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

General Comment:Dear Mr. Zeller I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's proposed rule deeming tobacco products to be subject to the Federal Food, Drug and Cosmetic Act as amended by the family Smoking and Prevention and Tobacco Control Act (the "proposed rule") published at 79 Fed. Reg. 23,142 and Federal Register No 2014-09491.  On behalf of my husband and myself, I am requesting that the comment period for the proposed rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed rule raises a number of significant issues and questions that are important and relevant to me as a consumer of products that are proposed for regulation.  The Proposed Rule asks about a hundred different question I might want to respond to.  I want to provide my thoughts and comments on many of these issues but my time to devote to research and providing thoughtful comments is limited.  I know the FDA took many years to come up with the rule, so I don't think it is unreasonable to allow the public a mere six months to comment on it.  This is our only opportunity as consumers to provide feedback to you.

We feel very strongly about the value of e cigarettes as an alternative to old fashioned cigarettes.  My husband smoked cigarettes for 63 years; I myself smoked for 55 years.   We are now cigarette free for six months.  We are weaning ourselves off the nicotine that so enslaved us for so many years and hope to quit completely within the next year.  We are so grateful for the easiest way to quit tobacco smoking that has ever been invented.  PLEASE consider this request!!

Please consider our request for an extension of public comment and give us old smokers a chance of quitting after so many years.


[Federal Register: August 4, 2009 (Volume 74, Number 148)]
[Notices]
[Page 38607]
[DOCID:fr04au09-34]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13393-000; Project No. 13422-000; Project No. 13425-000]

Consolidated Hydro New Hampshire, Inc.: Village of Swanton, VT;
TransCanada Hydro Northeast Inc.; Notice of Competing Preliminary
Permit Applications Accepted for Filing and Soliciting Comments, and
Motions To Intervene

July 28, 2009.
    Consolidated Hydro New Hampshire, Inc., the Village of Swanton,
Vermont, and TransCanada Hydro Northeast Inc. filed applications,
pursuant to section 4(f) of the Federal Power Act, proposing to study
the feasibility of the Murphy Dam Project, to be located at the
existing Murphy Dam owned by the State of New Hampshire located on the
Connecticut River in Coos County, New Hampshire.
    These permit applications are filed in competition with Rockhouse
Mountain Energy, LLC's proposed Murphy Dam Project No. 13243-000, which
was public noticed on January 9, 2009. The deadline for filing
competing applications and notices of intent was March 10, 2009. Both
the Village of Swanton, Vermont, and TransCanada Hydro Northeast Inc.
filed timely notices of intent to file competing permit applications.
    Descriptions of the proposed Murphy Dam Projects:
    Consolidated Hydro New Hampshire, Inc.'s Project No. 13393-000
application was filed on March 10, 2009. The project would consist of:
(1) A proposed 500-foot-long, 8-foot-diameter steel penstock; (2) a
proposed powerhouse containing one generating unit having a total
installed capacity of 3.0 MW; (3) a proposed 1,500-foot-long, 34.5-kV
transmission line; (4) a 30-foot-wide, 100-foot-long tailrace; and (5)
appurtenant facilities. The proposed project would have an average
annual generation of 12.4 gigawatt-hours, which would be sold to a
local utility.
    The Village of Swanton, Vermont's Project No. 13422-000 application
was filed on April 8, 2009. The project would consist of: (1) A
proposed 300-foot-long, 8-foot-diameter penstock; (2) a proposed
powerhouse containing one generating unit having a total installed
capacity of 2.0 MW; (3) a proposed 1,500-foot-long, 34.5-kV
transmission line; (4) a 30-foot-wide, 100-foot-long tailrace; and (5)
appurtenant facilities. The proposed project would have an average
annual generation of 12.4 gigawatt-hours, which would be sold to a
local utility.
    TransCanada Hydro Northeast Inc.'s Project No. 13425-000
application was filed on April 8, 2009. The project would consist of:
(1) A proposed 2,500-foot-long, 8-foot-diameter penstock; (2) a
proposed powerhouse containing one generating unit having a total
installed capacity of 2.51 MW; (3) a proposed 1,500-foot-long, 34.5-kV
transmission line; (4) a 30-foot-wide, 100-foot-long tailrace; and (5)
appurtenant facilities. The proposed project would have an average
annual generation of 11.1 gigawatt-hours, which would be sold to a
local utility.
    Applicants Contact: For Consolidated Hydro New Hampshire, Inc.: Mr.
Victor Engel, Consolidated Hydro New Hampshire, Inc., c/o Enel North
America, Inc., One Tech Drive, Suite 220, Andover, MA 01810; phone
(978) 681-1900 Ext. 811. For the Village of Swanton, Vermont: Mr. Paul
Nolan, 5515 North 17th Street, Arlington, VA 22205-2722; phone (703)
534-5509. For TransCanada Hydro Northeast Inc.: Mr. John L. Ragonese,
TransCanada Hydro Northeast Inc., 4 Park Street, Suite 402, Concord, NH
03301; phone<PHONE_NUMBER>.
    FERC Contact: Michael Spencer,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene: 60 days from
the issuance of this notice. Comments, motions to intervene and may be
filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii)
and the instructions on the Commission's Web site under the ``eFiling''
link. If unable to be filed electronically, documents may be paper-
filed. To paper-file, an original and eight copies should be mailed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC. 20426. For more information on how
to submit these types of filings please go to the Commission's Web site
located at http://www.ferc.gov/filing-comments.asp. More information
about this project can be viewed or printed on the ``eLibrary'' link of
the Commission's Web site at http://www.ferc.gov/docs-filing/
elibrary.asp. Enter the docket number (P-13393-000, P-13422-000, or P-
13425-000) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-18552 Filed 8-3-09; 8:45 am]

BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2000 TRAVERWOOD DRIVE

ANN ARBOR, MI  48105-2498

									     OFFICE OF

									AIR AND RADIATION

2/16/16

MEMORANDUM

SUBJECT: Feedbacks on the released debugging version of GEM with EMA

FROM: Houshun Zhang

TO:  Greenhouse Gas Emissions Standards and Fuel Efficiency Standards
for Medium- and

Heavy-Duty Engines and Vehicles - Phase 2 - Docket EPA-HQ-OAR-2014-0827

This memo documents communication on February 2, 2016 between
representatives of EMA and EPA to verbally discuss the feedbacks on the
released debugging version of GEM proposed in the Phase 2 greenhouse gas
and fuel efficiency standards for heavy-duty vehicles notice of proposed
rulemaking.

The feedback included numerous potential bugs and issues identified by
the EMA members and some of confusions resulted from lack of
documentation.  EPA agreed that we will look into the issues and add
more clarifications for the next release.


[Federal Register Volume 76, Number 31 (Tuesday, February 15, 2011)]
[Rules and Regulations]
[Pages 8656-8658]
[FR Doc No: 2011-3323]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0010]
RIN 1625-AA00

Safety Zone; Miami International Triathlon, Bayfront Park, Miami,
FL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone in the
waters east of Bayfront Park for the Miami International Triathlon in
Miami, Florida. The triathlon is scheduled to take place on March 20,
2011. The temporary safety zone is necessary for the safety of
triathlon participants, participant vessels, and the general public
during the swim portion of the triathlon. Persons and vessels are
prohibited from entering, transiting through, anchoring in, or
remaining within the safety zone unless specifically authorized by the
Captain of the Port Miami or a designated representative.

DATES: This rule is effective from 7 a.m. until 9:30 a.m. on March 20,
2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0010 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0010 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Lieutenant Paul A. Steiner, Sector Miami
Prevention Department, Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a)

of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard did not receive
notice of the triathlon with sufficient time to publish an NPRM and to
receive public comments prior to the triathlon. Any delay in the
effective date of this rule would be contrary to the public interest
because immediate action is needed to minimize the potential danger to
triathlon participants as well as the general public.

Background and Purpose

    On March 20, 2011, Paramount Productions LLC is hosting the Miami
International Triathlon. This triathlon includes a 0.9 mile swim, which
will take place in the waters east of Bayfront Park in Miami, Florida.
Approximately 1,500 individuals are scheduled to compete in the
triathlon. This safety zone is necessary to protect triathlon
participants, participant vessels, and the general public during the
effective period.

Discussion of Rule

    The safety zone encompasses certain navigable waters east of
Bayfront Park in Miami, Florida. Persons and vessels are prohibited
from entering, transiting through, anchoring in, or remaining within
the safety zone unless specifically authorized by the Captain of the
Port Miami or a designated representative. The safety zone will be in
effect from 7 a.m. until 9:30 a.m. on March 20, 2011.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this rule to be so minimal that a
full regulatory evaluation is unnecessary. This rule may have some
impact on the public, but these potential impacts will be minimal for
the following reasons: (1) The rule will be in effect for less than
three hours; (2) vessel traffic in the area during the effective period
will be minimal; (3) although persons and vessels will not be able to
enter, transit through, anchor in, or remain within the safety zone
without authorization from the Captain of the Port Miami or a
designated representative, they will be able to operate in the
surrounding area during the effective period; (4) persons and vessels
may still enter, transit through, anchor in, or remain within the
safety zone if authorized by the Captain of the Port Miami or a
designated representative; (5) advance notification will be made to the
local maritime community via broadcast notice to mariners; and (6) the
triathlon host will distribute informational materials in advance of
the triathlon.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule may affect the following entities, some of which
may be small entities: The owners or operators of vessels intending to
enter, transit through, anchor in, or remain within the waters east of
Bayfront Park that are encompassed within the safety zone from 7 a.m.
until 9:30 a.m. on March 20, 2011. For the reasons discussed in the
Regulatory Planning and Review section above, this rule will not have a
significant economic impact on a substantial number of small entities.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health

Risks and Safety Risks. This rule is not an economically significant
rule and does not create an environmental risk to health or risk to
safety that may disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
    This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves establishing a
temporary safety zone, as described in paragraph (34)(g), that will be
in effect for less than three hours. An environmental analysis
checklist and a categorical exclusion determination are available in
the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6,160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add a temporary Sec.  165.T07-0010 to read as follows:

Sec.  165.T07-0010  Safety Zone; Miami International Triathlon,
Bayfront Park, Miami, FL.

    (a) Regulated area. The following regulated area is a safety zone.
All waters east of Bayfront Park encompasses within an imaginary line
connecting the following points: Starting at Point 1 in position
25[deg]46'36'' N, 80[deg]11'04'' W; thence east to Point 2 in position
25[deg]46'36'' N, 80[deg]10'51'' W; thence southeast to Point 3 in
position 25[deg]46'25'' N, 80[deg]10'44'' W; thence southwest to Point
4 in position 25[deg]46'19'' N, 80[deg]11'05'' W; thence north back to
origin. All coordinates are North American Datum 1983.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
federal, state, and local officers designated by or assisting the
Captain of the Port Miami in the enforcement of the regulated area.
    (c) Regulations.
    (1) All persons and vessels are prohibited from entering,
transiting through, anchoring in, or remaining within the regulated
area unless authorized by the Captain of the Port Miami or a designated
representative.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated area may contact the Captain of the
Port Miami via telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to seek permission. If
permission to enter, transit through, anchor in, or remain within the
regulated area is granted by the Captain of the Port Miami or a
designated representative, all persons and vessels receiving such
permission must comply with the instructions of the Captain of the Port
Miami or a designated representative.
    (3) The Coast Guard will provide notice of the regulated area via
broadcast notice to mariners and by on-scene designated
representatives.
    (d) Effective Date. This rule is effective from 7 a.m. until 9:30
a.m. on March 20, 2011.

    Dated: January 26, 2011.
G.J. Depinet,
Captain, U.S. Coast Guard, Acting Captain of the Port Miami.
[FR Doc. 2011-3323 Filed 2-14-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 69 (Tuesday, April 10, 2012)]
[Notices]
[Pages 21603-21607]
[FR Doc No: 2012-8521]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66733; File No. SR-BX-2012-020]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing of Proposed Rule Change Regarding Registration, Qualification,
and Continuing Education Requirements for Associated Persons

April 4, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'' or ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on March 21, 2012, NASDAQ OMX BX, Inc.
(``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 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 the Rules of the Boston Options
Exchange Group, LLC (``BOX'') regarding the registration of associated
persons. The text of the proposed rule change is available from the
principal office of the Exchange, at the Commission's Public Reference
Room and also on the Exchange's Internet Web site at http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/Filings/.

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

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

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

1. Purpose
    The Exchange is proposing to amend its rules regarding
qualification, registration and continuing education of individual
associated persons.\3\ Specifically, in response to a request by the
Division of Trading and Markets of the U.S. Securities and Exchange
Commission, the Exchange is proposing to expand its registration and
qualification requirements to include additional types of individual
associated persons. The Exchange believes the proposed rule change is
consistent with Rule 15b7-1,\4\ promulgated under the Securities
Exchange Act of 1934, as amended (``Exchange Act''),\5\ which provides:
``No registered broker or dealer shall effect any transaction in * * *
any security unless any natural person associated with such broker or
dealer who effects or is involved in effecting such transaction is
registered or approved in accordance with the standards of training,
experience, competence, and other qualification standards* * *
established by the rules of any national securities exchange * * *''
---------------------------------------------------------------------------

    \3\ Under Chapter 1, Section 1(a)(3) of the BOX Rules, the term
``associated person'' or ``person associated with a Participant''
means any partner, officer, director or branch manager of [sic]
Options Participant (or any person occupying a similar status or
performing similar functions), any person directly or indirectly
controlling, controlled by, or under common control with a
Participant or any employee of a Participant. This filing refers
specifically to the classification of ``individual associated
persons'' as an organization could fall within the scope of this
definition, and it is not BOX's intention to require registration by
an organization.
    \4\ 17 CFR 240.15b7-1.
    \5\ 15 U.S.C. 78a et seq.
---------------------------------------------------------------------------

    Currently, an individual person engaged only in proprietary trading
or submitting quotations or orders for a BOX Market Maker is not
subject to a registration requirement under the BOX Rules. One purpose
of this proposed rule change is to recognize new categories of
registration that will subject such individuals to such a requirement.
Proposed Chapter II, Section 8 establishes the qualification and
registration requirements for associated persons of Participants, and
recognizes a new category of limited representative registration for
proprietary traders. Proposed changes to Chapter VI, Section 2
establish the qualification and registration requirements for
individual persons, Market Maker Authorized Traders

(``MMAT''),\6\ who submit quotations and orders to BOX on behalf of
Participants which are registered as BOX Market Makers. Further, this
proposed rule sets forth the circumstances under which the Exchange may
suspend or withdraw the registration of an MMAT.
---------------------------------------------------------------------------

    \6\ Persons with similar functions at other Exchanges are
subject to registration requirements. See, e.g., Rule 801 of the
International Securities Exchange, LLC (``ISE''), Rule 11.6 of BATS
Exchange, Inc., and Rule 6.34A of the NYSE Arca, Inc.
---------------------------------------------------------------------------

    The proposed Chapter II, Section 8 also establishes registration
requirements for a Chief Compliance Officer (``CCO'') for each
Participant and for a Financial/Operations Principal for each
Participant subject to Exchange Act Rule 15c3-1.\7\ Proposed Chapter
II, Section 8 also references the registration requirements set forth
in Chapter XI of the BOX Rules for associated persons of Participants
that conduct a public customer business.\8\
---------------------------------------------------------------------------

    \7\ 17 CFR 240.15c3-1.
    \8\ These proposed rule changes are consistent with those
previously adopted by the Chicago Board of Options Exchange
(``CBOE'') and International Securities Exchange, LLC (``ISE''). See
Securities Exchange Act Release Nos. 62977 (September 22, 2010), 75
FR 59773 (September 28, 2010) (``CBOE Registration Proposal'');
63314 (November 12, 2010), 75 FR 70957 (November 19, 2010) (``CBOE
Approval Order''), and 63843 (February 4, 2011), 76 FR 7884
(February 11, 2011) (``ISE Approval Order'').
---------------------------------------------------------------------------

    Under the proposal, individual associated persons acting in the
capacity of a sole proprietor, officer, partner, director or CCO will
be subject to heightened qualification requirements. In addition, an
individual associated person that is engaged in the supervision or
monitoring of proprietary trading, market-making or brokerage
activities and/or that is engaged in the supervision or training of
those engaged in proprietary trading, market-making or brokerage
activities will be subject to heightened qualification requirements.
The Exchange believes that the heightened qualification requirements
should enhance the supervisory structure for Participants that do not
conduct a public customer business.\9\
---------------------------------------------------------------------------

    \9\ Proposed Chapter II, Section 8 specifies that individual
associated persons of a Participant that conducts a public customer
business, including Registered Options Principals and Registered
Representatives, are also subject to the registration requirements
set forth in Chapter XI, Sections 2 and 3 of the BOX Rules. It also
specifies that individual persons entering quotations or orders for
a Participant registered as a BOX Market Maker must also comply with
the registration requirements set forth in Chapter VI, Section 2 of
the BOX Rules for Market Maker Authorized Traders.
---------------------------------------------------------------------------

    Specifically, the Exchange is proposing to require additional
associated persons to submit the appropriate application for
registration online through the Central Registration Depository system
(``Web CRD''), which is operated by the Financial Industry Regulatory
Authority, Incorporated (``FINRA''), successfully complete the
qualification examination(s) as prescribed by the Exchange and submit
any required registration and examination fees.\10\ Proposed Chapter
II, Section 8 will require registration and qualification by individual
associated persons engaged or to be engaged in the securities business
of a Participant.\11\ An individual associated person will be
considered to be a person engaged in the securities business of a
Participant if (i) the individual associated person conducts
proprietary trading, acts as a market-maker, effects transactions on
behalf of a broker-dealer account, supervises or monitors proprietary
trading, market-making or brokerage activities on behalf of the broker-
dealer, supervises or conducts training for those engaged in
proprietary trading, market-making or brokerage activities on behalf of
a broker-dealer account; or (ii) the individual associated person
engages in the management of any individual associated person
identified in (i) above as an officer, partner or director.\12\
---------------------------------------------------------------------------

    \10\ Under the proposal, each individual associated person
subject to the registration requirements in proposed Chapter II,
Section 8 will be required to electronically file a Uniform
Application for Securities Industry Registration (``Form U4'')
through Web CRD.
    \11\ An individual with an indirect ownership interest in a
Participant that is engaged in the securities business of such
Participant is required to register under proposed Chapter II,
Section 8.
    \12\ This requirement is consistent with FINRA's registration
requirement for ``Principals'' (as defined in NASD Rule 1021). BOX
is declining to adopt the term ``Principal'' in the proposed rule
change to avoid confusion with existing terms, such as ``Option
Principal.''
---------------------------------------------------------------------------

    The Exchange is also proposing to recognize a new category of
limited representative registration for individual persons associated
with a BOX Options Participant that is a ``proprietary trading firm''
as defined in Supplementary Material .07 to the proposed Section 8.\13\
Further, the Exchange is proposing to extend the registration
requirements to Market Maker Authorized Traders, i.e., individual
persons submitting to BOX quotations or orders for Participants
registered as BOX Market Makers.\14\
---------------------------------------------------------------------------

    \13\ For purposes of this requirement, a Participant is
considered to conduct only proprietary trading if it has the
following characteristics: (i) The Participant is not required by
Section 15(b)(8) of the Exchange Act to become a FINRA member but is
a member of another registered securities exchange not registered
solely under Section 6(g) of the Exchange Act; (ii) all funds used
or proposed to be used by the Participant are the Participant's own
capital, traded through the Participant's own accounts; (iii) the
Participant does not, and will not, have customers; and (iv) all
persons registered on behalf of the Participant acting or to be
acting in the capacity of a trader must be owners of, employees of,
or contractors to the Participant.
    \14\ See proposed Chapter VI, Section 2.
---------------------------------------------------------------------------

    With respect to the new qualification examination associated with
the proposed rule changes,\15\ the Exchange has developed, with other
self-regulatory organizations (``SROs''), the Series 56 examination
that would be applicable to proprietary traders. A subset of
individuals associated with Participants, those engaged only in
proprietary trading, may use the Series 56 examination to qualify for
registration under the new category of limited representative
registration as a proprietary trader.\16\ Persons who conduct a public
customer business do not fit in the registration category proposed for
proprietary traders and as noted in note 6 above, must continue to
comply with the registration requirements in Chapter XI of the BOX
Rules and register and be qualified by passing the General Securities
Registered Examination (Series 7). The Exchange believes the Series 7
examination covers a great deal of material that is not relevant to
proprietary trading functions. Instead, the Series 56 covers both
equities and options trading rules, but not all of the rules applicable
to firms and persons conducting business with public customers. The
Exchange will describe the Series 56 in greater detail in a separate
proposed rule change and the Exchange will notify its Participants via
regulatory circular that the Series 56 examination will be acceptable
for compliance with the requirements proposed in Chapter II, Section 8.
---------------------------------------------------------------------------

    \15\ See Securities Exchange Act Rel. No. 64699, (June 17,
2011), 76 FR 36945 (June 23, 2011), (SR-CBOE-2011-056) Notice of
Filing and Immediate Effectiveness of Proposed Rule Change to Adopt
the Selection Specifications and Content Outline for the Proprietary
Traders Examination Program (Series 56). The Series 56 examination
recognized by the Exchange for the category of Proprietary Trader
became available on Web CRD on June 20, 2011.
    \16\ The Exchange, with other SROs, has developed the Series 56
examination that would be applicable to proprietary traders required
to register under the proposed rule. The Exchange will submit a non-
controversial rule change to the Commission that, when effective,
will allow the Exchange to Adopt the Selection Specifications and
Content Outline for the Series 56 Examination Program [sic].
---------------------------------------------------------------------------

    Of course, persons registering as proprietary trader
representatives or an MMAT would be subject to the continuing education
requirements set forth in Chapter XI, Section 5 of the BOX Rules.
Additionally, the Exchange will require all associated persons required
to register under proposed Chapter II, Section 8 that are not already
registered in Web CRD to register (i.e., complete a Form U4) within 60
days of the approval date of this filing by the

U.S. Securities and Exchange Commission.\17\
---------------------------------------------------------------------------

    \17\ Web CRD has been enhanced by FINRA to allow for general
registration of applicable associated persons.
---------------------------------------------------------------------------

    This proposal does not require proprietary traders or MMATs who
have already registered and have passed the Series 7 examination to
register under the new proprietary trader category or to pass the
Series 56 because the Exchange believes this would be redundant.
Persons whom are registered with the Exchange and have passed the
Series 7 may, of course, perform the functions of a proprietary trader
or MMAT, because these new registration categories are limited
registration categories. This proposal does not preclude associated
persons from passing the Series 7 examination, registering with the
Exchange, and then functioning as a proprietary trader or MMAT.
    BOX expects that new BOX Options Participants might consider these
new registration alternatives when applying to be a Participant.
Accordingly, BOX believes that the [sic] these alternatives should be
helpful to attracting new Participants, while at the same time
preserving the important goals of appropriate registration and
qualification for persons in the securities business. Additionally,
proprietary trading or market making firms who hire new associated
persons might choose to register those persons using the Series 56
exam. Unlike the associated persons of proprietary trading and market
making firms covered by this proposal, associated persons of firms that
conduct business with public customers continue to be subject to
registration with the Exchange and have to pass the Series 7
examination. These individual associated persons are not eligible for
the new registration category and examination.
    The Exchange is proposing to identify in Chapter II, Section 8
several categories of persons that are exempt from these additional
registration requirements. The categories of individual associated
persons that are exempt from the registration requirements include: (i)
Individual associated persons functioning solely and exclusively in a
clerical or ministerial capacity; (ii) individual associated persons
that are not actively engaged in the securities business; (iii)
individual associated persons functioning solely and exclusively to
meet a need for nominal corporate officers or for capital
participation; and (iv) individual associated persons whose functions
are solely and exclusively related to transactions in commodities,
transactions in security futures and/or effecting transactions on the
floor of another national securities exchange and who are registered as
floor members with such exchange. The Exchange believes these
registration exemptions are appropriate because it would not consider
individuals that fall into the exemptions to be actively engaged in
securities business unless they are registered as floor members on
another national securities exchange, in which case, they are already
registered as floor members and not required to register with the
Exchange. The Exchange believes incorporating these exemptions into the
rule provides additional clarity to individual associated persons as to
who will or will not be required to register with the Exchange under
the proposed rule. Any applicable FINRA registration requirements would
continue to apply to Participants that are also members of FINRA.
    Additionally, under the proposal, the Exchange may, in exceptional
cases and where good cause is shown, waive the qualification
examination requirement. Similar rules are in place at the New York
Stock Exchange, Inc. (``NYSE'') and FINRA.\18\ In determining whether a
waiver shall be granted, the Exchange shall consider, among other
things, previous industry employment, training and/or the successful
completion of similar qualification examinations of other self-
regulatory organizations.
---------------------------------------------------------------------------

    \18\ See NASD Rule 1070 (Qualification Examinations and Waiver
of Requirements) and NYSE Rule 345 (Employees--Registration,
Approval, Records).
---------------------------------------------------------------------------

    The Exchange also is proposing to require the designation of a
Financial/Operations Principal by each Participant that is subject to
Exchange Act Rule 15c3-1, and the designation of a CCO by each
Participant. Under the proposed rule, the Financial/Operations
Principal and CCO are required to register and pass the appropriate
qualification examination.\19\ The Financial/Operations Principal and
CCO play important roles within a Participant's business by acting as
the persons responsible for the firm's compliance with applicable net
capital, recordkeeping, and other financial and operational rules and
regulations. The registration requirements for a Financial/Operations
Principal and for a CCO are consistent with CBOE Rule 3.6A \20\ (which
in turn are consistent with FINRA Rule 3130 and NASD Rule 1022). The
proposal includes a limited exemption from the requirement to pass the
appropriate qualification examination by a CCO. Specifically, a person
that has been designated as a CCO on Schedule A of Form BD for at least
two years immediately prior to January 1, 2002, and who has not been
subject within the last ten years to any statutory disqualification as
defined in Section 3(a)(39) of the Act; a suspension; or the imposition
of a $5,000 or more fine for a violation(s) of any provision of any
securities law or regulation, or any agreement with, rule or standard
of conduct of any securities governmental agency, securities self-
regulatory organization, or as imposed by any such self-regulatory
organization in connection with a disciplinary proceeding, shall be
required to register in the category of registration appropriate to the
function to be performed as prescribed by the Exchange, but shall be
exempt from the requirement to pass the heightened qualification
examination as prescribed by the Exchange. The Exchange believes that
implementing this proposed change will help meet the important goals of
appropriate registration and qualification for all persons engaged in
the securities business.
---------------------------------------------------------------------------

    \19\ The appropriate qualification examination for a Financial/
Operations Principal is the Series 27 exam. The appropriate
qualification examination for a CCO is the Series 14 exam. These
categories of registration and the accompanying qualification
examinations are available to the Exchange through Web CRD.
    \20\ The duties of a Financial/Operations Principal include
taking appropriate actions to assure that the Participant complies
with applicable financial and operational requirements under SRO
rules and the Exchange Act. The Exchange notes that it is not the
Designated Examining Authority for any BOX Participant, but for
consistency with other SRO rules, is proposing to include the
designation of a Financial/Operations Principals in the BOX Rules.
---------------------------------------------------------------------------

    All individuals who engage in supervisory functions of the
Participant's securities business shall be required to register and
pass the appropriate heightened qualification examination(s) relevant
to their particular category of registration. Each BOX Participant must
have at least two such persons. The Exchange is proposing to require
registration and successful completion of a heightened qualification
examination by at least two individuals [sic] for any person who is an
(i) officer; (ii) partner; (iii) director; (iv) supervisor of
proprietary trading, market-making or brokerage activities; and/or (v)
supervisor of those engaged in proprietary trading, market-making or
brokerage activities with respect to those activities.\21\ The Exchange
believes it is appropriate that any

person acting in a supervisory capacity be required to comply with
heightened requirements regarding their qualification and registration.
---------------------------------------------------------------------------

    \21\ With the exception of its application to sole proprietors,
this requirement is consistent with the registration requirement set
forth in NASD Rule 1021 addressing registration of two Principals
(as defined in NASD Rule 1021).
---------------------------------------------------------------------------

    The Exchange may waive the requirement to have two officers,
partners, directors, and/or supervisors registered if a Participant
conclusively demonstrates that only one such person should be required
to register. For example, a Participant could conclusively demonstrate
that only one individual is required to register if such Participant is
owned by one individual (such as a single member limited liability
company), such individual acts as the only trader on behalf of the
Participant, and the Participant employs only one other individual who
functions only in a clerical capacity. The ability to waive this
registration requirement is consistent with similar FINRA rules
regarding principal registration.\22\
---------------------------------------------------------------------------

    \22\ See NASD Rule 1021(e).
---------------------------------------------------------------------------

    The Exchange notes that Participants that are sole proprietors may
also be granted a waiver from the requirement that two officers,
partners, directors, and/or supervisors be registered. Further, the
Exchange is also proposing to allow a Participant that conducts only
proprietary trading and has 25 or fewer registered persons to have only
one officer or partner registered under this section rather than two.
This exception is similar to that of several other exchanges and
reflects that such Participants do not necessitate the same level of
supervisory structure as those Participants that have customers or are
larger in size. For purposes of this requirement, a Participant is
considered to conduct only proprietary trading if it has the following
characteristics: (i) The Participant is not required by Section
15(b)(8) of the Exchange Act to become a FINRA member but is a member
of another registered securities exchange not registered solely under
Section 6(g) of the Exchange Act; (ii) all funds used or proposed to be
used by the Participant are the Participant's own capital, traded
through the Participant's own accounts; (iii) the Participant does not,
and will not, have customers; and (iv) all persons registered on behalf
of the Participant acting or to be acting in the capacity of a trader
must be owners of, employees of, or contractors to the Participant. The
description of what constitutes proprietary trading for purposes of
this requirement is appropriate in that it provides additional clarity
for associated persons to evaluate whether two individuals are required
to register. The Exchange believes these potential waivers are
appropriate to allow proprietary trading firms and sole proprietor
firms to comply with the regulatory supervisory requirements in a
reasonable manner.
    Proposed Chapter II, Section 8 also sets forth the requirements for
examinations where there is a lapse in registration. Specifically, an
individual associated person shall be required to pass the appropriate
qualification examination for the category of registration if the
individual associated person's registration has been revoked by the
Exchange as a disciplinary sanction or whose most recent registration
has been terminated for a period of two or more years. The Exchange
believes that implementing this proposed change will help meet the
important goals of appropriate registration and qualification for all
persons engaged in the securities business.
    Additionally, the Exchange proposes to update Chapter XI, Section 5
of the BOX Rules regarding continuing education requirements so that it
is consistent with other SRO rules.\23\ Specifically, the Exchange
proposes to add a provision detailing the procedures required for in-
house delivery of the regulatory element. The required procedures
address responsibility for the education program, site requirements,
technology requirements, supervision requirements, and administration
of the program. Participants are required to file with their Designated
Examining Authority, [sic] a letter of attestation signed by a senior
officer or partner, attesting to the establishment of the required
procedures, and must annually represent that they have continued to
maintain all required procedures for the previous year. While BOX does
not have a floor, for consistency with other SRO rules, the Exchange
also proposes to delete language that excludes those people whose
activities are limited solely to the transaction of business on a floor
from the definition of ``registered person'' for purposes of Chapter
XI, Section 5 of the BOX Rules.\24\ The Exchange believes that
implementing this proposed change will help meet the important goals of
appropriate qualification and continuing education for all persons
engaged in the securities business.
---------------------------------------------------------------------------

    \23\ E.g., CBOE Rule 9.3A and ISE Rule 604.
    \24\ See CBOE Rule 9.3A and ISE Rule 604.
---------------------------------------------------------------------------

    Finally, this filing proposes to make non-substantive changes to
Chapter XI, Section 2 (Registration of Options Principals), Section 3
(Registration of Representatives) and Section 4 (Termination of
Registered Persons) of the BOX Rules to define and reference certain
terms consistently within these rules and with proposed Chapter II,
Section 8. Specifically, these rules currently contain inconsistent
references to the use of the Central Registration Depository, and the
registration and termination forms required to be filed under the
rules. Additionally, these rules contain reference [sic] to the
National Association of Securities Dealers which is now known as the
Financial Industry Regulatory Authority or ``FINRA.''
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\25\ in general, and Section
6(b)(5) of the Act,\26\ in particular, in that it is designed to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism for a free and open market and a national market
system and, in general, to protect investors and the public interest.
Specifically, the enhanced registration and qualification requirements
will provide additional protection to investors and further promote the
public interest. Additionally, the proposed rule change is intended to
provide uniformity across the various SROs with respect to the
registration and qualification requirements for individual persons. The
Exchange believes that implementing this proposed rule change will help
meet the important goals of subjecting all persons engage in the
securities business to appropriate registration requirements,
qualification requirements through the examination process, and
continuing education requirements, including those persons associated
with proprietary trading firms and BOX market makers.
---------------------------------------------------------------------------

    \25\ 15 U.S.C. 78f(b).
    \26\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    In addition, the Exchange believes that the proposed rule change is
consistent with Section 6(c) of the Exchange Act,\27\ in general, and
furthers the objectives of Section 6(c)(3)(B) of the Act,\28\ which
provides, among other things, that a national securities exchange may
bar a natural person from becoming associated with a member if such
natural person does not meet the standards of training, experience and
competence as prescribed by the rules of the national securities
exchange. The Exchange also believes that the

proposed rule change furthers the objectives of Section 6(c)(3)(C) of
the Exchange Act,\29\ which provides, among other things, that a
national securities exchange may bar any person from becoming
associated with a member if such person does not agree to supply the
exchange with such information with respect to its dealings with the
member as may be specified by the rules of the exchange and to permit
the examination of its books and records to verify the accuracy of any
information so supplied. The Exchange believes the Series 56
examination program establishes the appropriate qualifications for an
individual associated person that is required to register as a
Proprietary Trader under proposed Chapter II, Section 8 of the BOX
Rules, including, but not limited to, Market-Makers, proprietary
traders and individuals effecting transactions on behalf of other
broker-dealers. The Exchange also believes the Series 56 addresses
industry topics that establish the foundation for the regulatory and
procedural knowledge necessary for individuals required to register as
Market Maker Authorized Trader [sic] under proposed Chapter VI, Section
2 of the BOX Rules.
---------------------------------------------------------------------------

    \27\ 15 U.S.C. 78f(c).
    \28\ 15 U.S.C. 78f(c)(3)(B).
    \29\ 15 U.S.C. 78f(c)(3)(C).
---------------------------------------------------------------------------

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

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

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

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

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BX-2012-020 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-BX-2012-020. 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 on business days between the hours of 10 a.m. and 3 p.m. in
the Commission's Public Reference Room located at 100 F Street NE.,
Washington, DC 20549. Copies of such 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-BX-2012-020 and should be
submitted on or before May 1, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\30\
---------------------------------------------------------------------------

    \30\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-8521 Filed 4-9-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Page 22887]
[FR Doc No: 2013-08906]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0867]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Experimental Study on the Public
Display of Lists of Harmful and Potential Harmful Tobacco Constituents

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Experimental Study on the Public
Display of Lists of Harmful and Potential Harmful Tobacco
Constituents'' has been approved by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On May 8, 2012, the Agency submitted a
proposed collection of information entitled ``Experimental Study on the
Public Display of Lists of Harmful and Potential Harmful Tobacco
Constituents'' to OMB for review and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. OMB has now approved the information
collection and has assigned OMB control number 0910-0736. The approval
expires on March 31, 2016. A copy of the supporting statement for this
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: April 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08906 Filed 4-16-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Notices]
[Pages 42338-42339]
[FR Doc No: 2014-17081]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Joint Meeting of the Bone, Reproductive and Urologic Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee; 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 Committees: Bone, Reproductive and Urologic Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 18, 2014, from
8 a.m. to 1 p.m.
    Location: College Park Marriott Hotel and Conference Center, 3501
University Blvd. East, Hyattsville, MD 20783. The hotel's telephone
number is<PHONE_NUMBER>.
    Contact Person: Kalyani Bhatt, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., WO31-
2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area). 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: The committees will discuss new drug application (NDA)
206089 (oral testosterone undecanoate tablets), submitted by Clarus
Therapeutics, for the proposed indication of testosterone replacement
therapy in males for conditions associated with a deficiency or absence
of endogenous testosterone: Primary hypogonadism (congenital or
acquired) and hypogonadotropic hypogonadism (congenital or acquired).
    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 meeting
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
September 3, 2014. Oral presentations from the public will be scheduled
between approximately 10:45 a.m. and 11:45 a.m. 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 August 25, 2014. 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 August 26, 2014.
    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 Kalyani Bhatt 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 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17081 Filed 7-18-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39083-39084]
[FR Doc No: 2018-16910]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: RP18-1030-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Capacity Release
Agreements--8/1/2018 to be effective 8/1/2018.
    Filed Date: 8/1/18.
    Accession Number: 20180801-5031.
    Comments Due: 5 p.m. ET 8/13/18.

    Docket Numbers: RP18-1031-000.
    Applicants: WBI Energy Transmission, Inc.
    Description: Sec.  4(d) Rate Filing: 2018 Negotiated Rate Non-
Conforming SA's FT-1463 and FT-1464 to be effective 9/1/2018.
    Filed Date: 8/1/18.
    Accession Number: 20180801-5037.
    Comments Due: 5 p.m. ET 8/13/18.

    Docket Numbers: RP18-1032-000.
    Applicants: Portland Natural Gas Transmission System.
    Description: Sec.  4(d) Rate Filing: Implementation of Navigates to
be effective 9/1/2018.
    Filed Date: 8/1/18.
    Accession Number: 20180801-5051.
    Comments Due: 5 p.m. ET 8/13/18.

    Docket Numbers: RP18-1033-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmt (XTO
1846 to Southwest Energy 2022) to be effective 8/1/2018.
    Filed Date: 8/1/18.
    Accession Number: 20180801-5053.
    Comments Due: 5 p.m. ET 8/13/18.

    Docket Numbers: RP18-1034-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Remove Expired Agreements eff
8/1/2018.
    Filed Date: 8/1/18.
    Accession Number: 20180801-5054.
    Comments Due: 5 p.m. ET 8/13/18.

    Docket Numbers: RP18-1035-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20180801 Non Conforming to be
effective 9/1/2018.
    Filed Date: 8/1/18.
    Accession Number: 20180801-5106.
    Comments Due: 5 p.m. ET 8/13/18.

    Docket Numbers: RP18-1036-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: NC Neg Rate Agmt Filing
(Interim St Charles Exp Proj Entergy LA 48765) to be effective 9/1/
2018.
    Filed Date: 8/1/18.
    Accession Number: 20180801-5122.
    Comments Due: 5 p.m. ET 8/13/18.

    Docket Numbers: RP18-1037-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Compliance filing NEXUS Baseline Tariff re Docket No.
CP16-22 to be effective 9/30/2018.
    Filed Date: 8/1/18.
    Accession Number: 20180801-5124.
    Comments Due: 5 p.m. ET 8/13/18.

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

    Dated: August 2, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-16910 Filed 8-7-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 232 (Monday, December 3, 2018)]
[Notices]
[Pages 62319-62320]
[FR Doc No: 2018-26230]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R5-Superfund V-W-19-C-001; FRL-9987-21-Region 5]

Proposed CERCLA Administrative Settlement Agreement; A&L Iron and
Metal Company, Inc.

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed settlement agreement and request for public
comments.

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SUMMARY: The Environmental Protection Agency (EPA) hereby gives notice
of a proposed Administrative Settlement Agreement (Settlement)
pertaining to collection of Past Response Costs for a Fund-lead Removal
Action occurring between 2014 and 2015, at an approximately 16-acre
former industrial equipment manufacturing facility in Saginaw (Saginaw
County), Michigan, the Baker Perkins Superfund Site (``Site''). The
Settlement requires A&L Iron and Metal Company, Inc. (``A&L'') to pay
$1,611,788.29 (plus an additional sum for interest on that amount
calculated from March 31, 2018 through the date of payment to EPA) for
EPA's Past Response Costs within 45 days of the Effective Date of the
Settlement, in return for a covenant against any and all liability for
EPA Response Costs at the Site, and contribution protection against any
and all other liable parties.

DATES: Comments must be post marked or received on or before January 2,
2019.

ADDRESSES: The proposed settlement agreement and related site documents
can be viewed at the Superfund Records Center, (SRC-7J), United States
Environmental Protection Agency, Region 5, 77 W. Jackson Blvd.,
Chicago, IL 60604,<PHONE_NUMBER> and on-line at www.epa.gov/superfund/baker_perkins.

FOR FURTHER INFORMATION CONTACT: Further information or a copy of the
Settlement may be obtained from either Thomas P. Turner, Office of
Regional Counsel (C-14J), U.S. Environmental Protection Agency, Region
5, 77 W Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER> or
[email protected] or Superfund Division Enforcement Specialist Mike
Rafati, Superfund Division (SR-5J), U.S. Environmental Protection
Agency, Region 5, 77 W Jackson Boulevard, Chicago, Illinois 60604,
(312) 886-0390 or [email protected].

SUPPLEMENTARY INFORMATION:

I. Background Information

    In accordance with Section 122 (i) of the Comprehensive
Environmental Response, Compensation, and Liability Act, as amended
(``CERCLA''), 42 U.S.C. 9622 (i), notice is hereby given of a proposed
Settlement pertaining to the Baker Perkins Superfund Site in Saginaw,
Saginaw County, Michigan, with the following settling party: A&L Iron
and Metal Company, Inc. The Settlement requires A&L to pay
$1,611,788.29 (plus an additional sum for interest on that amount
calculated from March 31, 2018 through the date of payment to EPA) for
EPA's Past Response Costs within 45 days of the Effective Date of the
Settlement.
    The Settlement includes an EPA covenant not to sue the settling
party and contribution protection, pursuant to Sections 107(a),
113(f)(2), and 122(h)(4) of CERCLA, 42 U.S.C. Sections 9607(a),
9613(f)(2), and 9622(h)(4).

II. Opportunity To Comment

A. General Information

    For thirty (30) days following the date of publication of this
notice, the Agency will receive written comments relating to the
Settlement. The Agency will consider all comments received and may
modify or withdraw its consent to the Settlement if comments received
disclose facts or considerations which indicate that the Settlement is
inappropriate, improper, or inadequate.

B. Where do I send my comments or view responses?

    Your comments should be mailed to Mike Rafati, Superfund Division
(SR-5J), U. S. Environmental Protection Agency, Region 5, 77 W Jackson
Boulevard, Chicago, Illinois 60604, or [email protected]. The
Agency's response to any comments received will be available for public
inspection at the Superfund Records Center.

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

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

     Make sure to submit your comments by the identified
comment period deadline.

    Dated: November 14, 2018.
Douglas A. Ballotti,
Acting Director, Superfund Division.
[FR Doc. 2018-26230 Filed 11-30-18; 8:45 am]
 BILLING CODE 6560-50-P