[Federal Register Volume 83, Number 97 (Friday, May 18, 2018)]
[Rules and Regulations]
[Page 23221]
[FR Doc No: 2018-10650]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0432]

Drawbridge Operation Regulation; Sacramento River, Walnut Grove,
CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Walnut Grove Drawbridge across the
Sacramento River, mile 26.7, at Walnut Grove, CA. The deviation is
necessary to allow participants in the AMGEN Tour of California bicycle
race to cross the drawspan safely and without interruption. This
deviation allows the bridge to remain in the closed-to-navigation
position during the deviation period.

DATES: This deviation is effective from 11 a.m. through 3 p.m. on May
17, 2018.

ADDRESSES: The docket for this deviation, USCG-2018-0432, is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Carl T. Hausner, Chief, Bridge
Section, Eleventh Coast Guard District; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION: Sacramento County has requested a temporary
change to the operation of the Walnut Grove Drawbridge, mile 26.7, over
the Sacramento River, at Walnut Grove, CA. The drawbridge navigation
span provides a vertical clearance of 21 feet above Mean High Water in
the closed-to-navigation position. The draw operates as required by 33
CFR 117.189(a). Navigation on the waterway is commercial and
recreational.
    The drawspan will be secured in the closed-to-navigation position
from 11 a.m. through 3 p.m. on May 17, 2018, to allow the participants
in the AMGEN Tour of California bicycle race to cross the drawspan
safely and without interruption. This temporary deviation has been
coordinated with the waterway users. No objections to the proposed
temporary deviation were raised.
    Vessels able to pass through the bridge in the closed position may
do so at any time. The bridge will be able to open for emergencies and
there is no immediate alternate route for vessels to pass. The Coast
Guard will also inform the users of the waterway through our Local and
Broadcast Notices to Mariners of the change in operating schedule for
the bridge so that vessel operators can arrange their transits to
minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: May 15, 2018.
C.T. Hausner,
District Bridge Chief, Eleventh Coast Guard District.
[FR Doc. 2018-10650 Filed 5-17-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Rules and Regulations]
[Pages 39961-39963]
[FR Doc No: 2021-15833]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2021-0099]
RIN 1625-AA09

Drawbridge Operation Regulation; Okeechobee Waterway, Indiantown,
FL

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

ACTION: Final rule.

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

SUMMARY: The Coast Guard is changing the operating schedule that
governs the Seaboard System Railroad Bridge, across the Okeechobee
Waterway, mile 28.2, at Indiantown, FL. This change will allow the
swing bridge to be remotely operated, change the start and end times
for advance notification for an opening during the overnight hours and
update the name of the bridge.

DATES: This rule is effective August 25, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov. Type USCG-
2021-0099 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Omar Beceiro, U.S. Coast Guard Sector Miami Waterways
Management Division, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
OMB Office of Management and Budget
NPRM Notice of proposed rulemaking (Advance, Supplemental)
Sec.  Section
U.S.C. United States Code
FL Florida

II. Background Information and Regulatory History

    On March 5, 2021, the Coast Guard published a Test Deviation, with
a request for comments, entitled ``Drawbridge Operation Regulation;
Okeechobee Waterway, Indiantown, FL,'' in the Federal Register (86 FR
12821), to test this operating schedule for the Seaboard System
Railroad Bridge. Zero comments were received during the test period.
    On April 12, 2021, the Coast Guard published a notice of proposed
rulemaking entitled ``Drawbridge Operation Regulation; Okeechobee
Waterway, Indiantown, FL,'' in the Federal Register (86 FR 18929).
There we stated why we issued the NPRM, and invited comments on our
proposed regulatory action related to this regulatory change. During
the comment period that ended June 11, 2021, we received one comment
which is addressed in Section IV of this final rule.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority 33 U.S.C. 499.
The Seaboard System Railroad Bridge across the Okeechobee Waterway,
mile 28.2, at Indiantown, FL, is a swing bridge with a seven-foot
vertical clearance at mean high water in the closed position.
Navigation on the waterway is commercial and recreational. The
operating schedule for the bridge is set forth in 33 CFR 117.317(e).
    The rule allows the swing bridge to be remotely monitored and
operated. The

swing bridge will remain in the open to navigation position during
daylight hours and close only for the passage of rail traffic. The
start of the three hour advance notice for an opening will begin
earlier each evening and end one hour later each morning. The time
changes for the three hour advance notice will align with the operating
schedule of the U.S. Army Corps of Engineers (USACE) Locks along this
portion of the Okeechobee Waterway. The changes allow for the swing
bridge to operate more efficiently while taking into account the
reasonable needs of navigation. Additionally, the name of the swing
bridge would be updated to reflect the current bridge owner.
    This change allows vessels that are capable of transiting under the
bridge, without an opening, to do so at any time and vessels are able
to transit the bridge when advanced notice is given. Vessels in
distress and public vessels of the United States must be allowed to
pass at any time.

IV. Discussion of Comments, Changes, and the Final Rule

    The one comment received did not object to the rule change but
provided suggestions in addition to the proposed rule change. The
commenter felt the bridge should remain open until 6 p.m. before
shifting to the three hour advanced notice for an opening. The rule
allows the bridge to shift to the three hour advanced notice at 7 p.m.
until 7 a.m. daily. The commenter would like signage to be placed at
unspecified locations along the waterway approximately one mile before
the bridge. Per the commenter, this would greatly reduce congestion in
the narrow channel at the bridge when in the closed position. Contact
information for the bridge is found in 33 CFR 117.317(e) and posted on
the bridge per Federal drawbridge regulations. Additional posting
requirements, not in accordance Federal drawbridge regulations, are
outside the Coast Guard's authority. The Coast Guard provided the
bridge owner, CSX Transportation, with this recommendation from the
commenter for consideration.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protesters.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action'' under Executive Order 12866. Accordingly, it has
not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the fact that
vessels can still transit the bridge given advanced notice and vessels
that can transit under the bridge without an opening may do so at
anytime.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received zero comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
bridge may be small entities, for the reasons stated in section V.A
above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule may affect your small
business, organization, or governmental jurisdiction or you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, Rev.1, associated implementing
instructions, and Environmental Planning Policy COMDTINST 5090.1
(series) which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The
Coast Guard has determined that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on

the human environment. This rule promulgates the operating regulations
or procedures for drawbridges and is categorically excluded from
further review, under paragraph L49, of Chapter 3, Table 3-1 of the
U.S. Coast Guard Environmental Planning Implementation Procedures.
    Neither a Record of Environmental Consideration nor a Memorandum
for the Record are required for this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; and Department of
Homeland Security Delegation No. 0170.1.

0
2. Amend Sec.  117.317 by revising paragraph (e) to read as follows:

Sec.  117.317  Okeechobee Waterway.

* * * * *
    (e) Seaboard System Railroad bridge, mile 28.2 at Indiantown. The
draw of the CSX Railroad Bridge, mile 28.2 at Indiantown, FL, shall
operate as follows:
    (1) The swing bridge is not tendered locally, but will be monitored
and operated by a remote operator.
    (2) Marine radio communication shall be maintained, by the remote
operator, with mariners near the bridge for the safety of navigation.
Visual monitoring of the waterway shall be maintained with the use of
cameras. Detection sensors shall be installed for the detection of
vessels entering the radius of the swing span of the bridge while in
operation.
    (3) From 7 a.m. to 7 p.m., the bridge will be maintained in the
open to navigation position and will display green lights to indicate
that the span is fully open.
    (4) When a train approaches, the remote operator shall monitor for
vessels in the vicinity of the bridge. Provided the sensors do not
detect a vessel entering the swing radius of the bridge, the operator
shall initiate the closing sequence, which includes the sounding of a
horn. The span will remain in the closed position for the entire time
the track circuit is occupied displaying red lights.
    (5) After the train has cleared the track circuit, the span shall
open and green lights will be displayed.
    (6) From 7 p.m. to 7 a.m., the bridge will be in the closed to
navigation position and will open if at least a three hour advance
notice is requested via marine radio channel 9 VHF or telephone (813)
677-3974.
    (7) The bridge shall not be operated from the remote location in
the following events: Failure or obstruction of the detection sensors,
remote actuation systems, cameras, or marine radio communications, or
when directed by the Coast Guard. In these situations, a bridge
operator must be on-site and locally operate the bridge.
* * * * *

    Dated: July 7, 2021.
Eric C. Jones,
Rear Admiral, U.S. Coast Guard, Commander Seventh Coast Guard District.
[FR Doc. 2021-15833 Filed 7-23-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13864-13865]
[FR Doc No: 2015-06029]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0293]

Reprocessing Medical Devices in Health Care Settings: Validation
Methods and Labeling; Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Reprocessing Medical Devices in
Health Care Settings: Validation Methods and Labeling.'' This guidance
provides recommendations for the formulation and scientific validation
of reprocessing instructions for reusable medical devices. This
guidance document also provides recommendations for the content and
review procedures for premarket notification (510(k)) submissions,
premarket approval (PMA) applications, humanitarian device exemption
(HDE) applications, de novo requests, and investigational device
exemption (IDE) applications, concerning the labeling instructions for
reprocessing reusable medical devices. This guidance reflects the
scientific advances in knowledge and technology involved in
reprocessing reusable medical devices, especially more complex,
reusable medical device designs that are more difficult to reprocess.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Reprocessing Medical Devices in Health Care Settings: Validation
Methods and Labeling'' to the Office of the Center Director, Guidance
and Policy Development, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002; or the Office of Communication,
Outreach and Development, Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Angela C. Krueger, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-
796-6380; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
71, Rm. 7301, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, there has been a significant advance in knowledge
and technology involved in reprocessing reusable medical devices.
Additionally, there has been an evolution towards more complex medical
device designs that are more difficult to clean, disinfect, and
sterilize. This guidance reflects the scientific advances in these
areas. Under section 502(f) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352(f)), a device must have adequate directions for use,
which include instructions on preparing a device for use. Instructions
on how to reprocess (i.e., clean, disinfect, and sterilize) a reusable
device are critical to ensure that the device is appropriately prepared
for its next use.
    In the Federal Register of May 2, 2011 (76 FR 24494), FDA announced
the availability of the draft guidance. Interested persons were invited
to comment by August 1, 2011. FDA reviewed and considered all the
public comments we received and revised several sections of the
guidance, where applicable. On June 8 and 9, 2011, FDA held a public
workshop entitled ``Reprocessing of Reusable Medical Devices
Workshop.'' The purpose of the workshop was to discuss factors
affecting the reprocessing of reusable medical devices and FDA's plans
to address the identified issues. The discussion during this workshop
and the comments received were considered before revising the guidance.
This final guidance supersedes ``Labeling Reusable

Medical Devices for Reprocessing in Health Care Facilities: FDA
Reviewer Guidance'' dated April 1996.
    This final guidance contains the addition of ``Appendix E: Devices
for which a 510(k) Should Contain Data to Validate Reprocessing
Instructions,'' which includes a subset of medical devices that FDA has
identified that pose a greater likelihood of microbial transmission and
represent a high risk of infection if they are not adequately
reprocessed. Because of this greater public health risk, 510(k)
submissions for these devices should include protocols and complete
test reports of the validation of the reprocessing instructions so that
FDA has the information it needs to evaluate substantial equivalence.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on reprocessing validation methods and
labeling for medical devices. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to
download an electronic copy of ``Reprocessing Medical Devices in Health
Care Settings: Validation Methods and Labeling'' may send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of
the document. Please use the document number 1748 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance 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 parts 801 and 809 have been
approved under OMB control number 0910-0485 (medical device labeling);
the collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120 (premarket notification);
the collections of information in 21 CFR part 812 have been approved
under OMB control number 0910-0078 (investigational device exemption);
the collections of information in 21 CFR part 814, subparts A through E
have been approved under OMB control number 0910-0231 (premarket
approval); the collections of information in 21 CFR part 814, subpart H
have been approved under OMB control number 0910-0332 (humanitarian use
devices); and the collections of information in 21 CFR part 820 have
been approved under OMB control number 0910-0073 (quality system
regulation).

V. 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.

    Dated: March 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06029 Filed 3-16-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 5 (Friday, January 8, 2016)]
[Proposed Rules]
[Pages 885-886]
[FR Doc No: 2016-135]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

49 CFR Part 195

[Docket No. PHMSA-2015-0173]

Pipeline Safety: Notice of Liquid Pipeline Advisory Committee
Meeting

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA);
DOT.

ACTION: Notice of Liquid Pipeline Advisory Committee meeting.

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

SUMMARY: This document announces a public meeting of the Liquid
Pipeline Advisory Committee (LPAC). The committee will meet to consider
and vote on the proposed rule, ``Pipeline Safety: Safety of Hazardous
Liquid Pipelines,'' and the associated regulatory assessment.

DATES: The meeting will be held on Monday, February 1, 2016, from 10:00
a.m. to 5:00 p.m. EST.
    The meeting will not be web cast; however, presentations will be
available on the meeting Web site and posted on the E-Gov Web site:
http://www.regulations.gov under docket number PHMSA-2015-0173 within
30 days following the meeting.

ADDRESSES: The meeting will take place in the Washington, DC
Metropolitan area at a location yet to be determined. The location of
the meeting and other details will be posted on the PHMSA Web site
under Regulations/Pipeline Advisory Committees at http://www.phmsa.dot.gov/pipeline/regs/technical-advisory-comm about 15 days
before the meeting date. Individuals wishing to attend and receive an
email with the location should register in advance at https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=110 or contact the
individual listed under FOR FURTHER INFORMATION CONTACT by January 15,
2016.
    Comments on the meeting may be submitted to the docket in the
following ways:
    E-Gov Web site: http://www.regulations.gov. This site allows the
public to enter comments on any Federal Register notice issued by any
agency.
    Fax: 1-202-493-2251.
    Mail: Docket Management Facility; U.S. Department of Transportation
(DOT), 1200 New Jersey Avenue SE., West Building, Room W12-140,
Washington, DC 20590-001.
    Hand Delivery: Room W12-140 on the ground level of the DOT West
Building, 1200 New Jersey Avenue SE., Washington, DC, between 9:00 a.m.
and 5:00 p.m., Monday through Friday, except on Federal Holidays.
    Instructions: Identify the docket numbers, PHMSA-2010-0229 and
PHMSA-2015-0173 at the beginning of your comments. Note that all
comments received will be posted without change to http://www.regulations.gov, including any personal information provided. You
should know that anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). Therefore, you may
want to review DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000, (65 FR 19477) or view the Privacy
Notice at http://www.regulations.gov before submitting any such
comments.
    Docket: For access to the docket or to read background documents or
comments, go to http://www.regulations.gov at any time or to Room W12-
140 on the ground level of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC, between 9:00 a.m. and 5:00 p.m., Monday
through Friday, except Federal holidays.
    If you wish to receive confirmation of receipt of your written
comments, please include a self-addressed, stamped postcard with the
following statement: ``Comments on PHMSA-2010-0229 and PHMSA 2015-
0173.'' The Docket Clerk will date-stamp the postcard prior to
returning it to you via the U.S. mail. Please note that due to delays
in the delivery of U.S. mail to Federal offices in Washington, DC, we
recommend that persons consider an alternative method (internet, fax,
or professional delivery service) of submitting comments to the docket
and ensuring their timely receipt at DOT.

Privacy Act Statement

    Anyone may search the electronic form of all comments received for
any of our dockets. You may review DOT's complete Privacy Act Statement
in the Federal Register published on April 11,

2000, (70 FR 19477) or visit http://dms.dot.gov.

Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities, or to seek special assistance at the meeting, please
contact Cheryl Whetsel at<PHONE_NUMBER> by January 15, 2016.

FOR FURTHER INFORMATION CONTACT: For information about the meetings,
contact Cheryl Whetsel by phone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>or for technical questions about the proposed
rule contact Mike Israni by phone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Meeting Details

    Members of the public may attend and make a statement during the
advisory committee meetings. For a better chance to speak at the
meetings, please contact the individual listed under FOR FURTHER
INFORMATION CONTACT by January 15, 2016.

II. Committee Background

    The LPAC is a statutorily created committee that advises PHMSA on
proposed safety standards, risks assessments, and safety policies for
hazardous liquid pipelines (49 U.S.C. 60115). The committee's
activities are subject to the Federal Advisory Committee Act (Pub. L.
92-463, 5 U.S.C. App. 1). The committee consists of 15 members--with
membership evenly divided among the federal and state government, the
regulated industry, and the public. The committee advises PHMSA on
technical feasibility, practicability, and cost-effectiveness of each
proposed pipeline safety standard. PHMSA staff may also provide an
update on several regulatory and policy initiatives if time allows.

III. Preliminary Agenda

    The agenda will include the committee's discussion and vote on the
proposed rule, ``Pipeline Safety: Safety of Hazardous Liquid
Pipelines,'' published in the Federal Register on October 13, 2015, (80
FR 61610) and on the associated regulatory analysis.
    The proposed rule includes critical safety improvements for
hazardous liquid pipelines and seeks to strengthen the way they are
operated, inspected and maintained in the United States.
    In this proposed rule, PHMSA addresses effective measures that
hazardous liquid operators can take to improve the protection of high
consequence areas and other vulnerable areas along their hazardous
liquid onshore pipelines. In summary, the proposed rule addresses the
following areas:
     Requirements for gravity lines.
     Reporting requirements for gathering lines.
     Inspections of pipelines following extreme weather events.
     Periodic assessments of pipelines not subject to integrity
management.
     Pipeline repair criteria.
     Expanded use of leak detection systems.
     Increased use of in-line inspection tools.
     Clarifying other requirements.

    Issued in Washington, DC, on January 4, 2016, under authority
delegated in 49 CFR 1.97.
Alan K. Mayberry,
Deputy Associate Administrator for Policy and Programs.
[FR Doc. 2016-135 Filed 1-7-16; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 76, Number 143 (Tuesday, July 26, 2011)]
[Notices]
[Pages 44635-44636]
[FR Doc No: 2011-18798]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64929; File No. SR-C2-2011-015]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Extend a Pilot Program Related to the Exchange's Automated
Improvement Mechanism

July 20, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 14, 2011, the C2 Options Exchange, Incorporated (the
``Exchange'' or ``C2'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I and II below, which Items have been prepared by the
Exchange. The Exchange filed the proposal as a ``non-controversial''
proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
\3\ and Rule 19b-4(f)(6) thereunder.\4\ 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend its rules to extend a program
related to the Exchange's Automated Improvement Mechanism (``AIM'') for
one year, until July 18, 2012. The text of the proposed rule change is
available on the Exchange's Web site (http://www.cboe.org/legal), at
the Exchange's Office of the Secretary, and at the Commission.

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

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

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

1. Purpose
    In December 2009, the Commission approved adoption of C2's rules,
including the AIM auction process.\5\ AIM exposes certain orders
electronically to an auction process to provide such orders with the
opportunity to receive an execution at an improved price. The AIM
auction is available only for orders that an Exchange Trading Permit
Holder represents as agent (``Agency Order'') and for which a second
order of the same size as the Agency Order (and on the opposite side of
the market) is also submitted (effectively stopping the Agency Order at
a given price).
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 61152 (December 10,
2009), 74 FR 66699 (December 16, 2009).
---------------------------------------------------------------------------

    One component of AIM was approved on a pilot basis: that there is
no minimum size requirement for orders to be eligible for the
auction.\6\ The Commission has previously approved a one-year extension
to the pilot program.\7\ The proposed rule change merely extends the
duration of the pilot program until July 18, 2012. Extending the pilot
for an additional year will allow the Exchange time and opportunity to
implement AIM, which is intended to give all sized orders opportunity
for price improvement, at its discretion. Upon implementation, the
Exchange would provide AIM data to the Commission as requested so the
Commission can evaluate the impact of the pilot program on AIM order
executions.
---------------------------------------------------------------------------

    \6\ See Exchange Rule 6.51, Interpretation .03.
    \7\ See Securities Exchange Act Release No. 63238 (November 3,
2010), 75 FR 68844 (November 9, 2010) approving SR-C2-2010-008.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act \8\ in general and furthers the objectives of
Section 6(b)(5) \9\ in particular in that by allowing the Exchange
additional time and opportunity to implement AIM and the pilot program,
the Exchange could give all sized orders opportunity for price
improvement within AIM, which would serve to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and protect investors and the public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    C2 does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act.

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

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

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \10\ and Rule 19b-4(f)(6) thereunder.\11\
Because the 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) by its terms, become
operative prior to 30 days from the date on which it was filed, or such
shorter time as the Commission may designate, if consistent with the
protection of investors and the public

interest, the proposed rule change has become effective upon filing
with the Commission pursuant to Section 19(b)(3)(A) of the Act \12\ and
Rule 19b-4(f)(6)(iii) thereunder.\13\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 17 CFR 240.19b-4(f)(6).
    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires the Exchange to give the Commission written
notice of the Exchange's intent to file the proposed rule change,
along with a brief description and text of 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 Commission deems this requirement to have been met.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay period. The Commission believes that waiver of the 30-
day operative delay period is consistent with the protection of
investors and the public interest because such waiver will allow the
AIM pilot program to continue without interruption. Accordingly, the
Commission designates the proposed rule change operative upon filing
with the Commission.\14\
---------------------------------------------------------------------------

    \14\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-C2-2011-015 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-C2-2011-015. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such 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-C2-2011-015 and should be
submitted by August 16, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-18798 Filed 7-25-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Pages 46512-46514]
[FR Doc No: 2019-19066]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Docket No. CP19-488-000]

Columbia Gulf Transmission, LLC; Notice of Intent To Prepare an
Environmental Assessment for the Proposed Louisiana Xpress Project,
Request for Comments on Environmental Issues, and Notice of Public
Scoping Session

    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 Louisiana Xpress Project
involving construction and operation of facilities by Columbia Gulf
Transmission, LLC (Columbia Gulf) in Evangeline, East Carroll,
Catahoula, and Rapides Parishes, Louisiana. 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 September 27, 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 the project to the Commission before the
opening of the docket on July 15, 2019, you will need to file those
comments in Docket No. CP19-488-000 to ensure they are considered as
part of this proceeding.
    This notice is being sent to the Commission's current environmental
mailing lists for the project. State and local government
representatives should notify their constituents of the 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.
    Columbia Gulf 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 docket/project 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 four 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 also 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
(CP19-488-000) with your submission: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE, Room 1A,
Washington, DC 20426;
    (4) In lieu of sending written comments, the Commission invites you
to attend the public scoping session its staff will conduct in the
project area, scheduled as follows:

------------------------------------------------------------------------
               Date and time                          Location
------------------------------------------------------------------------
Wednesday, September 11, 2019, 4-8 p.m....  Holiday Inn, 701 4th St.,
                                             Alexandria, LA, 71301, 318-
                                             541-8333.
------------------------------------------------------------------------

    The primary goal of the scoping session is to have you identify the
specific environmental issues and concerns that should be considered in
the EA. Individual verbal comments will be taken on a one-on-one basis
with a court reporter. This format is designed to receive the maximum
amount of verbal comments, in a convenient way during the timeframe
allotted.
    The scoping session is scheduled from 4:00 p.m. to 8:00 p.m. CST.
You may arrive at any time after 4:00 p.m. There will not be a formal
presentation by Commission staff when the session opens. If you wish to
speak, the Commission staff will hand out numbers in the order of your
arrival. Comments will be taken until 8:00 p.m. However, if no
additional numbers have been handed out and all individuals who wish to
provide comments have had an opportunity to do so, staff may conclude
the session at 7:00 p.m. Please see appendix 1 for additional
information on the session format and conduct.\1\
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the 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<PHONE_NUMBER>. For instructions on connecting to
eLibrary, refer to the last page of this notice.
---------------------------------------------------------------------------

    Your scoping comments will be recorded by a court reporter (with
FERC staff or representative present) and become part of the public
record for these proceedings. Transcripts will be publicly available on
FERC's eLibrary system (see the last page of this notice for
instructions on using eLibrary). If a significant number of people are
interested in providing verbal comments in the one-on-one settings, a
time limit of 5 minutes may be implemented for each commentor.
    It is important to note that the Commission provides equal
consideration to all comments received, whether filed in written form
or provided verbally at a scoping session. Although there will not be a
formal presentation, Commission staff will be available throughout the
scoping session to answer your questions about the environmental review
process. Representatives from Columbia Gulf will also be present to
answer project-specific questions.

Summary of the Proposed Project

    Columbia Gulf proposes to construct and operate three new
greenfield compressor stations, and modify one existing compressor
station. According to Columbia Gulf, its project would provide open
access firm transportation from a primary receipt point at

Columbia Gulf's Mainline Pool to a primary delivery point at an
interconnection with KMLP in Evangeline Parish, Louisiana.
    Each new compressor station (Shelburn Compressor Station in East
Carroll Parish, Red Mountain Compressor Station in Catahoula Parish,
and Chicot Compressor Station in Evangeline Parish) would include two
23,470 horsepower (hp) Solar Turbine Titan 130 natural gas turbine
driven compressors (totaling 46,940 hp), filter/separators, gas cooling
bays, 48-inch-diameter suction and 42-inch-diameter discharge piping,
and related appurtenant facilities.
    Modifications to the existing Alexandria Compressor Station in
Rapides Parish would include additional cooling bays with associated
piping and appurtenant facilities.
    The general location of the Louisiana Xpress Project facilities is
shown in appendix 2.

Land Requirements for Construction

    Construction of the proposed facilities would disturb about 167.4
acres of land for the aboveground facilities. Following construction,
Columbia Gulf would maintain about 35.8 acres for permanent operation
of the project's facilities; the remaining acreage would be restored
and revert to former uses.

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;
     socioeconomics;
     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 the 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 Office,
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 these 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.
---------------------------------------------------------------------------

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, newspapers and local libraries. 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 3).

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-
488). 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: August 28, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-19066 Filed 9-3-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96005-96007]
[FR Doc No: 2016-31512]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4317]

Compounding and Repackaging of Radiopharmaceuticals by
Outsourcing Facilities; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Compounding and Repackaging of Radiopharmaceuticals by Outsourcing
Facilities.'' Specifically, this guidance sets forth FDA's policy
regarding compounding and repackaging of radiopharmaceuticals for human
use by entities that are registered with FDA as outsourcing facilities.
This guidance describes how FDA intends to apply section 503B of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) to
radiopharmaceuticals compounded by outsourcing facilities, and it
describes the conditions under which FDA does not intend to take action
for violations of certain provisions of the FD&C Act when an
outsourcing facility repackages radiopharmaceuticals.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 27, 2017. Submit either electronic or written
comments concerning the collection of information proposed in the draft
guidance by February 27, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-4317 for ``Compounding and Repackaging of
Radiopharmaceuticals by Outsourcing Facilities.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information

redacted/blacked out, will be available for public viewing and posted
on http://www.regulations.gov. Submit both copies to the Division of
Dockets Management. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.

SUPPLEMENTARY INFORMATION:

I. Background

    In 2013, the Drug Quality and Security Act created a new section
503B of the FD&C Act (21 U.S.C. 353b), which describes a new category
of compounders called outsourcing facilities. Section 503B of the FD&C
Act describes the conditions that must be satisfied for human drug
products compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility to qualify for exemptions from
the following three sections of the FD&C Act:
     Section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning
labeling with adequate directions for use);
     section 505 (21 U.S.C. 355) (concerning drug approval
requirements); and
     section 582 (21 U.S.C. 360eee-1 (concerning drug supply
chain security requirements).
    In contrast to section 503A (21 U.S.C. 353a), section 503B of the
FD&C Act does not exclude radiopharmaceuticals. In general, FDA's
policies regarding section 503B of the FD&C Act apply to the
compounding of radiopharmaceutical drug products. However, the Agency
has developed specific policies, applicable only to the compounding of
radiopharmaceuticals by outsourcing facilities, with respect to bulk
drug substances for use in compounding radiopharmaceuticals and
compounding radiopharmaceuticals that are essentially copies of
approved drugs when such compounding is limited to minor deviations, as
that term is defined in the guidance.
    In addition, because outsourcing facilities may sometimes repackage
radiopharmaceuticals for patients, but repackaged radiopharmaceuticals
are not eligible for the exemptions in section 503B of the FD&C Act,
the draft guidance describes the conditions under which the Agency does
not intend to take action for violations of sections 505 and 502(f)(1)
of the FD&C Act when an outsourcing facility repackages
radiopharmaceuticals for human use.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a separate draft guidance document concerning
compounding and repackaging of radiopharmaceuticals by State-licensed
nuclear pharmacies and Federal facilities that are not registered as
outsourcing facilities entitled ``Compounding and Repackaging of
Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal
Facilities.''
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Compounding
and Repackaging of Radiopharmaceuticals by Outsourcing Facilities.'' It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection are given under this section with an estimate of the annual
reporting and recordkeeping burdens. Included in the estimate is the
time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information.
    We invite comments on the following topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
    The draft guidance includes the following collections of
information under the PRA:
    One condition in the draft guidance is that if a
radiopharmaceutical is repackaged by an outsourcing facility, the label
on the immediate container (primary packaging, e.g., the syringe) of
the repackaged product includes the following information:
     The statement ``This radiopharmaceutical was repackaged by
[name of outsourcing facility].'';
     the address and phone number of the outsourcing facility
that repackaged the radiopharmaceutical;
     the established name of the original, approved
radiopharmaceutical that was repackaged;
     the lot or batch number of the repackaged
radiopharmaceutical;
     the dosage form and radioactive dose of the repackaged
radiopharmaceutical;
     a statement of either the quantity or volume of the
repackaged radiopharmaceutical, whichever is appropriate;
     the date the radiopharmaceutical was repackaged;
     the beyond-use-date of the repackaged radiopharmaceutical;
     storage and handling instructions for the repackaged
radiopharmaceutical;
     the National Drug Code (NDC) number of the repackaged
radiopharmaceutical, if available \1\;
---------------------------------------------------------------------------

    \1\ The NDC number of the original approved drug product should
not be placed on the repackaged drug product.

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

     the statement ``Not for resale,'' and, if the repackaged
radiopharmaceutical is distributed by an outsourcing facility other
than pursuant to a prescription for an individual identified patient,
the statement ``Office Use Only''; and
     a list of the active and inactive ingredients, unless such
information is included on the label for the container from which the
individual units are removed, as described in this document.
    Another condition in the draft guidance is that the label on the
container from which the individual units are removed for
administration (secondary packaging, e.g., the bag, box, or other
package in which the repackaged products are distributed) includes the
active and inactive ingredients, if the immediate product label is too
small to include this information, and directions for use, including,
as appropriate, dosage and administration, and the following
information to facilitate adverse event reporting: http://www.fda.gov/medwatch and 1-800-FDA-1088.
    We estimate that annually a total of approximately 2 outsourcing
facilities (``No. of Respondents'' in table 1, row 1) will each design,
test, and produce approximately 5 different labels (``No. of
Disclosures per Respondent'' in table 1, row 1) for a total of 10
labels that include the information described previously (including
directions for use) (``Total Annual Disclosures'' in table 1, row 1).
We also estimate that designing, testing, and producing each label will
take approximately 0.5 hours for each repackaged radiopharmaceutical
(``Average Burden Hours per Disclosure'' in table 1, row 1). The
provision to add the statement http://www.fda.gov/medwatch and 1-800-
FDA-1088 is not included in this burden estimate because it is not
considered a collection of information under the PRA because the
information is ``originally supplied by the Federal Government to the
recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).
    The draft guidance also references registration, adverse event
reporting, product reporting, and current good manufacturing practices
(CGMP) requirements for outsourcing facilities. The collection of
information for outsourcing facility registration has been approved by
the Office of Management and Budget (OMB) under OMB control number
0910-0777 (79 FR 69859, November 24, 2014). The collection of
information for adverse event reporting by outsourcing facilities has
been approved by OMB under OMB control number 0910-0800 (80 FR 60917,
October 8, 2015). In the Federal Register of August 1, 2016 (81 FR
50523), FDA estimated the burden resulting from outsourcing facility
electronic drug product reporting. In the Federal Register of July 2,
2014 (79 FR 37743), FDA estimated the burden resulting from outsourcing
facility compliance with CGMP requirements.
    The total estimated third-party disclosure burden resulting from
the draft guidance is as follows:

                                                 Table 1--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
    Repackaging by outsourcing facilities        Number of     disclosures per    Total annual        Average burden per disclosure        Total hours
                                                respondents       respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Designing, testing, and producing each label               2                5               10   .5 (30 minutes).......................               5
 on immediate containers, packages and/or
 outer containers.
--------------------------------------------------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31512 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P