
[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18603-18605]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07029]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0065]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
26, 2013.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0502. 
Also include the FDA 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, 301-796-5733, domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 the Food and Drug 
Administration (FDA). Sections 1.230 through 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

[[Page 18604]]

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) (Pub. L. 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, 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 
United States 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'' (section 
415(a)(2) of the FD&C Act 21 U.S.C. 350d(a)(2)); 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 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.
    In the Federal Register of January 22, 2013 (78 FR 4414), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments in response to the 
notice.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                                   No. of                          Average
 21 CFR Section and/or section of  FD&C act             FDA form No.               No. of       responses per   Total annual     burden per      Total
                                                                                 respondents     respondent       responses       response       hours
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                                                                     New Facilities
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                                                                        Domestic
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Sec.  Sec.   1.230-1.233 and section 415 of   FDA 3537 \2\                             11,080               1          11,080             2.7     29,916
 the FD&C Act.
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                                                                         Foreign
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Sec.  Sec.   1.230-1.233 and section 415 of   FDA 3537                                 19,900               1          19,900             8.9    177,110
 the FD&C Act.
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[[Page 18605]]

 
New Facility Registration Subtotal..........  ...............................  ..............  ..............  ..............  ..............    207,026
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                                                            Previously Registered Facilities
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Updates under Sec.   1.234 and section 415    FDA 3537                                118,530               1         118,530             1.2    142,236
 of the FD&C Act.
Cancellations under Sec.   1.235............  FDA 3537a                                 6,390               1           6,390               1      6,390
Biennial renewal of registration required by  FDA 3537                                224,930               1         224,930             0.5    112,465
 section 415 of the FD&C Act.                                                                                                    (30 minutes)
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Updates, Cancellations or Biennial Renewals   ...............................  ..............  ..............  ..............  ..............    261,091
 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 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 2. Thus, the total annual burden for biennial registration 
is estimated to be 112,465 hours (224,930 x 0.5 hours).

    Dated: March 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-07029 Filed 3-26-13; 8:45 am]
BILLING CODE 4160-01-P


