[Federal Register Volume 78, Number 20 (Wednesday, January 30, 2013)]
[Notices]
[Page 6313]
[FR Doc No: 2013-01925]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP13-38-000]

Tennessee Gas Pipeline Company, L.L.C.; Notice of Application

    Take notice that on January 14, 2013, Tennessee Gas Pipeline
Company, L.L.C. (Tennessee), 1001 Louisiana Street, Houston, Texas
77002, filed an application in Docket No. CP13-38-000 pursuant to
section 7(b) of the Natural Gas Act (NGA) and Part 157 of the
Commission's regulations, requesting authorization to abandon in place
the northern portion of Line No. 523M-2300 (Triple T Line) consisting
of approximately 15.76 miles of 30-inch diameter pipeline extending
from Eugene Island Block 299 to the Ship Shoal Block 198 Central
Gathering Platform, located in Federal offshore waters of the Outer
Continental Shelf, Louisiana. Tennessee states that the facilities have
been out of service since January 27, 2011, all as more fully set forth
in the application which is on file with the Commission and open to
public inspection.
    Any questions concerning this application may be directed to Thomas
G. Joyce, Manager, Certificates, Tennessee Gas Pipeline Company, L.L.C.
1001 Louisiana Street, Houston, Texas 77002, by telephone at (713) 420-
3299, by facsimile at<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>Susan T. Halbach, Senior Counsel, Tennessee Gas
Pipeline Company, L.L.C. 1001 Louisiana Street, Houston, Texas 77002,
by telephone at<PHONE_NUMBER>, or by email at<EMAIL_ADDRESS>or Debbie Kalisek, Regulatory Analyst,
Tennessee Gas Pipeline Company, L.L.C. 1001 Louisiana Street, Houston,
Texas 77002, by telephone at<PHONE_NUMBER>, by facsimile at (713) 420-
1605, or by email at<EMAIL_ADDRESS>    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit an original and 7 copies of filings made with the Commission and
must mail a copy to the applicant and to every other party in the
proceeding. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 7 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE., Washington,
DC 20426. This filing is accessible on-line at http://www.ferc.gov,
using the ``eLibrary'' link and is available for review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: February 13, 2013.

    Dated: January 23, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-01925 Filed 1-29-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 12, 2009 (Volume 74, Number 7)]
[Notices]
[Page 1213-1214]
[DOCID:fr12ja09-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 12958-001; 12962-001]

Symbiotics, LLC; Notice of Intent To File License Application,
Filing of Pre-Application Document, Commencement of Licensing
Proceeding, and Scoping; Request for Comments on the Pad and Scoping
Document, and Identification of Issues and Associated Study Requests

January 5, 2009.
    a. Type of Filing: Notice of Intent to File License Application for
an Original License and Commencing Licensing Proceeding.
    b. Project Nos.: 12958-001 and 12962-001.
    c. Dated Filed: October 31, 2008.
    d. Submitted By: Symbiotics, LLC.
    e. Name of Project: Uniontown Hydroelectric Project and Newburgh
Hydroelectric Project.
    f. Location: Both projects would be located on the Ohio River at
existing U.S. Army Corps of Engineers locks and dams. The Uniontown
Project would be located at the John T. Myers Locks and Dam, in Union
County, Kentucky and Posey County, Indiana. The Newburgh Project would
be located at the Newburgh Locks and Dam, in Henderson County, Kentucky
and Warrick County, Indiana.
    g. Filed Pursuant to: 18 CFR Part 5 of the Commission's
Regulations.
    h. Potential Applicant Contact: Brent L. Smith, COO, P.O. Box 535,
Rigby, Idaho 83442.
    i. FERC Contact: Jennifer Adams at<PHONE_NUMBER> or e-mail at
<EMAIL_ADDRESS>    j. We are asking federal, state, local, and tribal agencies with
jurisdiction and/or special expertise with respect to environmental
issues to cooperate with us in the preparation of the environmental
document. Agencies who would like to request cooperating status should
follow the instructions for filing comments described in paragraph o
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. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, Part 402 and (b) the State Historic
Preservation Officer, as required by Section 106, National Historical
Preservation Act, and the implementing regulations of the Advisory
Council on Historic Preservation at 36 CFR 800.2.
    l. Symbiotics, LLC filed a Pre-Application Document (PAD; including
a proposed process plan and schedule) with the Commission, pursuant to
18 CFR 5.6 of the Commission's regulations.
    m. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, of for TTY,
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in paragraph h.
    Register online at http://ferc.gov/esubscribenow.htm to be notified
via e-mail of new filing and issuances related to this or other pending
projects. For assistance, contact FERC Online Support.
    n. With this notice, we are soliciting comments on the PAD and
Scoping Document 1 (SD1), as well as study requests. All comments on
the PAD and SD1, and study requests should be sent to the address above
in paragraph h. In addition, all comments on the PAD and SD1, study
requests, requests for cooperating agency status, and all
communications to and from Commission staff related to the merits of
the potential application (original and eight copies) must be filed
with the Commission at the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. All filings with the Commission must include on
the first page, the project name(s) (Uniontown Hydroelectric Project
and/or Newburgh Hydroelectric Project) and number(s) (No. 12958-001
and/or No. 12962-001), and bear the heading ``Comments on Pre-
Application Document,'' ``Study Requests,'' ``Comments on Scoping
Document 1,'' ``Request for Cooperating Agency Status,'' or
``Communications to and from Commission Staff.'' Any individual or
entity interested in submitting study requests, commenting on the PAD
or SD1, and any agency requesting cooperating status must do so by
March 2, 2009.
    Comments on the PAD and SD1, study requests, requests for
cooperating agency status, and other permissible forms of
communications with the Commission may be filed electronically via the
Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov) under the ``e-
filing'' link.
    p. Although our current intent is to prepare an environmental
assessment (EA), there is the possibility that an Environmental Impact
Statement (EIS) will be required. Nevertheless, this meeting will
satisfy the NEPA scoping requirements, irrespective of whether an EA or
EIS is issued by the Commission.

Scoping Meetings

    Commission staff will hold two scoping meetings in the vicinity of
the project at the time and place noted below. The daytime meeting will
focus on resource agency, Indian tribes, and non-governmental
organization concerns, while the evening meeting is primarily for
receiving input from the public. We invite all interested individuals,
organizations, and agencies to attend one or both of the meetings, and
to assist staff in identifying particular study needs, as well as the
scope of environmental issues to be addressed in the environmental
document. The times and locations of these meetings are as follows:

Daytime Scoping Meeting

    Date: Friday, January 30, 2009.
    Time: 9 a.m. to 11 a.m. (CST).
    Location: Browning Events Room. Evansville Vanderburgh Public
Library, 200 South East Martin Luther King Boulevard, Evansville,
Indiana 47713.

Evening Scoping Meeting

    Date: Thursday, January 29, 2009.
    Time: 7 p.m. to 9 p.m. (CST).
    Location: Browning Events Room, Evansville Vanderburgh Public
Library, 200 South East Martin Luther King Boulevard, Evansville,
Indiana 47713.
    Scoping Document 1 (SD1), which outlines the subject areas to be
addressed in the environmental document, was mailed to the individuals
and entities on the Commission's mailing list. Copies of SD1 will be
available at the scoping meetings, or may be viewed on the Web

at http://www.ferc.gov, using the ``eLibrary'' link. Follow the
directions for accessing information in paragraph n. Based on all oral
and written comments, a Scoping Document 2 (SD2) may be issued. SD2 may
include a revised process plan and schedule, as well as a list of
issues, identified through the scoping process.

Meeting Objectives

    At the scoping meetings, staff will: (1) Initiate scoping of the
issues; (2) review and discuss existing conditions and resource
management objectives; (3) review and discuss existing information and
identify preliminary information and study needs; (4) review and
discuss the process plan and schedule for pre-filing activity that
incorporates the time frames provided for in Part 5 of the Commission's
regulations and, to the extent possible, maximizes coordination of
federal, state, and tribal permitting and certification processes; and
(5) discuss the appropriateness of any federal or state agency or
Indian tribe acting as a cooperating agency for development of an
environmental document.
    Meeting participants should come prepared to discuss their issues
and/or concerns. Please review the PAD in preparation for the scoping
meetings. Directions on how to obtain a copy of the PAD and SD1 are
included in item m of this document.

Meeting Procedures

    The meetings will be recorded by a stenographer and will become
part of the formal record of the Commission proceeding on the project.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-255 Filed 1-9-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Proposed Rules]
[Pages 2647-2650]
[FR Doc No: 2013-00388]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. FDA-2012-N-0677]

Dental Devices; Reclassification of Blade-Form Endosseous Dental
Implant

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 blade- form endosseous dental implant, a preamendments
class III device, into class II (special controls). On its own
initiative, based on new information, FDA is proposing to revise the
classification of blade-form endosseous dental implants.

DATES: Submit either electronic or written comments on this proposed
order by April 15, 2013. See section XI 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-0677, 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 ways:
     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-0677 for this rulemaking. 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 Docket
No. FDA-2012-N-0677 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 Federal Food, Drug, and Cosmetic Act (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
(Public Law 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), establish 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 rulemaking 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 21 CFR part 807.
    A preamendments device that has been classified into class III may
be marketed by means of premarket notification procedures (510(k)
process) without submission of a premarket approval application (PMA)
until FDA issues a final order under section 515(b) of the FD&C Act (21
U.S.C. 360e(b)) requiring premarket approval or until the device is
subsequently reclassified into class I or class II.
    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 preamendments device from rulemaking to an
administrative order.

    Section 513(e) of the FD&C Act governs reclassification of
classified preamendments devices. This section provides that FDA may,
by administrative order, reclassify a device 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 (D.C. 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) of the FD&C Act must be
``valid scientific evidence,'' as defined in section 513(a)(3) and 21
CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214
(D.C. Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (D.C. 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
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: Publication of
a proposed order in the Federal Register, a meeting of a device
classification panel described in section 513(b) of the FD&C Act; and
consideration of comments to a public docket.
    FDAMA added a new 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 December 30, 1980 (45 FR 86025), FDA published a proposed rule
for classification of endosseous dental implants (without
distinguishing implants based on geometry) as class III requiring
premarket approval. The panel recommended class III because the device
is implanted in the body and presents a potential unreasonable risk of
illness or injury including risks of abnormal spontaneous pain due to
nerve impingement and a risk of perforation of the lingual and labial
bony plates of the upper and lower jaws. On August 12, 1987 (52 FR
30082), a final rule was published for endosseous dental implants
(again without distinguishing implants based on geometry) classifying
these devices as class III. On December 7, 1989 (54 FR 50592), FDA
published a proposed rule to require PMA submissions for all dental
implants. A reclassification petition was subsequently submitted
requesting reclassification of dental implants.
    FDA held a reclassification panel meeting on October 24, 1991, and
the panel voted to deny the reclassification petition. At the request
of FDA, additional panel meetings were held on November 4, 1997, and
January 13, 1998, during which FDA presented new information regarding
root-form endosseous dental implants. During the January 1998 panel
meeting, the panel stated that sufficient clinical information was
presented to the panel to justify reclassification of root-form
implants, implants with special retention features, and temporary
implants, as class II (special controls) requiring a 510(k) premarket
notification. However, the panel also stated that sufficient evidence
had not yet been presented to reclassify blade-form endosseous dental
implants to class II.
    On May 14, 2002 (67 FR 34416), and May 12, 2004 (69 FR 26302),
proposed and final rules respectively were issued reclassifying only
root-form implants into class II. Blade-form endosseous dental implant
remained class III.
    In 2009, FDA published an order under sections 515(i) and 519 of
the FD&C Act (21 U.S.C. 360i) for the submission of information on
blade-form endosseous dental implants (74 FR 16214, April 9, 2009). In
response to that order, FDA received information from one device
manufacturer; however, the information was related to other types of
dental implants and was not relevant for this proposed rule.

III. Device Description

    The blade-form endosseous dental implant is a device placed into
the maxilla or mandible and composed of biocompatible material, such as
titanium alloy or commercially pure (c.p.) titanium, with sufficient
strength to support a dental restoration, such as a crown, bridge, or
denture, intended for the purpose of replacing tooth (or teeth) roots
and extending a support post through the gingival tissue into the oral
cavity to restore chewing function. The blade-form implants are either
one-piece or two-piece implants designed with one to three cylindrical
abutment posts extending from the coronal aspect of the blade through
the soft tissue and into the oral cavity. For the two-piece design, the
separate abutment post is retained to the blade implant with a screw.
    The blade-form implant is generally a rectangular shape or rounded
corner rectangle shape (in the mesio-distal plane) with a narrow
tapered (narrow at the apical edge) edge (in the bucco-lingual plane)
similar in shape to a razor blade. Other blade designs, such as square,
V-shaped, and triangles have also been used. The blade generally
contains open vents of various shapes and various sizes.

IV. Proposed Reclassification

    FDA is proposing that the device subject to this proposal be
reclassified from class III to class II. In this proposed order, the
Agency has identified special controls under section 513(a)(1)(B) of
the FD&C Act that, together with general controls applicable to the
devices, would provide reasonable assurance of their safety and
effectiveness. FDA believes that the identified special controls in
this proposed order, if finalized, together with general controls
applicable to the device, would provide reasonable assurance of safety
and

effectiveness. Absent the special controls identified in this proposed
order, general controls applicable to the device are insufficient to
provide reasonable assurance of the safety and effectiveness of the
device.
    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 and taking into account the public health benefit of the
use of the device and the nature and known incidence of the risk of the
device, FDA, on its own initiative, is proposing to reclassify this
preamendments class III device into class II. FDA believes that this
new information is sufficient to demonstrate that the proposed special
controls can effectively mitigate the risks to health identified in the
next section, and that these special controls, together with general
controls, will provide a reasonable assurance of safety and
effectiveness for blade-form endosseous dental implant devices.
    FDA has also considered blade-form endosseous dental implant
devices in accordance with the reserved criteria set forth in section
513(a) of the FD&C Act and decided that the device does require
premarket notification. The Agency does not intend to exempt this
proposed class II device from premarket notification (510(k))
submission as allowed under section 510(m) of the FD&C Act.

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 blade-form endosseous dental implant devices
and determined that the following risks to health are associated with
its use:
     Local tissue or existing dentition degeneration: Localized
tissue and existing dentition degeneration may be caused by endosseous
implants due to excessive mobility, loss of integration,
incompatibility of device components, or structural failure of the
device.
     Pain: Nerve impingement by the device may cause pain.
     Bone or nerve damage: Improper design or use of the device
may cause injury during surgery related to sinus perforation, alveolar
plate perforation, or nerve damage resulting in transient or chronic
pain/facial nerve paresis.
     Infection: Implantable devices may introduce
microorganisms that may cause local or systemic infections.
     Adverse tissue reaction: Inadequate tissue compatibility
of the materials used in this device could cause an immune reaction.
     Migration or thermal injury: Incompatibility with magnetic
resonance imaging may cause the device to migrate or heat.

VI. Summary of Reasons for Reclassification

    If properly manufactured and used, blade-form endosseous dental
implants can help restore the patient's chewing function by replacing
tooth roots and extending a support post through the gingival tissue
into the oral cavity in order to support a dental restoration, such as
a crown, bridge, or denture. FDA believes that blade-form endosseous
dental implant devices should be reclassified into class II because
special controls, together with general controls, can be established to
provide reasonable assurance of the safety and effectiveness of the
device, and because general controls themselves are insufficient to
provide reasonable assurance of its safety and effectiveness. 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 blade-form endosseous
dental implants to class II with special controls. FDA has been
reviewing these devices for many years and their risks are well known.
A review of the applicable clinical literature indicates that the
device has a high success rate (remaining implanted/not removed) and
that few relevant adverse events have been reported in the case of
these devices or related devices suggesting that the device has a high
long-term safety profile. FDA believes that the special controls
identified in this proposed order, if finalized, together with general
controls, can provide a reasonable assurance of the safety and
effectiveness of blade-form endosseous dental implants.

VIII. Proposed Special Controls

    FDA believes that the following special controls, together with
general controls, are sufficient to mitigate the risks to health
described in section V of this document:
     The design characteristics of the device must ensure that
the geometry and material composition are consistent with the intended
use;
     Mechanical performance (fatigue) testing under simulated
physiological conditions to demonstrate maximum load (endurance limit)
when the device is subjected to compressive and shear loads;
     Corrosion testing under simulated physiological conditions
to demonstrate corrosion potential of each metal or alloy, couple
potential for an assembled dissimilar metal implant system, and
corrosion rate for an assembled dissimilar metal implant system;
     The device must be demonstrated to be biocompatible;
     Sterility testing must demonstrate the sterility of the
device;
     Performance testing to evaluate the compatibility of the
device in a magnetic resonance (MR) environment;
     Labeling must include a clear description of the
technological features, how the device should be used in patients,
detailed surgical protocol and restoration procedures, and relevant
precautions and warnings based on the clinical use of the device;
     Patient labeling must contain a description of how the
devices works, how the device is placed, how the patient needs to care
for the implant, possible adverse events and how to report any
complications; and
     Documented clinical experience must demonstrate safe and
effective use and capture any adverse events observed during clinical
use.
    Blade-form endosseous dental implants are prescription devices
restricted to patient use only upon the authorization of a practitioner
licensed by law to administer or use the device. (Proposed 21 CFR
872.3640(a); see section 520(e) of the FD&C Act and 21 CFR 801.109
(Prescription devices)). Prescription-use restrictions are a type of
general controls authorized under section 520(e) of the FD&C Act and
defined as a general control in section 513(a)(1)(A)(i) of the FD&C
Act; and under 21 CFR 807.81, the device would continue to be subject
to 510(k) notification requirements.

IX. 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.

X. Paperwork Reduction Act of 1995

    This proposed rule 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 have been approved under
OMB control number 0910-0078; the collections of information in part
807, subpart E, have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 814, subpart B, have been
approved under OMB control number 0910-0231; and the collections of
information under 21 CFR part 801 have been approved under OMB control
number 0910-0485.

XI. Proposed Effective Date

    FDA is proposing that any final order based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final order.

XII. 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.

List of Subjects in 21 CFR Part 872

    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 872 be amended as follows:

PART 872--DENTAL DEVICES

0
1. The authority citation for 21 CFR part 872 continues to read as
follows:

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

0
2. Section 872.3640 is amended by revising paragraphs (a) and (b)(2) to
read as follows:

Sec.  872.3640  Endosseous dental implant.

    (a) Identification. An endosseous dental implant is a prescription
device made of a material such as titanium or titanium alloy that is
intended to be surgically placed in the bone of the upper or lower jaw
arches to provide support for prosthetic devices, such as artificial
teeth, in order to restore a patient's chewing function.
    (b) * * *
    (2) Class II (special controls). The device is classified as class
II if it is a blade-form endosseous dental implant. The special
controls for this device are:
    (i) The design characteristics of the device must ensure that the
geometry and material composition are consistent with the intended use;
    (ii) Mechanical performance (fatigue) testing under simulated
physiological conditions to demonstrate maximum load (endurance limit)
when the device is subjected to compressive and shear loads;
    (iii) Corrosion testing under simulated physiological conditions to
demonstrate corrosion potential of each metal or alloy, couple
potential for an assembled dissimilar metal implant system, and
corrosion rate for an assembled dissimilar metal implant system;
    (iv) The device must be demonstrated to be biocompatible;
    (v) Sterility testing must demonstrate the sterility of the device;
    (vi) Performance testing to evaluate the compatibility of the
device in a magnetic resonance (MR) environment;
    (vii) Labeling must include a clear description of the
technological features, how the device should be used in patients,
detailed surgical protocol and restoration procedures, and relevant
precautions and warnings based on the clinical use of the device;
    (viii) Patient labeling must contain a description of how the
devices works, how the device is placed, how the patient needs to care
for the implant, possible adverse events and how to report any
complications; and
    (ix) Documented clinical experience must demonstrate safe and
effective use and capture any adverse events observed during clinical
use.

    Dated: January 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00388 Filed 1-11-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37269-37270]
[FR Doc No: 2019-16276]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-475-000]

Gulfstream Natural Gas System, L.L.C.; Notice of Intent To
Prepare an Environmental Assessment for the Proposed Phase VI Expansion
Project; Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the proposed Phase VI Expansion
Project involving construction and operation of facilities by
Gulfstream Natural Gas System (Gulfstream) in Mobile County, Alabama
and Manatee County, Florida. The Commission will use this EA in its
decision-making process to determine whether the project is in the
public convenience and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies about issues regarding the project. The National Environmental
Policy Act (NEPA) requires the Commission to take into account the
environmental impacts that could result from its action whenever it
considers the issuance of a Certificate of Public Convenience and
Necessity. NEPA also requires the Commission to discover concerns the
public may have about proposals. This process is referred to as
``scoping.'' The main goal of the scoping process is to focus the
analysis in the EA on the important environmental issues. By this
notice, the Commission requests public comments on the scope of issues
to address in the EA. To ensure that your comments are timely and
properly recorded, please submit your comments so that the Commission
receives them in Washington, DC on or before 5:00 p.m. Eastern Time on
August 26, 2019.
    You can make a difference by submitting your specific comments or
concerns about the project. Your comments should focus on the potential
environmental effects, reasonable alternatives, and measures to avoid
or lessen environmental impacts. Your input will help the Commission
staff determine what issues they need to evaluate in the EA. Commission
staff will consider all filed comments during the preparation of the
EA. If you sent comments on this project to the Commission before the
opening of this docket on June 3, 2019 you will need to file those
comments in Docket No. CP19-475-000 to ensure they are considered as
part of this proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable easement agreement. You
are not required to enter into an agreement. However, if the Commission
approves the project, that approval conveys with it the right of
eminent domain. Therefore, if you and the company do not reach an
easement agreement, the pipeline company could initiate condemnation
proceedings in court. In such instances, compensation would be
determined by a judge in accordance with state law.
    Gulfstream provided landowners with a fact sheet prepared by the
FERC entitled ``An Interstate Natural Gas Facility On My Land? What Do
I Need To Know?'' This fact sheet addresses a number of typically asked
questions, including the use of eminent domain and how to participate
in the Commission's proceedings. It is also available for viewing on
the FERC website (www.ferc.gov) at https://www.ferc.gov/resources/guides/gas/gas.pdf.

Public Participation

    The Commission offers a free service called eSubscription which
makes it easy to stay informed of all issuances and submittals
regarding the dockets/projects to which you subscribe. These instant
email notifications are the fastest way to receive notification and
provide a link to the document files which can reduce the amount of
time you spend researching proceedings. To sign up go to www.ferc.gov/docs-filing/esubscription.asp.
    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature, which is located on the Commission's website (www.ferc.gov)
under the link to Documents and Filings. Using eComment is an easy
method for submitting brief, text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature, which is located on the Commission's website (www.ferc.gov)
under the link to Documents and Filings. With eFiling, you can provide
comments in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You will be asked to select the type of filing you
are making; a comment on a particular project is considered a ``Comment
on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket number
(CP19-475-000) with your submission: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE, Room 1A,
Washington, DC 20426.

Summary of the Proposed Project

    Gulfstream proposes to construct and operate a compressor unit and
metering equipment in Mobile County, Alabama and metering equipment and
related auxiliary facilities and appurtenances in Manatee County,
Florida. The Phase VI Expansion Project would provide about 78,000
Dekatherms per day (Dth/d) of natural gas. According to Gulfstream its
project would supply firm transportation of natural gas to its mainline
system in order to supply the Big Bend Power Station in Hillsborough
County, Florida.
    Facilities for The Phase VI Expansion Project would include:
     A new 16,000 horsepower (HP) compressor unit at
Gulfstream's existing Compressor Station 410 located in Mobile County;
     abandonment in place of approximately 4 miles of existing
36-inch-dameter pipeline in Mobile County; \1\
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE, Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the last page of this notice.

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

     approximately 4 miles of new 36-inch-diameter pipeline
with increased wall thickness in Mobile County;
     new metering equipment at Gulfstream's existing Compressor
Station 420 located in Manatee County; and
     related auxiliary facilities and appurtenances in Manatee
County.
    Gulfstream also plans to request a special permit from The U.S.
Department of Transportation's Pipeline and Hazardous Material Safety
Administration to increase their maximum allowable operating pressure
(MAOP) for approximately 59 miles of its 36-inch-dameter offshore
pipeline. The increase in MAOP would require no construction offshore.
    The general location of the project facilities is shown in appendix
1.\1\

Land Requirements for Construction

    Construction of the proposed facilities would disturb about 50
acres of land. Following construction, Gulfstream would maintain about
1.5 acres for permanent operation of the project's facilities; the
remaining acreage would be restored and revert to former uses. One
hundred percent of the proposed pipeline route parallels existing
pipeline, utility, or road rights-of-way.

The EA Process

    The EA will discuss impacts that could occur as a result of the
construction and operation of the proposed project under these general
headings:
     Geology and soils;
     water resources and wetlands;
     vegetation and wildlife;
     threatened and endangered species;
     cultural resources;
     land use;
     air quality and noise;
     public safety; and
     cumulative impacts
    Commission staff will also evaluate reasonable alternatives to the
proposed project or portions of the project, and make recommendations
on how to lessen or avoid impacts on the various resource areas.
    The EA will present Commission staffs' independent analysis of the
issues. The EA will be available in electronic format in the public
record through eLibrary \2\ and the Commission's website (https://www.ferc.gov/industries/gas/enviro/eis.asp). If eSubscribed, you will
receive instant email notification when the EA is issued. The EA may be
issued for an allotted public comment period. Commission staff will
consider all comments on the EA before making recommendations to the
Commission. To ensure Commission staff have the opportunity to address
your comments, please carefully follow the instructions in the Public
Participation section, beginning on page 2.
---------------------------------------------------------------------------

    \2\ For instructions on connecting to eLibrary, refer to the
last page of this notice.
---------------------------------------------------------------------------

    With this notice, the Commission is asking agencies with
jurisdiction by law and/or special expertise with respect to the
environmental issues of this project to formally cooperate in the
preparation of the EA.\3\ Agencies that would like to request
cooperating agency status should follow the instructions for filing
comments provided under the Public Participation section of this
notice.
---------------------------------------------------------------------------

    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
---------------------------------------------------------------------------

Consultation Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, the Commission is using this notice to initiate
consultation with the applicable State Historic Preservation Offices,
and to solicit their views and those of other government agencies,
interested Indian tribes, and the public on the project's potential
effects on historic properties.\4\ The EA for this project will
document findings on the impacts on historic properties and summarize
the status of consultations under section 106.
---------------------------------------------------------------------------

    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
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Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers.
    This list also includes all affected landowners (as defined in the
Commission's regulations) who are potential right-of-way grantors,
whose property may be used temporarily for project purposes, or who own
homes within certain distances of aboveground facilities, and anyone
who submits comments on the project. Commission staff will update the
environmental mailing list as the analysis proceeds to ensure that
Commission notices related to this environmental review are sent to all
individuals, organizations, and government entities interested in and/
or potentially affected by the proposed project.
    If the Commission issues the EA for an allotted public comment
period, a Notice of Availability of the EA will be sent to the
environmental mailing list and will provide instructions to access the
electronic document on the FERC's website (www.ferc.gov). If you need
to make changes to your name/address, or if you would like to remove
your name from the mailing list, please return the attached ``Mailing
List Update Form'' (appendix 2).

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website at www.ferc.gov using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number
in the ``Docket Number'' field, excluding the last three digits (i.e.,
CP19-475). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or<PHONE_NUMBER>, or for TTY, contact (202)
502-8659. The eLibrary link also provides access to the texts of all
formal documents issued by the Commission, such as orders, notices, and
rulemakings.
    Public sessions or site visits will be posted on the Commission's
calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along
with other related information.

     Dated: July 25, 2019.
 Kimberly D. Bose,
Secretary.
[FR Doc. 2019-16276 Filed 7-30-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 104 (Thursday, June 1, 2017)]
[Notices]
[Pages 25433-25435]
[FR Doc No: 2017-11253]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80771; File No. SR-MRX-2017-05]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend
Supplementary Material .03 to Rule 713

May 25, 2017.
    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 May 19, 2017, Nasdaq MRX, LLC (``MRX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``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 amend Supplementary Material .03 to Rule
713 to change the allocation entitlement for Preferred PMMs.
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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 Exchange 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 these 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 aspects of such
statements.

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

1. Purpose
    Supplementary Material .03 to Rule 713 allows an Electronic Access
Member (``EAM'') to designate a ``Preferred Market Maker'' on orders it
enters into the System (``Preferenced Orders''). A Preferred Market
Maker may be the Primary Market Maker (``PMM'') appointed to the
options class or any Competitive Market Maker (``CMM'') appointed to
the options class.\3\ The purpose of the proposed rule change is to
amend Supplementary Material .03 to Rule 713 to change the allocation
entitlement for PMMs that receive Preferenced Orders (i.e., ``Preferred
PMMs''), consistent with allocation entitlements for PMM equivalents on
other options exchanges.
---------------------------------------------------------------------------

    \3\ See Supplementary Material .03(a) to Rule 713.
---------------------------------------------------------------------------

    Currently, a Preferred Market Maker that is quoting at the national
best bid of offer (``NBBO'') at the time the Preferenced Order is
received,\4\ is entitled to participation rights equal to the greater
of: (i) The proportion of the total size at the best price represented
by the size of its quote, or (ii) sixty percent (60%) of the contracts
to be allocated if there is only one (1) other Professional Order or
market maker quotation at the best price and forty percent (40%) if
there are two (2) or more other Professional Orders and/or market maker
quotes at the best price.\5\ This allocation entitlement is in lieu of
the regular allocation provided in Supplementary Material .01 to Rule
713, and applies regardless of whether the Preferred Market Maker is a
PMM or CMM. In some instances where the Preferred Market Maker is the
PMM appointed to the options class this results in a preferenced
allocation that is worse than the market maker's regular allocation
entitlement. Specifically, Supplementary Material .01(c) to Rule 713
provides a small order entitlement whereby orders of five contracts or
fewer are executed first by the PMM. A PMM that normally receives an
allocation entitlement for orders of five contracts or fewer,\6\ would
not receive this allocation entitlement if it were designated as the
Preferred Market Maker.
---------------------------------------------------------------------------

    \4\ If the Preferred Market Maker is not quoting at a price
equal to the NBBO at the time the Preferenced Order is received, the
Exchange's regular allocation procedure applies to the execution of
the Preferenced Order. See Supplementary Material .03(b) to Rule
713.
    \5\ See Supplementary Material .03(c) to Rule 713.
    \6\ See Supplementary Material .01(c) to Rule 713.
---------------------------------------------------------------------------

    The Exchange now proposes to amend the participation rights of
Preferred PMMs such that the PMM appointed in an option class will
receive participation rights that are consistent with the higher
allocation entitlement given to PMM equivalents on the MIAX Options
Exchange (``MIAX''), and with the allocation entitlement recently
adopted on the Exchange's affiliates, Nasdaq ISE, LLC (``ISE'') and
Nasdaq GEMX, LLC (``GEMX''). In particular, the Exchange proposes to
amend Supplementary Material .03(c) to Rule 713 to provide that, the
Preferred Market Maker has participation rights equal to the greater
of: (i) The proportion of the total size at the best price represented
by the size of its quote, (ii) sixty percent (60%) of the contracts to
be allocated if there is only one (1) other Professional Order or
market maker quotation at the best price and forty percent (40%) if
there are two (2) or more other Professional Orders and/or market maker
quotes at the best price, or (iii) the full size of a Preferenced Order
for five (5) contracts or fewer if the Primary Market Maker appointed
to the options class is designated as the Preferred Market Maker--i.e.,
the small order allocation entitlement contained in Supplementary
Material .01(c) to Rule 713. Thus, the PMM appointed to an options
class would receive an allocation entitlement for orders of five
contracts or fewer, regardless of whether that order is submitted as a
Preferenced Order. The Exchange believes that this is appropriate since
the PMMs obligations to the market are the same regardless of whether
an order happens to be submitted with a preference instruction. PMM
equivalents on other options exchanges currently receive this
participation right when preferenced, in addition to the regular 60% or
40% preferenced allocation currently provided in the rule.\7\ Preferred
CMMs will continue to receive the same allocation entitlement that they
receive today.
---------------------------------------------------------------------------

    \7\ See MIAX Rule 514(g), (i). See also Securities Exchange Act
Release Nos. 80239 (March 14, 2017), 82 FR 14413 (March 20, 2017)
(SR-ISEGemini-2017-14); 80438 (April 12, 2017), 82 FR 18329 (April
18, 2017) (SR-ISE-2017-31).
---------------------------------------------------------------------------

    Pursuant to Supplementary Material .01(c) to Rule 713 the Exchange
evaluates on a quarterly basis what percentage of the volume executed
on the Exchange is comprised of orders for five (5) contracts or fewer
executed by PMMs. The Exchange represents that this review will extend
to the small order entitlement for Preferred PMMs. Thus, consistent
with Supplementary Material .01(c) to Rule 713, the Exchange will
reduce the size of the orders included in the small order entitlement
if such percentage is over forty percent (40%).
Implementation
    The proposed rule change will be implemented on the Exchange's new
INET trading system, which is scheduled to launch in Q3 2017,\8\
provided that the Exchange will provide notice of this change in a
circular to be distributed to members prior to implementing the new
allocation entitlement on INET. The INET migration will take place on a
symbol by symbol basis as specified by the Exchange in a notice to be
provided to Members. The Exchange is proposing to implement this rule
change on the INET platform as the symbols migrate to that platform. As
such, PMMs will begin receiving the small order entitlement in symbols
as they migrate to the INET platform.
---------------------------------------------------------------------------

    \8\ See SR-MRX-2017-02 (pending publication).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6(b) of the Act.\9\ In
particular, the proposal is consistent

with Section 6(b)(5) of the Act,\10\ because it is designed to promote
just and equitable principles of trade, remove impediments to and
perfect the mechanisms of a free and open market and a national market
system and, in general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is consistent
with the protection of investors and the public interest as it will
allow EAMs to send Preferenced Orders to the PMM appointed in an
options class without inadvertently disadvantaging the PMM compared to
if the order was not preferenced. The regular allocation entitlements
for PMMs, including the small order entitlement, are designed to
balance the obligations that the PMM has to the market with
corresponding benefits. The Exchange believes that it is appropriate to
provide the small order entitlement also when the PMM is designated as
a Preferred Market Maker as the obligations that the PMM has to the
market are not diminished when it receives a Preferenced Order. Other
options exchanges similarly provide the small order entitlement to the
PMM regardless of whether the order is submitted as a Preferenced
Order.\11\ At the same time, the proposed rule change does not amend
the current participation rights for Preferred CMMs, which is also
consistent with allocation rules of other options exchanges. While the
Exchange believes that it is appropriate to grant PMMs an allocation
entitlement for small sized orders preferenced to them in recognition
of the obligations that PMMs have to maintain fair and orderly markets,
the Exchange does not believe that it is appropriate at this time to
extend this entitlement to CMMs, preferenced or otherwise.
---------------------------------------------------------------------------

    \11\ See supra note 7.
---------------------------------------------------------------------------

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

    In accordance with Section 6(b)(8) of the Act,\12\ the Exchange
does not believe that the proposed rule change will impose any burden
on intermarket or intramarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
rule change is designed to allow EAMs to send Preferenced Orders to the
PMM appointed in an options class without inadvertently disadvantaging
the PMM by reducing its participation rights. The proposed allocation
entitlements are equivalent to those currently in effect on other
options exchanges.\13\ The proposed rule change is therefore not
designed to impose any significant burden on competition.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(8).
    \13\ See supra note 7.
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \14\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\15\
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

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 email to<EMAIL_ADDRESS>Please include
File Number SR-MRX-2017-05 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MRX-2017-05. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of 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-MRX-2017-05 and should be
submitted on or before June 22, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-11253 Filed 5-31-17; 8:45 am]
BILLING CODE 8011-01-P


Johnd Bachmann 12/ 10/ 2003 07: 11 PM To: Amy_ L._ Farrell@ omb. eop. gov cc: Jeff Holmstead/ DC/ USEPA/ US@ EPA, Bill Wehrum/ DC/ USEPA/ US@ EPA, Stephanie Daigle/ DC/ USEPA/ US@ EPA, Don Zinger/ DC/ USEPA/ US@ EPA, Peter Tsirigotis/ RTP/ USEPA/ US@ EPA, Lisaa Jones/ DC/ USEPA/ US@ EPA, Sarah Dunham, Sam Napolitano, Lydia Wegman/ RTP/ USEPA/ US@ EPA Subject: Updated section XI of transport rule with full benefits results As promised, here is a redline version of section XI, which adds the final missing numbers to the version sent last night  each of the numerical changes is highlighted in red, as are other additions from the original sent earlier this week.

John Bachmann U. S. EPA C404 04 Research Triangle Park, NC27711 Voice 919 541 5359 Fax 919 541 2464 email Bachmann. JohnD@ epa. gov


Agency Response to Avecia's Comments Regarding PHMB HIARC Reports September 24, 2004 Case 3122 PC Code 111801 Jonathan Chen, Ph. D. Toxicologist Office of Pesticide Programs Antimicrobials Division U. S. Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460 Page 2 of 6 On 12/ 18/ 2000 and 01/ 25/ 2001, the Health Effects Division's Hazard Identification Assessment Review Committee evaluated the toxicology data base of Poly( hexamethylenebiguanide) ( PHMB), established the Reference Doses ( RfDs) and selected the toxicological endpoints for dietary as well as occupational exposure risk assessments. On March 21, 2002 Avecia made comments on the first PHMB HIARC report. To addressed concerns, HIARC meet again After receiving the comments from Avecia; on 01/ 30/ 2003 and 02/ 06/ 2003, to discussed the comments from Avecia. A second PHMB HIARC report was prepared afterward. On March 18, 2004 Avecia made comments on the second HIARC report. RASSB prepared this memorandum to respond to all the comments from Avecia.

The Comments and Responses to the comments are listed below:

ISSUE 1  Dermal Absorption Factor October 21, 2002 Avecia's Comments: The dermal absorption factor for PHMB is estimated to be less than 1% ( MRID 45710806)

March 18, 2004 Avecia's Comments: The dermal absorption for PHMB was reviewed in the report titled " Dermal Absorption Factor for PHMB", MRID 45710806. This report reviews the polymeric nature of PHMB, the PHMB absorption, distribution, metabolism and excretion data, and several PHMB in vitro dermal absorption studies ( conducted to be OECD draft Guidelines). Taking the results of these studies and other studies referred to in MRID 45710806, a factor of less than 1% dermal absorption for humans is considered to be highly conservative for risk assessment purposes.

EPA Response:

The dermal absorption factor cited in HIARC Report is used in the situation when route to route extrapolation is necessary for the risk assessment. It is a relative factor when compare the dermal absorption vs. the absorption through oral routes. For PHMB, there is no acceptable dermal absorption study.

The studies submitted to the agency are in vitro dermal absorption studies. These studies are not accepted by the agency because the in vitro study protocol does not account for the influence of systemic distribution and excretion kinetics upon dermal absorption. Although through these studies, Avecia is trying to demonstrate the absorption through dermal routes is low, the absorption of PHMB through oral route is also low. Therefore, in the HIARC report, it specifically emphasized the dermal absorption factor of 100% is an oral equivalent factor.

ISSUE 2  Intermediate Term and Chronic Reference Dose October 21, 2002 Avecia's Comments: In its 4/ 18/ 01 HIARC Report, the Agency indicated that the intermediate term reference dose was based on effects seen in a 26 week dog study ( MRID 86362). Because that study was found to have been deficient and unacceptable during the reregistration process under FIFRA 88 ( reference Phase 4 response of May 29, 1992) it is not an acceptable basis for establishment of a reference dose. The Agency's final decision under Page 3 of 6 Reregistration Phase 4 was that this study was unacceptable and that a new study was required. Avecia accepted this decision and conducted a new study to fulfill this data requirement. The new 1 year dog study ( MRID 43620501) was determined to be acceptable and to fulfill the data requirement. The NOAEL in the 1 year dog study is 37.5 mg/ kg bw/ day. Further background on the unacceptable 26 week dog study is presented in the Toxicological End Point report. There are a number of other acceptable studies which should be considered for the determination of an intermediate or chronic oral reference dose for PHMB, based on EPA Guidance, which identifies that chronic reference doses are to be set on the basis of chronic studies, if such studies are available, and that chronic studies can be used for intermediate term reference dose. The lowest NOAEL is 36 mg/ kg bw/ day for the dietary chronic toxicity study in rats ( MRID 44059301 & 44042801) and should be the basis for establishing an intermediate and chronic oral reference dose for PHMB.

March 18, 2004 Avecia's Comments: Avecia's letter of October 21, 2003 and the report titled " Selection of Toxicological End Points for Determination of Reference Dose Values for PHMB", MRID 45789601, state that EPA Guidance indicated that chronic reference doses are to be set on the basis of chronic studies, if available, and the chronic studies can be used for an intermediate term reference dose. As pointed out in these two documents ( Avecia's 10/ 21/ 03 letter and MRID 45789601), there are four separate PHMB chronic studies ( MRID 43617401, MRID 44059301, MRID 44074201, MRID 43620501). The lowest NOAEL is 36 mg/ kg/ day for the dietary chronic study in rats ( MRID 44059301) and Avecia believes that this should be the basis for establishing an intermediate term or chronic oral reference dose for PHMB.

EPA's Response:

Because reduce body weight, reduce body weight gain are the concerns for all the PHMB related studies. These effects begin at the early stage of each study and do not get worse with longer period time of exposure. Therefore, the decision is based not only the duration of the study, but also the types of effects seen in all studies.

ISSUE 3  PHMB Dermal Sensitization October 21, 2002 Avecia's Comments: The 4/ 18/ 01 HIARC report raised the issue of dermal sensitization and Avecia believes it is important to review the dermal sensitization potential of PHMB at this time. There have been dermal irritation and dermal sensitization studies in animals and humans and these are on file at EPA. These studies are reviewed in the report titled " Dermal Sensitization Potential of PHMB", being submitted herewith. Additionally, a report titled " Polyhexamethylene biguanide Cosmocil CQ: Skin Irritation Study in Humans" is also being submitted at this time. The sensitization studies are reviewed in the former report. PHMB has been shown to be a dermal irritant in studies with humans and animals. In addition, the dermal sensitization potential of PHMB has been evaluated in guinea pigs and humans. The overall assessment of the sensitization potential of PHMB is confounded since PHMB is a dermal irritant and, in many cases, it is difficult to separate dermal sensitization from dermal irritation responses. The dermal sensitization review report presents the results for dermal irritation and sensitization studies with human subjects to facilitate the evaluation of the dermal sensitization potential of PHMB in humans. This Page 4 of 6 review concluded that the threshold for dermal irritation in human subjects is at least 1.0% PHMB. Overall results of relevant dermal sensitization studies with humans show that PHMB is not a dermal sensitizer and that PHMB should not be considered a human sensitizer under actual or proposed conditions for use.

March 18, 2004 Avecia's Comments: The April 9, 2003 HIARC report states that " PHMB is a moderate skin sensitization agent in guinea pig study ( MRID# 00160084)'. This citation is incorrect. MRID # 00160084 is not a PHMB study, but a study titled " Dermal Sensitization ( with HS Sanitizing Carpet Shampoo). The subject active ingredient in this study was alkyl benzyl ammonium chloride, not PHMB.

Avecia's letter of October 21,2003, in response to the first PHMB HIARC report, reviewed PHMB's potential for human sensitization, and referred to the report, " Dermal Sensitization Potential of Polyhexamethylene Biguanide ( PHMB)" MRID45789602. These two documents point out that 1981 PHMB dermal sensitization study in humans ( MRID127871) was confounded by the fact that induction does was significantly irritating to test subjects. Guideline for human testing ( OECD, 1997) indicate that any skin irritation is sufficient grounds to terminate treatment for exposed individuals ( MRID45789602). Therefore, MRID 127871 should be disregarded when evaluating the human skin sensitization potential for PHMB. MRID 45789602 points to other human skin sensitization studies that are in EPA's files and concluded that " overall results of relevant dermal sensitization studies with humans show that PHMB is not a dermal sensitizer".

EPA's Response:

The correct MRID for the guinea dermal sensitization studies is 42674201. In the study moderate dermal sensitization was observed in response to dermal application of 20.2% PHMB to female guinea pigs.

There are two PHMB human skin sensitization studies been submitted to the agency:

1. Smith, I. 1981. Human Sensitiztion Testing of Vantocil IB. Prepared by Ian Smith Consultancy, Longniddry, Edinburgh, EM32 OLH. ISC Project No. 0018. [ MRID 00127871]. Unpublished Report.

2. Kaidbey, K. 1995. An Assessment of the Contact Sensitizating Potential of Cosmocil CQ (# S2082001) by means of the maximization assay in Humans. Ivy Laboratories ( KGL, Inc.) 3401 Market Street, Suite 226 & 232. Philadelphia, PA 19104 3355. Project ID:# KS950101. [ MRID45187705]. Unpublished Report.

A total of 209 volunteers commenced the 1981 study, a total of 191 subjects completed the human repeated insult patch study, according to the study protocol, which involved induction of PHMB testing material at 2% ( v/ v) with challenge applications of six week applications at both this and lower concentrations. The conclusion of the study is that PHMB when applied under patch conditions on human volunteers at level of 2% v/ v can induce skin sensitization. In the elicitation phase, at concentration as 0.1% v/ v can elicitate the skin sensitization. The researcher discussed the irritation issue in the report. Page 5 of 6 It was mentioned that low level of irritation was observed in the subjects applied at 2% showed that it is not capable of causing primary irritation reaction. The Agency considers PHMB is a dermal sensitization agent is based on the response of subjects at 0.1 0.2% v/ v at the elicitation phase of the study.

There are 27 healthy normal adult volunteers are involved in the 1995 study. None of the subjects had a medical or dermatological illness and none were sensitive to sunlight or to topical preparations and/ or cosmetics. One subject was dropped from the study during the induction phase for lack of compliance, while another withdraws voluntarily for personal reasons. The study was composed of two phases: ( 1) an induction phase, and ( 2) a challenge phase. In the induction phase, the site of application was pretreated with 0.25% aqueous sodium sulfate ( SLS) for a period of 24 hours. After pretreatment, a 1.0% ( v/ v) PHMB in water was applied to the upper outer arm, volar part of forearm or the back of each subject for either 48 hours ( or 72 hours when placed over a weekend). A total of 5 induction exposure sequences ( 24 hour SLS pretreatment followed by 48 hours of test material) was applied to each subject. There are no adverse effects happened at any of subjects. Therefore, the induction phase indicate that these individuals are not been induced with the 1.0 % v/ v of PHMB solution. After 10 day resting period, in the induction phase, the researcher continue to challenge these not been induced subjects to 1.0% and 0.2% to new skin on the opposite arm for 48 hours. There is no adverse effects or unanticipated reactions were encountered in any of the panelists. It is agreed that any skin irritation is sufficient grounds to terminate treatment for exposed individuals. However, in the study, none of the subjects reached a state of any signs of irritation in the induction phase of the study. Therefore, with limited number of individual involved in the study and inadequate dosing in the induction phase, the agency consider the Kaidbey ( 1995) study is inadequate to assess the dermal sensitization potential of PHMB.

ISSUE 4  PHMB Acute Toxicity Avecia's Comments: Avecia believes that there are inaccuracies in the PHMB acute toxicity data table listed in the 4/ 18/ 01 HIARC report. Some of the studies listed were repeated and replaced by other studies. The studies that should be listed are those that were submitted/ cited for reregistration and have been found to be at least tentatively acceptable, or determined to be accepted for other regulatory actions. Also, the MRID listed in the table as MRID 150084 is for an efficacy study on a quaternary ammonium end use product submitted by Lonza. A table outlining PHMB acute toxicity data on 20% active ingredient products is attached. This table lists MRID numbers of acute toxicity studies submitted or cited at reregistration or submitted to EPA and found to be acceptable under other regulatory actions. Page 6 of 6 EPA's Response:

Following table will be used for PHMB related risk assessment.

Table: Acute Toxicity of PHMB Product a. i. / EPA Reg. No. Baquacil 20% PHMB / 72674 19 Baquacil Ultra 20% PHMB / 72674 22 A Breeze 96% PHMB / 72674 32 870.1100 Acute oral toxicity MRID Tox Category LD50 = 2747 mg/ kg 00030330 III LD50 = 1831mg/ kg ( M) LD50 = 1617mg/ kg ( F) 44940701 III LD50 = 1049mg/ kg ( F)

45916505 III 870.1200 Acute dermal toxicity MRID Tox Category LD50 > 2.0 ml/ kg 00065124 III LD50 > 2000mg/ kg 44940702 III LD50 > 5000mg/ kg 45916506 IV 870.1300 Acute inhalation toxicity MRID Tox Category waived LC50 = 1.76mg/ L 44970403 III waived 870.2400 Acute eye irritation MRIDs Tox Category moderate irritant 00046789; 00065120 II moderate irritant 44963902 II corrosive 45916508 I 870.2500 Acute dermal irritation MRIDs Tox Category moderate irritant 00046789; 00065120 II slight irritant 44949704 IV slight irritant 45916509 IV 870.2600 Skin sensitization MRID moderate sensitizer 42674201 Moderate Sensitization mild sensitizer 44940705


[Federal Register Volume 86, Number 128 (Thursday, July 8, 2021)]
[Rules and Regulations]
[Page 36070]
[FR Doc No: 2021-14543]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2021-0499]

Safety Zones; Annual Events in the Captain of the Port Buffalo
Zone

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce a safety zone located in Federal
regulations for a recurring marine event. This action is necessary and
intended for the safety of life and property on navigable waters during
this event. During the enforcement period, no person or vessel may
enter the respective safety zone without the permission of the Captain
of the Port Buffalo or a designated representative.

DATES: The regulations listed in 33 CFR 165.939 as listed in Table
165.939(a)(7) will be enforced from 8:15 a.m. through 1:15 p.m. on July
24, 2021.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email MST2 Natalie Smith, Waterways
Management Division, U.S. Coast Guard Marine Safety Unit Cleveland;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the Safety
Zones; Annual Events in the Captain of the Port Buffalo Zone listed in
33 CFR 165.939, Table 165.939(a)(7), for Blazing Paddles in Cleveland,
OH, on all waters of the Cuyahoga River in Cleveland, OH, beginning at
position 41[deg]29'36'' N, 081[deg]42'13'' W to the turnaround point at
position 41[deg]27'53'' N, 081[deg]40'38'' W. The safety zone will be
enforced from 8:15 a.m. through 1:15 p.m. on July 24, 2021. Pursuant to
33 CFR 165.23, entry into, transiting, or anchoring within the safety
zone during an enforcement period is prohibited unless authorized by
the Captain of the Port Buffalo or a designated representative. Those
seeking permission to enter the safety zone may request permission from
the Captain of Port Buffalo via channel 16, VHF-FM. Vessels and persons
granted permission to enter the safety zone shall obey the directions
of the Captain of the Port Buffalo or a designated representative.
While within a safety zone, all vessels shall operate at the minimum
speed necessary to maintain a safe course.
    This notice of enforcement is issued under authority of 33 CFR
165.939 and 5 U.S.C. 552(a). In addition to this notice of enforcement
in the Federal Register, the Coast Guard will provide the maritime
community with advance notification of this enforcement period via
Broadcast Notice to Mariners or Local Notice to Mariners. If the
Captain of the Port Buffalo determines that the safety zone need not be
enforced for the full duration stated in this notification she may use
a Broadcast Notice to Mariners to grant general permission to enter the
respective safety zone.

L.M. Littlejohn,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2021-14543 Filed 7-7-21; 8:45 am]
BILLING CODE 9110-04-P