[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11643-11644]
[FR Doc No: 2013-03742]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0680; FRL-9528-2]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Emission Guidelines and
Compliance Times for Existing Municipal Solid Waste Landfills (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before March 21,
2013.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2012-0680, to: (1) EPA online, using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, mail code
28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460; and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On October 17, 2012 (77 FR 63813), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to both EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2012-0680, which is available for either public
viewing online at http://www.regulations.gov, or in person viewing at
the Enforcement and Compliance Docket in the EPA Docket Center (EPA/
DC), EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC.
The EPA Docket Center 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 Reading Room is<PHONE_NUMBER>, and the
telephone number for the Enforcement and Compliance Docket is (202)
566-1752.
    Use EPA's electronic docket and comment system at http://www.regulations.gov to either submit or view public comments, access
the index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidentiality of Business Information (CBI), or
other information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to
www.regulations.gov.
    Title: Emission Guidelines and Compliance Times for Existing
Municipal Solid Waste Landfills (Renewal).
    ICR Numbers: EPA ICR Number 1893.06, OMB Control Number 2060-0430.
    ICR Status: This ICR is scheduled to expire on March 31, 2013.
Under OMB regulations, the Agency may continue to either conduct or
sponsor the collection of information while this submission is pending
at OMB.
    Abstract: The affected entities are subject to the General
Provisions of the Emission Guidelines at 40 CFR part 60, subpart A, and
any changes, or additions to the Provisions specified at 40 CFR part
60, subpart Cc and part 62, Subpart GGG.
    Owners or operators of the affected facilities must submit periodic
reports and results. Owners or operators are also required to maintain
records of control system monitoring, accumulated refuse, surface
methane monitoring, and collection and control system exceedances.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 15
hours per response. ``Burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Entities potentially affected by
this action are the owners or operators of municipal solid waste
landfills.
    Estimated Number of Respondents: 511.
    Frequency of Response: Monthly, Quarterly, and Annually.
    Estimated Total Annual Hour Burden: 42,277.
    Estimated Total Annual Cost: $4,717,854, which includes $4,054,254
in labor costs, no capital/startup costs, and $663,600 in operation and
maintenance (O&M) costs.
    Changes in the Estimates: There is a net decrease in the total
burden associated with both privately- and publicly-owned landfills.
This decrease is due to an adjustment to the estimated average number
of respondents. To account for landfill closures that have occurred
since the previous ICR was approved, this ICR applies a three-percent
per year landfill closure rate to the previous ICR's estimated number
of respondents. This adjustment decreased the total burden hours
associated with privately- and publicly-owned landfills. There is an
increase in burden cost from the most recently approved ICR. This is

due to the fact that this ICR uses updated labor rates from the Bureau
of Labor Statistics to calculate respondent burden costs.
    There is an increase in the respondent burden and cost associated
with State and local agencies. This increase is due to an adjustment in
the labor burden calculations. The previous ICR assumed that, for each
burden item, person-hours per occurrence included technical,
managerial, and clerical labor hours. To be consistent with the
estimation methodology used in other ICRs, this ICR assumes that
person-hours per occurrence includes technical labor only, and that
managerial and clerical hours account for an additional 5 and 10
percent, respectively, of technical labor hours. This adjustment
increased the State and local agency burden hours and costs.
    There is a decrease in the Federal Agency burden due to adjustments
in the labor burden calculations. The previous ICR included a burden
item for Agency review of surface methane monitoring reports.
Respondents, however, are not required to submit reports; therefore, no
Agency burden will be incurred. For this reason we have adjusted the
calculations to exclude any Agency burden associated with surface
methane monitoring. We have also adjusted the total labor burden
attributed to EPA technical, managerial, and clerical labor. As
described in the previous paragraph, we adjusted the calculations for
consistency with other ICRs, and so that managerial and clerical hours
account for an additional 5 and 10 percent, respectively, of technical
labor hours. The net result of these adjustments was a decrease in
burden.
    There is also a decrease in O&M costs from the most recently
approved ICR. This decrease is not due to any program changes, and is
attributed to the decrease in the number of respondents due to landfill
closures that have occurred since the previous ICR was approved. As a
result, there is a proportional decrease in the O&M cost.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2013-03742 Filed 2-15-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13304-13305]
[FR Doc No: 2019-06549]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-3883]

Determination That CORTISPORIN (Hydrocortisone/Neomycin Sulfate/
Polymyxin B Sulfate) Otic Solution, 10 Milligrams/Milliliter
Hydrocortisone, 3.5 Milligrams Base/Milliliter Neomycin Sulfate, 10,000
Units/Milliliter Polymyxin B Sulfate, Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that CORTISPORIN (hydrocortisone/neomycin sulfate/polymyxin
B sulfate) otic solution, 10 milligrams (mg)/milliliter (mL)
hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was not withdrawn from sale for reasons of safety
or effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002, 240-
402-1748.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    CORTISPORIN (hydrocortisone/neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone, 3.5 mg base/mL neomycin
sulfate, 10,000 units/mL polymyxin B sulfate, is the subject of NDA
050479, held by Monarch Pharmaceuticals LLC, and initially approved on
December 9, 1975. CORTISPORIN is indicated for the treatment of
superficial bacterial infections of the external auditory canal caused
by organisms susceptible to the action of the antibiotics.
    CORTISPORIN (hydrocortisone/neomycin sulfate/polymyxin B sulfate)
otic solution, 10 mg/mL hydrocortisone, 3.5 mg base/mL neomycin
sulfate, 10,000 units/mL polymyxin B sulfate, is currently listed in
the ``Discontinued Drug Product List'' section of the Orange Book.
    Foley & Lardner LLP submitted a citizen petition dated October 11,
2018 (Docket No. FDA-2018-P-3883), under Sec.  10.30 (21 CFR 10.30),
requesting that the Agency determine whether CORTISPORIN
(hydrocortisone/neomycin sulfate/polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was withdrawn from sale for reasons of safety or
effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that CORTISPORIN (hydrocortisone/neomycin sulfate/
polymyxin B sulfate) otic solution, 10 mg/mL hydrocortisone, 3.5 mg
base/mL neomycin sulfate, 10,000 units/mL polymyxin B sulfate, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that CORTISPORIN
(hydrocortisone/neomycin sulfate/polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of CORTISPORIN (hydrocortisone/neomycin
sulfate/polymyxin B sulfate) otic solution, 10 mg/mL hydrocortisone,
3.5 mg base/mL neomycin sulfate, 10,000 units/mL polymyxin B sulfate,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have found no
information that would indicate that this drug product was withdrawn
from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list CORTISPORIN
(hydrocortisone/neomycin sulfate/polymyxin B sulfate) otic solution, 10
mg/mL hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL
polymyxin B sulfate, in the ``Discontinued Drug Product List'' section
of the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. FDA will not
begin procedures to withdraw approval of approved ANDAs that refer to
this drug product. Additional ANDAs for this drug product may also be
approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs.
    If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06549 Filed 4-3-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Rules and Regulations]
[Pages 12556-12558]
[FR Doc No: 2011-5292]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0157; Directorate Identifier 2010-NM-261-AD;
Amendment 39-16630; AD 2011-04-09]
RIN 2120-AA64

Airworthiness Directives; Various Transport Category Airplanes
Equipped With Chemical Oxygen Generators Installed in a Lavatory

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: This document publishes in the Federal Register an amendment
adopting airworthiness directive (AD) 2011-04-09 that was sent
previously by individual notices to the known U.S. owners and operators
of affected airplanes identified above. This AD requires modifying the
chemical oxygen generators in the lavatory. This AD was prompted by
reports that the current design of these oxygen generators presents a
hazard that could jeopardize flight safety. We are issuing this AD to
eliminate this hazard.

DATES: This AD becomes effective March 14, 2011 to all persons except
those persons to whom it was made immediately effective by AD 2011-04-
09, which contained the requirements of this amendment.
    We must receive comments on this AD by April 22, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jeff Gardlin, Aerospace Engineer,
Cabin Safety Branch, ANM-115, FAA, Transport Airplane Directorate, 1601
Lind Avenue, SW., Renton, Washington 98057-3356; telephone 425-227-
2136; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>or
    Robert Hettman, Aerospace Engineer, Propulsion and Mechanical
Systems Branch, ANM-112, FAA, Transport Airplane Directorate, 1601 Lind
Avenue, SW., Renton, Washington 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On February 10, 2011, we issued AD 2011-04-
09, which applies to certain passenger-carrying transport category
airplanes operating in 14 CFR part 121 air carrier service; or U.S.-
registered and operating under 14 CFR part 129, with a maximum
passenger capacity of 20 or greater; and equipped with any chemical
oxygen generator installed in any lavatory.

Background

    This AD was prompted by reports that the current design of these
oxygen generators presents a hazard that could jeopardize flight
safety. We are issuing this AD to eliminate this hazard.

FAA's Determination and Requirements of This AD

    Since the unsafe condition described is likely to exist or develop
on other airplanes of the same type design, we issued AD 2011-04-09 to
eliminate a hazard with chemical oxygen generators in the lavatory,
which, if not corrected, could jeopardize flight safety. The AD
requires either activating all chemical oxygen generators in the
lavatories until the generator oxygen supply is expended, or removing
the oxygen generator(s); and, for each chemical oxygen generator, after
the generator is expended (or removed), removing or re-stowing the
oxygen masks and closing the mask dispenser door.
    We have determined that notice and opportunity for prior public
comment on AD 2011-04-09 were contrary to the public interest, and good
cause existed to make the AD effective immediately by individual
notices issued on February 10, 2011, to the known U.S. owners and
operators of certain passenger-carrying transport category airplanes
operating in 14 CFR part 121 air carrier service; or U.S.-registered
and operating under 14 CFR part 129, with a maximum passenger capacity
of 20 or greater; and equipped with any chemical oxygen generator
installed in any lavatory.
    These conditions still exist, and the AD is hereby published in the
Federal Register as an amendment to section 39.13 of the Federal
Aviation Regulations (14 CFR 39.13) to make it effective to all
persons.

Differences Between This Federal Register Version and the Individual
Notices

    This Federal Register version of the AD is different from the
individual notices previously issued. These individual notices
contained a time-limited flight crew notification procedure. This
procedure required that the pilot in command be notified that the
oxygen generators in the lavatories had been rendered inoperative, and
instructed the pilot in command to brief the crew that in the event of
a rapid

decompression the lavatories needed to be checked. Since flight crews
have been made aware of this AD by the actions in the individual
notices, and these procedures were to be applied for a limited time (30
days) only, the procedures are considered no longer necessary, and are
not included in this AD. Flight crews are still made aware of
corrective actions taken as a result of this AD since maintenance
activities are recorded and available to the flight crew using existing
maintenance procedures.

Related Rulemaking

    We are currently planning to issue a special Federal Aviation
Regulation (SFAR) to address the regulatory compliance issues resulting
from carrying out the actions required by this AD until the type
certification and operational rules are modified.
    This AD is applicable to U.S.-registered transport category
airplanes operating under 14 CFR part 129 as identified in paragraph
(c) of this AD. We will monitor actions taken by other airworthiness
authorities to implement the requirements of this AD into their own
fleets to determine if additional rulemaking actions are necessary.

Action by the State of Design

    This AD is applicable to all transport category airplanes
identified in paragraph (c) of this AD. For the purposes of the FAA's
responsibility to notify other airworthiness authorities of continued
airworthiness issues under International Civil Aviation Organization
(ICAO) Annex 8, this AD is considered an action by the State of Design
for United States products.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
``Docket No. FAA-2011-0157; Directorate Identifier 2010-NM-261-AD'' at
the beginning of your comments. We specifically invite comments on the
overall regulatory, economic, environmental, and energy aspects of this
AD. We will consider all comments received by the closing date and may
amend this AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
subtitle VII, part A, subpart III, section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2011-04-09 Transport Category Airplanes: Amendment 39-16630. Docket
No. FAA-2011-0157; Directorate Identifier 2010-NM-261-AD.

Effective Date

    (a) This AD becomes effective March 14, 2011, to all persons
except those persons to whom it was made immediately effective by AD
2011-04-09, issued on February 10, 2011, which contained the
requirements of this amendment.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to transport category airplanes, in
passenger-carrying operations, that are equipped with any chemical
oxygen generator installed in any lavatory, and are:
    (1) Operating under 14 CFR part 121; or
    (2) U.S.-registered and operating under 14 CFR part 129, with a
maximum passenger capacity of 20 or greater.

Subject

    (d) Joint Aircraft System Component (JASC)/Air Transport
Association (ATA) of America Code 35, Oxygen.

Unsafe Condition

    (e) This AD was prompted by reports that the current design of
chemical oxygen generators in the lavatories presents a hazard that
could jeopardize flight safety. We are issuing this AD to eliminate
this hazard.

Compliance

    (f) Comply with this AD within the compliance times specified,
unless already done.

Oxygen Generator Deactivation

    (g) Within 21 days after the effective date of this AD, do the
actions specified in paragraphs (g)(1) and (g)(2) of this AD.
    (1) Activate all chemical oxygen generators in the lavatories
until the generator oxygen supply is expended. An operator may also
remove the oxygen generator(s), in accordance with existing
maintenance practice, in lieu of activating it.
    (2) For each chemical oxygen generator, after the generator is
expended (or removed), remove or re-stow the oxygen masks and close
the mask dispenser door.

    Note 1:  Chemical oxygen generators are considered a hazardous
material and subject to specific requirements under Title 49 CFR for
shipping. Oxygen generators must be expended prior to disposal but
are considered a hazardous waste; therefore, disposal must be in
accordance with all Federal, State, and local regulations. Expended
oxygen generators are forbidden in air transportation as cargo. For
more information, contact 1-800-HMR-4922.

    Note 2:  Design approval holders are not expected to release
service instructions for this action.

Compliance with Federal Aviation Regulations

    (h) Notwithstanding the requirements of Sections 25.1447,
121.329, 121.333, and 129.13 of the Federal Aviation Regulations (14
CFR 25.1447, 121.329, 121.333, and 129.13), operators complying with
this AD are authorized to operate affected airplanes until this
action is superseded by other rulemaking.

Parts Installation

    (i) After the effective date of this AD, no person may install a
chemical oxygen generator in any lavatory on any affected airplane.

Special Flight Permit

    (j) Special flight permits, as described in Section 21.197 and
Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed.

Alternative Methods of Compliance (AMOCs)

    (k)(1) The Manager, Transport Standards Staff, ANM-110, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to an individual
identified in either paragraph (k)(1)(i) or (k)(1)(ii) of this AD.
    (i) Jeff Gardlin, Aerospace Engineer, Cabin Safety Branch, ANM-
115, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425)
227-1149; e-mail<EMAIL_ADDRESS>    (ii) Robert Hettman, Aerospace Engineer, Propulsion and
Mechanical Systems Branch, ANM-112, FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector or, lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

Contact Information

    (l) For technical information about this AD, contact:
    (1) Jeff Gardlin, Aerospace Engineer, Cabin Safety Branch, ANM-
115, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425)
227-1149; e-mail<EMAIL_ADDRESS>    (2) Robert Hettman, Aerospace Engineer, Propulsion and
Mechanical Systems Branch, ANM-112, FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>    (m) For FAA Flight Standards information about this AD, contact
the manager at your local certificate management office (CMO) or
certificate management team (CMT).

    Issued in Renton, Washington, on March 2, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-5292 Filed 3-7-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Proposed Rules]
[Pages 17482-17483]
[FR Doc No: 2014-07080]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 1

[Docket No. USCG-2008-1259]
RIN 1625-AB32

Assessment Framework and Organizational Restatement Regarding
Preemption for Certain Regulations Issued by the Coast Guard

AGENCY: Coast Guard, DHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Coast Guard is extending the comment period for the notice
of proposed rulemaking (NPRM) entitled ``Assessment Framework and
Organizational Restatement Regarding Preemption for Certain Regulations
Issued by the Coast Guard,'' which published on December 27, 2013. For
reasons discussed in this notice, the comment period is extended until
May 26, 2014.

DATES: The comment period for the proposed rule published on December
27, 2013 (78 FR 79242), is extended. Comments and related material must
be submitted to our online docket via http://www.regulations.gov on or
before May 26, 2014, or reach the Docket Management Facility by that
date.

ADDRESSES: You may submit comments, identified by Coast Guard docket
number USCG-2008-1259, using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these methods. For
instructions on submitting comments, see the ``Public Participation and
Request for Comments'' portion of the SUPPLEMENTARY INFORMATION section
below.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email Lieutenant Commander Lineka Quijano, Office of Maritime
and International Law, Coast Guard, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

A. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2008-1259), indicate the specific section of this
document to which each comment applies, and provide the reason for each
suggestion or recommendation. You may submit your comments and material
online, or by fax, mail, or hand delivery, but please use only one of
these means. We recommend that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comment online, go to http://www.regulations.gov,
search for the docket number USCG-2008-1259, and then click on the
``comment now'' link. If you submit your comments by mail or hand
delivery, submit them in an unbound format, no larger than 8\1/2\ by 11
inches, suitable for copying and electronic filing. If you submit them
by mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope.
    We will consider all comments and material received during the
comment period. We may change this proposed rule in view of them.

B. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
search for the docket number USCG-2008-1259, and then click ``Open
Docket Folder.'' If you do not have access to the Internet, you may
view the docket online by visiting the Docket Management Facility in
Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. We have an agreement
with the Department of Transportation to use the Docket Management
Facility.

C. Privacy Act

    Anyone can search the electronic form of all comments received into
any of our dockets by the name of the individual submitting the comment
(or signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

D. Public Meeting

    We intend to hold a public meeting on this topic. We will announce
the time and place of that meeting in a later notice in the Federal
Register.

II. Reasons for Extension

    On December 27, 2013, the Coast Guard published its NPRM,
``Assessment Framework and Organizational Restatement Regarding
Preemption for Certain Regulations Issued by the Coast Guard'' (78 FR
79242). The NPRM provided for a comment period of 90 days, which is now
extended by an additional 60 days for a total comment period length of
150 days. This notice of extension is issued under authority of 5
U.S.C. 552(a).
    The NPRM discusses existing law on preemption, and identifies the
laws and regulations that have preemptive effect. It clarifies (but
does not alter) the Coast Guard's application of statutes and case law
regarding the preemptive effect of its regulations. It also sets forth
a process the Coast Guard will use in future rulemakings for evaluating
the preemptive impact of those future regulations.
    The Coast Guard has received requests for extension of the comment
period. Some of these requests are from members of the public and of
State agencies who are concerned that the proposed rule would interfere
with existing State permitting practices, or would require a thorough
review of State regulations to find out what State regulations may be
preempted by the proposed rule. The Coast Guard does not believe the
proposed rule should raise such concerns. As stated here and throughout
the NPRM, the proposed rule merely restates the current preemptive
impact of our regulations as it exists today as a result of statute and
court decisions. The proposed rule does not make any new determinations
or assertions, but only summarizes in one

location existing law and the Coast Guard's statement of preemptive
impact. The proposed rule does not alter in any way the rights of
States. Likewise, it does not serve to prospectively give preemptive
impact to any future regulatory effort. The proposed rule does not
change the law as it exists today.
    However, we are interested in better understanding the concerns
expressed, and we want to allow ample time for the public to consider
the proposed rule. Accordingly, we have extended the comment period. We
encourage all members of the public, and especially States, to send
comments explaining what, if any, impact the proposed rule could have.
Please be as specific as possible in explaining how the proposed rule
would affect you.

    Dated: March 26, 2014.
F.J. Kenney,
Rear Admiral, U.S. Coast Guard, Judge Advocate General.
[FR Doc. 2014-07080 Filed 3-27-14; 8:45 am]
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