[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Proposed Rules]
[Page 33028-33030]
[DOCID:fr11jn08-19]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0246]
RIN 1625-AA00

Safety zone; BWRC Annual Thanksgiving Regatta; Lake Moolvalya,
Parker, AZ

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes a safety zone, on the navigable
waters of Lake Moolvalya region on the lower Colorado River in support
of the Bluewater Resort and Casino Annual Thanksgiving Regatta. This
safety zone is necessary to provide for the safety of the participants,
crew, spectators, participating vessels, and other vessels and users of
the waterway. Persons and vessels are prohibited from entering into,
transiting through, or anchoring within this safety zone unless
authorized by the Captain of the Port, or his designated
representative.

DATES: Comments and related material must reach the Coast Guard on or
before July 11, 2008.

ADDRESSES: You may submit comments identified by Coast Guard docket
number USCG-2008-0246 to the Docket Management Facility at the U.S.
Department of Transportation. To avoid duplication, please use only one
of the following methods:
    (1) Online: http://www.regulations.gov.
    (2) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (3) Hand delivery: Room W12-140 on the Ground Floor of the West
Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Petty Officer Kristen Beer, USCG, Waterways Management, U.S.
Coast Guard Sector San Diego at<PHONE_NUMBER>. If you have questions
on viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided. We have an agreement with the
Department of Transportation (DOT) to use the Docket Management
Facility. Please see DOT's ``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2008-0246), indicate the specific section of this
document to which each comment applies, and give the reason for each
comment. We recommend that you include your name and a mailing address,
an e-mail address, or a phone number in the body of your document so
that we can contact you if we have questions regarding your submission.
You may submit your comments and material by electronic means, mail,
fax, or delivery to the Docket Management Facility at the address under
ADDRESSES; but please submit your comments and material by only one
means. If you submit them by mail or delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period. We may change this
proposed rule in view of them.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov at
any time. Enter the docket number for this rulemaking (USCG-2008-0246)
in the Search box, and click ``Go >>.'' You may also visit either the
Docket Management Facility in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays; or the U.S. Coast Guard Sector San Diego, 2710 N. Harbor
Drive, San Diego, CA 92101 between 8 a.m. and 3 p.m., Monday through
Friday, except Federal holidays.

Privacy Act

    Anyone can search the electronic form of all comments received into
any of our dockets by the name of the individual submitting the comment
(or signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review the Department of
Transportation's Privacy Act Statement in the Federal Register
published on April 11, 2000 (65 FR 19477), or you may visit http://
DocketsInfo.dot.gov.

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one to the Docket Management Facility at the address under
ADDRESSES explaining why one would be beneficial. If we determine that
one would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

Background and Purpose

    Southern California Speedboat Club is sponsoring the Bluewater
Resort and Casino Annual Thanksgiving Regatta. The event is a circle
boat race consisting of 85 powerboats ranging from 12 to 22 feet in
length. The sponsor will provide two water rescue boats and two patrol
boats for this event. This safety zone is necessary to provide for the
safety of the participants, crew, spectators, sponsor vessels, and
other users of the waterway.

Discussion of Proposed Rule

    The Coast Guard proposes a safety zone that would be enforced from
6 a.m. on November 28, 2008 to 6 p.m. on November 30, 2008. The limits
of the safety zone would be as follows: The Headgate Dam at
34[deg]10.19 N, 114[deg]16.26 W following the river east to
34[deg]10.30 N, 114[deg]15.72 W.
    This safety zone is necessary to provide for the safety of the
crews, spectators, and participants of the event and to protect other
vessels and users of the waterway. Persons and vessels will be
prohibited from entering into, transiting through, or anchoring within
this safety zone unless authorized by the Captain of the Port or his
designated representative.

Regulatory Evaluation

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order.

    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary.
    This determination is based on the size and location of the safety
zone. Commercial vessels will not be hindered by the safety zone.
Recreational vessels will not be allowed to transit through the
designated safety zone during the specified times.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities.
    This proposed rule would affect the following entities, some of
which might be small entities: The owners or operators of vessels
intending to transit or anchor in the region of Lake Moolvalya on the
lower Colorado River from 6 a.m. on November 28, 2008 to 6 p.m. on
November 30, 2008.
    This safety zone would not have a significant economic impact on a
substantial number of small entities for the following reasons. This
rule would be in effect for twelve hours for a period of 3 days.
Although the safety zone would apply to the entire width of the river,
traffic would be allowed to pass through the zone with the permission
of the Coast Guard patrol commander. Before the effective period, we
will publish a local notice to mariners (LNM) and will issue broadcast
notice to mariners (BNM) alerts via marine channel 16 VFH before the
safety zone is enforced.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    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 so that they can better
evaluate its effects on them and participate in the rulemaking. 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 Petty Officer Kristen Beer,
USCG, Waterways Management, U.S. Coast Guard Sector San Diego at (619)
278-7233. The Coast Guard will not retaliate against small entities
that question or complain about this rule or any policy or action of
the Coast Guard.

Collection of Information

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

Federalism

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

Unfunded Mandates Reform Act

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

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    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.

Energy Effects

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

Technical Standards

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

Environment

    We have analyzed this proposed rule under Commandant Instruction
M16475.lD which guides the Coast Guard in complying with the National

Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is not likely to
have a significant effect on the human environment. A preliminary
``Environmental Analysis Check List'' supporting this preliminary
determination is available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

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

Words of Issuance and Proposed Regulatory Text

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

    2. Add a new temporary safety zone Sec.  165.T11-034.

Sec.  165.T11-034  Safety zone; BWRC Annual Thanksgiving Regatta; Lake
Moolvalya, Parker, AZ.

    (a) Location. The limits of the proposed safety zone are as
follows: The Headgate Dam at 34[deg]10.19 N, 114[deg]16.26 W following
the river east to 34[deg]10.30 N, 114[deg]15.72 W.
    (b) Enforcement Period. This section will be enforced from 6 a.m.
to 6 p.m. on November 28, 2008 through November 30, 2008. If the event
concludes prior to the scheduled termination time, the Captain of the
Port will cease enforcement of this safety zone and will announce that
fact via Broadcast Notice to Mariners.
    (c) Definitions. The following definition applies to this section:
designated representative, means any commissioned, warrant, and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, state, and federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated on-scene representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Patrol Commander
(PATCOM). The PATCOM may be contacted on VHF-FM Channel 16.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: May 22, 2008.
C.V. Strangfeld,
Captain, U.S. Coast Guard, Captain of the Port Sector San Diego.
[FR Doc. E8-13142 Filed 6-10-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Notices]
[Pages 41273-41274]
[FR Doc No: 2017-18376]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-P-1461]

Determination That CENESTIN (Estrogens, Conjugated Synthetic A)
Tablets, 0.3 Milligrams, 0.45 Milligrams, 0.625 Milligrams, 0.9
Milligrams, and 1.25 Milligrams, 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 or Agency) has
determined that CENESTIN (estrogens, conjugated synthetic A) Tablets,
0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9

mg, and 1.25 mg, were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for these products, if all other legal
and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Bronwen Blass, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
796-5092.

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 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic 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 was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been 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.
    CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 mg, 0.45
mg, 0.625 mg, 0.9 mg, and 1.25 mg, is the subject of NDA 020992, held
by Teva Branded Pharmaceutical Products R&D, Inc. (Teva), and was
initially approved on March 24, 1999. CENESTIN is indicated for
treatment of moderate to severe vasomotor symptoms due to menopause and
treatment of moderate to severe symptoms of vulvar and vaginal atrophy
due to menopause.
    In 2016, Teva notified FDA that CENESTIN (estrogens, conjugated
synthetic A) Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg,
were being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
    Foley & Lardner submitted a citizen petition dated March 8, 2017
(Docket No. FDA-2017-P-1461), under 21 CFR 10.30, requesting that the
Agency determine whether CENESTIN (estrogens, conjugated synthetic A)
Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were withdrawn
from sale for reasons of safety or effectiveness.
    After considering the citizen and reviewing Agency records and
based on the information we have at this time, FDA has determined under
Sec.  314.161 that CENESTIN (estrogens, conjugated synthetic A)
Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 mg, were not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that these products
were withdrawn for reasons of safety or effectiveness. We have
carefully reviewed our files for records concerning the withdrawal of
these products from sale. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
found no information that would indicate that these drug products were
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list CENESTIN (estrogens,
conjugated synthetic A) Tablets, 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg, and
1.25 mg, 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
CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 mg, 0.45 mg,
0.625 mg, 0.9 mg, and 1.25 mg, may be approved by the Agency as long as
they meet all other legal and regulatory requirements for the approval
of ANDAs. If FDA determines that labeling for this drug product should
be revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18376 Filed 8-29-17; 8:45 am]
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