[Federal Register Volume 77, Number 235 (Thursday, December 6, 2012)]
[Notices]
[Pages 72869-72870]
[FR Doc No: 2012-29461]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1135]

Guidance for Industry on Limiting the Use of Certain Phthalates
as Excipients in Center for Drug Evaluation and Research-Regulated
Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Limiting the Use of
Certain Phthalates as Excipients in CDER-Regulated Products.'' This
guidance provides the pharmaceutical industry with the Center for Drug
Evaluation and Research's (CDER's) current thinking on the potential
human health risks associated with exposure to dibutyl phthalate (DBP)
and di(2-ethylhexyl) phthalate (DEHP). In particular, the guidance
recommends that the pharmaceutical industry avoid the use of these two
specific phthalates as excipients in CDER-regulated drug and biologic
products, including prescription and nonprescription products.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Laurie Muldowney, Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, Bldg.
51, Rm. 4154, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-1571.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Limiting the Use of Certain Phthalates as Excipients in
CDER-Regulated Products.'' This guidance provides the pharmaceutical
industry with CDER's current thinking on the potential human health
risks associated with exposure to DBP and DEHP. In particular, the
guidance recommends that the pharmaceutical industry avoid the use of
these two specific phthalates as excipients in CDER-regulated drug and
biologic products, including prescription and nonprescription products.
The recommendations in this guidance do not address the use of DBP or
DEHP in other types of FDA-regulated products or exposure to DBP or
DEHP due to the presence of any of these compounds as an impurity--
including as a result of leaching from packaging materials and delivery
systems.
    Phthalate esters (phthalates) are synthetic chemicals with a broad
spectrum of uses. Phthalates are found in certain pharmaceutical
formulations, primarily as a plasticizer in enteric-coatings of solid
oral drug products to maintain flexibility, but they also may be used
for different functions in other dosage forms. Phthalates also are
found in other products for uses such as softeners of plastics,
solvents in perfumes, and additives to nail polish, as well as in
lubricants and insect repellents.
    Phthalates have been studied extensively in animals, and DBP and
DEHP have been shown to be developmental and reproductive toxicants in
laboratory animals. While the data in humans are less clear,
epidemiological studies suggest that certain phthalates may affect
reproductive and developmental outcomes. Other studies have confirmed
the presence of DBP and DEHP in amniotic fluid, breast milk, urine, and
serum.
    Data from the National Health and Nutrition Examination Survey
indicate widespread exposure of the general population to phthalates.
Humans are exposed to phthalates by multiple

routes, including inhalation, ingestion, and to a lesser degree
absorption through the skin. Several observational human studies have
reported an association between exposure to certain phthalates and
adverse developmental and reproductive effects. The ubiquitous presence
of phthalates in the environment and the potential consequences of
human exposure to phthalates have raised concerns, particularly in
vulnerable populations such as pregnant women and infants.
    Although the currently available human data are limited, the Agency
has determined that there is evidence that exposure to DBP and DEHP
from pharmaceuticals presents a potential risk of developmental and
reproductive toxicity. While it is recognized that drug products may
carry inherent risks, DBP and DEHP are used as excipients, and safer
alternatives are available. Therefore, the Agency recommends avoiding
the use of DBP and DEHP as excipients in CDER-regulated drug and
biologic products.
    These recommendations apply to CDER-regulated drug and biologic
products that are under development (i.e., investigational new drugs),
nonapplication products (e.g., over the counter monograph products),
and both marketed approved products and those currently under review
for marketing consideration (i.e., new drug applications, abbreviated
new drug applications, and biologics license applications).
    There are alternatives to DBP and DEHP for use as excipients in
CDER-regulated products. Manufacturers with products that contain DBP
or DEHP should consider alternative excipients and determine if the
alternative excipient they plan to use has been used in similar CDER-
approved products and at what level.
    The Inactive Ingredients Database provides information on
excipients present in FDA-approved drug products, and this information
can be helpful in developing drug products. As manufacturers
reformulate their products, the listings for DBP and DEHP will be
removed from the Inactive Ingredients Database.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on limiting the use of certain phthalates as
excipients in CDER-regulated products. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and
have been approved under OMB control numbers 0910-0014 and 0910-0001.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29461 Filed 12-5-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 18, 2009 (Volume 74, Number 51)]
[Notices]
[Page 11535]
[DOCID:fr18mr09-39]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM96-1-029]

Standards for Business Practices for Interstate Natural Gas
Pipelines; Notice Clarifying Implementation Date and Compliance Date

March 11, 2009.
    On February 24, 2009, the Commission issued a final rule in the
above-captioned proceeding, Order No. 587-T, that incorporated by
reference into the Commission's regulations, revisions adopted by the
North American Energy Standards Board to the business practices
standards for natural gas pipelines. Standards of Business Practices
for Interstate Natural Gas Pipelines, 126 FERC ] 61,129 (2009). The
final rule was published in the Federal Register on March 3, 2009, (74
FR 9162) and became effective April 2, 2009. Under the implementation
schedule established in the rule, natural gas pipelines are required to
implement the standards on August 1, 2009, and file tariff sheets to
reflect the changed standards on June 1, 2009.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-5774 Filed 3-17-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 165 (Tuesday, August 25, 2020)]
[Notices]
[Pages 52394-52396]
[FR Doc No: 2020-18563]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89608; File No. SR-NYSEArca-2019-77]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting
Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To
List and Trade Shares of the AdvisorShares Pure US Cannabis ETF Under
NYSE Arca Rule 8.600-E

August 19, 2020.

I. Introduction

    On December 13, 2019, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade shares (``Shares'') of the
AdvisorShares Pure US Cannabis ETF (``Fund'') under NYSE Arca Rule
8.600-E (``Managed Fund Shares''). The proposed rule change was
published for comment in the Federal Register on December 26, 2019.\3\
On January 28, 2020, pursuant to Section 19(b)(2) of the Act,\4\ the
Commission designated a longer period within which to approve the
proposed rule change, disapprove the proposed rule change, or institute
proceedings to determine whether to approve or disapprove the proposed
rule change.\5\ On March 13, 2020, the Commission instituted
proceedings under Section 19(b)(2)(B) of the Act \6\ to determine
whether to approve or disapprove the proposed rule change.\7\ On June
12, 2020, pursuant to Section 19(b)(2) of the Act,\8\ the Commission
designated a longer period within which to issue an order approving or
disapproving the proposed rule change.\9\ On July 7, 2020, the Exchange
filed Amendment No. 1 to the proposed rule change.\10\ The Commission
has received no comment letters on the proposal. This order approves
the proposed rule change, as modified by Amendment No. 1.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 87791 (December 18,
2019), 84 FR 71057.
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 88066, 85 FR 6009
(February 3, 2020). The Commission designated March 25, 2020, as the
date by which it should approve, disapprove, or institute
proceedings to determine whether to approve or disapprove the
proposed rule change.
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 88378, 85 FR 15834
(March 19, 2020).
    \8\ 15 U.S.C. 78s(b)(2).
    \9\ See Securities Exchange Act Release No. 89057, 85 FR 36910
(June 18, 2020). The Commission designated August 22, 2020, as the
date by which the Commission shall either approve or disapprove the
proposed rule change.
    \10\ In Amendment No. 1, the Exchange (i) represented that the
Fund has obtained an opinion of counsel that provides that (a) the
Fund and its shareholders will not violate the Controlled Substances
Act, 21 U.S.C. 801, et seq., (``Controlled Substances Act'') or the
Money Laundering Control Act, 18 U.S.C. 1956, et seq., for the
Fund's purchase of securities issued by Cannabis Companies (as
defined herein) which participate in the cannabis industry in full
compliance with state law and (b) the Fund's execution of a cash-
settled total return swap, under certain circumstances, would not
subject the Fund and its shareholders to regulatory liability should
a court hold that the total return swap violates the Act or the
Controlled Substances Act; and (ii) made other conforming technical
changes. Because Amendment No. 1 to the proposed rule change does
not materially alter the substance of the proposed rule change and
makes conforming and technical changes, Amendment No. 1 is not
subject to notice and comment. Amendment No. 1 is available on the
Commission's website at: https://www.sec.gov/comments/sr-nysearca-2019-77/srnysearca201977-7394645-218996.pdf.
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II. Description of the Proposed Rule Change, as Modified by Amendment
No. 1 11
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    \11\ Additional information regarding the Shares and the Fund
can be found in Amendment No. 1, supra note 10, and the Registration
Statement, infra note 13.
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    The Exchange proposes to list and trade Shares of the Fund under
Commentary .01 to NYSE Arca Rule 8.600-E, which governs the listing and
trading of Managed Fund Shares on the Exchange. AdvisorShares
Investments, LLC (``Adviser'') is the investment

adviser for the Fund.\12\ AdvisorShares Trust (``Trust'') and the
Adviser manage the Fund's investments, subject to the oversight and
supervision by the Board of Trustees of the Trust.\13\ Foreside Fund
Services, LLC, a registered broker-dealer, will act as the distributor
for the Fund's Shares. The Bank of New York Mellon will serve as the
administrator, custodian, and transfer agent for the Fund.
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    \12\ The Exchange represents that the Adviser is not registered
as a broker-dealer, and the Adviser is not affiliated with any
broker-dealers. In the event (a) the Adviser becomes registered as a
broker-dealer or newly affiliated with a broker-dealer, or (b) any
new adviser is a registered broker-dealer or becomes affiliated with
a broker-dealer, it will implement and maintain a ``fire wall'' with
respect to its relevant personnel or broker-dealer affiliate
regarding access to information concerning the composition of, and/
or changes to, the portfolio, and will be subject to procedures,
each designed to prevent the use and dissemination of material non-
public information regarding the portfolio.
    \13\ The Trust is registered under the 1940 Act. On August 19,
2019, the Trust filed with the Commission Post-Effective Amendment
No. 145 to the Trust's registration statement on Form N-1A under the
Securities Act of 1933 (15 U.S.C. 77a) and under the 1940 Act
relating to the Fund (File Nos. 333-157876 and 811-22110)
(``Registration Statement''). In addition, the Commission has issued
an order granting certain exemptive relief to the Trust under
the1940 Act. See Investment Company Act Release No. 29291 (May 28,
2010) (File No. 812-13677).
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A. Principal Investments of the Fund

    According to the Exchange, the investment objective of the Fund is
to seek long-term capital appreciation. The Fund will seek to achieve
its investment objective by investing, under normal market
conditions,\14\ at least 80% of its net assets in securities of
companies that derive at least 50% of their net revenue from the
marijuana and hemp business in the United States (``Cannabis
Companies'') and in derivatives that have economic characteristics
similar to such securities.\15\
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    \14\ The term ``normal market conditions'' is defined in NYSE
Arca Rule 8.600-E(c)(5).
    \15\ The Fund's investments in derivatives will include
investments in both listed derivatives and over-the-counter
(``OTC'') derivatives, as those terms are defined in Commentary
.01(d) and (e) to NYSE Arca Rule 8.600-E.
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    In addition to its investment in securities of companies that
derive a significant portion of their revenue from the marijuana and
hemp business, and in derivatives providing exposure to such
securities, the Fund may invest in securities of companies that, in the
opinion of the Advisor, may have current or future revenues from
cannabis-related business or that are registered with the United States
Drug Enforcement Agency (DEA) specifically for the purpose of handling
marijuana for lawful research and development of cannabis or
cannabinoid-related products.
    According to the Exchange, all of the Fund's investments, including
derivatives instruments, would be made in accordance with all
applicable laws, including U.S. federal and state laws.\16\ The Fund
will concentrate at least 25% of its investments in the
pharmaceuticals, biotechnology and life sciences industry group within
the health care sector.
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    \16\ The Fund filed an opinion of counsel on July 1, 2020 as an
exhibit to the Registration Statement. See supra notes 10 and 13.
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    The Fund primarily may invest in U.S. and foreign exchange-listed
equity securities and in derivative instruments, as further described
in this section, intended to provide exposure to such securities.
    The Fund may invest in the following types of U.S. and foreign
exchange-listed equity securities: Common stock; preferred stock;
warrants; Real Estate Investment Trusts (REITs); and rights. The Fund
may also invest in U.S. exchange-listed exchange-traded funds
(``ETFs'') \17\ and in U.S. exchange-listed closed-end funds.
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    \17\ For purposes of this filing, the term ``ETFs'' includes
Investment Company Units (as described in NYSE Arca Rule 5.2-
E(j)(3)); Portfolio Depositary Receipts (as described in NYSE Arca
Rule 8.100-E); and Managed Fund Shares (as described in NYSE Arca
Rule 8.600-E). All ETFs will be listed and traded in the U.S. on a
national securities exchange. While the Fund may invest in inverse
ETFs, the Fund will not invest in leveraged (e.g., 2X, -2X, 3X or -
3X) ETFs.
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    The Fund may hold cash and cash equivalents.\18\
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    \18\ For purposes of this filing, ``cash equivalents'' are the
short-term instruments enumerated in Commentary .01(c) to NYSE Arca
Rule 8.600-E.
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    The Fund may hold OTC total return swaps on U.S. and foreign
exchange-listed equity securities.

B. Other Investments of the Fund

    In addition to the Fund's principal investments described above,
the Fund may invest in U.S. exchange-listed equity options and equity
index options and in Rule 144A securities.

C. Investment Restrictions

    The Fund's investments, including derivatives, will be consistent
with the Fund's investment objective and will not be used to enhance
leverage (although certain derivatives and other investments may result
in leverage). That is, the Fund's investments will not be used to seek
performance that is the multiple or inverse multiple (e.g., 2X or -3X)
of the Fund's primary broad-based securities benchmark index (as
defined in Form N-1A).
    The Fund will not invest in securities or other financial
instruments that have not been described in the proposed rule change.

D. Application of Generic Listing Requirements

    The Exchange is submitting the proposed rule change because the
portfolio for the Fund will not meet all of the ``generic'' listing
requirements of Commentary .01 to NYSE Arca Rule 8.600-E applicable to
the listing of Managed Fund Shares. The Fund's portfolio will meet all
such requirements except for those set forth in Commentary .01(e).\19\
Specifically, the Exchange proposes that the Fund's investments in OTC
total return swaps on U.S. and foreign exchange-listed equity
securities may exceed the 20% limit on investments in OTC derivatives
set forth in in Commentary .01(e). The Exchange proposes that up to 60%
of the Fund's assets (calculated as the aggregate gross notional value)
may be invested in OTC total return swaps on U.S. and foreign exchange-
listed equity securities.\20\ The only OTC derivatives that the Fund
may invest in are OTC total return swaps on U.S. and foreign exchange-
listed equity securities. Price information relating to OTC swaps will
be available from major market data vendors. Other than Commentary
.01(e), the Shares of the Fund will conform to the initial and
continued listing criteria under NYSE Arca Rule 8.600-E and will meet
all other requirements of NYSE Arca Rule 8.600-E and Commentary .01
thereto.
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    \19\ Commentary .01(e) to NYSE Arca Rule 8.600-E provides that a
portfolio may hold OTC derivatives, including forwards, options and
swaps on commodities, currencies and financial instruments (e.g.,
stocks, fixed income, interest rates, and volatility) or a basket or
index of any of the foregoing; however, on both an initial and
continuing basis, no more than 20% of the assets in the portfolio
may be invested in OTC derivatives. For purposes of calculating this
limitation, a portfolio's investment in OTC derivatives will be
calculated as the aggregate gross notional value of the OTC
derivatives.
    \20\ The Exchange represents that the Adviser monitors
counterparty credit risk exposure (including for OTC derivatives)
and evaluates counterparty credit quality on a continuous basis.
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III. Discussion and Commission's Findings

    After careful review, the Commission finds that the proposed rule
change, as modified by Amendment No. 1, is consistent with the Act and
the rules and regulations thereunder applicable to a national
securities exchange.\21\ In particular, the Commission finds that the
proposed rule change, as modified by Amendment No. 1, is consistent
with

Section 6(b)(5) of the Act,\22\ which requires, among other things,
that the Exchange's rules be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest.
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    \21\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \22\ 15 U.S.C. 78f(b)(5).
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    As discussed above, the Exchange proposes that the Fund may invest
up to 60% of its assets (calculated as the aggregate gross notional
value) in OTC derivatives. The only OTC derivatives that the Fund may
invest in are OTC total return swaps on U.S. and foreign exchange-
listed equity securities, so the underlying securities are trading on
transparent and regulated markets. In addition, the Fund will disclose
on its website information regarding the Disclosed Portfolio required
under NYSE Arca Rule 8.600-E(c)(2) to the extent applicable and such
website information will be publicly available at no charge.\23\ Other
than Commentary .01(e), the Shares of the Fund will conform to the
initial and continued listing criteria under NYSE Arca Rule 8.600-E and
will meet all other requirements of NYSE Arca Rule 8.600-E and
Commentary .01 thereto. All Fund investments, including derivative
instruments (i.e., OTC total return swaps on U.S. and foreign exchange-
listed equity securities), will be made in accordance with all
applicable laws, including U.S. federal and state laws.
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    \23\ See Amendment No. 1, supra note 10, at 12.
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    In evaluating these aspects of the proposal, the Commission
believes that the proposal is reasonably designed to mitigate the
Shares' susceptibility to manipulation because (i) the investments of
the Fund will be transparent in that they are required to be disclosed
daily and specifically will include information regarding the Fund's
investments in OTC derivatives; (ii) the instruments underlying the
Fund's OTC derivative investments will be traded on transparent and
regulated markets, as the only OTC derivatives that the Fund may invest
in are total return swaps on U.S. and foreign exchange-listed equity
securities; and (iii) the Fund's investments otherwise are consistent
with the Exchange's generic listing standards. In addition, the
Commission believes that the proposal is consistent with the listing of
other series of Managed Fund Shares that have been approved by the
Commission.\24\
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    \24\ See, e.g., Securities Exchange Act Release No. 82080
(November 15, 2017), 82 FR 55449 (November 21, 2017) (NYSEArca-2017-
86) (Order Granting Approval of a Proposed Rule Change, as Modified
by Amendment Nos. 1 and 2, To List and Trade Shares of the JPMorgan
Managed Futures ETF Under NYSE Arca Rule 8.600-E); Securities
Exchange Act Release No. 82492 (January 12, 2018), 83 FR 2850
(January 19, 2018) (SR-NYSEArca-2017-87) (Order Granting Approval of
a Proposed Rule Change, as Modified by Amendment No. 6, To List and
Trade Shares of the JPMorgan Long/Short ETF Under NYSE Arca Rule
8.600-E).
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    Pursuant to Commentary .01 to NYSE Arca Rule 8.600-E, all
statements or representations made in the filing regarding (a) the
description of the portfolio or reference asset, (b) limitations on
portfolio holdings or reference assets, or (c) the applicability of
Exchange listing rules specified in the filing shall constitute
continued listing requirements for listing the Shares on the Exchange.
In addition, the issuer must notify the Exchange of any failure by the
Fund to comply with the continued listing requirements. Pursuant to its
obligations under Section 19(g)(1) of the Act, the Exchange will
monitor \25\ for compliance with the continued listing requirements. If
the Fund is not in compliance with the applicable listing requirements,
the Exchange will commence delisting procedures under NYSE Arca Rule
5.5-E(m).
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    \25\ The Commission notes that certain proposals for the listing
and trading of exchange-traded products include a representation
that the exchange will ``surveil'' for compliance with the continued
listing requirements. See, e.g., Securities Exchange Act Release No.
77499 (April 1, 2016), 81 FR 20428, 20432 (April 7, 2016) (SR-BATS-
2016-04). In the context of this representation, it is the
Commission's view that ``monitor'' and ``surveil'' both mean ongoing
oversight of compliance with the continued listing requirements.
Therefore, the Commission does not view ``monitor'' as a more or
less stringent obligation than ``surveil'' with respect to the
continued listing requirements.
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    Accordingly, for the foregoing reasons, the Commission finds that
the proposed rule change, as modified by Amendment No. 1, is consistent
with Section 6(b)(5) of the Act \26\ and the rules and regulations
thereunder applicable to a national securities exchange.
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    \26\ 15 U.S.C. 78f(b)(5).
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\27\ that the proposed rule change (SR-NYSEArca-2019-77), as
modified by Amendment No. 1, be, and it hereby is, approved.
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    \27\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\28\
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    \28\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-18563 Filed 8-24-20; 8:45 am]
BILLING CODE 8011-01-P