[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Notices]
[Pages 14377-14378]
[FR Doc No: 2013-05089]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, March
7, 2013 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting will be:
    institution and settlement of injunctive actions;
    institution and settlement of administrative proceedings; and
    other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: February 28, 2013.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-05089 Filed 3-1-13; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 27 (Wednesday, February 9, 2011)]
[Notices]
[Pages 7219-7220]
[FR Doc No: 2011-2890]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-P-0394] (formerly Docket No. 2005P-0168)

Determination That DECASPRAY (Dexamethasone) Topical Aerosol,
0.04%, and AEROSEB-DEX (Dexamethasone) Topical Aerosol, 0.01%, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX
(dexamethasone) Topical Aerosol, 0.01%, were not withdrawn from sale
for reasons of safety or effectiveness. This determination will allow
FDA to approve abbreviated new drug applications (ANDAs) for
dexamethasone topical aerosol, 0.04% and 0.01%, if all other legal and
regulatory requirements are met. However, in considering whether to
file an ANDA for dexamethasone topical aerosol, 0.04% and 0.01%, future
applicants are advised that they may not be able to obtain DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, for bioequivalence testing because the products
have not been commercially available for a number of years. An ANDA
applicant who is unable to obtain DECASPRAY (dexamethasone) Topical
Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%,
for bioequivalence testing should contact the Office of Generic Drugs
for a determination of what is necessary to show bioavailability and
same therapeutic effect.

FOR FURTHER INFORMATION CONTACT: Janice Weiner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6304, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA). The only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)(7)),
which requires FDA to publish a list of all approved drugs. FDA
publishes this list as part of the ``Approved Drug Products with
Therapeutic Equivalence Evaluations,'' which is known generally as the
``Orange Book.'' Under FDA regulations, drugs are removed from the list
if the Agency withdraws or

suspends approval of the drug's NDA or ANDA for reasons of safety or
effectiveness or if FDA determines that the listed drug was withdrawn
from sale for reasons of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug that has been
voluntarily withdrawn from sale was withdrawn for reasons of safety or
effectiveness. This determination may be made at any time after the
drug has been voluntarily withdrawn from sale, but must be made prior
to approving an ANDA that refers to the listed drug (Sec.  314.161 (21
CFR 314.161)). FDA may not approve an ANDA that does not refer to a
listed drug.
    AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, is the subject
of ANDA 83-296, held by Allergan Herbert (Allergan) and initially
approved on June 15, 1973. AEROSEB-DEX is indicated for relief of the
inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses.
    In its June 1997 annual report, Allergan notified FDA that AEROSEB-
DEX (dexamethasone) Topical Aerosol, 0.01%, was being discontinued, and
FDA moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book. In a letter dated August 28, 1998, Allergan
requested withdrawal of ANDA 83-296 for AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%. In the Federal Register of June 10, 1999 (64 FR
31226), FDA announced that it was withdrawing approval of ANDA 83-296,
effective July 12, 1999.
    Acaderm Inc., (Acaderm) submitted a citizen petition dated April
28, 2005 (Docket No. FDA-2005-P-0394), under 21 CFR 10.30, requesting
that the Agency determine whether AEROSEB-DEX (dexamethasone) Topical
Aerosol, 0.01%, was withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, that dexamethasone topical
aerosol product has also been discontinued. On our own initiative, we
have also determined whether DECASPRAY (dexamethasone) Topical Aerosol,
0.04%, was withdrawn for safety or effectiveness reasons.
    DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, is the subject of
NDA 12-731, held by Merck & Co., Inc. (Merck). DECASPRAY, a synthetic
adrenocortical steroid, was initially approved on March 29, 1961,
solely on the basis of safety. The 1962 amendments to the FD&C Act
require that drugs be shown to be effective as well. To accomplish
this, FDA initiated the Drug Efficacy Study Implementation (DESI)
review to evaluate the effectiveness of drugs that had been previously
approved on safety grounds alone. In its DESI review of topical
corticosteroids, FDA concluded that NDA 12-731 for dexamethasone
topical aerosol was effective for certain indications (see 36 FR 7982,
April 28, 1971), and it was labeled for relief of the inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses.
    In its annual report, Merck notified FDA that DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, was being discontinued, and FDA
moved the drug product to the ``Discontinued Drug Product List''
section of the Orange Book. In a letter dated June 25, 2002, Merck
requested withdrawal of NDA 12-731 for DECASPRAY (dexamethasone)
Topical Aerosol, 0.04%. In the Federal Register of August 18, 2003 (68
FR 49481), FDA announced that it was withdrawing approval of NDA 12-
731, effective September 17, 2003.
    After considering the citizen petition and comments submitted to
the docket, and reviewing Agency records, FDA has determined under
Sec.  314.161 that AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%,
was not withdrawn from sale for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of AEROSEB-DEX
(dexamethasone) Topical Aerosol, 0.01%, from sale and have found no
information that would indicate that this product was withdrawn from
sale for reasons of safety or effectiveness.
    FDA has also determined under Sec.  314.161 that DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, was not withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of DECASPRAY (dexamethasone) Topical
Aerosol, 0.04%, from sale. We have also independently evaluated
relevant literature and data for possible postmarketing adverse events
and have found no information that would indicate that this product was
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, and AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to DECASPRAY (dexamethasone) Topical
Aerosol, 0.04%, and AEROSEB-DEX (dexamethasone) Topical Aerosol, 0.01%,
may be approved by the Agency as long as they meet all other legal and
regulatory requirements for approval of ANDAs. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
    In considering whether to file an ANDA for this drug product,
future applicants should be advised that they may not be able to obtain
DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX
(dexamethasone) Topical Aerosol, 0.01%, for bioequivalence testing
because the products have not been commercially available for a number
of years. An ANDA applicant who is unable to obtain DECASPRAY
(dexamethasone) Topical Aerosol, 0.04%, or AEROSEB-DEX (dexamethasone)
Topical Aerosol, 0.01%, for bioequivalence testing should contact the
Office of Generic Drugs for a determination of what showing is
necessary to satisfy the requirements of section 505(j)(2)(A)(iv) of
the FD&C Act. If an ANDA is approved without a showing of
bioequivalence, the approved product will not be considered
therapeutically equivalent to the reference listed drug, i.e., granted
an AB rating, in the Orange Book.

    Dated: February 3, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-2890 Filed 2-8-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 87, Number 68 (Friday, April 8, 2022)]
[Proposed Rules]
[Pages 20796-20798]
[FR Doc No: 2022-07540]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0915]
RIN 1625-AA00

Safety Zones for Parallel Thimble Shoal Tunnel Project on the
Chesapeake Bay Bridge Tunnel; Chesapeake Bay, VA

AGENCY: Coast Guard, Homeland Security (DHS).

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish temporary safety
zones for certain waters of the Chesapeake Bay. This action is
necessary to provide for the safety of life on these navigable waters
near the Chesapeake Bay Bridge Tunnel (CBBT), linking Southeastern
Virginia to the Eastern Shore, during an already ongoing construction
project on the CBBT. This proposed rulemaking would prohibit persons
and vessels from operating within 500 feet of the construction area
unless authorized by the Captain of the Port (COTP) Sector Virginia or
a designated representative. We invite your comments on this proposed
rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before May 23, 2022.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0915 using the Federal Decision Making 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.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LCDR Ashley Holm, Sector Virginia,
Waterways Management Division, U.S. Coast Guard, Telephone: (757) 668-
5581; Email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CBBT Chesapeake Bay Bridge Tunnel
CFR Code of Federal Regulations
COTP Captain of the Port Sector Virginia
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    In December, 2021, the COTP was notified by project management for
the Parallel Thimble Shoals Tunnel Project that construction work in
vicinity of the CBBT's southern two islands, South Thimble Island and
North Thimble Island, creates hazards to the maritime public and
recommended the establishment of safety zones. Hazards include the
operation of heavy machinery and loads suspended by cranes over the
waters surrounding the islands and attached structures. Specifically,
safety concerns were raised that involved kayakers and vessels fishing
in the vicinity of the construction site despite posted signs
indicating not to approach the site within 500 feet. The COTP has
determined that potential hazards associated with the construction
equipment used in this project creates a safety concern for those
transiting within 500 feet of the project site. This construction
project has been ongoing for 4 years, workers are present at all hours
and the work is projected to continue for the next 5 years.
    This rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the safety zone while the
bridge tunnel is under construction. The Coast Guard is proposing this
rulemaking under authority in 46 U.S.C. 70034.

III. Discussion of Proposed Rule

    The COTP is proposing to establish two temporary safety zones
extending 500 feet in all directions from the edge of both South
Thimble Island and North Thimble Island. These islands are located
approximately 3.3 miles and 4.5 miles respectively, from the shores of
Virginia Beach, Virginia, along Highway 13, and serve as the ends of
what is commonly called the Chesapeake Bay Bridge [southern] Tunnel.
The safety zones would be in effect until January 31, 2027. No vessel
or person would be permitted to enter either of the safety zones
without obtaining permission from the COTP or a designated
representative. The regulatory text we are proposing appears at the end
of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and

Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on its minimal impact
to the local economy, as any fishery needing to use these waters can be
accommodated by the two other man-made islands approximately 5 miles to
the north and the attached 15 miles of bridge trestle which are not
covered with construction equipment, and therefore will not be covered
by these safety zones.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zones may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. We have analyzed this proposed rule under that order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this proposed 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 made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves the
establishment of safety zones to protect the public from hazards
created by ongoing construction work. Normally such actions are
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A
preliminary Record of Environmental Consideration supporting this
determination is available in the docket. For instructions on locating
the docket, see the ADDRESSES section of this preamble. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

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

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2021-0915 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.

    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. We review all comments received, but we will only
post comments that address the topic of the proposed rule. We may
choose not to post off-topic, inappropriate, or duplicate comments that
we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

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 is
proposing to amend 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.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T05-0915 to read as follows:

Sec.  165.T05-0915  Safety Zones; Chesapeake Bay Bridge Tunnel,
Chesapeake Bay Entrance, VA.

    (a) Location. The following areas are safety zones:
    (1) Any waters located within 500 feet in all directions from the
edge of South Thimble Island. South Thimble Island is located
approximately 3.3 miles north of the shores of Virginia Beach on
Highway 13, also known as the Chesapeake Bay Bridge Tunnel (CBBT).
    (2) Any waters located within 500 feet in all directions from the
edge of North Thimble Island. North Thimble Island is located
approximately 4.5 miles north of Virginia Beach on Highway 13.
    (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 and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Sector Virginia (COTP) in the enforcement of the
safety zones. The term also includes an employee or contractor of
Chesapeake Tunnel Joint Venture (CTJV) for the sole purpose of
designating and establishing safe transit corridors, to permit passage
into or through these safety zones, or to notify vessels and
individuals that they have entered a safety zone and are required to
depart immediately.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, no vessel or person may enter or remain in any
safety zone described in paragraph (a) of this section unless
authorized by the COTP, or designated representative. If a vessel or
person is notified by the COTP, or designated representative that they
have entered one of these safety zones without permission, they are
required to immediately depart in a safe manner following the
directions given.
    (2) Mariners requesting to transit any of these safety zones must
first contact the CTJV designated representatives, CTJV Marine General
Superintendant by phone at<PHONE_NUMBER>, CTJV Safety Director at 702-
415-8600, or CTJV Construction Manager at<PHONE_NUMBER>. CTJV will be
monitoring VHF-FM channels 13 and 16 while work is ongoing. If
permission is granted, mariners must proceed at their own risk and
strictly observe any and all instructions provided by the COTP, or
designated representative to the mariner regarding the conditions of
entry to and exit from any location within the fixed safety zones.
    (d) Enforcement. The Sector Virginia COTP may enforce the
regulations in this section and may be assisted by any Federal, state,
county, or municipal law enforcement agency.
    (e) Enforcement period. This section will be enforced until January
31, 2027, unless cancelled sooner by the COTP.

    Dated: April 04, 2022.
Samson C. Stevens,
Captain, U.S. Coast Guard, Captain of the Port Sector Virginia.
[FR Doc. 2022-07540 Filed 4-7-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 133 (Tuesday, July 12, 2011)]
[Notices]
[Pages 40903-40904]
[FR Doc No: 2011-17478]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2524-019]

Grand River Dam Authority; Notice of Application for Amendment of
License and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Amendment of License.
    b. Project No: 2524-019.
    c. Date Filed: January 21, 2011.
    d. Applicant: Grand River Dam Authority.
    e. Name of Project: Salina Pumped Storage Project.
    f. Location: The project is located on the Saline Creek arm Lake
Hudson in Mayes County, Oklahoma.
    g. Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Gretchen Zumwalt-Smith, General Counsel,
Grand River Dam Authority, P.O. Box 409, Vinita, OK 73401-0409. Tel:
(918) 256-5545.
    i. FERC Contact: Any questions on this notice should be addressed
to Vedula Sarma at<PHONE_NUMBER> or<EMAIL_ADDRESS>    j. Deadline for filing comments and or motions: July 21, 2011.
    Comments, protests, and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site (http://www.ferc.gov/docs-filing/efiling.asp). Commenters can submit brief comments up to
6,000 characters, without prior registration, using the eComment system
(http://www.ferc.gov/

docs-filing/ecomment.asp) and must include name and contact information
at the end of comments. The Commission strongly encourages electronic
filings.
    All documents (original and seven copies) filed by paper should be
sent to: Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426. Please include the project number
(P-2524-019) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervener files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    k. Description of Application: The licensee proposes to relocate
the current Chimney Rock substation to a new location within the
project boundary for greater safety and reliability. The major
construction related work items for the relocation include (a)
Extending the double-circuit 161-kV transmission line from Chimney Rock
substation to new Saline Creek substation, (b) installing a new 161 kV
transmission line from Saline Creek substation to existing 161 kV bus
top of Chimney Rock powerhouse, (c) installing protective relays for
161 kV line at Salina pumped storage powerhouse, and (d) installing
underground 13.2 kV station lines from Saline Creek substation to
Chimney Rock powerhouse.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site using the ``eLibrary'' link at http://elibrary.ferc.gov/idmws/search/fercgensearch.asp. Enter the docket
number excluding the last three digits (P-2524) in the docket number
field to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via e-mail of
new filings and issuances related to this or other pending projects.
For assistance, call 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Any filings must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as applicable,
and the Project Number of the particular application to which the
filing refers.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

    Dated: July 6, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-17478 Filed 7-11-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 43 (Monday, March 5, 2018)]
[Notices]
[Pages 9306-9307]
[FR Doc No: 2018-04375]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2007-1196; FRL-9974-41-OAR]

Recent Postings of Broadly Applicable Alternative Test Methods

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: This notice announces the broadly applicable alternative test
method approval decisions that the Environmental Protection Agency
(EPA) has made under and in support of New Source Performance Standards
(NSPS) and the National Emission Standards for Hazardous Air Pollutants
(NESHAP) between January 1, 2017, and December 31, 2017.

FOR FURTHER INFORMATION CONTACT: An electronic copy of each alternative
test method approval document is available at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods. For questions
about this notice, contact Mrs. Lula H. Melton, Air Quality Assessment
Division, Office of Air Quality Planning and Standards (E143-02),
Environmental Protection Agency, Research Triangle Park, NC 27711;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address: [email protected]. For technical questions about individual
alternative test method decisions, refer to the contact person
identified in the individual approval document(s).

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this notice apply to me?

    This notice will be of interest to entities regulated under 40 Code
of Federal Regulations (CFR) parts 60, 61, and 63; state, local, and
tribal agencies; and the EPA Regional offices responsible for
implementation and enforcement of regulations under 40 CFR parts 60,
61, and 63.

B. How can I get copies of this information?

    You may access copies of the broadly applicable alternative test
method approval documents at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods.

II. Background

    This notice identifies broadly applicable alternative test method
approval decisions made by the EPA in 2017 under the NSPS, 40 CFR part
60 and the NESHAP programs, and 40 CFR parts 61 and 63 (see Table 1).
Source owners and operators may voluntarily use these broadly
applicable alternative test methods in lieu of otherwise specified
reference test methods. Use of these broadly applicable alternative
test methods does not change the applicable emission standards.
    The Administrator has the authority to approve the use of
alternative test methods for compliance with requirements under 40 CFR
parts 60, 61, and 63. This authority is found in sections 60.8(b)(3),
61.13(h)(1)(ii), and 63.7(e)(2)(ii). Additional and similar authority
can be found in 40 CFR 65.158(a)(2). The criteria for approval and
procedures for submission and review of broadly applicable alternative
test methods are explained in a previous Federal Register notice
published at 72 FR 4257 (January 30, 2007) and located at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods.
As explained in this notice, we will announce approvals for broadly
applicable alternative test methods at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods and publish an annual
notice that summarizes approvals for broadly applicable alternative
test methods during the preceding year.
    As also explained in the January 30, 2007, notice, our approval
decisions involve thorough technical reviews of numerous source-
specific requests for alternatives and modifications to test methods
and procedures. Based on these reviews, we have often found that these
modifications or alternatives would be equally valid and appropriate to
apply to other sources within a particular class, category, or
subcategory. Consequently, we have concluded that where a method
modification or an alternative method is clearly broadly applicable to
a class, category, or subcategory of sources, it is both equitable and
efficient to approve its use for all appropriate sources and situations
at the same time.
    Use of approved alternative test methods are not mandatory but
rather

permissive. Sources are not required to employ such a method but may
choose to do so in appropriate circumstances. As per section
63.7(f)(5), however, a source owner or operator electing to use an
alternative method for 40 CFR part 63 standards must continue to use
the alternative method until otherwise authorized. Source owners or
operators should, therefore, review the specific broadly applicable
alternative method approval decision at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods before electing to
employ any alternative method.

III. Approved Alternative Test Methods and Modifications to Test
Methods

    This notice specifies three broadly applicable alternative test
methods that the EPA approved between January 1, 2017, and December 1,
2017. The alternative method decision letter/memo number, the reference
method affected, sources allowed to use this alternative, and the
modification or alternative method allowed are summarized in Table 1 of
this notice. A summary of approval documents was previously made
available on our Technology Transfer Network between January 1, 2017,
and December 31, 2017. For more detailed information, please refer to
the complete copies of these approval documents available at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods.
    As also explained in our January 30, 2007, notice, we will revisit
approvals of alternative test methods in response to written requests
or objections indicating that a particular approved alternative test
method either should not be broadly applicable or that its use should
in some way be limited. Any objection to a broadly applicable
alternative test method, as well as the resolution of that objection,
will be announced at https://www.epa.gov/emc/broadly-applicable-approved-alternative-test-methods and in a subsequent Federal Register
notice. If we decide to retract a broadly applicable test method, we
will likely consider the need for an appropriate transition period for
users either to request case-by-case approval or to transition to an
approved method.

    Dated: February 13, 2018.
Panagiotis E. Tsirigotis,
Director, Office of Air Quality Planning and Standards.

  Table 1--Approved Alternative Test Methods and Modifications to Test Methods Referenced in or Published Under
            Appendices in 40 CFR Parts 60, 61, and 63 Posted Between January 2017 and December 2017.
----------------------------------------------------------------------------------------------------------------
 Alternative method decision    As an alternative or
     letter/memo number        modification to . . .             For . . .                  You may . . .
----------------------------------------------------------------------------------------------------------------
ALT-120.....................  40 CFR                   Sources subject to 40 CFR     Use the alternative
                               63.1350(k)(2)(ii) and    part 63, subpart LLL-         procedure for above span
                               (iii).                   National Emission Standards   mercury calibrations
                                                        for Hazardous Air             through January 1, 2019,
                                                        Pollutants from the           only as specified in the
                                                        Portland Cement               Agency's approval letter
                                                        Manufacturing Industry.       dated December 7, 2017.
ALT-121.....................  Method 3-Gas Analysis    Sources subject to 40 CFR     Use Method 3A-Determination
                               for the Determination    part 60, subpart Ja-          of Oxygen and Carbon
                               of Dry Molecular         Standards of Performance      Dioxide Concentrations in
                               Weight.                  for Petroleum Refineries      Emissions From Stationary
                                                        for Which Construction,       Sources (Instrumental
                                                        Reconstruction, or            Analyzer Procedures).
                                                        Modification Commenced
                                                        After May 14, 2007.
ALT-122.....................  Method 325 A-Volatile    Sources subject to 40 CFR     Use the alternative
                               Organic Compounds From   part 63, subpart CC-          approaches for temperature
                               Fugitive and Area        National Emission Standards   and pressure corrections,
                               Sources: Sampler         for Hazardous Air             sample collection timing,
                               Deployment and VOC       Pollutants From Petroleum     and duplicate and field
                               Sample Collection and    Refineries.                   blank samples as specified
                               Method 325B-Volatile                                   in the Agency's approval
                               Organic Compounds From                                 letter dated September 11,
                               Fugitive and Area                                      2017.
                               Sources: Sampler
                               Preparation and
                               Analysis.
----------------------------------------------------------------------------------------------------------------
Source owners or operators should review the specific broadly applicable alternative method approval letter at
  https://www.epa.gov/emc/ broadly-applicable-approved-alternative-test-methods before electing to employ it.

[FR Doc. 2018-04375 Filed 3-2-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Rules and Regulations]
[Pages 51483-51484]
[FR Doc No: 2014-20541]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0762]

Drawbridge Operation Regulations; Townsend Gut, Boothbay Harbor
and Southport, ME

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the operation of the Southport SR27
Bridge across Townsend Gut, mile 0.7, between Boothbay Harbor and
Southport, Maine. The bridge owner, Maine Department of Transportation
will be performing structural repairs at the bridge. This deviation
allows the bridge to operate on a temporary schedule for eleven weeks
to facilitate scheduled bridge maintenance.

DATES: This deviation is effective from September 8, 2014 through
November 22, 2014.

ADDRESSES: The docket for this deviation, [USCG-2014-0762] is

available at http://www.regulations.gov. Type the docket number in the
``SEARCH'' box and click ``SEARCH.'' Click on Open Docket Folder on the
line associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140, on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC, 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. John McDonald, Project Officer, First Coast Guard
District, telephone<PHONE_NUMBER><EMAIL_ADDRESS>If you
have questions on viewing the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Southport SR27 Bridge, across Townsend
Gut, mile 0.7, between Boothbay Harbor and Southport, Maine, has a
vertical clearance in the closed position of 10 feet above mean high
water and 19 feet above mean low water. The bridge operating
regulations are listed at 33 CFR 117.537.
    The waterway is transited by recreational and commercial fishing
boats.
    The bridge owner, Maine Department of Transportation, requested a
temporary deviation from the normal operating schedule to facilitate
deck repairs at the bridge.
    Under this temporary deviation the Southport SR27 Bridge shall
operate as follows: From September 8, 2014 through November 22, 2014,
the draw shall open on signal at 12 a.m., 3 a.m., 6 a.m., 9 a.m., 12
p.m., 3 p.m., 6 p.m., and 9 p.m. The draw shall remain in the closed
position from 6 p.m. through 6 a.m. on twelve dates to be announced in
the Local Notice to Mariners (LNTM) and via a broadcast notice to
mariners (BNTM), at least two weeks prior to each closure date. There
is an alternate route for navigation around Southport. Vessels that can
pass under the bridge in the closed position may do so at all times.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: August 15, 2014.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2014-20541 Filed 8-28-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 77 (Tuesday, April 21, 2020)]
[Notices]
[Page 22244]
[FR Doc No: 2020-08363]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2020-0385]

Agency Information Collection Activities: Requests for Comments;
Clearance of a Renewed Approval of Information Collection: Competition
Plans, Passenger Facility Charges

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the
FAA invites public comments about our intention to request the Office
of Management and Budget (OMB) approval to renew an information
collection.

DATES: Written comments should be submitted by June 22, 2020.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Rachel McCoy, Office of Airport Planning and Programming,
Federal Aviation Administration, 800 Independence Ave. SW, Suite 620,
Washington, DC 20591.
    By fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For further information please contact
Amanda Shotto by email at<EMAIL_ADDRESS>phone:<PHONE_NUMBER>

SUPPLEMENTARY INFORMATION: The FAA, in accordance with the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the
general public and Federal agencies with an opportunity to comment on
proposed, revised, and continuing collections of information. This
helps the FAA assess the impact of its information collection
requirements and minimize the public's reporting burden.
    The FAA invites comment on any aspect of this information
collection, including (a) Whether the proposed collection of
information is necessary for the FAA's performance; (b) the accuracy of
the estimated burden; (c) ways for the FAA to enhance the quality,
utility and clarity of the information collection; and (d) ways that
the burden could be minimized without reducing the quality of the
collected information. The agency will summarize and/or include your
comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0661.
    Title: Competition Plans, Passenger Facility Charges.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The DOT/FAA will use any information submitted in
response to this requirement to carry out the intent of Title 49,
Sections 40117(k) and 47106(f). These rules assure that a covered
airport has, and implements, a plan that provides opportunities for
competitive access by new entrant air carriers or air carriers seeking
to expand. The affected public includes public agencies controlling
medium or large hub airports.
    Respondents: 5 affected airports annually.
    Frequency: On occasion.
    Estimated Average Burden per Response: Approximately 150 hours.
    Estimated Total Annual Burden: Approximately 750 annually.

    Issued in Washington, DC, on April 15, 2020.
David F. Cushing,
Manager, Airports Financial Assistance Division, APP-500.
[FR Doc. 2020-08363 Filed 4-20-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 203 (Monday, October 23, 2017)]
[Notices]
[Page 49015]
[FR Doc No: 2017-22888]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC17-86-001.
    Applicants: Green Mountain Power Corporation.
    Description: Notice of Non-Material Change in Circumstances of
Green Mountain Power Corporation.
    Filed Date: 10/13/17.
    Accession Number: 20171013-5187.
    Comments Due: 5 p.m. ET 11/3/17.

    Docket Numbers: EC17-109-000.
    Applicants: ALLETE, Inc., ALLETE Clean Energy, Inc.
    Description: Response of ALLETE, Inc., et al. to September 15, 2017
letter requesting additional information.
    Filed Date: 10/13/17.
    Accession Number: 20171013-5184.
    Comments Due: 5 p.m. ET 11/3/17.

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

    Docket Numbers: ER12-1923-003; ER10-2334-004; ER12-1924-003; ER11-
3406-004; ER11-3407-004; ER10-2897-006; ER12-1865-005; ER12-1925-003.
    Applicants: Big Savage, LLC, Big Sky Wind, LLC, EverPower
Commercial Services LLC, Highland North LLC, Howard Wind LLC, Krayn
Wind LLC, Mustang Hills, LLC, Patton Wind Farm, LLC.
    Description: Supplement to June 30, 2017 Triennial Market Power
Update for the Northeast Region of the EverPower Companies.
    Filed Date: 10/12/17.
    Accession Number: 20171012-5153.
    Comments Due: 5 p.m. ET 11/2/17.

    Docket Numbers: ER15-1456-004; ER11-4634-004; ER17-436-002; ER17-
437-004; ER15-1457-004.
    Applicants: Beaver Falls, L.L.C., Hazleton Generation LLC, Marcus
Hook Energy, L.P., Marcus Hook 50, L.P., Syracuse, L.L.C.
    Description: Supplement to June 30, 2017 Triennial Market Power
Update for the Northeast Region of Beaver Falls, L.L.C., et al.
    Filed Date: 10/12/17.
    Accession Number: 20171012-5161.
    Comments Due: 5 p.m. ET 11/2/17.

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

    Dated: October 16, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-22888 Filed 10-20-17; 8:45 am]
BILLING CODE 6717-01-P