Notice2022-16062
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facilities
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) 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.
Full Text
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<title>Federal Register, Volume 87 Issue 143 (Wednesday, July 27, 2022)</title>
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[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45112-45113]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-16062]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1302]
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 or we) 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 August 26, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
<a href="/cdn-cgi/l/email-protection#045456455770656262446260652a6c6c772a636b72"><span class="__cf_email__" data-cfemail="306062716344515656705654511e5858431e575f46">[email protected]</span></a>.
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
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188) 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 1.230 to 1.235) 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.
Advance notice of imported food allows FDA, with the support of the
Bureau of 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 21 CFR 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 <a href="https://www.access.fda.gov">https://www.access.fda.gov</a>. Registrations, updates, and cancellations are
required to be 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.
In the Federal Register of January 13, 2022 (87 FR 2159), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
[[Page 45113]]
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
respondents respondent responses response
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New domestic facility 9,795 1 9,795 2.7 26,447
registration; 1.230-1.233......
New foreign facility 13,697 1 13,697 8.7 119,164
registration; 1.230-1.233......
Updates; 1.234.................. 53,836 1 53,836 1.2 64,603
Cancellations; 1.235............ 6,390 1 6,390 1 6,390
Biennial renewals; 1.235........ 97,883 1 97,883 0.38 37,196
3rd party registration 41,256 1 41,256 0.25 10,314
verification...................
U.S. Agent verification......... 57,070 1 57,070 0.25 14,268
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Total....................... .............. .............. 279,927 .............. 278,382
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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 made no adjustments to our burden
estimate.
Dated: July 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16062 Filed 7-26-22; 8:45 am]
BILLING CODE 4164-01-P
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