[Federal Register Volume 84, Number 155 (Monday, August 12, 2019)]
[Rules and Regulations]
[Pages 39756-39758]
[FR Doc No: 2019-17127]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0822; FRL-9997-85-Region 4]

Air Plan Approval; KY; Jefferson County Existing and New
Miscellaneous Metal Parts and Products Surface Coating Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve two revisions to the Jefferson County portion of the
Kentucky State Implementation Plan (SIP), provided by the Commonwealth
of Kentucky, through the Kentucky Division of Air Quality (KDAQ),
through a letter dated March 15, 2018. The revisions were submitted by
KDAQ on behalf of the Louisville Metro Air Pollution Control District
(also referred to herein as Jefferson County) and add a recordkeeping
provision for certain sources of volatile organic compounds along with
other administrative changes. EPA is approving the changes because they
are consistent with the Clean Air Act (CAA or Act).

DATES: This rule is effective September 11, 2019.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R04-OAR-2018-0822. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the internet and will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at the Air
Regulatory Management Section, Air Planning and Implementation Branch,
Air and Radiation Division (formerly the Air, Pesticides and Toxics
Management Division), U.S. Environmental Protection Agency, Region 4,
61 Forsyth Street SW, Atlanta, Georgia 30303-8960. EPA requests that if
at all possible, you contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection. The Regional
Office's official hours of business are Monday through Friday 8:30 a.m.
to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Evan Adams of the Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-9009. Mr. Adams can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    EPA is taking final action to approve changes to the Jefferson
County portion of the Kentucky SIP that were provided to EPA through a
letter dated March 15,

2018.\1\ Specifically, EPA is finalizing approval of the portions of
these SIP revisions that make changes to the District's Regulation
6.31, Standards of Performance for Existing Miscellaneous Metal Parts
and Products Surface Coating Operations, and Regulation 7.59, Standards
of Performance for New Miscellaneous Metal Parts and Products Surface
Coating Operations.\2\ The March 15, 2018, SIP revisions add a new
recordkeeping provision to both Regulation 6.31 and 7.59 and make a
minor, administrative change that clarifies the applicability of
Regulation 6.31. The SIP revisions update the current SIP-approved
versions of Regulation 6.31 (Version 5) and Regulation 7.59 (Version 5)
to Version 6 of each. In a notice of proposed rulemaking (NPRM)
published on April 24, 2019 (84 FR 17127), EPA proposed to approve the
aforementioned changes to Regulations 6.31 and 7.59 in the Jefferson
County portion of the Kentucky SIP, which address the control of
emissions from existing and new miscellaneous metal parts and products
surface coating operations, respectively. The NPRM provides additional
details regarding EPA's action. Comments on the NPRM were due on or
before May 24, 2019. EPA received no comments on the proposed action,
so EPA is now taking final action to approve the above-referenced
revisions.
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    \1\ EPA notes that the Agency received these SIP revisions on
March 23, 2018, along with other revisions to the Jefferson County
portion of the Kentucky SIP. EPA will be considering action for
those SIP revisions in separate rulemakings.
    \2\ EPA also notes that the Agency received several other
revisions to the Jefferson County portion of the Kentucky SIP
submitted with the same March 15, 2018, cover letter. EPA will be
considering action on the remaining revisions in separate actions.
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II. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of Jefferson
County portion of the Kentucky SIP. Regulation 6.31, Standards of
Performance for Existing Miscellaneous Metal Parts and Products Surface
Coating Operations, Version 6, and Regulation 7.59, Standards of
Performance for New Miscellaneous Metal Parts and Products Surface
Coating Operations, Version 6, both State effective January 17, 2018.
EPA has made, and will continue to make, these materials generally
available through www.regulations.gov and at the EPA Region 4 Office
(please contact the person identified in the For Further Information
Contact section of this preamble for more information). Therefore,
these materials have been approved by EPA for inclusion in the State
implementation plan, have been incorporated by reference by EPA into
that plan, are fully federally enforceable under sections 110 and 113
of the CAA as of the effective date of the final rulemaking of EPA's
approval, and will be incorporated by reference in the next update to
the SIP compilation.\3\
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    \3\ See 62 FR 27968 (May 22, 1997).
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III. Final Action

    EPA is taking final action to approve the aforementioned changes to
the Jefferson County portion of the Kentucky SIP. These rule revisions
do not contravene federal permitting requirements or existing EPA
policy, nor will they impact the National Ambient Air Quality Standards
or interfere with any other applicable requirement of the Act.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by October 11, 2019. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Volatile organic compounds.

    Dated: July 29, 2019.
Mary S. Walker,
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42.U.S.C. 7401 et seq.

Subpart (S)--Kentucky

0
2. In Sec.  52.920, in paragraph (c), table 2, is amended:
0
a. Under ``Reg 6--Standards of Performance for Existing Affected
Facilities'' by revising the entry for ``6.31''; and
0
b. Under ``Reg 7--Standards of Performance for New Affected
Facilities'' by revising the entry for ``7.59''.
    The revisions read as follows:

Sec.  52.920  Identification of plan.

* * * * *
    (c) * * *

                         Table 2--EPA-Approved Jefferson County Regulations for Kentucky
----------------------------------------------------------------------------------------------------------------
                                         EPA approval    Federal Register     District
      Reg            Title/subject           date             notice       effective date       Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                         Reg 6-Standards of Performance for Existing Affected Facilities
----------------------------------------------------------------------------------------------------------------

                                                   * * * * * *
6.31..........  Standards of                   8/12/19  [Insert citation          1/17/18
                 Performance for                         of publication].
                 Existing
                 Miscellaneous Metal
                 Parts and Products
                 Surface Coating
                 Operations.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                           Reg 7--Standards of Performance for New Affected Facilities
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
7.59..........  Standards of                   8/12/19  [Insert citation          1/17/18  .....................
                 Performance for New                     of publication].
                 Miscellaneous Metal
                 Parts and Products
                 Surface Coating
                 Operations.

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

* * * * *
[FR Doc. 2019-17127 Filed 8-9-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: November 20, 2009 (Volume 74, Number 223)]
[Notices]
[Page 60283-60284]
[DOCID:fr20no09-90]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2009-0800]

Notification of the Imposition of Conditions of Entry for Certain
Vessels Arriving to the United States, Madagascar

AGENCY: Coast Guard, DHS.

ACTION: Notice.

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SUMMARY: The Coast Guard announces that it will impose conditions of
entry on vessels arriving to the United States from Madagascar, with
the exception of vessels arriving from the port of Toamasina (also
known as Tamatave).

DATES: The requirements announced in this notice will become effective
December 4, 2009.

ADDRESSES: This notice will be available for inspection and copying at
the Docket Management Facility at the U.S. Department of
Transportation, Room W12-140 on the Ground Floor of the West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call Mr. Michael Brown, International Port Security Evaluation
Division, Coast Guard, telephone<PHONE_NUMBER>. If you have questions on
viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    Section 70110 of the Maritime Transportation Security Act of 2002
(Pub. L. 107-295, Nov. 25, 2002) (46 U.S.C. 70110) provides that the
Secretary of Homeland Security may impose conditions of entry on
vessels requesting entry into the United States arriving from ports
that are not maintaining effective anti-terrorism measures, may deny
entry into the United States to any vessel that does not meet such
conditions set forth herein, and shall provide public notice for
passengers of the ineffective antiterrorism measures. The Coast Guard
has been delegated the authority by the Secretary to carry out the
provisions of this section. Previous notices have imposed or removed
conditions of entry on vessels arriving from certain countries and
those conditions of entry and the countries they pertain to remain in
effect unless modified by this notice.
    Based on an assessment conducted pursuant to the provisions of 46
U.S.C. 70108 and the International Ship and Port Facility Security
(ISPS) Code, the Coast Guard has determined that ports in Madagascar
are not maintaining effective anti-terrorism measures. Inclusive to
this determination is an assessment that Madagascar presents
significant risk of introducing instruments of terror into
international maritime commerce.
    Consistent with 46 U.S.C. 70109, the United States notified
Madagascar of this determination on May 17, 2007, and identified steps
necessary to improve the antiterrorism measures in Madagascar. To date,
the United States cannot confirm that the identified deficiencies have
been corrected.
    Accordingly, effective December 4, 2009 the Coast Guard will impose
the following conditions of entry on vessels that visited ports in
Madagascar, with the exception of vessels arriving from the port of
Toamasina (also known as Tamatave) during their last five port calls.
Vessels must:
     Implement measures per the ship's security plan equivalent
to ``Security Level 2'' while in a port in Madagascar. As defined in
the ISPS Code and incorporated herein, ``Security Level 2'' refers to
the ``level for which appropriate additional protective security
measures shall be maintained for a period of time as a result of
heightened risk of a security incident.''
     Ensure that each access point to the ship is guarded and
that the guards have total visibility of the exterior (both landside
and waterside) of the vessel while the vessel is in ports in
Madagascar. Guards may be provided by the ship's crew, however
additional crewmembers should be placed on the ship if necessary to
ensure that limits on maximum hours of work are not exceeded and/or
minimum hours of rest are met. Guards may also be provided by outside
security forces approved by the ship's master and ``Company Security
Officer.'' As defined in the ISPS Code and incorporated herein,
``Company Security Officer'' refers to the ``person designated by the
Company for ensuring that a ship security assessment is carried out;
that a ship security plan is developed, submitted for approval, and
thereafter implemented and maintained and for liaison with port
facility security officers and the ship security officer.''
     Attempt to execute a Declaration of Security while in port
in Madagascar;
     Log all security actions in the ship's log; and

     Report actions taken to the cognizant Coast Guard Captain
of the Port prior to arrival into U.S. waters.

In addition, based on the findings of a Coast Guard boarding or
examination, vessels may be required to ensure that each access point
to the ship is guarded by armed security guards and that they have
total visibility of the exterior (both landside and waterside) of the
vessel while in U.S. ports. The number and position of the guards has
to be acceptable to the cognizant Coast Guard Captain of the Port prior
to the vessel's arrival. Consistent with 46 U.S.C. 70110, the United
States may deny entry into the United States to any vessel that does
not meet the conditions set forth herein. This notice also informs
passengers of the ineffective antiterrorism measures at ports in
Madagascar with the exception of the Port of Toamasina, also known as
Tamatave.
    This notice is issued under authority of 46 U.S.C. 70110(a).

    Dated: October 15, 2009.
Sally Brice-O'Hara,
USCG, Deputy Commandant for Operations.
[FR Doc. E9-27876 Filed 11-19-09; 8:45 am]

BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Notices]
[Page 5193]
[FR Doc No: 2015-01829]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Thirteenth Meeting: RTCA Special Committee 227, Standards of
Navigation Performance

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

ACTION: Meeting Notice of RTCA Special Committee 227, Standards of
Navigation Performance.

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SUMMARY: The FAA is issuing this notice to advise the public of the
thirteenth meeting of the RTCA Special Committee 227, Standards of
Navigation Performance.

DATES: The meeting will be held March 16-20 from 9:00 a.m.-4:30 p.m.

ADDRESSES: RTCA Headquarters, 1150 18th Street NW., Suite 910,
Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at<PHONE_NUMBER>
or<PHONE_NUMBER>, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org. In addition, Sophie Bousquet may be contacted directly at
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 227. The agenda will
include the following:

March 16-20, 2015

 Welcome/Introductions/Administrative Remarks
 Agenda Overview
 Overview of Planned Work Program for the Week
    [cir] Working Group 2 MOPS Change Proposals
    [cir] MOPS Draft Review
    [cir] SC-186 proposed addition to MASPS Appendix
 Plenary Review/Discussion
    [cir] Planned Work Schedule (Note, schedule subject to change)
    [cir] MOPS Change Proposals for Incorporation into draft MOPS
 Technical Requirements Breakout Sessions (as needed)
 Other Business
 Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on January 27, 2015.
Mohannad Dawoud,
Management Analyst, NextGen, Program Oversight and Administration,
Federal Aviation Administration.
[FR Doc. 2015-01829 Filed 1-29-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75338-75339]
[FR Doc No: 2020-26062]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0380]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Product Jurisdiction
and Combination Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act (PRA) of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by December 28, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0523. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Product Jurisdiction and Combination Products--21 CFR Part 3

OMB Control Number 0910-0523--Revision

    This information collection supports implementation of section
503(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 353(g)), as amended by the 21st Century Cures Act (Pub. L. 114-
255) (Cures Act), section 563 of the FD&C Act (21 U.S.C 360bbb-2) added
to the FD&C Act by the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115), and Agency regulations in 21 CFR part 3.
Section 503(g) of the FD&C Act expressly provides for the regulation of
combination products, including how primary Agency responsibility shall
be designated for such products and how certain submissions regarding
such products may be made to the Agency. Section 563 of the FD&C Act
requires FDA to classify products as biological products, devices,
drugs, or combination products and to assign products to an Agency
component for regulation, in response to requests for designation
(RFDs) submitted by product sponsors. We updated our regulations in 21
CFR part 3 in 2005 to clarify the meaning of the statutory term
``primary mode of action,'' which determines the FDA component to which
a combination product is assigned. We proposed to update these
regulations further on May 15, 2018 (83 FR 22428), intending to: (1)
Clarify the scope of our regulations; (2) streamline and clarify the
appeals process; (3) align the regulations with more recent legislative
and regulatory measures; (4) update advisory content; and (5) clarify
Agency policies and practices.
    We are revising the information collection to include changes to
these existing procedures and current statutory and legislative
mandates. Specifically, as amended by the Cures Act, section 503(g) of
the FD&C Act includes provisions exclusive to FDA's Office of
Combination Products (OCP) and/or to provide for combination product-
specific submission types, including provisions addressing engagement
between OCP and combination product sponsors and Combination Product
Agreement Meetings (CPAMs) for sponsors to engage with FDA. In
addition, FDA has developed an associated jurisdictional process to the
RFD process, the pre-RFD process, for sponsors to obtain feedback
regarding medical product classification and assignment.
    To assist respondents with format and content elements related to
the information collection for RFDs and pre-RFDs, we have developed
proposed Forms FDA 5003, 5004, and 5005 (pre-request and request for
designation). To support RFD and pre-RFD submissions, FDA has also made
information technology improvements, enabling sponsors to use preferred
submission methods, including automated, electronic, mechanical, and
other technological collection techniques. We expect the use of
improved technology to enhance sponsors' user experience with
submissions.
    We have also developed Agency guidance consistent with sections
503(g) and 563 of the FD&C Act and with our Good Guidance Practice
regulations in 21 CFR 10.115 (approved under OMB control number 0910-
0191).
    The guidance entitled ``How to Write a Request for Designation''
(issued April 2011), provides instruction regarding the information
that needs to be submitted to OCP in a RFD as described in 21 CFR 3.7.
The guidance is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-write-request-designation-rfd. In the Federal Register of July 17, 2019 (84 FR
34188), we published a notice requesting public comment on the proposed
collection of information associated with 21 CFR part 3; no comments
were received.
    The guidance entitled ``How to Prepare a Pre-Request for
Designation,'' was developed to assist sponsors in obtaining a
preliminary, nonbinding assessment from OCP through the pre-RFD
process. The guidance explains the pre-RFD process and helps a sponsor
understand the type of information to provide in a pre-RFD submission.
The guidance is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-prepare-pre-request-designation-pre-rfd. In the Federal Register of January 13, 2017 (82 FR
4351), we published a notice announcing the availability of the draft
guidance that included an analysis under the PRA and solicited public
comment on the recommended information collection. In consideration of
comments, we made minor edits to the guidance, including clarifying our
pledge of confidentiality for information submitted and clarifying that
OCP may be contacted at any time to discuss questions. No comments
suggested revision to the information collection, and therefore we made
no adjustment in our burden estimate.
    The guidance entitled ``Requesting FDA Feedback on Combination
Products,'' was developed to discuss ways in which combination product
sponsors can obtain feedback from FDA on scientific and regulatory
questions

and to describe best practices for FDA and sponsors when interacting on
these topics. The guidance is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requesting-fda-feedback-combination-products. In the Federal Register of December 26,
2019 (84 FR 70976), we published a notice announcing the availability
of the draft guidance that included an analysis under the PRA and
solicited public comment on the proposed collection of information for
CPAMs. One comment was received in support of the collection but
suggested no change in FDA's burden estimate.
    Respondents to the information collection are sponsors of medical
products, including combination products. We estimate the burden of
this collection of information as follows:

                                  Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
    21 CFR section; activity         Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses        (hours)
----------------------------------------------------------------------------------------------------------------
3.7; request for designation....              53               1              53              24           1,272
Pre-RFD submissions.............              83               1              83              24           1,992
CPAMs requests..................               3               1               3              25              75
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............            3339
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    For RFDs and pre-RFDs, our estimate is based on the number of
submissions received from October 1, 2018, to September 30, 2019. We
assume 1 submission per respondent, for an annual average of 53 RFD
submissions, and 83 pre-RFD submissions and assume that each submission
requires an average of 24 hours to prepare and submit to FDA.
    Our estimate for CPAM requests is based on future activity in light
of the minimal use of CPAMs to date; FDA has received two CPAM requests
since the enactment of the Cures Act in December 2016. We estimate one
CPAM request will be received per year by each medical product center
(Center for Biologics Evaluation and Research, Center for Drug
Evaluation and Research, and Center for Devices and Radiological
Health). We assume it will take sponsors approximately 25 hours to
compile and submit the recommended information. Because we expect
burden associated with application submissions is already captured by
approved information collection requests for drug, biologic, and
medical device applications, respectively (approved under OMB control
numbers 0910-0001, 0910-0338, and 0910-0231), we do not include burden
associated with application submissions captured by these programs in
this information collection request.

    Dated: November 18, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26062 Filed 11-24-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Pages 23552-23553]
[FR Doc No: 2013-09261]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP13-113-000; PF12-16-000]

Dominion Cove Point LNG, LP; Notice of Application

    Take notice that on April 1, 2013, Dominion Cove Point LNG, LP
(Dominion Cove Point), 120 Tredegar Street, Richmond, Virginia, filed
in Docket No. CP13-113-000 an application under section 3 of the
Natural Gas Act (NGA) seeking authorization to construct, modify, own
and operate certain facilities to enable the liquefaction of natural
gas for the export at its existing Cove Point LNG terminal in Calvert
County, Maryland. Additionally, pursuant to section 7 of the NGA,
Dominion Cove Point seeks authority to construct, install, own, operate
and maintain facilities on its Cove Point Pipeline at its existing
compressor station and metering and regulating (M&R) site in Fairfax
County, Virginia, and at its M&R site located in Loudon County,
Virginia, for the transportation of natural gas for customers of
Dominion Cove Point's LNG terminal, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection. Copies of this filing are available for review at the
Commission in the Public Reference Room, or may be viewed on the
Commission's Web site web at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or
TTY,<PHONE_NUMBER>.
    Questions regarding this application should be directed to Amanda
K. Prestage, Regulatory and Certificates Analyst III, Dominion
Transmission, Inc., 701 East Cary Street, Richmond, Virginia 23219, or
by telephone at<PHONE_NUMBER>, or email at<EMAIL_ADDRESS>    On June 26, 2012, the Commission staff granted Dominion Cove
Point's request to utilize the Pre-Filing Process and assigned Docket
No. PF12-16 to staff activities involved with Dominion Cove Point's
Liquefaction Project. Now, as of the filing of the application on April
1, 2013, the Pre-Filing Process for this project has ended. From this
time forward, this proceeding will be conducted in Docket No. CP13-113-
000, as noted in the caption of this Notice.
    Pursuant to section 157.9 of the Commission's regulations, 18 CFR
157.9, within 90 days of this Notice, the Commission's staff will
either complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission's staff issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to reach a final decision on a request
for federal authorization within 90 days of the date of issuance of the
Commission staff's EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, before the
comment date of this notice, file with the Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426, a motion to
intervene in accordance with the requirements of the Commission's Rules
of Practice and Procedure (18 CFR 385.214 or 385.211) and the
Regulations under the NGA (18 CFR 157.10). A person obtaining party
status will be placed on the service list maintained by the Secretary
of the Commission and will receive copies of all documents filed by the
applicant and by all other parties. A party must submit 14 copies of
filings made with the Commission

and must mail a copy to the applicant and to every other party in the
proceeding. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on May 3, 2013.

    Dated: April 12, 2013.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2013-09261 Filed 4-18-13; 8:45 am]
BILLING CODE 6717-01-P


Page 1 of 2 ATTACHMENT 1 Issues for February, 2005 FIFRA Scientific Advisory Panel Meeting Similar to the scientific peer process followed for the Cumulative Risk Assessment ( CRA) for the Organophosphorus Pesticides ( OPs), OPP plans to consult with the FIFRA Science Advisory Panel ( SAP) to seek expert review, advice, and recommendations at each major step in development of the CRA for the N methyl carbamates. The following text describes the general framework being considered by EPA as it develops its CRA for the N methyl carbamate pesticides focusing on the SAP meeting scheduled for mid February. This framework is meant to provide the SAP members along with the public with an overview of the various aspects of the assessment.

February 15 18, 2005: FIFRA SAP Meeting: N methyl carbamate pesticide cumulative risk assessment: Pilot Cumulative Analysis At the February 2005 SAP meeting, EPA plans to discuss key issues related to hazard assessment, PBPK/ PD modeling of carbaryl, drinking water exposure assessment, and the integration of hazard and exposure.

Hazard assessment:

EPA acknowledges that there are toxicological characteristics unique to the N methyl carbamates which need to be considered in a cumulative risk assessment for this group. Specifically, the mechanism of action for this group of pesticides is carbamylation of the AChE active site leading to rapid recovery of inhibition. OPP is collaborating with laboratory scientists and statisticians from EPA's National Health and Environmental Effects Research Laboratory ( NHEERL) to evaluate biological and empirical aspects of recovery. EPA expects to solicit comment on specific issues related to dose response modeling of AChE data, empirical estimation of time to recovery, and the impact of the laboratory method used to measure AChE inhibition on estimates of relative potency.

PBPK/ PD Modeling for Carbaryl:

OPP is collaborating with scientists from EPA's National Exposure Research Laboratory ( NERL) to develop a PBPK/ PD model for carbaryl within the Exposure Related Dose Estimating Model ( ERDEM) Platform ( Blancato et al., 2002; Okino et al. 2004). The carbaryl model will form the Page 2 of 2 basic structure of a generalized model for the N methyl carbamates. A Quantitative Structure Activity Relationship ( QSAR) database of physicochemical descriptors and provisional PK and PD parameter values has been assembled for selected N methyl carbamates. The completeness and representativeness of the QSAR database will influence the application of the PBPK/ PD model for use in the cumulative risk assessment of the N methyl carbamates. EPA will solicit comment on specific aspects of the appropriate use of ERDEM for this Risk Assessment.

Drinking water exposure assessment:

Unlike the OP CRA where the only anticipated exposure to OP pesticides in drinking water was expected to be from surface water sources, OPP must consider both surface and ground water sources of drinking water for the N methyl carbamates. OPP will solicit comment from the SAP on the use of one or more existing ground water models to provide a pilot ground water exposure assessment for the carbamates. OPP also expects to request feedback from the panel on approaches for refining regional drinking water exposures in the event that such exposure from surface and/ or ground water sources contributes substantially to the cumulative exposure in one or more regions.

Integration of hazard and exposure assessment:

EPA will present a pilot cumulative analysis of food, water, and residential exposure. This analysis will be presented using three different exposure models: LifeLine, CARES, and Calendex. This presentation will also include a discussion of the unique challenges related to rapid recovery of AChE inhibition posed by this group of pesticides and different approaches for considering these characteristics in the quantitative estimates of cumulative risk. EPA expects to request the panel to provide comment on potential approaches for integrating hazard and exposure for this group and specifically characterizing recovery in risk estimates.


[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Proposed Rules]
[Pages 2131-2134]
[FR Doc No: 2016-00374]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-2134; Directorate Identifier 2015-CE-012-AD]
RIN 2120-AA64

Airworthiness Directives; B/E Aerospace Protective Breathing
Equipment Part Number 119003-11

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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

SUMMARY: We are revising an earlier proposed airworthiness directive
(AD) for certain B/E Aerospace protective breathing equipment (PBE)
that is installed on airplanes. The NPRM proposed inspecting the PBE to
determine if the pouch has the proper vacuum seal and replacing if
necessary. The NPRM was prompted by reports of a compromise in the
vacuum seal of the pouch that contains the PBE. This action revises the
NPRM by requiring replacement of the PBE following newly issued service
information regardless of inspection results. We are proposing this
supplemental NPRM (SNPRM) to correct the unsafe condition on these
products. Since these actions impose an additional burden over that
proposed in the NPRM, we are reopening the comment period to allow the
public the chance to comment on these proposed changes.

DATES: We must receive comments on this SNPRM by February 29, 2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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.
    For service information identified in this proposed rule, contact
B/E Aerospace, Inc., Commercial Aircraft Products Group, 10800 Pflumm
Road, Lenexa, Kansas 66215; telephone:<PHONE_NUMBER>; fax: (913) 338-
8419; Internet: www.beaerospace.com. You may review this referenced
service information at the FAA, Small Airplane Directorate, 901 Locust,
Kansas City, Missouri 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
2134; 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 proposed 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: David Enns, Aerospace Engineer,
Wichita Aircraft Certification Office, FAA, 1801 S. Airport Road, Room
100, Wichita, Kansas 67209; telephone:<PHONE_NUMBER>; fax: (316) 946-
4107; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-2134;
Directorate Identifier 2015-CE-012-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed 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 proposed AD.

Discussion

    We issued an NPRM to amend 14 CFR part 39 by adding an AD that
would apply to certain B/E Aerospace protective breathing equipment
(PBE) that is installed on airplanes. The NPRM published in the Federal
Register on June 16, 2015 (80 FR 34330). The NPRM proposed to require
inspecting the PBE to determine if the pouch has the proper vacuum seal
and replacing if necessary.

Actions Since Previous NPRM Was Issued

    Since we issued the NPRM (80 FR 34330, June 16, 2015), further
investigation into the fire of the PBE, part number (P/N) 119003-11,
found that the ignitor candles from the PBE units that caught fire had
a breach of the filter in the candle assembly. The breach of the filter
in the candle assembly allowed hot particles from the igniter candle to
enter the oxygen rich environment of the PBE hood, which could cause a
fire. All ignitor candles that were examined after fire events showed a
breach in the filter. Due to the complexities involved with the
chemical reaction within the candle, a definitive cause for the
breached filters has not been identified. B/E Aerospace PBE, P/N
119003-21, contains a stainless steel mesh in the outlet path of the
igniter candle. It has been established that the installation of the
stainless steel mesh will prevent hot particles from entering the PBE
hood as a result of a breached filter. Also, it was initially believed
that the fire events occurred only with PBEs that had compromised
vacuum sealed pouches. Two recent events occurred with PBEs that were
reported by the operators to be in serviceable conditions, although the
FAA and PBE manufacturer could not verify the condition of the pouch or
PBE before the event. Therefore, we can no longer conclude that a PBE,
P/N 119003-11, with an intact vacuum seal will prevent the possibility
of spark and fire.
    This condition, if not corrected, could result in the PBE catching
fire.

Comments

    We gave the public the opportunity to comment on the NPRM (80 FR
34330, June 16, 2015). The following presents the comments received on
the NPRM (80 FR 34330, June 16, 2015) and the FAA's response to each
comment.

Request To Change Cost of Compliance Section

    B/E Aerospace, Inc. requested that the labor cost stated for doing
the inspection be changed from .5 work-hour to .1 work-hour.
    The commenter stated that the manpower specified in the related
service bulletin for doing the inspection is 1 minute for 1 person. By
comparison, the labor cost stated in the NPRM is .5 work-hour. The
commenter believes that 0.5 work-hour is unreasonably long based on
experience with the PBE. The commenter also stated that as a
consequence, this aspect of the NPRM incorrectly suggests a substantial
burden on the industry given the number of PBE units requiring the
inspection.
    The commenter requested that the labor cost for doing the
inspection be changed to be consistent with the related service
information.
    We partially agree with the commenter. Even though we agree that it
may take less than .5 work-hour to inspect the PBE, it is FAA practice
to present labor cost in .5 work-hour increments. We have not changed
this proposed AD based on this comment.

Request To Change Applicability

    Airbus stated that the Applicability section should also include
PBE, P/N 119003-21, all FAA-approved PBEs.
    The commenter stated that the candle in PBE, P/N 119003-21, is
identical to the one in PBE, P/N 119003-11, and the abnormal behavior
of the candle is also possible on the PBE, P/N 119003-21. The remaining
effects of a candle malfunction from a PBE, P/N 119003-21, are still
not sufficiently known, e.g. functional aspects, heat, or generation of
noxious gases. A compromised seal could also lead to a malfunction of a
PBE, P/N 119003-21, or other FAA-approved PBEs as well.
    The commenter requested that the inspections also apply to PBE, P/N
119003-21, and all other FAA-approved PBEs as well.
    We do not agree with the commenter. Our investigation revealed that
the cause of the unsafe condition has been limited to PBE, P/N 119003-
11. The manufacturer has tested PBE, P/N 119003-21, with candle
assemblies that had a breach in the filter. The PBE, P/N 119003-21, has
been shown to stop hot particles from entering the hood and causing a
fire. Due to additional testing and investigation, this proposed AD now
requires replacing the PBE, P/N 119003-11, with a PBE, P/N 119003-21,
or other FAA-approved PBE. We are still allowing inspecting the PBE, P/
N 119003-11, until the required replacement time.
    We have not changed this proposed AD based on this comment.

Request To Include Allowance for Minimum Equipment List (MEL) Relief

    United Airlines requested incorporating existing MEL procedures
into the AD.
    The commenter stated that the proposed AD requires replacing a PBE
that has a compromised vacuum seal before further flight. The commenter
requested a revision to the AD to allow airplane operation with a
minimum equipment list (MEL).
    We agree with the commenter. An MEL is intended to permit operation
with inoperative instruments or equipment for a period of time until
repairs can be done. Repairs must be done at the earliest opportunity.
To maintain an acceptable level of safety and reliability, the MEL
establishes limitations on the duration of and conditions for operation
with inoperative equipment.
    We have changed this proposed AD based on this comment.

Related Service Information Under 1 CFR Part 51

    We reviewed B/E Aerospace Service Bulletin No. 119003-35-011, Rev.
000, dated February 4, 2015, and Service Bulletin 119003-35-009, Rev.
009, dated November 9, 2015. The B/E Aerospace Service Bulletin No.
119003-35-011, Rev. 000, dated February 4, 2015, describes procedures
for inspecting PBE, P/N 119003-11, to determine if the vacuum seal of
the pouch containing the PBE is compromised. B/E Aerospace Service
Bulletin 119003-35-009, Rev. 009, dated November 9, 2015, describes
procedures for replacing PBE, P/N 119003-11, with P/N 119003-21. This
service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section of this SNPRM.

FAA's Determination

    We are proposing this SNPRM because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.
Certain changes described above expand the scope of the NPRM (80 FR
34330, June 16, 2015). As a result, we have determined that it is
necessary to reopen the comment period to provide additional
opportunity for the public to comment on this SNPRM.

Proposed Requirements of This SNPRM

    This SNPRM would require accomplishing the actions specified in the
service information described

previously, except as discussed under ``Differences Between this SNPRM
and the Service Information.

Differences Between This SNPRM and the Service Information

    B/E Aerospace Service Bulletin No. 119003-35-011, Rev. 000, dated
February 4, 2015, applies to all PBE with P/N 119003-11 and P/N 119003-
21. We have determined that this proposed AD would apply only to a PBE
with P/N 119003-11 with regard to the inspection requirement of
paragraph (g) of this proposed AD. B/E Aerospace Service Bulletin
119003-35-009, Rev. 009, dated November 9, 2015, includes instructions
for disposal. In this proposed AD, we are requiring only the
replacement action.

Costs of Compliance

    We estimate that this proposed AD affects 9,000 products installed
on airplanes of U.S. registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                    Labor cost             Parts cost             product        operators
----------------------------------------------------------------------------------------------------------------
Inspecting the pouch containing    .5 work-hour x $85   Not applicable..........          $42.50        $382,500
 the PBE for proper vacuum seal.    per hour = $42.50.
Replace the PBE P/N 119003-11      .5 work-hour x $85   $1,510..................        1,552.50      13,972,500
 with a PBE P/N 119003-21.          per hour = $42.50.
----------------------------------------------------------------------------------------------------------------

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

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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):

B/E Aerospace: Docket No. FAA-2015-2134; Directorate Identifier
2015-CE-012-AD.

(a) Comments Due Date

    We must receive comments by February 29, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to B/E Aerospace Protective Breathing Equipment
(PBE), part number (P/N) 119003-11, that is installed on airplanes.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by a report of a PBE, P/N 119003-11,
catching fire upon activation by a crewmember. We are issuing this
AD to correct the unsafe condition on these products.

(f) Compliance

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

(g) Inspection

    Within 3 months after the effective date of this AD, while still
in the stowage box, physically inspect the PBE pouch to determine if
it has an intact vacuum seal. Do this inspection following paragraph
III.A.1. of the Accomplishment Instructions in B/E Aerospace Service
Bulletin No. 119003-35-011. Rev. 000, dated February 4, 2015.

(h) Replacement

    (1) If a PBE pouch is found that does not have an intact vacuum
seal during the inspection required in paragraph (g) of this AD:
Before further flight or following existing minimum equipment list
(MEL) procedures, replace the PBE with a PBE, P/N 119003-21,
following paragraphs III.C., III.D.(4), III.D.(6), and III.D.(7) of
the Accomplishment Instructions in B/E Aerospace Service Bulletin
No. 119003-35-009, Rev. 000, dated November 9, 2015, or replace it
with another FAA-approved serviceable PBE.
    (2) If a PBE pouch is found during the inspection required in
paragraph (g) of this AD where the vacuum seal is intact: Within 18
months after the effective date of this AD, remove PBE, P/N 119003-
11, and replace the PBE with PBE, P/N 119003-21, following
paragraphs III.C., III.D.(4), III.D.(6), and III.D.(7) of the
Accomplishment Instructions in B/E Aerospace Service Bulletin No.
119003-35-009, Rev. 000, dated November 9, 2015, or replace it with
another FAA-approved serviceable PBE.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly

to the manager of the ACO, send it to the attention of the person
identified in paragraph (j)(1) of this AD.
    (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.

(j) Related Information

    (1) For more information about this AD, contact David Enns,
Aerospace Engineer, Wichita ACO, FAA, 1801 S. Airport Road, Room
100, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax: (316) 946-
4107; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact B/E
Aerospace, Inc., 10800 Pflumm Road, Commercial Aircraft Products
Group, Lenexa, Kansas 66215; telephone:<PHONE_NUMBER>; fax: (913)
338-8419; Internet: www.beaerospace.com. You may review this
referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.

    Issued in Kansas City, Missouri, on January 6, 2016.
Kelly Broadway,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-00374 Filed 1-14-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Rules and Regulations]
[Pages 2873-2875]
[FR Doc No: 2017-00191]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-8830; Airspace Docket No. 16-AGL-18]

Amendment of Class E Airspace for the Following Wisconsin Towns;
Land O' Lakes, WI; Manitowish Waters, WI; Merrill, WI; Oconto, WI;
Phillips, WI; Platteville, WI; Solon Springs, WI; Superior, WI; and
West Bend, WI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies Class E airspace extending upward from
700 feet above the surface at Kings Land O' Lakes Airport, Land O'
Lakes, WI; Manitowish Waters Airport, Manitowish Waters, WI; Merrill
Municipal Airport, Merrill, WI; Oconto-J. Douglas Bake Municipal
Airport, Oconto, WI; Price County Airport, Phillips, WI; Platteville
Municipal Airport, Platteville, WI; Solon Springs Municipal Airport,
Solon Springs, WI; Richard I. Bong Airport, Superior, WI; and West Bend
Municipal Airport, West Bend, WI. Decommissioning of non-directional
radio beacons (NDBs), cancellation of NDB approaches, and
implementation of area navigation (RNAV) procedures have made this
action necessary for the safety and management of Instrument Flight
Rules (IFR) operations at these airports. This action also updates the
geographic coordinates for Kings Land O' Lakes Airport; Manitowish
Waters Airport; Oconto-J. Douglas Bake Municipal Airport; and Solon
Springs Municipal Airport to coincide with the FAA's aeronautical
database. The name of Oconto-J. Douglas Bake Municipal Airport
(formerly Oconto Municipal Airport) is also adjusted to coincide with
the FAA's aeronautical database.

DATES: Effective 0901 UTC, April 27, 2017. The Director of the Federal
Register approves this incorporation by reference action under Title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11A, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC, 20591; telephone: 202-267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go to
http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace extending upward from 700 feet above the
surface at Kings Land O' Lakes Airport, Land O' Lakes, WI; Manitowish
Waters Airport, Manitowish Waters, WI; Merrill Municipal Airport,
Merrill, WI; Oconto-J. Douglas Bake Municipal Airport, Oconto, WI;
Price County Airport, Phillips, WI; Platteville Municipal Airport,
Platteville, WI; Solon Springs Municipal Airport, Solon Springs, WI;
Richard I. Bong Airport, Superior, WI; and West Bend Municipal Airport,
West Bend, WI.

History

    On September 8, 2016, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM), (81 FR 62044) Docket No. FAA-
2016-8830, to modify Class E airspace

extending upward from 700 feet above the surface at Kings Land O' Lakes
Airport, Land O' Lakes, WI; Manitowish Waters Airport, Manitowish
Waters, WI; Merrill Municipal Airport, Merrill, WI; Oconto-J. Douglas
Bake Municipal Airport, Oconto, WI; Price County Airport, Phillips, WI;
Platteville Municipal Airport, Platteville, WI; Solon Springs Municipal
Airport, Solon Springs, WI; Richard I. Bong Airport, Superior, WI; and
West Bend Municipal Airport, West Bend, WI. Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11A, Airspace Designations and
Reporting Points, dated August 3, 2016, and effective September 15,
2016. FAA Order 7400.11A is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11A lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 modifies Class E airspace extending upward from 700 feet above
the surface at the following airports:
    Within a 6.4-mile radius (reduced from the 7-mile radius) of Kings
Land O' Lakes Airport, Land O' Lakes, WI, and updating the geographic
coordinates of the airport to coincide with the FAA's aeronautical
database;
    Within a 6.3-mile radius (reduced from the 7-mile radius) of
Manitowish Waters Airport, Manitowish, WI, and removing the 9-mile
segment southeast of the airport, and updating the geographic
coordinates of the airport to coincide with the FAA's database;
    Within a 6.6-mile radius (reduced from the 7-mile radius) of
Merrill Municipal Airport, Merrill, WI;
    By removing the 7-mile segment extending from the 6.3-mile radius
southeast of Oconto-J. Douglas Bake Municipal Airport, Oconto, WI, and
updating the name and geographic coordinates of the airport to coincide
with the FAA's aeronautical database;
    By removing the 7-mile segments extending from the 6.6-mile radius
southwest and northeast of Price County Airport, Phillips, WI;
    Within a 6.4-mile radius (reduced from the 7.4-mile radius) of
Platteville Municipal Airport, Platteville, WI, with an extension
southeast of the airport from the 6.4-mile radius to 10.2 miles;
    Within a 6.3-mile radius (reduced from the 6.6-mile radius) of
Solon Springs Municipal Airport, Solon Springs, WI, and removing the
7.4-mile segment north of the airport, and updating the geographic
coordinates of the airport to coincide with the FAA's aeronautical
database;
    Within an 8.5-mile radius (increased from a 6.7-mile radius) of
Richard I. Bong Airport, Superior, WI, and removing the 12.2-mile
segment southeast of the airport;
    And within a 6.8-mile radius (reduced from the 7.4-mile radius) of
the West Bend Municipal Airport, West Bend, WI, reducing existing
segment extending from the 6.8-mile radius to 11.4 miles southwest, and
adding segments extending from the 6.8-mile radius to 7 miles northeast
and 10 miles northwest of the airport.
    Airspace reconfiguration is necessary due to the decommissioning of
NDBs, cancellation of NDB approaches, or implementation of RNAV
standard instrument procedures at these airports. Controlled airspace
is necessary for the safety and management of the standard instrument
approach procedures for IFR operations at these airports.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (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) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL WI E5 Land O' Lakes, WI [Amended]

Kings Land O' Lakes Airport, WI
    (Lat. 46[deg]09'15'' N., long. 89[deg]12'43'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Kings Land O'Lakes Airport.
* * * * *

AGL WI E5 Manitowish Waters, WI [Amended]

Manitowish Waters Airport, WI
    (Lat. 46[deg]07'13'' N., long. 89[deg]52'56'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of Manitowish Waters Airport.
* * * * *

AGL WI E5 Merrill, WI [Amended]

Merrill Municipal Airport, WI
    (Lat. 45[deg]11'56'' N., long. 89[deg]42'46'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Merrill Municipal Airport.
* * * * *

AGL WI E5 Oconto, WI [Amended]

Oconto-J. Douglas Bake Municipal Airport, WI

    (Lat. 44[deg]52'27'' N., long. 87[deg]54'35'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of Oconto-J. Douglas Bake Municipal
Airport.
* * * * *

AGL WI E5 Phillips, WI [Amended]

Price County Airport, WI
    (Lat. 45[deg]42'32'' N., long. 90[deg]24'09'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Price County Airport.

AGL WI E5 Platteville, WI [Amended]

Platteville Municipal Airport, WI
    (Lat. 42[deg]41'22'' N., long. 90[deg]26'40'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Platteville Municipal Airport, and
within 4 miles each side of the 145[deg] bearing from the airport
extending from the 6.4-mile radius to 10.2 miles southeast of the
airport.
* * * * *

AGL WI E5 Solon Springs, WI [Amended]

Solon Springs Municipal Airport, WI
    (Lat. 46[deg]18'53'' N., long. 91[deg]48'59'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of Solon Springs Municipal Airport.
* * * * *

AGL WI E5 Superior, WI [Amended]

Richard I. Bong Airport, WI.
    (Lat. 46[deg]41'23'' N., long. 92[deg]05'41'' W.)

    That airspace extending upward from 700 feet above the surface
within an 8.5-mile radius of Richard I. Bong Airport.
* * * * *

AGL WI E5 West Bend, WI [Amended]

West Bend Municipal Airport, WI
    (Lat. 43[deg]25'20'' N., long. 88[deg]07'41'' W.)

West Bend VOR
    (Lat. 43[deg]25'19'' N., long. 88[deg]07'31'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of West Bend Municipal Airport, and within
2 miles each side of the 239[deg] bearing from the airport extending
from the 6.8-mile radius to 11.4 miles southwest of the airport, and
within 1.2 miles each side of the West Bend VOR 052[deg] radial
extending from the 6.8-mile radius to 7 miles northeast of the
airport, and within 1.3 miles each side of the West Bend VOR
303[deg] radial extending from the 6.8-mile radius to 10 miles
northwest of the airport, excluding that airspace within the
Hartford, WI, Class E airspace area.

    Issued in Fort Worth, Texas, on December 28, 2016.
Thomas L. Lattimer,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-00191 Filed 1-9-17; 8:45 am]
 BILLING CODE 4910-13-P