[Federal Register Volume 79, Number 145 (Tuesday, July 29, 2014)]
[Notices]
[Pages 44019-44020]
[FR Doc No: 2014-17759]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13755-002]

FFP Missouri 12, 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: Original Major License.
    b. Project No.: 13755-002.
    c. Date Filed: February 3, 2014.
    d. Applicant: FFP Missouri 12, LLC.
    e. Name of Project: Allegheny Lock and Dam Number 2.
    f. Location: The proposed project would be located at the U.S. Army
Corps of Engineers' (Corps) Allegheny Lock and Dam Number 2 on the
Allegheny River in Allegheny County, Pennsylvania. The project would
occupy 37.5 acres of federal land managed by the Corps.
    g. Filed Pursuant to: Federal Power Act, 16 USC 791 (a)-825(r).
    h. Applicant Contact: Thomas Feldman, Vice President, Free Flow
Power Corporation, 239 Causeway Street, Suite 300, Boston, MA 02114; or
at<PHONE_NUMBER>.
    Ramya Swaminathan, Chief Operating Officer, Free Flow Power
Corporation, 239 Causeway Street, Suite 300, Boston, MA 02114; or at
(978) 283-2822.
    Daniel Lissner, General Counsel, Free Flow Power Corporation, 239
Causeway Street, Suite 300, Boston, MA 02114; or at<PHONE_NUMBER>.
    i. FERC Contact: Allyson Conner,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests and
requests for cooperating agency status: 60 days from the date of this
notice.
    The Commission strongly encourages electronic filing. Please file
additional study requests and requests for cooperating agency status
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202)
502-8659 (TTY). In lieu of electronic filing, please send a paper copy
to: Secretary, Federal Energy Regulatory Commission, 888 First Street
NE., Washington, DC 20426. The first page of any filing should include
docket number P-13755-002.
    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, but is not ready
for environmental analysis at this time.
    l. The proposed project would utilize the existing Corps' Allegheny
Lock and Dam Number 2, and would consist of the following new
facilities: (1) A 170-foot-wide, 120-foot-long, 70-foot-high intake
structure with two 5-inch clear bar spacing trash racks; (2) two 45-
foot-wide, 40-foot-high spillway bays; (3) an 1,100-foot-long, 2.5-
foot-high adjustable crest gate on top of the existing dam crest; (4) a
170-foot-wide by 180-foot-long powerhouse along the east side of the
river; (5) three Kaplan turbine-generator units with a combined
installed capacity of 17,000 kilowatts; (6) a 50-foot-wide by 60-foot-
long substation; (7) a 1,265-foot-long, single overhead, 69-kilovolt
transmission line to connect the project substation to an existing
distribution line owned by Duquesne Light Company; and (8) appurtenant
facilities. The project is

estimated to generate an average of 81,950 megawatt-hours annually.
    Free Flow Power proposes to operate the project in a ``run-of-
river'' mode using flows made available by the Corps. The proposed
project would not change existing flow releases or water surface
elevations upstream or downstream of the proposed project.
    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.
    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. Any qualified applicant desiring to file a competing application
must submit to the Commission, on or before the specified intervention
deadline date, a competing development application, or a notice of
intent to file such an application. Submission of a timely notice of
intent allows an interested person to file the competing development
application no later than 120 days after the specified intervention
deadline date. Applications for preliminary permits will not be
accepted in response to this notice.
    A notice of intent must specify the exact name, business address,
and telephone number of the prospective applicant, and must include an
unequivocal statement of intent to submit a development application. A
notice of intent must be served on the applicant named in this public
notice.
    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 for the
particular application.
    When the application is ready for environmental analysis, the
Commission will issue a public notice requesting comments,
recommendations, terms and conditions, or prescriptions.
    All filings must (1) bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE,'' ``NOTICE OF INTENT TO FILE
COMPETING APPLICATION,'' or ``COMPETING APPLICATION;'' (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 applications
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.

    Dated: July 18, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-17759 Filed 7-28-14; 8:45 am]
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    Release 03-11

    FOR IMMEDIATE RELEASE
April 24, 2003

      CONTACT:
    Jerry Martin
(916) 322-2990
Richard
      Varenchik
(626) 575-6730

www.arb.ca.gov

ARB Modifies Zero Emission Vehicle Regulation

SACRAMENTO - The California Air Resources Board (ARB) today voted to
make modifications and upgrades to the state's zero emission vehicle (
ZEV) regulation.

    "The ZEV mandate is the most powerful idea and the most
motivating force that this board has ever unleashed in the vehicle sector, “
said ARB Chairman, Dr. Alan Lloyd.

    The most important modification creates a new ZEV pathway,
giving manufacturers a choice of two options for meeting their ZEV requirements.

    Auto manufacturers can meet their ZEV obligations by
meeting standards that are similar to the ZEV rule as it existed in 2001. This
means using a formula allowing a vehicle mix of 2 percent pure ZEVs, 2 percent
AT-PZEVs (vehicles earning advanced technology partial ZEV credits) and 6
percent PZEVs (extremely clean conventional vehicles). The ZEV obligation is
based on the number of passenger cars and small trucks a manufacturer sells in
California.

    Or, manufacturers may chose a new alternative ZEV
compliance strategy, meeting part of their ZEV requirement by producing their
sales-weighted market share of approximately 250 fuel cell vehicles by 2008. The
remainder of their ZEV requirements could be achieved by producing 4 percent
AT-PZEVs and 6 percent PZEVs.  The required number of fuel cell vehicles
will increase to 2,500 from 2009-11, 25,000 from 2012-14 and 50,000 from 2015
through 2017. Automakers can substitute battery electric vehicles for up to 50
percent of their fuel cell vehicle requirements.

    With the ZEV regulations on hold for 2003-04 because of
automaker lawsuits, the above requirements will not fully go into effect until
2005.  However, automakers can receive credit for any ZEV, PZEV or AT-PZEV
vehicles they choose to sell or lease in 2003-04.

    ARB will appoint an independent review panel of
technology/industry experts with no financial ties to motor vehicle
manufacturers to report on ZEV technology progress, costs and consumer
acceptance.  In addition, ARB staff will report annually on the progress of
the ZEV program.

    Chairman Lloyd continued, “Over the last 13 years since
the ZEV mandate was first adopted, we’ve seen the near impossible accomplished
with gasoline vehicles: zero evaporative emissions, exceedingly clean exhaust –
cleaner, in some cases, than the outside air entering the cabin for ventilation
purposes, and emission control systems that are twice as durable than their
conventional forebearers, forecasted to last an astonishing 150,000 miles.”
ZEV Rule Vehicle Types

    Zero Emission Vehicle (ZEV):  A vehicle that
essentially produces no emissions as it operates.  Currently, this would
mean a pure battery electric (not a hybrid) or a hydrogen fuel cell vehicle.

    Advanced Technology Partial Zero Emission Vehicle
(AT-PZEV): An AT-PZEV is a vehicle that uses some ZEV technology.
Currently, there are no AT-PZEVs available to consumers. Staff expects that
certain gasoline/electric hybrid vehicles and natural gas vehicles will be
certified in the AT-PZEV class.  A plug-in hybrid could also qualify as an
AT-PZEV.

    Partial Zero Emission Vehicle (PZEV): These are vehicles
that have achieved the ARB's cleanest tailpipe emission standard -- the Super
Ultra Low Emission Vehicle (SULEV) standard.  In addition, they have nearly
zero evaporative emissions and their emission control equipment is warranted for
15 years/150,000 miles. There are at least 10 vehicles currently eligible to
earn a partial ZEV credit.  They are listed under 2003 passenger cars in
the ARB's Clean Car Buyer's Guide at www.arb.ca.gov.

The Air Resources Board is a department of the California Environmental
Protection Agency.  ARB’s mission is to promote and protect public health,
welfare, and ecological resources through effective reduction of air pollutants
while recognizing and considering effects on the economy.  The ARB oversees
all air pollution control efforts in California to attain and maintain health
based air quality standards.

 The energy challenge facing California is real.  Every
Californian needs to take immediate action to reduce energy consumption. For a
list of simple ways you can reduce demand and cut your energy costs, see our
website at http://www.arb.ca.gov

# # # # #


[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 131-133]
[FR Doc No: 2017-28252]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-1846]

Labeling for Combined Hormonal Contraceptives; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Labeling
for Combined Hormonal Contraceptives.'' This draft guidance provides
recommendations on information that should be included in the
prescribing information for combined hormonal contraceptives (CHCs),
which contain estrogen and progestin. CHC products include combined
oral contraceptives (COCs), as well as non-oral products such as
transdermal systems and vaginal rings. Many of the labeling
recommendations in this draft guidance represent class labeling that
should be included in all CHC prescribing information. The draft
guidance reflects many of the modifications to prescribing information
mandated by the physician labeling rule (PLR) and the pregnancy and
lactation labeling rule (PLLR). General advice is provided where
modifications to the prescribing information for specific products are
needed.

DATES: Submit either electronic or written comments on the draft
guidance by March 5, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): 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-2017-D-1846 for ``Labeling for Combined Hormonal Contraceptives;
Draft Guidance for Industry.'' Received comments 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 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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jennifer Dao, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5333, Silver Spring, MD 20993-0002, 301-
796-8189.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Labeling for Combined Hormonal Contraceptives.'' This draft
guidance provides recommendations on information that should be
included in the prescribing information for CHCs, which contain
estrogen and a progestin. Such products include COCs, as well as non-
oral products such as transdermal systems and vaginal rings. Many of
the labeling recommendations in this draft guidance represent class
labeling that should be included in all CHC prescribing information.
The draft guidance reflects many of the modifications to prescribing
information mandated by the PLR \1\ and the PLLR.\2\

General advice is provided where modifications of the prescribing
information for specific products are needed.
---------------------------------------------------------------------------

    \1\ See the final rule ``Requirements on Content and Format of
Labeling for Human Prescription Drug and Biological Products'' (71
FR 3922, January 24, 2006) (21 CFR 201.56(d)(1) and 201.57(c)(9)(i)
through (iii)); see also the guidance for industry entitled
``Labeling for Human Prescription Drug and Biological Products--
Implementing the PLR Content and Format Requirements'' available at
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075082.pdf.
    \2\ See the final rule ``Content and Format of Labeling for
Human Prescription Drug and Biological Products; Requirements for
Pregnancy and Lactation Labeling'' (79 FR 72064, December 4, 2014)
(21 CFR 201.56(d) and 201.57); see also the draft guidance for
industry entitled ``Pregnancy, Lactation, and Reproductive
Potential: Labeling for Human Prescription Drug and Biological
Products--Content and Format'' available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM425398.pdf. When final, this guidance will represent FDA's
current thinking on this topic.
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    FDA previously issued draft guidance on the prescribing information
for COCs in March 2004 and invited public comment. That draft guidance
was withdrawn in July 2015. However, the development of the current
draft guidance took into consideration public comments submitted to the
2004 draft guidance that were science-based and consistent with current
PLR and PLLR labeling regulations. This draft guidance has been
broadened to incorporate the more general class of CHCs.
    FDA invites comments on the content of this draft guidance. In
particular, FDA seeks comments on the proposed language under section
7.1 of labeling that identifies a drug interaction with all metabolic
enzyme inducers. A variety of metabolic enzyme inducers have been
reported to decrease the plasma concentration of the estrogen and/or
progestin components of CHCs. FDA seeks comments and data regarding
specific enzyme inducers or classes of inducers (e.g., cytochrome p450
3A strong inducers) that interact with CHCs; in particular, comments
are requested on whether the CHC labeling should include specific
inducers or classes of inducers, or if it should remain broad and
essentially cover all possible cytochrome p (CYP) enzyme inducers of
any pathway and potency.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on labeling for
CHCs. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 201.56 and 201.57
(``Requirements on Content and Format of Labeling for Human
Prescription Drug and Biological Products'') are approved under OMB
control number 0910-0572. The collections of information from the final
rule entitled ``Content and Format of Labeling for Human Prescription
Drug and Biological Products; Requirements for Pregnancy and Lactation
Labeling'' are approved under OMB control number 0910-0624.

III. Electronic Access

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

    Dated: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28252 Filed 12-29-17; 8:45 am]
BILLING CODE 4164-01-P