Paperwork Reduction Act (PRA) analysis of the information collection
provisions found in the proposed regulation. In the analysis we invited
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.
    FSMA (Pub. L. 111-353), enacted on January 4, 2011, amended section
415 of the FD&C Act to require, among other things, that registrants
for food facilities renew registrations biennially (section 415(a)(3)
of the FD&C Act). FSMA also amended section 415 of the FD&C Act to
require that food facility registrations include the email address for
the contact person of a domestic facility and the email address of the
United States agent for a foreign facility, as well as an assurance
that FDA will be permitted to inspect the facility (section 415(a)(2)
of the FD&C Act). These requirements went into effect upon enactment of
FSMA. In addition, 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. FDA issued a guidance document entitled

``Guidance for Industry: Necessity of the Use of Food Product
Categories in Food Facility Registrations and Updates to Food Product
Categories'' in October 2012.
    To comply with the statutory deadline under the provisions of FSMA,
FDA initially obtained a 6-month OMB approval of these self-
implementing FSMA reporting burdens under the emergency processing
provisions of the PRA, and subsequently obtained a 3-year approval of
these requirements under the same assigned OMB control number 0910-
0502. OMB extended the approval for an additional 3 years in 2013. The
current expiration date of the information collection is August 31,
2016.
    The final rule will require food facilities to submit certain
additional registration information to FDA with initial registrations,
updates, and biennial renewals. The final rule will also require
mandatory electronic registration submissions beginning in 2020, which
we estimate would cause some food facilities to submit a request for a
waiver from that requirement. Finally, the final rule will establish
certain verification procedures. These requirements are discussed in
depth in the preamble to the final rule.
    The currently approved reporting burden for food facility
registration under OMB control number 0910-0502 is 468,117 hours. The
estimated reporting burden for food facility registration under the
final rule is 278,382 hours, a decrease of 189,735 hours. This decrease
is due in large part to a reduction in the number of registered food
facilities, which we believe is reflective of the fact that the 2012
biennial registration renewal cycle appear to have had the effect of
removing many out-of-date registrations from the registration system.
As discussed in the PRA for the proposed rule, we are making additional
changes to the currently approved reporting burden as well. Since
obtaining the FSMA-related emergency OMB approval and subsequent 3-year
approval, we have refined our estimates for the time required to comply
with the self-implementing FSMA provisions. As we explain in detail in
the preliminary economic impact analysis, this is in part because we no
longer assume that it will take domestic and foreign facilities
different amounts of time to comply with the provisions of the proposed
rule. It is also in part because the option to submit abbreviated
registration renewals did not previously exist and in part because we
have revised additional assumptions.
    We received many comments regarding requirements of this rule, but
none of the comments specifically addressed the four topics about which
we invited comments in the PRA analysis that accompanied the proposed
rule.
    Although FDA is making some generally minor revisions to the
proposed rule, we are finalizing most of the key aspects of the
proposed rule. The following three changes are substantial enough to
require us to revise the estimates in the PRA for the proposed rule:
(1) We are clarifying that if a waiver under Sec.  1.245 has been
granted from the electronic submission requirement, the facility is not
required to submit future waiver requests each time the facility
submits a renewal or update; (2) we will continue to allow 60 calendar
days to submit updates to registrations in Sec.  1.234, instead of
shortening the time period to 30 calendar days as we proposed; and
finally (3) we plan to implement a VIS for U.S. agents.
    These revisions are necessary to address changes to the proposed
regulation included in this final rule, as discussed in the following
paragraphs. For more information on our original calculations of the
information collection burden associated with this rulemaking, you may
refer to the PRA analyses found under Docket No. FDA-2002-N-0323 at
http://www.regulations.gov.
    FDA revises its estimate of the one-time burden of the FSMA-related
provisions of this final rule on registered facilities as follows:

                                                    Table 5--Estimated One Time Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           Activity/21 CFR section               Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
All facility registrations (1.230-1.233)....         172,274               1         172,274  0.18 (11 minutes).........................          31,009
Waiver requests (1.245).....................           2,121               1           2,121  0.17 (10 minutes).........................             361
                                             -----------------------------------------------------------------------------------------------------------
    Total One Time Reporting Burden.........  ..............  ..............  ..............  ..........................................          31,370
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operations and maintenance costs associated with one-time recordkeeping burden.

    To determine the number of facilities in table 5, we assume that
some of the participants in the 2012 biennial registration renewal
cycle were new registrants. We do not consider those new registrations
in estimating the total burden associated with the FSMA requirements.
FDA used the Small Business Administration's (SBA's) estimate that 12
percent of all businesses are new. Although SBA's estimate does not
necessarily mean that 12 percent of all food facilities are new, we
nevertheless find the SBA's estimate sufficiently relevant to apply to
food facilities. We therefore estimate that 12 percent of currently
registered food facilities were not registered at the time of the 2012
registration renewal cycle. As such, we estimate that 88 percent of
currently registered food facilities, or 172,274 facilities, were
already registered in 2012.
    Using our updated estimates for the time required to comply with
the self-implementing FSMA provisions, we now estimate that the
requirement for an email address for a domestic facility's contact
person and a foreign facility's U.S. agent will take 1 minute. We also
now estimate that the assurance statement required by FSMA will take 5
minutes to provide, and that the post-FSMA changes to food product
categories will not result in any additional burden for facilities.
    We also estimate the one-time burden from the new data elements in
this final rule. We estimate an increase in the average burden per
response due to the new data elements required by this final rule. FDA
believes that the new information will be readily available to the
firms. We estimate that entering the four additional pieces of
information that are currently optional will require, on average, an
additional minute for each new data element per response. The four
additional pieces of information that are currently optional are: (1)
Preferred mailing address, (2) email address for the owner operator or
agent in charge, (3) type of activity or type of storage conducted at
the facility,

and (4) email address of the emergency contact of a domestic facility.
As explained in the preamble to the final rule, we revised the final
rule and no longer require facilities to use D-U-N-S numbers. Instead,
the final rule requires the use of a UFI recognized as acceptable by
FDA. We are also postponing the requirement to submit a UFI until the
registration renewal period beginning October 1, 2020. We estimate that
entering a unique facility identifier requires, on average, an
additional minute per response. Thus, we estimate that entering these
five new data elements will require a total of 5 additional minutes. We
estimate that the submission of the FSMA data elements and new data
elements will jointly increase the one-time burden from those
activities by a total of 11 minutes (0.18 hour). The estimated one-time
burden for currently registered facilities is 172,274 facilities x 0.18
hours = 31,009 hours. According to 2014 registration data, 2,121
registrations were from facilities that submitted paper registrations.
We believe these same facilities are more likely to request a waiver
from the requirement to electronically submit their registration. We
estimate that it will take a respondent 10 minutes to prepare the
waiver request submission and attach it to their paper Form FDA 3537
registration submission. Thus, the one-time burden of submitting waiver
requests is estimated to be 361 hours (2,121 x 0.17 hours), as reported
in table 5. The estimated total one-time burden for currently
registered facilities is therefore 31,370 hours.
    We estimate the annual burden for this information collection as
follows:

                                 Table 6--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of     responses per   Total annual     burden per         Total
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
New domestic facility                      9,795               1           9,795             2.7          26,447
 registrations (1.230-1.233)....
New foreign facility                      13,697               1          13,697             8.7         119,164
 registrations (1.230-1.233)....
Updates (1.234).................          53,836               1          53,836             1.2          64,603
Cancellations (1.230(b))........           6,390               1           6,390               1           6,390
Biennial renewals (1.235).......          97,883               1          97,883            0.38          37,196
Third party registration                  41,256               1          41,256            0.25          10,314
 verification procedure.........
U.S. Agent verification                   57,070               1          57,070            0.25          14,268
 procedure with VIS.............
                                 -------------------------------------------------------------------------------
    Total Hours.................  ..............  ..............  ..............  ..............         278,382
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The currently approved annual reporting burden for food facility
registration under OMB control number 0910-0502 is 468,117 hours. The
estimated reporting burden for food facility registration under this
final rule is 278,382 hours, a decrease of 189,735 hours. This decrease
is due to the recently reduced number of active registrations in the
food facility registration database.
    Our estimates of the number of facilities that will submit new
facility registrations are based on estimates by SBA that 12 percent of
all businesses each year are new. As such, we estimate that 12 percent
of registrations (or 23,500 registrations) are from new facilities
entering the market. We are making additional changes to the currently
approved reporting burden as well. As discussed previously, FDA
obtained a 6-month emergency OMB approval of the self-implementing FSMA
reporting burdens, and subsequently obtained a 3-year approval of these
requirements. As described in the preliminary economic impact analysis,
we estimate that on an annualized basis 97,833 respondents will file
biennial renewals, a decrease from the estimated number of 224,930
respondents reported in the 2013 request for extension. These decreases
are due to recent reductions in the number of active registrations in
the food facility registration database.
    Prior to FSMA, FDA estimated that the average burden associated
with new domestic and foreign facility registrations was a respective
2.5 and 8.5 hours. (See 75 FR 30033.) We expect that this final rule
will add an additional 11 minutes to that burden as a result of the
required new data elements. Based on estimates by SBA that 12 percent
of all businesses are new, we estimate that all new facilities each
year will be equal to 12 percent of the total number of registered
facilities. Thus, we estimate that each year there will be 9,795 new
domestic and 13,697 new foreign facility registrations, and that the
average burden for those new registrations will be of 2.7 hours (2.5
hours plus 11 minutes) for new domestic facility registrations and 8.7
hours (8.5 hours plus 11 minutes) for new foreign facility
registrations, as reported in table 6, rows 1 and 2.
    This final rule does not shorten the time period for updates from
60 calendar days to 30 calendar days as originally proposed. We are not
finalizing our proposal to change the current requirement that updates
take places within 30 calendar days; instead, we are continuing to
allow 60 calendar days for updates, as provided in current Sec.  1.234.
In the PRA analysis for the proposed rule, in which we estimated the
burden for the proposed 30-day update requirement, we estimated that
68,518 respondents (70 percent of facilities) would submit updates each
year. For a 60-day update requirement, we estimated that the number of
respondents was 53,836 per year (55 percent of facilities). The average
burden per response for updates remains unchanged as 1.2 hours, as
reported in table 6 row 3. In the proposed rule, we also proposed to
shorten the time period to submit cancellations from 60 calendar days
to 30 calendar days. Although we are not finalizing that proposal, we
have not changed our estimate of the average burden per response for
cancellations because this final rule does not add new data elements
for cancellations.
    This final rule also establishes an abbreviated renewal process,
which modifies our previous estimate that on average it will take 0.5
hours per renewal. With the option for an abbreviated renewal process,
we estimate that half the facilities will take 15 minutes per renewal
using the abbreviated renewal process and that half of facilities will
take 30 minutes. This alters our previous estimate of 0.5 hours to
submit a renewal to an average of 0.38 hours (23 minutes) to submit a
renewal, as reported in table 6, row 5. This estimate takes into
account that some registered firms will be able to

take advantage of the abbreviated renewal process, while other firms
will take more time to prepare and submit the renewal, as discussed in
the preliminary economic impact analysis.
    Furthermore, this final rule also establishes a verification
procedure for registrations submitted by individuals other than the
owner, operator, or agent in charge (third party registrations), as
well as a verification procedure for U.S. agents. In connection with
requiring this verification process, this final rule adds email address
to the list of required information identifying the individual who
authorized submission of registrations submitted by individuals other
than the owner, operator, or agent in charge. As described in the
preliminary economic impact analysis, we estimate that it takes 15
minutes (0.25 hour) to participate in FDA's verification procedure. We
have not changed this estimate. We further estimate that 82,513
registrations will be affected once every other year, or 41,256
annually. Thus, the total annual burden of these verifications is
estimated to be 10,314 hours (41,256 x 0.25 hour = 10,314 hours), as
reported in table 6, row 6.
    For the U.S. agent verification process, in the PRIA we estimated a
resulting burden from the verification procedure to be about 30 minutes
(0.5 hours) by 114,139 affected registrations once every 2 years, or
57,070 facility registrations annually. However, this final rule also
provides for the creation of a U.S. agent VIS, which we estimate will
cut the time for verification procedures for U.S. agents in half (from
30 minutes to 15 minutes). As currently envisioned, the system is
designed to ensure the accuracy of U.S. agent information and enable
U.S. agents to independently identify the facility or facilities for
which the agent has agreed to serve. Specifically, the system will
allow a U.S. agent to directly provide their contact information (that
is, the same contact information required for foreign food facility
registration) and the name of the facility or facilities for which the
agent has agreed to serve. Currently, FDA only receives U.S. agent
contact information through foreign food facility registrations, many
of which are created and updated by the facility, rather than the U.S.
agent for the facility. We expect that the system will allow agents to
provide their name, full mailing address, phone number, email address,
and an emergency contact phone number, as well as the name of the
facility or facilities for which the agent agrees to serve. After a
U.S. agent provides this information, FDA will provide the agent with
an identification number that the agent could provide to foreign
facilities it has agreed to represent as a U.S. agent. If a foreign
facility uses a U.S. agent identified in the system, the facility will
have the option of providing the name and identification number for the
U.S. agent in its registration rather than the specific U.S. agent's
contact information required for food facility registrations (e.g.,
address, email address, phone number). After using the identification
number, and if the foreign facility name matches a facility name the
U.S. agent identified in the system, the U.S. agent contact information
in the system will then be linked and automatically populated in the
foreign facility registration. When the confirmation copy of a foreign
facility registration is sent to the U.S. agent, it will be sent to the
contact information provided by the U.S. agent to ensure that the U.S.
agent is aware of the connection with each foreign facility
registration.
    We expect that when a foreign facility uses an identification
number for a registered U.S. agent and the name of the facility matches
the facility name the agent has identified, that we will consider the
use of that identification a verification of U.S. agent information for
purposes of the U.S. agent verification step. Thus, we estimate the
total annual burden of the foreign facility U.S. agent verifications to
be 14,268 hours (57,070 x 0.25 hour = 14,268), as reported in table 6,
row 7.
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995. Before the effective date of this
final rule, FDA will publish a notice in the Federal Register
announcing OMB's decision to approve, modify, or disapprove the
information collection provisions in this final rule.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.

XVII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(j) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

XVIII. Federalism

    We have analyzed the final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.

XIX. References

    The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at http://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.

1. FDA, Amendments to Registration of Food Facilities--Preliminary
Regulatory Impact Analysis FDA-2002-N-0323, (http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM444325.pdf), April 2015.
2. FDA Memorandum, ``FDA Memorandum to Dockets on Records of
Outreach,'' 2013. See Reference 7 to the 2014 supplemental human
preventive controls notice.
3. FDA Memorandum, ``Memoranda of Outreach,'' 2015.
4. FDA, ``Food CGMP Modernization--A Focus on Food Safety,'' (http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm207458.htm), November
2, 2005. Accessed and printed on March 20, 2015. See Reference 1 to
the 2013 proposed human preventive controls rule.
5. FDA, ``Guidance for Industry: Necessity of the Use of Food
Product Categories in Food Facility Registrations and Updates to
Food Product Categories'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm324778.htm), October 2012. Accessed and printed on April 5, 2016.
6. FDA, ``Guidance for Industry: Questions and Answers Regarding
Food Facility Registration (Sixth Edition),'' (http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM332460.pdf), November 2014.
Accessed on May 2, 2016.
7. USDA Agricultural Marketing Service, ``Regional Food Hub Resource
Guide,'' (https://www.ams.usda.gov/sites/default/files/media/Regional%20Food%20Hub%20Resource%20Guide.pdf), April

2012. Accessed and printed on April 6, 2016.
8. FDA, ``Specification of the Unique Facility Identifier (UFI)
System for Drug Establishment Registration,'' Guidance for Industry,
(http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm421827.pdf),
November 2014. Accessed and printed on April 6, 2016.
9. FDA Memorandum, ``D-U-N-S and Registered Facilities,'' July 9,
2014, from John Gardner, MD, MPH Senior Technical Advisor, Medical
Informatics, Office of Informatics and Technology Innovation, Office
of Information Management and Technology, Office of Operations.
10. U.S. Government Accountability Office, ``Government Is Analyzing
Alternatives for Contractor Identification Numbers,'' (http://www.gao.gov/assets/600/591551.pdf), June 2012. Accessed and printed
on April 5, 2016.
11. Specially Designated Nationals List (SDN) (https://www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx). Accessed on April 5, 2016.
12. FDA, ``FDA's Voluntary Qualified Importer Program,'' Draft
Guidance for Industry, (http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM448558.pdf), June 2015. Accessed and printed on April 6, 2016.
13. FDA, ``Amendments to Registration of Food Facilities: Final
Regulatory Impact Analysis, Final Regulatory Flexibility Analysis,
and Final Unfunded Mandates Reform Act Analysis,'' 2016.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
1 is amended to read as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 is revised to read as follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c,
350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371,
374, 379j-31, 381, 382, 384a, 384b, 384d, 387, 387a, 387c, 393; 42
U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 107-188, 116 Stat. 594,
668-69; Pub. L. 111-353, 124 Stat. 3885, 3889.

0
2. In Sec.  1.227, revise the definitions for ``Retail food
establishment'' and ``U.S. agent'' to read as follows:

Sec.  1.227  What definitions apply to this subpart?

* * * * *
    Retail food establishment means an establishment that sells food
products directly to consumers as its primary function. The term
``retail food establishment'' includes facilities that manufacture,
process, pack, or hold food if the establishment's primary function is
to sell from that establishment food, including food that it
manufactures, processes, packs, or holds, directly to consumers. A
retail food establishment's primary function is to sell food directly
to consumers if the annual monetary value of sales of food products
directly to consumers exceeds the annual monetary value of sales of
food products to all other buyers. The term ``consumers'' does not
include businesses. A ``retail food establishment'' includes grocery
stores, convenience stores, and vending machine locations. A ``retail
food establishment'' also includes certain farm-operated businesses
selling food directly to consumers as their primary function.
    (1) Sale of food directly to consumers from an establishment
located on a farm includes sales by that establishment directly to
consumers:
    (i) At a roadside stand (a stand situated on the side of or near a
road or thoroughfare at which a farmer sells food from his or her farm
directly to consumers) or farmers' market (a location where one or more
local farmers assemble to sell food from their farms directly to
consumers);
    (ii) Through a community supported agriculture program. Community
supported agriculture (CSA) program means a program under which a
farmer or group of farmers grows food for a group of shareholders (or
subscribers) who pledge to buy a portion of the farmer's crop(s) for
that season. This includes CSA programs in which a group of farmers
consolidate their crops at a central location for distribution to
shareholders or subscribers; and
    (iii) At other such direct-to-consumer sales platforms, including
door-to-door sales; mail, catalog and Internet order, including online
farmers markets and online grocery delivery; religious or other
organization bazaars; and State and local fairs.
    (2) Sale of food directly to consumers by a farm-operated business
includes the sale of food by that farm-operated business directly to
consumers:
    (i) At a roadside stand (a stand situated on the side of or near a
road or thoroughfare at which a farmer sells food from his or her farm
directly to consumers) or farmers' market (a location where one or more
local farmers assemble to sell food from their farms directly to
consumers);
    (ii) Through a community supported agriculture program. Community
supported agriculture (CSA) program means a program under which a
farmer or group of farmers grows food for a group of shareholders (or
subscribers) who pledge to buy a portion of the farmer's crop(s) for
that season. This includes CSA programs in which a group of farmers
consolidate their crops at a central location for distribution to
shareholders or subscribers; and
    (iii) At other such direct-to-consumer sales platforms, including
door-to-door sales; mail, catalog and Internet order, including online
farmers markets and online grocery delivery; religious or other
organization bazaars; and State and local fairs.
    (3) For the purposes of this definition, ``farm-operated business''
means a business that is managed by one or more farms and conducts
manufacturing/processing not on the farm(s).
* * * * *
    U.S. agent means a person (as defined in section 201(e) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(e))) residing or
maintaining a place of business in the United States whom a foreign
facility designates as its agent for purposes of this subpart. A U.S.
agent may not be in the form of a mailbox, answering machine or
service, or other place where an individual acting as the foreign
facility's agent is not physically present.
    (1) The U.S. agent acts as a communications link between FDA and
the foreign facility for both emergency and routine communications. The
U.S. agent will be the person FDA contacts when an emergency occurs,
unless the registration specifies another emergency contact.
    (2) FDA will treat representations by the U.S. agent as those of
the foreign facility, and will consider information or documents
provided to the U.S. agent the equivalent of providing the information
or documents to the foreign facility. FDA will consider the U.S. agent
the equivalent of the registrant for purposes of sharing information
and communications. The U.S. agent of a foreign facility may view the
information submitted in the foreign facility's registration.
    (3) Having a single U.S. agent for the purposes of this subpart
does not preclude facilities from having multiple agents (such as
foreign suppliers) for other business purposes. A firm's commercial
business in the United States need not be conducted through the U.S.
agent designated for purposes of this subpart.
* * * * *

0
3. Revise Sec.  1.230 to read as follows:

Sec.  1.230  When must you register or renew your registration?

    (a) Registration. You must register before your facility begins to
manufacture, process, pack, or hold food for consumption in the United
States. You may authorize an individual to register the facility on
your behalf.
    (b) Registration renewal. You must submit a registration renewal
containing the information required under Sec.  1.232 every other year,
during the period beginning on October 1 and ending on December 31 of
each even-numbered year. You may authorize an individual to renew a
facility's registration on your behalf. If the individual submitting
the registration renewal is not the owner, operator, or agent in charge
of the facility, the registration renewal must also include a statement
in which the individual certifies that the information submitted is
true and accurate, certifies that he/she is authorized to submit the
registration renewal, and identifies by name, address, and telephone
number, the individual who authorized submission of the registration
renewal. In addition, the registration renewal must also identify the
individual who authorized submission of the registration renewal by
email address, unless FDA has granted a waiver under Sec.  1.245. Each
registration renewal must include the name of the individual submitting
the registration renewal, and the individual's signature (for the paper
option). Each electronic registration renewal must include the name of
the individual submitting the renewal.
    (c) Abbreviated registration renewal process. If you do not have
any changes to the information required under Sec.  1.232 since you
submitted the preceding registration, registration renewal, or update
for your facility, you may use the abbreviated registration renewal
process. If you use the abbreviated registration renewal process, you
must confirm that no changes have been made to the information required
under Sec.  1.232 since you submitted the preceding registration,
registration renewal or update, and you must certify that the
information submitted is truthful and accurate. Each abbreviated
registration renewal must include the name of the individual submitting
the abbreviated renewal, and the individual's signature (for the paper
option). Each electronic abbreviated registration renewal must include
the name of the individual submitting the abbreviated renewal. For
abbreviated registration renewals not submitted by the owner, operator,
or agent in charge of the facility, the abbreviated renewal must
provide the email address of the individual who authorized submission
of the abbreviated renewal, unless FDA has granted a waiver under Sec.
1.245. You must use Form FDA 3537 to submit abbreviated registration
renewals to FDA.

0
4. Revise Sec.  1.231 to read as follows:

Sec.  1.231  How and where do you register or renew your registration?

    (a) Electronic registration and registration renewal. (1) To
register or renew a registration electronically, you must go to http://www.fda.gov/furls, which is available for registration 24 hours a day,
7 days a week. This Web site is available from wherever the Internet is
accessible, including libraries, copy centers, schools, and Internet
cafes. An individual authorized by the owner, operator, or agent in
charge of a facility may also register a facility electronically.
    (2) Beginning on January 4, 2020, you must submit your registration
or registration renewal to FDA electronically, unless FDA has granted
you a waiver under Sec.  1.245.
    (3) After you submit your electronic registration, FDA will verify
the accuracy of your unique facility identifier (UFI) recognized as
acceptable by FDA and will also verify that the facility-specific
address associated with the UFI is the same address associated with
your registration. FDA will not confirm your registration or provide
you with a registration number until FDA verifies the accuracy of your
facility's UFI and verifies that the facility-specific address
associated with the UFI is the same address associated with your
registration. With respect to electronic registration renewals, after
you submit your electronic registration renewal, FDA will provide you
with an electronic confirmation of your registration renewal. When you
update your facility's UFI as part of your electronic registration
renewal, FDA will verify the accuracy of your facility's UFI and will
also verify that the facility-specific address associated with the UFI
is the same address associated with your registration. FDA will not
provide you with a confirmation of your registration renewal until FDA
verifies the accuracy of your UFI and verifies that the facility-
specific address associated with the UFI is the same address associated
with your registration.
    (4) For electronic registrations not submitted by the owner,
operator, or agent in charge of the facility, after submission of the
registration, FDA will verify that the individual identified as having
authorized submission of the registration in fact authorized the
submission on behalf of the facility. FDA will not confirm the
registration or provide a registration number until that individual
confirms that he or she authorized the submission. With respect to
electronic registration renewals, after completion of the electronic
registration renewal, FDA will provide an electronic confirmation of
the registration renewal. For electronic registration renewals not
submitted by the owner, operator, or agent in charge of the facility,
FDA will verify that the individual identified as having authorized
submission of the registration renewal in fact authorized the
submission on behalf of the facility. FDA will not provide an
electronic confirmation of the registration renewal until that
individual confirms that he or she authorized the submission.
    (5) For a foreign facility, after you submit your electronic
registration, FDA will verify that the person identified as the U.S.
agent for your foreign facility has agreed to serve as your U.S. agent.
FDA will not confirm your registration or provide you with a
registration number until that person confirms that the person agreed
to serve as your U.S. agent. With respect to electronic registration
renewals, after you complete your electronic registration renewal, FDA
will provide you with an electronic confirmation of your registration
renewal. When you update information about your U.S. agent as part of
your electronic registration renewal, FDA will verify that the person
identified as the U.S. agent for your foreign facility has agreed to
serve as your U.S. agent. FDA will not provide you with an electronic
confirmation of your registration renewal until that person confirms
that the person agreed to serve as your U.S. agent.
    (6) If any information you previously submitted was incorrect at
the time of submission, you must immediately update your facility's
registration as specified in Sec.  1.234.
    (7) You will be considered registered once FDA electronically sends
you your confirmation and registration number.
    (b) Registration or registration renewal by mail or fax. Beginning
January 4, 2020, you must submit your registration or registration
renewal to FDA electronically, unless FDA has granted you a waiver
under Sec.  1.245. If FDA has granted you a waiver under Sec.  1.245,
you may register or renew a registration by mail or by fax.
    (1) You must register or renew a registration (including
abbreviated registration renewals) using Form FDA 3537. You may obtain
a copy of this form by writing to the U.S. Food and Drug
Administration, Center for Food

Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), College Park,
MD 20740 or by requesting the form by phone at 1-800-216-7331 or 301-
575-0156.
    (2) When you receive the form, you must fill it out completely and
legibly and either mail it to the address in paragraph (b)(1) of this
section or fax it to<PHONE_NUMBER>.
    (3) If any required information on the form is incomplete or
illegible when FDA receives it, FDA will return the form to you for
revision, provided that your mailing address or fax number is legible
and valid. When returning a registration form for revision, FDA will
use the means by which the form was received by the Agency (i.e., by
mail or fax).
    (4) FDA will enter complete and legible mailed and faxed
registration submissions into its registration system, as soon as
practicable, in the order FDA receives them.
    (5) After you submit your registration, FDA will verify the
accuracy of your facility's UFI and will also verify that the facility-
specific address associated with the UFI is the same address associated
with your registration. FDA will not confirm your registration or
provide you with a registration number until FDA verifies the accuracy
of your facility's UFI and verifies that the facility-specific address
associated with the UFI is the same address associated with your
registration. With respect to registration renewals, after you submit
your registration renewal by mail or fax, FDA will provide you with a
confirmation of your registration renewal. When you update your
facility's UFI as part of your registration renewal, FDA will verify
the accuracy of your facility's UFI and will also verify that the
facility-specific address associated with the UFI is the same address
associated with your registration. FDA will not provide you with a
confirmation of your registration renewal until FDA verifies the
accuracy of your UFI and verifies that the facility-specific address
associated with the UFI is the same address associated with your
registration.
    (6) For registrations not submitted by the owner, operator, or
agent in charge of the facility, after submission of the registration
by mail or fax, FDA will verify that the individual identified as
having authorized submission of the registration in fact authorized the
submission on behalf of the facility. FDA will not confirm the
registration or provide a registration number until that individual
confirms that he or she authorized the submission. With respect to
registration renewals, after completion of the registration renewal by
mail or fax, FDA will provide a confirmation of the registration
renewal. For registration renewals not submitted by the owner,
operator, or agent in charge of the facility, FDA will verify that the
individual identified as having authorized submission of the
registration renewal in fact authorized the submission on behalf of the
facility. FDA will not provide a confirmation of the registration
renewal until that individual confirms that he or she authorized the
submission.
    (7) For a foreign facility, after you submit your registration by
mail or fax, FDA will verify that the person identified as the U.S.
agent for your foreign facility has agreed to serve as your U.S. agent.
FDA will not confirm your registration or provide you with a
registration number until that person confirms that the person agreed
to serve as your U.S. agent. With respect to registration renewals,
after you complete your registration renewal by mail or fax, FDA will
provide you with a confirmation of your registration renewal. When you
update information about your U.S. agent as part of your registration
renewal, FDA will verify that the person identified as the U.S. agent
for your foreign facility has agreed to serve as your U.S. agent. FDA
will not provide you with a confirmation of your registration renewal
until that person confirms that the person agreed to serve as your U.S.
agent.
    (8) FDA will mail or fax you a copy of the registration as entered,
confirmation of registration, and your registration number. When
responding to a registration submission, FDA will use the means by
which the registration was received by the Agency (i.e., by mail or
fax).
    (9) If any information you previously submitted was incorrect at
the time of submission, you must immediately update your facility's
registration as specified in Sec.  1.234.
    (10) Your facility is considered registered once FDA enters your
facility's registration data into the registration system and the
system generates a registration number.
    (c) Fees. No registration fee is required.
    (d) Language. You must submit all registration information in the
English language except an individual's name, the name of a company,
the name of a street, and a trade name may be submitted in a foreign
language. All information, including these items, must be submitted
using the Latin (Roman) alphabet.
0
5. Revise Sec.  1.232 to read as follows:

Sec.  1.232  What information is required in the registration?

    (a) For a domestic and foreign facility, the following information
is required:
    (1) The name, full address, and phone number of the facility;
    (2) Beginning October 1, 2020, the facility's UFI recognized as
acceptable by FDA;
    (3) The preferred mailing address, if different from that of the
facility;
    (4) The name, full address, and phone number of the parent company,
if the facility is a subsidiary of the parent company;
    (5) All trade names the facility uses;
    (6) The name, full address, and phone number of the owner,
operator, or agent in charge of the facility. In addition, the email
address of the owner, operator, or agent in charge is required, unless
FDA has granted you a waiver under Sec.  1.245;
    (7) The applicable food product categories of any food
manufactured/processed, packed, or held at the facility as identified
on Form FDA 3537;
    (8) The type of activity conducted at the facility for each food
product category identified. You may select more than one activity type
for each food product category identified. The activity type options
are as follows:
    (i) Ambient human food storage warehouse/holding facility;
    (ii) Refrigerated human food warehouse/holding facility;
    (iii) Frozen human food warehouse/holding facility;
    (iv) Interstate conveyance caterer/catering point;
    (v) Contract sterilizer;
    (vi) Labeler/relabeler;
    (vii) Manufacturer/processor;
    (viii) Acidified food processor;
    (ix) Low-acid food processor;
    (x) Farm mixed-type facility;
    (xi) Packer/repacker;
    (xii) Salvage operator (reconditioner);
    (xiii) Animal food warehouse/holding facility;
    (xiv) Other activity.
    (9) A statement in which the owner, operator, or agent in charge
provides an assurance that FDA will be permitted to inspect the
facility at the times and in the manner permitted by the Federal Food,
Drug, and Cosmetic Act;
    (10) A statement in which the owner, operator, or agent in charge
certifies that the information submitted is true and accurate. If the
individual submitting the form is not the owner, operator, or agent in
charge of the facility, the registration must also include a statement
in which the individual certifies that the information submitted is
true and accurate, certifies that he/she is authorized to submit the
registration, and identifies by name, address, and

telephone number, the individual who authorized submission of the
registration. In addition, the registration must identify the
individual who authorized submission of the registration by email
address, unless FDA has granted a waiver under Sec.  1.245. Each
registration must include the name of the individual submitting the
registration, and the individual's signature (for the paper option).
    (b) For a domestic facility, the following additional information
is required:
    (1) The email address for the contact person of the facility;
    (2) An emergency contact phone number and email address if
different from the email address for the contact person in paragraph
(b)(1) of this section.
    (c) For a foreign facility, the following additional information is
required:
    (1) The name, full address, phone number, and email address of the
foreign facility's U.S. agent;
    (2) An emergency contact phone number and email address.
0
6. Revise Sec.  1.233 to read as follows:

Sec.  1.233  Are there optional items included in the registration
form?

    Yes. FDA encourages, but does not require, you to submit items that
are indicated as optional on the Form FDA 3537 that you submit.
0
7. Revise Sec.  1.234 to read as follows:

Sec.  1.234  How and when do you update your facility's registration
information?

    (a) Update requirements. You must update a facility's registration
within 60 calendar days of any change to any of the information
previously submitted under Sec.  1.232 (e.g., change of operator, agent
in charge, or U.S. agent), except a change of the owner. You may
authorize an individual to update a facility's registration on your
behalf. For updates not submitted by the owner, operator, or agent in
charge of the facility, the update must provide the email address of
the individual who authorized submission of the update, unless FDA has
granted a waiver under Sec.  1.245.
    (b) Cancellation due to ownership changes. If the reason for the
update is that the facility has a new owner, the former owner must
cancel the facility's registration as specified in Sec.  1.235 within
60 calendar days of the change and the new owner must submit a new
registration for the facility as specified in Sec.  1.231. The former
owner may authorize an individual to cancel a facility's registration.
    (c) Electronic update. (1) To update your registration
electronically, you must update at http://www.fda.gov/furls.
    (2) After you submit your electronic update, FDA will provide you
with an electronic confirmation of your update. When updating UFI
information, FDA will verify the accuracy of your facility's UFI and
will also verify that the facility-specific address associated with the
UFI is the same address associated with your registration. FDA will not
provide you with an electronic confirmation of your registration update
until FDA verifies the accuracy of your facility's UFI and verifies
that the facility-specific address associated with the UFI is the same
address associated with your registration. For foreign facilities, when
updating information about your U.S. agent, FDA will verify that the
person identified as the U.S. agent for your foreign facility has
agreed to serve as your U.S. agent. FDA will not provide you with an
electronic confirmation of your registration update until that person
confirms that the person agreed to serve as your U.S. agent.
    (3) For electronic updates not submitted by the owner, operator, or
agent in charge of the facility, after submission of the electronic
update, FDA will verify that the individual identified as having
authorized submission of the update in fact authorized the submission
on behalf of the facility. FDA will not confirm the update to the
registration until that individual confirms that he or she authorized
the submission.
    (4) Your registration will be considered updated once FDA sends you
your update confirmation, unless notified otherwise.
    (d) Update by mail or fax. Beginning January 4, 2020, you must
submit your update electronically, unless FDA has granted you a waiver
under Sec.  1.245. If FDA has granted you a waiver under Sec.  1.245,
you may update your facility's registration by mail or by fax.
    (1) You must update your registration using Form FDA 3537. You may
obtain a copy of this form by writing to the U.S. Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 5001
Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form
by phone at 1-800-216-7331 or<PHONE_NUMBER>.
    (2) When you receive the form, you must legibly fill out the
sections of the form reflecting your updated information and either
mail it to the address in paragraph (d)(1) of this section or fax it to
301-436-2804.
    (3) If the information on the form is incomplete or illegible when
FDA receives it, FDA will return the form to you for revision, provided
that your mailing address or fax number is legible and valid. When
returning a registration form for revision, FDA will use the means by
which the registration was received by the Agency (i.e., by mail or
fax).
    (4) FDA will enter complete and legible updates into its
registration system as soon as practicable, in the order FDA receives
them.
    (5) FDA will then mail to the address or fax to the fax number on
the registration form a copy of the update as entered and confirmation
of the update. When responding to an update submission, FDA will use
the means by which the form was received by the Agency (i.e., by mail
or fax). After you submit your update by mail or fax, FDA will verify
the accuracy of your facility's UFI and will also verify that the
facility-specific address associated with the UFI is the same address
associated with your registration. FDA will not provide a confirmation
of your registration update until FDA verifies the accuracy of your
facility's UFI and verifies that the facility-specific address
associated with the UFI is the same address associated with your
registration. For foreign facilities, when updating information about
your U.S. agent, FDA will verify that the person identified as the U.S.
agent for your foreign facility has agreed to serve as your U.S. agent.
FDA will not provide you with a confirmation of your registration
update until that person confirms that the person agreed to serve as
your U.S. agent.
    (6) For registration updates not submitted by the owner, operator,
or agent in charge of the facility, after submission of the
registration update by mail or fax, FDA will verify that the individual
identified as having authorized submission of the update in fact
authorized the submission on behalf of the facility. FDA will not
confirm the registration update until that individual confirms that he
or she authorized the update.
    (7) If any update information you previously submitted was
incorrect at the time of submission, you must immediately resubmit your
update.
    (8) Your registration will be considered updated once FDA enters
your facility's update data into the registration system and the system
generates an update confirmation.
0
8. Revise Sec.  1.235 to read as follows:

Sec.  1.235  How and when do you cancel your facility's registration
information?

    (a) Notification of registration cancellation. You must cancel a
registration within 60 calendar days of the reason for cancellation
(e.g., your facility ceases operations, ceases providing food for
consumption in the

United States, or is sold to a new owner).
    (b) Cancellation requirements. The cancellation of a facility's
registration must include the following information:
    (1) The facility's registration number;
    (2) Whether the facility is domestic or foreign;
    (3) The facility name and address;
    (4) The name, address, and email address (if available) of the
individual submitting the cancellation;
    (5) For registration cancellations not submitted by the owner,
operator, or agent in charge of the facility, the email address of the
individual who authorized submission of the registration cancellation,
unless FDA has granted a waiver under Sec.  1.245; and
    (6) A statement certifying that the information submitted is true
and accurate, and that the person submitting the cancellation is
authorized by the facility to cancel its registration.
    (c) Electronic cancellation. (1) To cancel your registration
electronically, you must cancel at http://www.fda.gov/furls.
    (2) Once you complete your electronic cancellation, FDA will
provide you with an electronic confirmation of your cancellation.
    (3) For registration cancellations not submitted by the owner,
operator, or agent in charge of the facility, after submission of the
registration cancellation, FDA will verify that the individual
identified as having authorized submission of the cancellation in fact
authorized the submission on behalf of the facility. FDA will not
confirm the registration cancellation until that individual confirms
that he or she authorized the registration cancellation.
    (4) Your registration will be considered cancelled once FDA sends
you your cancellation confirmation.
    (d) Cancellation by mail or fax. Beginning January 4, 2020, you
must cancel your registration electronically, unless FDA has granted
you a waiver under Sec.  1.245. If FDA has granted a waiver under Sec.
1.245, you may cancel your facility's registration by mail or fax.
    (1) You must cancel your registration using Form FDA 3537a. You may
obtain a copy of this form by writing to the U.S. Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 5001
Campus Dr. (HFS-681), College Park, MD 20740 or by requesting the form
by phone at 1-800-216-7331 or<PHONE_NUMBER>.
    (2) When you receive the form, you must completely and legibly fill
out the form and either mail it to the address in paragraph (d)(1) of
this section or fax it to<PHONE_NUMBER>.
    (3) If the information on the form is incomplete or illegible when
FDA receives it, FDA will return the form to you for revision, provided
that your mailing address or fax number is legible and valid. When
returning a cancellation form for revision, FDA will use the means by
which the cancellation was received by the Agency (i.e., by mail or
fax).
    (4) FDA will enter complete and legible mailed and faxed
cancellations into its registration system as soon as practicable, in
the order FDA receives them.
    (5) FDA will mail to the address or fax to the fax number on the
cancellation form a copy of the cancellation as entered and
confirmation of the cancellation. When responding to a cancellation,
FDA will use the means by which the form was received by the Agency
(i.e., by mail or fax).
    (6) For registration cancellations not submitted by the owner,
operator, or agent in charge of the facility, after submission of the
registration cancellation by mail or fax, FDA will verify that the
individual identified as having authorized submission of the
cancellation in fact authorized the submission on behalf of the
facility. FDA will not confirm the registration cancellation until that
individual confirms that he or she authorized the registration
cancellation.
    (7) Your registration will be considered cancelled once FDA enters
your facility's cancellation data into the registration system. FDA
will send you your cancellation confirmation.
0
9. Revise Sec.  1.241 to read as follows:

Sec.  1.241  What are the consequences of failing to register, update,
renew, or cancel your registration?

    (a) Section 301 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331) prohibits the doing of certain acts or causing such acts to
be done. Under section 302 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 332), the United States can bring a civil action in Federal
court to enjoin a person who commits a prohibited act. Under section
303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), the
United States can bring a criminal action in Federal court to prosecute
a person who is responsible for the commission of a prohibited act.
Under section 306 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 335a), FDA can seek debarment of any person who has been
convicted of a felony relating to importation of food into the United
States. Failure of an owner, operator, or agent in charge of a domestic
or foreign facility to register its facility, renew the registration of
its facility, update required elements of its facility's registration,
or cancel its registration in accordance with the requirements of this
subpart is a prohibited act under section 301(dd) of the Federal Food,
Drug, and Cosmetic Act.
    (b) FDA will consider a registration for a food facility to be
expired if the registration is not renewed, as required by Sec.
1.230(b). Thus, if you previously submitted a registration to FDA, but
do not submit a registration renewal to FDA during the period beginning
on October 1 and ending on December 31 of each even-numbered year, FDA
will consider the registration for the facility to be expired. FDA will
consider a food facility with an expired registration to have failed to
register in accordance with section 415 of the Federal Food, Drug, and
Cosmetic Act.
    (c) FDA will cancel a registration if FDA independently verifies
that the facility is no longer in business or has changed owners, and
the owner, operator, or agent in charge of the facility fails to cancel
the registration, or if FDA determines that the registration is for a
facility that does not exist, is not required to register, or where the
information about the facility's address was not updated in a timely
manner in accordance with Sec.  1.234(a) or the registration was
submitted by a person not authorized to submit the registration under
Sec.  1.225. Also, FDA will cancel a registration if the facility's
registration has expired because the facility has failed to renew its
registration in accordance with Sec.  1.230(b). If FDA cancels a
facility's registration, FDA will send a confirmation of the
cancellation using contact information submitted by the facility in the
registration database.
    (d) If an article of food is imported or offered for import into
the United States and a foreign facility that manufactured/processed,
packed, or held that article of food has not registered in accordance
with this subpart, the disposition of the article of food shall be
governed by the procedures set out in subpart I of this part.
0
10. Add Sec.  1.245 to subpart H to read as follows:

Sec.  1.245  Waiver request.

    Under Sec. Sec.  1.231(a)(2) and (b), 1.234(d), and 1.235(d),
beginning January 4, 2020, you must submit your registration,
registration renewal, updates, and cancellations to FDA electronically
unless FDA has granted a waiver from such requirement. Under Sec.
1.232(a)(6), you must provide the email address of the owner, operator,
or agent in charge

of the facility unless FDA has granted a waiver from such requirement.
In addition, under Sec. Sec.  1.230(b) and (c), 1.232(a)(10), 1.234(a),
and 1.235(b)(5), registration renewals, abbreviated registration
renewals, registrations, updates, and cancellations not submitted by
the owner, operator, or agent in charge must include the email address
for the individual who authorized the submission, unless FDA has
granted a waiver. To request a waiver from these requirements, you must
submit a written request to FDA that explains why it is not reasonable
for you to submit your registration, registration renewal, update, or
cancellation to FDA electronically or to provide the email address of
the owner, operator, or agent in charge of the facility. You must
submit your request to: U.S. Food and Drug Administration, Center for
Food Safety and Applied Nutrition, 5001 Campus Dr. (HFS-681), College
Park, MD 20740.

    Dated: July 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16531 Filed 7-13-16; 8:45 am]
BILLING CODE 4164-01-P