accordance with the negative air flow requirements in Sec.
63.1506(c)(4). The owner or operator of a sweat furnace must
demonstrate negative air flow into the sweat furnace in accordance with
paragraphs (d)(3)(i) through (iii) of this section.
    (i) Perform an annual visual smoke test to demonstrate airflow into
the sweat furnace or towards the plane of the sweat furnace opening;
    (ii) Perform the smoke test using a smoke source, such as a smoke
tube, smoke stick, smoke cartridge, smoke candle or other smoke source
that produces a persistent and neutral buoyancy aerosol; and
    (iii) Perform the visual smoke test at a safe distance from and
near the center of the sweat furnace opening.
* * * * *
0
6. Section 63.1511 is amended by revising paragraph (b)(1) to read as
follows:

Sec.  63.1511  Performance test/compliance demonstration general
requirements.

* * * * *

    (b) * * *
    (1) The performance tests must be conducted under representative
(normal) conditions expected to produce the highest level of HAP
emissions expressed in the units of the emission standards for the HAP
(considering the extent of scrap contamination, reactive flux addition
rate and feed/charge rate). If a single test condition is not expected
to produce the highest level of emissions for all HAP, testing under
two or more sets of conditions (for example high contamination at low
feed/charge rate, and low contamination at high feed/charge rate) may
be required. Any subsequent performance tests for the purposes of
establishing new or revised parametric limits shall be allowed upon
pre-approval from the permitting authority for major sources, or the
Administrator for area sources. These new parametric settings shall be
used to demonstrate compliance for the period being tested.
* * * * *
0
7. Section 63.1512 is amended by adding paragraphs (e)(4) through (7)
to read as follows:

Sec.  63.1512  Performance test/compliance demonstration requirements
and procedures.

* * * * *
    (e) * * *
    (4) When testing an existing uncontrolled furnace, the owner or
operator must comply with the requirements of either paragraphs
(e)(4)(i) or (ii) of this section at the next required performance
test.
    (i) Install hooding that meets ACGIH Guidelines, or
    (ii) Assume a 67-percent capture efficiency for the furnace exhaust
(i.e., multiply emissions measured at the furnace exhaust outlet by
1.5). If the source fails to demonstrate compliance using the 67-
percent capture efficiency assumption, the owner or operator must re-
test with a hood that meets the ACGIH Guidelines within 180 days, or
petition the permitting authority for major sources, or the
Administrator for area sources, within 180 days that such hoods are
impractical under the provisions of paragraph (e)(6) of this section
and propose testing procedures that will minimize fugitive emissions
during the performance test according to paragraph (e)(7) of this
section.
    (iii) Existing round top furnaces are exempt from the requirements
of paragraphs (e)(4)(i) and (ii) of this section. Round top furnaces
must be operated to minimize fugitive emissions according to paragraph
(e)(7) of this section.
    (5) When testing a new uncontrolled furnace the owner or operator
must:
    (i) Install hooding that meets ACGIH Guidelines or petition the
permitting authority for major sources, or the Administrator for area
sources, that such hoods are impracticable under the provisions of
paragraph (e)(6) of this section and propose testing procedures that
will minimize fugitive emissions during the performance test according
to the provisions of paragraph (e)(7); and
    (ii) Subsequent testing must be conducted in accordance with
paragraphs (e)(4)(i) and (ii) of this section.
    (6) The installation of hooding that meets ACGIH Guidelines is
considered impractical if any of the following conditions exist:
    (i) Building or equipment obstructions (for example, wall, ceiling,
roof, structural beams, utilities, overhead crane or other
obstructions) are present such that the temporary hood cannot be
located consistent with acceptable hood design and installation
practices;
    (ii) Space limitations or work area constraints exist such that the
temporary hood cannot be supported or located to prevent interference
with normal furnace operations or avoid unsafe working conditions for
the furnace operator; or
    (iii) Other obstructions and limitations subject to agreement of
the permitting authority for major sources, or the Administrator for
area sources.
    (7) Testing procedures that will minimize fugitive emissions may
include, but are not limited to the following:
    (i) Installing a hood that does not entirely meet ACGIH guidelines;
    (ii) Using the building as an enclosure, and measuring emissions
exhausted from the building if there are no other furnaces or other
significant sources in the building of the pollutants to be measured;
    (iii) Installing temporary baffles on those sides or top of furnace
opening if it is practical to do so where they will not interfere with
material handling or with the furnace door opening and closing;
    (iv) Increasing the exhaust rate from the furnace with draft fans,
so as to capture emissions that might otherwise escape into the
building if it can be done without increasing furnace emissions in a
way that make the test non-representative;
    (v) Minimizing the time the furnace doors are open or the top is
off;
    (vi) Delaying gaseous reactive fluxing until charging doors are
closed and, for round top furnaces, until the top is on;
    (vii) Agitating or stirring molten metal as soon as practicable
after salt flux addition and closing doors as soon as possible after
solid fluxing operations, including mixing and dross removal;
    (viii) Keeping building doors and other openings closed to the
greatest extent possible to minimize drafts that would divert emissions
from being drawn into the furnace; or
    (ix) Maintaining burners on low-fire or pilot operation while the
doors are open or the top is off.
* * * * *
0
8. Section 63.1513 is amended by adding paragraph (f) to read as
follows:

Sec.  63.1513  Equations for determining compliance.

* * * * *
    (f) Periods of startup and shutdown. For a new or existing affected
source, or a new or existing emission unit subject to an emissions
limit in paragraphs Sec.  63.1505(b) through (j) expressed in units of
pounds per ton of feed/charge, or [mu]g TEQ or ng TEQ per Mg of feed/
charge, demonstrate compliance during periods of startup and shutdown
in accordance with paragraph (f)(1) of this section or determine your
emissions per unit of feed/charge during periods of startup and
shutdown in accordance with paragraph (f)(2) of this section. Startup
and shutdown emissions for group 1 furnaces and in-line fluxers must be
calculated individually, and not on the basis of a SAPU. Periods of
startup and shutdown are excluded from the calculation of SAPU emission
limits in Sec.  63.1505(k), the SAPU monitoring requirements in Sec.
63.1510(t) and the SAPU emissions calculations in Sec.  63.1513(e).
    (1) For periods of startup and shutdown, records establishing a
feed/charge rate of zero, a flux rate of zero, and that the affected
source or emission unit was either heated with electricity, propane or
natural gas as the sole sources of heat or was not heated, may be used
to demonstrate compliance with the emission limit, or
    (2) For periods of startup and shutdown, divide your measured
emissions in lb/hr or [mu]g/hr or ng/hr by the feed/charge rate in
tons/hr or Mg/hr from your most recent performance test associated with
a production rate greater than zero, or the rated capacity of the
affected source if no prior performance test data is available.
0
9. Amend section 63.1514, as proposed to be added at 77 FR 8576
(February 14, 2012), by revising paragraph (e) to read as follows:

Sec.  63.1514  Change of furnace classification.

* * * * *

    (e) Limit on Frequency of changing furnace operating mode.
    (1) Changing furnace operating mode including reversion to the
previous mode, as provided in paragraphs (a) through (d) of this
section, may not be done more frequently than 4 times in any 6-month
period.
    (2) If additional changes are needed, the owner or operator must
apply in advance to the permitting authority, for major sources, or the
Administrator, for area sources, for approval.
0
10. Section 63.1517 is amended by adding paragraphs (b)(18) and (19) to
read as follows:

Sec.  63.1517  Records.

* * * * *
    (b) * * *
    (18) For each period of startup or shutdown for which the owner or
operator chooses to demonstrate compliance for an affected source based
on a feed/charge rate of zero, a flux rate of zero and the use of
electricity, propane or natural gas as the sole sources of heating or
the lack of heating, the owner or operator must maintain the following
records:
    (i) The date and time of each startup and shutdown,
    (ii) The quantities of feed/charge and flux introduced during each
startup and shutdown, and
    (iii) The types of fuel used to heat the unit, or that no fuel was
used, during startup and shutdown.
    (19) For owners or operators that choose to change furnace
operating modes, the following records must be maintained:
    (i) The date and time of each change in furnace operating mode, and
    (ii) The nature of the change in operating mode (for example, group
1 controlled furnace processing other than clean charge to group 2).
0
11. Table 2 to subpart RRR of part 63 is amended by revising the entry
for ``All affected sources and emission units with an add-on air
pollution control device'' to read as follows:

Table 2 to Subpart RRR of Part 63--Summary of Operating Requirements for
          New and Existing Affected Sources and Emission Units
------------------------------------------------------------------------
                                     Monitor type/         Operating
  Affected source/emission unit    operation/process     requirements
------------------------------------------------------------------------
All affected sources and          Emission capture    Design and install
 emission units with an add-on     and collection      in accordance
 air pollution control device.     system.             with ACGIH
                                                       Guidelines;
                                                       operate in
                                                       accordance with
                                                       OM&M plan (sweat
                                                       furnaces may be
                                                       operated
                                                       according to
                                                       63.1506(c)(4)).\b
                                                       \

                              * * * * * * *
------------------------------------------------------------------------
* * * * *
\b\ OM&M plan_Operation, maintenance, and monitoring plan.

* * * * *
0
12. Table 3 to subpart RRR of part 63 is amended by revising the entry
for ``All affected sources and emission units with an add-on air
pollution control device'' and revising footnote d to Table 3 to read
as follows:

  Table 3 to Subpart RRR of Part 63--Summary of Monitoring Requirements
        for New and Existing Affected Sources and Emission Units
------------------------------------------------------------------------
                                     Monitor type/        Monitoring
  Affected source/emission unit    operation/process     requirements
------------------------------------------------------------------------
All affected sources and          Emission capture    Annual inspection
 emission units with an add-on     and collection      of all emission
 air pollution control device.     system.             capture,
                                                       collection, and
                                                       transport systems
                                                       to ensure that
                                                       systems continue
                                                       to operate in
                                                       accordance with
                                                       ACGIH Guidelines.
                                                       Inspection
                                                       includes
                                                       volumetric flow
                                                       rate measurements
                                                       or verification
                                                       of a permanent
                                                       total enclosure
                                                       using EPA Method
                                                       204.\d\

                              * * * * * * *
------------------------------------------------------------------------
\d\ The frequency of volumetric flow rate measurements may be decreased
  to once every 5 years if daily differential pressure measures or daily
  fan RPM measurements are made in accordance with Sec.   63.1510(d)(ii)
  and (iii). The frequency of annual verification of a permanent total
  enclosure may be decreased to once every 5 years if negative pressure
  measurements in the enclosure are made daily in accordance with Sec.
  63.1510(d)(iv). In lieu of volumetric flow rate measurements or
  verification of permanent total enclosure, sweat furnaces may
  demonstrate annually negative air flow into the sweat furnace opening
  in accordance with Sec.   63.1510(d)(3).

[FR Doc. 2014-27497 Filed 12-5-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 88 (Tuesday, May 7, 2013)]
[Notices]
[Pages 26636-26637]
[FR Doc No: 2013-10822]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9809-9]

Notification of a Public Meeting of the Great Lakes Advisory
Board

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) announces a public
meeting and teleconference of the Great Lakes Advisory Board (GLAB).
The meeting will be held on May 21 and 22, 2013 in Chicago, Illinois.

DATES: The public meeting will be held on Tuesday, May 21, 2013 from
1:00 p.m. to 5:00 p.m. and Wednesday, May22, 2013 from 9:00 a.m. to
12:00 p.m. (Central Daylight Time). The teleconference numbers is:
(877) 226-9607; Participant code:<PHONE_NUMBER>.

ADDRESSES: The meeting will be held at the EPA Region 5 Offices, Lake
Michigan Room, in the Ralph H. Metcalfe Federal Building, 77 West
Jackson Boulevard, Chicago, IL 60604.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this meeting may contact Rita Cestaric,
Designated Federal Officer (DFO), GLAB, by telephone at<PHONE_NUMBER>
or email at

<EMAIL_ADDRESS>General information on the Great Lakes
Restoration Initiative (GLRI) and the GLAB can be found on the GLRI Web
site at http://www.glri.us.

SUPPLEMENTARY INFORMATION:
    Background: The GLAB is a federal advisory committee chartered
under the Federal Advisory Committee Act (FACA), Public Law 92-463. EPA
established the GLAB in 2013 to provide independent advice to the EPA
Administrator in his or her capacity as Chair of the federal Great
Lakes Interagency Task Force. The GLAB conducts business in accordance
with FACA and related regulations.
    The GLAB consists of 18 members appointed by EPA's Administrator.
Members serve as representatives of state, local and tribal government,
environmental groups, agriculture, business, transportation,
foundations, educational institutions and as technical experts.
    The purpose of the May 21-22 meeting is for individual members of
the GLAB to provide recommendations on refinements to the existing
interagency Great Lakes Restoration Initiative (GLRI) Action Plan (FY
2010--FY 2014) to inform the development of a draft FY 2015-2019 Action
Plan.
    The May 21-22 meeting will provide opportunity for members of the
public to submit oral comments in response to the charge questions for
consideration by the GLAB.
    Also, periodic opportunities for the public to provide input for
the GLAB to consider will be provided after the May 21-22 public
meeting and teleconference.
    Availability of Meeting Materials: The agenda and other materials
in support of the meeting will be available on the GLRI Web site at
http://www.glri.us in advance of the meeting/teleconference.
    Procedures for Providing Public Input: Federal advisory committees
provide independent advice to federal agencies. Members of the public
can submit relevant comments for consideration by the GLAB. Input from
the public to the GLAB will have the most impact if it provides
specific information for the GLAB to consider. Members of the public
wishing to provide comments should contact the DFO directly.
    Oral Statements: In general, individuals or groups requesting an
oral presentation at this public meeting will be limited to three
minutes per speaker, subject to the number of people wanting to
comment. Interested parties should contact Rita Cestaric, DFO, in
writing (preferably via email) at the contact information noted above
by May 14, 2013 to be placed on the list of public speakers for the
meeting.
    Written Statements: Written statements must be received by May 14,
2013 so that the information may be made available to the GLAB for
consideration. Written statements should be supplied to the DFO in the
following formats: One hard copy with original signature and one
electronic copy via email. Commenters are requested to provide two
versions of each document submitted: one each with and without
signatures because only documents without signatures may be published
on the GLRI Web page.
    Accessibility: For information on access or services for
individuals with disabilities, please contact Rita Cestaric at the
phone number or email address noted above, preferably at least 10 days
prior to the meeting, to give EPA as much time as possible to process
your request.

    Dated: April 30, 2013.
Susan Hedman,
Great Lakes National Program Manager.
[FR Doc. 2013-10822 Filed 5-6-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83850-83852]
[FR Doc No: 2016-28046]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-2663; FDA-2015-E-2890]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for RUCONEST and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications 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 January
23, 2017. 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 May 22, 2017. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets

Management, FDA will post your comment, as well as any attachments,
except for information submitted, marked and identified, as
confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2015-E-2663 and FDA-2015-E-2890 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; RUCONEST.'' 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 Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

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 of 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 RUCONEST
(rhC1INH). RUCONEST is indicated for treatment of acute attacks of
hereditary angioedema in adult and adolescent patients. Subsequent to
this approval, the USPTO received patent term restoration applications
for RUCONEST (U.S. Patent Nos. 7,067,713 and RE43,691) from Pharming
Intellectual Property B.V., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated October 19, 2015, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of RUCONEST 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
RUCONEST is 3,502 days. Of this time, 3,045 days occurred during the
testing phase of the regulatory review period, while 457 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: December
15, 2004. The applicant claims July 29, 2004, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was December 15, 2004,
which was the first date after receipt of the IND that the
investigational studies were allowed to proceed.
    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): April 16, 2013. FDA has verified the
applicant's claim that the biologics license application (BLA) for
RUCONEST (BLA 125495) was initially submitted on April 16, 2013.
    3. The date the application was approved: July 16, 2014. FDA has
verified the applicant's claim that BLA 125495 was approved on July 16,
2014.
    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 applications for patent extension,
this applicant seeks 1,698 days or 557 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 ask for
a redetermination (see DATES). 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.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (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 Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: November 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28046 Filed 11-21-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: July 13, 2009 (Volume 74, Number 132)]
[Notices]
[Page 33425-33426]
[DOCID:fr13jy09-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2232-566]

Duke Energy Carolinas, LLC; Notice of Application for Amendment
of License and Soliciting Comments, Motions To Intervene, and Protests

July 2, 2009.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-Project Use of Public Lands and Waters.
    b. Project No.: 2232-566.
    c. Date Filed: April 22, 2009.
    d. Applicant: Duke Energy Carolinas, LLC.
    e. Name of Project: Catawba-Wateree Project.
    f. Location: The Catawba-Wateree Project is located in Alexander,
Burke, Caldwell, Catawba, Gaston, Iredell, Lincoln, McDowell and
Mecklenburg Counties, North Carolina and Chester, Fairfield, Kershaw,
Lancaster, and York Counties, South Carolina. This project does not
occupy any Federal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. Joe Hall, Lake Management Representative,
Duke Energy Carolinas, LLC, P.O. Box 1006, Charlotte, North Carolina
28201-1006,<PHONE_NUMBER>.
    i. FERC Contact: Joy Jones, Telephone<PHONE_NUMBER>, and e-mail:
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and protest:
August 02, 2009. All documents (original and eight copies) should be
filed with: Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervener 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. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    k. Description of Request: Duke Energy Carolinas, LLC requests
Commission approval of an agreement that would allow Duke to authorize
the Town of Mooresville, North Carolina to construct and operate
expanded water intake facilities on, and to withdraw water from, Lake
Norman. The existing water intake structure would be expanded by
connecting a water line to the existing water intake structure and the
existing pumping plant. Approximately 125 feet of water line would be
within the project boundary. Additionally, new screens with screen
openings that do not exceed 0.25 inch would be installed on the
existing intake structure. Intake velocities at the intake structure
would not exceed 0.5 feet per second. Under the agreement, the expanded
facility would have a gross maximum annual average rate of 18 million
gallons per day (MGD), a 6 MGD increase from the current approved
withdrawal rate. The water intake and pump facility is located in
Iredell County, North Carolina.

    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also 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. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments 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 comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Any filings must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as applicable,
and the Project Number of the particular application to which the
filing refers.
    p. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov
under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-16430 Filed 7-10-09; 8:45 am]

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DRAFT -8/14/07 EPA/Environmental Defense Meeting Summary

Richard Denison of Environmental Defense (ED) requested to meet with
OPPT to present ED’s views regarding EPA’s proposed Nanoscale
Materials Stewardship Program (NMSP) and EPA’s approach for
determining new versus existing chemical nanoscale materials under TSCA.
 ED highlighted three areas for discussion: 1) EPA’s approach for
determining new versus existing chemical nanoscale materials under TSCA;
2) applicability of SNURs to nanoscale materials; and 3) use of TSCA
section 8(a) reporting rules for nanoscale materials.

1. New vs Existing Chemicals: ED and EPA discussed how EPA applies
“molecular identity” to determine whether a chemical substance is on
the TSCA Inventory.  ED raised the use of factors other than chemical
structure (e.g., process, physical/chemical properties) that have been
considered by EPA in TSCA Inventory determinations for UVCB chemical
mixtures.  OPPT explained how it applies information on specific
properties, such as vapor pressure and boiling point, to further
describe the differences between complex but chemically distinct UVCB
chemical mixtures and noted that this approach was not really analogous
to considering particle size for Inventory determinations.  OPPT
discussed examples of nanoscale materials that would likely be
considered new chemicals, e.g., carbon nanotubes, and those that likely
would be considered existing chemicals, e.g., anatase form of TiO2.  ED
raised quantum dots and other examples and whether these would be new or
existing chemicals.  OPPT said it is difficult to answer such questions
generally and that detailed information would be needed.

2. SNURs: OPPT and ED discussed how new and existing chemical SNURs
could be applied to nanoscale materials and the “triggers” or
statutory factors (e.g., extent to which a use changes the type, form,
or magnitude of exposure, manner and methods of manufacture or
processing, etc) that are considered under TSCA section 5(a)(2).  ED
asked why SNURs weren’t explained further in the NMSP paper.  OPPT
replied that its approach was to engage in an open discussion in
designing the NMSP rather than put out a detailed proposal.  OPPT also
indicated that the information from the NMSP and the new chemical
notices will inform our understanding of nanoscale materials and our
ability to use the SNUR authority.  ED asked about several SNURs that
used properties/size in the trigger and noted a 2007 SNUR that used
particle size.  ED indicated it will provide views on the use of SNURs
in its written comments.

3. TSCA Section 8(a) Reporting: ED discussed its view of the value of
using section 8(a) reporting as a backstop for the NMSP and to further
our understanding of how many and what types of nanoscale materials are
in or soon to enter into commerce.  ED said that a voluntary NMSP will
likely give a skewed view of nanoscale materials in the market as not
all manufacturers will participate.  ED discussed the idea of a tailored
PAIR-type section 8(a) reporting rule for nanoscale materials and the
need to consider the issue of the exemption for small businesses.  ED
indicated it will provide written comments to EPA on this point.


[Federal Register Volume 79, Number 145 (Tuesday, July 29, 2014)]
[Notices]
[Pages 44084-44085]
[FR Doc No: 2014-17823]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Commercial Air
Tour Limitations in the Grand Canyon National Park Special Flight Rules
Area

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on May 2, 2014, vol. 79, no. 85, page 25171. The FAA uses the
information gathered from Grand Canyon National Park air tour operators
to monitor their compliance with the Federal regulations.

DATES: Written comments should be submitted by August 28, 2014.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: OMB Control Number: 2120-0653.
    Title: Commercial Air Tour Limitations in the Grand Canyon National
Park Special Flight Rules Area
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: Each operator seeking to obtain or in possession of an
air carrier operating certificate must comply with the requirements of
14 CFR Part 135 or part 121, as appropriate. Each of these operators
conducting air tours in the Grand Canyon National Park must
additionally comply with the collection requirements for that airspace.
The FAA will use the information it collects and reviews to monitor
compliance with the regulations and, if necessary, take enforcement
action against violators of the regulations.
    Respondents: Approximately 14 air operators.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 44 minutes.
    Estimated Total Annual Burden: 40 hours.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Docket Library, Room 10102, 725 17th Street NW., Washington, DC
20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on July 23, 2014.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, ASP-110.
[FR Doc. 2014-17823 Filed 7-28-14; 8:45 am]
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