[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57089-57094]
[FR Doc No: 2019-21515]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87110]

Order Granting a Conditional Exemption From Exchange Act Section
11(D)(1) and Exchange Act Rules 10B-10, 15C1-5, 15C1-6, and 14E-5 for
Certain Exchange Traded Funds

AGENCY: Securities and Exchange Commission.

ACTION: Exemptive order.

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SUMMARY: The Securities and Exchange Commission (``Commission'' or
``SEC'') is issuing an order granting an exemption from compliance with
certain provisions of the Securities Exchange Act of 1934 (``Exchange
Act'') and the rules thereunder to broker-dealers and certain other
persons engaging in certain transactions in securities of exchange-
traded funds (``ETFs'') relying on rule 6c-11 under the Investment
Company Act of 1940 (``Investment Company Act'').

DATES: This exemptive order is effective December 23, 2019.

FOR FURTHER INFORMATION CONTACT: Darren Vieira, Special Counsel,
Brandon Hill, Special Counsel, or Joanne Rutkowski, Assistant Chief
Counsel, at<PHONE_NUMBER>; in the Division of Trading and Markets;
Daniel Duchovny, Special Counsel, Office of Mergers and Acquisitions,
at<PHONE_NUMBER>, in the Division of Corporation Finance; Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549.

SUPPLEMENTARY INFORMATION:

I. Introduction

    The Commission adopted rule 6c-11 under the Investment Company Act,
which permits ETFs that satisfy certain conditions to operate without
the expense and delay of obtaining an exemptive order from the
Commission under the Investment Company Act.\1\ Rule 6c-11 is designed
to create a consistent, transparent, and efficient regulatory framework
for ETFs and to facilitate greater competition and innovation among
ETFs.
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    \1\ Exchange Traded Funds, Investment Company Act Release No.
33646 (Sep. 25, 2019) (``Rule 6c-11 Adopting Release'').
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    While the relief under rule 6c-11 is limited to exemptions under
the Investment Company Act,\2\ commenters on proposed rule 6c-11 also
recommended that the Commission harmonize with rule 6c-11 certain
Exchange Act relief that ETFs currently rely on in order to operate,
including relief from section 11(d)(l) of the Exchange Act and Exchange
Act rules 10b-10, 15c1-5, 15c1-6, and 14e-5.\3\ Commenters expressed
concern that the conditions that have been associated with Exchange Act
relief are duplicative or, in some cases, inconsistent with other
requirements applicable to ETFs.\4\
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    \2\ In the Rule 6c-11 Adopting Release, the Commission also
provided an interpretation of certain other Exchange Act rules
containing exemptions for transactions in redeemable securities
issued by open-end companies and unit investment trusts as follows:
    After considering comments, we believe that it is appropriate to
make all ETFs, including those that do not rely on rule 6c-11,
eligible for the redeemable securities exceptions in rules 101(c)(4)
and 102(d)(4) of Regulation M and rule 10b-17(c) under the Exchange
Act in connection with secondary market transactions in ETF shares
and the creation or redemption of creation units and the exemption
in rule 11d1-2 under the Exchange Act for a registered open-end
investment company or unit investment trust.
    \3\ See Comment Letter of Blackrock, Inc. at 21 (Sept. 26, 2018)
(``BlackRock Comment Letter''); Comment Letter of the Investment
Company Institute at 32 (Sept. 21, 2018) (``ICI Comment Letter'');
Comment Letter of Fidelity Management & Research Company at 12
(Sept. 28, 2018); Comment Letter of Dechert LLP at 8 (Sept. 28,
2018) (``Dechert Comment Letter''); Comment Letter of the Securities
Industry and Financial Markets Association--Asset Management Group
at 22 and 23 (Sept. 28, 2018) (``SIFMA AMG Comment Letter'');
Comment Letter of Vanguard at 2 (Sept. 28, 2018); Comment Letter of
WisdomTree Asset Management at 2 (Oct. 1, 2018); Comment Letter of
the American Bar Association at 4 (Oct. 11, 2018); Comment Letter of
John Hancock Investments at 5 (Oct. 1, 2018); and Comment Letter of
Flow Traders US LLP at 2 (Oct. 1, 2018).
    \4\ See, e.g., BlackRock Comment Letter. See also, e.g., ICI
Comment Letter (``Currently, ETFs often must satisfy multiple and
sometimes conflicting requirements from different divisions within
the SEC.''). Commenters also expressed concerns about delays in
obtaining such additional relief. See, e.g., SIFMA AMG Comment
Letter I.
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    The Commission agrees that such relief could further reduce
regulatory complexity and administrative delay, and eliminate potential
inconsistencies between rule 6c-11 and the related Exchange Act relief
that ETFs have obtained to operate.\5\ The Commission has considered
the issues raised and believes that it is appropriate to grant relief
from section 11(d)(1) and rules 10b-10, 15c1-5, 15c1-6, and 14e-5
because broker-dealers and certain other persons that engage in these
transactions and satisfy the conditions below, as applicable, would not
raise the issues or concerns that underlie those provisions.
Accordingly, the Commission finds that it is necessary and appropriate
in the public interest and consistent with the protection of investors
to grant an exemption from section 11(d)(1) of the Exchange Act and
Exchange Act rules 10b-10, 15c1-5, 15c1-6, and 14e-5,to broker-dealers
and certain other persons, as applicable, that engage in certain
transactions with ETFs relying on rule 6c-11, subject to the conditions
below.
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    \5\ Although the exemption granted by this order applies only to
transactions in securities of ETFs that meet certain requirements
and conditions, the beneficiaries of the relief, other than the
relief under Exchange Act rule 14e-5, are broker-dealers that engage
in transactions subject to the relevant provisions of the Exchange
Act and rules thereunder. The beneficiaries of the relief under
Exchange Act rule 14e-5 are ETFs, the legal entity of which the ETF
is a series, and authorized participants, as described below.
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II. Background

    An ETF issues shares that can be bought or sold throughout the day
in the secondary market at a market-determined price. Like other
investment companies, an ETF pools the assets of multiple investors and
invests those assets according to its investment objective and
principal investment strategies. Each share of an ETF represents an
undivided interest in the underlying assets of the ETF. Similar to
mutual funds, ETFs continuously offer their shares for sale.
    Unlike mutual funds, however, ETFs do not sell or redeem individual
shares. Instead, ``authorized participants'' that have contractual
arrangements with the ETF, or one of its service providers, purchase
and redeem ETF shares directly from the ETF in blocks called ``creation
units.'' \6\ An authorized participant may act as a principal for its
own account when purchasing or redeeming creation units from the ETF.
Authorized participants also may act as agent for others, such as
market makers, proprietary trading firms, hedge funds or other
institutional investors, and receive fees for processing creation units

on their behalf.\7\ Market makers, proprietary trading firms, and hedge
funds provide additional liquidity to the ETF market through their
trading activity. Institutional investors may engage in primary market
transactions with an ETF through an authorized participant as a way to
efficiently hedge a portion of their portfolio or balance sheet or to
gain exposure to a strategy or asset class.\8\ Redemptions from ETFs
are often made in kind (that is, by delivering certain assets from the
ETF's portfolio), rather than in cash, thereby avoiding the need for
the ETF to sell assets and potentially realize capital gains that are
distributed to its shareholders. Similarly, ETF creations may be made
in kind by delivering certain assets to the ETF's portfolio, rather
than solely delivering cash.
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    \6\ Rule 6c-11(a)(1) defines ``authorized participant'' as a
member or participant of a clearing agency registered with the
Commission, which has a written agreement with the ETF or one of its
service providers that allows the authorized participant to place
orders for the purchase and redemption of creation units. See Rule
6c-11 Adopting Release.
    \7\ See David J. Abner, The ETF Handbook: How to Value and Trade
Exchange Traded Funds, 2nd ed. (2016).
    \8\ Id.
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    An authorized participant that purchases a creation unit of ETF
shares directly from the ETF deposits with the ETF a ``basket'' of
securities and other assets identified by the ETF that day, and then
receives the creation unit of ETF shares in return for those assets.\9\
The basket is generally representative of the ETF's portfolio,\10\ and
together with a cash balancing amount, it is equal in value to the
aggregate net asset value (``NAV'') of the ETF shares in the creation
unit.\11\ After purchasing a creation unit, the authorized participant
may hold the individual ETF shares, or sell some or all of them in
secondary market transactions.\12\ Investors then purchase individual
ETF shares in the secondary market.
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    \9\ An ETF may impose fees in connection with the purchase or
redemption of creation units that are intended to defray operational
processing and brokerage costs to prevent possible shareholder
dilution (``transaction fees'').
    \10\ The basket might not reflect a pro rata slice of an ETF's
portfolio holdings. Subject to the terms of the applicable exemptive
relief, an ETF may substitute other securities or cash in the basket
for some (or all) of the ETF's portfolio holdings. Conditions
related to flexibility in baskets have varied over time. See Rule
6c-11 Adopting Release, at section II.C.5.
    \11\ An open-end fund is required by law to redeem its
securities on demand from shareholders at a price approximating
their proportionate share of the fund's NAV at the time of
redemption. See 15 U.S.C. 80a-22(d). 17 CFR 270.22c-1 (``rule 22c-
1'') generally requires that funds calculate their NAV per share at
least once daily Monday through Friday. See rule 22c-1(b)(1). Today,
most funds calculate NAV per share as of the time the major U.S.
stock exchanges close (typically at 4:00 p.m. Eastern Time). Under
rule 22c-1, an investor who submits an order before the 4:00 p.m.
pricing time receives that day's price, and an investor who submits
an order after the pricing time receives the next day's price. See
also 17 CFR 270.2a-4 (``rule 2a-4'') (defining ``current net asset
value'').
    \12\ ETFs register offerings of shares under the Securities Act
of 1933 (the ``Securities Act''), and list their shares for trading
under the Exchange Act. Depending on the facts and circumstances,
authorized participants that purchase a creation unit and sell the
shares may be deemed to be participants in a distribution, which
could render them statutory underwriters and subject them to the
prospectus delivery and liability provisions of the Securities Act.
See 15 U.S.C. 77b(a)(11) (defining the term ``underwriter'').
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    By this order, the Commission is seeking to reduce the complexities
and burden that may otherwise be associated with the ETF creation and
redemption process, subject to appropriate conditions intended to
ensure investor protections.

III. Discussion of the Exemption

    The Commission is granting a conditional exemption from Exchange
Act section 11(d)(1) and Exchange Act rules 10b-10, 15c1-5, 15c1-6, and
14e-5 as discussed further below. The exemption should help to simplify
the offering and operating process for ETFs. The exemption will provide
relief to broker-dealers from these provisions of the Exchange Act with
respect to ETFs relying on rule 6c-11.\13\ In order for a broker-dealer
to rely on the relief, other than the relief from rule 14e-5, a
transaction must involve an ETF that further satisfies the
diversification requirement below. In addition, a broker-dealer relying
on this relief must meet certain conditions specific to each applicable
Exchange Act provision or rule. Finally, except as provided in Sections
III.E.2 and III.F below, this relief does not apply to purchases or
sales of ETF shares in the secondary market.\14\
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    \13\ Going forward, this exemptive order will provide exemptive
relief from section 11(d)(1) and rules 10b-10, 15c1-5, 15c1-6, and
14e-5 in connection with transactions in securities issued by newly
formed ETFs that rely on rule 6c-11. Commission staff will continue
to consider requests with respect to the relevant Exchange Act
provisions in connection with transactions in securities issued by
newly formed ETFs that do not rely on rule 6c-11 or otherwise do not
satisfy the conditions of this exemption.
    \14\ As discussed below, this order provides an exemption from
section 11(d)(1) for a Non-AP Broker-Dealer (defined below) that
transacts in shares of an ETF that relies on rule 6c-11, exclusively
in the secondary market, when it extends or maintains or arranges
for the extension or maintenance of credit to or for customers on
such ETF shares. This order also provides an exemption that allows
certain specified ``covered persons'' with respect to a tender offer
to engage in creation and redemption transactions with an ETF that
relies on rule 6c-11 subject to certain conditions described below.
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    The Commission is limiting relief under this exemption to
transactions in securities issued by ETFs that rely on rule 6c-11
because the specific findings in support of the exemptive order are
based, in part, on the conditions in rule 6c-11. The Commission
believes that the portfolio and other transparency requirements in rule
6c-11, when combined with the conditions in this order, address the
policy concerns underlying the relevant statutory provision and rules.
For example, rule 6c-11 requires ETFs to disclose their portfolio
holdings each day through their website. This portfolio transparency,
along with the availability of information regarding ETFs through the
National Securities Clearing Corporation (``NSCC''), other
intermediaries, and the ETF itself, should provide customers engaging
in creation or redemption transactions an opportunity to identify or
inquire about potential conflicts of interest involving a component
security a broker-dealer would otherwise be required to disclose. These
requirements should also help customers determine if they should
request that their broker-dealer provide any omitted information.

A. Reliance on Rule 6c-11

    The exemption from Exchange Act section 11(d)(1) and Exchange Act
rules 10b-10, 15c1-5, 15c1-6, and 14e-5 is only available with respect
to transactions involving securities of an ETF relying on rule 6c-11.
The rule defines an ETF as a registered open-end management investment
company that: (i) Issues (and redeems) creation units to (and from)
authorized participants in exchange for a basket and a cash balancing
amount (if any); and (ii) issues shares that are listed on a national
securities exchange and traded at market-determined prices.\15\ Among
the requirements to rely on rule 6c-11 are:
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    \15\ Rule 6c-11(a)(1). Under the rule, the term ``basket'' means
the securities, assets, or other positions in exchange for which an
ETF issues (or in return for which it redeems) creation units. See
id. ETFs will therefore transact on an in-kind basis, on a cash
basis, or both.
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    1. The ETF is structured as an open-end management investment
company;
    2. The ETF discloses portfolio holdings each business day on its
website before the opening of regular trading on the primary listing
exchange of the ETF's shares in a standardized manner;
    3. The ETF provides website disclosure of (i) the ETF's current NAV
per share, market price, and premium or discount, each as of the end of
the prior business day; (ii) a table showing the number of days the
ETF's shares traded at a premium or discount during the most recently
completed calendar year and calendar quarters of the current year;
(iii) a line graph showing ETF premiums and discounts for the most
recently completed year and calendar

quarter of the current year; (iv) for ETFs whose premium or discount
was greater than two percent for more than seven consecutive trading
days, disclosure of this premium or discount, along with a discussion
of the factors that are reasonably believed to have materially
contributed to the premium or discount; and (iv) the ETF's median bid-
ask spread over the most recent thirty calendar days;
    4. The ETF adopts and implement written policies and procedures
that govern the construction of baskets and the process that will be
used for the acceptance of baskets. If the ETF utilizes custom baskets,
these policies and procedures must (i) set forth detailed parameters
for the construction and acceptance of custom baskets that are in the
best interest of the ETF and its shareholders, including the process
for any revisions to, or deviations from, those parameters; and (ii)
specify the titles or roles of the employees of the ETF's investment
adviser who are required to review each custom basket for compliance
with those parameters; and
    5. The ETF preserves and maintains copies of all written agreements
between an authorized participant and the ETF (or one of the ETF's
service providers) that allow the authorized participant to purchase or
redeem creation units.
    Consistent with our approach in Rule 6c-11, the exemption provided
by this order will be available regardless of whether the ETF is
actively managed \16\ and without regard to the number of ETF shares in
the ETF's creation or redemption baskets or the value of those creation
and redemption baskets.\17\
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    \16\ Rule 6c-11 Adopting Release, sec. II.A.2.
    \17\ Id. at sec. II.C.1.
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B. Minimum Diversification Requirement

    The exemption provided by this order from Exchange Act section
11(d)(1) and Exchange Act rules 10b-10, 15c1-5, and 15c1-6 is available
only with respect to transactions involving an ETF that meets the
diversification requirement applicable to a regulated investment
company in Internal Revenue Code (``IRC'') Sec. 851(b)(3)(B), 26 U.S.C.
851(b)(3)(B) (the ``IRC diversification requirement'').\18\
Diversification is a consideration with respect to each requirement
from which the Commission is granting exemption in this order, except
for rule 14e-5. Creation and redemption transactions in diversified
ETFs involve the exchange of a basket that contains numerous
securities, which in turn implicates disclosure requirements, as
discussed below, under rules 10b-10, 15c1-5, and 15c1-6. At the same
time, the composite nature of a diversified basket means that the
securities of any one issuer will account for a relatively small share
of the basket. Diversification thus should mitigate any conflicts that
a broker-dealer would otherwise be required to disclose under rules
15c1-5 and 15c-6, and minimize the incentive for a broker-dealer to
seek to use an ETF to evade the new issue lending restriction in
Exchange Act section 11(d)(1).\19\
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    \18\ IRC Section 851(b)(3)(B) provides that a ``regulated
investment company'' must have:
    not more than 25 percent of the value of its total assets is
invested in--(i) the securities (other than Government securities or
the securities of other regulated investment companies) of any one
issuer, (ii) the securities (other than the securities of other
regulated investment companies) of two or more issuers which the
taxpayer controls and which are determined, under regulations
prescribed by the Secretary [of the Treasury], to be engaged in the
same or similar trades or businesses or related trades or
businesses, or (iii) the securities of one or more qualified
publicly traded partnerships (as defined in subsection (h)).
    \19\ A commenter on proposed Rule 6c-11 also noted that ETFs
generally must comply with the IRC diversification requirement,
which imposes a practical limit on the concentration of an ETF's
portfolio. Dechert Comment Letter at 12-13. The commenter stated
that it would be impractical and inefficient for a broker-dealer to
utilize an ETF as a mechanism for distribution of a particular
security or for accumulating substantial positions in one or more of
an ETF's underlying securities in a magnitude that would trigger
disclosure. Id.
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    Diversification, together with the conditions discussed below,
forms the basis for the Commission's conclusion that relief from
section 11(d)(1) and rules 10b-10, 15c1-5, and 15c1-6 is necessary and
appropriate in the public interest and consistent with investor
protection.

C. Exemption From Exchange Act Rule 10b-10

    Exchange Act rule 10b-10 generally requires a broker or dealer that
effects a securities transaction for a customer to send to the
customer, at or before the completion of the transaction, a written
notification (``confirmation'') disclosing certain information,
including among other items, the identity, price, and number of share
or units (or principal amount) of the security purchased or sold by the
customer. The confirmation requirement provides basic investor
protections by conveying information that allows investors to verify
the terms of their transactions; alerting investors to potential
conflicts of interest with their broker-dealers; acting as a safeguard
against fraud; and providing investors a means to evaluate the costs of
their transactions and the quality of their broker-dealer's
execution.\20\ When an authorized participant that is a registered
broker-dealer (``Broker-Dealer AP'') engages in creation and redemption
transactions for its customers, each tender or receipt of a component
security as part of a basket is a purchase \21\ or sale \22\ of a
security, and each purchase or sale requires confirmation pursuant to
Exchange Act rule 10b-10.
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    \20\ Exchange Act Release No. 34962 (November 10, 1994), 59 FR
59612, 59613 (November 17, 1994).
    \21\ Exchange Act Sec. 3(a)(13).
    \22\ Exchange Act Sec. 3(a)(14).
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    The Commission is granting an exemption from Exchange Act rule 10b-
10 that will allow a broker-dealer that is effecting an in-kind
creation or redemption transaction on behalf of a customer to confirm
the transaction without providing a contemporaneous statement of the
identity, price or number of shares or units (or principal amount) of
each component security tendered to or delivered by the ETF, subject to
the following conditions:
    1. Confirmation statements of issuance and redemption transactions
in ETF shares will contain all of the information specified in
paragraph (a) of rule 10b-10 other than identity, price, and number of
shares or units (or principal amount) of each component security
tendered or received by the customer in the transaction.
    2. Any confirmation statement of an issuance or redemption
transaction in ETF shares that omits the identity, price, or number of
shares or units (or principal amount) of component securities will
contain a statement that such omitted information will be provided to
the customer upon request; and
    3. All such requests will be fulfilled in a timely manner in
accordance with paragraph (c) of rule 10b-10.
    The requirement that confirmation statements include all of the
information specified in paragraph (a) of rule 10b-10 other than the
identity, price, and number of shares or units (or principal amount) of
each component security tendered or received in the transaction
preserves a customer's right to receive other important information
from the confirmation about the terms of the customer's transaction at
or before the completion of the transaction. The statement that the
omitted information will be provided upon request informs the customer
of the right to receive the omitted information. The requirement for a
broker-dealer to fulfill such requests in a timely manner in accordance
with paragraph (c) of rule 10b-10 clarifies that a broker-dealer

must fulfill the request within a prescribed period (i.e., within five
business days of receipt of the request, or within 15 business days of
a request pertaining to a transaction effected more than 30 days prior
to the receipt of the request) so that customers can be assured that
they receive the requested information in a timely manner.
    The Commission also believes that, in general, information
regarding ETFs is accessible through a variety of sources, including
the NSCC, intermediaries and the ETFs themselves. The Commission
believes that the conditions above will allow any customers who would
like additional information regarding identity, price, or number of
shares or units (or principal amount) to receive the information in a
timely manner. This exemption reduces the burden that may otherwise be
associated with creation and redemption transactions while preserving a
customer's ability to access the omitted information upon request.

D. Exemption From Exchange Act Rules 15c1-5 and 15c1-6

    Exchange Act rule 15c1-5 requires a broker-dealer effecting a
transaction to disclose any control relationship with an issuer of a
security that it purchases for or sells to a customer. Similarly, Rule
15c1-6 requires a broker-dealer to disclose its participation or
interest in a primary or secondary distribution of a security that it
purchases for or sells to a customer. The Commission is granting a
conditional exemption from Exchange Act rules 15c1-5 and 15c1-6 that
will allow a broker-dealer that is effecting an in-kind creation or
redemption transaction on behalf of a customer to effect that
transaction without providing disclosure regarding a control
relationship with an issuer or participation in a distribution of a
component security tendered to or delivered by the ETF.
    As discussed above, the composite nature of diversified ETF
portfolios and the relatively small proportionate share of any
component security in a basket mean that any individual ETF portfolio
security that would be subject to disclosure under rules 15c1-5 or
15c1-6 will be a small portion of the portfolio. This diversification
should reduce the impact that any potential conflicts of interest
involving a component security that a broker-dealer may have and
mitigate the concern that a broker-dealer could use an ETF to avoid
disclosure of a conflict of interest that would otherwise be required
to be disclosed under rules 15c1-5 and 15c-6.
    Rule 6c-11 provides ETFs with flexibility to use custom baskets
that contain a non-representative selection of the ETFs' portfolio
securities.\23\ To the extent the contents of custom creation or
redemption baskets are negotiated between an authorized participant and
the ETF, the customer, via the authorized participant, should have
visibility into the contents of the basket. This visibility should
provide a customer seeking to engage in creation or redemption
transactions an opportunity to identify or otherwise inquire about
control relationships with the issuer or interest in a distribution of
a component security that a broker-dealer would otherwise be required
to disclose pursuant to these rules.
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    \23\ If different baskets are used in transactions on the same
business day, each basket after the initial representative basket
would constitute a custom basket. See Rule 6c-11 Adopting Release,
sec. II.C.5.
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    The exemption from rules 15c1-5 and 15c1-6 is subject to a further
condition that requires the broker-dealer to provide any information to
which a customer is entitled under rule 15c1-5 or 15c1-6 upon request
and to fulfill such requests in a timely manner. The Commission
believes that this condition will ensure that any customers who would
like to access this information for any of the investor protections
needs described above will be able to receive it.
    Similar to rule 10b-10 above, the Commission believes that the
general availability of information regarding ETFs through a variety of
sources, including the NSCC, intermediaries and the ETFs themselves,
supports this exemption. This access allows market participants that
use basket information to obtain information regarding securities they
will exchange in a creation or redemption transaction. The Commission
believes that this information also should provide market participants
seeking to engage in creation or redemption transactions an opportunity
to identify or otherwise inquire about the control relationships or
interest in a distribution that a broker-dealer would otherwise be
required to disclose pursuant to these rules.

E. Exemption From Section 11(d)(1)

    Exchange Act section 11(d)(1) generally prohibits a person that is
both a broker and a dealer from extending or maintaining credit, or
arranging for the extension or maintenance of credit, to or for a
customer on any security (other than an exempted security) which was
part of a distribution of a new issue of securities in which the
broker-dealer participated. Because ETFs are in continuous
distribution, broker-dealers effecting creation and redemption
transactions on behalf of customers are participating in the
distribution of new issue securities with respect to shares of ETFs,
and thus are continuously subject to the restrictions of section
11(d)(1). Section 11(d)(1) issues arise both with Broker-Dealer APs and
with broker-dealers who effect only secondary market transactions
(``Non-AP Broker-Dealers'').
1. Conditions for Broker-Dealer Authorized Participants
    As noted in section II above, a Broker-Dealer AP is a registered
broker-dealer that has entered into a contractual arrangement with an
ETF or one of its service providers that allows the Broker-Dealer AP to
place orders for the purchase or redemption of creation units, but
Broker-Dealer APs are not compensated by ETFs in connection with the
creation or redemption of ETF shares. Broker-Dealers may have different
reasons for becoming authorized participants, including for their own
proprietary trading, to facilitate customer trades, to hedge or
otherwise manage their own risk, or to arbitrage differences between
the ETF's market price and its NAV.
    The Commission is granting an exemption from the new issue lending
restriction in section 11(d)(1) for a Broker-Dealer AP that extends or
maintains credit, or arranges for the extension or maintenance of
credit, on ETF shares subject to the following two conditions:
    1. Neither the Broker-Dealer AP, nor any natural person associated
with such Broker-Dealer AP, directly or indirectly (including through
any affiliate of such Broker-Dealer AP), receives from the ``Fund
Complex'' \24\ any payment, compensation, or other economic incentive
to promote or sell the shares of the ETF to persons outside the fund
complex, other than non-cash compensation currently permitted under
Financial Industry and Regulatory Authority (``FINRA'') rule
2341(l)(5)(A), (B), or (C) (``non-cash compensation'').\25\
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    \24\ For purposes of this order, a ``Fund Complex'' is the
issuer of the ETF shares, any other issuer of ETF shares that holds
itself out to investors as a related company for purposes of
investment or investor services; any investment adviser,
distributor, sponsor, or depositor of any such issuer; or any
``affiliated person'' (as defined in the Investment Company Act
section 2(a)(3)) of any such issuer or any such investment adviser,
distributor, sponsor, or depositor.
    \25\ Non-cash compensation currently permitted under FINRA rule
2341(l)(5)(A), (B), or (C) is limited to:
    (A) Gifts that do not exceed an annual amount per person fixed
periodically by FINRA and are not preconditioned on achievement of a
sales target;
    (B) An occasional meal, a ticket to a sporting event or the
theater, or comparable entertainment which is neither so frequent
nor so extensive as to raise any question of propriety and is not
preconditioned on achievement of a sales target; [and]
    (C) Payment or reimbursement by offerors in connection with
meetings held by an offeror or by a member for the purpose of
training or education of associated persons of a member, subject to
certain conditions.

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    2. The Broker-Dealer AP does not extend, maintain or arrange for
the extension or maintenance of credit to or for a customer on shares
of the ETF before thirty days have passed from the date that the ETF's
shares initially commence trading (except to the extent that such
extension, maintenance, or arranging of credit is otherwise permitted
pursuant to rule 11d1-1).
    The exemption permits a Broker-Dealer AP to accept only limited
forms of non-cash compensation that do not present broker-dealers with
the types of potential conflicts of interest in their sale of
securities that section 11(d)(1) addresses.\26\ This absence of any
special compensation to distribute shares mitigates the potential
conflicts of interest that section 11(d)(1) addresses. In addition,
requiring a Broker-Dealer AP to wait thirty days before margining its
customers' ETF shares is consistent with the section 11(d)(1)
prohibition against a broker-dealer extending credit on securities that
were part of a new issue, if the broker-dealer participated in the
distribution of the new issue securities within the preceding thirty
days. Thus, this condition ensures that Broker-Dealer APs do not use
credit to induce customers to buy ETF shares for at least a 30-day
period following launch of the ETF, similar to the prohibition against
extending credit that applies to other types of new issue securities
under section 11(d)(1).
---------------------------------------------------------------------------

    \26\ See Exchange Act Release No. 21557 (Dec. 18, 1984), 49 FR
50172 at 50173-74 (Dec. 27, 1984) (available at: https://cdn.loc.gov/service/ll/fedreg/fr049/fr049250/fr049250.pdf).
---------------------------------------------------------------------------

2. Conditions for Non-AP Broker-Dealers
    Many broker-dealers effect ETF securities transactions solely on
the secondary market, whether for themselves or as agent for their
customers. They do not enter contractual arrangements to effect
creation or redemption transactions with the ETF or one of its service
providers. Thus, these Non-AP Broker-Dealers have not undertaken to
distribute ETF shares and generally do not receive any compensation for
selling ETF shares, other than, in some cases, limited forms of non-
cash compensation. Non-AP Broker-Dealers may reasonably be considered
not to be participating in the distribution of new issue securities
within the meaning of section 11(d)(1). However, to remove any
ambiguity about the circumstances when Non-AP Broker-Dealers may offer
margin on ETF securities the Commission is granting this exemption from
section 11(d)(1).
    The Commission believes this relief is appropriate because, as
stated above, Non-AP Broker-Dealers do not engage in creation and
redemption transactions with ETFs and, thus, may reasonably be
considered not to be participating in the distribution of the ETFs'
securities. In addition, this relief is subject to the condition that
Non-AP Broker-Dealers do not (and their associated persons who are
natural persons do not), directly or indirectly (including through any
affiliate of such Non-AP Broker-Dealer), receive from the Fund Complex
any payment, compensation or other economic incentive to promote or
sell the shares of the ETF to persons outside the Fund Complex, other
than non-cash compensation. For the foregoing reasons, the Commission
believes it is necessary and appropriate and in the public interest and
consistent with investor protection to grant this exemption.

F. Exemption From Rule 14e-5

    Exchange Act rule 14e-5 prohibits ``covered persons'' from directly
or indirectly purchasing or arranging to purchase any securities that
are the subject of a tender offer (``subject securities'') \27\ or any
securities that are immediately convertible into, exchangeable for, or
exercisable for subject securities (``related securities'') \28\ except
as part of such tender offer. The term ``covered person'' includes,
among others, a dealer-manager of a tender offer and any person acting,
directly or indirectly, in concert with other covered persons in
connection with any purchase or arrangement to purchase any subject
securities or any related securities.\29\ Therefore, the prohibitions
of rule 14e-5 may apply to authorized participants who are broker-
dealers and acting as dealer-managers in tender offers, the ETF, and
any legal entity of which the ETF is a series.
---------------------------------------------------------------------------

    \27\ Exchange Act rule 14e-5(c)(7).
    \28\ Exchange Act rule 14e-5(c)(6).
    \29\ Exchange Act rule 14e-5(c)(3).
---------------------------------------------------------------------------

    The Commission is granting a conditional exemption from rule 14e-5
to an ETF, the legal entity of which the ETF is a series, and
authorized participants and any other persons who create and redeem
shares of the ETF in creation units pursuant to contractual
arrangements pertaining to such legal entity and the ETF, and who are
covered persons with respect to a tender offer involving an ETF's
component securities. The conditional exemption will allow such persons
(i) to redeem ETF shares in creation unit sizes for a redemption basket
that may include a subject security or related security, (ii) to engage
in secondary market transactions with respect to the ETF shares after
the first public announcement of the tender offer and during such
tender offer given that such transactions could include, or be deemed
to include, purchases of, or arrangements to purchase, subject
securities or related securities, and (iii) make purchases of, or
arrangements to purchase, subject securities or related securities in
the secondary market for the purpose of transferring such securities to
purchase one or more creation units of ETF shares. The exemption from
rule 14e-5 is subject to the following conditions:
    1. No purchases of subject securities or related securities made by
broker-dealers acting as dealer-managers of a tender offer would be
effected for the purpose of facilitating a tender offer;
    2. If there is a change in the composition of a ETF's portfolio of
component securities and a broker-dealer acting as a dealer-manager of
a tender offer is unable to rely on the exception found in rule 14e-
5(b)(5) for basket transactions because (i) the basket of subject
securities or related securities contains fewer than 20 securities or
(ii) the subject securities and related securities make up more than 5%
of the value of the basket, then any purchases of an ETF component
security by such dealer-manager during a tender offer will be effected
for the purpose of adjusting a basket of securities in the ordinary
course of its business and not for the purpose of facilitating a tender
offer; and
    3. Except for the relief specifically granted herein, any broker-
dealer acting as a dealer-manager of a tender offer will comply with
rule 14e-5.
    The Commission believes this exemption will facilitate the ability
of authorized participants and others to engage in creation or
redemption transactions between the public announcement of a tender
offer and its expiration, thereby permitting the ETF to operate as
intended for the benefit of its holders and as disclosed in publicly
filed documents. The conditions applicable to the relief will ensure
that authorized participants and other recipients of the relief do not
effect creation or redemption transactions

during the relevant tender offer period in an effort to facilitate the
tender offer. For the foregoing reasons, the Commission believes it is
necessary and appropriate and in the public interest and consistent
with investor protection to grant this exemption.

IV. Conclusion

    In light of the above, and in accordance with Exchange Act Section
36, the Commission finds that conditionally exempting broker-dealers
that engage in certain transactions in securities of ETFs that can rely
on Investment Company Act rule 6c-11 from the requirements of section
11(d)(1) of the Exchange Act and Exchange Act rules 10b-10, 15c1-5,
15c1-6, and 14e-5 necessary and appropriate in the public interest, and
consistent with the protection of investors.
    Therefore, it is hereby ordered, pursuant to section 36 of the
Exchange Act, subject to the conditions described in Sections III.A, B,
and C above, that a broker or dealer is exempt from Exchange Act rule
10b-10 with respect to creation or redemption transactions on behalf of
customers in securities issued by ETFs relying on Investment Company
Act rule 6c-11.
    It is further ordered, pursuant to section 36 of the Exchange Act,
subject to the conditions described in Sections III.A, B, and D above,
that a broker or dealer is exempt from Exchange Act rule 15c1-5 with
respect to creation or redemption transactions on behalf of customers
in securities issued by ETFs relying on Investment Company Act rule 6c-
11.
    It is further ordered, pursuant to section 36 of the Exchange Act,
subject to the conditions described in Sections III.A, B, and D above,
that a broker or dealer is exempt from Exchange Act rule 15c1-6 with
respect to creation or redemption transactions on behalf of customers
in securities issued by ETFs relying on Investment Company Act rule 6c-
11.
    It is further ordered, pursuant to section 36 of the Exchange Act,
subject to the conditions described in Sections III.A, B, and E.1.
above, that an AP Broker-Dealer in a particular ETF relying on
Investment Company Act rule 6c-11 is exempt from section 11(d)(1) of
the Exchange Act with respect to the extension or maintenance of
credit, or the arranging of the extension or maintenance of credit, on
securities issued by such ETF.
    It is further ordered, pursuant to section 36 of the Exchange Act,
subject to the conditions described in Section III.A, B, and E.2 above,
that a Non-AP Broker-Dealer that effects transactions in shares of an
ETF relying on Investment Company Act rule 6c-11, exclusively in the
secondary market, is exempt from section 11(d)(1) when it extends or
maintains, or arranges for the extension or maintenance of credit to or
for customers on such ETF shares.
    It is further ordered, pursuant to section 36 of the Exchange Act,
subject to the conditions described in Sections III.A and F above, the
ETF and other persons described in Section III.F are exempt from
Exchange Act rule 14e-5 with respect to the transactions described in
Section III.F above.
    This exemption is subject to modification or revocation at any time
the Commission determines that such action is necessary or appropriate
in furtherance of the purposes of the Exchange Act. In addition,
persons relying on this exemption are directed to the anti-fraud and
anti-manipulation provisions of the federal securities laws,
particularly section 10(b) of the Exchange Act and rule 10b-5
thereunder.

    By the Commission.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2019-21515 Filed 10-23-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Pages 36839-36841]
[FR Doc No: 2021-14788]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34324, File No. 812-15232]

Hartford Funds Exchange-Traded Trust, et al.

July 7, 2021.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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    Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (``Act'') for an exemption from sections
2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act and rule 22c-1 under the
Act, and under sections 6(c) and 17(b) of the Act for an exemption from
sections 17(a)(1) and 17(a)(2) of the Act, and under Section
12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and
12(d)(1)(B) of the Act.

Applicants: Hartford Funds Exchange-Traded Trust (the ``Trust''),
Hartford Funds Management Company, LLC (the ``Adviser''), and ALPS
Distributors, Inc. (the ``Distributor'').

Summary of Application: Applicants request an order (``Order'') that
permits: (a) The Funds (defined below) to issue shares (``Shares'')
redeemable in large aggregations only (``creation units''); (b)
secondary market transactions in Shares to occur at negotiated market
prices rather than at net asset value; (c) certain Funds to pay
redemption proceeds, under certain circumstances, more than seven days
after the tender of Shares for redemption; and (d) certain affiliated
persons of a Fund to deposit securities into, and receive securities
from, the Fund in connection with the purchase and redemption of
creation units. The relief in the Order would incorporate by reference
terms and conditions of the same relief of a previous order granting
the same relief sought by applicants, as that order may be amended from
time to time (``Reference Order'').\1\
---------------------------------------------------------------------------

    \1\ Fidelity Beach Street Trust, et al., Investment Company Act
Rel. Nos. 33683 (Nov. 14, 2019) (notice) and 33712 (Dec. 10, 2019)
(order). Applicants are not seeking relief under Section 12(d)(1)(J)
of the Act for an exemption from Sections 12(d)(1)(A) and
12(d)(1)(B) of the Act (the ``Section 12(d)(1) Relief''), and relief
under Sections 6(c) and 17(b) of the Act for an exemption from
Sections 17(a)(1) and 17(a)(2) of the Act relating to the Section
12(d)(1) Relief, except as necessary to allow a Fund's receipt of
Representative ETFs included in its Tracking Basket solely for
purposes of effecting transactions in Creation Units (as these terms
are defined in the Reference Order), notwithstanding the limits of
Rule 12d1-4(b)(3). Accordingly, to the extent the terms and
conditions of the Reference Order relate to such relief, they are
not incorporated by reference herein other than with respect to such
limited exception.

---------------------------------------------------------------------------
Filing Date: The application was filed on May 25, 2021.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by emailing the Commission's
Secretary at<EMAIL_ADDRESS>and serving applicants with a
copy of the request by email. Hearing requests should be received by
the Commission by 5:30 p.m. on August 2, 2021, and should be
accompanied by proof of service on applicants, in the form of an
affidavit or, for lawyers, a certificate of service. Pursuant to rule
0-5 under the Act, hearing requests should state the nature of the
writer's interest, any facts bearing upon the desirability of a hearing
on the matter, the reason for the request, and the issues contested.
Persons who wish to be notified of a hearing may request notification
by emailing the Commission's Secretary at<EMAIL_ADDRESS>
ADDRESSES: Secretary, U.S. Securities and Exchange Commission,
<EMAIL_ADDRESS>Applicants: Thomas R. Phillips, Esq.,
Hartford Funds Management Company, LLC,
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Jean E. Minarick, Senior Counsel, at
(202) 551-6811 or Kaitlin C. Bottock, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Applicants

    1. The Trust is a statutory trust organized under the laws of
Delaware and consists of, among other series, one or more series
operating as a Fund. The Trust is registered as an open-end management
investment company under the Act. Applicants seek relief with respect
to Funds (as defined below), including the initial Fund (the ``Initial
Fund''). The Initial Fund will offer exchange-traded shares utilizing
active management investment strategies as contemplated by the
Reference Order.\2\
---------------------------------------------------------------------------

    \2\ To facilitate arbitrage, among other things, each day a Fund
will publish a basket of securities and cash that, while different
from the Fund's portfolio, is designed to closely track its daily
performance.
---------------------------------------------------------------------------

    2. The Adviser, a Delaware limited liability company, will be the
investment adviser to the Initial Fund. Subject to approval by the
Trust's board of trustees, the Adviser (as defined below) will serve as
investment adviser to the Funds. The Adviser is, and any other Adviser
will be, registered as an investment adviser under the Investment
Advisers Act of 1940 (``Advisers Act''). The Adviser may enter into
sub-advisory agreements with other investment advisers to act as sub-
advisers with respect to a Fund (each a ``Sub-Adviser''). Any Sub-
Adviser to a Fund will be registered under the Advisers Act.
    3. The Distributor is a Colorado corporation and a broker-dealer
registered under the Securities Exchange Act of 1934, as amended, and
will act as the principal underwriter of Shares of the Funds.
Applicants request that the requested relief apply to any distributor
of Shares, whether affiliated or unaffiliated with the Adviser and/or
Sub-Adviser (included in the term ``Distributor''). Any Distributor
will comply with the terms and conditions of the Order.

Applicants' Requested Exemptive Relief

    4. Applicants seek the requested Order under section 6(c) of the
Act for an exemption from sections 2(a)(32), 5(a)(1), 22(d) and 22(e)
of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b)
of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the
Act and under Section 12(d)(1)(J) of the Act for an exemption from
Sections 12(d)(1)(A) and 12(d)(1)(B) of the Act. The requested Order
would permit applicants to offer Funds that operate as contemplated by
the Reference Order. Because the relief requested is the same as
certain of the relief granted by the Commission under the Reference
Order and because the Adviser has entered into a licensing agreement
with Fidelity Management & Research Company, or an affiliate thereof,
in order to offer Funds that operate as contemplated by the Reference
Order,\3\ the Order would incorporate by reference the terms and
conditions of the same relief of the Reference Order.
---------------------------------------------------------------------------

    \3\ Certain aspects of how the Funds will operate (as described
in the Reference Order) are the intellectual property of Fidelity
Management & Research Company (or its affiliates).
---------------------------------------------------------------------------

    5. Applicants request that the Order apply to the Initial Fund and
to any other existing or future registered open-end management
investment company or series thereof that: (a) Is advised by the
Adviser or any entity controlling, controlled by, or under common
control with the Adviser (any such entity included in the term
``Adviser''); (b) offers exchange-traded shares utilizing active
management investment strategies as contemplated by the Reference
Order; and (c) complies with the terms and conditions of the Order and
the terms and conditions of the Reference Order that are incorporated
by reference into the Order (each such company or series and the
Initial Fund, a ``Fund'').\4\
---------------------------------------------------------------------------

    \4\ All entities that currently intend to rely on the Order are
named as applicants. Any other entity that relies on the Order in
the future will comply with the terms and conditions of the Order
and the terms and conditions of the Reference Order that are
incorporated by reference into the Order.
---------------------------------------------------------------------------

    6. Section 6(c) of the Act provides that the Commission may exempt
any person, security or transaction, or any class of persons,
securities or transactions, from any provisions of the Act, if and to
the extent that such exemption is necessary or appropriate in the
public interest and consistent with the protection of investors and the
purposes fairly intended by the policy

and provisions of the Act. Section 17(b) of the Act authorizes the
Commission to exempt a proposed transaction from section 17(a) of the
Act if evidence establishes that the terms of the transaction,
including the consideration to be paid or received, are reasonable and
fair and do not involve overreaching on the part of any person
concerned, and the transaction is consistent with the policies of the
registered investment company and the general purposes of the Act.
Section 12(d)(1)(J) of the Act provides that the Commission may exempt
any person, security, or transaction, or any class or classes of
persons, securities or transactions, from any provision of section
12(d)(1) if the exemption is consistent with the public interest and
the protection of investors. Applicants submit that for the reasons
stated in the Reference Order the requested relief meets the exemptive
---------------------------------------------------------------------------
standards under sections 6(c), 17(b) and 12(d)(1)(J) of the Act.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-14788 Filed 7-12-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Page 57163]
[FR Doc No: 2021-22364]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4488-DR; Docket ID FEMA-2021-0001]

New Jersey; Amendment No. 7 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New Jersey (FEMA-4488-DR), dated March 25, 2020, and
related determinations.

DATES: This change occurred on August 23, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Chad Gorman, of
FEMA is appointed to act as the Federal Coordinating Officer for this
disaster.
    This action terminates the appointment of Thomas J. Fargione as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22364 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 86, Number 97 (Friday, May 21, 2021)]
[Notices]
[Pages 27631-27633]
[FR Doc No: 2021-10750]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0268]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Labeling of Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the recommended labeling of certain beers subject to our
labeling jurisdiction.

DATES: Submit either electronic or written comments on the collection
of information by July 20, 2021.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 20, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 20, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2009-D-0268 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Labeling of Certain Beers Subject
to the Labeling Jurisdiction of the Food and Drug Administration.''
Received comments, those filed in a timely manner (see ADDRESSES), 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both 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
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of

information they conduct or sponsor. ``Collection of information'' is
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information, including each proposed
extension of an existing collection of information, before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Labeling of Certain Beers Subject to the Labeling Jurisdiction of the
Food and Drug Administration

OMB Control Number 0910-0728--Extension

    The definition of ``food'' under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act (21 U.S.C. 321(f)), includes ``articles used
for food or drink'' and thus includes alcoholic beverages. As such,
alcoholic beverages are subject to the FD&C Act's adulteration and
misbranding provisions and implementing regulations related to food.
For example, manufacturers of alcoholic beverages are responsible for
adhering to the registration of food facilities requirements in 21 CFR
part 1 and to the good manufacturing practice regulations in 21 CFR
part 110. There are also certain requirements for nutrition labeling on
menus, menu boards, and other written materials for alcohol beverages
served in restaurants or similar retail food establishments in 21 CFR
part 101. However, as reflected in a 1987 Memorandum of Understanding
between FDA and the Alcohol and Tobacco Tax and Trade Bureau (TTB), TTB
is responsible for the dissemination and enforcement of regulations
with respect to the labeling of distilled spirits, certain wines, and
malt beverages issued in the Federal Alcohol Administration Act (the
FAA Act). In TTB Ruling 2008-3, dated July 7, 2008, TTB clarified that
certain beers, which are not made from both malted barley and hops but
are instead made from substitutes for malted barley (such as sorghum,
rice, or wheat) or are made without hops, do not meet the definition of
a ``malt beverage'' under the FAA Act. Accordingly, TTB stated in its
ruling that such products (other than sak[eacute], which is classified
as a wine under the FAA Act), are not subject to the labeling,
advertising, or other provisions of TTB regulations issued under the
FAA Act.
    In cases where an alcoholic beverage is not covered by the labeling
provisions of the FAA Act, the product is subject to ingredient and
other labeling requirements under the FD&C Act and the implementing
regulations that we administer. In addition, as provided for under the
Fair Packaging and Labeling Act (FPLA), alcoholic beverages that are
not covered by the labeling provisions of the FAA Act are subject to
the provisions of the FPLA, which we administer.
    Therefore, the beers described in TTB's ruling as not being a
``malt beverage'' are subject to the labeling requirements under the
FD&C Act and FPLA, and our implementing regulations. In general, we
require that food products under our jurisdiction be truthfully and
informatively labeled in accordance with the FD&C Act, the FPLA, and
FDA's regulations. Furthermore, some TTB labeling requirements, such as
the Government Health Warning Statement under the Alcoholic Beverage
Labeling Act and certain marking requirements under the Internal
Revenue Code, continue to apply to these products.
    Persons with access to the internet may obtain the guidance
entitled ``Labeling of Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug Administration,'' located at https://www.fda.gov/FoodGuidances. This guidance is intended to assist
manufacturers on how to label bottled or otherwise packaged beers that
are subject to our labeling laws and regulations.
    Our food labeling regulations under parts 101, 102, 104, and 105
(21 CFR parts 101, 102, 104, and 105) were issued under the authority
of sections 4, 5, and 6 of the FPLA (15 U.S.C. 1453, 1454, and 1455)
and under sections 201, 301, 402, 403, 409, 411, 701, and 721 of the
FD&C Act (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most
of these regulations derive from section 403 of the FD&C Act, which
provides that a food product shall be deemed to be misbranded if, among
other things, its label or labeling fails to bear certain required
information concerning the food product, is false or misleading in any
particular, or bears certain types of unauthorized claims. The
disclosure requirements and other collections of information in the
regulations in parts 101, 102, 104, and 105 are necessary to ensure
that food products produced or sold in the United States are in
compliance with the labeling provisions of the FD&C Act and the FPLA.
    The primary user of the information to be disclosed on the label or
labeling of food products is the consumer that purchases the food
product. Consumers will use the information to assist them in making
choices concerning their purchase of a food product, including choices
related to substances that the consumer must avoid to prevent adverse
reactions. This information also enables the consumer to determine the
role of the food product in a healthful diet. Additionally, FDA intends
to use the information to determine whether a manufacturer or other
supplier of food products is meeting its statutory and regulatory
obligations. Failure of a manufacturer or other supplier of food
products to label its products in compliance with section 403 of the
FD&C Act and parts 101, 102, 104, and 105 of FDA's food labeling
regulations may result in a product being misbranded under the FD&C
Act, subjecting the firm and product to regulatory action.
    Description of Respondents: The respondents to this collection of
information are manufacturers of beers that are subject to our labeling
laws and regulations.
    We estimate the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
            21 CFR part; activity                 Number of      disclosures    Total  annual        Average burden per disclosure          Total hours
                                                 respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.  Sec.   101.3 and 101.22; statement of                12               2              24  0.5 (30 minutes).........................              12
 identity labeling requirements.
Sec.   101.4; ingredient labeling                          12               2              24  1........................................              24
 requirements.
Sec.   101.5; requirement to specify the name              12               2              24  0.25 (15 minutes)........................               6
 and place of business of the manufacturer,
 packer, or distributor.
Sec.   101.9; labeling requirements for                    12               2              24  4........................................              96
 disclosure of nutrition information.
Sec.   101.7; declaration of net quantity of               12               2              24  0.5 (30 minutes).........................              12
 contents.
Section 403(w)(1) of the FD&C Act;                         12               2              24  1........................................              24
 declaration of food allergens.
Guidance document entitled ``Labeling of                   12               1              12  1........................................              12
 Certain Beers Subject to the Labeling
 Jurisdiction of the Food and Drug
 Administration''.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................             186
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. Our estimate of the number of respondents is based on the
number of regulatory submissions to TTB for beers that do not meet the
definition of a ``malt beverage'' under the FAA Act. Based on its
records of submissions received from manufacturers of such products,
TTB estimates the annual number of respondents to be 12 and the annual
number of disclosures to be 24.
    Our estimates of the average burden per disclosure for each
collection provision are based on our experience with food labeling
under the Agency's jurisdiction. The estimated average burden per
disclosure for Sec. Sec.  101.3, 101.4, 101.5, 101.9, 101.22, and 101.7
are equal to, and based upon, the estimated average burden per
disclosure approved by OMB in OMB control number 0910-0381. We further
estimate that the labeling burden of section 403(w)(1) of the FD&C Act,
which specifies requirements for the declaration of food allergens,
will be 1 hour based upon the similarity of the requirements to that of
Sec.  101.4. Finally, we estimate that a respondent will spend 1 hour
reading the guidance.
    The guidance also refers to previously approved collections of
information found in our regulations. The collections of information in
Sec. Sec.  101.3, 101.4, 101.5, 101.9, 101.22, and 101.7 have been
approved under OMB control number 0910-0381. Allergen labeling of these
beers under section 403(w)(1) of the FD&C Act, which was added by the
Food Allergen Labeling and Consumer Protection Act of 2004, has been
approved under OMB control number 0910-0792.

    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10750 Filed 5-20-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)]
[Rules and Regulations]
[Pages 22592-22593]
[FR Doc No: 2018-10447]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2018-0250]

Safety Zones; Fireworks and Swim Events in Captain of the Port
New York Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce various safety zones within the
Captain of the Port New York Zone on the specified dates and times.
This action is necessary to ensure the safety of vessels, spectators
and participants from hazards associated with fireworks. During the
enforcement period, no person or vessel may enter the safety zones
without permission of the Captain of the Port (COTP).

DATES: The regulation for the safety zones described in 33 CFR 165.160
will be enforced on the dates and times listed in the table below.

FOR FURTHER INFORMATION CONTACT: If you have questions regarding this
document, call or email Petty Officer First Class Ronald Sampert U.S.
Coast Guard; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones listed in 33 CFR 165.160 on the specified dates and times as
indicated in Tables 1 and 2 below. This regulation was published in the
Federal Register on November 9, 2011 (76 FR 69614).

                                 Table 1
------------------------------------------------------------------------

------------------------------------------------------------------------
1. 2018 Ellis Island Medals of Honor      Launch site: A barge
 (N.E.C.O.), Liberty Island Safety        located in approximate
 Zone, 33 CFR 165.160(2.1).               position 40[deg]41'16.5'' N
                                          074[deg]02'23'' W (NAD 1983)
                                          located in Federal Anchorage
                                          20-C, about 360 yards east of
                                          Liberty Island. This Safety
                                          Zone is a 360-yard radius from
                                          the barge.
                                          Date: May 12, 2018.
                                          Time: 11:30 p.m.-12:30
                                          a.m.
2. Carnival Horizon Ship Christening,     Launch site: A barge
 Pier 90 Hudson River Safety Zone, 33     located in approximate
 CFR 165.160(5.4).                        position 40[deg]46'11.8''N,
                                          074[deg]00'14.8''W (NAD 1983)
                                          about 375 yards west of Pier
                                          90. This Safety Zone is a 360-
                                          yard radius from the barge.
                                          Date: May 23, 2018.
                                          Time: 10:00 p.m.-10:30
                                          p.m.
3. Marist College O.A.C.A.C.,             Launch site: A barge
 Poughkeepsie, NY, Hudson River Safety    located in approximate
 Zone, 33 CFR 165.160(5.13).              position 41[deg]42'24.50'' N,
                                          073[deg]56'44.16'' W (NAD
                                          1983), approximately 420 yards
                                          north of the Mid Hudson
                                          Bridge. This Safety Zone is a
                                          300-yard radius from the
                                          barge.
                                          Date: June 7, 2018.
                                          Time: 8:30 p.m.-9:30
                                          p.m.
4. Boston Consulting Group, Ellis         Launch site: A barge
 Island Safety Zone, 33 CFR               located between Federal
 165.160(2.2).                            Anchorages 20-A and 20-B, in
                                          approximate position
                                          40[deg]41'45'' N,
                                          074[deg]03'42'' W (NAD 1983),
                                          about 260 yards south of Ellis
                                          Island. This Safety Zone is a
                                          240-yard radius from the
                                          barge.
                                          Date: June 8, 2018.
                                          Time: 10:00 p.m.-10:30
                                          p.m.
------------------------------------------------------------------------

                                 Table 2
------------------------------------------------------------------------

------------------------------------------------------------------------
5. Newburgh Beacon Swim, Safety Zone,     Location: Participants
 33 CFR 165.160(1.2).                     will cross the Hudson River
                                          between Newburgh, to Beacon,
                                          New York approximately 1300
                                          yards south of the Newburgh-
                                          Beacon bridges. This Safety
                                          Zone includes all waters
                                          within a 100-yard radius of
                                          each participating swimmer.
                                          Date: July 28, 2018.
                                          Time: 09:00 a.m.-11:30
                                          a.m.
------------------------------------------------------------------------

    Under the provisions of 33 CFR 165.160, vessels may not enter the
safety zones unless given permission from the COTP or a designated
representative. Spectator vessels may transit outside the safety zones
but may not anchor, block, loiter in, or impede the transit of other
vessels. The Coast Guard may be assisted by other Federal, State, or
local law enforcement agencies in enforcing this regulation.
    This document is issued under authority of 33 CFR 165.160(a) and 5
U.S.C. 552(a). In addition to the publication of this document in the
Federal Register, the Coast Guard will provide mariners with advanced
notification of enforcement periods via the Local Notice to Mariners
and marine information broadcasts. If the COTP determines that a safety
zone need not be enforced for the full duration stated in this
notification, a Broadcast Notice to Mariners may be used to grant
general permission to enter the safety zone.

    Dated: April 27, 2018.
M.H. Day,
Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2018-10447 Filed 5-15-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Notices]
[Page 58520]
[FR Doc No: 2011-24162]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Pediatric Oncology Subcommittee of the Oncologic
Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 2, 2011, from 8
a.m. to 3:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Bldg. 1.
    Contact Person: Caleb Briggs, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax: 301-847-
8533, e-mail<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On November 2, 2011, the subcommittee will consider and
discuss regulatory, academic, and industry perspectives regarding the
development of anticoagulant products (products to suppress clotting of
blood) in children. Issues for discussion will include identification
of strategies to encourage and facilitate studies of anticoagulants in
children that will result in informative pediatric labeling,
appropriate endpoints for studies of anticoagulants in pediatric
patients, and the role of pharmacokinetic/pharmacodynamic studies to
support a pediatric indication for anticoagulants.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 19, 2011. Oral presentations from the public will be scheduled
between approximately 12:50 p.m. and 1:50 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before October 11, 2011.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by October 12, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Caleb Briggs at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24162 Filed 9-20-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 9, 2010 (Volume 75, Number 45)]
[Notices]
[Page 10808-10809]
[DOCID:fr09mr10-62]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2005-C-0245, FDA-2005-C-0416, and FDA-2005-C-0504]
(formerly Docket Nos. 2005C-0302, 2005C-0303, and 2005C-0304)

CIBA Vision Corp.; Withdrawal of Color Additive Petitions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal, without prejudice to a future filing, of three color
additive petitions (CAP 5C0278, CAP 5C0279, and CAP 5C0280) proposing
that the color additive regulations be amended to provide for the safe
use of Color Index (C.I.) Pigment Violet 19, C.I. Pigment Yellow 154,
and C.I. Pigment Red 122 as color additives in contact lenses.

FOR FURTHER INFORMATION CONTACT: Celeste Johnston, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 17, 2005 (70 FR 48426), FDA announced that three
color additive petitions had been filed by CIBA Vision Corp., 11460
Johns Creek Pkwy., Duluth, GA 30097-1556. The petitions proposed to
amend the color additive regulations in Part 73 Listing of Color
Additives Exempt from Certification (21 CFR part 73) to provide for the
safe use of C.I. Pigment Violet 19 (CAP 5C0278, Docket No. FDA-2005-C-
0245), C.I. Pigment Yellow 154 (CAP 5C0279, Docket No. FDA-2005-C-
0416), and C.I. Pigment Red 122 (CAP 5C0280, Docket No. FDA-2005-C-
0504) as color additives in contact lenses. CIBA Vision Corp. has now
withdrawn the petitions without prejudice to a future filing (21 CFR
71.6(c)(2)).

    Dated: February 18, 2010.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive Safety, Center for Food Safety
and Applied Nutrition.
[FR Doc. 2010-4972 Filed 3-8-10; 8:45 am]
BILLING CODE 4160-01-S