[Federal Register: December 10, 2007 (Volume 72, Number 236)]
[Rules and Regulations]
[Page 69583-69585]
[DOCID:fr10de07-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28943; Directorate Identifier 2007-NM-011-AD;
Amendment 39-15295; AD 2007-25-13]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 767-300F Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Boeing Model 767-300F series airplanes. This AD requires
replacing the rotomolded duct(s) of the mix manifold system with new
duct(s). This AD results from a report of failures of the duct joint
seal of the mix manifold system. We are issuing this AD to prevent air
conditioning leakage into the mix manifold bay. Such leakage could
decrease the air flow to the flight compartment and main cabin or could
allow smoke into the flight compartment in the event of a fire in the
main cabin or forward cargo compartment.

DATES: This AD becomes effective January 14, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of January 14,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-
2207.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Management Facility

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jeffrey S. Palmer, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office,

1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6481; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to include an AD that would apply to certain Boeing Model
767-300F series airplanes. That NPRM was published in the Federal
Register on August 16, 2007 (72 FR 45980). That NPRM proposed to
require replacing the rotomolded duct(s) of the mix manifold system
with new duct(s).

Comments

    We provided the public the opportunity to participate in the
development of this AD. We have considered the comment received. Boeing
supports the NPRM.

Conclusion

    We have carefully reviewed the available data, including the
comment received, and determined that air safety and the public
interest require adopting the AD as proposed.

Costs of Compliance

    There are about 40 airplanes of the affected design in the
worldwide fleet. This AD affects about 32 airplanes of U.S. registry.
The required actions will take about 2 or 8 work hours per airplane, at
an average labor rate of $80 per work hour. Required parts will cost
about $4,123 or $42,825 per airplane. Based on these figures, the
estimated cost of the AD for U.S. operators is $4,283 or $43,465 per
airplane. (The estimated work hours and costs depend on the airplane
configuration).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket. See the ADDRESSES
section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
adding the following new airworthiness directive (AD):

2007-25-13 Boeing: Amendment 39-15295. Docket No. FAA-2007-28943;
Directorate Identifier 2007-NM-011-AD.

Effective Date

    (a) This AD becomes effective January 14, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 767-300F series airplanes,
certificated in any category; as identified in Boeing Special
Attention Service Bulletin 767-21-0192, dated March 23, 2006.

Unsafe Condition

    (d) This AD results from a report of failures of the duct joint
seal of the mix manifold system. We are issuing this AD to prevent
air conditioning leakage into the mix manifold bay. Such leakage
could decrease the air flow to the flight compartment and main cabin
or could allow smoke into the flight compartment in the event of a
fire in the main cabin or forward cargo compartment.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Replacement

    (f) Within 36 months after the effective date of this AD, do the
applicable action specified in Table 1 of this AD in accordance with
the Accomplishment Instructions of Boeing Special Attention Service
Bulletin 767-21-0192, dated March 23, 2006.

                          Table 1.--Replacement
------------------------------------------------------------------------
  For airplanes identified in
   the service bulletin as--            Do the following action--
------------------------------------------------------------------------
(1) Group 1 airplanes.........  Replace the rotomolded duct between the
                                 transition duct of the right cooling
                                 pack and the mix manifold with a new
                                 duct made of aluminum.
(2) Group 2 airplanes.........  Replace the rotomolded ducts of the mix
                                 manifold system with new ducts made
                                 from Kevlar[reg] and aluminum.
------------------------------------------------------------------------

Alternative Methods of Compliance (AMOCs)

    (g)(1) The Manager, Seattle Aircraft Certification Office, FAA,
has the authority to approve AMOCs for this AD, if requested in
accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District

Office (FSDO), or lacking a PI, your local FSDO.

Material Incorporated by Reference

    (h) You must use Boeing Special Attention Service Bulletin 767-
21-0192, dated March 23, 2006, to perform the actions that are
required by this AD, unless the AD specifies otherwise. The Director
of the Federal Register approved the incorporation by reference of
this document in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle,
Washington 98124-2207, for a copy of this service information. You
may review copies at the FAA, Transport Airplane Directorate, 1601
Lind Avenue, SW., Renton, Washington; or at the National Archives
and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
.

    Issued in Renton, Washington, on November 23, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E7-23685 Filed 12-7-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Pages 9324-9325]
[FR Doc No: 2019-04677]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC19-4-000]

Commission Information Collection Activities (FERC-714); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of information collection and request for comments.

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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-714 (Annual Electric Balancing Authority
Area and Planning Area Report) and submitting the information
collection to the Office of Management and Budget (OMB) for review. Any
interested person may file comments directly with OMB and should
address a copy of those comments to the Commission as explained below.
On November 7, 2018, the Commission published a Notice in the Federal
Register in Docket No. IC19-4-000 requesting public comments. The
Commission received no comments.

DATES: Comments on the collection of information are due April 15,
2019.

ADDRESSES: Comments filed with OMB, identified by OMB Control No. 1902-
0140, should be sent via email to the Office of Information and
Regulatory Affairs<EMAIL_ADDRESS>Attention: Federal Energy
Regulatory Commission Desk Officer.
    A copy of the comments should also be sent to the Commission, in
Docket No. IC19-4-000, 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-714, Annual Electric Balancing Authority Area and
Planning Area Report.
    OMB Control No.: 1902-0140.
    Type of Request: Three-year extension of the FERC-714 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: The Commission uses the FERC-714 data to analyze power
system operations. These analyses estimate the effect of changes in
power system operations resulting from the installation of a new
generating unit or plant, transmission facilities, energy transfers
between systems, and/or new points of interconnections. The FERC-714
data assists in providing a broad picture of interconnected balancing
authority area operations including comprehensive information of
balancing authority area generation, actual and scheduled inter-
balancing authority area power transfers, and net energy for load,
summer and winter generation peaks and system lambda. The Commission
also uses the data to prepare status reports on the electric utility
industry including a review of inter-balancing authority area bulk
power trade information. The Commission uses the collected data from
planning areas to monitor forecasted demands by electric utilities with
fundamental demand responsibilities and to develop hourly demand
characteristics.
    Type of Respondent: Electric utility balancing authorities and
planning areas in the United States.
    Estimate of Annual Burden: \1\ The Commission estimates the annual
public reporting burden and cost \2\ (rounded)

for the information collection as follows:
---------------------------------------------------------------------------

    \1\ Burden is defined 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, refer to 5 CFR 1320.3.
    \2\ The hourly cost (for salary plus benefits) uses the figures
from the Bureau of Labor Statistics, May 2017, for the listed
reporting requirements. These figures include salary (https://www.bls.gov/oes/current/naics2_22.htm) and benefits http://www.bls.gov/news.release/ecec.nr0.htm) and are:
    Management (Code 11-0000), $94.28/hr.
    Computer and mathematical (Code 15-0000), $63.25/hr.
    Electrical Engineers (Code 17-2071), $66.90/hr.
    Economist (Code 19-3011), $71.98/hr.
    Computer and Information Systems Managers (Code 11-3021),
$96.51/hr.
    Accountants and Auditors (Code 13-2011), $56.59/hr.
    Transportation, Storage, and Distribution Managers (Code 11-
3071), $75.34/hr.
    Power Distributors and Dispatchers (Code 51-8012), $53.48/hr.
    The average hourly cost (wages plus benefits) for the above
wages is $72.29/hour (rounded to $72.00/hour).

                  FERC-714 (Annual Electric Balancing Authority Area and Planning Area Report)
----------------------------------------------------------------------------------------------------------------
                         Annual number                                       Total annual burden
 Number of respondents   of responses    Total number     Average burden &      hours & total        Cost per
                        per respondent   of responses    cost per response       annual cost      respondent ($)
(1)                                (2)     (1) * (2) =  (4)................  (3) * (4) = (5)....       (5) / (1)
                                                   (3)
----------------------------------------------------------------------------------------------------------------
177                                  1             177  87 hrs.; $6,264.00.  15,399 hrs.;              $6,264.00
                                                                              $1,108,728.00.
----------------------------------------------------------------------------------------------------------------

    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: March 7, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-04677 Filed 3-13-19; 8:45 am]
BILLING CODE 6717-01-P


October 24, 2002  Forms included in Supporting Statement for ICR 0938.09 Form Source of Form 4700 4 Preaward Compliance Review Report pdf created from scanned hard copy 5700 20A Grant Agreement Amendment wpd file from Ellen O'Boyle 5700 30 Pre application for Federal Assistance pdf created from scanned hard copy 5700 049 Certification Regarding Debarment, Suspension pdf created from scanned hard copy 5700 52 MBE/ WBE Form wpd file from Kimberly Patrick 5700 53 Lobbying & Litigation Form wpd revised file from Bill Hedling 5700 54 Key Contacts Form wpd file from Ellen O'Boyle 5770 2 Fellowship Application pdf created from scanned hard copy 5770 3 Fellowship Facilities & Commitment Statement pdf created from scanned hard copy 5770 4 Fellowship Applicant Qualification Inquiry pdf created from scanned hard copy 5770 5 Agency Fellowship Certification pdf created from scanned hard copy 5770 7 Fellowship Activation Notice pdf created from scanned hard copy 5770 8 Fellowship Agreement pdf created from scanned hard copy 5770 9 Fellowship Termination Notice pdf created from scanned hard copy SF269 Financial Status Report pdf from GAD web site SF270 Request for Advance or Reimbursement pdf from GAD web site SF271 Outlay Report and Request for Construction Programs pdf from GAD web site SF 272 Federal Cash Transaction Report pdf from GAD web site SF 424 Applicagtion for Federal Assistance pdf from GAD web site and word doc SF LLL  Lobbying and Litigation pdf from OMB web site 20 documents total be merged into one pdf file


[Federal Register Volume 77, Number 227 (Monday, November 26, 2012)]
[Proposed Rules]
[Pages 70382-70384]
[FR Doc No: 2012-28435]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-1214; Directorate Identifier 2011-SW-071-AD]
RIN 2120-AA64

Airworthiness Directives; Eurocopter France Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Eurocopter France Model EC 155B, EC155B1, SA-366G1, SA-365N, SA-365N1,
AS-365N2, and AS 365 N3 helicopters, which would require modifying the
fuel tank draining system. This proposed AD is prompted by a closed
fuel tank drain that, in the event of a fuel leak, could result in fuel
accumulating in an area containing electrical equipment. The proposed
actions are intended to prevent accumulation of fuel in an area with
electrical equipment or other ignition source, which may lead to a
fire.

DATES: We must receive comments on this proposed AD by January 25,
2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Examining the AD Docket: You may examine the AD docket on the
Internet at http://www.regulations.gov or in person at the Docket
Operations Office between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this proposed AD, the
economic evaluation, any comments received, and other information. The
street address for the Docket Operations Office (telephone 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.
    For service information identified in this proposed AD, contact
American Eurocopter Corporation, 2701 N. Forum Drive, Grand Prairie, TX
75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>;
or at http://www.eurocopter.com/techpub. You may review a copy of the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.

FOR FURTHER INFORMATION CONTACT: Chinh Vuong, Aviation Safety Engineer,
Safety Management Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
No. 2011-0190, dated September 30, 2011 (AD No. 2011-0190), to correct
an unsafe condition for the Eurocopter France EC 155, SA 366, SA 365,
and AS 365 model helicopters, except those with certain modifications.
EASA reports that the fuel tank drains were closed with plugs during
production to maintain buoyancy during emergency landings in water.
EASA states that this closing of the fuel tank drains with plugs
``disregards compliance with an airworthiness certification
requirement'' and, in the event of a fuel leak in flight, creates ``the
risk of fuel accumulation and/or migration'' to an adjacent area that
may contain electrical equipment ``susceptible of constituting a source
of ignition.'' EASA states that this condition, if not corrected, could
result in ignition of fuel vapors, ``resulting in a fire and consequent
damage to the helicopter, or injury to its occupants.'' As a result,
EASA required modification of the fuel tank compartments' draining
system.

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an

unsafe condition is likely to exist or develop on other products of
these same type designs.

Related Service Information

    Eurocopter issued Alert Service Bulletin (ASB) No. EC155-53A031 for
its B and B1 model helicopters, ASB No. AS366-53.11 for its G1 model
helicopters, and ASB No. AS365-53.00.50 for its N, N1, N2 and N3 model
helicopters. The ASBs were all dated May 3, 2011, and were all followed
with Revision 1 dated September 21, 2011.
    For helicopters not equipped with emergency buoyancy fixed parts,
the ASBs describe procedures to modify the fuel tank draining system by
removing drain plugs in the fuel tanks, to make draining possible. For
helicopters equipped with emergency buoyancy fixed parts, the ASBs
contain additional procedures to seal one drain plug per fuel tank
compartment and to install new drain points and self-sealing drain
valves in specified fuel tanks. EASA AD No. 2011-0190 classifies these
ASBs as mandatory to ensure the airworthiness of these helicopters.

Proposed AD Requirements

    This proposed AD would require compliance with certain sections
within paragraph 3.B.2 of the manufacturer's service bulletins.
Helicopters equipped with emergency buoyancy fixed parts would be
required to comply within six months, and helicopters not equipped with
emergency buoyancy fixed parts would be required to comply within 110
hours time-in-service.

Costs of Compliance

    We estimate that this proposed AD would affect 46 helicopters of
U.S. Registry and that labor costs average $85 per work-hour. Based on
these estimates, we would expect the following costs:
    Sealing drain plugs, and installing new drain points and self-
sealing drain valves at other locations on helicopters equipped with
emergency buoyancy fixed parts would require 16 work-hours. Parts would
cost $11,154 for a total cost of $12,514 per helicopter. For
helicopters equipped with emergency buoyancy fixed parts and a sixth
fuel tank, this work would instead require 17 work-hours for a total
cost of $12,599 per helicopter.
    Removing drain plugs on helicopters not equipped with emergency
buoyancy fixed parts would require one work-hour and no parts for a
total cost of $85 per helicopter. For helicopters not equipped with
emergency buoyancy fixed parts but equipped with a sixth fuel tank,
this work would instead require two work-hours for a total cost of $170
per helicopter.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new
airworthiness directive (AD):

Eurocopter France: Docket No. FAA-2012-1214; Directorate Identifier
2011-SW-071-AD.

(a) Applicability

    This AD applies to Eurocopter France Model EC 155B, EC155B1, and
SA-366G1 helicopters, except those with modification 365A084485.00,
or modifications 0753C98 and 0745C96; and Model SA-365N, SA-365N1,
AS-365N2, and AS 365 N3 helicopters, except those with modifications
0753C98, 0745C96, and (if a sixth fuel tank is installed)
365A081003.00, or modification 365A081003.00 and (if a sixth fuel
tank is installed) 365A084485.00.

(b) Unsafe Condition

    This AD defines the unsafe condition as a closed fuel tank drain
that, in the event of a fuel leak, could result in fuel accumulating
in an area containing electrical equipment or other ignition source.
This condition could result in a fire in the helicopter.

(c) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(d) Required Actions

    (1) Within 110 hours time-in-service (TIS):
    (i) For helicopters without an emergency buoyancy system, remove
the fuel tank drain plugs listed in the Accomplishment Instructions,
paragraph 3.B.2.b., of Eurocopter Alert Service Bulletin (ASB) No.
EC155-53A031, Revision 1, dated September 21, 2011 (ASB 155); ASB
No. AS365-53.00.50, Revision 1, dated September 21, 2011 (ASB 365),
or ASB No. AS366-53.11, Revision 1, dated September 21, 2011 (ASB
366), as appropriate for your model helicopter.
    (ii) For the Model SA-365N, SA-365N1, AS-365N2, and AS 365 N3
helicopters, if there is an optional sixth fuel tank installed,
install a self-sealing drain valve in accordance with paragraph
3.B.2.c. of the ASB.
    (2) Within six months:
    (i) For helicopters with an emergency buoyancy system, modify
the fuel tank drain system in accordance with the Accomplishment
Instructions, paragraphs 3.B.2.a.1. through 3.B.2.a.3, of the ASB
appropriate for your model helicopter.
    (ii) For the Model SA-365N, SA-365N1, AS-365N2, AS 365 N3
helicopters, if there is an optional sixth fuel tank installed,
install a self-sealing drain valve in accordance with paragraph
3.B.2.c. of the ASB.

(e) Alternative Methods of Compliance (AMOC)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Chinh Vuong, Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 2601
Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(f) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2011-0190, dated September 30, 2011.

(g) Subject

    Joint Aircraft Service Component (JASC) Code: 2810, fuel
storage.

    Issued in Fort Worth, Texas, on November 8, 2012.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2012-28435 Filed 11-23-12; 8:45 am]
BILLING CODE 4910-13-P


 [Federal Register: August 26, 2008 (Volume 73, Number 166)] [ Notices]                [Page 50315] [DOCID:fr26au08-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2576-083]

  FirstLight Hydro Generating Company; Notice of Application

Soliciting Comments, Motions To Intervene, and Protests

August 19, 2008.

    Take notice that Commission staff is providing an opportunity for

public input regarding additional information that has been filed

regarding a pending proceeding before the Commission on the following

application:

    a. Application Type: Supplement(s) to Shoreline Management Plan.

    b. Project No: 2576-083.

    c. Date Filed: July 27, 2006, supplemented January 18, and June 27,

2008.

    d. Applicant: FirstLight Power Hydro Generating Company.

    e. Name of Project: Housatonic River Hydroelectric Project.

    f. Location: The project is located on the Housatonic River, in

Fairfield, Litchfield and New Haven Counties, Connecticut.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).

    h. Applicant Contact: Mr. Robert Gates, Station Manager-Connecticut

Hydro, 143 West St., Ext. Suite E , New Milford, CT 06776, (860) 350-

3617.

    i. FERC Contact: Any questions on this notice should be addressed

to Isis Johnson at<PHONE_NUMBER>, or by e-mail<EMAIL_ADDRESS>     j. Deadline for filing comments and/or motions: September 19, 2008.

    By letter dated December 12, 2007, and April 30, 2008, the

Commission requested that the applicant file additional information

regarding the shoreline management plan for the Housatonic Project.

This notice is intended to grant members of the public the opportunity

to provide comments on this supplemental information. Any entity that

has previously intervened with regard to this proceeding is a party and

not required to submit additional motions. Likewise, all comments that

have been filed with the Commission in this proceeding are still

applicable; as such, re-filing of comments is not necessary.

    All documents (original and eight copies) should be filed with: Ms.

Kimberley D. Bose, Secretary, Federal Energy Regulatory Commission,

DHAC, PJ-12.1, 888 First Street, NE., Washington, DC 20426. Please

include the project number (P-2576-083) on any comments or motions

filed. 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 under the ``e-Filing''

link. The Commission strongly encourages electronic filings.

    k. Description of Proposal: The shoreline management plan (SMP) was

filed with the Commission as required by the project license. The

proposed SMP provides for the maintenance of safe public access to lake

shorelines and riverfront lands and waters, as well as for the

stewardship and development of shoreline/riverfront areas. The SMP also

contains provisions to promote the conservation of land and water-

related resources, in addition to promoting education and public

awareness of resource protection and management programs. The SMP also

includes guidelines for permitting new and existing structures on

project lands, and a fee schedule to recover the administrative costs

of implementing the permitting program.

    l. This filing 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 at

<EMAIL_ADDRESS>or call toll-free 1-866-208-3372, or for

TTY, call<PHONE_NUMBER>.

    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. Filing and Service of Responsive Documents--Any filings must

bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS

FOR TERMS AND CONDITIONS'', ``PROTEST'', OR ``MOTION TO INTERVENE'', as

applicable, and the Project Number of the particular application to

which the filing refers. A copy of any motion to intervene must also be

served upon each representative of the Applicant specified in the

particular application.

    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.

Kimberly D. Bose,

Secretary.

 [FR Doc. E8-19689 Filed 8-25-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64229-64230]
[FR Doc No: 2022-23032]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2170]

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Topical
Dermatologic Corticosteroids: In Vivo Bioequivalence.'' This draft
guidance is intended to assist applicants who submit abbreviated new
drug applications (ANDAs) for topical dermatologic corticosteroid
products of all potency groups (referred to in this notice as topical
corticosteroids). The draft guidance describes recommendations for an
in vivo pharmacodynamic approach to demonstrate the bioequivalence of
topical corticosteroids. When finalized, this guidance will replace
FDA's 1995 guidance for industry of the same name. Revising this
guidance will provide clarity for potential ANDA applicants on the
appropriate pilot and pivotal studies and other recommendations for
pharmacodynamic approach to assess the bioequivalence of topical
dermatologic corticosteroids. These recommendations have evolved since
the original guidance was issued in 1995.

DATES: Submit either electronic or written comments on the draft
guidance by December 23, 2022 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-2022-D-2170 for ``Topical Dermatologic Corticosteroids: In Vivo
Bioequivalence.'' 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    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: Susan Levine, Office of Generic Drugs,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Topical Dermatologic Corticosteroids: In Vivo
Bioequivalence.'' This draft guidance is intended to assist applicants
who submit ANDAs for topical corticosteroids. This draft guidance
describes recommendations for an in vivo pharmacodynamic approach to
demonstrate the bioequivalence of topical corticosteroids. When
finalized, this guidance will replace FDA's 1995 guidance for industry
of the same name.
    This draft guidance provides recommendations for the study design,
method qualification, data analysis, and data reporting for the pilot
dose-duration vasoconstrictor response study and pivotal
vasoconstrictor bioequivalence study used for topical corticosteroids.
The draft guidance also discusses considerations and approaches for
estimating key study parameters and sample size for the pivotal
vasoconstrictor bioequivalence study.
    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 ``Topical
Dermatologic Corticosteroids: In Vivo Bioequivalence.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 314 have been approved under OMB control
number 0910-0001. The collections of information related to current
good manufacturing practices have been approved under OMB control
number 0910-0139. The collections of information pertaining to
controlled correspondence related to generic drug development have been
approved under OMB control number 0910-0797.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23032 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P


00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MACE NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MACE NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 UPNY NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ERCT NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ECAO NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 TVA NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MANO NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 FRCC NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 FRCC NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ERCT NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 FRCC NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 SOU NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 SOU NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 TVA NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ENTG NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MANO NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MANO NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MANO NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 DSNY NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ERCT NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MECS NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MECS NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MAPP NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MAPP NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MAPP NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MACE NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MACE NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 DSNY NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 UPNY NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MACT proposal 2003 Region: System Page: 2.572 Resource, Purchases and Sales by Season and Plant Year: 2010 Capacity WINTER SUMMER Total Plant Name R. M. Dispatch [ GWh] C. F. Avail . [ GWh] C. F. Avail. [ GWh] C. F. Avail.            UPNY NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 VACA NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 CALI NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 PNW NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 VACA NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 WUMS NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 WUMS NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 NENG NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 NENG NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ECAO NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ECAO NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 SOU NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 SOU NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 AZNM NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 VACA NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ECAO NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 VACA NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ECAO NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 FRCC NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 SOU NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 UPNY NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 NENG NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MACE NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 VACA NUKE 00 8000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 TVA NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 VACA NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 VACA NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ERCT NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ENTG NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MACW NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 WUMS NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MAPP NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ENTG NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 MANO NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 TVA NUKE 00 7000000 00 RET5 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0            Nuke Early Retirement 74 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 ======================================= ======= ======= ======== ===== ===== ======== ===== ===== ======== ===== ===== Grand Total 926046. 989029. 2339274. 46.5 83.0 1856354. 51.1 88.7 4195626. 48.4 85.4            Total Purchases 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0            Total Sales 0. 0. 0. N/ A 0.0 0. N/ A 0.0 0. N/ A 0.0 Pumping and Storage Losses 7163. 7471. 14633. Inter Region Trans.  5269.  4279.  9548.


[Federal Register: April 23, 2008 (Volume 73, Number 79)]
[Notices]
[Page 21963-21964]
[DOCID:fr23ap08-85]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0234]

Developing Guidance on Conducting Scientifically Sound
Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare
Data Sets; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) at the Food and
Drug Administration (FDA) are announcing a public workshop entitled
``Developing Guidance on Conducting Scientifically Sound
Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare
Data Sets.'' The purpose of the public workshop is to solicit
information and views from interested persons on best practices and
principles for the design and evaluation of pharmacoepidemiologic
safety studies using large electronic healthcare data sets. The input
from this workshop will be used to develop a draft Guidance to
Industry, and to provide consistent review criteria for FDA to use in
evaluating protocols and study reports submitted to the agency.

DATES: The public workshop will be held on Wednesday, May 7, 2008, from
8:30 a.m. to 5 p.m. See section III of this document for information on
the deadline and on how to attend or present at the meeting. Written or
electronic comments must be submitted to the docket by June 7, 2008.

ADDRESSES: The public workshop will be held in the Ballroom at the
Crowne Plaza Hotel Washington DC-Silver Spring, MD at 8777 Georgia
Ave., Silver Spring, MD 20910.
    Regardless of attendance at the public workshop, interested persons
may submit written electronic comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. Comments are to be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Lana Pauls, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.
Bldg. 51, rm. 6196, Silver Spring, MD 20903,<PHONE_NUMBER>, FAX: 301-
847-8753, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    As part of the reauthorization of the Prescription Drug User Fee
Act (PDUFA IV), FDA committed to certain performance goals (see http://
www.fda.gov/oc/pdufa4/pdufa4goals.html). In one of these goals, FDA
agreed to identify, with input from academia, industry, and others from
the general public, epidemiology best practices and to develop
guidance(s) describing these practices. In addition, in the Food and
Drug Administration Amendments Act of 2007 (FDAAA, Public Law 110-85,
121 Stat. 823 et seq.), Congress directed FDA to develop and implement
a postmarket risk identification and analysis system that would
include, among other things, advanced analysis of drug safety data
(FDAAA, section 905, 121 Stat. 944). This workshop represents the first
step in meeting the PDUFA goal and will provide valuable information as
we build our active postmarket surveillance system.
    New technologies and the ability to assemble large data sets for
use in epidemiologic research of drug safety issues have precipitated a
great deal of discussion over the appropriate use of these data in
conducting pharmacoepidemiologic studies. FDA is committed to
developing guidance to identify and encourage the use of best practices
in the conduct of epidemiologic studies of drug safety issues by
industry, FDA, and academic researchers. Experts from industry,
academia, and the general public are invited to contribute ideas and
concepts for consideration.
    The workshop objectives are as follows: (1) Initiate constructive
dialogue and information-sharing among regulators, researchers, the
pharmaceutical industry, health organizations, and individuals about
the design, conduct and interpretation of pharmacoepidemiologic safety
studies using electronic healthcare data sets; (2) share current FDA
experiences regarding the evaluation of protocols and study reports
submitted to the agency; and (3) obtain input on developing consistent
review criteria for FDA to use in evaluating protocols and study
reports submitted to the agency.
    Two panel discussions will focus on areas in which the agency
requests input.
    Panel 1 will focus on characteristics of electronic data used to
conduct pharmacoepidemiologic studies for use in regulatory assessment
of product safety. Topics include: differences in health care coverage,
determinants of enrollment, country or region of data collection,
characteristics of various healthcare systems and how these might
impact on the interpretation and the generalizability of the results to
the U.S. patient population. Specific questions include:
    1. What information and what level of detail are needed for FDA to
ensure the appropriateness of the data source to address the product
safety questions being asked? How does this differ by type of data
source (electronic medical records (EMR) vs. claims)?
    2. What are the challenges of using enrollment data for defining
study populations in claims databases? Describe effective strategies
for addressing the absence of formal enrollment data in some EMR
systems.
    3. Under what circumstances should FDA consider studies using non-
U.S. electronic data sources in its assessment of product safety
questions?
    Panel 2 will focus on characteristics related to study design,
conduct and interpretation of pharmacoepidemiologic safety studies,
specifically those using electronic healthcare data sources. Topics
include issues pertinent to definition of exposure, ascertainment of
outcome, analysis of data, and interpretation of study findings and
will address the following questions:
    1. How can FDA assure that the study design accurately captures the
clinical events, exposures of interest, and confounding factors needed
to answer the product safety question under investigation?
    2. What are effective strategies to address confounding by
indication and the effect of measured and unmeasured confounders?
    3. What are other challenges to internal and external validity in
studies using EMR and claims databases? What are the best practices for
addressing them?
    FDA is working to refine the workshop agenda and to invite panel
members. We are seeking broad participation by safety researchers,
health system officials, the pharmaceutical industry, and others. We
anticipate issuing a summary of the workshop, including a discussion of
implications and next steps for further development.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

III. Attendance and Registration

    The Workshop facility, the Ballroom in the Crowne Plaza Hotel at
8777 Georgia Ave. in Silver Spring, MD is not a secure facility.
Seating will be made available on a first-come basis. Individual
interested in attending the workshop need not register.
    Individuals who wish to speak during the public workshop must
register on or before April 7, 2008. You should identify the subject
matter you wish to address during the public workshop. Please specify
Panel 1, or Panel 2 (see I. Background). To register to speak, contact
<EMAIL_ADDRESS>or call<PHONE_NUMBER>.
    Ample time will be allowed during the scheduled agenda for
attendees to ask questions of panelists. In addition, we strongly
encourage written comments to the docket.
    If you need special accommodations because of disability, please
contact Lana Pauls (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the workshop.

IV. Workshop Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
It may be viewed at the Division of Dockets Management (see ADDRESSES).
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: April 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8772 Filed 4-22-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Rules and Regulations]
[Page 58611]
[FR Doc No: 2015-24829]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0883]

Drawbridge Operation Regulation; Sacramento River, Sacramento, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Tower Drawbridge across the
Sacramento River, mile 59.0 at Sacramento, CA. The deviation is
necessary to allow the community to participate in the Urban Cow Half
Marathon. This deviation allows the bridge to remain in the closed-to-
navigation position during the deviation period.

DATES: This deviation is effective from 7:30 a.m. to 10 a.m. on October
4, 2015.

ADDRESSES: The docket for this deviation, [USCG-2015-0883], 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, call or email David H. Sulouff, Chief, Bridge
Section, Eleventh Coast Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: California Department of Transportation has
requested a temporary change to the operation of the Tower Drawbridge,
mile 59.0, over Sacramento River, at Sacramento, CA. The drawbridge
navigation span provides a vertical clearance of 30 feet above Mean
High Water in the closed-to-navigation position. The draw opens on
signal from May 1 through October 31 from 6 a.m. to 10 p.m. and from
November 1 through April 30 from 9 a.m. to 5 p.m. At all other times
the draw shall open on signal if at least four hours notice is given,
as required by 33 CFR 117.189(a). Navigation on the waterway is
commercial and recreational.
    The drawspan will be secured in the closed-to-navigation position
from 7:30 a.m. to 10 a.m. on October 4, 2015, to allow the community to
participate in the Urban Cow Half Marathon. This temporary deviation
has been coordinated with the waterway users. No objections to the
proposed temporary deviation were raised.
    Vessels able to pass through the bridge in the closed position may
do so at anytime. The bridge will be able to open for emergencies and
there is no immediate alternate route for vessels to pass. The Coast
Guard will also inform the users of the waterway through our Local and
Broadcast Notices to Mariners of the change in operating schedule for
the bridge so that 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: September 15, 2015.
D.H. Sulouff,
District Bridge Chief,Eleventh Coast Guard District.
[FR Doc. 2015-24829 Filed 9-29-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63779-63780]
[FR Doc No: 2015-26782]

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

[EPA-HQ-OGC-2015-0691; FRL 9935-87-OGC]

Proposed Consent Decree, Clean Air Act Citizen Suit

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed consent decree; request for public comment.

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

SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``CAA'' or the ``Act''), notice is hereby given of a proposed
consent decree to address a lawsuit filed by the Environmental
Integrity Project and Sierra Club (collectively, ``Plaintiffs''):
Environmental Integrity Project, et al. v. McCarthy, No. 1:15-CV-745
(ABJ) (D. D.C.). Plaintiffs filed a complaint alleging that Gina
McCarthy, in her official capacity as Administrator of the United
States Environmental Protection Agency (``EPA''), failed to perform a
non-discretionary duty to grant or deny within 60 days a petition
submitted by Plaintiffs in October 2014, requesting that EPA object to
a revised CAA Title V permit issued by the Texas Commission on
Environmental Quality (``TCEQ'') to the Southwestern Electric Power
Company for operation of the H.W. Pirkey Power Plant in Harrison
County, Texas. The proposed consent decree would establish a deadline
for EPA to take such action.

DATES: Written comments on the proposed consent decree must be received
by November 20, 2015.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2015-0691, online at www.regulations.gov (EPA's preferred method);
by email to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Amy Branning, Air and Radiation Law
Office, Office of General Counsel, U.S. Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone:
(202) 564-1744; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Consent Decree

    The proposed consent decree would resolve a lawsuit filed by the
Environmental Integrity Project and Sierra Club seeking to compel the
Administrator to take action under CAA section 505(b)(2). Under the
terms of the proposed consent decree, EPA would agree to sign its
response granting or denying the petition filed by the Plaintiffs
regarding Southwestern Electric Power Company for operation of the H.W.
Pirkey Power Plant in Harrison County, Texas, pursuant to section
505(b)(2) of the CAA, on or before February 12, 2016.
    Under the terms of the proposed consent decree, EPA would
expeditiously deliver notice of EPA's response to the Office of the
Federal Register for review and publication following signature of such
response. In addition, the proposed consent decree outlines the
procedure for the Plaintiffs to request costs of litigation, including
attorney fees.
    For a period of thirty (30) days following the date of publication
of this notice, EPA will accept written comments relating to the
proposed consent decree from persons who are not named as parties or
intervenors to the litigation in question. EPA or the Department of
Justice may withdraw or withhold consent to the proposed consent decree
if the comments disclose facts or considerations that indicate that
such consent is inappropriate, improper, inadequate, or inconsistent
with the requirements of the Act. Unless EPA or the Department of
Justice determines that consent to this proposed decree should be
withdrawn, the terms of the consent decree will be affirmed.

II. Additional Information About Commenting on the Proposed Consent
Decree

A. How can I get a copy of the consent decree?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2015-0691 contains a copy of the proposed consent
decree. The official public docket is available for public viewing at
the Office of Environmental Information (OEI) Docket in the EPA Docket
Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OEI Docket is<PHONE_NUMBER>.
    An electronic version of the public docket is available through
www.regulations.gov. You may use www.regulations.gov to submit or view
public comments, access the index listing of the contents of the
official public docket, and to access those documents in the public
docket that are available electronically. Once in the system, key in
the appropriate docket identification number then select ``search.''
    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at www.regulations.gov without change, unless
the comment contains copyrighted material, CBI, or other information
whose disclosure is restricted by statute. Information claimed as CBI
and other information whose disclosure is restricted by statute is not
included in the official public docket or in the electronic public
docket. EPA's policy is that copyrighted material, including
copyrighted material contained in a public comment, will not be placed
in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section.
Please ensure that your comments are submitted within the specified
comment period. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    If you submit an electronic comment, EPA recommends that you
include your name, mailing address, and an email address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. Any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,

and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    Use of the www.regulations.gov Web site to submit comments to EPA
electronically is EPA's preferred method for receiving comments. The
electronic public docket system is an ``anonymous access'' system,
which means EPA will not know your identity, email address, or other
contact information unless you provide it in the body of your comment.
In contrast to EPA's electronic public docket, EPA's electronic mail
(email) system is not an ``anonymous access'' system. If you send an
email comment directly to the Docket without going through
www.regulations.gov, your email address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: October 7, 2015.
Lorie J. Schmidt,
Associate General Counsel.
[FR Doc. 2015-26782 Filed 10-20-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 70 (Thursday, April 13, 2017)]
[Notices]
[Pages 17849-17850]
[FR Doc No: 2017-07438]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4307-DR: Docket ID FEMA-2017-0001]

Nevada; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Nevada (FEMA-4307-DR), dated March 27, 2017,
and related determinations.

DATES: Effective March 27, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated March 27, 2017, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Nevada resulting from severe winter storms, flooding, and
mudslides during the period of February 5-22, 2017, is of sufficient
severity and magnitude to warrant a major disaster declaration under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act,
42 U.S.C. 5121 et seq. (the ``Stafford Act''). Therefore, I declare
that such a major disaster exists in the State of Nevada.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.
    The Federal Emergency Management Agency (FEMA) hereby gives
notice that pursuant to the authority vested in the Administrator,
under Executive Order 12148, as amended, Rosalyn L. Cole, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Nevada have been designated
as adversely affected by this major disaster:
     The counties of Douglas (including the Washoe Tribe of
Nevada and California within the State of Nevada), Elko (including
the South Fork Band of Te-Moak Tribe of Western Shoshone), Humboldt,
and Washoe and the independent city of Carson City for Public
Assistance.
    All areas within the State of Nevada are eligible for assistance
under the Hazard Mitigation Grant Program.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--

Disaster Housing Operations for Individuals and Households; 97.050,
Presidentially Declared Disaster Assistance to Individuals and
Households--Other Needs; 97.036, Disaster Grants--Public Assistance
(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.

Robert J. Fenton,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-07438 Filed 4-12-17; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: February 13, 2008 (Volume 73, Number 30)]
[Notices]
[Page 8307-8309]
[DOCID:fr13fe08-64]

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

[EPA-HQ-OPP-2008-0046; FRL-8351-5]

Notice of Filing of Pesticide Petitions for Residues of Pesticide
Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment or modification of regulations
for residues of pesticide chemicals in or on various commodities.

DATES: Comments must be received on or before March 14, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest, by one
of the following methods:
     Federal eRulemaking Portal:  http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket identification
(ID) number and the pesticide petition number of interest. EPA's policy
is that all comments received will be included in the docket without
change and may be made available on-line at http://www.regulations.gov,

including any personal information provided, unless the comment
includes information claimed to be Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Do not submit information that you consider to be CBI or otherwise
protected through regulations.gov or e-mail. The regulations.gov
website is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in

hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The person listed at the end of the
pesticide petition summary of interest.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed at the end of the pesticide petition
summary of interest.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.

    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Docket ID Numbers

    When submitting comments, please use the docket ID number and the
pesticide petition number of interest, as shown in the table.

------------------------------------------------------------------------
                 PP Number                        Docket ID Number
------------------------------------------------------------------------
PP 6F7094                                   EPA-HQ-OPP-2006-0855
------------------------------------------------------------------------
PP 6F7095                                   EPA-HQ-OPP-2006-0855
------------------------------------------------------------------------
PP 7F7246                                   EPA-HQ-OPP-2007-1065
------------------------------------------------------------------------
PP 5F6986                                   EPA-HQ-OPP-2005-0145
------------------------------------------------------------------------

III. What Action is the Agency Taking?

    EPA is printing notice of the filing of pesticide petitions
received under section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 180 for residues of pesticide chemicals in
or on various food commodities. EPA has determined that the pesticide
petitions described in this notice contain data or information
regarding the elements set forth in FFDCA section 408(d)(2); however,
EPA has not fully evaluated the sufficiency of the submitted data at
this time or whether the data support granting of the pesticide
petitions. Additional data may be needed before EPA rules on these
pesticide petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
included in this notice, prepared by the petitioner, is included in a
docket EPA has created for each rulemaking. The docket for each of the
petitions is available on-line at http://www.regulations.gov.

New Tolerances

     1. PP 6F7094. (EPA-HQ-OPP-2006-0855). BASF Corporation, 26 Davis
Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528, proposes
to establish a tolerance for residues of the fungicide metconazole, 5-
[(4-chlorophenyl)-methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol, measured as the sum of cis- and trans- isomers
in or on food commodities barley, grain at 2.0 parts per million (ppm);
barley, hay at 7.0 ppm, barley straw at 7.0 ppm; beet, sugar, root at
0.1 ppm; beet, sugar, tops at 2.0 ppm; beet, sugar, pulp, dry at 1.9
ppm; beet, sugar, molasses at 0.2 ppm; beet, sugar, raw at 0.25 ppm;
oat, grain at 1.0 ppm; oat, straw at 6.0 ppm; oat, hay at 17 ppm; rye,
grain at 0.25 ppm; rye, straw at 14.0 ppm; soybean, forage at 3.0 ppm;
soybean, hay at 6.0 ppm; soybean, seed at 0.10 ppm; soybean, aspirated
grain fractions at 1.0 ppm; soybean, hulls at 0.2 ppm; triticale at
0.25 ppm, wheat, grain at 0.15 ppm; wheat, hay at 16.0 ppm; wheat,
straw at 18.0 ppm; wheat, aspirated grain fractions at 10.0 ppm; wheat,
milled byproducts at 1.0 ppm. Independently validated analytical method
have been submitted for analyzing parent metconazole residues with
appropriate sensitivity in all the crop and processed commodities for
soybean, sugar beet, barley, wheat, oats, and rye for which tolerances
are being requested. Contact: Tracy Keigwin, telephone number: (703)
305-6605; e-mail address<EMAIL_ADDRESS>     2. PP 6F7095. (EPA-HQ-OPP-2006-0855). Valent U.S.A. Company, 1600
Riviera Ave., Suite 200, Walnut Creek, CA 94596-8025, proposes to
establish a tolerance for residues of the fungicide metconazole, 5-[(4-
chlorophenyl)-methyl]-2,2-dimethyl-1-(1H-1,2,4-triazol-1-
ylmethyl)cyclopentanol, measured as the sum of cis- and trans- isomers
in or on food commodities fruits, stone (crop group 12) at 0.2 ppm ;
nuts, tree (crop group 14) including pistachio at 0.02 ppm; almond
hulls at 5.0 ppm; and peanut at 0.02 ppm. Independently validated
analytical method have been submitted for analyzing parent metconazole
residues with appropriate sensitivity in all the crop and processed
commodities for stone fruit (crop group 12), tree nuts (crop group 14),
and peanuts for which tolerances are being requested. Contact: Tracy
Keigwin, telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
     3. PP 7F7246. (EPA-HQ-OPP-2007-1065). KIM-C1, LLC, c/o Siemer and
Associates, Inc., 135 W. Shaw, Suite 102, Fresno, CA 93704, proposes to
establish a time-limited tolerance for residues of the fungicide
forchlorfenuron (KT-30), in or on food commodities almond, cherry, fig,
pear, pistachio, plum/prune at 0.01 ppm. Two analytical methods, both
based on high performance liquid chromatography (HPLC) procedures have
been developed. The first method used a visible ultraviolet (UV)
detector, while the second method used a mass spectrophotometer (MS)
detector. Since the MS detector is capable of both qualitative as well
as quantitative measurement, it is the preferred method. The lowest
level of quantification (LOQ) in all of the crops (i.e. almond, cherry,
fig, pear, pistachio and prune) was 0.01 ppm. Contact: Tawanda Maignan,
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

Revised Notice of Filing of a Pesticide Petition

     PP 5F6986. (EPA-HQ-OPP-2005-00145). BASF Corporation, Research
Triangle Park, NC 27709, submitted a revised notice of filing for their
pesticide petition which supersedes/replaces the previous notice
published in the Federal Register of February 15, 2006 (71 FR 7951)
(FRL-7759-3). This revised notice proposes to establish a tolerance for
residues of the fungicide boscalid (BAS 510F), 3-pyridinecarboxamide,
2-chloro-N-(4'-chloro[1,1'-biphenyl]-2-yl) in or on food commodities
caneberry, crop group 13A at 6.0 ppm; bushberry, crop group 13B at 10.0
ppm; cucumber at 0.5 ppm; and vegetable, root, subgroup 1A, except
sugar beet, garden beet, radish and turnip at 1.0 ppm. In plants, the
parent residue is extracted using an aqueous organic solvent mixture
followed by liquid/liquid partitioning and a column clean up.
Quantitation is by gas chromatography using mass spectrometry (GC/MS).
In livestock, the residues are extracted with methanol. The extract is
treated with enzymes in order to release the conjugated glucuronic acid
metabolite. The residues are then isolated by liquid/liquid partition
followed by column chromatography. The hydroxylated metabolite is
acetylated followed by a column clean up. The parent and acetylated
metabolite are quantitated by gas chromatography with electron capture
detection. Contact: Bryant Crowe, telephone number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: February 4, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. E8-2551 Filed 2-12-08; 8:45 am]

BILLING CODE 6560-50-S