[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Rules and Regulations]
[Pages 79300-79303]
[FR Doc No: 2013-31218]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2013-N-0581]

Cardiovascular Devices; Reclassification of Intra-Aortic Balloon
and Control Systems for Acute Coronary Syndrome, Cardiac and Non-
Cardiac Surgery, or Complications of Heart Failure; Effective Date of
Requirement for Premarket Approval for Intra-Aortic Balloon and Control
Systems for Septic Shock or Pulsatile Flow Generation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final
order to reclassify intra-aortic balloon and control system (IABP)
devices when indicated for acute coronary syndrome, cardiac and non-
cardiac surgery, or complications of heart failure, a preamendments
class III device, into class II (special controls), and to require the
filing of a premarket approval application (PMA) or a notice of
completion of a product development protocol (PDP) for IABPs when
indicated for septic shock or pulsatile flow generation.

DATES: This order is effective December 30, 2013.

FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.
105-115), the Medical Device User Fee and Modernization Act of 2002
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub.
L. 108-214), the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85), and the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144), establish a comprehensive
system for the regulation of medical devices intended for human use.
Section 513 of the FD&C Act (21 U.S.C. 360c) established three
categories (classes) of devices, reflecting the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification (510(k)) procedures to such a preamendments device or to a
device within that type may be marketed without submission of a PMA
until FDA issues a final order under section 515(b) of the FD&C Act (21
U.S.C. 360e(b)) requiring premarket approval or until the device is
subsequently reclassified into class I or class II. Section 515(b)(1)
of the FD&C Act directs FDA to issue an order requiring premarket
approval for a preamendments class III device.
    Although, under the FD&C Act, the manufacturer of a class III
preamendments device may respond to the call for PMAs by filing a PMA
or a notice of completion of a PDP, in practice, the option of filing a
notice of completion of a PDP has not been used. For simplicity,
although corresponding requirements for PDPs remain available to
manufacturers in response to a final order under section 515(b) of the
FD&C Act, this document will refer only to the requirement for the
filing and receiving approval of a PMA.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA
amended section 513(e) of the FD&C Act changing the mechanism for
reclassifying a device from rulemaking to an administrative order.
Section 608(b) of FDASIA amended section 515(b) of the FD&C Act
changing the mechanism for requiring premarket approval for a
preamendments class III device from rulemaking to an administrative
order.

A. Reclassification

    FDA is reclassifying IABP devices when indicated for acute coronary
syndrome, cardiac and non-cardiac surgery, or complications of heart
failure from class III to class II.
    Section 513(e) of the FD&C Act governs reclassification of
classified preamendments devices. This section provides that FDA may,
by administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
a preamendments device. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland-Rantos
Co. v. United States Department of Health, Education, and Welfare, 587
F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available authority (see Bell, 366 F.2d at 181;
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951).
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) of the
FD&C Act must be ``valid scientific evidence,'' as defined in section
513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General
Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir.

1985); Contact Lens Manufacturers Association v. FDA, 766 F.2d 592
(D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).) Section
520(h)(4) of the FD&C Act, added by FDAMA, provides that FDA may use,
for reclassification of a device, certain information in a PMA 6 years
after the application has been approved. This can include information
from clinical and preclinical tests or studies that demonstrate the
safety or effectiveness of the device but does not include descriptions
of methods of manufacture or product composition and other trade
secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order reclassifying a device, the following must occur: (1) Publication
of a proposed order in the Federal Register; (2) a meeting of a device
classification panel described in section 513(b) of the FD&C Act; and
(3) consideration of comments to a public docket. FDA held a meeting of
a device classification panel described in section 513(b) of the FD&C
Act with respect to IABP devices on December 5, 2012 (the 2012 Panel).
The 2012 Panel recommended that IABP devices indicated for acute
coronary syndrome, cardiac and non-cardiac surgery, or complications of
heart failure be reclassified to class II with special controls. The
2012 Panel agreed with FDA's conclusion that the available scientific
evidence is adequate to support the safety and effectiveness of IABP
devices indicated for acute coronary syndrome, cardiac and non-cardiac
surgery, or complications of heart failure. The 2012 Panel further
agreed that the special controls identified by FDA were appropriate to
mitigate the relevant risks to health for this use. FDA published a
proposed order in the Federal Register of June 19, 2013 (78 FR 36702)
(the 2013 proposed order). FDA received and has considered one comment
on the 2013 proposed order as discussed in section II of this document.
Therefore, FDA has met this requirement under section 513(e)(1) of the
FD&C Act.

B. Requirement for Premarket Approval Application

    FDA is requiring PMAs for IABP devices when indicated for septic
shock or pulsatile flow generation.
    Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order requiring premarket approval for a preamendments class III
device, the following must occur: (1) Publication of a proposed order
in the Federal Register; (2) a meeting of a device classification panel
described in section 513(b) of the FD&C Act; and (3) consideration of
comments from all affected stakeholders, including patients, payers,
and providers. FDA held a meeting of a device classification panel
described in section 513(b) of the FD&C Act with respect to IABP
devices on December 5, 2012. The 2012 Panel recommended that IABP
devices when indicated for septic shock or pulsatile flow generation
remain in class III (subject to premarket approval application). The
2012 Panel supported FDA's conclusion that the effectiveness of IABP
devices when indicated for septic shock or pulsatile flow generation
has not been established through adequate scientific evidence. FDA
published the 2013 proposed order on June 19, 2013 (78 FR 36702). FDA
received and has considered one comment on the 2013 proposed order as
discussed in section II of this document, and therefore, has met this
requirement under section 515(b)(1) of the FD&C Act.
    Section 515(b)(2) of the FD&C Act provides that a proposed order to
require premarket approval shall contain: (1) The proposed order, (2)
the proposed findings with respect to the degree of risk of illness or
injury designed to be eliminated or reduced by requiring the device to
have an approved PMA or a declared completed PDP and the benefit to the
public from the use of the device, (3) an opportunity for the
submission of comments on the proposed order and the proposed findings,
and (4) an opportunity to request a change in the classification of the
device based on new information relevant to the classification of the
device. The 2013 proposed order satisfies these requirements.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed order, consideration of
any comments received, and a meeting of a device classification panel
described in section 513(b) of the FD&C Act, issue a final order to
require premarket approval or publish a document terminating the
proceeding together with the reasons for such termination. If FDA
terminates the proceeding, FDA is required to initiate reclassification
of the device under section 513(e) of the FD&C Act, unless the reason
for termination is that the device is a banned device under section 516
of the FD&C Act (21 U.S.C. 360f).
    A preamendments class III device may be commercially distributed
without a PMA until 90 days after FDA issues a final order (a final
rule issued under section 515(b) of the FD&C Act prior to the enactment
of FDASIA is considered to be a final order for purposes of section
501(f) of the FD&C Act (21 U.S.C. 351(f))) requiring premarket approval
for the device, or 30 months after final classification of the device
under section 513 of the FD&C Act, whichever is later. For IABP
devices, the preamendments class III devices that are the subject of
this final order, the later of these two time periods is the 90-day
period. Since these devices were classified in 1980, the 30-month
period has expired (45 FR 7966; February 5, 1980). Therefore, section
501(f)(2)(B) of the FD&C Act requires that a PMA for such device be
filed within 90 days of the date of issuance of this final order. If a
PMA is not filed for such device within 90 days after the issuance of
this final order, the device will be deemed adulterated under section
501(f) of the FD&C Act.
    Also, a preamendments device subject to the order process under
section 515(b) of the FD&C Act is not required to have an approved
investigational device exemption (IDE) (see part 812 (21 CFR part 812))
contemporaneous with its interstate distribution until the date
identified by FDA in the final order requiring the filing of a PMA for
the device. At that time, an IDE is required only if a PMA has not been
filed. If the manufacturer, importer, or other sponsor of the device
submits an IDE application and FDA approves it, the device may be
distributed for investigational use. If a PMA is not filed by the later
of the two dates, and the device is not distributed for investigational
use under an IDE, the device is deemed to be adulterated within the
meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure
and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if
its distribution continues. Other enforcement actions include, but are
not limited to, the following: Shipment of devices in interstate
commerce will be subject to injunction under section 302 of the FD&C
Act (21 U.S.C. 332) and the individuals responsible for such shipment
will be subject to prosecution under section 303 of the FD&C Act (21
U.S.C. 333). FDA

requests that manufacturers take action to prevent the further use of
devices for which no PMA has been filed.

II. Public Comments in Response to the Proposed Order

    In response to the 2013 proposed order to reclassify IABP devices
when indicated for acute coronary syndrome, cardiac and non-cardiac
surgery, or complications of heart failure, and require the filing of a
PMA or a notice of completion of a PDP for IABP devices when indicated
for septic shock or pulsatile flow generation, FDA received one
comment. The comment supported FDA's intent to call for PMAs for IABP
devices when indicated for septic shock or pulsatile flow generation,
but disagreed with FDA's intent to reclassify IABP devices when
indicated for acute coronary syndrome, cardiac and non-cardiac surgery,
or complications of heart failure, stating that the risks to health are
``serious,'' and ``special controls are inadequate to provide
reasonable assurance of safety and effectiveness for these complex,
life-supporting devices.''
    FDA disagrees with this comment. According to section 513(a)(1)(C)
of the FD&C Act, a class III device is defined as a device which (1)
``cannot be classified as a class I device because insufficient
information exists to determine that the application of general
controls are sufficient to provide reasonable assurance of the safety
and effectiveness of the device,'' and (2) ``cannot be classified as a
class II device because insufficient information exists to determine
that the special controls . . . would provide reasonable assurance of
its safety and effectiveness,'' and (3) ``is purported or represented
to be for a use in supporting or sustaining human life or for a use
which is of substantial importance in preventing impairment of human
health,'' or (4) ``presents a potential unreasonable risk of illness or
injury.'' Although FDA considers IABP devices to be life-supporting, a
viewpoint which was supported by the 2012 Panel, FDA believes that,
based on the available evidence, that special controls, in addition to
general controls, would be sufficient to provide a reasonable assurance
of safety and effectiveness, and there is not an unreasonable risk of
illness or injury for IABP devices when indicated for acute coronary
syndrome, cardiac and non-cardiac surgery, or complications of heart
failure. The 2012 Panel agreed with FDA's conclusions and provided the
following rationale for recommending that these devices be reclassified
to class II: (1) There is a wealth of clinical experience that attests
to the benefit of the device; (2) there is an important advantage to
use of intra-aortic balloon counter-pulsation to provide hemodynamic
stability or protection from ischemia in precarious or unstable
patients; and (3) the recommended special controls will mitigate the
health risks associated with the device. Therefore, FDA disagrees that
IABP devices when indicated for acute coronary syndrome, cardiac and
non-cardiac surgery, or complications of heart failure should be
classified as class III devices. FDA believes that the identified
special controls mitigate the risks to health and provide a reasonable
assurance of safety and effectiveness for this patient population with
high morbidity and mortality.
    The commenter also provided a summary of recalls and adverse event
reports in FDA's Manufacturer and User Facility Device Experience
(MAUDE) database for this device type to support their perspective that
reclassification is inappropriate for IABP devices when indicated for
acute coronary syndrome, cardiac and non-cardiac surgery, or
complications of heart failure. FDA is aware of this data, fully
considered this information prior to the proposed reclassification, and
presented this information to the 2012 Panel. As such, this is not new
information which would have a bearing on FDA's decision to reclassify
IABP devices when indicated for acute coronary syndrome, cardiac and
non-cardiac surgery, or complications of heart failure from class III
to class II.
    The commenter further notes that ``A major problem with this
proposed order is that it splits the device into two classifications
(Class III and Class II) . . . down-classification for any indication
would create an enormous and dangerous loophole that would allow
manufacturers to avoid the more rigorous PMA review process.'' FDA
disagrees with this comment. FDA does not regulate the practice of
medicine but rather regulates the use of a device as indicated by the
party offering the device for interstate commerce. The indications for
IABP devices are limited by the codified classification.
    The commenter also states that ``the down-classification of these
devices means that companies manufacturing new models with unique
characteristics in the future would not be required to provide that
their products are safe or effective.'' The commenter suggests that
classification to class II (special controls) precludes FDA from
requesting clinical data for these devices. FDA disagrees with this
comment. FDA believes that the proposed special controls provide a
reasonable assurance of safety and effectiveness for IABP devices that
feature similar technology when indicated for acute coronary syndrome,
cardiac and non-cardiac surgery, or complications of heart failure. FDA
is also not precluded from requesting clinical data for IABP devices
where it is necessary to demonstrate substantial equivalence.

III. The Final Order

    Under sections 513(e) and 515(b) of the FD&C Act, FDA is adopting
its findings as published in the preamble to the 2013 proposed order.
FDA is issuing this final order to require the filing of a PMA or a
notice of completion of a PDP for IABP devices when indicated for
septic shock or pulsatile flow generation. In addition, FDA is issuing
this final order to reclassify IABP devices when indicated for acute
coronary syndrome, cardiac and non-cardiac surgery, or complications of
heart failure from class III to class II and establish special
controls. This final order will revise part 870 (21 CFR part 870).
    Under the final order, a PMA or a notice of completion of a PDP is
required to be filed on or before 90 days after the date of publication
of the final order in the Federal Register, for any of these class III
preamendments devices that were in commercial distribution before May
28, 1976, or that has been found by FDA to be substantially equivalent
to such a device on or before 90 days after the date of publication of
the final order in the Federal Register. An approved PMA or a declared
completed PDP is required to be in effect for any such devices on or
before 180 days after FDA files the application. Any other class III
preamendments device subject to this order that was not in commercial
distribution before May 28, 1976, is required to have an approved PMA
or a declared completed PDP in effect before it may be marketed.
    If a PMA or a notice of completion of a PDP for any of the class
III preamendments devices is not filed on or before the 90th day past
the effective date of this regulation, that device will be deemed
adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial
distribution of the device must cease immediately. The device may,
however, be distributed for investigational use, if the requirements of
the IDE regulations (part 812) are met.
    Following the effective date of this final order, firms submitting
a 510(k) premarket notification for an IABP device when indicated for
acute coronary syndrome, cardiac and non-cardiac surgery, or
complications of

heart failure will need either to (1) comply with the particular
mitigation measures set forth in the codified special controls or (2)
use alternative mitigation measures, but demonstrate to the Agency's
satisfaction that those alternative measures identified by the firm
will provide at least an equivalent assurance of safety and
effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the devices. FDA has determined that premarket
notification is necessary to provide reasonable assurance of safety and
effectiveness of IABP devices when indicated for acute coronary
syndrome, cardiac and non-cardiac surgery, or complications of heart
failure, and therefore, this device type is not exempt from premarket
notification requirements.
    An applicant whose device was legally in commercial distribution
before May 28, 1976, or whose device has been found to be substantially
equivalent to such a device, who does not intend to market such device
for septic shock or pulsatile flow generation, may remove such intended
uses from the device's labeling by initiating a correction within 90
days after issuance of this final order. Under 21 CFR 806.10(a)(2) a
device manufacturer or importer initiating a correction to remedy a
violation of the FD&C Act that may present a risk to health is required
to submit a written report of the correction to FDA.

IV. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814, subpart B,
have been approved under OMB control number 0910-0231; and the
collections of information under 21 CFR part 801 have been approved
under OMB control number 0910-0485.

VI. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices and section
515(b) of the FD&C Act provided for FDA to issue regulations to require
approval of an application for premarket approval for preamendments
devices or devices found to be substantially equivalent to
preamendments devices. Although sections 513(e) and 515(b) of the FD&C
Act as amended require FDA to issue final orders rather than
regulations, FDASIA also provides for FDA to revoke previously issued
regulations by order. FDA will continue to codify reclassifications and
requirements for approval of an application for premarket approval in
the Code of Federal Regulations. Therefore, under section
513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this final
order, we are revoking the requirements in Sec.  870.3535 related to
the classification of IABP devices when indicated for acute coronary
syndrome, cardiac and non-cardiac surgery, or complications of heart
failure as class III devices and codifying the reclassification of
these devices into class II.

List of Subjects in 21 CFR Part 870

    Medical devices, Cardiovascular devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Revise Sec.  870.3535 to read as follows:

Sec.  870.3535  Intra-aortic balloon and control system.

    (a) Identification. An intra-aortic balloon and control system is a
prescription device that consists of an inflatable balloon, which is
placed in the aorta to improve cardiovascular functioning during
certain life-threatening emergencies, and a control system for
regulating the inflation and deflation of the balloon. The control
system, which monitors and is synchronized with the electrocardiogram,
provides a means for setting the inflation and deflation of the balloon
with the cardiac cycle.
    (b) Classification. (1) Class II (special controls) when the device
is indicated for acute coronary syndrome, cardiac and non-cardiac
surgery, or complications of heart failure. The special controls for
this device are:
    (i) Appropriate analysis and non-clinical testing must be conducted
to validate electromagnetic compatibility and electrical safety of the
device;
    (ii) Software verification, validation, and hazard analysis must be
performed;
    (iii) The device must be demonstrated to be biocompatible;
    (iv) Sterility and shelf-life testing must demonstrate the
sterility of patient-contacting components and the shelf life of these
components;
    (v) Non-clinical performance evaluation of the device must
demonstrate mechanical integrity, durability, and reliability to
support its intended purpose; and
    (vi) Labeling must include a detailed summary of the device- and
procedure-related complications pertinent to use of the device.
    (2) Class III (premarket approval) when the device is indicated for
septic shock and pulsatile flow generation.
    (c) Date premarket approval application (PMA) or notice of
completion of product development protocol (PDP) is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before March 31, 2014, for any intra-aortic
balloon and control system indicated for septic shock or pulsatile flow
generation that was in commercial distribution before May 28, 1976, or
that has, on or before March 31, 2014, been found to be substantially
equivalent to any intra-aortic balloon and control system indicated for
septic shock or pulsatile flow generation that was in commercial
distribution before May 28, 1976. Any other intra-aortic balloon and
control system indicated for septic shock or pulsatile flow generation
shall have an approved PMA or declared completed PDP in effect before
being placed in commercial distribution.

    Dated: December 23, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-31218 Filed 12-27-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Notices]
[Pages 13011-13012]
[FR Doc No: 2011-5377]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64027; File No. SR-CBOE-2011-020]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Modify the Fees Schedule for the CBOE Stock
Exchange

March 3, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 25, 2011, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify the Fees Schedule for its CBOE
Stock Exchange (``CBSX''). The text of the proposed rule change is
available on the Exchange's Web site (http://www.cboe.org/legal), at
the Exchange's Office of the Secretary, and at the Commission.

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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    This filing proposes to make several changes to the CBSX Fees
Schedule. The Exchange proposes to modify CBSX Maker and Taker
transaction fees and rebates for transactions in securities priced $1
or greater. Maker fees and Taker rebates for transactions in a select
group of stocks (BAC, BIL, BGZ, C, CIM, DXD, FAZ, IAU, LVLT, NBG, PVI,
QID, SDS, SIRI, SKF, SNV, UDN, UNG, UUP, XLF) will remain unchanged.
Transactions in securities priced $1 or greater in another select group
of stocks (AA, AMAT, AMD, ATML, BRCD, BSX, CMCSA, COCO, CSCO, CX, DELL,
DIA, DOW, DRYS, DUK, EBAY, EMC, EWJ, EWT, FAS, FAX, F, FITB, FLEX, GBG,
GDX, GE, GLD, GLW, HBAN, HPQ, IDIX, INTC, IWM, IYR, JPM, KEY, LVS, MDT,
MFE, MGM, MO, MRVL, MSFT, MU, NLY, NOK, NVDA, NWSA, ONNN, ORCL, PBR,
PFE, PSQ, QCOM, Q, QLD, QQQQ, RF, RFMD, SBUX, S, SH, SLV, SMH, SNDK,
SPLS, SPXU, SPY, SSO, SYMC, TBT, T, TLT, TNA,TSM, TWM, TXN, TZA, UCO,
USO, UWM, UYG, VALE, VWO, VXX, VZ, WFC, XHB, XLB, XLE, XLI, XLK, XLP,
XLU, XLV, XLY, XRT, XRX, YHOO) will incur Maker fees of $0.0009 per
share and Taker rebates of $0.0006 per share. Transactions in
securities priced $1 or greater for all other stocks will be assessed a
$0.0001 fee. The Exchange is customizing transaction by security based
on CBSX's experience in trades involving those securities.
    The Exchange also proposes to modify transaction fees for cross
trades that are the stock components of Qualified Contingent Trades.
The Exchange proposes to eliminate the minimum fee of $1 per trade and
raise the maximum fee from $15 to $20 in order to encourage more
submissions of such cross trades on CBSX while recouping more fees to
cover the Exchange's costs regarding such trades.
    CBSX also proposes to lower the perimeter booth fee for CBSX
Trading Permit Holders that are not CBSX Market-Makers who use booth
space on the CBOE trading floor from $350 per month to $195 per month
to make such fee consistent with the equivalent CBOE fee.
    The Exchange also proposes to raise to trading an average of
100,000 shares per day over a calendar month the threshold by which
CBSX Trading Permit Holders may avoid being subject to the Inactivity
Fee. This proposed change will ensure that CBSX Trading Permit Holders
are sufficiently active on CBSX.
    Finally, the Exchange proposes to reorganize the notes and
footnotes in Section 2 to eliminate any possible confusion between the
two. All of the fee changes described in this proposed rule filing will
take effect on March 1, 2011.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (``Act''),\3\ in general, and furthers
the objectives of Section 6(b)(4) \4\ of the Act in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees, and other charges among CBOE Trading Permit Holders and
other persons using Exchange facilities. The Exchange believes that the
proposed changes to the transaction fees will allow CBSX to remain
competitive with other exchanges. The elimination of the minimum
transaction fee for cross trades that are the stock components of
Qualified Contingent Trades also allows the Exchange to attract more
transactions to the Exchange, while the increase of the maximum fee for
such cross trades will provide for a more equitable allocation of fees.
Reducing the CBSX perimeter booth fee to the same amount charged on
CBOE also provides for a more equitable allocation of fees. Raising the
threshold by which CBSX Trading Permit Holders may avoid being subject
to the Inactivity Fee also provides for a more equitable allocation of
fees by requiring that CBSX Trading Permit Holders are sufficiently
active to cover the Exchange's costs of regulating the activity of such
CBSX Trading Permit Holders.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE 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 solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \5\ and paragraph (f)(2) of Rule 19b-4
thereunder.\6\ At any time within 60 days of the filing of the proposed
rule

change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2011-020 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-CBOE-2011-020. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of 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-CBOE-2011-020 and should be
submitted on or before March 30, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-5377 Filed 3-8-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 208 (Monday, October 28, 2013)]
[Notices]
[Page 64211]
[FR Doc No: 2013-25572]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0490; FRL-9902-06]

FIFRA Scientific Advisory Panel; Notice of Cancellation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Agency is issuing this notice to cancel the 3-day meeting
of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific
Advisory Panel (FIFRA SAP) to consider and review scientific
uncertainties associated with corn rootworm resistance monitoring for
Bt corn Plant Incorporated Protectants (PIPs) scheduled for October
30--November 1, 2013. The meeting was announced in the Federal Register
on August 9, 2013. The meeting will be rescheduled.

FOR FURTHER INFORMATION CONTACT: Fred Jenkins, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-3327; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The meeting was announced in the Federal
Register on August 9, 2013 (78 FR 48672, FRL-9394-3). This meeting will
be rescheduled in the near future and announced in the Federal
Register.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: October 23, 2013.
David Dix,
Director, Office of Science Coordination and Policy.
[FR Doc. 2013-25572 Filed 10-24-13; 4:15 pm]
BILLING CODE 6560-50-P


Supplemental Comments on Linkages between Projected and Historical Unit
Operation and Reliability Constraints

The purpose of this memo is to further link AEP’s system reliability
requirements (attachments A and B of “Updated AEP Comments on Proposed
Revisions to CSAPR 11 28 11”) to projected and historical utilization
(attachment C of “Updated AEP Comments on Proposed Revisions to CSAPR
11 28 11”) for units not operating within EPA’s IPM runs used in the
development of CSAPR state budgets.  The reliability and must run (RMR)
requirements are developed by AEP’s transmission group and are
approved by Southwest Power Pool (SPP) or PJM as part of AEP’s system
restoration and operating plan.  While attachments A and B describe
certain conditions under which units must run for reliability purposes,
there are distinct differences between how units are committed and
dispatched in SPP versus PJM.  As such, this memo will highlight the
differences in these areas and the relevant constraints requiring units
to operate. Appendix A at the end of this memo provides the percentage
of generation attributed SOLELY to reliability purposes. These
percentage factors can be multiplied by the heat input previously
provided in Attachment C, in order to adjust the heat input to only
capture operation for reliability purposes. In all cases, this is a
conservatively low assessment of the units operation for reliability
reasons.

SPP

Within SPP, AEP is required to ensure that specific gas units are
running when certain coal units are offline and the AEP control area’s
load warrants.  Certain gas units are also required to be online for
system support and blackstart restoration plans.  Next day system load
is required to be covered using firm capacity resources and can be
filled through either day-ahead, firm purchases or by AEP generation
that is planned to be online.  There are also transfer limits that must
be met to ensure that too much generation is not online in one of the
AEP control area sub-regions and that AEP is able to cover the loss of
the largest unit online in each sub-region as a “first contingency”
planning process.  Northeastern 2, Riverside 2, Knox Lee 5 and Wilkes 2
& 3 are some of the units that are frequently utilized to cover firm
capacity and transfer limit requirements.  When possible, these units
will also serve a double purpose by satisfying the must run requirements
and loss of largest load contingencies as well.

There are limits to capacity purchases due to transmission constraints
and availability, requiring units within the AEP system to be frequently
online for capacity reasons.  As an example, while units such as Lone
Star and Tulsa 3 are not explicitly listed within the reliability
criteria, they are frequently utilized within periods of peak demand to
satisfy capacity requirements within SPP due to transmission transfer
limits.

According to The South Joint Board for the Study of Security Constrained
Economic Dispatch, a FERC chartered panel, there are significant
limitations to economic dispatch within the SPP region.  “Because of
transmission limitations in the South, transmission dependent utilities
and the Southwest Power Pool say that the biggest impediment to economic
dispatch is constraints on the transmission system. Transmission
constraints can prevent efficient generation resources from being
dispatched. These parties say they are frequently unable to access
economic sources because of transmission limitations and often forgo
economic transactions because of a concern that the transaction could be
curtailed.”

The forecasted 2012 operation provided by AEP in attachment C to our
previous comments was modeled using the GenTrader application developed
by Power Costs Inc (PCI).  To model the AEP system the GenTrader
application requires various unit-specific operating and cost inputs.
Other inputs include forecasted internal load, contracts and estimated
market prices.  The hourly unit generation position is based on market
prices and each unit’s physical operating constraints, including heat
rates, ramp rates and unit minimums.  Most importantly, in contrast to
IPM, GenTrader is able to incorporate the reliability requirements and
various “security zones” within AEP’s control areas in SPP to
ensure that the correct resources are online to meet both reliability
and capacity requirements for each hour. In effect, the model takes into
account transmission constraints within the SPP region thru the use of
security zones. The combination of all these factors along with a
chronological dispatch makes GenTrader a much more precise predictor of
unit operation than IPM.  As such, AEP feels the GenTrader projected
2012 operation is the best indicator of expected unit performance.
Historical heat-input projections were also included as a basis for
justifying that the projected 2012 operation is “reasonable” as
compared to 2010 operation.  While it has been noted that certain units
are projected to run at greater than 2010 levels in 2012, this can be
attributed to the tightening of capacity markets requiring additional
firm capacity from within the AEP system.

Based on EPA’s concern that some of the heat input previously provided
in attachment C could be attributed solely to economic dispatch (which
theoretically should have been picked up by IPM), AEP reviewed the most
recent historical period to determine what portion of the operation in
attachment C of AEP’s previous filing was solely attributed to
reliability and capacity constraints during a recent 12 month period
(October 2010 to September 2011).  AEP calculated the % operation that
could be attributed SOLELY to reliability and capacity constraints
during this period based on the minimum load of units needed to serve
these requirements (see appendix A of this document).  This data can
potentially be used to adjust the projected heat input for these units
previously provided in attachment C of AEP’s comments.  The adjusted
heat input can then be used to adjust individual state budgets.  This is
a very conservative estimate of the non-economic factors contributing to
dispatch because once a unit is required to be online for capacity or
reliability purposes, additional generation from these units is often
less costly than units with lower long run economic and operational
costs due to the avoidance of start-up and ramping costs with the
utilization of units that are already online.  In addition, supplemental
generation from these must run resources is often required for
load-following purposes.  However, this aspect of reliability need
cannot be adequately quantified by AEP.

PJM

Three units within AEP’s previous attachment C, Muskingum River 1,
Muskingum River 2 and Picway 9 were projected not to run within IPM
under the CSAPR policy case.  However, AEP’s forecasting indicates
that these units will all operate during 2012 and have historically
operated at substantial levels.   Only one of the units, Muskingum River
1, is required to operate for system reliability, based on its Automatic
Load Reject (ALR) capability, which allows it to disconnect from the
grid in case of system failure and later reconnect to help restore the
grid.  The projection of Muskingum River 1 operation for reliability
purposes reflects Muskingum River 1’s operation at minimum load to
meet this reliability requirement.  Thus, the projection of reliability
operation for Muskingum River 1 is very conservative due to its ability
to overcome start up costs in displacement of more economic generation
and ability to follow load.

Due to the more developed nature of the PJM market and a more robust
system of transmission interconnection, running units to meet capacity
needs is not currently a constraint within the PJM region. Appendix A

Percent of Operation Reflected on Attachment C

Due Solely to Reliability and Capacity Constraints

 The Joint Board for the South Region. “Study and Recommendations
Regarding Security Constrained Economic Dispatch,” Docket No.
AD05-13-000.  July 11, 2006.


Mr. Marco Gonzalez Secretariat for the Montreal Protocol P. O. Box 30552, Nairobi, Kenya Dr. H. J. Banks 10 Beltana Road Pialligo, ACT 2609 Australia Dr. Nahum Marban Mendoza Autonomic University of Chapingo PO Box 56230 Chapingo, Mexico Dear Mr. Gonzalez, Dr. Banks, and Dr. Mendoza:

The United States submits the attached documents in response to the Methyl Bromide Technical Options Committee ( MBTOC) co chairs' 22 May letter to the U. S. Department of State requesting additional information on the U. S. Critical Use Exemption ( CUE) nomination. The attachment provides additional information requested in the letter and also addresses issues raised in the May 2003 Progress report of the Technology and Economic Assessment Panel ( TEAP). The attachments are organized as separate chapters for each sector, and include additional information for thirteen sectors in the U. S. CUE nomination. We are submitting these documents electronically, but would be pleased to provide you with a hard copy upon request.

We believe that we have provided all of the information requested by MBTOC. However, as our productive discussion in Montreal in July demonstrated, an immediate answer to a question can sometimes clear up an issue in a short time. Given the importance that both MBTOC and the Parties place on ensuring that recommendations are made in a timely manner on the basis of full and correct information, I urge MBTOC to contact us should it have questions regarding the attachment. If any such additional information is needed, please contact John Thompson at the U. S. Department of State ( ThompsonJE2@ state. gov or 202 647 9799).

I would like to take this opportunity to discuss several general issues that came up during the preparation of this document or that were discussed at the Open Ended Working Group in July: 2 Multi Year Nominations: The U. S. nomination requested a CUE for both 2005 and 2006, but it appears that the MBTOC's initial view was to make recommendations at this time for 2005 CUEs. While we recognize that there is some uncertainty because this is the first time the CUE process has been carried out, the United States still believes it is appropriate for the Parties to consider granting multi year exemptions with the understanding that an exemption for the second year is contingent, and can be reviewed if alternatives are found to be available sooner than expected. We believe that this can be advantageous in terms of providing greater certainty to the agricultural community as well as helping manage the work of the Parties and MBTOC in developing and reviewing applications and in addressing the issue at the Meeting of the Parties.

Aggregate Nominations: The U. S. Government is in the process of establishing domestic regulations to manage the amount of methyl bromide produced and/ or imported under a critical use exemption and to ensure that the amount is used solely for purposes determined to be critical needs by the Parties. We believe that while Parties take on such a responsibility to implement their CUEs, each Party should be given the freedom to do so as it best fits within its national context. In the context of the United States, this is particularly important. As one example, we note that while our analysis divided among the relevant crops the full level of 1,3 D allowed under the township caps in California, it is not possible to determine in advance which sectors will utilize 1,3 D in a future year. Accordingly, providing the exemption on a crop by crop basis will not enable the United States to utilize 1,3 D where it may be most effective. This is just one example of why we believe that, with respect to the United States, it is most appropriate to grant an aggregate allotment to be used within sectors agreed by the Parties to be critical. We believe there will be unnecessary burdens that will not benefit the environment associated with attempts to determine with great specificity exactly where methyl bromide will be used under approved CUEs. Under the procedure used in the essential use exemption process, Parties have the discretion to use their essential use allotment among approved CFCMDIs to allow the needs of patients to be fully met; we believe similar discretion should be provided for CUEs so that critical agricultural needs are met.

Economic Feasibility The United States does not believe it is appropriate to adopt the TEAP proposal to use an average cost effectiveness from Multilateral Fund projects as a threshold to evaluate economic feasibility. This single measure does not fully account for the specific conditions each applicant faces and, in recognition of this fact, the Multilateral Fund has not applied this value across sectors in such a manner.

The United States notes, however, that the CUE criteria specifically enable the grant of an exemption if alternatives are found to be economically infeasible. While we recognize the difficulties in applying the economic criterion, we do not believe it is appropriate for the MBTOC and the Parties to set aside this important criterion this year. Indeed, the Parties understand that while an alternative may be technically feasible, users should not be expected to adopt alternatives that make crop production economically infeasible. 3 Given the importance of economic feasibility, we believe the task warrants consideration of more than a single economic criterion. In fact, the United States used a ` portfolio' or ` weight of evidence' approach to assess economic feasibility using five measurements: ( 1) loss per hectare, ( 2) loss per kilogram of methyl bromide, ( 3) loss as a percent of gross revenue, ( 4) loss as a percent of net cash returns, and ( 5) change in profit margins. In certain specific sectors, other factors such as benefits to the environment not captured by cost measures were also considered. Using an approach involving weighing multiple measures allows for a more complete understanding and balancing of the potential impacts of using alternatives.

California Township Caps As noted above, a number of sector nominations for the United States in the State of California are impacted by regulatory township caps put in place to promote human health and environmental protection. The approach used in the U. S. CUE was to assume that 1,3 D would be used up to the amount of the cap, and this use was distributed proportionally within sectors where 1,3 D was a feasible alternative. Thus, the U. S. nomination did not request CUEs in townships where 1,3 D is feasible and can be used up to the level of the township cap.

Thank you very much for your consideration of the U. S. CUE nomination. The United States recognizes that the task taken on by the MBTOC and TEAP is an arduous and difficult one; particularly as this is the first year the CUE process has been used. We appreciate your efforts, and look forward to continuing to work with you on our nomination should additional information be needed.

Sincerely,

Jeffry Burnam Deputy Assistant Secretary for Environment


[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)]
[Notices]
[Pages 73449-73450]
[FR Doc No: 2016-25708]

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

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:

    Securities Rule 477, SEC File No. 270-493, OMB Control No. 3235-
0550.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Rule 477 (17 CFR 230.477) under the Securities Act of 1933 (15
U.S.C. 77a et seq.) sets forth procedures for withdrawing a
registration statement, including any amendments or exhibits to the
registration statement. The rule provides that if an issuer intends to
rely on the safe harbor contained in Securities Act Rule 155 to conduct
an unregistered private offering of securities, the issuer must
affirmatively state in the withdrawal application that it plans to
undertake a subsequent private offering of its securities. Without this
statement, the Commission would not be able to monitor a company's
reliance on, and compliance with, Securities Act Rule 155(c). All
information submitted to the Commission under Securities Act Rule 477
is available to the public for review. Information provided under
Securities Act Rule 477 is mandatory. The information is required on
occasion. We estimate that approximately 327 issuers will file
Securities Act Rule 477 submissions annually at an estimated one hour
per response for a total annual burden of approximately 327 hours. We
estimate that 100% of the reporting burden is prepared by the issuer.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

     Dated: October 18, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-25708 Filed 10-24-16; 8:45 am]
 BILLING CODE 8011-01-P