[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Proposed Rules]
[Pages 67326-67327]
[FR Doc No: 2013-26878]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 140-147

[Docket No. USCG-2012-0779]
RIN 1625-AC05

Safety and Environmental Management System Requirements for
Vessels on the U.S. Outer Continental Shelf--Extension of Comment
Period

AGENCY: Coast Guard, DHS.

ACTION: Notice.

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

SUMMARY: The Coast Guard is extending the comment period for the
advance notice of proposed rulemaking (ANPRM) entitled ``Safety and
Environmental Management System Requirements for Vessels on the U.S.
Outer Continental Shelf,'' published on September 10, 2013, until
January 23, 2014. We are extending the comment period at the request of
industry to ensure stakeholders have adequate time to submit complete
responses.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before January 23,
2014 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2012-0779 using any one of the following methods:
    (1) Online: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this advance
notice of proposed rulemaking, call or email LCDR Marc J. Montemerlo,
U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

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

A. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2012-0779), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online or by fax, mail, or hand delivery, but please use only one of
these means. We recommend that you include your name and a mailing
address, an email address, or a phone number in the body of your
document so that we can contact you if we have questions regarding your
submission.
    To submit your comment online, go to http://www.regulations.gov and
insert ``USCG-2012-0779'' in the ``Search'' box. Click on ``Submit a
Comment'' in the ``Actions'' column. If you submit your comments by
mail or hand delivery, submit them in an unbound format, no larger than
8[frac12] by 11 inches, suitable for copying and electronic filing. If
you submit comments by mail and would like to know that they reached
the Facility, please enclose a stamped, self-addressed postcard or
envelope.
    We will consider all comments and material received during the
comment period and may change this proposed rule based on your
comments.

B. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
insert ``USCG-2012-0779'' and click ``Search.'' Click the ``Open Docket
Folder'' in the ``Actions'' column. If you do not have access to the
Internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. We have an agreement with the Department of
Transportation to use the Docket Management Facility.

C. Privacy Act

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

II. Regulatory History and Information

    The Coast Guard published an ANPRM entitled ``Safety and
Environmental Management System Requirements for Vessels on the U.S.
Outer Continental Shelf,'' on September 10, 2013 (78 FR 55230)
proposing to promulgate regulations that will require all domestic and
foreign-flagged vessels engaged in OCS activities to develop,
implement, and maintain a SEMS that incorporates the management program
and principles of API RP 75. This requirement would apply to MODUs,
well stimulation vessels, FPSOs, shuttle tankers, OSVs, accommodation
vessels, and other vessels engaged in OCS activities. A Coast Guard-
required SEMS would help to prevent accidents, injuries, and
environmental damage by reducing the probability and severity of
uncontrolled releases and other undesirable events. By incorporating
the management program and principles of API RP 75 as the basis for the
Coast Guard's SEMS requirements for vessels, this regulatory action
would leverage industry safety expertise and harmonize with BSEE's
regulations for designated lease operators. All comments on this ANPRM
were originally due by December 9, 2013.

III. Background and Purpose

    On October 4, 2013, we received a letter from Offshore Marine
Service Association (OMSA) requesting an extension of the comment
period. It noted additional time was desired to review the proposal and
develop answers to the sixteen questions listed in the ANPRM. The U.S.
Coast Guard is extending the public comment period, as requested, to
ensure stakeholders have adequate time to submit complete responses.

IV. Authority

    This notice is issued under authority of 5 U.S.C. 552(a).

    Dated: November 4, 2013.
J.G. Lantz,
Director of Commercial Regulations and Standards, U.S. Coast Guard.
[FR Doc. 2013-26878 Filed 11-8-13; 8:45 am]
BILLING CODE P


                                    ROSTER
          FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA)
                        SCIENTIFIC ADVISORY PANEL (SAP)

             August 25, 2020 (Public Virtual Preparatory Meeting)
          September 15-18, 2020 (Public Virtual Peer Review Meeting)
                  FIFRA SAP Website: https://www.epa.gov/sap
                Docket ID Number: EPA - HQ - OPP - 2020 - 0263

            U.S. Environmental Protection Agency Peer Review for:
 The Use of New Approach Methodologies (NAMs) to Derive Extrapolation Factors and Evaluate Developmental Neurotoxicity for Human Health Risk Assessment

FIFRA SAP Chair

Robert E. Chapin, PhD
Senior Research Fellow (Retired)
Pfizer Global Research and Development
Groton, Connecticut

Designated Federal Officials

Tamue L. Gibson, MS
Biologist
U.S. Environmental Protection Agency
Office of Science Coordination and Policy
Washington, DC 20460
Phone:<PHONE_NUMBER>
Email<EMAIL_ADDRESS>
Sharlene R. Matten, PhD
Senior Biologist
U.S. Environmental Protection Agency
Office of Science Coordination and Policy
Washington, DC 20460
Phone:<PHONE_NUMBER>
Email<EMAIL_ADDRESS>
FIFRA Scientific Advisory Panel Members

Jeffrey R. Bloomquist, PhD
Professor
Department of Entomology and Nematology
University of Florida
Gainesville, Florida
George B. Corcoran, PhD
Chairman and Professor
Department of Pharmaceutical Sciences
Wayne State University
Detroit, Michigan

Gaylia Jean Harry, PhD
Group Leader, Neurotoxicology Laboratory
National Toxicology Program, National Institute of Environmental Health Sciences
Research Triangle Park, North Carolina

Rebecca L. Smith, DVM, PhD
Assistant Professor
Department of Pathobiology
College of Veterinary Medicine
University of Illinois at Urbana-Champaign
Urbana, Illinois

Clifford P. Weisel, PhD
Professor
Environmental and Occupational Health Sciences Institute
Rutgers University
Piscataway, New Jersey

Raymond S.H. Yang, PhD
Professor (Emeritus)
College of Veterinary Medicine and Biomedical Sciences
Colorado State University
Fort Collins, Colorado

FQPA Science Review Board Members

Veronica J. Berrocal, PhD
Associate Professor
Department of Statistics
University of California
Irvine, California

Harvey J. Clewell, PhD, DABT, FATS
Principal Consultant
Ramboll US Corporation
Raleigh, North Carolina

Holly Davies, PhD
Senior Toxicologist
Washington State Department of Health
Tumwater, Washington

Marion F. Ehrich, RPh, PhD, DABT, ATS
Professor, Pharmacology/Toxicology
Virginia Maryland College of Veterinary Medicine
Virginia Polytechnic Institute and State University
Blacksburg, Virginia

Penelope A. Fenner-Crisp, PhD
Independent Consultant
North Garden, Virginia

Helena T. Hogberg, PhD
Deputy Director
Center for Alternatives to Animal Testing (CAAT)
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland

David A. Jett, PhD
Program Director
National Institute of Neurological Disorders and Stroke
Bethesda, Maryland

Mark S. Johnson, PhD
Director of Toxicology
U.S. Army Public Health Center
Aberdeen Proving Ground, Maryland

John C. Lipscomb PhD, DABT, FATS
Senior Toxicologist
CTEH, LLC
North Little Rock, Arkansas

Kenneth Portier, PhD
Independent Consulting Biostatistician
Athens, Georgia

Daniel M. Quinn, PhD
Professor (Emeritus) & Adjunct Professor
Department of Chemistry
University of Iowa
Iowa City, Iowa

Pamela J. Spencer, PhD, DABT
Vice President, Regulatory, Product Stewardship & Quality
ANGUS Chemical Company
Buffalo Grove, Illinois

Lisa M. Sweeney, PhD, DABT, CHMM
Risk Assessment Toxicologist,
UES, Inc.
Dayton, Ohio


[Federal Register: January 17, 2008 (Volume 73, Number 12)]
[Rules and Regulations]
[Page 3192-3194]
[DOCID:fr17ja08-5]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2007-1075; FRL-8506-2]

Revisions to the California State Implementation Plan, Kern
County Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is taking direct final action to approve revisions to the
Kern County Air Pollution Control District (KCAPCD) portion of the
California State Implementation Plan (SIP). These revisions concern
particulate matter (PM-10) emissions from ambient dust, propellant
testing, and rocket testing. We are approving local rules under the
Clean Air Act as amended in 1990 (CAA or the Act).

DATES: This rule is effective on March 17, 2008 without further notice,
unless EPA receives adverse comments by February 19, 2008. If we
receive such comments, we will publish a timely withdrawal in the
Federal Register to notify the public that this direct final rule will
not take effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2007-1075, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. Follow

the on-line instructions.
     E-mail<EMAIL_ADDRESS>     Mail or deliver: Andrew Steckel (Air-4), U.S.
Environmental Protection Agency Region IX, 75 Hawthorne Street, San
Francisco, CA 94105.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov,

including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through http://www.regulations.gov or e-mail.

http://www.regulations.gov is an ``anonymous access'' system, and EPA will not

know your identity or contact information unless you provide it in the
body of your comment. If you send e-mail directly to EPA, your e-mail
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA Region

IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Al Petersen, EPA Region IX, (415) 947-
4118<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What are the purposes of the new rule and rule revisions?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. Public Comment and Final Action
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules we are approving with the dates that the
rules were adopted or amended by the local air agency and submitted by
the California Air Resources Board (CARB).

                                            Table 1.--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                                Rule
                Local agency                              Rule title             Amended     Submitted
----------------------------------------------------------------------------------------------------------------
KCAPCD.....................................       404.1  Particulate Matter                01/24/07     08/24/07
                                                          Concentration.
KCAPCD.....................................       431    Propellant Combustion and         03/08/07     08/24/07
                                                          Rocket Testing.
----------------------------------------------------------------------------------------------------------------

    On September 17, 2007, the submittal of KCAPCD Rules 404.1 and 431
was determined to meet the completeness criteria in 40 CFR part 51
appendix V, which must be met before formal EPA review.

B. Are there other versions of these rules?

    A version of KCAPCD Rule 404.1 was approved into the SIP on
September 22, 1972, 37 FR 19812). There are no versions of Rule 431 in
the SIP.

C. What are the purposes of the new rule and rule revisions?

    Section 110(a) of the Clean Air Act (CAA) requires states to submit
regulations that control volatile organic compounds, nitrogen oxides,
particulate matter, and other air pollutants which harm human health
and the environment. These rules were developed as part of local air
districts' programs to control these pollutants.
    The purposes of the submitted KCAPCD Rule 404.1 revisions relative
to the SIP rule are as follows:
     404.1.II: Exemptions are added to the rule for (a)
equipment that combusts only liquid fuels, gaseous fuels, or waste
gases and only emits combustion contaminants, (b) rocket test stand
operation with less than 75 pounds of propellant, and (c) fires set in
accordance with Rule 416.
     404.1.III: The particulate emission standard for existing
sources is deleted and the standard for new sources of 0.1 grains per
cubic foot is extended to include all sources.
     404.1.IV: Test methods are added to the rule.
    The purposes of new KCAPCD Rule 431 are as follows:
     431.I,II: The rule applicability and definitions are
provided.
     431.III: Exemptions to the rule are provided for (a)
rocket test stand operation with less than 75 pounds of propellant, (b)
emergency disposal by a qualified bomb squad, (c) combustion for fire
training, (d) rocket propulsion systems that do not require propellant,
and (e) rocket propellants composed primarily of liquid fuels.
     431.IV: A rocket test plan is required for the combustion
of rocket propellants at a permitted test stand unless (a) a rocket
motor contains less than 500 pounds of propellant or a rocket engine
contains less than 1000 pounds of propellant and (b) CARB has
designated the day of the test a permissible burn day.
     431.V: The requirements are provided for a test plan that
include a toxic risk analysis and identification of those
meteorological conditions under which propellant testing will cause
insignificant risk to the nearest receptor.
     431.VI,VII: The recordkeeping requirements and compliance
schedule are provided.
    EPA's technical support document (TSD) has more information about
these rules.

II. EPA's Evaluation and Action

A. How is EPA evaluating the rules?

    Generally, SIP rules must be enforceable (see section 110(a) of the
CAA) and must not relax existing requirements (see sections 110(l) and
193). SIP rules in moderate PM-10 nonattainment areas must require for
significant sources reasonably available control measures (RACM),
including reasonably available control technology (RACT) (see section
189(b)). KCAPCD regulates a PM-10 attainment area (see 40 CFR part 81),
so KCAPCD Rules 404.1 and 431 need not fulfill the requirements of
RACM/RACT.
    Guidance and policy documents that we used to help evaluate rules
consistently include the following:
     Requirements for Preparation, Adoption, and Submittal of
Implementation Plans, U.S. EPA, 40 CFR part 51.
     PM-10 Guideline Document (EPA-452/R-93-008).

B. Do the rules meet the evaluation criteria?

    We believe that KCAPCD Rules 404.1 and 431 are consistent with the
relevant policy and guidance regarding enforceability, RACM/RACT, and
SIP relaxations and should be given full approval. The TSD has more
information on our evaluation.

C. Public Comment and Final Action

    As authorized in section 110(k)(3) of the CAA, EPA is fully
approving the submitted rules because we believe they fulfill all
relevant requirements. We do not think anyone will object to this
approval, so we are finalizing it without proposing it in advance.
However, in the Proposed Rules section of this Federal Register, we are
simultaneously proposing approval of the same submitted rule. If we
receive adverse comments by February 19, 2008, we will publish a timely
withdrawal in the Federal Register to notify the public that the direct
final approval will not take effect and we will address the comments in
a subsequent final action based on the proposal. If we do not receive
timely adverse comments, the direct final approval will be effective
without further notice on March 17, 2008. This will incorporate the
rule into the federally enforceable SIP.
    Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

III. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it 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).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely approves a state rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997),

because it approves a state rule implementing a Federal standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission; to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. section 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
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of 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.
section 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by March 17, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule 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, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: November 23, 2007.
Alexis Strauss,
Acting Regional Administrator, Region IX.

0
Part 52, chapter I, title 40 of the Code of Federal Regulations 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 F--California

0
2. Section 52.220 is amended by adding paragraph (c)(351)(i)(D) to read
as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (351) * * *
    (i) * * *
    (D) Kern County Air Pollution Control District.
    (1) Rule 404.1, adopted on April 18, 1972 and amended on January
24, 2007.
    (i) Resolution No. 2007-001-01, Reference No. Item 5, Adoption of
Amendments to Rules and Regulations of the Kern County Air Pollution
Control District; to Wit: Rule 404.1.
    (2) Rule 431, adopted on January 24, 2007 and amended on March 8,
2007.
    (i) Resolution No. 2007-003-03, Reference No. Item 3, Amendments to
Rules and Regulations of the Kern County Air Pollution Control
District; To Wit: Rule 431 (Propellant Combustion and Rocket Testing).
* * * * *
 [FR Doc. E8-161 Filed 1-16-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Pages 11297-11298]
[FR Doc No: 2019-05741]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2018-0250; FRL-9991-01-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for New Residential Hydronic Heaters
and Forced-Air Furnaces (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NSPS for New Residential Hydronic
Heaters and Forced-Air Furnaces (EPA ICR No. 2442.03, OMB Control No.
2060-0693), to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. This is a
proposed extension of the ICR, which is currently approved through
March 31, 2019. Public comments were previously requested, via the
Federal Register, on May 30, 2018 during a 60-day comment period. This
notice allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may neither conduct nor sponsor, and
a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before April 25,
2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2018-0250, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change, including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov, or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The New Source Performance Standards (NSPS) for New
Residential Hydronic Heaters and Forced-Air Furnaces (40 CFR part 60,
subpart QQQQ) to new residential hydronic heaters, forced-air furnaces,
or other central heaters manufactured either on or after May 15, 2015
and sold or distributed in the United States. The residential hydronic
heater and forced-air furnace NSPS establishes a certification program,
instead of the usual NSPS requirement that each affected facility
demonstrate compliance with emission limits through performance
testing. Under this certification program, a single heating appliance
is tested to demonstrate compliance with particulate matter (PM)
emission limits for an entire model line which could consist of
thousands of stoves. The use of a certification approach significantly
reduces the compliance burden, including information collection, for
the manufacturers of hydronic heaters and forced-air furnaces. Each
manufacturer subject to Subpart QQQQ is required to keep records of all
documentation pertaining to the certification testing for each model
line, the results of the quality assurance program inspections, and a
sealed sample of each heater or furnace upon which certification tests
were performed and certification granted. Each approved test laboratory
and third-party certifier must maintain records consisting of all
documentation pertaining to each certification test, quality assurance
program inspection and audit test. Manufacturers must also submit the
test reports and other documentation to EPA when they apply for a
certificate of compliance for each model line. These reports, and
records are essential in determining compliance, and are required of
all affected facilities subject to NSPS. This information is being
collected to assure compliance with 40 CFR part 60, subpart QQQQ.
    Form Numbers: None.
    Respondents/affected entities: New residential hydronic heaters,
forced-air furnaces, or other central heaters manufactured either on or
after May 15, 2015 and sold or distributed in the United States. These
regulations also apply to EPA-approved testing laboratories and EPA-
approved third-party certifiers.
    Respondent's obligation to respond: Mandatory (40 CFR 60 Subpart
QQQQ).

    Estimated number of respondents: 50 respondents, consisting of 32
hydronic heater manufacturers, 7 forced-air furnace manufacturers, and
11 companies that are EPA-approved testing laboratories, third-party
certifiers or both.
    Frequency of response: Annual.
    Total estimated burden: 4,270 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $4,770,000 (per year), which includes
$4,280,000 in annualized capital/startup and/or operation & maintenance
costs.
    Changes in the Estimates: The increase in burden from the most
recently-approved ICR is due to an increase in the number of
respondents and an increase in the number of testing labs and third-
party certifiers. The increase in burden is also due to an adjustment
to the burden for reporting by third-party certifiers to include burden
for submittal of certifications, QA audit program reports, and
credentials. Additionally, there is an increase in the annual average
capital/startup costs as compared with the costs in the previous ICR,
due to a number of testing labs and third-party certifiers expected to
re-apply for re-accreditation in the three-year period. The overall
result is an increase in the number of responses and in the burden.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-05741 Filed 3-25-19; 8:45 am]
 BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD ROAD                            ANN ARBOR, MI  48105-2498

									          	OFFICE OF 										AIR AND RADIATION

January 18, 2011

MEMORANDUM

SUBJECT:	Meeting with the Engine Manufacturers Association (EMA)

FROM:	Angela Cullen

TO:		Docket EPA-HQ-OAR-2010-0162

This memorandum documents a meeting held on Tuesday, January 18, 2011 between EMA, NHTSA and EPA and included the following individuals:

      EMA: Tim Blubaugh - EMA, Jed Mandel  -  EMA, Tony Cook  -  Navistar, Patrick Charbonneau  -  Navistar, David Kayes  -  Daimler, Dan Kieffer  -  PACCAR, Margaret Sullivan  -  PACCAR, Brian Mormino - Cummins, Jackie Yeager  -  Cummins, Tony Greszler  -  Volvo, Marc Miller  -  Volvo, Brian Burton  -  Daimler, Tom Sloane  -  PACCAR,  Jack Gehring  -  Caterpillar, Don Keski-Hynnila  -  Detroit Diesel              NHTSA/DOT: James Tamm, Maurice Hicks, Coralie Cooper              EPA: Byron Bunker, Chuck Moulis, and Angela Cullen

The discussion focused on vehicle certification process; tractor and vocational vehicle definitions; vehicle speed limiters; determination of aerodynamic performance; credit fungibility; tire warranty; small business exemptions; innovative credits; and deterioration factors.


[Federal Register Volume 82, Number 80 (Thursday, April 27, 2017)]
[Notices]
[Pages 19397-19398]
[FR Doc No: 2017-08461]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80501; File No. SR-NYSEArca-2016-176]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change Relating to the Listing and Trading of Shares of the
EtherIndex Ether Trust Under NYSE Arca Equities Rule 8.201

April 21, 2017.
    On December 30, 2016, NYSE Arca, Inc. (``NYSE Arca'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to list and trade shares (``Shares'') of the
EtherIndex Ether Trust (``Trust'') under NYSE Arca Equities Rule 8.201.
The proposed rule change was published for comment in the Federal
Register on January 23, 2017.\3\ On February 23, 2017, pursuant to
Section 19(b)(2) of the Act,\4\ the Commission designated a longer
period within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
approve or disapprove the proposed rule change.\5\ The Commission has
received no comments on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 79792 (Jan. 13,
2017), 82 FR 7891 (Jan. 23, 2017) (``Notice'').
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 80094 (Feb. 23,
2017), 82 FR 12268 (Mar. 1, 2017). The Commission designated April
23, 2017, as the date by which it should approve, disapprove, or
institute proceedings to determine whether to approve or disapprove
the proposed rule change.
---------------------------------------------------------------------------

    This order institutes proceedings under Section 19(b)(2)(B) of the
Act \6\ to determine whether to approve or disapprove the proposed rule
change.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

I. Summary of the Proposal \7\
---------------------------------------------------------------------------

    \7\ The Commission notes that additional information regarding
the Trust and the Shares can be found in the Notice, see supra note
3, and the Registration Statement, which was filed by the Trust on
Form S-1 under the Securities Act of 1933 on July 15, 2016, and
amended on November 28, 2016. This additional information addresses
the Trust's investment objectives, risks, creation and redemption
procedures, fees, portfolio holdings disclosure policies,
calculation of the net asset value (``NAV''), distributions, and
taxes, as well as additional background information about ether and
the Ethereum Network, including information relating to, among other
things, Ethereum Network operations, ether transfers and
transactions, cryptographic security used in the Ethereum Network,
ether mining and creation of new ether, the supply of ether, and
modifications to the ether protocol.
---------------------------------------------------------------------------

    The Exchange proposes to list and trade the Shares under NYSE Arca
Equities Rule 8.201, which governs the listing and trading of
Commodity-Based Trust Shares on the Exchange.\8\ Each Share would
represent a fractional undivided beneficial interest in the Trust's net
assets. According to the Exchange, the Trust's assets primarily would
consist of ether,\9\ which would be held in the custody of, and secured
by, the Trust's ether custodian, Coinbase (``Custodian'').\10\ The
Trust would create and redeem the Shares only in ``Baskets'' of 10,000
Shares, and orders to create and redeem Baskets may be placed only by
Authorized Participants. The creation and redemption transactions would
be conducted for cash or, at the discretion of the sponsor of the
Trust, EtherIndex LLC, ``in-kind'' for ether, and the NAV of the
Baskets being created or redeemed would be based on the aggregate
number of ether represented by the Shares included in the Baskets as of
the day the order to create or redeem was properly received.
---------------------------------------------------------------------------

    \8\ See NYSE Arca Equities Rule 8.201 (permitting the listing
and trading of ``Commodity-Based Trust Shares,'' defined as a
security ``(a) that is issued by a trust that holds a specified
commodity deposited with the Trust; (b) that is issued by such Trust
in a specified aggregate minimum number in return for a deposit of a
quantity of the underlying commodity; and (c) that, when aggregated
in the same specified minimum number, may be redeemed at a holder's
request by such Trust which will deliver to the redeeming holder the
quantity of the underlying commodity'').
    \9\ The Exchange represents that ether is a digital asset
similar to bitcoin and is not issued by any government, bank, or
central organization, but rather is issued by, and is transmitted
through, the decentralized, open-source protocol of the peer-to-peer
Ethereum Network. The Exchange represents that unlike bitcoin, ether
was not designed to function purely as a store of value. Instead,
ether was meant to pay for specific actions on the Ethereum Network.
However, according to the Exchange, ether's market is currently
supported by many of the same online exchanges and the same
infrastructure that has developed around the bitcoin network.
    \10\ According to the Exchange, the private keys that control
the Trust's ether would be secured by the Custodian and stored
completely offline in a ``cold storage'' system. The Exchange
represents that the Custodian's cold storage system is founded on
the principles of (i) building defense-in-depth against external
threats, (ii) protecting against human error, and (iii) guarding
against misuse of insider access. The Custodian's cold storage
mechanism involves generating private keys on an ``air-gapped''
computer (i.e., a computer that has never been connected to the
Internet), then splitting these keys into segments using a special
algorithm to ensure that no one individual knows how the key was
fragmented, and finally distributing these fragments geographically
so that no one entity can access the cold storage without the other
individuals contributing their fragment of the key. According to the
Exchange, the Custodian maintains insurance against theft and
electronic compromise in an amount that exceeds the average value of
ether that it holds online at any one time. The Exchange also
represents that the Trust may hold cash for short periods in
connection with the creation and redemption process and to pay
certain fees, expenses, and liabilities.
---------------------------------------------------------------------------

    The investment objective of the Trust would be for the Shares to
track the price of ether as measured by the price of ether in U.S.
dollars reported by the Global Digital Asset Exchange (``GDAX'') as of
4:00 p.m., Eastern Time (``GDAX Price''). The NAV of the Trust would be
calculated each business day based on the GDAX Price. The Trust's Web
site would provide an intra-day indicative value (``IIV'') per Share
updated every 15 seconds, as calculated by the Exchange or a third-
party financial data provider during the Exchange's Core Trading
Session (i.e., 9:30 a.m. ET to 4:00 p.m. Eastern Time). The IIV would
be calculated by using the prior day's closing NAV per Share as a base
and updating that value during the NYSE Arca Core Trading Session to
reflect changes in the value of the Trust's ether holdings during the
trading day.

II. Proceedings to Determine Whether To Approve or Disapprove SR-
NYSEArca-2016-176 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act \11\ to determine whether the proposed rule
change should be approved or disapproved. Institution of such
proceedings is appropriate at this time in view of the legal and policy
issues raised by the proposed rule change. Institution of proceedings
does not indicate that the Commission has reached any conclusions with
respect to any of the issues involved. Rather, as described below, the
Commission seeks and encourages interested persons to provide comments
on the proposed rule change.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

    Pursuant to Section 19(b)(2)(B) of the Act,\12\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for additional
analysis of the proposed rule change's consistency with Section 6(b)(5)
of the Act, which requires, among other things, that the rules of a
national securities exchange be ``designed to prevent fraudulent and
manipulative acts and practices'' and ``to protect investors and the
public interest.'' \13\
---------------------------------------------------------------------------

    \12\ Id.
    \13\ 15 U.S.C. 78f(b)(5).

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

III. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposal is
consistent with Section 6(b)(5) or any other provision of the Act, or
the rules and regulations thereunder. Although there do not appear to
be any issues relevant to approval or disapproval that would be
facilitated by an oral presentation of views, data, and arguments, the
Commission will consider, pursuant to Rule 19b-4, any request for an
opportunity to make an oral presentation.\14\
---------------------------------------------------------------------------

    \14\ Section 19(b)(2) of the Act, as amended by the Securities
Act Amendments of 1975, Public Law 94-29 (June 4, 1975), grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by a self-regulatory
organization. See Securities Act Amendments of 1975, Senate Comm. on
Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st
Sess. 30 (1975).
---------------------------------------------------------------------------

    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposal should be approved or
disapproved by May 18, 2017. Any person who wishes to file a rebuttal
to any other person's submission must file that rebuttal by June 1,
2017. The Commission asks that commenters address the sufficiency of
the Exchange's statements in support of the proposal, which are set
forth in the Notice.\15\ In addition to any other comments commenters
may wish to submit about the proposed rule change, the Commission
invites commenters' views concerning any features that distinguish the
Exchange's proposal from other proposals to list and trade shares of
commodity-trust ETPs.
---------------------------------------------------------------------------

    \15\ See supra note 3.
---------------------------------------------------------------------------

    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2016-176 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Numbers SR-NYSEArca-2016-176. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of these filings also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2016-176 and should
be submitted on or before May 18, 2017. Rebuttal comments should be
submitted by June 1, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-08461 Filed 4-26-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 120 (Friday, June 21, 2013)]
[Notices]
[Page 37648]
[FR Doc No: 2013-14859]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Space Transportation Infrastructure Matching (STIM) Grants
Program

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of non-availability of Space Transportation
Infrastructure Matching Grants in FY 2013.

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

SUMMARY: The Office of Commercial Space Transportation (AST) will not
solicit or award grants under the STIM program this fiscal year.

FOR FURTHER INFORMATION CONTACT: Doug Graham (AST-100), Office of
Commercial Space Transportation (AST), 800 Independence Avenue SW.,
Room 331, Washington, DC 20591, telephone<PHONE_NUMBER>; Email
<EMAIL_ADDRESS>
    Issued in Washington, DC, on June 10, 2013.
George C. Nield,
Associate Administrator for Commercial Space Transportation.
[FR Doc. 2013-14859 Filed 6-20-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 238 (Wednesday, December 11, 2019)]
[Notices]
[Page 67740]
[FR Doc No: 2019-26664]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2607-006; ER10-2626-005.
    Applicants: Old Dominion Electric Cooperative, TEC Trading, Inc.
    Description: Triennial Market Power Update of the ODEC Entities.
    Filed Date: 12/4/19.
    Accession Number: 20191204-5173.
    Comments Due: 5 p.m. ET 2/3/20.

    Docket Numbers: ER20-517-000.
    Applicants: Crooked Run Solar, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authority and Request for Waivers, et al. to be effective 12/5/
2019.
    Filed Date: 12/4/19.
    Accession Number: 20191204-5170.
    Comments Due: 5 p.m. ET 12/26/19.

    Docket Numbers: ER20-518-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-12-05_SA 3269 OTP-
Tatanka Ridge Wind 1st Rev GIA (J493) to be effective 11/20/2019.
    Filed Date: 12/5/19.
    Accession Number: 20191205-5000.
    Comments Due: 5 p.m. ET 12/26/19.

    Docket Numbers: ER20-519-000; TS20-2-000.
    Applicants: Wilderness Line Holdings, LLC.
    Description: Request for Waivers of the Standards of Conduct and
Order Nos. 889 and 1000 Requirements of Wilderness Line Holdings, LLC.
    Filed Date: 12/4/19.
    Accession Number: 20191204-5182.
    Comments Due: 5 p.m. ET 12/26/19.

    Docket Numbers: ER20-520-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
GridLiance Heartland LLC.
    Description: Sec.  205(d) Rate Filing: 2019-12-05_GridLiance
Heartland Rate Mitigation Credits filing to be effective 12/31/9998.
    Filed Date: 12/5/19.
    Accession Number: 20191205-5002.
    Comments Due: 5 p.m. ET 12/26/19.

    Docket Numbers: ER20-521-000.
    Applicants: The Connecticut Light and Power Company.
    Description: Sec.  205(d) Rate Filing: CPV Towantic Preliminary
Engineering and Design Agreement to be effective 12/5/2019.
    Filed Date: 12/5/19.
    Accession Number: 20191205-5012.
    Comments Due: 5 p.m. ET 12/26/19.

    Docket Numbers: ER20-522-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEPTX-LCRA TSC Bakersfield-
Solstice FDA to be effective 11/17/2019.
    Filed Date: 12/5/19.
    Accession Number: 20191205-5016.
    Comments Due: 5 p.m. ET 12/26/19.

    Docket Numbers: ER20-523-000.
    Applicants: Portland General Electric Company.
    Description: Compliance filing: Show Cause Compliance Filing to be
effective 3/21/2018.
    Filed Date: 12/5/19.
    Accession Number: 20191205-5017.
    Comments Due: 5 p.m. ET 12/26/19.

    Docket Numbers: ER20-524-000.
    Applicants: San Diego Gas & Electric Company.
    Description: Sec.  205(d) Rate Filing: 2020 SDGE TACBAA Update to
Transmission Owner Tariff Filing to be effective 1/1/2020.
    Filed Date: 12/5/19.
    Accession Number: 20191205-5020.
    Comments Due: 5 p.m. ET 12/26/19.

    Docket Numbers: ER20-525-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: Avista Construction Agmt--
Saddle Mtn to be effective 12/6/2019.
    Filed Date: 12/5/19.
    Accession Number: 20191205-5027.
    Comments Due: 5 p.m. ET 12/26/19.

    Docket Numbers: ER20-526-000.
    Applicants: California Independent System Operator Corporation.
    Description: Tariff Cancellation: 2019-12-05 Notice of Cancellation
EIM Implementation Agreement--Idaho Power Co. to be effective 2/4/2020.
    Filed Date: 12/5/19.
    Accession Number: 20191205-5109.
    Comments Due: 5 p.m. ET 12/26/19.

    Docket Numbers: ER20-527-000.
    Applicants: California Independent System Operator Corporation.
    Description: Tariff Cancellation: 2019-12-05 Notice of Cancellation
EIM Implement. Agmt--Portland Gen. Electric to be effective 2/4/2020.
    Filed Date: 12/5/19.
    Accession Number: 20191205-5114.
    Comments Due: 5 p.m. ET 12/26/19.

    Docket Numbers: ER20-528-000.
    Applicants: Lincoln Power, L.L.C.
    Description: Baseline eTariff Filing: MBR Application to be
effective 2/4/2020.
    Filed Date: 12/5/19.
    Accession Number: 20191205-5119.
    Comments Due: 5 p.m. ET 12/26/19.

    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 comment date. 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: December 5, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-26664 Filed 12-10-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Rules and Regulations]
[Pages 34269-34271]
[FR Doc No: 2016-12683]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2016-N-1268]

Medical Devices; Ophthalmic Devices; Classification of the
Diurnal Pattern Recorder System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the
diurnal pattern recorder system into class II (special controls). The
special controls that will apply to the device are identified in this
order and will be part of the codified language for the diurnal pattern
recorder system's classification. The Agency is classifying the device
into class II (special controls) in order to provide a reasonable
assurance of safety and effectiveness of the device.

DATES: This order is effective May 31, 2016. The classification was
applicable on March 4, 2016.

FOR FURTHER INFORMATION CONTACT: Alexander Beylin, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2404, Silver Spring, MD 20993-0002, 301-
796-6463.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1) of
the FD&C Act. Under the first procedure, the person submits a premarket
notification under section 510(k) of the FD&C Act for a device that has
not previously been classified and, within 30 days of receiving an
order classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person requests a classification under section
513(f)(2). Under the second procedure, rather than first submitting a
premarket notification under section 510(k) of the FD&C Act and then a
request for classification under the first procedure, the person
determines that there is no legally marketed device upon which to base
a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
    On April 28, 2014, Sensimed AG submitted a request for
classification of the SENSIMED Triggerfish[supreg] device under section
513(f)(2) of the FD&C Act. The manufacturer recommended that the device
be classified into class II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on March 4, 2016, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 886.1925.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a diurnal
pattern recorder system will need to comply with the special controls
named in this final order.
    The device is assigned the generic name diurnal pattern recorder
system, and it is identified as a nonimplantable, prescription device
incorporating a telemetric sensor to detect changes in ocular dimension
for monitoring diurnal patterns of intraocular pressure (IOP)
fluctuations.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks
in Table 1:

 Table 1--Diurnal Pattern Recorder System Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Ocular Adverse Events:                   Clinical testing.
     Hyperemia                   Biocompatibility evaluation.
     Punctate keratitis          Labeling.
     Discomfort
     Dry eye--dry sensation in
     the eye where the sensor is placed
     Foreign body sensation--
     gritty feeling
     Itching, burning
     Swelling of eyelids
     Pink eye
     Excessive watering,
     unusual secretions or redness of
     the eye
     Eye pain or irritation
     Eye injury
Infection..............................  Sterilization validation.
                                         Labeling.
Adverse Tissue Reaction................  Biocompatibility evaluation.
                                         Labeling.
Software Malfunction...................  Software verification,
                                          validation, and hazard
                                          analysis.
Hardware Malfunction...................  Nonclinical testing.
Use Error (e.g., improper fit, device    Clinical testing.
 manipulation).
                                         Labeling.
Electromagnetic Interference with Other  Electromagnetic compatibility
 Devices.                                 (EMC) and electromagnetic
                                          interference (EMI) testing.
                                         Labeling.
Electrical Malfunction (e.g., shock,     Electrical safety testing.
 battery-related issues).
                                         Labeling.
Measurement Noise or Artifact Leading    Labeling.
 to Incorrect Graphical Representation
 of Variation.
------------------------------------------------------------------------

    FDA believes that the special controls, in addition to the general
controls, address these risks to health and provide reasonable
assurance of safety and effectiveness.
    Diurnal pattern recorder systems are not safe for use except under
the supervision of a practitioner licensed by law to direct the use the
device. As such, the device is a prescription device and must satisfy
prescription labeling requirements (see 21 CFR 801.109 Prescription
devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the diurnal pattern recorder system
they intend to market.

II. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR parts 801 and 809, regarding labeling, have
been approved under OMB control number 0910-0485.

IV. Reference

    The following reference is on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and is available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it
is also available electronically at http://www.regulations.gov.

    1. DEN140017: De novo request per 513(f)(2) from Sensimed AG,
dated April 28, 2014.

List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
886 is amended as follows:

PART 886--OPHTHALMIC DEVICES

0
1. The authority citation for part 886 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  886.1925 to subpart B to read as follows:

Sec.  886.1925  Diurnal pattern recorder system.

    (a) Identification. A diurnal pattern recorder system is a
nonimplantable, prescription device incorporating a telemetric sensor
to detect changes in ocular dimension for monitoring diurnal patterns
of intraocular pressure (IOP) fluctuations.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical performance data must demonstrate that the device and
all of its components perform as intended under anticipated conditions
of use. The

following performance characteristics must be demonstrated:
    (i) Ability of the device to detect diurnal changes.
    (ii) Tolerability of the system at the corneoscleral interface in
the intended use population.
    (2) Nonclinical testing must validate measurements in an
appropriate nonclinical testing model to ensure ability to detect
changes in intraocular pressure.
    (3) Patient-contacting components must be demonstrated to be
biocompatible.
    (4) Any component that is intended to contact the eye must be
demonstrated to be sterile throughout its intended shelf life.
    (5) Software verification, validation, and hazard analysis must be
performed.
    (6) Performance testing must demonstrate the electromagnetic
compatibility and electromagnetic interference of the device.
    (7) Performance testing must demonstrate electrical safety of the
device.
    (8) Labeling must include the following:
    (i) Warning against activities and environments that may put the
user at greater risk.
    (ii) Specific instructions for the safe use of the device, which
includes:
    (A) Description of all device components and instructions for
assembling the device;
    (B) Explanations of all available programs and instructions for
their use;
    (C) Instructions and explanation of all user-interface components;
    (D) Instructions on all safety features of the device; and
    (E) Instructions for properly maintaining the device.
    (iii) A summary of nonclinical testing information to describe EMC
safety considerations.
    (iv) A summary of safety information obtained from clinical
testing.
    (v) Patient labeling to convey information regarding appropriate
use of device.

    Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12683 Filed 5-27-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Notices]
[Page 1474]
[FR Doc No: 2022-00241]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at the Saline County Regional Airport, Benton, Arkansas

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of request to release airport property.

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

SUMMARY: The FAA proposes to rule and invite public comment on the
release of land at the Saline County Regional Airport under the
provisions of Section 125 of the Wendell H. Ford Aviation Investment
Reform Act for the 21st Century (AIR 21).

DATES: Comments must be received on or before (from 30 days of the
posting of this Federal Register Notice).

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Mr. Glenn A. Boles, Manager, Federal
Aviation Administration, Southwest Region, Airports Division, Arkansas/
Oklahoma Airports Development Office, ASW-630, Fort Worth, Texas 76177.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Judge Jeff Arey, Saline County Judge, at the
following address: 200 North Main Street, RM117, Benton, AR 72015.

FOR FURTHER INFORMATION CONTACT:  Ms. Sara K. Fields-Pack, Program
Manager, Federal Aviation Administration, Arkansas/Oklahoma Airports
Development Office, ASW-630, 10101 Hillwood Parkway, Fort Worth, Texas
76177, Telephone:<PHONE_NUMBER>, Email: [email protected].

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release property at the Saline County Regional Airport under
the provisions of the AIR 21.
    The following is a brief overview of the request:
    Saline County requests the release of 28.97 acres of excess
aeronautical land. The property will be sold for non-aeronautical land
use purposes.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the application,
notice and other documents relevant to the application in person at the
Saline County Attorney, telephone number<PHONE_NUMBER>.

Ignacio Flores,
Director, Office of Airports Southwest Region.
[FR Doc. 2022-00241 Filed 1-10-22; 8:45 am]
BILLING CODE P


[Federal Register Volume 81, Number 161 (Friday, August 19, 2016)]
[Notices]
[Pages 55519-55520]
[FR Doc No: 2016-19779]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2016-89]

Petition for Exemption; Summary of Petition Received; The Boeing
Company

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of title 14 of the Code of Federal
Regulations. The purpose of this notice is to improve the public's
awareness of, and participation in, the FAA's exemption process.
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 and must be received on or before September 8, 2016.

ADDRESSES: Send comments identified by docket number FAA-2016-7855
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: Deana Stedman, ANM-113, Federal
Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356,
email<EMAIL_ADDRESS>phone<PHONE_NUMBER>.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on August 2, 2016.
Dale Bouffiou,
Acting Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2016-7855.
    Petitioner: The Boeing Company.
    Section(s) of 14 CFR Affected: Sec. Sec.  25.901(c) and 25.1309(b).
    Description of Relief Sought: The Boeing Company seeks temporary
relief from the requirements of 14 CFR 25.901(c) and 25.1309(b) to
allow time necessary to fully develop, certify, and

incorporate a design change to correctly accommodate single failures of
the thrust control module which can cause un-commanded high thrust.
Boeing intends to correct the design by December 31, 2018, for
production 787 Model airplanes, and provide retrofit instructions to
the fleet.

[FR Doc. 2016-19779 Filed 8-18-16; 8:45 am]
 BILLING CODE 4910-13-P