[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44908-44911]
[FR Doc No: 2020-16014]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3277]

Revocation of Authorization of Emergency Use of an In Vitro
Diagnostic Device for Detection and/or Diagnosis of Zika Virus

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to Chembio Diagnostic Systems, Inc. (``Chembio'') for the DPP
Zika IgM Assay System. FDA revoked this Authorization on June 3, 2020,
under

the Federal Food, Drug, and Cosmetic Act (FD&C Act), in consideration
of the premarket notification clearance by FDA for the DPP Zika IgM
System, DPP Zika IgM System Control Pack, and DPP Micro Reader that was
determined to be substantially equivalent to a legally marketed class
II predicate device on June 3, 2020. The revocation, which includes an
explanation of the reasons for revocation, is reprinted in this
document.

DATES: The Authorization is revoked as of June 3, 2020.

ADDRESSES: Submit written requests for single copies of the revocation
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. On September 27, 2017, FDA issued an EUA to Chembio, for
the DPP Zika IgM Assay System, subject to the terms of the
Authorization. Notice of the issuance of the Authorization was
published in the Federal Register on November 17, 2017 (82 FR 54361),
as required by section 564(h)(1) of the FD&C Act. In response to
requests from Chembio, the EUA was amended on February 6, 2018, and
August 3, 2018. Subsequently, on June 3, 2020, Chembio submitted a
premarket notification to FDA for the DPP Zika IgM System, DPP Zika IgM
System Control Pack, and DPP Micro Reader (K200506), that was
determined to be substantially equivalent to a legally marketed Class
II predicate device.

II. EUA Criteria for Issuance No Longer Met

    Under section 564(g)(2) of the FD&C Act, the Secretary of Health
and Human Services may revoke an EUA if, among other things, the
criteria for issuance are no longer met. On June 3, 2020, FDA revoked
the EUA for Chembio's DPP Zika IgM Assay System because the criteria
for issuance were no longer met. Under section 564(c)(3) of the FD&C
Act, an EUA may be issued only if FDA concludes there is no adequate,
approved, and available alternative to the product for diagnosing,
preventing, or treating the disease or condition. FDA has determined
that the criteria for issuance of such authorization under section
564(c)(3) of the FD&C Act are no longer met because Chembio's DPP Zika
IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader was
determined on June 3, 2020, to be substantially equivalent to a legally
marketed class II predicate device with the generic name ``Zika virus
serological reagents.'' As such, FDA concluded that there is an
adequate, approved, and available alternative for diagnosing Zika virus
infection for purposes of section 564(c)(3) of the FD&C Act and
accordingly revoked the Authorization pursuant to section 564(g)(2)(B)
of the FD&C Act.

III. Electronic Access

    An electronic version of this document and the full text of the
revocation are available on the internet at https://www.regulations.gov/.

IV. The Revocation

    Having concluded that the criteria for revocation of the
Authorization under section 564(g) of the FD&C Act are met, FDA has
revoked the EUA for Chembio's DPP Zika IgM Assay System. The revocation
in its entirety follows and provides an explanation of the reasons for
revocation, as required by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

[GRAPHIC] [TIFF OMITTED] TN24JY20.002

[GRAPHIC] [TIFF OMITTED] TN24JY20.003

    Dated: July 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16014 Filed 7-23-20; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 78, Number 41 (Friday, March 1, 2013)]
[Proposed Rules]
[Pages 13835-13843]
[FR Doc No: 2013-04812]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 78, No. 41 / Friday, March 1, 2013 / Proposed
Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-0109; Notice No. 25-137]
RIN 2120-AK13

Harmonization of Airworthiness Standards--Miscellaneous
Structures Requirements

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to amend certain airworthiness regulations
for transport category airplanes, based on recommendations from the
Aviation Rulemaking Advisory Committee (ARAC). Adopting this proposal
would eliminate regulatory differences between the airworthiness
standards of the FAA and European Aviation Safety Agency (EASA). This
proposal would not add new requirements beyond what manufacturers
currently meet for EASA certification and would not affect current
industry design practices. This proposal would revise the structural
test requirements necessary when analysis has not been found reliable;
clarify the quality control, inspection, and testing requirements for
critical and non-critical castings; add control system requirements
that consider structural deflection and vibration loads; expand the
fuel tank structural and system requirements regarding emergency
landing conditions and landing gear failure conditions; add a
requirement that engine mount failure due to overload must not cause
hazardous fuel spillage; and revise the inertial forces requirements
for cargo compartments by removing the exclusion of compartments
located below or forward of all occupants in the airplane.

DATES: Send comments on or before May 30, 2013.

ADDRESSES: Send comments identified by docket number FAA-2013-0109
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA dockets, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact Todd Martin, Airframe and Cabin Safety Branch,
ANM-115, Transport Airplane Directorate, Aircraft Certification
Service, Federal Aviation Administration, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    For legal questions concerning this action, contact Sean Howe,
Office of the Regional Counsel, ANM-7, Federal Aviation Administration,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-2591; facsimile<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules on aviation safety is found in
Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
Requirements.'' Under that section, the FAA is charged with promoting
safe flight of civil aircraft in air commerce by prescribing
regulations and minimum standards for the design and performance of
aircraft that the Administrator finds necessary for safety in air
commerce. This regulation is within the scope of that authority. It
prescribes new safety standards for the design and operation of
transport category airplanes.

I. Background

    Part 25 of Title 14, Code of Federal Regulations (14 CFR)
prescribes airworthiness standards for type certification of transport
category airplanes, for products certified in the United States. Book 1
of the EASA Certification Specifications and Acceptable Means of
Compliance for Large Aeroplanes (CS-25) prescribes the corresponding
airworthiness standards for products certified in Europe. While part 25
and CS-25 Book 1 are similar, they differ in several respects. The
necessity of meeting two sets of certification requirements raises the
cost of developing new transport category airplanes with little to no
increase in safety. Therefore, the FAA tasked ARAC through the Loads
and Dynamics Harmonization Working Group (LDHWG) and the General
Structures Harmonization Working Group (GSHWG) to review existing
structures regulations and recommend changes that would eliminate
differences between the U.S. and European airworthiness standards,
while maintaining or improving the level of safety in the current
regulations. This proposed rule is a result of this harmonization
effort.

    The LDHWG and GSHWG developed recommendations, which EASA has
incorporated into CS-25 with some changes. The FAA agrees with the ARAC
recommendations as adopted by EASA, and we propose to amend part 25
accordingly. The proposals are not expected to be controversial and
should reduce certification costs to industry without adversely
affecting safety. The complete analyses for the proposed changes made
in response to ARAC recommendations can be found in the ARAC
recommendation reports, located in the docket for this rulemaking.

II. Overview of Proposed Rule

    The FAA proposes to amend the airworthiness regulations described
below. This action would harmonize part 25 requirements with the
corresponding requirements in EASA CS-25 Book 1.
    1. Section 25.307(a), ``Proof of structure,'' would be revised to
allow a ``sufficient'' level of structural testing, in some cases less
than ultimate, when analysis has not been shown to be reliable.
    2. Section 25.621, ``Casting factors,'' would be revised to clarify
the--
     Definition of critical casting and
     Quality control, inspection, and testing requirements for
critical and non-critical castings.
    3. Section 25.683, ``Operation tests,'' would be revised to add a
requirement that--
     The control system must remain free from jamming,
friction, disconnection, and permanent damage in the presence of
structural deflection and
     Under vibration loads, no hazard may result from
interference or contact of the control system with adjacent elements.
    4. Section 25.721, ``Landing Gear--General,'' would be revised to--
     Expand the landing gear failure conditions to include side
loads, in addition to up and aft loads, and expand this requirement to
include nose landing gear in addition to the main landing gear,
     Specify that the wheels-up landing conditions are assumed
to occur at a descent rate of 5 feet per second,
     Add a sliding-on-ground condition, and
     Require the engine mount be designed so that, when it
fails due to overload, this failure does not cause the spillage of
enough fuel to constitute a fire hazard.
    5. Section 25.787, ``Stowage compartments,'' would be revised to
expand the inertia forces requirements for cargo compartments by
removing the exclusion of compartments located below or forward of all
occupants in the airplane.
    6. Section 25.963, ``Fuel tanks: general,'' would be revised to--
     Require that fuel tanks be designed so that no fuel is
released in or near the fuselage, or near the engines, in quantities
that would constitute a fire hazard in otherwise survivable emergency
landing conditions,
     Define fuel tank pressure loads for fuel tanks located
within and outside the fuselage pressure boundary and near the fuselage
or near the engines, and
     Specify the wheels-up landing conditions and landing gear
and engine mount failure conditions that must be considered when
evaluating fuel tank structural integrity.
    7. Section 25.994, ``Fuel system components,'' would be revised to
specify the wheels-up landing conditions to be considered when
evaluating fuel system components.

III. Discussion of the Proposal

A. Section 25.307(a), ``Proof of Structure''

    Section 25.307(a) currently requires that applicants for a type
design conduct strength testing unless structural analysis has been
shown to be reliable. When analysis has not been shown to be reliable,
the regulation states that the FAA ``may require ultimate load tests in
cases where limit load tests may be inadequate.''
    Rather than specifying ``limit load'' or ``ultimate load,'' the
GSHWG proposed that the harmonized requirement state that
substantiating load tests must be made that are ``sufficient'' to
verify structural behavior up to the load levels required by Sec.
25.305 (strength and deformation). Where it is justified, these test
load levels may be less than ultimate.
    We propose to revise Sec.  25.307(a) to state that, when analysis
has not been shown to be reliable, tests must be conducted to
``sufficient'' load levels. Normally, testing to ultimate load levels
is required, but when previous relevant test evidence can be used to
support the analysis, then a lower level of testing may be accepted.
The proposed rule would allow this intermediate level of testing. While
the rule has changed, the intent remains the same: to ensure that the
structure will not have any structural deformation under limit load or
any failure under ultimate load.
    This action would harmonize Sec.  25.307(a) with the corresponding
EASA standard.

B. Section 25.621, ``Casting Factors''

    Section 25.621 currently requires classification of structural
castings as either critical or non-critical, and depending on
classification, specifies inspection requirements, test requirements,
and casting factors for strength and deformation. These casting factors
are applied in addition to the factor of safety required by Sec.
25.303, ``Factor of safety.'' The application of factors of safety to
castings is necessary because the casting process can be inconsistent.
Castings are subject to variability in mechanical properties due to
this casting process, which can result in imperfections (such as voids)
within the cast part.
    We propose to revise Sec.  25.621 to define ``critical casting''
and to clarify the quality control, inspection, and testing
requirements for critical and non-critical castings. The proposed rule
would specify the inspection and testing requirements based on the
casting factor chosen by the applicant--from 1.0 to 2.0 or greater.
    Section 25.621 currently requires that critical castings in
structural applications have a minimum casting factor of 1.25. A
casting factor of 1.0 would be allowed by the proposed rule, as
described below, because casting technology has improved since the
current Sec.  25.621 was adopted, and much higher quality castings can
be produced using improved foundry methods. The proposed rule would
require the following for critical castings:
     A visual and special non-destructive inspections. The
special non-destructive inspections would be limited to specified areas
of the casting where defects are likely to occur.
     A casting factor of 1.5 or greater would be allowed
provided that one casting undergoes static testing and is shown to meet
the relevant strength and deformation requirements. A casting factor of
1.25 or greater would be allowed provided that three castings undergo
static testing and are shown to meet the relevant strength and
deformation requirements.
     A casting factor of 1.0 or greater would be allowed
provided that one casting undergoes static testing and is shown to meet
the relevant strength and deformation requirements, and it is
demonstrated that a process is in place to ensure the castings produced
have material variation equivalent to those of wrought alloy products
of similar composition. Draft Advisory Circular (AC) 25.621-X,
``Casting Factors,'' will be published concurrently with this NPRM.
This draft AC outlines a process for using a casting factor of 1.0,

including any changes to that process that may occur over time. The
proposed rule requires ``process monitoring,'' which is intended to
mean continuous process monitoring for the entire production lifecycle.
    The proposed rule would also specify quality control, inspection,
and testing requirements for non-critical castings with casting factors
ranging from 1.0 to 2.0 or greater.

C. Section 25.683, ``Operation Tests''

    Section 25.683 currently requires the airplane control system to be
free from jamming, excessive friction, and excessive deflection when
subjected to pilot effort and control system loads. We propose to
revise Sec.  25.683 by adding a requirement to substantiate that, in
the presence of deflections of the airplane structure due to maneuver
loads, the control system can be exercised and remain free from
jamming, friction, disconnection, and any form of permanent damage. In
addition, we propose adding a requirement to substantiate that, under
vibration loads, no interference or contact of the control system with
adjacent elements can result in hazard.
    Since control systems are typically attached or routed through
adjacent aircraft structure, it is necessary to ensure that deflections
of that adjacent structure do not adversely affect the safe operation
of the control system through interference, jamming, or induced
loading. Also, the control system design should be such that the
effects of vibration loads in normal flight and ground operating
conditions will not affect the safe operation of the control system.
    These actions would harmonize Sec.  25.683 with the corresponding
EASA standard.

D. Section 25.721, ``Landing Gear--General (Emergency Landing
Conditions)''

    Section 25.721(a) currently requires that the main landing gear
system be designed so that if it fails due to overloads during takeoff
and landing, the failure does not cause the spillage of enough fuel to
constitute a fire hazard. This is intended to protect fuel tanks from
rupture and puncture due to the failure of the landing gear and its
supports. This requirement applies only to fuel systems inside the
fuselage for airplanes with 9 seats or less, and all fuel systems for
airplanes with 10 seats or more. We propose to revise Sec.  25.721(a)
to:
    1. Apply to the nose landing gear as well as the main landing gear,
    2. Clarify that landing gear failure is assumed,
    3. Expand the failure conditions to include side loads, in addition
to up and aft loads, and
    4. Remove the exception for airplanes with less than 10 seats.
    We propose revising Sec.  25.721(a) to apply to the nose gear as
well as the main landing gear because nose gear failures can also
impact fuel tanks. We would also clarify that landing gear failure is
assumed by stating that the design must consider such failures ``when''
they occur, rather than ``if'' they occur. This clarification is needed
because in some past cases, applicants relied on over-designing the
landing gear beyond ultimate strength requirements rather than showing
safe separation in the event of failure.
    We would expand the failure conditions to consider side loads to
ensure that a comprehensive range of failure conditions are considered.
Lastly, we would remove the exception for airplanes with less than 10
seats.
    This exception in Sec.  25.721 was originally introduced at
Amendment 25-32 (37 FR 3969, February 24, 1972). In the preamble to
that final rule, the FAA determined that:

[C]ertain of the requirements in proposed Secs. 25.562, 25.721,
25.787, 25.807, and 25.812 are inappropriate and unnecessary, or are
unnecessarily severe, for transport category airplanes that have
maximum passenger seating configurations, excluding pilots seats, of
nine seats or less. In those instances, the proposed requirements
have been revised to provide exceptions and to include requirements
for such airplanes that provide a level of safety for such airplanes
equivalent to that for airplanes with larger passenger seating
configurations.

    This exception is appropriate for certain cabin safety provisions
that necessitate the egress of large numbers of passengers. However,
the FAA believes that for the hazards associated with fuel fires, there
is no technical justification for limiting the applicability of any of
the fuel tank protection provisions based on the passenger seating
capacity.
    Section 25.721(b) currently states that airplanes must be able to
land on a paved runway, with any one or more landing gear legs not
extended, without failures that result in spillage of enough fuel to
constitute a fire hazard. This condition is not intended to treat a
collapsed gear condition, but is intended to cover cases in which one
or more gear legs do not extend for whatever reason, and the airplane
must make a controlled landing on a paved runway in this condition. The
current requirement applies only to airplanes with 10 seats or more. We
propose to revise Sec.  25.721(b) to:
    1. Specify that the wheels-up landing conditions are assumed to
occur at a descent rate of 5 feet per second,
    2. Clarify the combinations of retracted landing gear that must be
considered,
    3. Add a sliding-on-ground condition, and
    4. Remove the exception for airplanes with less than 10 seats.
    At the time Sec.  25.721(b) was adopted by Amendment 25-32 (37 FR
3969, February 24, 1972), Sec.  25.561 contained a landing descent
speed of ``5 feet per second'' as an alternative criterion that could
allow a reduction in the specified vertical emergency landing design
load factor. Amendment 25-64 (53 FR 17646, May 17, 1988) removed this
alternative to make the specified vertical design load factor the
minimum design condition. However, the 5-feet-per-second descent speed
contained in Sec.  25.561 had become, by design practice and
interpretation, the design descent velocity for the wheels-up landing
conditions addressed in Sec. Sec.  25.721 and 25.994. By removing it,
the quantitative definition of the wheels-up landing condition on a
paved runway was lost. We propose to revise Sec.  25.721(b) to re-
establish the 5-feet-per-second descent rate for the ``minor crash
landing'' condition.
    We would add a sliding-on-ground condition to ensure that the
wheels-up landing conditions are evaluated beyond the initial impact.
The exception for airplanes with less than 10 seats would be removed
from Sec.  25.721(a) and (b) as noted above.
    We propose to replace Sec.  25.721(c) with a new requirement that
the engine mount and pylon be designed so that, when it fails due to
overload, the failure mode is not likely to cause the spillage of
enough fuel to constitute a fire hazard. Service experience has shown
that landing gear malfunctions can lead to the airplane landing on the
engine nacelles for some configurations. This can result in the engine
nacelle breaking away, creating much the same fuel tank rupture
potential as the landing gear breaking away.
    These actions would harmonize Sec.  25.721 with the corresponding
EASA standard.

E. Section 25.787(a), ``Stowage Compartments''

    Section 25.787(a) currently requires that cargo compartments be
designed to the emergency landing conditions of Sec.  25.561(b), but
excludes compartments located below or forward of all occupants in the
airplane. We propose

to revise Sec.  25.787(a) to include compartments located below or
forward of all occupants in the airplane. This change would ensure
that, in these compartments, inertia forces in the up and aft direction
will not injure passengers, and inertia forces in any direction will
not cause penetration of fuel tanks or lines, or cause other hazards.
This action would harmonize Sec.  25.787(a) with the corresponding EASA
standard.
    The LDHWG originally recommended that Sec.  25.561(c) be revised to
achieve this objective of addressing cargo compartments below or
forward of airplane occupants. However, when evaluating the LDHWG
recommendation, EASA determined that CS 25.787 already addressed the
issue and noted that Sec.  25.787(a) and CS 25.787(a) were different in
this regard. Separately, ARAC also tasked the Cabin Safety
Harmonization Working Group with reviewing Sec.  25.787, and that group
also recommended that the FAA harmonize Sec.  25.787(a) with CS
25.787(a). The FAA agrees that the change should be made to Sec.
25.787(a), rather than Sec.  25.561.

F. Section 25.963(d), ``Fuel Tanks: General (Emergency Landing
Conditions)''

    Section 25.963(d) currently requires that fuel tanks within the
fuselage contour be able to resist rupture and retain fuel under the
inertia forces defined in Sec.  25.561. In addition, these tanks must
be in a protected position so that exposure of the tanks to scraping
action with the ground is unlikely. We propose to revise Sec.
25.963(d), as described below, based on recommendations provided by the
LDHWG.
    1. The introductory sentence to Sec.  25.963(d) would require that,
``so far as it is practicable,'' fuel tanks be designed, located and
installed so that no fuel is released in or near the fuselage, or near
the engines, in quantities that would constitute a fire hazard in
``otherwise survivable emergency landing conditions.'' This is
considered a general requirement, while more specific criteria are
provided in Sec.  25.963(d)(1) through (d)(5). The term ``practicable''
here means that any feasible or workable design should be considered in
order to protect the fuel tanks. The phrase ``otherwise survivable
emergency landing conditions'' is not specifically quantified. However,
past events should be considered in developing a robust fuel tank
design.
    2. Section 25.963(d)(1) through (d)(3) would define fuel tank
pressure loads for fuel tanks located within and outside the fuselage
pressure boundary, and near the fuselage or near the engines, as
described below.
    The LDHWG recommended revising Sec.  25.963(d) to delete the
reference to Sec.  25.561 for emergency landing load factors, which are
used to develop the fuel tank pressure loads. The emergency landing
load factors of Sec.  25.561(b)(3) are based upon the restraint of
fixed mass items, and the response of a fluid during emergency landings
is different and much more complex to quantify. The proposed
requirements for fuel tanks both within and outside of the fuselage
pressure boundary have been simply formulated in terms of equations
with factors that are justified based upon the satisfactory service
experience of the existing fleet.
    The current regulation addresses only fuel tanks within the
fuselage contour, although the FAA has issued special conditions to
require fuel inertia loading conditions on horizontal tail tanks
outside the fuselage contour.
    The LDHWG determined that the safety record for fuel tank rupture
caused solely by fuel inertia loads is excellent. Manufacturers'
records of accidents and serious incidents involving large transport
airplanes showed no event where fuel inertia pressure caused
significant loss of fuel. Fuel losses that did occur were mainly caused
by direct impact and external-object punctures.
    Nevertheless, a fuel inertia criterion for wing fuel tanks is
needed to ensure that future designs meet the same level of safety
achieved by the current fleet. The wing fuel tanks of many current
aircraft types were designed to a simple criterion in which fuel
pressure was calculated using an inertia head equal to the local
geometrical stream-wise distance between the fuel tank solid
boundaries. Service experience has shown this criterion produces fuel
tank designs with an acceptable level of safety. Therefore, it is
appropriate that the future airworthiness standards for fuel tanks
should require a similar level of design fuel pressure for similar fuel
tank designs.
    For fuel tanks within the fuselage pressure boundary, the current
fuel inertia load criterion, as generally applied, covers up to a full
fuel tank, an inertia head equal to maximum pressure head, and inertia
load factors equal to those of Sec.  25.561(b)(3). This level of
rupture resistance for fuel tanks is justified based upon occupant
survivability considerations. Therefore, the LDHWG recommended, and the
FAA concurs, that the current minimum level of rupture resistance
should be retained for fuel tanks within the fuselage pressure
boundary. For fuel tanks outside the fuselage pressure boundary, the
design load factors for the inboard and outboard (lateral) loading
conditions and forward loading conditions are proposed as one-half of
those for fuel tanks within the fuselage. The design load factors for
the up, down, and aft loading conditions would be the same for all fuel
tanks.
    When EASA adopted the LDHWG recommendations, it noted an objection
that had been raised by the Joint Aviation Authorities (JAA) Power
Plant Study Group (PPSG). The PPSG did not agree with the LDHWG
recommendation regarding fuel tank pressure loads for fuel tanks ``near
the fuselage or near the engines,'' which had been specifically
addressed by Joint Aviation Regulation. In response to the PPSG
objection, EASA added criteria for fuel tanks near the fuselage and
near the engines. We agree with these criteria and propose to add the
same to Sec.  25.963(d).
    3. Section 25.963(d)(4) would require that the effects of crushing
and scraping actions with the ground not cause fuel spillage, or
generate temperatures that would constitute a fire hazard under the
conditions specified in proposed Sec.  25.721(b). By reference to Sec.
25.721(b), this rule would require consideration of the 5 feet-per-
second wheels-up landing criteria and subsequent sliding on the ground.
The potential effects of crushing and scraping, including thermal
effects, must be evaluated for these minor crash landing conditions.
    4. Section 25.963(d)(5) would require that fuel tank installations
be such that the tanks will not rupture as a result of an engine pylon
or engine mount or landing gear tearing away as specified in proposed
Sec.  25.721(a) and (c). This requirement would be largely redundant to
the proposed Sec.  25.721(a) and (c), but is included in Sec.
25.963(d) for completeness.
    These actions would harmonize Sec.  25.963(d) with the
corresponding EASA standard with the following two exceptions:
    CS 25.963(d) requires that fuel tanks be designed and located so
that no fuel is released in quantities ``sufficient to start a serious
fire'' in otherwise survivable emergency landing conditions. The
proposed rule would require that no fuel is released in quantities
``that would constitute a fire hazard.'' The two phrases have the same
intent and meaning, and the latter phrase is consistent with the
wording in CS 25.721/Sec.  25.721, CS 25.963(d)(4)/Sec.  25.963(d)(4),
and CS 25.994/Sec.  25.994.
    The fuel tank pressure criteria in CS 25.963(d) vary depending on
whether the fuel tank is ``within the fuselage

contour'' or ``outside the fuselage contour.'' The proposed rule would
be more specific by referring to ``those parts of fuel tanks within the
fuselage pressure boundary or that form part of the fuselage pressure
boundary'' versus ``those parts of fuel tanks outside the fuselage
pressure boundary.'' The proposed wording is clearer and has the same
intent and meaning as that specified in CS 25.963(d).

G. Section 25.994, ``Fuel System Components''

    Section 25.994 currently requires that fuel system components in an
engine nacelle or in the fuselage be protected from damage that could
result in spillage of enough fuel to constitute a fire hazard as a
result of a wheels-up landing on a paved runway. We propose to revise
Sec.  25.994 to specify that the wheels-up landing conditions that must
be considered are those defined in proposed Sec.  25.721(b). This
action would harmonize Sec.  25.994 with the corresponding EASA
standard.
    As noted previously, the 5-feet-per-second descent speed contained
in an earlier amendment to Sec.  25.561 had become, by design practice
and interpretation, the design descent velocity for the wheels-up
landing conditions addressed in Sec. Sec.  25.721 and 25.994. In fact,
Advisory Circular (AC) 25.994-1, ``Design Considerations to Protect
Fuel Systems During a Wheel-Up Landing,'' dated July 24, 1986,
specifically referred to Sec.  25.561 for the design conditions, which
at that time contained the 5-feet-per-second landing descent criteria.

H. Advisory Material

    The FAA is developing three new proposed ACs to be published
concurrently with the proposed regulations in this NPRM. The proposed
ACs would provide guidance material for acceptable means, but not the
only means, of demonstrating compliance with proposed Sec. Sec.
25.307, 25.561, 25.621, 25.721, 25.963, and 25.994. We will accept
public comments to the following proposed ACs on the ``Aviation Safety
Draft Documents Open for Comment'' Internet Web site at http://www.faa.gov/aircraft/draft_docs/:
     AC 25-X, ``Fuel Tank Strength in Emergency Landing
Conditions.'' (AC 25-X would provide guidance for the fuel tank
structural integrity requirements of Sec. Sec.  25.561, 25.721, and
25.963.)
     AC 25.307-X, ``Proof of Structure.''
     AC 25.621-X, ``Casting Factors.''

IV. Regulatory Notices and Analyses

A. Regulatory Evaluation

    Proposed changes to Federal regulations must undergo several
economic analyses. First, Executive Order 12866 and Executive Order
13563 direct that each Federal agency shall propose or adopt a
regulation only upon a reasoned determination that the benefits of the
intended regulation justify its costs. Second, the Regulatory
Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze
the economic impact of regulatory changes on small entities. Third, the
Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting
standards that create unnecessary obstacles to the foreign commerce of
the United States. In developing U.S. standards, the Trade Act requires
agencies to consider international standards and, where appropriate,
that they be the basis of U.S. standards. Fourth, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a
written assessment of the costs, benefits, and other effects of
proposed or final rules that include a Federal mandate likely to result
in the expenditure by State, local, or tribal governments, in the
aggregate, or by the private sector, of $100 million or more annually
(adjusted for inflation with base year of 1995). This portion of the
preamble summarizes the FAA's analysis of the economic impacts of this
proposed rule.
    Department of Transportation Order DOT 2100.5 prescribes policies
and procedures for simplification, analysis, and review of regulations.
If the expected cost impact is so minimal that a proposed or final rule
does not warrant a full evaluation, this order permits that a statement
to that effect and the basis for it be included in the preamble if a
full regulatory evaluation of the cost and benefits is not prepared.
Such a determination has been made for this proposed rule. The
reasoning for this determination follows.
    The FAA proposes to amend certain airworthiness standards for
transport category airplanes. Adopting this proposal would eliminate
regulatory differences between the airworthiness standards of the FAA
and EASA. This proposal would not add new requirements beyond what
manufacturers currently meet for EASA certification and would not
affect current industry design practices. Meeting two sets of
certification requirements raises the cost of developing new transport
category airplanes with little to no increase in safety. In the
interest of fostering international trade, lowering the cost of
manufacturing new transport category airplanes, and making the
certification process more efficient, the FAA, EASA, and several
industry working groups came together to create, to the maximum extent
possible, a single set of certification requirements that would be
accepted in both the United States and Europe. Therefore, as a result
of these harmonization efforts, the FAA proposes to amend the
airworthiness regulations described in section II of this NPRM,
``Overview of the Proposed Rule.'' This action would harmonize part 25
requirements with the corresponding requirements in EASA CS-25 Book 1.
    Currently, all manufacturers of transport category airplanes,
certificated under part 25 are expected to continue their current
practice of compliance with the EASA certification requirements in CS-
25 Book 1. Since future certificated transport airplanes are expected
to meet CS-25 Book 1, and this rule simply adopts the same EASA
requirements, manufacturers will incur minimal or no additional cost
resulting from this proposed rule. Therefore, the FAA estimates that
there are no additional costs associated with this proposed rule.
    In fact, manufacturers could receive cost savings because they will
not have to build and certificate transport category airplanes to two
different authorities' certification specifications and rules.
    The FAA, however, has not attempted to quantify the cost savings
that may accrue from this rule, beyond noting that while they may be
minimal, they contribute to a potential harmonization savings. The
agency concludes that because the compliance cost for this proposed
rule is minimal and there may be harmonization cost savings, further
analysis is not required.
    The FAA has, therefore, determined that this proposed rule is not a
``significant regulatory action'' as defined in section 3(f) of
Executive Order 12866, and is not ``significant'' as defined in DOT's
Regulatory Policies and Procedures.

B. Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation. To achieve this principle, agencies are required
to solicit and

consider flexible regulatory proposals and to explain the rationale for
their actions to assure that such proposals are given serious
consideration.'' The RFA covers a wide-range of small entities,
including small businesses, not-for-profit organizations, and small
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines that it will, the agency must
prepare a regulatory flexibility analysis as described in the RFA.
    However, if an agency determines that a rule is not expected to
have a significant economic impact on a substantial number of small
entities, section 605(b) of the RFA provides that the head of the
agency may so certify, and a regulatory flexibility analysis is not
required. The certification must include a statement providing the
factual basis for this determination, and the reasoning should be
clear.
    The FAA believes that this rule would not have a significant
economic impact on a substantial number of small entities for the
following reason. The net effect of this rule is minimum regulatory
cost relief as the proposed rule would adopt those EASA requirements
that industry already complies with. Moreover, manufacturers of part 25
airplanes are not small entities. Because those manufacturers already
meet or expect to meet this CS-25 standard as well as the existing CFR
requirement, the net effect of this proposed rule is regulatory cost
relief.
    Because manufacturers of transport category airplanes are not small
entities, this proposed rule is expected to have minimal to no
additional costs, and could be cost-relieving, as the acting FAA
Administrator, I certify that this proposed rule would not have a
significant economic impact on a substantial number of small entities.

C. International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing standards or engaging in related activities
that create unnecessary obstacles to the foreign commerce of the United
States. Pursuant to these Acts, the establishment of standards is not
considered an unnecessary obstacle to the foreign commerce of the
United States, so long as the standard has a legitimate domestic
objective, such the protection of safety, and does not operate in a
manner that excludes imports that meet this objective. The statute also
requires consideration of international standards and, where
appropriate, that they be the basis for U.S. standards. The FAA has
assessed the potential effect of this proposed rule and determined that
it is in accord with the Trade Agreements Act as the rule uses European
standards as the basis for United States regulation.

D. Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently
uses an inflation-adjusted value of $143.1 million in lieu of $100
million. This proposed rule does not contain such a mandate; therefore,
the requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. The FAA has determined that
there would be no new requirement for information collection associated
with this proposed rule.

F. International Compatibility and Cooperation

    (1) In keeping with U.S. obligations under the Convention on
International Civil Aviation, it is FAA policy to conform to
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. The FAA has
reviewed the corresponding ICAO Standards and Recommended Practices and
has identified no differences with these proposed regulations.
    (2) Executive Order (EO) 13609, Promoting International Regulatory
Cooperation, (77 FR 26413, May 4, 2012) promotes international
regulatory cooperation to meet shared challenges involving health,
safety, labor, security, environmental, and other issues and reduce,
eliminate, or prevent unnecessary differences in regulatory
requirements. The FAA has analyzed this action under the policy and
agency responsibilities of Executive Order 13609, Promoting
International Regulatory Cooperation. The agency has determined that
this action would eliminate differences between U.S. aviation standards
and those of other civil aviation authorities by creating a single set
of certification requirements for transport category airplanes that
would be acceptable in both the United States and Europe.

G. Environmental Analysis

    FAA Order 1050.1E identifies FAA actions that are categorically
excluded from preparation of an environmental assessment or
environmental impact statement under the National Environmental Policy
Act in the absence of extraordinary circumstances. The FAA has
determined this rulemaking action qualifies for the categorical
exclusion identified in paragraph 312f of Order 1050.1E and involves no
extraordinary circumstances.

V. Executive Order Determinations

A. Executive Order 13132, Federalism

    The FAA has analyzed this proposed rule under the principles and
criteria of Executive Order 13132, Federalism. The agency has
determined that this action would not have a substantial direct effect
on the States, or the relationship between the Federal Government and
the States, or on the distribution of power and responsibilities among
the various levels of government, and, therefore, would not have
Federalism implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy
Supply, Distribution, or Use

    The FAA analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (May 18, 2001). The agency has determined that it
would not be a ``significant energy action'' under the executive order
and would not be likely to have a significant adverse effect on the
supply, distribution, or use of energy.

VI. Additional Information

A. Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. The agency
also invites comments relating to the economic, environmental, energy,
or federalism impacts that might result from adopting the proposals in
this document. The most helpful comments reference a specific portion
of the proposal, explain the reason for any recommended

change, and include supporting data. To ensure the docket does not
contain duplicate comments, commenters should send only one copy of
written comments, or if comments are filed electronically, commenters
should submit only one time.
    The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments it receives on or before
the closing date for comments. The FAA will consider comments filed
after the comment period has closed if it is possible to do so without
incurring expense or delay. The agency may change this proposal in
light of the comments it receives.
    Proprietary or Confidential Business Information: Commenters should
not file proprietary or confidential business information in the
docket. Such information must be sent or delivered directly to the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this document, and marked as proprietary or confidential. If submitting
information on a disk or CD ROM, mark the outside of the disk or CD
ROM, and identify electronically within the disk or CD ROM the specific
information that is proprietary or confidential.
    Under 14 CFR 11.35(b), if the FAA is aware of proprietary
information filed with a comment, the agency does not place it in the
docket. It is held in a separate file to which the public does not have
access, and the FAA places a note in the docket that it has received
it. If the FAA receives a request to examine or copy this information,
it treats it as any other request under the Freedom of Information Act
(5 U.S.C. 552). The FAA processes such a request under Department of
Transportation procedures found in 49 CFR part 7.

B. Availability of Rulemaking Documents

    An electronic copy of rulemaking documents may be obtained from the
Internet by--
    1. Searching the Federal eRulemaking Portal at http://www.regulations.gov,
    2. Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies, or
    3. Accessing the Government Printing Office's Web page at http://www.gpo.gov/fdsys/.
    Copies may also be obtained by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
Commenters must identify the docket or notice number of this
rulemaking.
    All documents the FAA considered in developing this proposed rule,
including economic analyses and technical reports, may be accessed from
the Internet through the Federal eRulemaking Portal referenced in item
(1) above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend chapter I of title 14, Code of Federal
Regulations as follows:

PART 25--AIRWORTHINESS STANDARDS: TRANSPORT CATEGORY AIRPLANES

0
1. The authority citation for part 25 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, and 44704.

0
2. Amend Sec.  25.307 by revising paragraph (a) to read as follows:

Sec.  25.307  Proof of structure.

    (a) Compliance with the strength and deformation requirements of
this subpart must be shown for each critical loading condition.
Structural analysis may be used only if the structure conforms to that
for which experience has shown this method to be reliable. In other
cases, substantiating tests must be made to load levels that are
sufficient to verify structural behavior up to loads specified in Sec.
25.305.
* * * * *
0
3. Amend Sec.  25.621 by revising paragraphs (a), (c), and (d) to read
as follows:

Sec.  25.621  Casting factors.

    (a) General. For castings used in structural applications, the
factors, tests, and inspections specified in paragraphs (b) through (d)
of this section must be applied in addition to those necessary to
establish foundry quality control. The inspections must meet approved
specifications. Paragraphs (c) and (d) of this section apply to any
structural castings, except castings that are pressure tested as parts
of hydraulic or other fluid systems and do not support structural
loads.
    (b) * * *
    (c) Critical castings. Each casting whose failure could preclude
continued safe flight and landing of the airplane or could result in
serious injury to occupants is considered a critical casting. Each
critical casting must have a factor associated with it for showing
compliance with strength and deformation requirements, and must comply
with the following criteria associated with that factor:
    (1) A casting factor of 1.0 or greater may be used, provided that--
    (i) It is demonstrated, in the form of process qualification, proof
of product, and process monitoring that, for each casting design and
part number, the castings produced by each foundry and process
combination have coefficients of variation of the material properties
that are equivalent to those of wrought alloy products of similar
composition. Process monitoring must include testing of coupons cut
from the prolongations of each casting (or each set of castings, if
produced from a single pour into a single mold in a runner system) and,
on a sampling basis, coupons cut from critical areas of production
castings. The acceptance criteria for the process monitoring
inspections and tests must be established and included in the process
specifications to ensure the properties of the production castings are
controlled to within levels used in design.
    (ii) Each casting receives:
    (A) Inspection of 100% of its surface, using visual and liquid
penetrant, or equivalent, inspection methods; and
    (B) Inspection of structurally significant internal areas and areas
where defects are likely to occur, using radiographic, or equivalent,
inspection methods.
    (iii) One casting undergoes a static test and is shown to meet the
strength and deformation requirements of Sec.  25.305(a) and (b).
    (2) A casting factor of 1.25 or greater may be used, provided
that--
    (i) Each casting receives:
    (A) Inspection of 100% of its surface, using visual and liquid
penetrant, or equivalent inspection methods; and
    (B) Inspection of structurally significant internal areas and areas
where defects are likely to occur, using radiographic, or equivalent,
inspection methods.
    (ii) Three castings undergo static tests and are shown to meet:
    (A) The strength requirements of Sec.  25.305(b) at an ultimate
load corresponding to a casting factor of 1.25; and
    (B) The deformation requirements of Sec.  25.305(a) at a load of
1.15 times the limit load.
    (3) A casting factor of 1.50 or greater may be used, provided
that--
    (i) Each casting receives:
    (A) Inspection of 100% of its surface, using visual and liquid
penetrant, or equivalent, inspection methods; and

    (B) Inspection of structurally significant internal areas and areas
where defects are likely to occur, using radiographic, or equivalent,
inspection methods.
    (ii) One casting undergoes a static test and is shown to meet:
    (A) The strength requirements of Sec.  25.305(b) at an ultimate
load corresponding to a casting factor of 1.50; and
    (B) The deformation requirements of Sec.  25.305(a) at a load of
1.15 times the limit load.
    (d) Non-critical castings. For each casting other than critical
castings, as specified in paragraph (c) of this section, the following
apply:
    (1) A casting factor of 1.0 or greater may be used, provided that
the requirements of (c)(1) of this section are met, or all of the
following conditions are met:
    (i) Castings are manufactured to approved specifications that
specify the minimum mechanical properties of the material in the
casting and provides for demonstration of these properties by testing
of coupons cut from the castings on a sampling basis.
    (ii) Each casting receives:
    (A) Inspection of 100% of its surface, using visual and liquid
penetrant, or equivalent, inspection methods; and
    (B) Inspection of structurally significant internal areas and areas
where defects are likely to occur, using radiographic, or equivalent,
inspection methods.
    (iii) Three sample castings undergo static tests and are shown to
meet the strength and deformation requirements of Sec.  25.305(a) and
(b).
    (2) A casting factor of 1.25 or greater may be used, provided that
each casting receives:
    (i) Inspection of 100% of its surface, using visual and liquid
penetrant, or equivalent, inspection methods; and
    (ii) Inspection of structurally significant internal areas and
areas where defects are likely to occur, using radiographic, or
equivalent, inspection methods.
    (3) A casting factor of 1.5 or greater may be used, provided that
each casting receives inspection of 100% of its surface using visual
and liquid penetrant, or equivalent, inspection methods.
    (4) A casting factor of 2.0 or greater may be used, provided that
each casting receives inspection of 100% of its surface using visual
inspection methods.
    (5) The number of castings per production batch to be inspected by
non-visual methods in accordance with paragraphs (d)(2) and (d)(3) of
this section may be reduced when an approved quality control procedure
is established.
0
4. Amend Sec.  25.683 by redesignating the introductory text as
paragraph (a), redesignating paragraphs (a), (b), and (c) as paragraphs
(a)(1), (a)(2), and (a)(3) respectively, and adding paragraphs (b) and
(c) to read as follows:

Sec.  25.683  Operation tests.

    (a) It must be shown by operation tests that when portions of the
control system subject to pilot effort loads are loaded to 80% of the
limit load specified for the system and the powered portions of the
control system are loaded to the maximum load expected in normal
operation, the system is free from--
    (1) Jamming;
    (2) Excessive friction; and
    (3) Excessive deflection.
    (b) It must be shown by analysis and, where necessary, by tests
that in the presence of deflections of the airplane structure due to
the separate application of pitch, roll, and yaw limit maneuver loads,
the control system, when loaded to obtain these limit loads and
operated within its operational range of deflections, can be exercised
about all control axes and remain free from--
    (1) Jamming;
    (2) Excessive friction;
    (3) Disconnection, and
    (4) Any form of permanent damage.
    (c) It must be shown that under vibration loads in the normal
flight and ground operating conditions, no hazard can result from
interference or contact with adjacent elements.
0
5. Revise Sec.  25.721 to read as follows:

Sec.  25.721  General.

    (a) The landing gear system must be designed so that when it fails
due to overloads during takeoff and landing, the failure mode is not
likely to cause spillage of enough fuel to constitute a fire hazard.
The overloads must be assumed to act in the upward and aft directions
in combination with side loads acting inboard and outboard. In the
absence of a more rational analysis, the side loads must be assumed to
be up to 20% of the vertical load or 20% of the drag load, whichever is
greater.
    (b) The airplane must be designed to avoid any rupture leading to
the spillage of enough fuel to constitute a fire hazard as a result of
a wheels-up landing on a paved runway, under the following minor crash
landing conditions:
    (1) Impact at 5 feet-per-second vertical velocity, with the
airplane under control, at Maximum Design Landing Weight--
    (i) With the landing gear fully retracted and, as separate
conditions,
    (ii) With any other combination of landing gear legs not extended.
    (2) Sliding on the ground, with--
    (i) The landing gear fully retracted and with up to a 20[deg] yaw
angle and, as separate conditions,
    (ii) Any other combination of landing gear legs not extended and
with 0[deg] yaw angle.
    (c) For configurations where the engine nacelle is likely to come
into contact with the ground, the engine pylon or engine mounting must
be designed so that when it fails due to overloads (assuming the
overloads to act predominantly in the upward direction and separately,
predominantly in the aft direction), the failure mode is not likely to
cause the spillage of enough fuel to constitute a fire hazard.
0
6. Amend Sec.  25.787 by revising paragraph (a) to read as follows:

Sec.  25.787  Stowage compartments.

    (a) Each compartment for the stowage of cargo, baggage, carry-on
articles, and equipment (such as life rafts), and any other stowage
compartment, must be designed for its placarded maximum weight of
contents and for the critical load distribution at the appropriate
maximum load factors corresponding to the specified flight and ground
load conditions, and to the emergency landing conditions of Sec.
25.561(b)(3) where the breaking loose of the contents of such
compartments could--
    (1) Cause direct injury to occupants;
    (2) Penetrate fuel tanks or lines or cause fire or explosion hazard
by damage to adjacent systems; or
    (3) Nullify any of the escape facilities provided for use after an
emergency landing.

If the airplane has a passenger-seating configuration, excluding pilot
seats, of 10 seats or more, each stowage compartment in the passenger
cabin, except for under seat and overhead compartments for passenger
convenience, must be completely enclosed.
* * * * *
0
7. Amend Sec.  25.963 by revising paragraph (d) to read as follows:

Sec.  25.963  Fuel tanks: general.

* * * * *
    (d) Fuel tanks must, so far as it is practicable, be designed,
located, and installed so that no fuel is released in or near the
fuselage, or near the engines, in quantities that would constitute a
fire hazard in otherwise survivable emergency landing conditions, and--
    (1) Fuel tanks must be able to resist rupture and retain fuel under
ultimate hydrostatic design conditions in which

the pressure P within the tank varies in accordance with the formula:

P = K[rho]gL

Where

P = fuel pressure at each point within the tank.
[rho] = typical fuel density.
g = acceleration due to gravity.
L = a reference distance between the point of pressure and the tank
farthest boundary in the direction of loading.
K = 4.5 for the forward loading condition for those parts of fuel
tanks outside the fuselage pressure boundary.
K = 9 for the forward loading condition for those parts of fuel
tanks within the fuselage pressure boundary, or that form part of
the fuselage pressure boundary.
K = 1.5 for the aft loading condition.
K = 3.0 for the inboard and outboard loading conditions for those
parts of fuel tanks within the fuselage pressure boundary, or that
form part of the fuselage pressure boundary.
K = 1.5 for the inboard and outboard loading conditions for those
parts of fuel tanks outside the fuselage pressure boundary.
K = 6 for the downward loading condition.
K = 3 for the upward loading condition.

    (2) For those parts of wing fuel tanks near the fuselage or near
the engines, the greater of the fuel pressures resulting from
paragraphs (d)(2)(i) and (d)(2)(ii) of this section must be used:
    (i) The fuel pressures resulting from paragraph (d)(1) of this
section, and
    (ii) The lesser of the two following conditions:
    (A) Fuel pressures resulting from the accelerations as specified in
Sec.  25.561(b)(3) considering the fuel tank full of fuel at maximum
fuel density. Fuel pressures based on the 9.0g forward acceleration may
be calculated using the fuel static head equal to the streamwise local
chord of the tank. For inboard and outboard conditions, an acceleration
of 1.5g may be used in lieu of 3.0g as specified in Sec.  25.561(b)(3),
and
    (B) Fuel pressures resulting from the accelerations as specified in
Sec.  25.561(b)(3) considering a fuel volume beyond 85% of the maximum
permissible volume in each tank using the static head associated with
the 85% fuel level. A typical density of the appropriate fuel may be
used. For inboard and outboard conditions, an acceleration of 1.5g may
be used in lieu of 3.0g as specified in Sec.  25.561(b)(3).
    (3) Fuel tank internal barriers and baffles may be considered as
solid boundaries if shown to be effective in limiting fuel flow.
    (4) For each fuel tank and surrounding airframe structure, the
effects of crushing and scraping actions with the ground should not
cause the spillage of enough fuel, or generate temperatures that would
constitute a fire hazard under the conditions specified in Sec.
25.721(b).
    (5) Fuel tank installations must be such that the tanks will not
rupture as a result of an engine pylon or engine mount or landing gear,
tearing away as specified in Sec.  25.721(a) and (c).
* * * * *
0
8. Revise Sec.  25.994 to read as follows:

Sec.  25.994  Fuel system components.

    Fuel system components in an engine nacelle or in the fuselage must
be protected from damage that could result in spillage of enough fuel
to constitute a fire hazard as a result of a wheels-up landing on a
paved runway under each of the conditions prescribed in Sec.
25.721(b).

    Issued in Washington, DC, on February 14, 2013.
Dorenda D. Baker,
Director, Aircraft Certification Service.
[FR Doc. 2013-04812 Filed 2-28-13; 8:45 am]
BILLING CODE 4910-13-P


LYONDELL Gail B. Kelly Manager, Solvents Development 3801 West Chester Pike Newtown Square, PA 19073 Telephone: 61 0 3596443 Fax: 610 359 3155 E mail: gail. kelly@ lyondell. com August 27,2001 Terry J. Keating, Ph. D. AAAS Environmental Science Fellow EPA Office of Air and Radiation Ariel Rios North 5442 ( MC6 103A) 1200 Pennsylvania Ave, N W Washington DC 20460 Dear Dr. Keating:

In response to your request, Lyondell is providing a copy ( attached) of our submittal to the California Air Resources Board, summarizing the toxicological data for tertiary butyl acetate ( TBAc). As explained in that submittal, we believe the existing data indicate that TBAc is of a low order of toxicity and would not present significant health or environmental concerns from its use as a solvent. On the other hand, use of TBAc could provide a health benefit to the extent it replaces use of solvents that are Clean Air Act hazardous air pollutants or that have hijjher photochemical reactivity and so contribute to ozone formation.

We hope this information is helpful to you. Please feel free to call, write, or email me with any questions.

Sincerely,

W Gail B. Kelly Attachment Lyondell Chemical Company


[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Page 57279]
[FR Doc No: 2017-26015]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6475]

Food and Drug Administration Fiscal Year 2017 Performance Review
Board Members

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the names
of the members who will serve on its Performance Review Board (PRB).
The purpose of the PRB is to provide fair and impartial review of
senior executive service (SES), senior professional and Title 42(f) SES
Equivalents performance appraisals, bonus recommendations, and pay
adjustments.

DATES: Effective October 30, 2017.

FOR FURTHER INFORMATION CONTACT: Abu Sesay, Office of Human Resources
Executive and Resources Management Staff, Food and Drug Administration,
Three White Flint North, 05C68, 11601 Landsdown St., North Bethesda, MD
20852,<PHONE_NUMBER> (not a toll free number).

SUPPLEMENTARY INFORMATION: This action is being taken pursuant to 5
U.S.C. 4314(c)(4), which requires that members of performance review
boards be appointed in a manner to ensure consistency, stability, and
objectivity in performance appraisals and requires that notice of the
appointment of an individual to serve as a member be published in the
Federal Register.
    The following persons will serve on the FDA Performance Review
Board, which oversees the evaluation of performance appraisals of FDA's
senior executives:

James Sigg, PRB Chair
Tania Tse, PRB Officiator
Glenda Barfell
Janelle Barth
Vincent Bunning
Mary Beth Clarke
Tracey Forfa
Leslie Kux
Diane Maloney
Edward Margerrison
Lynne Rice
William Tootle

    Dated: November 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26015 Filed 12-1-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Pages 78985-78986]
[FR Doc No: 2010-31711]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13841-000]

County of DuPage; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

December 10, 2010.
    On September 21, 2010, the County of DuPage, Illinois, filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Elmhurst Quarry Pumped Storage Project (Elmhurst Quarry Project or
project) to be located on Salt Creek, near Elmhurst City, DuPage
County, Illinois. The sole purpose of a preliminary permit, if issued,
is to grant the permit holder priority to file a license application
during the permit term. A preliminary permit does not authorize the
permit holder to perform any land-disturbing activities or otherwise
enter upon lands or waters owned by others without the owners' express
permission.
    The proposed project would consist of the following: (1) A surface
quarry (upper reservoir) having a total storage capacity of 8,145 acre-
feet at a normal maximum operating elevation of 667 feet mean sea level
(msl) and a usable capacity of 7,465 acre-feet; (2) an upper inlet/
outlet structure equipped with trash racks and one or two slide gates
for isolating and dewatering the penstock; (3) an 870-foot-long, 28-
foot-diameter penstock consisting of both shaft and tunnel segments and
extending between the upper inlet/outlet and the pump/turbines below;
(4) an underground mine (lower reservoir) 250 feet below the bottom of
the upper reservoir having a total/usable storage capacity of 7,465
acre-feet at normal maximum operation elevation of 210 feet msl; (5) a
powerhouse with approximate dimensions of 185 feet long by 80 feet wide
by 120 feet high and containing two vertical Francis reversible pump/
turbine-motor/generator units rated for 125 megawatts each at 415 feet
of net head; (6) a 120-foot-long, 28-foot-diameter tailrace tunnel
connecting the pump/turbine draft tubes with the lower inlet/outlet;
(7) a lower inlet/outlet structure equipped with one or two slide gates
for isolating and dewatering the tailrace tunnel; (8) a substation
containing step-up transformers, circuit breakers, and disconnect
switches; (9) an underground 2-mile-long, 138-kilovolt (kV)
transmission line extending from the project substation to an overhead
138-kV transmission line owned by Commonwealth Edison (the point of
interconnection); (10) a switchyard constructed at the point of
interconnection; and (11) appurtenant facilities. The estimated annual
generation of the Elmhurst Quarry Project would be 708.5 gigawatt-
hours.
    Applicant Contact: Mr. Anthony Charlton, Director, Department of
Environmental Concerns, DuPage County Center, 421 N. County Farm Road,
Wheaton, Illinois 60187; phone:<PHONE_NUMBER>.

    FERC Contact: Sergiu Serban; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13841-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-31711 Filed 12-16-10; 8:45 am]
BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days from its current 75-day period to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks countless questions I might want to respond to. I would like to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful, relevant comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but as this will be my only chance to voice my opinions, I would like to be as thorough as possible. I do not think it is at all unreasonable to allow myself and other interested parties a mere six months to comment on the Proposed Rule.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they have saved my life and the lives of several of my family members and friends, not to mention thousands of others and potentially millions of future ex-smokers. I wish to provide you with my own personal story as well as science- and evidence-based responses to fully and accurately address your questions and concerns. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

Most sincerely,

Aaron Miller


[Federal Register Volume 76, Number 106 (Thursday, June 2, 2011)]
[Proposed Rules]
[Pages 31895-31898]
[FR Doc No: 2011-13688]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0125]
RIN 1625-AA11

Regulated Navigation Area; Magothy River, Sillery Bay, MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary regulated
navigation area (RNA) in certain waters of the Magothy River, in
Sillery Bay, Maryland, on July 23, 2011. This RNA is necessary to
provide for the safety of life, property and the environment. This RNA
restricts the movement of vessels throughout the regulated area during
The Bumper Bash 2011 event.

DATES: Comments and related material must be received by the Coast
Guard on or before July 5, 2011. Requests for public meetings must be
received by the Coast Guard on or before the end of the comment period.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0125 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or e-mail Mr. Ronald Houck, Sector Baltimore Waterways
Management Division, Coast Guard; telephone<PHONE_NUMBER>, e-mail
<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:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2011-0125), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2011-0125'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit comments by mail and
would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period and may change
the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the

``read comments'' box, which will then become highlighted in blue. In
the ``Keyword'' box insert ``USCG-2011-0125'' and click ``Search.''
Click the ``Open Docket Folder'' in the ``Actions'' column. You may
also visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. We have an agreement
with the Department of Transportation to use the Docket Management
Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before the end of the comment period using one of
the four methods specified under ADDRESSES. Please explain why you
believe a public meeting would be beneficial. If we determine that one
would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

Basis and Purpose

    On July 23, 2011, hundreds of recreational boaters are expected to
gather in Sillery Bay at Dobbins Island, Maryland for an event called
``The Bumper Bash 2011.'' The activity began in 2007. Due to the
growing presence of boaters in recent years, the annual event has
become increasingly congested. An estimated 700 recreational boats were
anchored or moored alongside other boats (rafted). The gathering of
persons on recreational vessels or other water craft create large lines
of rafted boats filling in the beachfront area of Dobbins Island. The
persons and vessels exceeded a safe limit. Accidental drownings,
personnel injuries, boat fires, boat capsizings and sinkings, and
boating collisions are safety concerns during such overcrowded events.
Access on the water for emergency response to the beach area is
critical. The Coast Guard has the authority to impose appropriate
controls on activities that may pose a threat to persons, vessels and
facilities under its jurisdiction. The Coast Guard proposes to
establish a temporary RNA that will be enforced during a gathering of
persons on recreational vessels and other water craft held in the
Magothy River, in Sillery Bay, Maryland. The proposed rule is needed to
control movement within a waterway that is expected to be populated by
persons and vessels seeking to attend The Bumper Bash 2011 event.

Discussion of Proposed Rule

    The Coast Guard anticipates a large recreational boating fleet in
the Magothy River, in Sillery Bay, during The Bumper Bash at Dobbins
Island, Maryland on July 23, 2011. Due to the need for vessel control
during the activity, vessel traffic will be restricted to provide for
the safety of persons and vessels within the regulated area.
    The purpose of this rule is to promote maritime safety, and to
protect the environment and mariners transiting the area from the
potential hazards associated with a large gathering of recreational
vessels and other watercraft along a confined beachfront area with
swimmers and others present. This rule proposes to establish a
temporary RNA in the Magothy River, in Sillery Bay, within lines
connecting the following positions: from position latitude
39[deg]04[min]48[sec] N, longitude 076[deg]27[min]35[sec] W; thence to
position latitude 39[deg]04[min]48[sec] N, longitude
076[deg]27[min]19[sec] W; thence to position latitude
39[deg]04[min]59[sec] N, longitude 076[deg]27[min]45[sec] W; thence to
position latitude 39[deg]04[min]59[sec] N, longitude
076[deg]28[min]01[sec] W; thence to position latitude
39[deg]04[min]41[sec] N, longitude 076[deg]27[min]51[sec] W. All
coordinates reference Datum NAD 1983. The rule will impact the movement
of all persons and vessels in the regulated area, and will limit the
density of vessels and other watercraft operating, remaining or
anchoring within the regulated area at the discretion of the District
Commander, to ensure an open water route remains accessible to law
enforcement and emergency personnel during the effective period. Public
vessels located within the regulated area will not contribute to the
density determination.

Regulatory Analyses

    We developed this proposed 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.

Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order. The effect of this
regulation will not be significant due to the limited size and duration
that the regulated area will be in effect and vessels transiting the
Magothy River may proceed safely around the RNA. In addition,
notifications will be made to the maritime community via marine
information broadcasts so mariners may adjust their plans accordingly.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities. This proposed rule may affect the following
entities, some of which might be small entities: The owners or
operators of vessels intending to operate, remain or anchor within the
RNA, from 8 a.m. until 10 p.m. on July 23, 2011. This temporary RNA
will not have a significant economic impact on a substantial number of
small entities for the following reasons. Traffic would be allowed to
pass within the RNA with the permission of the District Commander.
Vessels transiting the Magothy River may proceed safely around the RNA.
Also, the Coast Guard will issue maritime advisories widely available
to users of the waterway before the effective period.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

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 proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. 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 Coast Guard Sector Baltimore, Waterways Management Division, at
telephone number<PHONE_NUMBER>. The Coast Guard will not retaliate
against small entities that question or complain about this proposed
rule or any policy or action of the Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

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 proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

Taking of Private Property

    This proposed rule would 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.

Civil Justice Reform

    This proposed 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.

Protection of Children

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

Indian Tribal Governments

    This proposed rule does not have Tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed 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 made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. A preliminary
environmental analysis checklist supporting this determination is
available in the docket where indicated under ADDRESSES. This proposed
rule involves establishing a temporary regulated navigation area. We
seek any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 165

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

Words of Issuance and Proposed Regulatory Text

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

    2. Add temporary Sec.  165.T05-0125 to read as follows:

Sec.  165.T05-0125  Regulated Navigation Area; Magothy River, Sillery
Bay, MD.

    (a) Regulated area. The following area is a regulated navigation
area: All waters of the Magothy River, in Sillery Bay, within lines
connecting the following positions: from position latitude
39[deg]04'48'' N, longitude 076[deg]27'35'' W; thence to position
latitude 39[deg]04'48'' N, longitude 076[deg]27'19'' W; thence to
position latitude 39[deg]04'59'' N, longitude 076[deg]27'45'' W; thence
to position latitude 39[deg]04'59'' N, longitude 076[deg]28'01'' W;
thence to position latitude 39[deg]04'41'' N, longitude 076[deg]27'51''
W. All coordinates reference Datum NAD 1983.
    (b) Definition. The District Commander means the Commander, Fifth
Coast Guard District or any Coast Guard commissioned, warrant, or petty
officer who has been authorized by the Commander, Fifth Coast Guard
District to act on his or her behalf, or his or her designated
representative.
    (c) Regulations. The general regulated navigation area regulations
found in 33

CFR 165.13 apply to the regulated navigation area created by this
temporary section, Sec.  165.T05-0125.
    (1) All vessels and persons are prohibited from entering and
accessing this regulated navigation area, except as authorized by the
District Commander or his or her designated representative.
    (2) Persons or vessels requiring entry into or passage within the
regulated navigation area must request authorization from the District
Commander or his or her designated representative, by telephone at
(410) 576-2693 or by marine band radio on VHF-FM Channel 16 (156.8
MHz), from 8 a.m. until 10 p.m. on July 23, 2011. All Coast Guard
vessels enforcing this regulated navigation area can be contacted on
marine band radio VHF-FM Channel 16 (156.8 MHz).
    (3) All vessels and persons must comply with instructions of the
District Commander or the designated representative.
    (4) The operator of any vessel entering or located within this
regulated navigation area shall:
    (i) Travel at no-wake speed,
    (ii) Stop the vessel immediately upon being directed to do so by
any commissioned, warrant or petty officer on board a vessel displaying
a Coast Guard Ensign, and
    (iii) Proceed as directed by any commissioned, warrant or petty
officer on board a vessel displaying a Coast Guard Ensign.
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the regulated navigation area by any Federal, State,
and local agencies.
    (e) Enforcement period. This section will be enforced from 8 a.m.
until 10 p.m. on July 23, 2011.

    Dated: May 23, 2011.
William D. Lee,
Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District.
[FR Doc. 2011-13688 Filed 6-1-11; 8:45 am]
BILLING CODE 9110-04-P