Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Tank Cars and Trucks; Gasoline: Submerged Loading (Clean Tanks)
                                   40600162
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Tank Cars and Trucks; Gasoline: Loaded with Fuel (Transit Losses)
                                   40600163
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Tank Cars and Trucks; Gasoline: Return with Vapor (Transit Losses)
                                   40600199
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Tank Cars and Trucks; Not Classified
                                   40600231
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Gasoline: Loading Tankers: Cleaned and Vapor Free Tanks
                                   40600232
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Gasoline: Loading Tankers
                                   40600233
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Gasoline: Loading Barges: Cleaned and Vapor Free Tanks
                                   40600234
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Gasoline: Loading Tankers: Ballasted Tank
                                   40600235
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Gasoline: Ocean Barges Loading - Ballasted Tank
                                   40600236
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Gasoline: Loading Tankers: Uncleaned Tanks
                                   40600237
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Gasoline: Ocean Barges Loading - Uncleaned Tanks
                                   40600238
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Gasoline: Loading Barges: Uncleaned Tanks
                                   40600239
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Gasoline: Tankers: Ballasted Tank
                                   40600240
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Gasoline: Loading Barges: Average Tank Condition
                                   40600241
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Gasoline: Tanker Ballasting
                                   40600299
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Marine Vessels; Not Classified
                                   40600301
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Gasoline Retail Operations - Stage I; Splash Filling
                                   40600302
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Gasoline Retail Operations - Stage I; Submerged Filling w/o Controls
                                   40600305
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Gasoline Retail Operations - Stage I; Unloading
                                   40600306
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Gasoline Retail Operations - Stage I; Balanced Submerged Filling
                                   40600307
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Gasoline Retail Operations - Stage I; Underground Tank Breathing and Emptying
                                   40600399
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Gasoline Retail Operations - Stage I; Not Classified **
                                   40600401
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Filling Vehicle Gas Tanks - Stage II; Vapor Loss w/o Controls
                                   40600501
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Pipeline Petroleum Transport - General - All Products; Pipeline Leaks
                                   40600502
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Pipeline Petroleum Transport - General - All Products; Pipeline Venting
                                   40600503
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Pipeline Petroleum Transport - General - All Products; Pump Station
                                   40600504
                                      RBT
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Pipeline Petroleum Transport - General - All Products; Pump Station Leaks
                                   40600602
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Consumer (Corporate) Fleet Refueling - Stage II; Liquid Spill Loss w/o Controls
                                   40600701
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Consumer (Corporate) Fleet Refueling - Stage I; Splash Filling
                                   40600702
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Consumer (Corporate) Fleet Refueling - Stage I; Submerged Filling w/o Controls
                                   40600706
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Consumer (Corporate) Fleet Refueling - Stage I; Balanced Submerged Filling
                                   40600707
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Consumer (Corporate) Fleet Refueling - Stage I; Underground Tank Breathing and Emptying
                                   40688801
                                    BTP/BPS
 Petroleum and Solvent Evaporation; Transportation and Marketing of Petroleum Products; Fugitive Emissions; Specify in Comments Field
<PHONE_NUMBER>
                                      RBT
 Storage and Transport; Petroleum and Petroleum Product Storage; Bulk Terminals: All Evaporative Losses; Gasoline
<PHONE_NUMBER>
                                    BTP/BPS
 Storage and Transport; Petroleum and Petroleum Product Storage; Bulk Plants: All Evaporative Losses; Gasoline
<PHONE_NUMBER>
                                    BTP/BPS
 Storage and Transport; Petroleum and Petroleum Product Storage; Gasoline Service Stations; Stage 1: Total
<PHONE_NUMBER>
                                    BTP/BPS
 Storage and Transport; Petroleum and Petroleum Product Storage; Gasoline Service Stations; Stage 1: Submerged Filling
<PHONE_NUMBER>
                                    BTP/BPS
 Storage and Transport; Petroleum and Petroleum Product Storage; Gasoline Service Stations; Stage 1: Splash Filling
<PHONE_NUMBER>
                                    BTP/BPS
 Storage and Transport; Petroleum and Petroleum Product Storage; Gasoline Service Stations; Stage 1: Balanced Submerged Filling
<PHONE_NUMBER>
                                    BTP/BPS
 Storage and Transport; Petroleum and Petroleum Product Storage; Gasoline Service Stations; Underground Tank: Total
<PHONE_NUMBER>
                                    BTP/BPS
 Storage and Transport; Petroleum and Petroleum Product Storage; Gasoline Service Stations; Underground Tank: Breathing and Emptying
<PHONE_NUMBER>
                                    BTP/BPS
 Storage and Transport; Petroleum and Petroleum Product Storage; All Storage Types: Working Loss; Total: All Products
<PHONE_NUMBER>
                                      RBT
 Storage and Transport; Petroleum and Petroleum Product Transport; All Transport Types; Gasoline
<PHONE_NUMBER>
                                      RBT
 Storage and Transport; Petroleum and Petroleum Product Transport; Marine Vessel; Gasoline
<PHONE_NUMBER>
                                      RBT
 Storage and Transport; Petroleum and Petroleum Product Transport; Marine Vessel; Gasoline - Barge
<PHONE_NUMBER>
                                    BTP/BPS
 Storage and Transport; Petroleum and Petroleum Product Transport; Truck; Gasoline
<PHONE_NUMBER>
                                      RBT
 Storage and Transport; Petroleum and Petroleum Product Transport; Pipeline; Gasoline
<PHONE_NUMBER>
                                    BTP/BPS
 Waste Disposal, Treatment, and Recovery; Leaking Underground Storage Tanks; Leaking Underground Storage Tanks; Total: All Storage Types


[Federal Register Volume 76, Number 209 (Friday, October 28, 2011)]
[Proposed Rules]
[Pages 66867-66869]
[FR Doc No: 2011-27928]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-1146; Airspace Docket No. 11-ASO-36]

Proposed Amendment of Class E Airspace; Rockingham, NC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E Airspace at Rockingham,
NC, as the Roscoe Non-Directional Beacon (NDB) has been decommissioned
and new Standard Instrument Approach Procedures have been developed at
Richmond County Airport. This action also would update the airport's
geographic coordinates and note the name change to Richmond County
Airport. This action would enhance the safety and airspace management
of Instrument Flight Rules (IFR) operations at the airport.

DATES: Effective 0901 UTC, Comments must be received on or before
December 12, 2011. The Director of the Federal Register approves this
incorporation by reference action under title 1, Code of Federal
Regulations, part 51, subject to the annual revision of FAA, Order
7400.9 and publication of conforming amendments.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Ave., SE., Washington, DC 20590-0001;
Telephone: 1-(800) 647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2011-1146; Airspace Docket No. 11-ASO-36, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2011-1146; Airspace Docket No. 11-ASO-36) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2011-1146; Airspace Docket No. 11-ASO-36.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. An
informal docket may also be examined during normal business hours at
the office of the Eastern Service Center, Federal Aviation
Administration, room 350, 1701 Columbia Avenue, College Park, Georgia
30337.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>, to
request a copy of Advisory circular No. 11-2A, Notice of Proposed
Rulemaking distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class E airspace extending upward
from 700 feet above the surface to support new standard instrument
approach procedures developed at Richmond County Airport, Rockingham,
NC. Airspace reconfiguration is necessary due to the decommissioning of
the Roscoe NDB and cancellation of the NDB approach, and for continued
safety and management of IFR operations at the airport. The geographic
coordinates for Richmond County Airport also would be adjusted to
coincide with the FAA's aeronautical database. Also, the airport name
would be changed from Rockingham-Hamlet Airport to Richmond County
Airport.
    Class E airspace designations are published in Paragraph 6005 of
FAA order 7400.9V, dated August 9, 2011, and effective September 15,
2011, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part A, Subpart I, Section 40103. Under that
section, the FAA is charged with prescribing regulations to assign the
use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would amend Class E airspace at Richmond County
Airport, Rockingham, NC.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

    1. The authority citation for Part 71 continues to read as follows:

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, effective September 15, 2011,
is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ASO NC E5 Rockingham, NC [Amended]

Richmond County Airport, NC
    (Lat. 34[deg]53'48'' N., long. 79[deg]45'58'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of the Richmond County Airport.

    Issued in College Park, Georgia, on October 21, 2011.
Michael Vermuth,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2011-27928 Filed 10-27-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)]
[Proposed Rules]
[Pages 60795-60796]
[FR Doc No: 2014-24007]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R04-RCRA-2012-0179; FRL-9917-52-Region-4]

Florida: Final Authorization of State Hazardous Waste Management
Program Revisions

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: Florida has applied to the Environmental Protection Agency
(EPA) for final authorization of changes to its hazardous waste program
under the Resource Conservation and Recovery Act (RCRA). These changes
correspond to certain Federal rules promulgated between July 1, 2007
and June 30, 2009, and July 1, 2010 and June 30, 2011 (also known as
RCRA Clusters XVIII, XIX and XXI). With this proposed rule, EPA is
proposing to grant final authorization to Florida for these changes.
Along with this proposed rule, EPA is publishing an immediate final
rule in the ``Rules and Regulations'' section of today's Federal
Register pursuant to which EPA is authorizing these changes. EPA did
not issue a proposed rule before today because EPA believes this action
is not controversial and does not expect comments that oppose it. EPA
has explained the reasons for this authorization in the immediate final
rule. Unless EPA receives written comments that oppose this
authorization during the comment period, the immediate final rule in
today's Federal Register will become effective on the date it
establishes, and EPA will not take further action on this proposal. If
EPA receives comments that oppose this action, EPA will withdraw the
immediate final rule and it will not take effect. EPA will then respond
to public comments in a later final rule based on this proposed rule.
You may not have another opportunity to comment on these State program
changes. If you want to comment on this action, you must do so at this
time.

DATES: Send your written comments by November 7, 2014.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
RCRA-2012-0179, by one of the following methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow
the on-line instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (prior to faxing, please notify the
EPA contact listed below)
     Mail: Send written comments to Anita K. Shipley, Permits
and State Programs Section, RCRA Programs and Materials Management
Branch, RCRA Division, U.S. Environmental Protection Agency, Atlanta
Federal Center, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960.
     Hand Delivery or Courier: Deliver your comments to Anita
K. Shipley, Permits and State Programs Section, RCRA Programs and
Materials Management Branch, RCRA Division, U.S. Environmental
Protection Agency, Atlanta Federal Center, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. Such deliveries are only accepted during
the Regional Office's normal hours of operation, and special

arrangements should be made for deliveries of boxed information.
    Please see the immediate final rule in the ``Rules and
Regulations'' section of today's Federal Register for detailed
instructions on how to submit comments.

FOR FURTHER INFORMATION CONTACT: Anita K. Shipley, Permits and State
Programs Section, RCRA Programs and Materials Management Branch, RCRA
Division, U.S. Environmental Protection Agency, Atlanta Federal Center,
61 Forsyth Street SW., Atlanta, Georgia 30303; telephone number: (404)
562-8466; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For additional information, please see the
immediate final rule published in the ``Rules and Regulations'' section
of today's Federal Register.

    Dated: August 27, 2014.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2014-24007 Filed 10-7-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Notices]
[Pages 71848-71849]
[FR Doc No: 2023-22979]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3240-040]

Briar Hydro Associates, LLC; Notice of Application Accepted for
Filing and Soliciting Motions To Intervene and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New License.
    b. Project No.: 3240-040.
    c. Date Filed: November 30, 2022.
    d. Applicant: Briar Hydro Associates, LLC.
    e. Name of Project: Rolfe Canal Hydroelectric Project.
    f. Location: On the Contoocook River, in the City of Concord,
Merrimack County New Hampshire. No federal lands are located within the
project boundary.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Andrew J. Locke, Essex Hydro Associates, LLC,
55 Union Street, Boston, MA 02108;<PHONE_NUMBER>; email:
[email protected].
    i. FERC Contact: Jeanne Edwards at<PHONE_NUMBER>; or
[email protected].
    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
motions to intervene and protests using the Commission's eFiling system
at https://ferconline.ferc.gov/FERCOnline.aspx. For assistance, please
contact FERC Online Support at [email protected], (866) 208-
3676 (toll free), or<PHONE_NUMBER> (TTY). In lieu of electronic
filing, you may submit a paper copy. Submissions sent via the U.S.
Postal Service must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE, Room 1A,
Washington, DC 20426. Submissions sent via any other carrier must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. All
filings must clearly identify the project name and docket number on the
first page: Rolfe Canal Hydroelectric Project (P-3240-040).
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted but is not ready for
environmental analysis.
    l. The Rolfe Canal Project diverts water from the York Dam into the
Rolfe Canal and consists of the following existing facilities: (1) York
impoundment with a surface area of 50-acres, at elevation of 342.5 feet
National Geodetic Vertical Datum 1929 (NGVD29); (2) a 300-foot-long,
10-foot-high diversion dam (York Dam); (3) a 50-foot-wide concrete
gated intake structure; (4) a 7,000-foot-long, 75-foot-

wide, and 9-foot-deep power canal; (5) an additional impoundment
(created by York Dam at the end of the power canal) with surface area
of 3-acres, at elevation of 342.5 feet NGVD29, and a negligible storage
capacity; (6) a 130-foot-long, 17-foot-high granite block intake dam;
(7) a 950-foot-long underground penstock; (8) a 32-foot-wide by 90-
foot-long, concrete powerhouse containing one Kaplan turbine-generating
unit with a capacity of 4.285 megawatts; (9) a 1,200-foot-long
tailrace; (10) transmission facilities consisting of a three-phase
4.16/34.5- kilovolt (kV) transformer, and a 34.5-kV, 650-foot-long
transmission line; and (11) other appurtenances. The project has a
4,000-foot-long bypassed reach.
    The project operates in a run-of-river mode with a minimum flow of
338 cubic feet per second (cfs), or inflow, whichever is less, into the
York impoundment, a minimum flow of 50 cfs into the York bypass, and a
minimum flow of 5 cfs into a historic channel that bypasses the
penstock. The project had an average annual generation of 19,585,884
kilowatt-hours between 2014 and 2018. Briar Hydro proposes to increase
the minimum flow into the York bypass to 100 cfs.
    m. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number, excluding the last
three digits in the docket number field to access the document. At this
time, the Commission has suspended access to the Commission's Public
Reference Room. For assistance, contact FERC at
[email protected], or call<PHONE_NUMBER> (toll free) or (202)
502-8659 (TTY).
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members, and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER>, or [email protected].
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests filed, but
only those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any protests
or motions to intervene must be received on or before the specified
deadline date for the particular application.
    All filings must (1) bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (2) set forth in the heading
the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR. 385.2001 through 385.2005.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application.
    o. Procedural schedule: The application will be processed according
to the following schedule. Revisions to the schedule will be made as
appropriate.

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

------------------------------------------------------------------------
Issue Scoping Document 1 for comments.....  November 2023.
Request Additional Information (if          November 2023.
 necessary).
Issue Scoping Document 2..................  December 2023.
Issue Notice of Ready for Environmental     December 2023.
 Analysis.
------------------------------------------------------------------------

    Dated: October 12, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-22979 Filed 10-17-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Notices]
[Pages 78874-78875]
[FR Doc No: 2014-30608]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2254]

The Drug Supply Chain Security Act Implementation: Product
Tracing Requirements--Compliance Policy; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``DSCSA
Implementation: Product Tracing Requirements--Compliance Policy.'' This
guidance announces FDA's intention with regard to enforcement of
certain product tracing requirements of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act
(DSCSA). FDA does not intend to enforce these requirements against
manufacturers, wholesale distributors, and repackagers who do not,
prior to May 1, 2015, provide or capture the transaction information,
transaction history, and transaction statement required by the FD&C Act
(product tracing information) for transaction of certain human,
finished prescription drugs that are covered in the statute.

DATES: Effective December 31, 2014. For information about enforcement
dates, please see the SUPPLEMENTARY INFORMATION section.

ADDRESSES: All responses to this notice should be identified with
Docket No. FDA-2014-D-2254 and directed to the office listed in the FOR
FURTHER INFORMATION CONTACT section of this document.

FOR FURTHER INFORMATION CONTACT: Office of Compliance, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``DSCSA Implementation: Product Tracing Requirements--
Compliance Policy.'' This guidance is being issued consistent with
FDA's good guidance practices regulation (21 CFR 10.115). This guidance
has been implemented without prior public comment because the Agency
has determined that prior public participation is not feasible or
appropriate. (Sec.  10.115(g)(2)). This guidance document provides
information pertaining to statutory requirements that will take effect
on January 1, 2015, regarding the provisions to provide and capture
product tracing information under section 582(b)(1), (c)(1), and (e)(1)
of the FD&C Act (21 U.S.C. 360eee-1(b)(1), (c)(1), and (e)(1)). It is
important that FDA provide this information before that date. Although
this guidance document is immediately in effect, it remains subject to
comment in accordance with the Agency's good guidance practices. (Sec.
10.115(g)(3)).
    On November 27, 2013, the DSCSA (Title II of Pub. L. 113-54) was
signed into law. Section 202 of the DSCSA added sections 581 and 582 to
the FD&C Act, which set forth new definitions and requirements for the
tracing of products through the pharmaceutical distribution supply
chain. Starting in 2015, trading partners (manufacturers, wholesale
distributors, dispensers, and repackagers) will be required under
section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act, to
exchange product tracing information when engaging in transactions
involving certain prescription drugs. Manufacturers, wholesale
distributors, and repackagers must meet these requirements by January
1, 2015; dispensers must meet these requirements by July 1, 2015.
    Although the product tracing requirements under section 582(b),
(c), and (e) of the FD&C Act go into effect for manufacturers,
wholesale distributors, and repackagers on January 1, 2015, some
trading partners have expressed concern that unforeseen complications
with the exchange of the required information may result in disruptions
in the pharmaceutical supply chain, and ultimately could impact
patients' access to needed prescription drugs. FDA recognizes that some
manufacturers, wholesale distributors, and repackagers may need time
beyond January 1, 2015, to work

with trading partners to ensure that all the proper product tracing
information is provided and captured. To minimize possible disruptions
in the distribution of prescription drugs in the United States, FDA
does not intend to take action against trading partners who do not,
prior to May 1, 2015, provide or capture the product tracing
information required by section 582(b)(1), (c)(1), and (e)(1) of the
FD&C Act. This compliance policy is limited to the requirements that
trading partners provide and capture product tracing information; it
does not extend to other requirements in section 582 of the FD&C Act,
such as verification of suspect and illegitimate products (including
quarantine, investigation, notification, and recordkeeping) or the
requirement to engage only in transactions with authorized trading
partners.

II. Comments

    This guidance is for immediate implementation. FDA is issuing this
guidance for immediate implementation in accordance with Sec.
10.115(g)(2). Submit one set of either electronic or written comments
on this guidance at any time. Submit electronic comments 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. You should identify all comments with
Docket No. FDA-2014-D-2254.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.regulations.gov.

    Dated: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30608 Filed 12-30-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 4, 2005 (Volume 70, Number 213)]
[Notices]
[Page 67204-67205]
[DOCID:fr04no05-111]

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SECURITIES AND EXCHANGE COMMISSION

Self-Regulatory Organizations; Notice of Application of Sunoco,
Inc. To Withdraw Its Common Stock, $1.00 par value, From Listing and
Registration on the Philadelphia Stock Exchange, Inc. File No. 1-06841

October 31, 2005.
    On October 3, 2005, Sunoco, Inc., a Pennsylvania corporation
(``Issuer''), filed an application with the Securities and Exchange
Commission (``Commission''), pursuant to Section 12(d) of the
Securities Exchange Act of 1934 (``Act''),\1\ and Rule 12d2-2(d)
thereunder,\2\ to withdraw its common stock, $1.00 par value
(``Security''), from listing and registration on the Philadelphia Stock
Exchange, Inc. (``Phlx'' or ``Exchange'').
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78l(d).
    \2\ 17 CFR 240.12d2-2(d).
---------------------------------------------------------------------------

    The Board of Directors (``Board'') of the Issuer approved
resolutions on September 1, 2005 to withdraw the Security from listing
on the Exchange. The Issuer stated that the following reasons factored
into the Board's decision to withdraw the Security from Phlx: (i) The
Issuer maintains the principal listing for the Security on the New York
Stock Exchange (``NYSE''); (ii) since the Sarbanes-Oxley Act of 2002,
new, more stringent corporate governance rules have been adopted by
various exchanges, including NYSE and Phlx; (iii) maintaining multiple
listings and compliance with the rules and disclosure requirements of
both NYSE and Phlx requires administrative time and internal costs; and
(iv) the benefits of continued listing on Phlx are outweighed by the
administrative burden and internal cost of such listing.
    The Issuer stated in its application that it has complied with the
requirements of Phlx Rule 809 governing an issuer's voluntary
withdrawal of a security from listing and registration by providing the
required documents for withdrawal from Phlx. The Issuer's application
relates solely to the withdrawal of the Security from listing on Phlx,
and shall not affect its continued listing on NYSE or its obligation to
be registered under Section 12(b) of the Act.\3\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 781(b).
---------------------------------------------------------------------------

    Any interested person may, on or before November 21, 2005, comment
on the facts bearing upon whether the application has been made in
accordance with the rules of Phlx, and what terms, if any, should be
imposed by the Commission for the protection of investors. All comment
letters may be submitted by either of the following methods:

Electronic Comments

     Send an e-mail to<EMAIL_ADDRESS>Please include
the File Number 1-06841 or;

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.
    All submissions should refer to File Number 1-06841. This file
number should be included on the subject line if e-mail is used. To
help us 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/delist.shtml).

Comments are also available for public inspection and copying in the
Commission's Public Reference Room. All comments received will be
posted without change; we do not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly.
    The Commission, based on the information submitted to it, will
issue an order granting the application after the date mentioned above,
unless the Commission determines to order a hearing on the matter.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\4\
---------------------------------------------------------------------------

    \4\ 17 CFR 200.30-3(a)(1).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-6121 Filed 11-3-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 227 (Monday, November 25, 2013)]
[Notices]
[Pages 70392-70394]
[FR Doc No: 2013-28138]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Waiver of Requirement To Enter Into a Reciprocal Waiver of Claims
Agreement With All Customers for Orbital Sciences Corporation

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of waiver.

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

SUMMARY: This notice concerns a petition for waiver submitted to the
Federal Aviation Administration (FAA) by Orbital Sciences Corporation
(Orbital) to waive, in part, the requirement that a launch operator
enter into a reciprocal waiver of claims with each customer. The FAA
grants the petition on the condition that no employees of NASA-
sponsored CubeSat operators will be inside a hazard area associated
with the Minotaur I launch.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this waiver, contact Charles P. Brinkman, Licensing Program Lead,
Commercial Space Transportation--Licensing and Evaluation Division, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
7715; email<EMAIL_ADDRESS>For legal questions concerning this
waiver, contact Sabrina Jawed, Attorney-Adviser, Space Law Branch, AGC-
250, Office of the Chief Counsel, Regulations Division, Federal
Aviation Administration, 800 Independence Avenue SW., Washington, DC
20591; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On November 8, 2013, Orbital submitted a petition to the FAA's
Office of Commercial Space Transportation (AST) requesting a waiver
under its launch license for flight of the Minotaur I launch vehicle
carrying the Air Force Operationally Responsive Space Office-3 (ORS-3)
payload. Orbital requested a partial waiver of 14 CFR 440.17, which
requires a licensee to enter into a

reciprocal waiver of claims (a ``cross-waiver'') with each of its
customers.
    The FAA licenses the launch of a launch vehicle and reentry of a
reentry vehicle under authority granted to the Secretary of
Transportation by the Commercial Space Launch Act of 1984, as amended
and re-codified by 51 U.S.C. Subtitle V, chapter 509 (Chapter 509), and
delegated to the FAA Administrator and the Associate Administrator for
Commercial Space Transportation, who exercises licensing authority
under Chapter 509.
    The petition for waiver applies to Orbital's November 2013 launch
of a Minotaur I launch vehicle and its ORS-3 payload. The ORS-3 mission
will demonstrate and validate launch and range improvements for NASA
and the military. The ORS-3 payloads consist of a Space Test Program
Satellite-3 (STPSat-3), twenty-eight other CubeSats, and two government
experiments that will not separate from the upper stage of the launch
vehicle. STPSat-3 is an Air Force technology demonstration mission.
Nineteen of the CubeSats are U.S. Government owned, one of which is
NASA's Small Satellite Program PhoneSat 2 second generation smartphone
mission. NASA is sponsoring the remaining ten CubeSats through its
CubeSat Launch Initiative. NASA's CubeSat Launch Initiative provides
opportunities for small satellite payloads to fly on rockets as part of
research addressing science, exploration, technology development,
education or operations.\1\ The operators of the ten NASA-sponsored
CubeSats are University of Hawaii, Vermont Technical College,
University of New Mexico, University of Louisiana at Lafayette,
University of Florida, University of Alabama in Huntsville, Thomas
Jefferson High School for Science and Technology, St. Louis University,
University of Kentucky, and Drexel University. Among the NASA-sponsored
CubeSats is the first CubeSat built by high school students.\2\
---------------------------------------------------------------------------

    \1\ NASA's CubeSat Launch Initiative (CSLI), http://www.nasa.gov/directorates/heo/home/CubeSats_initiative.html (last
visited Nov. 13, 2013).
    \2\ Chris Chester, Fairfax County School To Put First Student-
Built Satellite in Orbit, WAMU 88.5 News, Nov. 4, 2013, http://wamu.org/news/13/11/01/fairfax_county_school_helps_put_first_student_built_satellite_in_orbit.
---------------------------------------------------------------------------

    NASA obtained cross-waivers of liability with each of the above
educational institutions through Cooperative Research and Development
Agreements (CRADAs). These ten educational institutions are part of
NASA's Educational Launch of Nanosatellites (ELaNa) program. ELaNa is
an initiative created by NASA to attract and retain students in the
science, technology, engineering and mathematics disciplines. Students
participating in ELaNa are involved in developing, assembling, and
testing payloads as well as working with NASA and the launch vehicle
integration teams.\3\
---------------------------------------------------------------------------

    \3\ NASA's Educational Launch of Nanosatellites, http://www.nasa.gov/mission_pages/smallsats/elana/ (last visited Nov. 13,
2013).
---------------------------------------------------------------------------

    Cross-waivers are not required for the nineteen U.S. Government
owned CubeSats, or the two U.S. Government owned experiments that will
remain attached to the upper stage. The operators of the remaining ten
NASA-sponsored CubeSats qualify as customers under the FAA's
definitions. Section 440.3 defines a customer, in relevant part, as any
person with rights in the payload or any part of the payload, or any
person who has placed property on board the payload for launch,
reentry, or payload services. A person is an individual or an entity
organized or existing under the laws of a State or country. 51 U.S.C.
50901(12) (2013), 14 CFR 401.5 (2013). The subjects of this waiver are
persons because University of Hawaii, Vermont Technical College,
University of New Mexico, University of Louisiana at Lafayette,
University of Florida, University of Alabama in Huntsville, Thomas
Jefferson High School for Science and Technology, St. Louis University,
University of Kentucky, and Drexel University are entities organized or
existing under the laws of Hawaii, Vermont, New Mexico, Louisiana,
Florida, Alabama, Virginia, Missouri, Kentucky, and Pennsylvania,
respectively. Accordingly, because these persons have rights in their
respective payloads due to their ownership of those objects, and
because they have placed property on board, they are customers. Section
440.17 requires their signatures as customers.
    In this instance, however, each of the CubeSat operators is also
subject to a NASA reciprocal waiver of claims, a cross-waiver, which is
governed by NASA's regulations at 14 CFR 1266.104. Article 7 of the
CRADAs between NASA and the various NASA-sponsored CubeSat operators
governs liability and risk of loss and establishes a cross-waiver of
liability.
    Orbital's petition for partial waiver of the FAA requirement that
Orbital implement a cross-waiver with each customer applies to each of
the NASA-sponsored CubeSat operators, all of whom have signed a CRADA
with NASA, and who are customers of the November 2013 launch of the
Minotaur I launch vehicle carrying the ORS-3 payload.

Waiver Criteria

    Chapter 509 allows the FAA to waive a license requirement if the
waiver 1. will not jeopardize public health and safety, safety of
property; 2. will not jeopardize national security and foreign policy
interests of the United States; and 3. will be in the public interest.
51 U.S.C. 50905(b)(3); 14 CFR 404.5(b).

Waiver of FAA Requirement for Each Customer To Sign a Reciprocal Waiver
of Claims

    The FAA waives 14 CFR 440.17, which requires a licensee to enter
into a reciprocal waiver of claims with each of its customers, with
respect to the NASA-sponsored CubeSat operators, each of which has
signed a CRADA with NASA, and who are customers of the November 2013
launch of the Minotaur I launch vehicle carrying the ORS-3 payload.
    In 1988, as part of a comprehensive financial responsibility and
risk sharing regime that protects launch participants and the U.S.
Government from the risks of catastrophic loss and litigation, Congress
required that all launch participants agree to waive claims against
each other for their own property damage or loss, and to cover losses
experienced by their own employees. 51 U.S.C. 50915(b). This part of
the regime was intended to relieve launch participants of the burden of
obtaining property insurance by having each party be responsible for
the loss of its own property and to limit the universe of claims that
might arise as a result of a launch. H. Rep. 100-639, at 11-12 (1988);
S. Rep. 100-593, at 14, (1988); Financial Responsibility Requirements
for Licensed Launch Activities, Notice of Proposed Rulemaking, 61 FR
38992, 39011 (Jul. 25, 1996). The FAA's implementing regulations may be
found at 14 CFR part 440.
    In its request for a waiver, Orbital submits that the NASA CRADA
reciprocal waivers of claims imposed on the NASA-sponsored CubeSat
operators are equivalent to the requirements imposed on each customer
under the FAA's requirements of 14 CFR part 440. A comparison of the
two regimes shows that in this particular situation the two sets of
cross-waivers are sufficiently similar that the statutory goals of 51
U.S.C. 50914(b) will be met by the FAA agreeing to accept the NASA
cross-waivers in this instance, provided that no employees of NASA-
sponsored CubeSat operators will be inside a

hazard area associated with the Minotaur I launch.
    The FAA cross-waivers require the launch participants, including
the U.S. Government and each customer, and their respective contractors
and subcontractors, to waive and release claims against all the other
parties to the waiver and agree to assume financial responsibility for
property damage sustained by that party and for bodily injury or
property damage sustained by the party's own employees, and to hold
harmless and indemnify each other from bodily injury or property damage
sustained by their respective employees resulting from the licensed
activity, regardless of fault. 14 CFR 440.17(b) and (c). Each party \4\
to the cross-waiver must indemnify the other parties from claims by the
indemnifying party's contractors and subcontractors if the indemnifying
party fails to properly extend the requirements of the cross-waivers to
its contractors and subcontractors. 14 CFR 440.17(d).
---------------------------------------------------------------------------

    \4\ Indemnification by the U.S. Government is conditioned upon
the passage of legislation. 51 U.S.C. 50915; 14 CFR 440.17(d).
---------------------------------------------------------------------------

    A comparison of each element shows that, although there are some
differences, because Article 7 of the NASA CRADAs addressing liability
and risk of loss and signed by each of the NASA-sponsored CubeSat
operators is consistent with Congressional intent and the FAA's
regulations, and relevant employees will not be present at the launch
site, the FAA waives the requirement of 14 CFR 440.17 that NASA-
sponsored CubeSat operators must sign a cross-waiver. Additionally, the
FAA notes that because the only customers for the Minotaur I November
2013 launch are the U.S. Government, for which cross-waivers are not
required, and the various NASA-sponsored CubeSat operators, for which
the CRADAs provide waivers of liability, the only signatories to the
FAA cross-waivers as required by 14 CFR 440.17 are the FAA, on behalf
of the U.S. Government, and Orbital. Therefore, Orbital does not need
to amend its cross-waivers to provide that signing customers waive
claims against any other customer as defined by 14 CFR 440.3, as the
FAA has previously required before granting a similar waiver.\5\
---------------------------------------------------------------------------

    \5\ See Waiver of Requirement to Enter Into a Reciprocal Waiver
of Claims Agreement With All Customers for Orbital Sciences
Corporation, Notice of Waiver, 78 FR 57215, 57216 (Sept. 17, 2013).
---------------------------------------------------------------------------

    The FAA bases this determination of sufficient similarity between
the FAA and NASA cross-waiver schemes on the reasons stated in the
waiver the FAA published for Space Exploration Technologies Corporation
on October 16, 2012,\6\ and for the reasons stated above.\7\ The FAA
finds that that this waiver implicates no safety, national security or
foreign policy issues. The waiver is consistent with the public
interest goals of Chapter 509. Under 51 U.S.C. 50914, Congress
determined that it was necessary to reduce the costs associated with
insurance and litigation by requiring launch participants, including
customers, to waive claims against each other. Because the CRADAs under
14 CFR part 1266 accomplish these goals by the same or similar means,
the FAA finds this request in the public interest. The FAA grants the
waiver with respect to the NASA-sponsored CubeSat operators in reliance
on the representations Orbital made in its petition, and on the
condition that no employees of NASA-sponsored CubeSat operators will be
inside a hazard area associated with the Minotaur I launch.
---------------------------------------------------------------------------

    \6\ Waiver of Requirement to Enter Into a Reciprocal Waiver of
Claims Agreement With All Customers, Notice of Waiver, 77 FR 63221
(Oct. 16, 2012).
    \7\ The FAA also notes that although its previous waiver cited
above discussed NASA's Space Act Agreements rather than CRADAs, the
waiver of liability language in both types of NASA contract has the
same effect and therefore the FAA applies the same reasoning.

    Issued in Washington, DC, on November 15, 2013.
Kenneth Wong,
Commercial Space Transportation, Licensing and Evaluation Division
Manager.
[FR Doc. 2013-28138 Filed 11-22-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Page 49681]
[FR Doc No: 2016-17865]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Oncologic Drugs Advisory
Committee. The general function of the committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues. The
meeting will be open to the public.

DATES: The meeting will be held on September 14, 2016, from 8 a.m. to 1
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Lauren D. Tesh, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER><EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The committee will discuss new drug application 208714,
apaziquone for intravesical instillation, application submitted by
Spectrum Pharmaceuticals, Inc. The proposed indication (use) for this
product is for immediate intravesical instillation post-transurethral
resection of bladder tumors in patients with non-muscle invasive
bladder cancer.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 30, 2016. Oral presentations from the public will be scheduled
between approximately 10:45 a.m. and 11:45 a.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before August 22, 2016. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by August 23, 2016.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require special accommodations due to a
disability, please contact Lauren D. Tesh at least 7 days in advance of
the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: July 25, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-17865 Filed 7-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Pages 68881-68883]
[FR Doc No: 2014-27388]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC15-30-000.
    Applicants: DTE Electric Company, Renaissance Power, L.L.C.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities of DTE Electric Company and Renaissance
Power, L.L.C.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5352.
    Comments Due: 5 p.m. ET 12/3/14.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG15-13-000.
    Applicants: Iberdrola Arizona Renewables, LLC.
    Description: Self-Certification of EWG Status of Iberdrola Arizona
Renewables, LLC.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5363.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: EG15-14-000.
    Applicants: Iberdrola Texas Renewables, LLC.
    Description: Self-Certification of EWG Status of Iberdrola Texas
Renewables, LLC.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5392.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: EG15-15-000.
    Applicants: Chief Conemaugh Power, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Chief Conemaugh Power, LLC.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5393.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: EG15-16-000.
    Applicants: Chief Keystone Power, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Chief Keystone Power, LLC.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5394.
    Comments Due: 5 p.m. ET 12/3/14.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER15-371-000.
    Applicants: Alabama Power Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Georgia
SNF Development I LGIA Filing to be effective 10/31/2014.
    Filed Date: 11/10/14.
    Accession Number: 20141110-5269.
    Comments Due: 5 p.m. ET 12/1/14.

    Docket Numbers: ER15-377-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2236R4
Golden Spread Electric Cooperative, Inc. NITSA to be effective 9/1/
2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5207.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-378-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Midcontinent Independent System Operator, Inc. submits
Notice of Termination of Generator Interconnection Agreement No. 1135
for Project G117.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5237.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-379-000.
    Applicants: PacifiCorp.
    Description: Tariff Withdrawal per 35.15: Termination of IPCo
Communications Replacement Agreement to be effective 1/28/2015.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5269.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-380-000.
    Applicants: Lower Mount Bethel Energy, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5309.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-381-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2014-
11-12_SA 2713 OTP-CPEC Turtle Lake T-L IA to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5324.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-382-000.
    Applicants: PPL Brunner Island, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov 12
Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5330.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-383-000.
    Applicants: PPL Colstrip I, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5329.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-384-000.
    Applicants: PPL Colstrip II, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5335.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-385-000.
    Applicants: PPL Electric Utilities Corporation.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5336.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-386-000.
    Applicants: PPL EnergyPlus, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5342.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-387-000.
    Applicants: PPL Holtwood, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5343.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-388-000.
    Applicants: PPL Martins Creek, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5350.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-389-000.
    Applicants: PPL Montana, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5351.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-390-000.
    Applicants: PPL New Jersey Biogas, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5355.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-391-000.
    Applicants: PPL New Jersey Solar, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5361.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-392-000.
    Applicants: PPL Renewable Energy, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5362.
    Comments Due: 5 p.m. ET 12/3/14.

    Docket Numbers: ER15-393-000.
    Applicants: PPL Susquehanna, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Nov
2014 Market-Based Rate Tariff Revisions to be effective 11/13/2014.
    Filed Date: 11/12/14.
    Accession Number: 20141112-5365.
    Comments Due: 5 p.m. ET 12/3/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and

385.214) on or before 5:00 p.m. Eastern time on the specified comment
date. Protests may be considered, but intervention is necessary to
become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 12, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-27388 Filed 11-18-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Notices]
[Pages 69742-69743]
[FR Doc No: 2011-29058]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0797]

Agency Information Collection Activities; Proposed Collection;
Comment Request; State Enforcement Notifications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting requirements
contained in existing FDA regulations governing State enforcement
notifications.

DATES: Submit either electronic or written comments on the collection
of information by January 9, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, II, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

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

State Enforcement Notifications--21 CFR 100.2(d) (OMB Control Number
0910-0275)--Extension

    Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 337(b)) authorizes States to enforce certain
sections of the FD&C Act in their own names but provides that States
must notify FDA before doing so. Section 100.2(d) (21 CFR 100.2(d))
sets forth the information that a State must provide to FDA in a letter
of notification when it intends to take enforcement action under the
FD&C Act against a particular food located in the State. The
information required under Sec.  100.2(d) will enable FDA to identify
the food against which the State intends to take action and advise the
State whether Federal action has been taken against it. With certain
narrow exceptions, Federal enforcement action precludes State action
under the FD&C Act.
    FDA estimates the burden of this collection of information as
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR section                               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.2(d)...........................................................               1                1                1               10               10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated reporting burden for Sec.  100.2(d) is minimal
because enforcement notifications are seldom used by States. During the
last 3 years, FDA has not received any new enforcement notifications;
therefore, the Agency estimates that one or fewer notifications will be
submitted annually. Although FDA has not received any new enforcement
notifications in the last 3 years, it believes these information
collection provisions should be extended to provide for the potential
future need of a State government to submit enforcement notifications
informing FDA when it intends to take enforcement action under the FD&C
Act against a particular food located in the State.

    Dated: November 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29058 Filed 11-8-11; 8:45 am]
BILLING CODE 4160-01-P