[Federal Register Volume 90, Number 184 (Thursday, September 25, 2025)]
[Notices]
[Pages 46222-46223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-18616]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0373]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration of Food
Facilities
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by October 27, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0502. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Registration of Food Facilities
OMB Control Number 0910-0502--Extension
This information collection supports FDA regulations. The Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
(the Bioterrorism Act) amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act), to require, among other things, domestic and foreign
facilities that manufacture, process, pack, or hold food for human or
animal consumption in the United States to register with FDA. Sections
1.230 to 1.235 of our regulations (21 CFR part 1, subpart H) set forth
the requirements for the registration of food facilities. Information
provided to us under these regulations helps us to quickly notify the
facilities that might be affected by a deliberate or accidental
contamination of the food supply. In addition, data collected through
registration is used to support FDA enforcement activities and to
screen imported food shipments.
Advanced notice of imported food allows FDA, with the support of
U.S. Customs and Border Protection, to target import inspections more
effectively and help protect the nation's food supply against terrorist
acts and other public health emergencies. If a facility is not
registered or the registration for a facility is not updated when
necessary, we may not be able to contact the facility and may not be
able to target import inspections effectively in case of a known or
potential threat to the food supply or other food-related emergency,
putting consumers at risk of consuming hazardous food products that
could cause serious adverse health consequences or death.
To assist respondents of the information collection we developed
the following forms. Each facility that manufactures, processes, packs,
or holds food for human or animal consumption in the United States must
register with FDA using Form FDA 3537 entitled, ``Food Facility
Registration'' (Sec. 1.231), unless exempt under Sec. 1.226 from the
requirement to register. To cancel a registration, respondents must use
Form FDA 3537a entitled, ``Cancellation of Food Facility Registration''
(Sec. 1.235). The terms ``Form FDA 3537'' and ``Form FDA 3537a'' refer
to both the paper version of each form and the electronic system known
as the Food Facility Registration Module, which is available at https://www.access.fda.gov. Registrations, updates, and cancellations are
required to be submitted electronically. Domestic facilities are
required to register regardless of whether food from the facility
enters interstate commerce. Foreign facilities that manufacture,
process, pack, or hold food also are required to register unless food
from that facility undergoes further processing (including packaging)
by another foreign facility outside the United States. However, if the
further manufacturing/processing conducted by the subsequent facility
consists of adding labeling or any similar activity of a de minimis
nature, the former facility is required to register. In addition to the
initial registration requirements, a
[[Page 46223]]
facility is required to submit timely updates within 60 days of a
change to any required information on its registration form, using Form
FDA 3537 (Sec. 1.234), and to cancel its registration when the
facility ceases to operate or is sold to new owners or ceases to
manufacture, process, pack, or hold food for consumption in the United
States, using Form FDA 3537a (Sec. 1.235).
Registration is one of several tools under the Bioterrorism Act
that enables us to act quickly in responding to a threatened or actual
bioterrorist attack on the U.S. food supply or other food-related
emergency. Further, in the event of an outbreak of foodborne illness,
the information provided helps us determine the source and cause of the
event and enables us to quickly notify food facilities that might be
affected by an outbreak, terrorist attack, or other emergency. Finally,
the registration requirements enable us to quickly identify and remove
from commerce an article of food for which there is a reasonable
probability that the use of or exposure to such article of food will
cause serious adverse health consequences or death to humans or
animals.
Description of Respondents: Respondents to this collection of
information are 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.
In the Federal Register of June 27, 2025 (90 FR 27619), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although two comments were received, they
were not responsive to the four collection of information topics
solicited under 5 CFR 1320.8(d).
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity; 21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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New domestic facility 7,420 1 7,420 2.7 20,034
registration; 1.230-1.233......
New foreign facility 17,592 1 17,592 8.7 153,050
registration; 1.230-1.233......
Updates; 1.234.................. 124,001 1 124,001 1.2 148,801
Cancellations; 1.235............ 464 1 464 1 464
Biennial renewals; 1.235........ 89,182 1 89,182 0.38 33,889
3rd party registration 6,491 1 6,491 0.25 1,623
verification...................
U.S. Agent verification......... 15,655 1 15,655 0.25 3,914
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Total....................... .............. .............. 260,805 .............. 361,775
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18616 Filed 9-24-25; 8:45 am]
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