[Federal Register Volume 84, Number 113 (Wednesday, June 12, 2019)]
[Notices]
[Pages 27341-27342]
[FR Doc No: 2019-12359]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2019-0353]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0049

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0049,
Waterfront Facilities Handling Liquefied Natural Gas (LNG) and
Liquefied Hazardous Gas (LHG); without change. Our ICR describe the
information we seek to collect from the public. Before submitting this
ICR to OIRA, the Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before August 12,
2019.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2019-0353] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. Consistent with
the requirements of Executive Order 13771, Reducing Regulation and
Controlling Regulatory Costs, and

Executive Order 13777, Enforcing the Regulatory Reform Agenda, the
Coast Guard is also requesting comments on the extent to which this
request for information could be modified to reduce the burden on
respondents. In response to your comments, we may revise this ICR or
decide not to seek an extension of approval for the Collection. We will
consider all comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2019-0353], and
must be received by August 12, 2019.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://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.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: Waterfront Facilities Handling Liquefied Natural Gas (LNG)
and Liquefied Hazardous Gas (LHG).
    OMB Control Number: 1625-0049.
    Summary: Liquefied Natural Gas (LNG) and other liquefied Hazardous
Gases (LHG) present a risk to the public when handled at waterfront
facilities. These rules should either prevent accidental releases at
waterfront facilities or mitigate their results. They are necessary to
promote and verify compliance with safety standards.
    Need: Title 33 CFR part 127 prescribe safety standards for the
design, construction, equipment, operations, maintenance, personnel
training, and fire protection at waterfront facilities handling LNG or
LHG.
    Forms: None.
    Respondents: Owners and operators of waterfront facilities that
transfer LNG or LHG.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has decreased from 9,734
hours to 5,029 hours a year, due to a decrease in the estimated annual
number of responses.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: June 6, 2019.
James D. Roppel,
U.S. Coast Guard, Chief, Office of Information Management.
[FR Doc. 2019-12359 Filed 6-11-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: September 23, 2009 (Volume 74, Number 183)]
[Notices]
[Page 48539-48541]
[DOCID:fr23se09-52]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8954-9; Docket ID No. EPA-HQ-ORD-2009-0245]

Draft Toxicological Review of Hydrogen Cyanide and Cyanide Salts:
In Support of the Summary Information in the Integrated Risk
Information System (IRIS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period and listening session.

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SUMMARY: EPA is announcing a public comment period and a public
listening session for the external review draft document titled,
``Toxicological Review of Hydrogen Cyanide and Cyanide Salts: In
Support of Summary Information on the Integrated Risk Information
System (IRIS)'' (EPA/635/R-08/016). The draft document was prepared by
the National Center for Environmental Assessment (NCEA) within the
EPA's Office of Research and Development (ORD). The public comment
period and the external peer-review workshop, which will be scheduled
at a later date and announced in the Federal Register, are separate
processes that provide opportunities for all interested parties to
comment on the document. EPA intends to forward the public comments
that are submitted in accordance with this notice to the external peer-
review panel prior to the meeting for their consideration. When
finalizing the draft document, EPA intends to consider any public
comments that EPA receives in accordance with this notice.
    EPA is also announcing a listening session to be held on October
27, 2009, during the public comment period for this draft document.
This listening session is a step in EPA's revised IRIS process,
announced on May 21, 2009, to develop human health assessments for
inclusion in the IRIS database. The purpose of the listening session is
to allow all interested parties to present scientific and technical
comments on draft IRIS health assessments to EPA and other interested
parties during the public comment period and before the external peer
review meeting. EPA welcomes the scientific and technical comments that
will be provided to the Agency by the listening session participants.
The comments will be considered by the Agency as it revises the draft
assessment in response to the independent external peer review and the
public comments. All presentations will become part of the official
public record.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination.

DATES: The public comment period begins September 23, 2009, and ends
November 23, 2009. Technical comments should be in writing and must be
received by EPA by November 23, 2009.
    The listening session on the draft IRIS health assessment for
Hydrogen Cyanide and Cyanide Salts will be held on October 27, 2009,
beginning at 9 a.m. and ending at 4 p.m., Eastern Daylight Time. If you
want to make a presentation at the listening session, you should
register by October 20, 2009, indicate that you wish to make oral
comments at the session, and indicate the length of your presentation.
When you register, please indicate if you will need audio-visual aid
(e.g., lap top and slide projector). In general, each presentation
should be no more than 30 minutes. If, however, there are more requests
for presentations than the allotted time allows, then the time limit
for each presentation will be adjusted. A copy of the agenda for the
listening session will be available at the meeting. If no speakers have
registered by October 20, 2009, the listening session will be cancelled
and EPA will notify those registered of the cancellation.
    Listening session participants who want EPA to share their comments
with the external peer reviewers should also submit written comments
during the public comment period using the detailed and established
procedures described in the SUPPLEMENTARY INFORMATION section of this
notice. Comments submitted to the docket prior to the end of the public
comment period will be submitted to the external peer reviewers and
considered by EPA in the disposition of public comments. All comments
must be submitted to the docket, but comments received after the public
comment period closes will not be submitted to the external peer
reviewers.

ADDRESSES: The draft ``Toxicological Review of Hydrogen Cyanide and
Cyanide Salts: In Support of Summary Information on the Integrated Risk
Information System (IRIS)'' is available primarily via the Internet on
the NCEA home page under the Recent Additions and Publications menus at
http://www.epa.gov/ncea. A limited number of paper copies are available
from the Information Management Team, NCEA; telephone:<PHONE_NUMBER>;
facsimile:<PHONE_NUMBER>. If you are requesting a paper copy, please
provide your name, mailing address, and the document title.
    Comments may be submitted electronically via http://
www.regulations.gov, by mail, by facsimile, or by hand delivery/
courier. Please follow the detailed instructions as provided in the
SUPPLEMENTARY INFORMATION section of this notice.
    The listening session on the draft Hydrogen Cyanide and Cyanide
Salts assessment will be held at the EPA

offices at Two Potomac Yard (North Building), 7th Floor, Room 7100,
2733 South Crystal Drive, Arlington, Virginia, 22202. To attend the
listening session, register by October 20, 2009, via e-mail at
<EMAIL_ADDRESS>(subject line: Hydrogen Cyanide and Cyanide Salts
listening session), by phone:<PHONE_NUMBER> extension 545, or by faxing
a registration request<PHONE_NUMBER> (please reference the ``Hydrogen
Cyanide and Cyanide Salts Listening Session'' and include your name,
title, affiliation, full address and contact information). Please note
that to gain entrance to this EPA building to attend the meeting,
attendees must have photo identification with them and must register at
the guard's desk in the lobby. The guard will retain your photo
identification and will provide you with a visitor's badge. At the
guard's desk, attendees should give the name Christine Ross and the
telephone number,<PHONE_NUMBER>, to the guard on duty. The guard will
contact Ms. Ross who will meet you in the reception area to escort you
to the meeting room. When you leave the building, please return your
visitor's badge to the guard and you will receive your photo
identification.
    A teleconference line will also be available for registered
attendees/speakers. The teleconference number is<PHONE_NUMBER> and the
access code is<PHONE_NUMBER>, followed by the pound sign ().
The teleconference line will be activated at 8:45 a.m., and you will be
asked to identify yourself and your affiliation at the beginning of the
call.
    Information on Services for Individuals with Disabilities: EPA
welcomes public attendance at the ``Hydrogen Cyanide and Cyanide Salts
Listening Session'' and will make every effort to accommodate persons
with disabilities. For information on access or services for
individuals with disabilities, please contact Christine Ross at 703-
347-8592 or<EMAIL_ADDRESS>To request accommodation of a
disability, please contact Ms. Ross, preferably at least 10 days prior
to the meeting, to give EPA as much time as possible to process your
request.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or e-mail:
<EMAIL_ADDRESS>    For information on the public listening sessions, please contact
Christine Ross, IRIS Staff, National Center for Environmental
Assessment, (8601P), U.S. EPA, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>;
or e-mail<EMAIL_ADDRESS>    If you have questions about the document, contact Kathleen
Newhouse, National Center for Environmental Assessment (NCEA),1200
Pennsylvania Ave 8601P, Washington DC, 20460; telephone:<PHONE_NUMBER>;
facsimile:<PHONE_NUMBER>; or e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Information About IRIS

    IRIS is a database that contains potential adverse human health
effects information that may result from chronic (or lifetime) exposure
to specific chemical substances found in the environment. The database
(available on the Internet at http://www.epa.gov/iris) contains
qualitative and quantitative health effects information for more than
540 chemical substances that may be used to support the first two steps
(hazard identification and dose-response evaluation) of a risk
assessment process. When supported by available data, the database
provides oral reference doses (RfDs) and inhalation reference
concentrations (RfCs) for chronic health effects, and oral slope
factors and inhalation unit risks for carcinogenic effects. Combined
with specific exposure information, government and private entities can
use IRIS data to help characterize public health risks of chemical
substances in a site-specific situation and thereby support risk
management decisions designed to protect public health.

II. How to Submit Technical Comments to the Docket at http://
www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2009-
0245 by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center's Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Such deliveries are only accepted during
the docket's normal hours of operation, and special arrangements should
be made for deliveries of boxed information. If you provide comments by
mail or hand delivery, please submit one unbound original with pages
numbered consecutively, and three copies of the comments. For
attachments, provide an index, number pages consecutively with the
comments, and submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2009-0245. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at http://
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-
mail. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the

http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.

    Dated: August 21, 2009.
Rebecca Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E9-22912 Filed 9-22-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Pages 64168-64170]
[FR Doc No: 2019-25108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87538; File No. SR-NASDAQ-2019-087]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Modify Certain Annual Listing Fees

November 14, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 6, 2019, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III, below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify certain listing fees. While changes
proposed herein are effective upon filing, the Exchange has designated
the proposed amendments to be operative on January 1, 2020.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.cchwallstreet.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 aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to modify the Exchange's
all-inclusive annual listing fees for all domestic and foreign
companies listing equity securities covered by Listing Rules 5910 and
5920 on the Nasdaq Global Select, Global and Capital Markets.
    Currently, for companies listed on the Capital Market, other than,
in part, ADRs, Closed-end Funds and Limited Partnerships, the all-
inclusive annual fee ranges from $42,000 to $75,000; for ADRs listed on
the Capital Market the all-inclusive annual fee ranges from $42,000 to
$50,000; and for Limited Partnerships listed on the Capital Market the
all-inclusive annual fee ranges from $30,000 to $37,500. On the Global
and Global Select Markets, the all-inclusive annual fee for companies
other than, in part, ADRs, Closed-end Funds and Limited Partnerships
ranges from $45,000 to $155,000; for ADRs the all-inclusive annual fee
ranges from $45,000 to $80,000; and for Limited Partnerships the all-
inclusive annual fee ranges from $37,500 to $77,500. The all-inclusive
annual fee for Closed-end Funds listed on any market tier ranges from
$30,000 to $100,000. In each case, a company's all-inclusive annual fee
is based on its total shares outstanding.\3\
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    \3\ REITs are subject to the same fee schedule as other equity
securities; however for the purpose of determining the total shares
outstanding, shares outstanding of all members in a REIT Family
listed on the same Nasdaq market tier may be aggregated. Similarly,
for the purpose of determining the total shares outstanding, fund
sponsors may aggregate shares outstanding of all Closed-End Funds in
the same fund family listed on the Nasdaq Global Market or the
Nasdaq Capital Market. See Listing Rules 5910(b)(2) and 5920(b)(2).
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    Nasdaq proposes to amend the all-inclusive annual fee for all
domestic and foreign companies listing equity securities on the Nasdaq
Global Select, Global and Capital Markets to the following amounts,\4\
effective January 1, 2020:
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    \4\ The proposed fee change reflects about 2.5% increase rounded
to the nearest $500.

                      Global/Global Select Markets
------------------------------------------------------------------------
                                   Annual fee before      Annual fee
    Total shares outstanding         the proposed      effective January
                                        change              1, 2020
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Equity securities other than, in
 part, ADRs, Closed-end Funds
 and Limited Partnerships:
    Up to 10 million shares.....             $45,000             $46,000
    10+ to 50 million shares....              55,000              56,500
    50+ to 75 million shares....              75,000              77,000

    75+ to 100 million shares...             100,000             102,500
    100+ to 125 million shares..             125,000             128,000
    125+ to 150 million shares..             135,000             138,500
    Over 150 million shares.....             155,000             159,000
ADRs:
    Up to 10 million ADRs and                 45,000              46,000
     other listed equity
     securities.................
    10+ to 50 million ADRs and                50,000              51,500
     other listed equity
     securities.................
    50+ to 75 million ADRs and                60,000              61,500
     other listed equity
     securities.................
    Over 75 million ADRs and                  80,000              82,000
     other listed equity
     securities.................
Closed-end Funds:
    Up to 50 million shares.....              30,000              31,000
    50+ to 100 million shares...              50,000              51,500
    100+ to 250 million shares..              75,000              77,000
    Over 250 million shares.....             100,000             102,500
Limited Partnerships:
    Up to 75 million shares.....              37,500              38,500
    75+ to 100 million shares...              50,000              51,500
    100+ to 125 million shares..              62,500              64,000
    125+ to 150 million shares..              67,500              69,000
    Over 150 million shares.....              77,500              79,500
------------------------------------------------------------------------

                             Capital Market
------------------------------------------------------------------------
                                   Annual fee before      Annual fee
    Total shares outstanding         the proposed      effective January
                                        change              1, 2020
------------------------------------------------------------------------
Equity securities other than, in
 part, ADRs, Closed-end Funds
 and Limited Partnerships:
    Up to 10 million shares.....             $42,000             $43,000
    10+ to 50 million shares....              55,000              56,500
    Over 50 million shares......              75,000              77,000
ADRs:
    Up to 10 million ADRs and                 42,000              43,000
     other listed equity
     securities.................
    Over 10 million ADRs and                  50,000              51,500
     other listed equity
     securities.................
Closed-end Funds:
    Up to 50 million shares.....              30,000              31,000
    50+ to 100 million shares...              50,000              51,500
    100+ to 250 million shares..              75,000              77,000
    Over 250 million shares.....             100,000             102,500
Limited Partnerships:
    Up to 75 million shares.....              30,000              31,000
    Over 75 million shares......              37,500              38,500
------------------------------------------------------------------------

    Nasdaq also proposes to update the maximum fee applicable to a
Closed-End Fund family and the maximum fee applicable to a REIT Family
to reflect the proposed fee change for other equity securities, as
described above.\5\
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    \5\ See footnote 3 above.
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    As described below, Nasdaq proposes to make the aforementioned fee
increases to better reflect the Exchange's costs related to listing
equity securities and the corresponding value of such listing to
issuers.
    Nasdaq also proposes to remove references to fees that are no
longer applicable because they were superseded by new fee rates
specified in the rule text.
    While these changes are effective upon filing, Nasdaq has
designated the proposed amendments to be operative on January 1, 2020.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\6\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\7\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4) and (5).
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    Nasdaq believes that it is not unfairly discriminatory and
represents an equitable allocation of reasonable fees to amend Listing
Rules 5910(b)(2) and 5920(b)(2) to increase the various listing fees
\8\ as set forth above because of the increased costs incurred by
Nasdaq

since it established the current rates. In that regard, the Exchange
notes that its general costs have increased since its most recent fee
adjustments, including due to price inflation. In addition, the
Exchange continues to improve the services it provides to listed
companies. These improvements include the continued development and
enhancement of Nasdaq's online tools, including the Listing Center and
Reference Library, to the benefit of all listed companies, their
shareholders and prospective investors. In addition, Nasdaq has
invested in upgrades to the Nasdaq MarketSite, which houses a state-of-
the-art digital broadcast studio and can be utilized as a New York
venue by listed companies, and the MarketSite Tower. The proposed
increase also will help Nasdaq continue to invest in these initiatives
and its regulatory programs.
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    \8\ In 2014, Nasdaq adopted an all-inclusive annual listing fee
schedule to simplify, clarify and enhance transparency around the
annual fee to which listed companies are subject. See Securities
Exchange Act Release No. 73647 (November 19, 2014), 79 FR 70232
(November 25, 2014) (SR-NASDAQ-2014-87). Effective January 1, 2017,
Nasdaq reduced the fees for limited partnerships listed on Nasdaq.
See Securities Exchange Act Release No. 79770 (January 10, 2017), 82
FR 4947 (January 17, 2017) (SR-NASDAQ-2016-173). Effective January
1, 2019, Nasdaq modified the fee schedule for ADRs listed on Nasdaq,
including to subject ADRs to the same minimum fee as other companies
listing equity securities on the same tier of Nasdaq and to bring
the ADRs fees closer to the fees paid by other domestic and foreign
companies listing equity securities on Nasdaq. See Securities
Exchange Act Release No. 84880 (December 20, 2018), 83 FR 67374
(December 28, 2018) (SR-NASDAQ-2018-103).
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    Nasdaq also believes that it is not unfairly discriminatory and
represents an equitable allocation of reasonable fees to amend Listing
Rules 5910(b)(2) and 5920(b)(2) to increase the various listing fees
while rounding the increase to the nearest $500 as set forth above
because such rounding represents di minimus variation in fees for
Nasdaq listed companies. In addition, Nasdaq has used the same
methodology since the adoption of the all-inclusive annual listing fee
schedule and all annual listing fees under Listing Rules 5910(b)(2) and
5920(b)(2) are rounded to $500.
    The proposed change to update the maximum fee applicable to a
Closed-End Fund family and the maximum fee applicable to a REIT Family
to reflect the proposed fee change for other equity securities, as
described above, is not unfairly discriminatory because it merely
reflects the change in fees for other equity securities without
changing the substance of the rule.
    Finally, Nasdaq notes that it operates in a highly competitive
market in which market participants can readily switch exchanges if
they deem the listing fees excessive.\9\ In such an environment, Nasdaq
must continually review its fees to assure that they remain
competitive.
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    \9\ The Justice Department has noted the intense competitive
environment for exchange listings. See ``NASDAQ OMX Group Inc. and
IntercontinentalExchange Inc. Abandon Their Proposed Acquisition Of
NYSE Euronext After Justice Department Threatens Lawsuit'' (May 16,
2011), available at http://www.justice.gov/atr/public/press_releases/2011/271214.htm.
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    The proposed removal of text relating to fees that are no longer
applicable is ministerial in nature and has no substantive effect.

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

    Nasdaq 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 market for
listing services is extremely competitive and listed companies may
freely choose alternative venues, both within the U.S. and
internationally. For this reason, Nasdaq does not believe that the
proposed rule change will result in any burden on competition for
listings.

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)(ii) of the Act.\10\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2019-087 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-NASDAQ-2019-087. 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 the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. 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-NASDAQ-2019-087, and should be submitted
on or before December 11, 2019.

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

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-25108 Filed 11-19-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Page 21230]
[FR Doc No: 2020-08024]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL20-20-000; QF14-782-001]

GRE 314 East Lyme LLC; Notice of Revised Refund Report

    Take notice that on April 10, 2020, GRE 314 East Lyme LLC
(Petitioner), submitted a Revised Refund Report (Corrected Refund
Calculation) to the Petition for Declaratory Order filed on February 3,
2020, seeking requirements applicable to qualifying small power
production facilities set forth in section 292.203(a)(3) for the period
June 6, 2014 to September 18, 2014.
    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.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' 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.
    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://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 the 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 the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on May 1, 2020.

    Dated: April 10, 2020.
Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2020-08024 Filed 4-15-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Rules and Regulations]
[Pages 34795-34797]
[FR Doc No: 2022-11580]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R08-OAR-2021-0808; FRL-9595-02-R8]

Approval and Promulgation of Implementation Plans; Montana;
Whitefish PM10 Nonattainment Area Limited Maintenance Plan and
Redesignation Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving the
Limited Maintenance Plan (LMP) submitted by the State of Montana to EPA
on August 6, 2021, for the Whitefish Moderate nonattainment area (NAA)
for particulate matter with an aerodynamic diameter less than or equal
to a nominal 10 micrometers (PM10) and concurrently
redesignating the NAA to attainment for the 24-hour PM10
National Ambient Air Quality Standard (NAAQS). In order to approve the
LMP and redesignation, EPA determined that the Whitefish NAA has
attained the 1987 24-hour PM10 NAAQS of 150 [micro]g/m\3\.
This determination is based upon monitored air quality data for the
PM10 NAAQS during the years 2015 through 2020. The EPA is
taking this action pursuant to the Clean Air Act (CAA).

DATES: This rule is effective on July 8, 2022.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R08-OAR-2021-0808. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available through http://www.regulations.gov, or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Kate Gregory, Air and Radiation
Division, U.S. Environmental Protection Agency (EPA), Region 8, Mail
Code 8P-ARD-QP, 1595 Wynkoop Street, Denver, Colorado 80202-1129,
telephone number:<PHONE_NUMBER>, email address: [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' means the EPA.

I. Background

    The background for this action is discussed in detail in our March
8, 2022 proposal (87 FR 12912). In that document, we proposed to
approve the LMP for the Whitefish NAA and the State's request to
redesignate the Whitefish NAA from nonattainment to attainment for the
1987 24-hour PM10 NAAQS. Additionally, we proposed to
determine that the Whitefish NAA has attained the NAAQS for
PM10. That determination was based upon monitored air
quality data for the PM10 NAAQS during the years 2015
through 2020. Finally, in our March 8, 2022 proposal, EPA proposed to
approve the Whitefish LMP as meeting the appropriate transportation
conformity requirements found in 40 CFR part 93, subpart A.
    The public comment period on the EPA's proposed rule opened on
March 8, 2022, the date of its publication in the Federal Register (87
FR 12912) and closed on April 7, 2022. During this comment period we
received no comments on our proposal.

II. Environmental Justice Considerations

    As discussed on the proposed rule, to identify environmental
burdens and susceptible populations in underserved communities in the
Whitefish area, we performed a screening-level analysis using the EPA's
environmental justice (EJ) screening and mapping tool
(``EJSCREEN'').\1\ The results of this screening level analysis are
described in our proposed rule (87 FR 12912). This action addresses a
plan for continued attainment of the 1987 PM10 NAAQS for the
Whitefish area. Approval of this plan does not impose any additional
regulatory requirements on sources beyond those imposed by state law.
As discussed in our proposed rule, Montana has demonstrated that the
Whitefish area is attaining the 1987 PM10 NAAQS and the
Whitefish Maintenance Plan provides for the maintenance of the NAAQS
for 10 years beyond redesignation. For these reasons, this action will
not result in disproportionately high and adverse human health or
environmental effects on communities with environmental justice
concerns.
---------------------------------------------------------------------------

    \1\ See `Whitefish NAA EJSCREEN' document available in docket.
---------------------------------------------------------------------------

III. Final Action

    For the reasons explained in our proposed action, we are approving
the LMP for the Whitefish NAA and the State's request to redesignate
the Whitefish NAA from nonattainment to attainment for the 1987 24-hour
PM10 NAAQS. Additionally, the EPA is determining that the
Whitefish NAA has attained the NAAQS for PM10. This
determination is based upon monitored air quality data for the
PM10 NAAQS during the years 2015 through 2020. The EPA is
approving that the Whitefish LMP as meeting the appropriate
transportation conformity requirements found in 40 CFR part 93, subpart
A.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, described in the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement

Act of 1995 (15 U.S.C. 272 note) because application of those
requirements would be inconsistent with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by August 8, 2022. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Greenhouse gases, Incorporation by reference, Intergovernmental
relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting
and recordkeeping requirements, Sulfur oxides, Volatile organic
compounds.

40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
and Wilderness areas.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: May 24, 2022.
K.C. Becker,
Regional Administrator, Region 8.

    40 CFR parts 52 and 81 are amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart BB--Montana

0
2. In Sec.  52.1370, the table in paragraph (e) is amended by adding
the entry ``Whitefish 1987 PM10 Limited Maintenance Plan''
under the heading entitled ``(3) Flathead County'' at the end of the
section to read as follows:

Sec.  52.1370  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
                                                 Notice of
        Title/subject              State        final rule                       NFR citation
                              effective date       date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                               (3) Flathead County
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Whitefish 1987 PM10 Limited   ..............        6/8/2022  [insert Federal Register citation].
 Maintenance Plan.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
3. In Sec.  52.1374, add paragraph (g) to read as follows:

Sec.  52.1374  Control strategy: Particulate matter.

* * * * *
    (g) On August 6, 2021, the State of Montana submitted limited
maintenance plans for the Whitefish PM10 nonattaiment areas
and requested that this area be redesignated to attainment for the
PM10 National Ambient Air Quality Standards. The
redesignation request and limited maintenance plans satisfy all
applicable requirements of the Clean Air Act.

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
4. The authority citation for part 81 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

Subpart C--Section 107 Attainment Status Designations

0
5. In Sec.  81.327, in the table entitled ``Montana--PM-10'' under the
entry ``Flathead County:'' revise the fourth entry to read as follows:

Sec.  81.327  Montana.

* * * * *

                                                 Montana--PM-10
----------------------------------------------------------------------------------------------------------------
                                                      Designation                         Classification
           Designated area           ---------------------------------------------------------------------------
                                           Date                  Type                  Date            Type
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Flathead County:

                                                  * * * * * * *
    The City of Whitefish and               7/8/2022  Attainment................
     surrounding vicinity bounded by
     lines from Universal
     Transmercator (UTM) coordinates
     695000 mE, 5370000 mN, east to
     699000 mE, 5370000 mN, south to
     699000 mE, 5361000 mN, west to
     695000 mN, 5361000 mN, and
     north to 695000 mE, 5370000 mN.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2022-11580 Filed 6-7-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Rules and Regulations]
[Pages 9460-9462]
[FR Doc No: 2021-03101]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2021-0057]
RIN 1625-AA00

Emergency Safety Zone; Richmond Entrance Channel, Richmond, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone in the
navigable waters of the Richmond Entrance Channel off of Richmond, CA
in support of the safe navigation of vessels and environmental response
efforts to address the hydrocarbon release from the Richmond Long Wharf
on February 09, 2021. Based on this information, this safety zone is
necessary to protect life, vessels, and the maritime environment.
Unauthorized persons or vessels are prohibited from entering into,
transiting through, or remaining in the safety zone without permission
from the Captain of the Port San Francisco or a Captain of the Port San
Francisco designated representative.

DATES: This rule is effective without actual notice on February 16,
2021. For the purposes of enforcement, actual notice will be used from
12:01 a.m. February 10, 2021 until February 16, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0057 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Warrant Officer Mickey Price, Waterways Management,
U.S. Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port San Francisco
DHS Department of Homeland Security
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking with
respect to this rule because it is impracticable. The Coast Guard
received notice of the hydrocarbon release into the waterway and the
resulting need for this safety zone on February 9, 2021. It is
impracticable to go through the full rulemaking process, including
providing a reasonable comment period and considering those comments,
because the Coast Guard must establish this emergency temporary safety
zone by February 10, 2021.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to public interest because immediate action
is

needed to protect personnel, vessels, and the maritime environment from
potential hazards near the Richmond Long Wharf.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port San
Francisco has determined that potential hazards associated with the
hydrocarbon release exist near the Richmond Long Wharf. This rule is
needed because environmental response operations create a significant
hazard to any vessels transiting the safety zone area. The
environmental response operations may be complex in nature and involve
multiple vessels. These operations, when conducted in close proximity
to transiting vessels, create unpredictable hazards, making it
necessary to restrict vessel traffic within the impacted area until
environmental response operations are completed.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone in navigable waters
250 yards around the Richmond Long Wharf, Richmond, CA as announced in
a mariner information broadcast from February 10, 2021 at 12:01 a.m.
through February 16, 2021 at 11:59 p.m. The effect of the temporary
safety zone will be to restrict vessel navigation in this area until
the Coast Guard determines that the hazards associated with the
hydrocarbon release and response efforts are no longer present. Except
for persons or vessels authorized by the Captain of the Port or a
designated representative, no vessel may enter or remain in the
restricted area. A ``designated representative'' means a Coast Guard
Patrol Commander, including a Coast Guard coxswain, petty officer, or
other officer operating a Coast Guard vessel or a Federal, State, or
local officer designated by or assisting the COTP in the enforcement of
the safety zone.

V. Regulatory Analyses

    We developed this 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. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the limited
duration and narrowly tailored geographic area of the safety zone.
Although this rule restricts access to the water encompassed by the
safety zone, the effect of this rule will not be significant because
the local waterway users will be notified to ensure the safety zone
will result in minimum impact. The vessels desiring to transit through
or around the temporary safety zone may do so upon express permission
from the COTP or the COTP's designated representative.

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 rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A. above, this rule will not have a significant economic
impact on any vessel owner or operator.
    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 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.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

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 rule will 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
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined 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 rule involves a safety zone established to deal with
an emergency situation, lasting less than one week, that will prohibit
vessel traffic near the hydrocarbon response efforts in the vicinity of
the Richmond Long Wharf. It is categorically excluded from further
review under paragraph L60(c) of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 1.

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.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T11-048 to read as follows:

Sec.  165.T11-048   Emergency Safety Zone; Richmond Entrance Channel,
Richmond, CA.

    (a) Location. The following area is a safety zone: All navigable
waters 250 yards around the Richmond Long Wharf, Richmond, CA.
    (b) Definitions. As used in this section, ``designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer operating a Coast
Guard vessel or a Federal, State, or local officer designated by or
assisting the Captain of the Port San Francisco (COTP) in the
enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or the COTP's designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or the COTP's designated representative to
obtain permission to do so. Vessel operators given permission to enter
or operate in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative. Persons and vessels may request permission to enter the
safety zone on VHF-23A or through the 24-hour Command Center at
telephone<PHONE_NUMBER>.
    (d) Enforcement period. This section will be enforced from February
10, 2021 at 12:01 a.m. until Febuary 16, 2021 at 11:59 p.m. or as
announced via marine information broadcast.
    (e) Information broadcasts. The COTP or the COTP's designated
representative will notify the maritime community of periods during
which this zone will be enforced in accordance with 33 CFR 165.7.

    Dated: February 9, 2021.
Marie B. Byrd,
Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
[FR Doc. 2021-03101 Filed 2-11-21; 11:15 am]
BILLING CODE 9110-04-P


Site Visit Report

	Big Bend Station

	13031 Wyandette Rd

	Apollo Beach, FL 33572

March 27, 2008

Background and Objectives

The Environmental Protection Agency (EPA) is in the process of
developing 316(b) cooling water intake structure requirements that
reflect the best technology available (BTA) for minimizing adverse
environmental impact for all existing power plants and manufacturing
facilities. As part of this process, EPA staff is visiting electric
generators and manufacturers to better understand the cooling water
intake structure (CWIS) technologies in use at facilities, including the
site-specific characteristics of each facility and how these affect the
selection and performance of CWIS technologies.  EPA is also visiting
facilities to better understand cooling water use and specific issues or
technologies that can affect 316(b) compliance.  Big Bend Station (Big
Bend) was selected for a site visit due to its use of fine mesh
traveling screens and its large intake flows.

Facility Description

Big Bend is located on the western coast of Florida and withdraws from
Tampa Bay.  The facility is owned by Tampa Electric Company (TECO) and
is situated on a 1492 acre site.  Big Bend began operations in 1970 and
employs approximately 350 people.  The facility discharges via a 4000
foot discharge canal along the southern side of the property.

The facility’s NPDES permit (FL0000817) expires in 2010.

Electricity Generation and Transmission

Big Bend has four coal-fired generating units with a total generating
capacity of 1800 MW.  Units 1-3 were built in 1970, 1973, and 1976,
respectively.  Unit 4 was initially designed with a cooling dilution
system that would add ambient water to cool the effluent, but the
permitting authority eventually decided on a 4000 acre mixing zone to
address the thermal discharge.  Facility representatives estimated that
Big Bend’s capacity utilization rate was approximately 80% in recent
years.  Normally the facility is a baseload plant, but the retrofit of
Selective Catalytic Reduction (SCR) air pollution control equipment on
all four units to reduce NOx emissions, boiler maintenance, and other
substantial maintenance has necessitated longer than normal outages.
The facility estimates a 6 month total outage per unit to complete the
SCR retrofits.  Ideally, the facility would have a scheduled outage of
2-6 weeks every 2 years.  The facility’s highest peak demand is in
winter, but summer demand is sustained at a higher level on average.

TECO also owns the switchyard and transmission facilities.

Cooling Water Intake Structure

Big Bend withdraws from a 3000 foot long intake canal at a depth of 25
feet from Tampa Bay.  The facility has two cooling water intake
structure (CWISs); Units 1 and 2 share one CWIS and Units 3 and 4 share
the other.  Both CWISs use a trash rack to screen larger debris; there
is no cleaning system for this first layer of screening.

Both CWISs employ dual flow screens.  Units 1 and 2 have a standard
3/8” mesh traveling screen with no return system.  The screens are
rotated approximately once per shift and all materials on the screen are
collected and disposed of in a landfill.

Units 3 and 4 employ fine mesh traveling screens with a mesh size of 0.5
mm.  The fine mesh screens (installed as overlays to the existing coarse
mesh screen panels) are deployed seasonally, from March 15 to October
15.  The off-season is used to repair and clean the fine mesh screen
panels. Facility representatives estimated that the maintenance costs
(including personnel) for the fine mesh screen assembly is approximately
$500,000-$600,000 per year; this includes screen repair, oil changes,
preventative maintenance measures for wash pumps and return pumps, and
replacement of the chain every other year.  Cleaning and repair takes 5
to 6 contractors and 4 staff on a full-time basis for several weeks, and
3 staff work 7 days a week during downtime. By comparison, the facility
estimates that the coarse mesh screens on Units 1 and 2 have annual
maintenance costs of approximately $50,000.  The facility noted the
harsh salt environment (up to 30 ppt) in which the screens are operated
and that Asian/New Zealand mussels necessitate the 6 month repair and
maintenance cycle.

During operation, the screens are rotated continuously, but also have
multiple rotation speeds and use an automated head differential system
to trigger faster screen rotation speeds.  Units 3 and 4 share an
organism return system, which pumps organisms to Apollo Bay.  While
running, the system is monitored daily.

Units 1 and 2 have four screen assemblies and four pumps while Units 3
and 4 have 6 screen assemblies and four pumps.  Each screen assembly can
withdraw 120,000 gallons per minute and generally two screens are
required to operate a generating unit.  The total design intake flow
(DIF) for the facility is nearly 1.4 billion gallons per day.

Facility representatives estimate that the through-screen velocity at
Units 1 and 2 are 1-2 feet per second.  At Units 3 and 4, the
through-screen velocity is approximately 0.55 feet per second at normal
tide.  The tides vary by approximately 2.5 feet at the intake structure.

The facility periodically dredges the intake canal, as sedimentation
near the intake structures is a substantial problem.  Dredging
activities are generally in the area of the CWIS for Units 3 and 4, as
silt cascades into the screenwell when the screens are removed for
maintenance.  Additionally, dredging activities must avoid the manatee
season.

Big Bend does not use biocides, instead relying on mechanical cleaning
of its intake structure.

Impingement and Entrainment Information

The most frequently impinged organism at Big Bend is the horseshoe crab.
 During the site visit, substantial amounts of the crabs were visible in
the screenwash.

Facility representatives stated that they expected that the fine mesh
screens on Units 3 and 4 would have been compliant with the entrainment
requirements of the now-suspended Phase II rule.  The facility expected
to make improvements to Units 1 and 2, but had not considered any
specific options in great detail.  The facility indicated it would most
likely have needed to make improvements to comply with the now suspended
impingement requirements.  The facility does not know of any physical
limitations that would restrict further expansion of the intake
structures in the intake canal.

Cooling Tower Feasibility

Facility representatives stated that retrofitting cooling towers would
be problematic for several reasons.  First, there are water use
restrictions in the Tampa area and the evaporative losses from a tower
may be unacceptable (meaning that the towers would need to use salt
water).  Second, given the site configuration, towers would need to be
sited on the southern portion of the property, and would be much closer
to residential areas and wetlands.  It is likely that some wetlands
would be filled to provide enough space to construct cooling towers.
Third, the facility assumed that plume abatement towers would be
required due to proximity to the town of Apollo Beach, necessitating a
straight line configuration for towers and further limiting the possible
locations.  Fourth, the high average wet bulb temperature would cause
technical challenges.  Lastly, Big Bend’s discharge canal is listed as
a federal manatee refuge and cooling towers would remove nearly all of
the thermal discharge and eliminate the cold-weather refuge for the
endangered species.

Additional Information

A municipal desalinization plant is co-located to the north of the
facility.  The plant withdraws approximately 50 mgd from Big Bend’s
discharge canal, creates 25 mgd of potable water, and returns the
remaining 25 mgd to the canal.  Big Bend’s circulating pumps stay on
during outages for the desalination plant’s continuous operation.

Attachments

Attachment A		List of Attendees

Attachment B		Aerial Photo

Attachment C		Email to Kevin Young, TECO re: Manatees and Power Plants

Attachment D	An Assessment of the Biological Effectiveness of 0.5 mm
Fine-Mesh Traveling Screens in Reducing Entrainment at the Big Bend
Power Station (DRAFT)

Attachment E	Letter to Paul Shriner, EPA re: Units 3&4 Fine Mesh Screens
Follow-up Information

Attachment F	Site Visit Photos

Attachment A--List of Attendees

Paul Shriner, EPA

Jan Matuszko, EPA

Kelly Meadows, Tetra Tech

Kevin Young, TECO

Karen Zwolak, TECO

Stanley Kroh, TECO

Attachment B—Big Bend Aerial Photo

Please see DCN 10-6502D accompanying this document.

Attachment C--Email to Kevin Young, TECO re: Manatees and Power Plants

Please see DCN 10-6502A accompanying this document.

Attachment D--An Assessment of the Biological Effectiveness of 0.5 mm
Fine-Mesh Traveling Screens in Reducing Entrainment at the Big Bend
Power Station (DRAFT)

Please see DCN 10-6502B accompanying this document.

Attachment E--Letter to Paul Shriner, EPA re: Units 3&4 Fine Mesh
Screens Follow-up Information

Please see DCN 10-6502C accompanying this document.

Attachment F--Site Visit Photos

Please see DCNs 10-6502E-J accompanying this document.

 Big Bend uses eastern bituminous coal from mines in Kentucky.

 The estuary is very shallow, leading to the warming of intake water
withdrawals; intake temperatures can exceed 90 degrees in the summer.
The facility is designed for a delta T of 17 degrees.  The canal is
tidal and fluctuates approximately 2.5 feet.

 At the urging of EPA Region IV, a pilot study for fine mesh screens for
Unit 4 was conducted in 1985 and demonstrated a 50% reduction in
entrainment exclusion. In order to reach an approximate reduction of no
net loss, fine mesh screen were also added to Unit 3.  The screen
material is a polymer mesh.

 The organism return system screens some larger organisms for collection
and disposal.

 PAGE

 PAGE   6


               1999United States Environmental Protection Agency                                                              Docket Index for Proposed Rulemaking                              EPA-R09-OAR-2019-0432                                         Air Plan Approval; California; Santa Barbara County Air Pollution Control District; Stationary Source Permits and Exemptions                                 September 2019

Note: Copies of the Federal Register (FR) notices listed in Section D are included in the docket only if they are not publicly accessible in an electronic format. Please follow the hyperlink link provided for all other FR notices; or visit: https://www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR.                                         Index No. Document Title Date Regulations.gov Document ID A. State Implementation Plan Submittal Documents A.1 CARB SIP Submittal (October 18, 2016)

A.1.1 SIP submittal letter from CARB to EPA  10/18/2016                                      0003 A.1.2 SIP submittal letter Enclosure A 10/18/2016                                      0003 A.1.3 Executive Order S-16-007 10/18/2016                                      0003 A.1.4 NSR-SIP Checklist 10/18/2016                                      0003 A.1.5 NSR-Rule Evaluation 10/18/2016                                      0003 A.1.6 NSR-Resolution 10/18/2016                                      0003 A.1.7 Rule 102 Change Version 10/18/2016                                      0003 A.1.8 Rule 105 Change Version 10/18/2016                                      0003 A.1.9 Rule 202 Change Version 10/18/2016                                      0003 A.1.10 Rule 204 Change Version 10/18/2016                                      0003 A.1.11 Rule 102 Clean Version  10/18/2016                                      0003 A.1.12 Rule 105 Clean Version 10/18/2016                                      0003 A.1.13 Rule 202 Clean Version 10/18/2016                                      0003 A.1.14 Rule 204 Clean Version 10/18/2016                                      0003 A.1.15 Rule 809 Clean Version 10/18/2016                                      0003 A.1.16 NSR-SIP Proof of Publication 10/18/2016                                      0003 A.1.17 Staff Report 10/18/2016                                      0003 A.2 CARB SIP Submittal (March 10, 1998)

A.2.1 SIP submittal letter from CARB to EPA, Enclosure A, Executive Order G-125-227  3/10/1998                                      0004 A.2.2 Rule 205 Clean Version 3/10/1998                                      0004 A.2.3 Santa Barbara APCD Workshop Package  -  SIP completeness checklist, Rule Evaluation Form, Minute Order, Adoption Resolution 3/10/1998                                      0004 B. Copies of Submitted Rules

B.1 SBAPCD Rule 102, Definitions 10/18/2016                                      0005 B.2 SBAPCD Rule 105, Applicability 10/18/2016                                      0005 B.3 SBAPCD Rule 202, Exemptions to Rule 201 10/18/2016                                      0005 B.4 SBAPCD Rule 204, Applications 10/18/2016                                      0005 B.5 SBAPCD Rule 205, Standards for Granting Permits 3/10/1998                                      0005 B.6 SBAPCD Rule 809, Federal Minor New Source Review 10/18/2016                                      0005 C. Supporting Material and Other Documents C.1 Technical Support Document (TSD) 9/2019                                      0006 C.2 Attachment A - Minor NSR Requirements Analysis 9/2019                                      0006 C.3 Attachment B - Rule 202 Analysis 9/2019                                      0006 C.4 Attachment C - Santa Barbara Ag Emissions 9/2019                                      0006 C.5 CARB Staff Report: Initial Statement of Reasons for Rulemaking, Public Hearing to Consider the Large Confined Animal Facility Definition 5/6/2005                                      0006 C.6 California Senate Bill 700 9/22/2003                                      0006 C.7 SBAPCD Rule 102 SIP Approved (78 FR 21545) 4/11/2013                                      0006 C.8 SBAPCD Rule 105 SIP Approved (64 FR 29790) 6/3/1999                                      0006 C.9 SBAPCD Rule 202 SIP Approved (47 FR 19330) 5/5/1982                                      0006 C.10 SBAPCD Rule 204 SIP Approved (81 FR 6758) 2/9/2016                                      0006 C.11 SBAPCD Rule 205 SIP Approved (47 FR 19330) 5/5/1982                                      0006 D. EPA Guidance Documents, Policies, and Rulemakings D.1 76 FR 38748 − Review of New Sources and Modifications in Indian Country; Final Rule 7/1/2011                                      0007 D.2 78 FR 21537 - Approval of Revisions to Santa Barbara County Air Pollution Control District's Rules and Regulations in State of California; Direct Final Rule 4/11/2013                                      0007 D.3 81 FR 6758 - Revisions to the California State Implementation Plan, Santa Barbara County Air Pollution Control District; Permit Program 2/9/2016                                      0007 D.4 64 FR 29790  -  Approval and Promulgation of Implementation Plans; Santa Barbara Air Pollution Control District ; Direct Final Rule 6/3/1999                                      0008 D.5 69 FR 29880  -  Revisions to the California State Implementation Plan, Santa Barbara Air Pollution Control District; Direct Final Rule 5/26/2004                                      0008 D.6 80 FR 69880  -  Approval of Air Plans; California; Santa Barbara Air Pollution Control District; Prevention of Significant Deterioration 11/12/2015                                      0008


[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3832-3833]
[FR Doc No: 2014-01307]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-E-0760]

Determination of Regulatory Review Period for Purposes of Patent
Extension; GADAVIST

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for GADAVIST and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are necessary) and written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA 2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, rm. 6284, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product GADAVIST
(gadobutrol). GADAVIST is indicated for intravenous use in diagnostic
magnetic resonance imaging in adults and children (2 years of age and
older) to detect and visualize areas with disrupted blood brain barrier
and/or abnormal vascularity of the central nervous system. Subsequent
to this approval, the Patent and Trademark Office received a patent
term restoration application for GADAVIST (U.S. Patent No. 5,980,864)
from Bayer Schering Pharma Aktiengesellschaft and the Patent and
Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
July 10, 2012, FDA advised the Patent and Trademark Office that this
human drug product had undergone a regulatory review period and that
the approval of GADAVIST represented the first permitted commercial
marketing or use of the product. Thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
    FDA has determined that the applicable regulatory review period for
GADAVIST is 4,269 days. Of this time, 3,964 days occurred during the
testing phase of the regulatory review period, while 305 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: July 8, 1999. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on July 8, 1999.

    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: May 14,
2010. FDA has verified the applicant's claim that the new drug
application (NDA) for GADAVIST (NDA 201-277) was initially submitted on
May 14, 2010.
    3. The date the application was approved: March 14, 2011. FDA has
verified the applicant's claim that NDA 201-277 was approved on March
14, 2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,470 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by March 24, 2014. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by July 22, 2014. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, you must
submit two copies of the written petition. A petition submitted
electronically must be submitted to http://www.regulations.gov, Docket
No. FDA 2013-S-0610. Comments and petitions that have not been made
publicly available on http://www.regulations.gov may be viewed in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01307 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Page 24722]
[FR Doc No: 2017-11011]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2016-N-2544; FDA-2013-N-0823; FDA-2013-N-0795; FDA-
2013-N-1147; FDA-2013-N-1064; FDA-2008-D-0150; FDA-2013-N-0663; FDA-
2010-D-0319; FDA-2013-N-0403; FDA-2012-D-0530; FDA-2016-N-0544]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 11601 Landsdown
St., North Bethesda, MD 20852,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under Sec.  3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and
expiration date of OMB approval for each information collection are
shown in table 1. Copies of the supporting statements for the
information collections are available on the Internet at http://www.reginfo.gov/public/do/PRAMain. 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.

        Table 1--List of Information Collections Approved By OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Current Good Manufacturing Practice;           0910-0073       1/31/2020
 Quality System Regulation..............
Format and Content Requirements for Over-      0910-0340       1/31/2020
 the-Counter Drug Product Labeling......
Medical Devices; Third Party Review            0910-0375       1/31/2020
 Under FDAMA............................
Preparing a Claim of Categorical               0910-0541       1/31/2020
 Exclusion or an Environmental
 Assessment for Submission to the Center
 for Food Safety and Applied Nutrition..
Application for Participation in the           0910-0551       1/31/2020
 Medical Device Fellowship Program; Form
 FDA 3608...............................
GFI: Hypertension Indication; Drug             0910-0670       1/31/2020
 Labeling for Cardiovascular Outcome
 Claims.................................
Investigational New Drug Safety                0910-0672       1/31/2020
 Reporting Requirements for Human Drug
 and Biological Products and Safety
 Reporting Requirements for
 Bioavailability and Bioequivalence
 Studies in Humans......................
GFI: Dear Health Care Provider Letters;        0910-0754       1/31/2020
 Improving Communication of Important
 Safety Information.....................
Protection of Human Subjects: Informed         0910-0755       1/31/2020
 Consent; Institutional Review Boards...
Requests for Feedback on Medical Device        0910-0756       1/31/2020
 Submissions............................
National Direct-to-Consumer Advertising        0910-0828       1/31/2020
 Survey.................................
------------------------------------------------------------------------

    Dated: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11011 Filed 5-26-17; 8:45 am]
 BILLING CODE 4164-01-P


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

General Comment:SUPPORTING & RELATED MATERIALS

January 6, 2006 Ltr from representatives of the U.S.-flag maritime industry re  proposed NOAD AIS regulatory action