Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities, 16519-16521 [2019-07839]
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Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Notices
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IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in the
following FDA regulations and
guidances have been approved by OMB
as listed in the following table:
OMB Control
No.
21 CFR Part; guidance; or FDA form
Topic
807, subpart E ................................................................................................
814, subparts A through E .............................................................................
814, subpart H ................................................................................................
812 ..................................................................................................................
‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’.
‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’.
800, 801, and 809 ..........................................................................................
Premarket notification ............................................
Premarket approval ................................................
Humanitarian Device Exemption ............................
Investigational Device Exemption ..........................
De Novo classification process ..............................
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
Q-submissions ........................................................
0910–0756
Medical Device Labeling Regulations ....................
0910–0485
Dated: April 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07936 Filed 4–18–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
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number 18017 to identify the guidance
you are requesting.
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ADDRESSES:
Written/Paper Submissions
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’’).
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
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.
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Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Notices
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/201523389.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, PRAStaff@
fda.hhs.gov.
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
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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
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‘‘Food Facility Registration’’ (§ 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’’ (§ 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 (§ 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
(§ 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 foodrelated 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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Federal Register / Vol. 84, No. 76 / Friday, April 19, 2019 / Notices
pack, or hold food for human or animal
consumption in the United States.
16521
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form
No.2
Activity; 21 CFR section
New domestic facility registration;
1.230–1.233.
New foreign facility registration;
1.230–1.233.
Updates; 1.234 .............................
Cancellations; 1.235 ....................
Biennial renewals; 1.235 ..............
3rd party registration verification
U.S. Agent verification .................
Total ......................................
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
3537
9,795
1
9,795
2.7 .............................
26,447
3537
13,697
1
13,697
8.7 .............................
119,164
3537
3537a
3537
3537
3537
53,836
6,390
97,883
41,256
57,070
1
1
1
1
1
53,836
6,390
97,883
41,256
57,070
1.2 .............................
1 ................................
0.38 (23 minutes) ......
0.25 (15 minutes) ......
0.25 (15 minutes) ......
64,603
6,390
37,196
10,314
14,268
........................
........................
........................
........................
....................................
278,382
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
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0023]
Agency Information Collection
Activities; Extension, Without Change,
of a Currently Approved Collection:
Application To Register Permanent
Residence or Adjust Status
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: 30-Day notice.
AGENCY:
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The purpose of this notice is to
allow an additional 30 days for public
comments.
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The purpose of this notice is to
allow an additional 30 days for public
comments. Comments are encouraged
and will be accepted until May 20,
2019.
DATES:
Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, must be
directed to the OMB USCIS Desk Officer
via email at dhsdeskofficer@
omb.eop.gov. All submissions received
must include the agency name and the
OMB Control Number 1615–0023 in the
subject line.
You may wish to consider limiting the
amount of personal information that you
provide in any voluntary submission
you make. For additional information
please read the Privacy Act notice that
is available via the link in the footer of
https://www.regulations.gov.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division,
Samantha Deshommes, Chief, 20
Massachusetts Avenue NW,
Washington, DC 20529–2140,
Telephone number (202) 272–8377
(This is not a toll-free number;
comments are not accepted via
telephone message). Please note contact
information provided here is solely for
questions regarding this notice. It is not
for individual case status inquiries.
Applicants seeking information about
the status of their individual cases can
check Case Status Online, available at
the USCIS website at https://
www.uscis.gov, or call the USCIS
National Customer Service Center at
(800) 375–5283; TTY (800) 767–1833.
SUPPLEMENTARY INFORMATION:
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Comments
The information collection notice was
previously published in the Federal
Register on February 1, 2019, at 84 FR
1193, allowing for a 60-day public
comment period. USCIS did receive two
comments in connection with the 60day notice.
You may access the information
collection instrument with instructions,
or additional information by visiting the
Federal eRulemaking Portal site at:
https://www.regulations.gov and enter
USCIS–2009–0020 in the search box.
Written comments and suggestions from
the public and affected agencies should
address one or more of the following
four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 16520]]
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,
[[Page 16521]]
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------------------------------------------
Total........................... .............. .............. .............. .............. .................................. 278,382
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
