[Federal Register Volume 77, Number 199 (Monday, October 15, 2012)]
[Notices]
[Pages 62506-62507]
[FR Doc No: 2012-25274]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-2794-004; ER10-2849-003; ER11-2028-004.
    Applicants: EDF Trading North America, LLC, EDF Industrial Power
Services (IL), LLC, EDF Industrial Power Services (NY), LLC.
    Description: Revised Pivotal Supplier Screen of EDF Trading North
America, LLC, EDF Industrial Power Services (NY), LLC and EDF
Industrial Power Services (IL), LLC.
    Filed Date: 8/20/12.
    Accession Number: 20120820-5043.
    Comments Due: 5 p.m. ET 10/24/12.

    Docket Numbers: ER12-1007-001.
    Applicants: AP Gas & Electric (NY), LLC.
    Description: Notification of Non-Material Change-in-Status of AP
Gas & Electric (NY), LLC.
    Filed Date: 10/3/12.
    Accession Number: 20121003-5042.
    Comments Due: 5 p.m. ET 10/24/12.

    Docket Numbers: ER12-1626-000.
    Applicants: Topaz Solar Farms LLC.
    Description: Topaz Solar Farms LLC submits Request for Waiver to
File an Updated Market Power Analysis for the Central Region.
    Filed Date: 10/2/12.
    Accession Number: 20121002-5186.
    Comments Due: 5 p.m. ET 10/23/12.

    Docket Numbers: ER12-2588-001.
    Applicants: Hess Small Business Services LLC.
    Description: Amendment to September 6, 2012 Filing to be effective
11/5/2012.
    Filed Date: 10/2/12.
    Accession Number: 20121002-5114.
    Comments Due: 5 p.m. ET 10/23/12.

    Docket Numbers: ER12-2709-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits Order No.
1000 Compliance Filing.
    Filed Date: 9/27/12.

    Accession Number: 20120927-5210.
    Comments Due: 5 p.m. ET 10/18/12.

    Docket Numbers: ER13-11-000.
    Applicants: Sierra Pacific Power Company.
    Description: Rate Schedule No. 55--Amended and Restated PPA--
CalPeco to be effective 12/1/2012.
    Filed Date: 10/2/12.
    Accession Number: 20121002-5145.
    Comments Due: 5 p.m. ET 10/23/12.

    Docket Numbers: ER13-12-000.
    Applicants: Midwest Independent Transmission System.
    Description: 10-2-12 ATCLLC Attachment MM to be effective 12/1/
2012.
    Filed Date: 10/2/12.
    Accession Number: 20121002-5165.
    Comments Due: 5 p.m. ET 10/23/12.

    Docket Numbers: ER13-13-000.
    Applicants: NV Energy, Inc.
    Description: Service Agreement No. 11-00052 Amended and Restated
LGIA--Patua Project LLC to be effective 9/11/2012.
    Filed Date: 10/2/12.
    Accession Number: 20121002-5170.
    Comments Due: 5 p.m. ET 10/23/12.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 3, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-25274 Filed 10-12-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 90 (Wednesday, May 9, 2018)]
[Proposed Rules]
[Pages 21194-21196]
[FR Doc No: 2018-09742]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0384; Product Identifier 2017-SW-061-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus 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
Airbus Helicopters Model AS-365N2, AS 365 N3, EC 155B, EC155B1, SA-
365N1, and SA-366G1 helicopters. This proposed AD would require
repetitive inspections of the aft fuselage outer skin. This proposed AD
is prompted by several reports of aft fuselage outer skin disbonding.
The actions of this proposed AD are intended to address an unsafe
condition on these products.

DATES: We must receive comments on this proposed AD by July 9, 2018.

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 by searching for and locating Docket No. FAA-2018-
0384; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the European Aviation Safety Agency (EASA) AD, the
economic evaluation, any comments received, and other information. The
street address for Docket Operations (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.
    For service information identified in this proposed rule, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.helicopters.airbus.com/website/en/ref/Technical-Support_73.html. You may review the referenced service information at
the FAA, Office of the Regional Counsel, Southwest Region, 10101
Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

FOR FURTHER INFORMATION CONTACT: Matt Fuller, Senior Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected].

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

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2017-0165, dated September 5,
2017 (EASA AD 2017-0165), to correct an unsafe condition for Airbus
Helicopters Model SA 365 N1, AS 365 N2, AS 365 N3, SA 366 G1, EC 155 B
and EC 155 B1 helicopters. EASA advises of several reports of aft
fuselage (baggage compartment area) outer skin disbonding found during
a 600-hour inspection. EASA advises that most of the reports of
disbonding occurred on Model EC 155 helicopters and may occur in the
same area on Model AS 365, SA 365, and SA 366 helicopters due to design
similarity. According to EASA, the cause of the disbonding has not yet
been determined and the investigation is continuing. Airbus Helicopters
states possible causes that are being considered include exhaust gas
heat from the exhaust pipes and environmental conditions. EASA states
that this condition, if not detected and corrected, could reduce the
structural integrity of the aft fuselage, possibly affecting safe
flight and landing.
    To address this unsafe condition, EASA AD 2017-0165 requires a
repetitive tap inspection of the aft fuselage outer skin for
disbonding, a repetitive visual inspection of the aft fuselage outer
skin for distortion, wrinkling, and corrosion, and contacting Airbus
Helicopters if there is any disbonding.

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 the same type design.

Related Service Information Under 1 CFR Part 51

    We reviewed Airbus Helicopters Alert Service Bulletin (ASB) No.
AS365-05.00.77 for Model AS365 N, N1, N2, and N3 and non-FAA-
certificated Model AS365 F, Fs, Fi, K, and K2 helicopters; ASB No.
SA366-05.48 for Model SA366 G1 and non-FAA-certificated Model SA366 GA
helicopters; and ASB No. EC155-05A033 for Model EC155 B and B1
helicopters, all Revision 0 and all dated July 21, 2017. This service
information specifies repetitive tap and visual inspections between aft
fuselage outer skin frames X4630 and X6630 and defines the allowable
limit of disbonding for this area. If there is distortion, wrinkling,
or corrosion, this service information specifies performing a tap
inspection. If there is disbonding within the allowable limit, this
service information specifies reporting the inspection results to
Airbus Helicopters and performing the recurring tap inspection at a
shorter compliance time interval. If there is disbonding that exceeds
the allowable limit, this service information specifies contacting
Airbus Helicopters for repair before further flight.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Proposed AD Requirements

    This proposed AD would require, within 110 hours time-in-service
(TIS), a tap inspection of the aft fuselage outer skin for disbonding.
If there is no disbonding, repeating the tap inspection at intervals
not to exceed 660 hours TIS would be required. If there is disbonding,
either repeating the tap inspections at intervals not to exceed 110
hours TIS or repairing or replacing the panel before further flight and
then tap inspecting the panel at intervals not to exceed 660 hours TIS
would be required. This proposed AD would also require, within 220
hours TIS and thereafter at intervals not to exceed 110 hours TIS,
cleaning the aft fuselage outer skin and visually inspecting for
distortion, wrinkling, and corrosion. If there is any distortion,
wrinkling, or corrosion, tap inspecting the area for disbonding would
be required before further flight.

Differences Between This Proposed AD and the EASA AD

    If there is disbonding within the allowable limit, the EASA AD
specifies reporting the inspection results to Airbus Helicopters,
whereas this proposed AD would not. If there is disbonding that exceeds
the allowable limit, the EASA AD specifies contacting Airbus
Helicopters for approved skin panel repair or replacement instructions,
whereas this proposed AD would require repairing or replacing the panel
instead.

Interim Action

    We consider this proposed AD to be an interim action. If final
action is later identified, we might consider further rulemaking then.

Costs of Compliance

    We estimate that this proposed AD would affect 46 helicopters of
U.S. Registry. We estimate that operators may incur the following costs
in order to comply with this AD. Labor costs are estimated at $85 per
work-hour.
    Tap inspecting the aft fuselage outer skin would take about 3 work-
hours for an estimated cost of $255 per helicopter and $11,730 for the
U.S. fleet per inspection cycle. Visually inspecting the aft fuselage
outer skin would take about 0.3 work-hour for an estimated cost of $26
per helicopter and $1,196 for the U.S. fleet per inspection cycle.
Repairing a panel would take about 5 work-hours and parts would cost
about $500 for an estimated cost of $925. Replacing a panel would take
about 10 work-hours and parts would cost about $20,000 for an estimated
cost of $20,850.

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

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

Airbus Helicopters: Docket No. FAA-2018-0384; Product Identifier
2017-SW-061-AD.

(a) Applicability

    This AD applies to Model AS-365N2, AS 365 N3, EC 155B, EC155B1,
SA-365N1, and SA-366G1 helicopters, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as disbonding of the aft
fuselage outer skin. This condition could result in loss of aft
fuselage structural integrity and subsequent loss of control of the
helicopter.

(c) Comments Due Date

    We must receive comments by July 9, 2018.

(d) 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.

(e) Required Actions

    (1) Within 110 hours time-in-service (TIS), tap inspect the aft
fuselage outer skin for disbonding between frames X4630 and X6630 in
the areas depicted in Figure 1 of Airbus Helicopters Alert Service
Bulletin (ASB) No. AS365-05.00.77, ASB No. SA366-05.48, or ASB No.
EC155-05A033, all Revision 0 and dated July 21, 2017 (ASB AS365-
05.00.77, ASB SA366-05.48, or ASB EC155-05A033), as applicable for
your model helicopter. Examples of acceptable and unacceptable
disbonding areas are depicted in Figure 2 of ASB AS365-05.00.77, ASB
SA366-05.48, and ASB EC155-05A033, as applicable for your model
helicopter.
    (i) If there is no disbonding, repeat the tap inspection at
intervals not to exceed 660 hours TIS.
    (ii) If there is disbonding within one square-shaped area
measuring 3.94 in. x 3.94 in. (10 cm x 10 cm) that does not cross
two skin panels, repeat the tap inspection at intervals not to
exceed 110 hours TIS.
    (iii) If there is disbonding that exceeds one square-shaped area
measuring 3.94 in. x 3.94 in. (10 cm x 10 cm) or crosses two skin
panels, before further flight, repair or replace the panel.
Thereafter, tap inspect the panel at intervals not to exceed 660
hours TIS.
    (2) Within 220 hours TIS, and thereafter at intervals not to
exceed 110 hours TIS, clean the aft fuselage outer skin and using a
light, visually inspect for distortion, wrinkling, and corrosion
between frames X4630 and X6630 as depicted in Figure 1 of ASB AS365-
05.00.77, ASB SA366-05.48, or ASB EC155-05A033, as applicable for
your model helicopter. If there is any distortion, wrinkling, or
corrosion, before further flight, tap inspect the area for
disbonding by following the inspection instructions in paragraph
(e)(1) of this AD.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
Matt Fuller, Senior Aviation Safety Engineer, Safety Management
Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy.,
Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email [email protected].
    (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.

(g) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2017-0165, dated September 5, 2017. You may
view the EASA AD on the internet at http://www.regulations.gov in
the AD Docket.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 5302, Rotorcraft
tail boom.

    Issued in Fort Worth, Texas, on April 26, 2018.
Lance T. Gant,
Director, Compliance & Airworthiness Division,Aircraft Certification
Service.
[FR Doc. 2018-09742 Filed 5-8-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: June 27, 2008 (Volume 73, Number 125)]
[Proposed Rules]
[Page 36489-36490]
[DOCID:fr27jn08-27]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Parts 383, 384, 390, and 391

[Docket No. FMCSA-1997-2210]
RIN 2126-AA10

Medical Certification Requirements as Part of the Commercial
Driver's License; Availability of Supplemental Document

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Proposed rule; availability of supplemental document.

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SUMMARY: This notice advises the public that FMCSA is placing in the
public docket an additional document that the Agency may rely on in
support of a final rule to integrate information regarding the medical
certification status of a driver into the commercial driver's license
(CDL) process. FMCSA published a notice of proposed rulemaking (NPRM)
on this matter on November 16, 2006. Because the involved state cost
analysis document was completed after publication of the NPRM and
subsequent public comment period, the Agency now dockets and invites
comment on it.

DATES: Comments on the document are due by July 28, 2008.

ADDRESSES: You may submit comments, identified by docket number FMCSA-
1997-2210, by one of the following methods: Internet, facsimile,
regular mail, or hand delivery. Please do not submit the same comments
by more than one method. FMCSA encourages use of the Federal
eRulemaking portal. It provides the most efficient and timely method of
receiving and processing your comments.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility; U.S. Department of
Transportation; 1200 New Jersey Avenue, SE.; Washington, DC 20590-0001.
     Hand Delivery: Ground floor, Room W12-140, 1200 New Jersey
Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday
through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number (FMCSA-1997-2210) or Regulatory Identification Number
(RIN 2126-AA10) for this action. Note that all comments received will
be posted without change to http://www.regulations.gov, including any
personal information provided. Refer to the Privacy Act heading at
http://www.regulations.gov for further information.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review the
Department of Transportation's complete Privacy Act Statement in the
Federal Register published on April 11, 2000 (65 FR 19476) or you may
visit http://DocketsInfo.dot.gov.
    Submitting Comments:
     You can find electronic submission and retrieval help and
guidelines under the ``help'' section of the Web site.
     For notification that FMCSA received your comments, please
include a self-addressed, stamped envelope or postcard, or print the
acknowledgement page that appears after submitting comments on line.
     All comments received before the close of business on the
comment closing date indicated above will be considered and will be
available for examination in the docket at the above address or on the
Web site.
     Comments received after the comment closing date will be
available in the docket and will be considered to the extent it is
practical.
    FMCSA will continue to put relevant information in the docket as it
becomes available after the comment period closing date, and interested
persons should continue to examine the docket for new material.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs, FMCSA, Room W64-224, U.S. Department of Transportation, 1200
New Jersey Avenue, SE., Washington, DC 20590-0001. Telephone: (202)
366-4001. E-mail address<EMAIL_ADDRESS>Office hours are from
8:30 a.m. to 5 p.m. Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION: On November 16, 2006, FMCSA published an
NPRM on how the Agency proposes to integrate information regarding the
medical certification status of a driver of a commercial motor vehicle
into the CDL process (71 FR 66723). This rulemaking is required by
section 215 of the Motor Carrier Safety Improvement Act of 1999 (MCSIA)
(Pub. L. 106-159, 113 Stat. 1767, December 9, 1999; set out as a note
to 49 U.S.C. 31305).
    For a full explanation of this proposal, please see the preamble to
the NPRM. The docket for this rulemaking (FMCSA-1997-2210) contains the
NPRM and all of the background information for this rulemaking,
including comments.
    This notice calls attention to an additional docketed document
which was not used in developing the NPRM that FMCSA may rely on in
support of its final rule. Placing this document in the docket now is
necessary because it only became available after the NPRM was published
and after conclusion of the comment period established in the NPRM.
    The Agency has placed the state cost analysis document referenced
below in the docket for this rulemaking and will accept comments on
this document until July 28, 2008.
    The document that FMCSA is placing in the docket is titled: State
Cost Analysis to Implement Notice of Proposed Rulemaking (NPRM) dated
November 16, 2006 titled ``Medical Certification Requirements as Part
of the CDL,'' prepared for the U.S. Department of Transportation by the
North American Driver Safety Foundation, October 2007. Several States
asserted in their comments to the NPRM that they believe the Agency
underestimated State costs for complying with the proposed rule. They
requested FMCSA to gather additional data from States on the
anticipated costs for this proposal. In response, the Agency arranged
to survey a sample of nine States to evaluate whether the costs to
States to implement this rule would be different than those used in the
NPRM. This report describes what cost information was collected and how
that additional cost information was analyzed to better estimate the
national costs of implementing the requirements outlined in the NPRM.

    Issued on: June 20, 2008.
John H. Hill,
Administrator.
 [FR Doc. E8-14608 Filed 6-26-08; 8:45 am]

BILLING CODE 4910-EX-P


ENVIRONMENTAL PROTECTION AGENCY [ OPA 2004 0001, FRL 7633 8]

Agency Information Collection Activities: Proposed Collection; Comment Request; Renewal of Information Collection Request for the Implementation of the Oil Pollution Act Facility Response Plan Requirements ( 40 CFR Part 112); EPA ICR Number 1630.08; OMB Control Number 2050 0135.

Comment and Response to Comment:

Comment ( Docket number OPA 2004 0001 0006 dated 06/ 12/ 2004):

usepa opa 2004 0001 frl 7669 4 omb review of OIL POLLUTION ACT It is clear that this oil pollution act is not doing the job it should be doing in protection for the american public. this act needs revision and upgrading. Collecting the information you are collecting is not helping the american public one iota.

a ship off the NJ coast in bradley beach spilled tons of oil, polluting the beach, killing wildlife/ birds and no one knows who did it. that has to change. there has to be enforcement and inspection on ships entering our harbors. we cannot have this secret spillage going on.

The present response is inadequate and negligent. This agency is sitting on its duff while shippers pollute our waters, kill our people and animals.

We also need to identify the polluters so that they can be found and brought to justice and made to pay the millions upon millions in damage that they cause. There is no reason to make the people who live in NJ pay for that oil spilll off bradley beach when it was plainly caused by one of the ships that your agency is supposed to be aware of.

The focus of this agency must be changed to catching the polluters. There will be less pollution if we catch the malignant polluters among us.

b. sachau 15 elm st florham park nj 07932 Response to Comment:

As further explained in the FRP ICR renewal ( OPA 2004 0001), this Information Collection Request ( ICR) covered information regarding the paperwork and cost burden place upon facilities that prepare and maintain Facility Response Plans ( FRPs). According to the Clean Water Act, as amended by OPA, certain facilities that handle, store, and transport oil must prepare, submit, and maintain FRPs. The FRP regulation is designed to ensure that facilities have adequate oil spill response capabilities. The FRPs assist the facility owner and operator in identifying the substantial threat of a worst case discharge of oil and oil spill response mechanisms.

Although EPA recognizes the need to protect the environment, there are certain jurisdictions between different governmental agencies when dealing with oil spill response. The U. S. Coast Guard regulates transportation related facilities and vessels that transport oil. The EPA regulates non transportation facilities that store, use and dispose of oil. The U. S. Coast Guard and EPA do co regulate complex facilities that have a combination of transportation related and non transportation related components ( e. g. marine transportation facilities with above ground storage tanks).

Regarding the February 2004 oil spill off the New Jersey coast that affected Bradley Beach, this oil spill occurred in an area of Coastal Waterways that is under the jurisdiction of the United States Coast Guard. U. S. Coast Guard On Scene Coordinators and the New Jersey Department of Environmental Protection monitored the clean up during this oil spill.


[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Rules and Regulations]
[Pages 72589-72591]
[FR Doc No: 2015-29633]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2015-P-1197]

Medical Devices; Exemption From Premarket Notification; Class II
Devices; Electric Positioning Chair

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
publishing an order granting a petition requesting exemption from
premarket notification requirements for electric positioning chair
devices. An electric positioning chair is a device with a motorized
positioning control that is intended for medical purposes and that can
be adjusted to various positions. These devices are used to provide
stability for patients with athetosis (involuntary spasms) and to alter
postural positions. This order exempts electric positioning chairs,
class II devices, from premarket notification, subject to certain
conditions for exemption. This exemption from premarket notification,
subject to these conditions (and the limitations in the physical
medicine devices limitations of exemptions from premarket notification
section of the device regulations), is immediately in effect for
electric positioning chairs. FDA is publishing this order in accordance
with the exemption from class II premarket notification section of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act).

DATES: This order is effective November 20, 2015.

FOR FURTHER INFORMATION CONTACT: John Marszalek, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1427, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its
implementing regulations (21 CFR part 807) require persons who propose
to begin the introduction or delivery for introduction into interstate
commerce for commercial distribution of a device intended for human use
to submit a premarket notification (510(k)) to FDA. The device may not
be marketed until FDA finds it ``substantially equivalent'' within the
meaning of section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a
legally marketed device that does not require premarket approval.
    On November 21, 1997, the President signed into law the Food and
Drug Administration Modernization Act of 1997 (FDAMA). Section 206 of
FDAMA added section 510(m) to the FD&C Act. Section 510(m)(1) of the
FD&C Act requires FDA, within 60 days after enactment of FDAMA, to
publish in the Federal Register a list of each type of class II device
that does not require a report under section 510(k) of the FD&C Act to
provide reasonable assurance of safety and effectiveness. Section
510(m) of the FD&C Act further provides that a 510(k) will no longer be
required for these devices upon the date of publication of the list in
the Federal Register. FDA published that list in the Federal Register
of January 21, 1998 (63 FR 3142).
    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a
device from premarket notification requirements on its own initiative,
or upon petition of an interested person, if FDA determines that a
510(k) is not necessary to assure the safety and effectiveness of the
device. This section requires FDA to publish in the Federal Register a
notice of intent to exempt a device, or of the petition, and to provide
a 30-day comment period. FDA must publish in the Federal Register its
final determination regarding the exemption of the device that was the
subject of the notice. If FDA fails to respond to a petition under this
section within 180 days of receiving it, the petition shall be deemed
granted.

II. Criteria for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to assure the safety and effectiveness of a class
II device. These factors are discussed in the guidance that the Agency
issued on February 19, 1998, entitled ``Procedures for Class II Device
Exemptions From Premarket Notification, Guidance for Industry and CDRH
Staff'' (Class II 510(k) Exemption Guidance). That guidance can be
obtained through the Internet on the Center for Devices and
Radiological Health home page at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm or by
sending an email request to<EMAIL_ADDRESS>to receive a copy
of the document. Please use the document number 159 to identify the
guidance you are requesting.

III. Device Description

    Electric positioning chairs are devices with a motorized
positioning control that are intended for medical purposes and that can
be adjusted to various positions. Existing legally marketed devices
have identified a range of specific procedures or conditions for which
an electric positioning chair could be used to provide stability and to
alter postural positions (e.g., muscular dystrophy, Parkinson's
syndrome, or joint replacements). The devices are primarily intended to
provide stability and a controlled lift from a seated position to a
standing position, while supporting the patient's weight (alter
postural positions). The device consists of a frame (where the user
would sit) and a lift mechanism, and may also allow the patient to
recline in the device.

IV. Petition

    On April 10, 2015, FDA received a petition requesting an exemption
from premarket notification for electric positioning chair devices.
(See Docket No. FDA-2015-P-1197.) These devices are currently
classified under 21 CFR 890.3110 Electric positioning chair.
    In the Federal Register of June 12, 2015 (80 FR 33525), FDA
published a notice announcing that this petition had been received and
provided opportunity for interested persons to submit comments on the
petition by July 13, 2015. FDA received no comments.
    FDA has assessed the need for 510(k) clearance for this type of
device using the criteria laid out in the Class II 510(k) Exemption
Guidance and in the January 21, 1998, notice (63 FR 3142 at 3143).
Based on its review, FDA believes that premarket notification is not
necessary to assure the safety and effectiveness of the device, as long
as certain conditions are met. FDA believes that the risks posed by the
device (such as instability, entrapment, use error, falls and
associated injuries, battery/electrical/mechanical failure, pressure
sores, bruising, burns, electric shock, and

electromagnetic incompatibility/interference) and the characteristics
of the device necessary for its safe and effective performance (such as
safety features, weight capacity, power source, drive mechanism/
actuator, and user controls) are well established. Moreover, FDA
believes that changes in the device that could affect safety and
effectiveness will be readily detectable by certain types of routine
analysis and non-clinical testing, such as those detailed in certain
consensus standards. Therefore, after reviewing the petition, FDA has
determined that premarket notification is not necessary to assure the
safety and effectiveness of electric positioning chairs, as long as the
conditions for 510(k) exemption in section V are met. FDA responded to
the petition by letter dated October 9, 2015, to inform the petitioner
of this decision within the 180-day timeframe under section 510(m)(2)
of the FD&C Act.

V. Conditions for Exemption

    This final order provides conditions for exemption from premarket
notification. The following conditions must be met for the device to be
510(k)-exempt: (1) Appropriate analysis and non-clinical testing must
demonstrate that the safety controls are adequate to ensure safe use of
the device and prevent user falls from the device in the event of a
device failure; (2) appropriate analysis and non-clinical testing must
demonstrate the ability of the device to withstand the rated user
weight load with an appropriate factor of safety; (3) appropriate
analysis and non-clinical testing must demonstrate the longevity of the
device to withstand external forces applied to the device and provide
the user with an expected service life of the device; (4) appropriate
analysis and non-clinical testing must demonstrate proper environments
of use and storage of the device to maximize the longevity of the
device; (5) appropriate analysis and non-clinical testing (such as that
outlined in the currently FDA-recognized editions of ANSI/AAMI ES60601-
1: ``Medical Electrical Equipment--Part 1: General Requirements for
Basic Safety and Essential Performance,'' and ANSI/AAMI/IEC 60601-1-2,
``Medical Electrical Equipment--Part 1-2: General Requirements for
Basic Safety and Essential Performance--Collateral Standard:
Electromagnetic Disturbances--Requirements and Tests'') must validate
electromagnetic compatibility and electrical safety; (6) appropriate
analysis and non-clinical testing (such as that outlined in the
currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1,
``Biological Evaluation of Medical Devices--Part 1: Evaluation and
Testing Within a Risk Management Process,'' ANSI/AAMI/ISO 10993-5,
``Biological Evaluation of Medical Devices--Part 5: Tests for In Vitro
Cytotoxicity,'' and ANSI/AAMI/ISO 10993-10, ``Biological Evaluation of
Medical Devices--Part 10: Tests for Irritation and Skin
Sensitization'') must validate that the skin-contacting components of
the device are biocompatible; (7) appropriate analysis and non-clinical
testing (such as that outlined in the currently FDA-recognized editions
of IEC 62304, ``Medical Device Software--Software Life Cycle
Processes'') must validate the software life cycle and that all
processes, activities, and tasks are implemented and documented; (8)
appropriate analysis and non-clinical testing must validate that the
device components are found to be non-flammable; (9) appropriate
analysis and non-clinical testing must validate that the battery in the
device (if applicable) performs as intended over the anticipated
service life of the device; and (10) adequate patient labeling is
provided to the user to document proper use and maintenance of the
device to ensure safe use of the device by the patient in the intended
use environment.
    Firms are now exempt from 510(k) requirements for electric
positioning chairs as long as they meet these conditions of exemption,
subject to the limitations in 21 CFR 890.9. Firms must comply with the
conditions for exemption or submit and receive clearance for a 510(k)
prior to marketing.

VI. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VII. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 801, regarding medical device
labeling, have been approved under OMB control number 0910-0485 and the
collections of information in 21 CFR part 820, regarding the quality
system regulation, have been approved under OMB control number 0910-
0073.

List of Subjects in 21 CFR Part 890

    Medical devices, Physical medicine devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
890 is amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for 21 CFR part 890 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. In Sec.  890.3110, revise paragraph (b) to read as follows:

Sec.  890.3110  Electric positioning chair.

* * * * *
    (b) Classification. Class II. The electric positioning chair is
exempt from premarket notification procedures in subpart E of part 807
of this chapter, subject to Sec.  890.9 and the following conditions
for exemption:
    (1) Appropriate analysis and non-clinical testing must demonstrate
that the safety controls are adequate to ensure safe use of the device
and prevent user falls from the device in the event of a device
failure;
    (2) Appropriate analysis and non-clinical testing must demonstrate
the ability of the device to withstand the rated user weight load with
an appropriate factor of safety;
    (3) Appropriate analysis and non-clinical testing must demonstrate
the longevity of the device to withstand external forces applied to the
device and provide the user with an expected service life of the
device;
    (4) Appropriate analysis and non-clinical testing must demonstrate
proper environments of use and storage of the device to maximize the
longevity of the device;
    (5) Appropriate analysis and non-clinical testing (such as that
outlined in the currently FDA-recognized editions of ANSI/AAMI/ES60601-
1, ``Medical Electrical Equipment--Part 1: General Requirements for
Basic Safety and Essential Performance,'' and ANSI/AAMI/IEC 60601-1-2,
``Medical Electrical Equipment--Part 1-2: General Requirements for
Basic Safety and Essential Performance--Collateral Standard:
Electromagnetic Disturbances--Requirements and Tests'') must validate
electromagnetic compatibility and electrical safety;
    (6) Appropriate analysis and non-clinical testing (such as that
outlined in

the currently FDA-recognized editions of ANSI/AAMI/ISO 10993-1,
``Biological Evaluation of Medical Devices--Part 1: Evaluation and
Testing Within a Risk Management Process,'' ANSI/AAMI/ISO 10993-5,
``Biological Evaluation of Medical Devices--Part 5: Tests for In Vitro
Cytotoxicity,'' and ANSI/AAMI/ISO 10993-10, ``Biological Evaluation of
Medical Devices--Part 10: Tests for Irritation and Skin
Sensitization'') must validate that the skin-contacting components of
the device are biocompatible;
    (7) Appropriate analysis and non-clinical testing (such as that
outlined in the currently FDA-recognized editions of IEC 62304,
``Medical Device Software--Software Life Cycle Processes'') must
validate the software life cycle and that all processes, activities,
and tasks are implemented and documented;
    (8) Appropriate analysis and non-clinical testing must validate
that the device components are found to be non-flammable;
    (9) Appropriate analysis and non-clinical testing must validate
that the battery in the device (if applicable) performs as intended
over the anticipated service life of the device; and
    (10) Adequate patient labeling is provided to the user to document
proper use and maintenance of the device to ensure safe use of the
device by the patient in the intended use environment.

     Dated: November 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29633 Filed 11-19-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 1, 2010 (Volume 75, Number 230)]
[Notices]
[Page 74705-74706]
[DOCID:fr01de10-54]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-30-000]

Tennessee Gas Pipeline Company; Notice of Application

November 24, 2010.
    Take notice that on November 12, 2010, Tennessee Gas Pipeline
Company (Tennessee), 1001 Louisiana Street, Houston, Texas 77002, filed
an application in Docket No. CP11-30-000 pursuant to section 7(c) of
the Natural Gas Act for a certificate of public convenience and
necessity to construct, and operate certain pipeline and compression
facilities to be located in Pennsylvania and New York to increase its
pipeline capacity by up to an additional 250,000 dekatherms per day
(Dth/d) of firm natural gas transportation service. In addition to the
certificate authority for the facilities identified above, Tennessee
seeks authorization to lease pipeline capacity from Dominion
Transmission, Inc. (Dominion), as more fully described in Tennessee's
application. The application is on file with the Commission and open to
public inspection. 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, please
contact FERC Online Support at<EMAIL_ADDRESS>or toll free
at<PHONE_NUMBER>, or for TTY, contact<PHONE_NUMBER>.
    The proposed project involves (1) installing approximately seven
miles of a 30-inch pipeline loop segment in Bradford and Tioga
Counties, Pennsylvania, (2) modifying Tennessee's wholly-owned
facilities located on the Niagara Spur Line, including certain
modifications to a compressor unit, modification of piping and valving
at an existing check measurement facility at East Aurora, New York, and
installation of chromatographs at four existing meter stations, and (3)
increasing the capacity of an existing interconnection between
Tennessee's 200 Line and Dominion's pipeline system by replacing an 8-
inch tap with a 16-inch tap.
    Dominion filed an application in Docket No. CP11-41-000 on November
19, 2010, for authorization to provide the proposed capacity lease to
Tennessee.
    Any questions concerning this application may be directed to
Jacquelyne Rocan, Senior Counsel, Tennessee Gas Pipeline Company, 1001
Louisiana Street, Houston, Texas 77002, phone:<PHONE_NUMBER>, fax:
(713) 420-1601, or e-mail<EMAIL_ADDRESS>or Thomas
Joyce, Manager, Rates and Regulatory Affairs, Tennessee Gas Pipeline
Company, 1001 Louisiana Street, Houston, Texas 77002, phone: (713) 420-
3299, fax:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS)

or EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's FEIS
or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: December 15, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-30250 Filed 11-30-10; 8:45 am]
BILLING CODE 6717-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on May 17, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2002-13828

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  China Eastern Airlines Corp. Ltd.			  		Date Filed:  March
5, 2004

Relief requested:  Renew exemption from 49 U.S.C. § 41301 to conduct
scheduled foreign air transportation of persons, property and mail
between Harbin, People’s Republic of China, on the one hand, and Los
Angeles, California, on the other hand.

If renewal, date and citation of last action:  March 6, 2003, in this
docket.

Applicant representatives:   Thomas J. Whalen & Evelyn D. Sahr
202-289-0500

DOT Analyst:  Shelita A. Smith—(202) 366-1226

Responsive pleadings:  None

DISPOSITION

Action:  Approved								Action date:  May 17, 2004

Effective dates of authority granted:  May 17, 2004 – May 17, 2005

Basis for approval (bilateral agreement/reciprocity): U.S. China Air
Transport Agreement

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

    X    Standard exemption conditions (attached)            X   Foreign
air carrier permit conditions (Order 92-11-7)

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:  Paul L. Gretch, Director

		   Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant is qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied

all requests in the referenced Docket.  We may amend, modify, or revoke
the authority granted in this Notice at any time without hearing at our
discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

05/2004


Page 1 of 9 April 19, 2004 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING MAY 4 6, 2004 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2004 0099 CONSULTATION ON DERMAL SENSITIZATION ISSUES FOR EXPOSURES TO PESTICIDES PANEL MEMBER BIOGRAPHICAL SKETCHES Gary R. Burleson, Ph. D.

Dr. Burleson received his Ph. D. from the Medical College of Wisconsin with post doctoral training at the University of Notre Dame. He has over 20 years professional experience in academia, clinical, contract research, government research and the pharmaceutical industry. This experience includes academic appointments and affiliations at the University of Notre Dame, North Carolina State University, the University of North Carolina at Chapel Hill, and New York University; clinical experience at Milwaukee County General Hospital; contract research organization experience, government regulatory experience at the U. S. Environmental Protection Agency ( USEPA); and pharmaceutical experience in drug discovery at Procter & Gamble. Dr. Burleson has scientific expertise in the following broad areas: Microbiology, Immunology, Virology, Clinical Microbiology, Viral Pathology, Pulmonary Immunology, Tumor Metastasis, Immunomodulation, Inflammation, Immunotoxicology, Hypersensitivity, and Computer Disease Modeling. Page 2 of 9 Ih Chu, Ph. D.

Dr. Chu obtained his Ph. D. in pharmacology in 1973. Following 2 year post doctoral training, he joined Health Canada as research scientist. As Head of Systemic Toxicology and Pharmacokinetics section, he directs research on pharmacokinetics, biochemical toxicology, neurotoxicology, endocrine disputers, reproductive and systemic effects of persistent environmental pollutants. The section also engages in developing molecular biomarkers and alternative methods for toxicity and exposure assessments.

Dr. Chu's current research focuses on the interactive and mixture effects of environmental pollutants, and toxicology studies of oxygenated and renewal fuels. He leads projects funded by the Program on Energy Research and Development and Northern Contaminants Program to investigate toxicity of advanced transportation fuels and the developmental neurotoxicity of the mixtures of persistent organic pollutants. He has authored and co authored some 150 research papers in peer reviewed journals, book chapters and reviews in toxicology. He also serves on a number of expert panels and task groups reviewing test guidelines and test methods. Research from his group has strongly impacted the development of test guidelines and regulatory requirements for toxic chemicals. Page 3 of 9 Peter Griem, Ph. D.

Dr. Peter Griem is currently a Toxicologist with the fine and specialty chemicals company Clariant ( Muttenz, Switzerland) working at the German subsidiary Clariant GmbH in Sulzbach Germany. His primary areas of interest include skin sensitization and how this endpoint can be addressed in regulatory toxicology. Dr. Griem holds a Diploma degree in Biochemistry from Tuebingen University ( Germany), a Ph. D. ( Dr. rer. nat) in Immunology/ Immunotoxicology from Duesseldorf University ( Germany) and a Certification as Toxicologist from the German Society for Pharmacology and Toxicology ( DGPT). He formerly worked with a toxicology consultant firm and a cosmetics company. Page 4 of 9 A. Wallace Hayes, PhD, DABT, FATS, FIBiol, FACFE, ERT Dr. Hayes is a toxicologist with over 30 years of experience. He has written over 200 peer reviewed publications and is the editor of the textbook, Principles and Methods of Toxicology, the international Journal of Human and Experimental Toxicology and a co editor of the Target Organ Toxicity Series. Dr. Hayes also is the editor of the Journal of Toxicology Cutaneous and Ocular Toxicology. Before joining Harvard School of Public Health as a visiting scientist, Dr. Hayes was Vice President of Corporate Product Integrity at the Gillette Company, where he had management responsibility for the safety evaluation of a variety of consumer products, plant safety, environmental stewardship, and quality control. Dr. Hayes is an adjunct professor at Wake Forest University School of Medicine, the University of Louisville School of Medicine and the School of Public Health, The University of Massachusetts. Dr. Hayes holds degrees from Auburn University ( PhD in biochemistry, M. S. in physiology) and Emory University. Dr. Hayes was a NSF predoctoral fellow at Auburn University, a NIH postdoctoral fellow at the Vanderbilt University School of Medicine, and a NATO Senior Scientist at the Central Veterinary Laboratory, Weybridge, England. Dr. Hayes currently lectures at the Harvard School of Public Health and at Virginia Polytechnic and State University and in the Risk Assessment Summer School of the International Union of Toxicology. Dr. Hayes has served the International Union of Toxicology as the editor of the Proceedings of ICT III ( Developments in the Science and Practice of Toxicology) and as the editor of the Proceedings of the 5th Congress of Toxicology in Developing Countries ( Toxicology in New Century Opportunity and Challenge). Dr. Hayes has served as a delegate to IUTOX and on several IUTOX committees. In addition, Dr. Hayes has served on committees for the National Academy of Sciences, the National Institution of Health, and the Department of Defence. Dr. Hayes is a diplomat of the American Board of Toxicology, The Academy of Toxicology Sciences, the American Board of Forensic Medicine and the American Board of Forensic Examiners. He is a Fellow of the Academy of Toxicological Sciences and Institute of Biological Sciences ( UK). Dr. Hayes is a registered toxicologist in the European Union ( EUROTOX). Page 5 of 9 Abigail Jacobs, Ph. D.

Dr. Jacobs is currently Associate Director for Pharmacology / Toxicology for Offices of Drug Evaluation ( ODEs) 4 and 5, Center for Drug Evaluation ( CDER)/ FDA. Dr. Jacobs received a B. S. in chemistry at the U. of Michigan, Ann Arbor, and a Ph. D. in biochemistry at the U. of California, Berkeley. After postdoctoral work in immunochemistry and mast cell biochemistry, she became a toxicologist. She spent numerous years working for the National Cancer Institute/ National Toxicology Program and the Division of AIDS, NIAID, NIH, as a contractor for toxicologic evaluation before joining the Division of Antiviral Drug Products, CDER/ FDA, as a toxicology reviewer in 1991. From 1995 2003, Dr. Jacobs was Pharmacology/ Toxicology Supervisor of the Division of Dermatologic and Dental Drug Products, CDER/ FDA. She is a standing member of the CDER, FDA, Executive Carcinogenicity Assessment Committee, is chair of a number of CDER, FDA, Pharm/ Tox Coordinating Committee working groups, and represents CDER on ICCVAM ( Interagency Committee for the Validation of Alternative Methods) and on a number of ICCVAM working groups. She also represents CDER/ FDA on OECD pharm/ tox issues. Page 6 of 9 Nancy Ann Monteiro Riviere, Ph. D.

Dr. Monteiro Riviere is a Professor of Investigative Dermatology and Toxicology in the Center for Chemical Toxicology Research and Pharmacokinetics, Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University ( NCSU) in Raleigh NC. She received her B. S. in Biology ( cum laude) from Stonehill College in North Easton, MA and her M. S. and Ph. D. in Anatomy from Purdue University in West Lafayette, IN. She completed post doctoral training in Experimental Pathology / Toxicology at the Chemical Industry Institute of Toxicology in Research Triangle Park, NC. She joined the faculty at NCSU in 1984. Dr. Monteiro Riviere is also a Professor in the NCSU/ UNC CH Biomedical Engineering Faculty as well as being a Research Adjunct Professor in the Department of Dermatology, School of Medicine at the University of North Carolina at Chapel Hill. She is a member of Sigma Xi and Phi Zeta honor societies. Dr. Monteiro Riviere is President of the Dermatotoxicology Specialty Section, and past president of the In Vitro Specialty Section of the Society of Toxicology. She presently serves on the NIH Scientific Advisory Committee on Alternative Toxicological methods ( SACATM), the Board of Publications of the Society of Toxicology and Editorial Boards of the Journal of Applied Toxicology, Journal of Toxicology  Cutaneous and Ocular, Toxicology In Vitro, and Toxicology Mechanisms and Methods. Dr. Monteiro Riviere has published more than 145 publications, holds a US patent, and has been the recipient of 9 million dollars in extramural research support from various government and private sources. Her current research interests relate to chemical absorption and mechanisms of chemical irritation to skin. Page 7 of 9 Richard C. Pleus, Ph. D.

Dr. Pleus is Director and a toxicologist of Intertox, Inc. He is an expert in neurological and reproductive toxicology with over 20 years experience assessing the risk to humans exposed to chemical and biological agents via food, consumer products, therapeutic agents, and the environment. He has a proven ability to communicate risks of toxicants to a variety of audiences   skillfully facilitating both public forums and industry meetings, in litigation support, on expert panels, and as an expert witness. His clients include industry, citizen groups, and governmental agencies, both nationally and internationally. He continues to be involved in research, publications, and education.

Dr. Pleus' research focuses on human health risk, including mode of action studies aimed at quantifying exposure to critical organ systems, with particular interest in human and laboratory animal nervous system development. In association with these activities, he has conducted a variety of human health risk evaluations of exposures to chemical and biological agents in air, water, food, and soil, as well as risk evaluations relating to consumer products and therapeutic agents. His work is focused on the application of academic research results to protect human health and resolve public health issues. He has presented the results of his research at national and international meetings in Australia, France, South Africa, and the Czech Republic.

Dr. Pleus' contribution to peer reviewed journals and books include his work regarding perchlorate, published in Environmental Health Perspectives and his chapter contribution, Perchlorate Regulation and Regulatory Activity ( Chapter IX) to GFS Chemicals book Perchloric Acid and Perchlorate. He has also co authored chapters to Biological Risk Engineering Handbook: Infection Control and Decontamination ( Lewis Publishers), chapter 4, Toxicology, and chapter 5, Risk Assessment.

Dr. Pleus was an instructor for 10 years at the University of Minnesota where he taught human science classes for both lower and upper level undergraduate students. In addition, he taught courses in physiological psychology and psychopharmacology for Metropolitan State University. He periodically serves as a graduate level guest lecturer in toxicology at the School of Public Health at the University of Washington. He is an adjunct Associate Professor in the Department of Pharmacology at the University of Nebraska Medical Center, as well as a faculty member of the Center for Environmental Toxicology at the University of Nebraska. He is an elected member of the Delta Omega Honorary Society in Public Health.

Dr. Pleus' credentials include a B. S. with Honors from Michigan State University, an M. S. in Environmental Health, a Ph. D. in Environmental Toxicology from the University of Minnesota, and postdoctoral research in neuropharmacology at the University of Nebraska Medical Center. Page 8 of 9 Paul David Siegel, Ph. D., M. S. P. H.

Dr. Siegel is Team Leader Bioorganic Chemistry/ Director Scientist, Research Officer and the National Institute for Occupational Safety and Health, Analytical Services Branch/ Health Effects Laboratory Division, and an Adjunct Associate Professor at the West Virginia University School of Pharmacy, Department of Basic Pharmaceutical Sciences. Dr. Siegel's major research interests are in the area of immunological sensitization and asthma from occupational chemicals. This includes modeling of exposure routes ( dermal and inhalation) and asthma like responses, biomarkers of sensitization and response, and exposure characterization. His research has resulted in 53 published abstracts and 50 peer reviewed scientific articles, 2 book chapters, 9 internet reports and 10 invited presentations. He is chair and/ or serve on multiple NIOSH committees and has taught both graduate and undergraduate Pharmacy courses, co chaired an international occupational asthma conference and am an ad hoc reviewer for several scientific journals. He has a B. A. in Biology from the University of Missouri, Columbia, MO, a MSPH in Environmental Health from Tulane University and a Ph. D. in Pharmacology/ Toxicology from Tulane University. Page 9 of 9 Alan H. Stern, D. P. H.

Dr. Stern holds a Dr. P. H. ( Doctor of Public Health) and a M. P. H. in Environmental Sciences from Columbia University. He is the Chief of the Bureau for Risk Analysis in the Division of Science and Research at the New Jersey Department of Environmental Protection. He is an Adjunct Associate Professor in the Division of Environmental and Occupational Health in the School of Public Health, University of Medicine and Dentistry of New Jersey ( UMDNJ), and an Adjunct Associate Professor in the Department of Environmental and Community Medicine , UMDNJ Robert Wood Johnson Medical School. He specializes in toxicology, human health risk assessment and exposure assessment. Dr. Stern's primary research areas include risk assessment of heavy metals including mercury, chromium and lead, and probabilistic methods in health risk assessment. He regularly teaches graduate classes in risk assessment, biological monitoring of metals, and general biological monitoring of exposure. Dr. Stern is certified in toxicology ( DABT) by the American Board of Toxicology. He has served on a number of peer review panels for the US EPA, National Academy of Sciences, Toxicology Excellence for Risk Assessment and the White House Office of Science and Technology Policy and National Institute of Environmental Health Sciences.