[Federal Register Volume 78, Number 70 (Thursday, April 11, 2013)]
[Rules and Regulations]
[Page 21537]
[FR Doc No: 2013-08404]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0183]

Drawbridge Operation Regulations; Upper Mississippi River, Rock
Island, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Rock Island Railroad and Highway
Drawbridge across the Upper Mississippi River, mile 482.9, at Rock
Island, Illinois. The deviation is necessary to allow the Front Street
5K Run to cross the bridge. This deviation allows the bridge to be
maintained in the closed-to-navigation position for one hour.

DATES: This deviation is effective from 7 p.m. to 8 p.m. on June 15,
2013.

ADDRESSES: The docket for this deviation, [USCG-2013-0183] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Eric A. Washburn, Bridge
Administrator, Western Rivers, Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Barbara Hairston, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The U.S. Army Rock Island Arsenal requested
a temporary deviation for the Rock Island Railroad and Highway
Drawbridge, across the Upper Mississippi River, mile 482.9, at Rock
Island, Illinois to remain in the closed-to-navigation position for a
one hour period from 7 p.m. to 8 p.m., June 15, 2013, while a 5K run is
held between the cities of Davenport, IA and Rock Island, IL. The Rock
Island Railroad and Highway Drawbridge currently operates in accordance
with 33 CFR 117.5, which states the general requirement that
drawbridges shall open promptly and fully for the passage of vessels
when a request to open is given in accordance with the subpart.
    There are no alternate routes for vessels transiting this section
of the Upper Mississippi River.
    The Rock Island Railroad and Highway Drawbridge, in the closed-to-
navigation position, provides a vertical clearance of 23.8 feet above
normal pool. Navigation on the waterway consists primarily of
commercial tows and recreational watercraft. This temporary deviation
has been coordinated with waterway users. No objections were received.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: March 21, 2013.
Eric A. Washburn,
Bridge Administrator, Western Rivers.
[FR Doc. 2013-08404 Filed 4-10-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 74, Number 85 (Tuesday, May 5, 2009)]
[Notices]
[Pages 20776-20777]
[FR Doc No: E9-10209]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2008-0078]

Commercial Driver's License (CDL) Standards; Rotel North American
Tours, LLC; Amendment of Exemption

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of amendment; request for comments.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces that the Rotel North American Tours, LLC
(Rotel), has applied for amendment of its existing exemption that
permits 22 named drivers, employed by Rotel and possessing German CDLs,
to operate commercial motor vehicles (CMVs) in the U.S. without a CDL
issued by one of the States. Rotel proposes to amend the roster of 22
exempt Rotel drivers in order to substitute three new Rotel drivers for
three drivers no longer employed by Rotel. The new Rotel drivers would
be subject to all the terms and conditions of the current exemption,
including its expiration date of July 30, 2010.

DATES: Comments must be received on or before May 20, 2009.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA-2008-0078 by any of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Telefax: 1-202-493-2251.

     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Ave., SE., West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Ave., SE., Washington, DC 20590, between
9 a.m. and 5 p.m., E.T., Monday through Friday, except Federal
holidays.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments and
additional information on the exemption process, see the Public
Participation heading below. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, and follow the
online instructions for accessing the dockets, or go to the street
address listed above.
    Privacy Act: You may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review the
DOT's complete Privacy Act Statement in the Federal Register published
on April 11, 2000 (65 FR 19476) or you may visit http://DocketInfo.dot.gov.
    Public Participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You may obtain electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal Web site. If you want us to notify
you that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgment page that
appears after submitting comments online. Comments received after the
comment closing date will be included in the docket, and we will
consider late comments to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Mr. Robert F. Schultz, Jr., FMCSA
Driver and Carrier Operations Division, Office of Bus and Truck
Standards and Operations: Telephone:<PHONE_NUMBER>. E-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    Section 4007 of the Transportation Equity Act for the 21st Century
(Pub. L. 105-178, 112 Stat. 107, June 9, 1998) amended 49 U.S.C. 31315
and 31136(e) to provide FMCSA authority to grant exemptions from its
motor carrier safety regulations, including the HOS rules. The
procedure for requesting an exemption is prescribed in 49 CFR part 381.
FMCSA must publish a notice of each exemption request in the Federal
Register (49 CFR 381.315(a)). The Agency must provide the public an
opportunity to inspect the information relevant to the application,
including any safety analyses that have been conducted, and to comment
on the request.
    The Agency must review the safety analyses and public comments.
Then it may grant the exemption for up to 2 years if it finds ``such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption'' (49 CFR 381.305). The decision of the Agency must be
published in the Federal Register (49 CFR 381.315(b)) with the reason
for denying or, in the alternative, the specific person or class of
persons receiving the exemption, and the regulatory provision or
provisions from which the exemption is granted. The notice must also
specify the effective period of the exemption and its terms and
conditions.
    Rotel provides seasonal motorcoach tours for non-English speaking
tourists. The service is unique because the drivers of these buses
serve as the tour guides, providing oral commentary to the passengers
in their native language, usually German. Rotel states that none of the
States of the U.S. will issue CDLs to these drivers because they are
not State residents. Until recent years, Rotel drivers were able to
obtain a non-resident CDL from certain States. Rotel asserts that
without the exemption from the requirement that its drivers have a CDL
issued by a State, it would have to terminate these tour operations.
Complete details of Rotel's operations can be found in its original
application, dated August 27, 2007, which is contained in the docket of
this notice.
    On July 30, 2008, FMCSA granted, after notice and comment, Rotel's
request to allow 22 drivers, each holding a German CDL, to operate
Rotel motor coaches in the U.S. without a CDL issued by one of the
States as required by 49 CFR 383.23 (73 FR 44313). FMCSA found that
these drivers, operating specialty tour buses in the U.S., would
``likely achieve a level of safety that is equivalent to, or greater
than, the level that would be achieved absent such exemption,'' in
accordance with 49 CFR 381.305. The 2-year exemption expires on July
30, 2010.

Rotel's Request for Amendment

    By letter dated February 6, 2009, supplemented by an e-mail message
dated April 9, 2009, Rotel applied for an amendment to its exemption
for the sole purpose of replacing three drivers on the original roster
of 22 Rotel drivers approved for this exemption. Both documents are
available in the docket for this notice. Rotel asks that Jens Radloff,
Christian Hafner, and Ludwig Gerlsberger be dropped from that roster,
and that, in their place, Rotel employees Klaus Endres, Sebastian
Nicki, and Karl-Heinz Schmitz, non-residents of the U.S. and holders of
German CDLs, be added to the roster as drivers exempt from the CDL
licensing requirement. Rotel believes these three new drivers, like the
non-resident Rotel drivers already operating under this exemption,
possess sufficient knowledge, skills, and experience to ensure a level
of safety that is equivalent to, or greater than, the level of safety
that would be obtained by complying with the requirement for a U.S.
CDL. If the Agency determines that this amendment should be granted,
the three new drivers would be subject to the terms and conditions of
the original Rotel exemption.
    In accordance with 49 U.S.C. 31315(b)(4) and 31136(e), FMCSA
requests public comments on Rotel's request for amendment of its
exemption to allow it to substitute three new Rotel CDL drivers for
three of the 22 original Rotel CDL drivers granted exemption from 49
CFR 383.23 on July 30, 2008. FMCSA will consider all comments received
by close of business on May 20, 2009. All comments will be available
for examination in the docket at the location listed under the
ADDRESSES section of this notice. The Agency will consider to the
extent practicable comments received in the public docket after the
closing date of the comment period.

    Issued on: April 28, 2009.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-10209 Filed 5-4-09; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Notices]
[Page 68870]
[FR Doc No: 2013-27324]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Rule 101
    SEC File No. 270-408, OMB Control No. 3235-0464.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 101 of Regulation M (17
CFR 242.101), under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.). The Commission plans to submit this existing collection of
information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Rule 101--Activities by Distribution Participants--prohibits
distribution participants from purchasing activities at specified times
during a distribution of securities. Persons otherwise covered by this
rule may seek to use several applicable exceptions such as a
calculation of the average daily trading volume of the securities in
distribution, the maintenance of policies regarding information
barriers between their affiliates, and the maintenance of a written
policy regarding general compliance with Regulation M for de minimus
transactions.
    There are approximately 1,762 respondents per year that require an
aggregate total of 34,525 hours to comply with this rule. Each
respondent makes an estimated 1 annual response. Each response takes on
average approximately 19.594 hours to complete. Thus, the total
compliance burden per year is 34,525 burden hours. The total estimated
internal labor compliance cost for the respondents is approximately
$2,175,075.00, resulting in an estimated internal labor cost of
compliance for each respondent per response of approximately $1,234.435
(i.e., $2,175,075.00/1,762 responses).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Thomas Bayer, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>
    Dated: November 8, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-27324 Filed 11-14-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58432-58433]
[FR Doc No: 2012-23180]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67865; File No. SR-ISE-2012-22]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Designation of Longer Period for Commission Action on
Proceedings To Determine Whether To Disapprove Proposed Rule Change, as
Modified by Amendment No. 1, To Add an Index Option Product for Trading
on the Exchange

September 14, 2012.
    On March 9, 2012, the International Securities Exchange, LLC
(``Exchange'' or ``ISE'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to list and trade options on the
ISE Max SPY Index. The proposed rule change was published for comment
in the Federal Register on March 22, 2012.\3\ The Commission initially
received three comment letters on the proposed rule change.\4\ On May
1, 2012, the Commission extended the time period for Commission action
to June 20, 2012.\5\ On May 4, 2012, the Exchange submitted a response
to the comment letters \6\ and filed Amendment No. 1 to the proposed
rule change. The Commission subsequently received three additional
comment letters \7\ and a second response letter from the Exchange.\8\
On June 20, 2012, the Commission instituted proceedings to determine
whether to disapprove the proposed rule change, as modified by

Amendment No. 1.\9\ The Commission thereafter received six comment
letters \10\ and two response letters from the Exchange.\11\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 66614 (March 16,
2012), 77 FR 16883.
    \4\ See letters to Elizabeth M. Murphy, Secretary, Commission,
from Janet McGinness, EVP & Corporate Secretary, NYSE Euronext,
dated April 2, 2012; Kenneth M. Vittor, Executive Vice President and
General Counsel, McGraw-Hill Companies, Inc., dated April 11, 2012;
and Edward T. Tilly, President and Chief Operating Officer, Chicago
Board Options Exchange, Incorporated (``CBOE''), dated April 13,
2012.
    \5\ See Securities Exchange Act Release No. 66889 (May 1, 2012),
77 FR 26812 (May 7, 2012).
    \6\ See letter to Elizabeth M. Murphy, Secretary, Commission,
from Michael J. Simon, Secretary and General Counsel, ISE, dated May
4, 2012.
    \7\ See letters to Elizabeth M. Murphy, Secretary, Commission,
from Edward T. Tilly, President and Chief Operating Officer, CBOE,
dated June 7, 2012; Kenneth M. Vittor, Executive Vice President and
General Counsel, McGraw-Hill Companies, Inc., dated June 18, 2012;
and Edward T. Tilly, President and Chief Operating Officer, CBOE,
dated June 19, 2012.
    \8\ See letter to Elizabeth M. Murphy, Secretary, Commission,
from Michael J. Simon, Secretary and General Counsel, ISE, dated
June 15, 2012.
    \9\ See Securities Exchange Act Release No. 67225 (June 20,
2012), 77 FR 38100 (June 26, 2012) (``Order Instituting
Proceedings'').
    \10\ See letters to Elizabeth M. Murphy, Secretary, Commission,
from Christopher Nagy, President, KOR Trading LLC, dated August 6,
2012; John L. Jacobs, Executive Vice President, NASDAQ OMX Global
Index Group, NASDAQ OMX Group, Inc., dated August 10, 2012; Kenneth
M. Vittor, Executive Vice President and General Counsel, McGraw-Hill
Companies, Inc., dated August 10, 2012; Edward T. Tilly, President
and Chief Operating Officer, CBOE, dated August 10, 2012; John V.
O'Hanlon, Dechert LLP, on behalf of the Index Industry Association,
dated August 10, 2012; and Edward T. Tilly, President and Chief
Operating Officer, CBOE, dated August 27, 2012.
    \11\ See letters to Elizabeth M. Murphy, Secretary, Commission,
from Michael J. Simon, Secretary, ISE, dated August 10, 2012 and
August 27, 2012.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \12\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule change was published for notice and comment in the
Federal Register on March 22, 2012. September 18, 2012 is 180 days from
that date, and November 17, 2012 is 240 days from that date.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider this proposed
rule change, the issues raised in the comment letters that have been
submitted in response to the proposed rule change, including comment
letters submitted in response to the Order Instituting Proceedings, and
the Exchange's responses to such comments.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\13\ designates November 17, 2012 as the date by which the
Commission shall either approve or disapprove the proposed rule change
(File No. SR-ISE-2012-22).
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-23180 Filed 9-19-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Page 11786]
[FR Doc No: 2016-04952]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP02-31-000; CP07-457-000; CP06-76-000]

Stephen Kohlhase, v. Iroquois Gas Transmission System, L.P.,
Algonquin Gas Transmission, LLC; Notice of Complaint

    Take notice that on February 12, 2016, pursuant to section 5 of the
Natural Gas Act (NGA) \1\ and section 385.206 of the Commission's Rules
of Practice and Procedure,\2\ Stephen Kohlhase (Complainant) filed a
formal complaint against Iroquois Gas Transmission System, L.P. and
Algonquin Gas Transmission (collectively, Respondents) alleging that a
2009 modification of the Brookfield Compressor Station in Brookfield,
Connecticut, and related pipeline infrastructure, caused an increase in
low-frequency noise and vibration in violation of the Commission's
regulations.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 717d (2012).
    \2\ 18 CFR 385.206 (2015).
    \3\ The Complainant cites the noise quality specifications in
sections 380.12(k)(4)(v)(A) and (B) of the Commission's regulations.
---------------------------------------------------------------------------

    The complainant certifies that copies of the complaint were served
on the contacts for the Respondents as listed on the Commission's list
of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure.\4\ Protests will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Any person
wishing to become a party must file a notice of intervention or motion
to intervene, as appropriate. The Respondents' answer, motions to
intervene, and protests must be served on the Complainant.
---------------------------------------------------------------------------

    \4\ 18 CFR 385.211 and 385.214 (2015).
---------------------------------------------------------------------------

    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on March 7, 2016.

    Dated: February 24, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-04952 Filed 3-4-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 149 (Friday, August 4, 2023)]
[Notices]
[Pages 51876-51879]
[FR Doc No: 2023-16622]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-98028; File No. SR-MEMX-2023-14]

Self-Regulatory Organizations; MEMX LLC; Notice of Filing and
Immediate Effectiveness of a Proposed Rule Change To Amend the Manner
in Which the Exchange Will Designate Certain Options Members To
Participate in its Mandatory Disaster Recovery Testing for Calendar
Year 2023

    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 25, 2023, MEMX LLC (``MEMX'' or the ``Exchange'') filed
with the Securities and Exchange Commission (the ``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing with the Commission a proposed rule change
to amend the manner in which the Exchange will designate certain
Options Members to participate in mandatory

disaster recovery testing, pursuant to Regulation SCI and MEMX Rule 2.4
for calendar year 2023. The text of the proposed rule change is
provided in Exhibit 5.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In preparation for the launch of the Exchange's options market
(``MEMX Options''),\3\ the Exchange proposes to amend MEMX Rule 2.4,
Mandatory Participation in Testing of Backup Systems, to specify how
the Exchange will designate certain Options Members \4\ to participate
in mandatory disaster recovery pursuant to Regulation SCI and MEMX Rule
2.4 for calendar year 2023. Regulation SCI requires MEMX, as an SCI
entity, to maintain business continuity and disaster recovery plans
that provide for resilient and geographically diverse backup and
recovery capabilities that are reasonably designed to achieve two-hour
resumption of critical SCI systems and next business day resumption of
other SCI systems following a wide-scale disruption.\5\
---------------------------------------------------------------------------

    \3\ On August 8, 2022, the Commission approved SR-MEMX-2022-10,
which proposed rules for the trading of options on the Exchange. See
Securities Exchange Act Release No. 95445 (August 9, 2022), 87 FR
49884 (August 12, 2022) (SR-MEMX-2022-010). The Exchange plans to
launch MEMX Options in September of 2023.
    \4\ As of July 18, 2023, 15 firms have filed paperwork with the
Exchange making them eligible for MEMX Options membership.
    \5\ Securities Exchange Act Release No. 73639 (November 19,
2014), 79 FR 72252 (December 5, 2014).
---------------------------------------------------------------------------

    Regulation SCI and MEMX Rule 2.4 also require MEMX to designate
certain Members \6\ to participate in business continuity and disaster
recovery testing in a manner specified by MEMX and at a frequency of
not less than once every 12 months.\7\ Such testing is part of an
industry-wide test, which is next scheduled for October 14, 2023.
---------------------------------------------------------------------------

    \6\ The term ``Member'' refers to any registered broker or
dealer that has been admitted to membership in the Exchange. A
Member will have the status of a member of the Exchange as that term
is defined in section 3(a)(3) of the Act. Membership may be granted
to a sole proprietor, corporation, limited liability company or
other organization which is a registered broker or dealer pursuant
to section 15 of the Act, and which has been approved by the
Exchange. See MEMX Rule 1.5(p). The term ``Options Member'' means a
firm, or organization that is registered with the Exchange pursuant
to Chapter 17 of the Exchange's Rules for purposes of participating
in options trading on MEMX Options as an ``Options Order Entry
Firm'' or ``Options Market Maker''. See MEMX Rule 16.1.
    \7\ MEMX Rule 2.4(a) and (b).
---------------------------------------------------------------------------

    MEMX Rule 2.4 governs mandatory participation in testing of the
Exchange's backup systems, and states that the Exchange will designate
Members that account for a specified percentage of executed volume on
MEMX as required to connect to the Exchange's backup systems and
participate in functional and performance testing of such system.\8\
MEMX Options, which is scheduled to launch in September 2023, is not
expecting to have sufficient trading data on which to base its Options
Member designation prior to the October 14, 2023 test. Thus, as
currently written, Rule 2.4 would not permit the Exchange to designate
any Options Members to participate in the industry-wide test for 2023
because no Options Members will have sufficient trading volume on MEMX
Options upon which a designation can be based.
---------------------------------------------------------------------------

    \8\ Id.
---------------------------------------------------------------------------

    To address the unique circumstances for disaster recovery testing
in 2023, the year in which MEMX Options will become operational, the
Exchange proposes to amend paragraph (c). Proposed paragraph (c) would
provide that for calendar year 2023 with respect to MEMX Options,
notwithstanding paragraph (b) which assigns the Exchange responsibility
of ``identifying Members that account for a meaningful percentage of
the Exchange's overall volume,'' the Exchange will instead designate at
least three Options Members who have a meaningful percentage of trading
volumes in options on other options exchanges. This would allow the
Exchange to identify Options Members for industry-wide disaster
recovery testing in the absence of metrics that will be used in
ordinary course to designate such firms.
    MEMX believes that designating at least three Options Members who
are likely already to be participating in the industry-wide test by
virtue of their trading activities on MEMX and other exchanges is
likely to reduce the burdens associated with being designated for
disaster recovery testing by MEMX Options in absence of significant
trading volumes on the Exchange. Moreover, to reduce the burdens on
designated Options Members, the Exchange proposes, where possible, to
designate firms that have already established connections to its backup
systems. This is intended to address the ``notice'' requirements in the
existing Rule 2.4.\9\ The Exchange believes that designating three or
more such firms is reasonably designed to provide the minimum necessary
for the maintenance of fair and orderly markets in the event of the
activation of such plans.
---------------------------------------------------------------------------

    \9\ Pursuant to Rule 2.4(b), the Exchange will provide at least
six months prior notice to a Member that is designated for mandatory
testing. See MEMX Rule 2.4(b).
---------------------------------------------------------------------------

    MEMX intends to notify Options Members of their designation for
disaster recovery testing no later than October 1, 2023. With respect
to industry-wide disaster recovery testing in 2024 and beyond, the
Exchange will issue one or more regulatory circulars establishing the
standards to be used for determining which Options Members contribute a
meaningful percentage of the Exchange's overall volume and thus are
required to participate in functional and performance testing. Such
standards will be informed by the Exchange's actual market and trading
data, in accordance with MEMX Rule 2.4(b).
2. Statutory Basis
    The Exchange believes that its proposal is consistent with section
6(b) of the Act,\10\ in general, and furthers the objectives of section
6(b)(5) of the Act,\11\ in particular, in that it is designed to
prevent fraudulent and manipulative practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general to
protect investors and the public interest.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    MEMX believes that, in the absence of sufficient trading data on
MEMX Options, its proposed methodology of designating Options Members
who have meaningful levels of trading activity on other exchanges and
who have established connectivity to the Exchange's backup systems is
consistent with the protection of investors and the public interest.
The Exchange further

believes that the proposed rule change will ensure that the Options
Members necessary to ensure the maintenance of fair and orderly markets
in the event of the activation of the Exchange's disaster recovery
plans have been designated consistent with MEMX Rule 2.4 and Rule 1004
of Regulation SCI. Specifically, the proposal will address the unique
circumstances of industry-wide testing taking place within a short time
of MEMX Options commencing operations. The Exchange believes that the
proposed rule change balances the objectives of having Options Members
participate in industry-wide disaster recovery testing, including MEMX
Options' backup systems, and the burdens on such Options Members who,
at the time of designation, will not have traded on MEMX Options.
    As set forth in the SCI Adopting Release, ``SROs have the
authority, and legal responsibility, under section 6 of the Exchange
Act, to adopt and enforce rules (including rules to comply with
Regulation SCI's requirements relating to BC/DR testing) applicable to
their members or participants that are designed to, among other things,
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public
interest.'' \12\ The Exchange believes that this proposal is consistent
with such authority and legal responsibility.
---------------------------------------------------------------------------

    \12\ See supra note 7 at 72350.
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes its proposed rule change would not impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. To the contrary, the Exchange
believes that the proposed rule change promotes fair competition among
brokers and dealers and exchanges by ensuring the Exchange can
designate Options Members to participate in mandatory disaster recovery
testing pursuant to Regulation SCI for calendar year 2023. The Exchange
believes that designating three or more such firms is reasonably
designed to provide the minimum necessary for the maintenance of fair
and orderly markets in the event of the activation of such plans,
thereby promoting intermarket competition between exchanges in
furtherance of the principles of section 11(a)(1) of the Act.\13\ The
Exchange notes that MEMX and the Long-Term Stock Exchange, Inc.
(``LTSE'') adopted similar rules for 2020 in advance of launches that
year.\14\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78k-1(a)(1).
    \14\ See Securities Exchange Act Release No. 89899 (September
16, 2020), 85 FR 59580 (September 22, 2020) (SR-MEMX-2020-07), and
Release No. 89216 (July 2, 2020), 85 FR 41259 (July 9, 2020) (SR-
LTSE-2020-10).
---------------------------------------------------------------------------

    With respect to intramarket competition, the proposed rule change
seeks to reduce the burdens on Members by only designating Options
Members who are likely already participating in the industry-wide test
by virtue of their trading activities on other exchanges. Under the
proposed rule change, the Exchange will designate firms that have
already established connections to the Exchange's backup systems.
Consequently, MEMX does not believe that the proposed rule change would
impose any burden on intramarket competition that is not necessary or
appropriate in furtherance of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received comments on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to section 19(b)(3)(A) of the Act \15\ and Rule 19b-
4(f)(6) thereunder.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-MEMX-2023-14 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to file number SR-MEMX-2023-14. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-MEMX-2023-14 and should be
submitted on or before August 25, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

    Dated: July 31, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-16622 Filed 8-3-23; 8:45 am]
BILLING CODE 8011-01-P


electronically transmitted to FDA’s OASIS and confirmed by FDA for review are not feasible
because CBP also needs finality so it can complete its own screening of the entry.
Changes to confirmed prior notice submissions, other than those relating to estimated
quantity, anticipated arrival information, and planned shipment information, must be processed
by resubmission of prior notice unless the article of food will not be offered for import or
imported into the United States.  The responsibility is on submitters to provide accurate prior
notice to FDA, and we encourage affected parties to take appropriate measures to verify entries
for accuracy before sending.  FDA notes that both ABI and PNSI systems allow for correction of
errors that are revealed by the systems’ validation process.  In PNSI, a PN confirmation number
will not be provided if it detects errors in the submitted data.
Moreover, FDA notes that if CBP is unavailable to cancel a prior notice, submitters can
create and submit new replacement entries and prior notices using either ABI or a combination
of ABI and PNSI even when the original entry has not yet been cancelled.  However, the
submitter should cancel the previously submitted inaccurate ABI entry (via request to CBP) at
the first chance possible to avoid subsequent administrative and operational problems with entry
release.  This is a revision to the IFR in that § 1.282(c) of the final rule uses the correct term

264
“cancel” versus “delete” when describing what CBP should be requested to do in this case.
When an entry is “deleted” versus “cancelled” in ABI, the filer is able to re-use the original entry
number.  However, PNSI will reject a prior notice submission that attempts to re-use a previous
entry number.  Therefore, we revised the final rule to provide for cancellation of the entry, rather
than deletion of an entry.
(Comments) Some comments request that FDA and CBP develop a process for reviewing
amendments that do not affect the security of the cargo in less than the full eight hours, so that
the shipments’ release from the port is not delayed unduly.
(Response) The requirements for amendments set forth in the proposed rule were
eliminated from the IFR.  This final rule provides that if required information (except estimated
quantity, anticipated arrival information, including the anticipated date of mailing, and planned
shipment information) changes after FDA has confirmed prior notice for review, the prior notice
should be cancelled and a prior notice with the correct information must be submitted.  The
reduced timeframes in the IFR, which are continued in the final rule, provide very little leeway in
the time FDA has to receive, review, and respond to the prior notice submissions.   Moreover,
the timeframes are based, in part, on not receiving amendments because allowing amendments
would increase the review time.  In addition, ACS cannot accommodate changes in prior notice
submissions that have been confirmed by FDA for review because CBP also needs finality so it
can complete its own screening of the entry.  Because we are maintaining the IFR timeframes in
the final rule, it is difficult to accommodate amendments.
(Comments) Some comments state that changes to prior notice should be required for
material changes only.  Materiality would need to be determined.

265
(Response) We agree.  The final rule requires that, if certain required information
changes after FDA has confirmed prior notice for review, the prior notice should be cancelled
and a prior notice with the correct information must be submitted.  Changes to other information
(i.e., estimated quantity, anticipated arrival information, and planned shipment information) do
not require the submitter to re-submit a revised prior notice.
(Comments) Some comments suggest that entry deletions, rather than cancellations,
should be permitted for legitimate reasons.
(Response) FDA believes the comment misunderstands § 1.282(c) of the IFR since that
provision states, “If you submitted the prior notice via ABI/ACS, you should cancel the prior
notice via ACS by requesting that CBP delete the entry” (emphasis added).  However, the final
rule now recommends that if you cancelled a prior notice submitted via ABI/ACS, you should
cancel the prior notice via ACS by requesting that CBP cancel, rather than delete, the entry (§
1.282(c)).  When an entry is “deleted” versus “cancelled” in ABI, the filer is able to re-use the
original entry number.  However, PNSI will reject a prior notice submission that attempts to re-
use a previous entry number.  Therefore, we revised the final rule to provide for cancellation of
the entry, rather than deletion of an entry.
(Comments) One comment requested clarification regarding whether the additional
requirement for planned shipment information as applicable (carrier, vessel name, voyage flight
numbers, and bill of lading number) will necessitate a resubmission when those details change
due to transportation arrangements outside the control of the supplier.
(Response) No.  The final rule does not require resubmission of prior notice if the
planned shipment information changes after prior notice has been submitted and confirmed for
review by FDA.

266
(Comments) One comment notes that part of the process of completing a prior notice is to
obtain a CBP entry number, which many firms use a customs broker to do.  The comment states
that this works well in most cases, but can create problems for products arriving by boat.  The
comment further states that of all the modes of transportation, boats are the most unpredictable
and can arrive earlier or later than expected.  Early arrivals pose a problem because of the 8 hour
notice period and the relatively short timeframe in which a company learns of an impending
early arrival.  Given the fact that customs brokers may not work a 24-hour, 7-day per week
schedule, prior notice shipments that arrive on the weekend, holiday, or after normal business
hours will be filed late and could be subject to civil penalties. The comment recommends that
the prior notice system allow custom entry numbers to be updated after the customs entry has
been filed by the customs brokers and that any penalty considerations be deferred under these
circumstances.
(Response) The type of updates recommended by this comment is not necessary because
prior notice can be submitted without a customs entry number.  In the situation described, where
prior notice must be submitted before entry can be filed, prior notice may be submitted using
PNSI without a CBP entry identifier (e.g., a CBP entry number).  PNSI will provide a system-
generated entry identifier. Once a customs broker is secured during normal business hours to file
the entry, the prior notice confirmation number(s) can be given to the broker who can affiliate
the prior notice(s) to the customs entry via the ABI submission.
(Comments) Some comments request clarification on what happens to the food if the
information relating to product identity, estimated quantity, or anticipated arrival changes after
prior notice is submitted.

267
(Response) The final rule requires that if required information (except estimated quantity,
anticipated arrival information, including the anticipated date of mailing, and planned shipment
information) changes after FDA has confirmed prior notice for review, the prior notice must be
resubmitted. As we explained in the preamble to the IFR, “FDA proposed to allow changes to
certain information in the prior notice after a prior notice was submitted. * * *. Some comments
stated that if the timeframe for submitting prior notice was changed, i.e., shortened to 4 hours for
land and air and 8 hours for water, then amendments and updates would not be necessary. * * *
FDA agrees with the comments that state that if the deadline for submission of prior notice were
reduced, amendments and updates would not be necessary. FDA has chosen timeframes that
provide it with very little leeway in the time it has to ‘receive, review and respond’ to the prior
notice submissions. Thus, we concluded that we could no longer permit changes to prior notice
without restarting the clock. In addition, the use of ABI/ACS precludes amendments and
updates: changes to ABI/ACS submissions that have been electronically transmitted to FDA’s
OASIS and confirmed by FDA for review are not feasible because CBP also needs finality so it
can complete its own screening of the entry. Therefore, the interim final rule does not allow for
changes to a prior notice after the transmitter has been notified that FDA has confirmed the prior
notice for review.” (68 FR 58974 at 59013 and 59014)
We retain this view and therefore, changes in product identity require resubmission of a
prior notice with the correct information.  We do not require resubmission of a prior notice if the
estimated quantity, anticipated arrival information, including the anticipated date of mailing, and
planned shipment information changes, because these data elements are not firm in the first
place.  Moreover, such changes would not alter FDA’s ability to review the prior notice or to
examine the food.

268
(Comments) Some comments request that FDA maintain the flexibility, as provided by
the IFR, to provide anticipated port arrival information for date and time of arrival and point of
crossing.  The comments state that this flexibility is critical for minimizing trade disruption and
note that times of arrival and entry locations often change and importers need the flexibility to
accommodate these unanticipated changes without refiling entry information.
(Response) Section 1.281(a)(11), which requires anticipated arrival information, has been
revised in the final rule.  The requirement to provide the identity of the border crossing within
the anticipated port of arrival has been eliminated in the final rule.  As with the IFR, in the final
rule, changes in anticipated port of arrival, anticipated date of arrival, and anticipated time of
arrival do not require cancellation and resubmission of the prior notice.
(Comments) Some comments suggest that the requirement that all prior notice data be
transmitted via the PNSI portal after the prior notice time limitations or refusal will increase the
load on this limited system. The comments state that the PNSI system capacity must be
dramatically increased before the August 2004 full enforcement deadline in order to ensure that
legitimate trade is not impacted due to a failure of the system.
(Response) FDA does not agree that post-refusal prior notice submissions have or will
impact or overload PNSI.  PNSI has operated effectively since the IFR took effect and has
sufficient capacity for any increase in submissions after the effective date of this final rule.  FDA
has carefully monitored both PNSI and OASIS system usage and performance.  No issues related
to load on PNSI have been identified since the IFR took effect.  Until such time as ACS or its
successor system can accommodate such transactions, post-refusal prior notice must be
submitted via PNSI (see § 1.280(a)(2)).

269
(Final Rule) Section 1.282 of the final rule requires that if required information (except
estimated quantity, anticipated arrival information, including the anticipated date of mailing, and
planned shipment information) changes after FDA has confirmed prior notice for review, the
prior notice should be cancelled and a prior notice with the updated information must be
submitted.
J. What Happens to Food That Is Imported or Offered for Import Without Adequate Prior
Notice? (§ 1.283)
The IFR in § 1.283 identifies consequences and procedures for failure to provide
adequate prior notice and describes the requirements and procedures for various situations.
The comments received will be discussed below in the order each issue appears in
§ 1.283 of the IFR, proceeded by comments generally addressing consequences.
1. General Comments
(Comments) Some comments suggest that enforcement actions should be based on levels
of culpability (e.g., negligent, grossly negligent, and fraudulent), number of infractions, and
seriousness of infractions.
(Response) FDA and CBP take various considerations, such as the seriousness of the
violation, into account when deciding whether to take an enforcement action in response to
violations of the prior notice rule and, if so, what actions to take.  For areas in which we have
established enforcement policies for prior notice, these are contained in, and communicated to
the public through a Compliance Policy Guide (CPG).  Elsewhere in this issue of the FEDERAL
REGISTER, we are announcing the availability of the Prior Notice Final Rule Draft CPG, which
describes our proposed enforcement policies for the final rule.

270
(Comments) Some comments request clarification on the penalties for inadvertent errors,
such as clerical errors, in the prior notice submission.
(Response) As described in the previous response, FDA and CBP take into account the
nature of the violation in determining how to respond to prior notice violations.  The validation
process built into ABI and PNSI should assist in catching inadvertent errors, such as clerical
errors, since the systems will not accept data with certain errors.  This validation process then
allows the submitter to correct errors before final submission of prior notice data.
(Comments) Some comments ask if there are any measures that importers should
undertake to avoid delays at the port of entry.
(Response) FDA advises that most delays based on inaccurate and untimely submission
of prior notice are avoidable and recommends that importers focus on measures to increase
accurate and timely submissions of prior notice.
(Comments) Some comments state that the "Category 3" refusal and fine provision is
excessive for a shipment showing up at the border in advance of the 2-hour timeframe elapsing
and FDA should consider lowering the penalty for this type of offense.  Other comments request
clarification about what will happen to trucks that arrive too early, i.e., will they be turned away
or will they be allowed to wait in the compound?
(Response) Section 1.283(a)(1)(iii) of the final rule provides that if an article of food
arrives early (i.e., before the prior notice time has elapsed), its arrival will not be considered
untimely if FDA already has reviewed the prior notice, determined its response to the prior
notice, and advised CBP of that response.  However, if FDA has not reviewed the prior notice
submission and responded to CBP before the food arrives, the food is subject to refusal.  As
noted previously, in determining whether to refuse the food, assess a CBP civil monetary

271
penalty, or take other regulatory action, we will take into account the seriousness of the violation
and other considerations. Trucks arriving before FDA has processed the prior notice will be
handled as appropriate under the individual circumstances.
(Comments) Some comments state that the implementation plan for the prior notice rule
must include a contingency plan to ensure that border traffic can still be cleared and does not
come to a standstill as new systems are put in place and problems are resolved.  Comments point
out that it is essential for FDA and CBP to have appropriate mechanisms and procedures in place
(such as referral to a secondary inspection, where appropriate) so that border congestion is not
increased by the application of the rules.
Some comments request clarification on arrangements between FDA and CBP, the
Canada Border Services Agency, and the bridge authorities to address issues surrounding refusal
of entry due to missing or incomplete prior notice information.  The comments indicate that the
relevant agencies on both sides of the border should have a plan in place to deal with the
inevitable problems posed by larger volumes of returning trucks to ensure that busy border
crossings do not become a “no man’s” land.  Some comments indicate that local staff at busy
border crossings, such as the Peace Bridge and Ambassador Bridge, have indicated that trucks
will be turned back for missing/incomplete prior notice if secure storage cannot be arranged.
Comments suggest that CBP could stamp a shipping document (such as the bill of lading)
"Refused--BTA" or implement procedures that CBP had in place for refused trucks prior to the
Bioterrorism Act.
Some comments suggest that carriers should be permitted a variety of options when and
if they are advised that one or more products within a shipment have been refused due to a
failure to have an adequate prior notice.  According to the comments, these options may include,

272
permission to hold the cargo at the border while the proper information is submitted to the FDA
and before mandatory notice of intended destination for delivery; returning the cargo to the
exporting facility directly; holding the cargo at a designated carrier’s closest facility; and/or
holding the cargo at a designated FDA holding facility, not necessarily a general order bonded
warehouse, near the port of entry.
(Response) FDA and CBP have not experienced any major disruptions in border traffic as
a result of the implementation of the IFR in December 2003.  The agencies also have not made
any significant revisions to the IFR in this final rule that cause us to believe there will be major
disruptions in trade once the provisions in this final rule take effect, particularly since we are
providing a 180-day period between publication of this rule and the effective date of its
provisions.  This period of time should allow for full understanding by affected parties of the
requirements of the final rule.
We also note that the automated validation process in ABI and PNSI will catch most
missing and incomplete submissions before refusal since the systems will not accept submissions
with certain errors or omissions.  If refusal does occur, the carrier will have the option to
segregate refused food from the rest of the shipment (§ 1.283(a)(3)), the option to export after
refusal with CBP concurrence (§ 1.283(a)(5)), and the option to have refused food held at the
port of entry, unless directed otherwise by CBP or FDA (see § 1.283(a)(1)).
(Comments) Some comments recommend establishing an electronic means to resolve the
refused admission status.
(Response) Both the IFR and the final rule provide for a response to an 801(m) refusal to
be provided to FDA by mail, e-mail, fax, or courier.  FDA will respond in kind, as we have not
experienced any problems as a result of this flexibility.

273
2. Inadequate Prior Notice (§ 1.283(a)(1))
(Comments) Several comments request that FDA notify the submitter, filer, importer, or
ultimate consignee, either in lieu of or in addition to the carrier, about inadequacies in a prior
notice submission that result in refusal of the food.  The comments state that the carrier is not in
a position to resolve the problem when the article of food is refused.  The comments note that the
carrier has temporary possession of the product, has minimal vested interest in the shipment,
particularly if is offloaded, and has little, if any, resources or incentive to resolve the refusal.
However, according to the comments, the exporter, importer, or ultimate consignee has an
ownership interest in the refused food and a strong economic incentive to resolve the refusal
swiftly, or to export or destroy the refused food if the prior notice defects cannot be corrected.
The comments state that delaying notification to the submitter, importer, and ultimate consignee,
unduly hinders the resolution of the problem.
One comment specifies that the filer of the prior notice, who is in most cases the
importer, supplier, owner of the merchandise, or a representative of one of these entities, should
be notified directly, without any intermediate communication, so that the filer may promptly take
corrective action and mitigate any possible adverse regulatory and commercial consequences.
Some comments request that FDA or CBP notify the General Order Manager (GOM) when a
shipment has been rejected or denied entry and also provide the rationale for that decision.
(Response) FDA disagrees.  The IFR does not require FDA or CBP to provide notice
about a refusal, and we continue to believe this is appropriate.  As an operational matter, the
carrier would have to be notified of the refusal.  The carrier can then notify others, such as the
entity that hired the carrier to transport the article of food, that there is a problem with the prior
notice.  It would be resource-intensive for FDA or CBP to assume responsibility for notifying

274
various other entities of the refusal.  FDA notes that, although we collect the contact information
for the submitter and transmitter, which we could use to contact parties about certain actions,
including refusals, routinely notifying these and other parties about a refusal would take limited
staff resources away from other functions, such as reviewing prior notices.  FDA will try to
notify other parties (e.g., submitter), in addition to the carrier, if feasible, and we often do contact
these other parties as resources allow.  FDA notes that for the future migration of ABI/ACS to
the ITDS/ACE environment, FDA has requested the ability to provide electronic prior notice
“refusal” messaging.  This capability does not currently exist.  If electronic prior notice refusal
messaging is in place, it would significantly reduce the resources required to notify ITDS
participants of these refusals.
(Comments) Some comments express concern that trucking companies that pick up FDA-
regulated freight in Canada or Mexico bound for the United States cannot ascertain that the
importer, shipper, or customs broker has filed the appropriate prior notice.  The comments ask
what form of proof FDA (or other border regulatory agencies) will consider acceptable in order
to release the motor carrier from responsibility if the prior notice was not filed appropriately.
The comments state that it is not clear whether FDA will supply an official document that the
importer, shipper, or customs broker would issue to the motor carrier to assure the carrier that
prior notice has been filed.
(Response) Under § 1.279(d) of the final rule, FDA notifies the submitter when the prior
notice has been confirmed for review, with a message containing a prior notice confirmation
number.  Section 1.279(g) of the final rule requires that the prior notice confirmation number
must accompany any article of food for which the prior notice was submitted through PNSI
when the article arrives in the United States and must be provided to CBP or FDA upon arrival.

275
To address the concern in the comments, carriers may consider, as a matter of business practice,
requesting from their customers proof of confirmation of prior notice submission prior to
transporting the food to the United States, even when there is no requirement to provide the
confirmation number to CBP or FDA upon arrival.
(Comments) Some comments request clarification on whether information for FDA
clearance will be allowed to be transmitted via ABI, PNSI or either, for a shipment of food that
will be entered after the arrival of a vessel or an aircraft.  Comments ask what error message will
be sent back to the transmitter for entry that is untimely filed, e.g., will the transmitter receive a
refused admission status or some other error message? In addition, comments ask what the
mechanism is for communicating with the carrier on the disposition of the prior notice.  The
comment states that carriers cannot view the FDA “may proceed” messages in CBP’s AMS, and
the ABI participant (usually the customs broker) is responsible for communicating freight holds
to the various parties involved, including importers, container freight stations (CFS), and
truckers.
(Response) FDA clarifies that if an article of food subject to prior notice requirements
arrives in the United States and prior notice has not been received for review by FDA in the
timeframes prescribed in the final rule, the food is subject to refusal under section 801(m) of the
act, unless FDA already reviewed the prior notice, determined its response, and advised CBP of
that response.  See also the discussion above regarding communication of refusal status.
(Comments) One comment requests clarification as to how transmitters may confirm the
validity and existence of registration numbers provided by the shippers, importers, and carriers.
The comment states that the transmitter might bring in goods based on erroneous, but good faith
information.

276
(Response) FDA will identify anomalies in the initial submission of registration numbers
based on review of the information prior to confirmation of receipt of the prior notice, and will
respond accordingly.  If our subsequent review, after the prior notice is confirmed for review,
reveals problems with a submitted registration number that causes the prior notice submission to
be deemed inaccurate, the food is subject to refusal under section 801(m) of the act.  Subsequent
corrections to the submitted information can be provided by resubmitting corrected information
in a post-refusal prior notice (see § 1.283(c)).
If our subsequent review reveals problems with the submitted registration number such
that an article of food is from a foreign facility that is not registered under section 415 of the act
and 21 CFR, part 1, subpart H, and is imported or offered for import into the United States, the
food is subject to hold under section 801(l) of the act.  To resolve a hold, the facility must
register and obtain a registration number, and that number must be provided to FDA.  This is
covered under § 1.285(i) of the final rule.
As discussed in response to comments 157 and 158 in the preamble to the Registration of
Food Facilities Interim Final Rule (68 FR 58894 at 58931, October 10, 2003), section 305 of the
Bioterrorism Act states that FDA's list of registered facilities and registration documents FDA
receives under the rule are not subject to disclosure under FOIA. Furthermore, section 305 of the
Bioterrorism Act provides that any information derived from the list of facilities or registration
documents that would disclose the identity or location of a specific registered person is not
subject to disclosure under FOIA.  This does not preclude the registered facility from disclosing
its registration number, such as to the submitter or others with whom it has a business
relationship.

277
(Comments) Some comments request that FDA clarify the penalties for inadequate prior
notice.  One comment asks about the consequences when foods are accidentally shipped without
meeting the prior notice requirements, i.e. can they be transshipped?
(Response) Prior notice is required for food imported or offered for import into the
United States, including shipments intended for transshipment.  If adequate prior notice is not
provided, the food is subject to refusal.  Refused food must be held, in accordance with the
provisions of § 1.283(a), unless CBP concurrence is obtained for export and the food is
immediately exported from the port of arrival under CBP supervision.  An article of food that has
been refused is considered general order merchandise and can only be moved under appropriate
custodial bond unless immediately exported under CBP supervision.  If the food is held at a
secure facility outside of the port, FDA must be notified of the location of the secure facility
before the food is moved there.  Post-refusal prior notice can be submitted as provided by §
1.283(c).
We also note that CBP may seize goods imported contrary to law, assess civil monetary
penalties, including those under 19 U.S.C. 1595a(b) against every person who directs, assists,
financially or otherwise, or is in any way concerned in the importation of any merchandise
contrary to law, and refer violations for criminal investigation and prosecution.  Section 1.284 of
the final rule lists other consequences for failure to submit adequate prior notice.  For example,
under 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 or any person who has engaged in a
pattern of importing or offering for import adulterated food that presents a threat of serious
adverse health consequences or death to humans or animals.

278
(Comments) Some comments ask whether an entry of food would be subject to detention
if the product code does not precisely reflect the nature of the product.
(Response) The final rule requires the submission of accurate information that is
submitted in the prior notice, including the product code, which is required in § 1.281 (a)(5)(i),
(b)(4)(i), and (c)(5)(i) of the final rule.  If the product code does not accurately identify the food,
the food is subject to refusal.  Section 1.283(a)(1)(ii) of the final rule states that if prior notice
has been submitted and confirmed by FDA for review, but upon review of the notice or
examination of the article of food, the notice is determined to be inaccurate, the food is subject to
refusal of admission under section 801(m)(1) of the act.
3. Status and Movement of Refused Food (§ 1.283(a)(2))
(Comments) Some comments request that FDA clarify the process for food that is refused
and later deemed to be admissible.
(Response) Section 1.283 of the final rule identifies the consequences and procedures for
food that is refused because of inadequate prior notice.  If the refused food is not immediately
exported with CBP concurrence, it is considered general order merchandise and must be held
until adequate prior notice is submitted and FDA has notified CBP and the transmitter that the
food is no longer refused because of inadequate prior notice.  If in response to a request for FDA
review, FDA determines that the article is not subject to the prior notice requirements or that the
prior notice submission is complete and accurate, it will notify the requester, the transmitter, and
CBP that the food is no longer subject to refusal under section 801(m)(1) of the act. A
determination that an article of food is no longer refused under section 801(m)(1) of the act is
different than, and may come before, determinations of admissibility under other provisions of
the act or other U.S. laws.  Moreover, a determination that an article of food is no longer refused

279
under section 801(m)(1) does not mean that it will be granted admission under other provisions
of the act or other U.S. laws (§ 1.283(g)). Further information regarding the process may be
found in the preamble to the IFR (68 FR 58974 at 59016 through 59022).
(Comments) Some comments state that the holding period for prior notice should be no
longer than the original required prior notice timeframe.  The comments contend that exceeding
this time period does not increase the safety to the public and may cause a bottleneck for all
freight movements if thousands of shipments are held at their port of arrival.  Comments suggest
that, before the holding period is fully implemented, FDA should determine the percentage of
shipments that are still not in conformity with the prior notice rule and determine the potential
for harming the movement of all freight into and out of the United States when prior notice is
fully implemented.
(Response) Section 1.283(a)(2) of the final rule states that refused food will be
considered general order merchandise.  In the first instance, it is not within our control how long
it will take the parties associated with the article of food being held to satisfy the prior notice
requirements.  Moreover, CBP regulations address the length of time an imported product will be
held in General Order (G.O.) Status (19 CFR part 127).  Section 1.283(a)(1) of the final rule
states that refused food that is not immediately exported must be held at the port of entry unless
directed by CBP or FDA.  Accordingly, the final rule does not require refused food to be held at
the port of arrival unless so directed by CBP or FDA.  In § 1.283(c)(3), we state that FDA will
try to review and respond to post-refusal prior notice submissions within the prior notice
timeframes.
(Comments) Some comments request that FDA establish procedures for handling refused
merchandise.  The comments contend that secure storage facilities and cargo movement

280
procedures have not been established for refused merchandise.  According to the comments,
there is no mechanism to handle refused refrigerated or frozen shipments.  The comments state
that perishable food that is held or is not properly stored may no longer be commercially viable
when it is released or sold at auction. Comments also state that highly perishable shipments that
are held past their commercially viable time period and small shipments that have little
commercial value will quickly fill any warehouse, including any G.O. warehouse, with no one to
claim them.  Other comments request that FDA and CBP develop a joint operational plan for
handling refused merchandise with input from the importing and shipping industries.  Another
comment states that directions on executing CBP 6043 Permit to Transfer or CBP 7512
"Restricted in-bond" is needed to avoid major congestion.
(Response) Section 1.283(a)(2)(i) of the final rule provides that food refused under
section 801(m)(1) of the act has “General Order” status.  Under CBP laws and regulations,
general order merchandise must generally be held in a general order warehouse (19 CFR 127.1).
CBP regulations also empower the port director, if merchandise requires specialized storage


[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Rules and Regulations]
[Pages 3714-3716]
[FR Doc No: 2016-01091]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 117

[Docket No. FDA-2011-N-0920]
RIN 0910-AG36

Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is amending a
final rule that published in the Federal Register of September 17,
2015. That final rule amended our regulation for current good
manufacturing practice in manufacturing, packing, or holding human food
to modernize it, and to add requirements for domestic and foreign
facilities that are required to register under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) to establish and implement hazard
analysis and risk-based preventive controls for human food. That final
rule also revised certain definitions in our current regulation for
registration of food facilities to clarify the scope of the exemption
from registration requirements provided by the FD&C Act for ``farms.''
The final rule published with some editorial and inadvertent errors.
This document corrects those errors.

DATES: Effective January 22, 2016.

FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of Thursday,
September 17, 2015 (80 FR 55908), FDA published the final rule
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food'' with some editorial and
inadvertent errors. This

action is being taken to correct inadvertent errors by making the
following correcting amendments.

List of Subjects

21 CFR Part 1

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

21 CFR Part 117

    Food packaging, Foods.

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 continues 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, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374,
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.

0
2. Amend Sec.  1.227 to revise the definitions of ``harvesting'' and
``packing'' to read as follows:

Sec.  1.227  What definitions apply to this subpart?

* * * * *
    Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed on farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities, or on
processed foods created by drying/dehydrating a raw agricultural
commodity without additional manufacturing/processing, on a farm.
Harvesting does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of
harvesting include cutting (or otherwise separating) the edible portion
of the raw agricultural commodity from the crop plant and removing or
trimming part of the raw agricultural commodity (e.g., foliage, husks,
roots or stems). Examples of harvesting also include cooling, field
coring, filtering, gathering, hulling, shelling, sifting, threshing,
trimming of outer leaves of, and washing raw agricultural commodities
grown on a farm.
* * * * *
    Packing means placing food into a container other than packaging
the food and also includes re-packing and activities performed
incidental to packing or re-packing a food (e.g., activities performed
for the safe or effective packing or re-packing of that food (such as
sorting, culling, grading, and weighing or conveying incidental to
packing or re-packing)), but does not include activities that transform
a raw agricultural commodity, as defined in section 201(r) of the
Federal Food, Drug, and Cosmetic Act, into a processed food as defined
in section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
* * * * *

0
3. Amend Sec.  1.328 to revise the definition of ``harvesting'' to read
as follows:

Sec.  1.328  What definitions apply to this subpart?

* * * * *
    Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed on farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities, or on
processed foods created by drying/dehydrating a raw agricultural
commodity without additional manufacturing/processing, on a farm.
Harvesting does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of
harvesting include cutting (or otherwise separating) the edible portion
of the raw agricultural commodity from the crop plant and removing or
trimming part of the raw agricultural commodity (e.g., foliage, husks,
roots, or stems). Examples of harvesting also include cooling, field
coring, filtering, gathering, hulling, shelling, sifting, threshing,
trimming of outer leaves of, and washing raw agricultural commodities
grown on a farm.
* * * * *

PART 117--CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND
RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

0
4. The authority citation for 21 CFR part 117 continues to read as
follows:

    Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note,
371, 374; 42 U.S.C. 243, 264, 271.

0
5. In Sec.  117.1, revise paragraph (b) to read as follows:

Sec.  117.1  Applicability and status.

* * * * *
    (b) The operation of a facility that manufactures, processes,
packs, or holds food for sale in the United States if the owner,
operator, or agent in charge of such facility is required to comply
with, and is not in compliance with, section 418 of the Federal Food,
Drug, and Cosmetic Act or subpart C, D, E, F, or G of this part is a
prohibited act under section 301(uu) of the Federal Food, Drug, and
Cosmetic Act.
* * * * *
0
6. Amend Sec.  117.3 to:
0
a. Revise the definitions of ``audit'', ``harvesting'', and
``packing'';
0
b. Revise the introductory text of paragraph (1) of the definition of
``qualified end-user''; and
0
c. Revise the definition of ``small business''.
    The revisions read as follows:

Sec.  117.3  Definitions.

* * * * *
    Audit means the systematic, independent, and documented examination
(through observation, investigation, records review, discussions with
employees of the audited entity, and, as appropriate, sampling and
laboratory analysis) to assess an audited entity's food safety
processes and procedures.
* * * * *
    Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed on farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities, or on
processed foods created by drying/dehydrating a raw agricultural
commodity without additional manufacturing/processing, on a farm.
Harvesting does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of
harvesting include cutting (or otherwise separating) the edible portion
of the raw agricultural commodity from the crop plant and removing or
trimming part of the raw agricultural commodity (e.g., foliage, husks,
roots or stems). Examples of harvesting also include cooling, field
coring, filtering, gathering, hulling, shelling, sifting, threshing,
trimming of outer leaves of, and washing raw agricultural commodities
grown on a farm.
* * * * *
    Packing means placing food into a container other than packaging
the food

and also includes re-packing and activities performed incidental to
packing or re-packing a food (e.g., activities performed for the safe
or effective packing or re-packing of that food (such as sorting,
culling, grading, and weighing or conveying incidental to packing or
re-packing)), but does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act.
* * * * *
    Qualified end-user * * *
    (1) Is located:
* * * * *
    Small business means, for purposes of this part, a business
(including any subsidiaries and affiliates) employing fewer than 500
full-time equivalent employees.
* * * * *

0
7. In Sec.  117.5, revise the first sentence of paragraph (a), and
revise paragraph (h)(3)(v) to read as follows:

Sec.  117.5  Exemptions.

    (a) Except as provided by subpart E of this part, subparts C and G
of this part do not apply to a qualified facility. * * *
* * * * *
    (h) * * *
    (3) * * *
    (v) Extracting (including by pressing, by distilling, and by
solvent extraction) dried/dehydrated herb and spice products (e.g.,
dried mint), fresh herbs (e.g., fresh mint), fruits and vegetables
(e.g., olives, avocados), grains (e.g., oilseeds), and other herb and
spice products (e.g., chopped fresh mint, chopped dried mint);
* * * * *

0
8. In Sec.  117.136, revise paragraphs (a)(2) introductory text,
(a)(5), and (b)(5) to read as follows:

Sec.  117.136  Circumstances in which the owner, operator, or agent in
charge of a manufacturing/processing facility is not required to
implement a preventive control.

    (a) * * *
    (2) You rely on your customer who is subject to the requirements
for hazard analysis and risk-based preventive controls in this subpart
to ensure that the identified hazard will be significantly minimized or
prevented and you:
* * * * *
    (5) You have established, documented, and implemented a system that
ensures control, at a subsequent distribution step, of the hazards in
the food you distribute and you document the implementation of that
system.
    (b) * * *
    (5) Your system, in accordance with paragraph (a)(5) of this
section, that ensures control, at a subsequent distribution step, of
the hazards in the food you distribute.

0
9. In Sec.  117.145, revise paragraph (a) to read as follows:

Sec.  117.145  Monitoring.

* * * * *
    (a) Written procedures. You must establish and implement written
procedures, including the frequency with which they are to be
performed, for monitoring the preventive control; and
* * * * *

0
10. In Sec.  117.201, revise paragraphs (b)(2)(i)(B) and (b)(2)(ii) to
read as follows:

Sec.  117.201  Modified requirements that apply to a qualified
facility.

* * * * *
    (b) * * *
    (2) * * *
    (i) * * *
    (B) Write to the U.S. Food and Drug Administration (HFS-681), 5100
Paint Branch Pkwy., College Park, MD 20740; or
* * * * *
    (ii) Send a paper Form FDA 3942a to the U.S. Food and Drug
Administration (HFS-681), 5100 Paint Branch Pkwy., College Park, MD
20740. We recommend that you submit a paper copy only if your facility
does not have reasonable access to the Internet.
* * * * *

0
11. In Sec.  117.257, revise paragraph (e) to read as follows:

Sec.  117.257  Contents of an order to withdraw a qualified facility
exemption.

* * * * *
    (e) A statement that a facility may request that FDA reinstate an
exemption that was withdrawn by following the procedures in Sec.
117.287;
* * * * *

0
12. In Sec.  117.264, revise paragraph (a)(1) to read as follows:

Sec.  117.264  Procedure for submitting an appeal.

    (a) * * *
    (1) Submit the appeal in writing to the FDA District Director in
whose district the facility is located (or, in the case of a foreign
facility, the Director of the Office of Compliance in the Center for
Food Safety and Applied Nutrition), at the mailing address, email
address, or facsimile number identified in the order within 15 calendar
days of the date of receipt of confirmation of the order; and
* * * * *

    Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01091 Filed 1-21-16; 8:45 am]
BILLING CODE 4164-01-P