[Federal Register Volume 78, Number 132 (Wednesday, July 10, 2013)]
[Notices]
[Pages 41389-41390]
[FR Doc No: 2013-16503]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13346-003]

Free Flow Power Corporation; Notice of Application Ready for
Environmental Analysis and Soliciting Comments, Recommendations, Terms
and Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original Major License.
    b. Project No.: P-13346-003.
    c. Date filed: December 3, 2012.
    d. Applicant: Free Flow Power Corporation (Free Flow Power), on
behalf of its subsidiary PayneBridge, LLC.
    e. Name of Project: Williams Dam Water Power Project.
    f. Location: At the existing Williams dam owned by the Indiana
Department of Natural Resources on the East Fork White River in
Lawrence County, Indiana. No federal lands are occupied by the project
works or located within the project boundary.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)--825(r)

    h. Applicant Contacts: Ramya Swaminathan, Chief Operating Officer,
Free Flow Power Corporation, 239 Causeway Street, Suite 300, Boston, MA
02114; or at<PHONE_NUMBER>.
    Daniel Lissner, General Counsel, Free Flow Power Corporation, 239
Causeway Street, Suite 300, Boston, MA 02114; or at<PHONE_NUMBER>.
    i. FERC Contact: Aaron Liberty at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    All documents may be filed electronically via the Internet. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and five copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    The Commission's Rules of Practice and Procedures 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 for filing and is now ready
for environmental analysis.
    l. The 21.3-foot-high, 294-foot-long Williams dam is currently
owned by the Indiana Department of Natural Resources and impounds a
553-acre reservoir at a normal pool elevation of 472.2 North American
Vertical Datum of 1988 (NAVD 88). In addition to the dam, the Williams
Dam Water Power Project would consist of the following new facilities:
(1) An 80-foot-long, 21.5-foot-high, 100-foot-wide intake structure
with trashracks having 3-inch clear bar spacing; (2) a 126-foot-long,
81-foot-wide powerhouse integral to the dam; (3) four turbine-generator
units with a combined installed capacity of 4.0 megawatts; (4) a 40-
foot by 40-foot substation; (5) a 265-foot-long, three-phase, 12.5-
kilovolt overhead transmission line connecting the project's substation
to local utility distribution lines; and (6) other appurtenant
facilities.
    The proposed project would operate in a run-of-river mode and the
water surface elevation of the impoundment would be maintained at the
existing normal pool elevation (crest of the dam spillway) or above.
The average annual generation would be about 17,850 megawatt-hours.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    All filings must (1) bear in all capital letters the title
``COMMENTS'', ``REPLY COMMENTS'', ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS;'' (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 submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b), and 385.2010.
    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.
    n. Public notice of the filing of the initial development
application, which has already been given, established the due date for
filing competing applications or notices of intent. Under the
Commission's regulations, any competing development application must be
filed in response to and in compliance with public notice of the
initial development application. No competing applications or notices
of intent may be filed in response to this notice.
    o. A license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.

    Dated: July 2, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-16503 Filed 7-9-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 166 (Monday, August 27, 2012)]
[Notices]
[Pages 51848-51849]
[FR Doc No: 2012-20935]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2012-0215]

Pipeline Safety: Information Collection Activities

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

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, PHMSA
invites comments on two information collections that we will be
submitting to the Office of Management and Budget (OMB) for renewal.
The information collections relate to the program for Control Room
Management/Human Factors and the Integrity Management Program for Gas
Distribution Pipelines.

DATES: Interested persons are invited to submit comments on or before
October 26, 2012.

ADDRESSES: Comments may be submitted 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 20590-0001.
    Hand Delivery: Room W12-140 on the ground level of DOT, West
Building, 1200 New Jersey Avenue SE., Washington, DC, between 9:00 a.m.
and 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: Identify the docket number, PHMSA-2012-0215, 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 visit 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 DOT, West Building, 1200 New Jersey Avenue
SE., Washington, DC, between 9 a.m. and 5 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-2012-0215.''
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.

FOR FURTHER INFORMATION CONTACT: Angela Dow by telephone at 202-366-
1246, by fax at<PHONE_NUMBER>, or by mail at DOT, PHMSA, 1200 New Jersey
Avenue SE., PHP-30, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION: Section 1320.8(d), Title 5, Code of Federal
Regulations, requires PHMSA to provide interested members of the public
and affected agencies an opportunity to comment on information
collection and recordkeeping requests. This notice identifies an
information collection request that PHMSA will be submitting to OMB for
renewal. The following information is provided for that information
collection: (1) Title of the information collection; (2) OMB control
number; (3) Current expiration date; (4) Type of request; (5) Abstract
of the information collection activity; (6) Description of affected
public; (7) Estimate of total annual reporting and recordkeeping
burden; and (8) Frequency of collection. PHMSA will request a three-
year term of approval for the information collection activity. PHMSA
requests comments on the following information collections:
    Title: Pipeline Safety: Control Room Management/Human Factors.
    OMB Control Number: 2137-0624.
    Current Expiration Date: 1/31/2013.
    Abstract: 49 CFR 192.631 and 195.446 address human factors and
other components of control room management. These regulations require
operators of hazardous liquid pipelines and gas pipelines to develop
and implement a human factors management plan designed to reduce risk
associated with human factors in each control room.
    Affected Public: Private sector; Operators of both natural gas and
hazardous liquid pipeline systems.
    Annual Reporting and Recordkeeping Burden:
    Total Annual Responses: 2,702.
    Total Annual Burden Hours: 1,018,807.
    Frequency of Collection: On Occasion.
    Title: Integrity Management Program for Gas Distribution Pipelines.
    OMB Control Number: 2137-0625.
    Current Expiration Date: 1/31/2013.
    Abstract: The Federal Pipeline Safety Regulations in 49 CFR, Part
192, Subpart P require operators of gas distribution pipelines to
develop and implement integrity management (IM) programs. The purpose
of these programs is to enhance safety by identifying and reducing
pipeline integrity risks. PHMSA requires that operators maintain
records demonstrating compliance with these requirements for 10 years,
and that these records must include superseded IM plans.
    Affected Public: Operators of gas distribution pipeline systems.
    Annual Reporting and Recordkeeping Burden:
    Total Annual Responses: 9,343.
    Total Annual Burden Hours: 865,178.
    Frequency of Collection: On occasion.
    Comments are invited on:
    (a) The need for the proposed collection of information for the
proper performance of the functions of the agency, including whether
the information will have practical utility;
    (b) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (c) Ways to enhance the quality, utility, and clarity of the
information to be collected; and
    (d) Ways to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques.

    Issued in Washington, DC, on August 21, 2012.
John A. Gale,
Director, Office of Standards and Rulemaking.
[FR Doc. 2012-20935 Filed 8-24-12; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register: November 15, 2006 (Volume 71, Number 220)]
[Notices]
[Page 66510]
[DOCID:fr15no06-42]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-45-000]

Northern Natural Gas Company; Notice of Proposed Changes in FERC
Gas Tariff

November 7, 2006.
    Take notice that Northern Natural Gas Company (Northern) on
November 3, 2006 tendered for filing to become part of its FERC Gas
Tariff, Fifth Revised Volume No. 1, Substitute Sixth Revised Sheet No.
54A, proposed to be effective on December 1, 2006.
    Northern further states that copies of the filing have been mailed
to each of its customers and interested state commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Sec.  154.210 of the Commission's regulations (18 CFR 154.210). Anyone
filing an intervention or protest must serve a copy of that document on
the Applicant. Anyone filing an intervention or protest on or before
the intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-19222 Filed 11-14-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Notices]
[Pages 5463-5465]
[FR Doc No: 2013-01446]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0032]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Antimicrobial Animal
Drug Distribution Reports Under Section 105 of the Animal Drug User Fee
Amendments of 2008

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
February 25, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0659 and
title, ``Antimicrobial Animal Drug Distribution Reports Under Section
105 of the Animal Drug User Fee Amendments of 2008.'' Also include the
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance. Antimicrobial Animal Drug Distribution Reports
Under Section 105 of the Animal Drug User

Fee Amendments of 2008--(OMB Control Number 0910-0659)--Extension

    Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA
II) (Pub. L. 316) amended section 512 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360b) by, among other things,
creating section 512(l)(3) to require that the sponsor of each new
animal drug that contains an antimicrobial agent submit an annual
report to FDA on the amount of each antimicrobial active ingredient in
the drug that is sold or distributed for use in food-producing animals,
including information on any distributor-labeled product. The
legislation was enacted to address the problem of antimicrobial
resistance and to help ensure that FDA has the necessary information to
examine safety concerns related to the use of antibiotics in food-
producing animals (154 Congressional Record H7534).
    Each report must specify: (1) The amount of each antimicrobial
active ingredient by container size, strength,

and dosage form; (2) quantities distributed domestically and quantities
exported; and (3) a listing of the target animals, indications, and
production classes that are specified on the approved label of the
product. The first report under the statute was to be submitted not
later than March 31, 2010.
    The report covered the period of the preceding calendar year and
included separate information for each month of the calendar year.
    We are now seeking to further implement the statutory requirements
of ADUFA II and enhance its public health and safety mission as
envisioned by Congress by introducing an electronic form for the
submission of the required annual reports under ADUFA II. The e-form
FDA 3744a will enable sponsors to submit electronically and capture all
information as mandated by Section 105 of ADUFA II. Form FDA 3744 will
continue to be designated for paper submissions.
    List of information required on form FDA 3744 and e-form FDA 3744a:
     Application Type
     Application Number
     Firm Name
     Dosage Form(s)
     Production Class(es)
     Animal Species--Food Animal or Food and Non-Food Animal
     Indications
     Active Ingredient(s)
     Domestic Quantities
    [cir] Unit of Measure for All Active Ingredients
    [cir] Calendar Year
    [cir] Quantity Sold by Month for All Active Ingredients
    [cir] Annual Total Sold for All Active Ingredients
     Export Quantities
    [cir] Unit of Measure for All Active Ingredients
    [cir] Calendar Year
    [cir] Quantity Sold by Month for All Active Ingredients
    [cir] Annual Total Sold for All Active Ingredients
     Individual Product Information for All Active Ingredients
    [cir] Dosage Form
    [cir] Container Size
    [cir] Container Units
    [cir] Active Ingredient Strength
     Quantities of Individual Products Sold or Distributed
(Domestic and Export)
    [cir] Unit of Measure for All Active Ingredients
    [cir] Quantity Sold by Month for All Active Ingredients
    [cir] Annual Total Sold for All Active Ingredients
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                        Average
    FD&C Act section 512(1)(3)          Form FDA No.         Number of     responses per   Total annual     burden per      Total hours    Capital costs
                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Reports for Sponsors With    3744................              14             5.9              83              60           4,980          $6,975
 Active Applications--Paper
 Submission.
Annual Reports for Sponsors With    e-Form 3744a........              12             6.7              80              50           4,000               0
 Active Applications--Electronic
 Submission.
Annual Reports for Sponsors With    3744................              13             6.2              81               2             162               0
 Inactive Applications--Paper
 Submission.
Annual Reports for Sponsors With    e-Form 3744a........              11             7.3              80               2             160               0
 Inactive Applications--Electronic
 Submission.
                                                         -----------------------------------------------------------------------------------------------
    Total.........................  ....................  ..............  ..............  ..............  ..............           9,302          $6,975
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    The total annual responses were calculated by multiplying the
number of respondents times the number of responses per respondent.
Total burden hours were calculated by multiplying total annual
responses times the average burden per response. As explained in the
supporting statement for the subject collection of information (OMB
control number 0910-0659), the initial one-time capital costs are for
the design of the report. Here, e-form FDA 3744a and reporting via the
Electronic Submission Gateway are provided by FDA. Thus, the remaining
cost, as described in approved OMB control number 0910-0659 is $6,975
per year (3 hours x $46.50 wage rate x 50 sponsors) = $6,975. FDA
believes that the sponsors already possess the computer equipment
needed to prepare the report so that additional capital expenditures
will not be necessary.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Number of       Number of records     Total annual     Average burden per
                 21 CFR 514.80(b)(5)                     recordkeepers     per recordkeeper         records          recordkeeping        Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Records and reports concerning experience with                       34                   1                  34                   2                  68
 approved new animal drugs--special drug experience
 report.............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Total annual records were calculated by multiplying the number of
recordkeepers times the number of records per recordkeeper. Total hours
were calculated by multiplying total annual records times the average
burden per recordkeeping.
    In the Federal Register of January 17, 2012 (77 FR 2302), FDA
published a 60-day notice requesting public comment on the proposed
collection of information to which three comments were received: two
from organizations and one from a member of Congress. The commenters
generally supported the collection of sales data, and stated that this
information would be useful in assessing antimicrobial drugs used in
food-producing animals to better address the problem of antimicrobial
resistance. One commenter stated that the information supplied by drug
companies should be submitted in a format that would allow it to be
easily merged with data from other FDA databases.
    Beyond the scope of this Federal Register notice, all commenters
recommended collection of antimicrobial use information in addition to
the current requirements of ADUFA II sales reporting. All commenters
also recommended revisions to the public reporting of the data being
collected. The commenters requested FDA report sales of antimicrobial
drug classes by month, by route of administration, by indication, by
over-the-counter or prescription status, or grouped by their importance
in human medicine. It was recommended that FDA collect and publicly
report distribution information down to the state or regional level.
ADUFA II requires that no class with fewer than three distinct sponsors
of approved applications shall be independently reported; it was
recommended that FDA seek additional authority from Congress to report
sales figures for all antimicrobial classes regardless of the number of
distinct drug sponsors. There was also a recommendation that all of the
information collected be made publicly available in a searchable
database.
    FDA has considered the comments, but at this time we can only
require the submission of information on the new e-form FDA 3744a that
is expressly required to be submitted by section 512(l)(3) of the FD&C
Act. We are pursuing notice and comment rulemaking to codify these
requirements, and are currently assessing any additional data
requirements. In this regard, FDA published an Advance Notice of
Proposed Rulemaking on July 27, 2012, in which FDA solicited comment on
the following: (1) Whether FDA should require submission of an estimate
of the amount of antimicrobial ingredient sold or distributed for use
in each approved food animal species, (2) how FDA can best compile and
present required summary information, and (3) alternative methods there
may be for obtaining additional data and information about the extent
of antimicrobial drug use in food-producing animals and are there
alternative methods the Agency can employ within its existing
authority.

    Dated: January 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01446 Filed 1-24-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: June 12, 2009 (Volume 74, Number 112)]
[Proposed Rules]
[Page 27953-27956]
[DOCID:fr12jn09-21]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-0359]
RIN 1625-AA00

Safety Zone; Sabine River, Orange, TX

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary safety zone
on September 19 and 20, 2009 for a portion of the Sabine River,
shoreline to shoreline, adjacent to the Naval Reserve Center and the
Orange public boat ramps located in Orange, TX. The northern boundary
is from the end of Navy Pier One at 30[deg]05'45'' N 93[deg]43'24'' W
then easterly to the river's eastern shore. The southern boundary is a
line shoreline to shoreline at latitude 30[deg]05'33'' N. This safety
zone is needed to protect spectators and vessels from potential safety
hazards associated with a high speed boat race. With the exception of
participating vessels and patrol craft, entry into this zone is
prohibited unless specifically authorized by the Captain of the Port,
Port Arthur, or a designated representative.

DATES: Comments and related material must reach the Coast Guard on or
before July 13, 2009.

ADDRESSES: You may submit comments identified by Coast Guard docket
number USCG-2009-0359 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: Mr. Scott Whalen, Marine Safety Unit
Port Arthur, telephone<PHONE_NUMBER> or e-mail
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2009-0359), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via www.regulations.gov, it will be considered received
by the Coast Guard when you successfully transmit the comment. If you
fax, hand deliver, or mail your comment, it will be considered as
having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert ``USCG-2009-0359'' in the Docket ID box, press Enter,
and then click on the balloon shape in the Actions column. If you
submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert USCG-2009-0359 in the Docket ID box, press Enter, and
then click on the item in the Docket ID column. You may also visit the
Docket Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue,
SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. We have an agreement with the
Department of Transportation to use the Docket Management Facility.

Privacy Act

    Anyone can 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.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008 issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the four methods specified under ADDRESSES
explaining why one would be beneficial. If we determine that one would
aid this rulemaking, we will hold one at a time and place announced by
a later notice in the Federal Register.

Background and Purpose

    The City of Orange is sponsoring high speed boat races on the
Sabine River in Orange, TX on September 19 and September 20, 2009. Race
boats will be traveling at a very high rate of speed and at times may
not be able to stop or avoid a collision if spectator or other vessels
are operating in close proximity to the race course. The proposed
safety zone is needed to protect the race boats, persons and spectators
from the potential safety hazards associated with high speed boat
races.

Discussion of Proposed Rule

    The Coast Guard proposes to establish a temporary safety zone for a
portion of the Sabine River, shoreline to shoreline, adjacent to the
Naval Reserve Center and the Orange public boat ramps located in
Orange, TX. The northern boundary is from the end of Navy Pier One at
30[deg]05'45'' N 93[deg]43'24'' W then easterly to the river's eastern
shore. The southern boundary is a line shoreline to shoreline at
latitude 30[deg]05'33'' N.
    All vessels except event participants and patrol craft are
prohibited from entering the safety zone unless authorized by the
Captain of the Port, Port Arthur or his designated representative. For
authorization to enter the proposed safety zone, vessels can contact
the Captain of the Port's on scene representative on VHF Channel 16 or
Vessel Traffic Service Port Arthur on VHF Channel 65A, by telephone at
(409) 719-5070, or by facsimile at<PHONE_NUMBER>.

Regulatory Analysis

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order.
    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary. The basis of
this finding is that the safety zone will only be in effect for 10
hours each day and notifications

to the marine community will be made through broadcast notice to
mariners and Marine Safety Information Bulletin. During non-enforcement
hours all vessels will be allowed to transit through the safety zone
without permission of the Captain of the Port, Port Arthur or a
designated representative. Additionally, breaks will be provided to
allow waiting vessels to transit safely through the safety zone. The
impacts on routine navigation are expected to be minimal.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. 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 certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities.
    This proposed rule would not have a significant economic impact on
a substantial number of small entities for the following reasons: (1)
This rule will only be enforced from 9 a.m. until 6 p.m. each day that
it is effective; (2) during non-enforcement hours all vessels will be
allowed to transit through the safety zone without having to obtain
permission from the Captain of the Port, Port Arthur or a designated
representative; and (3) vessels will be allowed to pass through the
zone with permission of the Coast Guard Patrol Commander during
scheduled break periods between races and at other times when permitted
by the Coast Guard Patrol Commander.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.

Assistance for Small Entities

    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 proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact Mr. Scott Whalen at (409) 719-
5086. 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.

Collection of Information

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

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

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 or more in any
one year. Though this proposed rule would not result in such
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.

Taking of Private Property

    This proposed rule would not affect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that Order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies. This proposed rule would not use technical standards.
Therefore, we did not consider the use of voluntary consensus
standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of

actions which do not individually or cumulatively have a significant
effect on the human environment. A preliminary environmental analysis
checklist supporting this preliminary determination is available in the
docket where indicated under ADDRESSES. This proposed rule involves
establishing a temporary safety zone. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    1. The authority citation for part 165 continues to read as
follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Public Law 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    2. Add new temporary Sec.  165.T08-0359 to read as follows:

Sec.  165.T08-0359  Safety Zone; Sabine River, Orange, TX.

    (a) Definitions. As used in this section Participant Vessel means
all vessels officially registered with event officials to race or work
in the event. These vessels include race boats, rescue boats, tow
boats, and picket boats associated with the race.
    (b) Location. The following area is a safety zone: all waters of
the Sabine River, shoreline to shoreline, adjacent to the Naval Reserve
Unit and the Orange public boat ramps located in Orange, TX. The
northern boundary is from the end of Navy Pier One at 30[deg]05'45'' N
93[deg]43'24'' W then easterly to the river's eastern shore. The
southern boundary is a line shoreline to shoreline at latitude
30[deg]05'33'' N.
    (c) Effective date. This rule is effective from 9 a.m. on September
19, 2009 until 6 p.m. on September 20, 2009.
    (d) Periods of Enforcement. This rule will be enforced from 9 a.m.
until 6 p.m. on September 19, 2009 and 9 a.m. until 6 p.m. on September
20, 2009. The Captain of the Port, Port Arthur will inform the public
through broadcast notice to mariners of the enforcement periods for the
safety zone.
    (e) Regulations.
    (1) In accordance with the general regulations in Sec.  165.23 of
this part, entry into this zone is prohibited to all vessels except
participant vessels and those vessels specifically authorized by the
Captain of the Port, Port Arthur or a designated representative.
    (2) Persons or vessels requiring entry into or passage through must
request permission from the Captain of the Port, Port Arthur, or a
designated representative. They may be contacted on VHF Channel 13 or
16, or by telephone at<PHONE_NUMBER>.
    (3) All persons and vessels shall comply with the instructions of
the Captain of the Port, Port Arthur, designated representatives and
designated on-scene U.S. Coast Guard patrol personnel. On-scene U.S.
Coast Guard patrol personnel include commissioned, warrant, and petty
officers of the U.S. Coast Guard.

    Dated: May 5, 2009.
J.J. Plunkett,
Captain, U.S. Coast Guard, Captain of the Port, Port Arthur.
[FR Doc. E9-13775 Filed 6-11-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Page 23569]
[FR Doc No: 2013-09181]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0324]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry, FDA Staff,
and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small
Business Qualification and Certification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance for Industry, FDA Staff,
and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small
Business Qualification and Certification'' has been approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On January 31, 2013, the Agency submitted a
proposed collection of information entitled ``Guidance for Industry,
FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device
User Fee Small Business Qualification and Certification'' to OMB for
review and clearance under 44 U.S.C. 3507. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
OMB has now approved the information collection and has assigned OMB
control number 0910-0508. The approval expires on March 31, 2016. A
copy of the supporting statement for this information collection is
available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: April 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09181 Filed 4-18-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: August 10, 2007 (Volume 72, Number 154)]
[Notices]
[Page 45025]
[DOCID:fr10au07-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-546-000]

Dauphin Island Gathering Partners; Notice of Proposed Changes in
FERC Gas Tariff

August 3, 2007.
    Take notice that on August 1, 2007, Dauphin Island Gathering
Partners (Dauphin Island) tendered for filing as part of its FERC Gas
Tariff, First Revised Volume No. 1, the tariff sheets listed below to
become effective September 1, 2007.

Second Revised Sheet No. 111
Second Revised Sheet No. 112
Second Revised Sheet No. 162
Third Revised Sheet No. 179
Second Revised Sheet No. 180

    Dauphin Island states that these tariff sheets are being filed to
more accurately reflect current operations.
    Dauphin Island states that copies of the filing are being served
contemporaneously on its customers and other interested parties.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-15632 Filed 8-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Page 76683]
[FR Doc No: 2015-31126]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2179-043--California; Project No. 2467-020--California]

Merced Irrigation District; Pacific Gas and Electric Company;
Notice of Availability of the Final Environmental Impact Statement for
the Merced River and Merced Falls Hydroelectric Projects

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission (Commission or FERC)
regulations contained in the Code of Federal Regulations (CFR) (18 CFR
part 380 [FERC Order No. 486, 52 FR 47897]), the Office of Energy
Projects has reviewed the applications for license for the Merced River
Hydroelectric Project (FERC No. 2179), and the Merced Falls
Hydroelectric Project (FERC No. 2467) and prepared a final multi-
project environmental impact statement (EIS) for the projects.
    Both projects are located on the Merced River. The Merced River
Project is located at river mile (RM) 62.5 and 56.3, respectively,
about 23 miles northeast of the city of Merced in Mariposa County,
California. The Merced River Project occupies 3,154.9 acres of federal
land administered by the U.S. Department of the Interior, Bureau of
Land Management (BLM). The Merced Falls Project is located at RM 55 on
the border of Merced and Mariposa Counties, California. The Merced
Falls Project occupies 1.0 acre of federal land administered by BLM.
    The final EIS contains staff evaluations of the applicants'
proposals and the alternatives for relicensing the Merced River and
Merced Falls projects. The final EIS documents the views of
governmental agencies, non-governmental organizations, affected Indian
tribes, the public, the license applicants, and Commission staff.
    A copy of the final EIS is available for review at the Commission
or may be viewed on the Commission's Web site at http://www.ferc.gov,
using the ``e-Library'' link. Enter the docket number, excluding the
last three digits, to access the document. For assistance, contact FERC
Online Support at<EMAIL_ADDRESS>or toll-free at (866) 208-
3676, or for TTY, contact<PHONE_NUMBER>.
    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.
    For further information, please contact Matt Buhyoff at (202) 502-
6824 or at<EMAIL_ADDRESS>
    Dated: December 4, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-31126 Filed 12-9-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Rules and Regulations]
[Page 52188]
[FR Doc No: 2015-21369]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0807]

Drawbridge Operation Regulation; Newark Bay, Newark, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Lehigh Valley Drawbridge, across
Newark Bay, mile 4.3, at Newark, New Jersey. This deviation is
necessary to replace bridge timbers and miter rails. This deviation
allows the bridge to remain in the closed position for 10 hours for two
days.

DATES: This deviation is effective from 7 a.m. to 5 p.m. on September
13, 2015 and from 7 a.m. to 5 p.m. on September 14, 2015, with a rain
date on September 20, 2015 from 7 a.m. to 5 p.m.

ADDRESSES: The docket for this deviation, [USCG-2015-0807] 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. You may also visit the Docket
Management Facility in Room W12-140, on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, contact Mr. Joe M. Arca, Project Officer, First
Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the docket, call
Ms. Cheryl Collins, Program Manager, Docket Operations, telephone (202)
366-9826.

SUPPLEMENTARY INFORMATION: The Lehigh Valley Drawbridge, mile 4.3,
across Newark Bay has a vertical clearance in the closed position of 35
feet at mean high water and 39 feet at mean low water. The existing
bridge operating regulations are found at 33 CFR 117.5.
    The waterway has commercial oil barge traffic of various sizes and
recreational vessels.
    Consolidated Rail Corporation requested this temporary deviation
from the normal operating schedule to facilitate essential maintenance
repairs.
    Under this temporary deviation, the Lehigh Valley Drawbridge will
operate according to the schedule below:
    a. From 7 a.m. through 5 p.m. on September 13, 2015 the bridge will
not open to marine traffic.
    b. From 7 a.m. through 5 p.m., on September 14, 2015 the bridge
will not open for marine traffic.
    c. Should a rain date be necessary, from 7 a.m. through 5 p.m. on
September 20, 2015 the bridge will not open to marine traffic.
    The bridge will not be able to open in the event of an emergency.
There is no alternate route for vessel traffic; however, vessels that
can pass under the closed draws during this closure may do so at any
time.
    The Coast Guard will inform the users of the waterway through our
Local Notice to Mariners of the change in operating schedule for the
bridge so that vessels 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: August 19, 2015.
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2015-21369 Filed 8-27-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53259-53260]
[FR Doc No: 2018-22957]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-3916]

Determination of Regulatory Review Period for Purposes of Patent
Extension; TECENTRIQ

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for TECENTRIQ and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
December 21, 2018. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by April 22,
2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 21, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-E-3916 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; TECENTRIQ.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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 Sec.  10.20 (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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product TECENTRIQ
(atezolizumab). TECENTRIQ is indicated for the treatment of patients
with locally advanced or metastatic urothelial carcinoma who have
disease progression during or following platinum-containing
chemotherapy or who have disease progression within 12 months of
neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy. This indication is approved under accelerated approval
based on tumor response rate and duration of response. Continued
approval for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials. Subsequent to
this approval, the USPTO received a patent term restoration application
for TECENTRIQ (U.S. Patent No. 8,217,149) from Genentech, Inc., and the
USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated September
20, 2017, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of TECENTRIQ
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
TECENTRIQ is 1,836 days. Of this time, 1,708 days occurred during the
testing phase of the regulatory review period, while 128 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: May 11,
2011. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 11,
2011.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C.262): January 12, 2016. FDA has verified the
applicant's claim that the biologics license application (BLA) for
TECENTRIQ (BLA 761034) was initially submitted on January 12, 2016.
    3. The date the application was approved: May 18, 2016. FDA has
verified the applicant's claim that BLA 761034 was approved on May 18,
2016.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 769 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22957 Filed 10-19-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 171 (Wednesday, September 4, 2019)]
[Notices]
[Pages 46506-46508]
[FR Doc No: 2019-19044]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC19-40-000]

Commission Information Collection Activities (FERC-516A); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Notice of information collection and request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC-516A, Small Generator Interconnection
Agreements.

DATES: Comments on the collection of information are due November 4,
2019.

ADDRESSES: You may submit comments (identified by Docket No. IC19-40-
000) by either of the following methods:
     eFiling at Commission's Website: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-516A, Standardization of Small Generator
Interconnection Agreements and Procedures.
    OMB Control No.: 1902-0203.
    Type of Request: Three-year extension of the FERC-516A information
collection requirements with no changes to the current reporting
requirements.
    Abstract: Under Sections 205 and 206 of the Federal Power Act (FPA)
the Commission is charged with ensuring just and reasonable electric
transmission rates and charges as well as ensuring that jurisdictional
providers do not subject any person to any undue prejudice or
disadvantage.
    The lack of consistent and readily accessible terms and conditions
for connecting resources to the grid led to a large number of disputes
between jurisdictional transmission providers and small generators in
the late 1990s and early 2000s. In response, the Commission directed
transmission providers to include Commission-approved, standard, pro-
forma interconnection procedures (small generator interconnection
procedures or SGIP) and a single uniformly applicable interconnection
agreement (small generator interconnection agreement or SGIA) in their
open-access transmission tariffs (OATTs). The requirement to create and
file these documents was instituted August 2005 by Commission Order No.
2006 and is codified in 18 CFR 35.28(f). This requirement set and
maintained a standard in OATTs for consistent consideration and
processing of interconnection requests by transmission providers.
    Since the issuance of Order No. 2006, many aspects of the energy
industry have changed including the growth of small generator
interconnection requests and the growth in solar photovoltaic (PV)
installations. These changes have been driven, in part, by state
renewable energy goals and policies. For example, approximately 3,300
MW of grid-connected PV capacity were installed in the U.S. in 2012
compared to 79 MW in 2005, the year Order No. 2006 was issued.
    In February 2012, pursuant to Sections 205 and 206 of the FPA and
Rule 207 of the Commission's Rules of Practice and Procedures, and
noting that the Commission encouraged stakeholders to submit proposed
revisions to the regulations set forth in Order No. 2006, the Solar
Energy Industries Association (SEIA) filed a Petition to Initiate
Rulemaking (Petition). The Petition requested the Commission revise the
pro forma SGIA and SGIP set forth in Order No. 2006. SEIA asserted that
the pro forma SGIP and SGIA as applied to small solar generation were
no longer just and reasonable, had become unduly discriminatory, and
presented unreasonable barriers to market entry.

SEIA noted that its Petition would apply exclusively to solar electric
generation due to its unique characteristics.
    In 2012 the Commission issued a Notice of Petition for Rulemaking
in Docket No. RM12-10-000 and began a public process to explore SEIA's
Petition through the Commission's formal notice and comment process as
well as technical conferences.
    In November 2013, the Commission issued Order No. 792 to amend the
pro forma Small Generator Interconnection Procedures and pro forma
Small Generator Interconnection Agreement.
    Order No. 792: (1) Incorporates provisions that provide an
Interconnection Customer with the option of requesting from the
Transmission Provider a pre-application report providing existing
information about system conditions at a possible Point of
Interconnection; (2) revised the 2 megawatt (MW) threshold for
participation in the Fast Track Process included in section 2 of the
pro forma SGIP; (3) revised the customer options meeting and the
supplemental review following failure of the Fast Track screens so that
the supplemental review is performed at the discretion of the
Interconnection Customer and includes minimum load and other screens to
determine if a Small Generating Facility may be interconnected safely
and reliably; (4) revised the pro forma SGIP Facilities Study Agreement
to allow the Interconnection Customer the opportunity to provide
written comments to the Transmission Provider on the upgrades required
for interconnection; (5) revised the pro forma SGIP and the pro forma
SGIA to specifically include energy storage devices; and (6) clarified
certain sections of the pro forma SGIP and the pro forma SGIA.
    With these modifications, the Commission concluded that the package
of reforms adopted in Order No. 792 will reduce the time and cost to
process small generator interconnection requests for Interconnection
Customers and Transmission Providers, maintain reliability, increase
energy supply, and remove barriers to the development of new energy
resources.
    Type of Respondents: Jurisdictional transmission service providers.
    Estimate of Annual Burden: \1\ The Commission estimates the annual
public reporting burden for the information collection as:
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    \1\ The Commission defines burden as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal
agency. For further explanation of what is included in the
information collection burden, reference 5 Code of Federal
Regulations 1320.3.

                                 FERC-516A--Standardization of Small Generator Interconnection Agreements and Procedures
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Number of     Annual number                  Average burden    Total annual burden
                Requirements \2\                   respondents    of responses    Total number     & cost per      hours & total annual      Cost per
                                                    annually     per respondent   of responses    response \3\             cost           respondent ($)
                                                            (1)             (2)     (1) * (2) =             (4)          (3) * (4) = (5)       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of Documents--Transmission                       46               1              46               1                       46           84.38
 Providers.....................................                                                          $84.38                   $3,881
Filing of Agreements--Transmission Providers...              95               1              95              25                    2,375        2,109.50
                                                                                $2,109.50                 $200,403
Pre-Application Report--Interconnection                     800               1             800               1                      800           84.38
 Customers \4\.................................                                                          $84.38                  $67,504
Pre-Application Report--Transmission Providers.             142            5.63             800             2.5                    2,000        1,188.45
                                                                                $210.95                 $168,760
Supplemental Review--Interconnection Customers.             500               1             500             0.5                      250           42.19
                                                                                $42.19                  $21,095
Supplemental Review--Transmission Providers....             142            3.52             500              20                   10,000        5,942.25
                                                                                $1,687.60                 $843,800
Review of Required Upgrades--Interconnection                250               1             250               1                      250           84.38
 Customers.....................................                                                          $84.38                  $21,095
Review of Required Upgrades--Transmission                   142            1.76             250               2                      500          297.11
 Providers.....................................                                                         $168.76                  $42,190
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............           3,241  ..............                   16,221  ..............
                                                                                $1,368,728
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\2\ All requirements for transmission providers are mandatory. All requirements for interconnection customers are voluntary.
\3\ The estimates for cost per response are derived using the following formula: Average Burden Hours per Response * $84.38 per Hour = Average Cost per
  Response. This figure is the average of the salary plus benefits for an attorney, electrical engineer, and administrative staff: Attorney (Occupation
  Code: 23-0000): $142.86/hour, Electrical Engineer (Occupation Code: 17-2071): $68.17/hour, Office and Administrative Support (Occupation Code: 43-
  0000): $42.11/hour. The wages are derived from the Bureau of Labor and Statistics at http://bls.gov/oes/current/naics3_221000.htm and the benefits
  figure from http://www.bls.gov/news.release/ecec.nr0.htm.
\4\ We assume each request for a pre-application report corresponds with one Interconnection Customer.

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: August 28, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-19044 Filed 9-3-19; 8:45 am]
 BILLING CODE 6717-01-P