	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2006-0921; FRL-         ]

	Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Amendments to VOC and NOx Emission Control Areas and VOC
Control Regulations

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

SUMMARY:  EPA is approving State Implementation Plan (SIP) revisions
submitted by the Commonwealth of Virginia.  These revisions amend
existing volatile organic compound (VOC) and nitrogen oxide (NOx)
emissions control areas, and amend certain VOC and NOx regulations in
order to manage the extension of applicability of these provisions to
the amended VOC and NOx emission control areas.  EPA is approving these
revisions in accordance with the requirements of the Clean Air Act
(CAA).

EFFECTIVE DATE:  This final rule is effective on [insert date 30 days
from date of publication].

ADDRESSES:  EPA has established a docket for this action under Docket
ID Number EPA-R03-OAR-2006-0921.  All documents in the docket are listed
in the www.regulations.gov website.  Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute.  Certain other material, such as copyrighted
material, is not placed on the Internet and

will be publicly available only in hard copy form.  Publicly available
docket materials are

available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103.  Copies of the State
submittal are available at the Virginia Department of Environmental
Quality, 629 East Main Street, Richmond, Virginia, 23219.

FOR FURTHER INFORMATION CONTACT:  Ellen Wentworth,<PHONE_NUMBER>, or by
e-

mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:

I.	 Background

On  December 26, 2006 (71 FR 77353), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Virginia.  The NPR proposed
approval of amendments to 9 VAC  5 Chapter 20, Volatile Organic Compound
and Nitrogen Oxides Emissions Control Areas, (9 VAC 5-20-206), and also
proposed approval of amendments to 9 VAC-5 Chapter 40, Articles 4,
Emission Standards for General Process Operations; Article 36, Emission
Standards for Flexographic, Packaging Rotogravure, and Publication
Rotogravure Printing Lines; Article 37, Emission Standards for Petroleum
Liquid Storage and Transfer Operations; and Article 53, Emission
Standards for Lithographic Printing Processes.  The formal SIP revisions
were submitted by the Commonwealth of Virginia on September 12, 2006,
and October 2, 2006.

II.  Summary of SIP Revisions

The September 12, 2006 formal SIP revision consists of amendments to 9
VAC 5-20-206 of Chapter 20, Volatile Organic Compound and Nitrogen
Oxides Emission Control Areas. Specifically, this revision creates a new
VOC and NOx emissions control area (the

Fredericksburg Area), consisting of Spotsylvania County and
Fredericksburg City, and expands the existing Richmond VOC and NOx
Emissions Control Areas to include Prince George County and Petersburg
City.  In addition this revision expands the existing Hampton Roads VOC
and NOx Emissions Control Areas to include Gloucester and Isle of Wight
Counties.  These amendments are necessary to implement VOC control and
contingency measures within the 8-hour ozone nonattainment areas and
1-hour ozone maintenance areas.

The October 2, 2006 formal SIP revision consists of amendments to 9 VAC
5 Chapter 40 that implement non-CTG and CTG VOC RACT control
requirements within those areas that are designated as VOC emissions
control areas.  While most of the Chapter 40 rules apply to sources of
VOCs in VOC emissions control areas designated in Chapter 20, 9 VAC
5-206, certain Chapter 40 rules (specifically Articles 4, 36, 37, and
53) have provisions mandating that these regulations apply only to
certain VOC and NOx emission control areas.  Article 4, Emission
Standards for General Process Operations is being amended to ensure that
VOC RACT is not required from large VOC sources in the new areas within
the expanded Richmond VOC Emissions Control Areas; Article 36, Packaging
and Publishing Rotogravure Printing, and Flexographic Printing, is being
amended to add appropriate exemptions for small facilities in

those VOC emissions control areas that currently have no such
exemptions; and Article 37, Storage or Transfer of Petroleum Liquids, is
also being amended to ensure that Stage II Vapor Recovery is not
required at gasoline dispensing stations in the new areas within the
expanded Richmond VOC Emissions Control Area.  Lastly, Article 53,
Lithographic Printing, is being amended to apply in all VOC emissions
control areas instead of just in the Northern Virginia and Richmond VOC
Emissions Control Areas, and is also being amended to provide
appropriate exemptions for small facilities in the newly applicable VOC
emissions control areas.  In this rulemaking, EPA is also recodifying
the lithographic printing rule (9 VAC 5-40-7800-7940, inclusive) as
Article 53 and Rule 4-53.  Other specific requirements and the rationale
for EPA’s proposed action are explained in the NPR and will not be
restated here.  No public comments were received on the NPR.

III.  General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

In 1995, Virginia adopted legislation that provides, subject to certain
conditions, for an environmental assessment (audit) (privilege(' for
voluntary compliance evaluations performed by a regulated entity.  The
legislation further addresses the relative burden of proof for parties
either asserting the privilege or seeking disclosure of documents for
which the privilege is claimed.  Virginia's legislation also provides,
subject to certain conditions, for a penalty waiver for violations of
environmental laws when a regulated entity discovers such violations
pursuant to a voluntary compliance evaluation and voluntarily discloses
such violations to the Commonwealth and takes prompt and appropriate
measures to remedy the violations.  Virginia's Voluntary Environmental
Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege
that protects from disclosure documents and information about the
content of those documents that are the product of a voluntary
environmental assessment. The Privilege Law does not extend to documents
or information (1) that are generated or developed before the
commencement of a voluntary environmental assessment; (2) that are
prepared independently of the assessment process; (3) that demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the Privilege
law,Va. Code Sec. 10.1-1198,  precludes granting a privilege to
documents and information (required by law,( including documents and
information (required by Federal law to maintain program delegation,
authorization or approval,( since Virginia must (enforce Federally
authorized environmental programs in a manner that is no less stringent
than their Federal counterparts. . . .(   The opinion concludes that
([r]egarding ( 10.1-1198, therefore, documents or other information
needed for civil or criminal enforcement under one of these programs
could not be privileged because such documents and information are
essential to pursuing enforcement in a manner required by Federal law to
maintain program delegation, authorization or approval.(

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that ([t]o
the extent consistent with requirements imposed by Federal law,(  any
person making a voluntary disclosure of information to a state agency
regarding a violation of an environmental statute, regulation, permit,
or administrative order is granted immunity from administrative or civil
penalty.  The Attorney General's January 12, 1998 opinion states that
the quoted language renders this statute inapplicable to enforcement of
any Federally authorized programs, since (no immunity could be afforded
from administrative, civil, or criminal penalties because granting such
immunity would not be consistent with Federal law, which is one of the
criteria for immunity.(

Therefore, EPA has determined that Virginia's Privilege and Immunity
statutes will not preclude the Commonwealth from enforcing its program
consistent with the Federal requirements.  In any event, because EPA has
also determined that a state audit privilege and immunity law can affect
only state enforcement and cannot have any impact on Federal enforcement
authorities, EPA may at any time invoke its authority under the Clean
Air Act, including, for example, sections 113, 167, 205, 211 or 213, to
enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort.  In addition, citizen
enforcement under section 304 of the Clean Air Act is likewise
unaffected by this, or any, state audit privilege or immunity law.

IV. 	Final Action

EPA is approving Virginia SIP revisions submitted on September 12, and
October 2, 2006,  amending the VOC and NOx emission control areas found
in Chapter 20, and amending certain provisions found in Chapter 40 which
implement non-CTG and CTG VOC RACT control requirements within certain
areas designated as VOC emissions control areas.

V.  Statutory and Executive Order Reviews

A.  General Requirements

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action
is not a "significant regulatory action" and therefore is not subject to
review by the Office of Management and Budget.  For this reason, this
action is also not subject to Executive Order 13211, "Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use" (66 FR 28355, May 22, 2001).  This action merely approves state law
as meeting Federal requirements and imposes no additional requirements
beyond those imposed by state law.  Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).  Because

this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by state
law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded Mandates

Reform Act of 1995 (Public Law 104-4).   This rule also does not have
tribal implications

because it will 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, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000).  This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999).  This action merely approves a state rule
implementing a Federal requirement, and does not alter the relationship
or the distribution of power and responsibilities established in the
Clean Air Act.  This rule also is not subject to Executive Order 13045
(62 FR 19885, April 23, 1997), because it approves a state rule
implementing a Federal standard.

In reviewing SIP submissions, EPA(s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  In this
context, in the absence of a prior existing requirement for the State to
use voluntary consensus standards (VCS), EPA has no authority to
disapprove a SIP submission for failure to use VCS.  It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act.  Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply.  This rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B.   Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.   EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.  This rule is not a
(major rule( as defined by 5 U.S.C. 804(2).

C.  Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the appropriate circuit by [insert date 60 days from date of
publication of this document in the Federal Register].  Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.  This action, pertaining to amendments to Chapter 20 and
Chapter 40 of Virginia’s regulations, may not be challenged later in
proceedings to enforce its requirements.  (See section 307(b)(2).)

List of Subjects in 40 CFR part 52

Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

 _______________________ 		___________/s/_____________________

Dated: February 21, 2007      			Donald S. Welsh,
         								Regional Administrator,

                                  				Region III.40 CFR Part 52 is
amended as follows:

PART 52 - [AMENDED]

1.  The authority citation for 40 CFR part 52 continues to read as
follows:

               Authority:  42 U.S.C. 7401 et seq.

Subpart VV ( Virginia

2.  In ( 52.2420, the table in paragraph (c) is amended by:

 a. Revising the entries for 5-20-206, 5-40-300, 5-40-5060, and
5-40-5200.

  b. For Chapter 40, Part II, removing the entry for Article 45 and
replacing it with an entry for Article 53.

( 52.2420  	Identification of plan.

*	*	*	*	*

(c) * * *

	EPA-APPROVED VIRGINIA REGULATIONS AND STATUTES

State citation     (9 VAC 5)

Title/subject

State effective date

EPA approval date

Explanation [former SIP citation]

*     *     *     *     *    *     *

Chapter 20	General Provisions

*     *     *     *     *    *     *

Part II Air Quality Programs

*     *     *     *     *    *     *

5-20-206	Volatile organic compound and nitrogen oxides emissions control
areas	10/04/06	[Insert Federal Register publication date] [Insert page
number where the document begins]	Addition of new Fredericksburg Area
and expansion of Richmond and Hampton Roads Emission Control Areas

*     *     *     *     *    *     *

Chapter 40 Existing Stationary Sources

*     *     *     *     *    *     *

Part II	Emission Standards

*     *     *     *     *    *     *

Article 4	Emission Standards for General Process Operations (Rule 4-4)

*     *     *     *     *    *     *

5-40-300	Standard for volatile organic compounds	10/04/06	[Insert
Federal Register publication date] [Insert page number where the
document begins

	*     *     *     *     *    *     *

Article 36	Flexographic, Packaging Rotogravure, and Publication
Rotogravure Printing Lines (Rule 4-36)

5-40-5060	Applicability and designation of affected facility	04/01/96

10/04/06

	[Insert Federal Register publication date] [Insert page number where
the document begins

	*     *     *     *     *    *     *

Article 37	Emission Standards for Petroleum Liquid Storage and Transfer
Operations (Rule 4-37)

5-40-5200	Applicability and designation of affected facility	04/01/96

10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins

	*     *     *     *     *    *     *

*     *     *     *     *    *     *

Article 53	Emission Standards for Lithographic Printing Processes (Rule
4-53) [Formerly Article 45]

5-40-7800	Applicability and designation of affected facility	10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins	Revised to include and exempt certain emission control
areas

5-40-7810	Definitions of “alcohol,” “Cleaning solution,”
“fountain solution,” lithographic printing,” “printing
process”	04/01/96

10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins

	5-40-7820	Standard for Volatile Organic Compounds	04/01/96

10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins

	5-40-7840	Standard for Visible Emissions	04/01/96

10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins

	5-40-7850	Standard for Fugitive Dust Emissions	04/01/96

10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins

	5-40-7880	Compliance	10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins	Revisions to compliance dates

5-40-7890	Test Methods and Procedures	04/01/96

10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins

	5-40-7900	Monitoring	04/01/96

10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins

	5-40-7910	Notification, Records and Reporting	04/01/96

10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins

	5-40-7920	Registration	04/01/96

10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins

5-40-7930	Facility and Control Equipment Maintenance and Malfunction
04/01/96

10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins

	5-40-7940	Permits	04/01/96

10/04/06

	Insert Federal Register publication date] [Insert page number where the
document begins

	*     *     *     *     *    *     *

* * * * *

 PAGE  9

 PAGE  14


[Federal Register Volume 76, Number 199 (Friday, October 14, 2011)]
[Rules and Regulations]
[Pages 63822-63823]
[FR Doc No: 2011-26557]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2011-1107; Special Conditions No. 25-447-SC]

Special Conditions: Gulfstream Aerospace LP (GALP) Model G280
Airplane, Limit Engine Torque Loads for Sudden Engine Stoppage

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Gulfstream
Aerospace LP (GALP) model G280 airplane. This airplane will have a
novel or unusual design feature associated with engine torque loads
imposed by sudden engine stoppage. The applicable airworthiness
regulations do not contain adequate or appropriate safety standards for
this design feature. 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 October 6,
2011. We must receive your comments by November 28, 2011.

ADDRESSES: You must mail two copies of your comments to: Federal
Aviation Administration, Transport Airplane Directorate, Attn: Rules
Docket (ANM-113), Docket No. FAA-2011-1107, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356. You may deliver two copies to the
Transport Airplane Directorate at the above address. You must mark your
comments: Docket No. FAA-2011-1107. You can inspect comments in the
Rules Docket weekdays, except Federal holidays, between 7:30 a.m. and 4
p.m.

FOR FURTHER INFORMATION CONTACT: Carl Niedermeyer, Transport Airplane
Directorate, Aircraft Certification Service, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; facsimile
(425) 227-1149.

SUPPLEMENTARY INFORMATION: The FAA has determined that notice of, and
opportunity for prior public comment on, these special conditions are
impracticable because these procedures would significantly delay
issuance of the design approval and thus delivery of the affected
aircraft. In addition, 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 ask
that you send us two copies of written comments.
    We will file in the docket all comments we receive, as well as a
report summarizing each substantive public contact with FAA personnel
about these special conditions. You can inspect the docket before and
after the comment closing date. If you wish to review the docket in
person, go to the address in the ADDRESSES section of this preamble
between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal
holidays.
    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.
    If you want us to acknowledge receipt of your comments on these
special conditions, include with your comments a self-addressed,
stamped postcard on which you have written the docket number. We will
stamp the date on the postcard and mail it back to you.

Background

    On March 30, 2006, GALP applied for a type certificate for their
new Model G280 airplane. The G280 is an 8- to 10-passenger (19
maximum), twin-engine airplane with a 41,000-foot cruise altitude,
maximum operating altitude of 45,000 feet, and a range of approximately
3,400 nautical miles.

Type Certification Basis

    Under the provisions of 14 CFR 21.17, GALP must show that the Model
G280 airplane meets the applicable provisions of part 25 as amended by
Amendments 25-1 through 25-117.
    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 G280 airplane 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 novel or
unusual design feature, the special conditions would also apply to the
other model.
    In addition to the applicable airworthiness regulations and special
conditions, the Model G280 airplane 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 under 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 GALP Model G280 airplane incorporates a novel or unusual design
feature involving engine size and related torque load that affect
sudden engine-stoppage conditions.

Discussion

    The size, configuration, and failure modes of jet engines have
changed considerably from those envisioned by 14 CFR 25.361(b), when
the engine-seizure requirement was first adopted. Engines have become
larger and are now designed with large bypass fans capable of producing
much larger and more complex dynamic loads. Relative to the engine
configurations that existed when the rule was developed in 1957, the
present generation of engines is sufficiently different and novel to
justify issuance of a special condition to establish appropriate design
standards for the GALP Model G280 airplane type design.
    Consideration of the limit engine torque load imposed by sudden
engine stoppage due to malfunction or structural failure (such as
compressor jamming) has been a specific requirement for transport-
category airplanes since 1957. In the past, the design torque loads
associated with typical failure scenarios have been estimated by the
engine manufacturer and were provided to the airframe manufacturer as
limit loads. These limit loads were considered simple and pure torque
static loads.
    It is evident from service history that the engine-failure events
that tend to cause the most severe loads are fan-blade failures, which
occur much less frequently than the typical ``limit'' load condition.
    The regulatory authorities and industry have developed a
standardized requirement in the Aviation Rulemaking Advisory Committee
(ARAC) forum.

The technical aspects of this requirement have been agreed upon and
have been accepted by the ARAC Loads and Dynamics Harmonization Working
Group, and incorporated in EASA CS-25. The proposed special conditions
outlined below reflect the ARAC recommendation and CS-25. In addition,
the ARAC recommendation includes corresponding advisory material that
is considered an acceptable means of compliance to the proposed special
conditions outlined below.
    To maintain the level of safety envisioned by Sec.  25.361(b), more
comprehensive criteria are needed for the new generation of high-bypass
engines. These proposed special conditions would distinguish between
the more-common engine-failure events and those rare events resulting
from structural failures. The more-common events would continue to be
treated as static torque limit load conditions. The more-severe events
resulting from extreme engine-failure conditions (such as loss of a
full fan blade at redline speed), would be treated as full dynamic-load
conditions. These would be considered ultimate loads, and include all
transient loads associated with the event. An additional safety factor
would be applied to the more-critical airframe supporting structure.

Applicability

    As discussed above, these special conditions are applicable to the
GALP Model G280 airplane. Should GALP apply at a later date for a
change to the type certificate to include another model incorporating
the same novel or unusual design feature, 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 airplane. It is not a rule of general applicability.
    Under standard practice, the effective date of final special
conditions would be 30 days after the date of publication in the
Federal Register. However, as the certification date for the GALP Model
G280 airplane is imminent, the FAA finds that good cause exists to make
these special conditions effective upon issuance.

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 GALP Model G280 airplane.
    In lieu of 14 CFR 25.361(b), the following special conditions are
proposed:
    1. For turbine-engine installations, the engine mounts, pylons and
adjacent supporting airframe structure must be designed to withstand 1g
level flight loads acting simultaneously with the maximum limit torque
loads imposed by each of the following:
    (a) Sudden engine deceleration due to a malfunction, which could
result in a temporary loss of power or thrust; and
    (b) the maximum acceleration of the engine.
    2. For auxiliary power unit (APU) installations, the APU mounts and
adjacent supporting airframe structure must be designed to withstand 1g
level flight loads acting simultaneously with the maximum limit torque
loads imposed by each of the following:
    (a) Sudden APU deceleration due to malfunction or structural
failure; and
    (b) The maximum acceleration of the APU.
    3. For engine-supporting structure, an ultimate loading condition
must be considered that combines 1g flight loads with the transient
dynamic loads resulting from:
    (a) The loss of any fan, compressor, or turbine blade; and
separately
    (b) Where applicable to a specific engine design, any other engine
structural failure that results in higher loads.
    4. The ultimate loads developed from the conditions specified in
paragraphs 3(a) and 3(b) of these special conditions are to be
multiplied by a factor of 1.0 when applied to engine mounts and pylons,
and multiplied by a factor of 1.25 when applied to adjacent supporting
airframe structure.
    5. Any permanent deformation that results from the conditions
specified in paragraph 3 of these special conditions must not prevent
continued safe flight and landing.

    Issued in Renton, Washington, on October 6, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-26557 Filed 10-13-11; 8:45 am]
BILLING CODE 4910-13-P


The Motor Vehicle Manufacturing Industry Applying Aluminum Parts --

Total Barium Data

Facility Name	City	State	Sample Date	Sample ID	Duplicate Indicator Constituent Name	Total Actual or Calculated	Analytical Method	Total Concentration Result	Units	Total Non-Detect Indicator	Total Detection Limit Data Qualifier	Description

BMW Manufacturing Corporation	SPARTANBURG	SC

Comp-1	N	barium	actual

402	mg/kg

?	Unknown

BMW Manufacturing Corporation	SPARTANBURG	SC

Comp-2	N	barium	actual

387	mg/kg

?	Unknown

BMW Manufacturing Corporation	SPARTANBURG	SC

Comp-3	N	barium	actual

377	mg/kg

?	Unknown

BMW Manufacturing Corporation	SPARTANBURG	SC

Comp-4	N	barium	actual

368	mg/kg

?	Unknown

BMW Manufacturing Corporation	SPARTANBURG	SC

Dup-00101 (Comp-2)	Y	barium	actual

383	mg/kg

?	Unknown

BMW Manufacturing Corporation	SPARTANBURG	SC	5/24/2001	composite 1	N barium	actual

456	mg/kg

	BMW Manufacturing Corporation	SPARTANBURG	SC	5/24/2001	composite 2	N barium	actual

359	mg/kg

	BMW Manufacturing Corporation	SPARTANBURG	SC	5/24/2001	composite 3	N barium	actual

471	mg/kg

	BMW Manufacturing Corporation	SPARTANBURG	SC	5/24/2001	composite 4	N barium	actual

411	mg/kg

	BMW Manufacturing Corporation	SPARTANBURG	SC	8/8/2003	Comp-1 3-211-3063 N	barium	actual

1400	mg/kg

	BMW Manufacturing Corporation	SPARTANBURG	SC	8/8/2003	Comp-2 3-211-3064 N	barium	actual

1180	mg/kg

	BMW Manufacturing Corporation	SPARTANBURG	SC	8/8/2003	Comp-3 3-211-3065 N	barium	actual

1620	mg/kg

	BMW Manufacturing Corporation	SPARTANBURG	SC	8/8/2003	Comp-4 3-211-3066 N	barium	actual

1870	mg/kg

	DaimlerChrysler Jefferson North Assembly Plant	DETROIT	MI

JN-1	N	barium	actual

336	mg/kg

	DaimlerChrysler Jefferson North Assembly Plant	DETROIT	MI

JN-2	N	barium	actual

527	mg/kg

	DaimlerChrysler Jefferson North Assembly Plant	DETROIT	MI

JN-3	N	barium	actual

386	mg/kg

	DaimlerChrysler Jefferson North Assembly Plant	DETROIT	MI

JN-4	N	barium	actual

328	mg/kg

	DaimlerChrysler Jefferson North Assembly Plant	DETROIT	MI

JN-5	N	barium	actual

359	mg/kg

	DaimlerChrysler Jefferson North Assembly Plant	DETROIT	MI

JN-6	N	barium	actual

277	mg/kg

	DaimlerChrysler Jefferson North Assembly Plant	DETROIT	MI

JN-7	N	barium	actual

319	mg/kg

	Ford MI Truck/Wayne Integrated Stamping & Assembly	WAYNE	MI

Drum #2	N	barium	actual

336	mg/kg

J	The associated value is an estimated quantity.

Ford MI Truck/Wayne Integrated Stamping & Assembly	WAYNE	MI

Drum #2 Duplicate	Y	barium	actual

271	mg/kg

J	The associated value is an estimated quantity.

Ford MI Truck/Wayne Integrated Stamping & Assembly	WAYNE	MI

Drum #3	N	barium	actual

247	mg/kg

J	The associated value is an estimated quantity.

Ford MI Truck/Wayne Integrated Stamping & Assembly	WAYNE	MI

Drum #4	N	barium	actual

306	mg/kg

J	The associated value is an estimated quantity.

Ford MI Truck/Wayne Integrated Stamping & Assembly	WAYNE	MI

Drum #5	N	barium	actual

185	mg/kg

J	The associated value is an estimated quantity.

Ford MI Truck/Wayne Integrated Stamping & Assembly	WAYNE	MI

Drum #6	N	barium	actual

143	mg/kg

J	The associated value is an estimated quantity.

Ford Wixom Assembly Plant	WIXOM	MI

Drum #1	N	barium	actual

331	mg/kg

J	The associated value is an estimated quantity.

Ford Wixom Assembly Plant	WIXOM	MI

Drum #2	N	barium	actual

379	mg/kg

J	The associated value is an estimated quantity.

Ford Wixom Assembly Plant	WIXOM	MI

Drum #2 Duplicate	Y	barium	actual

340	mg/kg

J	The associated value is an estimated quantity.

Ford Wixom Assembly Plant	WIXOM	MI

Drum #3	N	barium	actual

496	mg/kg

J	The associated value is an estimated quantity.

Ford Wixom Assembly Plant	WIXOM	MI

Drum #4	N	barium	actual

319	mg/kg

J	The associated value is an estimated quantity.

Ford Wixom Assembly Plant	WIXOM	MI

Drum #5	N	barium	actual

370	mg/kg

J	The associated value is an estimated quantity.

Ford Wixom Assembly Plant	WIXOM	MI

Drum #6	N	barium	actual

383	mg/kg

J	The associated value is an estimated quantity.

GM Flint Truck	FLINT	MI

FT-1	N	barium	actual

530	mg/kg

J	Estimate

GM Flint Truck	FLINT	MI

FT-2	N	barium	actual

694	mg/kg

J	Estimate

GM Flint Truck	FLINT	MI

FT-3	N	barium	actual

576	mg/kg

J	Estimate

GM Flint Truck	FLINT	MI

FT-4	N	barium	actual

637	mg/kg

J	Estimate

GM Flint Truck	FLINT	MI

FT-5	N	barium	actual

458	mg/kg

J	Estimate

GM Flint Truck	FLINT	MI

FT-6	N	barium	actual

481	mg/kg

J	Estimate

GM Flint Truck	FLINT	MI

FT-7	N	barium	actual

686	mg/kg

J	Estimate

GM Grand River Plant	LANSING	MI

LGR-1	N	barium	actual

30	mg/kg

	GM Grand River Plant	LANSING	MI

LGR-2	N	barium	actual

17	mg/kg

	GM Grand River Plant	LANSING	MI

LGR-3	N	barium	actual

36	mg/kg

	GM Grand River Plant	LANSING	MI

LGR-4	N	barium	actual

57	mg/kg

	GM Grand River Plant	LANSING	MI

LGR-5	N	barium	actual

47	mg/kg

	GM Grand River Plant	LANSING	MI

LGR-6	N	barium	actual

54	mg/kg

	GM Grand River Plant	LANSING	MI

LGR-7	N	barium	actual

17	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H1-1	N	barium	actual

134	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H1-2	N	barium	actual

118	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H1-3	N	barium	actual

110	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H1-4	N	barium	actual

142	mg/kg

J	Estimate

GM Hamtramck Plant	DETROIT	MI

H1-5	N	barium	actual

110	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H1-6	N	barium	actual

130	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H1-7	N	barium	actual

125	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H2-1	N	barium	actual

202	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H2-2	N	barium	actual

232	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H2-3	N	barium	actual

100	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H2-4	N	barium	actual

141	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H2-5	N	barium	actual

220	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H2-6	N	barium	actual

253	mg/kg

	GM Hamtramck Plant	DETROIT	MI

H2-7	N	barium	actual

187	mg/kg

	GM Lansing Assembly Center	LANSING	MI	12/19/1997	LAN-S01-01	N	barium actual	Method 6020	226	mg/kg

J	Estimate

GM Lansing Assembly Center	LANSING	MI	12/19/1997	LAN-S01-02	N	barium actual	Method 6020	317	mg/kg

J	Estimate

GM Lansing Assembly Center	LANSING	MI	12/19/1997	LAN-S01-03	N	barium actual	Method 6020	267	mg/kg

J	Estimate

GM Lansing Assembly Center	LANSING	MI	1/29/1998	LAN-S02-01	N	barium actual	Method 6020	727	mg/kg

	GM Lansing Assembly Center	LANSING	MI	1/29/1998	LAN-S02-02	N	barium actual	Method 6020	400	mg/kg

J	Estimate

GM Lansing Assembly Center	LANSING	MI	1/29/1998	LAN-S02-03	N	barium actual	Method 6020	656	mg/kg

	GM Lordstown Assembly Plant	LORDSTOWN	OH	12/16/1997	LOR-S01-01	N	barium actual

3550	mg/kg

J	Estimate

GM Lordstown Assembly Plant	LORDSTOWN	OH	12/16/1997	LOR-S01-02	N	barium actual

4090	mg/kg

J	Estimate

GM Lordstown Assembly Plant	LORDSTOWN	OH	12/16/1997	LOR-S01-03	N	barium actual

2540	mg/kg

J	Estimate

GM Lordstown Assembly Plant	LORDSTOWN	OH	12/16/1997	LOR-S01-04	N	barium actual

3500	mg/kg

J	Estimate

GM Lordstown Assembly Plant	LORDSTOWN	OH	12/16/1997	LOR-S01-05	N	barium actual

2600	mg/kg

J	Estimate

GM Lordstown Assembly Plant	LORDSTOWN	OH	6/9/1998	LOR-S02-01	N	barium actual

4280	mg/kg

	GM Lordstown Assembly Plant	LORDSTOWN	OH	6/9/1998	LOR-S02-02	N	barium actual

3870	mg/kg

	GM Oklahoma City	OKLAHOMA CITY	OK	12/16/1997	OKL-S01-01	N	barium	actual

3070	mg/kg

J	Estimate

GM Oklahoma City	OKLAHOMA CITY	OK	12/16/1997	OKL-S01-02	N	barium	actual

3080	mg/kg

J	Estimate

GM Oklahoma City	OKLAHOMA CITY	OK	12/16/1997	OKL-S01-03	N	barium	actual

3440	mg/kg

J	Estimate

GM Oklahoma City	OKLAHOMA CITY	OK	12/16/1997	OKL-S01-04	N	barium	actual

3510	mg/kg

J	Estimate

GM Oklahoma City	OKLAHOMA CITY	OK	12/16/1997	OKL-S01-05	N	barium	actual

3600	mg/kg

J	Estimate

GM Oklahoma City	OKLAHOMA CITY	OK	6/11/1998	OKL-S02-01	N	barium	actual

3860	mg/kg

	GM Oklahoma City	OKLAHOMA CITY	OK	6/11/1998	OKL-S02-02	N	barium	actual

3630	mg/kg

	GM Oklahoma City	OKLAHOMA CITY	OK	6/11/1998	OKL-S02-03	N	barium	actual

3910	mg/kg

	GM Oklahoma City	OKLAHOMA CITY	OK	6/11/1998	OKL-S02-04	N	barium	actual

2770	mg/kg

	GM Oklahoma City	OKLAHOMA CITY	OK	6/11/1998	OKL-S02-05	N	barium	actual

3090	mg/kg

	GM Orion Assembly Center	LAKE ORION	MI	2/20/1995	UPCU 4103788/255-008 - RB-4	N	barium	actual

550	mg/kg

	GM Orion Assembly Center	LAKE ORION	MI	2/20/1995	UPCU<PHONE_NUMBER>-007 - RB-3	N	barium	actual

420	mg/kg

	GM Orion Assembly Center	LAKE ORION	MI	2/20/1995	UPCU 4108183/255-002 - RB-3-Dup	Y	barium	actual

560	mg/kg

	GM Orion Assembly Center	LAKE ORION	MI	2/20/1995	UPCU 4108183/255-003 - RB-1	N	barium	actual

620	mg/kg

	GM Orion Assembly Center	LAKE ORION	MI	2/20/1995	UPCU 4117098/255-004 - RB-2	N	barium	actual

530	mg/kg

	GM Pontiac East Plant	PONTIAC	MI

PE-1	N	barium	actual

129	mg/kg

J	Estimate

GM Pontiac East Plant	PONTIAC	MI

PE-2	N	barium	actual

100	mg/kg

J	Estimate

GM Pontiac East Plant	PONTIAC	MI

PE-3	N	barium	actual

84	mg/kg

	GM Pontiac East Plant	PONTIAC	MI

PE-4	N	barium	actual

139	mg/kg

J	Estimate

GM Pontiac East Plant	PONTIAC	MI

PE-5	N	barium	actual

101	mg/kg

J	Estimate

GM Pontiac East Plant	PONTIAC	MI

PE-6	N	barium	actual

112	mg/kg

J	Estimate

GM Pontiac East Plant	PONTIAC	MI

PE-7	N	barium	actual

95	mg/kg

J	Estimate

Nissan North America Manufacturing Facility	SMYRNA	TN	6/24/2002	NS-06a	N barium	actual

1300	mg/kg

E	Estimate

Nissan North America Manufacturing Facility	SMYRNA	TN	6/26/2002	NS-07a	N barium	actual

1800	mg/kg

	Nissan North America Manufacturing Facility	SMYRNA	TN	6/28/2002	NS-08a N	barium	actual

1900	mg/kg

	Nissan North America Manufacturing Facility	SMYRNA	TN	7/1/2002	NS-09a	N barium	actual

1900	mg/kg

	Nissan North America Manufacturing Facility	SMYRNA	TN	7/3/2002	NS-10a	N barium	actual

2200	mg/kg

	Nissan North America Manufacturing Facility	SMYRNA	TN	7/8/2002	NS-11a	N barium	actual

3800	mg/kg

	Nissan North America Manufacturing Facility	SMYRNA	TN	7/10/2002	NS-12a N	barium	actual

4000	mg/kg

	Nissan North America Manufacturing Facility	SMYRNA	TN	7/10/2002	NS-13a N	barium	actual

3800	mg/kg

	Nissan North America Manufacturing Facility	SMYRNA	TN	7/15/2002	NS-14a N	barium	actual

3900	mg/kg

	n 	105

MAXIMUM	4280

MEAN	1065.419048

MEDIAN	386

Std. Dev.	1321.297234

	90th Percentile	3580

50th Percentile	386


[Federal Register Volume 85, Number 235 (Monday, December 7, 2020)]
[Notices]
[Pages 78931-78932]
[FR Doc No: 2020-26782]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2020-0135]

Pipeline Safety: Random Drug Testing Rate; Management Information
System Reporting; and Obtaining Drug and Alcohol Management Information
System Sign-In Information

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of calendar year 2021 minimum annual percentage rate for
random drug testing, reminder for operators to report contractor
management information system (MIS) data using PHMSA supplemental
instructions, and reminder of method for operators to obtain user name
and password for electronic reporting.

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

SUMMARY: PHMSA has determined that the minimum random drug testing rate
for covered employees will remain at 50 percent during calendar year
2021. Operators are reminded that drug and alcohol (D&A) testing
information must be submitted for contractors who are performing or are
ready to perform covered functions. For calendar year 2020 reporting,
the user name and password for the Drug and Alcohol Management
Information System (DAMIS) will be available in the PHMSA Portal.

DATES: Effective January 1, 2021, through December 31, 2021.

FOR FURTHER INFORMATION CONTACT: Wayne Lemoi, Drug & Alcohol Program
Manager, Office of Pipeline Safety, by phone at<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Notice of Calendar Year 2021 Minimum Annual Percentage Rate for Random
Drug Testing

    Operators of natural gas, hazardous liquid, and carbon dioxide
pipelines, liquefied natural gas (LNG) facilities, and underground
natural gas storage facilities must randomly select and test a
percentage of all covered employees for prohibited drug use in
accordance with 49 CFR part 199. Pursuant to Sec.  199.105(c)(1), the
PHMSA minimum annual random drug testing rate for all covered employees
is 50 percent. The Administrator can adjust this random drug testing
rate based on the reported positive rate in the pipeline industry's
random drug tests, which is submitted in operators' annual Management
Information System (MIS) reports as required by Sec.  199.119(a). In
accordance with Sec.  199.105(c)(3), if the reported positive drug test
rate is below 1 percent for 2 consecutive years, the Administrator can
reduce the random drug testing rate to 25 percent of all covered
employees. In calendar year 2019, the random drug test positive rate
for the entire pipeline industry was reported at greater than 1
percent; therefore, the minimum annual random drug testing rate for
calendar year 2021 is maintained at 50 percent of all covered
employees.

Reminder for Operators To Report Contractor MIS Data

    PHMSA developed and released online new PHMSA Supplemental
Instructions for DOT Drug & Alcohol Management Information System
Reporting. These instructions provide operators with the appropriate
process for collecting and reporting annual D&A MIS testing data for
contractors. The Supplemental Instructions help ensure that PHMSA can
identify all the contractors who performed D&A covered functions for a
specific pipeline operator; identify all the pipeline operators for
whom a specific contractor performed D&A covered functions; and, has
received a complete and accurate D&A MIS report for each contractor who
performed D&A covered functions on any PHMSA regulated pipeline or
facility in the applicable calendar year.
    Pursuant to Sec. Sec.  199.119(a) and 199.229(a), an operator
having more than 50 covered employees is a large operator and an
operator having 50 or fewer covered employees is a small operator.
While contractor employees are covered employees per the regulations in
Sec.  199.3 and must be treated as such with regards to part 199,
contractor employees are not included

in the calculation to determine if an operator is a large or small
operator.
    Large operators are always required to submit annual MIS reports
whereas small operators are only required to submit MIS reports upon
written request from PHMSA. If a small operator has submitted a MIS
report in or after calendar year 2018, the PHMSA Portal message may
state that no MIS report is required for calendar year 2020. If a small
operator has grown to more than 50 covered employees during calendar
year 2020, the PHMSA Portal message will include instructions for how
to obtain a DAMIS user name and password for the 2020 calendar year
reporting period.
    If an operator is required to submit a MIS report in accordance
with part 199, that report is not complete until PHMSA receives a MIS
data report for each contractor that performed covered functions as
defined in Sec.  199.3. Operators must submit operator and contractor
employee testing data in separate MIS reports to avoid duplicative
reporting and inaccurate data that could affect the positive rate for
the entire industry.

Reminder of Method for Operators To Obtain User Name and Password for
Electronic Reporting

    By early January 2021, the user name and password required for an
operator to access DAMIS and enter calendar year 2020 data will be
available to all operator staff with access to the PHMSA Portal.
Pipeline operators have been submitting reports required by 49 CFR
parts 191 and 195 through the PHMSA Portal (https://portal.phmsa.dot.gov/pipeline) since 2011. PHMSA determined that
distributing information via the Portal would be more effective than
the previous mailing process.
    When the DAMIS user name and password are available in the PHMSA
Portal, all registered users will receive an email to that effect. If
operator staff responsible for submitting MIS reports do not receive
the DAMIS information, they should coordinate with other registered
PHMSA Portal users within their company to obtain the DAMIS user name
and password. Registered PHMSA Portal users for an operator typically
include operator staff or consultants who submit annual and incident
reports through PHMSA F 7000- and 7100-series forms.
    Operators that have not previously registered staff in the PHMSA
Portal for the reporting purposes of parts 191 and 195 can register
users by following the instructions at: https://portal.phmsa.dot.gov/PHMSAPortal2/staticContentRedesign/howto/PortalAccountCreation.pdf.

    Issued in Washington, DC, on December 1, 2020, under authority
delegated in 49 CFR 1.97.
Alan K. Mayberry,
Associate Administrator for Pipeline Safety.
[FR Doc. 2020-26782 Filed 12-4-20; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7198-7199]
[FR Doc No: 2014-02511]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0220]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Guidance for Industry on Pharmacogenomic Data
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
resulting from the submission to the Agency of pharmacogenomic data
during the drug development process.

DATES: Submit either electronic or written comments on the collection
of information by April 7, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane., Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance for Industry on Pharmacogenomic Data Submissions--(OMB Control
Number 0910-0557)--Extension

    The guidance provides recommendations to sponsors submitting or
holding investigational new drug applications (INDs), new drug
applications (NDAs), or biologics license applications (BLAs) on what
pharmacogenomic data should be submitted to the Agency during the drug
development process. Sponsors holding, and applicants submitting, INDs,
NDAs, or BLAs are subject to FDA requirements for submitting to the
Agency data relevant to drug safety and efficacy (21 CFR 312.22,
312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12).
    The guidance interprets FDA regulations for IND, NDA, or BLA
submissions, clarifying when the regulations require pharmacogenomics
data to be submitted and when the submission of such data is voluntary.
The pharmacogenomic data submissions described in the guidance that are
required to be submitted to an IND, NDA, BLA, or annual report are
covered by the information collection requirements under parts 312,
314, and 601 and are approved by OMB under control numbers 0910-0014
(part 312, INDs); 0910-0001 (part 314, NDAs and annual reports); and
0910-0338 (part 601, BLAs).
    The guidance distinguishes between pharmacogenomic tests that may
be considered valid biomarkers appropriate for regulatory
decisionmaking, and other, less well-developed exploratory tests. The
submission of exploratory pharmacogenomic data is not required under
the regulations, although the Agency encourages the voluntary
submission of such data.
    The guidance describes the voluntary genomic data submission (VGDS)
that can be used for such a voluntary submission. The guidance does not
recommend a specific format for the VGDS, except that such a voluntary
submission be designated as a VGDS. The data submitted in a VGDS and
the level of detail should be sufficient for FDA to be able to
interpret the information and independently analyze the data, verify
results, and explore possible genotype-phenotype correlations across
studies. FDA does not want the VGDS to be overly burdensome and time-
consuming for the sponsor.
    FDA has estimated the burden of preparing a voluntary submission
described in the guidance that should be designated as a VGDS. Based on
FDA's experience with these submissions over the past few years, and on
FDA's familiarity with sponsors' interest in submitting pharmacogenomic
data during the drug development process, FDA estimates that
approximately 4 sponsors will submit approximately 1 VGDS each, and
that, on average, each VGDS will take approximately 50 hours to prepare
and submit to FDA.
    FDA estimates the burden of this information collection as follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Voluntary Genomic Data Submissions.................................               4                1                4               50              200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02511 Filed 2-5-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 11, 2006 (Volume 71, Number 196)]
[Notices]
[Page 59766]
[DOCID:fr11oc06-69]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-614-000]

Transwestern Pipeline Company, LLC; Notice of Proposed Changes in
FERC Gas Tariff

October 3, 2006.
    Take notice that on September 29, 2006, Transwestern Pipeline
Company, LLC, (Transwestern) tendered for filing as part of its FERC
Gas Tariff, Third Revised Volume No. 1, the tariff sheets listed in
Appendices A and B, attached to the filing, to become effective
November 1, 2006.
    Any person desiring 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 in accordance with the provisions of
Sec.  154.210 of the Commission's regulations (18 CFR 154.210). 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>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-16771 Filed 10-10-06; 8:45 am]

BILLING CODE 6717-01-P


The Dalles Rufus Hood River Cascade Locks Wasco Dufur Mosier Columbia River Eightmile Creek Fivemile Creek Pine Creek Hood River Mosier Creek Larch Creek Fifteenmile Creek Dog River Neal Creek Rams ey Creek East Fork Hood River Mud Hollow Japa nese Hollow Rock Cree k Mill Creek Threemile Creek Rail Hollow Eagle Cree k Tony Creek Trout Creek South Fork Mill Cre ek Spanish Hollow Creek Evans Creek West Fork Hood Riv er Wolf Run Brown Creek China Hollow Lake Branch Davis Creek North Fork Mill Creek Indian Creek Herman Creek Odell Creek Long Hollow Coe Bran ch Ladd Creek Neece Canyon Phe lps Creek Mays Canyon Creek Chenoweth Creek Elliot Branch Stubb Hollow Tilly Jane Creek Cla rk Cree k Gree n Poin t Creek McGee Cree k Easton C anyon Sta ndard Hollow Elk Creek Bear Creek Middle Fork Hood River Doe Creek Cedar Creek Ditch Creek Dry Holl ow Newton Creek Po lallie Creek Shotgun Hollow Wisky Gulch Alder Creek Crow Creek Starveout Creek West Fork Mosie r Creek North F ork Fivemile Creek Locust Grove Canyon Griswell Creek Cold Spring Creek Lindsey Cre ek Douglas Hollow South Fo rk Fivemile Creek Hesslan Canyon Ruckel Creek Middle Fork Fiv emile C reek Divers Cre ek Dry Fork Rowena Creek Clear Br anch Opal Creek Henderson Hollow Laurel Creek Dry Creek Viento Creek Emil Creek Dry Run Company Ho llow Fret Creek Badger Creek Puppy Cre ek Gorto n Creek Jones Creek Frank Fu lton Canyon Wa rren Creek Kellar Creek Camp Creek Hon eysuckle Creek Ladore Creek C at C ree k Whiskey Creek Campbell Creek Mitchell Creek Compass Creek We st Fork Evan s Creek Tumbledown Creek Ash Creek Beaver Cre ek Culvert Creek Perham Creek Grays Creek Rimrock Creek Starvation Creek Collins Creek Birdie Creek Hutson Gulch Tumble Creek Deer Creek Baldwin Creek Spring Creek Rudolph Cree k Gate Creek Pocket Creek South Pine Creek Shakehead Creek Little Creek Boomer Creek Casey Creek Inlet Creek Hellroaring Creek Mullinix Creek India n Creek Spring Creek Dry Creek Rail Hollow Dry Creek Camp Creek Salmon, Steelhead & Bull Trout Spawning Through Fry Emergence Use Designations, Hood Basin, Oregon DRAFT, September 24, 2003 Legend Salmon & Steelhead Spawning Through Fry Emergence: 13C/ 55F Unassigned August 15 May 15 August 15 June 15 October 1 June 15 October 15 May 15 October 15 June 15 Bull Trout Juvenile Rearing and Spawning: 12C/ 54F Oregon Cities and Towns WASHINGTON OREGON Larger streams shown with heavier lines.

Map produced by Bill Bogue, EPA Region 10, September 24, 2003 Columbia River Columbia River Fifteenmile Creek Eightmile Creek


[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33710-33712]
[FR Doc No: 2021-13585]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1802]

Cancer Clinical Trial Eligibility Criteria: Approach to Available
Therapy in Non-Curative Settings; Draft Guidance for Sponsors;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for sponsors entitled ``Cancer
Clinical Trial Eligibility Criteria: Approach to Available Therapy in
Non-Curative Settings.'' The draft guidance provides recommendations to
sponsors of clinical trials of investigational cancer drugs regarding
the inclusion of patients who have not previously received available
therapy (commonly referred to as existing treatment options) for their
cancer in the non-curative setting. The draft guidance is intended to
facilitate increased clinical trial options for patients with non-
curable cancers by recognizing that, with appropriate informed consent,
it may be reasonable for patients to be eligible for inclusion in
trials of investigational cancer drugs, regardless of whether they have
received available therapy, in the non-curative setting.

DATES: Submit either electronic or written comments on the draft
guidance by August 24, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-D-1802 for ``Cancer Clinical Trial Eligibility Criteria:
Approach to Available Therapy in Non-Curative Settings.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jennifer Gao, Oncology Center of
Excellence, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 2135, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; Chana
Weinstock, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2357, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for sponsors
entitled ``Cancer Clinical Trial Eligibility Criteria: Approach to
Available Therapy in Non-Curative Settings.'' The draft guidance
provides recommendations regarding the inclusion of patients who have
not received available therapy for their cancer in clinical trials of
investigational cancer drugs and biological products in the non-
curative setting. For the purpose of this draft guidance, non-curative
is defined as circumstances where there is extremely low likelihood for
cure or for prolonged and/or near normal survival with available
therapies (i.e., hematologic malignancies or solid tumors that are
unresectable, locally advanced, or metastatic cancer with unfavorable
long-term overall survival).
    For clinical trials of products regulated under part 312 (21 CFR
part 312), FDA must determine that study subjects are not exposed to an
unreasonable and significant risk of illness or injury (21 CFR
312.42(b)(1)(i) and (b)(2)(i)) to allow such trials to proceed.
Therefore, eligibility criteria should generally require that patients
have received available therapy(ies) that offer the potential for cure
in a substantial proportion of patients in clinical trials evaluating
investigational cancer drugs. Alternatively, such available therapy
should be administered to all patients in the trial, where the
investigational drug is added to such therapy. However, eligibility
criteria in which patients receive an investigational drug(s) in lieu
of available therapy are reasonable in the non-curative setting when
patients have been provided with adequate information to make an
informed decision on trial participation. The draft guidance also
describes information that should be included in the informed consent
when this approach is taken. The draft guidance further includes
recommendations regarding efficacy analyses when this approach is
taken.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA

on ``Cancer Clinical Trial Eligibility Criteria: Approach to Available
Therapy in Non-Curative Settings.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in part 312 have been approved under OMB control number
0910-0014; the collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001; and the collections of
information in 21 CFR part 601 have been approved under OMB control
number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13585 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 123 (Monday, June 27, 2011)]
[Rules and Regulations]
[Pages 37263-37265]
[FR Doc No: 2011-15395]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30789; Amdt. No. 3431]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective June 27, 2011. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of June 27, 2011.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation

by reference are realized and publication of the complete description
of each SIAP contained in FAA form documents is unnecessary. This
amendment provides the affected CFR sections and specifies the types of
SIAP and the corresponding effective dates. This amendment also
identifies the airport and its location, the procedure and the
amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this 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. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC on June 10, 2011.
Ray Towles,
Deputy Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal Regulations, Part 97, 14 CFR part 97, is amended by
amending Standard Instrument Approach Procedures, effective at 0901 UTC
on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC Date           State             City               Airport          FDC No.      FDC Date                       Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
28-Jul-11............  AL            Birmingham.........  Birmingham-               1/0475       6/3/11  RNAV (RNP) Z RWY 24, Orig
                                                           Shuttlesworth Intl.
28-Jul-11............  NJ            Teterboro..........  Teterboro..........       1/0477      5/27/11  RNAV (RNP) Z RWY 6, Orig-A
28-Jul-11............  FL            Fort Lauderdale....  Fort Lauderdale/          1/0497      5/26/11  RNAV (RNP) Y RWY 9L, Orig-C
                                                           Hollywood Intl.
28-Jul-11............  GA            Atlanta............  Hartsfield-Jackson        1/0500       6/3/11  RNAV (RNP) Z RWY 26R, Orig-A
                                                           Atlanta Intl.
28-Jul-11............  GA            Atlanta............  Hartsfield-Jackson        1/0501       6/3/11  RNAV (RNP) Z RWY 8R, Orig-A
                                                           Atlanta Intl.
28-Jul-11............  GA            Atlanta............  Hartsfield-Jackson        1/0502       6/3/11  RNAV (RNP) Z RWY 8L, Orig-A
                                                           Atlanta Intl.
28-Jul-11............  GA            Atlanta............  Hartsfield-Jackson        1/0503       6/3/11  RNAV (RNP) Z RWY 9R, Orig-A
                                                           Atlanta Intl.
28-Jul-11............  KY            Covington..........  Cincinnati/Northern       1/0504       6/3/11  RNAV (RNP) Z RWY 18L, Orig
                                                           Kentucky Intl.
28-Jul-11............  GA            Atlanta............  Fulton County             1/0514      5/26/11  RNAV (RNP) Z RWY 8, Orig
                                                           Airport-Brown
                                                           Field.
28-Jul-11............  GA            Atlanta............  Hartsfield-Jackson        1/0515       6/3/11  RNAV (RNP) Z RWY 26L, Orig-A
                                                           Atlanta Intl.
28-Jul-11............  GA            Atlanta............  Hartsfield-Jackson        1/0516       6/3/11  RNAV (RNP) Z RWY 27L, Amdt 1
                                                           Atlanta Intl.
28-Jul-11............  GA            Atlanta............  Hartsfield-Jackson        1/0521       6/3/11  RNAV (RNP) Z RWY 9L, Orig-A
                                                           Atlanta Intl.
28-Jul-11............  GA            Atlanta............  Hartsfield-Jackson        1/0522       6/3/11  RNAV (RNP) Z RWY 27R, Orig-A
                                                           Atlanta Intl.
28-Jul-11............  KY            Louisville.........  Louisville Intl-          1/0523      5/26/11  RNAV (RNP) Z RWY 35L, Orig
                                                           Standiford Field.
28-Jul-11............  NJ            Teterboro..........  Teterboro..........       1/0525      5/27/11  RNAV (RNP) RWY 19, Orig-A
28-Jul-11............  TX            Waco...............  TSTC Waco..........       1/1061       5/6/11  NDB RWY 35R, Amdt 11
28-Jul-11............  CA            Ukiah..............  Ukiah Muni.........       1/1163      5/26/11  LOC RWY 15, Amdt 5B
28-Jul-11............  SC            Allendale..........  Allendale County...       1/2564       6/3/11  GPS RWY 17, Orig-A
28-Jul-11............  GA            Tifton.............  Henry Tift Myers...       1/3172      5/27/11  RNAV (GPS) RWY 33, Orig

28-Jul-11............  CA            Rio Vista..........  Rio Vista Muni.....       1/3380      5/27/11  Takeoff Minimus and Obstacle DP, Orig
28-Jul-11............  IN            Portland...........  Portland Muni......       1/3592      5/27/11  RNAV (GPS) RWY 27, Orig
28-Jul-11............  IN            Portland...........  Portland Muni......       1/3593      5/27/11  RNAV (GPS) RWY 9, Orig
28-Jul-11............  KY            Covington..........  Cincinnati/Northern       1/4250       6/3/11  RNAV (RNP) Z RWY 36L, Orig
                                                           Kentucky Intl.
28-Jul-11............  KY            Covington..........  Cincinnati/Northern       1/4252       6/3/11  RNAV (RNP) Z RWY 9, Orig
                                                           Kentucky Intl.
28-Jul-11............  KY            Covington..........  Cincinnati/Northern       1/4255       6/3/11  RNAV (RNP) Z RWY 27, Orig
                                                           Kentucky Intl.
28-Jul-11............  KY            Covington..........  Cincinnati/Northern       1/4256       6/3/11  RNAV (RNP) Z RWY 36R, Orig
                                                           Kentucky Intl.
28-Jul-11............  KY            Covington..........  Cincinnati/Northern       1/4257       6/3/11  RNAV (RNP) Z RWY 36C, Orig
                                                           Kentucky Intl.
28-Jul-11............  KY            Covington..........  Cincinnati/Northern       1/4259       6/3/11  RNAV (RNP) Z RWY 18C, Orig
                                                           Kentucky Intl.
28-Jul-11............  KY            Covington..........  Cincinnati/Northern       1/4260       6/3/11  RNAV (RNP) Z RWY 18R, Orig
                                                           Kentucky Intl.
28-Jul-11............  NY            New York...........  John F Kennedy Intl       1/4262       6/3/11  RNAV (RNP) Z RWY 4R, Orig
28-Jul-11............  NY            New York...........  John F Kennedy Intl       1/4263       6/3/11  RNAV (RNP) Z RWY 4L, Orig
28-Jul-11............  NY            New York...........  John F Kennedy Intl       1/4264       6/3/11  RNAV (RNP) Z RWY 31L, Orig
28-Jul-11............  NY            New York...........  John F Kennedy Intl       1/4265       6/3/11  RNAV (RNP) Z RWY 31R, Orig-A
28-Jul-11............  NY            New York...........  John F Kennedy Intl       1/4266       6/3/11  RNAV (RNP) Z RWY 22L, Orig
28-Jul-11............  FL            Fort Lauderdale....  Fort Lauderdale/          1/4337       6/3/11  RNAV (RNP) Z RWY 27R, Orig-C
                                                           Hollywood Intl.
28-Jul-11............  OR            Portland...........  Portland Intl......       1/4364      5/24/11  ILS OR LOC RWY 10L, Amdt 3A
28-Jul-11............  AL            Birmingham.........  Birmingham-               1/4371       6/3/11  RNAV (RNP) Z RWY 6, Orig
                                                           Shuttlesworth Intl.
28-Jul-11............  IL            De Kalb............  De Kalb Taylor Muni       1/4725       6/3/11  RNAV (GPS) RWY 2, Orig
28-Jul-11............  IL            De Kalb............  De Kalb Taylor Muni       1/4726       6/3/11  ILS OR LOC RWY 2, Orig
28-Jul-11............  TX            Hondo..............  Hondo Muni.........       1/5995       6/2/11  Takeoff Minimus and Obstacle DP, Orig
28-Jul-11............  NC            Charlotte..........  Charlotte/Douglas         1/9869      5/27/11  RNAV (RNP) Z RWY 18R, Orig
                                                           Intl.
28-Jul-11............  NC            Charlotte..........  Charlotte/Douglas         1/9871      5/27/11  RNAV (RNP) Z RWY 18L, Orig
                                                           Intl.
28-Jul-11............  NC            Charlotte..........  Charlotte/Douglas         1/9873      5/27/11  RNAV (RNP) Z RWY 36L, Orig
                                                           Intl.
28-Jul-11............  NC            Charlotte..........  Charlotte/Douglas         1/9874      5/27/11  RNAV (RNP) Z RWY 36R, Orig
                                                           Intl.
28-Jul-11............  NC            Charlotte..........  Charlotte/Douglas         1/9876      5/27/11  RNAV (RNP) Z RWY 5, Orig
                                                           Intl.
28-Jul-11............  NC            Charlotte..........  Charlotte/Douglas         1/9877      5/27/11  RNAV (RNP) Z RWY 18C, Orig
                                                           Intl.
28-Jul-11............  NC            Charlotte..........  Charlotte/Douglas         1/9879      5/27/11  RNAV (RNP) Z RWY 36C, Orig-A
                                                           Intl.
28-Jul-11............  NC            Charlotte..........  Charlotte/Douglas         1/9880      5/27/11  RNAV (RNP) Z RWY 23, Orig
                                                           Intl.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2011-15395 Filed 6-24-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 2, 2007 (Volume 72, Number 62)]
[Notices]
[Page 15729-15731]
[DOCID:fr02ap07-114]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55532; File No. S7-966]

Program for Allocation of Regulatory Responsibilities Pursuant to
Rule 17d-2; Order Granting Approval of Amendment to the Plan for the
Allocation of Regulatory Responsibilities Among the American Stock
Exchange, LLC, the Boston Stock Exchange, Inc., the Chicago Board
Options Exchange, Inc., the International Securities Exchange, LLC, the
National Association of Securities Dealers, Inc., the New York Stock
Exchange, LLC, the NYSE Arca, Inc., and the Philadelphia Stock
Exchange, Inc.

March 26, 2007.
    On December 5, 2006, the American Stock Exchange, LLC (``Amex''),
the Boston Stock Exchange, Inc. (``BSE''),

the Chicago Board Options Exchange, Inc. (``CBOE''), the International
Securities Exchange, LLC (``ISE''), the National Association of
Securities Dealers, Inc. (``NASD''), the New York Stock Exchange, LLC
(``NYSE''), the NYSE Arca, Inc. (``NYSE Arca''), and the Philadelphia
Stock Exchange, Inc. (``Phlx'') (collectively the ``SRO participants'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 17(d) \1\ of the Securities Exchange Act of 1934
(``Act'') and Rule 17d-2 thereunder,\2\ an amendment to their January
14, 2004 plan for the allocation of regulatory responsibility. The
proposed amended plan was published for comment on January 26, 2007.\3\
The Commission received no comments on the amended plan. This order
approves the amended plan.
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    \1\ 15 U.S.C. 78q(d).
    \2\ 17 CFR 240.17d-2.
    \3\ Securities Exchange Act Release No. 55145 (January 22,
2007), 72 FR 3882.
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I. Introduction

    Section 19(g)(1) of the Act,\4\ among other things, requires every
national securities exchange and registered securities association
(``SRO'') to examine for, and enforce, compliance by its members and
persons associated with its members with the Act, the rules and
regulations thereunder, and the SRO's own rules, unless the SRO is
relieved of this responsibility pursuant to Section 17(d) or 19(g)(2)
of the Act.\5\ Without this relief, the statutory obligation of each
individual SRO could result in a pattern of multiple examinations of
broker-dealers that maintain memberships in more than one SRO (``common
members''). This regulatory duplication would add unnecessary expenses
for common members and their SROs.
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    \4\ 15 U.S.C. 78s(g)(1).
    \5\ 15 U.S.C. 78q(d) or 15 U.S.C. 78s(g)(2).
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    Section 17(d)(1) of the Act was intended, in part, to eliminate
unnecessary multiple examinations and regulatory duplication.\6\ With
respect to a common member, Section 17(d)(1) authorizes the Commission,
by rule or order, to relieve an SRO of the responsibility to receive
regulatory reports, to examine for and enforce compliance with
applicable statutes, rules and regulations, or to perform other
specified regulatory functions.
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    \6\ See Securities Act Amendments of 1975, Report of the Senate
Committee on Banking, Housing, and Urban Affairs to Accompany S.
249, S. Rep. No. 94-75, 94th Cong., 1st Session. 32 (1975).
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    To implement Section 17(d)(1), the Commission adopted two rules:
Rule 17d-1 and Rule 17d-2 under the Act.\7\ Rule 17d-1, adopted on
April 20, 1976,\8\ authorizes the Commission to name a single SRO as
the designated examining authority (``DEA'') to examine common members
for compliance with the financial responsibility requirements imposed
by the Act, or by Commission or SRO rules. When an SRO has been named
as a common member's DEA, all other SROs to which the common member
belongs are relieved of the responsibility to examine the firm for
compliance with applicable financial responsibility rules.
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    \7\ 17 CFR 240.17d-1 and 17 CFR 240.17d-2.
    \8\ See Securities Exchange Act Release No. 12352 (April 20,
1976), 41 FR 18809 (May 3, 1976).
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    Rule 17d-1 deals only with an SRO's obligations to enforce broker-
dealers' compliance with the financial responsibility requirements.
Rule 17d-1 does not relieve an SRO from its obligation to examine a
common member for compliance with its own rules and provisions of the
federal securities laws governing matters other than financial
responsibility, including sales practices, and trading activities and
practices.
    To address regulatory duplication in these other areas, on October
28, 1976, the Commission adopted Rule 17d-2 under the Act.\9\ This rule
permits SROs to propose joint plans allocating regulatory
responsibilities with respect to common members. Under paragraph (c) of
Rule 17d-2, the Commission may declare such a plan effective if, after
providing for notice and comment, it determines that the plan is
necessary or appropriate in the public interest and for the protection
of investors, to foster cooperation and coordination among the SROs, to
remove impediments to and foster the development of a national market
system and a national clearance and settlement system, and in
conformity with the factors set forth in Section 17(d) of the Act.
Commission approval of a plan filed pursuant to Rule 17d-2 relieves an
SRO of those regulatory responsibilities allocated by the plan to
another SRO.
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    \9\ See Securities Exchange Act Release No. 12935 (October 28,
1976), 41 FR 49093 (November 8, 1976).
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II. The Plan

    On September 8, 1983, the Commission approved the SRO participants'
plan for allocating regulatory responsibilities pursuant to Rule 17d-
2.\10\ On May 23, 2000, the Commission approved an amendment to the
plan that added the ISE as a participant.\11\ On November 8, 2002, the
Commission approved another amendment that replaced the original plan
in its entirety and, among other things, allocated regulatory
responsibilities among all the participants in a more equitable
manner.\12\ On February 5, 2004, the parties submitted an amendment to
the plan, primarily to include the BSE, which was establishing a new
options trading facility to be known as the Boston Options Exchange
(``BOX''), as an SRO participant.\13\
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    \10\ See Securities Exchange Act Release No. 20158 (September 8,
1983), 48 FR 41256 (September 14, 1983).
    \11\ See Securities Exchange Act Release No. 42816 (May 23,
2000), 65 FR 24759 (May 31, 2000).
    \12\ See Securities Exchange Act Release No. 46800 (November 8,
2002), 67 FR 69774 (November 19, 2002).
    \13\ See Securities Exchange Act Release No. 49197 (February 5,
2004), 69 FR 7046. (February 12, 2004).
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    The plan reduces regulatory duplication for a large number of firms
currently members of two or more of the SRO participants by allocating
regulatory responsibility for certain options-related sales practice
matters to one of the SRO participants. Generally, under the current
plan, the SRO participant responsible for conducting options-related
sales practice examinations of a firm, and investigating options-
related customer complaints and terminations for cause of associated
persons of that firm, is known as the firm's ``Designated Options
Examining Authority'' (``DOEA''). Pursuant to the current plan, any
other SRO of which the firm is a member is relieved of these
responsibilities during the period the firm is assigned to a DOEA.

III. Proposed Amendment to the Plan

    The purpose of the amended plan is to: (i) Provide that NASD and
NYSE will be DOEAs under the plan, (ii) provide that the Designated
Examination Authority pursuant to Commission Rule 17d-1 under the Act
for a broker-dealer that is a member of more than one SRO participant
(but not a member of the NASD or the NYSE) shall perform the regulatory
responsibility under the agreement as if such DEA were the DOEA, (iii)
to incorporate a more formal procedure for updating the list of common
rules, and (iv) make certain other changes to the plan. The amended
plan replaces the previous plan in its entirety.

IV. Discussion

    The Commission finds that the amended plan is consistent with the
factors set forth in Section 17(d) of the Act \14\ and Rule 17d-2(c)
thereunder \15\

in that the amended plan is necessary or appropriate in the public
interest and for the protection of investors, to foster cooperation and
coordination among self-regulatory organizations, and to remove
impediments to and foster the development of a national market system.
In particular, the Commission continues to believe that the plan is an
achievement in cooperation among the SRO participants, and that the
plan will reduce unnecessary regulatory duplication by allocating to
the designated SRO the responsibility for certain options-related sales
practice matters that would otherwise be performed by multiple SROs.
The plan promotes efficiency by reducing costs to firms that are
members of more than one of the SRO participants. In addition, because
the SRO participants coordinate their regulatory functions in
accordance with the plan, the plan promotes, and will continue to
promote, investor protection.
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    \14\ 15 U.S.C. 78q(d).
    \15\ 17 CFR 240.17d-2(c).
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V. Conclusion

    This order gives effect to the amended plan submitted to the
Commission that is contained in File No. S7-966. The SRO participants
shall notify all members affected by the amended plan of their rights
and obligations under the amended plan.
    It is therefore ordered, pursuant to Sections 17(d) \16\ of the
Act, that the amended plan of the Amex, BSE, CBOE, ISE, NASD, NYSE,
NYSE Arca, and Phlx filed pursuant to Rule 17d-2 \17\ is approved.
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    \16\ 15 U.S.C. 78q(d).
    \17\ 17 CFR 240.17d-2.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(34).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-5981 Filed 3-30-07; 8:45 am]

BILLING CODE 8010-01-P