[Federal Register Volume 87, Number 8 (Wednesday, January 12, 2022)]
[Notices]
[Pages 1737-1738]
[FR Doc No: 2022-00413]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2445-028]

Notice of Application Tendered for Filing With the Commission and
Soliciting Additional Study Requests and Establishing Procedural
Schedule for Relicensing and a Deadline for Submission of Final
Amendments; Green Mountain Power Corporation

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Subsequent Minor License.
    b. Project No.: 2445-028.
    c. Date filed: December 23, 2021.
    d. Applicant: Green Mountain Power Corporation (GMP).
    e. Name of Project: Center Rutland Hydroelectric Project (project).
    f. Location: On Otter Creek in Rutland County, Vermont. The project
does not occupy any federal land.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. John Greenan, PE, Green Mountain Power
Corporation, 2152 Post Road, Rutland, VT 05701; Phone at (802) 770-
2195, or email at [email protected].
    i. FERC Contact: Taconya D. Goar at<PHONE_NUMBER>, or
[email protected].
    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See 94 FERC ]
61,076 (2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: February 21, 2022.
    The Commission strongly encourages electronic filing. Please file
additional study requests and requests for cooperating agency status
using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. For assistance, please contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
MD 20852. All filings must clearly identify the project name and docket
number on the first page: Center Rutland Hydroelectric Project (P-2445-
028).
    m. The application is not ready for environmental analysis at this
time.
    n. Project Description: The existing Center Rutland Project
consists of: (1) A 190-foot-long, 14-foot-high concrete and stone
masonry gravity dam that includes: (i) A 174-foot-long spillway section
with 2.3-foot-high wooden flashboards and a crest elevation of 507.1
feet mean seal level (msl) at the top of the flashboards; and (ii) a
16-foot-long non-overflow section; (2) an impoundment with a surface
area of 13 acres and a storage capacity of 30 acre-feet at an elevation
of 507.4 feet msl; (3) a forebay; (4) a concrete and marble masonry
intake structure; (5) a 6-foot-diameter, 75-foot-long steel penstock;
(6) a 40-foot-long, 33-foot-wide stone and marble masonry powerhouse
containing one 275-kilowatt horizontal-shaft turbine-generator unit;
(7) a substation; (8) an 80-foot-long, 12.47-kilovolt transmission
line; (9) a 0.35-mile-long fiber optic cable for smart grid
communications with the electric system; and (10) appurtenant
facilities. The project creates an approximately 100-foot-long bypassed
reach of Otter Creek.
    The project includes a small off-street parking area (with 3 to 5
car spaces), signage, landscaping, and a marked footpath to Otter
Creek.
    The current license requires the project to operate in a run-of-
river mode such that outflow from the project approximates inflow to
the impoundment to protect aquatic resources in Otter Creek. The
current

license also requires a minimum bypassed reach flow of 80 cubic feet
per second or inflow to the impoundment, whichever is less, from June 1
through October 15 to protect aquatic resources in Otter Creek and
aesthetic resources in the project area. The average annual generation
of the project was approximately 541.7 megawatt-hours from 2014 through
2020.
    The applicant proposes to: (1) Continue to operate the project in a
run-of-river mode to protect aquatic resources; (2) continue to release
a minimum bypassed reach flow of 80 cfs or inflow, whichever is less,
from June 1 through October 15, to protect aquatic resources; (3)
release a minimum bypassed reach flow of 40 cfs or inflow, whichever is
less, from October 16 through May 31, to protect aquatic resources; and
(4) implement a seasonal clearing restriction from April 15 through
October 31, for trees that are 4 inches in diameter or greater, to
protect the federally threatened northern long-eared bat. In addition,
GMP states that the flashboards have not been in place since prior to
2012, and proposes to reinstall them.
    o. In addition to publishing the full text of this notice in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this notice, as well
as other documents in the proceeding (e.g., license application) via
the internet through the Commission's Home Page (http://www.ferc.gov)
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document (P-
2445). For assistance, contact FERC at [email protected] or
call toll-free,<PHONE_NUMBER> or<PHONE_NUMBER> (TTY).
    You may also register online at https://ferconline.ferc.gov/FERCOnline.aspx to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    p. Procedural schedule: The application will be processed according
to the following preliminary schedule. Revisions to the schedule will
be made as appropriate.

Issue Deficiency Letter (if necessary)--February 2022
Request Additional Information--February 2022
Issue Scoping Document 1 for comments--May 2022
Request Additional Information (if necessary)--June 2022
Issue Acceptance Letter--June 2022
Issue Scoping Document 2--July 2022
Issue Notice of Ready for Environmental Analysis--July 2022

    q. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: January 6, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-00413 Filed 1-11-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Proposed Rules]
[Pages 62080-62081]
[FR Doc No: 2014-24618]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-1055; Airspace Docket No. 13-ANM-27]

Proposed Establishment of Class E Airspace; Rogue Valley, OR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace at the
Rogue Valley VHF Omni-Directional Radio Range Tactical Air Navigation
Aid (VORTAC), Rogue Valley, OR, to facilitate vectoring of Instrument
Flight Rules (IFR) aircraft under control of Seattle and Oakland Air
Route Traffic Control Centers (ARTCCs). The FAA is proposing this
action to enhance the safety and management of aircraft operations
within the National Airspace System.

DATES: Comments must be received on or before December 1, 2014.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2013-
1055; Airspace Docket No. 13-ANM-27, at the beginning of your comments.
You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Steve Haga, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA 2013-1055 and Airspace Docket No. 13-ANM-27) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2013-1055 and Airspace Docket No. 13-ANM-27''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will

be available for examination in the public docket both before and after
the closing date for comments. A report summarizing each substantive
public contact with FAA personnel concerned with this rulemaking will
be filed in the docket.

Availability of NPRM's

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by establishing Class E en route domestic
airspace extending upward from 1,200 feet above the surface at the
Rogue Valley VORTAC navigation aid, Rogue Valley, OR. This action would
contain aircraft while in IFR conditions under control of Seattle and
Oakland ARTCCs by vectoring aircraft from en route airspace to terminal
areas.
    Class E airspace designations are published in paragraph 6006, of
FAA Order 7400.9Y, dated August 6, 2014, and effective September 15,
2014, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (1) is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for 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 would establish controlled airspace at the Rogue Valley VORTAC,
Rogue Valley, OR.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR 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(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 the Federal
Aviation Administration Order 7400.9Y, Airspace Designations and
Reporting Points, dated August 6, 2014, and effective September 15,
2014 is amended as follows:

Paragraph 6006 En Route Domestic Airspace Areas.

* * * * *

ANM OR E6 Rogue Valley, OR [New]

Rogue Valley VORTAC, OR
    (Lat. 42[deg]28'47'' N., long. 122[deg]54'47'' W.)

    That airspace extending upward from 1,200 feet above the surface
within an area bounded by lat. 43[deg]27'19'' N., long.
119[deg]56'31'' W.; to lat. 42[deg]39'54'' N., long. 119[deg]42'02''
W.; to lat. 41[deg]00'07'' N., long. 120[deg]10'44'' W.; to lat.
40[deg]45'47'' N., long. 120[deg]14'45'' W.; to lat. 40[deg]27'51''
N., long. 119[deg]37'10'' W.; to lat. 39[deg]33'53'' N., long.
120[deg]19'02'' W.; to lat. 39[deg]05'16'' N., long. 124[deg]05'00''
W.; to lat. 39[deg]42'30'' N., long. 124[deg]25'58'' W.; to lat.
40[deg]01'00'' N., long. 124[deg]35'00'' W.; to lat. 40[deg]25'25''
N., long. 124[deg]40'06'' W.; to lat. 42[deg]50'00'' N., long.
124[deg]50'00'' W.; thence to the point of beginning.

    Issued in Seattle, Washington, on October 8, 2014.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2014-24618 Filed 10-15-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 5 (Tuesday, January 8, 2013)]
[Proposed Rules]
[Pages 1162-1166]
[FR Doc No: 2013-00085]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2012-N-1173]

Cardiovascular Devices; Reclassification of External Cardiac
Compressor

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify the external cardiac compressor, including cardiopulmonary
resuscitation (CPR) aids, from class III devices into class II (special
controls). FDA is proposing this reclassification on its own initiative
based on new information. FDA is taking this action under the Federal
Food, Drug, and Cosmetic Act (the FD&C Act), as amended.

DATES: Submit either electronic or written comments on this proposed
order by April 8, 2013. See section XII of this document for the
proposed effective date of a final order based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-1173, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following way:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-N-1173 for this order. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
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: Melissa Burns, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1646, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The FD&C Act, as amended by the Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of
1990 (Pub. L. 101-629), the Food and Drug Administration Modernization
Act of 1997 (FDAMA) (Pub. L. 105-115), the Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices
Technical Corrections Act of 2004 (Pub. L. 108-214), the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food
and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L.
112-144), established a comprehensive system for the regulation of
medical devices intended for human use. Section 513 of the FD&C Act (21
U.S.C. 360c) established three categories (classes) of devices,
reflecting the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three categories of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
    Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA process. Those devices remain in class III and
require premarket approval unless, and until, the device is
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).
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126
Stat. 1056) amended section 513(e) of the FD&C Act, changing the
process for reclassifying a device from rulemaking to an administrative
order.
    Section 513(e) of the FD&C Act governs reclassification of
preamendments devices. This section provides that FDA may, by
administrative order, reclassify a device (in a proceeding that
parallels the initial classification proceeding) based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
a preamendments device. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland Rantos v.
United States Department of Health, Education, and Welfare, 587 F.2d
1173, 1174 n.1 (DC Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir.
1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)

    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F.Supp. 382, 389-391 (D.D.C. 1991)) or in light of changes in ``medical
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951.) Whether data
before the Agency are past or new data, the ``new information'' to
support reclassification under section 513(e) must be ``valid
scientific evidence,'' as defined in section 513(a)(3) of the FD&C Act
and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770
F.2d 214 (DC Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (DC
Cir.), cert. denied, 474 U.S. 1062 (1985).)
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the valid scientific
evidence upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
premarket approval application (PMA). (See section 520(c) of the FD&C
Act (21 U.S.C. 360j(c)).) Section 520(h)(4) of the FD&C Act, added by
FDAMA, provides that FDA may use, for reclassification of a device,
certain information in a PMA 6 years after the application has been
approved. This includes information from clinical and preclinical tests
or studies that demonstrate the safety or effectiveness of the device,
but does not include descriptions of methods of manufacture or product
composition and other trade secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order reclassifying a device, the following must occur: (1) Publication
of a proposed order in the Federal Register; (2) a meeting of a device
classification panel described in section 513(b) of the FD&C Act; and
(3) consideration of comments from all affected stakeholders, including
patients, payors, and providers.
    FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the
FD&C Act provides that a class II device may be exempted from the
premarket notification requirements under section 510(k) of the FD&C
Act, if the Agency determines that premarket notification is not
necessary to assure the safety and effectiveness of the device.

II. Regulatory History of the Device

    On March 9, 1979 (44 FR 13424), FDA published a proposed rule for
classification of external cardiac compressors as class III requiring
premarket approval. The Cardiovascular Device Classification Panel and
the Anesthesiology Device Classification Panel recommended class III
because the device is life supporting and is potentially hazardous to
life or health even when properly used, and the Panel believed that
there was not sufficient information to develop a performance standard
to provide a reasonable assurance of safety and effectiveness. No
comments were received on the proposed rule and on February 5, 1980 (45
FR 7966), a final rule was published for external cardiac compressors,
classifying these devices as class III. In 1987, FDA published a final
rule amending the codified language for this device to clarify that no
effective date had been established for the requirement for premarket
approval for external cardiac compressor devices (52 FR 17732 at 17737;
May 11, 1987). In 2009, FDA published an order under sections 515(i)
and 519 of the FD&C Act (21 U.S.C. 360e and 360i) for the submission of
safety and effectivness information on external cardiac compressors (74
FR 16214; April 9, 2009). In response to that order, FDA received
information from four manufacturers of external cardiac compressor
devices.

III. Device Description

    External cardiac compressors (ECCs), also known as chest
compressors, assist in the act of CPR. The devices in this
classification are divided into two types: (1) Devices that provide
automatic chest compressions at a fixed compression rate and depth
(automated external cardiac compressors), which are placed directly on
the patient's chest and are powered manually, pneumatically, or
electrically and (2) devices that aid the emergency medical
professional in delivering manual compressions at a compression depth
and rate that are consistent with current guidelines (CPR Aids). These
devices are placed beneath the hands of the emergency medical
professional or in the vicinity of the cardiac arrest victim and
provide audio and/or visual feedback to assist emergency personnel in
following the recommended steps for CPR and maintaining the recommended
rate and depth of compressions for the duration of CPR.

IV. Proposed Reclassification

    FDA is proposing that the device subject to this proposed order be
reclassified from class III to class II. FDA believes CPR Aid devices
and automated external cardiac compressor devices when used as
indicated can supplement the effective delivery of CPR.
    FDA believes that the identified special controls, in addition to
general controls, would provide reasonable assurance of safety and
effectiveness. Therefore, in accordance with sections 513(e) and 515(i)
of the FD&C Act and 21 CFR 860.130, based on new information with
respect to the devices, FDA, on its own initiative, is proposing to
reclassify this preamendments class III device into class II. FDA
believes that this information is sufficient to demonstrate that the
proposed special controls can effectively mitigate the risks to health
identified in section V of this document, and that these special
controls in addition to the general controls will provide a reasonable
assurance of safety and effectiveness for ECCs.
    FDA has considered automated external cardiac compressor devices in
accordance with the reserved criteria and has determined that the
device should be subject to the premarket notification (510(k) of the
FD&C Act) requirements as provided for under section 510(m) of the FD&C
Act. However, the Agency does intend to exempt a CPR Aid device when it
is a prescription use device and when the feedback provided to the
rescuer is consistent with the current version of the American Heart
Association (AHA) guidelines for CPR (Ref. 1) from premarket
notification (section 510(k) of the FD&C Act) submission as provided
for under section 510(m) of the FD&C Act. The AHA guidelines recommend
that chest compressions be the highest priority and the initial action
when starting CPR in the adult victim of sudden cardiac arrest. Chest
compressions are an especially critical component of CPR because
perfusion during CPR depends on these compressions.

V. Risks to Health

    After considering available information, including the
recommendations of the advisory committees (panels) for the
classification of these devices, FDA has evaluated the risks to health
associated with the use of external cardiac compressor devices and
determined that the following risks to health are

associated with use of the automated external cardiac compressor
devices:
     Tissue damage or bone breakage, or inadequate blood flow.
Damage to the heart, other organs or tissues, can result from poor
mechanical design, improper surface area of the plunger, improper
vertical excursion of the plunger, improper force applied by the
plunger, or improper energy transmission by the device.
     Cardiac arrhythmias or electrical shock. Excessive
electrical leakage current can disturb the normal electrophysiology of
the heart, leading to the onset of cardiac arrhythmias.
     Adverse skin reactions. Lack of biocompatibility in
materials contacting skin may cause an adverse immunological or
allergic reaction in a patient.
    FDA has evaluated the risks to health associated with the use of
CPR Aid devices and determined that the following risks to health are
associated with use of CPR Aid devices:
     Suboptimal CPR delivery. Inaccurate rate or depth feedback
from the device or inadequate labeling may result in suboptimal
delivery of CPR.
     Adverse skin reactions. Lack of biocompatibility in
materials contacting skin may cause an adverse immunological or
allergic reaction in a patient.

VI. Summary of Reasons for Reclassification

    FDA believes that automated external cardiac compressor devices
indicated for adjunctive use with manual CPR (e.g., during transport--
to assure more consistent and continuous therapy; or prolonged CPR--to
avoid/replace rescuer fatigue) and CPR Aid devices should be
reclassified into class II because special controls, in addition to
general controls, can be established to provide reasonable assurance of
the safety and effectiveness of the device. In addition, there is now
adequate effectiveness information sufficient to establish special
controls to provide such assurance.

VII. Summary of Data Upon Which the Reclassification Is Based

    Since the time of the Panel recommendation, sufficient evidence has
been developed to support a reclassification of automated external
cardiac compressors indicated for adjunctive use with manual CPR and
CPR Aid devices into class II with special controls.
    Automated external cardiac compressors are tools used by emergency
medical personnel to automate chest compressions during CPR. These
devices are typically used in situations where extended CPR is
required, such as during patient transport or when there are an
inadequate number of trained personnel during extended CPR. The review
of the available literature on mechanical versus manual chest
compressions both by AHA (Ref. 1) and in a recent systematic literature
review (Ref. 2) provided mixed results on whether mechanical
compressions are as effective as manual chest compressions. However, it
is well established that chest compressions are crucial to maintaining
perfusion and that compressions of adequate rate and depth are
necessary to increase the probability of survival in victims of sudden
cardiac arrest (Ref. 1). As such, FDA believes that these devices, when
indicated for use as an adjunct to manual CPR during patient transport
or for use in situations where fatigue of or inaccessibility to
emergency medical personnel may otherwise prevent adequate chest
compressions, can be regulated as class II devices. These devices
should not be used as a replacement for manual CPR. FDA believes that
the special controls, including adequate labeling of the device for the
appropriate use population, use conditions, and use by appropriately
trained personnel, and performance testing of the device to ensure
adequate chest compression rate and depth, adequately mitigate the
risks.
    CPR Aid devices are used to remind emergency medical personnel of
appropriate CPR steps and technique and to provide feedback on the rate
and depth of compressions. AHA guidelines on CPR and emergency
cardiovascular care (Ref. 1) conclude that ``real-time CPR prompting
and feedback technology such as visual and auditory prompting devices
can improve the quality of CPR.'' In addition, these devices have been
reviewed by FDA for many years, and their risks are well-known. Between
January 2000 and June 2012, FDA has not received any adverse event
reports (medical device reports) associated with CPR Aid devices. FDA
believes that the identified special controls, in addition to the
general controls, provide reasonable assurance of safety and
effectiveness.

VIII. Proposed Special Controls

    FDA believes that the following special controls, in addition to
general controls, are sufficient to mitigate the risks to health
described in section V of this document for automated external cardiac
compressor devices:
     Performance testing under simulated physiological
conditions must demonstrate the reliability of the delivery of specific
compression depth and rate over the intended duration and environment
of use;
     Labeling must include the clinical training for the safe
use of this device and information on the patient population for which
the device has been demonstrated to be effective;
     For devices that incorporate electrical components,
appropriate analysis and testing must validate electrical safety and
electromagnetic compatibility;
     For devices containing software, software verification,
validation, and hazard analysis must be performed; and
     Any elements of the device that may contact the patient
must be demonstrated to be biocompatible;
    In addition, under 21 CFR 801.109, the sale, distribution, and use
of the automated external cardiac compressor device are restricted to
prescription use.
    FDA believes that the following special controls, in addition to
general controls, are sufficient to mitigate the risks to health
described in section V of this document for CPR Aid devices:
     Performance testing under simulated physiological or use
conditions must demonstrate the accuracy and reliability of the
feedback to the user on specific compression rate and/or depth over the
intended duration of use;
     Labeling must include the clinical training, if needed,
for the safe use of this device and information on the patient
population for which the device has been demonstrated to be effective;
     For devices that incorporate electrical components,
appropriate analysis and testing must validate electrical safety and
electromagnetic compatibility;
     For devices containing software, software verification,
validation, and hazard analysis must be performed;
     Any elements of the device that may contact the patient
must be demonstrated to be biocompatible; and
     For over-the counter-devices, human factors testing and
analysis must validate that the device design and labeling are
sufficient for lay use.

IX. Exemption From Premarket Notification Requirements

    FDA, on its own initiative, is also proposing to exempt CPR Aid
devices that provide feedback consistent with the current AHA
guidelines for CPR from premarket notification, subject to limitations.
The AHA guidelines are intended to support emergency medical personnel
with a series of sequential assessments and actions for resuscitation
of the victim. The intent of

the AHA guideline is to provide recommendations on the most effective
CPR practices, rather than specific instructions for using CPR Aid or
other devices on a victim of sudden cardiac arrest.
    FDA may consider a number of factors in determining whether
premarket notification is necessary to provide reasonable assurance of
the safety and effectiveness of a class II device. These factors are
discussed in the guidance the Agency issued on February 19, 1998,
entitled ``Procedures for Class II Device Exemptions From Premarket
Notification, Guidance for Industry and CDRH Staff '' (Ref. 3).
    FDA believes that a CPR Aid, when it is a prescription use device
that provides feedback compliant with the current AHA guidelines for
CPR, is appropriate for exemption from premarket notification, subject
to the limitations of exemptions identified in 21 CFR 870.9, because
the applicable special controls and general controls provide reasonable
assurance of safety and effectiveness if device manufacturers follow
the special controls requirements.
    FDA advises that exemption from the requirement of premarket
notification for prescription CPR Aids does not mean that these devices
would be exempt from any other statutory or regulatory requirements,
unless such exemption is explicitly provided by order or regulation.
Indeed, FDA's proposal to exempt these devices from the requirement of
premarket notification is based, in part, on the assurance of safety
and effectiveness that other regulatory controls, such as current good
manufacturing practice requirements (21 CFR part 820) and the
identified special controls, provide.

X. 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.

XI. Paperwork Reduction Act of 1995

    This proposed order refers to previously approved collections of
information found in 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 21 CFR part 812 are approved under OMB
control number 0910-0078; the collections of information in part 807,
subpart E, are approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 814, subpart B, are approved
under OMB control number 0910-0231; and the collections of information
under 21 CFR part 801 are approved under OMB control number 0910-0485.

XII. Proposed Effective Date

    FDA is proposing that any final order based on this proposal become
effective 30 days after date of publication of the final order in the
Federal Register.

XIII. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XIV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified all the Web site addresses in this reference section, but
we are not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.)

    1. Berg R. A., R. Hemphill, B. S. Abella, et al., ``2010
American Heart Association Guidelines for Cardiopulmonary
Resuscitation and Emergency Cardiovascular Care Circulation,'' vol.
122, issue 18, suppl. 3, 2010, available at http://
circ.ahajournals.org/content/122/18--suppl--3/S685.full.pdf+html.
    2. Brooks S. C., B. L. Bigham, and L. J. Morrison, ``Mechanical
Versus Manual Chest Compressions for Cardiac Arrest (Review),'' The
Cochrane Library, issue 1, 2011, available at http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007260.pub2/pdf.
    3. FDA guidance, ``Procedures for Class II Device Exemptions
From Premarket Notification, Guidance for Industry and CDRH Staff,''
1998, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 870 be amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as
follows:

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

0
2. Section 870.5200 is revised to read as follows:

Sec.  870.5200  External cardiac compressor.

    (a) Identification. An automated external cardiac compressor is an
external device that is electrically, pneumatically, or manually
powered and is used to compress the chest periodically in the region of
the heart to provide blood flow during cardiac arrest. Automated
external cardiac compressor devices are used as an adjunct to manual
cardiopulmonary resuscitation (CPR) during patient transport or
extended CPR. This also includes CPR Aid devices, which are external
devices intended to provide audio and/or visual feedback to the rescuer
regarding compression rate and/or depth, to aid in the consistent
application of manual CPR.
    (b) Classification. (1) Class II (special controls) for the
automated external cardiac compressor device. The special controls for
this device are:
    (i) Performance testing under simulated physiological conditions
must demonstrate the reliability of the delivery of specific
compression depth and rate over the intended duration of use;
    (ii) Labeling must include the clinical training for the safe use
of this device and information on the patient population for which the
device has been demonstrated to be effective;
    (iii) For devices that incorporate electrical components,
appropriate analysis and testing must validate electrical safety and
electromagnetic compatibility;
    (iv) For devices containing software, software verification,
validation, and hazard analysis must be performed; and
    (v) Any elements of the device that may contact the patient must be
demonstrated to be biocompatible.
    (2) Class II (special controls) for the CPR Aid device. The special
controls for this device are:
    (i) Performance testing under simulated physiological conditions
must demonstrate the accuracy and reliability of the feedback to the
user on specific compression rate and/or depth

over the intended duration and environment of use;
    (ii) Labeling must include the clinical training, if needed, for
the safe use of this device and information on the patient population
for which the device has been demonstrated to be effective;
    (iii) For devices that incorporate electrical components,
appropriate analysis and testing must validate electrical safety and
electromagnetic compatibility;
    (iv) For devices containing software, software verification,
validation, and hazard analysis must be performed;
    (v) Any elements of the device that may contact the patient device
must be demonstrated to be biocompatible; and
    (vi) For over-the-counter devices, human factors testing and
analysis must validate that the device design and labeling are
sufficient for lay use.
    (c) Premarket notification. The CPR aid device is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter if it is a prescription use device that provides feedback to
the rescuer consistent with the current American Heart Association
guidelines for CPR and in compliance with the special controls under
paragraph (b)(2) of this section, subject to the limitations of
exemptions in Sec.  870.9.

    Dated: January 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00085 Filed 1-7-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 64 (Tuesday, April 6, 2021)]
[Notices]
[Pages 17879-17880]
[FR Doc No: 2021-07079]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2021-0003]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 11 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) to operate a commercial motor vehicle (CMV) in interstate
commerce. They are unable to meet the vision requirement in one eye for
various reasons. The exemptions enable these individuals to operate
CMVs in interstate commerce without meeting the vision requirement in
one eye.

DATES: The exemptions were applicable on March 26, 2021. The exemptions
expire on March 26, 2023.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Dockets Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, FMCSA-2021-0003, in the keyword box, and click ``Search.''
Next, sort the results by ``Posted (Newer-Older),'' choose the first
notice listed, and click ``Browse Comments.'' If you do not have access
to the internet, you may view the docket online by visiting Dockets
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays.
To be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    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 www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    On February 23, 2021, FMCSA published a notice announcing receipt
of applications from 11 individuals requesting an exemption from vision
requirement in 49 CFR 391.41(b)(10) and requested comments from the
public (86 FR 11046). The public comment period ended on March 25,
2021, and two comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by complying with Sec.  391.41(b)(10).
    The physical qualification standard for drivers regarding vision
found in Sec.  391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.

III. Discussion of Comments

    FMCSA received two comments in this proceeding. Jason Gaddy and an
anonymous individual submitted comments in support of the Agency's
decision to grant the exemptions.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on medical reports about the applicants' vision, as well as their
driving records and experience driving with the vision deficiency. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the February 23, 2021 Federal
Register notice (86 FR 11046) and will not be repeated here.
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their
limitation and demonstrated their ability to drive safely. The 11
exemption applicants

listed in this notice are in this category. They are unable to meet the
vision requirement in one eye for various reasons, including amblyopia,
complete loss of vision, corneal scarring, prosthesis, and retinal
detachment. In most cases, their eye conditions did not develop
recently. Eight of the applicants were either born with their vision
impairments or have had them since childhood. The three individuals
that developed their vision conditions as adults have had them for a
range of 9 to 38 years. Although each applicant has one eye that does
not meet the vision requirement in Sec.  391.41(b)(10), each has at
least 20/40 corrected vision in the other eye, and, in a doctor's
opinion, has sufficient vision to perform all the tasks necessary to
operate a CMV.
    Doctors' opinions are supported by the applicants' possession of a
valid license to operate a CMV. By meeting State licensing
requirements, the applicants demonstrated their ability to operate a
CMV with their limited vision in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. We
believe that the applicants' intrastate driving experience and history
provide an adequate basis for predicting their ability to drive safely
in interstate commerce. Intrastate driving, like interstate operations,
involves substantial driving on highways on the interstate system and
on other roads built to interstate standards. Moreover, driving in
congested urban areas exposes the driver to more pedestrian and
vehicular traffic than exists on interstate highways. Faster reaction
to traffic and traffic signals is generally required because distances
between them are more compact. These conditions tax visual capacity and
driver response just as intensely as interstate driving conditions.
    The applicants in this notice have driven CMVs with their limited
vision in careers ranging from 3 to 50 years. In the past three years,
no drivers were involved in crashes, and no drivers were convicted of
moving violations in CMVs. All the applicants achieved a record of
safety while driving with their vision impairment that demonstrates the
likelihood that they have adapted their driving skills to accommodate
their condition. As the applicants' ample driving histories with their
vision deficiencies are good predictors of future performance, FMCSA
concludes their ability to drive safely can be projected into the
future.
    Consequently, FMCSA finds that in each case exempting these
applicants from the vision requirement in Sec.  391.41(b)(10) is likely
to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must be physically examined every year (a) by an
ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in Sec.  391.41(b)(10) and
(b) by a certified medical examiner (ME) who attests that the
individual is otherwise physically qualified under Sec.  391.41; (2)
each driver must provide a copy of the ophthalmologist's or
optometrist's report to the ME at the time of the annual medical
examination; and (3) each driver must provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file, or keep a copy in his/her driver's qualification
file if he/she is self-employed. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 11 exemption applications, FMCSA
exempts the following drivers from the vision requirement, Sec.
391.41(b)(10), subject to the requirements cited above:

Antonio R. Barros (NY)
Robert D. Boudreau (AZ)
Doris J. Goldsmith (KY)
Todd C. Kraese (IN)
Kathy A. Mason (TX)
Luke A. Perry (VT)
Percy C. Robinson (AL)
Harvinder S. Sahota (CA)
Michael J. Wells (NC)
Dennis C. Welpe (TX)
Kevin D. White (TX)

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption
will be valid for 2 years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136(e) and 31315(b).

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2021-07079 Filed 4-5-21; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Page 47772]
[FR Doc No: 2017-22175]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2017-0010]

Nevada State Plan; Change in Level of Federal Enforcement:
Private-Sector Employment on Military Bases

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

ACTION: Notice.

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SUMMARY: This document gives notice of OSHA's approval of a change to
the state of Nevada's Occupational Safety and Health State Plan
reinstating federal OSHA enforcement authority over private-sector
employment on military facilities and bases in Nevada. The Nevada State
Plan currently has coverage over some private-sector contractors on
military bases. Therefore, OSHA amends the Nevada State Plan's coverage
to reflect this change in the level of federal enforcement.

DATES: Applicable Date: October 13, 2017.

FOR FURTHER INFORMATION CONTACT: For press inquiries: Francis
Meilinger, Director, OSHA Office of Communications: Telephone: (202)
693-1999; email<EMAIL_ADDRESS>    For general and technical information: Douglas J. Kalinowski,
Director, OSHA Directorate of Cooperative and State Programs:
Telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Section 18 of the Occupational Safety and
Health Act of 1970, 29 U.S.C. 667 (OSH Act), provides that states that
assume responsibility for developing and enforcing their own
occupational safety and health standards may do so by submitting and
obtaining federal approval of a State Plan. State Plan approval occurs
in stages which include initial approval under section 18(c) of the OSH
Act and, ultimately, final approval under section 18(e).
    The Nevada State Plan was initially approved under Section 18(c) of
the OSH Act on January 4, 1974 (39 FR 1009). The Nevada State Plan is
administered by the Department of Business and Industry, Division of
Industrial Relations, Nevada Occupational Safety and Health
Administration (Nevada OSHA). On April 18, 2000, OSHA announced the
final approval of the Nevada State Plan pursuant to section 18(e) and
amended 29 CFR part 1952 to reflect the Assistant Secretary's decision
(65 FR 20742). As a result, federal OSHA relinquished its enforcement
authority with regard to occupational safety and health issues covered
by the Nevada State Plan.
    Federal OSHA retained its authority over safety and health in the
private sector over maritime employment; contract workers, and
contractor-operated facilities engaged in U.S. Postal Service mail
operations; contractors and subcontractors on land under exclusive
federal jurisdiction; employment on Indian Land; and any hazard,
industry, geographical area, operation, or facility over which the
state is unable to effectively exercise jurisdiction for reasons not
related to the required performance or structure of the plan.
    To establish military facilities, the Federal Government may
privately purchase or lease land, as any other entity would, and in
those cases a State Plan can cover private-sector occupational safety
and health on such land. In other cases, the Federal Government may ask
a State to cede the land to the Federal Government, in which case the
latter obtains jurisdiction over it; however, a State may retain some
jurisdiction. Thus, the determination whether the State Plan or federal
OSHA covers private-sector employers on military facilities can be
complicated. For example, military facilities in Nevada sometimes
encompass both land where jurisdiction has been ceded and land
privately owned by the Federal Government (though federal OSHA covers
all federal civilian employees on military facilities). This situation
has created confusion as to whether federal OSHA or the Nevada State
Plan covers private-sector employers on a military facility, and is a
resource-intensive inquiry. Thus, the Nevada State Plan requested on
December 14, 2016, that federal OSHA resume enforcement authority over
all private-sector employment on military facilities and bases. After
discussions between federal OSHA and Nevada OSHA, both agencies agreed
that federal coverage of all private-sector contractors on military
bases was the best solution to ensure prompt and effective protection
to workers on military bases in Nevada.
    Accordingly, notice is hereby given of the change in federal
enforcement authority over private-sector contractors on military bases
in Nevada, and coverage is transferred from the Nevada State Plan to
federal OSHA.

Authority and Signature

    Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational
Safety and Health, U.S. Department of Labor, authorized the preparation
of this notice. OSHA is issuing this notice under the authority
specified by Section 18 of the Occupational Safety and Health Act of
1970 (29 U.S.C. 667), Secretary of Labor's Order No. 1-2012 (77 FR
3912), and 29 CFR parts 1902, 1953 and 1955.

    Signed in Washington, DC, on October 3, 2017.
Loren Sweatt,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2017-22175 Filed 10-12-17; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 76, Number 70 (Tuesday, April 12, 2011)]
[Notices]
[Pages 20396-20399]
[FR Doc No: 2011-8732]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64216; File No. SR-NYSEArca-2011-16]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Modifying Credits
for Posting Liquidity for Certain Transactions and Imposing Routing
Fees To Defray the Costs of Routing Orders to Away Markets

April 6, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on April 1, 2011, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify credits for posting liquidity for
certain transactions and impose routing fees to defray the costs of
routing orders to away markets. The text of the proposed rule change is
available at the Exchange, at the Commission's Public Reference Room,
on the Commission's Web site at http://www.sec.gov, and http://www.nyse.com.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    NYSE Arca proposes to modify its credits for posting liquidity in
Penny Pilot issues.\3\ The Exchange also proposes to replace certain
premium credits in high volume issues and volume tier pricing
incentives for Customers and Market Makers in Penny Pilot issues with a
Customer Monthly Posting Threshold structure in Penny Pilot issues that
will provide increased credits in certain circumstances. In addition,
the Exchange is proposing a routing fee and is also eliminating certain
references to products that are no longer traded on the Exchange.
---------------------------------------------------------------------------

    \3\ 363 issues have been approved to trade in a minimum price
variation of $0.01 as part of a Pilot Program (``Penny Pilot'') in
accordance with NYSE Arca Rule 6.72.
---------------------------------------------------------------------------

Changes to Post Liquidity Credits
    Electronic transactions in Penny Pilot issues are assessed Take
Liquidity fees and credited with Post Liquidity credits. The Exchange
proposes to increase the Post Liquidity credit for Lead Market Makers
and Market Makers from $0.30 per contract to $0.32 per contract. The
Exchange proposes to reduce the Post Liquidity credit for Firm and
Broker Dealer Electronic orders from $0.25 per contract to $0.10 per
contract to reflect the fact that attempts to attract Firm and Broker
Dealer liquidity with higher posting credits have not proved fruitful
because based on our observations, such entities are proprietary
traders who seek opportunities and venues to trade against Customer
order flow to capture the spread rather than trade based on rebates and
fees.
    Lead Market Makers and Market Makers pay significantly higher OTP
fees than OTP Holders that are Firm proprietary traders, while Broker
Dealers that are not OTP Holders pay no OTP fee. The proposed
difference in Posting Credits between these categories is intended to
partially offset the difference in OTP costs. Additionally, Market
Makers and Lead Market Makers have an affirmative continuous quoting
obligation that does not apply to Firms and Broker Dealers. This
obligation imposes greater costs and potentially greater risks on
Market Makers and Lead Market Makers than the costs and risks realized
by Firms and Broker Dealers, and Market Makers and Lead Market Makers
should thus be rewarded with a greater posting credit. The proposed
differential is less than that found on NASDAQ OMX PHLX (``Phlx''), a
competing market, which provides an ``adding liquidity rebate'' of
$0.23 for market makers and $0.00 for Firms and Broker-Dealers, while
charging an ``adding liquidity fee'' of $0.00 for Market Makers, but
$0.05 for Firms and Broker Dealers. The differential on Phlx between
the two classifications of market participants is $0.28, while NYSE
Arca proposes a differential of $0.22.\4\
---------------------------------------------------------------------------

    \4\ See Phlx Price List, ``Make/Take Pricing Program'' at
(http://www.nasdaqtrader.com/Micro.aspx?id=PHLXPricing).
---------------------------------------------------------------------------

    The Exchange proposes to eliminate the ``Premium Tier'' of issues
which received an additional $0.05 per contract Post Liquidity credit
above the stated Post Liquidity rates. The Premium Tier distinction did
not have the intended effect of increasing market share in these
products, and the Exchange proposes a more streamlined fee schedule.
    In addition, the Exchange proposes to increase the Post Liquidity
credit above the base Customer Post Liquidity credit of $0.25 per
contract for OTP Holders that aggregate Customer orders that meet
certain volume thresholds in Penny Pilot issues. An OTP Holder sending
Customer orders that in the aggregate exceed 500,000 contracts executed
in a month from posting liquidity will receive a posting credit of
$0.32 per contract on all executions resulting from posted liquidity.
If such aggregated Customer orders exceed 800,000 contracts executed in
a month from posting liquidity, the OTP Holder will receive a posting
credit of $0.34 per contract on all executions resulting from posted
liquidity. If such aggregated Customer orders exceed 1,200,000
contracts executed in a month from posting liquidity, the OTP Holder
will receive a posting credit of $0.38 per contract on all executions
resulting from posted liquidity. The volume thresholds are intended to
incentivize firms that route some Customer orders to the Exchange to
increase the number of orders that are posted to achieve the next
threshold. Increasing the number of orders posted on the Exchange will
in turn provide tighter and more liquid markets, and therefore attract
more business overall.
    It is possible for an OTP Holder routing Customer orders to the
Exchange to reach a threshold that provides for a greater posting
credit than that of a Market Maker or Lead Market Maker. Market Makers
and Lead Market Makers incorporate Post Liquidity credits into their
models for quote calculations based on their overhead costs and prefer
to have a single credit apply across all similar transactions. OTP
Holders who aggregate Customer business are subject to the relative
level of activity of the industry, and thus may not have enough
business in a particular month to meet a volume threshold. To the
extent that Market Makers have an obligation to be present on the
Exchange, but Customer order flow may be directed anywhere, the
Exchange wishes to incentivize the directing of Customer order flow to
NYSE Arca. As indicated above, Firms and Broker Dealers are proprietary
traders that seek to trade with Customer order flow to capture the
spread rather than trade based on rebates and fees. We have found over
time that the higher Post Liquidity credit for such entities has not
caused them to post more liquidity on the Exchange. To incentivize such
entities to send order flow to the Exchange, we have determined to
increase the incentive to send Customer order flow to the Exchange,
which in turn is designed to attract more trading interest from such
entities to trade with that Customer order flow, and enhance trading
opportunities for all market participants.
    The Exchange proposes to eliminate the ``Tiered Pricing For Penny
Pilot Issues,'' which provided escalating Take Discounts for Customer
executions in certain volume ranges, and provided additional Post
Credits for Market Maker executions in certain volume ranges. The Take
Discounts for Customers did not encourage more business, because
Customers generally only take liquidity if there is no charge, or if
there is liquidity at the NBBO that does not have a fee. Because of
this, there is no structural incentive to increase the amount of
liquidity-taking order flow since the Take Discounts only eliminate a
portion of the fee. The Penny Pilot Tiered Pricing, which provided
increased posting credits for Market Makers with volume in certain
tiers, was problematic in that Market Makers, as stated above, could
not build the potential credit into their overhead models for quote
calculations. Market Makers preferred a definite credit for the first
contract rather than those over 1,000,000.
    The Exchange believes the adjustments to the Post Liquidity credits
will encourage Market Makers and Customers to post liquidity in Penny
Pilot issues on NYSE Arca, thereby providing reduced market spreads
overall and increasing available liquidity on the Exchange.
Routing Fees
    In order to defray costs associated with non-Penny Pilot
executions, the

Exchange is proposing a routing surcharge of $0.11 per contract for
orders that are routed and executed at away market centers pursuant to
order protection requirements of the Options Order Protection and
Locked/Crossed Market Plan. In addition, the Exchange proposes to pass
through any transaction fees charged by the destination exchange on
executions of routed orders. This is a new fee for NYSE Arca options
intended to offset the costs and fees of routing orders for execution
in non-Penny Pilot issues. NYSE Arca pays a fee to its routing brokers,
and in turn pays clearing fees to OCC to clear routed orders. At this
time the fee is to be charged only to non-Penny Pilot issues, as orders
in Penny Pilot issues which are routed are charged a take liquidity fee
that offsets the cost of routing.
    Firms may avoid routing charges by either routing orders themselves
directly to the away market that is at the NBBO, or by use of various
order types on NYSE Arca which carry an instruction to not route the
order.
Deletion of Obsolete Reference
    The Exchange is also proposing to delete references to Foreign
Currency Options in the Transaction Fee schedule and in endnote 6, as
Foreign Currency Options are no longer listed on the Exchange.
    The proposed changes will be effective on April 1, 2011.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Securities Exchange Act of 1934
(the ``Act''),\5\ in general, and Section 6(b)(4) of the Act,\6\ in
particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees, and other charges among its
members and other persons using its facilities. In addition, the
Exchange believes that the proposed rule change is consistent with
Section 6(b)(5) of the Exchange Act in that it is not designed to
permit unfair discrimination between customers, issuers, brokers, or
dealers.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The proposed changes to the fee schedule are equitable and
reasonable in that they apply uniformly to all similarly situated
market participants, are within the range of fees assessed by other
exchanges employing similar pricing schemes, and are designed to
increase liquidity at the Exchange. In particular, the proposed
increase in the Post Liquidity credit from $0.30 to $0.32 per contract
for Lead Market Makers and Market Makers is equitable and reasonable
because it is within the range of a rebate paid on the NASDAQ Options
Market (``NOM'').\7\ Moreover, the Exchange is seeking to provide an
additional incentive for Lead Market Makers and Market Makers to post
liquidity on the Exchange. In addition, the proposed decrease in the
Post Liquidity credit from $0.25 to $0.10 per contract for Firms and
Broker Dealers is reasonable because it is consistent with a rebate
paid on NOM and a similar decrease NOM imposed in July 2010.\8\
Further, as discussed above, the Exchange has observed that such
entities are proprietary traders that seek to trade against Customer
order flow to capture the spread rather than trade based on rebates and
fees.
---------------------------------------------------------------------------

    \7\ See (http://www.nasdaqtrader.com/Micro.aspx?id=OptionsPricing). NOM provides a rebate of $0.36 per
contract for customers adding liquidity.
    \8\ Id. NOM provides a rebate of $0.10 per contract for firms
adding liquidity. In addition, we note that in July 2010, NASDAQ
decreased its rebate for firms adding liquidity from $0.25 to $0.10
per contract. See Exchange Act Release No. 62543 (July 21, 2010), 75
FR 44037 (July 27, 2010).
---------------------------------------------------------------------------

    The proposed differential in the Post Liquidity credits between the
(1) Lead Market Maker/Market Maker, and (2) Firm/Broker Dealer
Electronic categories, is equitable and not unfairly discriminatory in
that it is intended to partially offset the significantly higher OTP
fees paid by Lead Market Makers and Market Makers. Further, this
differential is also equitable and not unfairly discriminatory in that
it provides additional compensation for the affirmative continuous
quoting obligation that Lead Market Makers and Market Makers have, but
which does not apply to Firms and Broker Dealers. In addition, as noted
above, the proposed differential will still be less than the equivalent
differential at the Phlx, a competing market.
    Similarly, the proposed increase in Post Liquidity credits for OTP
Holders that aggregate Customer orders that meet certain volume
thresholds in Penny Pilot issues is equitable and reasonable in that it
applies uniformly to all similarly situated OTP Holders that direct
Customer orders to the Exchange and is very similar to rebates paid on
NOM.\9\ The fact that an OTP Holder routing Customer orders to the
Exchange may reach a threshold that provides for a greater posting
credit than that of a Market Maker or Lead Market Maker is not
inequitable or unfairly discriminatory because (1) Market Makers and
Lead Market Makers prefer a fixed credit not dependent on volume for
purposes of their models for quote calculations based on their overhead
costs, and (2) the higher posting credits for the top two threshold
levels (which would exceed the posting credit applicable to Market
Makers and Lead Market Makers) is subject to the overall level of
market activity and may not be reached in any given month. Moreover,
the difference between (1) the Post Liquidity credits received by OTP
Holders that aggregate Customer orders, and (2) the Post Liquidity
credit received by Firms and Broker Dealers, is not inequitable or
unfairly discriminatory because the Exchange believes that it has
structured its fee schedule in a manner to attract order flow from all
such entities. In this regard, the Exchange has found that the higher
Post Liquidity credit for Firms and Broker Dealers has not caused them
to send additional order flow to the Exchange. Based on its
observations, the Exchange believes that such entities focus on the
ability to trade with Customer order flow to capture the spread rather
than on rebates and fees. Accordingly, the Exchange is proposing to
increase the Post Liquidity credits for Customer order flow to attract
such order flow to the Exchange. With the anticipated increase in such
order flow to the Exchange, the Exchange expects to attract additional
order flow from Firms and Broker Dealers to trade with such order flow.
---------------------------------------------------------------------------

    \9\ See supra note 7.
---------------------------------------------------------------------------

    The imposition of routing fees in non-Penny Pilot issues is
reasonable in that it is intended to defray the significant cost of
routing orders, and these charges may be avoided by direct routing of
an order to the away market that is at the NBBO or by the use of do-
not-route order types on NYSE Arca. The routing fees are equitable and
not unfairly discriminatory in that they are applied in an identical
manner to all market participants with similarly situated orders.
    Overall, the proposed changes to the fee schedule are structured to
increase incentives for posting liquidity in Penny Pilot names so that
the overall market is more competitive and spreads are tighter.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \10\ of the Act and subparagraph (f)(2) of Rule
19b-4 \11\ thereunder, because it establishes a due, fee, or other
charge imposed by the NYSE Arca.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2011-16 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2011-16. This
file number should be included on the subject line if e-mail 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 a.m. and 3 p.m. Copies of the filing 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-2011-16 and should be submitted on or before May 3, 2011.
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-8732 Filed 4-11-11; 8:45 am]
BILLING CODE 8011-01-P


SN-20-0006 Sanitized Support Documents Index:
 SN-20-0006 Sanitized Determination Document (linked)
 SN-20-0006 Sanitized CHEM Report (attached)
 SN-20-0006 Sanitized ECO Report (attached)
 SN-20-0006 Sanitized ENG Report (attached)
 SN-20-0006 Sanitized EXP Report (attached)
 SN-20-0006 Sanitized Fate Report (attached)
 SN-20-0006 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


                              Action Information

 Action Title:  Proposed Information Collection Request; Comment Request; Regional Haze Regulations (Renewal)

 Purpose: This notice solicits public comments on specific aspects of the proposed information collection which is the first step in the renewal process of an information collection request (ICR). This is a proposed extension of the ICR, which is currently approved through August 31, 2020. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. We are planning to submit an information collection request (ICR), "Regional Haze Regulations (Renewal)" (EPA ICR No. 2540.03, OMB Control No. 2060-0704) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.) after we have addressed any comments received during this comment period.

Background: Subpart P of 40 CFR 51, Protection of Visibility, also known as the regional haze rule, is the subject of this clearance request. 40 CFR 51.308(f) requires states to develop regional haze implementation plan revisions evaluating and reassessing reasonable progress goals, calculations of baseline and natural visibility conditions, the long-term strategy, the monitoring strategy and other implementation plan requirements. There are similar reporting requirements under 40 CFR 51.309, a section of the regional haze rule in which three states (Utah, Wyoming, and New Mexico) elected to submit their SIPs. Under section 309, these states adopted regional haze strategies for the period from 2003 to 2018 for sulfur dioxide emissions. These strategies are based on recommendations from the Grand Canyon Visibility Transport Commission (GCVTC) for protecting the 16 Class I areas in the Colorado Plateau area. 40 CFR 51.308(g) requires states to develop periodic reports evaluating progress towards the reasonable progress goals for improving visibility in Class I areas inside the state and in neighboring states, and 40 CFR 51.309(d)(10) requires similar actions on the part of the 3 states that submitted regional haze SIPs under 40 CFR 51.309. Each regional haze implementation plan revision will also include a section that serves as a progress report. In between each SIP revision, periodic reports are required every five years. The next periodic report is due in January 2025. Under the 1999 regional haze rule, states are required to set periodic goals for improving visibility in the 156 Mandatory Class I Federal Areas. States working to reach these goals must develop regional haze implementation plans that contain enforceable measures and strategies for reducing visibility-impairing pollution. Initial implementation plans were due in December 2007. Periodic comprehensive revisions to implementation plans are due July 31, 2021, July 31, 2028, and every 10 years thereafter. The primary focus for estimating burden for this 3-year period (2020  -  2023) will apply to the next program milestone which are the periodic comprehensive SIP revisions due in July 2021 (see 40 CFR 51.308(f)) for all states, including those covered under 40 CFR 51.309. The current ICR was approved in 2016 and expires on August 31, 2020.

Stakeholder Involvement: None

Key Issues/Internal Review: None

Legal Deadlines: None

Timing: This notice needs to publish as quickly as possible so that we may have time to prepare the second notice and take comment for an additional 30 days before the ICR expires on August 31, 2020.