[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Notices]
[Pages 4414-4417]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01157]
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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 Under the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 March 25, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, domini.bean@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
[[Page 4415]]
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 Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.230-1.235
(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) added
section 415 to the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 350d), which 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-
1.235 of FDA's regulations (21 CFR 1.230-1.235) set forth the
procedures for registration of food facilities. Information provided to
FDA under these regulations helps the Agency 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, FDA 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.
FDA's regulations require that each facility that manufactures,
processes, packs, or holds food for human or animal consumption in the
United States register with FDA using Form FDA 3537 (Sec. 1.231). The
term ``Form FDA 3537'' refers to both the paper version of the form and
the electronic system known as the Food Facility Registration Module,
which is available at http://www.access.fda.gov. 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 before the food is exported to the United States.
However, if the subsequent foreign facility performs only a minimal
activity, such as putting on a label, both facilities are required to
register.
Information FDA requires on the registration form includes the name
and full address of the facility; emergency contact information; all
trade names the facility uses; applicable food product categories; and
a certification statement that includes the name of the individual
authorized to submit the registration form. Additionally, facilities
are encouraged to submit their preferred mailing address; type of
activity conducted at the facility; type of storage, if the facility is
primarily a holding facility; and approximate dates of operation if the
facility's business is seasonal.
In addition to registering, 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).
The FDA Food Safety Modernization Act (FSMA) (Public Law 111-353),
enacted on January 4, 2011, amended section 415 of the FD&C Act in
relevant part to require registrants for food facilities to submit
additional registration information to FDA, and to require facilities
required to register with FDA to renew such registrations biennially.
Section 415(a)(2) of the FD&C Act (21 U.S.C. 350d(a)(2)), as amended by
FSMA, also provides that, when determined necessary by FDA ``through
guidance,'' a food facility is required to submit to FDA information
about the general food category of a food manufactured, processed,
packed or held at such facility, as determined appropriate by FDA,
including by guidance. These amendments took effect October 1, 2012. To
comply with this statutory deadline, FDA initially obtained OMB
approval of the following additional collection of information
requirements under the emergency processing provisions of the PRA:
Modification of food facility registration forms to
include the following mandatory fields: The email address for the
contact person of a domestic facility and the email address of the U.S.
agent for a foreign facility, an assurance that FDA will be permitted
to inspect the facility, and specific food categories as identified in
the guidance document entitled, ``Guidance for Industry: Necessity of
the Use of Food Product Categories in Food Facility Registrations and
Updates to Food Product Categories'' (77 FR 64999, October 24, 2012)
(section 415(a)(2) of the FD&C Act); and
The requirement that registered facilities submit
registration renewals to FDA biennially (section 415(a)(3) of the FD&C
Act (21 U.S.C. 350d(a)(3)).
Food Facility Registration, in conjunction with advance notice of
imported food, helps FDA act quickly in responding to a threatened or
actual bioterrorist attack on the U.S. food supply or to other food-
related emergencies. Food Facility Registration provides FDA with
information about facilities that manufacture, process, pack, or hold
food for consumption in the United States. In the event of an outbreak
of foodborne illness, such information helps FDA and other authorities
determine the source and cause of the event. In addition, the
registration information enables FDA to notify more quickly the
facilities that might be affected by the outbreak. See Interim Final
Rule entitled, ``Registration of Food Facilities Under the Public
Health Security and Bioterrorism Preparedness and Response Act of
2002'' (68 FR 58894, at 58895; October 10, 2003).
Implementation of the new FSMA requirements described previously
helps enable FDA 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
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serious adverse health consequences or death to humans or animals. FDA
uses the information collected under these provisions to help ensure
that such food products are quickly and efficiently removed from the
market.
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR Section and/or section of FD&C Form FDA No. Number of responses per Total annual Average burden per Total hours
Act respondents respondent responses response
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New Facilities
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Domestic
Sec. 1.230-1.233 and section FDA 3537 \2\......... 11,080 1 11,080 2.7 29,916
415 of the FD&C Act.
Foreign
Sec. 1.230-1.233 and section FDA 3537............. 19,900 1 19,900 8.9 177,110
415 of the FD&C Act.
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New Facility Registration ..................... .............. .............. .............. .......................... 207,026
Subtotal.
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Previously Registered Facilities
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Updates under Sec. 1.234 and FDA 3537............. 118,530 1 118,530 1.2 142,236
section 415 of the FD&C Act.
Cancellations under Sec. 1.235..... FDA 3537a............ 6,390 1 6,390 1 6,390
Biennial renewal of registration FDA 3537............. 224,930 1 224,930 0.5 112,465
required by section 415 of the FD&C (30 mins.)
Act.
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Updates, Cancellations or ..................... .............. .............. .............. .......................... 261,091
Biennial Renewals Subtotal.
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Total Hours Annually......... ..................... .............. .............. .............. .......................... 468,117
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3537'' refers to both the paper version of the form and the electronic system known as the Food Facility Registration Module,
which is available at http://www.access.fda.gov.
This estimate is based on FDA's experience and the average number
of new facility registrations, updates and cancellations received in
the past 3 years. FDA received 12,011 new domestic facility
registrations during 2010, 10,646 during 2011, and 10,584 during 2012.
Based on this experience, FDA estimates the annual number of new
domestic facility registrations will be 11,080. FDA estimates that
listing the information required by the Bioterrorism Act and presenting
it in a format that will meet the Agency's registration regulations
will require a burden of approximately 2.5 hours per average domestic
facility registration. We estimate that the FSMA-required additional
information for new facility registrations will require an additional
12 minutes (0.2 hour) per response for domestic facilities. The average
domestic facility burden hour estimate of 2.7 hours takes into account
that some respondents completing the registration may not have readily
available Internet access. Thus, the total annual burden for new
domestic facility registrations is estimated to be 29,916 hours (11,080
x 2.7 hours).
FDA received 20,598 new foreign facility registrations during 2010;
20,009 during 2011 and 19,092 during 2012. Based on this experience,
FDA estimates the annual number of new foreign facility registrations
will be 19,900. FDA estimates that listing the information required by
the Bioterrorism Act and presenting it in a format that will meet the
Agency's registration regulations will require a burden of
approximately 8.5 hours per average foreign facility registration. We
estimate that the FSMA-required additional information for new facility
registrations will require an additional 24 minutes (0.4 hour) per
response for foreign facilities. The average foreign facility burden
hour estimate of 8.9 hours includes an estimate of the additional
burden on a foreign facility to obtain a U.S. agent, and takes into
account that for some foreign facilities the respondent completing the
registration may not be fluent in English and/or not have readily
available Internet access. Thus, the total annual burden for new
foreign facility registrations is estimated to be 177,110 hours (19,900
x 8.9 hours).
Based on its experience, FDA estimates that the average annual
number of updates to facility registrations will remain unchanged at
118,530 updates annually over the next 3 years. FDA also estimates that
updating a registration will, on average, require a burden of
approximately 1 hour, taking into account fluency in English and
Internet access. We estimate that the FSMA-required additional
information for updates will require an additional 12 minutes (0.2
hour) per response. Thus, the total annual burden of submitting updates
to facility registrations is estimated to be 142,236 hours (118,530 x
1.2 hours).
Based on its experience, FDA estimates that the average annual
number of cancellations of facility registrations will remain unchanged
at 6,390 cancellations annually over the next 3 years. FDA also
estimates that cancelling a registration will, on average, require a
burden of approximately 1 hour, taking into account fluency in English
and Internet
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access. FSMA did not change the required information for cancellations.
Thus, the total annual burden for cancelling registrations is estimated
to be 6,390 hours.
We estimate that the new biennial registration required by FSMA,
which will require the submission of certain new data elements and the
verification and possible updating of other information rather than re-
entering all information, will require 30 minutes (0.5 hour) per
response, including time for the new FSMA-required information. FDA
estimates that, on an annualized basis, the number of biennial
registrations submitted over the next 3 years will be 224,930. This
estimate is based on the number of currently registered firms (449,860)
divided by two. Thus, the total annual burden for biennial registration
is estimated to be 112,465 hours (224,930 x 0.5 hours).
Dated: January 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01157 Filed 1-18-13; 8:45 am]
BILLING CODE 4160-01-P