21 CFR 1.280 - How must you submit prior notice?

Status message

There are 10 Updates appearing in the Federal Register for 21 CFR Part 1. View below or at eCFR (GPOAccess)
§ 1.280 How must you submit prior notice?
(a) You must submit the prior notice electronically to FDA. You must submit all prior notice information in the English language, except that an individual's name, the name of a company, and the name of a street may be submitted in a foreign language. All information, including the items listed in the previous sentence, must be submitted using the Latin (Roman) alphabet. Unless paragraph (c) of this section applies, you must submit prior notice through:
(1) The U.S. Customs and Border Protection (CBP) Automated Broker Interface of the Automated Commercial System (ABI/ACS); or
(2) The FDA PNSI at http://www.access.fda.gov. You must submit prior notice through the FDA Prior Notice System Interface (FDA PNSI) for articles of food imported or offered for import by international mail, and other transaction types that cannot be made through ABI/ACS. Prior notice for articles that have been refused under section 801(m)(1) of the act and under this subpart must be submitted through the FDA PNSI until such time as FDA and CBP issue a determination that ACS or its successor system can accommodate such transactions.
(b) If a customhouse broker's or self-filer's system is not working or if the ABI/ACS interface is not working, prior notice must be submitted through the FDA PNSI.
(c) If FDA determines that FDA PNSI or the Operational and Administration System for Import Support (OASIS) is not working, FDA will post prominent notification and instructions at http://www.fda.gov. FDA will accept prior notice submissions in the format it deems appropriate during the system(s) outage.

Title 21 published on .

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

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 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