[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Proposed Rules]
[Pages 66474-66476]
[FR Doc No: 2021-25396]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-1012; Project Identifier MCAI-2021-00697-R]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Airbus Helicopters Deutschland GmbH Model EC135P1, EC135P2,
EC135P2+, EC135P3, EC135T1, EC135T2, EC135T2+, and EC135T3 helicopters.
This proposed AD was prompted by a report of restricted collective
lever movement caused by entanglement of the emergency flashlight strap
with the cargo hook emergency release lever, causing the emergency
flashlight to leave its seat. This proposed AD would require replacing
each affected emergency flashlight with a serviceable part, as
specified in a European Union Aviation Safety Agency (EASA) AD, which
is proposed for incorporation by reference (IBR). This proposed AD
would also prohibit installation of affected parts. The FAA is
proposing this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by January 7,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.0
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For EASA material that is proposed for IBR in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email [email protected]; internet www.easa.europa.eu. You
may find the EASA material on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. This material is also
available at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-1012.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-1012; 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 NPRM, the EASA AD,
any comments received, and other information. The street address for
Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Hal Jensen, Aerospace Engineer,
Operational Safety Branch, FAA, 950 L'Enfant Plaza SW, Washington, DC
20024; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-1012; Project Identifier
MCAI-2021-00697'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Hal
Jensen, Aerospace Engineer, Operational Safety Branch, FAA, 950
L'Enfant Plaza SW, Washington, DC 20024; telephone<PHONE_NUMBER>;
email [email protected]. Any commentary that the FAA receives that is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Background

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0149, dated June 21, 2021 (EASA
AD 2021-0149), to correct an unsafe condition for Airbus Helicopters
Deutschland GmbH Model EC135 P1, EC135 P2, EC135 P2+, EC135 P3, EC135
T1, EC135 T2, EC135 T2+, EC135 T3, EC635 P2+, EC635 P3, EC635 T1, EC635
T2+, and EC635 T3 helicopters, all variants, all serial numbers up to
820 inclusive. Model EC635 P2+, EC635 P3, EC635 T1, EC635 T2+, and
EC635 T3 helicopters are not certificated by the FAA and are not
included on the U.S. type certificate data sheet, except where the U.S.
type certificate data sheet explains that the Model EC635T2+ helicopter
having serial number 0858 was converted from Model EC635T2+ to Model
EC135T2+. This proposed AD, therefore, does not include Model EC635
P2+, EC635 P3, EC635 T1, EC635 T2+, and EC635 T3 helicopters in the
applicability.
    This proposed AD was prompted by a report of restricted collective
lever movement caused by entanglement of the emergency flashlight strap
with the cargo hook emergency release lever, causing the emergency
flashlight to leave its seat. The FAA is issuing this AD to address
entanglement of the

emergency flashlight strap with the cargo hook emergency release lever.
The unsafe condition, if not addressed, could result in reduced control
of the helicopter, resulting in damage to the helicopter and injury to
occupants. See EASA AD 2021-0149 for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0149 requires replacing each affected emergency
flashlight with a serviceable part. EASA AD 2021-0149 also specifies
that an affected part can be modified and re-identified into a
serviceable part. EASA AD 2021-0149 also prohibits the installation of
an affected part.
    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.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that
the unsafe condition described previously is likely to exist or develop
on other helicopters of these same type designs.

Proposed AD Requirements in This NPRM

    This proposed AD would require accomplishing the actions specified
in EASA AD 2021-0149, described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2021-0149 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2021-0149 in its entirety through that incorporation, except
for any differences identified as exceptions in the regulatory text of
this proposed AD. Using common terms that are the same as the heading
of a particular section in EASA AD 2021-0149 does not mean that
operators need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2021-
0149. Service information referenced in EASA AD 2021-0149 for
compliance will be available at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-1012 after the FAA final
rule is published.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 335 helicopters of U.S. Registry. The FAA estimates the
following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Replacement of affected part..........  1 work-hour x $85 per               $219            $304        $101,840
                                         hour = $85.
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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

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would 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 Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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:

Airbus Helicopters Deutschland GmbH: Docket No. FAA-2021-1012;
Project Identifier MCAI-2021-00697-R.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by January 7, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH Model
EC135P1, EC135P2, EC135P2+, EC135P3, EC135T1,

EC135T2, EC135T2+, and EC135T3 helicopters, certificated in any
category, as identified in European Union Aviation Safety Agency
(EASA) AD 2021-0149, dated July 5, 2021 (EASA 2021-0149).

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 2510, Flight
Compartment Equipment.

(e) Unsafe Condition

    This AD was prompted by a report of restricted collective lever
movement. Subsequent inspection determined that the emergency
flashlight was stuck under that lever caused by entanglement of the
emergency flashlight strap with the cargo hook emergency release
lever, causing the emergency flashlight to leave its seat. The FAA
is issuing this AD to address entanglement of the emergency
flashlight strap with the cargo hook emergency release lever. The
unsafe condition, if not addressed, could result in reduced control
of the helicopter, resulting in damage to the helicopter and injury
to occupants.

(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, EASA AD 2021-0149.

(h) Exceptions to EASA AD 2021-0149

    (1) Where EASA AD 2021-0149 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) This AD does not mandate compliance with the ``Remarks''
section of EASA AD 2021-0149.

(i) Alternative Methods of Compliance (AMOCs)

    (1) 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 local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (j)(2) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    (1) For EASA AD 2021-0149, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may view this
material at the FAA, Office of the Regional Counsel, Southwest
Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For
information on the availability of this material at the FAA, call
(817) 222-5110. This material may be found in the AD docket at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-1012.
    (2) For more information about this AD, contact Hal Jensen,
Aerospace Engineer, Operational Safety Branch, FAA, 950 L'Enfant
Plaza SW, Washington, DC 20024; telephone<PHONE_NUMBER>; email
[email protected].

    Issued on November 16, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.

[FR Doc. 2021-25396 Filed 11-22-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30917-30920]
[FR Doc No: 2014-12421]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72225; File No. SR-Phlx-2014-34]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing of Proposed Rule Change To Delete From Section IX of the
Exchange's Options Fee Schedule the PHOTO Historical Data Product

May 22, 2014.
    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 May 9, 2014, 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.
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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 the
Substance of the Proposed Rule Change

    The Exchange proposes to delete from Section IX of the Exchange's
Options Fee Schedule the PHOTO Historical data product.
    The text of the proposed rule change is below; proposed new
language is italicized.
* * * * *
NASDAQ OMX PHLX LLC Pricing Schedule
* * *
IX. Proprietary Data Feed Fees
Top of PHLX Options (``TOPO'')
    No change.
TOPO Plus Orders
    No change.
PHLX Orders
    No change.
PHLX Depth Data
    No change.
PHLX Options Trade Outline (``PHOTO'')

------------------------------------------------------------------------
                                                                Monthly
                         Account type                            charge
------------------------------------------------------------------------
End of Day Product Subscriber................................       $500
Intra-Day Product Subscriber.................................      1,500
------------------------------------------------------------------------

[PHOTO Historical Data

------------------------------------------------------------------------
                                                                 Charge
                                                                  per
                         Account type                           calendar
                                                                 month
                                                               requested
------------------------------------------------------------------------
End of Day Product Subscriber................................       $400
Intra-Day Product Subscriber.................................        750
------------------------------------------------------------------------

    \9\ For example, a subscriber who requests End of Day PHOTO
Historical Data for the Month of March, 2009 would be charged $400. A
subscriber who requests End of Day PHOTO Historical Data for the months
of March, 2009 and April, 2009 would be charged $400 for the March,
2009 End of Day data and $400 for the April, 2009 End of day data, for
a total of $800, etc. A subscriber who requests Intra-Day PHOTO
Historical Data for the Month of March, 2009 would be charged $750.00.
A subscriber who requests Intra-Day PHOTO Historical Data for the
months of March, 2009 and April, 2009 would be charged $750 for the
March, 2009 Intra-Day data and $750 for the April, 2009 Intra-Day data,
for a total of $1,500, etc.]
* * * * *
    (b) Not applicable.
    (c) Not applicable.
* * * * *

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 modify Section IX of the Exchange's
Options Pricing Schedule to delete references to the PHOTO Historical
data product. PHOTO Historical is a stored data product and not a real
time data feed. NASDAQ OMX stores the data on a server within a
technology subsidiary that functions like any vendor that receives and
stores real time data feed. PHOTO Historical is not a facility of the
Exchange and fees associated with it do not belong in the Exchange Rule
Manual.
    Background. In September 2010, the Exchange established fees for
its PHOTO market data product.\3\ PHOTO is a market data product
offered by the Exchange that provides proprietary electronic trade data
to subscribers. PHOTO is available as either an ``Intra-Day'' or ``End-
of-Day'' product. PHOTO Historical, as the name implies, is not a real-
time product; it is a stored product that permits a subscriber to
select a particular prior calendar month or months and receive the
``End of Day'' or ``Intra-Day'' data for each trading session conducted
during the calendar month(s) selected.
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    \3\ See Securities Exchange Act Release No. 62887 (September 10,
2010), 75 FR 57092 (September 17, 2010) (SR-Phlx-2010-121).
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    Like PHOTO subscribers, PHOTO Historical subscribers receive the
following data:

     Aggregate number of buy and sell transactions in the
affected series for each trading session conducted during the specified
calendar month(s);
     Aggregate volume traded electronically on the Exchange in
the affected series for each trading session conducted during the
specified calendar month(s);
     Aggregate number of trades effected on the Exchange to
open a position \4\ for each trading session conducted during the
specified calendar month(s);
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    \4\ PHOTO Historical Data provides subscribers with the
aggregate number of ``opening purchase transactions'' in the
affected series for each trading session conducted during the
calendar month(s) selected. An opening purchase transaction is an
Exchange options transaction in which the purchaser's intention is
to create or increase a long position in the series of options
involved in such transaction. See Exchange Rule 1000(b)(24). PHOTO
Historical Data also provides subscribers with the aggregate number
of ``opening writing transactions'' in the affected series for each
trading session conducted during the calendar month(s) selected. An
opening writing transaction is an Exchange options transaction in
which the seller's (writer's) intention is to create or increase a
short position in the series of options involved in such
transaction. See Exchange Rule 1000(b)(25).
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     Aggregate number of trades effected on the Exchange to
close a position \5\ for each trading session conducted during the
specified calendar month(s);
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    \5\ PHOTO Historical Data provides subscribers with the
aggregate number of ``closing purchase transactions'' in the
affected series for each trading session conducted during the
calendar month(s) selected. A closing purchase transaction is an
Exchange options transaction in which the purchaser's intention is
to reduce or eliminate a short position in the series of options
involved in such transaction. See Exchange Rule 1000(b)(27). PHOTO
Historical Data will also provide subscribers with the aggregate
number of ``closing sale transactions'' in the affected series for
each trading session conducted during the calendar month(s)
selected. A closing sale transaction is an Exchange options
transaction an Exchange options transaction in which the seller's
intention is to reduce or eliminate a long position in the series of
options involved in such transaction. See Exchange Rule 1000(b)(26).
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     Origin of the orders involved in trades on the Exchange in
the affected series for each trading session conducted during the
specified calendar month(s), specifically aggregated in the following
categories of participants: Customers, broker-dealers, market makers
(including specialists, Registered Options Traders (``ROTs''),
Streaming Quote Traders (``SQTs'') \6\ and Remote Streaming Quote
Traders (``RSQTs'') \7\), and professionals.\8\
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    \6\ An SQT is an Exchange Registered Options Trader (``ROT'')
who has received permission from the Exchange to generate and submit
option quotations electronically in options to which such SQT is
assigned. See Exchange Rule 1014(b)(ii)(A).
    \7\ An RSQT is an ROT that is a member or member organization
with no physical trading floor presence who has received permission
from the Exchange to generate and submit option quotations
electronically in options to which such RSQT has been assigned. An
RSQT may only submit such quotations electronically from off the
floor of the Exchange. See Exchange Rule 1014(b)(ii)(B).
    \8\ The term ``professional'' means any person or entity that
(i) is not a broker or dealer in securities, and (ii) places more
than 390 orders in listed options per day on average during a
calendar month for its own beneficial account(s). A professional
will be treated in the same manner as an off-floor broker-dealer for
purposes of Rules 1014(g) (except with respect to all-or-none
orders, which will be treated like customer orders), 1033(e),
1064.02 (except professional orders will be considered customer
orders subject to facilitation), and 1080.08 as well as Options
Floor Procedure Advices B-6, B-11 and F-5. Member organizations must
indicate whether orders are for professionals. See Exchange Rule
1000(b)(14).
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    The fee for the PHOTO Historical Data End of Day product for
subscribers is $400.00 per calendar month selected. The fee for the
PHOTO Historical Data Intra-day product subscribers is $750.00 per
calendar month selected.
    Proposal. NASDAQ believes that PHOTO Historical is not a facility
of the Exchange within the meaning of the Act, and that previous
proposed rule changes with respect to such PHOTO Historical were
unnecessary under the Act. Congress enacted the Exchange Act to impose
federal regulation on stock exchanges, and included in its definition
of ``exchange'' ``the market facilities maintained by such exchange.''
\9\ The Exchange Act separately defines ``facility,'' providing that
``[t]he term `facility' when used with respect to an exchange includes
[1] its premises, [2] tangible or intangible property whether on the
premises or not, [3] any right to the use of such premises or property
or any service thereof for the purpose of effecting or reporting a
transaction on an exchange (including among other things, any system of
communication to or from the exchange, by ticker or otherwise,
maintained by or with the consent of the exchange), and [4] any right
of the exchange to the use of any property or service.'' Id. The
Commission has not separately interpreted the definition of
``facility.'' \10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. Sec.  78c(a)(1).
    \10\ Securities Exchange Act Release No. 26708, at 4 n.28 (1989)
(recognizing that the definition of the term ``facility'' has not
changed since it was originally adopted and that no hearing
testimony referred to it because ``the Committee felt that the
definition was `self-explanatory''') (citation omitted).
---------------------------------------------------------------------------

    PHOTO Historical does not satisfy any of the four prongs set forth
in the statutory definition of ``facility.'' First, it is not the
``premises'' of the Exchange. The term ``premises'' is generally
understood to refer to a building, its land, and appurtenances. Second,
PHOTO Historical is not tangible or intangible property of the
Exchange. While the Exchange initially distributes the PHOTO product as
a facility; NASDAQ OMX stores and distributes PHOTO Historical as any
vendor would do. Third, PHOTO Historical is not used on the Exchange's
premises ``for the purpose of effecting or reporting a transaction'' on
an exchange.\11\ Fourth, PHLX, in its capacity as an exchange, does not
hold any right to PHOTO Historical other than as the original
distributor of such data for which it receives applicable, filed fees.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78c(a)(2).
---------------------------------------------------------------------------

    The Exchange's proposal is consistent with past precedent regarding
the distribution of historical data. Specifically, in 2010, the NASDAQ
Stock Market submitted a proposed rule change to eliminate from the
NASDAQ rule manual references to Historical TotalView.\12\ In that
case, TotalView was a real-time data product that was stored in a non-
exchange subsidiary that then redistributed the stored data in the same
manner and capacity as any market data vendor. The proposal was
designated as an immediately effective proposal and was not acted upon
by the Commission.
---------------------------------------------------------------------------

    \12\ Securities Exchange Act Release No. 61416 (Jan. 25, 2010)
(SR-NASDAQ-2010-010).
---------------------------------------------------------------------------

    Conversely, there is no Commission precedent for considering the
historical data of an exchange to be considered a facility when re-
distributed by a market data vendor. For example, when NASDAQ separated
from NASD, the Commission was asked to determine whether TRF LLC, which
would operate NASD's Trade Reporting Facility, was a facility of NASD
or the Nasdaq Exchange, which together owned TRF LLC.\13\ The Nasdaq
Exchange was to be ``primarily responsible for the management of the
TRF LLC's business affairs,'' and all ``profits and losses from the TRF
LLC [were] allocated to NASDAQ.'' Id. at 15; see also id. at 18
(``[T]he Nasdaq Exchange's parent company controls the board of the TRF
LLC, directs all business decisions, provides technology, and will reap
the economic benefits of the TRF LLC.''). Nevertheless, the Commission
concluded that the TRF LLC was a facility of NASD, not the Nasdaq
Exchange, because the ``Trade Reporting Facility is not a service `for
the purpose of effecting or reporting a transaction' on the Nasdaq
Exchange.'' Id. at 18. The

TRF LLC was instead ``a service for the purpose of reporting
transactions to the NASD.'' Id.
---------------------------------------------------------------------------

    \13\ Securities Exchange Act Release No. 54084 (June 30, 2006).
---------------------------------------------------------------------------

    Similarly, the Commission concluded that the ACES System, ``a
neutral communications service that allows NASDAQ members and non-
members to route orders to one another,'' is not a facility of the
NASDAQ Exchange.\14\ The Commission deemed it significant that the ACES
System does not route orders to NASDAQ and does not report executed
trades on the Exchange. Id. The Commission emphasized that, because the
ACES System is ``not linked to the Exchange's core systems, including
the NASDAQ Market Center,'' it ``is not possible for an order to be
routed to the NASDAQ Market Center via the ACES system.'' Id.
Accordingly, the Commission concluded that ACES does not have ``the
purpose of effecting or reporting a transaction on an exchange'' within
the meaning of the Exchange Act. Id. The Commission has also permitted
NASDAQ to remove from its rule book fees related to the Mutual Fund
Quotation Service and the NASDAQ Index Dissemination Service, both of
which disseminated market data not properly considered ``facilities''
of NASDAQ within the meaning of the Exchange Act.\15\
---------------------------------------------------------------------------

    \14\ Securities Exchange Act Release No. 56237 (August 9, 2007).
    \15\ See Securities Exchange Act Release No. 58392 (August 20,
2008) (removing MFQS from rule book); Securities Exchange Act
Release No. 58897 (November 3, 2008) (removing NIDS from rule book).
---------------------------------------------------------------------------

    Given the plain language of the Exchange Act and the above-
referenced precedents, there is no basis in the Act for determining
that a real-time market data facility of an exchange retains that
character when an affiliated vendor redistributes it on an historical
basis. First, the affiliated vendor is not an exclusive processor of
such data, unlike the data that PHLX produces directly. Second,
historical data does not provide access or order entry capability to
the Exchange's execution system; nor does it carry information from or
about executions currently within the execution system. Third, the
affiliated vendor receives the data via an arms-length agreement and it
has no inherent advantage over any other recipient of such data.
Moreover, historical data is available via multiple sources. It is a
completely voluntary product in that PHLX makes it available on a
voluntary basis, and clients purchase it from NASDAQ OMX (or another
vendor) only if they voluntarily choose to do so.
    For all of these reasons, PHLX believes that its PHOTO Historical
data service is not a facility of a national securities exchange within
the meaning of the Act and that it is not required under Section
19(b)(1) of the Act \16\ and Rule 19b-4 thereunder \17\ to file rules
regarding the applicable charges.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(1).
    \17\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

2. Statutory Basis
    PHLX believes that PHOTO Historical is not a facility of a national
securities exchange within the meaning of the Act and the terms of this
service are not rules that must be filed with the Commission under
Section 19(b)(1) of the Act \18\ and Rule 19b-4 thereunder.\19\
Therefore, removing the applicable provisions from the PHLX rule book
would be consistent with the provisions of Section 6(b) of the Act.\20\
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(1).
    \19\ 17 CFR 240.19b-4.
    \20\ 15 U.S.C. 78f(b).
---------------------------------------------------------------------------

    PHLX's proposal to remove PHOTO Historical from the rule manual is
also consistent with the Exchange Act insofar as it will have no impact
on PHLX's or its members' compliance with applicable regulations and
rules. First, PHLX has no obligation under the Exchange Act, either as
an exchange or a vendor, to offer PHOTO Historical to PHLX members.
Having chosen to offer such data and to do so on non-discriminatory
terms imposes no continuing obligation to do so. Second, even assuming
PHLX did have an obligation to make PHOTO Historical available, it will
continue to do so in the same manner if does now. Therefore, to the
extent PHLX members utilize PHOTO Historical, that use will be
uninterrupted. Third, there are multiple vendors of historical, many of
whom are not subject to Commission oversight.

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

    PHLX does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended. To the contrary,
PHLX believes that this proposed rule change removing from the PHLX
rule manual a service improperly included, promotes competition by
removing an impediment to PHLX's competition with unregulated market
data providers with which PHLX competes for these services. Removing
barriers to competition has the potential to promote innovation, reduce
prices, and increase efficiency.

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 Exchange 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-2014-34 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2014-34. 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
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices 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-2014-34,
and should be submitted on or before June 19, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
---------------------------------------------------------------------------

    \21\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-12421 Filed 5-28-14; 8:45 am]
BILLING CODE 8011-01-P


Revisions to Ambient Air Monitoring Regulations Docket ID EPA HQ OAR 2004 0018   Item: QA Strategy Workgroup Meeting with EPA Regions and QA representatives from monitoring agencies to discuss proposed QA requirements.

  Date: April 27, 2006   Location: 25th Annual Conference on Managing Environmental Quality Systems, Austin, Texas   OAQPS Attendees: Phil Lorang, Mike Papp, Mark Shanis, Dennis Crumpler, Jonathan Miller   Comments: Provided a brief discussion on the proposed 40 CFR Part 58 Appendix A QA regulations and the type of comments that are coming in. Discussed the need for independent audits and the issues related to funding these audits. Also explained the regulations related to the federal equivalency requirements ( FEM) and the approved regional method ( ARM)

Mike Papp EPA OAQPS C304 06 RTP, NC 27711 919/ 541 2408


[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Pages 53485-53488]
[FR Doc No: 2014-21363]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72969; File No. SR-Phlx-2014-56]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Relating to
Collection of Information Related to Aggregation of Activity of
Affiliates

September 3, 2014.
    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 August 20, 2014, 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 harmonize the process by which it collects
and aggregates information from its equity and option members and
member organizations for the purposes of assessing charges or credits
for options and equities trading.
    The Exchange requests that this filing become operative on December
1, 2014.

    The text of the proposed rule change is set forth below. Proposed
new language is in italics; deleted text is in brackets.
* * * * *

NASDAQ OMX PHLX LLC \1\ PRICING SCHEDULE

    ALL BILLING DISPUTES MUST BE SUBMITTED TO THE EXCHANGE IN WRITING
AND MUST BE ACCOMPANIED BY SUPPORTING DOCUMENTATION. ALL DISPUTES MUST
BE SUBMITTED NO LATER THAN SIXTY (60) DAYS AFTER RECEIPT OF A BILLING
INVOICE, EXCEPT FOR DISPUTES CONCERNING NASDAQ OMX PSX FEES,
PROPRIETARY DATA FEED FEES AND CO-LOCATION SERVICES FEES. AS OF JANUARY
3, 2011, THE EXCHANGE WILL CALCULATE FEES ON A TRADE DATE BASIS.

    \1\ PHLX[supreg] is a registered trademark of The NASDAQ OMX
Group, Inc.
* * * * *

PREFACE

    For purposes of assessing options fees and paying rebates, the
following references should serve as guidance.
    The term ``Customer'' applies to any transaction that is identified
by a member or member organization for clearing in the Customer range
at The Options Clearing Corporation (``OCC'') which is not for the
account of broker or dealer or for the account of a ``Professional''
(as that term is defined in Rule 1000(b)(14)).\2\
    The term ``Specialist'' applies to transactions for the account of
a Specialist \3\ (as defined in Exchange Rule 1020(a)).
    The term ``ROT, SQT and RSQT'' applies to transactions for the
accounts of Registered Option Traders \4\ (``ROTs''), Streaming Quote
Traders (``SQTs''),\5\ and Remote Streaming Quote Traders
(``RSQTs'').\6\ For purposes of the Pricing Schedule, the term ``Market
Maker'' will be utilized to describe fees and rebates applicable to
ROTs, SQTs and RSQTs.
    The term ``Firm'' applies to any transaction that is identified by
a member or member organization for clearing in the Firm range at OCC.
    The term ``Professional'' applies to transactions for the accounts
of Professionals (as defined in Exchange Rule 1000(b)(14)).
    The term ``Broker-Dealer'' applies to any transaction which is not
subject to any of the other transaction fees applicable within a
particular category.
    The term ``Joint Back Office'' or ``JBO'' \7\ applies to any
transaction that is identified by a member or member organization for
clearing in the Firm range at OCC and is identified with an origin code
as a JBO. A JBO will be priced the same as a Broker-Dealer as of
September 1, 2014.
    The term ``Common Ownership'' shall mean members or member
organizations under 75% common ownership or control.

For Purposes of Common Ownership Aggregation of Activity of Affiliated
Members and Member Organizations

    (a) For purposes of applying any options transaction fee or rebate
where the fee assessed, or rebate provided by the Exchange depends upon
the volume of a member or member organization's activity, a member or
member organization may request that the Exchange aggregate its
activity with the activity of its affiliates.
    (1) A member or member organization requesting aggregation of
affiliate activity shall be required to certify to the Exchange the
affiliate status of entities whose activity it seeks to aggregate prior
to receiving approval for aggregation, and shall be required to inform
the Exchange immediately of any event that causes an entity to cease to
be an affiliate. The Exchange shall review available information
regarding the entities, and reserves the right to request additional
information to verify the affiliate status of an entity. The Exchange
shall approve a request unless it determines that the certification is
not accurate.
    (2) If two or more members or member organizations become
affiliated on or prior to the sixteenth day of a month, and submit the
required request for aggregation on or prior to the twenty-second day
of the month, an approval of the request by the Exchange shall be
deemed to be effective as of the first day of that month. If two or
more members or member organizations become affiliated after the
sixteenth day of a month, or submit a request for aggregation after the
twenty-second day of the month, an approval of the request by the
Exchange shall be deemed to be effective as of the first day of the
next calendar month.
    (b) For purposes of applying any option transaction fee or rebate
where the fee assessed, or rebate provided by the Exchange depends upon
the volume of a member or member organization's activity, references to
an entity (including references to a ``member'' or ``member
organization'') shall be deemed to include the entity and its
affiliates that have been approved for aggregation.
    (c) For purposes of this provision, the term ``affiliate'' of a
member or member organization shall mean any member or member
organization under 75% common ownership or control of that member or
member organization.
* * * * *

VIII. NASDAQ OMX PSX FEES

* * * * *

Aggregation of Activity of Affiliated Member Organizations

    (a) For purposes of applying any PSX charge or credit where the
charge assessed, or credit provided, by the Exchange depends upon the
volume of a member organization's activity, a member organization may
request that the Exchange aggregate its activity with the activity of
its affiliates.
    (1) A member organization requesting aggregation of affiliate
activity shall be required to certify to the Exchange the affiliate
status of entities whose activity it seeks to aggregate prior to
receiving approval for aggregation, and shall be required to inform the
Exchange immediately of any event that causes an entity to cease to be
an affiliate. [In addition, the Exchange reserves the right to request
information to verify the affiliate status of an entity.] The Exchange
shall review available information regarding the entities, and reserves
the right to request additional information to verify the affiliate
status of an entity. The Exchange shall approve a request unless it
determines that the certification is not accurate.
    (2) If two or more member organizations become affiliated on or
prior to the sixteenth day of a month, and submit the required request
for aggregation on or prior to the twenty-second day of the month, an
approval of the request by the Exchange shall be deemed to be effective
as of the first day of that month. If two or more members become
affiliated after the sixteenth day of a month, or submit a request for
aggregation after the twenty-second day of the month, an approval of
the request by the Exchange shall be deemed to be effective as of the
first day of the next calendar month.
    (b) No Change.
    (c) No Change.
* * * * *

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 is proposing to amend both the Preface of the Pricing
Schedule, which applies to options, and Chapter VIII of the Pricing
Schedule, which applies to equities, to harmonize the process by which
the Exchange will collect information from members and member
organizations that desire their activity to be aggregated for the
purposes of assessing charges or credits. Today, equity and options
members may aggregate affiliate activity based on volume of activity
for purposes of pricing, but at different percentages (100 percent vs.
75 percent).\3\ The Exchange believes that having the same process for
equity and options members will provide consistency to its processes
when aggregating pricing.
---------------------------------------------------------------------------

    \3\ See Preface of the Pricing Schedule, which applies to
options, and Chapter VIII of the Pricing Schedule, which applies to
equities.
---------------------------------------------------------------------------

    Today, a PSX member organization requesting aggregation of
affiliate activity is required to certify to the Exchange the affiliate
status of entities whose activity it seeks to aggregate prior to
receiving approval for aggregation, and is required to inform the
Exchange immediately of any event that causes an entity to cease to be
an affiliate. In addition, the Exchange reserves the right to request
information to verify the affiliate status of an entity.
    The Exchange proposes to make this language consistent with the
requirements of The NASDAQ Stock Market LLC (``NASDAQ'') and NASDAQ OMX
BX, Inc. (``BX'') \4\ by further stating that it will approve a request
unless it determines that the certification is not accurate. Also, the
Exchange proposes to adopt the following NASDAQ and BX equity process
for determining the effective date for aggregation: ``If two or more
member organizations become affiliated on or prior to the sixteenth day
of a month, and submit the required request for aggregation on or prior
to the twenty-second day of the month, an approval of the request by
the Exchange shall be deemed to be effective as of the first day of
that month. If two or more members become affiliated after the
sixteenth day of a month, or submit a request for aggregation after the
twenty-second day of the month, an approval of the request by the
Exchange shall be deemed to be effective as of the first day of the
next calendar month.''
---------------------------------------------------------------------------

    \4\ See NASDAQ and BX Rules 7027(a).
---------------------------------------------------------------------------

    The Exchange also proposes to add the same process that would exist
for PSX members to the process that would be required for option
members by also adding the same language, as specified above, to the
Preface of the Pricing Schedule, which applies to options pricing. The
Exchange believes that harmonizing the process for collecting this
information will avoid confusion and simplify information requested of
equity and options members by requesting consistent information.
    Finally, the Exchange proposes to add language to clarify that the
defined terms in the Preface of the Pricing Schedule apply to options
pricing, fees and rebates.
    The Exchange proposes to apply this pricing as of December 1, 2014
and issue an Options Trader Alert to its members.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act\5\ in general, and furthers the objectives of Section
6(b)(5) of the Act\6\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest,
in that the proposal will harmonize the process by which the Exchange
collects information from equity and options members and member
organizations regarding the aggregation of activity of affiliated
member organizations for the purposes of assessing charges or credits.
---------------------------------------------------------------------------

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

    The Exchange believes that harmonizing this process by which the
Exchange collects information related to aggregation for equity and
options members to the process in place at NASDAQ and BX \7\ will
provide consistency to market participants with respect to meeting the
requirements to aggregate on NASDAQ, BX or Phlx. Also, the Exchange
believes that adopting this method for collecting such information on
aggregated pricing will ensure proper validation for firms entitled to
the aggregation.
---------------------------------------------------------------------------

    \7\ See note 4.
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange is merely seeking
to harmonize the manner in which it collects information related to the
aggregation of activity of affiliated member organizations for the
purposes of assessing charges or credits for equity and options
members. The Exchange intends to apply a uniform process to request
such aggregation for all Phlx members and member organizations.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(ii) of the Act \8\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \9\ 17 CFR 240.19b-4(f)(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: (i)
necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act.

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-2014-56 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2014-56. 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 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; 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-2014-56 and should be
submitted on or before September 30, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O' Neill,
Deputy Secretary.
[FR Doc. 2014-21363 Filed 9-8-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Pages 81780-81782]
[FR Doc No: 2016-27855]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3680]

Determination That BENEMID (Probenecid) Tablet and Other Drug
Products Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has

determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
applicants must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. ANDA applicants do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, a drug is removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
    FDA has become aware that the drug products listed in the table in
this document are no longer being marketed.

----------------------------------------------------------------------------------------------------------------
                                               Active                           Dosage form/
   Application No.        Drug name        ingredient(s)       Strength(s)          route           Applicant
----------------------------------------------------------------------------------------------------------------
NDA 007898..........  BENEMID..........  Probenecid.......  500 milligrams    Tablet; Oral....  Merck and Co.,
                                                             (mg).                               Inc.
NDA 008048..........  XYLOCAINE........  Lidocaine........  5%..............  Ointment;         AstraZeneca
                                                                               Topical.          Pharmaceuticals
                                                                                LP.
NDA 011111..........  VISTARIL.........  Hydroxyzine        25 mg/milliliter  Injectable;       Pfizer Inc.
                                          Hydrochloride      (mL); 50 mg/mL.   Injection.
                                          (HCl).
NDA 012209..........  FLUOROURACIL.....  Fluorouracil.....  500 mg/10 mL (50  Injectable;       Spectrum
                                                             mg/mL).           Injection.        Pharmaceuticals
                                                                                , Inc.
NDA 013220..........  PERIACTIN........  Cyproheptadine     2 mg/5 mL.......  Syrup; Oral.....  Merck and Co.,
                                          HCl.                                                   Inc.
NDA 017534..........  FIORINAL.........  Aspirin;           325 mg; 50 mg;    Tablet; Oral....  Allergan Sales,
                                          Butalbital;        40 mg.                              LLC.
                                          Caffeine.
NDA 017577..........  DITROPAN.........  Oxybutynin         5 mg............  Tablet; Oral....  Ortho-McNeil-
                                          Chloride.                                              Janssen
                                                                                Pharmaceuticals
                                                                                , Inc.
NDA 017781..........  DIPROSONE........  Betamethasone      Equivalent to     Lotion; Topical.  Schering Corp.
                                          Dipropionate.      (EQ) 0.05% Base.
NDA 018211..........  DITROPAN.........  Oxybutynin         5 mg/5 mL.......  Syrup; Oral.....  Ortho-McNeil-
                                          Chloride.                                              Janssen
                                                                                Pharmaceuticals
                                                                                , Inc.
NDA 018586..........  TOPICORT.........  Desoximetasone...  0.05%...........  Gel; Topical....  Taro
                                                                                Pharmaceuticals
                                                                                U.S.A., Inc.
NDA 018631..........  TRENTAL..........  Pentoxifylline...  400 mg..........  Extended-Release  U.S.
                                                                               Tablet; Oral.     Pharmaceutical
                                                                                Holdings II,
                                                                                LLC.
NDA 019155..........  LAC-HYDRIN.......  Ammonium Lactate.  EQ 12% Base.....  Lotion; Topical.  Ranbaxy
                                                                                Laboratories
                                                                                Inc.
NDA 019323..........  TEMOVATE.........  Clobetasol         0.05%...........  Ointment;         Fougera
                                          Propionate.                          Topical.          Pharmaceuticals
                                                                                Inc.
NDA 019778..........  PRINZIDE.........  Hydrochlorothiazi  12.5 mg/10 mg;    Tablet; Oral....  Merck Sharp &
                                          de; Lisinopril.    12.5mg/20mg.                        Dohme Corp.,
                                                                                Subsidiary of
                                                                                Merck & Co.,
                                                                                Inc.
NDA 019842..........  MOTRIN...........  Ibuprofen........  100 mg/5 mL.....  Suspension; Oral  McNeil Consumer
                                                                                Healthcare
                                                                                Division of
                                                                                McNEIL-PPC,
                                                                                Inc.
NDA 019915..........  MONOPRIL.........  Fosinopril Sodium  10 mg; 20 mg; 40  Tablet; Oral....  Bristol-Myers
                                                             mg.                                 Squibb Co.
NDA 020343..........  PRIMACOR IN        Milrinone Lactate  EQ 10 mg Base/    Injectable;       Sanofi-Aventis
                       DEXTROSE 5% IN                        100 mL; EQ 15     Injection.        U.S. LLC.
                       PLASTIC                               mg Base/100 mL;
                       CONTAINER.                            EQ 20 mg Base/
                                                             100 mL; EQ 40
                                                             mg Base/200 mL.
NDA 020508..........  LAC-HYDRIN.......  Ammonium Lactate.  EQ 12% Base.....  Cream; Topical..  Ranbaxy
                                                                                Laboratories,
                                                                                Inc.
NDA 020635..........  LEVAQUIN IN        Levofloxacin.....  EQ 250 mg/50 mL   Injectable;       Janssen
                       DEXTROSE 5% IN                        (EQ 5 mg/mL);     Injection.        Pharmaceuticals
                       PLASTIC                               EQ 500 mg/100                       , Inc.
                       CONTAINER.                            mL (EQ 5 mg/
                                                             mL); EQ 750 mg/
                                                             150 mL (EQ 5 mg/
                                                             mL).
NDA 020863..........  PLETAL...........  Cilostazol.......  50 mg; 100 mg...  Tablet; Oral....  Otsuka
                                                                                Pharmaceutical
                                                                                Co., Ltd.
NDA 20950...........  DUONEB...........  Albuterol          EQ 0.083% Base;   Solution;         Mylan Specialty,
                                          Sulfate;           0.017%.           Inhalation.       L.P.
                                          Ipratropium
                                          Bromide.
NDA 21460...........  METAGLIP.........  Glipizide;         2.5 mg/250 mg;    Tablet; Oral....  Bristol-Myers
                                          Metformin HCl.     2.5 mg/500 mg;                      Squibb Co.
                                                             5 mg/500 mg.
NDA 021759..........  ELOXATIN.........  Oxaliplatin......  200 mg/40 mL (5   Injectable;       Sanofi-Aventis
                                                             mg/mL).           Intravenous       U.S. LLC.
                                                                               (Infusion).
NDA 050442..........  VIBRAMYCIN.......  Doxycycline        EQ 100 mg Base/   Injectable;       Pfizer Inc.
                                          Hyclate.           Vial; EQ 200 mg   Injection.
                                                             Base/Vial.

NDA 050624..........  ROCEPHIN W/        Ceftriaxone        EQ 10 mg Base/    Injectable;       Hoffmann-La
                       DEXTROSE IN        Sodium.            mL; EQ 20 mg      Injection.        Roche, Inc.
                       PLASTIC                               Base/mL; EQ 40
                       CONTAINER.                            mg Base/mL.
NDA 050739..........  OMNICEF..........  Cefdinir.........  300 mg..........  Capsule; Oral...  AbbVie Inc.
NDA 050749..........  OMNICEF..........  Cefdinir.........  125 mg/5 mL; 250  For Suspension;   AbbVie Inc.
                                                             mg/5 mL.          Oral.
ANDA 060003.........  V-CILLIN K.......  Penicillin V       EQ 125 mg Base;   Tablet; Oral....  Eli Lilly and
                                          Potassium.         EQ 250 mg Base;                     Company.
                                                             EQ 500 mg Base.
ANDA 060463.........  GARAMYCIN........  Gentamicin         EQ 0.1% Base....  Ointment;         Schering-Plough
                                          Sulfate.                             Topical.          Corp.
ANDA 086833.........  CYPROHEPTADINE     Cyproheptadine     2 mg/5mL........  Syrup; Oral.....  Actavis Mid
                       HYDROCHLORIDE.     HCl.                                                   Atlantic LLC.
ANDA 088877.........  BENZTROPINE        Benztropine        0.5 mg..........  Tablet; Oral....  Lannett
                       MESYLATE.          Mesylate.                                              Holdings, Inc.
ANDA 088894.........  BENZTROPINE        Benztropine        1 mg............  Tablet; Oral....  Lannett
                       MESYLATE.          Mesylate.                                              Holdings, Inc.
ANDA 088895.........  BENZTROPINE        Benztropine        2 mg............  Tablet; Oral....  Lannett
                       MESYLATE.          Mesylate.                                              Holdings, Inc.
----------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs and ANDAs listed in this
document are unaffected by the discontinued marketing of the products
subject to those NDAs and ANDAs. Additional ANDAs that refer to these
products may also be approved by the Agency if they comply with
relevant legal and regulatory requirements. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: November 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27855 Filed 11-17-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Rules and Regulations]
[Pages 20167-20170]
[FR Doc No: 2015-08665]

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

ENVIRONMENTAL PROTECTION AGENCY

48 CFR Parts 1515 and 1552

[EPA-HQ-OARM-2015-0182; FRL 9923-85-OARM]

Environmental Protection Agency Acquisition Regulation (EPAAR);
Source Selection and Payments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) amends the EPA
Acquisition Regulation (EPAAR) to remove source selection guidance and
clauses that are not consistent with current EPA internal operating
procedures for source selections. Additionally, EPA is deleting a
clause for Payments--Fixed Rate Services Contracts because it is
inconsistent with sections in the Federal Acquisition Regulation (FAR).
EPA does not anticipate any adverse comments.

DATES: This rule is effective on June 15, 2015 without further notice,
unless adverse comment is received May 15, 2015. If adverse comment is
received, the EPA will publish a timely withdrawal of the rule in the
Federal Register.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OARM-2015-0182 by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: EPA-HQ-OARM-2015-0182, OEI Docket, Environmental
Protection Agency, 2822T, 1200 Pennsylvania Ave. NW., Washington, DC
20460. Please include a total of three (3) copies.
     Hand Delivery: EPA Docket Center--Attention OEI Docket,
EPA West, Room B102, 1301 Constitution Ave. NW., Washington DC 20004.
Such

deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OARM-
2015-0182. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through http://www.regulations.gov your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Government
Property--Contract Property Administration Docket, EPA/DC, EPA West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER> and the telephone number for the EPA
Docket Center is<PHONE_NUMBER>. This Docket Facility is open from 8:30
a.m. to 4:30 p.m. Monday through Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: Staci Ramrakha, Policy, Training, and
Oversight Division, Acquisition Policy and Training Service Center
(3802R), Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

General Information

    1. Do not submit Classified Business Information (CBI) to EPA Web
site http://www.regulations.gov or email. Clearly mark the part or all
of the information that you claim to be CBI. For CBI information in a
disk or CD-ROM that you mail to EPA, mark the outside of the disk or
CD-ROM as CBI, and then identify electronically within the disk or CD-
ROM the specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) Part or section number.
     Explain why you agree or disagree, suggest alternatives,
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
    3. Make sure to submit your comments by the comment period deadline
identified.

Background

    The EPA has recently issued new internal guidance for conducting
source selections in accordance with Federal Acquisition Regulation
(FAR) Part 15. As a result of the new guidance, existing EPAAR
subsection 1515.3, Source Selection, is no longer pertinent. The new
source selection guidance does not have a significant effect beyond the
internal operating procedures of the agency or have a significant cost
or administrative impact on contractors or offerors. Therefore, this
subpart and its related clauses are being removed in their entirety.
Additionally, the EPA is removing EPAAR 1552.232-73, Payments--Fixed
Rate Services Contracts, because it is inconsistent with FAR 52.232-7.

Final Rule

    This final rule makes the following changes:
    1. Amend EPAAR 1515.209 to delete source selection clauses that are
no longer applicable to EPA source selections.
    2. Remove EPAAR Subpart 15.3, Source Selection, in its entirety.
    3. Remove EPAAR 1552.215-70, EPA Source Evaluation and Selection
Procedures--Negotiated Procurements, in its entirety.
    4. Remove EPAAR 1552.215-71, Evaluation Factors for Award, in its
entirety.
    5. Remove EPAAR 1552.232-73, Payments--Fixed Rate Services
Contracts, in its entirety.
    6. Amend EPAAR 1552.215-72(b)(1)(iii) to delete reference to EPAAR
1552.232-73 which has been removed from the EPAAR.

Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and
is therefore not subject to review under the EO 12866 and 13563 (76 FR
3821, January 21, 2011).

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b).

C. Regulatory Flexibility Act (RFA), as amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et
seq.

    The RFA generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute; unless the agency certifies that the rule will not have
a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental jurisdictions. For purposes of assessing the
impact of today's final rule on small entities, ``small entity'' is
defined as: (1) A small business that meets the definition of a small
business found in the Small Business Act and codified at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; or (3) a small organization that is any
not-for-profit enterprise which is independently owned and operated and
is not dominant in its field. After considering the economic impacts of
this rule on small entities, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
In determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, because the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities'' 5 U.S.C. 503
and 604. Thus, an agency may certify that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves regulatory burden, or otherwise has a positive
economic effect on all of the small entities subject to the rule. This
action revises current EPAAR clauses and will not have a significant
economic impact on substantial number of small entities. We continue to
be interested in the potential impacts of the proposed rule on small
entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, and tribal governments or the private
sector. The action imposes no enforceable duty on any State, local or
tribal governments or the private sector. Therefore, this action is not
subject to the requirements of Sections 202 or 205 of the UMRA. This
action is also not subject to the requirements of section 203 of UMRA
because it contains no regulatory requirements that might significantly
or uniquely affect small governments.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. Thus, Executive Order 13132 does
not apply to this action. In the spirit of Executive Order 13132, and
consistent with EPA policy to promote communications between EPA and
State and local governments, EPA specifically solicits comment on this
action from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). Thus, Executive
Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    Executive Order 13045, entitled ``Protection of Children from
Environmental Health and Safety Risks'' (62 FR 19885, April 23, 1997),
applies to any rule that: (1) Is determined to be economically
significant as defined under EO 12886, and (2) concerns an
environmental health or safety risk that may have a proportionate
effect on children. This rule is not subject to EO 13045 because it is
not an economically significant rule as defined by EO 12866, and
because it does not have a proportionate effect on children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28335
May 22, 2001) because it is not a significant regulatory action under
Executive Order 12866.

I. National Technology Transfer and Advancement Act of 1995 (NTTAA)

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards. This action
does not involve technical standards. Therefore, EPA is not considering
the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629 (Feb. 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States. EPA has determined that this final
rule will not have disproportionately high and adverse human health or
environmental effects on minority or low-income populations because it
does not affect the level of protection provided to human health or the
environment in the general public.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Section 804 exempts from section 801 the following types
of rules (1) rules of particular applicability; (2) rules relating to
agency management or personnel; and (3) rules

of Agency organization, procedure, or practice that do not
substantially affect the rights or obligations of non-agency parties. 5
U.S.C. 804(3). EPA is not required to submit a rule report regarding
today's action under section 801 because this is a rule of agency
organization, procedure, or practice that does not substantially affect
the rights or obligations of non-agency parties.

List of Subjects

48 CFR Part 1515

    Environmental protection, Government procurement.

48 CFR Part 1552

    Environmental protection, Government procurement, Reporting and
recordkeeping requirements.

    Dated: April 2, 2015.
John R. Bashista,
Director, Office of Acquisition Management.
    For the reasons stated in the preamble, EPA amends 48 CFR Chapter
15, parts 1515 and 1552 as set forth below:

PART 1515--CONTRACTING BY NEGOTATION

0
1. The authority citation for part 1515 continues to read as follows:

    Authority: 5 U.S.C. 301; Sec. 205(c), 63 Stat. 390, as amended,
40 U.S.C. 486(c); and 41 U.S.C. 418b.

0
2. Revise 1515.209 to read as follows:

1515.209  Solicitation provisions and contract clauses.

    The contracting officer shall insert the clause at 1552.215-75,
Past Performance Information, or a clause substantially the same as
1552.215-75, in all competitively negotiated acquisitions with an
estimated value in excess of the simplified acquisition threshold.

Subpart 1515.3 [Removed]

0
3. Remove subpart 1515.3.

PART 1552--SOLICITATION PROVISIONS AND CONTRACT CLAUSES

0
4. The authority citation for part 1552 continues to read as follows:

    Authority: 5 U.S.C. 301; Sec. 205(c), 63 Stat. 390, as amended,
40 U.S.C. 486(c); and 41 U.S.C. 418b.

1552.215-70 and 1552.215-71  [Removed]

0
5. Remove 1552.215-70 and 1552.215-71.

0
6. Amend 1552.215-72 by revising paragraph (b)(1)(iii) to read as
follows:

1552.215-72  Instructions for the Preparation of Proposals.

* * * * *
    (b) * * *
    (1) * * *
    (iii) If the contract includes the clause at FAR 52.232-7,
``Payments Under Time and Materials and Labor-Hour Contracts,'' include
in the cost proposal the estimated costs and burden rate to be applied
to materials, other direct costs, or subcontracts. The Government will
include these costs as part of its cost proposal evaluation.
* * * * *

1552.232-73  [Removed]

0
7. Remove 1552.232-73.
[FR Doc. 2015-08665 Filed 4-14-15; 8:45 am]
 BILLING CODE 6560-50-P