[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Page 27784]
[FR Doc No: 2018-12762]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2156]

Ferring Pharmaceuticals, Inc.; Withdrawal of Approval of Two
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of two abbreviated new drug applications (ANDAs)
from Ferring Pharmaceuticals, Inc. (Ferring). Ferring notified the
Agency in writing that the drug products were no longer marketed and
requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of July 16, 2018.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Ferring has informed FDA that the drug
products listed in the table are no longer marketed and has requested
that FDA withdraw approval of the applications under the process
described in Sec.  314.150(c) (21 CFR 314.150(c)). Ferring has also, by
its request, waived its opportunity for a hearing. Withdrawal of
approval of an application or abbreviated application under Sec.
314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
        Application No.                  Drug               Applicant
------------------------------------------------------------------------
ANDA 073598...................  Menotropins (follicle-  Ferring
                                 stimulating hormone     Pharmaceuticals
                                 (FSH)/luteinizing       , Inc., 100
                                 hormone (LH)) for       Interpace
                                 Injection, 75           Pkwy.,
                                 international units     Parsippany, NJ
                                 (IU)/75 IU per vial.    07054.
ANDA 073599...................  Menotropins (FSH/LH)    Do.
                                 for Injection, 150 IU/
                                 150 IU per vial.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of July
16, 2018. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on July 16, 2018 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.

    Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12762 Filed 6-13-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 137 (Thursday, July 17, 2014)]
[Notices]
[Pages 41720-41721]
[FR Doc No: 2014-16800]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA- 2014-0103]

Qualification of Drivers; Application for Exemptions; Hearing

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

ACTION: Notice of applications for exemptions; request for comments.

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

SUMMARY: FMCSA announces that 10 individuals have applied for a medical
exemption from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs). In accordance with the statutory
requirements concerning applications for exemptions, FMCSA requests
public comments on these requests. The statute and implementing
regulations concerning exemptions require that exemptions must provide
an equivalent or greater level of safety than if they were not granted.
If the Agency determines the exemptions would satisfy the statutory
requirements and decides to grant theses requests after reviewing the
public comments submitted in response to this notice, the exemptions
would enable 10 individuals to operate CMVs in interstate commerce.

DATES: Comments must be received on or before August 18, 2014.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2014-0103 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    The Federal Motor Carrier Safety Administration has authority to
grant exemptions from many of the Federal Motor Carrier Safety
Regulations (FMCSRs) under 49 U.S.C. 31315 and 31136(e), as amended by
Section 4007 of the Transportation Equity Act for the 21st Century
(TEA-21) (Pub. L. 105-178, June 9, 1998, 112 Stat. 107, 401). FMCSA has
published in 49 C.F.R. part 381, subpart C final rules implementing the
statutory changes in its exemption procedures made by section 4007, 69
FR 51589 (August 20, 2004).\1\ Under the rules in part 381, subpart C,
FMCSA must publish a notice of each exemption request in the Federal
Register. The Agency must provide the public with an opportunity to
inspect the information relevant to the application, including any
safety analyses that have been conducted and any research reports,
technical papers and other publications referenced in the application.
The Agency must also provide an opportunity to submit public comment on
the applications for exemption.
---------------------------------------------------------------------------

    \1\ This action adopted as final rules the interim final rules
issued by FMCSA's predecessor in 1998 (63 FR 67600 (Dec. 8, 2008)),
and adopted by FMCSA in 2001 [66 FR 49867 (Oct. 1, 2001)].
---------------------------------------------------------------------------

    The Agency reviews the safety analyses and the public comments and
determines whether granting the exemption would likely achieve a level
of safety equivalent to or greater than the level that would be
achieved without the exemption. The decision of the Agency must be
published in the Federal Register. If the Agency denies the request, it
must state the reason for doing so. If the decision is to grant the
exemption, the notice must specify the person or class of persons
receiving the exemption and the regulatory provision or provisions from
which an exemption is granted. The notice must also specify the
effective period of the exemption (up to 2 years) and explain the terms
and conditions of the exemption. The exemption may be renewed.
    The current provisions of the FMCSRs concerning hearing state that
a person is physically qualified to drive a CMV if that person

    First perceives a forced whispered voice in the better ear at
not less than 5 feet with or without the use of a hearing aid or, if
tested by use of an audiometric device, does not

have an average hearing loss in the better ear greater than 40
decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a hearing
aid when the audiometric device is calibrated to American National
Standard (formerly ASA Standard) Z24.5-1951.

49 CFR 391.41(b)(11). This standard was adopted in 1970, with a
revision in 1971 to allow drivers to be qualified under this standard
while wearing a hearing aid, 35 FR 6458, 6463 (April 22, 1970) and 36
FR 12857 (July 3, 1971).

    FMCSA also issues instructions for completing the medical
examination report and includes advisory criteria on the report itself
to provide guidance for medical examiners in applying the hearing
standard. See 49 CFR 391.43(f). The current advisory criteria for the
hearing standard include a reference to a report entitled ``Hearing
Disorders and Commercial Motor Vehicle Drivers'' prepared for the
Federal Highway Administration, FMCSA's predecessor, in 1993.\2\
---------------------------------------------------------------------------

    \2\ This report is available on the FMCSA Web site at http://www.fmcsa.dot.gov/facts-research/research-technology/publications/medreport_archives.htm.
---------------------------------------------------------------------------

FMCSA Requests Comments on the Exemption Applications

    FMCSA requests comments from all interested parties on whether a
driver who cannot meet the hearing standard should be permitted to
operate a CMV in interstate commerce. Further, the Agency asks for
comments on whether a driver who cannot meet the hearing standard
should be limited to operating only certain types of vehicles in
interstate commerce, for example, vehicles without air brakes. The
statute and implementing regulations concerning exemptions require that
the Agency request public comments on all applications for exemptions.
The Agency is also required to make a determination that an exemption
would likely achieve a level of safety that is equivalent to, or
greater than, the level that would be achieved absent such exemption
before granting any such requests.

Submitting Comments

    You may submit your comments and material online or by fax, mail,
or hand delivery, but please use only one of these means. FMCSA
recommends that you include your name and a mailing address, an email
address, or a phone number in the body of your document so that FMCSA
can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov and
in the search box insert the docket number ``FMCSA-2014-0103'' and
click the search button. When the new screen appears, click on the blue
``Comment Now!'' button on the right hand side of the page. On the new
page, enter information required including the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. If you submit your comments by mail or
hand delivery, submit them in an unbound format, no larger than 8\1/2\
by 11 inches, suitable for copying and electronic filing. If you submit
comments by mail and would like to know that they reached the facility,
please enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments. FMCSA may issue a final rule at any time after the close of
the comment period.

Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this
preamble, To submit your comment online, go to http://www.regulations.gov and in the search box insert the docket number
``FMCSA-2014-0103'' and click ``Search.'' Next, click ``Open Docket
Folder'' and you will find all documents and comments related to the
proposed rulemaking.

Information on Individual Applicants

Kevin S. Beacham

    Mr. Beacham, 41, holds an operator's license in Maryland.

Tyler R. Carter

    Mr. Carter, 22, holds an operator's license in Louisiana.

Stephen K. Gensmer

    Mr. Gensmer, 28, holds an operator's license in Minnesota.

Nathaniel W. Godfrey

    Mr. Godfrey, 40, holds an operator's license in Kentucky.

Jared Y. Katakurd

    Mr. Katakurd, 39, holds an operator's license in Hawaii.

Ervin E. Mitchell

    Mr. Mitchell, 35, holds a Class A commercial driver's license (CDL)
in Alabama.

Robert L. Parrish, Jr.

    Mr. Parrish, 49, holds an operator's license in California.

Matthew B. Skelton

    Mr. Skelton, 35, holds a Class A commercial driver's license (CDL)
in Texas.

Charles A. Whitworth

    Mr. Whitworth, 44, holds a Class A commercial driver's license
(CDL) in Louisiana.

Jesse W. Shelander

    Mr. Shelander, 37, holds a Class A commercial driver's license
(CDL) in Texas.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315(b)(4), FMCSA
requests public comment from all interested persons on the exemption
petitions described in this notice. The Agency will consider all
comments received before the close of business August 18, 2014.
Comments will be available for examination in the docket at the
location listed under the ADDRESSES section of this notice. The Agency
will file comments received after the comment closing date in the
public docket, and will consider them to the extent practicable. In
addition to late comments, FMCSA will also continue to file, in the
public docket, relevant information that becomes available after the
comment closing date. Interested persons should monitor the public
docket for new material.

    Issued on: July 10, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-16800 Filed 7-16-14; 8:45 am]
BILLING CODE 4910-EX-P


Comment Info: =================

General Comment: Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks almost a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I am now almost 72 years old & had been a 2+ pack a day smoker for about 60 years. I tried every way to quit smoking, including acupuncture, hypnosis, patches & gums, all to no avail. I started using E-Cigarettes on Nov 17, 2011 and have been able to stay smoke free from that date(905 days). I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

Thanks David Burlakoff


[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Proposed Rules]
[Pages 34323-34324]
[FR Doc No: 2019-15225]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 282

[EPA-R01-UST-2018-0085; FRL-9996-55-Region 1]

Massachusetts: Final Approval of State Underground Storage Tank
Program Revisions, Codification, and Incorporation by Reference

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: Pursuant to the Resource Conservation and Recovery Act (RCRA
or Act), the Environmental Protection Agency (EPA) is proposing to
approve revisions to the State of Massachusetts' Underground Storage
Tank (UST) program submitted by the Massachusetts Department of
Environmental Protection (MassDEP). This action is based on EPA's
determination that these revisions satisfy all requirements needed for
program approval. This action also proposes to codify EPA's approval of
Massachusetts' state program and to incorporate by reference those
provisions of the State regulations that we have determined meet the
requirements for approval. The provisions will be subject to EPA's
inspection and enforcement authorities under sections 9005 and 9006 of
RCRA subtitle I and other applicable statutory and regulatory
provisions.

DATES: Send written comments by August 19, 2019.

ADDRESSES: Submit any comments, identified by EPA-R01-UST-2018-0085, by
one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions for submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Mail: Joan Coyle, RCRA Waste Management, UST, and Pesticides
Section; Land, Chemicals, and Redevelopment Division; EPA Region 1, 5
Post Office Square, Suite 100, (Mail Code 07-1), Boston, MA 02109-3912.
    4. Hand Delivery or Courier: Deliver your comments to Joan Coyle,
RCRA Waste Management, UST, and Pesticides Section; Land, Chemicals,
and Redevelopment Division; EPA Region 1, 5 Post Office Square, Suite
100, (Mail Code 07-1), Boston, MA 02109-3912.
    Instructions: Direct your comments to Docket ID No. EPA-R01-UST-
2018-0085. EPA's policy is that all comments received will be included
in the public docket without change and may be 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 that you
consider to be CBI or otherwise protected through http://www.regulations.gov, or email. The Federal http://www.regulations.gov.
Website 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 email comment directly to EPA
without going through http://www.regulations.gov, your email 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.
    You can view and copy the documents that form the basis for this
codification and associated publicly available materials from 8:30 a.m.
to 4:00 p.m. Monday through Friday at the following location: EPA
Region 1 Library, 5 Post Office Square, 1st floor, Boston, MA 02109-
3912; by appointment only; tel:<PHONE_NUMBER>. Interested persons
wanting to examine these documents should make an appointment with the
office at least two weeks in advance.

FOR FURTHER INFORMATION CONTACT: Joan Coyle,<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For additional information, see the direct
final rule published in the ``Rules and Regulations'' section of this
Federal Register.

    Authority:  This rule is issued under the authority of Sections
2002(a), 9004, and 7004(b) of the Solid Waste Disposal Act, as
amended, 42 U.S.C. 6912, 6991c, 6991d, and 6991e.

    Dated: June 20, 2019.
Deborah A. Szaro,
Acting Regional Administrator, EPA Region 1.
[FR Doc. 2019-15225 Filed 7-17-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: July 20, 2010 (Volume 75, Number 138)]
[Notices]
[Page 42094-42095]
[DOCID:fr20jy10-56]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0356]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Designated New Animal Drugs for Minor Use and Minor
Species

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the paperwork associated with
designation under the Minor Use and Minor Species (MUMS) Animal Health
Act of 2004.

DATES:  Submit either electronic or written comments on the collection
of information by September 20, 2010.

ADDRESSES:  Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:  Under the PRA (44 U.S.C. 3501-3520),
Federal agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3(c) and includes agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques,

when appropriate, and other forms of information technology.

Designated New Animal Drugs for Minor Use and Minor Species--21 CFR
Part 516 (OMB Control No. 0910-0605)--Extension

    The Minor Use and Minor Species (MUMS) Animal Health Act of 2004
amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize
FDA to establish new regulatory procedures intended to make more
medications legally available to veterinarians and animal owners for
the treatment of minor animal species as well as uncommon diseases in
major animal species. This legislation provides incentives designed to
help pharmaceutical companies overcome the financial burdens they face
in providing limited-demand animal drugs. These incentives are only
available to sponsors whose drugs are ``MUMS-designated'' by FDA. Minor
use drugs are drugs for use in major species (cattle, horses, swine,
chickens, turkeys, dogs, and cats) that are needed for diseases that
occur in only a small number of animals either because they occur
infrequently or in limited geographic areas. Minor species are all
animals other than the major species, for example, zoo animals,
ornamental fish, parrots, ferrets, and guinea pigs. Some animals of
agricultural importance are also minor species. These include animals
such as sheep, goats, catfish, and honeybees. Participation in the MUMS
program is completely optional for drug sponsors so the associated
paperwork only applies to those sponsors who request and are
subsequently granted ``MUMS designation.'' The rule specifies the
criteria and procedures for requesting MUMS designation as well as the
annual reporting requirements for MUMS designees.
    Under part 516 (21 CFR part 516), Sec.  516.20 provides
requirements on the content and format of a request for MUMS-drug
designation, Sec.  516.26 provides requirements for amending MUMS-drug
designation, Sec.  516.27 provides provisions for change in sponsorship
of MUMS-drug designation, Sec.  516.29 provides provisions for
termination of MUMS-drug designation, Sec.  516.30 provides
requirements for annual reports from sponsor(s) of MUMS-designated
drugs, and Sec.  516.36 provides provisions for insufficient quantities
of MUMS-designated drugs. Respondents are pharmaceutical companies that
sponsor new animal drugs.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents       per  Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
516.20                            15                  5                 75                 16              1,200
----------------------------------------------------------------------------------------------------------------
516.26                             3                  1                  3                  2                  6
----------------------------------------------------------------------------------------------------------------
516.27                             1                  1                  1                  1                  1
----------------------------------------------------------------------------------------------------------------
516.29                             2                  1                  2                  1                  2
----------------------------------------------------------------------------------------------------------------
516.30                            15                  5                 75                  2                150
----------------------------------------------------------------------------------------------------------------
516.36                             1                  1                  1                  3                  3
----------------------------------------------------------------------------------------------------------------
Total              .................  .................  .................  .................              1,362
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate for this reporting requirement was derived in
FDA's Office of Minor Use and Minor Species Animal Drug Development by
extrapolating the current investigational new animal drug (INAD) and
new animal drug (NAD) reporting requirements for similar actions by
this same segment of the regulated industry and from previous
interactions with the minor use/minor species community.

    Dated: July 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17609 Filed 7-19-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Pages 60491-60496]
[FR Doc No: 2012-24287]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67936; File No. SR-BOX-2012-013]

Self-Regulatory Organizations; BOX Options Exchange LLC; Notice
of Filing of Proposed Rule Change To Eliminate Position Limits for
Options on the SPDR[supreg] S&P 500[supreg] Exchange-Traded Fund,\1\
Which List and Trade Under the Symbol SPY
---------------------------------------------------------------------------

    \1\ ``SPDR[supreg],'' ``Standard & Poor's[supreg],''
``S&P[supreg],'' ``S&P 500[supreg],'' and ``Standard & Poor's 500''
are registered trademarks of Standard & Poor's Financial Services
LLC. The SPY ETF represents ownership in the SPDR S&P 500 Trust, a
unit investment trust that generally corresponds to the price and
yield performance of the SPDR S&P 500 Index.
---------------------------------------------------------------------------

September 27, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby given that
on September 17, 2012, BOX Options Exchange LLC (the ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the self-regulatory organization. The Commission
is publishing this notice to solicit comments on the proposed rule from
interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to amend IM-3120-2 to Rule 3120 (Position
Limits) to eliminate position limits for options on the SPDR[supreg]
S&P 500[supreg] exchange-traded fund (``SPY ETF''),\4\ which list and
trade under the symbol SPY. The text of the proposed rule change is
available from the principal office of the Exchange, on the Exchange's
Internet Web site at http://boxexchange.com, and at the Commission's
Public Reference Room.
---------------------------------------------------------------------------

    \4\ See supra note 1.
---------------------------------------------------------------------------

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 self-regulatory organization
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 self-regulatory organization
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 amend Interpretive Material IM-3120-2 to
Rule 3120 (Position Limits) to eliminate position limits for SPY
options.
Background
    Position limits serve as a regulatory tool designed to address
potential manipulative schemes and adverse market impact surrounding
the use of options. The Exchange understands that the Commission, when
considering the appropriate level at which to set option position and
exercise limits, has considered the concern that the limits be
sufficient to prevent investors from disrupting the market in the
security underlying the option.\5\ This consideration has been balanced
by the concern that the limits ``not be established at levels that are
so low as to discourage participation in the options market by
institutions and other

investors with substantial hedging needs or to prevent specialists and
market-makers from adequately meeting their obligations to maintain a
fair and orderly market.'' \6\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 40969 (January 22,
1999), 64 FR 4911, 4912-4913 (February 1, 1999) (SR-CBOE-98-23)
(citing H.R. No. IFC-3, 96th Cong., 1st Sess. at 189-91 (Comm. Print
1978)).
    \6\ Id. at 4913.
---------------------------------------------------------------------------

    SPY options are currently the most actively traded option class in
terms of average daily volume (``ADV'').\7\ The Exchange believes that,
despite the popularity of SPY options as evidenced by their significant
volume, the current position limits on SPY options could be a deterrent
to the optimal use of this product as a hedging tool. The Exchange
further believes that position limits on SPY options may inhibit the
ability of certain large market participants, such as mutual funds and
other institutional investors with substantial hedging needs, to
utilize SPY options and gain meaningful exposure to the hedging
function they provide.
---------------------------------------------------------------------------

    \7\ SPY ADV was 2,156,482 contracts in April 2012. ADV for the
same period for the next four most actively traded options was:
Apple Inc. (option symbol AAPL)--1,074,351; S&P 500 Index (option
symbol SPX)--656,250; PowerShares QQQ TrustSM, Series 1
(option symbol QQQ)--573,790; and iShares[supreg] Russell
2000[supreg] Index Fund (option symbol IWM)--550,316.
---------------------------------------------------------------------------

    The Exchange believes that current experience with the trading of
SPY options, as well as the Exchange's surveillance capabilities, has
made it appropriate to consider other, less prophylactic alternatives
to regulating SPY options, while still seeking to ensure that large
positions in SPY options will not unduly disrupt the options or
underlying cash markets. Accordingly, the Exchange proposes to
eliminate the position limits on SPY options--currently 900,000
contracts on the same side of the market.\8\ In proposing the
elimination of position limits on SPY options, the Exchange has
considered several factors, including (1) the availability of
economically equivalent products and their respective position limits,
(2) the liquidity of the option and the underlying security, (3) the
market capitalization of the underlying security and the related index,
(4) the reporting of large positions and requirements surrounding
margin, and (5) the potential for market on close volatility.
---------------------------------------------------------------------------

    \8\ See IM-3120-2 to Rule 3120.
---------------------------------------------------------------------------

Economically Equivalent Products
    The Exchange has considered the existence of economically
equivalent or similar products, and their respective position limits,
if any, in assessing the appropriateness of proposing an elimination of
position limits for SPY options. For example, AM-settled options on the
S&P 500 Index, which list and trade exclusively on the Chicago Board
Options Exchange (``CBOE'') under the symbol SPX, are currently not
subject to position limits.\9\ Moreover, SPX options are 10 times the
size of SPY options, so that a position of only 90,000 SPX options is
the equivalent of a position of 900,000 SPY options, which is the
current position limit for SPY options.\10\
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 44994 (October 26,
2001), 66 FR 55722 (November 2, 2001) (SR-CBOE-2001-22). Position
limits were also eliminated for options on the S&P 100 Index (option
symbol OEX) and the Dow Jones Industrial Average (option symbol
DJX).
    \10\ The Exchange notes that the reduced-value option on the S&P
500 Index (option symbol XSP) is the equivalent size of SPY options
and, similar to SPX options, is not subject to position limits. See
Securities Exchange Act Release No. 56350 (September 4, 2007), 72 FR
51878 (September 11, 2007) (SR-CBOE-2007-79).
---------------------------------------------------------------------------

    Similarly, the C2 Options Exchange (``C2'') has recently introduced
a PM-settled S&P 500 cash settled contract (``SPXPM''), which also is
not subject to position limits.\11\ This contract, unlike the existing
SPX contract, is cash-settled based on the closing value of the S&P 500
Index. In this respect, SPXPM is very much like SPY options in that it
is settled at the close, albeit into cash as opposed to shares of the
underlying like SPY options.
---------------------------------------------------------------------------

    \11\ See Securities Exchange Act Release No. 65256 (September 2,
2011), 76 FR 55969 (September 9, 2011) (SR-C2-2011-008) (``SPXPM
Approval'').
---------------------------------------------------------------------------

    The Exchange believes that, because SPX, SPXPM, and SPY options are
ultimately derivative of the same benchmark--the S&P 500 Index--they
should be treated equally from a position limit perspective. As a
practical matter, investors utilize SPX, SPXPM, and SPY options and
their respective underlying instruments and futures to gain exposure to
the same benchmark index: The S&P 500. Further, because the creation
and redemption process for the underlying SPY ETF allows large
investors to transfer positions from a basket of stocks comprising the
S&P 500 index to an equivalent number of ETF shares (and the reverse)
with relative ease, there is no reason to disadvantage options
overlying the one versus the other. The Exchange believes that this
view is supported by the recent expansion of various exemptions from
position limits, such as the Delta-Based Equity Hedge Exemption \12\
for positions of a BOX Options Participant (``Participant'') or non-
Participant affiliate that are delta neutral, which allows SPY option
positions to be delta-hedged by positions in SPX options. Given that
SPX options are not subject to position limits, a Participant (or non-
Participant affiliate thereof) could theoretically establish a position
in SPY options far in excess of the current 900,000 contract limit,
provided that the position is hedged with SPX options. The Exchange
believes that this situation accurately reflects the economic
equivalence of SPX and SPY options, supporting the Exchange's proposal
to further acknowledge this equivalence by eliminating position limits
in SPY options.
---------------------------------------------------------------------------

    \12\ See Rule 3130(c).
---------------------------------------------------------------------------

    The Exchange also believes that Commission findings in approving
the SPXPM options further support treating SPY options in the same
manner as SPX and SPXPM options for purposes of position limits. In
particular, the Commission noted in approving SPXPM options that ``C2's
proposal will offer investors another investment option through which
they could obtain and hedge exposure to the S&P 500 stocks,'' and that
``C2's proposal will provide investors with the ability to trade an
option on the S&P 500 index in an all-electronic market, which may
better meet the needs of investors who may prefer to trade
electronically.'' \13\ The Commission also noted that ``C2's proposal
will provide investors with added flexibility through an additional
product that may be better tailored to meet their particular
investment, hedging, and trading needs.'' \14\ The Exchange believes
that these Commission findings apply equally to SPY options. In this
respect, SPY options with no position limit will (1) offer investors
another investment option through which they could obtain and hedge
significant levels of exposure to the S&P 500 stocks, (2) be available
to trade on the Exchange (and presumably all other U.S. options
exchanges) electronically, and (3) provide investors with added
flexibility through an additional product that may be better tailored
to meet their particular investment, hedging, and trading needs,
because, among other things, they are PM-settled.
---------------------------------------------------------------------------

    \13\ See SPXPM Approval at 55975.
    \14\ Id.
---------------------------------------------------------------------------

    The Exchange notes that, with respect to competition amongst
economically equivalent products, a 2005 paper by Hans Dutt and
Lawrence Harris that set forth a model to determine appropriate
position limits for cash-settled index derivatives observed that
``markets and their regulators should take a closer look at the
underlying economic rationale for the levels at which they currently
set their position limits to ensure that the limits adequately protect
markets from manipulation and that inconsistent position limits do not
produce competitive advantages and

disadvantages among contracts.'' \15\ On this point, the Exchange
believes that if no position limits have been found to be warranted on
both SPX and SPXPM options, then such treatment should be extended to
SPY options so that inconsistent position limits do not produce
competitive advantages and disadvantages among contracts.
---------------------------------------------------------------------------

    \15\ The Journal of Futures Markets, Vol. 25, no. 10, 945-965,
949 (2005) (``Position Limits for Cash-Settled Derivative
Contracts,'' by Hans R. Dutt and Lawrence E. Harris) (``Dutt-Harris
Paper''). In the paper, the authors examined existing position
limits to determine whether they were consistent with the model the
authors developed, and found that the results indicated that
existing limits were not correlated with the limits suggested by
their model.
---------------------------------------------------------------------------

    In addition, the Exchange notes that the Dutt-Harris Paper focuses
its attention on the concerns relating to manipulation of cash-settled
derivatives, stating that ``[a]lthough several scholars have argued
that cash settlement may increase the risk of market manipulation,
until recently, the theoretical problems arising from potential cash
settlement manipulation has been considered minor, as evidenced by the
lack of academic interest in this area.'' \16\ The paper further noted
that ``[t]he reason for this may arise from the fact that most
exchange-traded derivative index contracts that are cash settled are
broad-based, and each of the underlying components typically possesses
ample liquidity,'' and that ``manipulation of the underlying components
would likely be extremely costly to the would-be manipulator.'' \17\
This suggests that whatever manipulation risk does exist in a cash-
settled, broad-based product such as SPXPM, the corresponding
manipulation risk in a physically-settled, but equally broad-based
product such as SPY, is likely to be equally low, if not lower.
---------------------------------------------------------------------------

    \16\ Id. at 946.
    \17\ Id.
---------------------------------------------------------------------------

    Similarly, the Exchange notes that in the Dutt-Harris Paper the
authors observed that the lack of scholarly interest in the cash-
settlement manipulation problem may have been ``due to the fact that,
until recently, most U.S. exchange-traded cash-settled derivative
contracts were based on broad indices of very liquid stocks,'' and that
``[m]anipulation of such instruments require very large trades that are
costly to make and easy to detect through conventional surveillance.''
\18\ This observation applies equally to SPY options, which are based
on a broad index of very liquid stocks and can easily be created by
submitting a position in the underlying securities. Moreover, it
provides additional support for the Exchange's view that the enhanced
reporting and surveillance for SPY options discussed below adequately
address concerns about manipulation.\19\
---------------------------------------------------------------------------

    \18\ Id. at 948.
    \19\ The authors of the Dutt-Harris Paper further posited that
``position limits need only apply during the period when cash
settlement takes place.'' Id. at 964. The Exchange notes that no
such period exists with respect to SPY options, which are physically
settled.
---------------------------------------------------------------------------

Liquidity in the Option and the Underlying Security
    The Exchange has also considered the liquidity of SPY options and
the underlying SPY ETF in assessing the appropriateness of proposing an
elimination of position limits for SPY options.
    In approving the elimination of position and exercise limits on SPX
options, the Commission noted that the deep, liquid markets for the
securities underlying the S&P 500 Index reduced concerns regarding
market manipulation or disruption in the underlying markets.\20\ The
Commission further noted that removing position limits for SPX options
could also bring additional depth and liquidity, in terms of both
volume and open interest, without increasing concerns regarding
intermarket manipulations or disruptions of the options or the
underlying securities.\21\ The Exchange similarly believes that this
would be the case if position limits for SPY options were eliminated.
---------------------------------------------------------------------------

    \20\ See supra note 5 at 4913.
    \21\ Id.
---------------------------------------------------------------------------

    In this regard, both the SPY ETF and SPY options similarly exhibit
deep, liquid markets. However, SPY options are not as active as SPX
options when adjusted for the difference in their notional size.\22\ As
described below, the Exchange believes that this is partly due to the
existence of position limits for SPY options. The table below compares
the ADV in both SPX and SPY options, and includes an ``implied SPY
volume'' figure that reflects theoretical SPY ADV without the
constraint of position limits:
---------------------------------------------------------------------------

    \22\ SPX options have a notional value 10 times greater than SPY
options (i.e., one SPX contract equals 10 SPY contracts).

----------------------------------------------------------------------------------------------------------------
                                                                                Implied SPY
           Date range               Trade days    SPX option ADV  SPY option ADV    Implied SPY     option ADV
                                                                                option ADV       shortfall
----------------------------------------------------------------------------------------------------------------
Jan. 1, 2011 to Dec. 31, 2011...             252       1,567,535       5,789,511      15,675,353       9,885,842
Jan. 1, 2012 to Apr. 19, 2012...              75       1,343,735       4,525,709      13,437,353       8,911,644
----------------------------------------------------------------------------------------------------------------

    The Exchange believes that certain factors may result in SPX
options--adjusted for their larger notional size--currently trading
with greater volume than SPY options.\23\ In this regard, the Exchange
believes that, based on input from various market participants, the
existence of position limits in SPY options is reason in itself to
instead utilize SPX options. Anecdotally, market participants perceive
value in avoiding the regulatory risk of exceeding the SPY option
position limit by instead using SPX options for their hedging needs.
The Exchange also believes that, while exemptions are available with
respect to position limits for SPY options, such exemptions, and the
regulatory burden attendant therewith, may dissuade investors from
using SPY options when they can instead use an SPX option without the
need for such an exemption. Because SPY and SPX options are
economically equivalent products, an investor deciding between the two
would generally trade the product with the least barriers or
requirements to engage in such activity. In this respect, SPX options
are currently the easier product to trade.
---------------------------------------------------------------------------

    \23\ The Exchange notes that the ``Implied SPY Option ADV
Shortfall'' has narrowed over time and at an accelerated rate, which
the Exchange believes is a direct result of the implementation of
the Delta-Based Equity Hedge Exemption that allows SPY options to be
hedged via SPX options.
---------------------------------------------------------------------------

    As a further comparison, the following table sets forth certain
data for both the SPY ETF and the combined volume for the component
securities upon which the S&P 500 Index is based:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                S&P 500 Index
                                                           S&P 500 Index         underlying component                             SPY ETF average daily
                     Date range                         underlying component     average daily value          SPY ETF ADV              value traded
                                                              ADV \24\                  traded
--------------------------------------------------------------------------------------------------------------------------------------------------------
Jan.1, 2011 to Dec. 31, 2011........................            3,289,595,675       $4,149,726,217,456              218,227,747          $27,297,097,993
Jan. 1, 2012 to Apr. 19, 2012.......................            2,851,457,600        3,860,704,307,080              145,164,527           19,684,577,239
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

    \24\ The data considers the aggregate volume for all component
stocks of the S&P 500 Index.
---------------------------------------------------------------------------

    This data shows that there is tremendous liquidity in both SPY ETF
shares and the component securities upon which the S&P 500 Index is
based. While the ADV for the components underlying the S&P 500 Index is
greater than the ADV for the SPY ETF, the Exchange believes that SPY
ETF volume has been, is currently and will likely continue to be within
a range that the Commission has previously determined to be a deep,
liquid market.\25\
---------------------------------------------------------------------------

    \25\ See supra note 5 at n. 13. The ADV for the components of
the indexes underlying the options for which position limits were
eliminated were 94.77 million shares (DJX), 244.3 million shares
(OEX), and 757.5 million shares (SPX).
---------------------------------------------------------------------------

Market Capitalization of the Underlying Security and the Related Index
    The Exchange has also considered the market capitalization of the
SPY ETF and the S&P 500 Index in assessing the appropriateness of
proposing an elimination of position limits for SPY options.
    The Exchange understands that the Commission similarly considered
the market capitalization of the underlying index when it approved the
elimination of position limits in SPX options. Accordingly, the
Exchange believes that the capitalization of and the deep, liquid
markets for the underlying SPY ETF reduces concerns regarding market
manipulation or disruption in the underlying market. The table below
shows the market capitalization of the SPY ETF and the S&P 500 Index:

----------------------------------------------------------------------------------------------------------------
                                                                 Average S&P 500 Index    Average SPY ETF market
                          Date range                                   market cap                  cap
----------------------------------------------------------------------------------------------------------------
Jan.1, 2011 to Dec. 31, 2011..................................      $11,818,270,341,270          $89,533,777,897
Jan. 1, 2012 to Apr. 19, 2012.................................       12,547,946,920,000           99,752,986,022
----------------------------------------------------------------------------------------------------------------

    This data shows the enormous capitalization of both the SPY ETF and
the component securities upon which the S&P 500 Index is based. While
the capitalization for the components underlying the S&P 500 Index is
greater than that for the SPY ETF, the Exchange believes that the SPY
ETF capitalization has nonetheless been, is currently and will likely
continue to be at a level consistent with that which the Commission has
previously determined to be enormously capitalized.\26\
---------------------------------------------------------------------------

    \26\ See supra note 10 at 51879. Specifically, the market
capitalization of the component securities of the Russell 2000 Index
(``RUT'') of $1.73 trillion was determined to be enormously
capitalized.
---------------------------------------------------------------------------

    The Exchange notes that the theoretical limit on one's ability to
hedge both SPX and SPY options is the full market capitalization of the
S&P 500 Index itself. This similarly contributes to the Exchange's
determination that it is appropriate for position limits on SPY options
to be eliminated.
Large Position Reporting and Margin Requirements
    The Exchange has also considered the reporting of large option
positions and related margin requirements in assessing the
appropriateness of proposing an elimination of position limits for SPY
options.
    The Exchange notes that the Large Option Position Reporting
(``LOPR'') requirement in Exchange Rule 3150 would continue to apply to
positions in SPY options. Rule 3150 requires Participants to file a
report with the Exchange with respect to each account in which any
general or special partner of the Participant, any officer or director
of the Participant, or any Participant, as such, in any joint, group or
syndicate account with the Participant or with any partner, officer or
director thereof of such Participant; and each customer account, that
has established an aggregate position (whether long or short) that
meets certain determined thresholds (e.g., 200 or more option contracts
of any single class of options). Additionally, Rule 3150(b) requires
that, ``Options Participants that maintain an end of day position in
excess of 10,000 non-FLEX equity options contracts on the same side of
the market on behalf of its own account or for the account of a
Customer, shall report whether such position is hedged and provide
documentation as to how such position is hedged.'' Further, Rule 3120
also permits the Exchange to impose a higher margin requirement upon
the account of a Participant when it determines that the account
maintains an under-hedged position pursuant to its authority under
Exchange Rule 10130(b). Additionally, it should be noted that the
clearing firm carrying the account will be subject to capital charges
under Securities Exchange Act Rule 15c3-1 to the extent of any margin
deficiency resulting from the higher margin requirements.
    Monitoring accounts maintaining large positions provides the
Exchange with the information necessary to determine whether to impose
additional margin and/or whether to assess capital charges upon a
Participant carrying the account. In addition, the Commission's net
capital rule, Rule 15c3-1 under the Securities Exchange Act of 1934
(the ``Act''),\27\ imposes a capital charge on Participants to the
extent of any margin deficiency resulting from the higher margin
requirement, which should serve as an additional form of protection.
---------------------------------------------------------------------------

    \27\ 17 CFR 240.15c3-1.
---------------------------------------------------------------------------

    In approving SPXPM, the Commission addressed concerns about the
lack of a position limit by noting that CBOE will rely on its enhanced
surveillance requirements and procedures for SPX options to monitor
trading activity in SPXPM options.\28\ Similarly, the Exchange notes
that certain option products are currently traded on the Exchange
without position limits (e.g., the NASDAQ[supreg] 100 Index option
(option symbol NDX)), and believes that the reporting, surveillance and
monitoring mechanisms in place for these products

are effective and could easily accommodate SPY options if position
limits thereon are eliminated.
---------------------------------------------------------------------------

    \28\ See SPXPM Approval at 55972.
---------------------------------------------------------------------------

Market on Close Volatility
    The Exchange has also considered the potential for resulting or
increased market on close volatility in assessing the appropriateness
of proposing an elimination of position limits for SPY options.
    SPY options are American-style, physically settled options that can
be exercised at any time and settle into shares of the underlying SPY
ETF. A key characteristic of the SPY ETF is that the number of shares
outstanding is limited only by the number of shares available in the
component securities of the S&P 500 Index, which can be used to create
additional SPY ETF shares as needed. This in-kind creation and
redemption mechanism has proven to be quite robust, as evidenced by the
SPY ETF's close tracking of its benchmark index and the relatively
small premiums or discounts to Net Asset Value (``NAV'') that it has
historically exhibited.\29\ Additionally, the ability to hedge with SPX
options against the stocks underlying the S&P 500 is limited to the
shares outstanding for those stocks--the same limit that applies to
hedging with SPY options. Accordingly, the Exchange believes that the
risk of distortions to the market resulting from the elimination of
position limits in SPY options is no greater than the risk presented by
SPX options not being subject to position limits.
---------------------------------------------------------------------------

    \29\ See SPDR[supreg] S&P 500[supreg] ETF Trust, Annual Report
(September 30, 2011), available at https://www.spdrs.com/librarycontent/public/SPY%20Annual%20Report%2009.30.11.pdf.
---------------------------------------------------------------------------

    As a physically-settled option, SPY options can be easily hedged
via long or short positions in SPY ETF shares, which, as noted above,
can be easily created or redeemed as needed. With a physically-settled
contract such as SPY options, once a hedge in the form of a long or
short position is obtained, that hedge can only be lost if the
underlying security becomes hard to borrow and the short position is
bought in.\30\ The Exchange believes that this ability to hedge with
shares of the SPY ETF is very important, and reduces the likelihood of
market on close volatility in the component securities underlying the
S&P 500 Index (i.e., a market participant can remain fully hedged
through expiration via shares of the SPY ETF), which should also be the
case if position limits for SPY options are eliminated. At the same
time, the Exchange believes that the elimination of position limits for
SPY options would not increase market volatility or facilitate the
ability to manipulate the market. The Exchange believes that any
potential concern regarding volatility at the closing that could result
from an elimination in the position limits for SPY options is further
alleviated by the current trading environment, including that there are
markets for individual securities on more than one exchange, via
unlisted trading privileges, that there is wide dispersion of trading
across multiple exchanges, and that exchange procedures and systems are
designed to facilitate orderly closings, even when there is volatility.
---------------------------------------------------------------------------

    \30\ As noted, the in-kind creation and redemption process
allows for short term imbalances in supply and demand to be resolved
readily, which in turn reduces the likelihood of getting ``bought
in'' on a short position in SPY. Since the implementation of
Regulation SHO, SPY has never been on the threshold security list,
which further evidences the efficacy of the in-kind creation and
redemption process in resolving imbalances in supply and demand.
---------------------------------------------------------------------------

Pilot Program
    The Exchange proposes that this rule change be adopted pursuant to
a pilot program, set to expire November 27, 2013. The Exchange will
perform an analysis of the initial pilot program to eliminate position
limits in SPY after the first twelve (12) months of the pilot program
(the ``Pilot Report''). The Pilot Report will be submitted within
thirty (30) days of the end of such twelve (12) month time period. The
Pilot Report will detail the size and different types of strategies
employed with respect to positions established as a result of the
elimination of position limits in SPY. In addition, the report will
note whether any problems resulted due to the no limit approach and any
other information that may be useful in evaluating the effectiveness of
the pilot program. The Pilot Report will compare the impact of the
pilot program, if any, on the volumes of SPY options and the volatility
in the price of the underlying SPY shares, particularly at expiration.
In preparing the report, the Exchange will utilize various data
elements such as volume and open interest. In addition the Exchange
will make available to Commission staff data elements relating to the
effectiveness of the pilot program. Conditional on the findings in the
Pilot Report, the Exchange will file with the Commission a proposal to
either extend the pilot program, adopt the pilot program on a permanent
basis, or terminate the pilot program. If the pilot program is not
extended or adopted on a permanent basis by November 27, 2013, the
position limits for SPY would revert to limits in effect at the
commencement of the pilot program.
Implementation
    In addition to Commission approval, the implementation of this
proposed rule change will be contingent on other factors, including the
completion of any changes that may be necessary to the Exchange's
regulatory and surveillance program. The Exchange will announce the
implementation of the elimination of position limits on SPY options
through a notice to Participants after any Commission notice of
effectiveness regarding this proposed rule change.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\31\ in general, and Section
6(b)(5) of the Act,\32\ in particular, that the rules of an exchange be
designed to promote just and equitable principles of trade, to prevent
fraudulent and manipulative acts, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and to perfect the mechanism for a
free and open market and a national market system, and, in general, to
protect investors and the public interest. The Exchange believes that
the proposed rule change would be beneficial to market participants,
including market makers, institutional investors and retail investors,
by permitting them to establish greater positions when pursuing their
investment goals and needs. The Exchange also believes that
economically equivalent products should be treated in an equivalent
manner so as to avoid regulatory arbitrage, especially with respect to
position limits. Treating SPY and SPX options differently by virtue of
imposing different position limits is inconsistent with the notion of
promoting just and equitable principles of trade and removing
impediments to perfect the mechanisms of a free and open market. At the
same time, the Exchange believes that the elimination of position
limits for SPY options would not increase market volatility or
facilitate the ability to manipulate the market.
---------------------------------------------------------------------------

    \31\ 15 U.S.C. 78f(b).
    \32\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

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

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

    Because the 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 prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \33\ and Rule 19b-
4(f)(6) thereunder.\34\
---------------------------------------------------------------------------

    \33\ 15 U.S.C. 78s(b)(3)(A).
    \34\ 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 pursuant to Rule 19b-4(f)(6) under the
Act \35\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6) \36\ permits the Commission to
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, noting that doing
so will allow the Exchange to remain competitive with other options
exchanges, avoid potential regulatory inconsistencies for Participants
that are also members of NYSE Amex and seamlessly continue to offer
traders and the investing public the ability to use SPY options as an
effective hedging and trading vehicle. The Commission believes that
waiving the 30-day operative delay is consistent with the protection of
investors and the public interest. Therefore, the Commission designates
the proposal operative as of September 27, 2012.\37\
---------------------------------------------------------------------------

    \35\ 17 CFR 240.19b-4(f)(6).
    \36\ 17 CFR 240.19b-4(f)(6).
    \37\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule'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.

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-BOX-2012-013 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BOX-2012-013. 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 Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site 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-BOX-2012-013 and
should be submitted on or before October 24, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\38\
---------------------------------------------------------------------------

    \38\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-24287 Filed 10-2-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 118 (Tuesday, June 21, 2022)]
[Notices]
[Page 36848]
[FR Doc No: 2022-13221]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP22-979-000.
    Applicants: WBI Energy Transmission, Inc.
    Description: Sec.  4(d) Rate Filing: 2022 Negotiated and Non-
Conforming SA Blue Flint to be effective 7/15/2022.
    Filed Date: 6/14/22.
    Accession Number: 20220614-5030.
    Comment Date: 5 p.m. ET 6/27/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 14, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-13221 Filed 6-17-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 231 (Tuesday, December 1, 2020)]
[Rules and Regulations]
[Pages 76955-76958]
[FR Doc No: 2020-26422]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1027; Project Identifier MCAI-2020-01375-R;
Amendment 39-21333; AD 2020-24-03]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
Airbus Helicopters Model AS350B, AS350BA, AS350B1, AS350B2, AS350D,
AS355E, AS355F, AS355F1, and AS355F2 helicopters. This AD requires
testing the UP/DOWN switches of a certain part-numbered DUNLOP cyclic
stick grip, installing a placard, and revising the existing Rotorcraft
Flight Manual (RFM) for your helicopter, or removing the DUNLOP cyclic
stick grip. This AD was prompted by an inadvertent activation of the
rescue hoist cable cutter. The actions of this AD are intended to
address an unsafe condition on these products.

DATES: This AD becomes effective December 16, 2020.
    The Director of the Federal Register approved the incorporation by
reference of certain documents listed in this AD as of December 16,
2020.
    The FAA must receive comments on this AD by January 15, 2021.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to https://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.

     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
1027; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, the European Union Aviation Safety Agency (EASA) AD, any
service information that is incorporated by reference, any comments
received, and other information. The street address for Docket
Operations is listed above. Comments will be available in the AD docket
shortly after receipt.
    For service information identified in this final rule, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.airbus.com/helicopters/services/technical-support.html. You may
view the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
1027.

FOR FURTHER INFORMATION CONTACT: Daniel E. Moore, Aviation Safety
Engineer, Regulations & Policy Section, Rotorcraft Standards Branch,
FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone 817-222-
5110; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include the docket number FAA-2020-1027 and Project
Identifier MCAI-2020-01375-R at the beginning of your comments. The
most helpful comments reference a specific portion of the final rule,
explain the reason for any recommended change, and include supporting
data. The FAA will consider all comments received by the closing date
and may amend this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Daniel
E. Moore, Aviation Safety Engineer, Regulations & Policy Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX
76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA Emergency AD No. 2020-0217-E, dated
October 6, 2020, to correct an unsafe condition for Airbus Helicopters
(AH), formerly Eurocopter, Eurocopter France, Aerospatiale, Model AS
350 B, AS 350 BA, AS 350 B1, AS 350 B2, AS 350 D, AS 355 E, AS 355 F,
AS 355 F1, and AS 355 F2 helicopters. EASA advises of a report of an
unintended release of the rescue hoist hook on a Model AS 350 B2
helicopter during a ground check. The operator was using the UP/DOWN
switches for rescue hoist control, installed on DUNLOP cyclic stick
grip part number (P/N) AC66444, when the hoist's electrically-actuated
cable cutter function activated. EASA states that this condition, if
not corrected, could lead to further events of inadvertent activation
of the rescue hoist cable cutter function and consequent detachment of
an external load or person from the helicopter hoist, possibly
resulting in personal injury or injury to persons on the ground.
    To address this potential unsafe condition, Airbus Helicopters
published Emergency Alert Service Bulletin (EASB) Nos. 01.00.58 and
01.00.72, each Revision 0 and dated October 1, 2020, to introduce an
operational limitation.
    Accordingly, the EASA AD requires installing a dedicated placard in
the cockpit and amending the applicable RFM to prohibit the in-flight
use of the UP/DOWN switches for rescue hoist control installed on
DUNLOP cyclic stick grip P/N AC66444. EASA states its AD is considered
an interim action and further AD action may follow.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA of the
unsafe condition described in its AD. The FAA is issuing this AD after
evaluating all information provided by EASA and determining the unsafe
condition exists and is likely to exist or develop on other helicopters
of these same type designs.

Related Service Information Under 1 CFR Part 51

    The FAA has reviewed Airbus Helicopters EASB No. 01.00.58 for Model
AS355-series helicopters and Airbus Helicopters EASB No. 01.00.72 for
Model AS350-series helicopters, each Revision 0 and dated October 1,
2020, which are co-published as one document. This service information
specifies installing a placard and revising the Flight Manual to
prohibit the use of the UP/DOWN switches of the DUNLOP cyclic stick
grip manufacturer P/N (MP/N) AC66444.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

AD Requirements

    This AD requires accomplishing a ground test of the UP/DOWN
switches of DUNLOP cyclic stick grip MP/N AC66444 for proper function
before each hoist operation. If there is any uncommanded hoist action,
this AD requires removing the DUNLOP cyclic stick grip from service.
    If DUNLOP cyclic stick grip MP/N AC66444 is installed, before the
next hoist operation, this AD requires installing a placard and
revising the existing RFM for your helicopter to prohibit the use of
the UP/DOWN

switches of the DUNLOP cyclic stick grip. Alternatively, this AD allows
removing DUNLOP cyclic stick grip MP/N AC66444, however before the
DUNLOP cyclic stick grip is re-installed, this AD requires
accomplishing the ground test of the UP/DOWN switches and installing
the placard and revising the existing RFM for your helicopter. This AD
also prohibits installing an affected DUNLOP cyclic stick grip unless
the ground testing of the UP/DOWN switches has been accomplished, the
placard has been installed, and the existing RFM for your helicopter
has been revised.

Differences Between This AD and the EASA AD

    The EASA AD applies to all Airbus Helicopters Model AS 350 B, AS
350 BA, AS 350 B1, AS 350 B2, AS 350 D, AS 355 E, AS 355 F, AS 355 F1,
and AS 355 F2 helicopters, whereas this AD applies to Airbus
Helicopters Model AS350B, AS350BA, AS350B1, AS350B2, AS350D, AS355E,
AS355F, AS355F1, and AS355F2 helicopters with DUNLOP cyclic stick grip
MP/N AC66444 with UP/DOWN switches for rescue hoist control installed
instead. This AD requires accomplishing a ground test of the UP/DOWN
switches for proper function before each hoist operation, whereas the
EASA AD does not.

Interim Action

    The FAA considers this AD to be an interim action. If final action
is later identified, the FAA might consider further rulemaking then.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because FAA has determined
that it has good cause to adopt this rule without prior notice and
comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 390 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates that operators may incur the following
costs in order to comply with this AD.
    Accomplishing a ground test of the UP/DOWN switches for proper
function takes a minimal amount of time for a nominal cost. Installing
a placard and revising the existing RFM for your helicopter takes about
0.5 work-hour for an estimated cost of $43 per helicopter and $16,770
for the U.S. fleet. Alternatively, replacing the affected DUNLOP cyclic
stick grip takes about 2.5 work-hours and parts cost about $2,500 for
an estimated cost of $2,713.

FAA's Justification and Determination of the Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C.)
authorizes agencies to dispense with notice and comment procedures for
rules when the agency, for ``good cause'' finds that those procedures
are ``impracticable, unnecessary, or contrary to the public interest.''
Under this section, an agency, upon finding good cause, may issue a
final rule without seeking comment prior to the rulemaking.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule
because there are required corrective actions that must be completed
before the next hoist operation. Therefore, notice and opportunity for
prior public comment are impracticable and contrary to public interest
pursuant to 5 U.S.C. 553(b)(3)(B). In addition, for the reasons stated
above, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d)
for making this amendment effective in less than 30 days.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect 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.
    For the reasons discussed, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866, and
    2. Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2020-24-03 Airbus Helicopters: Amendment 39-21333; Docket No. FAA-
2020-1027; Project Identifier MCAI-2020-01375-R.

(a) Applicability

    This airworthiness directive (AD) applies to Airbus Helicopters
Model AS350B, AS350BA, AS350B1, AS350B2, AS350D, AS355E, AS355F,
AS355F1, and AS355F2 helicopters, certificated in any category, with
DUNLOP cyclic stick grip manufacturer part number AC66444 with UP/
DOWN switches for rescue hoist control installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as inadvertent activation
of the rescue hoist cable cutter and consequent detachment of an
external load or person from the helicopter hoist. This condition
could result in personal injury or injury to persons on the ground.

(c) Effective Date

    This AD becomes effective December 16, 2020.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Before each hoist operation, accomplish a ground test of the
UP/DOWN switches for proper function. If there is any

uncommanded hoist action, before further flight, remove the DUNLOP
cyclic stick grip from service.
    (2) Before the next hoist operation:
    (i) Install a placard in full view of the pilot by following the
Accomplishment Instructions, paragraph 3.B., of Airbus Helicopters
Emergency Alert Service Bulletin (EASB) No. 01.00.58 or 01.00.72,
each Revision 0 and dated October 1, 2020 (EASB 01.00.58 or
01.00.72), as applicable to your helicopter.
    (ii) Revise the existing Rotorcraft Flight Manual (RFM) for your
helicopter by inserting the Limitations page applicable to your
helicopter model and version from Appendix 4.C. through L, of EASB
01.00.58 or 01.00.72. Inserting a different document with
information identical to that in Appendix 4.C. through L., of EASB
01.00.58 or 01.00.72, as applicable to your helicopter model and
version, is acceptable for compliance with the requirement of this
paragraph.
    (3) After complying with paragraph (e)(2) of this AD, each time
the DUNLOP cyclic stick grip that is identified in paragraph (a) of
this AD is removed from the helicopter, you may remove the placard
and RFM revision that are required by paragraphs (e)(2)(i) and (ii)
of this AD. Before the DUNLOP cyclic stick grip is re-installed, you
must re-install the placard and RFM revision that are required by
paragraphs (e)(2)(i) and (ii) of this AD.
    (4) As of the effective date of this AD, do not install a DUNLOP
cyclic stick grip that is identified in paragraph (a) of this AD
unless the requirements of paragraphs (e)(1) and (2) of this AD have
been accomplished.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Rotorcraft Standards Branch, FAA, may approve
AMOCs for this AD. Send your proposal to: Daniel E. Moore, Aviation
Safety Engineer, Regulations & Policy Section, Rotorcraft Standards
Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone
817-222-5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, the FAA suggests
that you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office, before operating any
aircraft complying with this AD through an AMOC.

(g) Additional Information

    The subject of this AD is addressed in European Union Aviation
Safety Agency (EASA) AD No. 2020-0217-E, dated October 6, 2020. You
may view the EASA AD on the internet at https://www.regulations.gov
by searching for and locating it in Docket No. FAA-2020-1027.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6700, Rotorcraft
Flight Control.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Airbus Helicopters Emergency Alert Service Bulletin (EASB)
No. 01.00.58, Revision 0, dated October 1, 2020.
    (ii) Airbus Helicopters EASB No. 01.00.72, Revision 0, dated
October 1, 2020.

    Note 1 to paragraph (i)(2):  Airbus Helicopters EASB Nos.
01.00.58 and 01.00.72, each Revision 0 and dated October 1, 2020,
are co-published as one document.

    (3) For service information identified in this AD, contact
Airbus Helicopters, 2701 N Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
https://www.airbus.com/helicopters/services/technical-support.html.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on November 12, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-26422 Filed 11-30-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: March 13, 2007 (Volume 72, Number 48)]
[Notices]
[Page 11406]
[DOCID:fr13mr07-85]

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

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copy Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension:
    Form N-5, SEC File No. 270-172, OMB Control No. 3235-0169.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Form N-5 (17 CFR 239.24 and 274.5)--Registration Statement of Small
Business Investment Companies Under the Securities Act of 1933 (15
U.S.C. 77a et seq.) and the Investment Company Act of 1940 (15 U.S.C.
80a-1 et seq.) Form N-5 is the integrated registration statement form
adopted by the Commission for use by a small business investment
company which has been licensed as such under the Small Business
Investment Act of 1958 and has been notified by the Small Business
Administration that the company may submit a license application, to
register its securities under the Securities Act of 1933 (``Securities
Act''), and to register as an investment company under section 8 of the
Investment Company Act of 1940 (``Investment Company Act''). The
purpose of registration under the Securities Act is to ensure that
investors are provided with material information concerning securities
offered for public sale that will permit investors to make informed
decisions regarding such securities. The Commission staff reviews the
registration statements for the adequacy and accuracy of the disclosure
contained therein. Without Form N-5, the Commission would be unable to
carry out the requirements of the Securities Act and the Investment
Company Act for registration of small business investment companies.
The respondents to the collection of information are small business
investment companies seeking to register under the Investment Company
Act and to register their securities for sale to the public under the
Securities Act. The estimated number of respondents is one and the
proposed frequency of response is annually. The estimate of the total
annual reporting burden of the collection of information is
approximately 352 hours per respondent, for a total of 352 hours.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication. Please direct your written comments to R.
Corey Booth, Director/Chief Information Officer, Securities and
Exchange Commission, C/O Shirley Martinson 6432 General Green Way,
Alexandria, Virginia, 22312; or send an e-mail to:
<EMAIL_ADDRESS>

    Dated: March 5, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-4461 Filed 3-12-07; 8:45 am]

BILLING CODE 8010-01-P