[Federal Register Volume 79, Number 219 (Thursday, November 13, 2014)]
[Notices]
[Pages 67467-67468]
[FR Doc No: 2014-26797]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2014-0001]

National Advisory Committee on Occupational Safety and Health
(NACOSH)

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Announcement of a meeting of NACOSH.

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SUMMARY: NACOSH will meet December 10, 2014, in Washington, DC.

DATES: NACOSH meeting: NACOSH will meet from 9 a.m. to 5 p.m.,
Wednesday, December 10, 2014.
    Comments, requests to speak, speaker presentations, and requests
for special accommodations: You must submit (postmark, send, transmit)
comments, requests to address NACOSH, speaker presentations (written or
electronic), and requests for special accommodations for the NACOSH
meeting by December 2, 2014.

ADDRESSES: NACOSH meeting: NACOSH will meet in Room N-4437 A/B/C, U.S.
Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210.
    Submission of comments and requests to speak: You may submit
comments and requests to speak at the NACOSH meeting, identified by
docket number for this Federal Register notice (Docket No. OSHA-2014-
0001), by one of the following methods:
    Electronically: You may submit materials, including attachments,
electronically at http://www.regulations.gov, the Federal eRulemaking
Portal. Follow the online instructions for making submissions.
    Facsimile: If your submission, including attachments, does not
exceed 10 pages, you may fax it to the OSHA Docket Office at (202) 693-
1648.
    Regular mail, express mail, hand delivery, or messenger/courier
service (hard copy): You may submit your materials to the OSHA Docket
Office, Docket No. OSHA-2014-0001, Room N-2625, U.S. Department of
Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone
(202) 693-2350 (TTY<PHONE_NUMBER>). OSHA's Docket Office accepts
deliveries (hand deliveries, express mail, and messenger/courier
service) during normal business hours, 8:15 a.m. to 4:45 p.m. e.t.,
weekdays.
    Requests for special accommodations: Please submit requests for
special accommodations to attend the NACOSH meeting by email,
telephone, or hard copy to Ms. Gretta Jameson, OSHA, Office of
Communications, Room N-3647, U.S. Department of Labor, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER> (TTY (887)
889-5627); email<EMAIL_ADDRESS>    Instructions: Your submissions must include the Agency name and
docket number for this Federal Register notice (Docket No. OSHA-2014-
0001). Due to security-related procedures, submissions by regular mail
may experience significant delays. Please contact the OSHA Docket
Office for information about security procedures for making submissions
by hand delivery, express delivery, or messenger/courier service. For
additional information about submitting comments and requests to speak,
see the SUPPLEMENTARY INFORMATION section of this notice.
    OSHA will post in the public docket, without change, any comments,
requests to speak, and speaker presentations, including any personal
information that you provide. Therefore, OSHA cautions interested
parties about submitting personal information such as Social Security
numbers and birthdates.

FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, U.S. Department of Labor, Room N-3647, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER> (TTY (877)
889-5627); email<EMAIL_ADDRESS>    For general information: Ms. Michelle Walker, Director, OSHA
Technical Data Center, Directorate of Technical Support and Emergency
Management, U.S. Department of Labor, Room N-2625, 200 Constitution
Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER> (TTY (877)
889-5627); email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: NACOSH will meet December 10, 2014, in
Washington, DC. Some NACOSH members may attend electronically. NACOSH
meetings are open to the public.
    NACOSH was established by Section 7(a) of the Occupational Safety
and Health Act of 1970 (OSH Act) (29 U.S.C. 651, 656) to advise,
consult with and make recommendations to the Secretary of Labor and the
Secretary of Health and Human Services on matters relating to the
administration of the OSH Act. NACOSH is a continuing advisory
committee of indefinite duration.
    NACOSH operates in accordance with the Federal Advisory Committee
Act (FACA) (5 U.S.C. App. 2), its implementing regulations (41 CFR part
102-3), and OSHA's regulations on NACOSH (29 CFR part 1912a).
    The tentative agenda for the NACOSH meeting includes:
     Remarks from the Assistant Secretary of Labor for
Occupational Safety and Health;
     Remarks from the Director of the National Institute for
Occupational Safety and Health;
     Updates on Ebola activities;
     Request for information (RFI) on Chemical Management and
Permissible Exposure Limits (PELs); and
     Protecting Temporary Workers: Recommended Practices.
    OSHA transcribes and prepares detailed minutes of NACOSH meetings.
OSHA posts the transcripts and minutes in the public docket along with
written comments, speaker presentations, and other materials submitted
to NACOSH or presented at NACOSH meetings.

Public Participation, Submissions and Access to Public Record

    NACOSH meetings: NACOSH meetings are open to the public.
Individuals attending NACOSH meetings at the U.S. Department of Labor
must enter the building at the Visitors' Entrance at 3rd and C Streets
NW., and pass through building security. Attendees must have valid
government-issued photo identification (e.g., driver's license) to
enter the building. For additional information about building security
measures for attending NACOSH meetings, please contact Ms. Jameson (see
ADDRESSES section).
    Individuals requesting special accommodations to attend the NACOSH
meeting should contact Ms. Jameson.
    Submission of comments: You may submit comments using one of the
methods listed in the ADDRESSES section. Your submission must include
the Agency name and Docket number for this NACOSH meeting (Docket No.
OSHA-2014-0001). OSHA will provide copies of your submissions to NACOSH
members.
    Because of security-related procedures, submissions by regular mail
may experience significant delays. For information about security
procedures for submitting materials by hand delivery, express mail, and
messenger/courier service, please contact the OSHA Docket Office.
    Requests to speak and speaker presentations: If you want to address
NACOSH at the meeting you must submit a request to speak, as well as
any written or electronic presentation, by December 2, 2014, using one
of the

methods listed in the ADDRESSES section. Your request must state:
     The amount of time requested to speak;
     The interest you represent (e.g., business, organization,
affiliation), if any; and
     A brief outline of the presentation.
    PowerPoint presentations and other electronic materials must be
compatible with PowerPoint 2010 and other Microsoft Office 2010
formats. The NACOSH Chair may grant requests to address NACOSH as time
and circumstances permit.
    Public docket of NACOSH meetings: OSHA places comments, requests to
speak, and speaker presentations, including any personal information
you provide, in the public docket, without change. Those documents also
may be available online at http://www.regulations.gov. Therefore, OSHA
cautions you about submitting certain personal information such as
Social Security numbers and birthdates.
    OSHA also places in the public docket meeting transcripts, meeting
minutes, documents presented at the NACOSH meeting, and other documents
pertaining to NACOSH meetings. These documents may be available online
at http://www.regulations.gov.
    Access to the public record of NACOSH meetings: To read or download
documents in the public docket, go to Docket No. OSHA-2014-0001 at
http://www.regulations.gov. The index of that Web page lists all of the
documents in the public record for this meeting; however, some
documents (e.g., copyrighted materials) are not publicly available
through that Web page. All documents in the public record, including
materials not available through http://www.regulations.gov, are
available for inspection in the OSHA Docket Office. Please contact the
OSHA Docket Office for assistance in making submissions to, or
obtaining materials from, the public docket.
    Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This notice, as well as news releases and
other relevant information, are also available on OSHA's Web page at
http://www.osha.gov.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this notice
under the authority granted by 29 U.S.C. 656; 5 U.S.C. App. 2; 29 CFR
part 1912a; 41 CFR part 102-3; and Secretary of Labor's Order No. 1-
2012 (77 FR 3912 (January 25, 2012)).

    Signed at Washington, DC, on November 6, 2014.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2014-26797 Filed 11-12-14; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 80, Number 122 (Thursday, June 25, 2015)]
[Rules and Regulations]
[Pages 36469-36470]
[FR Doc No: 2015-15546]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2015-0758; Special Conditions No. 25-586-SC]

Special Conditions: L-3 Communications Integrated Systems, Boeing
Model 747-8 Series Airplanes; Therapeutic Oxygen for Medical Use

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions.

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SUMMARY: These special conditions are issued for the Boeing Model 747-8
series airplanes. These airplanes, as modified by L-3 Communications
Integrated Systems (L-3 Communications), will have a novel or unusual
design feature when compared to the state of technology envisioned in
the airworthiness standards for transport category airplanes. This
design feature is therapeutic oxygen for medical use installed in an
executive-interior airplane. The applicable airworthiness regulations
do not contain adequate or appropriate safety standards for this design
feature. These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

DATES: Effective June 25, 2015.

FOR FURTHER INFORMATION CONTACT: Robert Hettman, FAA, Propulsion and
Mechanical Systems, ANM-112, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington, 98057-
3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On May 10, 2011, L-3 Communications applied for a supplemental type
certificate (STC) for therapeutic oxygen for medical use in the Boeing
Model 747-8 series airplanes equipped with executive interiors. The
Boeing Model 747-8 series airplane, which is a derivative of the Boeing
Model 747-400 airplane currently approved under Type Certificate No.
A20WE, is a four-engine jet transport airplane that will have a maximum
takeoff weight of 970,000 lbs. The Model 747-8 airplane will have 153
seats approved for taxi, takeoff, and landing (19 crewmembers and 134
passengers).
    Section 25.1445 includes standards for oxygen distribution systems
when oxygen is supplied to flightcrew and passengers. If a common
source of supply is used, Sec.  25.1445(a)(2) requires a means to
separately reserve the minimum supply required by the flightcrew. This
requirement was included in Sec.  25.1445 when the regulations were
codified, and was originally added to Civil Air Regulations 4b.831 at
Amendment 4b-13, effective September 21, 1949.
    It is apparent that the regulation is intended to protect the
flightcrew by ensuring that an adequate supply of oxygen is available
to complete a descent and landing following a loss of cabin pressure.
When the regulation was written, the only passenger oxygen system
designs were supplemental oxygen systems intended to protect passengers
from hypoxia in the event of a decompression. Existing passenger oxygen
systems did not include design features that would allow the flightcrew
to control oxygen to passengers during flight. There are no similar
requirements when oxygen is supplied from the same source to passengers
for use during a decompression and for discretionary/first-aid use any
time during the flight. In the proposed design, the passenger and
therapeutic oxygen systems use the same source of oxygen. The
flightcrew oxygen emergency system uses a dedicated source of oxygen
independent from the passenger oxygen system. An oxygen duration chart
and operation procedures will be incorporated into the ``Flight Crew
Operating Manual'' and ``Flight Manual Supplement,'' as part of the
STC, to provide information to the flightcrew to determine when to
cease operation of the therapeutic system as a means by which to
reserve the minimum supply of supplemental passenger oxygen.

Type Certification Basis

    Under the provisions of Sec.  21.101, L-3 Communications must show
that the Boeing Model 747-8 series airplanes, as changed, continue to
meet the applicable provisions of the regulations listed in Type
Certificate No. A20WE, or the applicable regulations in effect on the
date of application for the change, except for earlier amendments as
agreed upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., Title 14, Code of Federal Regulations (14 CFR) part
25) do not contain adequate or appropriate safety standards for the
Boeing Model 747-8 series airplanes because of a novel or unusual
design feature, special conditions are prescribed under the provisions
of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the applicant apply for a supplemental type
certificate to modify any other model included on the same type
certificate to incorporate the same or similar novel or unusual design
feature, these special conditions would also apply to the other model
under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Boeing Model 747-8 series airplanes must comply with
the fuel vent and exhaust emission requirements of 14 CFR part 34; and
the noise certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The L-3 Communications modifications to the Boeing Model 747-8
series airplanes will incorporate the following novel or unusual design
feature:
    L-3 Communications is seeking certification of an interior
modification to Boeing Model 747-8 series airplanes to include
executive and medical patient transport. As a part of the executive
interior installation, the airplane will be outfitted with a
therapeutic oxygen system. The therapeutic oxygen system shares the
same supply of oxygen with the existing passenger oxygen system and
consists of multiple constant flow oxygen outlets located throughout
the cabin. The

flightcrew can turn the therapeutic oxygen system on and off from the
flight deck to allow use at any point during the flight, and to
preserve a sufficient remaining oxygen reserve, in the event
therapeutic oxygen is used for medical purposes, to accommodate the
passengers in the event of an emergency oxygen situation.
    The gaseous passenger oxygen system will be modified to accommodate
additional supply cylinders and several therapeutic oxygen outlets
located throughout the cabin. Each therapeutic outlet will provide a
constant flow of oxygen at either 2 or 4 liters per minute. The
flightcrew will be able to control the flow of therapeutic oxygen at
any time during flight. Therapeutic oxygen systems previously have been
certified, and were generally considered an extension of the passenger
oxygen system for the purpose of defining the applicable regulations.
As a result, the applicable regulations included those that applied to
oxygen systems in general, or supplemental oxygen systems.

Discussion

    No specific regulations address the design and installation of
oxygen systems used specifically for therapeutic applications. Existing
requirements, such as Sec. Sec.  25.1309, 25.1441(b) and (c), 25.1451,
and 24.1453, in the Boeing Model 747-8 series airplanes certification
basis applicable to this STC project, provide some design standards
appropriate for oxygen system installations. However, additional design
standards for systems supplementing the existing oxygen system are
needed to complement the existing applicable requirements. The addition
of equipment involved in this installation, and the unsafe conditions
that can exist when the oxygen content of an enclosed area becomes too
high because of system leaks, malfunction, or damage from external
sources, make it necessary to ensure that adequate safety standards are
applied to the design and installation of the oxygen system in Boeing
Model 747-8 series airplanes. These potential hazards also necessitate
development and application of appropriate additional design and
installation standards.
    These special conditions contain the additional safety standards
that the Administrator considers necessary to establish a level of
safety equivalent to that established by the existing airworthiness
standards.

Discussion of Comments

    Notice of proposed special conditions No. 25-15-05-SC for the L-3
Communications modifications to the Boeing Model 747-8 series airplanes
was published in the Federal Register on April 30, 2015 (80 FR 24225).
No comments were received, and the special conditions are adopted as
proposed.

Applicability

    As discussed above, these special conditions are applicable to
Boeing Model 747-8 series airplanes. Should L-3 Communications apply at
a later date for a supplemental type certificate to modify any other
model included on Type Certificate No. A20WE to incorporate the same
novel or unusual design feature, these special conditions would apply
to that model as well.
    Under standard practice, the effective date of final special
conditions would be 30 days after the date of publication in the
Federal Register; however, as the certification date for the L-3
Communications modifications to Boeing Model 747-8 series airplanes is
imminent, the FAA finds that good cause exists to make these special
conditions effective upon publication.

Conclusion

    This action affects only certain novel or unusual design features
on one model series of airplanes. It is not a rule of general
applicability, and affects only the applicant who applied to the FAA
for approval of these features on the airplane.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Boeing Model 747-8 series airplanes as
modified by L-3 Communications Integrated Systems.
    The distribution system for the therapeutic-oxygen system must be
designed and installed as follows:
    When oxygen is supplied to passengers for both supplemental and
therapeutic purposes, the distribution system must be designed for
either--
    1. A source of supplemental supply for protection from hypoxia
following a loss of cabin pressure, and a separate source for
therapeutic purposes, or
    2. A common source of supply, with means to separately reserve the
minimum supply required by the passengers for supplemental use
following a loss of cabin pressure.

    Issued in Renton, Washington, on June 17, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-15546 Filed 6-24-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 106 (Thursday, June 2, 2011)]
[Rules and Regulations]
[Pages 31858-31860]
[FR Doc No: 2011-13567]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2011-0055-201136; FRL-9313-8]

Approval and Promulgation of Implementation Plans and
Designations of Areas for Air Quality Planning Purposes; Georgia:
Macon; Determination of Attaining Data for the 1997 Annual Fine
Particulate Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA has determined that the Macon, Georgia, fine particulate
(PM2.5) nonattainment area (hereafter referred to as ``the
Macon Area'' or ``Area'') has attained the 1997 annual average
PM2.5 national ambient air quality standard (NAAQS). The
Macon Area is comprised of Bibb County in its entirety and a portion of
Monroe County. This determination of attainment is based upon complete,
quality-assured and certified ambient air monitoring data for the 2007-
2009 period showing that the Area has monitored attainment of the 1997
annual PM2.5 NAAQS. The requirements for the Area to submit
an attainment demonstration and associated reasonably available control
measures (RACM), a reasonable further progress (RFP) plan, contingency
measures, and other planning State Implementation Plan (SIP) revisions
related to attainment of the standard shall be suspended so long as the
Area continues to attain the 1997 annual PM2.5 NAAQS.

DATES: Effective Date: This final rule is effective on July 5, 2011.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R04-OAR-2011-0055. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the
electronic docket, some information is not publicly available, i.e.,
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 either electronically through http://www.regulations.gov or in hard copy for public inspection during normal
business hours at the Regulatory Development Section, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960.

FOR FURTHER INFORMATION CONTACT: Joel Huey or Sara Waterson, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Mr. Huey may be
reached by phone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>Ms. Waterson may be reached by phone at (404) 562-
9061 or via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What action is EPA taking?
II. What is the effect of this action?
III. What is EPA's final action?
IV. Statutory and Executive Order Reviews

I. What action is EPA taking?

    EPA is determining that the Macon Area (comprised of Bibb County in
its entirety and a portion of Monroe

County) has attaining data for the 1997 annual PM2.5 NAAQS.
This determination is based upon quality assured, quality controlled
and certified ambient air monitoring data that shows the Area has
monitored attainment of the 1997 annual PM2.5 NAAQS based on
the 2007-2009 data.
    Other specific requirements of the determination and the rationale
for EPA's action are explained in the notice of proposed rulemaking
(NPR) published on March 22, 2011 (76 FR 15892). For summary purposes,
the Macon-Allied Chemical monitor (13-021-0007) did not meet 75 percent
completeness for the first quarter of 2008 and the Macon SE monitor
(13-021-0012) did not meet 75 percent completeness for the second and
fourth quarters of 2008 and third quarter of 2009. The 3-year average
annual concentrations for 2007-2009 without data substitution are 13.7
[micro]g/m\3\ for Macon Allied and 12.0 [micro]g/m\3\ for Macon SE. The
3-year average annual concentrations for 2007-2009 on this table with
data substitution are 14.9 [micro]g/m\3\ for Macon Allied and 13.3
[micro]g/m\3\ for Macon SE. EPA proposed that the Macon Area is meeting
the 1997 annual PM2.5 NAAQS both with and without data
substitution and is now meeting the 1997 annual PM2.5 NAAQS.
The design value without data substitution, 13.3 [mu]g/m\3\, is
considered to be the official design value. The comment period closed
on April 21, 2011. No comments were received in response to the NPR.

II. What is the effect of this action?

    This final action, in accordance with 40 CFR 51.1004(c), suspends
the requirements for this Area to submit attainment demonstrations,
associated RACM, RFP plans, contingency measures, and other planning
SIPs related to attainment of the 1997 annual PM2.5 NAAQS as
long as this Area continues to meet the 1997 annual PM2.5
NAAQS. Finalizing this action does not constitute a redesignation of
the Macon Area to attainment for the 1997 annual PM2.5 NAAQS
under section 107(d)(3) of the Clean Air Act (CAA). Further, finalizing
this action does not involve approving maintenance plans for the Area
as required under section 175A of the CAA, nor does it involve a
determination that the Area has met all requirements for a
redesignation.

III. What is EPA's final action?

    EPA is determining that the Macon Area has attaining data for the
1997 annual PM2.5 NAAQS. This determination is based upon
quality assured, quality controlled, and certified ambient air
monitoring data showing that this Area has monitored attainment of the
1997 annual PM2.5 NAAQS during the period 2007-2009. This
final action, in accordance with 40 CFR 51.1004(c), will suspend the
requirements for this Area to submit attainment demonstrations,
associated RACM, RFP plans, contingency measures, and other planning
SIPs related to attainment of the 1997 annual PM2.5 NAAQS as
long as the Area continues to meet the 1997 annual PM2.5
NAAQS. EPA is taking this final action because it is in accordance with
the CAA and EPA policy and guidance.

IV. Statutory and Executive Order Reviews

    This action makes a determination of attainment based on air
quality, and will result in the suspension of certain Federal
requirements, and it will 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 Order
12866 (58 FR 51735, October 4, 1993);
     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). In addition,
this 1997 PM2.5 clean NAAQS data determination for the Macon
Area does not have Tribal implications as specified by Executive Order
13175 (65 FR 67249, November 9, 2000), because the SIP is not approved
to apply in Indian country located in the state, and EPA notes that it
will not 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 August 1, 2011. 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, Particulate matter.

    Dated: May 19, 2011.
Gwendolyn Keyes Fleming,
Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

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

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

Subpart L--Georgia

0
2. Section 52.578 is amended by adding paragraph (c) to read as
follows:

Sec.  52.578  Control Strategy: Sulfur oxides and particulate matter.

* * * * *
    (c) Determination of Attaining Data. EPA has determined, as of June
2, 2011, the Macon, Georgia, nonattainment area has attaining data for
the 1997 annual PM2.5 NAAQS. This determination, in
accordance with 40 CFR 52.1004(c), suspends the requirements for this
area to submit an attainment demonstration, associated reasonably
available control measures, a reasonable further progress plan,
contingency measures, and other planning SIPs related to attainment of
the standard for as long as this area continues to meet the 1997 annual
PM2.5 NAAQS.

[FR Doc. 2011-13567 Filed 6-1-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Page 24772]
[FR Doc No: 2017-11015]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2017-37]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, this aspect of the FAA's regulatory activities.
Neither publication of this notice nor the inclusion or omission of
information in the summary is intended to affect the legal status of
the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before June 19, 2017.

ADDRESSES: Send comments identified by docket number FAA-2017-0445
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Lynette Mitterer, ANM-113, Federal
Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356,
email<EMAIL_ADDRESS>phone<PHONE_NUMBER>; or Alphonso
Pendergrass, ARM-200, Office of Rulemaking, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591,
email<EMAIL_ADDRESS>phone<PHONE_NUMBER>.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Renton, Washington.
Victor Wicklund,
Manager, Transport Standards Staff.

Petition for Exemption

    Docket No.: FAA-2017-0445.
    Petitioner: Bombardier Aerospace.
    Section of 14 CFR Affected: Sec.  25.981(a)(3) .
    Description of Relief Sought: The petitioner seeks an exemption
from the requirements of 14 CFR 25.981(a)(3) at Amendment 25-125, with
respect to fuel tank ignition prevention for Models BD-700-2A12 (Global
7000) and BD-700-2A13 (Global 8000) business jets. This petition is
made in accordance with FAA Policy PS-ANM-25.981-02 dated June 24,
2014, providing alternate requirements in lieu of full compliance to
ensure that an acceptable level of safety is provided.

[FR Doc. 2017-11015 Filed 5-26-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 112 (Wednesday, June 10, 2020)]
[Notices]
[Page 35420]
[FR Doc No: 2020-12544]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

    Docket Numbers: RP01-382-030.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Company submits Carlton
Reimbursement Report under RP01-382.
    Filed Date: 6/1/20.
    Accession Number: 20200601-5171.
    Comments Due: 5 p.m. ET 6/15/20.

    Docket Numbers: RP20-939-000.
    Applicants: Rover Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Summary of Negotiated Rate
Capacity Release Agreements on 6-2-20 to be effective 6/1/2020.
    Filed Date: 6/2/20.
    Accession Number: 20200602-5016.
    Comments Due: 5 p.m. ET 6/15/20.

    Docket Numbers: RP20-940-000.
    Applicants: National Fuel Resources, Inc., Marathon Power LLC.
    Description: Joint Petition for Temporary Waivers of Capacity
Release Regulations, et al. of National Fuel Resources, Inc., et al.
under RP20-940.
    Filed Date: 6/2/20.
    Accession Number: 20200602-5156.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: RP20-941-000.
    Applicants: Elba Express Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Change to Fuel Tracker
Effective Date to be effective 8/1/2020.
    Filed Date: 6/3/20.
    Accession Number: 20200603-5004.
    Comments Due: 5 p.m. ET 6/15/20.

    Docket Numbers: RP20-942-000.
    Applicants: NiSource Inc., Bay State Gas Company, Eversource
Energy, Eversource Gas Company of Massachusetts.
    Description: Joint Petition for Temporary Waivers of Capacity
Release Regulations, et al. of NiSource Inc., et al. under RP20-942.
    Filed Date: 6/2/20.
    Accession Number: 20200602-5172.
    Comments Due: 5 p.m. ET 6/15/20.

    Docket Numbers: RP20-943-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: TCO WBX WGL Negotiated Rate
Agreement Amendments to be effective 11/16/2018.
    Filed Date: 6/3/20.
    Accession Number: 20200603-5095.
    Comments Due: 5 p.m. ET 6/15/20.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 4, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-12544 Filed 6-9-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Notices]
[Page 78591]
[FR Doc No: 2016-26957]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9954-45-Region 6]

Adequacy Status of the Dallas-Fort Worth, Texas Attainment
Demonstration 8-Hour Ozone Motor Vehicle Emission Budgets for
Transportation Conformity Purposes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of adequacy.

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

SUMMARY: The Environmental Protection Agency (EPA) is notifying the
public that it has found that the motor vehicle emissions budgets
(MVEBs) in the Dallas-Fort Worth, Texas (DFW) Attainment Demonstration
(AD) State Implementation Plan (SIP) revision for the 2008 8-hour ozone
National Ambient Air Quality Standard (NAAQS), submitted on August 5,
2016 by the Texas Commission on Environmental Quality (TCEQ) are
adequate for transportation conformity purposes. As a result of EPA's
finding, the DFW area must use these budgets for future conformity
determinations.

DATES: These budgets are effective November 23, 2016.

FOR FURTHER INFORMATION CONTACT: The essential information in this
notice will be available at EPA's conformity Website: https://www.epa.gov/state-and-local-transportation/adequacy-review-state-implementation-plan-sip-submissions-conformity. You may also contact
Mr. Jeffrey Riley, State Implementation Section (6MM-AA), U.S.
Environmental Protection Agency, Region 6, 1445 Ross Avenue, Dallas,
Texas 75202-2733, at<PHONE_NUMBER> or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refers to EPA. The word ``budget(s)'' refers to the mobile
source emissions budget for volatile organic compounds (VOCs) and the
mobile source emissions budget for nitrogen oxides (NOX).
    On August 5, 2016, we received a SIP revision from the TCEQ. This
revision consisted of an AD SIP for the DFW 2008 8-hour ozone NAAQS
nonattainment area. This submission established MVEBs for the DFW 2008
ozone nonattainment area for the year 2017. The MVEB is the amount of
emissions allowed in the SIP for on-road motor vehicles; it establishes
an emissions ceiling for the DFW area regional transportation network,
used to develop the 2017 on-road motor vehicle emissions projections
contained in the AD SIP. The MVEBs are provided in Table 1:

  Table 1--Dallas-Fort Worth Attainment Demonstration NOX and VOC MVEBS
                      [Summer season tons per day]
------------------------------------------------------------------------
                                                               2017
------------------------------------------------------------------------
NOX.....................................................          130.77
VOC.....................................................           64.91
------------------------------------------------------------------------

    On September 7, 2016, EPA posted the revised DFW area MVEBs on
EPA's Web site for the purpose of soliciting public comments, as part
of the adequacy process. The comment period closed on October 6, 2016,
and we received no comments.
    Today's notice is simply an announcement of a finding that EPA has
already made. EPA Region 6 sent a letter to TCEQ on October 17, 2016,
finding that the MVEBs in the DFW AD SIP, submitted on August 5, 2016
are adequate and must be used for transportation conformity
determinations in the DFW area. This finding has also been announced on
EPA's conformity Web site: https://www.epa.gov/state-and-local-transportation/adequacy-review-state-implementation-plan-sip-submissions-conformity.
    Transportation conformity is required by section 176(c) of the
Clean Air Act. EPA's conformity rule, 40 Code of Federal Regulations
(CFR) part 93, requires that transportation plans, programs and
projects conform to state air quality implementation plans and
establishes the criteria and procedures for determining whether or not
they do so. Conformity to a SIP means that transportation activities
will not produce new air quality violations, worsen existing
violations, or delay timely attainment of the national ambient air
quality standards.
    The criteria by which EPA determines whether a SIP's MVEB is
adequate for transportation conformity purposes are outlined in 40 CFR
93.118(e)(4). We have also described the process for determining the
adequacy of submitted SIP budgets in our July 1, 2004, final rulemaking
entitled, ``Transportation Conformity Rule Amendments for the New 8-
hour Ozone and PM2.5 National Ambient Air Quality Standards
and Miscellaneous Revisions for Existing Areas; Transportation
Conformity Rule Amendments: Response to Court Decision and Additional
Rule Changes'' See 69 FR 40004 (July 1, 2004). Please note that an
adequacy review is separate from EPA's completeness review, and it
should not be used to prejudge EPA's ultimate approval of the DFW 2008
8-hour ozone NAAQS AD SIP revision submittal. Even if EPA finds the
budgets adequate, the DFW AD SIP revision submittal could later be
disapproved.
    Within 24 months from the effective date of this notice, the DFW-
area transportation partners, such as the North Central Texas Council
of Governments, will need to demonstrate conformity to the new MVEBs if
the demonstration has not already been made, pursuant to 40 CFR
93.104(e). See 73 FR 4419 (January 24, 2008).

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

    Dated: November 2, 2016.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2016-26957 Filed 11-7-16; 8:45 am]
 BILLING CODE 6560-50-P


                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

              Office of Chemical Safety and Pollution Prevention

MEMORANDUM

Date:	 October 24, 2013

	SUBJECT:	Common Triazole Metabolites:  Updated Aggregate Human Health Risk Assessment to Address The New Section 3 Registrations For Use of Propiconazole on Rapeseed Crop Subgroup 20A; Use of Difenoconazole on Rapeseed Crop Subgroup 20A; and Use of Tebuconazole on Imported Oranges.

PC Codes:  	600074 (1,2,4-Triazole),
		600011 (Triazolylalanine),
		600082 (Triazolylacetic Acid),
		625618 (Triazolylpyruvic Acid)
DP Barcode:	414952
Decision No.: 473635
Registration No.:  None
Petition Nos.:  2F8134, 2F8135, & 2E8138
Regulatory Action:  Section 3
Assessment Type:  Single Chemical, Aggregate
Registration Case No.:  NA
TXR No.:  None
CAS No.:  Multiple
MRID No.:  None

	From:	Thurston G. Morton, Senior Chemist
		Risk Assessment Branch IV
		Health Effects Division (HED) 7509P

	Through:	Elissa Reaves, Ph.D., Branch Chief
		Risk Assessment Branch IV
		Health Effects Division (HED) 7509P

	To:	Rosemary Kearns/Tony Kish RM 22
		Registration Division (RD; 7505P)

I.	 CONCLUSIONS

Based on conservative, health-protective assumptions, aggregate risk estimates associated with 1,2,4-triazole (T) and the conjugated triazole metabolites [i.e., combined residues of triazolylalanine (TA), triazolylacetic acid (TAA), and triazolylpyruvic acid (TP)] are below HED's level of concern.  There are no human heath risk issues for these metabolites that would preclude the requested uses of propiconazole, difenoconazole, and tebuconazole.

II.	ACTION REQUESTED

Update the aggregate human health risk assessments for T and the conjugated triazole metabolites to account for the new uses of propiconazole, difenoconazole, and tebuconazole.

III.	BACKGROUND

In 2006, HED issued aggregate human health risk assessments for T and the conjugated triazole metabolites (M. Doherty, et al., D322215, 7 FEB 06).  Those assessments addressed a back-log of triazole use requests that had been held by the Agency pending resolution of various toxicological and exposure concerns for the common triazole metabolites.  The findings of that assessment were that risk estimates for all exposure scenarios were below HED's level of concern.  Since that time, a number of requests for new uses of triazole-derivative fungicides have been submitted to the Agency.  As a result of these requests, new dietary exposure estimates have been made for T and combined residues of TA, TAA, and TP, and new aggregate exposure and risk estimates are necessary.  Neither the toxicological information nor the non-dietary exposure estimates detailed in the 2006 memorandum have changed; thus the only alterations to the previous aggregate exposure and risk estimates are due to changes in the dietary exposure estimates.  For complete hazard characterization and non-dietary exposure assessments for the common triazole metabolites, see the 2006 risk assessment.

IV.	RESULTS/DISCUSSION

As noted above, the only revisions to the components of the previous aggregate exposure and risk estimates are to the dietary exposure estimates.  For the common triazole metabolites, acute and chronic aggregate risks consist only of dietary (food + water) components and, therefore, are equivalent to the dietary risk estimates provided in the most recent dietary exposure assessment (T. Morton, 411385, May 1, 2013).

The revised aggregate estimates are summarized below for short- and intermediate-term scenarios for T (Tables 2 and 3, respectively).  The conjugated triazole metabolites are formed in plants by the conjugation of 1,2,4-T to serine.  The TA may then be further metabolized to form TAA and/or TP.  Because of the nature of this process, HED has assumed that it occurs within the plant itself and not on leaf surfaces.  Therefore, the residues are not available for dermal, hand-to-mouth, or object-to-mouth exposures and HED has not conducted a residential exposure assessment for the triazole conjugates.  Residues of TA, TAA, and TP may occur in soil.  1,2,4-Triazole is more toxic than TA/TAA/TP and exposures to these via soil ingestion are unlikely to exceed those of 1,2,4-T.  The assessment for soil ingestion of 1,2,4-T shows that risk estimates are below HED's level of concern; therefore, risk estimates for soil ingestion of the conjugates will also be below HED's level of concern.

 Table 1.  Summary of Dietary (Food and Drinking Water) Exposure and Risk for the Common Triazole Metabolites Adding the New Uses for Propiconazole, Difenoconazole, and Tebuconazole.
                              Population Subgroup
                                 Acute Dietary
                              (95[th] Percentile)
                                Chronic Dietary
                                     Cancer

                          Dietary Exposure (mg/kg/day)
                                    % aPAD*
                                Dietary Exposure
                                  (mg/kg/day)
                                    % cPAD*
                                Dietary Exposure
                                  (mg/kg/day)
                                      Risk
                                 1,2,4-Triazole
 General U.S. Population
0.008240
27
0.001276
26
                                 Not Applicable
                                 Not Applicable
 All Infants (< 1 year old)
0.012026
40
0.001822
36

 Children 1-2 years old
0.022883
76
0.003629
73

 Children 3-5 years old
0.018815
63
0.002896
58

 Children 6-12 years old
0.010932
36
0.001588
32

 Youth 13-19 years old
0.007167
24
0.001036
21

 Adults 20-49 years old
0.006581
22
0.001101
22

 Adults 50-99 years old
0.005808
19
0.001036
21

 Females 13-49 years old
0.006730
22
0.001073
22

         Triazolylalanine + Triazolylacetic Acid+Triazolylpyruvic acid
 General U.S. Population
                                 Not Applicable
                                 Not Applicable
0.017658
20
                                 Not Applicable
                                 Not Applicable
 All Infants (< 1 year old)

0.021510
24

 Children 1-2 years old

0.054965
61

 Children 3-5 years old

0.044098
49

 Children 6-12 years old

0.023459
26

 Youth 13-19 years old

0.014759
16

 Adults 20-49 years old

0.014662
16

 Adults 50-99 years old

0.013721
15

 Females 13-49 years old
0.078443
78
0.014260
16

 * The values for the highest exposed population for each type of risk assessment are bolded.

Table 2.  Short-term Aggregate Exposure and Risk Estimates for 1,2,4-Triazole.
Population Subgroup
                        Exposure Estimate, mg/kg/day[1]
                               Aggregate MOE[2]

                                    Dietary
                                    Dermal
                                    (M/L/A)
                             Dermal (Post-Applic.)
                                 Hand-to-Mouth
                                Object-to-Mouth
                                Soil Ingestion
                                   Aggregate

U.S. Population (total)
0.001276
                                    0.00183
                                    0.0051
                                      N/A
                                      N/A
                                      N/A
                                   0.008206
                                     3700
All infants (< 1 year)
0.001822
                                      N/A
                                    0.0086
                                    0.0041
                                    0.0010
                                   0.000019
                                   0.015541
                                     1900
Children 1-2 yrs
0.003629
                                      N/A
                                    0.0086
                                    0.0041
                                    0.0010
                                   0.000019
                                   0.017348
                                     1700
Children 3-5 yrs
0.002896
                                      N/A
                                    0.0086
                                    0.0041
                                    0.0010
                                   0.000019
                                   0.016615
                                     1800
Children 6-12 yrs
0.001588
                                      N/A
                                    0.0086
                                      N/A
                                      N/A
                                      N/A
                                   0.010188
                                     2900
Youth 13-19 yrs
0.001036
                                    0.00183
                                    0.0051
                                      N/A
                                      N/A
                                      N/A
                                   0.007966
                                     3800
Adults 20-49 yrs
0.001101
                                    0.00183
                                    0.0051
                                      N/A
                                      N/A
                                      N/A
                                   0.008031
                                     3700
Adults 50-99 yrs
0.001036
                                    0.00183
                                    0.0051
                                      N/A
                                      N/A
                                      N/A
                                   0.007966
                                     3800
Females 13-49 yrs
0.001073
                                    0.00183
                                    0.0051
                                      N/A
                                      N/A
                                      N/A
                                   0.008003
                                     3700
1 Exposure estimates for dermal, hand-to-mouth, object-to-mouth, and soil ingestion are from J. Arthur, DP 322240, 12/9/05.
2 Aggregate MOE = NOAEL (30 mg/kg/day) / Aggregate Exposure Estimate (mg/kg/day).  Level of Concern = 1000.

Table 3.  Intermediate-term Aggregate Exposure and Risk Estimates for 1,2,4-Triazole.
Population Subgroup
                         Exposure Estimate, mg/kg/day
                               Aggregate MOE[2]

                                    Dietary
                               Soil Ingestion[1]
                                   Aggregate

U.S. Population (total)
0.001276
                                      N/A
                                   0.001276
12000
All infants (< 1 year)
0.001822
                                   0.000019
                                   0.001841
8100
Children 1-2 yrs
0.003629
                                   0.000019
                                   0.003648
4100
Children 3-5 yrs
0.002896
                                   0.000019
                                   0.002915
5100
Children 6-12 yrs
0.001588
                                      N/A
                                   0.001588
9400
Youth 13-19 yrs
0.001036
                                      N/A
                                   0.001036
14000
Adults 20-49 yrs
0.001101
                                      N/A
                                   0.001101
14000
Adults 50-99 yrs
0.001036
                                      N/A
                                   0.001036
14000
Females 13-49 yrs
0.001073
                                      N/A
                                   0.001073
14000
1 Soil ingestion estimates are from J. Arthur, DP 322240, 12/9/05
2 Aggregate MOE = NOAEL (15 mg/kg/day) / Aggregate Exposure Estimate (mg/kg/day).  Level of Concern = 3000.


[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42896-42899]
[FR Doc No: 2018-18313]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0567]

Notice of Decision Not To Designate Pneumocystis Pneumonia as a
Tropical Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency), in response
to suggestions submitted to Docket No. FDA-2008-N-0567, has analyzed
whether Pneumocystis pneumonia (PCP) meets the statutory criteria for
designation as a tropical disease for the purposes of obtaining a
priority review voucher (PRV) under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), namely whether it primarily affects poor and
marginalized populations and whether there is ``no significant market''
for drugs that prevent or treat PCP in developed countries. The Agency
has determined that PCP does not meet the statutory criteria for
designation as a tropical disease and declines to designate it as such.

DATES: August 24, 2018.

ADDRESSES: Submit electronic comments on additional diseases suggested
for designation to https://www.regulations.gov. Submit written comments
on additional diseases suggested for designation to the Dockets
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified
with the docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-
796-1300, [email protected]; or Office of Communication,
Outreach and Development (OCOD), Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER> or<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background: Priority Review Voucher Program
II. Decision Not To Designate Pneumocystis Pneumonia
    A. Significant Market in Developed Nations
    B. Disproportionately Affects Poor and Marginalized Populations
    C. FDA Determination
III. Process for Requesting Additional Diseases To Be Added to the
List
IV. Paperwork Reduction Act
V. References

I. Background: Priority Review Voucher Program

    Section 524 of the FD&C Act (21 U.S.C. 360n), which was added by
section 1102 of the Food and Drug Administration Amendments Act of 2007
(FDAAA), uses a PRV incentive to encourage the development of new
drugs, including biologics, for prevention and treatment of certain
diseases that, in the aggregate, affect millions of people throughout
the world. Further information about the tropical disease PRV program
can be found in guidance for industry ``Tropical Disease Priority
Review Vouchers'' (81 FR 69537, October 6, 2016, available at https://www.federalregister.gov/documents/2015/08/20/2015-20554/designating-additions-to-the-current-list-of-tropical-diseases-in-the-federal-food-drug-and-cosmetic). Additions to the statutory list of tropical
diseases published in the Federal Register can be accessed at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm534162.htm.
    In August 2015, FDA published a final order (80 FR 50559, August
20, 2015) (final order) designating Chagas disease and
neurocysticercosis as tropical diseases. That final order also sets
forth FDA's interpretation of the statutory criteria for tropical
disease designation and expands the list of tropical diseases under
section 524(a)(3)(R) of the FD&C Act, which authorizes the FDA to
designate by order ``[a]ny other infectious disease for which there is
no significant market in developed nations and that disproportionately
affects poor and marginalized populations'' as a tropical disease.
    FDA has applied its August 2015 criteria as set forth in the final
order to analyze whether PCP meets the statutory criteria for addition
to the tropical disease list. As discussed below, the Agency has
determined that PCP does not meet the statutory criteria for
designation as a ``tropical disease'' and thus will not add it to the
list of tropical diseases whose applications may be eligible for a
priority review voucher.

II. Decision Not To Designate Pneumocystis Pneumonia

    FDA has considered all diseases submitted to the public docket
(FDA-2008-N-0567) between August 20, 2015, and June 20, 2018, as
potential additions to the list of tropical diseases under section 524
of the FD&C Act, under the docket review process explained on the
Agency's website (see

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm534162.htm). Based on an
assessment using the criteria from its final order, FDA has determined
that PCP will not be designated as a ``tropical disease'' under section
524 of the FD&C Act.
    Pneumocystis species are genetically distinct, host-specific
opportunistic fungal pathogens widely found in nature. Pneumocystis
jirovecii, found in humans, causes PCP in immunocompromised patients.
Human immunodeficiency virus (HIV)-infected patients with a low CD4
count are at the highest risk of PCP. Others at substantial risk
include hematopoietic cell and solid organ transplant recipients, those
with cancer (particularly hematologic malignancies), and those
receiving glucocorticoids, chemotherapeutic agents, and other
immunosuppressive medications. Among patients with acquired
immunodeficiency syndrome (AIDS) and PCP, the mortality rate is 10 to
20 percent during the initial infection, but the rate increases
substantially when the patient requires mechanical ventilation. The
mortality rate among patients with PCP in the absence of AIDS is 30 to
60 percent, depending on the population at risk, with a greater risk of
death among patients with cancer than among patients undergoing
transplantation or those with connective tissue disease (Ref. 1).

A. Significant Market in Developed Nations

    In developed nations, a sizable market exists for PCP prophylaxis
drugs. The prevalence of stage-3 AIDS by year end 2014 in the United
States (i.e., with AIDS requiring PCP prophylaxis) was approximately
530,000 (Ref 2). In addition, approximately 30,000 solid organ
transplantations (Ref. 3) and 19,000 hematopoietic stem cell
transplants (Ref. 4) are performed annually in the United States. These
patients receive PCP prophylaxis for 6 months to one year in the post-
transplantation period. There were also about 6,590 new cases of acute
lymphocytic leukemia (ALL) eligible for PCP prophylaxis in the United
States in 2016 (Ref. 5).
    Regarding treatment of PCP, the incidence of PCP has declined
substantially with widespread use of PCP prophylaxis and anti-
retroviral therapy (ART) (see, e.g., Refs. 6-9). In a prospective
cohort study of 8070 participants at 12 HIV clinics across the United
States, the incidence in 2003-2007 was <1 case per 100 person-years
(Ref. 10). PCP now mainly occurs in individuals who are unaware that
they are HIV positive, lack access to medical care, or are noncompliant
with medications.
    In contrast to HIV-positive patients, the incidence of PCP in non-
HIV patients is rising in some areas (see, e.g., Refs. 8, 9, 11);
however, the number of cases in non-HIV patients is still below the
number of cases in HIV-positive patients (Ref. 12). In the United
States, the incidence of PCP is estimated to be 9 percent among
hospitalized HIV/AIDS patients and 1 percent among solid organ
transplant recipients (Ref. 13).
    Current clinical guidelines recommend chemoprophylaxis against
primary PCP for HIV infected persons with a CD4 cell count <200 cells/
[micro]L or a history of oral candidiasis (Ref. 14). As indicated
above, the prevalence of stage-3 HIV infection (i.e., AIDS requiring
PCP prophylaxis) by year end 2014 in the United States was
approximately 530,000 patients, including 18,303 patients diagnosed
with stage-3 HIV infection in 2015 (Ref. 2). These subjects were
eligible for PCP prophylaxis.
    In summary, a sizable market in developed nations exists for drugs
indicated for prevention of PCP. At present, FDA is unaware of any
significant funding by military, the Biomedical Advanced Research and
Development Authority (BARDA), or any other United States Government
sources for drug development targeting treatment of or prophylaxis
against PCP.

B. Disproportionately Affects Poor and Marginalized Populations

    Although no disability-adjusted life year (DALY) data were found to
distinguish the disease burden of PCP in developing versus developed
countries, it is noted that PCP occurs frequently among HIV-infected
patients in many parts of the developing world. In addition, the
prevalence of HIV-infected persons with PCP ranges from 24 percent (42/
177) in Mexico (Ref. 15) to 55 percent in Thailand (Ref. 16). A
Brazilian study found 55 percent (15/27) of HIV-infected persons with
respiratory symptoms had PCP (Ref. 17).
    Studies estimating the burden of fungal infections in different
countries suggest low total yearly number of PCP cases in Belgium (n =
120), in contrast, for example, to 9,600 cases among HIV-infected
people in Tanzania in 2012 (Refs. 18 and 19). In Uganda, the frequency
of PCP among HIV-infected patients hospitalized with suspected
pneumonia who had negative sputum acid-fast bacilli smears and
underwent bronchoscopy decreased from nearly 40 percent of
bronchoscopies between 1999 and 2000 to less than ten percent between
2007 and 2008 (Ref. 20). However, it is estimated that there are
approximately 800 HIV-positive adults with PCP annually and up to
42,000 children with PCP annually in Uganda (Ref. 21). In Vietnam, the
prevalence of PCP was 608 cases in 2012, 1149 cases per year in Senegal
and 990 cases yearly in Nepal (HIV positive individuals) (Refs. 22, 23,
24). In Ukraine, 13.5 per 100,000 individuals develop PCP annually
(Ref. 25).
    High rates of anti-Pneumocystis antibodies among African children
suggest that exposure to the organism is common, and that Pneumocystis
jirovecii is a common cause of pneumonia among children in sub-Saharan
Africa (Ref. 26). Furthermore, limited diagnostic resources and less
commonly performed induced sputum and bronchoalveolar lavage with
reliance on empiric therapy may cause underestimation of the true
incidence of PCP (Ref. 27). Several studies suggest that the incidence
of PCP is increasing in Africa (Refs. 26, 28, 29).
    PCP has been reported to be a leading cause of death in HIV-
infected infants, responsible for at least one quarter of all pneumonia
deaths in HIV-infected infants (Ref. 30). A recent review found PCP to
be one of the factors strongly associated with mortality from acute
lower respiratory infections in children under five years of age in
low-income economies, lower-middle-income economies, and upper-middle-
income economies (referred to as low- and middle-income countries
(LMICs)), with odds ratio of 95 percent confidence interval of 4.79,
2.67-8.61 (Ref. 31). However, the incidence of PCP in infants and
children in developed countries has decreased because PCP prophylaxis
has been initiated in all neonates born to HIV-positive mothers (Refs.
32 and 33).
    The HIV epidemic imposes a particular burden on women and children,
specifically in sub-Saharan Africa where women account for
approximately 57 percent of all people living with HIV (Ref. 34). In
2012, there were an estimated 260,000 newly infected children in LMICs
(id.). Children with HIV are more likely to face gaps in access to HIV
treatment. In 2012, approximately 34 percent of children had access to
HIV treatment versus approximately 64 percent for adults (id.). Since
PCP is the most prevalent in persons infected with HIV (Ref. 1) and HIV
disproportionately impacts women and children, it is reasonable to
conclude that PCP also disproportionately affects these populations.

    PCP has not been designated by the World Health Organization (WHO)
as a neglected tropical disease (Ref. 35).

C. FDA Determination

    In sum, although PCP disproportionately affects poor and
marginalized populations, it is an infectious disease for which there
is a significant market in developed nations for drugs indicated for
prevention of PCP. Based on the information reviewed, FDA has
determined that PCP does not meet the statutory criteria for a tropical
disease in section 524 of the FD&C Act.

III. Process for Requesting Additional Diseases To Be Added to the List

    FDA's current determination regarding PCP does not preclude
interested persons from requesting its consideration in the future. To
facilitate the consideration of future additions to the list, FDA
established a public docket (see https://www.regulations.gov, Docket
No. FDA-2008-N-0567) through which interested persons may submit
requests for additional diseases to be added to the list. Such requests
should be accompanied by information to document that the disease meets
the criteria set forth in section 524(a)(3)(S) of the FD&C Act. FDA
will periodically review these requests, and, when appropriate, expand
the list. For further information, see https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm534162.htm.

IV. Paperwork Reduction Act

    This notice reiterates the ``open'' status of the previously
established public docket through which interested persons may submit
requests for additional diseases to be added to the list of tropical
diseases that FDA has found to meet the criteria in section
524(a)(3)(S) of the FD&C Act. Such a request for information is exempt
from Office of Management and Budget review under 5 CFR 1320.3(h)(4) of
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
Specifically, ``[f]acts or opinions submitted in response to general
solicitations of comments from the public, published in the Federal
Register or other publications, regardless of the form or format
thereof'' are exempt, ``provided that no person is required to supply
specific information pertaining to the commenter, other than that
necessary for self-identification, as a condition of the Agency's full
consideration of the comment.''

V. References

    The following references have been placed on display at the Dockets
Management Staff (see ADDRESSES). They may be seen by interested
persons between 9 a.m. and 4 p.m. Monday through Friday and are
available electronically at https://www.regulations.gov. (FDA has
verified the website addresses, but FDA is not responsible for any
subsequent changes to the websites after this document publishes in the
Federal Register.)

1. Thomas, C.F., Jr. and A.H. Limper, ``Pneumocystis Pneumonia,''
The New England Journal of Medicine, 350(24):2487-2498, June 10,
2004.
2. Centers for Disease Control and Prevention (CDC), ``HIV
Surveillance Report, 2015,'' vol. 27, November 2016, available at
https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html,
accessed January 19, 2017.
3. United Network for Organ Sharing, ``Annual Reports,'' accessed
December 16, 2016, available at https://www.unos.org/about/annual-report/.
4. The U.S. Health Resources and Services Administration,
``Transplant Activity Report: Total Transplants by Year,'' accessed
January 19, 2017, available at https://bloodcell.transplant.hrsa.gov/research/transplant_data/transplant_activity_report/index.html.
5. The American Cancer Society, ``Key Statistics for Acute
Lymphocytic Leukemia,'' accessed January 19, 2017, available at
http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-key-statistics.
6. Miller, R.F., L. Huang, and P.D. Walzer, ``Pneumocystis Pneumonia
Associated with Human Immunodeficiency Virus,'' Clinics in Chest
Medicine, 34(2):229-241, June 2013.
7. Morris, A., J.D. Lundgren, H. Masur, et al., ``Current
Epidemiology of Pneumocystis Pneumonia,'' Emerging Infectious
Diseases, 10(10):1713-720, October 2004.
8. Azoulay, E., A. Bergeron, S. Chevret, N. Bele, et al.,
``Polymerase Chain Reaction for Diagnosing Pneumocystis Pneumonia in
Non-HIV Immunocompromised Patients with Pulmonary Infiltrates,''
Chest, 135(3):655-661, March 2009.
9. Gamaletsou, M.N., M. Drogari-Apiranthitou, D.W. Denning, et al.,
``An Estimate of the Burden of Serious Fungal Diseases in Greece,''
European Journal of Clinical Microbiology & Infectious Diseases
(official publication of the European Society of Clinical
Microbiology), 35(7):1115-1120, July 2016.
10. Buchacz, K., R.K. Baker, F.J. Palella, Jr., et al., ``AIDS-
Defining Opportunistic Illnesses in US patients, 1994-2007: A Cohort
Study,'' AIDS, 24(10):1549-1559, Jun 19, 2010.
11. Maini, R., K.L. Henderson, E.A. Sheridan, et al., ``Increasing
Pneumocystis Pneumonia, England, UK, 2000-2010,'' Emerging
Infectious Diseases, 19(3):386-392, March 2013.
12. Walzer, P.D. and A.G. Smulian, ``Pneumocystis species,'' in:
Mandell, G.L., Bennett, J.E., Dolin, R., eds. Mandell, Douglas, and
Bennett's Principles and Practice of Infectious Disease, 7th ed. PA:
Elsevier; 2010, 3377-90.
13. CDC, Fungal Diseases, ``Pneumocystis Pneumonia,'' February 21,
2018, available at https://www.cdc.gov/fungal/diseases/pneumocystis-pneumonia, accessed November 21, 2016.
14. Kaplan, J.E., H. Masur, K.K. Holmes, et al., ``USPHS/IDSA
Guidelines for the Prevention of Opportunistic Infections in Persons
Infected with Human Immunodeficiency Virus: A Summary,'' USPHS/IDSA
Prevention of Opportunistic Infections Working Group, Clinical
Infectious Diseases: An Official Publication of the Infectious
Diseases Society of America, 21(Suppl 1):S12-31, August 1995.
15. Mohar, A., J. Romo, F. Salido, et al., ``The Spectrum of
Clinical and Pathological Manifestations of AIDS in a Consecutive
Series of Autopsied Patients in Mexico,'' AIDS, 6(5):467-473, May
1992.
16. Wannamethee, S.G., S. Sirivichayakul, A. N. Phillips, et al.,
``Clinical and Immunological Features of Human Immunodeficiency
Virus Infection in Patients from Bangkok, Thailand,'' International
Journal of Epidemiology, 27(2):289-295, April 1998.
17. Weinberg, A. and M.I. Duarte, ``Respiratory Complications in
Brazilian Patients Infected with Human Immunodeficiency Virus,''
Revista do Instituto de Medicina Tropical de Sao Paulo, 35(2):129-
139, March-April 1993.
18. Lagrou, K., J. Maertens, E. Van Even, et al., ``Burden of
Serious Fungal Infections in Belgium,'' Mycoses, 58(Suppl 5):1-5,
October 2015.
19. Faini, D., W. Maokola, W., H. Furrer, et al., ``Burden of
Serious Fungal Infections in Tanzania,'' Mycoses, 58(Suppl 5):70-79,
October 2015.
20. Worodria, W., J.L. Davis, A. Cattamanchi, et al., ``Bronchoscopy
is Useful for Diagnosing Smear-Negative Tuberculosis in HIV-Infected
Patients,'' The European Respiratory Journal, 36(2):446-448, August
2010.
21. Parkes[hyphen]Ratanshi, R., B. Achan, R. Kwizera, et al.,
``Cryptococcal Disease and the Burden of Other Fungal Diseases in
Uganda; Where are the Knowledge Gaps and How Can We Fill Them?''
Mycoses, 58(Suppl 5):85-93, October 2015.
22. Beardsley, J., D.W. Denning, N.V. Chau, et al., ``Estimating the
Burden of Fungal Disease in Vietnam,'' Mycoses, 58(Suppl 5):101-106,
October 2015.
23. Badiane, A.S., D. Ndiaye, D.W. Denning, ``Burden of Fungal
Infections in Senegal,'' Mycoses, 58(Suppl 5):63-69, October 2015.
24. Khwakhali, U.S. and D.W. Denning, ``Burden of Serious Fungal
Infections in Nepal,'' Mycoses, 58(Suppl 5):45-50, October 2015.

25. Osmanov, A. and D.W. Denning, ``Burden of Serious Fungal
Infections in Ukraine,'' Mycoses, 58(Suppl 5): 94-100, October 2015.
26. Morrow, B.M., N.Y. Hsaio, M. Zampoli, et al., ``Pneumocystis
Pneumonia in South African Children with and Without Human
Immunodeficiency Virus Infection in the Era of Highly Active
Antiretroviral Therapy,'' The Pediatric Infectious Disease Journal,
29(6):535-539, June 2010.
27. Stansell, J.D., D.H. Osmond, E. Charlebois, E., et al.,
``Predictors of Pneumocystis carinii Pneumonia in HIV-Infected
Persons. Pulmonary Complications of HIV Infection Study Group,''
American Journal of Respiratory and Critical Care Medicine,
155(1):60-66, January 1997.
28. Wasserman, S., M.E. Engel, M. Mendelson, ``Burden of
Pneumocystis Pneumonia in HIV-Infected Adults in Sub-Saharan Africa:
Protocol for a Systematic Review,'' Systematic Reviews, 2:112,
December 12, 2013.
29. Fisk, D.T., S. Meshnick, S., and P.H. Kazanjian, ``Pneumocystis
carinii Pneumonia in Patients in the Developing World Who Have
Acquired Immunodeficiency Syndrome,'' Clinical Infectious Diseases:
An Official Publication of the Infectious Diseases Society of
America, 36(1):70-78, January 1, 2003.
30. de Boer, M.G., J.W. de Fijter, F.P. Kroon, ``Outbreaks and
Clustering of Pneumocystis Pneumonia in Kidney Transplant
Recipients: A Systematic Review,'' Medical Mycology, 49(7):673-680,
October 2011.
31. Sonego, M., M.C. Pellegrin, G. Becker, et al., ``Risk Factors
for Mortality from Acute Lower Respiratory Infections (ALRI) in
Children under Five Years of Age in Low and Middle-Income Countries:
A Systematic Review and Meta-Analysis of Observational Studies,''
PLOS One, 10(1):e0116380, 2015.
32. Morris, A., J.D. Lundgren, H. Masur, et al., ``Current
Epidemiology of Pneumocystis Pneumonia,'' Emerging Infectious
Diseases, 10(10):1713-1720, October 2004.
33. Avino, L.J., S.M. Naylor, A.M. Roecker, ``Pneumocystis jirovecii
Pneumonia in the Non-HIV-Infected Population,'' The Annals of
Pharmacotherapy, 50(8):673-679, August 2016.
34. Joint United Nations Programme on HIV/AIDS (UNAIDS), ``Global
Report: UNAIDS Report on the Global AIDS Epidemic 2013,'' accessed
December 9, 2016, available at http://files.unaids.org/en/media/unaids/contentassets/documents/epidemiology/2013/gr2013/UNAIDS_Global_Report_2013_en.pdf.
35. WHO, ``Neglected Tropical Diseases,'' accessed December 9, 2016,
available at http://www.who.int/neglected_diseases/diseases/en/.

    Dated: August 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18313 Filed 8-23-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Proposed Rules]
[Pages 18487-18488]
[FR Doc No: 2021-07216]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0227; Airspace Docket No. 21-AGL-16]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Huron, SD

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend the Class E airspace at Huron
Regional Airport, Huron, SD. The FAA is proposing this action as the
result of an airspace review caused by the decommissioning of the Huron
VHF omnidirectional range (VOR) navigation aid as part of the VOR
Minimum Operational Network (MON) Program. The geographic coordinates
of the airport would also be updated to coincide with the FAA's
aeronautical database.

DATES: Comments must be received on or before May 24, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2021-0227/Airspace Docket No. 21-AGL-16 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://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 7400.11E at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

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 would amend the Class E surface airspace and the Class E airspace
extending upward from 700 feet above the surface at Huron Regional
Airport, Huron, SD, to support instrument flight rule operations at
this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2021-0227/
Airspace Docket No. 21-AGL-16.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel

concerned with this rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to 14 CFR 71 by:
    Amending the Class E surface airspace to within a 4.2-mile
(decreased from a 4.5-mile) radius of Huron Regional Airport, Huron,
SD; and updating the geographic coordinates of the airport to coincide
with the FAA's aeronautical database;
    And amending the Class E airspace extending upward from 700 feet
above the surface at Huron Regional Airport by removing the Huron
VORTAC, Beady NDB, and all extensions from the airspace legal
description as they are no longer required; and updating the geographic
coordinates of the airport to coincide with the FAA's aeronautical
database.
    This action is necessary due to an airspace review caused by the
decommissioning of the Huron VOR, which provided navigation information
for the instrument procedures this airport, as part of the VOR MON
Program.
    Class E airspace designations are published in paragraph 6002 and
6005, respectively, of FAA Order 7400.11E, dated July 21, 2020, and
effective September 15, 2020, 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.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

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 will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR 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 14 CFR 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 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6002 Class E Airspace Areas Designated as a Surface Area.

* * * * *

AGL SD E2 Huron, SD [Amended]

Huron Regional Airport, SD
    (Lat. 44[deg]23'07'' N, long. 98[deg]13'43'' W)

    Within a 4.2-mile radius of Huron Regional Airport.

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

* * * * *

AGL SD E5 Huron, SD [Amended]

Huron Regional Airport, SD
    (Lat. 44[deg]23'07'' N, long. 98[deg]13'43'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.7-mile radius of the Huron Regional Airport.

    Issued in Fort Worth, Texas, on April 5, 2021.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2021-07216 Filed 4-8-21; 8:45 am]
BILLING CODE 4910-13-P


1 March 26, 2004 MEMORANDUM TO: EPA Air Docket OAR 2003 0012 FROM: William Charmley Engineer Office of Transportation and Air Quality U. S. EPA SUBJECT: Summary of Meeting with the Engine Manufacturers Association and the California Air Resources Board, October 14, 2003 On October 14, 2003, representatives from EPA, the Engine Manufacturers Association ( EMA), and the California Air Resources Board ( CARB), met at the Westin Hotel inside the Detroit Metropolitan Airport to discuss the nonroad diesel Tier 4 proposal. A list of the attendees for this meeting is attached.

The following topics were discussed during the meeting;

 trailer refrigeration unit test cycle  crankcase standards and measurement options  add on values for in use compliance  CO standards for engines < 11hp and engines in the 25 50hp range  HC versus NMHC gaseous emissions measurement  emissions deterioration factor testing  engine installation requirements and separate shipment of engine and aftertreatment  defect reporting provisions  engine labeling provisions  use of good engineering judgement in the regulations  treatment of confidential business information in the certification regulations  EPA right of entry into engine manufacturers facilities under the regulations  confirmatory testing  regulations applicable to engines used for competition  transition program for equipment manufacturers  replacement engine regulatory provisions  certification test engine selection criteria  definition of engine power for determining power categories under Tier 4 attachments: Attendees List Attachment: Attendees List EPA Meeting with Engine Manufacturers Association, October 14, 2003 EMA Member Attendees: Kevin Korkada, EMA Rick Bishop, John Deere John Duerr, Detroit Diesel Corp. Bill Passie, Caterpillar Todd Hendrickson, Cummins Inc. Roy Mann, CNH Cameron Larson, Kubota Joe Unseth, Deutz Christina Lyons, Isuzu EPA Attendees Cle Jackson, Assessment & Standards Division, Office of Transportation & Air Quality Don Kopinski, Assessment & Standards Division, Office of Transportation & Air Quality Alan Stout, Assessment & Standards Division, Office of Transportation & Air Quality Chuck Moulis, Assessment & Standards Division, Office of Transportation & Air Quality Bill Charmley, Assessment & Standards Division, Office of Transportation & Air Quality Jean Marie Revelt, Assessment & Standards Division, Office of Transportation & Air Quality Rick Gezelle, Certification and Compliance Division, Office of Transportation & Air Quality George Lawrence, Office of Enforcement and Compliance Assurance by phone  Steve Silverman, Office of General Counsel CARB Attendees, by phone: Jackie Lourenco


[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Proposed Rules]
[Pages 72612-72613]
[FR Doc No: 2020-25100]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0944; Airspace Docket No. 20-ACE-26]
RIN 2120-AA66

Proposed Amendment of V-67, V-190, and V-429; Establishment of T-
312; and Revocation of V-125 and V-335 in the Vicinity of Marion, IL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking, correction.

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

SUMMARY: The FAA is correcting the airspace docket number listed in a
notice of proposed rulemaking (NPRM) that published in the Federal
Register of November 5, 2020. That NPRM proposing to amend VHF
Omnidirectional Range (VOR) Federal airways V-67, V-190, and V-429;
establish Area Navigation (RNAV) route T-312; and remove VOR Federal
airways V-125 and V-335 in the vicinity of Marion, IL. This action
reflects the correct airspace docket number.

DATES: Comments for the NPRM published on November 5, 2020 (85 FR
70532), continue to be accepted on or before December 21, 2020, to be
considered in the formulation of a rule determination.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Background

    The FAA published a NPRM for Docket No. FAA-2020-0944 in the
Federal Register (85 FR 70532; November 5, 2020), for amending VOR
Federal airways V-67, V-190, and V-429; establishing RNAV route T-312;
and removing VOR Federal airways V-125 and V-335 in the vicinity of
Marion, IL. Subsequent to publication, it was determined that the
airspace docket number for the NPRM incorrectly listed the FAA regional
abbreviation for the geographic area that the airspace action falls
within as ``AGL'' instead of ``ACE''. The correct airspace docket
number is ``20-ACE-26'' and is reflected in the heading of this
correction.

Need for Correction

    As published, the NPRM contained an error in the airspace docket
number listed in the header, ADDRESSES, and Comments Invited sections
which is misleading and requires correction. This corrective action is
necessary to avoid confusion as to the correct airspace docket number
for that rulemaking, Docket No. FAA-2020-0944. The FAA will review and
consider comments submitted on or before December 21, 2020, to the
incorrect docket, but this action establishes what the correct airspace
docket number is for this rulemaking.

Correction to NPRM

    Accordingly, pursuant to the authority delegated to me, the
airspace docket number reflected in Docket No. 2020-0944, as published
in the Federal Register of November 5, 2020 (85 FR 70532, FR Doc. 2020-
24489), is corrected as follows:
    1. In FR Doc. 2020-24489, appearing on page 70532, in the first
column, at line 5, correct ``20-AGL-26'' to read ``20-ACE-26.''
    2. In FR Doc. 2020-24489, appearing on page 70532, in the first
column, at line 46, correct ``20-AGL-26'' to read ``20-ACE-26.''
    3. In FR Doc. 2020-24489, appearing on page 70532, in the second
column,

at lines 50 and 51, correct ``20-AGL-26'' to read ``20-ACE-26.''
    4. In FR Doc. 2020-24489, appearing on page 70532, in the second
column, at line 64, correct ``20-AGL-26'' to read ``20-ACE-26.''

    Issued in Washington, DC, on November 9, 2020.
George Gonzalez,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2020-25100 Filed 11-12-20; 8:45 am]
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