[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)]
[Notices]
[Pages 60206-60207]
[FR Doc No: 2017-27246]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4678]

Modified Risk Tobacco Product Applications: Applications for Six
Camel Snus Smokeless Tobacco Products Submitted by R.J. Reynolds
Tobacco Company; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability for public comment of modified risk tobacco product
applications (MRTPAs) for six Camel Snus smokeless tobacco products
submitted by R.J. Reynolds Tobacco Co.

DATES: Electronic or written comments on the applications may be
submitted until June 18, 2018; however, FDA may modify the comment
period by providing notice as described in section I.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-4678 for ``Modified Risk Tobacco Product Applications:
Applications for Six Camel Snus Smokeless Tobacco Products Submitted by
R.J. Reynolds Tobacco Company.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read the electronic and
written/paper comments received, go to https://www.regulations.gov and
insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco
Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373, email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 387k) addresses the marketing and distribution of modified
risk tobacco products (MRTPs). MRTPs are tobacco products that are sold
or distributed for use to reduce harm or the risk of tobacco-related
disease associated with commercially marketed tobacco products. Section
911(a) of the FD&C Act prohibits the introduction or delivery for
introduction into interstate commerce of any MRTP unless an order
issued by FDA under section 911(g) of the FD&C Act is effective with
respect to such product.
    Section 911(d) of the FD&C Act describes the information that must
be included in an MRTPA, which must be filed and evaluated by FDA
before an applicant can receive an order from FDA. FDA is required by
section 911(e) of the FD&C Act to make an MRTPA available to the public
(except for matters in the application that are trade secrets or
otherwise confidential commercial information) and to request comments
by interested persons on the information contained in the application
and on the label, labeling, and advertising accompanying the
application. The determination of whether an order is appropriate under
section 911(g) of the FD&C Act is based on the scientific information
submitted by the applicant as well as the scientific evidence and other
information that is made available to the Agency, including through
public comments.
    Section 911(g) of the FD&C Act describes the demonstrations
applicants must make to obtain an order from FDA under either section
911(g)(1) or (2). The applicant, R.J. Reynolds Tobacco Co., is seeking
orders under section 911(g)(1) for each of the 6 products that are the
subject of the submitted MRTPAs. A

person seeking an order under section 911(g)(1) of the FD&C Act must
show that the tobacco product, as it is actually used by consumers,
will significantly reduce harm and the risk of tobacco-related disease
to individual tobacco users and will benefit the health of the
population as a whole taking into account both users of tobacco
products and persons who do not currently use tobacco products. Section
911(g)(4) of the FD&C Act describes factors that FDA must take into
account in evaluating whether a tobacco product benefits the health of
individuals and the population as a whole.
    FDA is issuing this notice to inform the public that the MRTPAs for
the following products submitted by R.J. Reynolds Tobacco Co. have been
filed and are being made available for public comment:
 MR0000068: Camel Snus Frost
 MR0000069: Camel Snus Frost Large
 MR0000070: Camel Snus Mellow
 MR0000071: Camel Snus Mint
 MR0000072: Camel Snus Robust
 MR0000073: Camel Snus Winterchill
    In this document, FDA is announcing the availability of the
applications for public comment. FDA will make any amendments submitted
by the applicant available for public comment on a rolling basis. The
applications will be available for public comment for 180 days from the
date this notice is published; however, in the event that fewer than 30
days remain in the 180-day comment period when an amendment is posted,
FDA will extend or reopen the comment period to allow for at least 30
days of public comment on the amendment. FDA believes that this comment
period is appropriate given the volume and complexity of the
applications being posted. FDA will notify the public about the
availability of amendments to these applications and changes to related
comment periods via the Agency's website and other means of public
communication. To encourage public participation consistent with
section 911(e) of the FD&C Act, FDA is making the redacted MRTPAs that
are the subject of this notice available electronically (see section
II).

II. Electronic Access

    Persons with access to the internet may obtain the documents at:
https://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/UCM564399.htm.

    Dated: December 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27246 Filed 12-18-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Rules and Regulations]
[Pages 12176-12179]
[FR Doc No: 2012-4437]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1067; Directorate Identifier 2011-NM-034-AD;
Amendment 39-16944; AD 2012-03-03]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Fokker Services B.V. Model F.27 Mark 050 and F.28 Mark 0070 and 0100
airplanes. This AD was prompted by reports that the brightness of the
tritium exit signs and lighting strips deteriorated below accepted
levels. This AD requires a detailed inspection of tritium exit signs
and emergency lighting strips, and replacement if necessary. We are
issuing this AD to detect and correct insufficient brightness of the
tritium exit signs and lighting strips, which could lead to an unsafe
evacuation during an emergency, possibly resulting in injury to
occupants.

DATES: This AD becomes effective April 4, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of April 4,
2012.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-1137; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on October 11, 2011 (76
FR 62658). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    As required by current certification standards, each transport
aeroplane has passenger compartment exit signs and emergency
lighting strips installed to locate the emergency exits. A number of
these strips and signs are not electrically powered, but are self
illuminated by means of a hydrogen isotope, known as Tritium. As
this isotope decays over time, these signs will [lose] their
brightness.
    To remain compliant with regulations, Tritium exit signs and
lighting strips should be replaced when their brightness has
deteriorated below accepted levels. Currently, the Maintenance
Review Board (MRB) Maintenance Planning Document does not include an
inspection task for signs and strips containing Tritium.
    This condition, if not detected and corrected, could result in
insufficiently bright exit signs and lighting strips, preventing
safe evacuation during an emergency, possibly resulting in injury to
occupants.
    To correct this unsafe condition, EASA issued AD 2010-0200,
which required [a detailed visual] inspection of the brightness of
all Tritium exit signs and strips and, depending on findings,
replacement of insufficiently bright signs and lighting strips.
    Following the issuance of [EASA] AD 2010-0200, Fokker Services
discovered that one Service Bulletin (SB), SBF100-33-023, contained
errors in the two groups of aeroplane serial numbers and,
consequently, in the related instructions for those aeroplanes in
that SB.
    For the reasons described above, this new [EASA] AD retains the
requirements of EASA AD 2010-0200, which is superseded, amends the
Applicability and refers to Revision 1 of SBF100-33-023 for the
accomplishment instructions.
    Note: The MRB document will be updated before July 2011 to
include an appropriate maintenance task to ensure that the Tritium
exit signs and lighting strips meet the minimum brightness
requirements.

You may obtain further information by examining the MCAI in the AD
docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comment received. The commenter supports the
NPRM (76 FR 62658, October 11, 2011).

Additional Change Made to This Final Rule

    We have revised the heading for and wording in paragraph (i) of
this AD; this change has not changed the intent of that paragraph.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD with the change described previously--and minor editorial changes.
We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (76 FR 62658, October 11, 2011) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (76 FR 62658, October 11, 2011).

Costs of Compliance

    We estimate that this AD will affect 4 products of U.S. registry.
We also estimate that it will take about 1 work-hour per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Based on these figures, we estimate the cost of
this AD to the U.S. operators to be $340, or $85 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 2 work-hours and require parts costing $833, for a cost of
$1,003 per product. We have no way of determining the number of
products that may need these actions.

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.
    We are 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

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ''significant regulatory action'' under Executive Order
12866;
    2. Is not a ''significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not affect intrastate aviation in Alaska; and
    4. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (76 FR 62658, October 11,
2011), the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator,

the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2012-03-03 Fokker Services B.V.: Amendment 39-16944. Docket No. FAA-
2011-1067; Directorate Identifier 2011-NM-034-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective April 4,
2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Fokker Services B.V. Model airplanes
identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD,
certificated in any category.
    (1) F.27 Mark 050 airplanes having serial numbers (S/Ns): 20104,
20105, 20121 through 20123 inclusive, 20130 through 20135 inclusive,
20141 through 20145 inclusive, 20150, 20156 through 20176 inclusive,
20178 through 20180 inclusive, 20182 through 20199 inclusive, 20202,
20204 through 20207 inclusive, 20210, 20211, 20213 through 20252
inclusive, 20254 through 20266 inclusive, 20270 through 20279
inclusive, 20281, 20283 through 20288 inclusive, 20296 through 20303
inclusive, 20306, 20307, 20312, 20313, 20316, 20317, 20328, 20331,
20333, and 20335.
    (2) F.28 Mark 0070 and 0100 airplanes having S/Ns: 11257, 11258,
11262, 11264 through 11266 inclusive, 11287, 11301, 11317, 11340,
11342, 11352 through 11356 inclusive, 11360, 11368 through 11370
inclusive, 11376, 11377, 11385, 11395, 11402, 11403, 11405 through
11408 inclusive, 11411 through 11419 inclusive, 11425 through 11428
inclusive, 11434 through 11437 inclusive, 11447 through 11449
inclusive, 11457 through 11459 inclusive, 11467, 11469, 11478,
11479, 11481, 11482, 11487, 11492 through 11495 inclusive, 11497,
11498, 11501, 11503, 11506, 11507, 11509, 11514, 11521, 11528,
11529, 11532, 11536 through 11541 inclusive, 11543, 11545, 11547,
11549, 11551, 11553 through 11583 inclusive, and 11585.
    (3) F.28 Mark 0100 airplanes, if in a post-Fokker Service
Bulletin SBF100-52-060 configuration, having S/Ns: 11244 through
11256 inclusive, 11259 through 11261 inclusive, 11263, 11267 through
11286 inclusive, 11288 through 11300 inclusive, 11302 through 11316
inclusive, 11318 through 11339 inclusive, 11341, 11343 through 11351
inclusive, 11357 through 11367 inclusive, 11371 through 11375
inclusive, 11378 through 11384 inclusive, 11386 through 11394
inclusive, 11396 through 11401 inclusive, 11404, 11409, 11410, 11420
through 11424 inclusive, 11429 through 11433 inclusive, 11438
through 11446 inclusive, 11450 through 11456 inclusive, 11460
through 11466 inclusive, 11468, 11470 through 11477 inclusive,
11480, 11483 through 11486 inclusive, 11488 through 11491 inclusive,
11496, 11499, 11500, 11502, 11504, 11505, 11508, 11510 through 11513
inclusive, 11515 through 11520 inclusive, 11522, 11523, and 11527.

(d) Subject

    Air Transport Association (ATA) of America Code 33: Lights.

(e) Reason

    This AD was prompted by reports that the brightness of the
tritium exit signs and lighting strips deteriorated below accepted
levels. We are issuing this AD to detect and correct insufficient
brightness of the tritium exit signs and lighting strips, which
could lead to an unsafe evacuation during an emergency, possibly
resulting in injury to occupants.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Actions

    Within six months after the effective date of this AD, do a
detailed visual inspection of the tritium exit signs and emergency
lighting strips for required brightness, in accordance with the
Accomplishment Instructions of Fokker Service Bulletin SBF50-33-038,
dated July 5, 2010; or SBF100-33-023, Revision 1, dated November 4,
2010; as applicable. If any exit signs or emergency lighting strips
are insufficiently bright, before further flight, replace the exit
signs or emergency lighting strips, in accordance with the
Accomplishment Instructions of Fokker Service Bulletin SBF50-33-038,
dated July 5, 2010; or SBF100-33-023, Revision 1, dated November 4,
2010; as applicable. A review of airplane maintenance records is
acceptable in lieu of the inspection in this paragraph if the
tritium exit signs and emergency lighting strips can be conclusively
determined to have been manufactured in 2003 or earlier, from that
review; however, the replacement in this paragraph must be
accomplished before further flight after doing the review.

(h) Parts Installation

    As of the effective date of this AD, no person may install any
tritium exit signs or emergency lighting strips if the manufacturing
date is seven years or more before the intended installation date,
or if the manufacturing date cannot be determined; unless the
tritium exit sign or emergency lighting strip has been inspected in
accordance with paragraph (g) of this AD, and does not need
replacement.

(i) Credit for Previous Actions

    This paragraph provides credit for inspection and replacement of
the tritium exit sign or emergency lighting strip, as required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using Fokker Service Bulletin SBF100-33-
023, dated July 5, 2010, as applicable.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(k) Related Information

    Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2010-0261, dated December 9, 2010; for related
information.
    (1) Fokker Service Bulletin SBF50-33-038, dated July 5, 2010;
and
    (2) Fokker Service Bulletin SBF100-33-023, Revision 1, dated
November 4, 2010.

(l) Material Incorporated by Reference

    (1) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise. The
Director of the Federal Register approved the incorporation by
reference (IBR) of the following service information under 5 U.S.C.
552(a) and 1 CFR part 51:
    (i) Fokker Service Bulletin SBF50-33-038, dated July 5, 2010.
    (ii) Fokker Service Bulletin SBF100-33-023, Revision 1, dated
November 4, 2010.
    (2) For service information identified in this AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 231, 2150
AE Nieuw-Vennep, the Netherlands; telephone +31 (0)252-627-350; fax
+31 (0)252-627-211; email
<EMAIL_ADDRESS>Internet http://www.myfokkerfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the

availability of this material at the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on January 26, 2012.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-4437 Filed 2-28-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 133 (Tuesday, July 12, 2011)]
[Notices]
[Pages 40967-40969]
[FR Doc No: 2011-17380]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64819; File No. SR-OPRA-2011-02]

Options Price Reporting Authority; Notice of Filing and Immediate
Effectiveness of Proposed Amendment to the Plan for Reporting of
Consolidated Options Last Sale Reports and Quotation Information To
Adopt a New Hosted Solution Fee and Other Changes to the Fee Schedule

July 6, 2011.
    Pursuant to Section 11A of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 608 thereunder,\2\ notice is hereby given that
on June 24, 2011, the Options Price Reporting Authority (``OPRA'')
submitted to the Securities and Exchange Commission (``Commission'') an
amendment to the Plan for Reporting of Consolidated Options Last Sale
Reports and Quotation Information (``OPRA Plan'').\3\ The proposed
amendment would make several change to the fees payable by OPRA Vendors
and to the terms that describe when those fees are payable. The
Commission is publishing this notice to solicit comments from
interested persons on the proposed OPRA Plan amendment.
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    \1\ 15 U.S.C. 78k-1.
    \2\ 17 CFR 242.608.
    \3\ The OPRA Plan is a national market system plan approved by
the Commission pursuant to Section 11A of the Act and the Rule 608
thereunder (formerly Rule 11Aa3-2). See Securities Exchange Act
Release No. 17638 (March 18, 1981), 22 S.E.C. Docket 484 (March 31,
1981). The full text of the OPRA Plan is available at http://www.opradata.com.
---------------------------------------------------------------------------

I. Description and Purpose of the Plan Amendment

    The purpose of this amendment is to make several changes in the
fees payable by OPRA Vendors and in the terms that describe when those
fees are payable.
    The first change is to adopt a new fee (referred to in this filing
as the ``Hosted Solution Fee'') that will be payable by any OPRA Vendor
that supplies OPRA Data to a ``Hosted Solution'' sponsored by a
``Client Organization.'' The terms ``Hosted Solution'' and ``Client
Organization'' are defined in a revised Policy entitled ``Policy with
respect to Hosted Solutions.'' The revised Policy replaces a Policy
entitled ``OPRA Policy on Persons Providing Internet Access to Real-
Time OPRA Data.'' The definitions of the terms ``Hosted Solution'' and
``Client Organization'' are described below.
    The second change is to permit a Client Organization that sponsors
a Hosted Solution that displays delayed OPRA Data not to pay a
Redistribution Fee as a result of its sponsorship of the Hosted
Solution.
    The third change is to add a new footnote to OPRA's Fee Schedule to
clarify the circumstances in which an OPRA Vendor may pay OPRA's
``Internet Service Only'' Redistribution Fee ($650/month) instead of
the standard Redistribution Fee ($1500/month).

(a) New Hosted Solution Fee; Revised Policy

    OPRA is proposing to adopt a new fee, referred to in this filing as
the ``Hosted Solution Fee.'' The fee will be payable by OPRA Vendors
that supply OPRA Data to ``Hosted Solutions.'' A ``Hosted Solution'' is
a market data delivery vehicle, such as a Web site or a page on a
website, that satisfies certain requirements: (i) The delivery vehicle
displays ``current'' or ``delayed'' OPRA Data,\4\ and the OPRA Data is
displayed only on a ``per inquiry'' basis; \5\ (ii) the

delivery vehicle is offered (``sponsored'') by a second company (a
``Client Organization''); (iii) the delivery vehicle is administered by
the OPRA Vendor; \6\ and (iv) the delivery vehicle clearly and
prominently identifies the OPRA Vendor that administers the delivery
vehicle.
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    \4\ OPRA defines the term ``current'' to refer to OPRA Data that
has been transmitted to the Vendor within the immediately preceding
15 minutes, and the term ``delayed'' to refer to OPRA Data that is
no longer current. See paragraph 1(e) of the OPRA form of Vendor
Agreement, available on OPRA's website (http://www.opradata.com).
    \5\ The requirement that the OPRA Data is displayed only on a
``per inquiry'' basis means that an offering of OPRA Data on a bulk
data feed basis does not qualify as a Hosted Solution. (A recipient
of OPRA Data on a bulk data feed basis has the ability to select
data for display on a continuous basis and to format the display.)
    \6\ The delivery vehicle is ``administered'' by the OPRA Vendor
if the Vendor controls the OPRA Data that is displayed or
distributed via the delivery vehicle. For current OPRA Data, this
means that the OPRA Vendor is responsible for assuring that each
person having access to the OPRA Data either has a Subscriber
Agreement in place with the Vendor or has a Professional Subscriber
Agreement in place with OPRA. (This is stated in paragraph 3 of the
revised Policy.)
---------------------------------------------------------------------------

    The Hosted Solution Fee would be payable by the OPRA Vendors that
administer Hosted Solutions, not the Client Organizations that sponsor
Hosted Solutions. For current OPRA Data the Hosted Solution Fee would
be $100 per month per Hosted Solution. For delayed OPRA Data the Hosted
Solution Fee would be $50 per month per Hosted Solution. The Hosted
Solution Fee would also include two ``Enterprise Fee'' alternatives: an
OPRA Vendor would be authorized to provide delayed OPRA Data to an
unlimited number of Hosted Solutions for an Enterprise Fee of $5,000
per month, or would be authorized to provide current and/or delayed
OPRA Data to an unlimited number of Hosted Solutions for an Enterprise
Fee of $10,000 per month.\7\ The Hosted Solution fee would be in
addition to any other applicable fees payable by the Vendor, including
the Redistribution Fee, Usage-based Vendor Fees, Nonprofessional
Subscriber Fees and Direct Access Fee.\8\
---------------------------------------------------------------------------

    \7\ For example, if an OPRA Vendor were to administer four
Hosted Solutions, three of which display current OPRA Data with two
of those being sponsored by one Client Organization and the third
being sponsored by another Client Organization, and one of which
displays delayed OPRA Data, the Hosted Solution Fee payable by the
OPRA Vendor would be $350/month.
    \8\ These fees are all described in OPRA's Fee Schedule.
---------------------------------------------------------------------------

    The current Policy applies only to ``an Internet site on which
there is a link or a framed page through which OPRA data provided by a
person that is an OPRA Vendor may be accessed.'' OPRA believes that
``links'' and ``framed pages'' are now used relatively rarely, and that
the more common arrangement is for the upstream Vendor to supply data
to the Web site of the downstream client of the Vendor in response to
queries to the Web site.\9\ Accordingly, OPRA believes that there is
uncertainty under its current Policy as to the circumstances in which
the downstream entity that sponsors a website must itself become a
Vendor and pay a Redistribution Fee. The revised Policy addresses this
uncertainty by replacing the references to ``links'' and ``framed
pages'' with the more general ``Hosted Solution'' definition.
---------------------------------------------------------------------------

    \9\ The terms ``upstream'' and ``downstream'' are used in this
filing with reference to the ``flow'' of OPRA Data; an entity is
``upstream'' from a second entity if the first entity is supplying
OPRA Data to the second entity.
---------------------------------------------------------------------------

    The revised Policy also differs from the existing Policy in that it
eliminates an alternative arrangement that OPRA believes has never been
used. The existing Policy contemplates, as an alternative to the
ordinary arrangement in which the upstream Vendor controls the
entitlement process for persons who have access to current OPRA Data
via a downstream client's website, that the downstream client may
become a ``Correspondent Subscriber'' and control the entitlement
process. To become a Correspondent Subscriber for a Vendor, a person
must enter into a ``Correspondent Subscriber Agreement'' with the
Vendor and the Correspondent Subscriber Agreement must be approved by
OPRA.\10\ No OPRA Vendor has ever submitted a form of Correspondent
Subscriber Agreement to OPRA for approval, and accordingly OPRA
believes that the Correspondent Subscriber alternative has never been
used to comply with the existing Policy. The revised Policy eliminates
the Correspondent Subscriber alternative.
---------------------------------------------------------------------------

    \10\ OPRA's requirements with respect to Correspondent
Subscriber Agreements are set out in Section 7 of the OPRA Vendor
Agreement.
---------------------------------------------------------------------------

(b) No Redistribution Fee for a Client Organization That Sponsors a
Hosted Solution Displaying Delayed OPRA Data

    In general, if a legal person redistributes current or delayed OPRA
Data ``externally'' (i.e., outside its own organization), OPRA
classifies the person as a ``Vendor,'' requires the person to execute a
Vendor Agreement with OPRA and requires the person to pay an OPRA
Redistribution Fee. The existing Policy entitled ``OPRA Policy on
Persons Providing Internet Access to Real-Time OPRA Data'' states that
OPRA does not regard a person as a Vendor if the person does no more
than sponsor a Web site on which real time (i.e., current) OPRA Data is
displayed, and accordingly allows such a person not to pay a
Redistribution Fee.
    The revised Policy extends these concepts so that they apply to
delayed OPRA Data as well as current OPRA Data. Accordingly, the
revised Policy provides that OPRA will not regard a person as a Vendor
if the person does no more than sponsor a Hosted Solution on which
either current or delayed OPRA Data is displayed, and accordingly
allows such a person not to pay a Redistribution Fee.

(c) Clarification of Circumstances in Which an OPRA Vendor May Pay
OPRA's ``Internet Service Only'' Redistribution Fee

    OPRA has always referred to the basic fee payable by each OPRA
Vendor as the ``Redistribution Fee.'' The standard Redistribution Fee
has been $1500 per month for many years. OPRA implemented an ``Internet
service only'' Redistribution Fee effective January 1, 1999, applicable
in lieu of the standard Redistribution Fee to any Vendor whose
redistribution of OPRA Data is made solely by means of the
Internet.\11\
---------------------------------------------------------------------------

    \11\ The ``Internet Service only'' fee implemented effective
January 1, 1999 was $600 per month. The fee was changed to its
current $650/month in 2002.
---------------------------------------------------------------------------

    When OPRA implemented the ``Internet service only'' Redistribution
Fee, an ``Internet service only'' was a service that was generally for
retail customers and not for high traffic volumes. More recently,
Vendors have occasionally asked OPRA if they qualify for the ``Internet
service only'' Redistribution Fee in circumstances in which the Fee is
not applicable, such as where a Vendor is providing a data feed to a
downstream Vendor. OPRA is proposing to add a footnote to its Fee
Schedule to provide additional guidance as to the circumstances in
which a Vendor is eligible to pay the ``Internet service only''
Redistribution Fee. The footnote would state that a Vendor does not
qualify for the ``Internet service only'' rate if the Vendor
redistributes OPRA Data via dedicated lines or if the Vendor
redistributes OPRA Data to the systems of one or more downstream
Vendors or to one or more Hosted Solutions.

(d) Rationale for the Changes to OPRA's Fees

    OPRA anticipates that these changes may result in a small
incremental increase in its revenues, with the Hosted Solution Fees
that it receives at least partially offset by revenues that it will not
receive from firms that sponsor Hosted Solutions as Client
Organizations rather than becoming Vendors. OPRA believes that its
overall fee structure is appropriately adjusted by requiring certain
Vendors to pay Hosted Solution Fees while providing relief from paying
the OPRA Redistribution Fee to Client Organizations that sponsor Hosted
Solutions. OPRA believes that the amounts that it is proposing for the
new Hosted Solution Fees are reasonable in

terms of the value received by Vendors, and will represent an
appropriate revenue contribution to covering the overall costs of OPRA
and its member exchanges of collecting, consolidating, processing,
disseminating and assuring the reliability and integrity of options
market information.
    The text of the proposed amendment to the OPRA Plan is available at
OPRA, the Commission's Public Reference Room, http://opradata.com, and
on the Commission's Web site at http://www.sec.gov.

II. Implementation of the OPRA Plan Amendment

    OPRA designated this amendment as qualified to be put into effect
upon filing with the Commission in accordance with clause (i) of
paragraph (b)(3) of Rule 608 under the Act.\12\ OPRA intends to
implement the amendment effective as of the first day of a calendar
quarter after having given OPRA Vendors at least 30-days notice of the
revised fees and the revised Policy.
---------------------------------------------------------------------------

    \12\ 17 CFR 242.608(b)(3)(i).
---------------------------------------------------------------------------

    The Commission may summarily abrogate the amendment within sixty
days of its filing and require refiling and approval of the amendment
by Commission order pursuant to Rule 608(b)(2) under the Act \13\ if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or the
maintenance of fair and orderly markets, to remove impediments to, and
perfect the mechanisms of, a national market system, or otherwise in
furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \13\ 17 CFR 242.608(b)(2).
---------------------------------------------------------------------------

III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed OPRA
Plan amendment 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 e-mail to<EMAIL_ADDRESS>Please include
File No. SR-OPRA-2011-02 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-OPRA-2011-02. This file
number should be included on the subject line if e-mail 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 plan amendment that are
filed with the Commission, and all written communications relating to
the proposed plan amendment 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 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of OPRA.
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-OPRA-2011-02
and should be submitted on or before August 2, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(29).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-17380 Filed 7-11-11; 8:45 am]
BILLING CODE 8011-01-P


% Food exposure
% Once daily oral exposure, dose from cpfs SS F13_49 foodonly exp distribution.csv 99.5th percentile
% Female adult, Body weight set to 72.9 kg
% Cecilia Tan
% August 26, 2015

prepare @clear @all
% Setting model parameters
start @NoCallback
use human_parameters_MRP
use preg_female_parameters

BWSW=1;		% Set to 1 if BWT is provided
BWST=72.9;	% Initial BW in kg
PREG=0;		% Not pregnant
TSTOP= 1008; 	% Exposure duration in hrs

%Single daily oral exposure
DT = xlsRead("Food.xls", "995p", "A1:A43"); % Dosing Times
DORAL=xlsRead("Food.xls", "995p", "B1:B43"); % Dose in ug/kg
prepare time rbcce cv urinetcpy
start@nocallback

mytable = [_time _rbcce _urinetcpy _cv*350.6]; %unit of conc = ug/L
save mytable @file='food_995.txt' @format=ascii


[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)]
[Notices]
[Pages 36912-36913]
[FR Doc No: 2011-15713]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER09-1400-004.
    Applicants: Milford Wind Corridor Phase I, LLC.
    Description: Milford Wind Corridor Phase I, LLC submits Change in
Status Notice.
    Filed Date: 05/13/2011.
    Accession Number: 20110513-5175.
    Comment Date: 5 p.m. Eastern Time on Friday, July 08, 2011.

    Docket Numbers: ER10-2651-001.
    Applicants: Lockhart Power Company.
    Description: Lockhart Power Company submits its Triennial Market
Power Analysis.
    Filed Date: 06/16/2011.
    Accession Number: 20110616-5131.
    Comment Date: 5 p.m. Eastern Time on Monday, August 15, 2011.

    Docket Numbers: ER11-2544-002.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff filing per 35: NYISO Compliance Filing to Revise Specified
Effective Date to be effective 6/30/2011.
    Filed Date: 06/16/2011.
    Accession Number: 20110616-5088.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 07, 2011.

    Docket Numbers: ER11-3460-001.
    Applicants: Bayonne Energy Center, LLC.
    Description: Bayonne Energy Center, LLC submits tariff filing per
35.17(b): Amendment to MBR Application to be effective 4/28/2011.
    Filed Date: 06/17/2011.
    Accession Number: 20110617-5097.
    Comment Date: 5 p.m. Eastern Time on Monday, June 27, 2011.

    Docket Numbers: ER11-3810-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits tariff filing per
35.13(a)(2)(iii: Amendment to Attachment V of the Tariff to be
effective 8/16/2011.
    Filed Date: 06/16/2011.
    Accession Number: 20110616-5059.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 07, 2011.

    Docket Numbers: ER11-3811-000.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits tariff
filing per 35: 20110616--Compliance Filing Redesignating Rate Schedule
No. 6 to be effective N/A.
    Filed Date: 06/16/2011.
    Accession Number: 20110616-5068.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 07, 2011.

    Docket Numbers: ER11-3812-000.
    Applicants: LSP Energy Limited Partnership.
    Description: LSP Energy Limited Partnership submits tariff filing
per 35.1: Baseline Filing of Market-Based Rate Tariff to be effective
6/16/2011.
    Filed Date: 06/16/2011.
    Accession Number: 20110616-5072.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 07, 2011.

    Docket Numbers: ER11-3813-000.
    Applicants: Allegheny Energy Supply Company, LLC.
    Description: Allegheny Energy Supply Company, LLC submits tariff
filing per 35: AE Supply Compliance ER11-2942 to be effective 6/1/2011.
    Filed Date: 06/16/2011.
    Accession Number: 20110616-5089.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 07, 2011.

    Docket Numbers: ER11-3814-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff filing per 35.13(a)(2)(iii: 205 Filing of NYISO PJM JOA
Schedules A and B to be effective 8/16/2011.
    Filed Date: 06/16/2011.
    Accession Number: 20110616-5110.
    Comment Date: 5 p.m. Eastern Time on Thursday, July 07, 2011.

    Docket Numbers: ER11-3815-000.
    Applicants: FirstEnergy Solutions Corp.
    Description: FirstEnergy Solutions Corp. submits tariff filing per
35.15: Cancellation of Tariff for Sales to be effective 6/18/2011.
    Filed Date: 06/17/2011.
    Accession Number: 20110617-5039.
    Comment Date: 5 p.m. Eastern Time on Friday, July 08, 2011.

    Docket Numbers: ER11-3816-000.
    Applicants: PacifiCorp.
    Description: PacifiCorp submits tariff filing per 35.13(a)(2)(iii:
Nevada Power Transmission Facilities Agreement to be effective 6/17/
2011.
    Filed Date: 06/17/2011.
    Accession Number: 20110617-5083.
    Comment Date: 5 p.m. Eastern Time on Friday, July 08, 2011.

    Docket Numbers: ER11-3818-000.
    Applicants: LSP Energy Limited Partnership.
    Description: LSP Energy Limited Partnership submits tariff filing
per 35.13(a)(2)(iii: Tariff Amendment to be effective 8/16/2011.
    Filed Date: 06/17/2011.
    Accession Number: 20110617-5100.
    Comment Date: 5 p.m. Eastern Time on Friday, July 08, 2011.

    Docket Numbers: ER11-3819-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Company submits tariff filing per
35.13(a)(2)(iii:

Amendment of Rate Schedule No. 54--Cancellation of Schedule J to be
effective 5/2/2011.
    Filed Date: 06/17/2011.
    Accession Number: 20110617-5107.
    Comment Date: 5 p.m. Eastern Time on Friday, July 08, 2011.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 17, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-15713 Filed 6-22-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 16, 2009 (Volume 74, Number 72)]
[Notices]
[Page 17699-17701]
[DOCID:fr16ap09-83]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59743; File No. SR-NYSEAmex-2009-11]

Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Making Available an
NYSE Amex Order Imbalance Information Datafeed as a Separate, Stand-
Alone Market Data Product

April 9, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 2, 2009, NYSE Amex LLC (``NYSE Amex'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by NYSE Amex. NYSE Amex filed the proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6) thereunder,\4\ which renders it effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to make available an NYSE Amex Order
Imbalance Information datafeed as a separate, stand-alone market data
product. The text of the proposed rule change is available at the
Exchange, the Commission's Public Reference Room, and http://
www.nyse.com.

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

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

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

1. Purpose
    NYSE Amex LLC proposes to make available an NYSE Amex Order
Imbalance Information datafeed as a separate, stand-alone market data
product.
    Currently, NYSE Amex Equities Rules 15 and 123C allow Exchange
systems to make available a datafeed of real-time order imbalances that
accumulate prior to the opening of trading on the Exchange and prior to
the closing of trading on the Exchange. Through this instant filing,
the Exchange proposes to establish the NYSE Amex Order Imbalance
Information services to which NYSE Amex Equities Rules 15 and 123C
refer.\5\
---------------------------------------------------------------------------

    \5\ NYSE Amex currently makes the NYSE Amex Order Imbalance
Information datafeed available to vendors, broker-dealers and any
other party that wishes to subscribe to this market data feed
service. There is no fee for the service and the Exchange does not
propose to establish one at this time. If the Exchange determines to
establish fees for this service, it will be submit a proposed rule
change to the Commission pursuant to the 19b-4 process.
---------------------------------------------------------------------------

    NYSE Amex Order Imbalance Information is a datafeed of real-time
order imbalances that accumulate prior to the opening of trading on the
Exchange and prior to the close of trading on the Exchange. The
datafeed contains aggregate information about orders that are subject
to execution at the market's opening or closing price, as the case may
be, and represent issues that are likely to be of particular trading
interest at the opening or closing.
    Order Imbalance Information Prior to the Opening Transaction
    The order imbalance information disseminated prior to the opening
transaction, consistent with NYSE Amex Equities Rule 15, contains all
interest eligible for execution in the opening transaction of the
security in Exchange systems. The previous trading day's closing price
on NYSE Amex in the security will serve as the reference price for the
order imbalance information disseminated prior to the opening
transaction. The order imbalance information disseminated prior to the
opening transaction indicates to market participants the number of
shares that would be required to equalize buy and sell interest (i.e.,
flat) at the reference price. The Exchange proposes to distribute order
imbalance information at specified intervals prior to the opening:
     Every five minutes between 8:30 a.m. EST and 9 a.m. EST.
     Every one minute between 9 a.m. EST and 9:20 a.m. EST.
     Every 15 seconds between 9:20 a.m. EST and the opening (or
9:35 a.m. EST if the opening is delayed).
    Order Imbalance Information Prior to the Closing Transaction
    The order imbalance information disseminated prior to the closing
transaction is consistent with the provisions of subparagraphs (5) and
(6) of NYSE Amex Equities Rule 123C.\6\

Order imbalance information disseminated prior to the close uses the
last sale price in the security on NYSE Amex prior to dissemination of
the order imbalance information as its reference price to indicate the
number of shares required to close ``flat,'' i.e., at the reference
price.
---------------------------------------------------------------------------

    \6\ ``MOC'' or Market-at-the-Close orders are to be executed in
their entirety at the closing price. If not executed due to a
trading halt or by its terms, e.g., buy minus or sell plus, the
order will be cancelled. ``LOC'' or Limit-at the-Close orders are
entered for execution at the closing price, provided that the
closing price is at or within the limit specified. LOC orders
limited at the closing price are not guaranteed an execution. NYSE
Amex Equities Rule 123C(5) provides in part: ``Imbalance
publications will include MOC orders as well as marketable LOC
orders. In that regard, LOC orders to buy at a price higher than the
last sale price are to be included with the buy MOC orders; LOC
orders to sell at a price lower than the last sale price are to be
included with the sell MOC orders. LOC orders with a limit equal to
the last sale price would not be included in the imbalance
calculation. The last sale price at 3:40 p.m. is used for the first
mandatory publication and 3:50 p.m. for the second.''
---------------------------------------------------------------------------

    Similar to the dissemination of order imbalance information prior
to the open, order imbalance information disseminated prior to the
close is distributed at specified intervals:
     Every fifteen seconds between 3:40 p.m. EST and 3:50 p.m.
EST.
     Every five seconds between 3:50 p.m. EST and 4 p.m. EST.
    On any day that the scheduled close of trading on the Exchange is
earlier than 4 p.m. EST, the dissemination of order imbalance
information prior to the closing transaction will commence 20 minutes
before the scheduled closing time. Order imbalance information will be
disseminated every 15 seconds for approximately 10 minutes. Thereafter,
the order imbalance information will be disseminated every five seconds
until the scheduled closing time.
    NYSE Amex Order Imbalance Information includes the imbalance
information that the Exchange is required to disseminate pursuant to
NYSE Rule 123C(5), as well as automated real-time streaming order
imbalance information at specified intervals. The datafeed containing
NYSE Amex Information contains an automated real-time streaming order
imbalance information at specified intervals as well as MOC Imbalances
that Designated Market Makers disseminate pursuant to NYSE Amex
Equities Rule 123C(5) at 3:40 p.m. and 3:50 p.m.
    The Exchange proposes to offer this order imbalance information as
a stand-alone market data product in order to provide all investors
with an opportunity to obtain information regarding opening and closing
imbalances on the Exchange. The Exchange is not imposing end-user fees,
is not requiring end-users to sign contracts and is subjecting vendor
receipt and use of the information to very few administrative burdens
(e.g., no reporting requirements and no end-user contracts).
    The Exchange proposes to make the NYSE Amex Order Imbalance
Information datafeed available under the same contracting arrangement
that the Commission has approved for the receipt and use of market data
under the CTA and CQ Plans. That arrangement contemplates that each
datafeed recipient enter into the Commission-approved standard form of
``Agreement for Receipt and Use of Market Data'' that Network A uses
for data redistributors and other parties that use the data for
purposes other than interrogation.\7\ Exhibit A to each of those
agreements would need to be updated to reflect the receipt and use of
NYSE Amex Order Imbalance Information. The arrangement does not require
an end-user of the information (other than a data feed recipient) to
enter into any agreement.
---------------------------------------------------------------------------

    \7\ The Participants in the CTA and CQ Plans first submitted the
Consolidated Vendor Form to the Commission for immediate
effectiveness in 1990. See Securities Exchange Act Release No. 28407
(September 6, 1990), 55 FR 37276 (September 10, 1990) (SR-CTA/CQ-4-
281). The Commission approved a revised version of it in 1996 in
conjunction with the participants' restatement of the CTA and CQ
Plans. See Securities Exchange Act Release No. 37191 (May 9, 1996),
61 FR 24842 (May 16, 1996) (SR-CTA/CQ-96-1).
---------------------------------------------------------------------------

    The Exchange submits that the NYSE Amex Order Imbalance Information
datafeed benefits market participants by facilitating their prompt
access to widespread order imbalance information.
2. Statutory Basis
    The basis under the Securities Exchange Act of 1934 (the ``Act'')
for the proposed rule change is the requirement under Section 6(b)(5)
\8\ that an exchange have rules that are designed to promote just and
equitable principles of trade, to remove impediments to and perfect the
mechanism of a free and open market and a national market system and,
in general, to protect investors and the public interest. The Exchange
believes that this proposal is in keeping with those principles by
facilitating investors' prompt access to free, widespread NYSE Amex
Order Imbalance Information and providing increased transparency.
Additionally, this proposal provides market participants with
supplemental market information prior to the execution of the opening
and closing transactions on the Exchange, which supports the system of
a free and open market.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    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

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

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.\11\
However, Rule 19b-4(f)(6)(iii) \12\ permits the Commission to designate
a shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay and designate the proposed
rule change operative upon filing.
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has complied with this requirement.
    \12\ Id.
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    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because the Exchange may immediately provide increased transparency to
market participants without charge by disseminating supplemental
information prior to the execution of the opening and closing
transactions on the Exchange. Therefore, the Commission

designates the proposal operative upon filing.\13\
---------------------------------------------------------------------------

    \13\ For purposes only of waiving the 30-day operative delay of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-NYSEAmex-2009-11 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAmex-2009-11. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room, on official
business days between the hours of 10 a.m. and 3 p.m. Copies of such
filing also will be available for inspection and copying at the
principal office of NYSE Amex. 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-NYSEAmex-2009-11 and should be submitted on or before
May 7, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E9-8683 Filed 4-15-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Pages 36135-36136]
[FR Doc No: 2017-16372]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0011; FRL-9961-84]

Registration Review; Draft Human Health and/or Ecological Risk
Assessments for Benfluralin, Bromuconazole, Carbaryl, Clodinafop-
propargyl, Deltamethrin, Diflufenzopyr, Esfenvalerate, Lufenuron, and
Mepiquat Chloride/Mepiquat Pentaborate; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's draft risk
human health and/or ecological risk assessments for the registration
review of benfluralin, bromuconazole, carbaryl, clodinafop-propargyl,
deltamethrin, diflufenzopyr, esfenvalerate, lufenuron, and mepiquat
chloride/mepiquat pentaborate. Registration review is EPA's periodic
review of pesticide registrations to ensure that each pesticide
continues to satisfy the statutory standard for registration, that is,
the pesticide can perform its intended function without unreasonable
adverse effects on human health or the environment. As part of the
registration review process, the Agency has completed a comprehensive
draft human health and/or ecological risk assessments for all
pesticides listed in the Table in Unit III. After reviewing comments
received during the public comment period, EPA will issue revised risk
assessments, explain any changes to the draft risk assessments, and
respond to comments and may request public input on risk mitigation
before completing proposed registration review decisions for the
pesticides listed in the Table in Unit III. Through this program, EPA
is ensuring that each pesticide's registration is based on current
scientific and other knowledge, including its effects on human health
and the environment.

DATES: Comments must be received on or before October 2, 2017.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2015-0794, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For pesticide specific information contact: The Chemical Review
Manager identified for the pesticide of interest in the Table in Unit
III.
    For general questions on the registration review program, contact:
Dana Friedman, Pesticide Re-Evaluation Division (7508P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager identified for the pesticide of
interest in the Table in Unit III.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Authority

    EPA is conducting its registration review of the pesticides listed
in the Table in Unit III pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
Section 3(g) of FIFRA provides, among other things, that the
registrations of pesticides are to be reviewed every 15 years. Under
FIFRA, a pesticide product may be registered or remain registered only
if it meets the statutory standard for registration given in FIFRA
section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with
widespread and commonly recognized practice, the pesticide product must
perform its intended function without unreasonable adverse effects on
the environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

III. Registration Reviews

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations for the pesticides listed in the Table of this unit to
ensure that they continue to satisfy the FIFRA standard for
registration--that is, that these pesticides can still be used without
unreasonable adverse effects on human health or the environment.

                      Table--Draft Risk Assessments Being Made Available for Public Comment
----------------------------------------------------------------------------------------------------------------
                                                                                Chemical Review
  Registration review  case name and             Pesticide Docket ID No.             Manager,telephone number,
                 No.                                                                       email address
----------------------------------------------------------------------------------------------------------------
Benfluralin, Case 2030...............  EPA-HQ-OPP-2011-0931                        Brian Kettl,
<EMAIL_ADDRESS>(703)
                                                                                347-0535.
Bromuconazole, Case 7035.............  EPA-HQ-OPP-2015-0535                        Thomas Harty,
<EMAIL_ADDRESS>(703)
                                                                                347-0338.
Carbaryl, Case 0080..................  EPA-HQ-OPP-2010-0230                        Linsey Walsh,
<EMAIL_ADDRESS>(703)
                                                                                347-8030.
Clodinafop-propargyl, Case 7250......  EPA-HQ-OPP-2012-0424                        Wilhelmena Livingston,
<EMAIL_ADDRESS>(703) 308-8025.
Deltamethrin, Case 7414..............  EPA-HQ-OPP-2009-0637                        Bilin Basu,
<EMAIL_ADDRESS>(703)
                                                                                347-0455.
Diflufenzopyr, Case 7246.............  EPA-HQ-OPP-2011-0911                        Bilin Basu,
<EMAIL_ADDRESS>(703)
                                                                                347-0455.
Esfenvalerate, Case 7406.............  EPA-HQ-OPP-2009-0301                        Marianne Mannix,
<EMAIL_ADDRESS><PHONE_NUMBER>.
Lufenuron, Case 7627.................  EPA-HQ-OPP-2015-0098                        Bonnie Adler,
<EMAIL_ADDRESS>(703)
                                                                                308-8523.
Mepiquat Chloride/Mepiquat             EPA-HQ-OPP-2012-0083                        Caitlin Newcamp,
 Pentaborate, Case 2375<EMAIL_ADDRESS><PHONE_NUMBER>.
----------------------------------------------------------------------------------------------------------------

    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity,
through this notice of availability, for interested parties to provide
comments and input concerning the Agency's draft human health and/or
ecological risk assessments for the pesticides listed in the Table in
Unit III. Such comments and input could address, among other things,
the Agency's risk assessment methodologies and assumptions, as applied
to these draft risk assessments. The Agency will consider all comments
received during the public comment period and make changes, as
appropriate, to the draft human health and/or ecological risk
assessments. EPA will then issue revised risk assessments, explain any
changes to the draft risk assessments, and respond to comments. In the
Federal Register notice announcing the availability of the revised risk
assessments, if the revised risk assessment indicates risks of concern,
the Agency may provide a comment period for the public to submit
suggestions for mitigating the risk identified in the revised risk
assessment before developing proposed registration review decisions for
the pesticides listed in the Table in Unit III.
    1. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record. Written material may be submitted in paper or
electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
    As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all actions
required in the final decision on the registration review case have
been completed.

    Authority:  7 U.S.C. 136 et seq.

    Dated: May 11, 2017.
Yu-Ting Guilaran,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2017-16372 Filed 8-2-17; 8:45 am]
BILLING CODE 6560-50-P