[Federal Register: December 6, 2006 (Volume 71, Number 234)]
[Notices]
[Page 70810-70814]
[DOCID:fr06de06-109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54823; File No. SR-CBOE-2005-111]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing of a Proposed Rule Change and Amendment
No. 1 Thereto Relating to Multiple Representation Exception Procedures

November 28, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 16, 2005, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the CBOE.
On October 17, 2006, the Exchange filed Amendment No. 1 to the proposed
rule change.\3\ The Commission is publishing this notice to solicit
comments on the proposed rule

change, as amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaces and supersedes the original filing
in its entirety.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    CBOE proposes to amend CBOE Rule 6.55, ``Multiple Representation
Prohibited,'' to establish certain exceptions to the rule requirements
prohibiting multiple representation by Market-Makers and to update
other procedures in the rule that have become outdated. The Exchange
also proposes to make a corresponding change to CBOE Rule 6.74,
``Crossing Orders.'' The text of the proposed rule change appears
below. Additions are italicized; deletions are [bracketed].
Chicago Board Options Exchange, Incorporated
Rules
Rule 6.55 Multiple Representation Prohibited
    (a) No member, for any account in which the member has an interest
or on behalf of a customer, shall maintain with more than one broker
orders for the purchase or sale of the same option contract or other
security, or the same combination of option contracts or other
securities, with the knowledge that such orders are for the account of
the same principal.
    (b) Except in accordance with procedures established by the
appropriate Procedure Committee or with such Committee's permission in
individual cases, no Market-Maker shall enter or be present in a
trading crowd while a Floor Broker present in the trading crowd is
holding an order on behalf of the Market-Maker's individual account or
an order initiated by the Market-Maker for an account in which the
Market-Maker has an interest.
    * * * Interpretations and Policies:
    .01 A Market-Maker may permissibly enter a trading crowd in which a
Floor Broker is present who holds an order on behalf of the Market-
Maker's individual account or an order initiated by the Market-Maker
for an account in which the Market-Maker has an interest if one of the
following [three] procedures is followed:
    (a) The Market-Maker makes the Floor Broker aware of the Market-
Maker's intention to enter the trading crowd and the Floor Broker
cancels the order[time stamps the order ticket for the order and writes
the notation ``Cancel'' or ``CXL'' next to the time stamp]. If the
Market-Maker wishes to re-enter the order upon the Market-Maker's exit
from the trading crowd, a new order must be entered [Floor Broker must
at that time again time stamp the order ticket and write the notation
``Reentry'' or ``RNTRY'' next to such subsequent time stamp].
    (b) The Market-Maker cancels the order [by giving the Floor Broker
a written cancellation of the order which is time-stamped by the
Market-Maker immediately] prior to [its transmission to the Floor
Broker]the Market-Maker's entry into the trading crowd. If the Market-
Maker wishes to re-enter the order upon the Market-Maker's exit from
the trading crowd, a new order [ticket] must be [used]entered.
    [(c) The Market-Maker cancels the order by taking the order ticket
for the order back from the Floor Broker, provided that the Market-
Maker allows the Floor Broker to retain a copy of the order ticket
(which copy the Floor Broker must time-stamp at the time of
cancellation and retain for the Floor Broker's records). If the Market-
Maker wishes to re-enter the order upon the Market-Maker's exit from
the trading crowd, a new order ticket must be used.].02 Exchange
regulatory circulars concerning joint accounts should be consulted in
connection with procedures governing the simultaneous presence in a
trading crowd of participants in and orders for the same joint account.
    .03 Subject to the requirements of Rule 6.9 or 6.74, as applicable,
a Market-Maker may permissibly enter or be present in a trading crowd
in which a Floor Broker is present who holds (a) a solicited order on
behalf of the Market-Maker's individual or joint account or (b) a
solicited order initiated by the Market-Maker for an account in which
the Market-Maker has an interest, provided that the Market-Maker makes
the Floor Broker aware of the Market-Maker's intention to enter or to
be present in the trading crowd and the Market-Maker refrains from
trading in-person on the same trade as the original order. It is the
responsibility of the Market-Maker utilizing these procedures to
ascertain whether solicited orders for the Market-Maker's joint account
have been entered in a trading crowd prior to the Market-Maker trading
the joint account in-person.
    .04 A Market-Maker may permissibly enter or be present in a trading
crowd in which a Floor Broker is present who holds an order on behalf
of the Market-Maker's individual account or an order initiated by the
Market-Maker for an account in which the Market-Maker has an interest,
provided that the Market-Maker makes the Floor Broker aware of the
Market-Maker's intention to enter or to be present in the trading crowd
and the Market-Maker refrains from trading in-person on the same trade
as the order being represented by the Floor Broker.
* * * * *
Rule 6.74 ``Crossing'' Orders
    (a)-(f) No change.
    * * * Interpretations and Policies:
    .01--.06 No change.
    .07 [A Floor Broker, pursuant to paragraph (d) of this Rule, may
not cross an order that he is holding with an order from a market-maker
that is then in the trading crowd.]Reserved.
    .08 No change.
* * * * *

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 CBOE 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 CBOE 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
    Currently, CBOE Rule 6.55 provides in relevant part that, except in
accordance with procedures established by the appropriate Procedure
Committee or with such Procedure Committee's permission in individual
cases, no Market-Maker shall enter or be present in a trading crowd
while a Floor Broker present in the trading crowd is holding an order
on behalf of the Market-Maker's individual account or an order
initiated by the Market-Maker for an account in which the Market-Maker
has an interest. As discussed below, this principle against multiple
representation of a Market-Maker account has also been extended to
cover joint account activity in certain circumstances.
    Exceptions to the multiple presentation prohibition are noted in
the Interpretations and Policies to CBOE Rule 6.55. For example,
Interpretation and Policy .01 provides procedures under which a Market-
Maker may enter a trading crowd in which a Floor Broker is present who
holds an order on behalf of the Market-Maker's individual account or an
order initiated by the Market-Maker for an account in which

the Market-Maker has an interest.\4\ In addition, Interpretation and
Policy .02 advises CBOE members to consult Exchange regulatory
circulars for procedures governing the simultaneous presence in a
trading crowd of participants in and orders for the same joint
account.\5\ CBOE Rule 6.55, and the exceptions thereto, are designed to
prevent persons such as Market-Makers from being disproportionately
represented in the trading crowd.\6\
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    \4\ These procedures generally require the cancellation of the
order resting with the Floor Broker upon the Market-Maker's entry
into the trading crowd and allow the Market-Maker to re-enter the
order with the Floor Broker upon the Market-Maker's exit from the
crowd.
    \5\ Exchange Regulatory Circulars RG01-60 and RG01-128 set forth
Exchange procedures and requirements for trading in joint accounts
in equity options, index options, and options on exchange-traded
funds (``ETFs''). See Securities Exchange Act Release No. 44152
(April 5, 2001), 66 FR 19262 (April 13, 2001) (order approving
Regulatory Circular RG01-60 governing joint account trading in
equity options) and Securities Exchange Act Release No. 44433 (June
15, 2001), 66 FR 33589 (June 22, 2001) (order approving Regulatory
Circular RG01-128 governing joint account trading in certain index
options and options on ETFs).
    \6\ An account using multiple orders or quotes could be
represented disproportionately because, when an execution is divided
among competing brokers, an account using multiple orders or quotes
would receive a larger share of the execution than an account using
a single order or quote.
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    The Exchange is now proposing to adopt additional exception
procedures for the handling of solicited orders, as well as for the
handling of a Market-Maker's orders generally. These new exception
procedures are intended to be in addition to, and not a limitation of,
the existing exception procedures identified in CBOE Rule 6.55, its
Interpretations and Policies, and related regulatory circulars
concerning joint accounts. In addition, the Exchange is proposing to
amend the text of Interpretation and Policy .01 to CBOE Rule 6.55,
which has become outdated.
    First, with respect to solicitations, under the Exchange's rules, a
member representing an order (the ``original order'') may solicit
customers, non-member broker-dealers, members and member firms, and
Market-Makers to transact in-person or by order with the original
order. When the solicitation and crossing procedures in CBOE Rules 6.9,
``Solicited Transactions,'' \7\ and 6.74, ``Crossing Orders'',\8\ as
applicable, are read in conjunction with the current multiple
representation prohibitions of CBOE Rule 6.55, the result is that a
Market-Maker present in the trading crowd is generally able to
represent a solicited order in-person for his individual account or for
an account in which he has an interest (including a joint account).
However, unless otherwise excepted, a Market-Maker is generally
prohibited from being present in the trading crowd at the same time a
Floor Broker is representing (i) a solicited order on behalf of the
Market-Maker's individual account or a joint account in which the
Market-Maker is a participant while the Market-Maker is trading on
behalf of that account, or (ii) a solicited order initiated by the
Market-Maker for an account in which he has an interest, and is
crossing that solicited order pursuant to CBOE Rule 6.74(d).\9\
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    \7\ An original order and the solicited person or order are
subject to the procedures and priority provisions of CBOE Rule 6.9,
which generally provide that a solicited person or order gains
priority over the trading crowd only if the terms of the original
order are disclosed to the crowd prior to solicitation, the original
order is continuously represented, and the solicited person or order
betters the market and matches the original order bid or offer. If
these requirements are not satisfied, non-solicited Market-Makers
and Floor Brokers with non-solicited discretionary orders in the
trading crowd have priority over the solicited person or order.
    \8\ CBOE Rule 6.74 describes the manner in which a Floor Broker
may cross orders, including solicitation orders. Crossing procedures
in the Rule provide the solicited person or order generally with
priority over all other parties (other than public customer orders)
for a certain percentage of contracts of the original order. For
example, paragraph (d) of CBOE Rule 6.74, which supercedes the
priority provisions of paragraph (d) of CBOE Rule 6.9, provides
procedures pursuant to which a Floor Broker is entitled to cross 40%
(or 20%, as applicable) of an original order with a solicited order
(after public customer orders are satisfied).
    \9\ Interpretation and Policy .07 to CBOE Rule 6.74 provides
that a Floor Broker, pursuant to paragraph (d), may not cross an
order he is holding with an order from a Market-Maker that is then
present in the trading crowd. The clarification was added to CBOE
Rule 6.74 because this type of multiple representation had generally
been prohibited by CBOE Rule 6.55(b). See Securities Exchange Act
Release No. 44394 (June 6, 2001), 66 FR 31726 (June 12, 2001) (SR-
CBOE-00-43) (order approving a rule change that, among other things,
adopted Interpretation and Policy .07 to CBOE Rule 6.74).
Conversely, a Floor Broker can cross an order he is holding with an
order from a Market-Maker that is not present in the trading crowd.
    As discussed below, CBOE is proposing to eliminate the
restriction in CBOE Rule 6.74, Interpretation and Policy .07 in
light of the revisions being proposed to CBOE Rule 6.55. In this
regard, the Exchange also notes that an exception to this
prohibition currently applies in the case of joint accounts
involving certain broad-based index options and options on ETFs. In
those classes, joint account participants who are not trading in-
person in the crowd may enter orders for the joint account with
Floor Brokers even if other participants are trading in their
individual accounts or the same joint account in-person. In such
instances, there are no restrictions on the other joint account
participants' ability to be present in the trading crowd or on the
number of joint account participants that may participate on the
same trade. Additionally, for equity options classes, it is
currently permissible for a joint account participant to be trading
in a crowd for his individual account or acting as a Floor Broker
for accounts unrelated to his joint account while another
participant of the joint account enters a solicited order for the
joint account with other Floor Brokers. See Regulatory Circulars
RG01-60 and RG01-128.
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    The Exchange believes that, if certain procedures are followed to
ensure that a Market-Maker present in the trading crowd is not
disproportionately represented, it is not necessary to limit crossing
transactions in this manner. Therefore, the Exchange is proposing to
adopt Interpretation and Policy .03 to CBOE Rule 6.55 to specify
additional procedures that would permit representation of solicited
orders when a Market-Maker is present in the trading crowd. These
procedures will be applicable for solicited orders represented by a
Floor Broker while the Market-Maker is present in the crowd in
essentially three scenarios: first, instances where the solicited order
is for the Market-Maker's individual account; \10\ second, instances
where the solicited order is for the Market-Maker's joint account,
whether initiated by the Market-Maker or another joint account
participant; \11\ and, third, instances where the solicited order is
initiated by a Market-Maker for an account in which he has an
interest.\12\
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    \10\ Only a Market-Maker may initiate an order for his
individual account, either in-person or by order with a Floor
Broker.
    \11\ Depending on the circumstance, any joint account
participant can initiate an order for a joint account, either in-
person or by order with a Floor Broker. The new procedure would
therefore apply to solicited orders that the Market-Maker in the
trading crowd initiates for the joint account himself and to
solicited orders that other joint account participants initiate for
the joint account. In this regard, the Exchange notes that certain
exception procedures already exist that relate to instances where
one participant in a joint account is present in the trading crowd
while another participant is trading in-person or by order. For
example, in the case of certain index options and options on ETFs,
joint accounts may be simultaneously represented in a crowd by
participants trading in-person for the joint account. In addition,
joint account participants who are not trading in-person in a crowd
may enter orders for the joint account with Floor Brokers even if
other participants are trading the same joint account in-person. See
Regulatory Circular RG01-128. In the case of equity options,
currently a joint account may be simultaneously represented in a
trading crowd only by participants trading in-person and orders for
a joint account may not be entered in a crowd where a participant of
the joint account is trading in-person for the joint account.
However, if no participant is trading in-person for the joint
account, orders may be entered via Floor Broker so long as the same
option series is not represented by more than one Floor Broker. In
addition, when a Market-Maker is trading in a crowd for his
individual account or acting as a Floor Broker for accounts
unrelated to his joint account, another participant of the joint
account may either trade in-person for the joint account or enter
orders for the joint account with other Floor Brokers. See
Regulatory Circular RG01-60.
    \12\ The procedures in proposed Interpretation and Policy .03 to
CBOE Rule 6.55 relate only to the ``solicited order'' in a
solicitation transaction. Instances where a Market-Maker order is
the ``original order'' in a solicitation transaction may qualify for
another one of the exception procedures described in Interpretations
and Policies .01, .02, and proposed .04 of CBOE Rule 6.55.
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    The new procedures would provide that a Market-Maker may
permissibly

enter or be present in a trading crowd in which a Floor Broker is
present who holds either a solicited order on behalf of the Market-
Maker's individual or joint account or a solicited order initiated by
the Market-Maker for an account in which he has an interest, provided
that the Market-Maker advises the Floor Broker of the Market-Maker's
intention to enter or be present in the trading crowd. The Market-Maker
must also refrain from trading in-person on the same trade as the
original order. In the case of joint accounts, the proposal also
provides that it is the responsibility of the Market-Maker to ascertain
whether solicited orders for his joint account have been entered with a
Floor Broker in a trading crowd prior to the Market-Maker trading for
the joint account in-person.
    In light of the new procedures in proposed Interpretation and
Policy .03 to CBOE Rule 6.55, the Exchange is proposing a corresponding
amendment to eliminate Interpretation and Policy .07 to CBOE Rule
6.74.\13\ A corresponding amendment to the text of CBOE Rule 6.9 is not
necessary.
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    \13\ See supra note 9.
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    On the one hand, the Exchange believes these procedures will
provide members with additional flexibility in determining how to
handle crossing transactions. The Exchange also believes these changes
will ensure that a Market-Maker in the trading crowd is not
disadvantaged when participating in solicited trades compared to other
solicited persons that are not present in the trading crowd, and will
thus promote liquidity in the marketplace by encouraging the Market-
Maker to be present in the crowd. This is because a Market-Maker will
now be permitted to have a solicited order represented by a Floor
Broker pursuant to CBOE Rule 6.74(d) while he is present in the trading
crowd if the required procedures are followed.\14\ This would be
permissible whether the solicited order is initiated by the Market-
Maker himself (in the case of an individual account or an account in
which he has an interest) or the solicited order is initiated by
another joint account participant (in the case of the Market-Maker's
joint account(s)).
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    \14\ By comparison, unless another exception procedure were
applicable, the existing procedures would require that the Market-
Maker not be present in the trading crowd to participate in a CBOE
Rule 6.74(d) crossing transaction.
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    On the other hand, the changes are also consistent with the purpose
of CBOE Rule 6.55 because the new procedures would only allow a Market-
Maker present in the trading crowd to have a solicited order
represented by a Floor Broker if the requirements of CBOE Rules 6.9 or
6.74, as applicable, are satisfied and the Market-Maker refrains from
trading in-person on the same trade as the original order. As a result,
the new procedures will continue to ensure that a Market-Maker
participating in a solicitation (whether in-person or by order) is not
disproportionately represented in the trading crowd. For the foregoing
reasons, the Exchange believes the proposed changes are reasonable and
appropriate, and should help CBOE maintain a fair and orderly market.
    As for the second aspect of this proposal, the Exchange is also
seeking to adopt procedures for an exception pertaining to the handling
of orders initiated by a Market-Maker. In particular, these new
procedures will provide that a Market-Maker may permissibly enter or be
present in a trading crowd in which a Floor Broker is present who holds
an order on behalf of the Market-Maker's individual account or an order
initiated by the Market-Maker for an account in which the Market-Maker
has an interest provided that the Market-Maker advises the Floor Broker
of the Market-Maker's intention to enter or be present. The Market-
Maker must also refrain from trading in-person on the same trade as the
order being represented by the Floor Broker.
    In comparison to proposed Interpretation and Policy .03 to CBOE
Rule 6.55 (which pertains to solicited orders on behalf of a Market-
Maker's individual or joint account, or solicited orders initiated by a
Market-Maker for an account in which he has an interest), the
procedures in proposed Interpretation and Policy .04 to CBOE Rule 6.55
will be applicable only for orders that the Market-Maker himself has
placed with the Floor Broker. These procedures will not apply to
instances where a joint account participant other than the Market-Maker
present in the crowd is initiating an order. Rather, other joint
account participants' activity via Floor Broker will continue to be
subject to CBOE Rule 6.55 and the exception procedures as provided in
Interpretations and Policies .02 and proposed .03 thereto.
    As with the exception procedures for solicited orders, these
general procedures for handling orders from a Market-Maker that is then
in the trading crowd will provide members with additional flexibility
in executing orders. By requiring that a Market-Maker's presence be
made known to the Floor Broker and by prohibiting the Market-Maker from
trading in-person in the same trade as the order represented,\15\ these
procedures are designed to prevent a Market-Maker from being
disproportionately represented in the trading crowd and have no
detrimental effect on other market participants. As such, the Exchange
believes that these changes are consistent with the purpose of CBOE
Rule 6.55.
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    \15\ Because the Market-Maker would initiate such orders
himself, he would know at all times whether a Floor Broker is
concurrently representing an order on his behalf.
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    Finally, the Exchange is proposing to make various revisions to the
text of CBOE Rule 6.55 to remove outdated references to manual
processes. In particular, the Exchange is proposing to delete
references in Interpretation and Policy .01 to CBOE Rule 6.55 relating
to time stamping and written notations on order tickets. Due to
technological advancements, these processes are now generally done
electronically. In light of these changes, the Exchange is proposing to
update this text by consolidating and simplifying these procedures.
Whereas the procedures currently describe three different ways for a
Market-Maker entering a trading crowd to manually cancel an order
pending with a Floor Broker, the revised procedures under the proposal
simply provide that a Market-Maker entering a crowd may either request
that the Floor Broker cancel his order or the Market-Maker can cancel
the order himself. If the Market-Maker wishes to re-enter the order
upon his exit from the crowd, a new order must be entered.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act,\16\ in general, and furthers the objectives of
Section 6(b)(5) of the Act,\17\ in particular, in that it should
promote just and equitable principles of trade, serve to remove
impediments to, and perfect the mechanism of, a free and open market
and a national market system, and protect investors and the public
interest.
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    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) by order approve such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be 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 (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2005-111 on the subject line.

Paper Comments

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

    All submissions should refer to File Number SR-CBOE-2005-111. This
file number should be included on the subject line if e-mail 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 Web site (http://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 inspection
and copying in the Commission's Public Reference Room. Copies of the
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-CBOE-2005-111 and should be submitted on or before
December 27, 2006.
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    \18\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\18\
Nancy M. Morris,
Secretary.
[FR Doc. E6-20621 Filed 12-5-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57156-57159]
[FR Doc No: 2021-22453]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0055]

Voluntary Sodium Reduction Goals: Target Mean and Upper Bound
Concentrations for Sodium in Commercially Processed, Packaged, and
Prepared Foods; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a final guidance for industry entitled ``Voluntary
Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for
Sodium in

Commercially Processed, Packaged, and Prepared Foods.'' The guidance
describes our views on voluntary short-term (2.5-year) goals for sodium
reduction in a variety of identified categories of foods that are
commercially processed, packaged, or prepared. These goals are intended
to address the excessive intake of sodium in the current population and
promote improvements in public health.

DATES: The announcement of the guidance is published in the Federal
Register on October 14, 2021.

ADDRESSES: You may submit either electronic or written comments on FDA
guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-0055 for ``Voluntary Sodium Reduction Goals: Target Mean and
Upper Bound Concentrations for Sodium in Commercially Processed,
Packaged, and Prepared Foods.'' Received comments will be placed in the
docket and, except for those submitted as ''Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
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should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
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confidential information redacted/blacked out, will be available for
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copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
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Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Food Additive Safety, Center for Food Safety and Applied
Nutrition (HFS-255), Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two self-addressed adhesive labels to
assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Kasey Heintz, Center for Food Safety
and Applied Nutrition, Office of Food Additive Safety, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>;
or Deirdre Jurand, Center for Food Safety and Applied Nutrition, Office
of Regulations and Policy, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Voluntary Sodium Reduction Goals: Target Mean and Upper
Bound Concentrations for Sodium in Commercially Processed, Packaged,
and Prepared Foods.'' We are issuing this guidance consistent with our
good guidance practices regulation (21 CFR 10.115). The guidance
represents the current thinking of FDA on this topic. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
    In the Federal Register of June 2, 2016 (81 FR 35363), we made
available a draft guidance for industry entitled ``Voluntary Sodium
Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium
in Commercially Processed, Packaged, and Prepared Foods.'' The draft
guidance described our tentative views on voluntary short-term and
long-term goals for sodium reduction in a variety of identified
categories of foods that are commercially processed, packaged, or
prepared. Section IV of the Federal Register notice, ``Issues for
Consideration,'' listed eight specific questions (or ``issues'') (81 FR
35363 at 35366). The comment period for issues related primarily to
short-term goals (Issues 1 through 4) was scheduled to close on August
31, 2016, and the comment period for issues related primarily to long-
term goals (Issues 5 through 8) was scheduled to close on October 31,
2016. In the Federal Register of August 30, 2017 (81 FR 59640), we
published a notice extending the comment period for Issues 1 through 4
until October 17, 2016, and for Issues 5 through 8 until December 2,
2016.
    We received approximately 200 comments on the draft guidance. The
comments generally recognized and

supported the benefit of sodium reduction efforts for public health.
Many comments discussed the categories proposed in the draft guidance,
including requests for greater clarity on our approach to establishing
categories and suggestions for how certain categories should be
changed. The comments also discussed sodium reduction efforts
generally, including examples of successful sodium reduction across
product categories or portfolios, examples of sodium reduction
technologies, and examples of successful sodium reduction initiatives
in other countries and jurisdictions. Some comments emphasized the
barriers to sodium reduction, such as the time and cost associated with
product reformulation, the standards of identity limitations for
certain foods, and consumer preferences for certain kinds of
ingredients. Several comments also requested more time to achieve the
targets. Other general comments discussed the role of sodium in foods,
recommended that we establish a monitoring plan, and recommended that
we establish a comprehensive, national consumer education campaign for
sodium reduction.
    After careful review of the comments, we have modified the guidance
to clarify the voluntary sodium targets, timeframe, product categories,
and descriptions. The guidance is intended to support an average sodium
intake reduction to 3,000 milligrams/day. In addition, we have extended
the milestone date for the short-term goals from 2 years to 2.5 years
from the publication of the final guidance. The 2.5-year goals are
intended to balance the need for broad and gradual reductions in sodium
and what is publicly known about technical and market constraints on
sodium reduction and reformulation. We are not finalizing the long-term
(10-year) sodium reduction targets discussed in the draft guidance at
this time. We revised the layout as well as category names and
descriptions of the sodium guidance target table to improve
understanding and provide additional clarity as to how foods should be
categorized, and made changes to categories where they were supported
by scientific data (e.g., we merged the ``Ready-to-Eat Cereal, Flakes''
category with the ``Ready-to-Eat Cereal, Puffed'' category and moved
Provolone cheese from the ``Monterey Jack and Other Semi-Soft Cheese''
category to the ``Pasta Filata Cheese (soft)'' category). We also made
technical corrections and editorial changes throughout the guidance to
improve clarity, and included more recent data in our references.
    The guidance announced in this notice finalizes the draft guidance
with respect to the short-term sodium reduction goals.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 101 have been approved under OMB control
number 0910-0381. The collections of information in 21 CFR 101.11 have
been approved under OMB control number 0910-0782.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

IV. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction or are not publications. Some may be available at the
website address, if listed. References without asterisks are available
for viewing only at the Dockets Management Staff or, in the case of
non-publication references, at any website listed. FDA has verified the
website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.

    1. Mattes RD and Donnelly D., ``Relative contributions of
dietary sodium sources.'' Journal of the American College of
Nutrition, 10(4) (Aug. 1991): pp. 383-393.
    2. Harnack LJ, Cogswell ME, Shikany JM, Gardner CD, Gillespie C,
Loria CM, Zhou X, Yuan K, Steffen LM., ``Sources of Sodium in US
Adults From 3 Geographic Regions.'' Circulation, 135 (May 9, 2017):
pp. 1775-1783.
    3. U.S. Department of Agriculture and U.S. Department of Health
and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th
Edition. December 2020. Available at https://www.dietaryguidelines.gov/ (accessed 1/26/2021).*
    4. National Academies of Sciences, Engineering and Medicine.
Dietary Reference Intakes for Sodium and Potassium (March 2019).
Washington, DC: The National Academies Press. Available at http://www.nationalacademies.org/hmd/Reports/2019/dietary-reference-intakes-sodium-potassium.aspx (accessed 01/28/2021).
    5. Food and Drug Administration, ``Memo: FDA's Voluntary Sodium
Reduction Goals Supplementary Memorandum to the Draft Guidance''
(2016).*
    6. Food and Drug Administration, ``Memo: Survey of
Microbiological Issues in FDA-Regulated Products'' (2016).*
    7. Food and Drug Administration, ``Memo: Survey of
Microbiological Issues in Meat and Poultry Products'' (2016).*
    8. Food and Drug Administration, ``Memo: Salt Taste Preference
and Sodium Alternatives'' (2016).*
    9. Food and Drug Administration, ``Memo: Supplementary Target
Development Example'' (2016).*
    10. Institute of Medicine. Strategies to Reduce Sodium Intake in
the United States. Report Brief (April 2010). Washington DC: The
National Academies Press.
    11. National Salt Reduction Initiative Corporate Achievements.
Available at: http://www1.nyc.gov/assets/doh/downloads/pdf/cardio/nsri-corporate-commitments.pdf (accessed 01/28/2021).
    12. Curtis, CJ, Clapp J, Niederman SA, Wen Ng S, Angell SY.,
``US Food Industry Progress During the National Salt Reduction
Initiative: 2009-2014.'' American Journal of Public Health, 106(10)
(October 1, 2016): pp. 1815-1819.
    13. Graudal NA, Hubeck-Graudal T, J[uuml]rgens G., ``Effects of
low sodium diet versus high sodium diet on blood pressure, renin,
aldosterone, catecholamines, cholesterol, and triglyceride.''
Cochrane Database of Systematic Reviews, Issue 4 (April 9, 2017).
    14. Strom BL, Anderson CAM, Ix JH., ``Sodium Reduction in
Populations: Insights From the Institute of Medicine Committee.''
Journal of the American Medical Association, 310(1) (July 3, 2013):
pp. 31-32.
    15. Newberry SJ, Chung M, Anderson C, Fu W, Chen C, Tang A, Zhao
N, Booth M, Marks J, Hollands S, Motala A, Larkin K, Shanman R,
Hempel S., ``Sodium and Potassium Intake: Effects on Chronic Disease
Outcomes and Risks.'' Comparative Effectiveness Review, No. 206
(June 2018). Southern California Evidence-based Practice Center for
the Agency for Healthcare Research and Quality. Available at https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/cer-206-report-sodium-potassium-update.pdf (accessed 01/28/2021).*
    16. Kochanek KD, Xu J, Arias E., ``Mortality in the United
States, 2019,'' NCHS Data Brief, No. 395 (December 2020): National
Center for Health Statistics, Centers for Disease Control and
Prevention, U.S. Dept. of Health and Human Services.*
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Franco LJ, et al.,

``Blood pressure in four remote populations in the INTERSALT
Study.'' Hypertension, 14(3) (1989): pp. 238-246.
    18. Cogswell ME, Loria CM, Terry AL, Zhao L, Wang CY, Chen TC,
Wright JD, Pfeiffer CM, Merritt R, Moy CS, Appel LJ., ``Estimated
24-hour urinary sodium and potassium excretion in US adults.''
Journal of the American Medical Association, 319(12) (March 27,
2018): pp. 1209-1220.
    19. Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha
D, et al., ``Effects on blood pressure of reduced dietary sodium and
the Dietary Approaches to Stop Hypertension (DASH) diet.'' New
England Journal of Medicine, 344(1) (Jan. 4, 2001): pp. 3-10.
    20. He F, Li J, MacGregor G., ``Effect of longer term modest
salt reduction on blood pressure: Cochrane systematic review and
meta-analysis of randomised trials.'' BMJ, 346 (April 4, 2013).
    21. Institute of Medicine. Dietary Reference Intakes for Water,
Potassium, Sodium Chloride and Sulfate. 2005. Washington, DC: The
National Academies Press.
    22. Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N,
Hubbard VS, et al., ``2013 AHA/ACC guideline on lifestyle management
to reduce cardiovascular risk: a report of the American College of
Cardiology/American Heart Association Task Force on Practice
Guidelines.'' Journal of the American College of Cardiology,
2014;63(25 Pt B) (2014): pp. 2960-2084.
    23. Dietary Guidelines Advisory Committee. Scientific Report of
the 2020 Dietary Guidelines Advisory Committee: Advisory Report to
the Secretary of Agriculture and the Secretary of Health and Human
Services. 2020. Washington, DC: U.S. Department of Agriculture,
Agricultural Research Service. Available at https://www.dietaryguidelines.gov/sites/default/files/2020-07/ScientificReport_of_the_2020DietaryGuidelinesAdvisoryCommittee_first-print.pdf (accessed 2/5/2021).*
    24. World Health Organization (WHO). Guideline: Sodium intake
for adults and children. 2012. Geneva: WHO Press. Available at
https://www.who.int/publications/i/item/9789241504836 (accessed 01/
28/2021).
    25. Santos JA, Tekle D, Rosewarne E, Flexner N, Cobb L, Al-
Jawaldeh A, Kim WJ, Breda J, Whiting S, Campbell N, Neal B, Webster
J, Trieu K., ``A Systematic Review of Salt Reduction Initiatives
Around the World: A Midterm Evaluation of Progress Towards the 2025
Global Non-Communicable Diseases Salt Reduction Target.'' Advances
in Nutrition, nmab008 (March 7, 2021): p. 3.
    26. McLaren L, Sumar N, Barberio AM, Trieu K, Lorenzetti DL,
Tarasuk V, Webster J, Campbell NRC., ``Population-level
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reduction.'' Cochrane Database of Systematic Reviews, Issue 9 (Sept.
16, 2016).
    27. Coxson PG, Cook NR, Joffres M, Hong Y, Orenstein D, Schmidt
SM, Bibbins-Domingo K., ``Mortality benefits from US population-wide
reduction in sodium consumption: projections from 3 modeling
approaches.'' Hypertension, 61(3) (Feb. 11, 2013): pp. 564-570.
    28. Pearson-Stuttard J, Kypridemos C, Collins B, Mozaffarian D,
Huang Y, Bandosz P, Capewell S, Whitsel L, Wilde P, O'Flaherty M,
Micha R., ``Estimating the health and economic effects of the
proposed US Food and Drug Administration voluntary sodium
reformulation: Microsimulation cost-effectiveness analysis.'' PLoS
Medicine, 15(4) (April 10, 2018).
    29. Smith-Spangler CM, Juusola JL, Enns EA, Owens DK, Garber
AM., ``Population strategies to decrease sodium intake and the
burden of cardiovascular disease: a cost-effectiveness analysis.''
Annals of Internal Medicine, 152(8) (April 20, 2010): pp. 481-487.
    30. Dehmer SP, Cogswell ME, Ritchey MD, Hong Y, Maciosek MV,
LaFrance AB, Roy K., ``Health and Budgetary Impact of Achieving 10-
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    31. National Salt and Sugar Reduction Initiative. Available at:
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    32. Webster JL, Dunford EK, Hawkes C, Neal BC., ``Salt reduction
initiatives around the world.'' Journal of Hypertension, 29(6) (June
2011): pp. 1045-1050.
    33. He FJ, Pombo-Rodrigues S, Macgregor GA., ``Salt reduction in
England from 2003 to 2011: its relationship to blood pressure,
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(April 14, 2014).
    34. Public Health England, Salt Reduction Targets for 2024
(September 2020). Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/915406/2024_salt_reduction_targets_070920-FINAL-1.pdf (accessed 01/28/2021).
    35. Health Canada, Sodium Reduction in Processed Foods in
Canada: An Evaluation of Progress toward Voluntary Targets from 2012
to 2016. Available at: https://www.canada.ca/content/dam/hc-sc/documents/services/food-nutrition/legislation-guidelines/guidance-documents/guidance-food-industry-reducing-sodium-processed-foods-progress-report-2017/pub1-eng.pdf (accessed 01/28/2021).
    36. Health Canada, Voluntary sodium reduction targets for
processed foods 2020-2025. Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/healthy-eating/sodium/sodium-reduced-targets-2020-2025.html (accessed 1/28/2021).
    37. Food and Drug Administration, ``Memo: Documentation of
access to and use of updated data sources from what was used for the
draft Voluntary Sodium Reduction Goals Guidance'' (2019).*

    Dated: October 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22453 Filed 10-13-21; 8:45 am]
BILLING CODE 4164-01-P