[Federal Register: June 2, 2008 (Volume 73, Number 106)]
[Rules and Regulations]
[Page 31357-31358]
[DOCID:fr02jn08-4]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage Form New Animal Drugs;
Butorphanol

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Lloyd, Inc. The ANADA provides for the
veterinary prescription use of butorphanol tartrate injectable solution
in horses for the relief of pain.

DATES: This rule is effective June 2, 2008.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Lloyd, Inc., 604 West Thomas Ave.,
Shenandoah, IA 51601, filed ANADA 200-332 that provides for the
veterinary prescription use of BUTORPHIC (butorphanol tartrate)
Injection in horses for the relief of pain associated with colic and
postpartum pain. Lloyd, Inc.'s BUTORPHIC Injection is approved as a
generic copy of TORBUGESIC, sponsored by Fort Dodge Animal Health,
Division of Wyeth, under NADA 135-780. The ANADA is approved as of May
1, 2008, and 21 CFR 522.246 is amended to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) 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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to

the Center for Veterinary Medicine, 21 CFR part 522 is amended as
follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  522.246   [Amended]

0
2. In paragraph (b)(3) of Sec.  522.246, remove ``057926 and 059130''
and in its place add ``057926, 059130, and 061690''.

    Dated: May 21, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-12160 Filed 5-30-08; 8:45 am]

BILLING CODE 4160-01-S


                EPA ICR No.  2487.01; OMB Control No.  2070-NEW

                                 ATTACHMENT F

Survey for EPA Design for the Environment (DfE)
                Post-Launch Awareness Test of New Visual Mark
                        General Adult Population Survey

                           OMB Control No. 2070-NEW
                         Approval expires XX/XX/XX

	The annual public burden for this collection of information is estimated at 0.17 hours per response for screened respondents, 2 hours for respondents that participate in the focus groups, 0.33 hours per response for pre-launch consumer online survey respondents, and 0.17 hours per response for post-launch online survey respondents. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed application to this address.
Survey for EPA Design for the Environment (DfE)
                Post-Launch Awareness Test of New Visual Mark
                        General Adult Population Survey

1. Are you familiar with a labeling program implemented by the U.S. Environmental Protection Agency (EPA) that enables consumers to select products that can help protect the environment and are safer for people, families, and pets?

 Yes
 No [SKIP to Q3]

1. What is the name of the labeling program? [Open-ended]

2. For 15 years, the U.S. Environmental Protection Agency (EPA) has implemented a voluntary labeling program that enables consumers to select products that can help protect the environment and are safer for families and pets. This labeling program, called "Design for the Environment" (DfE), evaluates human health and environmental concerns associated with traditional and alternative chemicals in a variety of products, including commonly used household cleaning products. Products that meet EPA's DfE Standard for Safer Products are allowed to carry the DfE label. When you see the DfE label on a product it means the DfE scientific review team has screened each ingredient for potential human health and environmental effects and has determined the product contains only those ingredients that pose the least concern.

   The labeling program, previously called the "Design for the Environment" (DfE) Safer Product Labeling Program, recently changed its name to [NEW NAME].

   Now that you have heard more about the labeling program, do you recall hearing or seeing anything about the EPA's [NEW NAME] program?

 Yes
 No
                                     Logo
1. Have you seen this visual mark on any products you have purchased or seen on store shelves?

 Yes
 No

1. Based on what you now know about the labeling program, how likely are you to use the EPA's [NEW NAME] visual mark to help you select a product to purchase?

 Extremely likely
 Very likely
 Somewhat likely
 Slightly likely
 Not at all likely


[Federal Register Volume 80, Number 204 (Thursday, October 22, 2015)]
[Rules and Regulations]
[Pages 63912-63914]
[FR Doc No: 2015-26874]

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

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Federal Aviation Administration

14 CFR Chapter I

[Docket No. FAA-2015-4378]

Clarification of the Applicability of Aircraft Registration
Requirements for Unmanned Aircraft Systems (UAS) and Request for
Information Regarding Electronic Registration for UAS

AGENCY: Department of Transportation and Federal Aviation
Administration.

ACTION: Clarification and request for information.

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

SUMMARY: This document clarifies the applicability of the statutory
requirements regarding aircraft registration to UAS, including those
operating as model aircraft. In addition, the DOT announces the
formation of a UAS registration task force to explore and develop
recommendations to streamline the registration process for UAS to ease
the burden associated with the existing aircraft registration process.
This document requests information and recommendations regarding what
information and registration platform would be appropriate for UAS
registration and ways to minimize the burden to the regulated
community. In addition, we request comment on which UAS, based on their
weight or performance capabilities, warrant a continued exercise of
discretion with respect to requiring registration because of the
negligible risk they pose to the national airspace system (NAS).

DATES: This clarification goes into effect October 22, 2015. To assist
the task force in developing its recommendations, the Department

requests that comments in response to the request for information be
submitted to docket FAA-2015-4378 at www.regulations.gov, by November
6, 2015.
    The docket will remain open after this time and the Department will
consider all comments received in developing a registration process.

ADDRESSES: You may submit comments by any of the following methods:
     Federal Rulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Dockets Management System; U.S. Department of
Transportation, Dockets Operations, M-30, Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: To U.S. Department of Transportation,
Dockets Operations, M-30, Ground Floor, Room W12-140, 1200 New Jersey
Avenue SE., Washington, DC 20590-0001, between 9:00 a.m. and 5:00 p.m.,
Monday through Friday, except Federal holidays. Instructions: Include
the agency name and docket number FAA-2015-4378 for this document at
the beginning of your comment. Note that all comments received will be
posted without change to http://www.regulations.gov including any
personal information provided. If sent by mail, comments must be
submitted in duplicate. Persons wishing to receive confirmation of
receipt of their comments must include a self-addressed stamped
postcard.
    Privacy Act: Anyone is able to search the electronic form of any
written communications and comments received into any of our dockets by
the name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement at
http://www.dot.gov/privacy.
    Docket: You may view the public docket through the Internet at
http://www.regulations.gov or in person at the Docket Operations office
at the above address (See ADDRESSES).

FOR FURTHER INFORMATION CONTACT: Questions regarding this document may
be directed to Earl Lawrence, Director, FAA UAS Integration Office, 800
Independence Ave. SW., Washington DC 20591; phone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    In the FAA Modernization and Reform Act of 2012 (Pub. L. 112-95)
(the Act), Congress mandated that the DOT, in consultation with other
government partners and industry stakeholders, develop a comprehensive
plan to safely accelerate the integration of civil UAS in the NAS.
Since 2012, the Department has made progress in enabling UAS
operations, through issuing exemptions under section 333 of the Act to
permit commercial operations; creating a UAS test site program to
encourage further research and testing of UAS operations in real-world
environments; issuing a notice of proposed rulemaking, Operation and
Certification of Small Unmanned Aircraft Systems (RIN 2120-AJ60) (small
UAS NPRM), that sets forth a framework for integrating small UAS
operations in the NAS; and developing a Pathfinder program to encourage
research and innovation that will enable advanced UAS operations.
    A foundational statutory and regulatory requirement that the
Department has employed for each of these integration programs is
aircraft registration and marking. In order to operate in the NAS, the
Department must ensure that operators are not only aware of the system
in which they are operating, but that we also have a means to identify
and track the UAS to its operator. One means to accomplish this is
through aircraft registration and marking. To date, UAS operators that
the Department has authorized have been required to register their UAS
through the FAA's existing paper-based registration process under 14
CFR part 47. As an exercise of discretion, historically we have not
required model aircraft to be registered under this system.
    UAS hold enormous promise for our economy and for the aviation
industry. But for the industry to develop to its full potential, we
have to ensure that it develops safely. Over the past several months,
we have received increasing reports of unauthorized and unsafe use of
small UAS. Pilot reports of UAS sightings in 2015 are double the rate
of 2014. Pilots have reported seeing drones at altitudes up to 10,000
feet, or as close as half-a-mile from the approach end of a runway. In
recent weeks, the presence of multiple UAS in the vicinity of wild
fires in the western part of the country prompted firefighters to
ground their aircraft on several occasions. These UAS operations are
unsafe and illegal. However, only a small percentage of these incidents
have resulted in enforcement actions against individuals for unsafe or
unauthorized UAS operation because identifying an individual or entity
responsible for the dangerous operation of UAS is very difficult. This
situation is troubling to the unmanned aircraft industry, to
responsible model aircraft users, and to users of the NAS, all of whom
always put safety first.
    The risk of unsafe operations will only increase as more UAS enter
the NAS. Some retailers have projected huge holiday sales. We are
committed to ensuring that the U.S. continues to lead the world in the
development and implementation of aviation technology, and in doing so,
that we create a space for the creativity, innovation and exploration
that will drive this industry forward in the years and decades ahead.
At the same time, we must create a culture of accountability and
responsibility among all UAS operators. To maintain safety in the NAS,
the Department has reconsidered its past practice of exercising
discretion with respect to requiring UAS to be registered, consistent
with statutory requirements of 49 U.S.C. 44101-44103, and has
determined that registration of all UAS is necessary to enforce
personal accountability while operating an aircraft in our skies.
    Federal law requires that a person may only operate an aircraft
when it is registered with the FAA. 49 U.S.C. 44101(a).\1\ ``Aircraft''
is defined as ``any contrivance invented, used, or designed to
navigate, or fly in, the air.'' \2\ 49 U.S.C. 40102(a)(6). In 2012,
Congress confirmed that UAS, including those used for recreation or
hobby purposes, are aircraft consistent with the statutory definition
set forth in 49 U.S.C. 40102(a)(6). See Public Law 112-95, sec. 331(8),
336 (defining an unmanned aircraft as ``an aircraft that is that is
operated without the possibility of direct human intervention from
within or on the aircraft,'' and model aircraft as ``an unmanned
aircraft that is capable of sustained flight in the atmosphere, flown
within visual line of sight of the person operating the aircraft, and
flown for hobby or recreational purposes''); see also Administrator v.
Pirker, NTSB Order No. EA-5730, at 12 (Nov. 17, 2014) (affirming that
the statutory definition of aircraft is clear and unambiguous and
``includes any air aircraft, manned or unmanned, large or small.'').
Because UAS, including model aircraft, are aircraft, they are subject
to FAA regulation, including the statutory

requirements regarding registration set forth in 49 U.S.C. 44101(a),
and further prescribed in regulation at 14 CFR part 47.
---------------------------------------------------------------------------

    \1\ The FAA is charged with registering and issuing a
certificate of registration to the owner of an aircraft that meets
the requirements of 49 U.S.C. 44102. See 49 U.S.C. 44102-03. These
statutory requirements are augmented by regulations in part 47 of
title 14, Code of Federal Regulations.
    \2\ Similarly, FAA regulations define ``aircraft'' as ``a device
that is used or intended to be used for flight in the air.'' 14 CFR
1.1.
---------------------------------------------------------------------------

    Historically, the FAA, through the exercise of its discretion, has
not enforced the statutory requirements for aircraft registration in 49
U.S.C. 44101 for model aircraft. As evidenced by the recent reports of
unsafe UAS operations, the lack of awareness of operators regarding
what must be done to operate UAS safely in the NAS, and the lack of
identification of UAS and their operators pose significant challenges
in ensuring accountability for responsible use. Without increased
awareness and knowledge of the statutory and regulatory requirements
for safe operation, the risk of unsafe UAS operations will only rise.
Aircraft identification and marking will assist the Department in
identifying owners of UAS that are operated in an unsafe manner, so we
may continue to educate these users, and when appropriate, take
enforcement action.
    Requiring registration of all UAS, including those operated for
hobby or recreation, embraces and applies the Academy of Model
Aeronautics' (AMA)'s policy of identification to UAS operators who may
not be modelers registered with the AMA. Additionally, it would ensure
consistency with other UAS operations currently required to be
registered, such as public aircraft, those operated under exemptions,
and certificated aircraft, as well as those operations contemplated in
the small UAS NPRM.
    Based on the Department's experience in registering small UAS
authorized by exemptions granted under the authority of section 333 of
the FAA Modernization and Reform Act of 2012, and the comments received
on the proposed registration requirements in the small UAS NPRM, it is
apparent that the current paper-based system for aircraft registration
is too burdensome for small UAS, to include model aircraft. To
facilitate compliance with the statutory obligation for registration,
the DOT is currently evaluating options for a streamlined, electronic-
based registration system for small UAS. The Department has convened a
UAS registration task force, under the FAA's authority in 49 U.S.C.
106(p)(5) to designate aviation rulemaking committees. This task force
will provide recommendations on the type of registration platform
needed to accommodate small UAS, as well as the information that will
need to be provided to register these aircraft. The UAS registration
task force also will explore and provide recommendations on whether it
is appropriate for the FAA to continue to exercise discretion with
respect to requiring registration of certain UAS based on their weight
and performance capabilities. The task force will meet and provide its
recommendations to the Department by November 20, 2015. To facilitate
the task force's work, we are requesting information and data from the
public in the following areas:
    1. What methods are available for identifying individual products?
Does every UAS sold have an individual serial number? Is there another
method for identifying individual products sold without serial numbers
or those built from kits?
    2. At what point should registration occur (e.g. point-of-sale or
prior-to-operation)? How should transfers of ownership be addressed in
registration?
    3. If registration occurs at point-of-sale, who should be
responsible for submission of the data? What burdens would be placed on
vendors of UAS if DOT required registration to occur at point-of-sale?
What are the advantages of a point-of-sale approach relative to a
prior-to-operation approach?
    4. Consistent with past practice of discretion, should certain UAS
be excluded from registration based on performance capabilities or
other characteristics that could be associated with safety risk, such
as weight, speed, altitude operating limitations, duration of flight?
If so, please submit information or data to help support the
suggestions, and whether any other criteria should be considered.
    5. How should a registration process be designed to minimize
burdens and best protect innovation and encourage growth in the UAS
industry?
    6. Should the registration be electronic or web-based? Are there
existing tools that could support an electronic registration process?
    7. What type of information should be collected during the
registration process to positively identify the aircraft owner and
aircraft?
    8. How should the registration data be stored? Who should have
access to the registration data? How should the data be used?
    9. Should a registration fee be collected and if so, how will the
registration fee be collected if registration occurs at point-of-sale?
Are there payment services that can be leveraged to assist (e.g.
PayPal)?
    10. Are there additional means beyond aircraft registration to
encourage accountability and responsible use of UAS?

Comments received by November 6, 2015 would be most helpful in
assisting the UAS registration task force in developing its
recommendations. The comment period will remain open after this period
and the Department will consider the comments received, in addition to
the UAS registration task force's recommendations, in developing a
stream-lined registration process for small UAS, including model
aircraft.

    Issued in Washington, DC, on October 19, 2015.
Anthony R. Foxx,
Secretary of Transportation.
Michael P. Huerta,
Administrator of the Federal Aviation Administration.
[FR Doc. 2015-26874 Filed 10-20-15; 11:15 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Rules and Regulations]
[Pages 28645-28646]
[FR Doc No: 2011-12246]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0389]

Drawbridge Operation Regulation; Calcasieu River, Westlake, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, Eighth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Union Pacific Railroad swing bridge across the Calcasieu River, mile
36.4, at Westlake, Calcasieu Parish, Louisiana. The deviation is
necessary to upgrade the electrical and mechanical systems of the
bridge. This deviation allows the bridge to remain closed-to-navigation
on five different dates in June.

DATES: This deviation is effective from 8 a.m. on Thursday, June 2,
2011, through 5 p.m. on Thursday, June 30, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2011-0389 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0389 in the
``Keyword'' box and then clicking ``Search.'' They are also available
for inspection or copying at the 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, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Kay Wade, Bridge Administration Branch, Coast Guard;
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Union Pacific Railroad has requested a
temporary deviation from the operating schedule for the swing span
bridge across the Calcasieu River, mile 36.4, at Westlake, Calcasieu
Parish, Louisiana. The swing span bridge has a vertical clearance of
1.07 feet above mean high water, elevation 3.56 feet Mean Gulf Level in
the closed-to-navigation position.
    In accordance with 33 CFR 117.5, the bridge currently opens on
signal for the passage of vessels. This deviation allows the swing span
of the bridge to remain closed to navigation from 8 a.m. through 5 p.m.
with an opening for the passage of vessels from 12 noon to 1 p.m. on
the following Thursdays: June 2, 9, 16, 23, and 30, 2011.
    The closures are necessary in order to remove and install the
structural steel, new gear motors, and shafts at both ends of the
bridge and the center pivot pier. This maintenance is essential for the
continued operation of the bridge. Notices will be published in the
Eighth Coast Guard District Local Notice to Mariners and will be
broadcast via the Coast Guard Broadcast Notice to Mariners System.
    Navigation on the waterway is minimal at the bridge site. The very
limited commercial traffic at the bridge site consists of commercial
tugs with tows. There are only two companies that transit above the
bridge. The bridge will be able to open for emergencies if necessary.
There are no alternate waterway routes available. Based on experience
and coordination with waterway users, it has been determined that these
closures will not have a significant effect on vessels that use the
waterway.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: May 9, 2011.
David M. Frank,
Bridge Administrator.
[FR Doc. 2011-12246 Filed 5-17-11; 8:45 am]
BILLING CODE 9110-04-P


Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 1 For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

PART 51  [ AMENDED]

1. The authority citation for part 51 continues to read as follows:

Authority: 23 U. S. C. 101; 42 U. S. C. 7401 7671q.

Subpart I  [ Amended]

2. Section 51.165 is amended:

a. By revising paragraph ( a)( 1)( v)( C)( 1).

b. By adding paragraphs ( a)( 1)( xliii) through ( xlvi),

and paragraphs ( h) and ( i).

The revision and additions read as follows:

§ 51.165 Permit requirements.

( a) * * *

( 1) * * *

( v) * * *

( C) * * *

( 1) Routine maintenance, repair and replacement.

Routine maintenance, repair and replacement shall include,

but not be limited to, any activity( s) that meets the requirements of the equipment replacement provisions contained in paragraph ( h) of this section.

* * * * * Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 2 ( xliii)( A) In general, process unit means any collection of structures and/ or equipment that processes,

assembles, applies, blends, or otherwise uses material inputs to produce or store an intermediate or a completed product. A single stationary source may contain more than one process unit, and a process unit may contain more than one emissions unit.

( B) Pollution control equipment is not part of the process unit, unless it serves a dual function as both process and control equipment. Administrative and warehousing facilities are not part of the process unit.

( C) For replacement cost purposes, parts shared between two or more process units are proportionately allocated based on capacity.

( D) The following list identifies the process units at specific categories of stationary sources.

( 1) For a steam electric generating facility, the process unit consists of those portions of the plant that contribute directly to the production of electricity. For example, at a pulverized coal fired facility, the process unit would generally be the combination of those systems from the coal receiving equipment through the emission stack ( excluding post combustion pollution controls), including Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 3 the coal handling equipment, pulverizers or coal crushers,

feedwater heaters, ash handling, boiler, burners,

turbinegenerator set, air preheaters, and operating control systems. Each separate generating unit is a separate process unit.

( 2) For a petroleum refinery, there are several categories of process units: those that separate and/ or distill petroleum feedstocks; those that change molecular structures; petroleum treating processes; auxiliary facilities, such as steam generators and hydrogen production units; and those that load, unload, blend or store intermediate or completed products.

( 3) For an incinerator, the process unit would consist of components from the feed pit or refuse pit to the stack,

including conveyors, combustion devices, heat exchangers and steam generators, quench tanks, and fans.

( xliv) Functionally equivalent part means a part that serves the same purpose as the replaced part.

( xlv) Fixed capital cost means the capital needed to provide all the depreciable components. " Depreciable components" refers to all components of fixed capital cost and is calculated by subtracting land and working capital from the total capital investment, as defined in paragraph Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 4 ( a)( 1)( xlvi) of this section.

( xlvi) Total capital investment means the sum of the following: all costs required to purchase needed process equipment ( purchased equipment costs); the costs of labor and materials for installing that equipment ( direct installation costs); the costs of site preparation and buildings; other costs such as engineering, construction and field expenses, fees to contractors, startup and performance tests, and contingencies ( indirect installation costs); land for the process equipment; and working capital for the process equipment.

* * * * *

( h) Equipment Replacement Provision. Routine maintenance, repair and replacement includes, but is not limited to, the replacement of any part of a process unit with an identical or functionally equivalent part( s), and maintenance or repair activity( s) if it is associated with the replacement of a part( s), without regard to other considerations, provided that all of the requirements in paragraphs ( h)( 1) through ( 3) of this section are met.

Repair and maintenance activities are associated with the replacement of a part of the process unit if they are conducted in conjunction with the replacement. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 5 ( 1) Capital Cost threshold for Equipment Replacement ( i) For an electric utility steam generating unit, as defined in 51.165( a)( 1)( xx), the fixed capital cost of the replacement part( s) plus the cost of any associated maintenance and repair activities shall not exceed 20 percent of the replacement value of the process unit.

( ii) For a process unit that is not an electric utility steam generating unit the fixed capital cost of the replacement part( s) plus the cost of any associated maintenance and repair activities shall not exceed 20 percent of the replacement value of the process unit.

( iii) At the time the owner or operator commences the replacement activity, the owner or operator shall determine the replacement value of the process unit; and, except as otherwise allowed under paragraph ( h)( 1)( iv) of this section, the replacement value of the process unit shall be based on an estimate of the fixed capital cost of constructing a new process unit, or on the current appraised value of the process unit.

( iv) As an alternative to paragraph ( h)( 1)( iii) of this section for determining the replacement value of a process unit, an owner or operator may choose to use insurance value ( where the insurance value covers only Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 6 complete replacement), investment value adjusted for inflation, or another accounting procedure if such procedure is based on Generally Accepted Accounting Principles,

provided that the owner or operator sends a notice to the reviewing authority at the beginning of the process unit's fiscal year. Unless the owner or operator submits a notice to the reviewing authority, then paragraph ( h)( 1)( iii) of this section will be used to establish the replacement value of the process unit. Once the owner or operator submits a notice to use an alternative accounting procedure, they must continue to use that procedure for the entire fiscal year for that process unit. In subsequent fiscal years, the owner or operator must continue to use this selected procedure unless an another notice is sent to the reviewing authority selecting another procedure consistent with this paragraph or paragraph ( h)( 1)( iii) of this section at the beginning of such fiscal year.

( 2) Basic Design Parameters. The replacement does not change the basic design parameters of the process unit.

( i) Except as provided in paragraph ( h)( 2)( iii) of this section, for a process unit at a steam electric generating facility, one basic design parameter is maximum hourly heat input and the owner or operator may select any Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 7 one of the following for the other basic design parameter:

maximum hourly electric output rate, maximum steam flow rate, or maximum hourly fuel consumption rate. When establishing fuel consumption specifications, the minimum fuel quality based on British Thermal Units content shall be used for determining the basic design parameters for a coalfired electric utility steam generating unit.

( ii) Except as provided in paragraph ( h)( 2)( iii) of this section, the basic design parameters for any process unit that is not at a steam electric generating facility are maximum rate of fuel input, maximum rate of material input,

or maximum rate of product output.

( iii) If the owner or operator believes the basic design parameters in paragraphs ( h)( 2)( i) and ( ii) of this section are not appropriate for a specific industry or type of process unit, the owner or operator may propose to the reviewing authority alternative basic design parameters for the source's process unit( s). If the reviewing authority approves of the use of an alternative basic design parameter, the reviewing authority shall issue a permit that is enforceable as a practical matter that records such basic design parameter( s) and requires the owner or operator to comply with such parameter( s). Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 8 ( iv) The basic design parameters specified in paragraphs ( h)( 2)( i) and ( ii) of this section shall be established by the owner or operator using credible information, such as results of historic maximum capability tests, operating design information from the manufacturer,

or engineering calculations.

( v) If design information is not available for a process unit, then the owner or operator shall determine the process unit's basic design parameters using the maximum value achieved by the process unit in the five year period immediately preceding the planned activity.

( vi) Efficiency of a process unit is not a basic design parameter.

( 3) The replacement activity shall not cause the process unit to exceed any emission limitation or operational limitation ( that has the effect of constraining emissions) that applies to any part of the process unit and that is enforceable as a practical matter. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 9 3. Section 51.166 is amended:

a. By revising paragraph ( b)( 2)( iii)( a).

b. By adding paragraphs ( b)( 53) through ( 56), and paragraphs ( y) and ( z).

The revision and additions read as follows:

§ 51.166 Prevention of significant deterioration of air quality.

( b) * * *

( 2) * * *

( iii) * * *

( a) Routine maintenance, repair and replacement.

Routine maintenance, repair and replacement shall include,

but not be limited to, any activity( s) that meets the requirements of the equipment replacement provisions contained in paragraph ( y) of this section.

* * * * *

( 53)( i) In general, process unit means any collection of structures and/ or equipment that processes, assembles,

applies, blends, or otherwise uses material inputs to produce or store an intermediate or a completed product. A single stationary source may contain more than one process unit, and a process unit may contain more than one emissions unit. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 10 ( ii) Pollution control equipment is not part of the process unit, unless it serves a dual function as both process and control equipment. Administrative and warehousing facilities are not part of the process unit.

( iii) For replacement cost purposes, parts shared between two or more process units are proportionately allocated based on capacity.

( iv) The following list identifies the process units at specific categories of stationary sources.

( a) For a steam electric generating facility, the process unit consists of those portions of the plant that contribute directly to the production of electricity. For example, at a pulverized coal fired facility, the process unit would generally be the combination of those systems from the coal receiving equipment through the emission stack ( excluding post combustion pollution controls), including the coal handling equipment, pulverizers or coal crushers,

feedwater heaters, ash handling, boiler, burners,

turbinegenerator set, air preheaters, and operating control systems. Each separate generating unit is a separate process unit.

( b) For a petroleum refinery, there are several categories of process units: those that separate and/ or Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 11 distill petroleum feedstocks; those that change molecular structures; petroleum treating processes; auxiliary facilities, such as steam generators and hydrogen production units; and those that load, unload, blend or store intermediate or completed products.

( c) For an incinerator, the process unit would consist of components from the feed pit or refuse pit to the stack,

including conveyors, combustion devices, heat exchangers and steam generators, quench tanks, and fans.

( 54) Functionally equivalent part means a part that serves the same purpose as the replaced part.

( 55) Fixed capital cost means the capital needed to provide all the depreciable components. " Depreciable components" refers to all components of fixed capital cost and is calculated by subtracting land and working capital from the total capital investment, as defined in paragraph ( b)( 56) of this section.

( 56) Total capital investment means the sum of the following: all costs required to purchase needed process equipment ( purchased equipment costs); the costs of labor and materials for installing that equipment ( direct installation costs); the costs of site preparation and buildings; other costs such as engineering, construction and Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 12 field expenses, fees to contractors, startup and performance tests, and contingencies ( indirect installation costs); land for the process equipment; and working capital for the process equipment.

* * * * *

( y) Equipment Replacement Provision. Routine maintenance, repair and replacement includes, but is not limited to, the replacement of any part of a process unit with an identical or functionally equivalent part( s), and maintenance or repair activity( s) if it is associated with the replacement of a part( s), without regard to other considerations, provided that all of the requirements in paragraphs ( y)( 1) through ( 3) of this section are met.

Repair and maintenance activities are associated with the replacement of a part of the process unit if they are conducted in conjunction with the replacement.

( 1) Capital Cost threshold for Equipment Replacement ( i) For an electric utility steam generating unit, as defined in 51.166( b)( 30), the fixed capital cost of the replacement part( s) plus the cost of any associated maintenance and repair activities shall not exceed 20 percent of the replacement value of the process unit.

( ii) For a process unit that is not an electric Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 13 utility steam generating unit the fixed capital cost of the replacement part( s) plus the cost of any associated maintenance and repair activities shall not exceed 20 percent of the replacement value of the process unit.

( iii) At the time the owner or operator commences the replacement activity, the owner or operator shall determine the replacement value of the process unit; and, except as otherwise allowed under paragraph ( y)( 1)( iv) of this section, the replacement value of the process unit shall be based on an estimate of the fixed capital cost of constructing a new process unit, or on the current appraised value of the process unit.

( iv) As an alternative to paragraph ( y)( 1)( iii) of this section for determining the replacement value of a process unit, an owner or operator may choose to use insurance value ( where the insurance value covers only complete replacement), investment value adjusted for inflation, or another accounting procedure if such procedure is based on Generally Accepted Accounting Principles,

provided that the owner or operator sends a notice to the reviewing authority at the beginning of the process unit's fiscal year. Unless the owner or operator submits a notice to the reviewing authority, then paragraph ( y)( 1)( iii) of Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 14 this section will be used to establish the replacement value of the process unit. Once the owner or operator submits a notice to use an alternative accounting procedure, they must continue to use that procedure for the entire fiscal year for that process unit. In subsequent fiscal years, the owner or operator must continue to use this selected procedure unless an another notice is sent to the reviewing authority selecting another procedure consistent with this paragraph or paragraph ( y)( 1)( iii) of this section at the beginning of such fiscal year.

( 2) Basic Design Parameters. The replacement does not change the basic design parameters of the process unit.

( i) Except as provided in paragraph ( y)( 2)( iii) of this section, for a process unit at a steam electric generating facility, one basic design parameter is maximum hourly heat input and the owner or operator may select any one of the following for the other basic design parameter:

maximum hourly electric output rate, maximum steam flow rate, or maximum hourly fuel consumption rate. When establishing fuel consumption specifications, the minimum fuel quality based on British Thermal Units content shall be used for determining the basic design parameters for a coalfired electric utility steam generating unit. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 15 ( ii) Except as provided in paragraph ( y)( 2)( iii) of this section, the basic design parameters for any process unit that is not at a steam electric generating facility are maximum rate of fuel input, maximum rate of material input,

or maximum rate of product output.

( iii) If the owner or operator believes the basic design parameters in paragraphs ( y)( 2)( i) and ( ii) of this section are not appropriate for a specific industry or type of process unit, the owner or operator may propose to the reviewing authority alternative basic design parameters for the source's process unit( s). If the reviewing authority approves of the use of an alternative basic design parameter, the reviewing authority shall issue a permit that is enforceable as a practical matter that records such basic design parameter( s) and requires the owner or operator to comply with such parameter( s).

( iv) The basic design parameters specified in paragraphs ( y)( 2)( i) and ( ii) of this section shall be established by the owner or operator using credible information, such as results of historic maximum capability tests, operating design information from the manufacturer,

or engineering calculations.

( v) If design information is not available for a Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 16 process unit, then the owner or operator shall determine the process unit's basic design parameters using the maximum value achieved by the process unit in the five year period immediately preceding the planned activity.

( vi) Efficiency of a process unit is not a basic design parameter.

( 3) The replacement activity shall not cause the process unit to exceed any emission limitation or operational limitation ( that has the effect of constraining emissions) that applies to any part of the process unit and that is enforceable as a practical matter. Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 17 PART 52  [ Amended]

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

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

Subpart A  [ Amended]

2. Section 52.21 is amended:

a. By revising paragraph ( b)( 2)( iii)( a).

b. By adding paragraphs ( b)( 55) through ( 58), and paragraphs ( cc) and ( dd).

The revision and additions read as follows:

§ 52.21 Prevention of significant deterioration of air quality.

( b) * * *

( 2) * * *

( iii) * * *

( a) Routine maintenance, repair and replacement.

Routine maintenance, repair and replacement shall include,

but not be limited to, any activity( s) that meets the requirements of the equipment replacement provisions contained in paragraph ( cc) of this section.

* * * * *

( 55)( i) In general, process unit means any collection of structures and/ or equipment that processes, assembles, Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 18 applies, blends, or otherwise uses material inputs to produce or store an intermediate or a completed product. A single stationary source may contain more than one process unit, and a process unit may contain more than one emissions unit.

( ii) Pollution control equipment is not part of the process unit, unless it serves a dual function as both process and control equipment. Administrative and warehousing facilities are not part of the process unit.

( iii) For replacement cost purposes, parts shared between two or more process units are proportionately allocated based on capacity.

( iv) The following list identifies the process units at specific categories of stationary sources.

( a) For a steam electric generating facility, the process unit consists of those portions of the plant that contribute directly to the production of electricity. For example, at a pulverized coal fired facility, the process unit would generally be the combination of those systems from the coal receiving equipment through the emission stack ( excluding post combustion pollution controls), including the coal handling equipment, pulverizers or coal crushers,

feedwater heaters, ash handling, boiler, burners, turbine Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 19 generator set, air preheaters, and operating control systems. Each separate generating unit is a separate process unit.

( b) For a petroleum refinery, there are several categories of process units: those that separate and/ or distill petroleum feedstocks; those that change molecular structures; petroleum treating processes; auxiliary facilities, such as steam generators and hydrogen production units; and those that load, unload, blend or store intermediate or completed products.

( c) For an incinerator, the process unit would consist of components from the feed pit or refuse pit to the stack,

including conveyors, combustion devices, heat exchangers and steam generators, quench tanks, and fans.

( 56) Functionally equivalent part means a part that serves the same purpose as the replaced part.

( 57) Fixed capital cost means the capital needed to provide all the depreciable components. " Depreciable components" refers to all components of fixed capital cost and is calculated by subtracting land and working capital from the total capital investment, as defined in paragraph ( b)( 58) of this section.

( 58) Total capital investment means the sum of the Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 20 following: all costs required to purchase needed process equipment ( purchased equipment costs); the costs of labor and materials for installing that equipment ( direct installation costs); the costs of site preparation and buildings; other costs such as engineering, construction and field expenses, fees to contractors, startup and performance tests, and contingencies ( indirect installation costs); land for the process equipment; and working capital for the process equipment.

* * * * *

( cc) Equipment Replacement Provision. Routine maintenance, repair and replacement includes, but is not limited to, the replacement of any part of a process unit with an identical or functionally equivalent part( s), and maintenance or repair activity( s) if it is associated with the replacement of a part( s), without regard to other considerations, provided that all of the requirements in paragraphs ( cc)( 1) through ( 3) of this section are met.

Repair and maintenance activities are associated with the replacement of a part of the process unit if they are conducted in conjunction with the replacement.

( 1) Capital Cost threshold for Equipment Replacement ( i) For an electric utility steam generating unit, as Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 21 defined in 52.21( b)( 31), the fixed capital cost of the replacement part( s) plus the cost of any associated maintenance and repair activities shall not exceed 20 percent of the replacement value of the process unit.

( ii) For a process unit that is not an electric utility steam generating unit the fixed capital cost of the replacement part( s) plus the cost of any associated maintenance and repair activities shall not exceed 20 percent of the replacement value of the process unit.

( iii) At the time the owner or operator commences the replacement activity, the owner or operator shall determine the replacement value of the process unit; and, except as otherwise allowed under paragraph ( cc)( 1)( iv) of this section, the replacement value of the process unit shall be based on an estimate of the fixed capital cost of constructing a new process unit, or on the current appraised value of the process unit.

( iv) As an alternative to paragraph ( cc)( 1)( iii) of this section for determining the replacement value of a process unit, an owner or operator may choose to use insurance value ( where the insurance value covers only complete replacement), investment value adjusted for inflation, or another accounting procedure if such procedure Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 22 is based on Generally Accepted Accounting Principles,

provided that the owner or operator sends a notice to the reviewing authority at the beginning of the process unit's fiscal year. Unless the owner or operator submits a notice to the reviewing authority, then paragraph ( cc)( 1)( iii) of this section will be used to establish the replacement value of the process unit. Once the owner or operator submits a notice to use an alternative accounting procedure, they must continue to use that procedure for the entire fiscal year for that process unit. In subsequent fiscal years, the owner or operator must continue to use this selected procedure unless an another notice is sent to the reviewing authority selecting another procedure consistent with this paragraph or paragraph ( cc)( 1)( iii) of this section at the beginning of such fiscal year.

( 2) Basic Design Parameters. The replacement does not change the basic design parameters of the process unit.

( i) Except as provided in paragraph ( cc)( 2)( iii) of this section, for a process unit at a steam electric generating facility, one basic design parameter is maximum hourly heat input and the owner or operator may select any one of the following for the other basic design parameter:

maximum hourly electric output rate, maximum steam flow Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 23 rate, or maximum hourly fuel consumption rate. When establishing fuel consumption specifications, the minimum fuel quality based on British Thermal Units content shall be used for determining the basic design parameters for a coalfired electric utility steam generating unit.

( ii) Except as provided in paragraph ( cc)( 2)( iii) of this section, the basic design parameters for any process unit that is not at a steam electric generating facility are maximum rate of fuel input, maximum rate of material input,

or maximum rate of product output.

( iii) If the owner or operator believes the basic design parameters in paragraphs ( cc)( 2)( i) and ( ii) of this section are not appropriate for a specific industry or type of process unit, the owner or operator may propose to the reviewing authority alternative basic design parameters for the source's process unit( s). If the reviewing authority approves of the use of an alternative basic design parameter, the reviewing authority shall issue a permit that is enforceable as a practical matter that records such basic design parameter( s) and requires the owner or operator to comply with such parameter( s).

( iv) The basic design parameters specified in paragraphs ( cc)( 2)( i) and ( ii) of this section shall be Internal and Deliberative Draft  Do not quote, cite, copy, or distribute August 15, 2003 24 established by the owner or operator using credible information, such as results of historic maximum capability tests, operating design information from the manufacturer,

or engineering calculations.

( v) If design information is not available for a process unit, then the owner or operator shall determine the process unit's basic design parameters using the maximum value achieved by the process unit in the five year period immediately preceding the planned activity.

( vi) Efficiency of a process unit is not a basic design parameter.

( 3) The replacement activity shall not cause the process unit to exceed any emission limitation or operational limitation ( that has the effect of constraining emissions) that applies to any part of the process unit and that is enforceable as a practical matter.


[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Page 37112]
[FR Doc No: 2023-11924]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97629; File No. SR-FINRA-2022-031]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Designation of a Longer Period for
Commission Action on Proceedings To Determine Whether To Approve or
Disapprove a Proposed Rule Change To Adopt FINRA Rules 6151 (Disclosure
of Order Routing Information for NMS Securities) and 6470 (Disclosure
of Order Routing Information for OTC Equity Securities)

    On November 16, 2022, the Financial Industry Regulatory Authority
Inc. (``FINRA'') 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 adopt rules regarding the disclosure of order
routing information for NMS securities and OTC equity securities. The
proposed rule change was published for comment in the Federal Register
on December 6, 2022.\3\ On January 18, 2023, the Commission extended
the time 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 to
March 6, 2023.\4\ On March 3, 2023, the Commission instituted
proceedings to determine whether to approve or disapprove the proposed
rule change.\5\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 96415 (November 30,
2022), 87 FR 74672 (December 6, 2022). Comments on the proposed rule
change are available at: https://www.sec.gov/comments/sr-finra-2022-031/srfinra2022031.htm.
    \4\ See Securities Exchange Act Release No. 96699, 88 FR 4260
(January 24, 2023).
    \5\ See Securities Exchange Act Release No. 97039, 88 FR 14653
(March 9, 2023).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \6\ provides that, after initiating
proceedings, the Commission shall issue an order approving or
disapproving the proposed rule change not later than 180 days after the
date of publication of notice of filing of the proposed rule change.
The Commission may extend the period for issuing an order approving or
disapproving the proposed rule change, however, by not more than 60
days if the Commission determines that a longer period is appropriate
and publishes the reasons for such determination. The proposed rule
change was published for notice and comment in the Federal Register on
December 6, 2022.\7\ June 4, 2023 is 180 days from that date, and
August 3, 2023 is 240 days from that date. The Commission finds it
appropriate to designate a longer period within which to issue an order
approving or disapproving the proposed rule change so that it has
sufficient time to consider the proposed rule change and its comments.
Accordingly, the Commission, pursuant to section 19(b)(2) of the
Act,\8\ designates August 3, 2023 as the date by which the Commission
shall either approve or disapprove the proposed rule change (File No.
SR-FINRA-2022-031).
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).
    \7\ See Notice, supra note 3.
    \8\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-11924 Filed 6-5-23; 8:45 am]
BILLING CODE 8011-01-P


Janet Cakir/RTP/USEPA/US

03/11/2008 07:29 PM

To

"King, Heidi R."<EMAIL_ADDRESS>"Johansson, Robert"
<EMAIL_ADDRESS><EMAIL_ADDRESS>
cc

Al McGartland/DC/USEPA/US@EPA, Bryan Hubbell/RTP/USEPA/US@EPA, Douglas
Solomon/RTP/USEPA/US@EPA, Erika Sasser/RTP/USEPA/US@EPA, Janet
Cakir/RTP/USEPA/US@EPA, Ken Adler/DC/USEPA/US@EPA, Kevin
Culligan/DC/USEPA/US@EPA, Rob Brenner/DC/USEPA/US@EPA, Ron
Evans/RTP/USEPA/US@EPA, Rosalina Rodriguez/RTP/USEPA/US@EPA, Scott
Mathias/RTP/USEPA/US@EPA, Tyler Fox/RTP/USEPA/US@EPA, Lydia
Wegman/RTP/USEPA/US@EPA, Allen Basala/RTP/USEPA/US@EPA, Amy
Lamson/RTP/USEPA/US@EPA, Charles Fulcher/RTP/USEPA/US@EPA, Cynthia
Morgan/DC/USEPA/US@EPA, Darryl Weatherhead/RTP/USEPA/US@EPA, David
Misenheimer/RTP/USEPA/US@EPA, Elizabeth Kopits/DC/USEPA/US@EPA, Jim
Ketcham-Colwill/DC/USEPA/US@EPA, Ken Davidson/DC/USEPA/US@EPA, Larry
Sorrels/RTP/USEPA/US@EPA, Lillian Bradley/RTP/USEPA/US@EPA, Mark
Corrales/DC/USEPA/US@EPA, Nathalie Simon/DC/USEPA/US@EPA, Neal
Fann/RTP/USEPA/US@EPA, Norm Possiel/RTP/USEPA/US@EPA, Pat
Dolwick/RTP/USEPA/US@EPA, Rich Mason/RTP/USEPA/US@EPA, Serpil
Kayin/DC/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA, Joseph-J
Dougherty/DC/USEPA/US@EPA, Bruce Schillo/DC/USEPA/US@EPA

Subject

Ozone Final RIA Chapters for Distribution to OMB (Executive Summary -
ch. 3)

Heidi,

Thank you for the time you spent with us today working out our remaining
outstanding issues.  Attached to this and the following emails is a full
version of the ozone NAAQS RIA.   This version is complete and reflects
all agreed to edits and changes.  The chapters and appendices I am
transmitting tonight exclude the Cost Effectiveness Analysis and UVB
analysis that OPEI indicated they would be sending separately on our
call today.  Additionally, concurrent with your review, contractors will
be changing chapter numbers and references to reflect our agreement to
make Ch. 6 an appendix to Ch. 5.

Typically these chapters would make their way to you via OPEI, however
due to the unusual circumstances regarding our deadline, and the need
for after-hours delivery, there was no person available at OPEI to
transmit it, so I am cc'ing them for their records.

Please let me know if you have any trouble with the files.  Hopefully
they will get to you tonight.  I have assigned high priority to the
emails so that the system does not delay their delivery for off-peak net
usage hours.

Thanks,

Janet

High-level TABLE OF CONTENTS:

Executive Summary

Ch. 1	Introduction and Background

Ch. 2 	Characterizing Ozone and Modeling Tools Used in This Analysis

Appendix Ch. 2

Ch. 3	Modeled Control Strategy:  Design and Analytical Results

Appendix Ch. 3

Ch. 4	Approach for Estimating Reductions for Full Attainment Scenario

Ch. 5	Control Strategy Cost Estimates

Appendix Ch. 5

Ch. 6	Economic and Social Cost Estimates (now an appendix to Ch. 5)

Appendix Ch. 6

Ch. 7	Incremental Benefits of Attaining Alternative Ozone Standards
Relative to the Current 8-hour Standard

Appendix A Ch. 7

Appendix C Ch. 7

Ch. 8	Discussion of Ozone Secondary Standard

Ch. 9	Conclusions and Implications of the Benefit-Cost Analysis

Appendix A Ch. 9 – Alternate Baseline

Appendix B Ch. 9 – San Joaquin and South Coast California Costs and
Benefits in 2030

Ch. 10 	Statutory and Executive Order Impact Analysis

_______________________________________

Janet F. Cakir, Ph.D.

Environmental Protection Specialist

Air Benefits Cost Group

109 TW Alexander Dr., (C439-02)

Research Triangle Park, NC 27711

Tel:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

email<EMAIL_ADDRESS>


[Federal Register Volume 87, Number 10 (Friday, January 14, 2022)]
[Rules and Regulations]
[Pages 2322-2324]
[FR Doc No: 2022-00457]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0479; Airspace Docket No. 21-AGL-5]
RIN 2120-AA66

Amendment of VOR Federal Airways V-170, V-175 and V-250;
Establishment of Area Navigation (RNAV) Route T-400; in the vicinity of
Worthington, MN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends VHF Omnidirectional Range (VOR) Federal
airways V-170, V-175, and V-250; and establishes RNAV T-route T-400, in
the vicinity of Worthington, Minnesota. This action is necessary due to
the planned decommissioning of the VOR portion of the Worthington, MN,
VOR/Distance Measuring Equipment (VOR/DME), which provides navigational
guidance for these Air Traffic Service (ATS) routes. The Worthington
VOR is being decommissioned as part of the FAA's VOR Minimum
Operational Network (VOR MON) program.

DATES: Effective date 0901 UTC, March 24, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11F, 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 Rules and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone:<PHONE_NUMBER>. FAA Order JO 7400.11F is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of FAA Order JO 7400.11F at NARA,
email: [email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

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

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
the 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 modifies the route structure to preserve the safe and
efficient flow of air traffic within the National Airspace System
(NAS).

History

    The FAA published a noticed of proposed rulemaking (NPRM) for
Docket No. FAA-2021-0479, in the Federal Register (86 FR 35233; July 2,
2021) amending VOR Federal Airways V-170, V-175, and V-250; and
establishing RNAV T-route T-400, in the vicinity of Worthington,
Minnesota, due to the planned decommissioning of the VOR portion of the
Worthington, MN, VOR/DME. The FAA invited interested parties to
participate in this rulemaking effort by submitting written comments on
the proposal. There were no comments received. Subsequent to the NPRM
for Docket No. FAA-2021-0479, in the Federal Register, (86 FR 35233),
the FAA published a final rule for Docket No. FAA-2020-1071, in the
Federal Register, (86 FR 40145, July 27, 2021) amending V-175 by
removing the Macon, MO, VOR/DME from the airway segment extending
between the Hallsville, MO, VORTAC and the Kirksville, MO, VORTAC. This
action results in one airway segment stopping at Hallsville VORTAC and
another airway segment beginning at Kirksville VORTAC. That airway
amendment was

effective October 7, 2021 and is included in this rule.
    VOR Federal airways and RNAV T-routes are published in paragraphs
6010(a) and 6011, respectively, of FAA Order JO 7400.11F, dated August
20, 2021, and effective September 15, 2021, which are incorporated by
reference in 14 CFR 71.1. The ATS routes listed in this document will
be published subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This action to amends FAA Order JO 7400.11F, Airspace Designations
and Reporting Points, dated August 10, 2021 and effective September 15,
2021. FAA Order JO 7400.11F is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11F lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends 14 CFR part 71 by amending VOR Federal airways
V-170, V-175, and V-250, and establishing RNAV T-route T-400, in the
vicinity of Worthington, MN. This action is required due to the planned
decommissioning of the VOR portion of the Worthington, MN, VOR/DME.
    The ATS route amendment actions are described below.
    V-170: V-170 extends between the Devils Lake, ND, VOR/DME and the
Worthington, MN, VOR/DME; between the Rochester, MN, VOR/DME and the
Salem, MI, VORTAC; and between the Slate Run, PA, VORTAC and the
intersection of the Andrews, MD, VORTAC 060[deg] radial and the
Baltimore, MD, VORTAC 165[deg] radial. The airspace within R-5802 is
excluded when active. This action removes the airway segment between
the Sioux Falls, SD, VORTAC and the Worthington, MN, VOR/DME. As a
result, the first segment of the route extends between the Devils Lake,
ND, VOR/DME and the Sioux Falls, SD, VORTAC. The second and third
segments of the airway, as well as the exclusionary language, remain
unchanged.
    V-175: V-175 extends between the Malden, MO VORTAC and the
Hallsville, MO, VORTAC; between Kirksville, MO, VORTAC and the Des
Moines, IA, VORTAC; and between the Worthington, MN, VOR/DME and the
Alexandria, MN, VOR/DME. This action removes the Worthington, MN, VOR/
DME from the airway segment extending between the Worthington, MN, VOR/
DME and the Redwood Falls, MN, VOR/DME. As a result, V-175 extends
between the Malden, MO VORTAC and the Hallsville, MO VORTAC; between
the Kirksville, MO, VORTAC and the Des Moines, IA, VORTAC; and between
the Redwood Falls, MN, VOR/DME and the Alexandria, MN, VOR/DME.
    V-250: V-250 extends between the O'Neill, NE, VORTAC and the
Mankato, MN, VOR/DME. This action removes the airway segment from the
Yankton, SD, VOR/DME and the Mankato, MN, VOR/DME. The resulting airway
extends between the O'Neill, NE, VORTAC and the Yankton, SD, VOR/DME.
    T-400: T-400 is a new RNAV route that extends between the LLUKY,
NE, waypoint (WP), located near the O'Neill, NE, VORTAC and the ZOSAG,
MN, WP, which is a new WP created for this action, near the Flying
Cloud, MN, VOR/DME.
    All of the navigational aid radials in the airway descriptions
below are stated in True degrees.
    FAA Order JO 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.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that only affects air traffic procedures
and air navigation, it is certified that this rule, when promulgated,
does not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action amending VOR Federal
airways V-170, V-175, and V-250, and establishing RNAV T-route T-400,
in the vicinity of Worthington, MN, due to the planned decommissioning
of the VOR portion of the Worthington, MN, VOR/DME navigational aid,
qualifies for categorical exclusion under the National Environmental
Policy Act (42 U.S.C. 4321 et seq.) and its implementing regulations at
40 CFR part 1500, and in accordance with FAA Order 1050.1F,
Environmental Impacts: Policies and Procedures, paragraph 5-6.5a, which
categorically excludes from further environmental impact review
rulemaking actions that designate or modify classes of airspace areas,
airways, routes, and reporting points (see 14 CFR part 71, Designation
of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes;
and Reporting Points). As such, this action is not expected to result
in any potentially significant environmental impacts. In accordance
with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary
Circumstances, the FAA has reviewed this action for factors and
circumstances in which a normally categorically excluded action may
have a significant environmental impact requiring further analysis.
Accordingly, the FAA has determined that no extraordinary circumstances
exist that warrant preparation of an environmental assessment or
environmental impact study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

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

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal airways.

* * * * *

V-170 [Amended]

    From Devils Lake, ND; INT Devils Lake 187[deg] and Jamestown,
ND, 337[deg] radials; Jamestown; Aberdeen, SD; to Sioux Falls, SD.
From Rochester, MN; Nodine, MN; Dells, WI; INT Dells 097[deg] and
Badger, WI, 304[deg] radials; Badger; INT Badger 121[deg] and
Pullman, MI, 282[deg] radials; Pullman; to Salem, MI. From Slate
Run, PA; Selinsgrove, PA; Ravine, PA; INT Ravine 125[deg] and
Modena, PA, 318[deg] radials; Modena; Dupont, DE; INT Dupont
223[deg] and Andrews, MD, 060[deg] radials; to INT Andrews 060[deg]
and Baltimore, MD, 165[deg]

radials. The airspace within R-5802 is excluded when active.
* * * * *

V-175 [Amended]

    From Malden, MO; Vichy, MO; Hallsville, MO. From Kirksville, MO;
to Des Moines, IA. From Redwood Falls, MN; to Alexandria, MN.
* * * * *

V-250 [Amended]

    From O'Neill, NE; to Yankton, SD.
* * * * *

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-400 LLUKY, NE to ZOSAG, MN [New]

LLUKY, NE WP
    (Lat. 42[deg]29'20.26'' N, long. 098[deg]38'11.44'' W)
IMUPP, SD WP
    (Lat. 42[deg]55'06.44'' N, long. 097[deg]23'05.22'' W)
DURWN, MN WP
    (Lat. 43[deg]38'48.91'' N, long. 095[deg]34'55.87'' W)
MEMCO, MN WP
    (Lat. 44[deg]13'11.42'' N, long. 093[deg]54'45.23'' W)
ZOSAG, MN WP
    (Lat. 44[deg]49'30.74'' N, long. 093[deg]26'34.08'' W)

    Issued in Washington, DC, on January 6, 2022.
Michael R. Beckles,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2022-00457 Filed 1-13-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49678-49680]
[FR Doc No: 2016-17802]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0530]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Pre-Submission Program for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of

information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on requests for feedback
submitted under the Pre-Submission program for medical devices.

DATES: Submit either electronic or written comments on the collection
of information by September 26, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2012-D-0530 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Pre-Submission Program for
Medical Devices.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20851<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Pre-Submission Program for Medical Devices--OMB Control Number 0910-
0756--Extension

    The guidance entitled ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and Drug
Administration Staff'' describes the Pre-Submission program for medical
devices reviewed in the Center for Devices and Radiological Health
(CDRH) and the Center for Biologics Evaluation and Research (CBER). The
guidance provides recommendations regarding the information that should
be submitted in a Pre-Submission package and procedures that should be
followed for meetings between CDRH and CBER staff and industry
representatives or application sponsors. In addition to Pre-
Submissions, the guidance addresses other feedback mechanisms including
Informational Meetings, Study Risk Determinations, Formal Early
Collaboration Meetings, and Submission Issue Meetings and the
procedures to request feedback using these mechanisms.
    A Pre-Submission is defined as a formal written request from an
applicant for feedback from FDA to be provided in the form of a formal
written response

or, if the manufacturer chooses, a meeting or teleconference in which
the feedback is documented in meeting minutes. A Pre-Submission is
appropriate when FDA's feedback on specific questions is necessary to
guide product development and/or application preparation. The proposed
collections of information are necessary to allow the Agency to receive
Pre-Submission packages in order to implement this voluntary submission
program.
    For clarity, we are requesting that the title of the information
collection request, OMB control number 0910-0756, be changed to ``Pre-
Submission Program for Medical Devices.''
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
           FDA Center                Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
----------------------------------------------------------------------------------------------------------------
CDRH............................           2,465               1           2,465             137         337,705
CBER............................              79               1              79             137          10,823
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         348,528
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents are medical device manufacturers subject to FDA's laws
and regulations. FDA's annual estimate of 2,544 submissions is based on
experienced trends over the past several years. FDA's administrative
and technical staffs, who are familiar with the requirements for
current Pre-Submissions, estimate that an average of 137 hours is
required to prepare a Pre-Submission.

    Dated: July 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17802 Filed 7-27-16; 8:45 am]
 BILLING CODE 4164-01-P


"Johansson, Robert"<EMAIL_ADDRESS> 06/12/2007 11:12 AM

To

Lydia Wegman/RTP/USEPA/US@EPA

cc

Subject

USDA Comments

Hi Lydia,

Here are some USDA comments they have asked me to send.

Cheers,

Rob

________________________________________________

Robert Johansson, Ph.D.

OMB/OIRA/NREA

725 17th St. NW, Room 10202

Washington, DC 20503

(P)<PHONE_NUMBER>

(F)<PHONE_NUMBER>

(E<EMAIL_ADDRESS>