The copy of the confirmation must be provided to U.S. Customs and Border Protection (CBP) or FDA upon arrival.
(g) The PN Confirmation Number must accompany any article of food for which the prior notice was submitted through the FDA PNSI when the article arrives in the United States and must be provided to CBP or FDA upon arrival.

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-05-29; vol. 79 # 103 - Thursday, May 29, 2014
    1. 79 FR 30716 - Administrative Detention of Drugs Intended for Human or Animal Use
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective June 30, 2014.
      21 CFR Parts 1 and 16

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 1 after this date.

  • 2014-10-23; vol. 79 # 205 - Thursday, October 23, 2014
    1. 79 FR 63346 - Food and Drug Administration Food Safety Modernization Act; Public Meeting
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of public meeting.
      See section II, “How to Participate in the Public Meeting,” in the SUPPLEMENTARY INFORMATION section of this document for the date and time of the public meeting, closing dates for advance registration, and information on deadlines for submitting either electronic or written comments to FDA's Division of Dockets Management.
      21 CFR Parts 1, 16, 112, 117, and 507