[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66612-66613]
[FR Doc No: 2015-27611]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2015-0052; Notice 2]

Goodyear Tire & Rubber Company, Grant of Petition for Decision of
Inconsequential Noncompliance

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Grant of petition.

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SUMMARY: Goodyear Tire & Rubber Company (Goodyear), has determined that
certain Goodyear G316 LHT commercial truck trailer tires do not fully
comply with paragraph S6.5(f) of Federal Motor Vehicle Safety Standard
(FMVSS) No. 119, New Pneumatic Radial Tires for motor vehicles with a
GVWR of more than 4,536 Kilograms (10,000 pounds) and Motorcycles.
Goodyear has filed an appropriate report dated April 27, 2015, pursuant
to 49 CFR part 573, Defect and Noncompliance Responsibility and
Reports.

ADDRESSES: For further information on this decision contact Abraham
Diaz, Office of Vehicles Safety Compliance, the National Highway
Traffic Safety Administration (NHTSA), telephone<PHONE_NUMBER>,
facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    I. Overview: Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see
implementing rule at 49 CFR part 556), Goodyear submitted a petition
for an exemption from the notification and remedy requirements of 49
U.S.C. Chapter 301 on the basis that this noncompliance is
inconsequential to motor vehicle safety.
    Notice of receipt of the Goodyear's petition was published, with a
30-day public comment period, on June 11, 2015 in the Federal Register
(80 FR 33336). No comments were received. To view the petition and all
supporting documents log onto the Federal Docket Management System
(FDMS) Web site at: http://www.regulations.gov/. Then follow the online
search instructions to locate docket number ``NHTSA-2015-0052.''
    II. Tires Involved: Affected are approximately 79 Goodyear G316 LHT
size 295/75R22.5 LRG commercial truck trailer tires manufactured
between March 22, 2015 and April 9, 2015.
    III. Noncompliance: Goodyear explains that because the sidewall
markings on the reference side of the subject tires incorrectly
identify the number of plies as ``4 Plies Steel Cord'' instead of the
actual number ``5 Plies Steel Cord,'' the tires do not meet the
requirements of paragraph S6.5(f) of FMVSS No. 119.
    IV. Rule Text: Paragraph S6.5 of FMVSS No. 119 requires in
pertinent part:

    S6.5 Tire markings. Except as specified in this paragraph, each
tire shall be marked on each sidewall with the information specified
in paragraphs (a) through (j) of this section. . . .
    (f) The actual number of plies and the composition of the ply
cord material in the sidewall and, if different, in the tread area;
. . .

    V. Summary of Goodyear's Arguments: Goodyear stated its belief that
the subject noncompliance is inconsequential to motor vehicle safety
for the following reasons:
    (A) Goodyear stated that the subject tires were manufactured as
designed and meet or exceed all applicable FMVSS performance standards.
    (B) Goodyear also stated that all of the sidewall markings related
to tire service (load capacity, corresponding inflation pressure, etc.)
are correct.
    (C) Goodyear believes that the mislabeling of the subject tires is
not a safety concern and also has no impact on the retreading,
repairing, and recycling industries.
    (D) Goodyear also pointed out that NHTSA has previously granted
petitions for non-compliances in sidewall marking that it believes are
similar to the subject noncompliance.
    Goodyear additionally informed NHTSA that the molds at the
manufacturing plant have been corrected so that no additional tires
will be manufactured or sold with the noncompliance.
    In summation, Goodyear believes that the described noncompliance of
the subject tires is inconsequential to motor vehicle safety, and that
its petition, to exempt Goodyear from providing recall notification of
noncompliance as required by 49 U.S.C. 30118 and remedying the recall
noncompliance as required by 49 U.S.C. 30120 should be granted.

NHTSA's Decision

    NHTSA's Analysis: Although tire construction affects a tire's
strength and durability, neither the agency nor the tire industry
provides information relating tire strength and durability to the
number of plies and types of ply cord material in the tread and
sidewall. Tire dealers and customers must therefore consider the tire
construction information along with other information such as load
capacity, maximum inflation pressure, and tread wear, temperature, and
traction ratings, to assess performance capabilities of various tires.
    Therefore, the agency agrees with Goodyear's statement that the
incorrect markings in this case do not present a safety concern. There
is no effect of the noncompliance on the operational safety of vehicles
on which these tires are mounted. In the agency's judgement, the
incorrect labeling of the tire construction information in this
instance will have an inconsequential effect on motor vehicle safety
because most consumers do not base tire purchases or vehicle operation
parameters on the number of tire plies. In addition, all of the
sidewall markings related to tire service, such as load capacity and
corresponding inflation pressure, are correct.
    Goodyear has also indicated that it has corrected the stamping
problem that caused the noncompliance. NHTSA's Decision: In
consideration of the foregoing, NHTSA has decided that Goodyear has met
its burden of persuasion that the noncompliance described is
inconsequential to motor vehicle safety. Accordingly, Goodyear's
petition is hereby granted and Goodyear is exempted from the obligation
of providing notification of, and remedy for the subject noncompliance.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners,

purchasers, and dealers of a defect or noncompliance and to remedy the
defect or noncompliance. Therefore, the decision only applies to the
subject tires that Goodyear no longer controlled at the time it
determined that the noncompliance existed. However, the granting of
this petition does not relieve equipment distributors and dealers of
the prohibitions on the sale, offer for sale, or introduction or
delivery for introduction into interstate commerce of the noncompliant
tires under their control after Goodyear notified them that the subject
noncompliance existed.

    Authority:  49 U.S.C. 30118, 30120: Delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2015-27611 Filed 10-28-15; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 117 (Tuesday, June 18, 2013)]
[Notices]
[Page 36633]
[FR Doc No: 2013-14443]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[US DOT Docket No. NHTSA-2013-0056]

Reports, Forms and Record Keeping Requirements, Agency
Information Collection Activity Under OMB Review, OMB Control Number
2127--NEW

AGENCY: National Highway Traffic Safety Administration, U.S. Department
of Transportation.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collection and its expected
burden. The Federal Register Notice with a 60-day comment period was
published on December 2, 2009 [74 FR 63225] in conjunction with a
notice of proposed rulemaking that would establish a new Federal Motor
Vehicle Safety Standard (FMVSS) No. 226 for which the collection of
information would be needed. No comments were received on the ICR.
    This document describes the collection of information for which
NHTSA intends to seek OMB approval. The collection of information
described is the ``Ejection Mitigation Phase in Reporting
Requirements--Part 585.'' (OMB Control Number: 2127-XXXX)

DATES: Comments must be submitted on or before July 18, 2013.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725--17th
Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.

FOR FURTHER INFORMATION CONTACT: Mr. Louis N. Molino at U.S. Department
of Transportation, NHTSA, 1200 New Jersey Avenue SE., West Building
Room W43-419, NVS-112, Washington, DC 20590. Mr. Molino's telephone
number is<PHONE_NUMBER> and fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: Ejection Mitigation Phase in Reporting Requirements--Part
585.
    OMB Control Number: 2127-XXXX.
    Type of Request: New collection.
    Abstract: 49 U.S.C. 30111 authorizes the issuance of Federal motor
vehicle safety standards (FMVSSs) and regulations. The agency, in
prescribing an FMVSS or regulations, considers available relevant motor
vehicle safety data, and consults with other agencies, as it deems
appropriate. Further, the statute mandates that in issuing any FMVSS or
regulation, the agency considers whether the standard or regulation is
``reasonable, practicable and appropriate for the particular type of
motor vehicle or item of motor vehicle equipment for which it is
prescribed,'' and whether such a standard will contribute to carrying
out the purpose of the Act.
    The Secretary is authorized to invoke such rules and regulations,
as deemed necessary to carry out these requirements. Using this
authority, on January 19, 2011, the agency published a final rule (76
FR 3212) establishing FMVSS No. 226, ``Ejection mitigation.'' The final
rule contained a collection of information because of the proposed
phase-in reporting requirements. The collection of information requires
manufacturers of passenger cars and of trucks, buses and multi-purpose
passenger vehicles (MPVs) with a GVWR of 4,536 kg (10,000 lb) or less,
to annually submit a report, and maintain records related to the
report, concerning the number of such vehicles that meet the ejection
mitigation requirements of this FMVSS. The phase-in of the test
requirements would be completed on September 1, 2017, at which time,
all affected vehicles are required to meet the new requirements. The
purpose of the reporting requirements is to aid the agency in
determining whether a manufacturer has complied with the ejection
mitigation requirements during the phase-in of those requirements.
    Affected Public: Businesses.
    Estimated Total Annual Burden: 1,260 hours.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Departments estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. A comment to OMB is most effective if OMB
receives it within 30 days of publication.

    Issued on: June 13, 2013.
Lori Summers,
Acting Associate Administrator for Rulemaking.
[FR Doc. 2013-14443 Filed 6-17-13; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Rules and Regulations]
[Pages 15608-15609]
[FR Doc No: 2012-6427]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-HQ-OAR-2011-0081; FRL-9648-9]
RIN 2060-AR42

Revisions to Final Response to Petition From New Jersey Regarding
SO[bdi2] Emissions From the Portland Generating Station

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

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SUMMARY: The EPA issued ``Revisions to Final Response to Petition From
New Jersey Regarding SO2 Emissions From the Portland
Generating Station'' as a direct final rule on December 22, 2011.
Because the EPA received an adverse comment to the parallel proposal
issued under the same name on December 22, 2011, we are withdrawing the
direct final rule amendments to ``Revisions to Final Response to
Petition From New Jersey Regarding SO2 Emissions From the
Portland Generating Station'' published in the Federal Register on
December 22, 2011.

DATES: As of March 16, 2012, the EPA withdraws the direct final rule
amendments published on December 22, 2011. See 76 FR 79541.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2011-0081. All documents in the docket are
listed on the http://www.regulations.gov Web site. Although listed in
the index, some information is not publicly available, e.g.,
confidential business information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or
in hard copy at Air Docket, EPA/DC, EPA West, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744.

FOR FURTHER INFORMATION CONTACT: Mr. Todd Hawes<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Ms. Gobeail McKinley<PHONE_NUMBER>,
<EMAIL_ADDRESS>Office of Air Quality Planning and Standards,
Air Quality Policy Division, Mail Code C539-04, Research Triangle Park,
NC 27711.

SUPPLEMENTARY INFORMATION:

I. Background Information

    The EPA issued ``Revisions to Final Response to Petition From New
Jersey Regarding SO2 Emissions From the Portland Generating
Station'' as a direct final rule on December 22, 2011. See 76 FR 79541.
The direct final rule revised the preamble and rule text to the ``Final
Response to Petition From New Jersey Regarding SO2 Emissions
From the Portland Generating Station'' (Portland) published November 7,
2011, to clarify that Portland significantly contributes to
nonattainment or interferes with maintenance of the 1-hour sulfur
dioxide national ambient air quality standard in the State of New
Jersey, and not in specific counties within the state. See 76 FR 69052.
The revisions did not change the conclusions that the EPA made in the
final rule and did not affect the emission limits, increments of
progress, compliance schedules, or reporting provisions.
    The EPA issued a parallel proposal under the same name on December
22, 2011, that proposed to make the same revisions outlined in the
direct final and solicited comment on those revisions. See 76 FR 79574.
We stated in the direct final rule amendments that if we received
adverse comment to the parallel proposal by February 21, 2012, we would
publish a timely notice of withdrawal of the direct final rule in the
Federal Register. We received one adverse comment on the proposed
amendments on February 21, 2012. We are consequently withdrawing the
``Revisions to Final Response to Petition From New Jersey Regarding
SO2 Emissions From the Portland Generating Station''
published as a direct final rule in the Federal Register on December
22, 2012 as of March 16, 2012. See 76 FR 79541. The EPA will address
the adverse comment in a subsequent final action based on the parallel
proposal also published on December 22, 2011. See 76 FR 79574. As
stated in the parallel proposal, we will not institute a second comment
period on this action.

List of Subjects in 40 CFR Part 52

    Approval and promulgation of implementation plans, Environmental
protection, Administrative practice and procedures, Air pollution
control, Incorporation by reference, Intergovernmental relations, and
Reporting and recordkeeping requirements, Sulfur dioxide.

    Dated: March 12, 2012.
Lisa P. Jackson,
Administrator.

PART 52--[AMENDED]

    Accordingly, the amendments to the rule published in the Federal
Register on December 22, 2011 (76 FR 79541) on pages 79541-79544 are
withdrawn as of March 16, 2012.

[FR Doc. 2012-6427 Filed 3-15-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Page 16908]
[FR Doc No: 2018-07961]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

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

Extension:
    Rule 15g-4, SEC File No. 270-347, OMB Control No. 3235-0393

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 15g-4--Disclosure of
compensation to brokers or dealers (17 CRF 240.15g-4) under the
Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.). The Commission
plans to submit this existing collection of information to the Office
of Management and Budget (``OMB'') for extension and approval.
    Rule 15g-4 requires brokers and dealers effecting transactions in
penny stocks for or with customers to disclose the amount of
compensation received by the broker-dealer in connection with the
transaction. The purpose of the rule is to increase the level of
disclosure to investors concerning penny stocks generally and specific
penny stock transactions.
    The Commission estimates that approximately 195 broker-dealers will
spend an average of 87 hours annually to comply with this rule. Thus,
the total compliance burden is approximately 16,965 burden-hours per
year.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimates of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Pamela Dyson, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Remi Pavlik-Simon, 100 F Street NE, Washington, DC 20549 or send an
email to [email protected].

    Dated: April 11, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-07961 Filed 4-16-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: June 12, 2009 (Volume 74, Number 112)]
[Rules and Regulations]
[Page 27919-27920]
[DOCID:fr12jn09-8]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2009-N-0665]

New Animal Drugs for Use in Animal Feeds; Chlortetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Alpharma Inc. The supplemental NADA
provides for revised Blue Bird labeling for chlortetracycline Type A
medicated articles used to formulate Type B and Type C medicated feeds
in various classes of livestock and poultry.

DATES: This rule is effective June 12, 2009.

FOR FURTHER INFORMATION CONTACT:  Timothy Schell, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Alpharma Inc., 440 Rte. 22, Bridgewater, NJ
08807, filed a supplement to NADA 46-699 that provides revised Blue
Bird labeling for CHLORMAX (chlortetracycline) Type A medicated
articles used to formulate Type B and Type C medicated feeds in various
classes of livestock and poultry. The supplemental NADA is approved as
of May 22, 2009, and the regulations are amended in Sec.  558.128 (21
CFR 558.128) to reflect the approval.
    In addition, Sec.  558.128 is amended to differentiate certain
withdrawal times in cattle for two chlortetracycline Type A medicated
articles sponsored by Alpharma Inc. under separate NADAs and to correct
the spelling of a turkey pathogen.
    Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to

the Center for Veterinary Medicine, 21 CFR part 558 is amended as
follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for 21 CFR part 558 continues to read as
follows:

    Authority: 21 U.S.C. 360b, 371.

0
2. In Sec.  558.128, in the table in paragraph (e)(2)(iii), in the
``Indications for use'' column, remove ``meleagrides'' and in its place
add ``meleagridis''; and revise paragraphs (e)(4)(iv), (e)(4)(v), and
(e)(4)(ix) to read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (4) * * *

----------------------------------------------------------------------------------------------------------------
        Chlortetracycline amount               Indications for use              Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------

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

(iv) 10 mg/lb of body weight daily......  1. Calves, beef and           Feed approximately 400 g/        012286,
                                           nonlactating dairy cattle;    ton, varying with body          048164,
                                           treatment of bacterial        weight and feed                 066104.
                                           enteritis caused by E. coli   consumption to provide 10
                                           and bacterial pneumonia       mg/lb per day. Treat for
                                           caused by P. multocida        not more than 5 d; in feed
                                           organisms susceptible to      including milk replacers;
                                           chlortetracycline.            withdraw 10 d prior to
                                                                         slaughter. To sponsor No.
                                                                         048164: zero withdrawal
                                                                         time. See paragraph (d)(1)
                                                                         of this section.

                                          2. Calves (up to 250 lb):     See paragraph (d)(1) of          012286,
                                           For the treatment of          this section.                   046573,
                                           bacterial enteritis caused                                    048164,
                                           by E. coli susceptible to                                     066104.
                                           chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(v) 500 to 4,000 g/ton..................  Calves, beef and              Feed continuously for not        046573.
                                           nonlactating dairy cattle;    more than 5 days to
                                           treatment of bacterial        provide 10 mg/lb body
                                           enteritis caused by E. coli   weight per day. To sponsor
                                           and bacterial pneumonia       No. 046573 under NADA 046-
                                           caused by P. multocida        699: 24-h withdrawal time.
                                           organisms susceptible to      To sponsor No. 046573
                                           chlortetracycline.            under NADA 048-761: zero
                                                                         withdrawal time.
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(ix) 350 mg/head/day....................  1. Beef cattle: For control   Withdraw 48 h prior to           012286,
                                           of bacterial pneumonia        slaughter. To sponsor No.       046573,
                                           associated with shipping      046573 under NADA 046-699:      048164,
                                           fever complex caused by       48-h withdrawal time. To        066104.
                                           Pasteurella spp.              sponsor No. 046573 under
                                           susceptible to                NADA 048-761 and No.
                                           chlortetracycline.            048164: zero withdrawal
                                                                         time.

                                          2. Beef cattle (under 700     Withdraw 48 h prior to           012286,
                                           lb): For control of active    slaughter. To sponsor No.       046573,
                                           infection of anaplasmosis     046573 under NADA 046-699:      048164,
                                           caused by A. marginale        48-h withdrawal time. To        066104.
                                           susceptible to                sponsor No. 046573 under
                                           chlortetracycline.            NADA 048-761 and No.
                                                                         048164: zero withdrawal
                                                                         time.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: June 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-13849 Filed 6-11-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)]
[Proposed Rules]
[Pages 55049-55050]
[FR Doc No: 2015-22876]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-3361; Airspace Docket No. 15-AEA-4]
RIN 2120-AA66

Proposed Amendment of Air Traffic Service (ATS) Routes; Northeast
United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify jet routes J-6, J-97, and J-
222, and VOR Federal airways V-196, and V-489, in the northeastern
United States due to the planned decommissioning of the Plattsburgh,
NY, VORTAC facility.

DATES: Comments must be received on or before October 29, 2015.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, 1200 New Jersey Avenue SE.,
West Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
telephone:<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2015-
3361 and Airspace Docket No. 15-AEA-4 at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov.
    FAA Order 7400.9Y, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy and Regulations Group, Federal Aviation Administration,
800 Independence Avenue, SW., Washington, DC, 20591; telephone: 202-
267-8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to
http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy and
Regulations Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it modifies the air traffic service route structure in the
northeast United States to maintain the efficient flow of air traffic.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2015-3361 and Airspace Docket No. 15-AEA-4) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2015-3361 and Airspace Docket No. 15-AEA-4.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Eastern Service Center, Federal
Aviation Administration, Room 210, 1701 Columbia Ave., College Park,
GA, 30337.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed

Rulemaking Distribution System, which describes the application
procedure.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Y, Airspace
Designations and Reporting Points, dated August 6, 2014, and effective
September 15, 2014. FAA Order 7400.9Y is publicly available as listed
in the ADDRESSES section of this proposed rule. FAA Order 7400.9Y lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to modify the descriptions of jet routes
J-6, J-97 and J-222; and VOR Federal airways V-196 and V-489, due to
the planned decommissioning of the Plattsburgh, NY, VORTAC. The
proposed route changes are outlined below.
    J6 Jet route J-6 extends from Salinas, CA, across the United States
to Albany, NY, then terminates at Plattsburgh, NY. The FAA proposes to
terminate the route at Albany, eliminating the segment between Albany
and Plattsburgh.
    J-97 Jet route J-97 extends between the SLATN fix and Plattsburgh,
NY. The FAA proposes to terminate the route at Boston, MA, eliminating
the segment between Boston and Plattsburgh.
    J-222 Jet route J-222 extends between Robbinsville, NJ, and
Plattsburgh, NY. The FAA proposes to terminate the route at Cambridge,
NY, eliminating the segment between Cambridge and Plattsburgh.
    V-196 VOR Federal airway V-196 extends from Utica, NY, to Saranac
Lake, NY to Plattsburgh, NY. The FAA proposes to terminate the route at
the intersection of the Saranac Lake, NY 058[deg](T) and the
Burlington, VT 296[deg](T) radials, eliminating the segment between
that intersection and Plattsburgh.
    V-489 VOR Federal airway V-489 extends between the intersection of
the Sparta, NJ 300[deg](T) and the Huguenot, NY 196[deg](T) radials and
Plattsburgh, NY. The FAA proposes to terminate the route at Glens
Falls, NY, eliminating the segment between Glens Falls and Plattsburgh.
    Except for VOR Federal airway V-196, all radials in the route
descriptions below are stated in True degrees. Both True and Magnetic
degrees are used to describe the intersecting radials in V-196 since
this intersection would be added to the airway description.
    Jet routes are published in paragraph 2004, and VOR Federal airways
are published in paragraph 6010(a), respectively, of FAA Order 7400.9Y
dated August 6, 2014, and effective September 15, 2014, which is
incorporated by reference in 14 CFR 71.1. The jet routes and VOR
Federal airways listed in this document would be subsequently published
in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation: (1) is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under Department of Transportation (DOT)
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

     Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y,
Airspace Designations and Reporting Points, dated August 6, 2014 and
effective September 15, 2014, is amended as follows:

Paragraph 2004 Jet Routes

* * * * *

J-6 [Amended]

    From Salinas, CA, via INT Salinas 145[deg] and Avenal, CA,
292[deg] radials; Avenal; INT Avenal 119[deg] and Palmdale, CA,
310[deg] radials; Palmdale; Hector, CA; Needles, CA; Drake, AZ;
Zuni, AZ; Albuquerque, NM; Tucumcari, NM; Panhandle, TX; Will
Rogers, OK; Little Rock, AR; Bowling Green, KY; Charleston, WV; INT
Charleston 076[deg] and Martinsburg, WV, 243[deg] radials;
Martinsburg; Lancaster, PA; Broadway, NJ; Sparta, NJ; to Albany, NY.

J-97 [Amended]

    From lat. 39[deg]07'00'' N., long. 67[deg]00'00'' W. via
Nantucket, MA; to Boston, MA.

J-222 [Amended]

    From Robbinsville, NJ; INT Robbinsville 039[deg] and Kennedy,
NY, 253[deg] radials; Kennedy; INT Kennedy 022[deg] and Cambridge,
NY, 179[deg] radials; to Cambridge.
* * * * *

Paragraph 6010(a) Domestic VOR Federal Airways

V-196 [Amended]

    From Utica, NY, Saranac Lake, NY; to INT Saranac Lake
058[deg](T)/072[deg](M) and Burlington, VT 296[deg](T)311[deg](M)
radials.

V-489 [Amended]

    From INT Sparta, NJ, 300[deg] and Huguenot, NY, 196[deg]
radials; Huguenot; INT Huguenot 008[deg] and Albany, NY, 209[deg]
radials; Albany; to Glens Falls, NY.

    Issued in Washington, DC, on September 3, 2015.
Gary A. Norek,
Manager, Airspace Policy and Regulations Group.
[FR Doc. 2015-22876 Filed 9-11-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 119 (Tuesday, June 21, 2011)]
[Notices]
[Page 36168]
[FR Doc No: 2011-15405]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities; Requests for Comments;
Clearance of Renewed Approval of Information Collection; General
Aviation Awards Program

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The collection is used to nominate private citizens for
recognition of their significant voluntary contribution to aviation
education and flight safety.

DATES: Written comments should be submitted by August 22, 2011.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0574.
    Title: General Aviation Awards Program.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The collection is used to nominate private citizens for
recognition of their significant voluntary contribution to aviation
education and flight safety. The agency/industry committee uses the
information collected to select eight regional winners and one national
winner from each group. The respondents are private citizens involved
in aviation.
    Respondents: Approximately 150 applicants.
    Frequency: Information is collected annually.
    Estimated Average Burden per Response: 1 hour.
    Estimated Total Annual Burden: 150 hours.
    Addresses: Send comments to the FAA at the following address: Ms.
Carla Scott, Room 336, Federal Aviation Administration, AES-300, 950
L'Enfant Plaza, SW., Washington, DC 20024.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for 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.

    Issued in Washington, DC on June 15, 2011.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2011-15405 Filed 6-20-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 30, 2007 (Volume 72, Number 19)]
[Notices]
[Page 4320-4321]
[DOCID:fr30ja07-124]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55157; File No. SR-NSCC-2006-12]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Order Granting Approval to Proposed Rule Change Relating
to Buy-Ins of Municipal Securities

January 23, 2007.

I. Introduction

    On October 16, 2006, the National Securities Clearing Corporation
(``NSCC'') submitted to the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to modify NSCC's rules concerning buy-ins of
municipal securities. The proposed rule change was published for
comment in the Federal Register on December 14, 2006.\3\ No comment
letters were received on the proposal. This order approves the
proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 54900 (Dec. 8, 2006), 71
FR 75286.
---------------------------------------------------------------------------

II. Description of the Proposal

    The purpose of this filing is to amend NSCC's rules to streamline
the processing of continuous net settlement (``CNS'') buy-ins of
municipal securities. At the request of members and after consultation
with the Buy-In Subcommittee of the Securities Industry Association,
NSCC is modifying Rule 11 (CNS System), Procedure VII (CNS Accounting
Operation), and Procedure X (Execution of CNS Buy-Ins) with respect to
CNS buy-ins of municipal securities as set forth below.
    Executions of buy-ins of municipal securities are governed by the
rules of the Municipal Securities Rulemaking Board (``MSRB'') and have
a ten-day cycle from notification of intent to buy-in to buy-in
execution. In contrast, buy-ins for equity and corporate bond
securities have a two-day cycle.
    Under NSCC's rules (except with respect to securities subject to
voluntary corporate reorganizations), an NSCC member that has a long
CNS position at the end of any day (``originator'') may submit to NSCC
a Notice of Intention to Buy-In (``Buy-In Notice'') specifying a
quantity of securities not exceeding such long CNS position that it
intends to buy-in (``Buy-In Position''). The day the Buy-In Notice is
submitted is referred to as N and the succeeding days are referred to
as N+1 and N+2. The Buy-In Position is given high priority for CNS
allocations until expiration of the buy-in.
    While increased priority is provided to facilitate the allocation
of the Buy-In Position in CNS, municipal securities are usually thinly
traded and the increased allocation priority has not been generally
effective in accelerating the delivery process. Accordingly, when a
municipal security Buy-In Position is not satisfied by a CNS
allocation, the long member must have its Buy-In Position exited from
CNS in order to be able to proceed under MSRB rules, which entails
issuing a new buy-in notice and then waiting an additional ten days
before executing the buy-in. As a result, a member typically will
request that NSCC exit the municipal security Buy-In Position from CNS,
and NSCC will exit the municipal security from CNS, which results in
receive and deliver obligations for the affected parties two days
later.
    To assist members in their timely processing of buy-ins of
municipal securities, NSCC is modifying its rules and procedures to
automatically exit from CNS unsatisfied municipal security Buy-In
Positions. Under the new procedures, CNS will automatically exit such
positions prior to the night cycle on N+1. This will create a broker-
to-broker close-out receive and deliver obligation between the member
with the long CNS position and the member(s)

with the oldest short CNS position(s). Thus, the Buy-In Position will
be automatically exited from CNS one day earlier than is currently the
case and the buy-in process under MSRB rules can likewise commence one
day earlier.

III. Discussion

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a registered clearing agency. In particular,
the Commission believes the proposal is consistent with the
requirements of Section 17A(b)(3)(F),\4\ which among other things,
requires the rules of a clearing agency to promote the prompt and
accurate clearance and settlement of securities transactions. By
automating and accelerating the exiting of unsatisfied municipal
securities Buy-In Positions, the new rule should expedite and make more
efficient the processing of municipal securities buy-ins. As a result,
the new rule should promote the prompt and accurate clearance and
settlement of such securities transactions.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \5\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\6\ that the proposed rule change (File No. SR-NSCC-2006-12) be,
and hereby is, approved.\7\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).
    \7\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-1381 Filed 1-29-07; 8:45 am]

BILLING CODE 8011-01-P


EPA Presentation on UST Regulations at Northwest Public Power Association (NWPPA) Environmental Task Force Meeting                                January 23, 2012

At this meeting EPA Region 10 presented an overview of the proposed changes to the UST regulations highlighting how to submit your comments and the changes from the current regulations.

EPA Attendee  -  Erik Sirs, EPA Region 10

NWPPA Environmental Task Force Meeting

                                        Jan 23, 2012

                                        Attendee list as of 1-9-12

                                        First Last  Job Title Org Name City                                      State Bryce Robbert Environmental Scientist Avista Corporation Spokane                                       WA Brian Cramer Utility Tree Coordinator Benton PUD Kennewick                                       WA Gary Splattstoesser Superintendent Of Support Services Benton PUD Kennewick                                       WA John Gander Utility Safety Director Blachly-Lane Electric Cooperative Mcminnville                                       OR Steve Sander Sr. Environmental Scientist Bonneville Power Administration Portland                                       OR Mark Hoefner Environmental Compliance Technician Chelan County PUD Wenatchee                                       WA Ed Ausman Purchasing Agent Clearwater Power Company Lewiston                                       ID John (jack) Himmelberger Purchasing/warehouseman Columbia Rural Electric Association Dayton                                       WA Diana MacDonald Mgr. Environ. & Regulatory Svcs Cowlitz County PUD Longview                                       WA David Shahon District Sales Manager FLIR Systems Nashua                                       NH Patricia Mitchell Hazardous Waste Technician Grant County PUD Ephrata                                       WA Lyle Powell Safety & Environmental Coord. Grays Harbor County PUD #1 Aberdeen                                       WA Kirk Clarich Hazardous Materials Administrator Idaho Power Company Boise                                       ID Krista Kinsey

Idaho Power Company Boise                                       ID George Brown Operations Manager Inland Power Spokane                                       WA Richard Campos Line Superintendent Inland Power & Light Company Spokane                                       WA Jim Bennett General Manager JACO Construction, Inc. Ephrata                                       WA Jennifer Richcreek Environmental Coordinator Kodiak Electric Association, Inc. Kodiak                                       AK Jason Danforth E&o Assistant/environmental Tech Mason County PUD No. 3 Shelton                                       WA Mary Taylor Engineering & Operations Support Supervisor Mason County PUD No. 3 Shelton                                       WA Yukon don"" Tanner Project Manager Matanuska Electric Association, Inc. Palmer                                       AK Marci Humlie Resource Specialist McMinnville Water and Light Mcminnville                                       OR Dan Boettger Director Of Regulatory & Enviromental Affairs Okanogan County PUD No. 1 Okanogan                                       WA Stan Yeend

PacifiCorp Portland                                       OR Patrick Durham Environmental Program Manager Sacramento Municipal Utility District Sacramento                                       CA Derrick McCarty Environmental Management Specialist Ii Sacramento Municipal Utility District Sacramento                                       CA Tony Schacher Engineer Salem Electric Salem                                       OR Jeff Defenbach Senior Environmental Specialist Snohomish County PUD No. 1 Everett                                       WA Robert Eden Environmental Specialist Snohomish County PUD No. 1 Everett                                       WA Russell Post Environmental Compliance Mgr Tacoma Public Utilities Tacoma                                       WA Mike Rhubright Senior Environmental Specialist Tacoma Public Utilities Tacoma                                       WA Samuel Rupert Sr. Environmental Specialist Tacoma Public Utilities Tacoma                                       WA Wayne Greeson Operations Assistant To Tillamook People's Utility District Tillamook                                       OR Devin Sexton Warehouse Person Tillamook People's Utility District Tillamook                                       OR Les Joel General Manager Transformer Technologies Salem                                       OR Todd McMillan Environmental Health & Safety Manager Transformer Technologies Salem                                       OR James Caple Assist Manager Operations Valley Electric Association, Inc. Pahrump                                       NV


[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Notices]
[Pages 56810-56814]
[FR Doc No: 2014-22514]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1359]

Development and Regulation of Abuse-Deterrent Formulations of
Opioid Medications; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to discuss the development, assessment, and regulation of
abuse-deterrent formulations of opioid medications. The meeting will
focus on scientific and technical issues related to the development and
in vitro assessment of these products, as well as FDA's approach
towards assessing the benefits and risks of all opioid medications,
including those with abuse-deterrent properties.
    FDA is seeking input on these issues from all stakeholders,
including patients, health care providers, the pharmaceutical industry,
patient advocates, academics, researchers, and other governmental
entities.

DATES: The public meeting will be held on October 30, 2014, from 8:30
a.m. to 5 p.m. and October 31, 2014, from 8:30 a.m. to 3 p.m. The
public meeting may be extended or may end early depending on the level
of public participation. Individuals who wish to present at the meeting
must register by October 14, 2014. Individuals who wish to attend the
meeting but do not wish to make a presentation should register by
October 24, 2014. See section III under the SUPPLEMENTARY INFORMATION
section for information on how to register to speak at the meeting.
Submit either electronic or written comments by January 9, 2015.

ADDRESSES: The public meeting will be held at the Sheraton Silver
Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910,<PHONE_NUMBER>,
FAX:<PHONE_NUMBER>.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. Identify all comments with the docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Mary C. Gross, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20903,<PHONE_NUMBER>, FAX: 301-796-
9899, email<EMAIL_ADDRESS>or Brutrinia D. Cain, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>or Georgiann Ienzi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>, FAX: 301-847-
8737, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Introduction

    Opioid analgesics are important medications that are widely
prescribed for the treatment of pain, and certain opioids are also used
in drug treatment programs. When used properly, opioid drugs provide
significant benefits for patients. However, they also carry a risk of
misuse, abuse, addiction, overdose, and death. According to an analysis
from the Centers for Disease Control and Prevention (CDC), in 2010,
opioid analgesics were involved in 16,651 overdose deaths, which
represented a 313 percent increase over the past decade (Ref. 1). The
Substance Abuse and Mental Health Services Administration (SAMHSA)
reports that for each overdose death, there were an additional 11
treatment admissions (Ref. 2), 33 emergency department visits (Ref. 3),
and 880 non-medical users of these drugs (Ref. 4).
    The development of and transition to use of opioids with meaningful
abuse-deterrent properties is one important component of a multipronged
approach to addressing abuse of opioid medications. FDA looks forward
to a future in which most or all opioid medications are available in
formulations that are less susceptible to abuse than the formulations
that are on the market today.
    To achieve this goal, FDA is taking steps to incentivize and
support the development of opioid medications with progressively better
abuse-deterrent properties. These steps include working with individual
sponsors on promising abuse-deterrent technologies, developing
appropriate testing methodologies for both innovator and generic
products, and publishing guidance on the development and labeling of
abuse-deterrent opioids.
    FDA understands that the iterative innovation in abuse-deterrent
technologies we envision could have implications for generic opioid
medications. It is important that generic options remain available to
ensure widespread access to effective analgesics for patients who need
them.
    The transition to abuse-deterrent formulations of opioid
medications presents a number of complex scientific and regulatory
challenges. The purpose of this public meeting is to share and solicit
comments on the Agency's ongoing work to identify and address these
challenges.

II. Background

    Opioid analgesics (e.g., hydrocodone, oxycodone, morphine, and
fentanyl) play a vital role in treating both chronic and acute pain.
The Institute of Medicine reports that millions of Americans are living
with chronic pain, including those suffering from back pain,
neuropathic pain, and pain associated with cancer, with an annual
economic cost of approximately $600 billion in health care expenses and
lost productivity (Ref. 5). Millions more suffer from acute pain
following common medical procedures performed every day across the
country, such as dental and orthopedic procedures. While FDA is working
to support the efficient development of safer, non-opioid alternatives
for treating pain, opioids are currently an indispensable component of
the pain treatment armamentarium, and will remain so for some time to
come.
    Unfortunately, the abuse and misuse of opioid medications has
become a public health crisis. Opioid-involved drug overdose death
rates in the United States have increased four-fold from 1999 to 2008
(Ref. 6). Emergency department visits, substance abuse treatment
admissions, and economic costs associated with opioid abuse have also
increased dramatically over the same period (Ref. 7). This rise in
adverse events has largely paralleled the

rise in the number of prescriptions for these products (Ref. 7). A
comprehensive approach is needed to address this crisis--one that
involves other Federal agencies, State governments, professional
medical organizations, academic institutions, and other stakeholders.
FDA, as one part of the Federal response to this crisis, is working to
improve the safe use of opioids.
    As part of this work, FDA strongly supports the development of
opioid medications with meaningful abuse-deterrent properties. Although
this field holds great promise, it is relatively new. Currently
available abuse-deterrent formulations are expected to provide
improvements over existing formulations, but their impact on the abuse
epidemic may be limited. For example, even though some abuse-deterrent
technologies have been demonstrated to deter some forms of abuse (e.g.,
injection or intranasal) to varying degrees in controlled settings, as
yet no marketed opioid formulation has been demonstrated to deter the
simplest and most common form of abuse--swallowing a number of intact
tablets or capsules. Further, all currently available formulations
designed to deter abuse can be defeated with sufficient time,
equipment, and expertise. These limitations may be impossible to
completely overcome as these products must release the opioids they
contain to have their intended therapeutic effects.
    FDA believes abuse-deterrent technologies can and will improve
substantially and can make a real impact in the fight against
prescription opioid abuse. FDA hopes that as the market for opioid
medications transitions to abuse-deterrent formulations, abuse rates
will decrease and the most significant consequences of that abuse
(addiction, overdose, and death) will diminish. To that end, fostering
the development, marketing, and iterative improvement of abuse-
deterrent formulations of opioid medications is a top priority. FDA's
work in support of this priority includes the following:
     Established an Opioids Taskforce to coordinate and support
FDA work on abuse-deterrent formulations of opioids.
     Consulted with advisory committees in connection with the
development, evaluation, and labeling of opioids with abuse-deterrent
technologies. For example, in October 2010, a joint meeting of the
Anesthetic and Life Support Drugs Advisory Committee and the Drug
Safety and Risk Management Advisory Committee was held to discuss,
among other things, how sponsors should design and conduct postmarket
epidemiological or observational studies to evaluate whether and to
what extent products designed to reduce the likelihood and incidence of
abuse actually do so.
     Issued draft guidance to assist industry in developing and
assessing abuse-deterrent opioid formulations (``Draft Guidance for
Industry: Abuse-Deterrent Opioids--Evaluation and Labeling,'' 78 FR
2676; January 14, 2013). FDA participated in the Abuse-Deterrence
Formulation Science meeting held on September 30 and October 1, 2013,
which provided a forum to discuss the draft guidance. FDA is committed
to publishing a final version of this guidance as soon as possible.
     Met and worked with sponsors regarding approval of
potentially abuse-deterrent formulations and reviewed applications
seeking approval, or, subsequent to such approval, seeking inclusion of
language in product labeling regarding the products' purportedly abuse-
deterrent properties.
     Determined that the original formulation of OXYCONTIN
posed an increased potential for abuse by certain routes of
administration compared to reformulated OXYCONTIN. Based on the
totality of the data and information available, FDA concluded that the
benefits of original OXYCONTIN no longer outweighed its risks. The
Agency determined that original OXYCONTIN was withdrawn for reasons of
safety and effectiveness, and accordingly will not accept abbreviated
new drug applications (ANDAs) that refer to original OXYCONTIN.
     Conducted or supported research on opioid formulations
designed to deter abuse. This includes development of in vitro testing
methodologies to assess purportedly abuse-deterrent opioid
formulations.
     Sought public comment on innovative packaging, storage,
and disposal systems that could help deter prescription opioid abuse
(see http://www.gpo.gov/fdsys/pkg/FR-2014-04-09/pdf/2014-07909.pdf).

III. Scope of the Public Meeting

    FDA is opening a docket and holding a public meeting to obtain
public input on issues related to abuse-deterrent formulations of
opioid medications. The first session of the meeting will focus on
scientific and technical issues related to the development and in vitro
assessment of these products. The second session will focus on FDA's
approach to assessing the benefits and risks of the opioids, including
opioids with abuse-deterrent properties. The second session will cover
both FDA's relevant actions to date as well as how FDA can continue to
and further support advances in this field.

A. Session 1: Development and Evaluation of Abuse-Deterrent Opioid
Formulations

    In this session FDA personnel and others will give presentations on
the manufacturing and formulation science related to abuse-deterrent
formulations, including methods used to evaluate the in vitro
performance of such formulations. FDA's goal is to develop
scientifically rigorous methods for assessing how well purportedly
abuse-deterrent opioid formulations--whether submitted in connection
with a new drug application (NDA) or an ANDA--actually deter abuse. As
discussed in the ``Draft Guidance for Industry: Abuse-Deterrent
Opioids--Evaluation and Labeling,'' for NDA products evidence from in
vitro studies, bioavailability studies, human abuse liability studies,
and/or epidemiological studies may be needed to fully evaluate a
product's potentially abuse-deterrent properties. In this session,
however, we are focusing only on the first category of testing--in
vitro studies.
    FDA will discuss its internal research in this area. This
discussion will include the manufacturing science behind the design of
abuse-deterrent formulations, a variety of manipulation techniques, and
the results of testing approved products and placebo formulations under
a range of different manipulation conditions. FDA will also discuss
results from its research contract with the National Institute for
Pharmaceutical Technology and Education on identifying excipient
material attributes that impact abuse-deterrent properties. As we will
discuss, these results show that while currently available technologies
have promise with regard to reducing abuse, additional work is needed,
as they also have significant limitations and vulnerabilities.
    FDA is developing standardized in vitro test methodologies to
assess how well purportedly abuse-deterrent formulations perform under
conditions designed to simulate the ways individuals who abuse opioids
manipulate opioid products for purposes of abuse (e.g., crushing,
heating, dissolving).

    For both NDAs and ANDAs, these methodologies could be used to
identify the critical performance attributes of the drug potentially
related to abuse-deterrence (e.g., crush-resistance, extraction-
resistance). For NDAs, these methodologies could be used to assess
comparative performance with predecessor products or appropriate
controls (e.g., a non-abuse-deterrent immediate-release (IR)
formulation with the same active ingredient). For ANDAs, FDA is still
considering the best approach, but these methodologies could be used to
assess the proposed generic product's critical performance attributes
related to abuse deterrence relative to those of the reference listed
drug (RLD).>
    For both NDAs and ANDAs, FDA intends to issue general guidance
defining common protocols for in vitro testing. FDA is considering
whether to provide more detailed, product-specific in vitro testing
recommendations for ANDAs as well, possibly by including such guidance
together with product-specific bioequivalence testing recommendations
where appropriate.
    Topics for Discussion:
     Please comment on the limitations of currently available
abuse-deterrent technologies and what next-generation technologies or
products might be able to overcome these limitations and provide
improved protection against abuse and misuse. Please comment both on
the development of iterative improvements in abuse-deterrent
technologies for solid oral dose forms of opioids and on the
development of abuse-deterrent formulation technologies for non-solid
oral dosage forms (e.g., transdermal patches, solutions, and buccal
films).
     Please comment on the approach discussed above whereby FDA
would focus on a given RLD's critical performance attributes related to
abuse deterrence for purposes of evaluating an ANDA referencing that
formulation. How would these critical performance attributes be
identified for a given product? What if certain attributes are not
described in the RLD's approved labeling?
     Please comment on the approach discussed above whereby FDA
develops and publishes a standard battery of in vitro test
manipulations to be conducted on all, or some appropriate subset of,
potentially abuse-deterrent formulations.
    [cir] Specifically, please comment on the utility of step-wise
testing, moving from simple manipulations to more complex ones. If the
abuse-deterrent features are compromised or defeated by simple
manipulations, would further testing that is more complex (e.g.,
involving more than one manipulation) and more destructive (e.g.,
higher temperatures, harsher solvents, etc.) be valuable?
    [cir] Please also comment on the availability and use of common
solvents in which extraction studies should be conducted.
    [cir] Please comment on the appropriate controls for in vitro
assessments of proposed generic abuse-deterrent formulations. Should
the proposed generic abuse-deterrent formulation only be compared with
the RLD formulation with abuse-deterrent properties or is the use of an
additional negative control necessary to ensure that the test is
sufficiently discriminatory? Please comment on the selection and
standardization of a negative control, and what degree of superiority
compared with the negative control should be viewed as meaningful.
    [cir] Please comment on what performance attributes should be
considered ``critical'' in assessing whether and to what extent a
formulation effectively deters abuse, such as the time delay or the
amount of effort needed by the abuser under controlled conditions to
access the drug for purposes of abuse. How can these performance
attributes be quantified and linked to their impact on abuse
deterrence? For example, an abuse-deterrent technology may only delay--
rather than completely prevent--access to the opioid for purposes of
abuse. Please comment on the amount of time delay that should be
considered significant and the basis for your recommendation.
    [cir] Please comment on how FDA should adapt and expand its testing
methodologies as new abuse-deterrent technologies become available. Are
there any specific emerging technologies that might require new types
of testing?

B. Session 2: FDA's Regulation of Abuse-Deterrent Opioid Formulations

    FDA assesses each opioid drug product's safety and efficacy on a
case-by-case basis. Abuse potential is one aspect of a product's safety
that the Agency considers, together with all other appropriate factors,
in determining whether a product's benefits outweigh its risks. As part
of this determination, FDA considers the benefit/risk profile of
available therapies.
    For instance, FDA determined that original OXYCONTIN, which lacked
abuse-deterrent properties, posed an increased potential for abuse by
certain routes of administration compared to reformulated OXYCONTIN.
After reformulated OXYCONTIN was approved, FDA concluded that the
benefits of original OXYCONTIN no longer outweighed its risks. The
Agency determined that original OXYCONTIN was withdrawn for reasons of
safety and effectiveness, and accordingly will not accept ANDAs that
refer to original OXYCONTIN.
    Regarding the labeling of opioid products with potentially abuse-
deterrent properties, FDA's current thinking is described in the
``Draft Guidance for Industry: Abuse-Deterrent Opioids--Evaluation and
Labeling.'' Studies designed to evaluate a product's purportedly abuse-
deterrent properties should be scientifically rigorous. In order to
support a description of such properties in labeling, the data should
predict or show that these properties can be expected to, or actually
do, result in a meaningful reduction in that product's abuse potential
(Ref. 8). To date, only two products--TARGINIQ and reformulated
OXYCONTIN--have obtained labeling for their abuse-deterrent properties
consistent with this thinking.
    Regarding generic versions of opioids designed to deter abuse, FDA
is still carefully considering its approach and much remains to be
worked out. See Session 1 above for a discussion of how comparative in
vitro testing may be used to assess these products.
    As abuse-deterrent technologies continue to improve and new opioid
products are developed and approved that meaningfully reduce abuse, FDA
expects the market for opioid medications to continue to transition to
abuse-deterrent formulations. Ultimately, FDA looks forward to a future
in which all or substantially all opioid medications are less
susceptible to abuse than the conventional formulations that dominate
the market today.
    Although FDA has received requests to require all opioid
medications, or some subset of them, to be formulated with abuse-
deterrent technologies, we have said that a class-wide requirement is
not feasible or in the interests of public health at this time (Ref.
9). This field is still in its early stages. Both the technologies
involved and the clinical, epidemiological, and statistical methods for
evaluating those technologies are new and rapidly evolving. As
discussed above, we have limited experience with these formulations and
currently available abuse-deterrent technologies have significant
limitations.
    Accordingly, FDA currently applies the product-by-product approach
described in Session 2, with a goal of incentivizing an incremental,
sponsor-

driven market transition from conventional opioid formulations to
formulations with meaningful abuse-deterrent properties. We anticipate,
however, that at some point--after abuse-deterrent formulations have
become available for a number of different opioid active moieties and
after we have obtained more experience with this field--FDA may
determine that the risks of all or most opioid products that lack
abuse-deterrent properties outweigh the benefits in light of available
therapies. We pose several questions about these approaches below.
    Finally, given that currently marketed abuse-deterrent technologies
have significant limitations, FDA is interested in appropriately
incentivizing and supporting meaningful improvements in abuse-deterrent
technologies so that progressively better abuse-deterrent formulations
become available. We pose questions about this below as well.
    Topics for Discussion:
     As described in the ``Draft Guidance for Industry: Abuse-
Deterrent Opioids--Evaluation and Labeling,'' FDA intends to approve
language in NDA product labeling that accurately and fairly describes
the abuse-deterrent properties of an opioid product if adequately
supported by data (Ref. 8). We hope that the availability of such
labeling claims will incentivize development and use of those products
preferentially where appropriate. Please comment on this approach,
including its impact on encouraging the development of generic opioids
with abuse-deterrent formulations.
     What does it mean for a product to have meaningful abuse-
deterrent properties? Please comment on what data should be provided to
support that determination.
     FDA is considering under what circumstances the benefit/
risk assessment methodology discussed in Session 2 would support a
refusal to approve, or withdrawal of approval for, an NDA for an opioid
formulation lacking meaningful abuse-deterrent properties if an
available therapy or therapies with meaningful abuse-deterrent
properties exist. Please comment on this approach and its implications
for the development of abuse-deterrent opioid formulations, patient
access to opioid medications, generic competition, and potential drug
shortages. What other considerations should pertain?
     One aspect of the benefit/risk assessment relates to the
consideration of available therapies. Please comment on FDA's
consideration of available therapies in assessing (or re-assessing) the
benefit/risk profile of an opioid drug product. What product or
products should FDA consider to be ``available therapies'' when
assessing or re-assessing the benefit/risk profile of an opioid
product?
     Much of the focus in developing abuse-deterrent
formulations has been on extended-release and long-acting (ER/LA)
opioids. As more ER/LA opioid products are reformulated with abuse-
deterrent technologies, individuals who abuse opioids may shift their
attention to opioid drugs lacking abuse-deterrent properties, including
IR products. Are there special considerations associated with IR
products that do not apply to ER/LA opioids? Also, please comment on
whether there are subclasses of opioid medications for which a shift to
abuse-deterrent formulations may be of limited public health benefit.
     As discussed above, FDA does not think a class-based,
abuse-deterrent formulation requirement is feasible or appropriate at
this time. Under what circumstances would it be appropriate to impose
such a requirement and on what classes or subclasses of opioid
products? What considerations should be taken into account to help
ensure that such an approach does not conflict with public health needs
for continued access to important medications?
     If FDA were to determine that the risks of an opioid
product--or, in the case of a class-based approach, many such
products--that lacks abuse-deterrent properties outweigh the benefits
in light of available therapies, how could the Agency minimize any
negative impact on patient access and on generic and innovator drug
development? One possible option would be to apply a delayed
implementation date (e.g., 2 years) to give affected sponsors a
``phase-out'' period to either reformulate or withdraw products lacking
abuse-deterrent properties. Please comment.
     As noted above, FDA is interested in encouraging the
development and introduction of opioid products with progressively
better abuse-deterrent properties, as well as the phase-out of products
with less meaningful properties, as abuse-deterrent technologies
improve. What actions could FDA take to support this goal? Under what
circumstances would it be appropriate to refuse to approve or initiate
withdrawal of a product with, for example, ``first generation'' abuse-
deterrent properties?
     Finally, FDA is aware of the importance of identifying
ways to measure the impacts (positive or negative) of the actions we
take to incentivize and support the development and introduction of
abuse-deterrent formulations of opioid medications. Are there specific
potential impacts of our actions that we need to consider in addition
to those addressed above?

III. Attendance and Registration

    Attendance is free and will be on a first-come, first served basis.
Individuals who wish to present at the public meeting must register on
or before October 14, 2014, at https://fda-abuse-deterrent-public-meeting.eventbrite.com. FDA will accommodate requests to speak, as time
permits, and will determine the amount of time allotted to each
presenter based on the numbers of speaker requests. Speakers should
plan on arriving to the meeting prior to the assigned time in order to
avoid forfeiting your assigned time should the agenda move ahead of
schedule. An agenda and additional meeting background material will be
available approximately 3 days before the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm408607.htm.
    Individuals who wish to attend the meeting but do not wish to make
a presentation should also register at https://fda-abuse-deterrent-public-meeting.eventbrite.com by October 24, 2014. Onsite registration
on the day of the meeting will be based on space availability.
    If you need special accommodations due to a disability, please
contact Mary Gross, Brutrinia Cain, or Georgiann Ienzi (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in advance.
    Information about how to view the live Web cast of this meeting
will posted at http://www.fda.gov/Drugs/NewsEvents/ucm408607.htm. A
video recording of the meeting will be available at the same Web
address for 1 year.

IV. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. To ensure
consideration, submit comments by January 9, 2015. Comments may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

V. Transcripts

    As soon as possible after a transcript of the public meeting is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.

VI. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen between
9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web
site addresses, but FDA is not responsible for any subsequent changes
to the Web sites after this document publishes in the Federal
Register.)

    1. CDC, ``Opioids Drive Continued Increase in Drug Overdose
Deaths'', 2013, available at http://www.cdc.gov/media/releases/2013/
p0220drugoverdosedeaths.html.
    2. SAMHSA, Center for Behavioral Health Statistics and Quality.
Treatment Episode Data Set (TEDS): 2001-2011. National Admissions to
Substance Abuse Treatment Services. BHSIS Series S-65, HHS
Publication No. (SMA) 13-4772. Rockville, MD, 2013, available at
http://www.samhsa.gov/data/2k13/TEDS2011/TEDS2011N.pdf.
    3. SAMHSA, Center for Behavioral Health Statistics and Quality,
``Drug Abuse Warning Network,'' 2011, available at http://
samhsa.gov/data/dawn/nations/Nation2011AllMA.xls.
    4. SAMHSA, ``Results from the 2012 National Survey on Drug Use
and Health,'' detailed table 1.1A, NSDUH Series H-46, HHS
Publication No. (SMA) 13-4795. Rockville, MD, 2013, available at
http://www.samhsa.gov/data/NSDUH/2012SummNatFindDetTables/NationalFindings/NSDUHresults2012.pdf.
    5. Institute of Medicine, ``Relieving Pain in America: A
Blueprint for Transforming Prevention, Care, Education, and
Research,'' available at http://www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx.
    6. CDC, ``Vital Signs: Overdoses of Prescription Opioid Pain
Relievers--United States, 1999-2008,'' available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm.
    7. Department of Health and Human Services, ``Addressing
Prescription Drug Abuse in the United States--Current Activities and
Future Opportunities,'' available at http://www.cdc.gov/
HomeandRecreationalSafety/pdf/
HHSPrescriptionDrugAbuseReport
09.2013.pdf.
    8. ``Draft Guidance for Industry: Abuse-Deterrent Opioids--
Evaluation and Labeling,'' January 2013, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf.
    9. Janet Woodcock, M.D., letter to Center for Lawful Access and
Abuse Deterrence et al., dated October 25, 2013, in Docket No. FDA-
2013-P-0703, available at http://www.regulations.gov/#!documentDetail;D=FDA-2013-P-0703-0004.

    Dated: September 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22514 Filed 9-22-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Rules and Regulations]
[Pages 81179-81181]
[FR Doc No: 2015-32735]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0358]
RIN 1625-AA09

Drawbridge Operation Regulation; Missouri River, Atchison, KS

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is changing the operating schedule that
governs the Atchison Railroad Drawbridge, Mile 422.5, across the
Missouri River at Atchison, KS. Under this rule the drawbridge will
open on signal if at least a two-hour notification is given. This rule
change allows the bridge to operate under the customary schedule

that has been adopted by the waterway users.

DATES: This rule is effective on January 28, 2016.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2014-0358 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Eric Washburn, Bridge Administrator, Western Rivers,
Bridge Branch, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Acronyms

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section Symbol
U.S.C. United States Code

II. Background Information and Regulatory History

    On April 10, 2015, we published a notice of proposed rulemaking
(NPRM) entitled, ``Drawbridge Operation Regulation; Missouri River,
Atchison, KS'' in the Federal Register (80 FR 19252). We received no
comments on the proposed rule. No public meeting was requested, and
none was held.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority 33 U.S.C. 499.
    The Atchison Railroad Drawbridge crosses the Missouri River at mile
422.5 in Atchison, Kansas and operates in accordance with 33 CFR
117.411 and 117.687 which apply to all drawbridges over the Missouri
River. The vertical clearance of the bridge in the closed position is
37.5 feet above zero on this gage. Due to very limited drawspan
openings and to codify the operating schedule that has been adopted by
the waterway usersc, the Union Pacific Railroad requested a two-hour
advance notice of opening the bridge's drawspan during the commercial
navigation season.
    The Union Pacific Railroad has documented the limited number of
vessel openings per year at this bridge. This information is available
at the Coast Guard Western Rivers, Bridge Branch; see the
aforementioned contact information.
    Upon this request and further review by the Coast Guard, it was
concluded that a two-hour advance notice on drawspan openings of the
Atchison Railroad Drawbridge would not create a consistency issue with
other bridges on the Missouri River nor adversely affect navigation.

IV. Discussion of Comments, Changes and the Final Rule

    The Coast Guard provided a comment period in which no comments were
received.
    This rule adds special operating requirements codifying the
customary advance notice for openings of the Atchison Railroad Bridge
under 33 CFR part 117, subpart B as required under 33 CFR 117.8. The
proposed change will add a paragraph (b) to 33 CFR 117.411, a reference
to this paragraph in 33 CFR 117.687, and allow for bridge drawspan
openings to take place provided at least a two-hour advance notice is
given.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders (E.O.s) related to rulemaking. Below we summarize our
analyses based on a number of these statutes and E.O.s, and we discuss
First Amendment rights of protesters.

A. Regulatory Planning and Review

    E.O.s 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.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a ``significant
regulatory action,'' under E.O. 12866. Accordingly, it has not been
reviewed by the Office of Management and Budget.
    This proposed rule is not a significant regulatory action and does
not require a full assessment. As a matter of custom in the area,
commercial mariners already provide advance notice; therefore this rule
has little, if any, impact on current navigation.

B. 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 received no comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a significant economic impact on a
substantial number of small entities.
    This rule is neutral to all business entities operating on the
waterway and simply requires a two-hour advance notice to open the
bridge. As stated above, it is custom in the area to provide advance
notice for a requested opening. This rule simply codifies such notice
already given as a customary practice. While some owners or operators
of vessels intending to transit the bridge may be small entities, for
the reasons stated in section V.A above, this rule will not have a
significant economic impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above. Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism

principles and preemption requirements described in E.O. 13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and 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
determination that this action is one of a category of actions which do
not individually or cumulatively have a significant effect on the human
environment. This rule simply promulgates the operating regulations or
procedures for drawbridges. This action is categorically excluded from
further review, under figure 2-1, paragraph (32)(e), of the
Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

G. Protest Activities

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

List of Subjects in 33 CFR Part 117

    Bridges.
    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. Revise Sec.  117.411 to read as follows:

Sec.  117.411  Missouri River.

    (a) The draws of the bridges across the Missouri River shall open
on signal; except during the winter season between the date of closure
and the date of opening of the commercial navigation season as
published by the Army Corps of Engineers, the draw need not open unless
at least 24 hours advance notice is given.
    (b) The draw of the Atchison Railroad Bridge, Mile 422.5, Missouri
River need not open unless a two-hour advance notice is given during
the commercial navigation season.
0
3. Revise Sec.  117.687 to read as follows:

Sec.  117.687  Missouri River.

    The draws of the bridges, except for the Atchison Railroad Bridge,
Mile 422.5, see Sec.  117.411(b) for further details, across the
Missouri River shall open on signal; except during the winter season
between the date of closure and date of opening of the commercial
navigation season as published by the Army Corps of Engineers, the
draws need not open unless at least 24-hours advance notice is given.

    Dated: December 11, 2015.
D.R. Callahan,
Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. 2015-32735 Filed 12-28-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: September 16, 2010 (Volume 75, Number 179)]
[Notices]
[Page 56654]
[DOCID:fr16se10-119]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

RTCA NextGen Advisory Committee (NAC)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA NextGen Advisory Committee (NAC)

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

SUMMARY: The FAA published a Notice in the Federal Register on
September 3, 2010 (75-FR-54221), concerning a Notice to advise the
public of a meeting of RTCA NextGen Advisory Committee. The Agenda in
that notice has been revised.

DATES: The meeting will be held September 23, 2010, from 8:30 a.m. to
11:30 a.m.

ADDRESSES: The meeting will be held at Bessie Coleman Room, Federal
Aviation Administration, 800 Independence Avenue, SW., Washington, DC
20591. Metro: L'Enfant Plaza Station (Use 7th & Maryland Exit).

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax (202)
833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: The Agenda published in the Federal Register
Notice on September 3, 2010, (75-FR-54221) is revised to read as
follows:
     Opening Plenary (Welcome and Introductions).
     Review Terms of Reference.
     Overview of NextGen--Setting the stage for Committee
actions.
     RTCA Task Force 5 Recommendations.
     FAA Actions and Activities.
     Close-out ATMAC Action Items.
     Discussion of Initial Task.
     Discussion of Working Subcommittee.
     Set Meeting Dates for 2011.
     Closing Plenary (Other Business, Adjourn).
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on September 10, 2010.
Robert L. Bostiga,
RTCA Advisory Committee.
[FR Doc. 2010-23071 Filed 9-15-10; 8:45 am]
BILLING CODE 4910-13-P