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.
This is a new information
collection. The ICR has been amended to include a revised
supporting statement reflecting a more detailed discussion of
changes to the agency's proposed final guidance, as well as to
include comparative documents highlighting where changes may be
found in the respective collection instruments since they were
issued in draft.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.