[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Notices]
[Pages 14054-14055]
[FR Doc No: 2014-05411]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0253]

Methods for Thrombogenicity Testing; Public Workshop; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Workshop on Methods for Thrombogenicity
Testing.'' Planned topics of discussion include the optimization of in
vitro and in vivo thrombogenicity test methods and the identification
of alternative in vitro tests.
    Date and Time: The public workshop will be held on April 14, 2014,
from 9 a.m. to 5 p.m.
    Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (rm. 1503, sections B and C), Silver Spring, MD 20993-0002.
Entrance for the public workshop participants (non-FDA employees) is
through Building 1 where routine security check procedures will be
performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Persons: Anchal Kaushiva, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1266, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or James
Kleinedler, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1102, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by April 4, 2014, at 5 p.m., EST. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the workshop will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan,<PHONE_NUMBER>, email<EMAIL_ADDRESS>no later than April 4, 2014.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm
and select this public workshop from the posted events list. Please
provide complete contact information for each attendee, including name,
title, and affiliation, email, and telephone number. Those without
Internet access should contact Susan Monahan to register. Registrants
will receive confirmation after they have been accepted. You will be
notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by April 4, 2014, at 5 p.m. Early registration is
recommended because

Webcast connections are limited. Organizations are requested to
register all participants, but to view using one connection per
location. Webcast participants will be sent technical system
requirements after registration and will be sent connection access
information after April 10, 2014. If you have never attended a Connect
Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
    Comments: FDA is holding this public workshop to obtain information
on in vitro and in vivo thrombogenicity test methods. In order to
permit the widest possible opportunity to obtain public comment, FDA is
soliciting either electronic or written comments on all aspects of the
public workshop topics. The deadline for submitting comments related to
this public workshop is May 14, 2014.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. Identify comments 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., EST, Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). 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 the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)

SUPPLEMENTARY INFORMATION:

I. Background

    Thrombosis, or blood clot formation, is a major complication in the
use of blood-contacting medical devices. Thrombosis often leads to
device malfunction and severe adverse events such as stroke or
myocardial infarction. To improve device quality and reduce the
occurrence of thrombus formation, it is important to fully assess the
thrombogenic potential of a medical device prior to clinical use and
make material or geometrical modifications if necessary.
    The current thrombogenicity test paradigm relies heavily on animal
studies. For implanted devices, where animal studies are often
conducted to assess safety and possible effectiveness, thrombogenicity
endpoints can also be included. However, for many interventional
devices, where other animal studies are not commonly requested, FDA has
traditionally recommended a 4-hour in vivo canine thrombogenicity test
model for assessment of thrombogenic potential. Because there have been
questions about the consistency, reliability, and clinical relevance of
this 4-hour canine thrombogenicity model, FDA is interested in
optimizing the conduct of this in vivo test and/or identifying
alternative in vitro tests that provide equivalent or improved clinical
insight into the potential for thrombogenicity of medical devices while
minimizing expenses and animal use, if possible.
    This workshop will bring together academia, industry professionals,
and FDA regulators to discuss the advantages, limitations, and
optimization of both in vivo and in vitro thrombogenicity test methods,
and identify alternative in vitro tests that show promising clinical
relevance. We will discuss testing methods related to a broad range of
blood contacting devices, especially for cardiovascular applications.
Ideas generated during this workshop may facilitate development of new
guidance and/or standards for thrombogenicity testing that optimize
current in vivo methods and/or utilize in vitro methods.

II. Topics for Discussion at the Public Workshop

    FDA seeks to address and receive comments on the following topics:
    1. Strengths, weaknesses, and optimization of in vivo
thrombogenicity test methods;
    2. Current methodologies for conducting in vitro thrombogenicity
testing (e.g., blood conditions, static versus dynamic methods, and
different test endpoints);
    3. Correlation between in vitro/in vivo thrombogenicity test
results and clinical outcomes;
    4. Special testing considerations for catheters, stents, grafts,
ventricular assist devices, and bypass circuit components.

    Dated: March 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05411 Filed 3-11-14; 8:45 am]
BILLING CODE 4160-01-P


PROPOSED HAZARD IDENTIFICATION METHODOLOGY FOR ASSESSMENT OF DERMAL SENSITIZATION RISK CASE STUDY   Cr( VI) in Wood Preservative Jonathan Chen, Ph. D.

Timothy F. McMahon, Ph. D Office of Pesticide Programs U. S. EPA, Washington D. C. May 4 6, 2004 2 Chromium ( Cr)   General Properties Oxidation states ranging from Cr( II) to Cr(+ VI).

Chromium occurs in the environment primary in two valence states, Cr( III) and Cr( VI).

Cr( VI) rarely occurs naturally, but is produced from anthropogenic sources. May 4 6, 2004 3 Chromium ( Cr)   General Properties ( Continued)

Trivalent chromium compounds , are generally insoluble in water ( with the exception of acetate,

hexahydrate of chloride, and nitrate salts).

Most Cr( VI) compounds, are readily soluble in water ( with the exception of alkaline salts, zinc and lead salts).

The hexavalent chromium compounds are reduced to the trivalent form in the presence of oxidizable organic matter. May 4 6, 2004 4 Chromium ( VI) is used as a component of Wood Preservatives.

For Example:

° CCA  Chromated Copper Arsenate ° ACC   Acid Copper Chromate Cr ( VI)   Background ( Continued) May 4 6, 2004 5 CHROMATED COPPER ARSENATE ( CCA)

CCA contains chromium, copper, and arsenic.

There are three formulations of CCA CCA Type A, CCA Type B, and CCA Type C CCA type C *

CrO3 ( chromic acid, Cr( VI)): 47.5%

CuO ( cupric oxide, Cu( II)): 18.5%

As2O5 ( arsenic pentoxide, As( V)): 34.0%

* The the standard is set by American Wood Preservatives Association ( AWPA). May 4 6, 2004 6 ACID COPPER CHROMATE ( ACC)

° Acid copper chromate ( ACC) is a liquid that contains 50% active ingredient ( Cr and Copper)

and 50% diluents ( water). May 4 6, 2004 7 CCA vs. ACC 34.0 47.5 18.5 CCA C

71.6 28.4 ACC 45.1 35.3 19.1 CCA B 16.4 65.5 18.1 CCA A As 2 O 5 (%)

CrO 3 (%)

CuO (%)

Type May 4 6, 2004 8 Cr ( VI)   Background ( continued)

What is fixation?

Degree of fixation is affected by:

Temperature

Concentration of reactants

Moisture content of the wood

pH

time

wood species May 4 6, 2004 9 Cr ( VI)   Background ( continued)

Why Fixation is important?

Research indicate Cr ( VI) may leach to wood surface when the fixation process is incomplete. May 4 6, 2004 10 Cr ( VI)   Background ( Continued)

One of the most common and potent contact sensitizers Exposure occurs in a number of occupational settings Non occupational exposures also occur May 4 6, 2004 11 ° On 8/ 28/ 2001, the OPP Hazard Identification Assessment Review Committee ( HIARC) :

" The potent skin allergenicity of chromium has been well documented in the literature, and chromium compounds have been reported to be the most frequent sensitizing agent in man.    No end point will be selected for risk assessment.

The risk concern of the dermal contact of Cr( VI) should be addressed through warning language used on the labels".

° However, OPP's current concern is for pesticide chemicals that are in consumer products, some of which are treated articles without a chance to include label warnings.

Cr ( VI)   Background ( Continued) May 4 6, 2004 12 ° The FIFRA Scientific Advisory Panel ( SAP) Meeting Held for " Preliminary Evaluation of the Non dietary hazard and Exposure to Children from Contact with Chromated Copper Arsenate Treated Wood Playground Structures and Contaminated Soil" in October 23  25, 2001:

" The Panel advises that EPA should base risk assessments for noncancer health effects of dermal exposure to hexavalent chromium on direct dermal effects   irritant and allergic contact dermatitis. The Panel was unable to provide EPA with methods for establishing endpoints and determining dose response relationships for these effects."

Cr ( VI)   Background ( Continued) May 4 6, 2004 13 Concentration of Concern for Dermal Sensitization ( CCDS)

CCDS stands for Concentration of Concern for Dermal Sensitization. In other words,

the Agency would consider that when the concentration of the chemical causing dermal sensitization is below the CCDS, it is not likely to start the dermal sensitization reaction toward the concerned population. May 4 6, 2004 14 Cr ( VI)   Different CCDS Two Types of Concentration of Concern for Dermal Sensitization ( CCDS):

CCDS for Induction Phase CCDS for Elicitation Phase May 4 6, 2004 15 Cr ( VI)   CCDS for Induction Phase Using Murine LLNA data LLNA data ( EC3 values) for hexavalent chromium using potassium dichromate as the test substance from five different laboratories were reported by Kimber et al. ( 1995).

Two different approaches have been proposed to establish the CCDS for Induction Phase :

Griem et al. ( 2003)

Gerberick et al. ( 2000, 2001) May 4 6, 2004 16 Hazard Assessment   Induction Phase Using Murine LLNA Data 0.034 0.038 0.037 0.035 0.044 0.038 0.017 CCDS µ g/ cm 2 10 10 10 10 10 10 10 UF Time ( Repeated Exposure) 10 10 10 10 10 10 10 UF intraspecies 3 3 3 3 3 3 3 UF interspecies 10.36 11.15 11.2 10.77 13.24 11.56 5.12 Area dose µ g/ cm 2 All US US US UK US UK country Avg.

E D C B A laboratory Based on Griem's Approach ( 2003) May 4 6, 2004 17 Hazard Assessment   Induction Phase Using Murine LLNA data ( Continued)

Default NOAEL for Use in Risk Assessment  Gerberick ( 2000, 2001)

1

10 Potent

10 1,000 1000   10,000 Weak 1000   10,000 10 10  100 Strong 10   100 100 100  1000 Moderate 100   1000 10,000 > 10,000 Extremely Weak > 10,000 NA NC Non Sensitizing NC Default NOAEL ( µ g/ cm 2)

Experimental Human NOAEL ( µ g/ cm 2)

Sensitization Potential A LLNA EC3 ( µ g/ cm 2)

NC = Not Calculated, No Positive response is obtained at any concentration tested. An EC3 value cannot be calculated.

NA = Not Applicable. The Material is non sensitiser. A default NOAEL is not needed for risk assessment. May 4 6, 2004 18 Hazard Assessment   Induction Phase Using Murine LLNA data ( Continued)

Based on Gerberick ( 2000, 2001)  s Approach 10 10 10 10 10 10 1 NOAEL

g/ cm 2 0.01 0.01 0.01 0.01 0.01 0.01 0.001 CCDS

g/ cm 2 10 10 10 10 10 10 10 UF Use 10 10 10 10 10 10 10 UF matrix 10 10 10 10 10 10 10 UF intraspecies 1 1 1 1 1 1 1 UF interspecies 10.36 11.15 11.2 10.77 13.24 11.56 5.12 Area dose

g/ cm 2 All US US US UK US UK country AVG E D C B A laboratory May 4 6, 2004 19 Cr ( VI)   CCDS for Elicitation Phase Two different types of data are considered:

Cr( VI) Sensitized Human Data; and

Murine LLNA Data Cr( VI) Sensitized Human Data Three Studies are considered:

Nethercott et al. ( 1994)

Hansen et al. ( 2003)

Basketter et al. ( 2001) May 4 6, 2004 20 Hazard Assessment   Elicitation Phase Using Sensitized Human data ( Continued)

Nethercott et al. ( 1994)

100 possible volunteers selected from examination of 6000 patient files from dermatologists. Eventually, 102 took part in the study. All were believed to be Cr( VI)

sensitized based on previous patch tests performed by their physicians. May 4 6, 2004 21 Hazard Assessment   Elicitation Phase Nethercott et al. 1994 ( Continued)

Three rounds of testing:

Round one patch test with 4.4  g of Cr( VI)/ cm 2 to verify sensitization. Those responding positively moved onto round two.

Round two  patch testing with 0.018 and 0.088  g Cr( VI)/ cm 2, and four concentrations of Cr( III). Those showing positive responses to the Cr( VI) were not tested in round three. Only those that did not respond were moved to round three.

Round three the negative responders in round two were tested with Cr ( VI) concentrations of 0.18 and 0.88  g/ cm 2. May 4 6, 2004 22 Hazard Assessment   Elicitation Phase Nethercott et al. 1994 ( Continued) May 4 6, 2004 23 Cr ( VI) Hazard Assessment   Elicitation Phase Nethercott et al. 1994 ( Continued)

From this study, a 10% MET of 0.089  g/ cm2 was reported.

However, lowest dose tested, 0.018  g/ cm2 also showed a response. May 4 6, 2004 24 Hazard Assessment   Elicitation Phase Hansen et al. ( 2003)

Purpose: to compare the 10% MET for Cr ( III) and Cr ( VI) in Cr( VI) sensitive patients. May 4 6, 2004 25 Cr ( VI) Hazard Assessment   Elicitation Phase Hansen et al. 2003 ( Continued)

Methods:

18 volunteers confirmed to be Cr( VI)

sensitized .

Patch testing ( Finn Chambers) with serial dilutions of Cr( VI) and Cr( III).

~ 20 patches tested at the same time. May 4 6, 2004 26 Cr ( VI) Hazard Assessment   Elicitation Phase Hansen et al. 2003 ( Continued)

Using a dose  response curve, the 10% MET for Cr( VI) was determined to be 0.03 µ g / cm2 ( 1 ppm).

The 10% MET for Cr( III) was determined to be 0.18 µ g / cm2 ( 6 ppm).

Both Cr( III) and Cr( VI) were capable of eliciting a response at low levels. May 4 6, 2004 27 Cr ( VI) Hazard Assessment   Elicitation Phase Basketter et al. ( 2001)

To investigate dose response relationships for Cr ( VI) elicitation in sensitized persons using both occluded patch and open application techniques. May 4 6, 2004 28 Cr ( VI) Hazard Assessment   Elicitation Phase Basketter et al. 2001 ( Continued)

Methods: 17 volunteers with history of contact allergy to Cr.

Part I of study: Finn chambers applied for 2 days on the back with aqueous dilutions of potassium dichromate 1, 10, 100, 1000 ppmapplied to normal skin and also to sites pretreated with 0.2% Sodium Lauryl Sulfate ( SLS). May 4 6, 2004 29 Cr ( VI) Hazard Assessment   Elicitation Phase Basketter et al. 2001 ( Continued)

Part II of study: Repeat open application tests ( ROPT) conducted on same volunteers using aqueous solutions of potassium dichromate containing 0.1% SLS.

Initial concentrations of 5 and 10ppm used; if negative, 20 and 50 ppm used after one month rest period. May 4 6, 2004 30 Cr ( VI) Hazard Assessment   Elicitation Phase Basketter et al. 2001 ( Continued)

Results: Closed patch test:

normal skin, no reactions

SLS treatment: 2/ 17 responded at 1 ppm Repeated Open Application Test ( ROAT) :

3/ 15 showed response at 5 and 10 ppm May 4 6, 2004 31 Hazard Assessment   Elicitation Phase Human Data: Nethercott et al. 1994 is a wellcontrolled study and was used for CCDS calculation. May 4 6, 2004 32 CCDS   Elicitation Phase ( Based on Human Data  Nethercott 1994)

3 3 UF intraspecies 3 3 UF LOAEL to NOAEL 0.0089 0.0018 CCDS µ g/ cm2 1 1 UF exposure 1 1 UF interspecies 0.089 0.018 Area dose µ g/ cm2 MET ( 10%)

LOAEL Nethercott 1994 Study May 4 6, 2004 33 CCDS   Elicitation Phase ( Based on Human Data  Nethercott 1994)

A similar approach can be applied to the MET values from Hansen et al. ( 2003) and Basketter et al. ( 2001) studies. The calculated CCDS for Elicitation Phase would be 0.001, and 0.003  g/ cm2 for persons previously sensitized to hexavalent chromium. May 4 6, 2004 34 CCDS   Elicitation Phase ( Based on Murine LLNA Data)

Murine LLNA hazard data reported by Kimber et al. ( 1995) from five different laboratories reported EC3 values for hexavalent chromium was used to assess the Cr( VI) CCDS for Elicitation phase.

Based on Griem's Approach ( 2003 and Public Comments) CCDS   Elicitation Phase ( Murine LLNA Data   Kimber et al. ( 1995) 10 10 10 10 10 10 10 UF Time ( Repeated Exposure) 0.007 0.007 0.007 0.007 0.009 0.008 0.003 CCDS µ g/ cm 2 15 15 15 15 15 15 15 UF ( Induction/

Elicitation 10 10 10 10 10 10 10 UF intraspecies 1 1 1 1 1 1 1 UF interspecies 11.36 10.156 11.2 10.77 13.24 11.56 5.12 Area dose µ g/ cm 2 All US US US UK US UK country Avg.

E D C B A laboratory Based on Griem's Approach ( Public Comments) May 4 6, 2004 36 SUMMARY ° Cr ( VI) is a potent dermal sensitizer. It is able to induce and to elicit ACD.

° Cr( III) is also capable of eliciting ACD, but studies indicate that it is less potent than Cr( VI).

° Using LLNA data, two different approaches have been proposed to estimate the CCDS for induction phase of dermal sensitization. May 4 6, 2004 37 SUMMARY ( Continued)

CCDS for Induction Phase:

Proposed Average induction CCDS for Cr( VI)

is :

0.034  g/ cm2   Griem ( 2003)

0.01  g/ cm2   Gerberick ( 200,2001) May 4 6, 2004 38 SUMMARY ( Continued)

CCDS for Elicitation Phase:

Based on the Human Data ( Nethercott et al, 1994),

Proposed Cr( VI) CCDS for Elicitation Phase is

0.0018  g/ cm2 ( based on the LOAEL).

0.0089  g/ cm2 ( based on MET10%)

Based on the LLNA Data and using Griem's approach,

Proposed average Cr( VI) CCDS for Elicitation Phase is

0.007  g/ cm2 ( based on the Kimber et al. 1995)


[Federal Register Volume 77, Number 128 (Tuesday, July 3, 2012)]
[Rules and Regulations]
[Pages 39422-39425]
[FR Doc No: 2012-16243]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2012-0354]
RIN 1625-AA00

Safety Zone; A Salute to our Heroes Fireworks, Hamlin Beach State
Park, Hamlin, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule

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SUMMARY: The Coast Guard will establish a temporary safety zone on
Hamlin Beach State Park, Hamlin, NY. This safety zone is intended to
restrict vessels from a portion of water off Hamlin Beach State Park
during the A Salute to our Heroes fireworks on July 7, 2012. The safety
zone is necessary to protect participants, spectators, and vessels from
the hazards associated with a firework display.

DATES: This regulation will be effective July 7, 2012 from 9:45 p.m.
until 11:30 p.m.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket [USCG-2012-0354]. To view documents mentioned in
this preamble as being available by going to http://www.regulations.gov, type the docket number in the ``SEARCH'' box and
click ``SEARCH.'' You may visit the Docket Management Facility,
Department of Transportation, West Building Ground Floor, Room W12-140,
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 rule, call or email LT Christopher Mercurio, Chief of
Waterway Management, U.S. Coast Guard Sector Buffalo; telephone 716-
843-9343, email<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Renee
V. Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    On May 23, 2012, we published a Notice of Proposed Rulemaking
(NPRM) entitled Safety Zone; A Salute to our Heroes, Hamlin Beach State
Park, Hamlin, NY in the Federal Register (77 FR 30448). We received 0
letters commenting on the proposed rule. No public meeting was
requested, and none was held.
    Under 5 U.S.C. 553(d)(3), the Coast Guard is issuing this temporary
final rule less than 30 days after publication in the Federal Register.
Under 5 U.S.C. 553(d)(3), an agency may issue a rule less than 30 days
before its effective date when the agency for good cause finds that
those procedures are ``impracticable, unnecessary, or contrary to the
public interest.'' Accordingly, the Coast Guard finds that good cause
exists for publishing this temporary final rule less than 30 days
before its effective date because delaying the effective date of this
temporary final rule would prevent its enforcement on the scheduled
night of the event and thus, would preclude the Coast Guard from
protecting spectators and vessels from the hazards associated with a
maritime fireworks display.

B. Basis and Purpose

    Between 10:15 p.m. and 11:00 p.m. on July 7, 2012, a fireworks
display will be held on the waters of Hamlin Beach State Park near
Hamlin, NY. The Captain of the Port Buffalo has determined that
fireworks launched proximate to watercraft pose a significant risk to
public safety and property. Such hazards include premature detonations,
dangerous detonations, dangerous projectiles, and falling or burning
debris.

C. Discussion of Comments, Changes and the Final Rule

    As mentioned above, no comments were received from the public in
response to the NPRM that preceded this temporary rule. Furthermore,
there were no changes made between the proposed rule and this temporary
final rule. Thus, there are no comments and no changes to discuss.
    Just as was described in the NPRM, the Captain of the Port Buffalo
has determined that a temporary safety zone is necessary to ensure the
safety of the boating public during the A Salute to Our Heroes
Fireworks. The safety zone will be effective and enforced from 9:45
p.m. until 11:30 p.m. on July 7, 2012. The safety zone will encompass
all waters off of Hamlin Beach State Park, Hamlin, NY within a 700 FT
radius of position 43[deg]21'51.9'' N, 77[deg]56'59.6'' W (DATUM: NAD
83). Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Buffalo or his
designated on-scene representative. The Captain of the Port or his
designated on-scene representative may be contacted via VHF Channel 16.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. It is not
``significant'' under the regulatory policies and procedures of the
Department of Homeland Security (DHS). We conclude that this rule is
not a significant regulatory action because we anticipate that it will
have minimal impact on the economy, will not interfere with other
agencies, will not adversely alter the budget of any grant or loan
recipients, and will not raise any novel legal or policy issues. The
safety zone created by this rule will be relatively small and enforced
for relatively short time. Also, the safety zone is designed to
minimize its impact on navigable waters. Furthermore, the safety zone
has been designed to allow vessels to transit around it. Thus,
restrictions on vessel movement within that particular area are
expected to be minimal. Under certain conditions, moreover, vessels may
still transit through the safety zone when permitted by the Captain of
the Port.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
received 0 comments from the Small Business Administration on this
rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    This temporary final rule may affect the following entities, some
of which may be small entities: The owners of operators of vessels
intending to transit or anchor in a portion of Lake Erie near Hamlin,
NY between 9:45 p.m. to 11:30 p.m. on July 7, 2012.
    This safety zone would not have a significant economic impact on a
substantial number of small entities for the following reasons. This
safety zone would be activated, and thus subject to enforcement, for
only 105 minutes late in the day when vessel traffic is low. Vessel
traffic could pass safely around the safety zone. Before the effective
period, maritime advisories will be

issued, which include a Broadcast Notice to Mariners.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children

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

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of a safety zone and
thus, is categorically excluded from further review under paragraph
34(g) of Figure 2-1 of the Commandant Instruction. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for Part 165 continues to read as follows:

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

0
2. Add Sec.  165.T09-0354 to read as follows:

Sec.  165.T09-0354  Safety Zone; A Salute to Our Heroes, Hamlin Beach
State Park, Hamlin, NY.

    (a) Location. The safety zone will encompass all waters off of
Hamlin Beach State Park, Hamlin, NY within a 700 FT radius of position
43[deg]21'51.9'' N and 77[deg]56'59.6'' W (NAD 83).
    (b) Effective and Enforcement Period. This regulation is effective
and will be enforced on July 7, 2012 from 9:45 p.m. until 11:30 p.m.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transiting, or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Buffalo or his designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his designated on-
scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Buffalo is any Coast Guard commissioned, warrant or

petty officer who has been designated by the Captain of the Port
Buffalo to act on his behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
Buffalo or his on-scene representative may be contacted via VHF Channel
16. Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port Buffalo, or his on-scene representative.

    Dated: June 15, 2012.
S.M. Wischmann,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2012-16243 Filed 7-2-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 235 (Thursday, December 6, 2012)]
[Proposed Rules]
[Pages 72778-72780]
[FR Doc No: 2012-29398]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0880; Directorate Identifier 2012-CE-004-AD]
RIN 2120-AA64

Airworthiness Directives; Cessna Aircraft Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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

SUMMARY: We are revising an earlier proposed airworthiness directive
(AD) for certain Cessna Aircraft Company (Cessna) Model 525 airplanes
equipped with certain part number (P/N) air conditioning (A/C)
compressor motors. That NPRM proposed to require inspection of the
number of hours on the A/C compressor hour meter, inspection of the
logbook, and replacement of the brushes on certain P/N A/C compressor
motors or deactivation of the A/C system until replacement of the
brushes and also require reporting of aircraft information related to
the replacement of the brushes. That NPRM was prompted by reports of
smoke and/or fire in the tailcone caused by brushes wearing beyond
their limits on the A/C motor. This action revises that NPRM by
providing correct steps for deactivation of the A/C compressor motor.
We are proposing this supplemental NPRM to correct the unsafe condition
on these products. Since these actions impose an additional burden over
that proposed in the NPRM, we are reopening the comment period to allow
the public the chance to comment on these proposed changes.

DATES: We must receive comments on this supplemental NPRM by January
22, 2013.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, 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 Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Christine Abraham, Aerospace Engineer,
Wichita Aircraft Certification Office, FAA, 1801 Airport Road, Room
100, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0880;
Directorate Identifier 2012-CE-004-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We issued an NPRM to amend 14 CFR part 39 to include an AD that
would apply to certain Cessna Airplane Company Model 525 airplanes
equipped with certain P/N A/C compressor motors. That NPRM published in
the Federal Register on August 22, 2012 (77 FR 50644). That NPRM
proposed to require inspection of the number of hours on the A/C
compressor hour meter, inspection of the logbook, and replacement of
the brushes on certain P/N A/C compressor motors or deactivation of the
A/C system until replacement of the brushes and also require reporting
of aircraft information related to the replacement of the brushes.

Actions Since Previous NPRM Was Issued

    Since we issued the previous NPRM (77 FR 50644, August 22, 2012),
we identified revised steps for deactivation of the A/C compressor
motor.

Comments

    We gave the public the opportunity to comment on the previous NPRM
(77 FR 50644, August 22, 2012). The following presents the comments
received on the NPRM and the FAA's response to each comment.

Request Task State Current Maintenance Manual Revision or Following
Revision 23 or Greater

    Timothy Garroutte requested the FAA state current manual revision
or following revision 23 or greater instead of using a specific
revision of the maintenance manual. Garroutte reasoned that using an
exact manual revision number and date in the AD will cause issues in
the future because the manual will be revised again with a new date. If
a specific revision is identified in the AD, the airplane mechanic will
need to call Cessna Aircraft Company or the FAA to figure out what to
do once the manual gets a revision higher than 23.
    We disagree with the request to state current manual revision or
following revision 23 or greater. The Airworthiness Directives Manual,
FAA-

IR-M-8040.1 C, dated May 17, 2010, (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgOrders.nsf/0/66DDD8E1D2E95DB3862577270062AABD?OpenDocument&Highlight=order8040.1c)
states in Chapter 7, paragraph 9 (specifically subparagraph (3)) that
the phrase ``or later FAA-approved revision'' when referring to the
service information is not allowed. This phrase violates Office of the
Federal Register policies for approving materials that are incorporated
by reference. Service information that we incorporate by reference in
an AD is often revised after we issue the AD. We can approve later
revisions of service information as an alternative method of
compliance.
    We did not change the proposed AD action based on these comments.

Request Correct Deactivation Instructions for the A/C

    Cessna requested we include revised procedures for deactivating the
A/C in the AD.
    Cessna stated that pulling the A/C circuit breaker does not disable
the A/C compressor motor. The A/C can be deactivated by removal of a
fuse limiter. Cessna provided specific deactivation instructions to
include in the AD and requested we incorporate these instructions in
the proposed AD.
    We agree with Cessna's request because the instructions for
deactivating the system were not correct in the NPRM (77 FR 50644,
August 22, 2012).
    We changed the proposed AD action based on these comments.

FAA's Determination

    We are proposing this supplemental NPRM because we evaluated all
the relevant information and determined the unsafe condition described
previously is likely to exist or develop in other products of the same
type design. Certain changes described above expand the scope of the
original NPRM. As a result, we have determined that it is necessary to
reopen the comment period to provide additional opportunity for the
public to comment on this supplemental NPRM.

Proposed Requirements of the Supplemental NPRM

    This supplemental NPRM would require inspection of the number of
hours on the A/C compressor hour meter, inspection of the logbook,
replacement of the brushes on certain P/N A/C compressor motors or
deactivation of the A/C system until replacement of the brushes, and
reporting of aircraft information related to the replacement of the
brushes.

Costs of Compliance

    We estimate that this proposed AD affects 408 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                    Labor cost             Parts cost             product        operators
----------------------------------------------------------------------------------------------------------------
Inspect and replace brushes on     11 work-hours x $85  $252....................          $1,187        $484,296
 the A/C motor.                     per hour = $935.
Return shipment of brushes to the  $15 per return with  Not applicable..........             $30         $12,240
 manufacturer.                      two required
                                    returns.
----------------------------------------------------------------------------------------------------------------

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 above, 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, 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.

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):

Cessna Aircraft Company: Docket No. FAA-2012-0880; Directorate
Identifier 2012-CE-004-AD.

(a) Comments Due Date

    We must receive comments by January 22, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Cessna Aircraft Company Model 525 airplanes,
serial number (S/N) 525-0001 through 525-0558, and 525-0600 through
525-0701, that:
    (1) Are equipped with part number (P/N) 1134104-1 or 1134104-5
air conditioning (A/C) compressor motor; and

    (2) Are certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 21, Air Conditioning.

(e) Unsafe Condition

    This AD was prompted by reports of smoke and/or fire in the
tailcone caused by brushes wearing beyond their limits on the A/C
motor. We are issuing this AD to require replacement of the brushes
on certain P/N A/C compressor motors or deactivation of the A/C
system until replacement of the brushes. This AD also requires
reporting of aircraft information related to the replacement of the
brushes.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspections

    Within the next 30 days after the effective date of this AD or
within the next 10 hours time-in-service (TIS) after the effective
date of this AD, whichever occurs first, do the following:
    (1) Inspect the number of hours on the A/C compressor hour
meter; and
    (2) Check the aircraft logbook for any entry for replacing the
A/C compressor motor brushes with new brushes or replacing the
compressor motor or compressor condenser module assembly (pallet)
with a motor or assembly that has new brushes.
    (i) If the logbook contains an entry for replacement of parts as
specified in the paragraph above, determine the number of hours on
the A/C compressor motor brushes by comparing the number of hours on
the compressor motor since replacement and use this number in
paragraph (h) of this AD; or
    (ii) If through the logbook check you cannot positively
determine the number of hours on the A/C compressor motor brushes as
specified in the paragraph above, you must use the number of hours
on the A/C compressor hour meter to comply with the requirements of
this AD and use this number in paragraph (h) of this AD or presume
the brushes have over 500 hours TIS.

(h) Replacement

    At whichever of the below compliance times occurs later, using
the hour reading on the A/C compressor hour meter determined in
paragraph (g) of this AD, replace the A/C compressor motor brushes
with new brushes. Thereafter, repeat the replacement of the A/C
compressor motor brushes no later than every 500 hours TIS on the A/
C compressor motor. Do the replacement following Cessna Aircraft
Company Model 525 Maintenance Manual, Revision 23, dated July 1,
2012.
    (1) Before or when the A/C compressor motor brushes reach a
total of 500 hours TIS; or
    (2) Before further flight after the inspection required in
paragraph (g)(2)(ii) of this AD if the A/C compressor motor brush
hours cannot be positively determined.

(i) Deactivation

    In lieu of replacing the A/C compressor motor brushes, before or
when the A/C compressor motor brushes reach a total of 500 hours
TIS, you may deactivate the A/C. Remove the fuse limiter that
supplies power to the A/C compressor motor, fabricate and install a
placard that states: ``A/C DISABLED.'' Install the placard by the A/
C selection switch prohibiting use of the vapor cycle air
conditioner and document deactivation of the system in the aircraft
logbook referring to this AD as the reason for deactivation. While
the system is deactivated, aircraft operators must remain aware of
operating temperature limitations as detailed in the specific
airplane flight manual.
    (1) Do the following steps to remove the compressor fuse
limiter.
    (i) Open aft baggage compartment.
    (ii) Remove aft baggage compartment dividers.
    (iii) Disconnect the main battery connector from the battery.
    (iv) Tag the battery and external power receptacle with a
warning tag that reads: WARNING: Do not connect the battery
connector or external power cart during the maintenance in progress.
    (v) Remove wing nuts that attach the cover to the aft power J-
Box.
    (vi) Remove the aft power J-Box cover.
    (vii) Remove nuts securing compressor fuse limiter (Reference
Designator HZ028, P/N ANL100) to bus bar. Retain nuts.
    (viii) Remove the compressor motor fuse limiter from the
terminals and retain for future reinstallation once compressor motor
brushes have been replaced.
    (2) A properly certified mechanic must fabricate and install the
placard as specified below:
    (i) Use \1/8\-inch black lettering on a white background; and
    (ii) Install the placard on the instrument panel in close
proximity to the A/C selection switch.
    (3) Do the following steps to return the aircraft to service
with the compressor motor fuse limiter removed.
    (i) Install fuse limiter nuts on the terminals and torque to 100
inch-pounds +5 or -5 inch-pounds.
    (ii) Install the aft power J-Box cover with the wing nuts.
    (iii) Remove the warning tag on the battery and external power
receptacle.
    (iv) Connect battery connector to battery.
    (v) Install aft baggage compartment dividers.

(j) Return of Replaced Parts and Reporting Requirement

    For the first two A/C compressor motor brush replacement cycles
on each aircraft, within 30 days after the replacement or within 30
days after the effective date of this AD, whichever occurs later,
send the brushes that were removed to Cessna Aircraft Company,
Cessna Service Parts and Programs, 7121 Southwest Boulevard,
Wichita, KS 67215. Provide the following information with the
brushes:
    (1) The Model and S/N of the airplane;
    (2) P/N of Motor;
    (3) P/N of the brushes, if known;
    (4) The elapsed amount of motor hours since the last brush/motor
replacement, if known;
    (5) If motor hours are unknown, report the elapsed airplane
flight hours since the last brush/motor replacement and indicate
that motor hours are unknown; and
    (6) Number of motor hours currently displayed on the pallet hour
meter.

(k) Special Flight Permit

    Special flight permits are permitted with the following
limitation: Operation of the A/C system is prohibited.

(l) Paperwork Reduction Act Burden Statement

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty
for failure to comply with a collection of information subject to
the requirements of the Paperwork Reduction Act unless that
collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(n) Related Information

    For more information about this AD, contact Christine Abraham,
Aerospace Engineer, Wichita ACO, FAA, 1801 Airport Road, Room 100,
Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
    Issued in Kansas City, Missouri, on November 29, 2012.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2012-29398 Filed 12-5-12; 8:45 am]
BILLING CODE 4910-13-P