
[Federal Register Volume 81, Number 87 (Thursday, May 5, 2016)]
[Notices]
[Pages 27140-27143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10559]



[[Page 27140]]

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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 or we) 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 July 5, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management 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 second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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 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,

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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 to 
1.235 OMB Control Number 0910-0502--Extension

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act) 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 to 1.235 of FDA's 
regulations (21 CFR 1.230 to 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), 
unless exempt under 21 CFR 1.226 from the requirement to register. 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 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.
    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) 
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. The modified food facility 
registration forms includes the following mandatory fields: (1) The 
email address for the contact person of a domestic facility and the 
email address of the United States agent for a foreign facility; (2) an 
assurance that FDA will be permitted to inspect the facility; and (3) 
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)).
    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 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.
    FDA estimates the burden of this collection of information as 
follows:

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                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                             Number of
  21 CFR section and/or section of FD&C      FDA form        Number of     responses per   Total annual     Average burden per response     Total hours
                   Act                        number        respondents     respondent       responses
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                                                                     New Facilities
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                                                                        Domestic
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Sec.  Sec.   1.230 to 1.233 and section     FDA 3537 \2\          11,080               1          11,080  2.7...........................          29,916
 415 of the FD&C Act.
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                                                                         Foreign
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Sec.  Sec.   1.230 to 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 Subtotal..  ..............  ..............  ..............  ..............  ..............................         207,026
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                                                            Previously Registered Facilities
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Updates under Sec.   1.234 and section          FDA 3537         118,530               1         118,530  1.2...........................         142,236
 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         104,786               1         104,786  0.50 (30 mins.)...............          52,393
 required by section 415 of the FD&C Act.
                                         ---------------------------------------------------------------------------------------------------------------
    Updates, Cancellations, or Biennial   ..............  ..............  ..............  ..............  ..............................         201,019
     Renewals Subtotal.
                                         ---------------------------------------------------------------------------------------------------------------
        Total Hours Annually............  ..............  ..............  ..............  ..............  ..............................         408,045
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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. Based on this experience, we estimate the annual 
number of new domestic facility registrations will be 11,080. We 
estimate 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 
calculated to be 29,916 hours (11,080 x 2.7 hours).
    Based on FDA's experience, we estimate the annual number of new 
foreign facility registrations will be 19,900. We estimate 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 calculated to be 177,110 
hours (19,900 x 8.9 hours).
    Based on FDA's experience, we estimate that the average annual 
number of updates to facility registrations will remain unchanged at 
118,530 updates annually over the next 3 years. We also estimate 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 calculated to be 142,236 hours (118,530 x 
1.2 hours).
    Based on FDA's experience, we estimate that the average annual 
number of cancellations of facility registrations will remain unchanged 
at 6,390 cancellations annually over the next 3 years. We also estimate 
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. We 
estimate that, on an annualized basis, the number of biennial 
registrations submitted over the next 3 years will be 104,786. This 
estimate is based on the number of currently registered firms (209,573) 
divided by two. Thus, the total annual burden for biennial registration 
is calculated to be 52,393 hours (104,786 x 0.5 hours).


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    Dated: May 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10559 Filed 5-4-16; 8:45 am]
 BILLING CODE 4164-01-P


