[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Notices]
[Pages 52380-52382]
[FR Doc No: 2014-20869]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 31226; File No. 812-14299]

Advisors Series Trust and Vivaldi Asset Management, LLC; Notice
of Application

August 27, 2014.
AGENCY: Securities and Exchange Commission (``Commission'').

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

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

Applicants:  Advisors Series Trust (the ``Trust'') and Vivaldi Asset
Management, LLC (the ``Advisor'').

DATES: The application was filed on April 10, 2014 and amended on
August 8, 2014.

Hearing or Notification of Hearing:  An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request a hearing by writing to the Commission's Secretary
and serving applicants with a copy of the request, personally or by
mail. Hearing requests should be received by the Commission by 5:30
p.m. on September 22, 2014, and should be accompanied by proof of
service on the applicants, in the form of an affidavit or, for lawyers,
a certificate of service. Hearing requests should state the nature of
the writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicants: Advisors Series
Trust, 615 East Michigan Street, Milwaukee, WI 53202 and Vivaldi Asset
Management, LLC, 1622 Willow Road, Suite 101, Northfield, IL 60093.

FOR FURTHER INFORMATION CONTACT: Deepak T. Pai, Senior Counsel, at
(202) 551-6876 or Mary Kay Frech, Branch Chief, at<PHONE_NUMBER>
(Division of Investment Management, Chief Counsel's Office).

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

Applicants' Representations

    1. The Trust, a Delaware statutory trust, is registered under the
Act as an open-end management investment company. The Trust offers
multiple series (each a ``Fund'' and together the ``Funds''), two of
which will be advised by the Advisor, each with its own investment
objectives, policies, and restrictions.\1\
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    \1\ Applicants also request relief with respect to any existing
or future series of the Trust or any other registered open-end
management investment company that: (a) Is advised by the Advisor,
or by a person controlling, controlled by or under common control
with the Advisor or its successor (included in the term
``Advisor''); (b) uses the manager of managers structure (``Manager
of Managers Structure'') described in the application; and (c)
complies with the terms and conditions of the application. The only
existing registered open-end management investment company that
currently intends to rely on the requested order is named as an
applicant. For purposes of the requested order, ``successor'' is
limited to an entity that results from a reorganization into another
jurisdiction or a change in the type of business organization. If
the name of any Fund contains the name of a Sub-Advisor (as defined
below), the name of the Advisor will precede the name of the Sub-
Advisor.
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    2. The Advisor, a limited liability company organized under
Delaware law, is registered as an investment adviser under the
Investment Advisers Act of 1940 (``Advisers Act''). The Advisor will
serve as investment adviser to the Funds pursuant to an investment
advisory agreement with the Trust (the ``Advisory Agreement''),\2\
approved by the board of trustees of the Trust (each a ``Board''),\3\
including a majority of the trustees who are not ``interested
persons,'' as defined in section 2(a)(19) of the Act, of the Trust, the
Funds, or the Advisor (the ``Independent Trustees'') and by the
shareholders of a Fund in the manner required by sections 15(a) and
15(c) of the Act and rule 18f-2 thereunder. Applicants are not seeking
any exemptions from the provisions of the Act with respect to any
Advisory Agreement.\4\
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    \2\ ``Advisory Agreement'' includes advisory agreements with an
Advisor for the Funds and any future Funds.
    \3\ The board of trustees of any future Fund is included in the
term ``Board''.
    \4\ Orinda Asset Management, LLC (``Orinda'') is the current
investment adviser to the Funds. Pursuant to a prior order, In the
Matter of Advisors Series Trust and Orinda Asset Management, LLC,
Investment Company Act Release Nos. 30043 (April 23, 2012) (notice)
and 30065 (May 21, 2012) (order), the Funds currently operate in a
Manager of Managers Structure. Orinda has indicated its intention to
resign as investment adviser to the Funds. The Board, including a
majority of the Independent Trustees, has determined to approve the
engagement of the Advisor as investment adviser to the Funds,
effective upon the resignation of Orinda. The Advisor has determined
not to accept the engagement as investment adviser, and Orinda has
agreed not to resign as investment adviser, unless and until (i)
shareholder approval to the engagement of the Advisor as investment
adviser is obtained, and (ii) the relief requested is granted.
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    3. Under the terms of the Advisory Agreement, the Advisor will
provide the Funds with overall investment management services and, as
it deems appropriate, will continuously review, supervise, and
administer each Fund's investment program, subject to the supervision
of, and policies established by, the Board. For the investment
management services it will provide to a Fund, the Advisor will receive
the fee specified in the Advisory Agreement from that Fund. The
Advisory Agreement will permit the Advisor to delegate certain
responsibilities to one or more investment subadvisers (each, a ``Sub-
Advisor''), to manage all or a portion of the assets of each Fund
pursuant to an investment subadvisory agreement with a Sub-Advisor
(``Sub-Advisory Agreement''). Each Sub-Advisor is, and any future Sub-
Advisor will be, an ``investment adviser,'' as defined in section
2(a)(20) of the Act, and registered as an investment adviser under the
Advisers Act, or not subject to such registration. The Advisor
evaluates, allocates assets to, and oversees the Sub-Advisors, and make

recommendations about their hiring, termination, and replacement to the
Board, at all times subject to the authority of the Board. The Advisor
will compensate the Sub-Advisors out of the advisory fee paid by the
Funds to the Advisor under the Advisory Agreement.
    4. Applicants request an order to permit the Advisor, subject to
Board approval, to engage Sub-Advisors to manage all or a portion of
the assets of a Fund pursuant to a Sub-Advisory Agreement and
materially amend Sub-Advisory Agreements without obtaining shareholder
approval. The requested relief will not extend to any Sub-Advisor that
is an ``affiliated person,'' as defined in section 2(a)(3) of the Act,
of the Trust, a Fund, or the Advisor, other than by reason of serving
as Sub-Advisor to one or more of the Funds (``Affiliated Sub-
Advisor'').
    5. Applicants also request an order exempting each Fund from
certain disclosure provisions described below that may require the
Funds to disclose fees paid by the Advisor to Sub-Advisors. Applicants
seek an order to permit each Fund to disclose (as both a dollar amount
and as a percentage of a Fund's net assets) only: (a) The aggregate
fees paid to the Advisor and any Affiliated Sub-Advisor; and (b) the
aggregate fees paid to Sub-Advisors other than Affiliated Sub-Advisors
(collectively, the ``Aggregate Fee Disclosure''). A Fund that employs
an Affiliated Sub-Advisor will provide separate disclosure of any fees
paid to the Affiliated Sub-Advisor.
    6. The Funds will inform shareholders of the hiring of a new Sub-
Advisor pursuant to the following procedures (``Modified Notice and
Access Procedures''): (a) Within 90 days after a new Sub-Advisor is
hired for a Fund, the Fund will send its shareholders either a Multi-
Manager Notice or a Multi-Manager Notice and Multi-Manager Information
Statement; \5\ and (b) the Fund will make the Multi-Manager Information
Statement available on the Web site identified in the Multi-Manager
Notice no later than when the Multi-Manager Notice (or Multi-Manager
Notice and Multi-Manager Information Statement) is first sent to
shareholders, and will maintain it on that Web site for at least 90
days.
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    \5\ A ``Multi-Manager Notice'' will be modeled on a Notice of
Internet Availability as defined in rule 14a-16 under the Securities
Exchange Act of 1934 (``Exchange Act''), and specifically will,
among other things: (a) Summarize the relevant information regarding
the new Sub-Advisor; (b) inform shareholders that the Multi-Manager
Information Statement is available on a Web site; (c) provide the
Web site address; (d) state the time period during which the Multi-
Manager Information Statement will remain available on that Web
site; (e) provide instructions for accessing and printing the Multi-
Manager Information Statement; and (f) instruct the shareholder that
a paper or email copy of the Multi-Manager Information Statement may
be obtained, without charge, by contacting the Fund. A ``Multi-
Manager Information Statement'' will meet the requirements of
Regulation 14C, Schedule 14C and Item 22 of Schedule 14A under the
Exchange Act for an information statement, except as modified by the
requested order to permit Aggregate Fee Disclosure. Multi-Manager
Information Statements will be filed electronically with the
Commission via the EDGAR system.
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Applicants' Legal Analysis

    1. Section 15(a) of the Act provides, in relevant part, that it is
unlawful for any person to act as an investment adviser to a registered
investment company except pursuant to a written contract that has been
approved by the vote of a majority of the company's outstanding voting
securities. Rule 18f-2 under the Act provides that each series or class
of stock in a series investment company affected by a matter must
approve that matter if the Act requires shareholder approval.
    2. Form N-1A is the registration statement used by open-end
investment companies. Item 19(a)(3) of Form N-1A requires disclosure of
the method and amount of the investment adviser's compensation.
    3. Rule 20a-1 under the Act requires proxies solicited with respect
to a registered investment company to comply with Schedule 14A under
the Exchange Act. Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and
22(c)(9) of Schedule 14A, taken together, require a proxy statement for
a shareholder meeting at which the advisory contract will be voted upon
to include the ``rate of compensation of the investment adviser,'' the
``aggregate amount of the investment adviser's fees,'' a description of
the ``terms of the contract to be acted upon,'' and, if a change in the
advisory fee is proposed, the existing and proposed fees and the
difference between the two fees.
    4. Regulation S-X sets forth the requirements for financial
statements required to be included as part of a registered investment
company's registration statement and shareholder reports filed with the
Commission. Sections 6-07(2)(a), (b) and (c) of Regulation S-X require
a registered investment company to include in its financial statement
information about the investment advisory fees.
    5. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provision of the Act, or
from any rule thereunder, if such exemption is necessary or appropriate
in the public interest and consistent with the protection of investors
and the purposes fairly intended by the policy and provisions of the
Act. Applicants state that the requested relief meets this standard for
the reasons discussed below.
    6. Applicants assert that the shareholders expect each Fund's
Advisor, subject to the review and approval of the Board, to select
Sub-Advisors who are best suited to achieve the Fund's investment
objective. Applicants assert that, from the perspective of the
shareholder, the role of the Sub-Advisor is substantially equivalent to
the role of the individual portfolio managers employed by traditional
investment company advisory firms. Applicants state that requiring
shareholder approval of each Sub-Advisory Agreement would impose
unnecessary delays and expenses on the Funds, and may preclude a Fund
from acting promptly when the applicable Board and Advisor believe that
a change would benefit the Fund and its shareholders. Applicants note
that the Advisory Agreements and any sub-advisory agreement with an
Affiliated Sub-Advisor will continue to be subject to the shareholder
approval requirements of section 15(a) of the Act and rule 18f-2 under
the Act.
    7. Applicants assert that the requested disclosure relief would
benefit shareholders of the Funds because it would improve the
Advisor's ability to negotiate the fees paid to Sub-Advisors.
Applicants state that the Advisor may be able to negotiate rates that
are below a Sub-Advisor's ``posted'' amounts, if the Advisor is not
required to disclose the Sub-Advisors' fees to the public. Applicants
submit that the requested relief will encourage Sub-Advisors to
negotiate lower sub-advisory fees with the Advisor if the lower fees
are not required to be made public.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Before a Fund may rely on the order requested in the
application, the operation of the Fund in the manner described in the
application will be approved by a majority of the Fund's outstanding
voting securities, as defined in the Act, or, in the case of a Fund
whose public shareholders purchase shares on the basis of a prospectus
containing the disclosure contemplated by condition 2 below, by the
sole initial shareholder before offering the Fund's shares to the
public.

    2. The prospectus for each Fund will disclose the existence,
substance and effect of any order granted pursuant to the application.
Each Fund will hold itself out to the public as employing the Manager
of Managers Structure described in the application. The prospectus will
prominently disclose that the Advisor has ultimate responsibility
(subject to oversight by the Board) to oversee the Sub-Advisors and
recommend their hiring, termination and replacement.
    3. The Funds will inform shareholders of the hiring of a new Sub-
Advisor within 90 days after the hiring of that new Sub-Advisor
pursuant to the Modified Notice and Access Procedures.
    4. The Advisor will not enter into a Sub-Advisory Agreement with
any Affiliated Sub-Advisor without that agreement, including the
compensation to be paid thereunder, being approved by the shareholders
of the applicable Fund.
    5. At all times, at least a majority of the Board will be
Independent Trustees, and the nomination and selection of new or
additional Independent Trustees will be placed within the discretion of
the then-existing Independent Trustees.
    6. When a Sub-Advisor change is proposed for a Fund with an
Affiliated Sub-Advisor, the Board, including a majority of the
Independent Trustees, will make a separate finding, reflected in the
applicable Board minutes, that such change is in the best interests of
the Fund and its shareholders and does not involve a conflict of
interest from which the Advisor or the Affiliated Sub-Advisor derives
an inappropriate advantage.
    7. Independent legal counsel, as defined in rule 0-1(a)(6) under
the Act, will be engaged to represent the Independent Trustees. The
selection of such counsel will be within the discretion of the then
existing Independent Trustees.
    8. Each Advisor will provide the Board, no less frequently than
quarterly, with information about the profitability of the Advisor on a
per-Fund basis. The information will reflect the impact on
profitability of the hiring or termination of any Sub-Advisor during
the applicable quarter.
    9. Whenever a Sub-Advisor is hired or terminated, the Advisor will
provide the Board with information showing the expected impact on the
profitability of the Advisor.
    10. The Advisor will provide general management services to a Fund,
including overall supervisory responsibility for the general management
and investment of a Fund's assets and, subject to review and approval
of the Board, will (i) set a Fund's overall investment strategies; (ii)
evaluate, select and recommend Sub-Advisors to manage all or part of a
Fund's assets; (iii) when appropriate, allocate and reallocate a Fund's
assets among multiple Sub-Advisors; (iv) monitor and evaluate the
performance of Sub-Advisors; and (v) implement procedures reasonably
designed to ensure that the Sub-Advisors comply with a Fund's
investment objective, policies and restrictions.
    11. No trustee or officer of the Trust or of a Fund, or director,
manager or officer of the Advisor, will own directly or indirectly
(other than through a pooled investment vehicle that is not controlled
by such person) any interest in a Sub-Advisor, except for (i) ownership
of interests in the Advisor or any entity that controls, is controlled
by or is under common control with the Advisor; or (ii) ownership of
less than 1% of the outstanding securities of any class of equity or
debt of a publicly traded company that is either a Sub-Advisor or an
entity that controls, is controlled by or is under common control with
a Sub-Advisor.
    12. Each Fund will disclose in its registration statement the
Aggregate Fee Disclosure.
    13. Any new Sub-Advisory Agreement or any amendment to an existing
Advisory Agreement or Sub-Advisory Agreement that directly or
indirectly results in an increase in the aggregate advisory fee rate
payable by a Fund will be submitted to the Fund's shareholders for
approval.
    14. In the event the Commission adopts a rule under the Act
providing substantially similar relief to that in the order requested
in the application, the requested order will expire on the effective
date of that rule.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-20869 Filed 9-2-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 244 (Thursday, December 19, 2019)]
[Proposed Rules]
[Pages 69687-69688]
[FR Doc No: 2019-27271]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2019-0892]
RIN 1625-AA09

Drawbridge Operation Regulation; Hackensack River, Jersey City,
NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to modify the operating schedules
that govern the Route 1 & 9 Bridge, mile 1.8, and Route 7 Bridge, mile
3.1, both crossing the Hackensack River, at Jersey City, NJ. The bridge
owner, the New Jersey Department of Transportation (NJDOT), submitted a
request to allow two hours advance notice for nighttime transits due to
infrequent bridge openings. This proposed rule would align the advance
notice requirement for the PATH Bridge at mile 3.0.

DATES: Comments and related material must reach the Coast Guard on or
before February 18, 2020.

ADDRESSES: You may submit comments identified by docket number USCG-
2019-0892 using the Federal eRulemaking Portal at http://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Judy Leung-Yee, Project Officer, First Coast Guard
District; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
NJDOT New Jersey Department of Transportation
DHS Department of Homeland Security
FR Federal Register
OMB Office of Management and Budget
NPRM Notice of Proposed Rulemaking (Advance, Supplemental)
Sec.  Section
U.S.C. United States Code

II. Background, Purpose and Legal Basis

    The Route 1 & 9 Bridge at mile 1.8 over the Hackensack River at
Jersey City, New Jersey, has a vertical clearance of 35 feet at mean
high water and 40 feet at mean low water. Horizontal clearance is
approximately 200 feet. The waterway users include recreational and
commercial vessels including tugboat/barge combinations.
    The Route 7 Bridge at mile 3.1 over the Hackensack River at Jersey
City, New Jersey, has a vertical clearance of 35 feet at mean high
water and 40 feet at mean low water. Horizontal clearance is
approximately 158 feet. The waterway users include recreational and
commercial vessels including tugboat/barge combinations.
    The existing regulation, 33 CFR 117.5, requires both bridges open
on signal at all times. NJ DOT has requested that overnight hours
between 11 p.m. and 7 a.m. be modified to two hours advance notice.
This rule change will allow for more efficient and economic operation
of the bridge while meeting the reasonable needs of navigation. The
Coast Guard is proposing this rulemaking under authority in 33 U.S.C.
499.

III. Discussion of Proposed Rule

    The bridge logs show that between 11 p.m. and 7 a.m., the Route 1 &
9 Bridge had 27 annual openings in 2017, 12 annual openings in 2018,
and 11 annual openings to date in 2019 (through October). During the
subject hours, the Route 7 Bridge had 16 annual openings in 2017, 1
annual opening in 2018, and 0 annual openings to date in 2019. The
Coast Guard proposes to permanently modify the operating regulation.
    The proposed rule would allow that both Route 1 & 9 and Route 7
Bridges shall open on signal; except that, from 11 p.m. to 7 a.m., the
draw shall open on signal if at least two hours advance notice is given
by calling the number posted at the bridge. It is the Coast Guard's
opinion that the proposed rule meets reasonable needs of marine
traffic.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive Orders related to rulemaking. Below we summarize our
analyses based on these statutes and Executive Orders and we discuss
First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the Office of Management and Budget (OMB) has not
reviewed the NPRM and pursuant to OMB guidance, it is exempt from the
requirements of Executive Order 13771.
    The Coast Guard believes this rule is not a significant regulatory
action. The bridges will still open for all vessel traffic after a two-
hour advance notice is given during overnight periods. The vertical
clearance under both bridges in the closed position are relatively high
enough to accommodate most vessel traffic. We believe that this
proposed change to the drawbridge operation regulations at 33 CFR
117.723 will meet the reasonable needs of navigation.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    The Route 1 & 9 and Route 7 Bridges provide 35 feet of vertical
clearance at mean high water that should accommodate all the present
vessel traffic except deep draft vessels. The bridges will continue to
open on signal for any vessel, except between 11 p.m. and 7 a.m. when a
two-hour advance notice will be required. While some owners or
operators of vessels intending to transit the bridge may be small
entities, for the reasons stated in section IV.A., above, this proposed
rule would not have a significant economic impact on any vessel owner
or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121),

we want to assist small entities in understanding this proposed rule.
If the rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please contact the person listed
in the FOR FURTHER INFORMATION CONTACT, above. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
(Federalism), if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section above.

E. 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 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this
proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01, and Environmental Planning
COMDTINST 5090.1 (series), which guides the Coast Guard in complying
with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C.
4321-4370f). We have made a preliminary determination that this action
is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
proposed rule promulgates the operating regulations or procedures for
drawbridges. Normally, this action is categorically excluded from
further review, under paragraph L49, of Chapter 3, Table 3-1 of the
U.S. Coast Guard Environmental Planning Implementation Procedures.
    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal e-
Rulemaking Portal at http://www.regulations.gov. If your material
cannot be submitted using http://www.regulations.gov, contact the
person in the FOR FURTHER INFORMATION CONTACT section of this document
for alternate instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacynotice.
    Documents mentioned in this NPRM as being available in this docket
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; and Department of
Homeland Security Delegation No. 0170.1.

0
2. In Sec.  117.223, add paragraphs (j) and (k) to read as follows:

Sec.  117.723  Hackensack River.

* * * * *
    (j) The draw of the Route 1 & 9 Bridge, mile 1.8, at Jersey City,
shall open on signal; except that, from 11 p.m. to 7 a.m., the draw
shall open on signal if at least two hours advance notice is given by
calling the number posted at the bridge.
    (k) The draw of the Route 7 Bridge, mile 3.1, at Jersey City, shall
open on signal; except that, from 11 p.m. to 7 a.m., the draw shall
open on signal if at least two hours advance notice is given by calling
the number posted at the bridge.

    Dated: December 5, 2019.
R.W. Warren,
Captain, U.S. Coast Guard, Acting Commander, First Coast Guard
District.
[FR Doc. 2019-27271 Filed 12-18-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 172 (Wednesday, September 5, 2018)]
[Notices]
[Pages 45149-45152]
[FR Doc No: 2018-19240]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84002; File No. SR-CboeBZX-2018-065]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
Fees for Use on Cboe BZX Exchange, Inc.

August 30, 2018.
    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 August 16, 2018, Cboe BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') 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 Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change 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)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The Exchange filed a proposal to amend the fee schedule to
institute a new fee for the distribution of data derived from BZX Top
on third-party websites or other electronic platforms.
    The text of the proposed rule change is available at the Exchange's
website at www.markets.cboe.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to introduce a new
pricing model to keep pace with an evolving practice. Other exchanges
have pricing programs in place that allow Distributors make ``Derived
Data'' available on a website or other electronic platform that is
branded by a third party, or co-branded by a Distributor and a third
party.\5\ The

proposed rule change would implement a new pricing structure for use of
Derived Data--i.e., the BZX Derived Data White Label Service Program
(the ``Program'')--that would compete with similar programs currently
offered on other equities markets.
---------------------------------------------------------------------------

    \5\ The Nasdaq Stock Market LLC (``Nasdaq''), for example,
operates a program whereby it charges Distributors that employ a
hosted display solution to distribute Derived Data taken from its
Nasdaq Basic product. See Securities Exchange Act Release No. 79228
(November 3, 2016), 81 FR 78890 (November 9, 2016) (SR-NASDAQ-2016-
144).
---------------------------------------------------------------------------

    ``Derived Data'' is pricing data or other data that (i) is created
in whole or in part from Exchange Data, (ii) is not an index or
financial product, and (iii) cannot be readily
reverse[hyphen]engineered to recreate Exchange Data or used to create
other data that is a reasonable facsimile or substitute for Exchange
Data. The type of Derived Data subject to the proposed fee is taken
from BZX Top, which is a proprietary data product that provides top of
book quotations and execution information for all equity securities
traded on the Exchange.\6\
---------------------------------------------------------------------------

    \6\ See Rule 11.22(d).
---------------------------------------------------------------------------

    The Derived Data subject to the proposed fee is made available to
subscribers within a White Label Service which is a type of hosted
display solution in which a Distributor hosts or maintains a website or
platform on behalf of a third-party entity. The service allows
Distributors to make Derived Data available on a platform that is
branded with a third-party brand, or co-branded with a third party and
a Distributor. The Distributor maintains control of the application's
data, entitlements and display.
    The White Label Service may be used for a number of different
purposes, to be determined by the Distributor. Possible uses include
the display of information or data, or the creation of derivative
instruments, such as swaps,\7\ swaptions,\8\ or contracts for
difference.\9\ The specific use of the data will be determined by the
Distributor, as the proposed fee will not depend on the purpose for
placing the Derived Data on a White Label Service.
---------------------------------------------------------------------------

    \7\ A swap is a derivative contract in which two parties agree
to exchange financial instruments.
    \8\ A swaption, or swap option, is an option to enter into a
swap at a specified time.
    \9\ A contract for difference is an agreement to exchange the
difference between the current value of an asset and its future
value. If the price increases, the seller pays the buyer the amount
of the increase. If the price decreases, the buyer pays the seller
the amount of the decrease.
---------------------------------------------------------------------------

    As proposed, a Distributor that provides a White Label Service for
Derived Data taken from BZX Top is liable for the following fees
instead of the fees normally applicable for the distribution of BZX
Top. First, instead of the regular fee for external distribution,
Distributors would be charged a tiered External Subscriber Fee based on
the number of White Label Service Platforms (i.e., ``External
Subscribers'') that receive Derived Data from the Distributor through a
White Label Service. Specifically, Distributors would be charged a fee
of: (1) $300 per month for each External Subscriber if the Distributor
makes Derived Data available to 1-5 External Subscribers; (2) $250 per
month for each External Subscriber if the Distributor makes Derived
Data available to 6-10 External Subscribers; and (3) $200 per month for
each External Subscriber if the Distributor makes Derived Data
available to 11 or more External Subscribers. The External Subscriber
Fee is non-progressive and, as mentioned above, is based on the number
of External Subscribers that receive Derived Data from the Distributor.
For example, a Distributor providing Derived Data based on BZX Top to
six External Subscribers would be charged a monthly fee of $1,500
(i.e., 6 External Subscribers x $250 each). Second, the Exchange would
charge a monthly Professional User fee of $4 per month for each
Professional User, which is equivalent to the current Professional User
fee for external distribution of BZX Top. There would be no monthly
Non-Professional User fee for accessing Derived Data through a White
Label Service.
    The Program is entirely optional, in that it applies only to
Distributors that opt to use Derived Data from BZX Top to create a
White Label Service, as described herein. It does not impact or raise
the cost of any other Exchange product, nor does it affect the cost of
BZX Top, except in instances where Derived Data is made available on a
White Label Service. A Distributor that provides a White Label Service
for BZX Top data that is not Derived Data or distributes Derived Data
through a platform other than a White Label Service would be liable for
the fees normally applicable for the distribution of BZX Top.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\10\ in general, and
furthers the objectives of Section 6(b)(4),\11\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its members and other recipients of
Exchange data. The Exchange believes that the proposed rates are
equitable and non-discriminatory in that they apply uniformly to all
recipients of Exchange data. The Exchange believes the proposed fees
are competitive with those charged by other venues and, therefore,
reasonable and equitably allocated to recipients.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f.
    \11\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange also believes that the proposed rule change is
consistent with Section 11(A) of the Act \12\ in that it supports (i)
fair competition among brokers and dealers, among exchange markets, and
between exchange markets and markets other than exchange markets and
(ii) the availability to brokers, dealers, and investors of information
with respect to quotations for and transactions in securities.
Furthermore, the proposed rule change is consistent with Rule 603 of
Regulation NMS,\13\ which provides that any national securities
exchange that distributes information with respect to quotations for or
transactions in an NMS stock do so on terms that are not unreasonably
discriminatory. In adopting Regulation NMS, the Commission granted
self-regulatory organizations and broker-dealers increased authority
and flexibility to offer new and unique market data to the public. It
was believed that this authority would expand the amount of data
available to consumers, and also spur innovation and competition for
the provision of market data.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78k-1.
    \13\ See 17 CFR 242.603.
---------------------------------------------------------------------------

    The Exchange notes that the Commission is not required to undertake
a cost-of-service or rate-making approach. The Exchange believes that,
even if it were possible as a matter of economic theory, cost-based
pricing for non-core market data would be so complicated that it could
not be done practically.\14\
---------------------------------------------------------------------------

    \14\ The Exchange believes that cost-based pricing would be
impractical because it would create enormous administrative burdens
for all parties, including the Commission, to cost-regulate a large
number of participants and standardize and analyze extraordinary
amounts of information, accounts, and reports. In addition, it is
impossible to regulate market data prices in isolation from prices
charged by markets for other services that are joint products. Cost-
based rate regulation would also lead to litigation and may distort
incentives, including those to minimize costs and to innovate,
leading to further waste. Under cost-based pricing, the Commission
would be burdened with determining a fair rate of return, and the
industry could experience frequent rate increases based on
escalating expense levels. Even in industries historically subject
to utility regulation, cost-based ratemaking has been discredited.
As such, the Exchange believes that cost-based ratemaking would be
inappropriate for proprietary market data and inconsistent with
Congress's direction that the Commission use its authority to foster
the development of the national market system, and that market
forces will continue to provide appropriate pricing discipline. See
Appendix C to NYSE's comments to the Commission's 2000 Concept
Release on the Regulation of Market Information Fees and Revenues,
which can be found on the Commission's website at http://www.sec.gov/rules/concept/s72899/buck1.htm. See also Securities
Exchange Act Release No. 73816 (December 11, 2014), 79 FR 75200
(December 17, 2014) (SR-NYSE-2014-64) (Notice of Filing and
Immediate Effectiveness of Proposed Rule Change to Establish an
Access Fee for the NYSE Best Quote and Trades Data Feed, Operative
December 1, 2014).

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

    The Exchange believes that the introduction of a fee for the use of
Derived Data on White Label Services is reasonable because: (i) All
proprietary data fees are constrained by the Exchange's need to compete
for order flow; and (ii) proprietary data fees are subject to market
competition from substitute products. The proposed rule change would
provide an alternate fee structure for providing BZX Top market data to
Distributors that make Derived Data available to External Subscribers
on White Label Services. The Exchange believes that this will encourage
additional Distributors to subscribe to BZX Top market data due to the
lower cost associated with Derived Data provided under the Program.
Nasdaq already has a similar pricing structure in place for providing
Derived Data through a hosted display solution.\15\ The Exchange
believes that Distributors of BZX Top market data would benefit from a
similar solution. Furthermore, the proposed fees are lower than those
currently in place on Nasdaq, which charges a fee of $400 per month for
each hosted display solution under their program,\16\ and may be
further lowered for Distributors of BZX Top Derived Data based on the
number of External Subscribers.
---------------------------------------------------------------------------

    \15\ See supra note 5.
    \16\ Id.
---------------------------------------------------------------------------

    As proposed, if a Distributor uses a White Label Service to display
Derived Data, the Distributor will be charged a fee that is tiered
based on the number of External Subscribers that are provided access to
that data instead of the higher fee normally charged for external
distribution. The Exchange believes that this fee is equitable and not
unfairly discriminatory because the Exchange will apply the same fees
to all similarly situated Distributors based on the number of External
Subscribers provided access to Derived Data through a White Label
Service. Furthermore, the proposed fees will only apply to Distributors
that elect to participate in the Program by distributing Derived Data
through a White Label Service. BZX Top market data is distributed and
purchased on a voluntary basis, in that neither the Exchange nor market
data distributors are required by any rule or regulation to make this
data available. Distributors of BZX Top are not required to participate
in the proposed Program, which is merely an alternative option being
proposed by the Exchange to potentially lower costs for market data
that is Derived Data. Accordingly, Distributors can discontinue use at
any time and for any reason, including due to an assessment of the
reasonableness of fees charged. Firms have a wide variety of
alternative market data products from which to choose, such as similar
proprietary data products offered by other exchanges and consolidated
data. Moreover, the Exchange is not required to make any proprietary
data products available or to offer any specific pricing alternatives
to any customers.
    In addition to the tiered distribution fee described above, the
Exchange will continue to charge a small fee for Professional Users but
would eliminate Non-Professional User fees for data provided under the
Program. The Exchange believes that it is equitable and not unfairly
discriminatory to charge a fee for Professional Users but no fee for
Non-Professional Users. Non-Professional Users are already subject to a
heavily discounted fee for BZX Top market data relative to Professional
Users. Differential fees for Professional and Non-Professional Users
are widely used by the Exchange and other exchanges for their
proprietary market data as this reduces costs for retail investors and
makes market data more broadly available.
    In addition, the fees that are the subject of this rule filing are
constrained by competition. As explained below in the Exchange's
Statement on Burden on Competition, the existence of alternatives to
the proposed program further ensures that the Exchange cannot set
unreasonable fees, or fees that are unreasonably discriminatory, when
subscribers can elect such alternatives. That is, the Exchange competes
with other exchanges and their affiliates that provide similar market
data products. If another exchange or its affiliate were to charge less
for a similar product than the Exchange charges under the proposed fee
structure, prospective subscribers likely would not subscribe to, or
would cease subscribing to, the Program.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
Exchange's ability to price this data product is constrained by: (i)
Competition among exchanges, other trading platforms, and Trade
Reporting Facilities (``TRF'') that compete with each other in a
variety of dimensions; (ii) the existence of inexpensive real-time
consolidated data and market-specific data and free delayed data; and
(iii) the inherent contestability of the market for proprietary data.
    The Exchange and its market data products are subject to
significant competitive forces and the proposed fees represent
responses to that competition. To start, the Exchange competes
intensely for order flow. It competes with the other national
securities exchanges that currently trade equities, with electronic
communication networks, with quotes posted in FINRA's Alternative
Display Facility, with alternative trading systems, and with securities
firms that primarily trade as principal with their customer order flow.
    The proposed fees apply to data derived from BZX Top, which is
subject to competition from the Nasdaq, NYSE, and other exchanges that
offer similar products, including exchanges that provide similar
pricing options for Derived Data made available on a White Label
Service. In sum, the availability of a variety of alternative sources
of information imposes significant competitive pressures on Exchange
data products and the Exchange's compelling need to attract order flow
imposes significant competitive pressure on the Exchange to act
equitably, fairly, and reasonably in setting the proposed data product
fees. The proposed data product fees are, in part, responses to that
pressure. The Exchange believes that the proposed fees would reflect an
equitable allocation of its overall costs to users of its facilities.
    In addition, when establishing the proposed fees, the Exchange
considered the competitiveness of the market for proprietary data and
all of the implications of that competition. The Exchange believes that
it has considered all relevant factors and has not considered
irrelevant factors in order to establish fair, reasonable, and not
unreasonably discriminatory fees and an equitable allocation of fees
among all subscribers. The existence of alternatives to BZX Top,
including existing similar feeds by other exchanges, consolidated data,
and proprietary data from other sources, ensures that the Exchange
cannot set unreasonable fees, or fees that are unreasonably
discriminatory, when subscribers can elect these alternatives or choose
not to purchase a specific proprietary data product if its cost to

purchase is not justified by the returns any particular vendor or
subscriber would achieve through the purchase.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \17\ and paragraph (f) of Rule 19b-4
thereunder.\18\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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 protected]. Please include
File Number SR-CboeBZX-2018-065 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CboeBZX-2018-065. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of this filing will also be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeBZX-2018-065 and should be submitted
on or before September 26, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-19240 Filed 9-4-18; 8:45 am]
BILLING CODE 8011-01-P


Creosote TWF Chemical Name Chemical Used CAS Number 12/ 04 TWF 08/ 04 TWF low high avg 12/ 04 08/ 04 acenaphthene Acenaphthene 83329 0.032569744 0.02902041 9% 14.7% 11.85% 0.00386 0.003439 antracene Anthracene 120127 2.545594545 2.546283079 2% 7% 4.5% 0.114552 0.114583 benz( a) anthracene Benzo( a) anthracene 56553 36.26 180.9752 0.16% 0.26% 0.21% 0.076146 0.380048 benzo( a) pyrene Benzo( a) pyrene 50328 100.66 4283.56 0.04% 0.06% 0.05% 0.05033 2.14178 benzofluourenes Benzofluorene, 2,3 243174 0.155555556 0.155555556 1% 2% 1.5% 0.002333 0.002333 biphenyl Biphenyl 92524 0.036555826 0.028882226 0.8% 1.6% 1.2% 0.000439 0.000347 carbazole Carbazole 86748 0.709070997 0.267310997 1.2% 2% 1.6% 0.011345 0.004277 chrysene Chrysene 218019 31.01 2.103752 2.6% 3% 2.8% 0.86828 0.058905 dibenz( a, h) anthtracene Dibenzo( a, h) anthracene 53703 30.66 1693.016 0.01% 0.04% 0.03% 0.007665 0.423254 dibenzofuran Dibenzofuran 132649 0.49215 0.19537 4% 8% 5.75% 0.028299 0.011234 dimethylnaphthalenes 2% 2% 2.15% 0 0 fluoranthene Fluoranthene 206440 0.828982394 0.803682394 0.5% 10% 5.25% 0.043522 0.042193 fluorene Fluorene 86737 0.70105 0.703744 7.3% 10% 8.65% 0.060641 0.060874 methylantracenes 3.9% 4% 3.95% 0 0 methylfluorenes Methylfluorene, 1 1730376 0.048695652 0.048695652 2.3% 3% 2.65% 0.00129 0.00129 1 methylnaphthalene Methylnaphthalene, 1 90120 0.006222222 0.006222222 0.9% 12% 6.45% 0.000401 0.000401 2 methylnaphthalene* Methylnaphthalene, 2 91576 0.193049257 0.080145257 1.2% 12% 6.6% 0.012741 0.00529 methylphenanthrenes Methylphenanthrene, 1 832699 0.103703704 0.103703704 3% 3% 3% 0.003111 0.003111 naphthalene Naphthalene 91203 0.015870135 0.015408135 1.3% 18% 9.65% 0.001531 0.001487 phenanthrene Phenanthrene 85018 0.294736842 0.294736842 16% 21% 18.5% 0.054526 0.054526 pyrene Pyrene 129000 0.093203279 0.111043279 1% 8.5% 4.75% 0.004427 0.005275 Total 60.21% 141.96% 101.085% 1.34544 3.314647 TWF for Creosote Note: All chemicals have the same TWF without RSC.

Note: Normalized TWF was calculated using avg/ 100, not avg/ 101.085 *  Value for 08/ 04 varies from one used in Creosote TWF. xls of 0.008235 1Typical composition of creosote from IARC Monographs, Vol 35,

" Coal Tar and Derived Products"

as cited in EPA 1991 PDS Percent in Creosote1 Fraction of TWF


[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)]
[Notices]
[Page 64814]
[FR Doc No: 2018-27311]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1250-000]

City of Pasadena, California; Notice of Authorization for
Continued Project Operation

    On December 29, 2016, City of Pasadena, California, licensee for
the Azusa Hydroelectric Project, filed an Application for an Exemption
from Licensing pursuant to the Federal Power Act (FPA) and the
Commission's regulations thereunder. The Azusa Hydroelectric Project is
located on the Azusa Conduit in Los Angeles County, California.
    The license for Project No. 1250 was issued for a period ending
December 31, 2018. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 1250 is issued to
the licensee for a period effective January 1, 2019 through December
31, 2019, or until the issuance of a new license for the project or
other disposition under the FPA, whichever comes first. If issuance of
a new license (or other disposition) does not take place on or before
December 31, 2019, notice is hereby given that, pursuant to 18 CFR
16.18(c), an annual license under section 15(a)(1) of the FPA is
renewed automatically without further order or notice by the
Commission, unless the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that the licensee, City of Pasadena, California, is
authorized to continue operation of the Azusa Hydroelectric Project,
until such time as the Commission acts on its Surrender of License and
application for (conduit) Exemption from Licensing.

    Dated: December 12, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-27311 Filed 12-17-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Notices]
[Pages 63488-63490]
[FR Doc No: 2018-26640]

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

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 Number: PR19-19-000.
    Applicants: Southern California Gas Company.
    Description: Tariff filing per 284.123(b),(e)+(g): Offshore
Delivery service rate increase filing 11-28 to be effective 11/28/2018.
    Filed Date: 11/29/18.
    Accession Number:<PHONE_NUMBER>00.
    Comments Due: 5 p.m. ET 12/20/18.
    284.123(g) Protests Due: 5 p.m. ET 1/28/19.

    Docket Number: PR19-20-000.
    Applicants: Louisville Gas and Electric Company.
    Description: Tariff filing per 284.123(b),(e)/: Revised Statement
of Operating Conditions Revised TCJA Surcredit to be effective 12/1/
2018.
    Filed Date: 11/29/18.
    Accession Number:<PHONE_NUMBER>49.
    Comments/Protests Due: 5 p.m. ET 12/20/18.

    Docket Number: PR19-21-000.
    Applicants: Aethon United Pipeline LP.
    Description: Tariff filing per 284.123(b)(2)+(g): Aethon Rate
Petition to be effective 12/1/2018.
    Filed Date: 11/30/18.
    Accession Number:<PHONE_NUMBER>25.
    Comments Due: 5 p.m. ET 12/21/18.
    284.123(g) Protests Due: 5 p.m. ET 1/29/19.

    Docket Numbers: RP19-324-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated rate--Yankee to
Direct Energy 798289 to be effective 11/29/2018.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5002.

    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-325-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Bay to UGI
798295 eff 12-1-18 to be effective 12/1/2018.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5037.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-326-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--CNX to BP
Energy 960023 to be effective 12/1/2018.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5044.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-327-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--BP to BP
Canada 960024 to be effective 12/1/2018.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5053.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-328-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Rate Schedule S-2 Tracker
Filing (ASA) eff 12/1/2018 to be effective 12/1/2018.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5056.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-329-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: Compliance filing TSCA--Informational Filing (11/29/
18).
    Filed Date: 11/29/18.
    Accession Number: 20181129-5062.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-330-000.
    Applicants: Young Gas Storage Company, Ltd.
    Description: Sec.  4(d) Rate Filing: Annual Reimbursement
Percentage Update Filing to be effective 1/1/2019.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5066.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-331-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Annual Fuel and L&U Filing
2019 to be effective 1/1/2019.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5073.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-332-000.
    Applicants: Dominion Energy Questar Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: FGRP 2019 to be effective 1/1/
2019.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5106.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-333-000.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: LUF Quarterly Update Filing to
be effective 1/1/2019.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5107.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-334-000.
    Applicants: Mojave Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Annual Fuel and L&U Filing
2019 to be effective 1/1/2019.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5116.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-335-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Article 11.2(a) Inflation
Adjustment Filing 2019 to be effective 1/1/2019.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5120.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-336-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Nextera and
ConocoPhillips to be effective 12/1/2018.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5127.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-337-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 112918 Negotiated Rates--Twin
Eagle Resource Management, LLC H-7300-89 to be effective 12/1/2018.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5126.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-338-000.
    Applicants: Sierrita Gas Pipeline LLC.
    Description: Operational Purchases and Sales Report of Sierrita Gas
Pipeline LLC under RP19-338.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5151.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-339-000.
    Applicants: Chandeleur Pipe Line, LLC, Chandeleur Pipe Line LLC.
    Description: Fuel and Line Loss Allowance Calculation of Chandeleur
Pipe Line, LLC under RP19-339.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5152.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-340-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Sec.  4(d) Rate Filing: New Service Agreement Ascend
filed 11-29-18 to be effective 12/1/2018.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5187.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-341-000.
    Applicants: Florida Gas Transmission Company, LLC.
    Description: Sec.  4(d) Rate Filing: Update Non-Conforming List
(Ascend) Filing on 11-29-18 to be effective 12/1/2018.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5190.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-342-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreements
Filing (ETC, EOG, TRMC Dec 18) to be effective 12/1/2018.
    Filed Date: 11/29/18.
    Accession Number: 20181129-5235.
    Comments Due: 5 p.m. ET 12/11/18.

    Docket Numbers: RP19-343-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: TETLP 2018 Rate Case Filing to
be effective 1/1/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5003.
    Comments Due: 5 p.m. ET 12/12/18.

    Docket Numbers: RP19-344-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement--
Spire LPS 12/1/2018 to be effective 12/1/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5026.
    Comments Due: 5 p.m. ET 12/12/18.

    Docket Numbers: RP19-345-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Hess 2019 Tioga Usage Charge
Filing to be effective 1/1/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5027.
    Comments Due: 5 p.m. ET 12/12/18.

    Docket Numbers: RP19-346-000.
    Applicants: Nautilus Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Nautilus FT-2 Form of Service
modification to be effective 1/1/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5031.
    Comments Due: 5 p.m. ET 12/12/18.

    Docket Numbers: RP19-347-000.
    Applicants: MarkWest Pioneer, L.L.C.
    Description: Sec.  4(d) Rate Filing: Quarterly Fuel Adjustment
Filing to be effective 1/1/2019.

    Filed Date: 11/30/18.
    Accession Number: 20181130-5034.
    Comments Due: 5 p.m. ET 12/12/18.

    Docket Numbers: RP19-348-000.
    Applicants: Rover Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Summary of Negotiated Rate
Capacity Relealse Agreements on 11-30-18 to be effective 12/1/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5052.
    Comments Due: 5 p.m. ET 12/12/18.

    Docket Numbers: RP19-349-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Chesapeake to
Tenaska 960030 eff 12-1-18 to be effective 12/1/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5062.
    Comments Due: 5 p.m. ET 12/12/18.

    Docket Numbers: RP19-350-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Compliance filing 2018 Refund Report--Texas Eastern
OFO Penalty Sharing (Rate Schedule S-2).
    Filed Date: 11/30/18.
    Accession Number: 20181130-5065.
    Comments Due: 5 p.m. ET 12/12/18.

    Docket Numbers: RP19-351-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: eTariff filing per 1430: Petition for an Extension of
Time to File FERC Form 501-G.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5076.
    Comments Due: 5 p.m. ET 12/4/18.

    Docket Numbers: RP19-352-000.
    Applicants: Sea Robin Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Sea Robin Section 4 Rate Case
to be effective 1/1/2019.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5078.
    Comments Due: 5 p.m. ET 12/12/18.

    Docket Numbers: RP19-353-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Cherokee
AGL--Replacement Shippers--Dec 2018 to be effective 12/1/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5081.
    Comments Due: 5 p.m. ET 12/12/18.

    Docket Numbers: RP19-354-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: 2018 December Negotiated Rate
Amendment to be effective 12/1/2018.
    Filed Date: 11/30/18.
    Accession Number: 20181130-5113.
    Comments Due: 5 p.m. ET 12/12/18.

    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 date(s). 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: November 30, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-26640 Filed 12-7-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Notices]
[Pages 17076-17077]
[FR Doc No: 2012-6961]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0274]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Adverse Event Reporting and Recordkeeping for Dietary
Supplements as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
associated with adverse event reporting and recordkeeping for dietary
supplements as required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act (the DSNDCPA).

DATES: Submit either electronic or written comments on the collection
of information by May 22, 2012.

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

FOR FURTHER INFORMATION CONTACT:  Denver Presley, II, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Adverse Event Reporting and Recordkeeping for Dietary Supplements as
Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act --21 U.S.C. 379aa-1(b)(1) (OMB Control Number 0910-
0635)--Extension

    The DSNDCPA (Public Law 109-462, 120 Stat. 3469) amends the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) with respect to serious
adverse event reporting and recordkeeping for dietary supplements and
nonprescription drugs marketed without an approved application. Section
761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1)) requires the
manufacturer, packer, or distributor whose name (under section
403(e)(1) of the FD&C Act (21 U.S.C. 343(e)(1))) appears on the label
of a dietary supplement marketed in the United States to submit to FDA
all serious adverse event reports associated with the use of a dietary
supplement, accompanied by a copy of the product label. The
manufacturer, packer, or distributor of a dietary supplement is
required by the DSNDCPA to use the MedWatch form (FDA 3500A) when
submitting a serious adverse event report to FDA. In addition, under
section 761(c)(2) of the FD&C Act, the submitter of the serious adverse
event report (referred to in the statute as the ``responsible person'')
is required to submit to FDA a followup report of any related new
medical information the responsible person receives within 1 year of
the initial report.
    Section 761(e)(1) of the FD&C Act (21 U.S.C. 379aa-1(e)(1))
requires that responsible persons maintain records related to the
dietary supplement adverse event reports they receive, whether or not
the adverse event is serious. Under the statute, the records must be
retained for a period of 6 years.
    As required by section 3(d)(3) of the DSNDCPA, FDA issued guidance
to describe the minimum data elements for serious adverse event reports
for dietary supplements. In the Federal Register of July 14, 2009 (74
FR 34024), FDA announced the availability of guidance entitled
``Guidance for Industry: Questions and Answers Regarding Adverse Event
Reporting and Recordkeeping for Dietary Supplements as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act.''
The guidance discusses how, when, and where to submit serious adverse
event reports for dietary supplements and followup reports. The
guidance also provides FDA's recommendation on records maintenance and
access for serious and non-serious adverse event reports and related
documents.
    The guidance recommends that the responsible person document its
attempts to obtain the minimum data elements for a serious adverse
event report. Along with these records, the guidance recommends that
the responsible person keep the following other records: (1)
Communications between the responsible person and the initial reporter
of the adverse event and between the responsible person and any other
person(s) who provided information about the adverse event, (2) the
responsible person's serious adverse event report to FDA with
attachments, (3) any new information about the adverse event received
by the responsible person, and (4) any reports to FDA of new
information related to the serious adverse event report.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
        21 U.S.C. Section            Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
21 U.S.C. 379aa-1(b)(1)--Serious             480              17           8,160               2          16,320
 adverse event reports for
 dietary supplements............
21 U.S.C. 379aa-1(c)(2)--                    120              17           2,040               1           2,040
 Followup reports of new medical
 information....................
                                                                                ---------------
                                  ..............  ..............  ..............  ..............          18,360
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This estimate is based on FDA's experience with similar adverse
event reporting programs and the number of serious adverse event
reports and followup reports received in the past 2 years. All dietary
supplement manufacturers, packers, or distributors are subject to
serious adverse event mandatory reporting. In 2007, we estimated in the
final rule entitled ``Current Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements'' (72 FR 34752, June 25, 2007) that there were 1,460 such
firms. FDA estimates that, in 2012, there are approximately 1,600 such
firms, based on the estimate of 1,460 provided in the rule, with a two
to three percent annual rate of growth applied.
    FDA received 830 initial serious adverse event reports in FY2010.
The number of reports more than doubled to 1,777 in FY2011. We expect
this trend to continue and, in fact, increase due to continued industry
compliance with mandatory reporting rules. Based on this, FDA expects
to receive over the next 3 years an increasing number of reports per
year: We estimate that we will receive 3,500 in 2012; 7,000 in 2013;
and 14,000 in 2014; for an annual average of 8,166.66 per year, rounded
to 8,160. Based on the Agency's records, the average number of initial
reports per year on a per firm basis during 2010 and 2011 was 17. Thus,
FDA estimates that, on average over the next 3 years, 480 firms will
file 17 initial dietary supplement serious adverse event reports, for a
total of 8,160 total annual responses.
    FDA estimates that it will take respondents an average of 2 hours
per report to collect information about a serious adverse event
associated with a dietary supplement and report the information to FDA
on Form FDA 3500A. Thus, the estimated total annual hour burden of
initial dietary supplement serious adverse event reports is 16,320
hours (8,160 responses x 2 hours) as shown in row 1 of Table 1.
    If a respondent that has submitted a serious adverse event report
receives new information related to the serious adverse event within 1
year of submitting the initial report, the respondent must provide the
new information to FDA in a followup report. FDA estimates that 25
percent of serious adverse event reports related to dietary supplements
will have a followup report submitted, resulting in approximately 2,040
followup reports submitted annually (8,160 x 0.25 = 2,040). Assuming
that 25 percent of submitters of initial reports will submit followup
reports (480 x 0.25 = 120) and the average number of followup reports
per year per firm to be 17, FDA estimates that, on average over the
next 3 years, 120 firms will file 17 followup reports, for a total of
2,040 total annual responses. We estimate that each followup report
will require an hour to assemble and submit, including the time needed
to copy and attach the initial serious adverse event report as
recommended in the guidance. The estimated total annual hour burden for
followup reports of new information is 2,040 hours (2,040 responses x 1
hour) as shown in row 2 of Table 1.
    The total reporting hour burden is 18,360 hours, which equals the
burden for the mandatory reports (16,320) plus the burden for the
followup new information (2,040).

                                                     Table 2--Estimated Annual Recordkeeping Burden1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of
               21 U.S.C. Section                    Number of       records per      Total annual    Average  burden per  recordkeeping    Total hours
                                                  recordkeepers     recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dietary Supplement Adverse Event Records (21              1,600               74          118,400   0.5 (30 minutes)...................          59,200
 U.S.C. 379aa-1(e)(1)).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    All 1,600 dietary supplement manufacturers, packers, or
distributors, are subject to serious adverse event mandatory
recordkeeping, thus FDA estimates that there are a total of 1,600
recordkeepers. FDA further estimates that each recordkeeper will keep
approximately 74 records per year, for a total of 118,400 records. The
Agency estimates that assembling and filing these records, including
any necessary photocopying, will take approximately 30 minutes, or 0.5
hours, per record. Therefore, 118,400 records x 0.50 hours = 59,200
total hours. FDA bases its estimates on its experience with similar
adverse event reporting programs.
    Once the documents pertaining to an adverse event report have been
assembled and filed under the Safety Reporting Portal, FDA expects the
records retention burden to be minimal, as the Agency believes most
establishments would normally keep this kind of record for at least
several years after receiving the report, as a matter of usual and
customary business practice.

    Dated: March 19, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6961 Filed 3-22-12; 8:45 am]
BILLING CODE 4160-01-P


Lydia Wegman/RTP/USEPA/US

06/17/2008 03:07 PM

To

"Sarah Rudolf"<EMAIL_ADDRESS> cc

<EMAIL_ADDRESS>"Jonathan Nwagbaraocha" <EMAIL_ADDRESS>"Ruth Ann Norton"<EMAIL_ADDRESS><EMAIL_ADDRESS>Tricia Crabtree/RTP/USEPA/US@EPA

Subject

Re: Baltimore leadsafe demolition info

Sarah,

Thanks very much for sending this to me and Jan.   We had wanted more information about the type of air monitoring that was done during demolition.  The paragraph in the document you sent does not provide any specific information about what monitors were used nor what kind of data the monitors collected during the demolition.  Do you have any other documents that provide specific information on those points?  Thanks again.

Lydia

"Sarah Rudolf"<EMAIL_ADDRESS> 06/17/2008 10:39 AM

To

Lydia Wegman/RTP/USEPA/US@EPA, <EMAIL_ADDRESS> cc

"Jonathan Nwagbaraocha"<EMAIL_ADDRESS>"Ruth Ann Norton" <EMAIL_ADDRESS> Subject

Baltimore leadsafe demolition info

Hello Lydia and Jan,

I am writing to follow up on last week’s NAAQS hearing and the request that the Coalition send additional air quality information to EPA for its consideration.

One of my first major projects at the Coalition was to compile the demolition protocol used in the East Baltimore Development, Inc. project, which can now be found online here http://www.ebdi.org/docs/Demolition%20Protocol.pdf

EBDI later engaged an independent advisory panel to serve as a third party expert and intermediary to ensure that the community was receiving accurate and scientifically-sound information in an appropriate and community-minded manner.  The panel found that the new protocol served to protect residents from potentially harmful levels of lead in air related to demolition by taking proactive and preventive steps prior to, during, and after active demolition.  I’ve attached the findings of the panel to this email for your reference.

It is our pleasure to share this information with EPA for its consideration and please do not hesitate to contact us should we be able to be of further assistance in this matter.

Regards,

Sarah Rudolf, MPP

Special Advisor, Policy & Strategic Development

Coalition to End Childhood Lead Poisoning

NEW Phone<PHONE_NUMBER>

Cell<PHONE_NUMBER>

Email<EMAIL_ADDRESS> Web www.leadsafe.org

To support the work of the Coalition, donate online at www.leadsafe.org - Thank you.

The Coalition to End Childhood Lead Poisoning ("CECLP") is a 501(c)(3) non-profit organization. Contributions to CECLP

are tax deductible to the extent permitted by law. A copy of our financial statement is available upon request. Documents

and information submitted to the State of Maryland under the Maryland Charitable Solicitation Act are available from the

Office of the Secretary of State for the cost of copying and postage. The information contained in this email may be

confidential and/or legally privileged. It has been sent for the sole use of the intended recipient(s). If the reader of this

message is not an intended recipient, you are hereby notified that any unauthorized review, use, disclosure, dissemination,

distribution, or copying of this communication, or any of its contents, is strictly prohibited. If you have received this

communication in error, please contact the sender by reply email and destroy all copies of the original message. To

contact our email administrator directly, send to <EMAIL_ADDRESS> Please consider the environment before printing this email.


[Federal Register: September 25, 2007 (Volume 72, Number 185)]
[Notices]
[Page 54440]
[DOCID:fr25se07-38]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RC07-7-000]

Strategic Energy, L.L.C.; Notice of Filing

September 18, 2007.
    Take notice that on September 11, 2007, Strategic Energy, L.L.C.
(Strategic Energy), submitted an appeal disputing its inclusion on the
North American Electric Reliability Corporation (NERC) within
ReliabilityFirst Corporation as a load serving entity. Strategic Energy
is concurrently filing a Request for Expedited Consideration.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is 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 docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on October 11, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-18836 Filed 9-24-07; 8:45 am]

BILLING CODE 6717-01-P