[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Proposed Rules]
[Pages 42440-42443]
[FR Doc No: 2015-17481]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0004]
RIN 1625-AA11

Regulated Navigation Area; Middle Waterway Superfund Cleanup
Site, Commencement Bay; Tacoma, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a regulated navigation
area (RNA) on the Middle Waterway in Tacoma, Washington. The RNA will
protect the sediment cap areas in the U.S. Environmental Protection
Agency (EPA)'s Commencement Bay Nearshore/Tideflats (CB-NT) Superfund
Cleanup Site in the Middle Waterway Problem Area. This regulated
navigation area would prohibit activities that could disrupt the
integrity of the engineered sediment caps that have been placed within
the Middle Waterway Problem Area. These activities include vessel
grounding, anchoring, dragging, trawling, spudding or other such
activities that would disturb the integrity of the sediment caps. It
will not affect transit or navigation of this area or the existing
industrial activities occurring in this area.

DATES: Comments and related material must be received by the Coast
Guard on or before October 15, 2015. Requests for public meetings must
be received by the Coast Guard on or before August 17, 2015.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: 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. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LTJG Johnny Zeng, Waterways Management Division, Sector
Puget Sound, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. 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.

1. Submitting comments

    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. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if

we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2015-0004] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand 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 comments 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 and may change the rule
based on your comments.

2. 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,
type the docket number (USCG-2015-0004) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. 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.

3. Privacy Act

    Anyone can search the electronic form of 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 a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one, using one of the methods specified under ADDRESSES.
Please explain why you believe a public meeting 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.

B. Regulatory History and Information

    The Coast Guard received notice from the U.S. EPA requesting the
establishment of a Regulated Navigation Area (RNA) for the Middle
Waterway Problem Area of the CB-NT Superfund Cleanup Site in Tacoma,
Washington. This request was received as a result of the need to
protect the engineered sediment caps in the Middle Waterway from
activities that could disrupt the integrity of the caps within the CB-
NT Superfund Cleanup Site.
    The CB-NT was added to the U.S. EPA's National Priorities List
(Superfund) in September 1983 because of hazardous substance
contamination in the sediment. The EPA selected the Middle Waterway
Problem Area for remedial action, and subsequently cleanup activities
were conducted pursuant to the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA).
    Remediation activities identified for the Middle Waterway included
dredging, placement of enhanced natural recovery material, placement of
caps, and natural recovery. The caps consist of approximately three
feet of sand and gravel and light-loose riprap, and were placed in
various locations within the waterway to contain the contaminated
sediments. These caps were designed to withstand activities common to a
working waterfront. The cap areas cover approximately two acres of
sediment in the waterway. Construction activities were initiated in
July 2003 and completed in January 2005. A Remedial Action Completion
Report documenting the cleanup activities was completed and approved by
the U.S. EPA in April 2005.

C. Basis and Purpose

    Under the Ports and Waterways Safety Act, the Coast Guard has the
authority to establish RNAs in defined water areas that are determined
to have hazardous conditions and in which vessel traffic can be
regulated in the interest of safety. See 33 U.S.C. 1231 and Department
of Homeland Security Delegation No. 0170.1. Coast Guard District
Commanders are granted authority under 33 CFR 165.11 to regulate vessel
traffic in areas with hazardous conditions. This rule is necessary to
prevent disturbance of the sediment caps established in the Middle
Waterway Problem Area of the CB-NT Superfund Cleanup Site. Disruption
of the integrity of the caps may result in a hazardous condition and
harm to the marine environment. As such, this RNA is necessary to
protect the integrity of the caps and will do so by prohibiting
maritime activities that could disturb or damage them. Enforcement of
this RNA will be managed by Coast Guard Sector Puget Sound assets
including Vessel Traffic Service Puget Sound through radar and closed
circuit television sensors. The Captain of the Port Puget Sound may
also be assisted by other state, local, or government agencies in the
enforcement of this rule.

D. Discussion of Proposed Rule

    The Coast Guard proposes to establish a permanent RNA on the Middle
Waterway to protect the sediment caps in the Middle Waterway Problem
Area of the CB-NT Superfund Site. It would do so by restricting vessel
anchoring, dragging, trawling, spudding or other activities that could
disrupt the integrity of the caps and the underlying contaminated
sediments located in the proposed RNA. Activities common in the
proposed regulated areas include tugboat and log-rafting activities,
tugboat moorage, removal and launching of ships for repair, and other
ship repair and maintenance activities. The cap areas were designed to
be compatible with the activities described above that are associated
with a working waterfront. The material used for the caps was chosen to
be able to contain underlying sediments without altering the main
activities of the working waterway.

E. 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 or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. This expectation is
based on the fact that the RNA established by the rule would encompass
a small area that should not impact commercial or recreational traffic,
and the prohibited activities are not routine for the designated areas.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small

businesses, not-for-profit organizations that are independently owned
and operated and are not dominant in their fields, and governmental
jurisdictions with populations of less than 50,000. The Coast Guard
certifies under 5 U.S.C. 605(b) that this proposed rule will not have a
significant economic impact on a substantial number of small entities.
This proposed rule would affect the following entities, some of which
may be small entities: The owners or operators of vessels intending to
anchor, drag, dredge, trawl, spud, or disturb the riverbed in any
fashion when this rule is in effect. The RNA would not have a
significant economic impact on small entities due to its small area and
waiver process for legitimate use.
    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 proposed rule would economically affect it.

3. 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. 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 contact the person listed in FOR FURTHER
INFORMATION CONTACT. 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.

4. Collection of Information

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

5. Federalism

    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
determined that this rulemaking does not have implications for
federalism.

6. 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.

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

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

9. 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.

10. Protection of Children From Environmental Health Risks

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

11. 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. The
Coast Guard and EPA consulted with the Puyallup tribe in coming to this
determination.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide 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 one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. This proposed rule
involves a regulated navigation area which prevents activities which
would disturb the riverbed within the areas outlined in this
regulation. This proposed rule is categorically excluded from further
review under paragraph 34(h) of Figure 2-1 of the Commandant
Instruction. A preliminary environmental analysis checklist supporting
this determination and a Categorical Exclusion Determination are
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, Waterways.

33 CFR Part 165

    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

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

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 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.  165.1342 to subpart F under the undesignated center
heading Thirteenth Coastguard District to read as follows:

Sec.  165.1342  Regulated Navigation Area; Middle Waterway Superfund
Cleanup Site, Commencement Bay; Tacoma, WA

    (a) Regulated Areas. The following areas are regulated navigation
areas: All waters within the Middle Waterway south of a line connecting
a point on the shore at 47[deg]15'51'' N, 122[deg]25'53'' W; thence
southwest to 47[deg]15'47'' N, 122[deg]25'59'' W [Datum: NAD 1983].
    (b) Regulations. (1) All vessels and persons are prohibited from
activities that would disturb the seabed, such as grounding, anchoring,
dragging, trawling, spudding, or other activities that involve
disrupting the integrity of the caps within the designated regulated
navigation area, pursuant to the remediation efforts of the U.S.
Environmental Protection Agency (EPA) in the Middle Waterway's EPA
superfund cleanup site. Vessels may otherwise transit or navigate
within this area in accordance with the Navigation Rules.
    (2) The prohibition described in paragraph (b)(1) of this section
does not apply to vessels or persons engaged in activities associated
with remediation efforts in the Middle Waterway superfund sites,
provided that the Captain of the Port, Puget Sound (COTP), is given
advance notice of those activities by the EPA.
    (c) Waivers. Upon written request stating the need and proposed
conditions of the waiver, and any proposed precautionary measures, the
COTP may authorize a waiver from this section if the COTP determines
that the activity for which the waiver is sought can take place without
undue risk to the remediation efforts described in paragraph (b)(1) of
this section. The COTP will consult with EPA in making this
determination when necessary and practicable.

    Dated: June 22, 2015.
R. T. Gromlich,
Rear Admiral, U.S. Coast Guard, Commander, Thirteenth Coast Guard
District.
[FR Doc. 2015-17481 Filed 7-16-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49102-49103]
[FR Doc No: 2018-21199]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3569]

GlaxoSmithKline, LLC, et al.; Withdrawal of Approval of 24
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 24 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of October 29, 2018.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
ANDA 061336............  Bactocill (oxacillin     GlaxoSmithKline, LLC,
                          sodium) Capsules,        Five Moore Dr., P.O.
                          Equivalent to (EQ) 250   Box 13398, Research
                          milligrams (mg) base     Triangle Park, NC
                          and EQ 500 mg base.      27709.
ANDA 061773............  Kefzol (cefazolin) for   ACS Dobfar S.p.A., c/o
                          Injection USP, EQ 250    Interchem Corp., 120
                          mg base/vial, EQ 500     Rte. 17 North,
                          mg base/vial, EQ 1       Paramus, NJ 07652.
                          gram (g) base/vial, EQ
                          10 g base/vial, and EQ
                          20 g base/vial.
ANDA 062615............  Nystatin Vaginal         Odyssey
                          Inserts USP, 100,000     Pharmaceuticals,
                          units.                   Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 063304............  Clindamycin Phosphate    Wockhardt Bio AG, c/o
                          Topical Solution USP,    Morton Grove
                          EQ 1% base.              Pharmaceuticals,
                                                   Inc., 6451 Main St.,
                                                   Morton Grove, IL
                                                   60053.
ANDA 065001............  Cefuroxime for           Fresenius Kabi USA,
                          Injection USP, EQ        LLC, Three Corporate
                          750mg base/vial and EQ   Dr., Lake Zurich, IL
                          1.5 g base/vial.         60047.
ANDA 065002............  Cefuroxime for           Do.
                          Injection USP, EQ 7.5
                          g base/vial (Pharmacy
                          Bulk Package).
ANDA 070736............  Ibuprofen Tablets USP,   Aurolife Pharma, LLC,
                          300 mg, 400 mg, and      279 Princeton
                          600 mg.                  Hightstown Rd., East
                                                   Windsor, NJ 08520.
ANDA 071202............  Sensorcaine--MPF Spinal  Fresenius Kabi USA,
                          (bupivacaine             LLC.
                          hydrochloride (HCl))
                          in Dextrose Injection
                          8.25% USP, 0.75%.
ANDA 071846............  Nitroglycerin in         Hospira, Inc., 275
                          Dextrose 5% Injection,   North Field Dr.,
                          10 mg/100 milliliter     Bldg. H1, Lake
                          (mL).                    Forest, IL 60045.
ANDA 071847............  Nitroglycerin in         Do.
                          Dextrose 5% Injection,
                          20 mg/100 mL.
ANDA 071848............  Nitroglycerin in         Do.
                          Dextrose 5% Injection,
                          40 mg/100 mL.
ANDA 072629............  Albuterol Tablets USP,   Watson Laboratories,
                          EQ 2 mg base.            Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 074991............  Loperamide HCl Oral      Duramed
                          Solution, 1 mg/5 mL.     Pharmaceuticals,
                                                   Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.

ANDA 077312............  Fentanyl Citrate Troche/ Par Pharmaceutical,
                          Lozenge, EQ 0.2 mg       Inc., One Ram Ridge
                          base, EQ 0.4 mg base,    Rd., Chestnut Ridge,
                          EQ 0.6 mg base, EQ 0.8   NY 10977.
                          mg base, EQ 1.2 mg,
                          and EQ 1.6 mg base.
ANDA 077853............  Metformin HCl Tablets    Provident
                          USP, 500 mg, 850 mg,     Pharmaceutical, Inc.,
                          and 1 g.                 c/o Vintage
                                                   Pharmaceuticals, LLC,
                                                   1400 Atwater Dr.,
                                                   Malvern, PA 19355.
ANDA 080355............  Hydrocortisone Tablets   Watson Laboratories,
                          USP, 20 mg.              Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc., Morris
                                                   Corporate Center III,
                                                   400 Interpace Pkwy.,
                                                   Parsippany, NJ 07054.
ANDA 080377............  Lidocaine HCl with       Watson Laboratories,
                          Epinephrine Injection,   Inc., Subsidiary of
                          1%; 0.01 mg/mL and 2%;   Teva Pharmaceuticals
                          0.01 mg/mL.              USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 087100............  Chlorthalidone Tablets   Do.
                          USP, 25 mg.
ANDA 087211............  Methocarbamol and        Ivax Pharmaceuticals,
                          Aspirin Tablets, 400     Inc., Subsidiary of
                          mg/325 mg.               Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
ANDA 090184............  Podofilox Topical        Bausch & Lomb, Inc.,
                          Solution, 0.5%.          Subsidiary of Valeant
                                                   Pharmaceuticals North
                                                   America, LLC, 400
                                                   Somerset Corporate
                                                   Blvd., Bridgewater,
                                                   NJ 08807.
ANDA 202002............  Imiquimod Cream, 5%....  Strides Pharma Global
                                                   Pte Ltd., c/o Strides
                                                   Pharma, Inc., 2 Tower
                                                   Center Blvd., Suite
                                                   1102, East Brunswick,
                                                   NJ 08816.
ANDA 203247............  Sodium Fluoride F-18     University of Texas MD
                          Injection, 10-200        Anderson Cancer
                          millicurie (mCi)/mL.     Center, Cyclotron
                                                   Radiochemistry
                                                   Facility, 1881 East
                                                   Rd., Unit 1903,
                                                   Houston, TX 77054.
ANDA 203933............  Ammonia N-13 Injection,  Do.
                          3.75-37.5 mCi/mL.
ANDA 205072............  Cefadroxil Capsules      CSPC Ouyi
                          USP, EQ 500 mg base.     Pharmaceutical Co.,
                                                   Ltd., c/o Megalith
                                                   Pharmaceuticals,
                                                   Inc., 9625 Hillside
                                                   Rd., Rancho
                                                   Cucamonga, CA 91737.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
October 29, 2018. Introduction or delivery for introduction into
interstate commerce of products without approved new drug applications
violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the
table that are in inventory on October 29, 2018 may continue to be
dispensed until the inventories have been depleted or the drug products
have reached their expiration dates or otherwise become violative,
whichever occurs first.

    Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21199 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13369-13370]
[FR Doc No: 2015-05687]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR15-20-000]

Express Pipeline LLC; Notice of Petition for Declaratory Order

    Take notice that on February 27, 2015, pursuant to Rule 207(a)(2)
of the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a)(2) (2014), Express Pipeline
LLC filed a petition for a declaratory order seeking approval of a
committed rate structure and related contract terms to support the cost
of additional tanks, pumps, and piping to ``debottleneck, '' a
constraint point on its system, all as more fully explained in the
petition.
    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 encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on March 20, 2015.

    Dated: March 4, 2015.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2015-05687 Filed 3-12-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Notices]
[Pages 52109-52110]
[FR Doc No: 2012-20756]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0031]

Agency Information Collection Activities; Revision of Currently-
Approved Information Collection Request: Annual Report of Class I and
Class II Motor Carriers of Property

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval. FMCSA requests approval to revise an ICR entitled,
``Annual Report of Class I and Class II Motor Carriers of Property
(formerly OMB 2139-0004),'' which is used to ensure that motor carriers
comply with FMCSA's financial and operating statistics requirements at
chapter III of title 49 CFR part 369 entitled, ``Reports of Motor
Carriers.'' The agency invites public comment on this ICR. On April 20,
2012, FMCSA published a Federal Register notice allowing for a 60-day
comment period on the ICR. One comment was received in responses to the
above notice from the National Motor Freight Traffic Association, Inc.,
(NMFTA) in support of continuing this ICR. FMCSA concurs with this
comment.

DATES: Please send your comments by September 27, 2012. OMB must
receive your comments by this date in order to act quickly on the ICR.

ADDRESSES: All comments should reference Federal Docket Management
System (FDMS) Docket Number FMCSA-2012-0031. Interested persons are
invited to submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the attention
of the Desk Officer, Department of Transportation/Federal Motor Carrier
Safety Administration, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street NW., Washington, DC
20503.

FOR FURTHER INFORMATION CONTACT: Ms. Vivian Oliver, Transportation
Specialist, Office of Information Technology, Operations Division,
Department of Transportation, Federal Motor Carrier Safety
Administration, West Building 6th Floor, 1200 New Jersey Avenue SE.,
Washington, DC 20590. Telephone:<PHONE_NUMBER>; email Address:
<EMAIL_ADDRESS>Office hours are from 9 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:
    Title: Annual Report of Class I and Class II Motor Carriers of
Property (formerly OMB 2139-0004).
    OMB Control Number: 2126-0032.
    Type of Request: Revision of a currently-approved information
collection.
    Respondents: Class I and Class II Motor Carriers of Property.
    Estimated Number of Respondents: 197(per year).
    Estimated Time per Response: 9 hours.
    Expiration Date: September 30, 2012.
    Frequency of Response: Annually.
    Estimated Total Annual Burden: 1,773 hours [197 respondents x 9
hours to complete form = 1,773].

Background

    The Annual Report of Class I and Class II Motor Carriers of
Property (Form M) is a mandated reporting requirement for all for-hire
motor carriers (See 49 U.S.C. 14123; and implementing FMCSA regulations
at 49 CFR part 369). Motor carriers (including interstate and
intrastate) subject to the Federal Motor Carrier Safety Regulations are
classified on the basis of their gross carrier operating revenues.\1\
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    \1\ For purposes of the Financial and Operating Statistics
(F&OS) program, carriers are classified into the following three
groups: (1) Class I carriers are those having annual carrier
operating revenues (including interstate and intrastate) of $10
million or more after applying the revenue deflator formula as set
forth in Note A of 49 CFR 369.2; (2) Class II carriers are those
having annual carrier operating revenues (including interstate and
intrastate) of at least $3 million, but less than $10 million after
applying the revenue deflator formula as set forth in 49 CFR 369.2;
and (3) Class III carriers are those having annual carrier operating
revenues (including interstate and intrastate) of less than $3
million after applying the revenue deflator formula as set forth in
Note A of 49 CFR 369.2.
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    Under the Financial and Operating Statistics (F&OS) program, FMCSA
collects from Class I and Class II property carriers balance sheet and
income statement data along with information on safety needs, tonnage,
mileage, employees, transportation equipment, and other related data.
FMCSA may also ask carriers to respond to surveys concerning their
operations. The data and information collected would be made publicly
available and used by FMCSA to determine a motor carrier's compliance
with the F&OS program requirements prescribed at chapter III of title
of 49 CFR part 369.
    The regulations were formerly administered by the Interstate
Commerce Commission and later transferred to the Secretary on January
1, 1996, by section 103 of the ICC Termination Act of 1995 (Pub. L.104-
88, 109 Stat. 803 (Dec. 29, 1995)), now codified at 49 U.S.C. 14123. On
September 30, 1998, the Secretary delegated and transferred the
authority to administer the F&OS program to the former Bureau of
Transportation Statistics (BTS), now part of the Research and
Innovative Technology Administration (RITA), to former chapter XI,
subchapter B of 49 CFR part 1420 (63 FR 52192).
    On September 29, 2004, the Secretary transferred the responsibility
for the F&OS program from BTS to FMCSA in the belief that the program
was more aligned with FMCSA's mission and its other motor carrier
responsibilities (69 FR 51009). On August 10, 2006, the Secretary
published a final rule (71 FR 45740) that transferred and redesignated
certain motor carrier financial and statistical reporting regulations
of BTS, that were formerly located at chapter XI, subchapter B of title
49 CFR part 1420, to FMCSA under chapter III of title 49 CFR part 369.

Public Comments Invited

    You are asked to comment on any aspect of this information
collection, including: (1) Whether the proposed collection is necessary
for the FMCSA to perform its functions; (2) the accuracy of the
estimated burden; (3) ways for FMCSA to enhance the quality,
usefulness, and clarity of the collected information; and (4) ways that
the burden could be minimized without reducing the quality of the
collected information.

    Issued on: August 13, 2012.
Kelly Leone,
Associate Administrator for Office of Research and Information
Technology.
[FR Doc. 2012-20756 Filed 8-27-12; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Page 49606]
[FR Doc No: 2017-23295]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL18-17-000]

Midcontinent Independent System Operator, Inc.; Notice of
Institution of Section 206 Proceeding and Refund Effective Date

    On October 19, 2017, the Commission issued an order in Docket No.
EL18-17-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2012), instituting an investigation into whether the Open
Access Transmission, Energy and Operating Reserve Markets Tariff of
Midcontinent Independent System Operator, Inc. may be unjust,
unreasonable, unduly discriminatory or preferential. Midcontinent
Indep. Sys. Operator, Inc., 161 FERC 61,076 (2017).
    The refund effective date in Docket No. EL18-17-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL18-17-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426, in accordance with Rule 214 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21
days of the date of issuance of the order.

    Dated: October 19, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-23295 Filed 10-25-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Pages 46267-46268]
[FR Doc No: 2015-19047]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP15-1135-000.
    Applicants: Questar Southern Trails Pipeline Company.
    Description: Section 4(d) Rate Filing: Statement of Negotiated
Rates Filing to be effective 7/1/2015.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5091.
    Comments Due: 5 p.m. ET 8/10/15.

    Docket Numbers: RP15-1136-000.
    Applicants: Washington Gas Light Company, Energy Corporation of
America.
    Description: Petition for Waiver of Washington Gas Light Company
and Energy Corporation of America under RP15-1136.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5103.
    Comments Due: 5 p.m. ET 8/5/15.

    Docket Numbers: RP15-1137-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Section 4(d) Rate Filing: 2015 NVE Converted Contracts
to be effective 8/1/2015.
    Filed Date: 7/28/15.
    Accession Number: 20150728-5190.
    Comments Due: 5 p.m. ET 8/10/15.

    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: July 29, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-19047 Filed 8-3-15; 8:45 am]
BILLING CODE 6717-01-P