This ICR collects information from owners, operators or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States asserting that a facility is a “qualified facility” and, therefore, subject to modified requirements of the Preventive Controls for Human Food and the Preventive Controls for Animal Food Rules. FDA has developed Forms FDA 3942a and 3942b for respondents to submit information attesting to their “qualified facility” status. FDA has also developed a guidance to assist respondents with the qualified facility process.
The latest form for Quality Facility Attestation expires 2021-07-31 and can be found here.
Approved with change
|New collection (Request for a new OMB Control Number)||2018-06-13|
Federal Enterprise Architecture: Health - Consumer Health and Safety
|Form Form FDA 3942a||Qualified Facility Attestation for Human Food Facility||Fillable Fileable Signable||Form and instruction|
|Form Form FDA 3942a||Qualified Facility Attestation for Human Food Facility||Fillable Fileable||Form and instruction|
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.