[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Rules and Regulations]
[Pages 7864-7866]
[FR Doc No: 2023-02529]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-1412; Project Identifier MCAI-2022-00805-T;
Amendment 39-22314; AD 2023-02-07]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus SAS Model A300 B2K-3C, B2-203, B4-2C, and B4-203 airplanes. This
AD was prompted by a determination that internal system pollution can
occur, most likely due to corroded unions in the pressurization lines,
with an associated risk of contamination of the check valves. This AD
requires repetitive inspections (functional checks) of the
pressurization of the hydraulic system reservoirs, and corrective
actions if necessary, as specified in a European Union Aviation Safety
Agency (EASA) AD, which is incorporated by reference. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective March 14, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 14,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2022-1412; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For material incorporated by reference in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email [email protected]; website easa.europa.eu. You may
find this material on the EASA website at ad.easa.europa.eu.
     You may view this material at the FAA, Airworthiness
Products Section,

Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195. It is also available in the AD docket at regulations.gov
under Docket No. FAA-2022-1412.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, FAA, International Validation Branch, 2200 South
216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Airbus SAS Model
A300 B2-203, A300 B2K-3C, A300 B4-203, and A300 B4-2C airplanes. The
NPRM published in the Federal Register on November 18, 2022 (87 FR
69222).
    The NPRM was prompted by AD 2022-0116, dated June 21, 2022, issued
by EASA, which is the Technical Agent for the Member States of the
European Union (EASA AD 2022-0116) (also referred to as the MCAI). The
MCAI states that internal system pollution can occur, most likely due
to corroded unions at the pressurization lines, with an associated risk
of contamination of the check valves. The three hydraulic system
reservoirs are pressurized by air coming from the engine or the
auxiliary power unit bleed air duct or from the ground connection. Air
tightness of the pressurization system of the reservoirs is achieved by
check valves that are located on the respective pressurization lines
and on top of each hydraulic reservoir.
    In the NPRM, the FAA proposed to require repetitive inspections
(functional checks) of the pressurization of the hydraulic system
reservoirs, and corrective actions if necessary, as specified in EASA
AD 2022-0116. The FAA is issuing this AD to address check valve
contamination, which could lead to hydraulic reservoir pressurization
issues and, if combined with an air pressurization line rupture, could
lead to loss of hydraulic systems and possibly result in loss of
control of the airplane. See the MCAI for additional background
information.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2022-1412.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data and determined
that air safety requires adopting this AD as proposed. Accordingly, the
FAA is issuing this AD to address the unsafe condition on this product.
Except for minor editorial changes, this AD is adopted as proposed in
the NPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0116 specifies procedures for repetitive detailed
inspections by performing functional checks for air leakage of the
hydraulic system reservoirs and corrective actions. Corrective actions
include a fault isolation to identify the source of depressurization
and replacement of the check valves. EASA AD 2022-0116 also specifies
procedures for reporting the inspection findings.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 2 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                           Labor cost                               Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
4 work-hours x $85 per hour = $340..............................              $0            $340            $680
1 work-hour x $85 per hour = $85 (reporting)....................               0              85             170
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data on which to base the cost
estimates for the corrective actions specified in this AD.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a currently valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public
reporting for this collection of information is estimated to take
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden, to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2023-02-07 Airbus SAS: Amendment 39-22314; Docket No. FAA-2022-1412;
Project Identifier MCAI-2022-00805-T.

(a) Effective Date

    This airworthiness directive (AD) is effective March 14, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS Model A300 B2K-3C, B2-203, B4-
2C, and B4-203 airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code: 29, Hydraulic
power.

(e) Unsafe Condition

    This AD was prompted by a determination that internal system
pollution can occur, most likely due to corroded unions at
pressurization lines level, with an associated risk of contamination
of the check valves. The FAA is issuing this AD to address check
valve contamination, which could lead to hydraulic reservoir
pressurization issues and, if combined with an air pressurization
line rupture, could lead to loss of hydraulic systems and possibly
result in loss of control of the airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2022-0116, dated June 21, 2022 (EASA AD 2022-0116).

(h) Exceptions to EASA AD 2022-0116

    (1) Where EASA AD 2022-0116 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Paragraph (3) of EASA AD 2022-0116 specifies to report the
first functional check (test) results to Airbus within a certain
compliance time. For this AD, report the first functional check
(test) results at the applicable time specified in paragraph
(h)(2)(i) or (ii) of this AD.
    (i) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (ii) If the inspection was done before the effective date of
this AD: Submit the report within 30 days after the effective date
of this AD.
    (3) The ``Remarks'' section of EASA AD 2022-0116 does not apply
to this AD.

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (j) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (i)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(j) Additional Information

    For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0116,
dated June 21, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0116, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on January 20, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-02529 Filed 2-6-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Rules and Regulations]
[Pages 59821-59824]
[FR Doc No: 2013-22761]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2013-0827]
RIN 1625-AA00

Safety Zone, Delaware River; Wilmington, DE

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone during
the dredging of Cherry Island Range Deepwater Point Anchorage No. 6 in
the Delaware River. Norfolk

Construction and the Dredge ESSEX have been contracted by the Army
Corps of Engineers for maintenance dredging of a portion of the
Delaware River. Submerged pipeline will be present in the northern half
of Deepwater Anchorage No. 6 to facilitate the project.
    This regulation is necessary to provide for the safety of life on
the navigable waters of the Delaware River. This safety zone is
intended to restrict vessel traffic movement to protect mariners from
the hazards associated with the presence of the submerged pipeline in
the anchorage.

DATES: This rule is effective as to persons with actual notice from 5
a.m. on September 10, 2013, until 11 p.m. on October 15, 2013. In
compliance with 5 U.S.C. 552(a)(1), this rule is effective without
actual notice from the date it is published in the Federal Register,
September 30, 2013, until 11 p.m. on October 15, 2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0827]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Veronica Smith, Chief Waterways Management,
Sector Delaware Bay, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

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

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable and contrary to
the public interest. Immediate action is necessary to provide for the
safety of life and property in the navigable water. Publishing an NPRM
is impracticable given that the final details for this event were not
received by the Coast Guard until August 28, 2013. Vessels transiting
or attempting to transit the northern half of Deepwater Point Anchorage
No. 6 during pipe-laying or dredging operations may be at risk.
Delaying this rule to wait for a notice and comment period to run would
be contrary to the public interest as it would inhibit the Coast
Guard's ability to protect the public from the hazards associated with
pipe-laying and dredging operations.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Any delay encountered in this
regulation's effective date would be contrary to the public interest
because immediate action is needed to provide for the safety of life
and property from the hazards associated with pipe-laying operations.

B. Basis and Purpose

    The Army Corps of Engineers has hired Norfolk Dredging Company to
conduct maintenance dredging in the Delaware River main channel.
Norfolk Dredging Company will be placing submerged pipeline in the
northern half of Deepwater Point Anchorage with the Dredge Essex to
facilitate this project. This regulation is necessary because there
will be pipe-laying and dredging operations conducted in the anchorage
and navigable channel. The purpose of the rule is to protect mariners
and spectators in the area from the potential hazards associated with
pipe-laying and dredging operations. The Captain of the Port is
establishing this safety zone to ensure the safety of life and property
of all mariners and vessels transiting the local area.

C. Discussion of the Final Rule

    To mitigate the risks associated with the pipe-laying and dredging
operations, the Captain of the Port, Sector Delaware Bay will enforce a
safety zone while submerged pipeline is present through the duration of
the dredging operations in Cherry Island Range. The safety zone will
encompass all waters of Deepwater Anchorage No. 6, Delaware River,
Wilmington, DE from the northeast corner of the anchorage at position
39[deg]42.675' N, 075[deg]29.872' W to the northwest corner of
Anchorage No. 6, next to the channel at position 39[deg]42.842' N,
075[deg]30.386' W, south along the eastern channel boundary to position
39[deg]42.214' N, 075[deg]30.619' W, east to position 39[deg]42.223' N,
075[deg]30.287' W, then north to the first position. The safety zone
will be in effect for an estimated 36 day period from September 10,
2013, from 5:00 a.m. until October 15, 2013 at 11:00 p.m. unless
cancelled earlier by the Captain of the Port. Entry into, transiting,
or anchoring within the safety zone is prohibited unless authorized by
the Captain of the Port, Sector Delaware Bay, or her on-scene
representative. The Captain of the Port, Sector Delaware Bay, or her
on-scene representative may be contacted via VHF channel 16.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    Although this regulation will restrict vessel traffic from
operating within the safety zone on the navigable waters of Deepwater
Point Anchorage No. 6, Delaware River, Wilmington, DE, the effect of
this regulation will not be significant due to the limited duration of
the safety zone and the availability of other nearby anchorages. The
safety zone will be enforced in an area and in a manner that does
conflict with transiting commercial and recreational traffic. The Coast
Guard does not anticipate any significant economic impact because the
safety zone will only be enforced in the upper half of the anchorage
for a limited period of time. Furthermore, during the enforcement
period, vessels may request permission to transit through the safety
zone; permission may be granted by the on-

scene Coast Guard vessel on a case-by-case basis.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities:
    (1) This rule will affect the following entities, some of which
might be small entities: the owners or operators of vessels intending
to operate, transit, or anchor in a portion of Deepwater Point
Anchorage No. 6 from September 10, 2013 until October 15, 2013 unless
cancelled earlier by the Captain of the Port.
    (2) This safety zone will not have a significant economic impact on
a substantial number of small entities for the following reasons: this
rule will only be enforced for a short period of time. In the event
that this temporary safety zone affects shipping, commercial vessels
may request permission from the Captain of the Port, Sector Delaware
Bay, to transit through the safety zone. Before activation of the zone,
we will give notice to the public via a Broadcast Notice to Mariners
that the regulation is in effect.

3. Assistance for Small Entities

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

4. Collection of Information

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

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children

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

11. Indian Tribal Governments

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

12. Energy Effects

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

13. Technical Standards

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

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves implementation of regulations within 33
CFR Part 165, applicable to safety zones on the navigable waterways.
This zone will temporarily restrict vessel traffic from transiting
through Deepwater Point Anchorage No. 6 in order to protect the safety
of life and property on the waters while submerged dredge pipe-laying
and dredging operations are conducted. This rule is categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of the
Commandant Instruction. We seek any comments or information that may
lead to the discovery of a significant environmental impact from this
rule.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. Add Sec.  165.T05-0827, to read as follows:

Sec.  165.T05-0827  Safety Zone, Submerged Dredge Pipeline and
Dredging, Deepwater Point Anchorage No. 6; Delaware River, Wilmington,
DE.

    (a) Regulated Area. The following area is a safety zone: The safety
zone will encompass all waters of Deepwater Anchorage No. 6, Delaware
River, Wilmington, DE from the northeast corner of the anchorage at
position 39[deg]42.675' N, 075[deg]29.872' W to the northwest corner of
Anchorage No. 6, next to the channel at position 39[deg]42.842'N,
075[deg]30.386' W, south along the eastern channel boundary to position
39[deg]42.214' N, 075[deg]30.619' W, east to position 39[deg]42.223' N,
075[deg]30.287' W, then north to the first position.
    (b) Regulations. The general safety zone regulations found in 33
CFR 165.23 apply to the safety zone created by this section Sec.
165.T05-0827.
    (1) All persons and vessels are prohibited from entering this zone,
except as authorized by the Coast Guard Captain of the Port or her
designated representative.
    (2) All persons or vessels wishing to transit through the Safety
Zone must request authorization to do so from the Captain of the Port
or her designated representative aboard the on-scene Coast Guard vessel
one hour prior to the intended time of transit.
    (3) Vessels granted permission to transit through the Safety Zone
must do so in accordance with the directions provided by the Captain of
the Port or her designated representative to the vessel.
    (4) To seek permission to transit this safety zone, the Captain of
the Port or her designated representative can be contacted via Sector
Delaware Bay Command Center<PHONE_NUMBER>.
    (5) This section applies to all vessels wishing to transit through
the safety zone except vessels that are engaged in the following
operations:
    (i) Enforcing laws;
    (ii) Servicing aids to navigation, and
    (iii) Emergency response vessels.
    (6) No person or vessel may enter or remain in a safety zone
without the permission of the Captain of the Port;
    (7) Each person and vessel in a safety zone shall obey any
direction or order of the Captain of the Port;
    (8) No person may board, or take or place any article or thing on
board, any vessel in a safety zone without the permission of the
Captain of the Port; and
    (9) No person may take or place any article or thing upon any
waterfront facility in a safety zone without the permission of the
Captain of the Port.
    (c) Definitions.
    (1) Captain of the Port means the Commander, Coast Guard Sector
Delaware Bay, or any Coast Guard commissioned, warrant or petty officer
who has been authorized by the Captain of the Port to act on her
behalf.
    (2) Designated representative means any Coast Guard commissioned,
warrant or petty officer who has been authorized by the Captain of the
Port Delaware Bay to assist in enforcing the safety zone described in
paragraph (a) of this section.
    (d) Enforcement. The U.S. Coast Guard may be assisted by Federal,
State, and local agencies in the patrol and enforcement of the zone.
    (e) Enforcement period. This section will be enforced for a 36 day
period from September 10, 2013, at 5:00 a.m. until October 15, 2013 at
11:00 p.m. unless cancelled earlier by the Captain of the Port.

    Dated: September 6, 2013.
Benjamin A. Cooper,
Captain, U.S. Coast Guard, Alternate Captain of the Port, Delaware Bay.
[FR Doc. 2013-22761 Filed 9-27-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45904-45906]
[FR Doc No: 2011-19383]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2011-0178]

Pipeline Safety: Information Collection Activities

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

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, PHMSA
invites comments on certain information collections pertaining to
pipeline safety for which PHMSA intends to request renewal from the
Office of Management and Budget (OMB).

DATES: Interested persons are invited to submit comments on or before
September 30, 2011.

ADDRESSES: Comments may be submitted in the following ways:
    E-Gov Web Site: http://www.regulations.gov. This site allows the
public to enter comments on any Federal Register notice issued by any
agency.
    Fax: 1-202-493-2251.
    Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building, Room W12-
140, Washington, DC 20590-0001.
    Hand Delivery: Room W12-140 on the ground level of the West
Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: Identify the docket number, PHMSA-2011-0178, at the
beginning of your comments. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. You should know that anyone is able to
search the electronic form of all comments received into any of our
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). Therefore, you may want to review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477) or visit http://www.regulations.gov before
submitting any such comments.
    Docket: For access to the docket or to read background documents or
comments, go to http://www.regulations.gov at any time or to Room W12-
140 on the ground level of the West Building, 1200 New Jersey Avenue,
SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. If you wish to receive confirmation of receipt
of your written comments, please include a self-addressed, stamped
postcard with the following statement: ``Comments on PHMSA-2011-0178.''
The Docket Clerk will date stamp the postcard prior to returning it to
you via the U.S. mail. Please note that due to delays in the delivery
of U.S. mail to Federal offices in Washington, DC, we recommend that
persons consider an alternative method (Internet, fax, or professional
delivery service) of submitting comments to the docket and ensuring
their timely receipt at DOT.

FOR FURTHER INFORMATION CONTACT: Angela Dow by telephone at 202-366-
1246, by fax at<PHONE_NUMBER>, or by mail at U.S. Department of
Transportation, Pipeline and Hazardous Materials Safety Administration,
1200 New Jersey Avenue, SE., PHP-30, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION: Section 1320.8(d), Title 5, Code of Federal
Regulations, requires PHMSA to provide interested members of the public
and affected agencies an opportunity to comment on information
collection and recordkeeping requests. This notice identifies several
information collection requests that PHMSA will be submitting to OMB
for renewal. The following information is provided for each information
collection: (1) Title of the information collection; (2) OMB control
number; (3) Current expiration date; (4) Type of request; (5) Abstract
of the information collection activity; (6) Description of affected
public; (7) Estimate of total annual reporting and recordkeeping
burden; and (8) Frequency of collection. PHMSA will

request a three-year term of approval for each information collection
activity. PHMSA requests comments on the following information
collections:
    Title: Requirements for Liquefied Natural Gas (LNG) Facilities.
    OMB Control Number: 2137-0048.
    Current Expiration Date: 1/31/2012.
    Abstract: Operators of liquefied natural gas facilities are
required under 49 CFR part 193 to maintain records, make reports, and
provide information to PHMSA and State pipeline safety agencies
concerning the operations of their facilities. The information aids
Federal and state pipeline safety inspectors in conducting compliance
inspections and investigating incidents.
    Affected Public: Operators of Liquefied Natural Gas Facilities.
    Annual Reporting and Recordkeeping Burden:

Total Annual Responses: 101.
Total Annual Burden Hours: 12,120.
Frequency of Collection: On Occasion.

    Title: Record Keeping for Natural Gas Pipeline Operators.
    OMB Control Number: 2137-0049.
    Current Expiration Date: 1/31/2012.
    Abstract: Operators of gas pipelines are required under 49 CFR part
192 to maintain records, make reports, and provide information to PHMSA
and State pipeline safety agencies concerning the operations of their
pipelines. The information aids Federal and state pipeline safety
inspectors in conducting compliance inspections and investigating
incidents.
    Affected Public: Operators of Natural Gas Pipeline Systems.
    Annual Reporting and Recordkeeping Burden:

Total Annual Responses: 2,300.
Total Annual Burden Hours: 940,454.
Frequency of collection: On occasion.

    Title: Pipeline Safety: Excess Flow Valves--Customer Notification.
    OMB Control Number: 2137-0593.
    Current Expiration Date: 1/31/2012.
    Abstract: Pipeline operators are required to provide notifications
about excess flow valves to service line customers as described in
Sec.  192.383. Upon request, an operator must make documentation of
compliance available to PHMSA or the appropriate state regulatory
agency.
    Affected Public: Pipeline Operators.
    Annual Reporting and Recordkeeping Burden:

Total Annual Responses: 900,000.
Total Annual Burden Hours: 18,000.
Frequency of collection: On Occasion.

    Title: Customer Owned Service Lines.
    OMB Control Number: 2137-0594.
    Current Expiration Date: 1/31/2012.
    Abstract: Operators of gas service lines who do not maintain
certain buried piping on behalf of their customers must provide
notification about maintenance to those customers (Sec.  192.16). Upon
request, an operator must make documentation of compliance available to
PHMSA or the appropriate state regulatory agency.
    Affected Public: Natural Gas Pipeline Operators.
    Annual Reporting and Recordkeeping Burden:

Total Annual Responses: 550, 000.
Total Annual Burden Hours: 9,167.
Frequency of collection: On Occasion.

    Title: Pipeline Safety: Qualification of Pipeline Safety, Training.
    OMB Control Number: 2137-0600.
    Current Expiration Date: 2/29/2012.
    Abstract: Pipeline operators are required to have continuing
programs for qualifying and training personnel performing safety-
sensitive functions on pipelines. (49 CFR part 192, Subpart N and 49
CFR part 195, Subpart G). Operators must maintain records, make
reports, and provide information to PHMSA and state pipeline safety
agencies concerning these programs. The information aids Federal and
state pipeline safety inspectors in conducting compliance inspections
and investigating incidents.
    Affected Public: Pipeline Operators.
    Annual Reporting and Recordkeeping Burden:

Total Annual Responses: 22,300.
Total Annual Burden Hours: 466,667.
Frequency of collection: On Occasion.

    Title: Pipeline Safety: Report of Abandoned Underwater Pipelines.
    OMB Control Number: 2137-0601.
    Current Expiration Date: 2/29/2012.
    Abstract: Pipeline operators are required to report certain
information about abandoned underwater pipelines to PHMSA (Sec.  195.59
and Sec.  192.727). The information aids Federal and state pipeline
safety inspectors in conducting compliance inspections and
investigating incidents.
    Affected Public: Operators of Underwater Pipelines.
    Annual Reporting and Recordkeeping Burden:

Annual Responses: 10.
Annual Burden Hours: 60.
Frequency of collection: On Occasion.

    Title: Pipeline Safety: Integrity Management in High Consequence
Areas for Operators with more than 500 Miles of Hazardous Liquid
Pipelines.
    OMB Control Number: 2137-0604.
    Current Expiration Date: 1/31/2012
    Abstract: Hazardous liquid operators with pipelines in high
consequence areas (i.e., commercially navigable waterways, high
population areas, other populated areas, and unusually sensitive areas
as defined in Sec.  195.450) are subject to certain information
collection requirements relative to the Integrity Management Program
provisions of Sec.  195.452.
    Affected Public: Pipeline operators with more than 500 miles of
hazardous liquid pipeline located in high consequence areas.
    Annual Reporting and Recordkeeping Burden:

Annual Responses: 71.
Annual Burden Hours: 57,510.
Frequency of collection: On Occasion.

    Title: Pipeline Safety: Integrity Management in High Consequence
Areas for Operators with Less than 500 Miles of Hazardous Liquid
Pipeline.
    OMB Control Number: 2137-0605.
    Current Expiration Date: 1/31/2012.
    Abstract: Hazardous liquid operators with pipelines in high
consequence areas (i.e., commercially navigable waterways, high
population areas, other populated areas, and unusually sensitive areas
as defined in Sec.  195.450) are subject to certain information
collection requirements relative to the Integrity Management Program
provisions of Sec.  195.452.
    Affected Public: Pipeline operators with less than 500 miles of
hazardous liquid pipeline located in high consequence areas.
    Annual Reporting and Recordkeeping Burden:

Annual Responses: 132.
Annual Burden Hours: 267,960.
Frequency of collection: On Occasion.

    Comments are invited on:
    (a) The need for the proposed collection of information for the
proper performance of the functions of the agency, including whether
the information will have practical utility;
    (b) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (c) Ways to enhance the quality, utility, and clarity of the
information to be collected; and
    (d) Ways to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques.

    Issued in Washington, DC, on July 27, 2011.
Alan K. Mayberry,
Deputy Associate Administrator for Field Operations.
[FR Doc. 2011-19383 Filed 7-29-11; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register: January 26, 2010 (Volume 75, Number 16)]
[Notices]
[Page 4134-4136]
[DOCID:fr26ja10-115]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2009-0421]

Pipeline Safety: Leak Detection on Hazardous Liquid Pipelines

AGENCY: Pipeline and Hazardous Materials Safety Administration; DOT.

ACTION: Notice; Issuance of Advisory Bulletin.

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SUMMARY: The Pipeline and Hazardous Materials Safety Administration
(PHMSA) is issuing this Advisory Bulletin to advise and remind
hazardous liquid pipeline operators of the importance of prompt and
effective leak detection capability in protecting public safety and the
environment.

FOR FURTHER INFORMATION CONTACT: Alan Mayberry by phone at<PHONE_NUMBER>
or by e-mail at<EMAIL_ADDRESS>regarding the subject matter of
this Advisory Bulletin,

or the Dockets Unit,<PHONE_NUMBER>, for copies of this Advisory Bulletin
or other material in the docket. All materials in this docket may be
accessed electronically at http://dms.dot.gov. General information
about the PHMSA Office of Pipeline Safety (OPS) can be obtained by
accessing OPS's Internet home page at http://www.phmsa.dot.gov/
pipeline.

SUPPLEMENTARY INFORMATION:

Background

    Pipeline leak detection is one of the many layers of protection in
PHMSA's approach to protecting people and the environment. The federal
hazardous liquid pipeline safety regulations require pipeline operators
to deploy a comprehensive set of safety measures to protect the public
and the environment including an effective means of identifying and
responding to hazardous liquid pipeline leaks at the earliest possible
time. Pipeline operators are continuously improving the cumulative
performance of these interconnected layers of protections, including
advances in leak detection systems. These protections include, but are
not limited to: Customized leak detection technology deployment;
periodic risk-based assessment and defect repair prioritized by
environmental and safety consequences; corrosion management; pipeline
right-of-way surveillance; public awareness activities resulting in
enhanced citizen leak condition recognition and response; emergency
preparedness and coordinated response, including ongoing liaison
efforts with emergency responders; and a review and incorporation of
lessons learned from accident analyses and investigations.
    Recently, the National Transportation Safety Board (NTSB) issued a
safety study on pipeline Supervisory Control and Data Acquisition
(SCADA) systems (NTSB/SS-05/02). The number of hazardous liquid
accidents investigated by the NTSB in which leaks went undetected after
indications of a leak on the SCADA interface was the impetus for this
study. The NTSB examined 13 hazardous liquid pipeline accidents that
they investigated from April 1992 to October 2004. The conclusions made
by the NTSB in the study reflected the importance of monitoring
systems, promptly recognizing leak incidents, and minimizing damage
with quick response. PHMSA encourages all hazardous liquid pipeline
operators to review the safety study which is available on the NTSB
webpage.
    Under current regulations, all hazardous liquid pipeline operators
are required to periodically patrol their pipeline right-of-ways. This
effort is performed principally to guard against third-party activity
that has the potential to damage the pipeline, and is also performed to
detect very small leaks not detected by other means. Often, the leaking
product has impacted vegetation or has pooled on the surface, and
therefore leaves visual cues. Conducting these surveillance activities
is very important, but they are not sufficient on their own to address
all aspects of leak detection. Hazardous liquid pipeline operators are
also expected to track product movement along the pipelines in order to
ensure that all product going into the pipeline arrives at interim
storage points, and eventually reaches its destination. This
traditional and basic method of leak detection by tracking product
movement is essential to an understanding of line balance. Relatively
short pipelines, operating with a single source and a single
destination, can usually perform this process rather simply, if
adequate and timely information is made available. With these more
simple pipelines, the line balance technique for leak detection can
often be performed with manual calculations, without the need of a
computerized process. Those pipeline operators with longer and more
complex systems, with multiple sources and/or destinations, are more
dependent on computerized processes to perform a thorough product
tracking resulting in a leak detection process. The more complex a
pipeline operation, especially when carrying numerous products through
batch operations, the greater the need for a sophisticated leak
detection process.
    Currently, there are 421 hazardous liquid pipeline operators. Two
hundred and twenty of the operators have pipelines less than 50 miles
long, 96 operators have pipelines 50 to 250 miles long, and 105
operators have pipelines longer than 250 miles in length. Many of the
operators with higher mileage have configured their pipelines into
networks, sometimes collecting product from multiple sources and
delivering product to multiple destinations, making the leak detection
process complex. At the same time, we recognize that in some cases the
engineering analysis performed on point-to-point pipeline systems has
determined that installing a computer-based leak detection system does
not offer substantial improvements in leak detection capability beyond
that of a simple manual line balance calculation process.
    Under 49 CFR 195.444, pipeline operators using a computer-based
leak detection system are required to comply with API RP 1130. Pipeline
operators who do not employ computerized leak detection still need to
safely and effectively perform the basic process of monitoring flow and
pressure to detect large pipeline breaks. The line balance processes
incorporating SCADA or other technology are geared to find less obvious
failures such as partial line breaks and smaller leaks not apparent in
general flow and pressure monitoring. When a pipeline operator has
determined or selected to use a traditional line balance process
through manual calculation, it is PHMSA's expectation that these
operators would have systems configured and staffed in such a manner as
to routinely, safely and accurately perform this manual calculation
process at a maximum of one-hour intervals. The appropriate interval
should be determined by engineering review, but should not exceed one
hour. This hourly process is especially important any time product is
flowing; but since leaks can occur at any time, all unexplained meter
movements or pressure changes should be promptly investigated to
minimize potential leak durations even if a line segment is shutdown.
In addition, operators need to ensure open and regular communication
between all active source and delivery points along the pipeline,
either through verbal communication or through the use of SCADA or
other similar technology.
    Operators of point-to-point hazardous liquid pipeline systems are
obligated to have a prompt and effective means of detecting and
responding to leaks. In order to ensure the safe and environmentally
sound operation of their hazardous liquid pipelines, the operating
plans and procedures required by the pipeline safety regulations should
include the performance of an engineering analysis to determine if a
computerized leak detection system is necessary and appropriate. If the
analysis determines that a computerized leak detection system is
unnecessary, the operator should perform a line balance calculation and
review process at no greater than one-hour intervals whenever product
is flowing through the line, and monitor for pressure changes, meter
movement and tank level changes even when the line is not flowing. As
part of the recordkeeping requirements under current regulations,
operators must retain documentation from any related engineering
analyses for the computerized leak detection and line balance
considerations to demonstrate the thoroughness of review during an
inspection.

II. Advisory Bulletin ADB-10-01

    To: Owners or Operators of Hazardous Liquid Pipelines.
    Subject: Leak Detection on Hazardous Liquid Pipelines.
    Advisory: The Pipeline and Hazardous Materials Safety
Administration (PHMSA) is advising and reminding hazardous liquid
pipeline operators of the importance of prompt and effective leak
detection capability in protecting public safety and the environment.
In order to ensure the safe and environmentally sound operation of
their hazardous liquid pipelines, the operating plans and procedures
required by the pipeline safety regulations should include the
performance of an engineering analysis to determine if a computer-based
leak detection system is necessary to improve leak detection
performance and line balance processes. If an operator that does not
have a computer-based leak detection system performs an engineering
analysis and determines that such a system would not improve leak
detection performance and line balance processes, the operator should
perform the periodic line balance calculation process outlined herein
and take any other necessary actions required to ensure public safety
and protect the environment.

    Issued in Washington, DC, on January 19, 2010.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2010-1497 Filed 1-25-10; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 77, Number 132 (Tuesday, July 10, 2012)]
[Notices]
[Pages 40684-40688]
[FR Doc No: 2012-16765]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67343; File No. SR-Phlx-2012-81]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing of Proposed Rule Change With Respect to the Authority of the
Exchange or NASDAQ Execution Services to Cancel Orders When a Technical
or System Issue Occurs on the Exchange's NASDAQ OMX PSX Facility and To
Describe the Operation of an Error Account for NES

July 3, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on June 27, 2012, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,
and III, below, which Items have been prepared by the Exchange. The

Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to file with the Commission a proposal with
respect to the authority of the Exchange or NASDAQ Execution Services
(``NES'') to cancel orders when a technical or system issue occurs on
the Exchange's NASDAQ OMX PSX facility (``PSX'') and to describe the
operation of an error account for NES.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaqtrader.com/micro.aspx?id=PHLXRulefilings,
at the principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The Exchange proposes to amend Rule 3315 by adding a new paragraph
(d) that addresses the authority of the Exchange or NES to cancel
orders when a technical or systems issue occurs on PSX and to describe
the operation of an error account for NES.\3\ NES is the approved [sic]
routing broker of PSX, subject to the conditions listed in Rule 3315.
The Exchange relies on NES to provide outbound routing services from
itself to routing destinations of NES (``routing destinations'').\4\
When NES routes orders to a routing destination, it does so by sending
a corresponding order in its own name to the routing destination. In
the normal course, routed orders that are executed at routing
destinations are submitted for clearance and settlement in the name of
NES, and NES arranges for any resulting securities positions to be
delivered to the member that submitted the corresponding order to the
Exchange. From time to time, however, the Exchange and NES encounter
situations in which it becomes necessary to cancel orders and resolve
error positions.\5\
---------------------------------------------------------------------------

    \3\ NES is a facility of the Exchange. Accordingly, under Rule
3315, the Exchange is responsible for filing with the Commission
rule changes and fees relating to NES's functions. In addition, the
Exchange is using the phrase ``NES or the Exchange'' in this rule
filing to reflect the fact that a decision to take action with
respect to orders affected by a technical or systems issue may be
made in the capacity of NES or the Exchange depending on where those
orders are located at the time of that decision. This filing applies
only to transactions in cash equities.
    From time to time, the Exchange also uses non-affiliate third-
party broker-dealers to provide outbound routing services (i.e.,
third-party Routing Brokers). In those cases, orders are submitted
to the third-party Routing Broker through NES, the third-party
Routing Broker routes the orders to the routing destination in its
name, and any executions are submitted for clearance and settlement
in the name of NES so that any resulting positions are delivered to
NES upon settlement. As described above, NES normally arranges for
any resulting securities positions to be delivered to the member
that submitted the corresponding order to the Exchange. If error
positions (as defined in proposed Rule 3315(d)(2)) result in
connection with the Exchange's use of a third-party Routing Broker
for outbound routing, and those positions are delivered to NES
through the clearance and settlement process, NES would be permitted
to resolve those positions in accordance with proposed Rule 3315(d).
If the third-party Routing Broker received error positions in
connection with its role as a routing broker for the Exchange, and
the error positions were not delivered to NES through the clearance
and settlement process, then the third-party Routing Broker would
resolve the error positions itself, and NES would not be permitted
to accept the error positions, as set forth in proposed Rule
3315(d)(2)(B).
    \4\ The Exchange has authority to receive inbound routes of
equities orders by NES from The NASDAQ Stock Market (``NASDAQ'') and
NASDAQ OMX BX, Inc. (``BX''). See Securities Exchange Act Release
Nos. 66178 (January 18, 2012), 77 FR 3539 (January 24, 2012) (SR-
Phlx-2011-170); 65553 (October 13, 2011), 76 FR 64987 (October 19,
2011) (SR-Phlx-2011-138).
    \5\ The examples described in this filing are not intended to be
exclusive. Proposed Rule 3315(d) would provide general authority for
the Exchange or NES to cancel orders in order to maintain fair and
orderly markets when technical and systems issues are occurring, and
Rule 3315(d) also would set forth the manner in which error
positions may be handled by the Exchange or NES. The proposed rule
change is not limited to addressing order cancellation or error
positions resulting only from the specific examples described in
this filing.
---------------------------------------------------------------------------

Examples of Circumstances That May Lead to Canceled Orders
    A technical or systems issue may arise at NES, a routing
destination, or the Exchange that may cause the Exchange or NES to take
steps to cancel orders if the Exchange or NES determines that such
action is necessary to maintain a fair and orderly market. The examples
set forth below describe some of the circumstances in which the
Exchange or NES may decide to cancel orders.

    Example 1. If NES or a routing destination experiences a
technical or systems issue that results in NES not receiving
responses to immediate or cancel (``IOC'') orders that it sent to
the routing destination, and that issue is not resolved in a timely
manner, NES or the Exchange would seek to cancel the routed orders
affected by the issue.\6\ For instance, if NES experiences a
connectivity issue affecting the manner in which it sends or
receives order messages to or from routing destinations, it may be
unable to receive timely execution or cancellation reports from the
routing destinations, and NES or the Exchange may consequently seek
to cancel the affected routed orders. Once the decision is made to
cancel those routed orders, any cancellation that a member submitted
to the Exchange on its initial order during such a situation would
be honored.\7\
---------------------------------------------------------------------------

    \6\ In a normal situation (i.e., one in which a technical or
systems issue does not exist), NES should receive an immediate
response to an IOC order from a routing destination, and would pass
the resulting fill or cancellation on to the Exchange member. After
submitting an order that is routed to a routing destination, if a
member sends an instruction to cancel that order, the cancellation
is held by the Exchange until a response is received from the
routing destination. For instance, if the routing destination
executes that order, the execution would be passed on to the member
and the cancellation instruction would be disregarded.
    \7\ If a member did not submit a cancellation to the Exchange,
however, that initial order would remain ``live'' and thus be
eligible for execution or posting on the Exchange, and neither the
Exchange nor NES would treat any execution of that initial order or
any subsequent routed order related to that initial order as an
error.
---------------------------------------------------------------------------

    Example 2. If the Exchange experiences a systems issue, the
Exchange may take steps to cancel all outstanding orders affected by
that issue and notify affected members of the cancellations. In
those cases, the Exchange would seek to cancel any routed orders
related to the members' initial orders.
Examples of Circumstances That May Lead to Error Positions
    In some instances, the technical or systems issue at NES, a routing
destination, the Exchange, or a non-affiliate third party Routing
Broker may also result in NES acquiring an error position that it must
resolve. The examples set forth below describe some of the
circumstances in which error positions may arise.

    Example A. Error positions may result from routed orders that
the Exchange or NES attempts to cancel but that are executed before
the routing destination receives the cancellation message or that
are executed because the routing destination is unable to process
the cancellation message. Using the situation described in Example 1
above, assume that the Exchange seeks to cancel orders routed to a
routing destination because it is not receiving timely execution or
cancellation reports from the routing destination. In such a
situation, NES may still receive executions from the routing
destination after connectivity is restored, which it would not then
allocate to members because of the earlier decision to cancel the

affected routed orders. Instead, NES would post those positions into
its error account and resolve the positions in the manner described
below.
    Example B. Error positions may result from an order processing
issue at a routing destination. For instance, if a routing
destination experienced a systems problem that affects its order
processing, it may transmit back a message purporting to cancel a
routed order, but then subsequently submit an execution of that same
order (i.e., a locked-in trade) to The Depository Trust & Clearing
Corporation (``DTCC'') for clearance and settlement. In such a
situation, the Exchange would not then allocate the execution to the
member because of the earlier cancellation message from the routing
destination. Instead, NES would post those positions into its error
account and resolve the positions in the manner described below.
    Example C. Error positions may result if NES receives an
execution report from a routing destination but does not receive
clearing instructions for the execution from the routing
destination. For instance, assume that a member sends the Exchange
an order to buy 100 shares of ABC stock, which causes NES to send an
order to a routing destination that is subsequently executed,
cleared, and closed out by that routing destination, and the
execution is ultimately communicated back to that member. On the
next trading day (T+1), if the routing destination does not provide
clearing instructions for that execution, NES would still be
responsible for settling that member's purchase, but would be left
with a short position in its error account.\8\ NES would resolve the
position in the manner described below.
---------------------------------------------------------------------------

    \8\ To the extent that NES incurred a loss in covering its short
position, it would submit a reimbursement claim to that routing
destination.
---------------------------------------------------------------------------

    Example D. Error positions may result from a technical or
systems issue that causes orders to be executed in the name of NES
that are not related to NES's function as the Exchange's routing
broker and are not related to any corresponding orders of members.
As a result, NES would not be able to assign any positions resulting
from such an issue to members. Instead, NES would post those
positions into its error account and resolve the positions in the
manner described below.
    Example E. Error positions may result from a technical or
systems issue through which the Exchange does not receive sufficient
notice that a member that has executed trades on the Exchange has
lost the ability to clear trades through DTCC. In such a situation,
the Exchange would not have valid clearing information, which would
prevent the trade from being automatically processed for clearance
and settlement on a locked-in basis. Accordingly, NES would assume
that member's side of the trades so that the counterparties can
settle the trades. NES would post those positions into its error
account and resolve the positions in the manner described below.
    Example F.  Error positions may result from a technical or
systems issue at the Exchange that does not involve routing of
orders through NES. For example, a situation may arise in which a
posted quote/order was validly cancelled but the system erroneously
matched that quote/order with an order that was seeking to access
it. In such a situation, NES would have to assume the side of the
trade opposite the order seeking to access the cancelled quote/
order. NES would post the position in its error account and resolve
the position in the manner described below.

    In the circumstances described above, neither the Exchange nor NES
may learn about an error position until T+1, either: (1) During the
clearing process when a routing destination has submitted to DTCC a
transaction for clearance and settlement for which NES never received
an execution confirmation; or (2) when a routing destination does not
recognize a transaction submitted by NES to DTCC for clearance and
settlement. Moreover, the affected members' trade may not be nullified
absent express authority under Exchange rules.\9\
---------------------------------------------------------------------------

    \9\ See, e.g., Rule 3312 (regarding clearly erroneous
executions).
---------------------------------------------------------------------------

Proposed Amendments to Rule 3315
    The Exchange proposes to amend Rule 3315 to add new paragraph (d)
to address the cancellation of orders due to technical or systems
issues and the use of an error account by NES.
    Specifically, under paragraph (d)(1) of the proposed rule, the
Exchange or NES would be expressly authorized to cancel orders as may
be necessary to maintain fair and orderly markets if a technical or
systems issue occurred at the Exchange, NES, or a routing
destination.\10\ The Exchange or NES would be required to provide
notice of the cancellation to affected members as soon as practicable.
---------------------------------------------------------------------------

    \10\ Such a situation may not cause the Exchange to declare
self-help against the routing destination pursuant to Rule 611 of
Regulation NMS. If the Exchange or NES determines to cancel orders
routed to a routing destination under proposed Rule 3315(d), but
does not declare self-help against that routing destination, the
Exchange would continue to be subject to the trade-through
requirements in Rule 611 with respect to that routing destination.
---------------------------------------------------------------------------

    Paragraph (d)(2) of the proposed rule would permit NES to maintain
an error account for the purpose of addressing positions that result
from a technical or systems issue at NES, the Exchange, a routing
destination, or a non-affiliate third-party Routing Broker that affects
one or more orders (``error positions''). By definition, an error
position would not include any position that results from an order
submitted by a member to the Exchange that is executed on the Exchange
and automatically processed for clearance and settlement on a locked-in
basis. NES also would not be permitted to accept any positions in its
error account from an account of a member and could not permit any
member to transfer any positions from the member's account to NES's
error account under the proposed rule.\11\ However, if a technical or
systems issue results in the Exchange not having valid clearing
instructions for a member to a trade, NES may assume that member's side
of the trade so that the trade can be processed for clearance and
settlement on a locked-in basis.\12\
---------------------------------------------------------------------------

    \11\ The purpose of this provision is to clarify that NES may
address error positions under the proposed rule that are caused by a
technical or systems issue, but that NES may not accept from a
member positions that are delivered to the member through the
clearance and settlement process, even if those positions may have
been related to a technical or systems issue at NES, the Exchange, a
routing destination of NES, or a non-affiliate third-party Routing
Broker. This provision would not apply, however, to situations like
the one described in Example C in which NES incurred a short
position to settle a member's purchase, as the member did not yet
have a position in its account as a result of the purchase at the
time of NES's action (i.e., NES's action was necessary for the
purchase to settle into the member's account). Similarly, the
provision would not apply to situations like the one described in
Example F, where a system issue caused one member to receive an
execution for which there was not an available contraparty, in which
case action by NES would be necessary for the position to settle
into that member's account. Moreover, to the extent a member
receives locked-in positions in connection with a technical or
systems issue, that member may seek to rely on Phlx Rule 3226 if it
experiences a loss. That rule provides members with the ability to
file claims against the Exchange for ``losses directly resulting
from the [PSX] System's actual failure to correctly process an
order, message, or other data, provided PSX has acknowledged receipt
of the order, message, or data.''
    \12\ See Example E above.
---------------------------------------------------------------------------

    Under paragraph (d)(3), in connection with a particular technical
or systems issue, NES or the Exchange would be permitted to either (i)
assign all resulting error positions to members, or (ii) have all
resulting error positions liquidated, as described below. Any
determination to assign or liquidate error positions, as well as any
resulting assignments, would be required to be made in a
nondiscriminatory fashion.
    NES or the Exchange would be required to assign all error positions
resulting from a particular technical or systems issue to the
applicable members affected by that technical or systems issue if NES
or the Exchange:
     Determined that it has accurate and sufficient information
(including valid clearing information) to assign the positions to all
of the applicable members affected by that technical or systems issue;
     Determined that it has sufficient time pursuant to normal
clearance and settlement deadlines to evaluate the information
necessary to assign the positions to all of the applicable members
affected by that technical or systems issue; and

     Had not determined to cancel all orders affected by that
technical or systems issue.
    For example, a technical or systems issue of limited scope or
duration may occur at a routing destination, and the resulting trades
may be submitted for clearance and settlement by such routing
destination to DTCC. If there were a small number of trades, there may
be sufficient time to match positions with member orders and avoid
using the error account.
    There may be scenarios, however, where NES determines that it is
unable to assign all error positions resulting from a particular
technical or systems issue to all of the affected members, or
determines to cancel all affected routed orders. For example, in some
cases, the volume of questionable executions and positions resulting
from a technical or systems issue might be such that the research
necessary to determine which members to assign those executions to
could be expected to extend past the normal settlement cycle for such
executions. Furthermore, if a routing destination experiences a
technical or systems issue after NES has transmitted IOC orders to it
that prevents NES from receiving responses to those orders, NES or the
Exchange may determine to cancel all routed orders affected by that
issue. In such a situation, NES or the Exchange would not pass on to
the members any executions on the routed orders received from the
routing destination.
    The proposed rule also would require NES to liquidate error
positions as soon as practicable.\13\ In liquidating error positions,
NES would be required to provide complete time and price discretion for
the trading to liquidate the error positions to a third-party broker-
dealer and could not attempt to exercise any influence or control over
the timing or methods of trading to liquidate the error positions.\14\
NES also would be required to establish and enforce policies and
procedures reasonably designed to restrict the flow of confidential and
proprietary information between the third-party broker-dealer and NES/
the Exchange associated with the liquidation of the error positions.
---------------------------------------------------------------------------

    \13\ If NES determines in connection with a particular technical
or systems issue that some error positions can be assigned to some
affected members but other error positions cannot be assigned, NES
would be required under the proposed rule to liquidate all such
error positions (including those positions that could be assigned to
the affected members).
    \14\ This provision is not intended to preclude NES from
providing the third-party broker with standing instructions with
respect to the manner in which it should handle all error account
transactions. For example, NES might instruct the broker to treat
all orders as ``not held'' and to attempt to minimize any market
impact on the price of the stock being traded.
---------------------------------------------------------------------------

    Under proposed paragraph (d)(4), NES and the Exchange would be
required to make and keep records to document all determinations to
treat positions as error positions and all determinations for the
assignment of error positions to members or the liquidation of error
positions, as well as records associated with the liquidation of error
positions through the third-party broker-dealer.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \15\ of
the Securities Exchange Act of 1934 (the ``Act''), in general, and
furthers the objectives of Section 6(b)(5),\16\ in particular, in that
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system and,
in general, to protect investors and the public interest, and it is not
designed to permit unfair discrimination among customers, brokers, or
dealers. The Exchange believes that this proposal is in keeping with
those principles since NES's or the Exchange's ability to cancel orders
during a technical and systems issue and to maintain an error account
facilitates the smooth and efficient operations of the market.
Specifically, the Exchange believes that allowing NES or the Exchange
to cancel orders during a technical or systems issue would allow the
Exchange to maintain fair and orderly markets. Moreover, the Exchange
believes that allowing NES to assume error positions in an error
account and to liquidate those positions, subject to the conditions set
forth in the proposed amendments to Rule 3315, would be the least
disruptive means to correct these errors, except in cases where NES can
assign all such error positions to all affected members of the
Exchange. Overall, the proposed amendments are designed to ensure full
trade certainty for market participants and to avoid disrupting the
clearance and settlement process. The proposed amendments are also
designed to provide a consistent methodology for handling error
positions in a manner that does not discriminate among members. The
proposed amendments are also consistent with Section 6 of the Act
insofar as they would require NES to establish controls to restrict the
flow of any confidential information between the third-party broker and
NES/the Exchange associated with the liquidation of error positions.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were either solicited or received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission shall:
(a) By order approve or disapprove such proposed rule change, or (b)
institute proceedings to determine whether the proposed rule change
should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2012-81 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2012-81. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use

only one method. The Commission will post all comments on the
Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549, on official business days between the hours of 10 a.m. and 3
p.m. Copies of the filing also will be available for inspection and
copying at the principal office of the Exchange. All comments received
will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2012-81, and should be submitted on
or before July 31, 2012.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-16765 Filed 7-9-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Notices]
[Page 24211]
[FR Doc No: 2013-09640]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0401]

Draft Guidance for Industry on Safety Considerations for
Container Labels and Carton Labeling Design To Minimize Medication
Errors; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Safety
Considerations for Container Labels and Carton Labeling Design to
Minimize Medication Errors.'' The draft guidance focuses on safety
aspects of the container label and carton labeling design for
prescription drug and biological products. The draft guidance provides
sponsors of new drug applications (NDAs), biologics licensing
applications (BLAs), abbreviated new drug applications (ANDAs), and
prescription drugs marketed without an approved NDA or ANDA with a set
of principles and recommendations for ensuring that critical elements
of product container labels and carton labeling are designed to promote
safe dispensing, administration, and use of the product to minimize
medication errors.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g), to ensure that the Agency considers your comments on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by June 24, 2013.

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

FOR FURTHER INFORMATION CONTACT: Carol Holquist, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4416, Silver Spring, MD 20993-0002, 301-
796-0171.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Safety Considerations for Container Labels and Carton
Labeling Design to Minimize Medication Errors.'' In Title I of the Food
and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-
85), Congress reauthorized and expanded the Prescription Drug User Fee
Act program for fiscal years (FYs) 2008 through 2012 (PDUFA IV). As
part of the performance goals and procedures set forth in an enclosure
to the letter from the Secretary of Health and Human Services referred
to in section 101(c) of FDAAA, FDA committed to certain performance
goals and procedures. (See http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm). In that letter, FDA stated that
it would use fees collected under PDUFA to implement various measures
to reduce medication errors related to look-alike and sound-alike
proprietary names, unclear label abbreviations, acronyms, dose
designations, and error-prone label and packaging designs. Among these
measures, FDA agreed that by the end of FY 2010, after public
consultation with academia, industry, other stakeholders, and the
general public, the Agency would publish draft guidance describing
practices for naming, labeling, and packaging drugs and biologics to
reduce medication errors. On June 24 and 25, 2010, FDA held a public
workshop and opened a public docket (Docket No. FDA-2010-N-0168) to
receive comments on these measures.
    This draft guidance document, which addresses safety achieved
through the design of drug product container labels and carton labeling
design, is the second in a series of three planned guidance documents
to minimize risks contributing to medication errors. The first guidance
focuses on minimizing risks with the design of drug product and
container closure design (December 13, 2012, 77 FR 74196), and the
third guidance will focus on minimizing risks with drug product
nomenclature.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance
represents the Agency's current thinking on addressing safety achieved
through drug product design to minimize medication errors. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520), before publication of the final guidance document, FDA
intends to solicit public comment and obtain OMB approval for any
information collections recommended in this draft guidance that are new
or that would represent material modifications to previously approved
collections of information found in FDA regulations.

IV. Electronic Access

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

    Dated: April 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09640 Filed 4-23-13; 8:45 am]
BILLING CODE 4160-01-P