[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35393-35395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15636]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0065]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Registration of Food 
Facilities

AGENCY: Food and Drug Administration, HHS.

[[Page 35394]]


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: Fax written comments on the collection of information by August 
22, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 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

    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), which, among other things, requires 
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 notify quickly 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. Beginning in January 2020, registrations, updates, 
and cancellations will be 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 April 19, 2019 (84 FR 16519), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received offering general 
support for the information collection.
    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              FDA form        Number of     responses per   Total annual   Average burden per  response    Total hours
                                                No.\2\        respondents     respondent       responses
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New domestic facility registration; 1.230-            3537           9,795               1           9,795  2.7.........................          26,447
 1.233.
New foreign facility registration; 1.230-             3537          13,697               1          13,697  8.7.........................         119,164
 1.233.
Updates; 1.234............................            3537          53,836               1          53,836  1.2.........................          64,603
Cancellations; 1.235......................           3537a           6,390               1           6,390  1...........................           6,390

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Biennial renewals; 1.235..................            3537          97,883               1          97,883  0.38 (23 minutes)...........          37,196
3rd party registration verification.......            3537          41,256               1          41,256  0.25 (15 minutes)...........          10,314
U.S. Agent verification...................            3537          57,070               1          57,070  0.25 (15 minutes)...........          14,268
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    Total.................................  ..............  ..............  ..............  ..............  ............................         278,382
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Forms FDA 3537 and FDA 3537a refer to both the paper version of the form and the electronic system known as the Food Facility Registration Module,
  which is available at https://www.access.fda.gov.

    These burden figures are based on currently available data and 
reflect an overall decrease to the information collection by 174,395 
and 31,370 hours. The decrease results from the realization of burden 
associated with implementing measures on newly established electronic 
registration requirements.

    Dated: July 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15636 Filed 7-22-19; 8:45 am]
 BILLING CODE 4164-01-P