[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


