[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

[[Page 4416]]

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.
                                      ------------------------------------------------------------------------------------------------------------------
    Updates, Cancellations or          .....................  ..............  ..............  ..............  ..........................         261,091
     Biennial Renewals Subtotal.
                                      ------------------------------------------------------------------------------------------------------------------
        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

[[Page 4417]]

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