[Federal Register Volume 84, Number 76 (Friday, April 19, 2019)]
[Notices]
[Pages 16519-16521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07839]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0065]
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: Submit either electronic or written comments on the collection
of information by June 18, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 18, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 18, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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 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-2013-N-0065 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Registration of Food Facilities
Under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002.'' 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.
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
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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.gpo.gov/fdsys/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.
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. 3501-3520), 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
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) amended the Federal Food,
Drug, and Cosmetic Act (the 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,
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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
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; 3537 9,795 1 9,795 2.7............................... 26,447
1.230-1.233.
New foreign facility registration; 3537 13,697 1 13,697 8.7............................... 119,164
1.230-1.233.
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
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: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07839 Filed 4-18-19; 8:45 am]
BILLING CODE 4164-01-P