[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Notices]
[Pages 46572-46573]
[FR Doc No: 2015-19205]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-533-000]

Hiland Partner Holdings, LLC; Notice of Application

    Take notice that on July 17, 2015 and supplemented on July 29,
2015, Hiland Partner Holdings LLC (Hiland), pursuant to section 7(c) of
the Federal Energy Regulatory Commission's (FERC) regulations under the
Natural Gas Act (NGA), filed in Docket No. CP15-533-000, an application
for a certificate of public convenience and necessity to own, operate,
and maintain the existing 9.64 mile long, 8 inch diameter natural gas
pipeline (Bakken Residue Line) located in Richland County, Montana, all
as more fully set forth in the application which is on file with the
Commission and open for public inspection. The filing may also be
viewed on the Web at 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 at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions concerning this application may be directed to: Mr.
Peter Trombley, Associate General Counsel, Kinder Morgan Inc., 1001
Louisiana Street, Suite 1000, Houston, Texas, 77002, by phone at (713)
420-3348, or email at<EMAIL_ADDRESS>    Specifically, Hiland requests (i) certificate authorization of
Bakken Residue Line for the limited purpose of transporting its own
natural gas from the Hiland owned Bakken processing plant to an
interconnect with Williston Basin Pipeline Company; (ii) a Part 157,
Subpart F blanket certificate authorizing certain routine construction,
operation, and abandonment activities; (iii) waivers of certain
regulatory requirements; and (iv) confirmation that the Commission's
assertion of jurisdiction over the Bakken Residue Line will not
jeopardize the non-jurisdictional status of Hiland's otherwise non-
jurisdictional gathering and processing facilities and operations.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule will serve to
notify federal and state agencies of the timing for the completion of
all necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
    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 5 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.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.

    Motions to intervene, protests and comments may be filed
electronically via the internet in lieu of paper; see, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: 5:00 p.m. Eastern Time August 20, 2015.

Kimberly D. Bose,
Secretary.
[FR Doc. 2015-19205 Filed 8-4-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Rules and Regulations]
[Pages 46485-46486]
[FR Doc No: 2015-19177]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 /
Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2015-N-2457]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Internal Tissue Marker

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

DATES: This order is effective August 5, 2015. The classification was
applicable on December 18, 2014.

FOR FURTHER INFORMATION CONTACT: David Talley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G454, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device. In
accordance with section 513(f)(1) of the FD&C Act, FDA issued an order
on April 22, 2013, classifying the Moerae Surgical Marking Pen into
class III, because it was not substantially equivalent to a device that
was introduced or delivered for introduction into interstate commerce
for commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II.
    On May 3, 2013, VasoPrep Surgical (formerly Moerae Matrix, Inc.)
submitted a request for classification of the VasoPrep (formerly
Moerae) Surgical Marking Pen under section 513(f)(2) of the FD&C Act.
The manufacturer recommended that the device be classified into class
II (Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1). FDA classifies devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
request, FDA determined that the device can be classified into class II
with the establishment of special controls. FDA believes these special
controls, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of the device.
    Therefore, on December 18, 2014, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding Sec.  878.4670.
    Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for an internal
tissue marker will need to comply with the special controls named in
this final order. The device is assigned the generic name internal
tissue marker, and it is identified as a prescription use device that
is intended for use prior to or during general surgical procedures to
demarcate selected sites on internal tissues.
    FDA has identified the following risks to health associated
specifically with

this type of device, as well as the mitigation measures required to
mitigate these risks in Table 1.

      Table 1--Internal Tissue Marker Risks and Mitigation Measures
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                Identified Risks and Mitigation Measures
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              Identified risk                    Mitigation measures
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Adverse Tissue Reaction...................  Biocompatibility Testing.
                                            Sterilization Testing.
                                            Shelf Life/Stability
                                             Testing.
                                            Performance Testing.
                                            Labeling.
Ineffective Marking.......................  Performance Testing.
                                            Shelf Life/Stability
                                             Testing.
                                            Labeling.
Improper Use..............................  Labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in combination
with the general controls, address these risks to health and provide
reasonable assurance of safety and effectiveness:
     The device must be demonstrated to be biocompatible.
Material names and specific designation numbers must be provided.
     Performance testing must demonstrate that the device
performs as intended to mark the tissue for which it is indicated.
     Performance data must demonstrate the sterility of the
device.
     Performance data must support the shelf life of the device
by demonstrating sterility, package integrity, device functionality,
and material stability over the requested shelf life.
     Labeling must include:
    [cir] A warning that the device must not be used on a non-sterile
surface prior to use internally.
    [cir] An expiration date/shelf life.
    [cir] Single use only labeling must be labeled directly on the
device.
    Internal tissue marker is a prescription device restricted to
patient use only upon the authorization of a practitioner licensed by
law to administer or use the device; see 21 CFR 801.109 (Prescription
devices).
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the internal tissue marker they intend
to market.

II. Environmental Impact

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

III. Paperwork Reduction Act of 1995

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

IV. Reference

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

1. DEN130004: De Novo Request from VasoPrep Surgical (formerly
Moerae Matrix, Inc.), dated May 3, 2013.

List of Subjects in 21 CFR Part 878

    Medical devices.

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

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as
follows:

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

0
2. Add Sec.  878.4670 to subpart E to read as follows:

Sec.  878.4670  Internal tissue marker.

    (a) Identification. An internal tissue marker is a prescription use
device that is intended for use prior to or during general surgical
procedures to demarcate selected sites on internal tissues.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The device must be demonstrated to be biocompatible. Material
names and specific designation numbers must be provided.
    (2) Performance testing must demonstrate that the device performs
as intended to mark the tissue for which it is indicated.
    (3) Performance data must demonstrate the sterility of the device.
    (4) Performance data must support the shelf life of the device by
demonstrating sterility, package integrity, device functionality, and
material stability over the requested shelf life.
    (5) Labeling must include:
    (i) A warning that the device must not be used on a non-sterile
surface prior to use internally.
    (ii) An expiration date/shelf life.
    (iii) Single use only labeling must be labeled directly on the
device.

    Dated: July 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-19177 Filed 8-4-15; 8:45 am]
 BILLING CODE 4164-01-P