[Federal Register: June 30, 2010 (Volume 75, Number 125)]
[Rules and Regulations]
[Page 37738-37739]
[DOCID:fr30jn10-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0465; FRL-8831-6]

 1-Naphthaleneacetic Acid; Time-Limited Tolerance, Technical
Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION:  Final rule; technical correction.

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SUMMARY: EPA issued a final rule in the Federal Register of September
11, 2009, (74 FR 46689) (FRL-8426-2) concerning azinphos-methyl,
disulfoton, esfenvalerate, ethylene oxide, fenvalerate, et al.;
tolerance actions. Today's rule restores the time-limited tolerance for
1-naphthaleneacetic acid in or on avocados which was inadvertently
deleted by the September 11, 2009 final rule.

DATES: This final rule is effective June 30, 2010.

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0465. All documents in the
docket are listed in the docket index available in http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

    The Agency included in the final rule a list of those who may be
potentially affected by this action. If you have questions regarding
the applicability of this action to a particular entity, consult the
person listed under FOR FURTHER INFORMATION CONTACT.

II. What Does this Technical Correction Do?

    EPA published a final rule in the Federal Register of August 12,
2009 (74 FR 40513) (FRL-8428-3) establishing a time-limited tolerance
for residues of 1-naphthaleneacetic acid ethyl ester in or on avocados.
That time-limited tolerance was inadvertently removed by a final rule
published in the Federal Register of September 11, 2009 (74 FR 46689)
(FRL-8426-2). Today's rule restores the time-limited tolerance for 1-
naphthaleneacetic acid in or on avocados inadvertently deleted by the
September 11, 2009 final rule.

III. Why is this Correction Issued as a Final Rule?

    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Section 408(l)(6) authorizes EPA to establish such tolerances
without providing notice or period for public comment. Section 408(e)
of FFDCA allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
    In addition, section 553 of the Administrative Procedure Act (APA),
5 U.S.C. 553(b)(3)(B), provides that, when an Agency for good cause
finds that notice and public procedure are impracticable, unnecessary
or contrary to the public interest, the Agency may issue a final rule
without providing notice and an opportunity for public comment. EPA has
determined that there is good cause for making this technical
correction final without prior proposal and opportunity for comment,
because the final rule amendment to Sec. 180.155 previously published
August 12, 2009 (74 FR 40513) (FRL-8428-3) was inadvertently deleted
September 11, 2009 (74 FR 46689) (FRL-8426-2). EPA finds that this
constitutes good cause under 5 U.S.C. 553(b)(3)(B).

IV. Do Any of the Statutory and Executive Order Reviews Apply to this
Action?

    This document corrects a final rule that established a tolerance
under section 408(d) of FFDCA in response to a petition submitted to
the Agency. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this final rule has been exempted from review under Executive
Order 12866, this final rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section

12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: June 21, 2010.
 Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is corrected as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.155(b) to read as follows:

Sec.  180.155  1-Naphthaleneacetic acid; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. A time-limited tolerance
specified in the following table is established for residues of the
ethyl ester of 1-naphthaleneacetic acid in or on the following raw
agricultural commodity resulting from use of the pesticide pursuant to
FIFRA section 18 emergency exemptions. The tolerance will expire and is
revoked on the date specified in the following table:

------------------------------------------------------------------------
                                           Parts per      Expiration/
                Commodity                   million        revocation
------------------------------------------------------------------------
Avocado.................................         0.05           12/31/12
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-15882 Filed 6-29-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 92 (Thursday, May 12, 2016)]
[Notices]
[Pages 29554-29556]
[FR Doc No: 2016-11192]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PF16-4-000]

Columbia Gas Transmission, LLC; Notice of Intent To Prepare an
Environmental Assessment for the Planned B-System Project and Request
for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the B-System Project involving
abandonment, construction, and operation of facilities by Columbia Gas
Transmission, LLC (Columbia) in Fairfield and Franklin Counties, Ohio.
The Commission will use this EA in its decision-making process to
determine whether the project is in the public convenience and
necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the project. You can make a difference by providing us with
your specific comments or concerns about the project. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
Your input will help the Commission staff determine what issues they
need to evaluate in the EA. To ensure that your comments are timely and
properly recorded, please send your comments so that the Commission
receives them in Washington, DC on or before June 6, 2016.
    If you sent comments on this project to the Commission before the
opening of this docket on March 10, 2016, you will need to file those
comments in Docket No. PF16-4-000 to ensure they are considered as part
of this proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this planned
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the planned facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves the project, that approval conveys with it the
right of eminent

domain. Therefore, if easement negotiations fail to produce an
agreement, the pipeline company could initiate condemnation proceedings
where compensation would be determined in accordance with state law.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility On My Land? What Do I Need To Know?'' is available for
viewing on the FERC Web site (www.ferc.gov). This fact sheet addresses
a number of typically asked questions, including the use of eminent
domain and how to participate in the Commission's proceedings.

Public Participation

    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has expert staff available to assist you at
(202) 502-8258 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' If you are filing a comment on a particular project,
please select ``Comment on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket number
(PF16-4-000) with your submission: Kimberly D. Bose, Secretary, Federal
Energy Regulatory Commission, 888 First Street NE., Room 1A,
Washington, DC 20426.

Summary of the Planned Project

    Columbia plans to abandon pipeline and appurtenant aboveground
facilities as well as construct replacement and new pipeline and
appurtenant aboveground facilities in Franklin and Fairfield Counties,
Ohio. The project would replace aging infrastructure and construct new
facilities as a part of Columbia's proposed Modernization II Program,
which would allow Columbia to achieve compliance with emerging
regulations and meet current and future service requirements.
    The B-System Project would:
     Abandon in place approximately 17.5 miles of 20-inch-
diameter pipeline and remove two associated mainline valves (mileposts
7.7 and 10.9) on Columbia's Line B-105;
     construct approximately 14.0 miles of 20-inch-diameter
replacement pipeline, and construct one new bi-directional pig \1\
launcher/receiver (milepost 0.0) and mainline valve (milepost 7.0) on
Columbia's Line B-111;
---------------------------------------------------------------------------

    \1\ A ``pig'' is a tool that the pipeline company inserts into
and pushes through the pipeline for cleaning the pipeline,
conducting internal inspections, or other purposes.
---------------------------------------------------------------------------

     replace approximately 0.1 mile of 4-inch-diameter pipeline
on Columbia's Line B-121;
     replace approximately 0.5 mile of 4-inch-diameter pipeline
on Columbia's Line B-130; and
     construct approximately 7.6 miles of new 20-inch-diameter
pipeline (``Line K-270'') connecting Columbia's K-System to its B-
System, one pig launcher and tie-in piping (milepost 0.0), and one pig
receiver, tie-in piping, gas heater, and regulation facility (milepost
7.6).
    The general location of the project facilities is shown in appendix
1.\2\
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    \2\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street NE.,
Washington, DC 20426, or call<PHONE_NUMBER>. For instructions on
connecting to eLibrary, refer to the last page of this notice.
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Land Requirements for Construction

    Columbia's planned abandonment and construction activities would
disturb about 387.6 acres of land. Following construction, Columbia
would utilize and maintain about 147.5 acres for permanent operation of
the new and replacement facilities.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\3\ to discover and address concerns the public may have about
proposals. This process is referred to as scoping. The main goal of the
scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
---------------------------------------------------------------------------

    \3\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
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    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the planned project under these
general headings:
     Geology and soils;
     land use;
     water resources, fisheries, and wetlands;
     cultural resources;
     vegetation and wildlife;
     air quality and noise;
     endangered and threatened species;
     public safety; and
     cumulative impacts.
    We will also evaluate possible alternatives to the planned project
or portions of the project, and make recommendations on how to lessen
or avoid impacts on the various resource areas.
    Although no formal application has been filed, we have already
initiated our NEPA review under the Commission's pre-filing process.
The purpose of the pre-filing process is to encourage early involvement
of interested stakeholders and to identify and resolve issues before
the FERC receives an application. As part of our pre-filing review, we
have begun to contact some federal and state agencies to discuss their
involvement in the scoping process and the preparation of the EA.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before we make our recommendations
to the Commission. To ensure we have the opportunity to consider and
address your comments, please carefully follow the instructions in the
Public Participation section, beginning on page 2.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues
related to this project to formally cooperate with us in the
preparation of the EA.\4\ Agencies that would like to request
cooperating agency status should follow the instructions for filing
comments

provided under the Public Participation section of this notice.
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    \4\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
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Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the applicable State Historic Preservation Office(s), and to
solicit their views and those of other government agencies, interested
Indian tribes, and the public on the project's potential effects on
historic properties.\5\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPO(s) as the project
develops. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
construction right-of-way, contractor/pipe storage yards, compressor
stations, and access roads). Our EA for this project will document our
findings on the impacts on historic properties and summarize the status
of consultations under section 106.
---------------------------------------------------------------------------

    \5\ The Advisory Council on Historic Preservation regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
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Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
planned project.
    If we publish and distribute the EA, copies of the EA will be sent
to the environmental mailing list for public review and comment. If you
would prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (appendix 2).

Becoming an Intervenor

    Once Columbia files its application with the Commission, you may
want to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Motions to intervene are more fully described at
http://www.ferc.gov/resources/guides/how-to/intervene.asp. Instructions
for becoming an intervenor are in the ``Document-less Intervention
Guide'' under the ``e-filing'' link on the Commission's Web site.
Please note that the Commission will not accept requests for intervenor
status at this time. You must wait until the Commission receives a
formal application for the project.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., PF16-
4). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: May 6, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-11192 Filed 5-11-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 238 (Monday, December 13, 2010)]
[Notices]
[Page 77680]
[FR Doc No: 2010-31393]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
December 16, 2010 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), (8), 9(ii) and (10), permit consideration of
the scheduled matters at the Closed Meeting.
    Commissioner Walter, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
December 16, 2010 will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Regulatory matters regarding financial institutions; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: December 9, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-31393 Filed 12-9-10; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 127 (Wednesday, July 1, 2020)]
[Rules and Regulations]
[Pages 39477-39479]
[FR Doc No: 2020-14082]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. FDA-2017-D-6841]

Unique Device Identification: Policy Regarding Compliance Dates
for Class I and Unclassified Devices and Certain Devices Requiring
Direct Marking; Immediately in Effect Guidance for Industry and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Availability of guidance.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance entitled ``Unique Device Identification:
Policy Regarding Compliance Dates for Class I and Unclassified Devices
and Certain Devices Requiring Direct Marking; Immediately in Effect
Guidance for Industry and Food and Drug Administration Staff.'' This
guidance revises the guidance by the same title issued November 5,
2018, and describes FDA's intention with respect to the enforcement of
unique device identification (UDI) requirements for class I and
unclassified devices, other than implantable, life-sustaining, or life-
supporting (I/LS/LS) devices. In this revised guidance, FDA clarifies
that, at this time, in light of the considerations described in the
guidance, it does not intend to enforce standard date formatting,
labeling, and Global Unique Device Identification Database (GUDID) data
submission requirements for these devices before September 24, 2022.
The guidance is immediately in effect, but it remains subject to
comment in accordance with the Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal
Register on July 1, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6841 for ``Unique Device Identification: Policy Regarding
Compliance Dates for Class I and Unclassified Devices and Certain
Devices Requiring Direct Marking; Immediately in Effect Guidance for
Industry and Food and Drug Administration Staff.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Unique Device Identification: Policy Regarding Compliance Dates for
Class I and Unclassified Devices and Certain Devices Requiring Direct
Marking; Immediately in Effect Guidance for Industry and Food and Drug
Administration Staff'' to the Office of the Center Director, Guidance
and Policy Development, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002 or the Center for Biologics
Evaluation and Research, Office of Communication, Outreach, and
Development, 10903 New Hampshire Ave., Bldg. 71, Room 3128, Silver
Spring, MD 20903. Send one self-addressed adhesive label to assist that
office in processing your request.

FOR FURTHER INFORMATION CONTACT:
    For Center for Devices and Radiological Health-regulated devices:
Christina Savisaar, UDI Regulatory Policy Support, 10903 New Hampshire

Ave., Bldg. 32, Rm. 3255,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    For Center for Biologics Evaluation and Research-regulated devices:
Stephen Ripley, Office of Communication, Outreach, and Development,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, or call 1-800-835-
4709 or<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``Unique
Device Identification: Policy Regarding Compliance Dates for Class I
and Unclassified Devices and Certain Devices Requiring Direct Marking;
Immediately in Effect Guidance for Industry and Food and Drug
Administration Staff.'' On September 24, 2013, FDA published a final
rule establishing a unique device identification system designed to
adequately identify devices through distribution and use (the UDI
Rule). Phased implementation of the regulatory requirements set forth
in that final rule is based on a series of established compliance dates
based primarily on device classification, which range from September
24, 2014, to September 24, 2020.
    The UDI Rule requires a device to bear a UDI on its label and
packages unless an exception or alternative applies (see 21 CFR
801.20), and special labeling requirements apply to stand-alone
software regulated as a device (21 CFR 801.50). The UDI Rule also
requires that data pertaining to the key characteristics of each device
required to bear a UDI be submitted to FDA's GUDID (21 CFR 830.300). In
addition, the UDI Rule added 21 CFR 801.18, which requires certain
dates on device labels to be in a standard format. For devices that:
(1) Must bear UDIs on their labels and (2) are intended to be used more
than once and reprocessed between uses, 21 CFR 801.45 requires the
devices to be directly marked with a UDI. Compliance dates for these
labeling, GUDID data submission, standard date format, and direct
marking requirements can be found in the preamble to the UDI Rule, 78
FR 58786 at 58815 to 58816.
    This guidance describes FDA's intention with regard to enforcement
of these requirements for class I and unclassified devices, other than
I/LS/LS devices. This revised guidance supersedes the November 2018
guidance of the same title, ``Unique Device Identification: Policy
Regarding Compliance Dates for Class I and Unclassified Devices and
Certain Devices Requiring Direct Marking; Immediately in Effect
Guidance for Industry and Food and Drug Administration Staff.'' In this
revised guidance, FDA states that, at this time, in light of the
considerations described in the guidance, it does not intend to enforce
the requirements under 21 CFR 801.18, 801.20, 801.50, and 830.300 for
class I and unclassified devices, other than I/LS/LS devices, prior to
September 24, 2022, regardless of the date they are manufactured and
labeled. The guidance explains that FDA believes it is important to
continue focusing its resources on addressing UDI implementation issues
and data quality for higher risk devices and, at this time, concludes
that continuing its existing policy with regard to enforcement of these
requirements for class I and unclassified devices, other than I/LS/LS
devices, is consistent with the public health. In addition, while some
editorial changes were made to improve clarity, other policies
described in the November 2018 guidance remain the same in the revised
guidance.
    FDA considered comments received on the guidance that appeared in
the Federal Register on November 5, 2018 (83 FR 55372) as the Agency
revised the guidance.
    This guidance is being implemented without prior public comment
because the Agency has determined that prior public participation is
not feasible or appropriate (see section 701(h)(1)(C) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR
10.115(g)(2)). FDA has determined that this guidance presents a less
burdensome policy that is consistent with public health. Although this
guidance is immediately in effect, FDA will consider all comments
received and revise the guidance document as appropriate.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Unique Device Identification: Policy
Regarding Compliance Dates for Class I and Unclassified Devices and
Certain Devices Requiring Direct Marking.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download an electronic
copy of ``Unique Device Identification: Policy Regarding Compliance
Dates for Class I and Unclassified Devices and Certain Devices
Requiring Direct Marking; Immediately in Effect Guidance for Industry
and Food and Drug Administration Staff'' may send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the
document. Please use the document number 17029 and complete title to
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in
the following FDA regulations have been approved by OMB as listed in
the following table:

------------------------------------------------------------------------
                                                            OMB control
            21 CFR part                     Topic               No.
------------------------------------------------------------------------
801 subpart B and 830.............  Unique Device              0910-0720
                                     Identification.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
------------------------------------------------------------------------

    Dated: June 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14082 Filed 6-30-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 85 (Friday, May 1, 2020)]
[Notices]
[Page 25490]
[FR Doc No: 2020-09293]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-107 OMB Control No. 3235-0116]

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Form 6-K

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form 6-K (17 CFR 249.306) is a disclosure document under the
Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.) that must be
filed by a foreign private issuer to report material information
promptly after the occurrence of specified or other important corporate
events that are disclosed in the foreign private issuer's home country.
The purpose of Form 6-K is to ensure that U.S. investors have access to
the same information that foreign investors do when making investment
decisions. Form 6-K takes approximately 8.7 hours per response and is
filed by approximately 34,794 issuers annually. We estimate that 75% of
the 8.7 hours per response (6.525 hours) is prepared by the issuer for
a total annual reporting burden of 227,031 hours (6.525 hours per
response x 34,794 responses).
    Written comments are invited on: (a) Whether this collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (b) the accuracy of the agency's estimate of the burden
imposed by the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information 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 unless it displays a
currently valid control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Cynthia
Roscoe 100 F Street NE, Washington, DC 20549 or send an email to:
<EMAIL_ADDRESS>
    Dated: April 28, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-09293 Filed 4-30-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Pages 71136-71137]
[FR Doc No: 2010-29349]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2010-0065]

Public Meetings of National Flood Insurance Program (NFIP) Reform
Effort; Correction

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Announcement of Public Meetings; correction.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) published a
document in the Federal Register on November 10, 2010 (75 FR 69096),
announcing two public meetings. The document contained an incorrect e-
mail address. Due to the incorrect e-mail address, FEMA is lengthening
the amount of time that the public has to contact FEMA to request
special accommodations. FEMA has chosen to republish the corrected
notice in its entirety. This notice announces two public meetings of
the National Flood Insurance Program (NFIP) Reform Effort. In
performing its mission, FEMA believes it is important to continually
update stakeholders on its programs and answer any questions and listen
to comments from them on how its programs can be more efficient and
effective at meeting the needs of the public. To this end, FEMA has
engaged in a comprehensive reform effort to address the concerns of the
wide array of stakeholders involved in the ongoing debate about the
NFIP. FEMA chose a participatory policy analysis framework to guide the
NFIP Reform effort. Policy analysis employs systematic inquiry and
evaluation to assess policy alternatives. The participatory policy
analysis process allows public decisions to be made in a structured,
defensible, and collaborative manner.
    The effort is comprised of three phases designed to engage the
greatest number of stakeholders and consider the largest breadth of
public policy options. Phase I focused on the capture and analysis of
stakeholder concerns and recommendations. During Phase II, FEMA
performed additional analysis of existing data and identified a set of
evaluation criteria. In Phase III, a portfolio of public policy
alternatives is being developed and will be analyzed using the
evaluation criteria. The resulting recommendations will be reported to
FEMA leadership. The purpose of the public meetings is to describe,
update, and explain straw man policy alternatives and to answer
questions and listen to comments from interested stakeholders.
Additional information on the straw man policy alternatives has been
made available prior to the meeting via the NFIP Reform website and has
been posted to Docket ID: FEMA-2010-0065.
    In addition, through these public meetings, FEMA will accept
stakeholder input of the policy evaluation process through the use of a
pair-wise comparison method. The pair-wise tool is also available via
the NFIP Reform Web site at http://www.fema.gov/business/nfip/nfip_reform.shtm.

DATES: Meeting Date: The first public meeting will be held on December
2, 2010, from 10 a.m. to 5 p.m. EST. This meeting will be held in
Washington, DC. The second public meeting will be held on December 9,
2010, from 10 a.m. to 5 p.m. MST. This meeting will be held in Denver,
CO.
    Comment Date: Written comments must be received by December 31,
2010.

ADDRESSES: All written comments must be received by Friday, December
31, 2010. All submissions received must include the Docket ID: FEMA-
2010-0065 and may be submitted by any one of the following methods:
    Federal Rulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments on the Web site.
    E-mail<EMAIL_ADDRESS>Include Docket ID: FEMA-2010-0065 in
the subject line of the message.
    Facsimile:<PHONE_NUMBER>.
    Mail: FEMA, Office of Chief Counsel, 500 C Street, SW., Room 840,
Washington, DC 20472-3100.
    Hand Delivery/Courier: FEMA, Office of Chief Counsel, 500 C Street,
SW., Room 840, Washington, DC 20472-3100.
    Instructions: All submissions received must include the Docket ID:
FEMA-2010-0065. Comments received will also be posted without
alteration at http://www.regulations.gov, including any personal
information provided. You may want to read the Privacy Act Notice
located on the Privacy and Use Notice link on the Administration
Navigation Bar of the Web site http://www.regulations.gov.
    Docket: For access to the docket to read documents or comments
received by FEMA, go to http://www.regulations.gov. The straw man
policy alternatives have been posted to Docket ID: FEMA-2010-0065.
    Special Accomodations: For anyone attending the meeting who is
hearing or visually impaired, or who requires special assistance or
accommodations, please contact Jason ``Tommy'' Kennedy by November 29,
2010. For further information, please contact Mr. Kennedy by telephone
at<PHONE_NUMBER>.
    Meeting Locations: The first public meeting will be held in
Washington, DC, at the Washington Marriott at Metro Center, 775 12th
Street NW., Washington, DC. The second public meeting will be held in
Denver, Colorado at the Denver Federal Center, Building 810--Entrance
W-5, Denver, CO.
    Meeting Accessibility: Due to space constraints of the facilities,
seating will be limited to 200 participants. To reserve a seat in
advance, please provide a request via email or mail with the contact
information of the participant (including name, mailing address, and e-
mail address), the meeting(s) to be attended, and include the subject/
attention line (or on the envelope if by mail): Reservation Request for
NFIP Reform Meeting. Advance reservations must be received 3 business
days prior to the meeting to ensure processing. Unregistered
participants will be accepted after all participants with reservations
have been accommodated and will be admitted on a first-come, first-
serve basis, provided the 200 person capacity is not exceeded. To
submit reservations, please email<EMAIL_ADDRESS>or send by
mail to the address listed in the FOR FURTHER INFORMATION CONTACT
caption.
    Web site: http://www.fema.gov/business/nfip/nfip_reform.shtm.

FOR FURTHER INFORMATION CONTACT: Michael Grimm, by telephone at 202-
646-2878 or by e-mail at<EMAIL_ADDRESS>Mailing Address:
NFIP Reform, 1800 South Bell Street, Room 970, Arlington, VA 20598-
3030.
    Meeting Topics: Background information about these topics is
available on the NFIP Reform website. The straw man policy alternatives
have

been be posted to Docket ID: FEMA-2010-0065.
    Procedure: This meeting is open to the public.

    Dated: November 16, 2010.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-29349 Filed 11-19-10; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)]
[Rules and Regulations]
[Pages 51160-51161]
[FR Doc No: 2017-23988]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[FRL-9970-25-OP]

Final Report on Review of Agency Actions That Potentially Burden
the Safe, Efficient Development of Domestic Energy Resources Under
Executive Order 13783

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final report; notification of availability.

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

SUMMARY: The EPA is announcing the availability of its Final Report on
Review of Agency Actions that Potentially Burden the Safe, Efficient
Development of Domestic Energy Resources Under Executive Order 13738.

DATES: November 3, 2017.

FOR FURTHER INFORMATION CONTACT: Samantha Dravis, Office of Policy,
Mail Code 1803-A, U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue NW., Washington, DC 20460. Telephone:<PHONE_NUMBER>;
email address: [email protected].

SUPPLEMENTARY INFORMATION: On March 28, 2017, President Trump signed
Executive Order 13783, Promoting Energy Independence and Economic
Growth. The Executive Order establishes a national policy to promote
the clean and safe development of domestic energy resources while
avoiding unnecessary regulatory burdens. It directs federal agencies to
``review all existing regulations, orders,

guidance documents, policies, and any other similar agency actions
(collectively, ``agency actions'') that potentially burden the
development or use of domestically produced energy resources[.]'' \1\
The Executive Order also orders the EPA to review specific rules. As
part of E.O. 13783, agencies are to develop a report detailing this
review that includes recommendations for reducing unnecessary
regulatory burdens. The EPA's final report is available at https://www.epa.gov/laws-regulations/regulatory-reform.
---------------------------------------------------------------------------

    \1\ 82 FR 16093 (Mar. 28, 2017).

    Dated: October 30, 2017.
E. Scott Pruitt,
Administrator.
[FR Doc. 2017-23988 Filed 11-2-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 204 (Friday, October 21, 2016)]
[Proposed Rules]
[Pages 72758-72759]
[FR Doc No: 2016-25313]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 271 and 272

[EPA-R06-RCRA-2015-0664; FRL-9951-20-Region 6]

Louisiana: Final Authorization of State-Initiated Changes and
Incorporation by Reference of State Hazardous Waste Management Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: During a review of Louisiana's regulations, the Environmental
Protection Agency (EPA) identified a variety of State-initiated changes
to Louisiana's hazardous waste program under the Resource Conservation
and Recovery Act (RCRA), as amended, for which the State had not
previously sought authorization. EPA proposes to authorize the State
for the program changes. In addition, EPA proposes to codify in the
regulations entitled ``Approved State Hazardous Waste Management
Programs'', Louisiana's authorized hazardous waste program. The EPA
will incorporate by reference into the Code of Federal Regulations
(CFR) those provisions of the State regulations that are authorized and
that EPA will enforce under RCRA.

DATES: Send written comments by November 21, 2016.

ADDRESSES: Submit any comments identified by Docket ID No. EPA-R06-
RCRA-2015-0664, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow
the on-line instructions for submitting comments.
    2. Email<EMAIL_ADDRESS>or<EMAIL_ADDRESS>    3. Mail: Alima Patterson, Region 6, Regional Authorization
Coordinator, or Julia Banks, Codification Coordinator, Permit Section
(RPM), Multimedia Planning and Permitting Division, EPA Region 6, 1445
Ross Avenue, Dallas, Texas 75202-2733.
    4. Hand Delivery or Courier: Deliver your comments to Alima
Patterson, Region 6, Regional Authorization Coordinator, or Julia
Banks, Codification Coordinator, Permit Section (RPM), Multimedia
Planning and Permitting Division, EPA Region 6, 1445 Ross Avenue,
Dallas, Texas 75202-2733.
    Instructions: Do not submit information that you consider to be
Confidential Business Information (CBI) or otherwise protected through
regulations.gov, or email. Direct your comments to Docket ID No. EPA-
R06-RCRA-2015-0664. The Federal regulations.gov Web site is an
``anonymous access'' system, which means the EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to the EPA without
going through regulations.gov, your email address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet. If you submit an
electronic comment, the EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If the EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, the
EPA may not be able to consider your comment. Electronic files should
avoid the use of special characters, any form of encryption, and be
free of any defects or viruses. You can view and copy the documents
that form the basis for this authorization and codification and
associated publicly available materials from 8:30 a.m. to 4 p.m. Monday
through Friday at the following location: EPA Region 6, 1445 Ross
Avenue, Dallas, Texas 75202-2733, phone number:<PHONE_NUMBER> or (214)
665-8178. Interested persons wanting to examine these documents should
make an appointment with the office at least two weeks in advance.

FOR FURTHER INFORMATION CONTACT: Alima Patterson, Region 6, Regional
Authorization Coordinator or Julia Banks, Codification Coordinator,
Permit Section (RPM), Multimedia Planning and Permitting Division, EPA
Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733, Phone number:
(214) 665-8533 or<PHONE_NUMBER>, and Email address:
<EMAIL_ADDRESS>or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For additional information, please see the
direct final rule published in the ``Rules and Regulations'' section of
this Federal Register. EPA did not make a proposal prior to the direct
final rule because we believe this action is not controversial and do
not expect comments that oppose it. We have explained the reasons for
this authorization in the preamble to the direct final rule. Unless we
get written comments which oppose this authorization during the comment
period, the direct final rule will become effective 60 days after
publication and we will not take further action on this proposal. If we
receive comments that oppose this action, we will withdraw the direct
final rule and it will not take effect. We will then respond to public
comments in a later final rule based on this proposal. You may not have
another opportunity for comment. If you want to comment on this action,
you must do so at this time.
    The purpose of this Federal Register document is to codify
Louisiana's base hazardous waste management program and its revisions
to that program through RCRA Clusters XXI, XXII including RCRA Cluster
XXIII Checklist 229 Exclusions for Solvent Contaminated Wipes. (See 80
FR 55032) September 14, 2015. The EPA provided

notices and opportunity for comments on the Agency's decisions to
authorize the Louisiana program, and the EPA is not now reopening the
decisions, nor requesting comments, on the Louisiana authorizations as
published in FR notices specified in Section I.F of the direct final
rule FR document.
    This document incorporates by reference Louisiana's hazardous waste
statutes and regulations and clarifies which of these provisions are
included in the authorized and federally enforceable program. By
codifying Louisiana's authorized program and by amending the Code of
Federal Regulations, the public will be more easily able to discern the
status of federally approved requirements of the Louisiana's hazardous
waste management program.

    Authority: This action is issued under the authority of sections
2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act, as
amended, 42 U.S.C. 6912(a), 6926, and 6974(b).

    Dated: August 1, 2016.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2016-25313 Filed 10-20-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 120 (Monday, June 23, 2014)]
[Rules and Regulations]
[Pages 35488-35490]
[FR Doc No: 2014-14457]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 93

[Docket No.: FAA-2010-0302; Amdt. No. 93-98]
RIN 2120-AK46

The Extension of the Expiration Date of the New York North Shore
Helicopter Route

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The action amends the expiration date of the final rule
requiring pilots flying civil helicopters under Visual Flight Rules to
use the New York North Shore Helicopter Route when operating along the
north shore of Long Island, New York. The current rule expires on
August 6, 2014. The FAA finds it necessary to extend this rule for an
additional two years to preserve the current operating environment in
order to determine whether the mandatory use of this route should be
made permanent. The FAA will conduct notice and comment rulemaking on
the permanent use of this route. A limited extension of the current
rule provides needed time to conduct the appropriate analysis to assess
the rule's impact and proper rulemaking procedures.

DATES: This final rule is effective August 6, 2014, through August 6,
2016.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact David Maddox, Airspace Regulation and ATC
Procedures Group, AJV-113, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone 202-267- 8783;
email<EMAIL_ADDRESS>    For legal questions concerning this action, contact Lorelei Peter,
International Law, Legislation and Regulations Division, AGC-200,
Office of the Chief Counsel, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules on 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.
    The FAA has broad authority and responsibility to regulate the
operation of aircraft, the use of the navigable airspace and to
establish safety standards for and regulate the certification of
airmen, aircraft, and air carriers. (49 U.S.C. 40104 et seq.,
40103(b)). The FAA's authority for this rule is contained in 49 U.S.C.
40103 and 44715. Under section 40103, the Administrator of the FAA has
authority to ``prescribe air traffic regulations on the flight of
aircraft (including regulations on safe altitudes) for * * * (B)
protecting individuals and property on the ground. (49 U.S.C.
40103(b)(2)). In addition, section 44715(a), provides that to ``relieve
and protect the public health and welfare from aircraft noise,'' the
Administrator of the FAA, ``as he deems necessary, shall prescribe * *
* (ii) regulations to control and abate aircraft noise * * *.''

I. Background

    In response to concerns from local residents regarding noise from
helicopters operating over Long Island, the FAA adopted the New York
North Shore Helicopter Route final rule (77 FR 39911). The rule is
based on a voluntary Visual Flight Rule (VFR) route that was developed
by the FAA working with the Eastern Region Helicopter Council. The rule
requires civil helicopter pilots operating under VFR, whose route of
flight takes them over the north shore of Long Island between the VPLYD
waypoint and Orient point, to use the North Shore Helicopter Route, as
published in the New York Helicopter Chart.\1\ The rule permits pilots
to deviate from the route and altitude requirements when necessary for
safety, weather conditions, or transitioning to or from a destination
or point of landing. The rule was promulgated to maximize use of the
route as published in order to secure and improve upon decreased levels
of noise that had been voluntarily achieved.
---------------------------------------------------------------------------

    \1\ The voluntary route originally was added to the Helicopter
Route Chart for New York on May 8, 2008.
---------------------------------------------------------------------------

    The current rule terminates on August 6, 2014. The FAA limited the
duration of the rule because at the time of promulgation the FAA did
not know the current rate of compliance with the voluntary route or the
circumstances surrounding an operator's decision to not use the route.
The FAA concluded that ``There is no reason to retain this rule if the
FAA determines that it is not actually improving the noise situation
along the north shore of Long Island.'' \2\ Accordingly, the agency
decided that

the rule would sunset in two years if it was determined that there is
no meaningful improvement in the effects of helicopter noise on quality
of life or that the rule was otherwise unjustified. Specifically, the
FAA stated ``Should there be such an improvement, the FAA may, after
appropriate notice and opportunity for comment, decide to make the rule
permanent. Likewise, should the FAA determine that reasonable
modification could be made to the route to better address noise
concerns (and any other relevant concerns), we may choose to modify the
rule after notice and comment.'' \3\
---------------------------------------------------------------------------

    \2\ See 77 FR 39918.
    \3\ Id.
---------------------------------------------------------------------------

II. The Final Rule

    This action extends the requirement for pilots of civil helicopters
to use the North Shore Helicopter Route when transiting along the north
shore of Long Island for an additional two years, while the FAA
considers whether to make the mandatory use of the route permanent. The
current rule requiring use of the route expires on August 6, 2014.
Public input to this consideration is critical and additional time is
needed to conduct the rulemaking process. However, the FAA does not
want to disrupt the operating environment and cause any confusion on
using the route during this interim period. Therefore, the FAA finds
that a two year extension of the current rule is warranted to maintain
the current operating environment and permit the agency to engage in
rulemaking to determine future action on this route. The FAA expects to
issue a Notice of Proposed Rulemaking on the permanent use of this
route in the immediate future. The FAA finds that under Title 5 of the
United States Code section 553(b) good cause exists that notice and
public comment are impracticable and contrary to the public interest.

III. Regulatory Notices and Analyses

A. Regulatory Evaluation

    Changes to Federal regulations must undergo several economic
analyses. First, Executive Order 12866 and Executive Order 13563 direct
that each Federal agency shall propose or adopt a regulation only upon
a reasoned determination that the benefits of the intended regulation
justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub.
L. 96-354) requires agencies to analyze the economic impact of
regulatory changes on small entities. Third, the Trade Agreements Act
(Pub. L. 96-39) prohibits agencies from setting standards that create
unnecessary obstacles to the foreign commerce of the United States. In
developing U.S. standards, the Trade Act requires agencies to consider
international standards and, where appropriate, that they be the basis
of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4) requires agencies to prepare a written assessment of
the costs, benefits, and other effects of proposed or final rules that
include a Federal mandate likely to result in the expenditure by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $100 million or more annually (adjusted for inflation with
base year of 1995). This portion of the preamble summarizes the FAA's
analysis of the economic impacts of this final rule.
    Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it to be included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this extension. The reasoning
for this determination follows.
    Since this rule only extends the current requirements for pilots of
civil helicopters to use the North Shore Helicopter Route when
transiting along the north shore of Long Island for an additional two
years, the expected outcome will be a minimal impact and a regulatory
evaluation was not prepared.
    The FAA has therefore determined that this extension is not a
``significant regulatory action'' as defined in section 3(f) of
Executive Order 12866, and is not ``significant'' as defined in DOT's
Regulatory Policies and Procedures.

B. Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation.'' To achieve this principle, agencies are
required to solicit and consider flexible regulatory proposals and to
explain the rationale for their actions to assure that such proposals
are given serious consideration. The RFA covers a wide-range of small
entities, including small businesses, not-for-profit organizations, and
small governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    This final rule will maintain the current operating environment for
two years, therefore the FAA maintains that it will only have a minimal
impact on any small entity affected by this rulemaking action.

C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing standards or engaging in related activities
that create unnecessary obstacles to the foreign commerce of the United
States. Pursuant to these Acts, the establishment of standards is not
considered an unnecessary obstacle to the foreign commerce of the
United States, so long as the standard has a legitimate domestic
objective, such as the protection of safety, and does not operate in a
manner that excludes imports that meet this objective. The statute also
requires consideration of international standards and, where
appropriate, that they be the basis for U.S. standards. The FAA has
assessed the potential effect of this final rule and determined that it
would have only a domestic impact and therefore no effect on
international trade.

D. Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently

uses an inflation-adjusted value of $151 million in lieu of $100
million. This final rule does not contain such a mandate; therefore,
the requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. The FAA has determined that
there is no new requirement for information collection associated with
this final rule.

F. International Compatibility and Cooperation

    In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to conform to
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
determined that there are no ICAO Standards and Recommended Practices
that correspond to these regulations.
    Executive Order 13609, Promoting International Regulatory
Cooperation, promotes international regulatory cooperation to meet
shared challenges involving health, safety, labor, security,
environmental, and other issues and to reduce, eliminate, or prevent
unnecessary differences in regulatory requirements. The FAA has
analyzed this action under the policies and agency responsibilities of
Executive Order 13609, and has determined that this action would have
no effect on international regulatory cooperation.

G. Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined that this action qualifies for categorical exclusion under
the National Environmental Policy Act in accordance with FAA Order
1050.1E, ``Environmental Impacts: Policies and Procedures,'' paragraph
312f. This action is not expected to cause any potentially significant
environmental impacts, and no extraordinary circumstances exist that
warrant preparation of an environmental assessment.

IV. Executive Order Determinations

A. Executive Order 13132, Federalism

    The FAA has analyzed this final rule under the principles and
criteria of Executive Order 13132, Federalism. The agency determined
that this action will not have a substantial direct effect on the
States, or the relationship between the Federal Government and the
States, or on the distribution of power and responsibilities among the
various levels of government, and, therefore, does not have Federalism
implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy
Supply, Distribution, or Use

    The FAA analyzed this final rule under Executive Order 13211,
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). The agency has determined that it
is not a ``significant energy action'' under the executive order and it
is not likely to have a significant adverse effect on the supply,
distribution, or use of energy.

V. Additional Information

A. Availability of Rulemaking Documents

    An electronic copy of rulemaking documents may be obtained from the
Internet by--
    1. Searching the Federal eRulemaking Portal (http://www.regulations.gov);
    2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies or
    3. Accessing the Government Printing Office's Web page at http://www.gpo.gov/fdsys/.
    Copies may also be obtained by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
Commenters must identify the docket or amendment number of this
rulemaking.
    All documents the FAA considered in developing this rulemaking
action, including economic analyses and technical reports, may be
accessed from the Internet through the Federal eRulemaking Portal
referenced in item (1) above.

List of Subjects in 14 CFR Part 93

    Air traffic control, Airspace, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends chapter I.

PART 93--SPECIAL AIR TRAFFIC RULES

0
1. The authority citation for part 93 is revised to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40109, 40113, 44502,
44514, 44701, 44715, 44719, 46301.

0
2. Amend Sec.  93.101 to read as follows:

Sec.  93.101  Applicability.

    This subpart prescribes a special air traffic rule for civil
helicopters operating VFR along the North Shore, Long Island, New York,
between August 6, 2012 and August 6, 2016.

    Issued under authority provided by 49 U.S.C. 106(f), 44701(a),
and 44703 in Washington, DC, on June 2, 2014.
Michael P. Huerta,
Administrator.
[FR Doc. 2014-14457 Filed 6-20-14; 8:45 am]
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