Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

OMB 0910-0520

Section 801(m) of the Federal Food Drug and Cosmetic Act (21 U.S.C.381(m) requires that FDA receive prior notice for food, including food for animals, that is imported or offered for import into the United States. This information collection supports the requirements for submitting prior notice under agency regulations. Advance notice of imported food allows FDA, with the support of the Bureau of Customs and Border Protection (CBP), to target import inspections more effectively and help protect the nations' food supply against terrorist acts and other public health emergencies. Respondents to this collection are manufacturers, packers, and distributors of food products.

The latest form for Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 expires 2023-08-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form Form FDA 3540 Prior Notice Submitted through ABI/ACS Form and Instruction
Form Form FDA 3540 Prior Notice Requests for Review & Post-Hold Submissions Form and Instruction
Form Form FDA 3540 Prior Notice Requests for Review & Post-Hold Submissions Form and Instruction
Form Form FDA 3540 Prior Notice Cancelled through PN Systen Interface Form and Instruction
Form Form FDA 3540 Prior Notice Cancelled through the ABI/ACS Form and Instruction
Form Form FDA 3540 Prior Notice Submitted through The PN System Interface Form and Instruction
0520_Supporting Statement_2023.docx Supporting Statement A
Prior Notice Submitted through ABI/ACS Form and Instruction
Prior Notice Requests for Review & Post-Hold Submissions Form and Instruction
Prior Notice Requests for Review & Post-Hold Submissions Form and Instruction
Prior Notice Cancelled through PN Systen Interface Form and Instruction
Prior Notice Cancelled through the ABI/ACS Form and Instruction
Prior Notice Submitted through The PN System Interface Form and Instruction

All Historical Document Collections

202301-0910-015 Approved without change	Extension without change of a currently approved collection	2023-08-08
202007-0910-006 Approved without change	Extension without change of a currently approved collection	2020-07-13
201705-0910-003 Approved without change	Extension without change of a currently approved collection	2017-06-16
201312-0910-013 Approved with change	Revision of a currently approved collection	2013-12-30
201005-0910-017 Approved with change	Extension without change of a currently approved collection	2010-05-28
200701-0910-002 Approved without change	Extension without change of a currently approved collection	2007-01-12
200310-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	2003-10-03

OMB Details

Prior Notice Submitted through ABI/ACS

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form Form FDA 3540

Prior Notice of Imported Foods

Fillable Fileable

Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.