[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Rules and Regulations]
[Pages 6945-6949]
[FR Doc No: 2012-3077]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2012-0154; Special Conditions No. 25-457-SC]

Special Conditions: Learjet Inc., Learjet Model LJ-200-1A10;
Interaction of Systems and Structures

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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SUMMARY: These special conditions are issued for the Learjet Model LJ-
200-1A10 airplane. This airplane will have novel or unusual design
features associated with systems that, directly or as a result of
failure or malfunction, affect structural performance. The applicable
airworthiness regulations do not contain adequate or appropriate safety
standards for these design features. These special conditions contain
the additional safety standards that the Administrator considers
necessary to establish a level of safety equivalent to that established
by the existing airworthiness standards.

DATES: The effective date of these special conditions is February 3,
2012. We must receive your comments by March 26, 2012.

ADDRESSES: Send comments identified by docket number FAA-2012-0154
using any of the following methods:
     Federal eRegulations 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 8 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 docket, 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: Todd Martin, FAA, Airframe and Cabin
Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The FAA has determined that notice of, and
opportunity for public comments on, these special conditions are
unnecessary. The substance of these special conditions has been subject
to the public comment process in several prior instances with no
substantive comments received. The FAA therefore finds that good cause
exists for making these special conditions effective upon issuance.

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We may change these special conditions based on the comments
we receive.

Background

    On February 9, 2009, Learjet Inc. applied for a type certificate
for their new Model LJ-200-1A10 (hereafter referred to as ``Model LJ-
200'') airplane. The Model LJ-200 is a business class aircraft powered
by 2 high bypass turbine engines with an estimated maximum takeoff
weight of 36,000 pounds and an interior configuration for up to 10
passengers.
    The airplane is equipped with systems that, directly or as a result
of failure or malfunction, affect its structural performance. Current
regulations do not take into account loads for the aircraft due to the
effects of system failures on structural performance. These special
conditions define criteria to be used in the assessment of the effects
of these systems on structures. The general approach of accounting for
the effect of system failures on structural performance would be
extended to include any system whose partial or complete failure, alone
or in combination with other system failures, would affect structural
performance.

Type Certification Basis

    Under the provisions of Title 14, Code of Federal Regulations (14
CFR) 21.17, Learjet Inc. must show that the Model LJ-200 meets the
applicable provisions of part 25, as amended by Amendments 25-1 through
25-127 thereto.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the Model LJ-200 because of a novel or
unusual design feature, special conditions are prescribed under the
provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, these special conditions would also
apply to the other model.
    In addition to the applicable airworthiness regulations and special
conditions, the Model LJ-200 must comply with the fuel vent and exhaust
emission requirements of 14 CFR part 34 and the noise certification
requirements of 14 CFR part 36; and the FAA must issue a finding of
regulatory adequacy pursuant to Sec.  611 of Public Law 92-574, the
``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Model LJ-200 will incorporate the following novel or unusual
design

features: systems that affect the airplane's structural performance,
either directly or as a result of failure or malfunction. That is, the
airplane's systems affect how it responds in maneuver and gust
conditions, and thereby affect its structural capability. These systems
may also affect the aeroelastic stability of the airplane. Such systems
include flight control systems, autopilots, stability augmentation
systems, load alleviation systems, and fuel management systems. Such
systems represent novel and unusual features when compared to the
technology envisioned in the current airworthiness standards.

Discussion

    Special conditions are needed to require consideration of the
effects of systems on the structural capability and aeroelastic
stability of the airplane, both in the normal and in the failed state,
because these effects are not covered by current regulations.
    These special conditions require that the airplane meet the
structural requirements of subparts C and D of 14 CFR part 25 when the
airplane systems are fully operative. The special conditions also
require that the airplane meet these requirements considering failure
conditions. In some cases, reduced margins are allowed for failure
conditions based on system reliability.
    These special conditions establish a level of safety that neither
raises nor lowers the standard set forth in the applicable regulations.

Applicability

    As discussed above, these special conditions are applicable to the
Learjet Model LJ-200-1A10. Should Learjet Inc. apply at a later date
for a change to the type certificate to include another model
incorporating the same novel or unusual design features, the special
conditions would apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on one model of airplanes. It is not a rule of general applicability.
    The substance of these special conditions has been subjected to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, the FAA has determined
that prior public notice and comment are unnecessary and impracticable,
and good cause exists for adopting these special conditions upon
issuance. The FAA is requesting comments to allow interested persons to
submit views that may not have been submitted in response to the prior
opportunities for comment described above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

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

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Learjet Model LJ-200-1A10 airplanes.

1. General

    For airplanes equipped with systems that affect structural
performance, either directly or as a result of a failure or
malfunction, the influence of these systems and their failure
conditions on structural performance must be taken into account when
showing compliance with the requirements of 14 CFR part 25, subparts C
and D. The following criteria must be used for showing compliance with
these special conditions for airplanes equipped with flight control
systems, autopilots, stability augmentation systems, load alleviation
systems, fuel management systems, and other systems that either
directly or as a result of failure or malfunction affect structural
performance.
    (a) The criteria defined herein only address the direct structural
consequences of the system responses and performances. They cannot be
considered in isolation but should be included in the overall safety
evaluation of the airplane. These criteria may in some instances
duplicate standards already established for this evaluation. These
criteria are only applicable to structures whose failure could prevent
continued safe flight and landing. Specific criteria that define
acceptable limits on handling characteristics or stability requirements
when operating in the system degraded or inoperative mode are not
provided in these special conditions.
    (b) Depending upon the specific characteristics of the airplane,
additional studies may be required that go beyond the criteria provided
in these special conditions in order to demonstrate the capability of
the airplane to meet other realistic conditions such as alternative
gust or maneuver descriptions for an airplane equipped with a load
alleviation system.
    (c) The following definitions are applicable to these special
conditions.
    Structural performance: Capability of the airplane to meet the
structural requirements of part 25.
    Flight limitations: Limitations that can be applied to the airplane
flight conditions following an in-flight occurrence and that are
included in the flight manual (e.g., speed limitations, avoidance of
severe weather conditions, etc.).
    Operational limitations: Limitations, including flight limitations,
that can be applied to the airplane operating conditions before
dispatch (e.g., fuel, payload and Master Minimum Equipment List
limitations).
    Probabilistic terms: The probabilistic terms (probable, improbable,
extremely improbable) used in these special conditions are the same as
those used in Sec.  25.1309.
    Failure condition: The term failure condition is the same as that
used in Sec.  25.1309; however, these special conditions apply only to
system failure conditions that affect the structural performance of the
airplane (e.g., system failure conditions that induce loads, change the
response of the airplane to inputs such as gusts or pilot actions, or
lower flutter margins).

2. Effects of Systems on Structures

    The following criteria will be used in determining the influence of
a system and its failure conditions on the airplane structure.
    (a) System fully operative. With the system fully operative, the
following apply:
    (1) Limit loads must be derived in all normal operating
configurations of the system from all the limit conditions specified in
subpart C (or defined by special condition or equivalent level of
safety in lieu of those specified in Subpart C), taking into account
any special behavior of such a system or associated functions or any
effect on the structural performance of the airplane that may occur up
to the limit loads. In particular, any significant nonlinearity (rate
of displacement of control surface, thresholds, or any other system
nonlinearities) must be accounted for in a realistic or conservative
way when deriving limit loads from limit conditions.
    (2) The airplane must meet the strength requirements of part 25
(static strength, residual strength), using the specified factors to
derive ultimate loads from the limit loads defined above. The effect of
nonlinearities must be

investigated beyond limit conditions to ensure the behavior of the
system presents no anomaly compared to the behavior below limit
conditions. However, conditions beyond limit conditions need not be
considered when it can be shown that the airplane has design features
that will not allow it to exceed those limit conditions.
    (3) The airplane must meet the aeroelastic stability requirements
of Sec.  25.629.
    (b) System in the failure condition. For any system failure
condition not shown to be extremely improbable, the following apply:
    (1) At the time of occurrence, starting from 1-g level flight
conditions, a realistic scenario including pilot corrective actions
must be established to determine the loads occurring at the time of
failure and immediately after failure.
    (i) For static strength substantiation, these loads, multiplied by
an appropriate factor of safety that is related to the probability of
occurrence of the failure, are ultimate loads to be considered for
design. The factor of safety is defined in Figure 1.
[GRAPHIC] [TIFF OMITTED] TR10FE12.000

    (ii) For residual strength substantiation, the airplane must be
able to withstand two thirds of the ultimate loads defined in
subparagraph 2(b)(1)(i) of these special conditions. For pressurized
cabins, these loads must be combined with the normal operating
differential pressure.
    (iii) Freedom from aeroelastic instability must be shown up to the
speeds defined in Sec.  25.629(b)(2). For failure conditions that
result in speeds beyond VC/MC, freedom from
aeroelastic instability must be shown to increased speeds, so that the
margins intended by Sec.  25.629(b)(2) are maintained.
    (iv) Failures of the system that result in forced structural
vibrations (oscillatory failures) must not produce loads that could
result in detrimental deformation of primary structure.
    (2) For the continuation of the flight. For the airplane, in the
system failed state and considering any appropriate reconfiguration and
flight limitations, the following apply:
    (i) The loads derived from the following conditions (or defined by
special condition or equivalent level of safety in lieu of the
following conditions) at speeds up to VC/MC, or
the speed limitation prescribed for the remainder of the flight, must
be determined:
    (A) The limit symmetrical maneuvering conditions specified in Sec.
25.331 and in Sec.  25.345.
    (B) The limit gust and turbulence conditions specified in Sec.
25.341 and in Sec.  25.345.
    (C) The limit rolling conditions specified in Sec.  25.349 and the
limit unsymmetrical conditions specified in Sec.  25.367 and Sec.
25.427(b) and (c).
    (D) The limit yaw maneuvering conditions specified in Sec.  25.351.
    (E) The limit ground loading conditions specified in Sec. Sec.
25.473, 25.491, 25.493(d) and 25.503.
    (ii) For static strength substantiation, each part of the structure
must be able to withstand the loads in paragraph 2(b)(2)(i) of these
special conditions multiplied by a factor of safety depending on the
probability of being in this failure state. The factor of safety is
defined in Figure 2.

[GRAPHIC] [TIFF OMITTED] TR10FE12.001

Qj = (Tj)(Pj)

Where:

Tj = Average time spent in failure condition j (in hours)
Pj = Probability of occurrence of failure mode j (per
hour)

    Note: If Pj is greater than 10-3 per
flight hour, then a 1.5 factor of safety must be applied to all
limit load conditions specified in Subpart C.

    (iii) For residual strength substantiation, the airplane must be
able to withstand two thirds of the ultimate loads defined in paragraph
2(b)(2)(ii) of these special conditions. For pressurized cabins, these
loads must be combined with the normal operating differential pressure.
    (iv) If the loads induced by the failure condition have a
significant effect on fatigue or damage tolerance, then their effects
must be taken into account.
    (v) Freedom from aeroelastic instability must be shown up to a
speed determined from Figure 3. Flutter clearance speeds V' and V'' may
be based on the speed limitation specified for the remainder of the
flight using the margins defined by Sec.  25.629(b).
[GRAPHIC] [TIFF OMITTED] TR10FE12.002

V1' = Clearance speed as defined by Sec.  25.629(b)(2).
V'' = Clearance speed as defined by Sec.  25.629(b)(1).
Qj = (Tj)(Pj)

Where:

Tj = Average time spent in failure condition j (in hours)
Pj = Probability of occurrence of failure mode j (per
hour)

    Note:  If Pj is greater than 10-\3\ per
flight hour, then the flutter clearance speed must not be less than
V''.

    (vi) Freedom from aeroelastic instability must also be shown up to
V' in Figure 3 above for any probable system failure condition combined
with any damage required or selected for investigation by Sec.
25.571(b).' ''
    (3) Consideration of certain failure conditions may be required by
other sections of part 25 regardless of calculated system reliability.
Where analysis shows the probability of these failure conditions to be
less than 10-\9\, criteria other than those specified in
this paragraph may be used for structural substantiation to show
continued safe flight and landing.
    (c) Failure indications. For system failure detection and
indication, the following apply:
    (1) The system must be checked for failure conditions, not
extremely improbable, that degrade the structural capability below the
level required by part 25 or significantly reduce the reliability of
the remaining system. As far as reasonably practicable, the flight crew
must be made aware of these failures before flight. Certain elements

of the control system, such as mechanical and hydraulic components, may
use special periodic inspections, and electronic components may use
daily checks, in lieu of detection and indication systems to achieve
the objective of this requirement. These certification maintenance
requirements must be limited to components that are not readily
detectable by normal detection and indication systems and where service
history shows that inspections will provide an adequate level of
safety.
    (2) The existence of any failure condition, not extremely
improbable, during flight that could significantly affect the
structural capability of the airplane and for which the associated
reduction in airworthiness can be minimized by suitable flight
limitations, must be signaled to the flight crew. For example, failure
conditions that result in a factor of safety between the airplane
strength and the loads of Subpart C below 1.25, or flutter margins
below V'', must be signaled to the crew during flight.
    (d) Dispatch with known failure conditions. If the airplane is to
be dispatched in a known system failure condition that affects
structural performance, or affects the reliability of the remaining
system to maintain structural performance, then the provisions of these
special conditions must be met, including the provisions of paragraph
2(a) for the dispatched condition, and paragraph 2(b) for subsequent
failures. Expected operational limitations may be taken into account in
establishing Pj as the probability of failure occurrence for
determining the safety margin in Figure 1. Flight limitations and
expected operational limitations may be taken into account in
establishing Qj as the combined probability of being in the
dispatched failure condition and the subsequent failure condition for
the safety margins in Figures 2 and 3. These limitations must be such
that the probability of being in this combined failure state and then
subsequently encountering limit load conditions is extremely
improbable. No reduction in these safety margins is allowed if the
subsequent system failure rate is greater than 10-\3\ per
hour.
    For each system for which these special conditions are applied, the
following must be identified for showing compliance:
    (a) The system that either directly or as a result of failure or
malfunction affects structural performance;
    (b) The failure condition of the system and the probability of that
failure;
    (c) The structure whose performance is affected directly or as a
result of failure or malfunction of the system; and,
    (d) The loading condition(s) on the structure affected by the
system.

    Issued in Renton, Washington, on February 3, 2012.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-3077 Filed 2-9-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 30, 2008 (Volume 73, Number 147)]
[Notices]
[Page 44247]
[DOCID:fr30jy08-67]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR08-13-002]

Houston Pipe Line Company, L.P.; Notice of Compliance Filing

July 23, 2008.
    Take notice that on July 10, 2008, Houston Pipe Line Company, L.P.
filed a Statement of Operating Conditions pursuant to section
284.123(e) of the Commission's regulations and to comply with the
Commission's letter order issued on June 18, 2008, in Docket Nos. PR08-
13-000 and PR08-13-001.
    Any person desiring to participate in this proceeding must file a
motion to intervene or to protest this filing must file in accordance
with Rules 211 and 214 of the Commission's Rules of Practice and
Procedure (18 CFR 385.211 and 385.214). Protests will be considered by
the Commission in determining the appropriate action to be taken, but
will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on August 5, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-17402 Filed 7-29-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 169 (Wednesday, August 31, 2011)]
[Proposed Rules]
[Pages 54152-54153]
[FR Doc No: 2011-22228]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0865; Airspace Docket No. 11-AAL-14]

Proposed Amendment of Class E Airspace Galbraith Lake, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Galbraith
Lake AK. The creation of two special instrument approach procedures at
the Galbraith Lake Airport has made this action necessary to enhance
safety and management of Instrument Flight Rules (IFR) operations.

DATES: Comments must be received on or before October 17, 2011.

ADDRESSES: Send comments on the proposal to the Docket Management
Facility, U.S. Department of Transportation, 1200 New Jersey Avenue,
SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-
0001. You must identify the docket number FAA-2011-0865/Airspace Docket
No. 11-AAL-14 at the beginning of your comments. You may also submit
comments on the Internet at http://www.regulations.gov. You may review
the public docket containing the proposal, any comments received, and
any final disposition in person in the Dockets Office between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527) is on the plaza level of the
Department of Transportation NASSIF Building at the above address.
    An informal docket may also be examined during normal business
hours at the office of the Manager, Safety, Alaska Flight Service
Operations, Federal Aviation Administration, 222 West 7th Avenue, Box
14, Anchorage, AK 99513-7587.

FOR FURTHER INFORMATION CONTACT: Martha Dunn, Federal Aviation
Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587;
telephone number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>Internet address: http://www.faa.gov/about/office_org/headquarters_offices/ato/service_units/systemops/fs/alaskan/rulemaking/.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2011-0865/
Airspace Docket No. 11-AAL-14.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this notice may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    Additionally, any person may obtain a copy of this notice by
submitting a request to the Federal Aviation Administration, Office of
Air Traffic Airspace Management, ATA-400, 800 Independence Avenue, SW.,
Washington, DC 20591 or by calling<PHONE_NUMBER>. Communications must
identify both docket numbers for this notice. Persons interested in
being placed on a mailing list for future NPRMs should contact the
FAA's Office of Rulemaking,<PHONE_NUMBER>, to request a copy of
Advisory Circular No. 11-2A, Notice of Proposed Rulemaking

Distribution System, which describes the application procedure.

The Proposal

    This action proposes to amend Title 14 Code of Federal Regulations
(14 CFR) part 71 by revising Class E5 airspace at the Galbraith Lake
Airport in Galbraith Lake, AK, to accommodate the creation of two
special instrument approach procedures at the Galbraith Lake Airport.
These special instrument approach procedures were created in 2009, and
the need for Class E transition area airspace upward from 1200 feet
above the surface was only recently identified. This amended Class E
airspace would provide adequate controlled airspace upward from the 700
feet and 1,200 feet above the surface, for the safety and management of
IFR operations at the Galbraith Lake Airport.
    Class E5 airspace areas designated as 700 and 1200 foot transition
areas are published in paragraph 6005 in FAA Order 7400.9U, Airspace
Designations and Reporting Points, signed August 18, 2010, and
effective September 15, 2010, which is incorporated by reference in 14
CFR 71.1. The airspaces listed in this document would be subsequently
published in that Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Because this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle 1, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart 1, Section 40103, Sovereignty and use of
airspace. Under that section, the FAA is charged with prescribing
regulations to ensure the safe and efficient use of the navigable
airspace. This regulation is within the scope of that authority because
it proposes to revise Class E airspace at the Galbraith Lake Airport,
Galbraith Lake, AK, and represents the FAA's continuing effort to
safely and efficiently use the navigable airspace.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

    1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, signed August 18, 2010, and effective September 15,
2010, is to be amended as follows:

* * * * *

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

AAL AK E5 Galbraith Lake, AK [Revised]

Galbraith Lake Airport, AK
    (Lat. 68[deg]28'47'' N., long. 149[deg]29'24'' W)

    That airspace extending upward from 700 feet above the surface
within a 9.5-mile radius of the Galbraith Lake Airport, AK and that
airspace extending upward from 1,200 feet above the surface within a
62-mile radius of the Galbraith Lake Airport, AK.

    Issued in Anchorage, AK, on August 19, 2011.
Marshall G. Severson,
Acting Manager, Alaska Flight Services.
[FR Doc. 2011-22228 Filed 8-30-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 128 (Thursday, July 2, 2020)]
[Notices]
[Pages 39964-39966]
[FR Doc No: 2020-14231]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89164; File No. SR-Phlx-2020-31]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Modify the
Implementation Date of the Proposed Rule Change To Amend Exchange Rules
3301A and 3301B

June 26, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 17, 2020, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I and II below, which Items have been
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify the operative date of SR-Phlx-2020-
15, which proposed to amend Exchange Rules 3301A and 3301B.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the

places specified in Item IV below. The Exchange has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On March 26, 2020, the Exchange filed with the Commission a rule
change to amend Exchange Rule 3301A and Rule 3301B to modify the
behavior of Order Types and Order Attributes in certain situations.\3\
The proposed rule change indicated that the implementation date of the
modifications would be on or before the end of the Second Quarter of
2020.\4\ The Exchange proposes to modify the operative date and delay
the implementation of the modifications until on or before the end of
the Third Quarter of 2020. The Exchange will announce the new
implementation date by an Equity Trader Alert, which shall be issued
prior to the implementation date.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 88583 (April 7,
2020), 85 FR 20533 (April 13, 2020) (SR-Phlx-2020-15).
    \4\ See id. at 20540.
---------------------------------------------------------------------------

    Due to the recent market volatility resulting from the novel
coronavirus pandemic, the Exchange has been adjusting its systems
testing schedule and assessing any risks to the operation of its
systems that could potentially be introduced by implementing new
functionalities during this time. The extension would therefore provide
the Exchange with flexibility and additional time to adjust its systems
testing schedule, and to develop and test the new functionalities, to
safeguard against any such risk. Furthermore, the extension would allow
the Exchange to implement the Order Type and Order Attribute
modifications after the Russell Rebalance, a significant market event
occurring in June 2020, and for which the Exchange will reduce the
number of changes to its systems. The Exchange has historically limited
rolling out new functionality before the Russell Rebalance to mitigate
the operational risk of introducing technology changes before this
significant market event.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\6\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest by
providing the Exchange additional time to implement SR-Phlx-2020-15. As
discussed above, the proposed delay is in recognition of both the
recent market volatility and upcoming annual Russell Rebalance in June
2020. The Exchange believes that the extension would therefore allow
the Exchange to mitigate any potential risks to the market and the
operation of its systems by limiting the implementation of new
functionality until after the Russell Rebalance, which, in turn,
protects investors and the public interest.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange's proposal to
delay the implementation of SR-Phlx-2020-15 does not impose an undue
burden on competition. Delaying the implementation will simply allow
the Exchange additional time to properly plan and implement SR-Phlx-
2020-15.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \7\ and Rule 19b-
4(f)(6) thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \9\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \10\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has requested that the Commission waive the 30-day operative delay. The
Exchange states that the proposed implementation delay is in
recognition of both the recent market volatility and upcoming annual
Russell Rebalance in June 2020, and would allow the Exchange to
mitigate any potential risks to the market and the operation of its
systems by limiting the implementation of new functionality until after
the Russell Rebalance. According to the Exchange, waiver of the
operative delay would allow the Exchange to provide prior notice of the
implementation delay by July 1, 2020. The Commission believes that
waiver of the 30-day operative delay is consistent with the protection
of investors and the public interest. Therefore, the Commission hereby
waives the 30-day operative delay and designates the proposed rule
change operative upon filing.\11\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2020-31 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2020-31. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2020-31, and should be submitted on
or before July 23, 2020.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-14231 Filed 7-1-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Proposed Rules]
[Pages 43615-43616]
[FR Doc No: 2011-18470]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0429; Airspace Docket No. 11-AGL-9]

Proposed Amendment of Class E Airspace; Evansville, IN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace at Evansville,
IN. Additional controlled airspace is necessary to accommodate new
Standard Instrument Approach Procedures at Evansville Regional Airport.
The FAA is taking this action to enhance the safety and management of
Instrument Flight Rules (IFR) operations for SIAPs at the airport.

DATES: 0901 UTC. Comments must be received on or before September 6,
2011.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2011-0429/Airspace Docket No. 11-
AGL-9, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.

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

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2011-0429/
Airspace Docket No. 11-AGL-9.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

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

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by amending Class E airspace extending upward from
700

feet above the surface to accommodate new standard instrument approach
procedures at Evansville Regional Airport, Evansville, IN. Controlled
airspace is needed for the safety and management of IFR operations at
the airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9U, dated August 18, 2010 and effective September 15, 2010, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend controlled airspace at Evansville Regional Airport,
Evansville, IN.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

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

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9U, Airspace Designations and Reporting Points, dated August 18,
2010, and effective September 15, 2010, is amended as follows:

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

* * * * *

AGL IN E5 Evansville, IN [Amended]

Evansville Regional Airport, IN
    (Lat. 38[deg]02'18'' N., long. 87[deg]31'51'' W.)
Pocket City VORTAC
    (Lat. 37[deg]55'42'' N., long. 87[deg]45'45'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of Evansville Regional Airport, and within
2.2 miles each side of the 001[deg] bearing from the airport
extending from the 6.8-mile radius to 11.2 miles north of the
airport, and within 2.2 miles each side of the 181[deg] bearing from
the airport extending from the 6.8-mile radius to 11.3 miles south
of the airport, and within 4 miles each side of the Pocket City
VORTAC 060[deg] radial extending from the 6.8-mile radius to the
VORTAC.

    Issued in Fort Worth, TX, on July 12, 2011.
Anthony D. Roetzel,
Manager, Operations Support Group, AJV-C2 ATO Central Service Center.
[FR Doc. 2011-18470 Filed 7-20-11; 8:45 am]
BILLING CODE 4901-13-P


[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Notices]
[Pages 34023-34024]
[FR Doc No: E9-16738]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0434 (Formerly Docket No. 2007D-0386)]

Guidance for Industry on Postmarketing Adverse Event Reporting
for Nonprescription Human Drug Products Marketed Without an Approved
Application; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Postmarketing
Adverse Event Reporting for Nonprescription Human Drug Products
Marketed Without an Approved Application.'' This document provides
guidance to industry on postmarketing serious adverse event reporting
for nonprescription (over-the-counter (OTC)) human drugs marketed
without an approved application. It gives guidance on the minimum data
elements that should be included in a serious adverse event report, the
label that should be included with the report, reporting formats for
paper and electronic submissions, and how and where to submit the
reports. Separate guidance, issued by FDA's Center for Food Safety and
Applied Nutrition on adverse event reporting for dietary supplements,
is announced elsewhere in this issue of the Federal Register.

DATES: Submit written or electronic comments on agency guidances at any
time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Kathleen Frost, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4312, Silver Spring, MD 20993-0002, 301-
796-2380.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Postmarketing Adverse Event Reporting for Nonprescription
Human Drug Products Marketed Without an Approved Application.'' Public
Law 109-462, the Dietary Supplement and Nonprescription Drug Consumer
Protection Act, enacted on December 22, 2006, required FDA to issue
guidance on the minimum data elements that should be included in a
serious adverse

event report (section 2(e)(3)). The guidance document provides
information on the following topics: (1) The minimum data elements that
should be included in a serious adverse event report, (2) the label
that should be included with the report, (3) reporting formats for
paper and electronic submissions, and (4) how and where to submit the
reports.
    Public Law 109-462 amends the Federal Food, Drug, and Cosmetic Act
(the act) to add safety reporting requirements for nonprescription drug
products that are marketed without an approved application. In
accordance with section 760(b) of the act (21 U.S.C. 379aa), the
manufacturer, packer, or distributor whose name appears on the label of
a nonprescription drug marketed in the United States without an
approved application (referred to as the ``responsible person'') must
submit to FDA any report of a serious adverse event associated with
such drug when used in the United States, accompanied by a copy of the
label on or within the retail package of such drug. In addition, the
responsible person must submit followup reports of new medical
information related to a submitted serious adverse event report that is
received within 1 year of the initial report (section 760(c)(2) of the
act). Public Law 109-462 also requires certain postmarketing safety
report!s for dietary supplements.
    In the Federal Register of October 15, 2007 (72 FR 58316), FDA
announced the availability of a draft guidance of the same title. FDA
received several comments on the draft guidance and considered those
comments when finalizing the guidance. The guidance announced in this
notice finalizes the draft guidance dated October 2007.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on postmarketing adverse event reporting for
nonprescription human drug products marketed without an approved
application. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance have been approved under
OMB Control No. 0910-0636.

III. Comments

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

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: July 8, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16738 Filed 7-13-09; 8:45 am]
BILLING CODE 4160-01-S