[Federal Register: December 11, 2009 (Volume 74, Number 237)]
[Proposed Rules]
[Page 65719-65724]
[DOCID:fr11de09-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2009-0566; FRL-9091-6]
RIN-2060-AP59

Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2010

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to allocate essential use allowances for
import and production of Class I ozone-depleting substances (ODSs) for
calendar year 2010. Essential use allowances enable a person to obtain
controlled Class I ODSs through an exemption to the regulatory ban on
the production and import of these chemicals, which became effective as
of January 1, 1996. EPA allocates essential use allowances for
production or import of a specific quantity of Class I substances
solely for the designated essential purpose. The proposed allocation in
this action is 30.0 metric tons (MT) of chlorofluorocarbons (CFCs) for
use in metered dose inhalers (MDIs) for 2010.

DATES: Written comments on this proposed rule must be received by the
EPA Docket on or before January 11, 2010, unless a public hearing is
requested. Comments must then be received on or before 30 days
following the public hearing. Any party requesting a public hearing
must notify the contact listed below under FOR FURTHER INFORMATION
CONTACT by 5 p.m. Eastern Standard Time on December 16, 2009. If a
hearing is held, it will take place on December 28, 2009 at EPA
headquarters in Washington, DC. EPA will post a notice on our Web site
(http://www.epa.gov/ozone/strathome.html) announcing further
information on the hearing if it is requested.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2009-0566, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Air Docket, Environmental Protection Agency,
Mailcode 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery or Courier: Deliver your comments to: EPA
Air Docket, EPA West, 1301 Constitution Avenue, NW., Room 3334, Mail
Code 2822T, Washington, DC 20460. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2009-0566. EPA's policy is that all comments received by the docket
will be included in the public docket without change and may be made
available online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
through http://www.regulations.gov or e-mail that you consider to be
CBI or otherwise protected. If you would like the Agency to consider
comments that include CBI, EPA recommends that you submit the comments
to the docket that exclude the CBI portion but that you provide a
complete version of your comments, including the CBI, to the person
listed under FOR FURTHER INFORMATION CONTACT below. The http://
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through http://www.regulations.gov your
e-mail address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of

special characters, any form of encryption, and be free of any defects
or viruses. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at http://www.epa.gov/epahome/
dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Docket, EPA/
DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC.
This Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jennifer Bohman, by regular mail: U.S.
Environmental Protection Agency, Stratospheric Protection Division
(6205J), 1200 Pennsylvania Avenue, NW., Washington, DC 20460; by
courier service or overnight express: 1301 L Street, NW., Room 1047A,
Washington, DC 20005; by telephone:<PHONE_NUMBER>; or by e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
    A. What should I consider when preparing my comments?
II. Basis for Allocating Essential Use Allowances
    A. What are essential use allowances?
    B. Under what authority does EPA allocate essential use
allowances?
    C. What is the process for allocating essential use allowances?
III. Essential Use Allowances for Medical Devices
IV. Proposed Allocation of Essential Use Allowances for Calendar
Year 2010
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. General Information

A. What should I consider when preparing my comments?

    1. Confidential Business Information. Do not submit this
information to EPA through http://www.regulations.gov or e-mail.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark
the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number). Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Basis for Allocating Essential Use Allowances

A. What are essential use allowances?

    Essential use allowances are allowances to produce or import
certain ozone depleting substances (ODSs) in the U.S. for purposes that
have been deemed ``essential'' by the U.S. Government and by the
Parties to the Montreal Protocol on Substances that Deplete the Ozone
Layer (Montreal Protocol).
    The Montreal Protocol is the international agreement aimed at
reducing and eliminating the production and consumption \1\ of ODSs.
The elimination of production and consumption of Class I ODSs is
accomplished through adherence to phaseout schedules for specific Class
I ODSs,\2\ which include CFCs, halons, carbon tetrachloride, and methyl
chloroform. As of January 1, 1996, production and import of most Class
I ODSs were phased out in developed countries, including the United
States.
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    \1\ ``Consumption'' is defined as the amount of a substance
produced in the United States, plus the amount imported into the
United States, minus the amount exported to Parties to the Montreal
Protocol (see Section 601(6) of the Clean Air Act).
    \2\ Class I ozone depleting substances are listed at 40 CFR part
82, subpart A, appendix A.
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    However, the Montreal Protocol and the Clean Air Act (the Act)
provide exemptions that allow for the continued import and/or
production of Class I ODSs for specific uses. Under the Montreal
Protocol, exemptions may be granted for uses that are determined by the
Parties to be ``essential.'' Decision IV/25, taken by the Parties to
the Protocol in 1992, established criteria for determining whether a
specific use should be approved as essential, and set forth the
international process for making determinations of essentiality. The
criteria for an essential use, as set forth in paragraph 1 of Decision
IV/25, are the following:

    ``(a) That a use of a controlled substance should qualify as
`essential' only if:
    (i) It is necessary for the health, safety or is critical for
the functioning of society (encompassing cultural and intellectual
aspects); and
    (ii) There are no available technically and economically
feasible alternatives or substitutes that are acceptable from the
standpoint of environment and health;
    (b) That production and consumption, if any, of a controlled
substance for essential uses should be permitted only if:
    (i) All economically feasible steps have been taken to minimize
the essential use and any associated emission of the controlled
substance; and
    (ii) The controlled substance is not available in sufficient
quantity and quality

from existing stocks of banked or recycled controlled substances,
also bearing in mind the developing countries' need for controlled
substances.''

B. Under what authority does EPA allocate essential use allowances?

    Title VI of the Act implements the Montreal Protocol for the United
States.\3\ Section 604(d) of the Act authorizes EPA to allow the
production of limited quantities of Class I ODSs after the phaseout
date for the following essential uses:
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    \3\ See Section 614(b) of the Act. EPA's regulations
implementing the essential use provisions of the Act and the
Protocol are located in 40 CFR part 82.
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    (1) Methyl Chloroform, ``solely for use in essential applications
(such as nondestructive testing for metal fatigue and corrosion of
existing airplane engines and airplane parts susceptible to metal
fatigue) for which no safe and effective substitute is available.''
Under section 604(d)(1) of the Act, this exemption was available only
until January 1, 2005. Prior to that date, EPA issued methyl chloroform
allowances to the U.S. Space Shuttle and Titan Rocket programs.
    (2) Medical devices (as defined in section 601(8) of the Act), ``if
such authorization is determined by the Commissioner [of the Food and
Drug Administration], in consultation with the Administrator [of EPA]
to be necessary for use in medical devices.'' EPA issues allowances to
manufacturers of MDIs that use CFCs as propellant for the treatment of
asthma and chronic obstructive pulmonary disease.
    (3) Aviation safety, for which limited quantities of halon-1211,
halon-1301, and halon-2402 may be produced ``if the Administrator of
the Federal Aviation Administration, in consultation with the
Administrator [of EPA] determines that no safe and effective substitute
has been developed and that such authorization is necessary for
aviation safety purposes.'' Neither EPA nor the Parties have ever
granted a request for essential use allowances for halon, because
alternatives are available or because existing quantities of this
substance are large enough to provide for any needs for which
alternatives have not yet been developed.
    An additional essential use exemption under the Montreal Protocol,
as agreed in Decision X/19, is the general exemption for laboratory and
analytical uses. This exemption is reflected in EPA's regulations at 40
CFR part 82, subpart A. While the Act does not specifically provide for
this exemption, EPA has determined that an exemption for essential
laboratory and analytical uses is allowable under the Act as a de
minimis exemption. The de minimis exemption is addressed in EPA's final
rule of March 13, 2001 (66 FR 14760-14770). The Parties to the Protocol
subsequently agreed (Decision XI/15) that the general exemption does
not apply to the following uses: testing of oil and grease, and total
petroleum hydrocarbons in water; testing of tar in road-paving
materials; and forensic finger-printing. EPA incorporated this
exemption at Appendix G to Subpart A of 40 CFR part 82 on February 11,
2002 (67 FR 6352). In a December 29, 2005, final rule, EPA extended the
general exemption for laboratory and analytical uses through December
31, 2007 (70 FR 77048), in accordance with Decision XV/8 of the Parties
to the Protocol. At the 19th Meeting of the Parties in September 2007,
the Parties agreed to extend the global laboratory and analytical use
exemption through December 31, 2011, in Decision XIX/18. In a December
27, 2007, final rulemaking EPA took action to (1) extend the laboratory
and analytical use exemption from December 31, 2007, to December 31,
2011, for specific laboratory uses, (2) apply the laboratory and
analytical use exemption to the production and import of methyl
bromide, and (3) eliminate the testing of organic matter in coal from
the laboratory and analytical use exemption (72 FR 73264).

C. What is the process for allocating essential use allowances?

    The procedure set out by Decision IV/25 calls for individual
Parties to nominate essential uses and the total amount of ODSs needed
for those essential uses on an annual basis. The Protocol's Technology
and Economic Assessment Panel (TEAP) evaluates the nominated essential
uses and makes recommendations to the Parties. The Parties make the
final decisions on whether to approve a Party's essential use
nomination at their annual meeting. This nomination process occurs
approximately two years before the year in which the allowances would
be in effect. The allowances proposed for allocation for 2010 were
first nominated by the United States in January 2008.
    For MDIs, EPA requests information from manufacturers about the
number and type of MDIs they plan to produce, as well as the amount of
CFCs necessary for production. EPA then forwards the information to the
Food and Drug Administration (FDA), which determines the amount of CFCs
necessary for MDIs in the coming calendar year. Based on FDA's
determination, EPA proposes allocations to each eligible entity. Under
the Act and the Montreal Protocol, EPA may allocate essential use
allowances in quantities that together are below or equal to the total
amount approved by the Parties. EPA will not allocate essential use
allowances in amounts higher than the total approved by the Parties.
For 2010, the Parties authorized the United States to allocate up to 92
MT of CFCs for essential uses.

III. Essential Use Allowances for Medical Devices

    The following is a step-by-step list of actions EPA and FDA have
taken thus far to implement the exemption for medical devices found at
section 604(d)(2) of the Act for the 2010 calendar year.
    1. On January 7, 2009, EPA sent letters to MDI manufacturers
requesting the following information under section 114 of the Act
(``114 letters''):
    a. The MDI product where CFCs will be used.
    b. The number of units of each MDI product produced from 1/1/08 to
12/31/08.
    c. The number of units anticipated to be produced in 2009.
    d. The number of units anticipated to be produced in 2010.
    e. The gross target fill weight per unit (grams).
    f. Total amount of CFCs to be contained in the MDI product for
2010.
    g. The additional amount of CFCs necessary for production.
    h. The total CFC request per MDI product for 2010.

The 114 letters are available for review in the Air Docket ID No. EPA-
HQ-OAR-2009-0566. The companies requested that their responses be
treated as confidential business information; for this reason, EPA has
placed the responses in the confidential portion of the docket.

    2. At the end of January 2009, as required by 40 CFR 82.13(u), EPA
received information from MDI manufacturers that included such data as
the type and quantity of CFCs held at the end of the year (i.e. stocks
of pre-1996 and post-1996 CFCs). The data submitted from the MDI
manufacturers is available for review in the Air Docket ID No. EPA-HQ-
OAR-2009-0566. The companies requested that their individual responses
be treated as confidential business information; for this reason, EPA
has placed the individual responses in the confidential portion of the
docket.
    3. On April 1, 2009, EPA sent FDA the information MDI manufacturers
provided in response to the 114 letters and information required by 40
CFR

82.13(u) with a letter requesting that FDA make a determination
regarding the amount of CFCs necessary for MDIs for calendar year 2010.
This letter is available for review in Air Docket ID No. EPA-HQ-OAR-
2009-0566.
    4. On July 10, 2009, FDA sent a letter to EPA stating the amount of
CFCs determined by the Commissioner to be necessary for each MDI
company in 2010. This letter is available for review in the Air Docket
ID No. EPA-HQ-OAR-2009-0566. FDA's letter informed EPA that it had
determined that 30.0 MT of CFCs were necessary for use in medical
devices in the year 2010.
    With respect to the 2010 determination, FDA stated, ``Our
determination for the allocation of CFCs is lower than the total amount
requested by manufacturers. In reaching this estimate, we took into
account the sponsors' production of MDIs that used CFCs as a propellant
in 2008, their estimated production in 2009, their estimated production
in 2010, their anticipated essential-use allocations in 2009, and their
current (as of December 31, 2008) stockpile levels. Our determination
took into account any transferred CFCs as well as pre-1996 CFC amounts.
Finally, we based our determination for 2010 on an estimate of the
quantity of CFCs that would allow manufacturers to have adequate
stockpiles at the end of 2010 consistent with the principles in
paragraph 3 of Decision XVI/12 and paragraph 2 of Decision XVII/5.''
    The letter stated that in making its determination, FDA made the
following assumptions:
     All manufacturers will receive the full essential-use
allocation proposed by EPA for calendar year 2009 (74 FR 2954, January
16, 2009);
     All manufacturers will procure the full quantity of CFCs
allocated to them for 2009; and
     No bulk CFCs currently held by, or allocated to, any
manufacturer will be exported from the United States.
    EPA has confirmed with FDA that this determination is consistent
with Decision XVII/5, including language on stocks that states that
Parties ``shall take into account pre- and post-1996 stocks of
controlled substances as described in paragraph 1(b) of Decision IV/25,
such that no more than a one-year operational supply is maintained by
that manufacturer.'' Allowing manufacturers to maintain up to a one-
year operational supply accounts for unexpected variability in the
demand for MDI products or other unexpected occurrences in the market
and therefore ensures that MDI manufacturers are able to produce their
essential use MDIs.
    In accordance with the FDA determination, today's action proposes
to allocate essential use allowances for a total of 30.0 MT of CFCs for
use in MDIs for calendar year 2010.
    The amounts listed in this proposal are subject to additional
review and revision by EPA and FDA if information demonstrates that the
proposed allocations are either too high or too low. We specifically
request comment on the extent to which the proposed allocation of CFCs
is sufficient to protect public health and ensure the manufacture and
continuous availability of CFCs necessary to meet the expected demand.
We also request comment on whether the proposed allocation, when
considered along with current stocks, will best protect consumers by
providing a smooth transition to non-CFC alternatives. Commenters
requesting increases or decreases of essential use allowances should
provide detailed information supporting a claim for additional or fewer
CFCs. Any company that needs less than the full amount listed in this
proposal should notify EPA of the actual amount needed.

IV. Proposed Allocation of Essential Use Allowances for Calendar Year
2010

        Table I--Essential Use Allowances for Calendar Year 2010
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                                                           2010 Quantity
            Company                      Chemical          (metric tons)
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 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong......................  CFC-11 or CFC-12 or CFC-           30.0
                                  114.
------------------------------------------------------------------------

    EPA proposes to allocate essential use allowances for calendar year
2010 to the entity listed in Table I. These allowances are for the
production or import of the specified quantity of Class I controlled
substances solely for the specified essential use.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993),
this action is a ``significant regulatory action'' because it raises
novel legal or policy issues. Accordingly, EPA submitted this action to
the Office of Management and Budget (OMB) for review under EO 12866 and
any changes made in response to OMB recommendations have been
documented in the docket for this action.
    EPA prepared an analysis of the potential costs and benefits
related to this action. This analysis is contained in the Agency's
Regulatory Impact Analysis (RIA) for the entire Title VI phaseout
program (U.S. Environmental Protection Agency, ``Regulatory Impact
Analysis: Compliance with Section 604 of the Clean Air Act for the
Phaseout of Ozone Depleting Chemicals,'' July 1992). A copy of the
analysis is available in the docket for this action and the analysis is
briefly summarized here. The RIA examined the projected economic costs
of a complete phaseout of consumption of ozone-depleting substances, as
well as the projected benefits of phased reductions in total emissions
of CFCs and other ozone-depleting substances, including essential use
CFCs used for MDIs.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
The recordkeeping and reporting requirements included in this action
are already included in an existing information collection burden and
this action does not propose any changes that would affect the burden.
The Office of Management and Budget (OMB) has previously approved the
information collection requirements contained in the existing
regulations at 40 CFR 82.8(a) under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control
number 2060-0170. The OMB control numbers for EPA's regulations in 40
CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any

rule subject to notice and comment rulemaking requirements under the
Administrative Procedure Act or any other statute unless the agency
certifies that the rule will not have a significant economic impact on
a substantial number of small entities. Small entities include small
businesses, small organizations, and small governmental jurisdictions.
    For purposes of assessing the impact of today's proposed rule on
small entities, small entity is defined as: (1) A small business that
is primarily engaged in pharmaceutical preparations manufacturing as
defined by NAICS code 325412 with less than 750 employees; (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant its field.
    After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the rule on small entities.'' 5 USC 603 and 604.
Thus, an agency may certify that a rule will not have a significant
economic impact on a substantial number of small entities if the rule
relieves regulatory burden, or otherwise has a positive economic effect
on all of the small entities subject to the rule.
    This proposed action will provide an otherwise unavailable benefit
to those companies that are receiving essential use allowances by
creating an exemption to the regulatory phaseout of
chlorofluorocarbons. We have therefore concluded that today's proposed
rule will relieve regulatory burden for all small entities. We continue
to be interested in the potential impact of the proposed rule on small
entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. The action imposes no enforceable duty on any State, local or
tribal governments or the private sector. This action does not impose
any new requirements on any entities. Therefore, this action is not
subject to the requirements of sections 202 and 205 of the UMRA. This
action is also not subject to the requirements of section 203 of UMRA
because it contains no regulatory requirements that might significantly
or uniquely affect small governments because this rule merely allocates
essential use allowances to entities under an exemption to the ban on
production and import of Class I ODSs.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. This action merely allocates
essential use allowances to entities under an exemption to the ban on
production and import of Class I ODSs. Thus, Executive Order 13132 does
not apply to this rule.
    In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed action
from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action
merely allocates essential use allowances to entities under an
exemption to the ban on production and import of Class I ODSs. This
action does not impose substantial direct compliance costs on Indian
tribal governments. Thus, Executive Order 13175 does not apply to this
action. EPA specifically solicits additional comment on this proposed
action from tribal officials.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets EO 13045 as applying to those regulatory actions
that concern health or safety risks, such that the analysis required
under section 5-501 of the Order has the potential to influence the
regulation. This proposed rule is not subject to EO 13045 because it
implements Section 604(d)(2) of the Clean Air Act which states that the
Agency shall authorize essential use exemptions should the Food and
Drug Administration determine that such exemptions are necessary.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy. This action merely allocates essential
use allowances to entities under an exemption to the ban on production
and import of Class I ODSs.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards. This proposed
rule does not involve technical standards. Therefore, EPA did not
consider the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has concluded that it is not practicable to determine whether
there would be disproportionately high and adverse human health or
environmental

effects on minority and/or low income populations from this proposed
rule. EPA believes, however, that this action affects the level of
environmental protection equally for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. Any ozone depletion that results from this proposed
rule will impact all affected populations equally because ozone
depletion is a global environmental problem with environmental and
human effects that are, in general, equally distributed across
geographical regions.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Chlorofluorocarbons, Imports, Methyl
Chloroform, Ozone, Reporting and recordkeeping requirements.

    Dated: December 7, 2009.
Lisa P. Jackson,
Administrator.

    40 CFR part 82 is proposed to be amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

    1. The authority citation for part 82 continues to read as follows:

    Authority:  42 U.S.C. 7414, 7601, 7671-7671q.

Subpart A--Production and Consumption Controls

    2. Section 82.8 is amended by revising the table in paragraph (a)
to read as follows:

Sec.  82.8  Grant of essential use allowances and critical use
allowances.

    (a) * * *

        Table I--Essential Use Allowances for Calendar Year 2010
------------------------------------------------------------------------
                                                           2010 quantity
              Company                     Chemical         (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong.........................  CFC-11 or CFC-12 or             30.0
                                     CFC-114.
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-29556 Filed 12-10-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: March 3, 2008 (Volume 73, Number 42)]
[Notices]
[Page 11451-11452]
[DOCID:fr03mr08-100]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 28170; 812-13481]

Eaton Vance Mutual Funds Trust, et al.; Notice of Application

February 26, 2008.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from rule 12d1-2(a)
under the Act.

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

    Summary of Application: Applicants request an order to permit funds
of funds relying on rule 12d1-2 under the Act to invest in certain
financial instruments.
    Applicants: Eaton Vance Mutual Funds Trust, Eaton Vance Special
Investment Trust (the ``Trusts''), Eaton Vance Management (``EVM''),
Boston Management and Research (``BMR,'' together with EVM, the
``Advisers''), and Eaton Vance Distributors, Inc. (the
``Distributor'').
    Filing Dates: The application was filed on January 18, 2008, and
amended on January 30, 2008.
    Hearing or Notification of Hearing: An order granting the
application will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on March 24, 2008 and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, Commission, 100 F Street, NE., Washington, DC
20549-1090; Applicants, 255 State Street, Boston, MA 02109.

FOR FURTHER INFORMATION CONTACT: Lewis Reich, Senior Counsel, at (202)
551-6919, or Nadya B. Roytblat,

Assistant Director, at<PHONE_NUMBER> (Division of Investment
Management, Office of Investment Company Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Branch, 100 F Street, NE., Washington, DC
20549-1520 (telephone<PHONE_NUMBER>).

Applicants' Representations

    1. The Trusts are organized as Massachusetts business trusts and
are registered under the Act as open-end management investment
companies. Applicants request an exemption to the extent necessary to
permit any existing or future series of the Trusts and any other
registered open-end investment company advised by the Advisers or any
person controlling, controlled by or under common control with the
Advisers, that may rely on rule 12d1-2 under the Act (each a `` Fund'')
to also invest to the extent consistent with its investment objective,
policies, strategies and limitations, in futures contracts, options on
futures contracts, swap agreements, other derivatives, and other
financial instruments that may not be securities within the meaning of
section 2(a)(36) of the Act (``Other Investments'') in addition to
registered investment companies (``Underlying Funds'') and other
securities.
    2. The Advisers, both Massachusetts business trusts registered
under the Investment Advisers Act of 1940, serve as investment advisers
to the Funds. EVM is a wholly-owned subsidiary of Eaton Vance
Corporation, a publicly held Maryland corporation, and BMR is a
subsidiary of EVM. The Distributor, an indirect wholly-owned subsidiary
of Eaton Vance Corporation, is registered as a broker-dealer under the
Securities Exchange Act of 1934 Act (``Exchange Act''), and serves as
the principal underwriter for the Funds.

Applicants' Legal Analysis

    1. Section 12(d)(1)(A) of the Act provides that no registered
investment company (``acquiring company'') may acquire securities of
another investment company (``acquired company'') if such securities
represent more than 3% of the acquired company's outstanding voting
stock or more than 5% of the acquiring company's total assets, or if
such securities, together with the securities of other investment
companies, represent more than 10% of the acquiring company's total
assets. Section 12(d)(1)(B) of the Act provides that no registered
open-end investment company may sell its securities to another
investment company if the sale will cause the acquiring company to own
more than 3% of the acquired company's voting stock, or cause more than
10% of the acquired company's voting stock to be owned by investment
companies.
    2. Section 12(d)(1)(G) of the Act provides that section 12(d)(1)
will not apply to securities of an acquired company purchased by an
acquiring company if: (i) The acquiring company and acquired company
are part of the same group of investment companies; (ii) the acquiring
company holds only securities of acquired companies that are part of
the same group of investment companies, government securities, and
short-term paper; (iii) the aggregate sales loads and distribution-
related fees of the acquiring company and the acquired company are not
excessive under rules adopted pursuant to section 22(b) or section
22(c) of the Act by a securities association registered under section
15A of the Exchange Act or by the Commission; and (iv) the acquired
company has a policy that prohibits it from acquiring securities of
registered open-end management investment companies or registered unit
investment trusts in reliance on section 12(d)(1)(F) or (G) of the Act.
    3. Rule 12d1-2 under the Act permits a registered open-end
investment company or a registered unit investment trust that relies on
section 12(d)(1)(G) of the Act to acquire, in addition to securities
issued by another registered investment company in the same group of
investment companies, government securities, and short-term paper: (1)
Securities issued by an investment company that is not in the same
group of investment companies, when the acquisition is in reliance on
section 12(d)(1)(A) or 12(d)(1)(F) of the Act; (2) securities (other
than securities issued by an investment company); and (3) securities
issued by a money market fund, when the investment is in reliance on
rule 12d1-1 under the Act. For the purposes of rule 12d1-2,
``securities'' means any security as defined in section 2(a)(36) of the
Act.
    4. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction from any provision of the Act, or
from any rule under the Act, if such exemption is necessary or
appropriate in the public interest and consistent with the protection
of investors and the purposes fairly intended by the policies and
provisions of the Act.
    5. Applicants state that the proposed arrangement would comply with
the provisions of rule 12d1-2 under the Act, but for the fact that the
Funds may invest a portion of their assets in Other Investments.
Applicants request an order under section 6(c) of the Act for an
exemption from rule 12d1-2(a) to allow the Funds to invest in Other
Investments. Applicants assert that permitting the Funds to invest in
Other Investments as described in the application would not raise any
of the concerns that the requirements of section 12(d)(1) were designed
to address.

Applicants' Conditions

    Applicants agree that the order granting the requested relief will
be subject to the following conditions:
    1. Prior to approving any investment advisory agreement under
section 15 of the Act, the board of trustees of the appropriate Fund,
including a majority of the trustees who are not ``interested persons''
as defined in section 2(a)(19) of the Act, will find that the advisory
fees, if any, charged under the agreement are based on services
provided that are in addition to, rather than duplicative of, services
provided pursuant to any Underlying Fund's advisory agreement. Such
finding, and the basis upon which the finding is made, will be recorded
fully in the minute books of the appropriate Fund.
    2. Applicants will comply with all provisions of rule 12d1-2 under
the Act, except for paragraph (a)(2), to the extent that it restricts
any Fund from investing in Other Investments as described in the
application.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-3960 Filed 2-29-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 25057-25059]
[FR Doc No: 2021-09772]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91765; File No. SR-MRX-2021-06]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Extend the
Expiration Date of the Temporary Amendments Concerning Video Conference
Hearings

May 4, 2021.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 28, 2021, Nasdaq MRX, LLC (``MRX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been substantially prepared by the Exchange. The Exchange has
designated the proposed rule change as constituting a ``non-
controversial'' rule change under paragraph (f)(6) of Rule 19b-4 under
the Act,\3\ which renders the proposal effective upon receipt of this
filing by the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to extend the expiration date of the
temporary amendments in SR-MRX-2020-23 from April 30, 2021, to August
31, 2021.\4\ The proposed rule change would not make any changes to the
text of the Exchange rules.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 90757 (Dec. 21,
2020), 85 FR 85771 (Dec. 29, 2020) (SR-MRX-2020-23). If the Exchange
seeks to provide additional temporary relief from the rule
requirements identified in this proposed rule change beyond August
31, 2021, the Exchange will submit a separate rule filing to further
extend the temporary extension of time. The amended Exchange rules
will revert to their original form at the conclusion of the
temporary relief period and any extension thereof.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
website at

https://listingcenter.nasdaq.com/rulebook/mrx/rules, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to continue to harmonize Exchange Rule
General 3, Section 2 with recent changes by the Financial Industry
Regulatory Authority, Inc. (``FINRA'') to its Rule 1015 in response to
the COVID-19 global health crisis and the corresponding need to
restrict in-person activities.\5\ The Exchange originally filed
proposed rule change SR-MRX-2020-23, which allows the Exchange Review
Council (``ERC'') to conduct hearings in connection with appeals of
Membership Application Program decisions, on a temporary basis, by
video conference, if warranted by the current COVID-19-related public
health risks posed by an in-person hearing. While there are signs of
improvement, the COVID-19 conditions necessitating the temporary
amendments persist and, based on its assessment of current COVID-19
conditions and the lack of certainty as to when COVID-19-related health
concerns and corresponding restrictions will meaningfully subside, the
Exchange has determined that there is a continued need for this
temporary relief for several months beyond April 30, 2021. Accordingly,
the Exchange proposes to extend the expiration date of the temporary
rule amendments in SR-MRX-2020-23 from April 30, 2021, to August 31,
2021.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 91495 (April 7,
2021), 86 FR 19306 (April 13, 2021) (SR-FINRA-2021-006) (``FINRA
Filing''). The Exchange notes that the FINRA Filing also proposed to
temporarily amend FINRA Rules 9261, 9524, and 9830, which govern
hearings in connection with appeals of disciplinary actions,
eligibility proceedings, and temporary and permanent cease and
desist orders. The Exchange's Rules 9261, 9524, and 9830 incorporate
by reference The Nasdaq Stock Market LLC rules, which are the
subject of a separate filing. See SR-NASDAQ-2021-033 (April 28,
2021). Therefore, the Exchange is not proposing to adopt that aspect
of the FINRA Filing.
---------------------------------------------------------------------------

    As set forth in SR-MRX-2020-23, the Exchange also relies on COVID-
19 data and criteria to determine whether the current public health
risks presented by an in-person hearing may warrant a hearing by video
conference. Based on that data and criteria, the Exchange does not
believe the COVID-19- related health concerns necessitating this relief
will meaningfully subside by April 30, 2021, and has determined that
there will be a continued need for this temporary relief for several
months beyond that date. Accordingly, the Exchange proposes to extend
the expiration date of the temporary rule amendments originally set
forth in SR-MRX-2020-23 from April 30, 2021, to August 31, 2021. The
extension of the temporary amendments allowing for specified ERC
hearings to proceed by video conference will allow the Exchange's
critical adjudicatory functions to continue to operate effectively in
these extraordinary circumstances--enabling the Exchange to fulfill its
statutory obligations to protect investors and maintain fair and
orderly markets--while also protecting the health and safety of hearing
participants.
    The Exchange has filed the proposed rule change for immediate
effectiveness and has requested that the SEC waive the requirement that
the proposed rule change not become operative for 30 days after the
date of the filing, so the Exchange can implement the proposed rule
change immediately.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\6\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\7\ in particular, in that it is designed 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,
by providing greater harmonization between the Exchange rules and FINRA
rules of similar purpose, resulting in less burdensome and more
efficient regulatory compliance.\8\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
    \8\ See supra note 5.
---------------------------------------------------------------------------

    The proposed rule change, which extends the expiration date of the
temporary amendments to the Exchange rules set forth in SR-MRX-2020-23,
will continue to aid the Exchange's efforts to timely conduct hearings
in connection with its core adjudicatory functions. Given current
COVID-19 conditions and the uncertainty around when those conditions
will meaningfully improve, without this relief allowing ERC hearings to
continue to proceed by video conference, such hearings may need to be
postponed indefinitely. The Exchange must be able to perform its
critical adjudicatory functions in order to fulfill its statutory
obligations to protect investors and maintain fair and orderly markets.
As such, this relief is essential to the Exchange's ability to fulfill
its statutory obligations and allows hearing participants to avoid the
serious COVID-19-related health and safety risks associated with in-
person hearings.
    Among other things, this relief will allow the ERC to timely
provide members, disqualified individuals and other applicants an
approval or denial of their applications. As set forth in detail in SR-
MRX-2020-23, this temporary relief allowing ERC hearings to proceed by
video conference accounts for fair process considerations and will
continue to provide fair process while avoiding the COVID-19-related
public health risks for hearing participants. Accordingly, the proposed
rule change extending this temporary relief is in the public interest
and consistent with the Act's purpose.

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

    The Exchange does not believe that the temporary proposed rule
change will impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act. As set forth in
SR-MRX-2020-23, the proposed rule change is intended solely to extend
temporary relief necessitated by the continued impacts of the COVID-19
outbreak and the related health and safety risks of conducting in-
person activities. The Exchange believes that the proposed rule change
will prevent unnecessary impediments to its operations, including its
critical adjudicatory processes, and its ability to fulfill its
statutory obligations to protect investors and maintain fair and
orderly markets that would otherwise result if the temporary amendments
were to expire on April 30, 2021.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \9\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \11\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\12\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange has
indicated that the proposed rule change to extend the expiration date
will continue to prevent unnecessary impediments to its operations,
including its critical adjudicatory processes, and its ability to
fulfill its statutory obligations to protect investors and maintain
fair and orderly markets that would otherwise result if the temporary
amendments were to expire on April 30, 2021.\13\ Importantly, extending
the relief provided in MRX-2020-23 immediately upon filing and without
a 30-day operative delay will allow the Exchange to continue critical
adjudicatory and review processes in a reasonable and fair manner and
meet its critical investor protection goals, while also following best
practices with respect to the health and safety of its employees.\14\
The Commission also notes that this proposal extends without change the
temporary relief previously provided by MRX-2020-23,\15\ and only
during the period in which the Exchange's operations are impacted by
COVID-19. As proposed, the changes would be in place through August 31,
2021 and the amended rules will revert back to their original state at
the conclusion of the temporary relief period and, if applicable, any
extension thereof.\16\ For these reasons, the Commission believes that
waiver of the 30-day operative delay for this proposal is consistent
with the protection of investors and the public interest. Accordingly,
the Commission hereby waives the 30-day operative delay and designates
the proposal operative upon filing.\17\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ See supra Item II.
    \14\ See FINRA Filing, 86 FR at 19308 (noting the same in
granting FINRA's request to waive the 30-day operative delay so that
SR-FINRA-2021-006 would become operative immediately upon filing).
    \15\ See supra note 4.
    \16\ See id. As noted above, the Exchange states that if it
requires temporary relief from the rule requirements identified in
this proposal beyond August 31, 2021, it may submit a separate rule
filing to extend the effectiveness of the temporary relief under
these rules.
    \17\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule change's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MRX-2021-06 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MRX-2021-06. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-MRX-2021-06 and should be
submitted on or before June 1, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-09772 Filed 5-7-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 87 (Monday, May 6, 2013)]
[Notices]
[Pages 26407-26410]
[FR Doc No: 2013-10606]

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

SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 30496; 812-14078]

Goldman Sachs Trust II, et al.; Notice of Application

April 29, 2013.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act, as well as from certain
disclosure requirements.

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

SUMMARY:  Summary of Application: Applicants request an order that
would permit them to enter into and materially amend subadvisory
agreements without shareholder approval and would grant relief from
certain disclosure requirements.

APPLICANTS:  Goldman Sachs Trust II (the ``Trust''), Goldman Sachs
Asset Management L.P. (``GSAM'') and Goldman Sachs Asset Management
International (``GSAMI'', each of GSAM and GSAMI an ``Adviser'' and
collectively, ``Advisers,'' and together with the Trust,
``Applicants'').

DATES:  Filing Dates: The application was filed September 21, 2012, and
amended on March 8, 2013.

HEARING OR NOTIFICATION OF HEARING:  An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on May 28, 2013 and should be accompanied by proof of service on
the applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Elizabeth M. Murphy, Secretary, U.S. Securities and Exchange
Commission, 100 F Street NE.,

Washington, DC 20549-1090. Applicants: Caroline Kraus, Goldman Sachs &
Co., 200 West Street, 15th Floor, New York, NY 10282.

FOR FURTHER INFORMATION CONTACT: Barbara T. Heussler, Senior Counsel,
at<PHONE_NUMBER>, or Jennifer L. Sawin, Branch Chief, at (202) 551-
6821 (Division of Investment Management, Office of Investment Company
Regulation).

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

Applicants' Representations

    1. The Trust is organized as a Delaware statutory trust and has
registered as an open-end management investment company under the Act
that will offer one or more series of shares (each a ``Series''). The
Trust has filed a registration statement on Form N-1A to register the
offering of shares of Goldman Sachs Multi-Manager Alternatives Fund, a
series of the Trust.\1\ Each Subadvised Fund may offer shares with its
own distinct investment objectives, policies and restrictions.
---------------------------------------------------------------------------

    \1\ Applicants request that the relief sought herein apply to
the Applicants, as well as to any future Series of the Trust and to
any other existing or future registered open-end investment company
or series thereof that: (a) is advised by either GSAM, GSAMI or
their successors (the foregoing advisers being included in the term
``Adviser,'' and any such series or investment company, including
the Trust and its Series, a ``Fund''); (b) uses the manager of
managers structure described in this Application (``Manager of
Managers Structure''); and (c) complies with the terms and
conditions of this Application (the ``Subadvised Funds,'' and each a
``Subadvised Fund''). The only Trust that currently intends to rely
on the requested order is named as an Applicant. For purposes of the
requested order, ``successor'' is limited to an entity that results
from a reorganization into another jurisdiction or a change in the
type of business organization. If the name of any Subadvised Fund
contains the name of a Subadviser, the name of the Adviser that
serves as the primary adviser to that Subadvised Fund or a trademark
or trade name that is owned by or publicly used to identify that
Adviser will precede the name of the Subadviser.
---------------------------------------------------------------------------

    2. GSAM, a Delaware limited partnership registered with the
Commission as an investment adviser under the Investment Advisers Act
of 1940 (``Advisers Act''), is expected to serve as investment adviser
to certain Series, in each case pursuant to an investment advisory
agreement with the Trust on behalf of the Series (each a ``GSAM
Investment Advisory Agreement''). GSAMI, a limited partnership
organized under the laws of the United Kingdom and registered with the
Commission as an investment adviser under the Advisers Act, may also
serve as investment adviser to certain Series, in each case pursuant to
an investment advisory agreement with the Trust on behalf of the Series
(each a ``GSAMI Investment Advisory Agreement'').\2\ The GSAM
Investment Advisory Agreements and the GSAMI Investment Advisory
Agreements are together referred to as the ``Investment Advisory
Agreements''. Each Investment Advisory Agreement will be approved by
the board of trustees of the Trust (the ``Board''), including a
majority of the trustees who are not ``interested persons,'' as defined
in section 2(a)(19) of the Act, of the Trust or the Adviser
(``Independent Trustees'') and by the shareholders of the relevant
Subadvised Fund in the manner required by sections 15(a) and 15(c) of
the Act and rule 18f-2 under the Act.\3\ Any future Adviser also will
be registered with the Commission as an investment adviser under the
Advisers Act and will enter into investment advisory agreements with or
on behalf of future Subadvised Funds, and such future agreements shall
be included in the term ``Investment Advisory Agreements.''
---------------------------------------------------------------------------

    \2\ GSAM and GSAMI are wholly-owned subsidiaries of the Goldman
Sachs Group, Inc.
    \3\ The term ``Board'' also includes the board of trustees or
directors of a future Subadvised Fund.
---------------------------------------------------------------------------

    3. Under the terms of each Investment Advisory Agreement, the
Adviser to a Subadvised Fund, subject to the oversight of the
applicable Board, shall furnish a continuous investment program for the
Subadvised Fund. The Adviser shall periodically review each Subadvised
Fund's investment policies and strategies and based on the need of a
particular Subadvised Fund may recommend changes to the investment
policies and strategies of the Subadvised Fund for consideration by its
Board. For its services to each Subadvised Fund, the Adviser shall
receive an investment advisory fee from that Subadvised Fund as
specified in the applicable Investment Advisory Agreement based on each
Subadvised Fund's average daily total or net assets. The terms of the
Investment Advisory Agreements also permit the applicable Adviser,
subject to the approval of the relevant Board, including a majority of
the Independent Trustees, and the shareholders of the applicable
Subadvised Fund (if required by applicable law), to delegate portfolio
management responsibilities of all or a portion of the assets of the
Subadvised Fund to one or more subadvisers (``Subadvisers''). Each
Subadviser will be an investment adviser as defined in section 2(a)(20)
of the Act, and either registered with the Commission as an investment
adviser under the Advisers Act or not subject to such registration. The
Adviser shall have overall responsibility for the management and
investment of the assets of each Subadvised Fund and, with respect to
each Subadvised Fund, the Adviser's responsibilities shall include, for
example, recommending the removal or replacement of Subadvisers, and
determining the portion of that Subadvised Fund's assets to be managed
by any given Subadviser and reallocating those assets as necessary from
time to time. The Adviser shall evaluate, select and recommend
Subadvisers to manage the assets of Subadvised Fund, and shall monitor
and review the Subadviser and its performance and its compliance with
that Subadvised Fund's investment policies and restrictions. For
services provided under each Subadvisory Agreement, it is currently
intended that the applicable Subadviser will receive from the
applicable Adviser a fee based on a percentage of the Subadvised Fund's
average daily total or net assets (``Subadvisory fees''). All
Subadvisers are expected to be compensated by the applicable Adviser
out of the advisory fees the Adviser receives pursuant to the relevant
Investment Advisory Agreement. As a matter of convenience, the
applicable Adviser may request that (a) amounts payable to a Subadviser
by the Adviser be transmitted directly to the Subadviser by the
Subadvised Fund and (b) that such amount be deducted from the amounts
payable by the Subadvised Fund to the Adviser. Subadvised Funds may
directly pay advisory fees to Subadvisers in the future, although any
amendment to a Subadvisory Agreement that would increase the total
management and advisory fees payable by a Subadvised Fund would require
shareholder approval.
    4. Applicants request an order to permit the Adviser, subject to
Board approval, to select certain Subadvisers to manage all or a
portion of the assets of a Subadvised Fund pursuant to a Sub-Advisory
Agreement and materially amend Sub-Advisory Agreements without
obtaining shareholder approval. The requested relief will not extend to
any Subadviser that is an affiliated person, as defined in section
2(a)(3) of the Act, of the Trust, a Subadvised Fund or the Adviser,
other than by reason of serving as a Subadviser to a Subadvised Fund
(``Affiliated Subadviser'').
    5. Applicants also request an order exempting the Subadvised Funds
from certain disclosure provisions described

below that may require the Applicants to disclose fees paid to each
Subadviser by the Adviser or a Subadvised Fund. Applicants seek an
order to permit each Subadvised Fund to disclose (as a dollar amount
and a percentage of a Subadvised Fund's total or net assets) only: (a)
The aggregate fees paid to the Subadvised Fund's Adviser and any
Affiliated Subadvisers; and (b) the aggregate fees paid to Subadvisers
other than Affiliated Subadvisers (collectively, the ``Aggregate Fee
Disclosure''). A Subadvised Fund that employs an Affiliated Subadviser
will provide separate disclosure of any fees paid to the Affiliated
Subadviser.

Applicants' Legal Analysis

    1. Section 15(a) of the Act provides, in relevant part, that it is
unlawful for any person to act as an investment adviser to a registered
investment company except pursuant to a written contract that has been
approved by the vote of a majority of the company's outstanding voting
securities. Rule 18f-2 under the Act provides that each series or class
of stock in a series investment company affected by a matter must
approve that matter if the Act requires shareholder approval.
    2. Form N-1A is the registration statement used by open-end
investment companies. Item 19(a)(3) of Form N-1A requires disclosure of
the method and amount of the investment adviser's compensation.
    3. Rule 20a-1 under the Act requires proxies solicited with respect
to an investment company to comply with Schedule 14A under the
Securities Exchange Act of 1934 (``Exchange Act''). Items 22(c)(1)(ii),
22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A, taken together,
require a proxy statement for a shareholder meeting at which the
advisory contract will be voted upon to include the ``rate of
compensation of the investment adviser,'' the ``aggregate amount of the
investment adviser's fees,'' a description of the ``terms of the
contract to be acted upon,'' and, if a change in the advisory fee is
proposed, the existing and proposed fees and the difference between the
two fees.
    4. Regulation S-X sets forth the requirements for financial
statements required to be included as part of a registered investment
company's registration statement and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b) and (c) of Regulation S-X require
a registered investment company to include in its financial statement
information about the investment advisory fees.
    5. Section 6(c) 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 provisions of the Act, or
from any rule thereunder, if 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. Applicants state that the requested relief meets this standard for
the reasons discussed below.
    6. Applicants assert that the shareholders expect the Adviser,
subject to the review and approval of the Board, to select the
Subadvisers who are best suited to achieve the Subadvised Fund's
investment objective. Applicants assert that, from the perspective of
the shareholder, the role of the Subadviser is substantially equivalent
to the role of the individual portfolio managers employed by an
investment adviser to a traditional investment company. Applicants
state that requiring shareholder approval of each Subadvisory Agreement
would impose unnecessary delays and expenses on the Subadvised Funds
and may preclude the Subadvised Funds from acting promptly when the
Adviser and Board consider it appropriate to hire Subadvisers or amend
Subadvisory Agreements. Applicants note that the Investment Advisory
Agreement for each Subadvised Fund and Subadvisory Agreements with
Affiliated Subadvisers (if any) will continue to be subject to the
shareholder approval requirements of section 15(a) of the Act and rule
18f-2 under the Act.
    7. If new Subadvisers are hired, the Subadvised Funds will inform
shareholders of the hiring of a new Subadviser pursuant to the
following procedures (``Modified Notice and Access Procedures''): (a)
Within 90 days after a new Subadviser is hired for any Subadvised Fund,
that Subadvised Fund will send its shareholders either a Multi-manager
Notice or a Multi-manager Notice and Multi-manager Information
Statement;\4\ and (b) the Subadvised Fund will make the Multi-manager
Information Statement available on the Web site identified in the
Multi-manager Notice no later than when the Multi-manager Notice (or
Multi-manager Notice and Multi-manager Information Statement) is first
sent to shareholders, and will maintain it on that Web site for at
least 90 days. In the circumstances described in this Application, a
proxy solicitation to approve the appointment of new Subadvisers
provides no more meaningful information to shareholders than the
proposed Multi-manager Information Statement. Moreover, as indicated
above, the applicable Board would comply with the requirements of
Sections 15(a) and 15(c) of the Act before entering into or amending
Sub-Advisory Agreements.
---------------------------------------------------------------------------

    \4\ A ``Multi-manager Notice'' will be modeled on a Notice of
Internet Availability as defined in rule 14a-16 under the Exchange
Act, and specifically will, among other things: (a) Summarize the
relevant information regarding the new Subadviser; (b) inform
shareholders that the Multi-manager Information Statement is
available on a Web site; (c) provide the Web site address; (d) state
the time period during which the Multi-manager Information Statement
will remain available on that Web site; (e) provide instructions for
accessing and printing the Multi-manager Information Statement; and
(f) instruct the shareholder that a paper or email copy of the
Multi-manager Information Statement may be obtained, without charge,
by contacting the Subadvised Funds.
    A ``Multi-manager Information Statement'' will meet the
requirements of Regulation 14C, Schedule 14C and Item 22 of Schedule
14A under the Exchange Act for an information statement, except as
modified by the requested order to permit Aggregate Fee Disclosure.
Multi-manager Information Statements will be filed electronically
with the Commission via the EDGAR system.
---------------------------------------------------------------------------

    8. Applicants assert that the requested disclosure relief would
benefit shareholders of the Subadvised Funds because it would improve
each Adviser's ability to negotiate the fees paid to Subadvisers.
Applicants state that if the Adviser is not required to disclose the
Subadvisers' fees to the public, the Adviser may be able to negotiate
rates that are below a Subadviser's ``posted'' amounts. Applicants
submit that the requested relief will also encourage Subadvisers to
negotiate lower subadvisory fees with the Adviser(s) if the lower fees
are not required to be made public.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Subadvised Fund may rely on the order requested herein,
the operation of the Subadvised Fund in the manner described in the
Application will be approved by a majority of the Subadvised Fund's
outstanding voting securities as defined in the Act or, in the case of
a Subadvised Fund whose public shareholders purchase shares on the
basis of a prospectus containing the disclosure contemplated by
condition 2 below, by the initial shareholder before such Subadvised
Fund's shares are offered to the public.
    2. The prospectus for each Subadvised Fund will disclose the
existence, substance, and effect of any order granted pursuant to the
Application. In addition, each Subadvised Fund will hold itself out to
the public as employing the Manager of

Managers Structure. The prospectus will prominently disclose that the
Adviser has the ultimate responsibility, subject to oversight by the
Board, to oversee the Subadvisers and recommend their hiring,
termination, and replacement.
    3. Subadvised Funds will inform shareholders of the hiring of a new
Subadviser within 90 days after the hiring of the new Subadviser
pursuant to the Modified Notice and Access Procedures.
    4. An Adviser will not enter into a Subadvisory Agreement with any
Affiliated Subadviser unless such agreement, including the compensation
to be paid thereunder, has been approved by the shareholders of the
applicable Subadvised Fund.
    5. At all times, at least a majority of the Board will be
Independent Trustees, and the nomination of new or additional
Independent Trustees will be placed within the discretion of the then-
existing Independent Trustees.
    6. Independent legal counsel, as defined in rule 0-1(a)(6) under
the Act, will be engaged to represent the Independent Trustees. The
selection of such counsel will be within the discretion of the then-
existing Independent Trustees.
    7. Whenever a Subadviser change is proposed for a Subadvised Fund
with an Affiliated Subadviser, the Board, including a majority of the
Independent Trustees, will make a separate finding, reflected in the
Board minutes, that the change is in the best interests of the
Subadvised Fund and its shareholders, and does not involve a conflict
of interest from which the applicable Adviser or the Affiliated
Subadviser derives an inappropriate advantage.
    8. Whenever a Subadviser is hired or terminated, the applicable
Adviser will provide the Board with information showing the expected
impact on the profitability of the Adviser.
    9. Each Adviser will provide the Board, no less frequently than
quarterly, with information about the profitability of the Adviser on a
per Subadvised Fund basis. The information will reflect the impact on
profitability of the hiring or termination of any Subadviser during the
applicable quarter.
    10. Each applicable Adviser will provide general management
services to each Subadvised Fund, including overall supervisory
responsibility for the general management and investment of the
Subadvised Fund's assets and, subject to review and approval of the
Board, will: (i) Set the Subadvised Fund's overall investment
strategies; (ii) evaluate, select, and recommend Subadvisers to manage
all or a portion of the Subadvised Fund's assets; (iii) allocate and,
when appropriate, reallocate the Subadvised Fund's assets among
Subadvisers; (iv) monitor and evaluate the Subadvisers' performance;
and (v) implement procedures reasonably designed to ensure that
Subadvisers comply with the Subadvised Fund's investment objective,
policies and restrictions.
    11. No Trustee or officer of a Trust or of a Fund or director or
officer of the applicable Adviser will own directly or indirectly
(other than through a pooled investment vehicle that is not controlled
by such person) any interest in a Subadviser except for (i) ownership
of interests in the Adviser or any entity that controls, is controlled
by or is under common control with the Adviser; or (ii) ownership of
less than 1% of the outstanding securities of any class of equity or
debt of any publicly traded company that is either a Subadviser or an
entity that controls, is controlled by or is under common control with
a Subadviser.
    12. Each Subadvised Fund will disclose in its registration
statement the Aggregate Fee Disclosure.
    13. In the event the Commission adopts a rule under the Act
providing substantially similar relief to that in the order requested
in the Application, the requested order will expire on the effective
date of that rule.
    14. For Subadvised Funds that pay fees to a Subadviser directly
from fund assets, any changes to a Subadvisory Agreement that would
result in an increase in the total management and advisory fees payable
by a Subadvised Fund will be required to be approved by the
shareholders of the Subadvised Fund.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-10606 Filed 5-3-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Notices]
[Page 20280]
[FR Doc No: 2015-08628]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74642A; File No. SR-NYSE-2014-59]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Withdrawal of a Proposed Rule Change, as Modified by Partial
Amendment No. 1, Amending Rule 13 and Related Rules Governing Order
Types and Modifiers; Correction

April 9, 2015.
AGENCY: Securities and Exchange Commission.

ACTION: Notice; correction.

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SUMMARY: The Securities and Exchange Commission published a document in
the Federal Register on April 9, 2015, concerning a Notice of
Withdrawal of a Proposed Rule Change, as Modified by Partial Amendment
No. 1, Amending Rule 13 and Related Rules Governing Order Types and
Modifiers. The document contained a typographical error.

FOR FURTHER INFORMATION CONTACT: Steve Kuan, Division of Trading and
Markets, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549,<PHONE_NUMBER>.

Correction

    In the Federal Register of April 9, 2015 in FR Doc. 2015-8107, on
page 19097, in the fourth line in the first column, correct the date
``February 26, 2014'' to ``February 26, 2015.''

    Dated: April 9, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-08628 Filed 4-14-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Pages 54102-54104]
[FR Doc No: 2016-19402]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0218]

Premarket Notification Submissions for Bipolar Electrosurgical
Vessel Sealers for General Surgery; Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Premarket Notification
(510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for
General Surgery.'' FDA has developed this guidance document to assist
industry in preparing premarket notification (510(k)) submissions for
bipolar electrosurgical vessel sealers intended for use in general
surgery.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-0218 for ``Premarket Notification (510(k)) Submissions for
Bipolar Electrosurgical Vessel Sealers for General Surgery.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Premarket Notification (510(k)) Submissions for Bipolar
Electrosurgical Vessel Sealers for General Surgery'' to the Office of
the Center Director, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Jismi Johnson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this guidance document to assist industry in
preparing premarket notification (510(k)) submissions for bipolar
electrosurgical vessel sealers intended for use in general surgery.
These devices are designed to seal isolated blood and lymphatic vessels
for hemostasis (as an alternative to ties) through the use of high-
frequency electrical current between two electrodes in close proximity.
The scope of this document is limited to the class II electrosurgical
devices and accessories classified under 21 CFR 878.4400,
Electrosurgical cutting and coagulation device and accessories. This
generic type of device includes bipolar vessel sealing instruments,
associated electrosurgical generators, and accessories for use in open
and minimally invasive general surgical procedures. This guidance is
intended only to address bipolar electrosurgical vessel sealers that
have general indications for use in general surgery.
    In the Federal Register of March 24, 2014 (79 FR 16009), FDA
announced the availability of the draft guidance. Interested persons
were invited to comment by June 23, 2014. Four sets of comments were
received. FDA reviewed and considered all the public comments received
and revised sections of the guidance, where applicable.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Premarket Notification (510(k)) Submissions
for Bipolar Electrosurgical Vessel Sealers for General Surgery. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Premarket Notification
(510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for
General Surgery'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1300048 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. 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). The collections of information in 21
CFR 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 820 have been
approved under OMB control number 0910-0073; the collections of
information in 21 CFR part 801 have been approved under OMB control
number 0910-0485; the collections of information in 21 CFR part 58 have
been approved under OMB control number 0910-0119; and the collections
of information in the guidance document ``Requests for Feedback on
Medical Device Submissions: The Pre-Submission Program and Meetings
with Food and Drug Administration Staff'' have been

approved under OMB control number 0910-0756.

    Dated: August 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-19402 Filed 8-12-16; 8:45 am]
BILLING CODE 4164-01-P