[Federal Register Volume 84, Number 132 (Wednesday, July 10, 2019)]
[Notices]
[Pages 32927-32928]
[FR Doc No: 2019-14660]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2338]

Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing the approval of 31 abbreviated new drug applications
(ANDAs) held by Apotex, Inc. (Apotex). Apotex, through its U.S. agent,
has requested withdrawal of these applications and has waived its
opportunity for a hearing.

DATES: Approval is withdrawn as of July 10, 2019.

FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Office of
Regulatory Policy, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA approved the following ANDAs on the
dates indicated in the table, for the conditions of use found in the
reference listed drug for each application:

------------------------------------------------------------------------
             ANDA                Date of approval   Name of drug product
------------------------------------------------------------------------
040774........................  October 3, 2007..  Hydrochlorothiazide
                                                    Tablets USP, 25
                                                    milligrams (mg) and
                                                    50 mg.
065507........................  July 13, 2011....  Azithromycin Tablets,
                                                    250 mg.
065508........................  July 13, 2011....  Azithromycin Tablets,
                                                    600 mg.
065509........................  July 13, 2011....  Azithromycin Tablets,
                                                    500 mg.
078389........................  May 16, 2008.....  Hydrochlorothiazide
                                                    Capsules, 12.5 mg.
078841........................  June 2, 2011.....  Donepezil
                                                    Hydrochloride
                                                    Tablets, 5 mg and 10
                                                    mg.
090150........................  October 6, 2010..  Losartan Potassium
                                                    and
                                                    Hydrochlorothiazide
                                                    Tablets, 50 mg/12.5
                                                    mg, 100 mg/12.5mg,
                                                    and 100 mg/25 mg.
090419........................  April 22, 2009...  Mycophenolate Mofetil
                                                    Capsules, 250 mg.
090463........................  August 30, 2010..  Perindopril Erbumine
                                                    Tablets, 2 mg, 4 mg,
                                                    and 8 mg.
090499........................  April 22, 2009...  Mycophenolate Mofetil
                                                    Tablets, 500 mg.
090790........................  October 6, 2010..  Losartan Potassium
                                                    Tablets USP, 25 mg,
                                                    50 mg, and 100 mg.
091260........................  August 25, 2011..  Cevimeline
                                                    Hydrochloride
                                                    Capsules, 30 mg.
091373........................  April 22, 2011...  Naratriptan Tablets
                                                    USP, 1 mg and 2.5
                                                    mg.
091379........................  November 6, 2012.  Sildenafil Citrate
                                                    Tablets, 20 mg.
200164........................  September 25,      Tolterodine Tartrate
                                 2012.              Tablets, 1 mg and 2
                                                    mg.
200832........................  October 15, 2012.  Irbesartan Tablets
                                                    USP, 75 mg, 150 mg,
                                                    and 300 mg.
200878........................  April 20, 2012...  Verapamil
                                                    Hydrochloride
                                                    Extended-Release
                                                    Tablets USP, 120 mg,
                                                    180 mg, and 240 mg.
201294........................  August 3, 2012...  Montelukast Sodium
                                                    Tablets, 10 mg.
201503........................  March 8, 2013....  Cabergoline Tablets,
                                                    0.5 mg.
201505........................  October 15, 2012.  Irbesartan and
                                                    Hydrochlorothiazide
                                                    Tablets USP, 150 mg/
                                                    12.5 mg, and 300 mg/
                                                    12.5 mg.
201508........................  August 3, 2012...  Montelukast Sodium
                                                    Chewable Tablets, 4
                                                    mg and 5 mg.
201950........................  September 12,      Rasagiline Mesylate
                                 2013.              Tablets, 0.5 mg and
                                                    1 mg.
202078........................  May 14, 2013.....  Zolmitriptan Tablets,
                                                    2.5 mg and 5 mg.
202079........................  January 10, 2014.  Candesartan Cilexetil
                                                    Tablets, 4 mg, 8 mg,
                                                    16 mg, and 32 mg.
202244........................  December 31, 2012  Rizatriptan Benzoate
                                                    Tablets, 5 mg and 10
                                                    mg.
202476........................  May 14, 2013.....  Zolmitriptan Orally
                                                    Disintegrating
                                                    Tablets, 2.5 mg and
                                                    5 mg.
202477........................  July 1, 2013.....  Rizatriptan Benzoate
                                                    Orally
                                                    Disintegrating
                                                    Tablets, 5 mg and 10
                                                    mg.
202884........................  December 4, 2012.  Candesartan Cilexetil
                                                    and
                                                    Hydrochlorothiazide
                                                    Tablets, 16 mg/12.5
                                                    mg, 32 mg/12.5 mg,
                                                    and 32 mg/25 mg.
203021........................  May 22, 2012.....  Nevirapine Tablets
                                                    USP, 200 mg.
203026........................  March 21, 2013...  Valsartan and
                                                    Hydrochlorothiazide
                                                    Tablets USP, 80 mg/
                                                    12.5 mg, 160 mg/12.5
                                                    mg, 160 mg/25 mg,
                                                    320 mg/12.5 mg, and
                                                    320 mg/25 mg.
205258........................  April 3, 2014....  Nevirapine Extended-
                                                    Release Tablets, 400
                                                    mg.
------------------------------------------------------------------------

    However, after these drugs were approved, FDA became aware of
concerns involving material manufactured at two Apotex facilities, at
least one of which was named in each of these applications. The
facilities involved were Apotex Private Research Ltd. (Federal Employer
Identification (FEI) number:<PHONE_NUMBER>) and Apotex Pharmachem India
Private Ltd. (FEI:<PHONE_NUMBER>). The application numbers for the
impacted ANDAs are listed above. In January 2018, Apotex requested
withdrawal of the above ANDAs and waived its opportunity for a hearing.
FDA interprets this withdrawal request as a request under Sec.
314.150(d) (21 CFR 314.150(d)).
    Therefore, for the reasons discussed above, and pursuant to
Apotex's request, FDA is withdrawing approval

of the ANDAs in the table above, and all amendments and supplements
thereto, under Sec.  314.150(d). In each case, approval of the entire
application is withdrawn, including any approved strengths
inadvertently missing from the table. Distribution of the products
listed in the table above in interstate commerce without an approved
application is illegal and subject to regulatory action (see sections
505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(a) and 331(d)).

    Dated: July 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14660 Filed 7-9-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 20, 2006 (Volume 71, Number 182)]
[Notices]
[Page 55036]
[DOCID:fr20se06-90]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

Extension:
    Rule 11Ac1-1; SEC File No. 270-404; OMB Control No. 3235-0461.

    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'') intends to submit to the Office of
Management and Budget (``OMB'') a request for extension of the
previously approved collection of information discussed below.
    Rule 11Ac1-1 (17 CFR 240.11Ac1-1), Dissemination of Quotations,
contains two related collections of information necessary to
disseminate market makers' published quotations to buy and sell
securities to the public. The first collection of information is found
in Rule 11Ac1-1(c) (17 CFR 240.11Ac1-1(c)). This reporting requirement
obligates each ``responsible broker or dealer,'' as defined under the
rule, to communicate to its exchange or association its best bids, best
offers, and quotation sizes for any subject security, as defined under
the rule. The second collection of information is found in Rule 11Ac1-
1(b), (17 CFR 240.11Ac1-1(b)). This reporting requirement obligates
each exchange and association to make available to quotation vendors
for dissemination to the public the best bid, best offer, and aggregate
quotation size for each subject security.\1\ Brokers, dealers, other
market participants, and members of the public rely on published
quotation information to determine the best price and market for
execution of customer orders.
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    \1\ A third requirement under the Rule 11Ac1-1, as amended at 17
CFR 11Ac1-1(c)(5), gives electronic communications networks
(``ECNs'') the option of reporting to an exchange or association for
public dissemination, on behalf of their OTC market maker or
exchange specialist customers, the best priced orders and the full
size for such orders entered by market makers, to satisfy such
market makers' reporting obligation under Rule 11Ac1-1(c). Because
this reporting requirement is an alternative method of meeting the
market makers' reporting obligation, and because it is directed to
nine or fewer persons (ECNs), this collection of information is not
subject to OMB review under the Paperwork Reduction Act.
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    It is anticipated that 721 respondents, consisting of 180 exchange
specialists and 541 OTC market makers, will make 246,788,000 total
annual responses pursuant to Rule 11Ac1-1, resulting in an annual
aggregate burden of approximately 205,486 hours.
    Written comments are invited on: (a) Whether the proposed
collections of information are 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 proposed collections of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of collections of
information on those who are to respond, 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>Comments must be submitted
within 60 days of this notice.

    Dated: September 7, 2006.
Nancy M. Morris,
Secretary.
[FR Doc. E6-15585 Filed 9-19-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: October 30, 2007 (Volume 72, Number 209)]
[Rules and Regulations]
[Page 61294-61296]
[DOCID:fr30oc07-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-29264; Airspace Docket No. 07-AEA-04]

Establishment of Class E Airspace; Tappahannock, VA

AGENCY:  Federal Aviation Administration (FAA), DOT.

ACTION:  Direct final rule, request for comments.

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SUMMARY:  This action establishes Class E Airspace at Tappahannock-
Essex County Airport, Tappahannock, VA (KXSA) to accommodate newly
developed Area Navigation (RNAV) Global Positioning System (GPS)
Standard Instrument Approach Procedures (SIAPs) that serve
Tappahannock-Essex County Airport, Tappahannock, VA.

DATES: Effective 0901 UTC, December 20, 2007. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.
Comments for inclusion in the Rules Docket must be received on or
before November 28, 2007.

ADDRESSES:  Send comments on this rule to: Docket Management Facility,
U.S. Department of Transportation, 1200 New Jersey, SE., West Building
Ground Floor, Room W12-140, Washington, DC 20590-0001; Telephone: 1-
800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket number
FAA-2007-29264; Airspace Docket 07-AEA-04, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov.
 You may review the public docket containing the

rule, any comments received, and any final disposition in person in the
Dockets Office (see ADDRESSES section for address and phone number)
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
Holidays. An informal docket may also be examined during normal
business hours at the office of the Eastern Service Center, Federal
Aviation Administration, Room C210, 1701 Columbia Avenue, College Park,
Georgia 30337.

FOR FURTHER INFORMATION CONTACT:  Daryl Daniels, Airspace Specialist,
System Support Group, Eastern Service Center, Federal Aviation
Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404)
305-5581.

SUPPLEMENTARY INFORMATION:

The Direct Final Rule Procedure

    The FAA anticipates that this regulation will not result in adverse
or negative comments, and, therefore, issues it as a direct final rule.
The FAA has determined that this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Unless a written adverse or negative comment or a written notice of
intent to submit an adverse or negative comment is received within the
comment period, the regulation will become effective on the date
specified above. After the close of the comment period, the FAA will
publish a document in the Federal Register indicating that no adverse
or negative comments were received and confirming the effective date.
If the FAA receives, within the comment period, an adverse or negative
comment, or written notice of intent to submit such a comment, a
document withdrawing the direct final rule will be published in the
Federal Register, and a notice of proposed rulemaking may be published
with a new comment period.

Comments Invited

    Although this action is in the form of a direct final rule, and was
not preceded by a notice of proposed rulemaking, interested persons are
invited to comment on this rule by submitting such written data, views,
or arguments as they may desire. Communications should identify both
docket numbers and be submitted in triplicate to the address specified
under the caption ADDRESSES. All communications received on or before
the closing date for comments will be considered, and this rule may be
amended or withdrawn in light of the comments received.
    Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the rule that might
suggest a need to modify the rule. Factual information that supports
the commenter's ideas and suggestions is extremely helpful in
evaluating the effectiveness of this action and determining whether
additional rulemaking action would be needed. All comments submitted
will be available, both before and after the closing date for comments,
in the Rules Docket for examination by interested persons. Commenters
wishing the FAA to acknowledge receipt of their comments submitted in
response to this rule must submit a self-addressed, stamped postcard on
which the following statement is made: ``Comments to Docket No. FAA-
2007-29264; Airspace Docket No. 07-AEA-04.'' The postcard will be date
stamped and returned to the commenter.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes Class E5 airspace at Tappahannock, VA establishing
the controlled airspace required to support the new RNAV GPS SIAPs at
Tappahannock-Essex County Airport, Tappahannock, VA. The Tappahannock-
Essex County Airport (new) has been built to replace the Tappahannock
Municipal Airport at Tappahannock, VA. Both airports will remain open
for most of 2008, after which Tappahannock Municipal is scheduled to
close. Two Standard Instrument Approach Procedures (SIAPs) were
developed to serve this new airport. Controlled airspace extending
upward from 700 feet Above Ground Level (AGL) is required to contain
the SIAPs and for Instrument Flight Rule (IFR) operations, therefore,
the FAA is amending Title 14, Code of Federal Regulations (14 CFR) part
71 to establish Class E5 Airspace at Tappahannock, VA. This action
establishes the required controlled airspace. Designations for Class E
airspace areas extending upward from 700 feet or more above the surface
of the Earth are published in FAA Order 7400.9R, signed August 15, 2007
effective September 15, 2007, which is incorporated by reference in 14
CFR part 71.1. The Class E designations listed in this document will be
published subsequently in the Order.
    The regulations adopted herein will not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among various levels of government. Therefore, it is
determined that this final rule does not have federalism implications
under Executive Order 13132.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace at Tappahannock-Essex County
Airport, Tappahannock, VA.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace Designations and Reporting
Points, effective September 15, 2007, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA VA E5 Tappahannock, VA [New]

Tappahannock-Essex County Airport, VA
    (Lat. 37[deg]51'35'' N., long. 76[deg]53'39'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.0-mile radius of Tappahannock-Essex County Airport.
* * * * *

    Issued in College Park, Georgia, on October 5, 2007.
Mark D. Ward,
Manager, System Support Group, Eastern Service Center.
[FR Doc. 07-5326 Filed 10-29-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Page 10951]
[FR Doc No: 2016-04580]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2010-0036]

Southeastern Pennsylvania Transportation Authority's Request for
Positive Train Control Safety Plan Approval and System Certification

AGENCY: Federal Railroad Administration (FRA), United States Department
of Transportation (DOT).

ACTION: Notice of availability and request for comments.

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SUMMARY: This document provides the public with notice that the
Southeastern Pennsylvania Transportation Authority (SEPTA) submitted to
FRA its Positive Train Control Safety Plan (PTCSP) Revision 0.7, dated
August 31, 2015, under a cover letter dated October 16, 2015. SEPTA
requests that FRA approve its PTCSP and issue a PTC System
Certification for SEPTA's Advanced Civil Speed Enforcement System II
(ACSES II), under 49 CFR 236.1009 and 236.1015.

DATES: FRA will consider communications received by April 1, 2016
before taking final action on the PTCSP. Comments received after that
date will be considered as far as practicable.

ADDRESSES: All communications concerning this proceeding should
identify the appropriate docket number and may be submitted by any of
the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.

FOR FURTHER INFORMATION CONTACT: Dr. Mark Hartong, P.E., Senior
Scientific Technical Advisor at<PHONE_NUMBER><EMAIL_ADDRESS>
or Mr. David Blackmore, Railroad Safety Program Manager for Advanced
Technology at<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In its PTCSP, SEPTA asserts that its ACSES
II is designed as a vital overlay PTC system as defined in 49 CFR
236.1015(e)(2). The PTCSP describes SEPTA's ACSES II implementation and
the associated ACSES II safety processes, safety analyses, and test,
validation, and verification processes used during development of ACSES
II. The PTCSP also contains SEPTA's operational and support
requirements and procedures. SEPTA's PTCSP and the accompanying request
for approval and system certification are available for review online
at www.regulations.gov (Docket No. FRA-2010-0036) and in person at
DOT's Docket Operations Facility, 1200 New Jersey Avenue SE., W12-140,
Washington, DC 20590. The Docket Operations Facility is open from 9
a.m. to 5 p.m., Monday through Friday, except Federal Holidays.
    Interested parties are invited to comment on the PTCSP by
submitting written comments or data. During its review of the PTCSP,
FRA will consider any comments or data submitted. However, FRA may
elect not to respond to any particular comment and, under 49 CFR
236.1009(d)(3), FRA maintains the authority to approve or disapprove
the PTCSP at its sole discretion. FRA does not anticipate scheduling a
public hearing regarding SEPTA's PTCSP because the circumstances do not
appear to warrant a hearing. If any interested party desires an
opportunity for oral comment, the party should notify FRA in writing
before the end of the comment period and specify the basis for his or
her request.

Privacy Act Notice

    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
In accordance with 49 CFR 211.3, FRA solicits comments from the public
to better inform its decisions. DOT posts these comments, without edit,
including any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy. See http://www.regulations.gov/#!privacyNotice for the privacy notice of
regulations.gov.

    Issued in Washington, DC, on February 26, 2016.
Robert C. Lauby,
Associate Administrator for Railroad Safety Chief Safety Officer.
[FR Doc. 2016-04580 Filed 3-1-16; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register: May 24, 2006 (Volume 71, Number 100)]
[Notices]
[Page 29953-29954]
[DOCID:fr24my06-85]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2006-0199;FRL-7767-6]

Source Reduction Assistance Grants Program for Seven of the
Regional Pollution Prevention Program Offices; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA is announcing the availability of grant funds to States,
Tribes, Intertribal Consortia, local governments, colleges/universities
and non-profits in fiscal year (FY) 2006 under the Source Reduction
Assistance (SRA) Grants Program. The program will support source
reduction/pollution prevention projects that address the reduction or
elimination of pollution at the source across all environmental media:
Air, land, and water. EPA will issue SRA awards under the statutory
authorities of the Clean Air Act, section 103(b) and (g); Clean Water
Act, section 104(b)(3); Federal Insecticide, Fungicide, and Rodenticide
Act, section 20; Safe Drinking Water Act, section 1442 (a)(1) and (c);
Solid Waste Disposal Act, section 8001(a); and Toxic Substances Control
Act, section 10. The total amount of funding available in FY 2006 is up
to $163,000 for each of the seven participating EPA regional program
offices or approximately $1.14 million in total funding. SRA awards
will support pollution prevention activities during the FY 2006-2007
budget cycle. The maximum funding level per project is $100,000. You
may access the full text of the grant announcement at http://www.epa.gov/oppt/p2home/grants/index.htm

DATES: For specific regional submission dates for proposals, please
refer to the grant announcement at http://www.epa.gov/oppt/p2home/grants/index.htm
.

FOR FURTHER INFORMATION CONTACT: Michele Amhaz, Pollution Prevention
Division (7409M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to States, Federally-recognized Tribes,
Intertribal Consortia, local governments, independent school districts,
public and private colleges/universities and non-profits. This notice
may, however, be of interest to for-profit entities and individuals,
who are not eligible to apply for funding under this program. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2006-0199. Publicly
available docket materials are available electronically at http://www.regulations.gov
 or in hard copy at the OPPT Docket, EPA Docket

Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW.,
Washington, DC. The EPA Docket Center Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280.
    2. Electronic access. You may obtain electronic copies of this
document through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/ You may access copies of the grant announcement at http://www.epa.gov/oppt/p2home/grants/index.htm.

ants/index.htm.

II. Overview

    The following listing provides certain key information concerning
the proposal opportunity.
     Federal agency name: Environmental Protection Agency.
     Funding opportunity title: Source Reduction Assistance
Grants Program.
     Funding opportunity number: EPA-OPPT-06-008.
     Announcement type: The initial announcement of a funding
opportunity.
     Catalog of Federal Domestic Assistance (CFDA) number:
66.717.
     Dates: For specific regional submission dates for
proposals, please refer to the grant announcement at http://www.epa.gov/oppt/p2home/grants/index.htm
.

    For detailed information concerning the grant announcement refer to
the Agency website at http://www.epa.gov/oppt/p2home/grants/index.htm.

The full text of the grant announcement includes specific information
regarding the: Purpose and scope; activities to be

funded; award information; eligibility requirements; application and
submission information; award review information; and regional agency
contacts if applicable.

List of Subjects

    Environmental protection, Grants, Pollution prevention.

    Dated: May 11, 2006.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.

[FR Doc. E6-7952 Filed 5-23-06; 8:45 am]

BILLING CODE 6560-50-S


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

General Comment:Hello, My name is Daniel Bojko and a 75 day period time to review the proposed regulations is just not sufficient.  I am requesting that the review period be extended to at least 180 days.

Thanks,

Daniel


FILE NAME: company. wpt ( 7/ 1/ 2005) ( xml) Template Number P25 COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE ( 1/ 1/ 2005)

EPA Registration Division contact: [ Bipin Gandhi, 703 308 8380]

TEMPLATE:

[ The Lubrizol Corporation]

[ 5E6990]

EPA has received a pesticide petition ([ 5E6990]) from [ The Lubrizol Corporation], [ 29400 Lakeland Blvd., Wickliffe, Ohio 44092] proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180.960 to establish an exemption from the requirement of a tolerance for [ 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers ( No CASRN; EPA Accession No. 251695)] in or on the raw agricultural commodity [ seeds]. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry a. Analytical chemistry: Lubrizol is petitioning that 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers ( No CASRN; EPA Accession No. 251695) be exempt from the requirement of a tolerance based on the definition of a low risk polymer under 40 CFR 723.250( e). Therefore, the analytical method to determine residues of 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers in raw agricultural commodities is not required. b. The polymeric substance is an acrylic copolymer latex, the product of the polymerization of methacrylic acid, ethyl acrylate and PEG behenyl ether methacrylate. The polymer is supplied as an aqueous dispersion of approximately 30 wt% latex solids in water containing sodium lauryl sulfate ( 0.4 wt%) as a surface active agent. c. 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers will be used in accordance with good agricultural practices and no residues are expected.] 2 B. Toxicological Profile 1. Acute toxicity. [ As part of the EPA policy statement on inert ingredients published in the Federal Register of April 22, 1987 ( 52 FR 13305), the Agency set forth a list of studies that would generally be used to evaluate the risks posed by the presence of an inert ingredient in a pesticide formulation. However, where it can be determined without the data that the inert ingredient will present minimal or no risk, the Agency generally does not require some or all of the listed studies to rule on the proposed tolerance, or exemption from the requirement of a tolerance, for an inert ingredient. The established set of criteria for polymers of low concern is described in 40 CFR 723.250 for polymers that are relatively unreactive and stable compared to other chemical substances. These properties generally limit the ability of a polymer to cause adverse effects. Lubrizol believes that the data and information described below is adequate to ascertain the toxicology and characterize the risk associated with the use of the polymer 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers as an inert ingredient in pesticide formulations applied to raw agricultural commodities ( seeds). a) 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers has been notified to the TSCA Inventory and is listed as polymer exempt ( XU) ( EPA PMN No. P 03 216; Accession No. 251695). b) 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers is not cationic. c) 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers contains as an integral part of its composition the atomic elements carbon, oxygen and hydrogen. d) 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers does not contain as an integral part of its composition, except as impurities, any elements other than those listed in 40 CFR 723.250 ( d) ( 2) ( ii). e) 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers is not designed, nor is it reasonably anticipated, to substantially degrade, decompose or depolymerize. f) 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers is not manufactured or imported from monomers and/ or other reactants that are not already on the TSCA chemical substance inventory g) 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers is a water absorbing polymer. However, this property was not considered a concern by the Agency. 1. The acrylic copolymer is a rheology modifier for use in aqueous compositions. The polymer is manufactured using a water soluble initiator in the emulsion polymerization reaction that yields an aqueous latex dispersion at an approximate 30 wt% solids content. The polymer is manufactured and only intended for commerce as an aqueous latex dispersion. The manufactured polymer can not readily be rendered, or used, in the form of a solid. Therefore, water swelling is not a concern for the Agency. 3 h) 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers does not contain reactive functional groups. i) The polymer 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers has a number average molecular weight of 94,600 Daltons ( molecular weight distribution 8,100   6,421,000 Daltons). Substances with molecular weight greater than 400 generally are not absorbed through the intact skin, and substances with molecular weights greater than 1000 generally are not absorbed through the intact gastrointestinal tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response. j) 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl esters contains < 0.01 wt% oligomeric material below molecular weight 500, and < 0.01 wt% oligomeric material below 1000 molecular weight. k) While not expected to be elicit systemic toxicity, the acrylic copolymer 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers is known to be a mild dermal and ocular irritant. Studies in rabbits resulted in a dermal Primary Irritant Index score = 0.5 ( mild irritant) and a maximum mean ocular irritation score = 10.0 ( scale 0   110; mild irritant). The irritation study reports are submitted as a separate attachment to this submission. This polymer would not contribute significantly to the irritation potential of the end use formulation. l) It should be noted that many similar acrylic copolymers have been found to be polymers of low concern and ruled to be low risk polymers by the Agency. 2. Sodium lauryl sulfate ( CASRN 151 21 3) is present in the commercial mixture as a surface active agent to a concentration of 0.4 wt%. The surfactant ( sodium lauryl sulfate) does not become an intrinsic part of the polymer, rather it is absorbed onto the surface of the polymer particles. a) Sodium lauryl sulfate ( CASRN 151 21 3) is listed as a food additive permitted for direct addition to food for human consumption ( 21 CFR 172.822) and as a surface active agent that may be safely used in the manufacture of articles, or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or holding food ( 21 CFR 178.3400). b) Sodium lauryl sulfate is listed under a larger grouping of inert ingredients ( alkyl [ C8 C18] sulfate and its ammonium, calcium, isopropylamine, magnesium, potassium, sodium and zinc salts) that are exempted from the requirement of a tolerance when used in accordance with good agricultural practice in pesticide formulations when applied to growing crops or to raw agricultural commodities after harvest ( 40 CFR 180.910).] 4 2. Endocrine disruption. [ The is no evidence that 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers is an endocrine disruptor, individually or in combination with any other chemical. Further, 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers is not part of a class of chemicals that have been previously alleged to cause adverse endocrine effects.]

C. Aggregate Exposure 1. Dietary exposure. [ Exposure to 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers is expected to be minimal based upon intended use as a agricultural seed coating rheology modifier. In light of the high molecular weight polymeric nature of 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers, this material is not expected to be absorbed through the intact gastrointestinal tract and is therefore considered incapable of eliciting a toxic response. The chemical characteristics of 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers leads to the conclusion the there is reasonable certainty of no harm from aggregate exposure to the polymer.]

i. Food. [ The Agency has maintained that polymers meeting the polymer exemption criteria will present minimal risk to human health when used as inert ingredients in pesticide formulations applied to food crops. EPA has also established exemptions from tolerance for polymeric materials used as pesticide inerts that it considers to be intrinsically safe based on the fact that they are listed on the TSCA Inventory or meet the requirements of the amended TSCA polymer exemption. Exposure to the final use dilution of 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers when used as an inert ingredient in pesticide formulations is believed to be inconsequential. ]

ii. Drinking water. [ Based on the aqueous insolubility of 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers, there is no reason to expect human exposure to residues in drinking water.]

2. Non dietary exposure. [ Based upon the intended use of 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers as a agricultural seed coating rheology modifier, the primary route of exposure would be dermal. However, with a molecular weight of the polymer is orders of magnitude greater than 400, indicating that this polymer is not expected to be absorbed through intact skin.]

D. Cumulative Effects [ At this time there is no indication that adverse effects produced by 2 propenoic, 2 methyl, polymers 5 with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers would be cumulative with those of any other chemical. 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers is categorized as a low risk polymer ( 40 CFR 723.250). Polymeric chemicals with molecular weights greater than 1000 are not absorbed through intact gastrointestinal tract or skin, and therefore are generally regarded as incapable of eliciting a toxic response. For the proposed use as an inert ingredient in per emerge pesticide formulations, there is no reasonable expectation of increased risk due to cumulative exposure.]

E. Safety Determination 1. U. S. population. [ 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers causes no safety concerns because it conforms to the definition of a low risk polymer given in 40 CFR 723.250, and as such is considered incapable of eliciting a toxic response. The Agency has maintained that polymers meeting the polymer exemption criteria will present minimal risk to human health when used as inert ingredients in pesticide formulations. Also, there are no additional pathways of exposure ( non occupational, drinking water, etc.) where there would be additional risk.]

2. Infants and children. [ 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers causes no additional concerns to infants and children because it conforms to the definition of a low risk polymer given in 40 CFR 723.250, and as such is considered incapable of eliciting a toxic response. The Agency has maintained that polymers meeting the polymer exemption criteria will present minimal risk to human health when used as inert ingredients in pesticide formulations. Also there are no additional pathways of exposure.]

F. International Tolerances [ No international tolerances have been established for 2 propenoic, 2 methyl, polymers with ethyl acrylate and polyethylene glycol methylacrylate C18 22 alkyl ethers.]


[Federal Register Volume 77, Number 117 (Monday, June 18, 2012)]
[Notices]
[Page 36330]
[FR Doc No: 2012-14790]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Pilot Schools

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on April 3, 2012, vol. 77, no. 64, page 20093. The
information on FAA Form 8420-8, Application for Pilot School
Certificates, is required from applicants who wish to be issued pilot
school certificates and associated ratings.

DATES: Written comments should be submitted by July 18, 2012.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0009.
    Title: Pilot Schools.
    Form Numbers: FAA form 8420-8.
    Type of Review: Renewal of a current information collection.
    Background: The information on FAA Form 8420-8, Application for
Pilot School Certificates, is required from applicants who wish to be
issued pilot school certificates and associated ratings. Pilot schools
train private, commercial, flight instructor, and airline transport
pilots, along with training for associated ratings in various types of
aircraft. The form is also necessary to assure continuing compliance
with Part 141, renewal of certificates every 24 months, and for any
amendments to pilot school certificates, FAA approval of pilot school
certificate amendments enables schools to provide new training courses
not previously approved.
    Respondents: Approximately 546 applicants.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 27 hours.
    Estimated Total Annual Burden: 29,770 hours.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street, NW., Washington,
DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on June 11, 2012.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2012-14790 Filed 6-15-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 121 (Tuesday, June 23, 2020)]
[Notices]
[Pages 37651-37652]
[FR Doc No: 2020-13445]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-183-002]

Radford's Run Wind Farm, LLC v. PJM Interconnection, LLC; Notice
of Filing

    Take notice that on June 15, 2020, PJM Interconnection, LLC
submitted a filing in compliance with the Federal Energy Regulatory
Commission's (Commission) Order on Paper Hearing and Requiring a
Compliance Filing, in the above captioned proceeding, on April 16,
2020.\1\
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    \1\ Radford's Run Wind Farm, LLC v. PJM Interconnection, L.L.C.,
171 FERC 61,025 (2020) (April 16 Order).
---------------------------------------------------------------------------

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of

intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    In addition to publishing the full text of this document in the
Federal Register, The Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the eLibrary link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Comment Date: 5:00 p.m. Eastern Time on July 6, 2020.

    Dated: June 16, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-13445 Filed 6-22-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 195 (Wednesday, October 7, 2020)]
[Proposed Rules]
[Pages 63235-63237]
[FR Doc No: 2020-22125]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0904; Product Identifier 2019-SW-041-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for Airbus Helicopters Model EC225LP helicopters. This proposed AD
would require various inspections of the left-hand side (LH) engine
fuel supply (fuel supply) hose and depending on the inspection results,
removing from service or reinstalling the hose. This proposed AD would
also prohibit installing any LH fuel supply hose unless it is installed
by following the service information. This proposed AD was prompted by
a report of an incorrect installation of the LH fuel supply hose
causing restricted fuel flow to the LH engine. The actions of this
proposed AD are intended to address an unsafe condition on these
products.

DATES: The FAA must receive comments on this proposed AD by November
23, 2020.

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-
0904; 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 proposed AD, the European Union Aviation Safety Agency (EASA) AD,
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 proposed 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.

FOR FURTHER INFORMATION CONTACT: James Blyn, Aviation Safety Engineer,
Regulations and Policy Section, Rotorcraft Standards Branch, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views. The most helpful comments reference a
specific portion of the proposal, explain the reason for any
recommended change, and include supporting data. To ensure the docket
does not contain duplicate comments, commenters should send only one
copy of written comments, or if comments are filed electronically,
commenters should submit only one time.
    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 file in the docket all comments received, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments received on or before the
closing date for comments. The FAA will consider comments filed after
the comment period has closed if it is possible to do so without
incurring expense or delay. The FAA may change this proposal in light
of the comments received.

Confidential Business Information

    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 NPRM 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 NPRM, 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 NPRM. Submissions containing
CBI should be sent to James Blyn, Aviation Safety Engineer, Regulations
and Policy Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2019-0092, dated April 26, 2019
(EASA AD 2019-0092), to correct an unsafe condition for Airbus
Helicopters (formerly Eurocopter) Model EC 225 LP helicopters, all
serial numbers. EASA advises that an occurrence was reported where
during an in-flight single engine power check, the LH side engine
experienced a power loss. EASA states that a subsequent investigation
determined that the fuel flow to the affected engine was restricted by
a twisted fuel supply hose. EASA states this condition if not detected
and corrected could lead to a decrease of the LH engine power when
accelerating to the power setting corresponding to One Engine
Inoperative power, and subsequent reduced control of the helicopter.
Accordingly, the EASA AD requires a one-time visual inspection of the
fuel supply hose and depending on the inspection results, removing from
service or replacing the affected part. EASA also introduces re-
installation requirements for a fuel supply hose that is being replaced
or reinstalled.

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 about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that an
unsafe condition is likely to exist or develop on other helicopters of
the same type designs.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Airbus Helicopters Alert Service Bulletin No.
EC225-71A019, Revision 1, dated February 28, 2019, which specifies
procedures for removing the fuel supply hose from the LH power plant,
visually inspecting the fuel supply hose for twisting, and depending on
inspection results, performing an endoscope inspection on the inside of
the hose. This service information also specifies procedures required
to install a serviceable fuel supply hose.
    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.

Proposed AD Requirements

    This proposed AD would require compliance with certain procedures
described in the manufacturer's service bulletin. For helicopters
delivered to the first operator before November 30, 2018, and for
helicopters delivered to the first operator on or after November 30,
2018 that have had the LH fuel supply hose replaced or reinstalled
before May 10, 2019, this proposed AD would require visually inspecting
the LH fuel supply hose for twisting, and if needed, borescope
inspecting the entire length of the inside of the fuel supply hose for
twisting and depending on the inspection results, reinstalling or
removing the fuel supply hose from service. Additionally, this proposed
AD would prohibit installing a certain part-numbered LH fuel supply
hose on any helicopter unless that LH fuel supply hose is installed by
following certain procedures described in the manufacturer's service
bulletin.

Differences Between This Proposed AD and the EASA AD

    The EASA AD requires compliance within 110 flight hours or 6
months, whichever occurs first, while this proposed AD would require
compliance within 110 hours time-in-service. The EASA AD requires
reporting information to Airbus Helicopters if the LH fuel supply hose
is twisted on the inside, while this proposed AD would not.

Interim Action

    The FAA considers this proposed AD to be an interim action. An
investigation is ongoing and if final action is later identified, the
FAA might consider further rulemaking then.

Costs of Compliance

    The FAA estimates that this proposed AD would affect 96 helicopters
of U.S. Registry. The FAA estimates that operators may incur the
following costs in order to comply with this proposed AD. Labor costs
are estimated at $85 per work-hour. Visually inspecting the LH fuel
supply hose for twisting would take about 1 work-hour for an estimated
cost of $85 per helicopter and $8,160 for the U.S. fleet. Replacing a
LH fuel supply hose would take about 8 work-hours and parts would cost
about $2,278 for an estimated replacement cost of $2,958 per
replacement. Borescope inspecting the LH fuel supply hose would take
about 8 work-hours for an estimated cost of $680 per helicopter.

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866,
    2. Will not affect intrastate aviation in Alaska, and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 (AD):

Airbus Helicopters: Docket No. FAA-2020-0904; Product Identifier
2019-SW-041-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model EC225LP helicopters,
certificated in any category, with left-hand side (LH) engine fuel
supply (fuel supply) hose part number (P/N) 704A34416087 installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as incorrect installation
of the LH fuel supply hose causing restricted fuel flow to the LH
engine. This condition could result in a decrease of the LH engine
power when accelerating to a power setting corresponding to One
Engine Inoperative power and subsequent reduced control of the
helicopter.

(c) Comments Due Date

    The FAA must receive comments by November 23, 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) For helicopters delivered to the first operator before
November 30, 2018; and for helicopters delivered to the first
operator on or after November 30, 2018 that have had the LH fuel
supply hose replaced or reinstalled before May 10, 2019:
    (i) Within 110 hours time-in-service (TIS), visually inspect the
LH fuel supply hose for twisting as shown in Figures 1 and 2 of
Airbus Helicopters Alert Service Bulletin No. EC225-71A019, Revision
1, dated February 28, 2019 (ASB EC225-71A019).
    (ii) If the LH fuel supply hose has any twisting, before further
flight, borescope inspect the entire length of the inside of the
fuel supply hose for twisting as shown in Figures 3 through 5 of ASB
EC225-71A019.
    (A) If the inside of the LH fuel supply hose has any twisting,
before further flight, remove the LH fuel supply hose from service
and install an airworthy LH fuel supply hose by following the
Accomplishment Instructions, paragraph 3.B.3.b of ASB EC225-71A019.
    (B) If the LH fuel supply hose does not have any twisting,
reinstall the LH fuel supply hose by following the Accomplishment
Instructions, paragraph 3.B.3.b of ASB EC225-71A019.
    (2) As of the effective date of this AD, do not install an LH
fuel supply hose P/N 704A34416087 on any helicopter unless it is
installed by following the Accomplishment Instructions, paragraph
3.B.3.b of ASB EC225-71A019.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Rotorcraft Standards Branch, FAA, may approve
AMOCs for this AD. Send your proposal to: James Blyn, Aviation
Safety Engineer, Regulations and Policy Section, Rotorcraft
Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177;
telephone<PHONE_NUMBER>; 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. 2019-0092, dated April 26, 2019. You may
view the EASA AD on the internet at https://www.regulations.gov in
the AD Docket.

 (h) Subject

    Joint Aircraft Service Component (JASC) Code: 2820, Aircraft
Fuel Distribution System.

    Issued on October 1, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-22125 Filed 10-6-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 136 (Monday, July 16, 2012)]
[Notices]
[Pages 41790-41791]
[FR Doc No: 2012-17193]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Advisory Committee for Pharmaceutical Science and Clinical
Pharmacology; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Advisory Committee for Pharmaceutical Science
and Clinical Pharmacology.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on August 9, 2012, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Yvette Waples, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, email<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), to find
out further information regarding FDA advisory committee information. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the

advisory committee information line to learn about possible
modifications before coming to the meeting.
    Agenda: During the morning session, the committee will discuss
FDA's draft guidance on tablet scoring. This topic will include an
overview of FDA's proposed plan to move forward and the United States
Pharmacopoeia's perspective on the topic. During the afternoon session,
the committee will discuss: (1) The Center for Drug Evaluation and
Research (CDER) Nanotechnology Risk Management Working Group
activities; (2) nanotechnology-related research conducted and published
by CDER, to include examples related to sunscreens; and (3) the
overview and preliminary analysis of nanotechnology-related information
collected from drug application submissions.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
26, 2012. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m. for the morning session, and 3:15
p.m. to 3:45 p.m. for the afternoon session. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before July 18, 2012. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by July 19, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Yvette Waples at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: July 10, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-17193 Filed 7-13-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 206 (Friday, October 24, 2014)]
[Rules and Regulations]
[Page 63539]
[FR Doc No: 2014-25390]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 98

Mandatory Greenhouse Gas Reporting

CFR Correction

    In Title 40 of the Code of Federal Regulations, Parts 96 to 99,
revised as of July 1, 2013, on page 765, in Sec.  98.226, paragraph (c)
is reinstated to read as follows:

Sec.  98.226  Data reporting requirements.

* * * * *
    (c) Annual nitric acid production from each nitric acid train
(tons, 100 percent acid basis).
* * * * *
[FR Doc. 2014-25390 Filed 10-23-14; 8:45 am]
BILLING CODE 1505-01-D


[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22741-22743]
[FR Doc No: 2014-09210]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71966; File No. SR-NYSEMKT-2014-35]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending Rule 900.3NY
(Orders Defined) To Remove the Size Restriction on Contra-Party
Participation on a Qualified Contingent Cross Order

April 17, 2014.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that on April 14, 2014, NYSE MKT LLC (``Exchange'' or ``NYSE MKT'')
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
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \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 Rule 900.3NY (Orders Defined) to
remove the size restriction on contra-party participation on a
Qualified Contingent Cross Order (``QCC Order''). The text of the
proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the 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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The purpose of this rule filing is to amend Rule 900.3NY to remove
the size restriction on contra-party participation on a QCC Order. The
proposed rule change, which mirrors a recently adopted rule by the
International Securities Exchange (``ISE''),\4\ would expand the
availability of QCC Orders by permitting multiple contra-parties on a
QCC Order, each of which may consist of an order for less than 1,000
contracts; provided however, that the originating QCC Order is a single
order that meets the 1,000 contract minimum (as well as the other
requirements of a QCC Order), as discussed below.\5\ The proposed
change is intended to allow the Exchange to compete fairly and equally
with other options exchanges, including the ISE, that have recently
adopted similar rule changes.\6\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 71863 (April 3,
2014) (SR-ISE-2014-72).
    \5\ In the case of mini options, the minimum size is 10,000
contracts.
    \6\ See supra n. 4.
---------------------------------------------------------------------------

    Rule 900.3NY(y) provides that a QCC Order must be comprised of an
order to

buy or sell at least 1,000 contracts \7\ that is identified as being
part of a qualified contingent trade,\8\ coupled with a contra-side
order to buy or sell an equal number of contracts. As Qualified
Contingent Cross Trades, QCC Orders are automatically executed upon
entry provided that the execution (i) is not at the same price as a
Customer Order in the Consolidated Book and (ii) is at or between the
NBBO.\9\ In addition, QCC Orders that cannot be executed when entered
will automatically cancel.\10\ Finally, QCC Orders may only be entered
in the regular trading increments applicable to the options class under
Rule 960NY (Trading Differentials).
---------------------------------------------------------------------------

    \7\ In the case of mini options, the minimum size is 10,000
contracts.
    \8\ A ``qualified contingent trade'' must meet the following
conditions: (i) At least one component must be an NMS Stock; (ii)
all the components must be effected with a product price contingency
that either has been agreed to by all the respective counterparties
or arranged for by a broker-dealer as principal or agent; (iii) the
execution of one component must be contingent upon the execution of
all other components at or near the same time; (iv) the specific
relationship between the component orders (e.g., the spread between
the prices of the component orders) must be determined by the time
the contingent order is placed; (v) the component orders must bear a
derivative relationship to one another, represent different classes
of shares of the same issuer, or involve the securities of
participants in mergers or with intentions to merge that have been
announced or cancelled; and (vi) the transaction must be fully
hedged (without regard to any prior existing position) as a result
of other components of the contingent trade. In addition, ATP
Holders must demonstrate that the transaction is fully hedged using
reasonable risk-valuation methodologies. See supra n.4 (citing
Securities Exchange Act Release No. 57620 (April 4, 2008), 73 FR
19271 (April 9, 2008)).
    \9\ See Rule 985NY (Qualified Contingent Cross Trade).
    \10\ Id.
---------------------------------------------------------------------------

    The Exchange adopted the QCC Order type on March 17, 2011.\11\ On
March 19, 2014, the Exchange submitted for immediate effectiveness a
filing, which amended Rule 900.3(y) to specify that a QCC Order could
have multiple contra-parties, so long as each contra-side order met the
minimum size requirements of 1,000 contacts, or 10,000 contracts for
mini-options.\12\
---------------------------------------------------------------------------

    \11\ See Securities Exchange Act Release No. 64085 (March 17,
2011), 76 FR 16024 (March 22, 2011) (SR-NYSEAmex-2011-14).
    \12\ See Securities and Exchange Act Release No. 71817 (March
27, 2014) (SR-NYSEMKT-2014-23), 79 FR 18601 (April 2, 2014). The
Exchange notes that the operative date for this rule change is April
21, 2014. To ensure that the instant proposal may be implemented
without delay, Exhibit 5 to the instant proposal reflects not only
the instant proposal but also the rule text changes that would not
have otherwise been operative until April 21, 2014.
---------------------------------------------------------------------------

    As discussed above, the Exchange now proposes to amend Rule
900.3(y) to remove the size limitation placed on each contra-party to a
QCC Order.\13\ The Exchange is proposing this change for competitive
reasons, as it will allow the Exchange to compete fairly and equally
with other option exchanges that have similarly amended their rules,
including ISE.\14\ The Exchange does not propose to remove the size
requirement on the originating order of a QCC Order.
---------------------------------------------------------------------------

    \13\ Per proposed Rule 900.3(y): ``A Qualified Contingent Cross
Order is comprised of an originating order to buy or sell at least
1,000 contracts, or 10,000 mini-options contracts, that is
identified as being part of a qualified contingent trade, as that
term is defined in Commentary .01 below, coupled with a contra-side
order or orders totaling an equal number of contracts.''
    \14\ See supra n. 4.
---------------------------------------------------------------------------

    In connection with this proposal, the Exchange represents that it
will track and monitor QCC Orders to determine which is the originating
side of the order and which is the contra-side(s) of the order to
ensure that ATP Holders are complying with the minimum 1,000 contract
size requirement on the originating side of the QCC Order. In this
regard, the Exchange will monitor whether ATP Holders are aggregating
multiple orders to meet the 1,000 contract minimum on the originating
side of the trade in violation of the requirements of the rule. The
rule requires that the originating side of the trade consist of one
party who is submitting a QCC Order for at least 1,000 contracts. The
Exchange represents that it will enforce compliance with this portion
of the rule by checking to see if an ATP Holder breaks up the
originating side of the order in a post trade allocation to different
Clearing Members, allocating less than 1,000 contracts to a party or
multiple parties. For example, an ATP Holder enters a QCC Order into
the system for 1,500 contracts and receives an execution. Subsequent to
the execution, the ATP Holder allocates the originating side of the
order to two different clearing firms on a post trade allocation basis,
thereby allocating 500 contracts to one Clearing Member and 1,000
contracts to another Clearing Member. The Exchange states that this
type of transaction would not meet the requirements of a QCC Order
under the current rule. With regard to order entry, the Exchange notes
that ATP Holders must designate orders entered in the system as either
the originating side or the contra-side(s). The Exchange will monitor
order entries to ensure that ATP Holders are properly entering QCC
Orders into the system.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act in general, and furthers the objectives of
Section 6(b)(5) of the Act, in that it is designed to promote just and
equitable principles of trade,remove impediments to and perfect the
mechanisms of a free and open market and a national market system and,
in general, to protect investors and the public interest.
    Specifically, because the proposal removes the size restriction
placed on each contra-party to a QCC Order, but leaves unchanged the
minimum size requirement for the originating order, the Exchange
believes that the proposal should provide more opportunity to
participate in QCC trades, consistent with the key principles behind
the QCC Order.
    The Exchange believes the proposed rule change is consistent with
Section 6(b)(8) of the Act, as it will enable the Exchange to compete
with other options exchanges, including the ISE,\15\ for QCC Orders. In
addition, the proposed rule change will be beneficial to market
participants because allowing multiple parties of any size on the
contra-side of a QCC Order should foster competition for filling QCC
Orders and thereby result in potentially better prices.
---------------------------------------------------------------------------

    \15\ Id.
---------------------------------------------------------------------------

    Furthermore, the Exchange believes that the proposed rule change
should improve the utility of the QCC Order without raising novel
regulatory issues, because the proposal does not impact the fundamental
aspects of the QCC Order type. Rather, the proposal merely permits
multiple contra-parties, regardless of size, on one side, while
preserving the 1,000 contract minimum on the originating QCC Order.

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 that is not necessary or appropriate
in furtherance of the purposes of the Act. In fact, the proposal is
intended to relieve a burden on competition, which results from
different exchanges interpreting their rules differently. Among the
options exchanges, the Exchange believes that the proposal to remove
the size requirement of at least 1,000 contracts (or, in the case of
mini-options, 10,000 contracts), as described above, should foster
competition for filling the contra-side of a QCC Order and thereby
result in potentially better prices for such orders. In addition, the
proposal will enable the Exchange to more effectively compete with
other option exchanges

like the ISE that have already implement similar rule changes.\16\
---------------------------------------------------------------------------

    \16\ Id.
---------------------------------------------------------------------------

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

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \17\ and Rule 19b-4(f)(6) thereunder.\18\
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, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.\19\
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \18\ 17 CFR 240.19b-4(f)(6).
    \19\ 17 CFR 240.19b-4(f)(6)(iii). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of 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.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \20\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\21\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Commission believes
that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest, as it will help
eliminate investor confusion and promote competition among the option
exchanges.\22\ Therefore, the Commission designates the proposed rule
change to be operative upon filing.
---------------------------------------------------------------------------

    \20\ 17 CFR 240.19b-4(f)(6).
    \21\ 17 CFR 240.19b-4(f)(6)(iii).
    \22\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    The Commission notes that, given the differing requirements as
between the originating side and contra-side for QCC Orders, it is
essential that the Exchange be able to clearly identify and monitor--
throughout the life of a QCC Order, beginning at time of order entry on
the Exchange through the post-trade allocation process--each side of
the QCC Order and ensure that the requirements of the order type are
being satisfied including, importantly, those relating to the
originating side. The Commission believes this to be critical so that
the Exchange can ensure that market participants are not able to
circumvent the requirements of the QCC Order (as amended by this
proposed rule change), each of which the Commission continues to
believe are critical to ensuring that the QCC Order is narrowly
drawn.\23\ Further, the Commission notes that the Exchange has made
certain representations regarding its enforcement and surveillance of
its ATP Holders' use of QCC Orders, including, for example, not only at
the time of order entry, but through the post-trade allocation process
as well.
---------------------------------------------------------------------------

    \23\ The Commission expects the Exchange to have the capability
to enable it to surveil that such requirements are being met. Though
the Exchange has stated its ability to do so, if the Exchange is not
able to have such monitoring at any point in time, the Commission
would expect the Exchange to take other steps to ensure that the QCC
Order cannot be improperly used. For example, if the Exchange were
not able to identify and monitor which side of a QCC Order is the
originating order, the Commission would expect that it would require
that both sides of the QCC Order meet the more stringent
requirements of the originating side, i.e., that it be for a single
order for at least 1,000 contracts.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \24\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSEMKT-2014-35 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2014-35. 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-NYSEMKT-2014-35, and should
be submitted on or before May 14, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\25\
---------------------------------------------------------------------------

    \25\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-09210 Filed 4-22-14; 8:45 am]
BILLING CODE 8011-01-P