Extension without change of a currently approved collection
No
Regular
09/30/2025
Requested
Previously Approved
36 Months From Approved
09/30/2025
260,805
279,927
361,775
278,382
0
0
Respondents to the information
collection are manufacturers, processors, holders, and distributors
of foods who must register with the agency. Through this
registration program and the information provided under the
regulations, the agency is able to identify firms in the event of
food-related emergencies as well as ensure that contaminated food
products are quickly and efficiently removed from the
marketplace.
Based on a review of the
information collection since our last request for OMB approval, we
have increased our burden estimate by 83,393 hours (from 278,382 to
361,775), although the number of responses decreased by 19,122
(from 279,927 to 260,805). Among other considerations, we attribute
this adjustment primarily due to a significant increase in the
number of foreign facility registrations and updates submitted
coupled with a drastic decrease in the number of cancellations and
third-party registration and U.S. Agent verifications
submitted.
$2,387,558
No
Yes
No
No
No
No
No
Domini Bean 301 796-5733
domini.bean@fda.hhs.gov
No
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.