[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45112-45113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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: 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, 
[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

    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 https://www.access.fda.gov. 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


