21 CFR 1.282 - What must you do if information changes after you have received confirmation of a prior notice from FDA?

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§ 1.282 What must you do if information changes after you have received confirmation of a prior notice from FDA?
(a)
(1) If any of the information required in § 1.281(a), except the information required in:
(i) Section 1.281(a)(5)(iii) (quantity),
(ii) Section 1.281(a)(11) (anticipated arrival information), or
(iii) Section 1.281(a)(17) (planned shipment information), changes after you receive notice that FDA has confirmed your prior notice submission for review, you must resubmit prior notice in accordance with this subpart unless the article of food will not be offered for import or imported into the United States.
(2) If any of the information required in § 1.281(b), except the information required in § 1.281(b)(10) (the anticipated date of mailing), changes after you receive notice that FDA has confirmed your prior notice submission for review, you must resubmit prior notice in accordance with this subpart, unless the article of food will not be offered for import or imported into the United States.
(b) If you submitted the prior notice via the FDA PNSI, you should cancel the prior notice via the FDA PNSI.
(c) If you submitted the prior notice via ABI/ACS, you should cancel the prior notice via ACS by requesting that CBP cancel the entry.

Title 21 published on 2013-04-01

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.

  • 2014-04-04; vol. 79 # 65 - Friday, April 4, 2014
    1. 79 FR 18799 - Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This final rule is effective April 4, 2014.
      21 CFR Part 1

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United States Code

Title 21 published on 2013-04-01

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

  • 2014-05-06; vol. 79 # 87 - Tuesday, May 6, 2014
    1. 79 FR 25758 - Administrative Destruction of Certain Drugs Refused Admission to the United States
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on the proposed rule by July 7, 2014.
      21 CFR Part 1