[Federal Register Volume 76, Number 10 (Friday, January 14, 2011)]
[Notices]
[Pages 2744-2745]
[FR Doc No: 2011-753]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Disclosure of Code-Share Service by Air Carriers and Sellers of
Air Transportation

AGENCY: Office of the Secretary, Department of Transportation.

ACTION: Notice.

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SUMMARY: The Department is publishing the following notice on the
enforcement of its rules relating to disclosure of code-share service
on Internet Web sites and elsewhere by air carriers, their agents, and
third party sellers of air transportation in view of recent amendments
to 49 U.S.C. 41712.

FOR FURTHER INFORMATION CONTACT: Nicholas Lowry, Attorney, Office of
Aviation Enforcement and Proceedings (C-70), 1200 New Jersey Ave., SE.,
Washington, DC 20590,<PHONE_NUMBER>.

United States of America, Department of Transportation, Office of the
Secretary, Washington, DC

Guidance on Disclosure of Code-Share Service Under Recent Amendments to
49 U.S.C. 41712

Notice
    This notice is intended to provide guidance on the disclosure of
code-share service in light of recent amendments to 49 U.S.C. 41712. It
is also intended to provide a reminder to ticket agents with respect to
their code-share disclosure responsibility, particularly as it concerns
the development and provision of Internet Web sites (Web sites) that
display code-share flights and to air carriers regarding their
responsibilities in connection with the Web sites of their agents.
    A recent amendment to section 41712, which has for some time
contained a general prohibition against unfair and deceptive practices
and unfair methods of competition on the part of air carriers, foreign
air carriers and ticket agents, added a new section 41712(c) that
specifically requires that these entities disclose in any oral, written
or electronic communication to the public, prior to the purchase of a
ticket, the name of the carrier providing the service for each segment
of a passenger's itinerary. The language is principally intended to
address service rendered pursuant to code-share arrangements. In
addition, the new language explicitly requires that on Web sites,
disclosure must be made ``on the first display of the Web site
following a search of a requested itinerary in a format that is easily
visible to a viewer.'' Airline Safety and Federal Aviation
Administration Extension Act of 2010, Public Law 111-216, Title II,
Sec.  210, 124 Stat. 2362, Aug. 1, 2010.
    The Department's current regulation on the disclosure of code-
sharing arrangements, 14 CFR part 257, which was issued in 1999, is
based on the general unfair and deceptive practice language of section
41712. Section 257.5(a) requires, in all Web sites and other publicly
available displays of schedule information, that code-share service be
indicated with ``an asterisk or other easily identifiable mark and that
the corporate name of the transporting carrier and any other name under
which that service is held out to the public is also disclosed.'' As
with the recently amended statutory language, the rule requires that in
oral communications with the public, ticket agents must inform the
consumer of the code-share service ``before booking transportation''
and state ``the name of the transporting

carrier by its corporate name and any other name under which that
service is held out to the public.'' (Section 257.5(b)) Written notice
of code-share service is also required where an itinerary is issued.
(Section 257.5(c)(1)) In printed advertisements, including those
published via a Web site, the code-share relationship must be
``prominently'' disclosed and an abbreviated notice must be included in
any radio or television advertisement. (For a recent enforcement
interpretation of this requirement, see Order 2010-7-4, Delta Air
Lines, Inc., and Northwest Airlines, Inc., and Order 2009-7-6, United
Air Lines, Inc., July 7, 2009.) With regard to Web sites, we have, as a
matter of enforcement policy, not pursued enforcement action in cases
where disclosure of an operating carrier's corporate name and other
pertinent names was provided through rollover or hyperlinked displays.
On the other hand, we have pursued enforcement action where neither
such disclosure nor direct disclosure of the operating carrier's name
or names was provided.
    The amended language of section 41712 makes explicit that the
disclosure of code-share service, in the context of Web site displays,
must be included in any schedule displayed in response to an itinerary
request by a consumer. To be ``easily visible,'' the disclosure should
be on the same screen as the itinerary and immediately adjacent to that
itinerary and to each alternative itinerary, if applicable. Nothing in
section 41712(c) would permit code-share disclosure to be made through
a hyperlink or rollover. Code-share service may be highlighted by an
asterisk or other mark, but should still include appropriate text on
the itinerary display that is easily visible to a viewer, identifying
the operating carrier by its corporate name. Because of this new
statutory provision, we intend to pursue enforcement action in the
future where the only code-share disclosure is by rollover or
hyperlinked displays.
    To avoid the initiation of enforcement action in the future, air
carriers, foreign air carriers, and their ticket agents, including
independent Web site vendors, are advised to promptly modify their
practices to conform to these statutory disclosure requirements. In
view of the fact that Web site sellers will need a period in which to
modify their Web site displays, the Aviation Enforcement Office will
not begin to enforce the new statutory provision until 60 days after
the date of publication of this notice. During the intervening period,
we will continue to pursue enforcement action against sites which fail,
at a minimum, to provide full disclosure of the operating carrier's
required name or names through hyperlinks or rollovers.
    By this notice we are also reminding air carriers of their general
responsibility regarding the advertising practices of their agents and
in particular with respect to disclosure of code-share service on the
agents' Web sites. Based on our preliminary review, it appears that
most U.S. air carrier Web sites already comply with section 41712(c),
while many of their agents' sites do not. Carriers are responsible for
the activities of their agents and must ensure compliance with code-
share disclosure requirements by those agents, or they could face
enforcement action.
    We are also taking this opportunity to warn ticket agents, in
particular global distribution systems, which may be assisting travel
agents to establish airline ticket sales Web sites, that they should
not be providing those agents Web site software that is not in
compliance with the Department's advertising requirements, in general,
or code-share disclosure requirements, in particular. Such actions that
facilitate violations of Department rules or section 41712 may
themselves violate 41712, and we will not hesitate to institute
enforcement action against ticket agents in such situations, if
appropriate.
    Questions regarding this notice may be addressed to the Office of
Aviation Enforcement and Proceedings (C-70), U.S. Department of
Transportation, 1200 New Jersey Ave., SE., Washington, DC 20590.
    An electronic version of this document is available at  http://www.regulations.gov.

    Dated: January 10, 2011.
Samuel Podberesky,
Assistant General Counsel for Aviation Enforcement and Proceedings.
[FR Doc. 2011-753 Filed 1-13-11; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: October 17, 2006 (Volume 71, Number 200)]
[Notices]
[Page 61037]
[DOCID:fr17oc06-78]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-9-000]

Egan Hub Storage, LLC; Notice of Proposed Changes in FERC Gas
Tariff

October 11, 2006.
    Take notice that on October 6, 2006, Egan Hub Storage, LLC (Egan
Hub) tendered for filing as part of its FERC Gas Tariff, First Revised
Volume No. 1, the tariff sheets listed in Appendix A of the filing to
be effective November 6, 2006.
    Egan Hub states that the purpose of this filing is to modify the
General Terms and Conditions of the Egan Hub Tariff to reflect the
current procedures that releasing customers and potential prearranged
and replacement customers are required to follow in order to effectuate
the temporary or permanent release of capacity via Egan Hub's capacity
release mechanism.
    Egan Hub states that copies of its filing have been mailed to all
affected customers and interested state commissions.
    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 and 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 in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not 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 email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-17221 Filed 10-16-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Pages 32008-32009]
[FR Doc No: 2014-12768]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72265; File No. SR-NYSEArca-2013-127]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change, as Modified by Amendments No. 1 and No. 2 Thereto, To List and
Trade Shares of Nine Series of the IndexIQ Active ETF Trust Under NYSE
Arca Equities Rule 8.600

May 28, 2014.
    On November 18, 2013, NYSE Arca, Inc. (``Exchange'' or ``NYSE
Arca'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'' or ``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to list and trade shares of the
IQ Long/Short Alpha ETF, IQ Bear U.S. Large Cap ETF, IQ Bear U.S. Small
Cap ETF, IQ Bear International ETF, IQ Bear Emerging Markets ETF, IQ
Bull U.S. Large Cap ETF, IQ Bull U.S. Small Cap ETF, IQ Bull
International ETF and IQ Bull Emerging Markets ETF (collectively,
``Funds''). On November 26, 2013, the Exchange filed Amendment No. 1 to
the proposed rule change.\3\ The proposed rule change, as modified by
Amendment No. 1, was published for comment in the Federal Register on
December 4, 2013.\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 clarifies (i) how certain holdings will be
valued for purposes of calculating a fund's net asset value, and
(ii) where investors will be able to obtain pricing information for
certain underlying holdings.
    \4\ Securities Exchange Act Release No. 70954 (November 27,
2013), 78 FR 72955 (``Notice'').
---------------------------------------------------------------------------

    On January 15, 2014, pursuant to Section 19(b)(2) of the Act,\5\
the Commission designated a longer period within which to either
approve the proposed rule change, disapprove the proposed rule change,
or institute proceedings to determine whether to disapprove the
proposed rule change.\6\ On March 4, 2014, the Commission instituted
proceedings to determine whether to approve or disapprove the proposed
rule change.\7\ On April 11, 2014, the Exchange submitted Amendment No.
2 to the proposed rule change.\8\ The Commission received no comments
on the proposed rule change.
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    \5\ 15 U.S.C. 78s(b)(2).
    \6\ See Securities Exchange Act Release No. 71309, 79 FR 3657
(January 22, 2014). The Commission determined that it was
appropriate to designate a longer period within which to take action
on the proposed rule change so that it has sufficient time to
consider the proposed rule change. Accordingly, the Commission
designated March 4, 2014 as the date by which it should approve,
disapprove, or institute proceedings to determine whether to
disapprove the proposed rule change.
    \7\ See Securities Exchange Act Release No. 71645, 79 FR 13349
(March 10, 2014).
    \8\ In Amendment No. 2, the Exchange provided additional details
describing how the contents of the portfolio composition of the Fund
would be disclosed on a daily basis. Specifically, the Fund will
disclose on the Fund's Web site the following information regarding
each portfolio holding, as applicable to the type of holding: ticker
symbol, CUSIP number or other identifier, if any; a description of
the holding (including the type of holding, such as the type of
swap); the identity of the security, commodity, index or other asset
or instrument underlying the holding, if any; for options, the
option strike price; quantity held (as measured by, for example, par
value, notional value or number of shares, contracts or units);
maturity date, if any; coupon rate, if any; effective date, if any;
market value of the holding; and the percentage weighting of the
holding in the applicable Fund's portfolio.
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    Section 19(b)(2) of the Act \9\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule change was published for notice and comment in the
Federal Register on December 4, 2013. June 2, 2014 is 180 days from
that date, and August 1, 2014 is 240 days from that date.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).

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

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider this proposed
rule change. The proposed rule change would permit the listing and
trading of shares of the Funds, which intend to invest primarily in
exchange-traded funds (``ETFs''), swap agreements, options contracts
and futures contracts. Four of the Funds would use the leverage
inherent in swaps and other derivatives to give the funds 200% exposure
to their investments.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\10\ designates August 1, 2014 as the date by which the Commission
should either approve or disapprove the proposed rule change (File
Number SR-NYSEArca-2013-127), as modified by Amendments No. 1 and No. 2
thereto.
---------------------------------------------------------------------------

    \10\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(57).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-12768 Filed 6-2-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Notices]
[Pages 36768-36769]
[FR Doc No: 2013-14573]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-1667-000]

Battery Utility of Ohio, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Battery Utility of Ohio, LLC's application for market-based rate
authority, with an accompanying rate schedule, noting that such
application includes a request for blanket authorization, under 18 CFR
Part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability is July 3, 2013.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by

clicking on the appropriate link in the above list. They are also
available for review in the Commission's Public Reference Room in
Washington, DC. There is an eSubscription link on the Web site that
enables subscribers to receive email notification when a document is
added to a subscribed docket(s). For assistance with any FERC Online
service, please email<EMAIL_ADDRESS>or call (866) 208-
3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 13, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-14573 Filed 6-18-13; 8:45 am]
BILLING CODE 6717-01-P


MEMORANDUM

DATE:		March 4, 2020
TO:	Revised Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS; Docket Id: OAR-2020-0272
FROM:		Kimberly Liu, US EPA
SUBJECT:	Meeting with Sierra Club
--------------------------------------------------------------------------------

SUMMARY
A meeting was held between EPA and Sierra Club on November 4, 2021 in which the Revised Cross-State Air Pollution Rule (CSAPR) Update was discussed amongst other rules. The Revised Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS proposal was signed by the Administrator on October 15, 2020 and published in the Federal Register on October 30, 2020.
ATTENDEES
Sierra Club
 John Coequyt
 Joanne Spalding
 Sanjay Narayan
 Patrick Drupp
 Liz Perera
 Al Armedariz
 Andrea Issod
 Josh Berman
 Melinda Pierce
 Zack Fabish
US EPA Representatives
Joseph Goffman		Office of Air and Radiation
Tomas Carbonell		Office of Air and Radiation
Eunjung Kim			Office of Air and Radiation
Mike Koerber			Office of Air and Radiation
Erika Sasser			Office of Air and Radiation


[Federal Register Volume 80, Number 190 (Thursday, October 1, 2015)]
[Notices]
[Pages 59148-59149]
[FR Doc No: 2015-25025]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0659; FRL--9935-10-ORD]

Proposed Information Collection Request; Comment Request; Generic
Clearance for Citizen Science and Crowdsourcing Projects (New)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Generic Clearance for
Citizen Science and Crowdsourcing Projects (New)'' (EPA ICR No.
2521.01, OMB Control No. 2080-NEW) to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.). Before doing so, EPA is
soliciting public comments on specific aspects of the proposed
information collection as described below. This is a request for
approval of a new collection. An Agency may not conduct or sponsor and
a person is not required to respond to a collection of information
unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before November 30, 2015.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-ORD-
2015-0659 referencing the Docket ID numbers provided for each item in
the text, online using www.regulations.gov (our preferred method), or
by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Generic Clearance for Citizen Science
and Crowdsourcing Projects (New), IOAA-ORD, (Mail Code 8101R),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number<PHONE_NUMBER>; fax number: 202-
565-2494; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will

be collecting are available in the public docket for this ICR. The
docket can be viewed online at www.regulations.gov or in person at the
EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: EPA relies on scientific information. Citizen science and
crowdsourcing techniques will allow the Agency to collect qualitative
and quantitative data that might help inform scientific research,
assessments, or environmental screening; validate environmental models
or tools; or enhance the quantity and quality of data collected across
the country's diverse communities and ecosystems to support the
Agency's mission. Information gathered under this generic clearance
will be used by the Agency to support the activities listed above and
might provide unprecedented avenues for conducting breakthrough
research. Collections under this generic ICR will be from participants
who actively seek to participate on their own initiative through an
open and transparent process (the Agency does not select participants
or require participation); the collections will be low-burden for
participants; collections will be low-cost for both the participants
and the Federal Government; and data will be available to support the
scientific research (including assessments, environmental screening,
tools, models, etc.) of the Agency, states, tribal or local entities
where data collection occurs. EPA may, by virtue of collaborating with
non-federal entities, sponsor the collection of this type of
information in connection with citizen science projects. When
applicable, all such collections will accord with Agency policies and
regulations related to human subjects research and will follow the
established approval paths through EPA's Human Subjects Research Review
Official. Finally, personally identifiable information (PII) will only
be collected when necessary and in accordance with applicable federal
procedures and policies. If a new collection is not within the
parameters of this generic ICR, the Agency will submit a separate
information collection request to OMB for approval.
    Form Numbers: None.
    Respondents/affected entities: Participants/respondents will be
individuals, not specific entities.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 17,500 (total).
    Frequency of response: The frequency of responses will range from
once to on occasion.
    Total estimated burden: 295,250 to 313,250 hours (per year). Burden
is defined at 5 CFR 1320.03(b).
    Total estimated cost: $9,910,997 to $10,483,217 (per year),
includes $525,000 annualized capital for operation & maintenance costs.
    Changes in Estimates: This is a new information collection. The
Agency will make adjustments to the burden numbers as needed.

    Dated: September 21, 2015.
Jay Benforado,
Deputy Chief Innovation Officer, Office of Research and Development.
[FR Doc. 2015-25025 Filed 9-30-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 42 (Friday, March 2, 2018)]
[Proposed Rules]
[Pages 8957-8959]
[FR Doc No: 2018-04298]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2017-1076]
RIN 1625-AA08

Special Local Regulation; Miami Grand Prix of the Seas, Biscayne
Bay, Miami, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a special local
regulation (SLR) for certain navigable waters of Biscayne Bay, Miami,
FL for the Miami Grand Prix of the Sea. This action is necessary to
provide for the safety of the public, spectators, vessels, and marine
environment from potential hazards during high-speed, offshore-style
boat and Personal Water Craft (PWC) races during the Miami Grand Prix
of the Sea. This SLR is necessary to provide for the safety of the
public, spectators, vessels, and marine environment during the Miami
Grand Prix of the Sea. The SLR would establish two regulated areas, a
safety zone and no anchoring zone. Non-participant persons and vessels
would be prohibited from entering, transiting, anchoring in, or
remaining within the safety zone unless authorized by the Captain of
the Port Miami (COTP) or a designated representative. All vessels would
be prohibited from anchoring in the no anchoring zone. We invite your
comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before April 2, 2018.

ADDRESSES: You may submit comments on the Federal eRulemaking Portal at
http://www.regulations.gov using docket number USCG-2017-1076 in the
``Search'' feature. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Petty Officer Mara J. Brown, Sector
Miami Waterways Management Division, U.S. Coast Guard; telephone 305-
535-4317, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
COTP Captain of the Port

II. Background, Purpose, and Legal Basis

    Powerboat P1-USA, LLC has notified the Coast Guard it will be
hosting the Miami Grand Prix of the Sea from 8:00 a.m. to 5:00 p.m.
from April 20, 2018 through 22, 2018. The event will consist of 28-foot
offshore-style powerboats and 200 to 300 Horsepower PWC racing inside
the Miami Marine Stadium basin. Approximately 90 participants are
scheduled to race in this event.
    The purpose of this rulemaking is to establish a SLR to ensure the
safety of

personnel, vessels, and marine environment before, during, and after
the scheduled event. The Coast Guard proposes this rulemaking under
authority in 33 U.S.C. 1233.

III. Discussion of Proposed Rule

    The COTP Miami proposes to establish a SLR from April 20 through
22, 2018 from 7:00 a.m. to 6:00 p.m.
    The SLR would establish two regulated areas, a safety zone and no
anchoring zone, that includes certain waters of Biscayne Bay and the
Miami Marine Stadium basin. The duration of the zones is intended to
ensure the safety of vessels and these navigable waters before, during,
and after the scheduled event. No vessel or person would be permitted
to enter the safety zone without obtaining permission from the COTP or
a designated representative. The regulatory text we are proposing
appears at the end of this document.

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 a number of 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 NPRM has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
would be able to safely transit around the regulated area, which may
affect a small, designated area of Biscayne Bay. Moreover, the Coast
Guard would issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 notifying boaters of the regulated area.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 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.
    While some owners or operators of vessels intending to transit the
safety zone 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
section. 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 not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    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.

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 would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, which guides the Coast Guard in complying
with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-
4370f), and 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
involves a regulation that would prohibit persons and vessels from
transiting or anchoring in the regulated areas during the event.
Normally such actions are categorically excluded from further review
under paragraphs L61 and of the DHS Instruction Manual Implementation
of the National Environmental Policy Act DHS Instruction Manual 023-01-
001-01, Rev 01. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this proposed
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 eRulemaking
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 the 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 100

    Marine safety; Navigation (water); Waterways; Reporting and
recordkeeping requirements.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233; 33 CFR 1.05-1.
0
2. Add Sec.  [thinsp]100.T07-1076 to read as follows:

Sec.  100.T07-1076   Special Local Regulation; Miami Grand Prix of the
Seas; Biscayne Bay, Miami, FL.

    (a) Location: The following regulated areas are established as a
SLR in Biscayne Bay; Virginia Key; Miami, FL. Coordinates listed are
based on North American Datum 1983.
    (1) Safety Zone: All waters of a Biscayne Bay encompassed within
the following points. Starting at Point 1 in position 25[deg]45'12'' N,
080[deg]11'01'' W; thence north along the Intracoastal Waterway to
Point 2 in position 25[deg]45'31'' N, 080[deg]11'02'' W; thence
southeast to Point 3 at the Marine Stadium northern jetty in position
25[deg]46'06'' N, 080[deg]10'22'' W; thence southeast along the Marine
Stadium basin shoreline to Point 4 in position 25[deg]44'21'' N,
080[deg]09'45'' W; thence northwest along Marine Stadium basin
shoreline to starting point. No persons/vessels, except participating
vessels, may enter, transit, anchoring in, or remaining within the
safety zone.
    (2) No Anchor Zone: All waters of Biscayne Bay extending
approximately 650 yards southwest, northwest and northeast from the
perimeter of the portion of the safety zone that extends beyond the
Miami Marine Stadium basin. No vessels may anchor within the no anchor
zone.
    (b) Definition. (1) The term ``designated representative'' means
Coast Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, State, and Local officers designated by or assisting the COTP
Miami in the enforcement of the regulated areas.
    (2) The term ``Patrol Commander'' means a commissioned, warrant, or
petty officer of the Coast Guard who has been designated by the
respective Coast Guard Sector Commander to enforce these regulations.
    (3) The term ``spectators'' means all persons and vessels not
registered with the event sponsor as participants or official patrol
vessels.
    (c) Regulations. (1) All non-participant vessels or persons are
prohibited from entering, transiting, anchoring in, or remaining within
the regulated area unless authorized by the COTP or a designated
representative.
    (2) Persons and vessels desiring to enter, transit, anchor in, or
remain within the regulated area may contact the COTP Miami by
telephone at<PHONE_NUMBER> or a designated representative via VHF-FM
radio on channel 16, to request authorization. If authorization is
granted, all persons and vessels receiving such authorization must
comply with the instructions of the COTP Miami or a designated
representative.
    (3) The Coast Guard will provide notice of the regulated area
through Broadcast Notice to Mariners via VHF-FM channel 16 or by on-
scene designated representatives.
    (d) Enforcement Period: This rule will be enforced daily from 7:00
a.m. to 6:00 p.m. on April 20, 2018 through April 22, 2018.

    Dated: February 16, 2018.
Megan M. Dean,
Captain, U.S. Coast Guard, Captain of the Port Miami.
[FR Doc. 2018-04298 Filed 3-1-18; 8:45 am]
 BILLING CODE 9110-04-P


INCIDENT REPORTS ASSOCIATED WITH

Iodine and Iodophors

PC CODES:

046923, 046903, 046904, 046905, 075701, 046901, 046914

December 15, 2008

Genevieve Angle

Jonathan Chen, Ph.D.

U.S. Environmental Protection Agency

Office of Pesticide Programs

Antimicrobials Division

TABLE OF CONTENTS

 TOC \f

0.0	INTRODUCTION	1

1.0 	INCIDENT REPORT DATA ASSOCIATED WITH THE HEALTH EFFECTS OF IODINE and IODOPHORS  EXPOSURE	1

1.1 	OPP's Incident Data System (IDS)	2

1.2 	Poison Control Center	2

1.3 	California Data - 1986 through 2006	2

1.4 	National Pesticide Telecommunications Network (NPTN)	4

1.5 	Incident Reports Associated with the Toxic Effects of Iodine and Iodine Compounds Published in the Scientific Literature.	4

2.0	SUMMARY AND CONCLUSION	10

3.0	REFERENCES	11

0.0	INTRODUCTION tc \l1 "0.0 INTRODUCTION

Iodine, a halogen, is a bluish-black, lustrous solid, and volatizing at ordinary temperatures into a blue-violet gas with an irritating odor. It forms compounds with many elements, but is less active than the other halogens, which displace it from iodides. Iodine exhibits some metallic-like properties. It dissolves readily in chloroform, carbon tetrachloride, or carbon disulfide to form beautiful purple solutions. It is only slightly soluble in water. Iodine compounds are important in organic chemistry and very useful in medicine.  This report summarizes the potential health effects of iodine and Iodophors in humans, reported as incident reports from different sources. Seven active ingredients are covered in this report:  PC codes 046923 ,046903,  046904, 046905, 075701, 046901, and 046914.

Two approaches are used in this section:

The potential health effects of iodine and iodophors in humans, reported as incident reports from different sources, are summarized.

A literature search of chronic health effects associated with iodine and iodophors exposure, including the results of epidemiological studies, is summarized.

1.0 	INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF IODINE AND IODOPHORS EXPOSURE tc \l1 "1.0 INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF IODINE AND IODOPHORS EXPOSURE

The following databases have been consulted for the poisoning incident data:

OPP Incident Data System (IDS) - The Incident Data System of The Office of Pesticide Programs (OPP) of the Environmental Protection Agency (EPA) contains  reports of incidents from various sources, including registrants, other federal and state health and environmental agencies and individual consumers, submitted to OPP since 1992.  Reports submitted to the Incident Data System represent anecdotal reports or allegations only, unless otherwise stated.  Typically no conclusions can be drawn implicating the pesticide as a cause of any of the reported health effects.  Nevertheless, with enough cases and/or enough documentation, risk mitigation measures may be suggested.

Poison Control Centers - as the result of a data purchase by EPA, OPP received Poison Control Center data covering the years 1993 through 1998 for all pesticides.  Most of the national Poison Control Centers (PCCs) participate in a national data collection system, the Toxic Exposure Surveillance System, which obtains data from about 65-70 centers at hospitals and universities.  PCCs provide telephone consultation for individuals and health care providers on suspected poisonings involving drugs, household products, pesticides, etc.

California Department of Pesticide Regulation - California has collected uniform data on suspected pesticide poisonings since 1986.  Physicians are required, by statute, to report to their local health officer all occurrences of illness suspected of being related to exposure to pesticides.  The majority of the incidents involve workers.  Information on exposure (worker activity), type of illness (systemic, eye, skin, eye/skin and respiratory), likelihood of a causal relationship, and number of days off work and in the hospital are provided.

National Pesticide Telecommunications Network (NPTN) - NPTN is a toll-free information service supported by OPP.  A ranking of the top 200 active ingredients for which telephone calls were received during calendar years 1984-1991, inclusive, has been prepared.  The total number of calls was tabulated for the categories of human incidents, animal incidents, calls for information, and others.

Published Incident Reports - Some incident reports associated with iodine and iodide related human health hazards are published in the scientific literature.

1.1 	OPP’s Incident Data System (IDS) tc \l2 "1.1 OPPs Incident Data System (IDS)

A total of 8 individual human incident cases submitted to the EPA Office of Pesticide Programs are associated with exposure to iodine-containing compounds.  Inhalation and dermal are the two most important routes of exposure.  The most common symptoms reported for cases of inhalation exposure were coughing, wheezing, tightness of chest and shortness of breath. Dermal exposure caused skin burning, blisters and rash.  None of these effects were considered severe effects.

1.2 	 Poison Control Center tc \l2 "1.2 Poison Control Center

There are no iodine incidents that have been reported in the American Association of Poison Control Centers (PCC) Toxic Exposure Surveillance System (TESS) in the years 1993 - 1998.

1.3 	California Data - 1986 through 2006 tc \l2 "1.3 California Data - 1982 through 2003

Detailed descriptions of 64 cases with a definite, probable or possible relationship to iodine-containing compounds have been submitted to the California Pesticide Illness Surveillance Program (1986-2006).  Table 1 presents the types of illnesses reported by year.  Table 2 gives the total number of workers that took time off work as a result of their illness and how many were hospitalized and for how long.

Table 1: Cases Due to Iodine, Iodine-Complex or Potassium Iodide Exposure in California Reported by Type of Illness and Year, 1986-2006.

Year	Illness Type

Systemic

Gastrointestinal

Eye

Skin

Respiratory

Combinationa

Total

1986

10

-

-

1

-

-

11

1987

-

-

1

2

1

-

4

1988

-

-

-

1

-

-

1

1989

5

-

-

3

-

2

10

1990

1

-

-

1

1

2

5

1991

1

-

3

3

3

-

10

1992

2

-

2

-

1

-

5

1993

1

-

1

-

1

-

3

1994

1

-

-

1

1

-

3

1995

-

-

1

-

-

-

1

1996

1

-

1

1

-

-

3

1997

-

-

-

1

-

-

1

1998

-

-

-

1

-

1

2

1999

-

-

-

-

-

-

-

2000

-

-

-

-

-

-

-

2001

-

-

1

-

-

-

1

2002

-

-

-

1

-

-

1

2003	-	-	-	-	-	-	-

2004	-	-	1	1	-	-	2

2005	-	-	-	-	-	-	-

2006	-	-	1	-	-	-	1

Total

22

-

12

17

8

5

64

a Category includes combined irritating effects to eye, skin, gastrointestinal and respiratory systems.

Table 2: Number of Persons Disabled (taking time off work) or Hospitalized for Indicated Number of Days After Iodine, Iodine-Complex or Potassium Iodide Exposure in California, 1986-2006.

Number of Persons Disabled

Number of Persons Hospitalized

One day

15

-

Two days

-

-

3-5 days

3

-

6-10 days

1

-

More than 10 days

-

-

Unknown

1

-

1.4 	National Pesticide Telecommunications Network (NPTN) tc \l2 "1.4 National Pesticide Telecommunications Network (NPTN)

There are no incidents reported in the NPTN database related to iodine-containing compounds.

1.5 	Incident Reports Associated with the Toxic Effects of Iodine and Iodine Compounds Published in the Scientific Literature tc \l2 "1.5 Incident Reports Associated with the Toxic Effects of Iodine and Iodine Compounds Published in the Scientific Literature

There are a large number of human incident reports and epidemiological studies on the effects of excess iodine on human health.  Based on incidents reported on the toxic effects of pure iodine on humans, an ingestion of 1 to 8 ounces of iodine can cause death within 48 hours.  Irrespective to the routes of exposure (oral, dermal) to iodine, gender, or age, acute irritation effects have been reported in several incidences. Both high dose exposure and low cumulative doses of iodine drugs have indicated severe effects in adults and children.  When pregnant mothers were exposed to iodine containing drugs during pregnancy, the infants had increased chances of suffering from goiter, hypothyroidism, cretinism, and several other abnormalities of the thyroid gland. Transient hypothyroidism may be observed in infants, if mothers underwent thyroxine treatment for hypothyroidism during pregnancy; however, infants can recover from transient hypothyroidism over a period of time.

Table 3: Incident Reports Associated with Oral or Dermal exposure to Iodine Containing Mixtures

Reference

Description of Incident

Dose

Effects

Finkelstein and Jacobi, 1937

18 deaths over a period of 6 years from suicides in which adults ingested iodine

1 ounce – 8 ounces of iodine

death within 48 hours after dosing

Finkelstein and Jacobi, 1937

A 29-year-old man was admitted to the hospital four days after attempting suicide by taking tincture of iodine (mixtures of molecular iodine and sodium triiodide)

unknown amount of tincture of iodine

Ulcerations in the mouth increased respiratory rate, vomiting, abdominal soreness/cramps, urinary retention, twitching, irrationality, fever, coma, and death.

Clark, 1981

A man was found dead in his residence with a skull fracture and severe pneumonia, he was known to be epileptic and a heavy consumer of alcohol; a 13 oz. rye whiskey bottle was found with him that was 3/4 full of a brownish liquid that turned out to be iodine

unclear

death

Dyck et al., 1979

A woman was admitted to the hospital after attempting suicide by ingesting an unknown quantity of Lugol’s iodine (5% diatomic iodine and 10% potassium iodide)

Not reported

Throat burning, esophagitis, gastritis, chemical pulmonary edema, dyspnea, tachycardia, hyperthyroidism, acute renal failure, metabolic acidosis.

Vicens-Colvet et al., 1998

A 28-yr-old asthmatic woman ingested iodine during pregnancy.

2 to 3 spoonfuls of 130 mg/15 ml of iodide per day.

Fetal goiter with hypothyroidism was caused by iodide over dose effect.

Shetty and Duthie, 1990

A 72-yr-old adult male received providone-iodine skin washes for 6 months to treat dermal ulcers; he had no other history of excess iodine intake.

not reported

hyperthyroidism and thyrotoxicosis

Prager and Gardner, 1979

A 26-year-old woman had an open fistula which was swabbed 3 days/week for 22 months with providone-iodine and packed with iodoform impregnated gauze.

22 mg I, 3 days/week for 22 months

Clinical hypothyroidism with thyroid enlargement; became euthyroid within 6 weeks after the treatment was discontinued.

Okano, 1989

A 2-year-old girl suffered extensive, patchy erythema on her back, buttocks and thighs after these areas were in contact with a 10% providone-iodine solution for 8 hours

10% providone-iodine solution (exact dose unknown)

acute irritant contact dermatitis

Tosti et al., 1990

A 44-yr-old woman suffered from dermatitis for 15 years duration on her hands and arms, extending to her face, neck, and trunk. Being a masseuse for 30 years, she had used several many topical medicaments, several anti-inflammatory drugs, massage creams, and cleansing disinfectants; thus, exposed to several chemicals.

Not reported

Patch test revealed a strong positive reaction to glutaraldehyde and 10% povidone-iodine solution.

Tosti et al., 1990

A 67-yr old woman developed an acute dermatitis with disinfection with 10% povidone-iodine at the skin biopsy site.

Not reported

Patch test revealed a strong positive reaction to betadine and 10% povidone-iodine solution.

Coakley et al., 1989

A mother took aminophylline and potassium iodide for asthma, during pregnancy.

383 mg iodide per 10 ml (during pregnancy). The dose of aminophylline was not reported.

The infant became hypothyroid.

Coakley et al., 1989

A mother took potassium iodide for asthma for sinus medication, during pregnancy. The mother continued to breast feed the baby while taking the sinus medication.

65 mg iodide per 10 ml (during pregnancy)

The infant became hypothyroid. The thyroid screen showed abnormality in the concentration of T4 and TSH. The infant also had a goiter. As soon as the breast feeding ceased, the thyroid function of the infant returned to normal.

Coakley et al., 1989

There were 12 infants who were applied betadine (10% of povidone-iodine with 1% of iodine)

Not reported

All developed hypothyroidism.

Coakley et al., 1989

A mother received thyroxine treatment for hypothyroidism, presumably Hashimoto’s thyroditis, at the time of both pregnancies.

Not reported

Both the infants had transient hypothyroidism due to maternal antithyroid antibodies.

Galina et al., 1962

A 23 yr old pregnant woman was treated for asthma with potassium iodide during her pregnancy. On the 44th week of her pregnancy, she delivered a boy, who died within 18 minutes from birth.

a total of 324 mg of potassium iodide during pregnancy

A large, trilobulated, firm-to-hard mass was palpable over the entire neck. It was not adhering to the overlying skin, and there were prominent vessels on the surface of the mass. The infant had a congenital thyroid goiter.

Galina et al., 1962	A 32-yr old woman took several medicines including potassium iodide during pregnancy, for bronchial asthma.	Total estimated intake of potassium iodide during pregnancy was 234 gm.	No effects were observed in the mother; however, the infant developed a cystic but a firm mass around the neck. The infant was cyanotic when out of oxygen. Gradually, the infant developed respiratory distress, and died within 40 hours.

Iancu et al., 1974

A 31-yr-old woman consumed cough elixir (sodium iodide) for two years, and even during her pregnancy.

200 mg I/day

hypothyroidism and goiter in infant

Penfold et al., 1978

During pregnancy a woman had been on multiple drug therapy (salbutamol, sodium chromoglycate, beclomethasone propionate, and an aminophylline potassium iodide mixture) for asthma.

It was estimated that KI ingested daily during the last trimester was 500 mg.

Four days after delivery, the infant showed moderate goiter, prominent tongues, small umbilical hernia, and slight inspiratory stridor. In addition, absence of epiphyseal centers at the knee and hip was consistent with intrauterine hypothyroidism. Transfer of trans-placental iodide was significant in the infant.

Penfold et al., 1978

A 13-yr old girl suddenly gained weight within two months. Being asthmatic she had been taking sodium cromoglycate, salbutamol, beclomethasone propionate, and elixophylline (600 gm of KI/day).

elixophylline (600 gm of KI/day)

Myxoedematous facies, slight obesity, and a moderate diffuse goiter. After 12 months of discontinuation of KI, she was euthyroid, with slight palpable goiter.

Hassan et al., 1968

During pregnancy a 33-yr-old woman received a treatment with potassium iodide for chronic asthma. She had been having potassium iodide for 10 years.

600 mg of Potassium iodide daily.

The infant (18 days-old) was mildly cyanotic, with marked inspiratory stridor, tongue enlarged and puffy, infants born with goiter and hypothyroidism. Skeletal x-ray showed delayed bone age, with absence of the epiphysial center of lower end of femur, upper end of tibia, and cuboid bone.

Hassan et al., 1968

During pregnancy a 28-yr-old woman received a treatment with potassium iodide for asthma.

Having potassium iodide (1 gm) from the age of 2 up to the time of delivery.

The infant appeared cretinoid, pale, with some puffiness of the face, a large protruded tongue, and some mottling of the skin, goiter and hypothyroidism.

Hassan et al., 1968

A 33-yr-old pregnant woman was maintained on bronchodilator for 3 years from delivery.

Daily dose of  0.9 gm of potassium iodide

The infant born was hypothyroid and had large enlargement of thyroid.

Bostanci et al., 2001

Mother ingested potassium iodide during her pregnancy.

170 mg potassium iodide/day starting from the 16th week of gestation.

Infant born with goiter and hypothyroidism.

Martin and Rento, 1962

Two years prior to her pregnancy, she received 2 gms of potassium iodide daily because of increased severity of asthma, and was maintained on it until delivery.

2 gm of potassium iodide therapy daily

Infant born appeared cretinoid and had a conspicuous goiter. The thyroid was 3 to 4 times the normal size and firm in consistency. After the first 2 weeks of her life, the baby lost the cretinoid appearance and the thyroid decreased in size.

Martin and Rento, 1962	During pregnancy a woman received excessive iodide therapy (quadrinal, 4 tablets daily) because of chronic asthma. In addition, in the last trimester, the mother was administered 60 mg of thyroid extract daily until delivery. 	1200 mg of potassium iodide daily for three years prior and during pregnancy	The infant born had an enlarged thyroid, measuring 4 to 9 cm., and firm. The infant had goitrous cretinism. At 6 months of age the thyroid gland was not palpable, and the thyroid function studies, and the bone age was normal.

Shilo and Hirsch, 1986

A 72-year-old woman without apparent preexisting thyroid problems ingested sea-kelp tablets (4-6 tablets per day); her thyroid status reverted to normal within 6 months after she stopped taking the tablets

2.8-4.2 mg I/day

hyperthyroidism

Rajatanavin et al., 1984

A 64-year-old man was given amiodarone (75 mg of iodine per 200 mg tablet) for intermittent atrial flutter

75 mg I/day

angina, fatigue, weight loss, hyperthyroidism, tremor, muscle weakness

Ahmed et al., 1974

A 15-year-old male received Tedral, Marax, intermittent subcutaneous epinephrine, SKKI, and organidine for 4 months, for continuous bronchial asthma. The thyroid gland was diffusely enlarged (estimated 50 g), was soft, and without a bruit. In addition, there is a family history of goiter and hyperthyroidism.

No specific information on dose was provided.

hyperthyroidism and thyrotoxicosis

After removal of iodide and iodine containing drugs, the patient’s thyroid status reverted to normal within 6 months.

Vagenakis et al., 1972

In a clinical study, eight healthy adult females (age between 34 to 66 yrs) with nontoxic goiter received oral doses of a saturated potassium iodide solution (5 drops dadily) for 10-18 weeks

180 mg I/day

Four of the eight patients developed hyperthyroidism and thyrotoxicosis.

Shelly, 1967

A 15-yr old boy was challenged with 10 drops of saturated solution of potassium iodide orally.

10 drops of KI administered orally

Subsequently, high temperature and generalized pruritus.

Shelly, 1967	A 49-yr woman was challenged with 10 drops of saturated solution of potassium iodide orally. 	500 mg of iodide on 2 separate occasions during remission	Several attacks similar to pustular psoriasis were provoked.

Rosenburg et al., 1972

A 47-yr-old female received oral doses (3 to 4 tablets per day) of Quadrinal (is a combination of ephedrine hydrochloride, 25 mg; theophylline calcium salicylate, 130 mg; phenobarbital, 25 mg; and potassium iodide, 324 mg) for 1 year as part of asthma treatment.  Other drugs used in the patient’s treatment were theophylline and prednisone.

3 to 4 tablets of Quadrinal daily, and 7.5 mg of theophylline and prednisone daily.

Vegetative lesions on the face and arms; healed within 3 weeks after the potassium iodide was discontinued.

Baumgartner, 1976

A 75-year-old male suffering from pneumonia was giving a saturated solution of potassium iodide among other medication

1,200 mg potassium iodide per day

skin lesions

Soria et al., 1990

 A 50-yr old woman received furosemide, aspirin, potassium iodide solution, predinisone, and cyclophosphamide for pneumonia.

520 mg KI/day

Lesions of the skin and oral mucosa were observed. Iododerma was diagnosed, and the medication potassium against iodide-labeled serum albumin was detected by radioimmunoassay and enzyme linked immunosorbent assay. The skin lesions healed within 3 weeks of discontinuing potassium iodide.

Soria et al., 1990

A 76-yr old adult male received potassium iodide along with theophylline for obstructive pulmonary disease for 8 months

160 mg/day of theophylline and potassium iodide was 260 mg/day.

Vegetative dermal lesions were observed on the neck and trunk. Iododerma was suspected, potassium iodide treatment was discontinued. Three weeks later, only post inflammatory hyperpigmentation and scarring remained.

Soria et al., 1990

A 58-yr old male received potassium iodide along with penicillin for an acute respiratory tract infection.

390 mg /day (potassium iodide along with penicillin)

After five days of dosing, nodular vegetating lesions with central ulceration and purulent exudation developed on the scalp, shoulder, face, and buttocks. A diagnosis of iododerma was suspected, and potassium iodide was discontinued.

Kincaid et al., 1981

A 60-yr old woman received three tablets per day of Quadrinal (is a combination of ephedrine hydrochloride, 25 mg; theophylline calcium salicylate, 130 mg; Phenobarbital, 25 mg; and potassium iodide, 324 mg) for 6 months as part of a treatment for chronic obstructive pulmonary disease.

740 mg I/day for 6 months

She developed nodular erythematous skin lesions on her nose, forehead, and malar areas. Clinically acne rosacea was suspected. A cheek lesion was excised and was also interpreted as showing chronic inflammation with psuedoepitheliomatous hyperplasia. In addition, lesions on the conjunctiva of the eye were observed. The diagnosis of iododerma was made.

Khan et al., 1973

A 65-year-old woman with pneumonia, left ventricular failure and chronic bronchitis was given potassium iodide daily by mouth

Treated with 24% oxygen by Venturi Mask, intravenous furosemide, and digitalis. In addition, parenteral penicillin and potassium iodide, 10 drops (65 mg) 3 times a day via mouth.

Lesions on skin and hand were erythematous and nodular, with a fungating, tumor-like appearance, and contained areas of suppuration and ulceration.

Skin lesions on the face and hands healed completely within 3 weeks after potassium iodide was discontinued

Pena-Penabad et al., 1993

A 75-year-old man had suffered from numerous colds that were treated with potassium iodide and theophylline taken orally.

not reported

Outbreaks of papulo-pustulous lesions that formed vegetating masses on the scalp and arms and conjunctival hemorrhage; lesions disappeared within one week after treatment with iodine was discontinued.

Kint and Van Herpe, 1976

A 53 yr-old woman was taking Calcidrine, an expectorant that contains 150 mg calcium iodide per 5 ml syrup, for respiratory infections.

not specified

Vegetative hard tumors on face, pre-sternal regions, arms amd lower legs.

Kint and Van Herpe, 1976	An 82-yr old woman was taking Calcidrine, an expectorant that contains 150 mg calcium iodide per 5 ml syrup, for respiratory infections.	not specified	Vegetative skin lesions on face and fore-arm.

Kurtz and Aber, 1982

A 73-yr-old male received oral doses of a potassium iodide solution for 15 years

10 drops of potassium iodide, three times a day for the past 15 years.

recurrent fevers; fevers stopped within 2 weeks after the potassium iodide was discontinued

Horn and Kabins, 1972

A 59-yr-old man was treated for pneumonia with a saturated solution of potassium iodide, ampicillin sodium and ephedrine sulfate.

10 drops of potassium iodide for 4 times a day (3 ml KI/day)

Fever was due to the hypersensitivity of drugs. Also, the man developed rash.

Horn and Kabins, 1972

A 48-yr-old woman received a saturated potassium iodide solution along with ampicillin to treat pneumonia

15 drops of potassium iodide for three times a day (3ml KI/day)

She had fever, and developed rigor, diaphoresis, malaise, and diffuses myalgia. Fever was temporarily associated with potassium iodide administration.

Horn and Kabins, 1972

A 41-yr-old diabetic woman received a saturated potassium iodide solution along with methicillin sodium, amphicillin sodium, and aminophylline, hydrocortistirone, for pneumonia.

10 drops of KI three times a day (2 ml/day)

Fever, chills, and leukocytosis were temporarily treated to ingestion of potassium iodide was discontinued.

Tresch et al., 1974

A 54-yr-old male inadvertently drank a potassium iodide solution.

600 ml of potassium iodide solution with 15 grams of iodide

Cardiac irritability; ventricular tachycardia; swelling of the face, neck and mouth; edema; conjunctivitis; enlarged salivary glands.

Garijo et al., 1996

A 37-yr old man underwent an intraarticular administration of mepivacaine hydrochloride and paramethasone acetate in his right knee.

Not reported

With the history of allergic rhinitis, the 37-yr old man presented urticaria, dyspnea, wheezing, rhinorrhea, and dysphonia. Only povidone present within paramethasone was responsible for severe anaphylactic responses in the patient.

2.0 Summary and Conclusion

Iodine is a naturally occurring element that is essential for the good health of people and animals. Iodine is found in small amounts in sea water and in certain rocks and sediments. Iodine occurs in many different forms. Most forms of iodine easily dissolve in water or alcohol. Iodine has many uses. Its most important use is as a disinfectant. Incidents of death due to iodine exposure have been reported but only happened at high doses.  Irritation effects were reported when exposure to iodine compounds occurred through any route of exposure (oral, dermal or inhalation). Goitrogenic effects were noticed in several incidences.

3.0 References

Ahmed M, Doe RP, Nuttall FQ.  1974.  Triiodothyronine thyrotoxicosis following iodide ingestion: A case report.  J Clin Endocrinol Metab 38: 574-576.

Baumgartner TG.  1976.  Potassium iodide and iododerma.  Am J Hosp Pharm 33: 601-603.

Bostanci I, Sarioglu A, Ergin H, et al.  2001.  Neonatal goiter caused by expectorant usage. Journal of Pediatric Endocrinology & Metabolism 14(8): 1161-1162.

Clark MN.  1981.  A fatal case of iodine poisoning.  Clin Toxicol 18(7): 807-811.

Coakley JC, Francis I, Gold H, et al. 1989.  Transient primary hypothyroidism in the newborn: Experience of the Victorian Neonatal Thyroid Screening Programme.  Aust Paediatr J 25: 25-30.

Dyck RF, Bear RA, Goldstein MB, et al.  1979.  Iodine/iodide toxic reaction: Case report with emphasis on the nature of the metabolic acidosis.  Can Med Assoc J 120: 704-706.

Finkelstein R, Jacobi M.  1937.  Fatal iodine poisening: A clinico-pathologic and experimental study.  Adv Intern Med 60: 1283-1296.

Galina MP, Avnet NL, Einhorn A.  1962.  Iodides during pregnancy: An apparent cause of neonatal death.  N Engl J Med 267: 1124-1127.

Hassan AI, Aref GH, Kassem AS.  1968.  Congenital iodide-induced goitre with hypothyroidism.  Arch Dis Child 43: 702-704.

Horn B, Kabins SA.  1972.  Iodide fever.  Am J Med Sci 264(6): 467-471.

Khan F, Einbinder JM, Seriff NS.  1973.  Suppurative ulcerating iododerma-a rare manifestation of inorganic iodide hypersensitivity.  N Engl J Med 289: 1018-1020.

Kincaid MC, Green WR, Hoover RE, et al.  1981.  Iododerma of the conjunctiva and skin. Ophthalmology 88: 1216-1220.

Kint A, Van Herpe L.  1977.  Iododerma.  Dermatologica 155(3): 171-173.

Kurtz SC, Aber RC.  1982.  Potassium iodide as a cause of prolonged fever.  Arch Intern Med 142: 1543-1544.

Iancu T, Boyanower Y, Laurian N.  1974.  Congenital goiter due to maternal ingestion of iodide.  Am J Dis Child 128: 528-530.

Martin MM, Rento RD.  1962.  Iodide goiter with hypothyroidism in 2 newborn infants. J Pediatr 61: 94-99.

Okano M. 1989.  Irritant contact dermatitis caused by the providone-iodine.  J Am Acad Dermatol 20(5): 860.

Pena-Penabad C, De Unamuno P, Garcis-Silva J, et al.  1993.  Vegetating iododerman and conjunctival involvement.  EJD Eur J Dermatol 3: 671-673.

Penfold, JL, Pearson CC, Savage JP, et al.  1978.  Iodide induced goitre and hypothyroidism in infancy and childhood.  Aust Paediatr J 14: 69-73.

Prager EM, Gardner RE.  1979.  Iatrogenic hypothyroidism from topical iodine-containing medications.  West J Med 130(6): 553-555.

Rajatanavin R, Safran M, Stoller WA, et al.  1984.  Five patients with iodine-induced hyperthyroidism.  Am J Med 77: 378-384.

Rosenberg FR, Einbinder J, Walzer RA, et al.  1972.  Vegetating iododerma.  Arch Dermatol 105: 900-905.

Shelly WB. 1967.  Generalized pustular psoriasis induced by potassium iodide.  JAMA 201(13): 133-138.

Shetty KR, Duthie EH.  1990.  Thyrotoxicosis induced by topical iodine application.  Arch Intern Med 150: 2400-2401.

Shilo S, Hirsch HJ.  1986.  Iodine-induced hyperthyroidism in a patient with a normal thyroid gland.  Postgrad Med J 62: 661-662.

Soria C, Allegue F, Espana A, et al.  1990.  Vegetating iododerma with underlying systemic diseases: Report of three cases.  J Am Acad Dermatol 22:418-422.

Tresch DD, Sweet DL, Keelan MHJ, et al.  1974.  Acute iodide intoxication with cardiac irritability.  Arch Intern Med 134: 760-762.

Vagenakis AG, Wang C-A, Burger A, et al.  1972.  Iodide-induced thyrotoxicosis in Boston.  N Engl J Med 287(11): 523-527.

Vicens-Calvet E, Potau N, Carreras E, et al.  1998.  Diagnosis and treatment in utero of goiter with hypothyroidism caused by iodide overload.  J Pediatr 133: 147-148.

 PAGE

 PAGE   1


[Federal Register Volume 87, Number 128 (Wednesday, July 6, 2022)]
[Notices]
[Pages 40232-40233]
[FR Doc No: 2022-14332]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP16-10-000; CP21-57-000; CP19-477-000]

Mountain Valley Pipeline, LLC; Notice of Request for Extension of
Time

    Take notice that on June 24, 2022, Mountain Valley Pipeline, LLC
(Mountain Valley) requested that the Federal Energy Regulatory
Commission (Commission) grant an extension of time, until October 13,
2026, to complete construction of the Mountain Valley Pipeline Project
(Project) and place the Project facilities into service, as authorized
in the October 13, 2017 Order Issuing Certificate.\1\ On October 9,
2020, the Commission issued an order granting a two-year extension of
time, until October 13, 2022, for Mountain Valley to complete
construction of the Project and place the Project facilities into
service.\2\ On April 8, 2022, the Commission issued an order amending
the Project certificate to permit Mountain Valley to: (1) change the
crossing method for 183 waterbodies and wetlands; (2) slightly shift
the permanent right-of-way at mileposts 0.70 and 230.8 to avoid one
wetland and one waterbody, respectively; and (3) conduct 24-hour
construction activities at eight trenchless crossings. The Commission
conditioned the Amendment Order on Mountain Valley completing
construction by the October 13, 2022 construction deadline.
---------------------------------------------------------------------------

    \1\ Mountain Valley Pipeline, LLC, 161 FERC ] 61,043 (2017),
order on reh'g, 163 FERC ] 61,197 (2018) (``Certificate Order''),
aff'd sub. nom., Appalachian Voices v. FERC, No. 17-1271, 2019 WL
847199 (D.C. Cir. Feb. 19, 2019). The Order required Mountain Valley
to construct and place the facilities in service within three years
of the date of the Order or October 13, 2020.
    \2\ Mountain Valley Pipeline, LLC, 173 FERC ] 61,026 (2020),
petition for review pending sub nom. Sierra Club v. FERC, No. 20-
1512 (D.C. Cir.) (oral argument held Apr. 7, 2022). On September 29,
2021, Mountain Valley filed a request for extension of time in
Docket No. CP19-477-000 to align the in-service deadline for its
already-constructed Greene Interconnect with that for the mainline
Project. The Commission has not yet acted on that uncontested
request. As part of the instant request, Mountain Valley is
modifying the pending request in that docket for consistency.
---------------------------------------------------------------------------

    Mountain Valley states that its request for an extension of time is
due to the ongoing litigation and remand proceedings related to several
permits and authorizations in the above identified dockets.
    Mountain Valley states that it has shown good cause for the
extension as Project construction is substantially complete and
Mountain Valley is actively working to reinstate all required permits
so that it can complete construction as expeditiously as possible.
Mountain Valley avers it is currently obtaining all necessary permits,
including updated environmental findings where applicable, that will be
in place before Mountain Valley is permitted to complete construction
of the Project. Mountain Valley states it has expended approximately
$5.5 billion on the Project to date and the Project's total cost is
targeted to be approximately $6.6 billion. Mountain Valley states its
extension of time request is necessary to maintain its erosion and
sedimentation control program. Finally, Mountain Valley states that the
Project remains fully subscribed under binding long-term agreements.
Accordingly, Mountain Valley requests an extension of the October 13,
2022 deadline until October 13, 2026, to complete construction of the
Mountain Valley Pipeline Project and place the Project facilities into
service.
    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on Mountain Valley's
request for an extension of time may do so. No reply comments or
answers will be considered. If you wish to obtain legal status by
becoming a party to the proceedings for this request, you should, on or
before the comment date stated below, file a motion to intervene in
accordance with the requirements of the Commission's Rules of Practice
and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the
Natural Gas Act (18 CFR 157.10).
    As a matter of practice, the Commission itself generally acts on
requests for extensions of time to complete construction for Natural
Gas Act facilities when such requests are contested before order
issuance. For those extension requests that are contested,\3\ the
Commission will aim to issue an order acting on the request within 45
days.\4\ The Commission will address all arguments relating to whether
the applicant has demonstrated there is good cause to grant the
extension.\5\ The Commission will not consider arguments that re-
litigate the issuance of the certificate order, including whether the
Commission properly found the project to be in the public convenience
and necessity and whether the Commission's environmental analysis for
the

certificate complied with the National Environmental Policy Act.\6\ At
the time a pipeline requests an extension of time, orders on
certificates of public convenience and necessity are final and the
Commission will not re-litigate their issuance.\7\ The OEP Director, or
his or her designee, will act on all of those extension requests that
are uncontested.
---------------------------------------------------------------------------

    \3\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2019).
    \4\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
    \5\ Id. at P 40.
    \6\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with NEPA.
    \7\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
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    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFile'' link at
http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on July 14, 2022.

    Dated: June 29, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-14332 Filed 7-5-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Page 13053]
[FR Doc No: 2015-05601]

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SECURITIES AND EXCHANGE COMMISSION

[OMB Control No. 3235-0503, SEC File No. 270-446]

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Form N-6.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    The title for the collection of information is ``Form N-6 (17 CFR
239.17c and 274.11d) under the Securities Act of 1933 (15 U.S.C. 77a et
seq.) and under the Investment Company Act of 1940 (15 U.S.C. 80a-1 et
seq.) registration statement of separate accounts organized as unit
investment trusts that offer variable life insurance policies.'' Form
N-6 is the form used by insurance company separate accounts organized
as unit investment trusts that offer variable life insurance contracts
to register as investment companies under the Investment Company Act of
1940 and/or to register their securities under the Securities Act of
1933. The primary purpose of the registration process is to provide
disclosure of financial and other information to investors and
potential investors for the purpose of evaluating an investment in a
security. Form N-6 also requires separate accounts organized as unit
investment trusts that offer variable life insurance policies to
provide investors with a prospectus and a statement of additional
information (``SAI'') covering essential information about the separate
account when it makes an initial or additional offering of its
securities.
    The Commission estimates that approximately 472 registration
statements (396 post-effective amendments plus 76 initial registration
statements) are filed on Form N-6 annually. The estimated hour burden
per portfolio for preparing and filing an initial registration
statement on Form N-6 is 770.25 hours. The estimated annual hour burden
for preparing and filing initial registration statements is 58,539
hours (76 initial registration statements annually times 770.25 hours
per registration statement). The Commission estimates that the hour
burden for preparing and filing a post-effective amendment on Form N-6
is 67.5 hours. The total annual hour burden for preparing and filing
post-effective amendments is 26,730 hours (396 post-effective
amendments annually times 67.5 hours per amendment). The frequency of
response is annual. The total annual hour burden for Form N-6,
therefore, is estimated to be 85,269 hours (58,539 hours for initial
registration statements plus 26,730 hours for post-effective
amendments).
    The Commission estimates that the cost burden for preparing an
initial Form N-6 filing is $24,169 per portfolio and the current cost
burden for preparing a post-effective amendment to a previously
effective registration statement is $8,788 per portfolio. The
Commission estimates that, on an annual basis, 76 portfolios will be
referenced in an initial Form N-6 and 396 portfolios will be referenced
in a post-effective amendment of Form N-6. Thus, the total cost burden
allocated to Form N-6 would be $5,316,892.
    The information collection requirements imposed by Form N-6 are
mandatory. Responses to the collection of information will not be kept
confidential. Estimates of average burden hours are made solely for the
purposes of the Paperwork Reduction Act, and are not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules and forms. An agency may not conduct or sponsor, and a
person is not required to respond to a collection of information unless
it displays a currently valid control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email
to<EMAIL_ADDRESS>
    Dated: March 6, 2015.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2015-05601 Filed 3-11-15; 8:45 am]
 BILLING CODE 8011-01-P