[Federal Register Volume 90, Number 122 (Friday, June 27, 2025)]
[Notices]
[Pages 27619-27621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11951]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-0373]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
the Agency's regulations that require registration for domestic and
foreign facilities that manufacture, process, pack, or hold food for
human or animal consumption in the United States.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 26, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 26, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your
[[Page 27620]]
comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-0373 for ``Agency Information Collection Activities; Proposed
Collection; Comment Request; Registration of Food Facilities.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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) 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
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submitted electronically. Domestic facilities are required to register
whether or not 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 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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Activity; 21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses 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.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11951 Filed 6-26-25; 8:45 am]
BILLING CODE 4164-01-P