[Federal Register: April 3, 2008 (Volume 73, Number 65)]
[Notices]
[Page 18295]
[DOCID:fr03ap08-76]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2008-0123]

National Boating Safety Advisory Council

AGENCY: Coast Guard, DHS.

ACTION: Notice of meetings.

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SUMMARY: The National Boating Safety Advisory Council (NBSAC) and its
subcommittees on boats and associated equipment, prevention through
people, and recreational boating safety strategic planning will meet to
discuss various issues relating to recreational boating safety. All
meetings will be open to the public.

DATES: NBSAC will meet on Friday, April 25, 2008, from 7:30 a.m. to 1
p.m. and on Sunday, April 27, 2008, from 7:30 a.m. to 12 p.m. The Boats
and Associated Equipment Subcommittee will meet on Friday, April 25,
2008, from 2 p.m. to 5:30 p.m. The Recreational Boating Safety
Strategic Planning Subcommittee will meet on Saturday, April 26, 2008
from 8 a.m. to 12 p.m. The Prevention through People Subcommittee will
meet on Saturday, April 26, 2008, from 1 p.m. to 4:30 p.m. These
meetings may close early if all business is finished. On Saturday,
April 26th, a Subcommittee meeting may start earlier if the preceding
Subcommittee meeting has closed early.

ADDRESSES: NBSAC will meet at the The Samoset, 220 Warrenton Street,
Rockport, ME 04856. The subcommittee meetings will be held at the same
address. Send written material and requests to make oral presentations
to Mr. Jeff Ludwig, Executive Secretary of NBSAC, Commandant (CG-
54221), U.S. Coast Guard Headquarters, 2100 Second Street, SW.,
Washington, DC 20593-0001. This notice is available on the Internet at
http://www.regulations.gov or at the Web site for the Boating Safety
Division at http://www.uscgboating.org.

FOR FURTHER INFORMATION CONTACT: Jeff Ludwig, Executive Secretary of
NBSAC, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463).

Tentative Agendas of Meetings

    National Boating Safety Advisory Council (NBSAC):
    (1) Remarks--Mr. James P. Muldoon, NBSAC Chairman;
    (2) Chief, Boating Safety Division Update on NBSAC Resolutions and
Recreational Boating Safety Program report.
    (3) Executive Secretary's report.
    (4) Chairman's session.
    (5) TSAC Liaison's report.
    (6) NAVSAC Liaison's report.
    (7) National Association of State Boating Law Administrators
report.
    (8) Report on upcoming national boating survey.
    (9) Prevention through People Subcommittee report.
    (10) Boats and Associated Equipment Subcommittee report.
    (11) Recreational Boating Safety Strategic Planning Subcommittee
report.
    A more detailed agenda can be found at: http://www.uscgboating.org/
nbsac/nbsac.htm, after April 10, 2008.
    Prevention Through People Subcommittee: Discuss current regulatory
projects, grants, contracts, and new issues affecting the prevention of
boating accidents through outreach and education of boaters.
    Boats and Associated Equipment Subcommittee: Discuss current
regulatory projects, grants, contracts, and new issues affecting boats
and associated equipment.
    Recreational Boating Safety Strategic Planning Subcommittee:
Discuss current status of the strategic planning process and any new
issues or factors that could impact, or contribute to, the development
of the strategic plan for the recreational boating safety program.

Procedural

    All meetings are open to the public. These meetings may close early
if all business is finished. At the Chairs' discretion, members of the
public may make oral presentations during the meetings. If you would
like to make an oral presentation at a meeting, please notify the
Executive Secretary of your request no later than Friday, April 4,
2008. If you would like a copy of your material distributed to each
member of the committee or subcommittee in advance of a meeting, please
submit 30 copies to the Executive Secretary no later than Friday, April
4, 2008. If you would like written material to be distributed at the
meeting, please submit at least 60 copies to the Executive Secretary no
later than Friday, April 18, 2008.

Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the meetings, contact
the Executive Secretary as soon as possible.

    Dated: March 27, 2008.
F.J. Sturm,
Captain, U.S. Coast Guard, Deputy for Prevention Policy.
 [FR Doc. E8-6877 Filed 4-2-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44847-44848]
[FR Doc No: 2014-18104]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket No. FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1359]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency; DHS.

ACTION: Notice; correction.

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SUMMARY: On January 30, 2014, FEMA published in the Federal Register a
proposed flood hazard determination notice that contained an erroneous
table. This notice provides corrections to that table, to be used in
lieu of the information published at 79 FR 4950. The table provided
here represents the proposed flood hazard determinations and
communities affected for Mercer County, New Jersey (All Jurisdictions).

DATES: Comments are to be submitted on or before October 30, 2014.

ADDRESSES: The Preliminary Flood Insurance Rate Map (FIRM), and where
applicable, the Flood Insurance Study (FIS) report for each community
are available for inspection at both the online location and the
respective Community Map Repository address listed in the table below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1359, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER> or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed in the table below, in
accordance with Section 110 of the Flood Disaster Protection Act of
1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own, or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are also used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the table below. Any request for reconsideration of the
revised flood hazard determinations shown on the Preliminary FIRM and
FIS report that satisfies the data requirements outlined in 44 CFR
67.6(b) is considered an appeal. Comments unrelated to the flood hazard
determinations will also be considered before the FIRM and FIS report
are made final.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP may only be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information

regarding the SRP process can be found online at http://www.fema.gov/pdf/media/factsheets/2011/srp_fs.pdf.

Correction

    In the proposed flood hazard determination notice published at 79
FR 4950, the table contained inaccurate information as to the watershed
or communities affected by the proposed flood hazard determinations, or
the associated community map repository or web addresses also featured
in the table. In this notice, FEMA is publishing a table containing the
accurate information, to address these prior errors. The information
provided below should be used in lieu of that previously published.

------------------------------------------------------------------------
                                             Community Map Repository
               Community                             Address
------------------------------------------------------------------------
              Mercer County, New Jersey (All Jurisdictions)
Maps Available for Inspection Online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
------------------------------------------------------------------------
Borough of Hightstown..................  Clerk's Office, 156 Bank
                                          Street, Hightstown, NJ 08520
Borough of Hopewell....................  Clerk's Office, 88 Broad
                                          Street, Hopewell, NJ 08525
Borough of Pennington..................  Borough Hall, 30 North Main
                                          Street, Pennington, NJ 08534
City of Trenton........................  Trenton Fire Department, 244
                                          Perry Street, Trenton, NJ
                                          08618
Municipality of Princeton..............  Office of Engineering, 400
                                          Witherspoon Street, Princeton,
                                          NJ 08540
Township of East Windsor...............  Engineering Department, 16
                                          Lanning Boulevard, East
                                          Windsor, NJ 08520
Township of Ewing......................  Construction Office, 2 Jake
                                          Garzio Drive, Ewing, NJ 08628
Township of Hamilton...................  Municipal Building, 2090
                                          Greenwood Avenue, Room 307,
                                          Hamilton, NJ 08609
Township of Hopewell...................  Hopewell Township Zoning
                                          Office, 201 Washington
                                          Crossing, Pennington Road,
                                          Titusville, NJ 08560
Township of Lawrence...................  Engineering Office, 2207
                                          Lawrence Road, Lawrence, NJ
                                          08648
Township of Robbinsville...............  Planning and Zoning Department,
                                          1 Washington Boulevard,
                                          Robbinsville, NJ 08691
Township of West Windsor...............  Community Development
                                          Department, 271 Clarksville
                                          Road, West Windsor, NJ 08550
------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: July 11, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2014-18104 Filed 7-31-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: October 22, 2008 (Volume 73, Number 205)]
[Rules and Regulations]
[Page 62872-62876]
[DOCID:fr22oc08-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0298; Directorate Identifier 2007-NM-316-AD;
Amendment 39-15696; AD 2008-22-01]
RIN 2120-AA64

Airworthiness Directives; Various Transport Category Airplanes
Equipped With Auxiliary Fuel Tanks Installed in Accordance With Certain
Supplemental Type Certificates

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for various
transport category airplanes. This AD requires deactivation of PATS
Aircraft, LLC, auxiliary fuel tanks. This AD results from fuel system
reviews conducted by the manufacturer, which identified unsafe
conditions for which the manufacturer has not provided corrective
actions. We are issuing this AD to prevent the potential of ignition
sources inside fuel tanks, which, in combination with flammable fuel
vapors, could result in fuel tank explosions and consequent loss of the
airplane.

DATES: This AD is effective November 26, 2008.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Mazdak Hobbi, Aerospace Engineer,
Airframe and Propulsion Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
various transport category airplanes. That NPRM was published in the
Federal Register on March 14, 2008 (73 FR 13803). That NPRM proposed to
require deactivation of PATS Aircraft, LLC, auxiliary fuel tanks.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received from the 22 commenters.

Withdraw NPRM

    Air National Australia, Chartwell Aviation Services, Continent
Aircraft Trust 720, and Boeing Executive Flight Operations
(EFO) question the need for the rule. Air National Australia states
that the installation of the PATS Aircraft, LLC (PATS), auxiliary fuel
system (AFS) in its aircraft was completed in February 2007 and was
verified to be in compliance with

Special Federal Aviation Regulation No. 88 (SFAR 88). Air National
Australia states that clearly the certification given to the
supplemental type certificate (STC) in late January 2007 by the FAA
would indicate that, at the time, the installation was compliant with
the requirements of SFAR 88. Further, the guidance material in FAA
Advisory Circular (AC) 25.981-1B, dated April 18, 2001, has not changed
significantly since 2001. Therefore, Air National Australia concludes
that the level of safety has not altered since the installation was
seen to be compliant.
    Chartwell states that the service history of the PATS AFS does not
support the drastic action proposed in the NPRM. Continent Aircraft
Trust 720 states that there have been no Boeing Business Jet
(BBJ)-related AFS anomalies that would justify deactivation of the
tanks in such a short time. Boeing EFO has been informed by PATS that
the technical changes to the existing fuel system are safety
enhancements and not an imminent safety concern. The fact that there
have been no reports of in-service findings on the Boeing airplanes to
support immediate safety concerns leads Boeing EFO to this conclusion.
However, Boeing EFO is not opposed to installing the safety
enhancements to improve system reliability and to conform the design to
an improved engineering standard.
    We infer that the commenters want us to withdraw the NPRM. We
disagree. This AD results from fuel system reviews conducted by the
manufacturer, which identified unsafe conditions that need corrective
actions to prevent fuel tank explosions. Although to date there has not
been an explosion in PATS fuel tanks, the types of ignition sources
identified by the manufacturer have resulted in catastrophic explosions
in other fuel tanks. Preventing such an explosion was the objective of
SFAR 88 and is not just a ``safety enhancement.'' However, we agree
with Air National Australia that the installation for its fleet (STC ST
00936NY-D, Configuration 3) is compliant with SFAR 88. We have also
revised Table 1 of this AD to specify that STC ST 00936NY-D,
Configuration 3 is not affected by this AD. If an operator shows that
corrective actions have been accomplished and its system complies with
SFAR 88, deactivation of the auxiliary fuel tanks is not required. We
find it necessary to issue the AD to address the identified unsafe
condition.

Extend Compliance Date

    The following commenters all request that we extend the compliance
time for deactivating the auxiliary fuel tanks: Peter J. Chapman, Amiri
Flight, PATS, Prime Aviation, Limited Brands, Tracinda Corporation,
Chartwell, Newsflight, Dobro Ltd., Saudi Oger Ltd., Sunrider
Corporation, PrivatAir SA, Continent Aircraft Trust 720,
NetJets Large Aircraft Company (LAC), Boeing, and Air National
Australia. The commenters state that the compliance date in the NPRM of
December 16, 2008, is disproportional to the risk. The commenters also
point out, among other items that make the compliance date unworkable,
that there is insufficient capacity within available overhaul
facilities and an insufficient number of kits to accomplish the actions
before the specified date.
    We agree with the commenters' requests to extend the compliance
date for deactivating the auxiliary fuel tanks and have revised
paragraph (g) of the AD to extend the compliance date to December 16,
2009. This date will give operators adequate time to plan and schedule
the modification in order to comply with this AD. Our intent was to
coordinate the compliance time of the NPRM with the December 16, 2008,
operations rule compliance date (see ``Transport Airplane Fuel Tank
System Design Review, Flammability Reduction and Maintenance and
Inspection Requirements'' (66 FR 23086, May 7, 2001)). However, as the
commenters noted, the lack of availability of kits and maintenance
facilities makes that date impractical. We have decided to extend the
compliance date by an additional 12 months to December 16, 2009. This
change does not affect any other maintenance/inspection programs
addressed by the fuel tank safety rule, and the compliance date for
those items remains December 16, 2008. The December 16, 2009 date for
this AD was chosen to balance the safety risk with the capability of
operators to comply in a reasonable timeframe.

Auxiliary Fuel Tanks Are Necessary for Operation

    Air National Australia, All Nippon Airways, the U.S. Air Force,
Sunrider, Chartwell, Continent Aircraft Trust 720, NetJets
LAC, and Boeing EFO emphasize that the PATS AFS is necessary to their
operation. The commenters state that deactivation of the AFS will
result in decreased utility, diminished market value, and increased
fuel consumption due to less efficient routing. The need to make more
fuel stops to fly the same mission profile could increase risk. In sum,
deactivation would have a dramatic effect on the range of the aircraft
and defeat the purpose of operating this type of aircraft in the fleet.
    As we stated in the NPRM, for operators who want to retain the
long-range capability provided by these fuel tanks, we will consider
approving alternative methods of compliance consisting of design
changes and maintenance instructions found to comply with SFAR 88. We
understand PATS might be developing such service information for at
least some of the affected STCs, but it has not yet been submitted for
our review and approval. We have not changed the AD in this regard.

Revise the Applicability To Remove Certain STCs

    PATS, Limited Brands, Boeing, All Nippon Airways, and Amiri request
that certain STCs be removed from the applicability listed in Table 1
of the NPRM. The commenters all suggest certain corrections to the
list. Limited Brands states that, as written, the NPRM includes FAA-
approved PATS SFAR 88-compliant STCs. Boeing points out that the STC
holder has determined that the specific STCs listed in its submission
were developed and approved to section 25.981, amendment 25-102, of the
Federal Aviation Regulations (14 CFR 25.981, amendment 102). All Nippon
Airways understands that STC ST01716NY-D is in compliance with SFAR 88
and is mistakenly listed in the NPRM. This STC is the updated version
of STC ST00936NY-D, and complies with SFAR 88 and 14 CFR 25.981,
amendment 102.
    We agree with the commenters' request that certain STCs need to be
removed from the applicability. We have determined that the following
STCs listed in Table 1 of the NPRM are currently in compliance with
SFAR 88 requirements:
     ST01716NY-D
     ST01650NY
     ST01713NY-D
     ST01552NY
     ST00365NY-D, Configuration 5
     SA725NE-D, Configuration 7
    We have revised Table 1 of the AD to remove these STCs. Operators
should note that prior configurations of ST00365NY-D and SA725NE-D are
still included in the applicability unless the operator has installed
ST00365NY-D, Configuration 5, or SA725NE-D, Configuration 7, as
applicable.

Revise the Applicability Based on PATS Service Bulletin Implementation

    PATS Aircraft, Limited Brands, Boeing, All Nippon Airways, Boeing
EFO, Amiri, and Chartwell request that we remove certain STCs from the

applicability listed in Table 1 of the NPRM. The commenters point out
that the implementation of new PATS service bulletins would bring
certain STCs into compliance with SFAR 88.
    We disagree with the request to remove certain STCs based on
accomplishment of certain PATS service bulletins. Although service
bulletins developed by PATS might modify an airplane for SFAR 88
compliance, the New York Aircraft Certification Office (ACO), FAA, has
not yet received the final version of the relevant service bulletins
for approval. However, under the provisions of paragraph (h) of the AD,
we will consider requests for approval of an alternative method of
compliance based on these service bulletins if sufficient data are
submitted to substantiate that the design change would provide an
acceptable level of safety. We have not changed this AD in this regard.

Change the Description of the Auxiliary Fuel Tanks

    PATS, Chartwell, and Air National Australia point out the
description of the PATS auxiliary fuel tank is incorrect in the section
of the NPRM titled ``Supplemental Type Certificates (STCs) for PATS
Aircraft, LLC, Auxiliary Fuel Tanks.'' The commenters point out that
PATS has never designed or certified a box and bladder tank.
    We infer that the commenters would like us to revise the
description. We agree that the description in the NPRM requires
clarification. Since that section of the preamble of the NPRM does not
reappear in the final rule, no change to the final rule is necessary.
However, we offer the following revision to the paragraph, suggested by
PATS' comment, as clarification:

    PATS' typical auxiliary fuel system (AFS) consists of several
interconnected auxiliary fuel cells located in the aircraft's cargo
holds. The cells are constructed of aluminum alloy with double walls
and mounted on longitudinal rails attached to the aircraft's frame.
The inner walls serve as the fuel storage cell, and the outer walls
serve as the fuel and fume-proof shroud around the cell. The two
walls are separated by an open-weave honeycomb structure bonded to
the walls. The cells resemble aircraft cargo containers. The
individual cells are usually arranged in two groups within the
forward and aft lower cargo holds. These forward and aft fuel cell
groups operate independently as two separate tanks.

Use PATS Service Bulletins for Deactivation Procedures

    PATS requests that we add certain service information to the AD.
PATS states that operators who do not place an order for SFAR 88
service bulletins or who elect not to bring their AFS into compliance
should deactivate their system using the procedures in the service
bulletins that PATS is developing.
    We disagree. The service bulletins for deactivation have not been
presented for review and approval by the Manager, New York ACO, FAA.
Any operator who chooses to deactivate the tank must do the
deactivation in accordance with paragraph (g) of this AD. That
deactivation procedure could include, for example, performing
procedures specified in the installation manual or returning the
airplane to the configuration it was in prior to the PATS STC
modification. If PATS submits service bulletins that meet the
requirements of paragraph (g) of this AD, we would approve them as
alternative methods of compliance (AMOCs) in accordance with the
provisions of paragraph (h) of this AD. We have not changed the AD in
this regard.

Remove Reporting Requirement

    Limited Brands and Tracinda question the need for the report
specified in paragraph (f) of the NPRM. Limited Brands states that it
seems this information has already been complied with and/or should
have been used in determining the effects of the NPRM and the condition
of safety, and should have been used in the risk analysis evaluation.
Tracinda questions the purpose of the report and states that the
information should already be known for justification of the NPRM.
    We infer that the commenters are requesting that we remove the
reporting requirement from this AD. We disagree. The submittal of
reports by operators will assist the FAA in determining whether
additional actions are needed to address the identified unsafe
conditions and to determine whether the scope of corrective actions
that might be proposed by PATS or others is adequate. The required
information can be obtained fairly easily and submitted without further
cost to the operator. We have not changed the AD regarding this issue.

Re-Evaluate Costs of Compliance

    Limited Brands requests that we revise the Costs of Compliance
section of the NPRM. The commenter states that the cost estimates
appear extremely low, and that the cost to each operator both in money
and in loss of usage should be considered. The costs should also
address other items like the cost to revise the manuals and support
data, and access to areas of the airplane for deactivation.
    We disagree with the commenter's request to include the additional
items in the cost estimate. The cost information in an AD generally
includes only the direct costs of the specific actions required by this
AD. We recognize that, in doing the actions required by an AD,
operators might incur incidental costs in addition to the direct costs.
Those incidental costs, which might vary significantly among operators,
are almost impossible to calculate. We have not changed the AD
regarding this issue.

Change AC Reference

    Boeing and Chartwell point out an incorrect title in Appendix A,
paragraph (4), of the NPRM, for FAA AC 25-8. We have revised the AD to
correct the title.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We also determined that
these changes will not increase the economic burden on any operator or
increase the scope of the AD.

Costs of Compliance

    The following table provides the estimated costs for the 59 U.S.-
registered airplanes to comply with this AD. Based on these figures,
the estimated costs for U.S. operators could be as high as $382,320 to
prepare and report the deactivation procedures, and $212,400 to
deactivate tanks.

                                                 Estimated Costs

----------------------------------------------------------------------------------------------------------------
                                                    Average
               Action                 Work hours   labor rate     Parts                Individual cost
                                                    per hour
----------------------------------------------------------------------------------------------------------------
Report.............................            1          $80         None  $80, per STC.
Preparation of tank deactivation              80           80         None  $6,400, per STC.
 procedure.
Physical tank deactivation.........           30           80       $1,200  $3,600, per airplane.
----------------------------------------------------------------------------------------------------------------

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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-22-01 Various Transport Category Airplanes: Amendment 39-15696.
Docket No. FAA-2008-0298; Directorate Identifier 2007-NM-316-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective November 26,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to airplanes, certificated in any category
and equipped with auxiliary fuel tanks installed in accordance with
specified supplemental type certificates (STCs), as identified in
Table 1 of this AD.

                       Table 1--Affected Airplanes
------------------------------------------------------------------------
               Airplanes                      Auxiliary tank STC(s)
------------------------------------------------------------------------
Boeing Model 727 series airplanes......  SA62NE, SA392NE, SA530NE.
Boeing Model 727-100 series airplanes..  SA62NE, SA387NE, SA392NE,
                                          SA530NE, ST00466NY.
Boeing Model 727-200 series airplanes..  SA84NE, SA387NE, SA450NE,
                                          SA496NE.
Boeing Model 737-200 series airplanes..  SA83NE, SA725NE (unless
                                          installed with SA725NE-D,
                                          Configuration 7), SA1078NE,
                                          SA1265EA.
Boeing Model 737-200C series airplanes.  SA725NE (unless installed with
                                          SA725NE-D, Configuration 7).
Boeing Model 737-300 series airplanes..  SA500NE, SA542NE, SA553NE,
                                          SA714NE, SA725NE (unless
                                          installed with SA725NE-D,
                                          Configuration 7).
Boeing Model 737-400 series airplanes..  SA553NE, SA725NE (unless
                                          installed with SA725NE-D,
                                          Configuration 7).
Boeing Model 737-500 series airplanes..  SA725NE (unless installed with
                                          SA725NE-D, Configuration 7),
                                          ST00040NY, ST01337NY.
Boeing Model 737-700 series airplanes    ST00936NY-D (unless installed
 (increased gross weight).                with Configuration 3),
                                          ST01650NY-D.
Boeing Model 737-800 series airplanes..  ST01384NY, ST01384NY-D.
Boeing Model 757-200 series airplanes    SA979NE.
 (without overwing doors).
Boeing Model 767-200 series airplanes..  ST00840NY.
Bombardier Model CL-600-2B19 (Regional   ST00365NY, ST00365NY-D (unless
 Jet Series 100 & 440) airplanes.         installed with Configuration
                                          5).
McDonnell Douglas Model DC-8-62          SA936NE.
 airplanes.
McDonnell Douglas Model DC-9-33F         ST00605NY.
 airplanes.
McDonnell Douglas Model DC-9-81 (MD-81)  ST00409NY.
 airplanes.
McDonnell Douglas Model DC-9-82 (MD-82)  ST00409NY.
 airplanes.
McDonnell Douglas Model DC-9-83 (MD-83)  ST00218AT, ST00409NY.
 airplanes.
McDonnell Douglas Model DC-9-87 (MD-87)  ST00523NY.
 airplanes.
------------------------------------------------------------------------

Unsafe Condition

    (d) This AD results from fuel system reviews conducted by the
manufacturer, which identified potential unsafe conditions for which
the manufacturer has not provided corrective actions. We are issuing
this AD to prevent the potential of ignition sources inside fuel
tanks, which, in combination with flammable fuel vapors, could
result in fuel tank explosions and consequent loss of the airplane.

Compliance

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

Report

    (f) Within 45 days after the effective date of this AD, submit a
report to the Manager, New York Aircraft Certification Office (ACO),
FAA. The report must include the information listed in paragraphs
(f)(1) and (f)(2) of this AD. Under the provisions of the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.), the Office of Management and
Budget (OMB) has approved the information collection requirements
contained in this AD, and assigned OMB Control Number 2120-0056.
    (1) The airplane registration and auxiliary tank STC number
installed.
    (2) The usage frequency in terms of total number of flights per
year and total number of flights per year for which the auxiliary
tank is used.

Prevent Usage of Auxiliary Fuel Tanks

    (g) Before December 16, 2009, deactivate the auxiliary fuel
tanks, in accordance with a deactivation procedure approved by the
Manager, New York ACO. Any auxiliary tank component that remains on
the airplane must be secured and must have no effect on the
continued operational safety and airworthiness of the airplane.
Deactivation must not result in the need for additional instructions
for continued airworthiness.

    Note 1: Appendix A of this AD provides criteria that should be
included in the deactivation procedure. The proposed deactivation
procedures should be submitted to the Manager, New York ACO, as soon
as possible to ensure timely review and approval.

    Note 2: For technical information, contact Mazdak Hobbi,
Aerospace Engineer, Airframe and Propulsion Branch, ANE-171, FAA,
New York Aircraft Certification Office (ACO), 1600 Stewart Avenue,
Suite 410, Westbury, New York 11590; telephone<PHONE_NUMBER>; fax
(516) 794-5531.

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, New York ACO, FAA, ATTN: Mazdak Hobbi,
Aerospace Engineer, Airframe and Propulsion Branch, ANE-171, FAA,
New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, New York
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

Material Incorporated by Reference

    (i) None.

Appendix A--Deactivation Criteria

    The auxiliary fuel tank deactivation procedure required by
paragraph (g) of this AD should address the following actions.
    (1) Permanently drain auxiliary fuel tanks, and clear them of
fuel vapors to eliminate the possibility of out-gassing of fuel
vapors from the emptied auxiliary tank.
    (2) Disconnect all electrical connections from the fuel quantity
indication system (FQIS), fuel pumps if applicable, float switches,
and all other electrical connections required for auxiliary tank
operation, and stow them at the auxiliary tank interface.
    (3) Disconnect all pneumatic connections if applicable, cap them
at the pneumatic source, and secure them.
    (4) Disconnect all fuel feed and fuel vent plumbing interfaces
with airplane original equipment manufacturer (OEM) tanks, cap them
at the airplane tank side, and secure them in accordance with a
method approved by the FAA; one approved method is specified in AC
25-8 Auxiliary Fuel System Installations. In order to eliminate the
possibility of structural deformation during cabin decompression,
leave open and secure the disconnected auxiliary fuel tank vent
lines.
    (5) Pull and collar all circuit breakers used to operate the
auxiliary tank.
    (6) Revise the weight and balance document, if required, and
obtain FAA approval.
    (7) Amend the applicable sections of the applicable airplane
flight manual (AFM) to indicate that the auxiliary fuel tank is
deactivated. Remove auxiliary fuel tank operating procedures to
ensure that only the OEM fuel system operational procedures are
contained in the AFM. Amend the Limitations Section of the AFM to
indicate that the AFM Supplement for the STC is not in effect. Place
a placard in the flight deck indicating that the auxiliary tank is
deactivated. The AFM revisions specified in this paragraph may be
accomplished by inserting a copy of this AD into the AFM.
    (8) Amend the applicable sections of the applicable airplane
maintenance manual to remove auxiliary tank maintenance procedures.
    (9) After the auxiliary fuel tank is deactivated, accomplish
procedures such as leak checks and pressure checks deemed necessary
before returning the airplane to service. These procedures must
include verification that the airplane FQIS and fuel distribution
systems have not been adversely affected.
    (10) Revise the instructions for continued airworthiness, as
required, after deactivation.
    (11) Include with the operator's proposed procedures any
relevant information or additional steps that are deemed necessary
by the operator to comply with the deactivation and return the
airplane to service.

    Issued in Renton, Washington, on October 9, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-25055 Filed 10-21-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Notices]
[Pages 82014-82016]
[FR Doc No: 2011-33488]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66049; File No. SR-FINRA-2011-035]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing of Amendment No. 2 to Proposed Rule
Change, as Modified by Amendment No. 1, To Adopt FINRA Rules 2210
(Communications With the Public), 2212 (Use of Investment Companies
Rankings in Retail Communications), 2213 (Requirements for the Use of
Bond Mutual Fund Volatility Ratings), 2214 (Requirements for the Use of
Investment Analysis Tools), 2215 (Communications With the Public
Regarding Security Futures), and 2216 (Communications With the Public
About Collateralized Mortgage Obligations (CMOs)) in the Consolidated
FINRA Rulebook

December 23, 2011.

I. Introduction

    On July 14, 2011, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Exchange Act'' or ``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to adopt NASD Rules 2210 and 2211
and NASD Interpretive Materials 2210-1 and 2210-3 through 2210-8 as
FINRA Rules 2210 and 2212 through 2216, and to delete paragraphs
(a)(1), (i), (j) and (l) of Incorporated NYSE Rule 472, Incorporated
NYSE Rule Supplementary Material 472.10(1), (3), (4) and (5) and
472.90, and Incorporated NYSE Rule Interpretations 472/01 and 472/03
through 472/11. The proposed rule change was published for comment

in the Federal Register on August 3, 2011.\3\ The Commission received
nine comment letters in response to the proposed rule change.\4\ On
October 31, 2011, FINRA filed Amendment No. 1 to the proposed rule
change and a letter responding to comments.\5\ The proposed Amendment
No. 1 was published for comment along with an order instituting
proceedings pursuant to Section 19(b)(2)(B) of the Act, to determine
whether to approve or disapprove the proposed rule change, as modified
by Amendment No. 1, in the Federal Register on November 7, 2011.\6\ The
comment period closed on December 7, 2011 and FINRA's rebuttal period
closed on December 22, 2011. The Commission received seven comment
letters in response to the Notice and Proceedings Order.\7\ On December
22, 2011, FINRA filed Amendment No. 2 to the proposed rule change and a
letter responding to comments.\8\ The text of Amendment No. 2 and
FINRA's Rebuttal Letter are available on FINRA's Web site at http://www.finra.org, at the principal office of FINRA and at the Commission's
Public Reference Room. FINRA's Rebuttal Letter is also available on the
Commission's Web site at http://www.sec.gov.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 64984 (July 28,
2011), 76 FR 46870 (August 3, 2011).
    \4\ Comment letters are available at www.sec.gov.
    \5\ See letter from Joseph P. Savage, FINRA, to Elizabeth
Murphy, Secretary, SEC, dated October 31, 2011 (``Response
Letter''). The text of proposed Amendment No. 1 and FINRA's Response
Letter are available on FINRA's Web site at http://www.finra.org, at
the principal office of FINRA and at the Commission's Public
Reference Room. FINRA's Response Letter is also available on the
Commission's Web site at http://www.sec.gov.
    \6\ See Securities Exchange Act Release No. 65663 (November 1,
2011), 76 FR 68800 (November 7, 2011) (Notice of Filing of Amendment
No. 1 and Order Instituting Proceedings SR-FINRA-2011-035) (``Notice
and Proceedings Order''). The comment period closed on December 7,
2011 and FINRA's rebuttal period closed on December 22, 2011.
    \7\ See letter from Melissa Callison, Vice President,
Compliance, Charles Schwab & Co., Inc., dated December 7, 2011
(``Schwab''); letter from Alexander C. Gavis, Vice President &
Associate General Counsel, Fidelity Investments, dated December 7,
2011 (``Fidelity''); letter from David T. Bellaire, General Counsel
and Director of Government Affairs, Financial Services Institute,
dated December 7, 2011 (``FSI''); letter from Dorothy M. Donohue,
Senior Associate Counsel, Investment Company Institute, dated
December 7, 2011 (``ICI''); letter from John Polanin and Claire
Santaniello, Co-Chairs, Compliance and Regulatory Policy Committee
of the Securities Industry and Financial Markets Association
(``SIFMA''); letter from Sandra J. Burke, Principal, Vanguard, dated
December 7, 2011 (``Vanguard''); and letter from Jeremiah McGair,
Attorney, Wolverine Execution Services, LLC, dated December 7, 2011
(``Wolverine''). Comment letters are available at www.sec.gov.
    \8\ See letter from Joseph P. Savage, FINRA, to Elizabeth M.
Murphy, Secretary, SEC, dated December 22, 2011 (``Rebuttal
Letter'').
---------------------------------------------------------------------------

II. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Amendment

    First, FINRA is proposing to amend proposed FINRA Rule 2210 to
exclude from the definition of ``institutional communication'' a
member's internal communications used to train or educate registered
persons about the products or services of the member. In this regard,
FINRA proposes to delete proposed Supplementary Material 2210.01 in its
entirety. FINRA also proposes to revise proposed FINRA Rule 2210(a)(3)
as set forth below. Proposed new language is in italics.
    (3) ``Institutional communication'' means any written (including
electronic) communication that is distributed or made available only to
institutional investors, but does not include a member's internal
communications.
    Second, FINRA is proposing to amend proposed FINRA Rule 2210 to
allow a member that is subject to the new member pre-use filing
requirements to file a broker-prepared free writing prospectus within
10 business days of first use, rather than at least 10 business days
prior to first use. In this regard, FINRA proposes to replace proposed
FINRA Rule 2210(c)(1)(A) with the following:
    (A) For a period of one year beginning on the date reflected in the
Central Registration Depository (CRD[supreg]) system as the date that
FINRA membership became effective, the member must file with the
Department at least 10 business days prior to first use any retail
communication that is published or used in any electronic or other
public media, including any generally accessible Web site, newspaper,
magazine or other periodical, radio, television, telephone or audio
recording, video display, signs or billboards, motion pictures, or
telephone directories (other than routine listings). To the extent any
retail communication that is subject to this filing requirement is a
free writing prospectus that has been filed with the SEC pursuant to
Securities Act Rule 433(d)(1)(ii), the member may file such retail
communication within 10 business days of first use rather than at least
10 business days prior to first use.
    Third, in response to comments received by the Commission, FINRA is
proposing to amend proposed FINRA Rule 2210 to exclude from the filing
requirements retail communications that are posted on an online
interactive electronic forum. FINRA also is proposing to amend FINRA
Rule 2210 to exclude from the filing requirements press releases issued
by closed-end investment companies that are listed on the New York
Stock Exchange (``NYSE'') pursuant to section 202.06 of the NYSE Listed
Company Manual (or any successor provision). In this regard, FINRA
proposes to insert the following new sub-paragraphs (M) and (N) at the
end of paragraph (c)(7) of proposed FINRA Rule 2210:
    (M) Retail communications that are posted on an online interactive
electronic forum.
    (N) Press releases issued by closed-end investment companies that
are listed on the New York Stock Exchange (NYSE) pursuant to section
202.06 of the NYSE Listed Company Manual (or any successor provision).

III. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the filing as
amended by Amendments 1 and 2 is consistent with the Act. Comments may
be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2011-035 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2011-035. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,

Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2011-035 and should be
submitted on or before January 18, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-33488 Filed 12-28-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 6, 2009 (Volume 74, Number 64)]
[Notices]
[Page 15497-15499]
[DOCID:fr06ap09-76]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0166]

Economically Motivated Adulteration; Public Meeting; Request for
Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comment.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting pertaining to economically motivated adulteration (EMA). The
purpose of the meeting is to stimulate and focus a discussion about
ways in which the food (including dietary supplements and animal food),
drug, medical device, and cosmetic industries, regulatory agencies, and
other parties can better predict and prevent economically motivated
adulteration with a focus on situations that pose the greatest public
health risk. FDA invites interested individuals, organizations, and
other stakeholders, including industry representatives, to present
information pertaining to predicting and preventing EMA of food
(including dietary supplements and animal food), drugs, medical
devices, and cosmetics. The agency also requests interested parties to
submit comments on this issue to the public docket.

DATES: The public meeting will be held on May 1, 2009, from 9 a.m. to 5
p.m. Submit written or electronic comments by August 1, 2009. See
section I of the SUPPLEMENTARY INFORMATION section for deadlines
regarding the meeting.

ADDRESSES: The public meeting will be held in the Wiley Auditorium,
Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy.,
College Park, MD 20740-3835. Submit written comments to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD, 20852. Submit electronic
comments to the docket at http://www.regulations.gov. See section V of
this document for additional information on submitting comments.

FOR FURTHER INFORMATION CONTACT:
    For registration, requests to make an oral presentation, and
submission of written material for the presentation: Deborah Harris,
EDJ Associates, Inc., 11300 Rockville Pike, suite 1001, Rockville, MD
20852,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>    For general questions about the meeting, to request onsite parking
for the meeting, or for special accommodations due to a disability:
Juanita Yates, Center for Food Safety and Applied Nutrition, Food and
Drug Administration (HFS-009), 5100 Paint Branch Pkwy., College Park,
MD 20740,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. How to Participate in the Meeting

    Due to limited space and time, we encourage all persons who wish to
attend the meeting, including those requesting an opportunity to make
an oral presentation at the meeting, to register in advance. Attendees
may register in advance for the meeting by April 23, 2009. Requests for
oral presentations should be made by April 16, 2009. Presenters should
submit final presentations by April 23, 2009, in order for us to
accommodate their request. Requests for special accommodations due to
disability should be made by April 23, 2009. Requests for onsite
parking may be made until April 27, 2009.
    We encourage attendees to register for this meeting electronically
at http://www.fda.gov/oc/meetings/ema.html. You may also register by
mail, fax, e-mail, or telephone by providing registration information
(including name, title, firm name, address, telephone number, fax
number, and e-mail address) to the contact person (see FOR FURTHER
INFORMATION CONTACT). Attendees will have an opportunity to provide
oral comments. Depending on the number of oral presentations, we

may need to limit the time of each oral presentation (e.g., 5 minutes
each). Requests to make an oral presentation, submission of written
material for the presentation, requests for special accommodations due
to disability, and requests for onsite parking should be directed to
the contact person (see FOR FURTHER INFORMATION CONTACT).

II. Background on the Meeting

A. Suspected Economically Motivated Adulteration of FDA-Regulated
Products

    For purposes of this public meeting, FDA proposes a working
definition of EMA as the fraudulent, intentional substitution or
addition of a substance in a product for the purpose of increasing the
apparent value of the product or reducing the cost of its production,
i.e., for economic gain. EMA includes dilution of products with
increased quantities of an already-present substance (e.g., increasing
inactive ingredients of a drug with a resulting reduction in strength
of the finished product, or watering down of juice) to the extent that
such dilution poses a known or possible health risk to consumers, as
well as the addition or substitution of substances in order to mask
dilution.
    Several recent incidents involving FDA-regulated products are
suspected to be examples of EMA. These incidents illustrate the
potential for serious public health harm from such adulterated
products.
    In March 2007, FDA received reports of kidney failure among cats
and dogs and a report that cats died during taste tests of certain
brands of pet food. In the subsequent investigation, melamine and
melamine-related compounds were found in products labeled as wheat
gluten and rice protein concentrate that had been imported from China.
Wheat gluten and rice protein concentrate are common ingredients in
numerous pet food products sold in the United States. Melamine and its
related compounds are not approved for use as an ingredient in animal
or human food, and FDA believes it was these contaminants that made the
cats and dogs sick. At certain exposure levels, the interaction of
melamine and melamine-related compounds appears to cause the formation
of crystals in the kidneys, resulting in kidney damage. Based on the
information that FDA has, it appears that these contaminants were added
to the products handled by Chinese suppliers to increase the apparent
protein content in those products. Consumers and veterinarians have
since reported many more animal illnesses and deaths potentially
associated with pet foods made from these products. Over 150 brands of
pet food and 1,000 products were voluntarily recalled by a number of
companies.
    In January 2008, FDA received reports of adverse reactions in
pediatric dialysis patients in the U.S. Initial investigations by the
Centers for Disease Control and Prevention indicated that the adverse
events appeared to be associated with heparin manufactured by Baxter
Healthcare Corp. that was administered during the dialysis procedures.
In January and February 2008, Baxter Healthcare Corp. voluntarily
recalled all of its heparin products. FDA's investigation ultimately
identified almost 150 U.S. deaths occurring between January 1, 2007,
and May 31, 2008, that appeared to be associated with the use of these
heparin products. During the investigation, FDA scientists collaborated
with academia and industry and identified a contaminant in the heparin
active pharmaceutical ingredient (API) obtained from suppliers in
China. The contaminant was a heparin-like molecule whose presence in
heparin API was not detected by the United States Pharmacopoeia (USP)
release tests for heparin. The contaminant was identified as
oversulfated chondroitin sulfate (OSCS). FDA posted two new analytical
tests to detect the contaminant OSCS on its Web site in March 2008, and
the agency collaborated with USP to revise the test methods and modify
the monograph for heparin to test for OSCS. These new tests were used
on heparin API imported into the United States and throughout the
world. Contaminated heparin API has been found in 11 countries.
    In September 2008, FDA issued a Health Information Advisory in
response to reports of melamine contaminated milk-based infant formula
manufactured in China. Melamine was apparently added to diluted milk in
order to increase measured nitrogen levels (indicators of protein
content) and thereby inflate the apparent protein content found in the
product. FDA issued further advisories to address additional milk-based
products. To date, official reports from the Chinese Ministry of Health
state that nearly 300,000 Chinese infants were sickened by the
contaminated infant formula, and that six infant deaths were likely due
to the contamination. There have been no confirmed illnesses or deaths
in the United States attributed to melamine in products containing milk
or milk-derived ingredients, although some contaminated products were
found at ethnic markets selling imported products.
    Adulteration of glycerin, an ingredient in cough syrup and other
drugs, with diethylene glycol (DEG) has resulted in several mass
poisonings around the world in the past two decades. In 1996,
contaminated acetaminophen syrup was responsible for the deaths of more
than 70 children in Haiti. In 2006, tainted cough syrup resulted in
dozens of deaths in Panama. In Nigeria, between 2008 and 2009, more
than 50 children died after ingesting contaminated teething syrup.
Incidents of DEG contamination in these two decades have not resulted
in any reported U.S. deaths or illnesses, but in 2007, foreign-made
toothpaste contaminated with DEG was reported in the United States
resulting in recalls and restriction on imports of suspect toothpastes.
FDA has collaborated with USP to revise the test methods for glycerin
and other monographs to test for the presence of DEG.
    As the preceding examples illustrate, despite longstanding FDA
requirements to assure the safety of regulated products, such as
requirements for the use of ingredients of known identity and quality
in drugs, economically motivated adulteration remains a public health
threat.

B. FDA Science Board Meeting and EMA Workgroup

    At the October 31, 2008, meeting of the FDA Science Board, FDA
presented a conceptual model of EMA. The model describes circumstances
and factors that are likely to lead to EMA, and points to certain types
of information that may be useful in trying to prevent EMA. In response
to the feedback obtained during the Science Board Meeting, FDA formed
an internal working group focused on predicting and addressing EMA
(``EMA Workgroup''). At the February 25, 2009, meeting of the Science
Board, FDA announced its intent to hold a public meeting on EMA.

III. Purpose of Meeting and Questions for Discussion

    The purpose of the public meeting is to raise awareness about the
potential for EMA and solicit input and comments on how industry,
regulators, and other parties can better predict, prevent, and address
EMA. FDA's EMA Workgroup has developed a set of questions to focus
discussion on the matter. These questions apply to food (including
dietary supplements and animal food), drug, device and cosmetic
products and their components/ingredients. The EMA Workgroup requests
comment and input on these

questions, as well as any responses to the questions themselves based
on information that may already be in the public domain. The EMA
Workgroup further requests comment on the utility of the working
definition of EMA used here. A transcript of the public meeting will be
made available.
    Please note that FDA does not wish to publicize sensitive
information that could potentially be used by those who wish to commit
EMA or other adulteration or that identifies those who may be
committing adulteration FDA would like to remind the public that if
they have information about these or any other problems they have
encountered with FDA products, they may report such information at
http://www.fda.gov/opacom/backgrounders/problem.html. In addition, if
the public has information pertaining to suspected criminal activity
with regard to FDA-regulated products (e.g., information about
individuals who may be committing EMA or other adulteration), they may
contact FDA's Office of Criminal Investigations at http://www.fda.gov/
oci/default.htm in lieu of responding publicly to this document.
(1) General Questions:
     a. What information should U.S. regulators seek and from what
sources to help predict and prevent EMA? What further steps can U.S.
regulators take to predict and prevent EMA?
     b. What are members of industry doing to prevent EMA? What further
steps can industry take to prevent EMA?
     c. What recent examples of known or suspected EMA domestically and
internationally should U.S. regulators study and learn from?
     d. What information do other organizations (including, but not
limited to, trade organizations and security service providers) have
that would be useful in predicting and preventing EMA? What are members
of other organizations doing to prevent EMA?
     e. What are other government regulators within and outside of the
United States doing to predict and address EMA?
     f. What indicators (economic-based, chemistry-based, etc.) might
be used to detect potential EMA?
(2) Questions pertaining to attributes of products, components/
ingredients that may be at risk for EMA:
     a. What are attributes of products or components/ingredients of
products that may cause them to be more vulnerable to EMA?
     b. What food products are marketed based on measured content of
certain constituents, such as content of certain proteins, certain
fats, or certain sugars?
(3) Questions pertaining to changes in the marketing environment: What
changes relevant to the risk for EMA have occurred recently in:
     a. The marketing environment of products or components/
ingredients?
     b. The sourcing and/or distribution of products?
     c. The prices, output, imports or exports of products or
components/ingredients?
     d. The supply of components/ingredients or source materials for
products?
(4) Questions about detection methods:
     a. What analytical equipment or methods currently used by industry
and regulators to establish the identity or quality of a product or its
conformity to specifications may be inadequate to detect evidence of
EMA or adulterated products or ingredients?
     b. Are there appropriate analytical methods/equipment that could
be used instead of, or in addition to, existing methods or equipment in
particular situations?
     c. What rapid methods can be used to detect adulteration of
products or ingredients?
(5) What systems are currently being used to track and verify
components/ingredients from their source?
(6) Are there particular types of industry structures or supply chains
that are especially vulnerable to or secure from potential EMA?

IV. 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 (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: April 1, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-7843 Filed 4-2-09; 4:15 pm]

BILLING CODE 4160-01-S


[Federal Register: December 8, 2009 (Volume 74, Number 234)]
[Rules and Regulations]
[Page 64613]
[DOCID:fr08de09-4]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2009-0764]

Drawbridge Operation Regulation; Gulf Intracoastal Waterway,
Dunedin, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Seventh Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Dunedin Causeway bridge across the Gulf Intracoastal Waterway, mile
141.9, at Dunedin, FL. The deviation is necessary to facilitate
rehabilitation of the bascule leaves of the bridge. This deviation
allows the bridge to conduct single leaf operations while repairs are
conducted with a three hour notice for double leaf operations.

DATES: This deviation is effective from 7 a.m. on September 8, 2009
through 6 p.m. on February 28, 2010.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2009-0764 and are available online
by going to http://www.regulations.gov, inserting USCG-2009-0764 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. 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 rule,
call or e-mail Mr. Gene Stratton, Bridge Branch, Seventh Coast Guard
district; telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If
you have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Coastal Marine Construction, INC, on behalf
of Pinellas County, FL, has requested a deviation to the regulations of
the Dunedin Causeway bridge, mile 141.9, across the Gulf Intracoastal
Waterway as required by 33 CFR 117.5: Except as otherwise authorized or
required by this part, drawbridges must open promptly and fully for the
passage of vessels when a request or signal to open is given in
accordance with this subpart. To facilitate the repair of the bascule
leaves, one leaf will be required to remain in the closed position upon
signal from a vessel, except with a three hour notification for an
opening requiring both leaves. This deviation effectively reduces the
horizontal clearance of 91 feet by half for vessels requiring an
opening. The Mean High Water clearance in the closed position remains
24 feet. Vessels not requiring an opening may pass at any time. This
action will affect a limited number of vessels as the ability to use
the full 91 foot horizontal clearance is available with a three hour
notification. This action is necessary to allow Coastal Marine
Construction, INC to conduct necessary repairs the bascule leaves
safely and efficiently.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: November 6, 2009.
Scott A. Buschman,
Captain, U.S. Coast Guard Commander, Seventh Coast Guard District,
Acting.
[FR Doc. E9-29126 Filed 12-7-09; 8:45 am]

BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 155 (Monday, August 12, 2013)]
[Proposed Rules]
[Pages 48838-48839]
[FR Doc No: 2013-19450]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0608; Airspace Docket No. 13-ACE-14]

Proposed Establishment of Class E Airspace; Curtis, NE

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class E airspace at Curtis,
NE. Controlled airspace is necessary to accommodate new Standard
Instrument Approach Procedures (SIAP) at Curtis Municipal Airport. The
FAA is taking this action to enhance the safety and management of
Instrument Flight Rules (IFR) operations for SIAPs at the airport.

DATES: Comments must be received on or before September 26, 2013.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2013-0608/Airspace Docket No. 13-
ACE-14, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9:00 a.m. and
5:00 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527), is on the ground floor of the
building at the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: 817-321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice of proposed
rulemaking must submit with those comments a self-addressed, stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2013-0608/Airspace Docket No. 13-ACE-14.'' The postcard will be
date/time stamped and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Central Service Center, 2601
Meacham Blvd., Fort Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by establishing Class E airspace extending upward
from 700 feet above the surface within a 7.6-mile radius to accommodate
new standard instrument approach procedures at Curtis Municipal
Airport, Curtis, NE. Controlled airspace is needed for the safety and
management of IFR operations at the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9W, dated August 8, 2012 and effective September 15, 2012, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This proposed regulation is within the scope of that
authority as it would establish controlled airspace at Curtis Municipal
Airport, Curtis, NE.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and

Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9W,
Airspace Designations and Reporting Points, dated August 8, 2012, and
effective September 15, 2012, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ACE NE E5 Curtis, NE [New]

Curtis Municipal Airport, NE
    (Lat. 40[deg]38'20'' N., long. 100[deg]28'24'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.6-mile radius of Curtis Municipal Airport.

    Issued in Fort Worth, TX on July 26, 2013.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2013-19450 Filed 8-9-13; 8:45 am]
BILLING CODE 4901-13-P