[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71853-71855]
[FR Doc No: 2015-29219]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76406; File No. SR-NYSE-2015-55]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Discontinue the NYSE Realtime Reference Price Market Data Product
Offering

November 10, 2015.
    Pursuant to Section 19(b)(1)\1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on October 30, 2015, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the self-
regulatory organization. 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\ 15 U.S.C. 78a.
    \3\ 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 discontinue the NYSE Realtime Reference
Price (``NYSE RRP'') market data product offering. The text of the
proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the 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
    In 2009, the Securities and Exchange Commission (``Commission'')
approved the NYSE RRP market data product and certain fees for it.\4\
The NYSE RRP market data product provides, on a real-time basis, last
sale prices in all securities that trade on the Exchange. Currently,
there are no subscribers to the NYSE RRP market data product.
Therefore, the Exchange has determined to discontinue the NYSE RRP
market data product. The Exchange also proposes to update the Fee
Schedule to remove reference to the NYSE RRP in connection with this
change.
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    \4\ See Securities Exchange Act Release No. 60004 (May 29,
2009), 74 FR 26905 (June 4, 2009) (SR-NYSE-2009-42).
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    The Exchange will announce the date that the NYSE RRP will be
decommissioned via an NYSE Market Data Notice.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b)\5\ of the
Act, in general, and furthers the objectives of Section 6(b)(5)\6\ of
the Act, in particular, in that it is designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest, and it is not designed to permit unfair discrimination
among customers, brokers, or dealers.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that discontinuing NYSE RRP and removing it
from the Fee Schedule would remove impediments to and perfect a free
and open market by streamlining the Exchange's market data product
offerings to include those for which there has been more demand and
would provide vendors and subscribers with a simpler and more
standardized suite of market data products. The proposal to discontinue
NYSE RRP is applicable to all members, issuers and other persons and
does not unfairly discriminate between customers, issuers, brokers or
dealers.
    In adopting Regulation NMS, the Commission granted self-regulatory
organizations (``SROs'') and broker-dealers increased authority and
flexibility to offer new and unique market data to consumers of such
data. It was believed that this authority would expand the amount of
data available to users and consumers of such data and also spur
innovation and competition for the provision of market data. The
Commission concluded that Regulation NMS--by lessening regulation of
the market in proprietary data--would itself further the Act's goals of
facilitating efficiency and competition:

    [E]fficiency is promoted when broker-dealers who do not need the
data beyond the prices, sizes, market center identifications of the
NBBO and consolidated last sale information are not required to
receive (and pay for) such data. The Commission also believes that
efficiency is promoted when broker-dealers may choose to receive
(and pay for) additional market data based on their own internal
analysis of the need for such data.\7\
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    \7\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496 (June 29, 2005) (File No. S7-10-04).

    The Exchange believes that the discontinuation of a market data
product for which there is little or no demand, as is the case with
NYSE RRP, is a direct example of efficiency because it acknowledges
that investors and the public have indicated that they have little or
no use for certain information and allows the Exchange to dedicate
resources to developing products (including through innovations of
existing products and entirely new products) that provide information
for which there is more of an expressed need.

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

    In accordance with Section 6(b)(8) of the Act,\8\ the Exchange does
not believe that the proposed rule change will impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act.
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    \8\ 15 U.S.C. 78f(b)(8).
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    The Exchange notes that it operates in a highly competitive market
in which other exchanges are free to offer similar products.
Additionally, since there has been little or no demand for the NYSE RRP
product the Exchange's proposed discontinuance will not harm
competition.

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

    Because the foregoing proposed rule 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 if consistent with the protection of
investors and the public interest, provided that the self-regulatory
organization has given the Commission written notice of its intent to
file the proposed rule change at least five business days prior to the
date of filing of the proposed rule change or such shorter time as
designated by the Commission,\9\ the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \10\ and Rule 19b-
4(f)(6) thereunder.\11\
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    \9\ The Exchange has fulfilled this requirement.
    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B)\12\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \12\ 15 U.S.C. 78s(b)(2)(B).
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    A proposed rule change filed under Rule 19b-4(f)(6)\13\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\14\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative because it believes that
immediate operation of this filing would not impact any users of NYSE
RRP. The Commission, noting that there are currently no subscribers to
these data

services, finds that it is consistent with the protection of investors
and the public interest to waive the 30-day operative date and to
permit the proposal to take effect upon filing.\15\
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    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ For purposes only of accelerating the operative date of
this proposal, the Commission has considered the proposed rule's
impact on efficiency, competition, and capital formation. 15 U.S.C.
78c(f).
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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-NYSE-2015-55 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2015-55. 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 will also be available
for inspection and copying at the NYSE's principal office and on its
Internet Web site at www.nyse.com. 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-NYSE-2015-55 and should be submitted on or before
December 8, 2015.
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    \16\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-29219 Filed 11-16-15; 8:45 am]
 BILLING CODE 8011-01-P


SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NSPS for Hospital/Medical/Infectious Waste Incinerators

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NSPS for Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60,
subpart Ec) (Renewal)

1(b)  Short Characterization/Abstract

The New Source Performance Standards (NSPS) for
Hospital/Medical/Infectious Waste Incinerators (HMIWI), 40 CFR part 60,
subpart Ec, were promulgated on September 15, 1997.  These standards
apply to HMIWIs for which construction commenced after June 20, 1996, or
for which modification commenced after the effective date of the NSPS.
Reporting and recordkeeping requirements differ for HMIWI burning
hospital waste and/or medical/infectious waste; for combustors co-firing
hospital waste and/or medical/infectious waste with other fuels; and for
incinerators burning only pathological, low-level radioactive, and/or
chemotherapeutic waste.  For this reason, reporting and recordkeeping
requirements are described separately for HMIWI burning hospital waste
and/or medical/infectious waste and for co-fired combustors and
incinerators burning only pathological, low-level radioactive, and/or
chemotherapeutic waste. This information is being collected to determine
compliance with 40 CFR part 60, subpart Ec and 40 CFR part 60, subpart A
( General Provisions.

The Emission Guidelines (EG) and Compliance Times for HMIWIs, 40 CFR
part 60, subpart Ec, were promulgated on September 15, 1997.  These
standards apply to existing HMIWIs for which construction commenced on
or before June 20, 1996.  The reporting and recordkeeping requirements
for existing HMIWIs regulated by 40 CFR Part 60, Subpart Ec are covered
in Information Collection 1899 and Office of Management and Budget (OMB)
Control Number 2060-0422.  HMIWIs built after June 20, 1996, are not
subject to the subpart Ec guidelines; they are considered new sources
and are subject to the standard.

In general, all NSPS standards require initial notifications,
performance tests, and periodic reports.  Owners or operators are also
required to maintain records of the occurrence and duration of any
startup, shutdown, or malfunction in the operation of an affected
facility, or any period during which the monitoring system is
inoperative.  These notifications, reports, and records are essential in
determining compliance, and are required of all sources subject to the
standard.  The owners or operators must also submit annual and
semiannual reports.

Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
two years following the date of such measurements, maintenance reports,
and records.  All reports are sent to the delegated state or local
authority.  In the event that there is no such delegated authority, the
reports are sent directly to the United States Environmental Protection
Agency (EPA) regional office.

Approximately nine sources are currently subject to the standard, and it
is estimated that an additional one source per year will become subject
to the regulation in the next three years.  It if further assumed that
one additional source per year will become subject to the standard due
to the reconstruction of an existing affected facility for an average of
nine sources over the next three years.  Based on our consultations with
industry representatives, there is an average of one affected facility
at each plant, and that each plant site has only one respondent (i.e.,
the owner/operator of the plant site).

There are approximately one hundred hospital/medical/infectious waste
incinerators in the United States, which are all publicly owned and
operated by the hospital/medical/infectious waste incinerators industry,
of these only nine facilities built after June 20, 1996 are subject to
NSPS subpart Ec.  None of the nine plants in the United States are owned
by either state, local, tribal or the Federal Government.  They are all
owned and operated solely by privately owned for-profit businesses.  You
can find the burden to the “Affected Public” listed below in Table
1: Annual Industry Burden and Cost - NSPS for
Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec).  The Federal government burden does not include work performed by
Federal employees only work performed by contractors, which could be
found listed below in Table 2: Average Annual EPA Burden - NSPS for
Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec).

The Office of Management and Budget (OMB) approved the currently active
ICR without any “Terms of Clearance.”

2.  Need for and Use of the Collection

2(a)  Need/Authority for the Collection

The EPA is charged under section 111 of the Clean Air Act (CAA), as
amended, to establish standards of performance for new stationary
sources that reflect:

. . . application of the best technological system of continuous
emissions reduction which (taking into consideration the cost of
achieving such emissions reduction, or any non-air quality health and
environmental impact and energy requirements) the Administrator
determines has been adequately demonstrated.  Section 111(a)(l).

The Agency refers to this charge as selecting the best demonstrated
technology (BDT).  Section 111 also requires that the Administrator
review and, if appropriate, revise such standards every four years.

In addition, section 114(a) states that the Administrator may require
any owner or operator subject to any requirement of this Act to:

(A) Establish and maintain such records; (B) make such reports; (C)
install, use, and maintain such monitoring equipment, and use such audit
procedures, or methods; (D) sample such emissions (in accordance with
such procedures or methods, at such locations, at such intervals, during
such periods, and in such manner as the Administrator shall prescribe);
(E) keep records on control equipment parameters, production variables
or other indirect data when direct monitoring of emissions is
impractical; (F) submit compliance certifications in accordance with
Section 114(a)(3); and (G) provide such other information as the
Administrator may reasonably require.

In the Administrator's judgment, pollutant from dioxins/furans
(CDD/CDF), particulate matter (PM), carbon monoxide (CO), lead (Pb),
cadmium (Cd), hydrochloric acid (HCI), sulfur dioxide (SO2), nitrogen
oxides (NOx), and mercury (Hg) emissions from HMIWIs causes or
contribute to air pollution that may reasonably be anticipated to
endanger public health or welfare.  Therefore, the NSPS was promulgated
for this source category at 40 CFR part 60, subpart Ec.

2(b)  Practical Utility/Users of the Data

The recordkeeping and reporting requirements in the standard ensure
compliance with the applicable regulations which where promulgated in
accordance with the Clean Air Act.  The collected information is also
used for targeting inspections and as evidence in legal proceedings.

Performance tests are required in order to determine an affected
facility’s initial capability to comply with the emission standard.
Continuous emission monitors are used to ensure compliance with the
standard at all times.  During the performance tests, a record of the
operating parameters under which compliance was achieved may be recorded
and used to determine compliance in place of a continuous emission
monitor.

The notifications required in the standard are used to inform the Agency
or delegated authority when a source becomes subject to the requirements
of the regulations.  The reviewing authority may then inspect the source
to ensure that the pollution control devices are properly installed and
operated, that leaks are being detected and repaired, and that the
standard is being met.  The performance test may also be observed.

The required semiannual and quarterly reports are used to determine
periods of excess emissions, identify problems at the facility, verify
operation/maintenance procedures, and for compliance determinations.

3.  Nonduplication, Consultations, and Other Collection Criteria

The requested recordkeeping and reporting are required under 40 CFR part
60, subpart Ec.

3(a)  Nonduplication

If the subject standards have not been delegated, the information is
sent directly to the appropriate EPA regional office.  Otherwise, the
information is sent directly to the delegated state or local agency.  If
a state or local agency has adopted their own similar standards to
implement the Federal standards, a copy of the report submitted to the
state or local agency can be sent to the Administrator in lieu of the
report required by the Federal standards.  Therefore, no duplication
exists.

3(b)  Public Notice Required Prior to ICR Submission to OMB

An announcement of a public comment period for the renewal of this ICR
was published in the Federal Register (72 FR 10735) on March 9, 2007.
No comments were received on the burden published in the Federal
Register.

3(c)  Consultations

In estimating the affected number of sources, the growth rate, and the
accuracy of other data for hospital/medical/infectious waste
incinerators subject to this standard, we contacted Wheelabrator Falls
Incorporated, Mr. Alan Lewis, at<PHONE_NUMBER>, the National Solid
Waste Management Association (NSWMA), Ms. Alice Jacobson, at (202)
244-4700, and York County Waste/York County Resources, Mr. Jonathan
Beuschlein, at<PHONE_NUMBER>.  We also referenced the most recent ICR,
and used other internal resources to obtain the most recent data
available.  We reviewed information available from the Online Tracking
Information System (OTIS) which is the primary source of information
regarding the number of existing sources.  OTIS data was used in
conjunction with industry consultation to verify the number of sources
and the industry growth rate.

3(d)  Effects of Less Frequent Collection

Less frequent information collection would decrease the margin of
assurance that facilities are continuing to meet the standards.
Requirements for information gathering and recordkeeping are useful
techniques to ensure that good operation and maintenance practices are
applied and emission limitations are met.  If the information required
by these standards was collected less frequently, the proper operation
and maintenance of control equipment and the possibility of detecting
violations would be less likely.

3(e)  General Guidelines

These reporting or recordkeeping requirements do not violate any of the
regulations promulgated by OMB under 5 CFR part 1320, section 1320.5.

3(f)  Confidentiality

Any information submitted to the Agency for which a claim of
confidentiality is made will be safeguarded according to the Agency
policies set forth in title 40, chapter 1, part 2, subpart B -
Confidentiality of Business Information (CBI) (see 40 CFR 2; 41 FR
36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43
FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

3(g)  Sensitive Questions

None of the reporting or recordkeeping requirements contain sensitive
questions.

4.  The Respondents and the Information Requested

4(a)  Respondents/SIC Codes

The respondents to the recordkeeping and reporting requirements are
stationary gas turbines.  The United States Standard Industrial
Classification (SIC) codes which correspond to the North American
Industry Classification System (NAICS) code could be found in the
following table:

40 CFR part 60, subpart Ec	SIC Codes	NAICS Codes

General Medical and Surgical Hospitals	8062 	622110

	8069	622110

Psychiatric and Substance Abuse Hospitals	8063	622210

	8069	622210

Continuing Care Retirement Communities	8051	623311

	8052	623311

	8059	623311

Nursing Care Facilities	8051	623110

	8052	623110

	8059	623110

Residential Mental Retardation Facilities	8051	623210

	8052	623210

	8059	623210

Specialty (except Psychiatric and Substance Abuse) hospitable	8069
622310

Research and Development in the Physical , Engineering, and Life
Sciences	8731	541710

Hazardous Waste Treatment and Disposal	4953	562211

Materials Recovery Facilities	4953	562920

Other Non-hazardous Waste Treatment and Disposal	4953	562219

Solid Waste Combustors and Incinerators	4953	562213

Solid Waste Landfill	4953	562212

Veterinary Services	0741	541940

	0742	541940

4(b)  Information Requested

None of these reporting or recordkeeping requirements violate any of the
regulations established by OMB at 5 CFR part 1320, section 1320.5.

(i)  Data Items

In this ICR, all the data recorded or reported is required by the New
Source Performance Standards for Hospital/Medical/Infectious Waste
Incinerators (40 CFR part 60, subpart Ec).

A source must make the following reports:

Notifications Reports

Statement if intent to construct/modify	60.58c(a)(1)(i)

Notification and application of construction or modification	60.58c(a),
60.7(a)

Notification of actual startup	60.7(a)

Notification of type(s) of waste to be combusted	60.58c(a)(2)(i)

Notification of HMIWI capacity	60.58c(a)(2)(ii)

Documents produced as a result of the siting requirements
60.58c(a)(1)(iii), 60.54c(c)

Waste reduction plan	60.58c(a)(2)(i)

Notification of initial performance tests (PM, stack opacity, fugitive
ash emissions, CDD/CDF, HCI, CD, Pb, Hg)	60.58c(c)(1), 60.8(d)

Notification of site-specific operating parameters or changes
60.58c(c)(2), 60.7(a)

Notification of initial performance tests (PM, stack opacity, fugitive
ash emissions, CDD/CDF, HCI, Cd, Pb, Hg)	60.58c(c)(1), 60.8(a)

Report of site-specific operating parameters	60.58c(d)(1)

Report of annual and semiannual emissions or operating parameter
exceedances, malfunctions, and periods for which data on emissions/
operating parameters were not obtained	60.58c(d), 60.58(e), 60.7(c)

Report of no excess emissions	60.59(d)(7), 60.7(c)

Petition for site-specific operating permits (if applicable)
60.58c(a)(iii)

Report of exceedances	60.58c(b)(5)

Report of performance test	60.58c(d)(6)

A source must keep the following records:

Recordkeeping

Retention of records for two-years	60.58c(b)

Records of startup. Shutdown, or malfunction	60.7(b)

Documentation produced as a result of siting requirements	60.58c(b)(7)

Records of persons completing review of HMIWI operating manual
60.58c(b)(8)

Records if operators completing operator training course and
qualification requirements	60.58c(b)(9), 60.58c(b)(10)

Records of annual testing of fugitives ash emissions	60.58c(b)(2)(ii)

Records of process and control device operating parameters
60.58c(b)(2)(xv), 60.8(f)

Records of emissions or operating parameter exceedances and periods for
which data on emissions/operating parameters were not obtained
60.58c(b)(3), 60.8(f)

Records of initial, annual and subsequent performance tests
60.58c(b)(6), 60.8(f)

Records of calibration of any monitoring devices	60.58c(b)(11)

Records of types and amounts of materials charged for co-fired
combustors and for incinerators burning only pathological, low-level
radioactive, and/or chemotherapeutical waste	60.50c(c)

Electronic Reporting

Some of the respondents are using monitoring equipment that
automatically records parameter data.  Although personnel at the
affected facility must still evaluate the data, internal automation has
significantly reduced the burden associated with monitoring and
recordkeeping at a plant site.

Also, regulatory agencies in cooperation with the respondents continue
to create reporting systems to transmit data electronically.  However,
electronic reporting systems are still not widely used.  At this time,
it is estimated that approximately 15 percent of the respondents use
electronic reporting.

Respondent Activities

Read instructions.

Install, calibrate, maintain, and operate continuous monitoring system
(CMS) or continuous emission monitoring systems for measuring and
recording the missions of pollutants from an affected facility.

Perform initial performance test, Reference Methods 1, 3, 3A, 3B, 9, 10,
10B, 22, 23, 26, 26A, 29, and repeat performance tests if necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Develop site-specific operating parameters.

Develop waste reduction plan.

Submit the required reports developing, acquiring, installing, and
utilizing technology and systems for the purpose of collecting,
validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the
purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the
purpose of disclosing and providing information.

Adjust the existing ways to comply with any previously applicable
instructions and requirements.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

	Currently, sources are using monitoring equipment that provides
parameter data in an automated way e.g., continuous parameter monitoring
system.  Although personnel at the source still need to evaluate the
data, this type of monitoring equipment has significantly reduced the
burden associated with monitoring and recordkeeping.

5.  The Information Collected: Agency Activities, Collection
Methodology, and Information Management

5(a)  Agency Activities

EPA conducts the following activities in connection with the
acquisition, analysis, storage, and distribution of the required
information.

Agency Activities

Observe initial performance tests and repeat performance tests if
necessary.

Review notifications and reports, including performance test reports,
excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Online Tracking Information
System (OTIS).

5(b)  Collection Methodology and Management

Following notification of startup, the reviewing authority might inspect
the source to determine whether the pollution control devices are
properly installed and operational.  Performance test reports are used
by the Agency to discern a source’s initial capability to comply with
the emission standard, and note the operating conditions under which
compliance was achieved.  Data and records maintained by the respondents
are tabulated and published for use in compliance and enforcement
programs.  The semiannual reports are used for problem identification,
as a check on source operation and maintenance, and for compliance
determinations.

Information contained in the reports is entered into OTIS which is
operated and maintained by the EPA Office of Compliance.  OTIS is an EPA
database for the collection, maintenance, and retrieval of compliance
data for approximately 125,000 industrial and government-owned
facilities.  EPA uses OTIS for tracking air pollution compliance and
enforcement by local and state regulatory agencies, EPA regional offices
and EPA headquarters.  EPA and its delegated Authorities can edit,
store, retrieve and analyze the data.

The records required by this regulation must be retained by the owner or
operator for two years.

5(c)  Small Entity Flexibility

The majority of the respondents are large entities (i.e., large
businesses).  However, the impact on small entities (i.e., small
businesses,) was taken into consideration during the development of the
regulation.  Due to technical considerations involving the process
operations and the types of control equipment employed, the
recordkeeping and reporting requirements are the same for both small and
large entities.  The Agency considers these to be the minimum
requirements needed to ensure compliance and, therefore, cannot reduce
them further for small entities.  To the extent that larger businesses
can use economies of scale to reduce their burden, the overall burden
will be reduced.

5(d)  Collection Schedule

The specific frequency for each information collection activity within
this request is shown in Table 1: Annual Industry Burden, NSPS for
Hospital/Medical/Infectious Waste Incinerators (40 CFR part 60, subpart
Ec).

6.  Estimating the Burden and Cost of the Collection

Table 1 documents the computation of individual burdens for the
recordkeeping and reporting requirements applicable to the industry for
the subpart included in this ICR.  The individual burdens are expressed
under standardized headings believed to be consistent with the concept
of burden under the Paperwork Reduction Act.  Wherever appropriate,
specific tasks and major assumptions have been identified.  Responses to
this information collection are mandatory.

The 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 OMB Control Number.

6(a)  Estimating Respondent Burden

The average annual burden to industry over the next three years from
these recordkeeping and reporting requirements is estimated to 6,617
(Total Labor Hours from Table 1).  These hours are based on Agency
studies and background documents from the development of the regulation,
Agency knowledge and experience with the NSPS program, the previously
approved ICR, and any comments received.

6(b)  Estimating Respondent Costs

(i)  Estimating Labor Costs

This ICR uses the following labor rates:

Managerial	$105.86 ($50.41 + 110%)

Technical	$92.61   ($44.10 + 110%)

Clerical	$45.32   ($21.58 + 110%)

These rates are from the United States Department of Labor, Bureau of
Labor Statistics, December 2006, Table 2. Civilian Workers, by
occupational and industry group.  The rates are from column 1, Total
compensation.  The rates have been increased by 110% to account for the
benefit packages available to those employed by private industry.

(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

The only cost to the existing regulated respondents resulting from
information collection activities required by the subject standard is
labor costs.  For existing regulated respondents, there is no
capital/startup costs required for the purchase or the installation of
equipment, because they comply by employing pollution prevention
measures.  New respondents have capital costs associated with the
purchase of the equipment necessary for compliance, as well as operation
and maintenance costs.  The annual operation and maintenance costs are
the ongoing costs to maintain the monitor and other costs such as
photocopying and postage.

		 (iii)  Capital/Startup vs. Operation and Maintenance (O&M) Costs

Capital/Startup vs. Operation and Maintenance (O&M) Costs

(A)

Continuous Monitoring Device	(B)

Capital/Startup Cost for One Respondent  	(C)

Number of New Respondents	(D)

Total Capital/Startup Cost,  (B X C)	(E)

Annual O&M Costs for One Respondent  	(F)

Number of Respondents with O&M 	(G)

Total O&M,

(E X F)

CMS	$2,377	1	$2,377	$2,800	9	$25,200

The total capital/startup costs to new respondents for this ICR are
$2,000 (rounded).  This is the total of column D in the above table.

The total operation and maintenance (O&M) costs for this ICR are $25,000
(rounded).  This is the total of column G.

The average annual cost for capital/startup and operation and
maintenance costs to industry over the next three years of the ICR is
estimated to be $27,000 (rounded).

6(c)  Estimating Agency Burden and Cost

The only costs to the Agency are those costs associated with analysis of
the reported information.  EPA's overall compliance and enforcement
program includes activities such as the examination of records
maintained by the respondents, periodic inspection of sources of
emissions, and the publication and distribution of collected
information.

The average annual Agency cost during the three years of the ICR is
estimated to be $27,419.

This cost is based on the average hourly labor rate as follows:

	Managerial	$58.18 (GS-13, Step 5, $36.36 + 60%)

	Technical	$43.17 (GS-12, Step 1, $26.98 + 60%)

	Clerical	$23.36 (GS-6, Step 3, $14.60 + 60%)

These rates are from the Office of Personnel Management (OPM) (2007
General Schedule( which excludes locality rates of pay.  The rates have
been increased by 60% to account for the benefit packages available to
government employees.  Details upon which this estimate is based appear
in Table 2: Average Annual EPA Burden, NSPS for
Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec), below.

6(d)  Estimating the Respondent Universe and Total Burden and Costs

Based on our research for this ICR, on average over the next three
years, approximately nine existing respondents will be subject to the
standard.  It is estimated that one additional respondent will become
subject over the next three years.

The number of respondents is calculated using the following table that
addresses the three years covered by this ICR.

Number of Respondents

Year	(A)

Number of 1 New Respondents	(B)

Number of Existing Respondents	(C)

Number of Existing Respondents That Keep Records But Do Not Submit
Reports	(D)

Number of Existing Respondents That Are Also New Respondents	(E)

Number of Respondents

(E=A+B+C-D)

1	2	7	0	1	8

2	2	8	0	1	9

3	2	9	0	1	10

Average	2	8	0	1	9

1 New respondent include sources with constructed, reconstructed and
modified affected facilities.

To avoid double-counting respondents, column D is subtracted.  As shown
above, the average Number of Respondents over the three-year period of
this ICR is nine.

The total number of annual responses per year is calculated using the
following table:

Total Annual Responses

(A)

Information Collection Activity	(B)

Number of Respondents	(C)

Number of Responses	(D)

Number of Existing Respondents That Keep Records But Do Not Submit
Reports	(E)

Total Annual Responses

E=(BxC)+D

Notification of intent to construct	1	1	n/a	1

Notification of actual startup 	1	1	n/a	1

Notification of waste to be combusted	1	1	n/a	1

Notification of HMIWI capacity	1	1	n/a	1

Notification of initial performance tests	1	1	n/a	1

Notification of initial CMS demonstration	1	1	n/a	1

Initial report for the site selection analysis	1	1	n/a	1

Waste reduction plan	1	1	n/a	1

Report of initial performance test	1	1	n/a	1

Notification of exemption claimed	1	1	n/a	1

Annual report	8	1	n/a	8

Semiannual reports	8	2	n/a	16

	Total	34

The number of total respondents is nine.

The number of Total Annual Responses is 34.  This is the number in
column E of the Respondent Universe and Number of Responses per year in
table above.

The total annual labor costs are $656,312.  Details regarding these
estimates may be found in Table 1: Annual Industry Burden, NSPS for
Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec), below.

6(e)  Bottom Line Burden Hours Burden Hours and Cost Tables

The detailed bottom line burden hours and cost calculations for the
respondents and the Agency are shown in Tables 1 and 2, respectively,
and summarized below.

(i) Respondent Tally

The total annual labor costs are $656,312.  Details regarding these
estimates may be found in Table 1. Annual Respondent Burden and Cost:
NSPS for Hospital/Medical (40 CFR part 60, subpart Ec), below.
Furthermore, the annual public reporting and recordkeeping burden for
this collection of information is estimated to average 195 hours per
response.

The total annual capital/startup and O&M cost to the regulated entity
are $27,000.

(ii) The Agency Tally

The average annual Agency burden and cost over next three years is
estimated to be 657 labor hours at a cost of $27,419.  See Table 2.
Annual Agency Burden and Cost: NSPS for Hospital/Medical/Infectious
Waste Incinerators (40 CFR part 60, subpart Ec), below.

6(f)  Reasons for Change in Burden

There is an increase in the total estimated burden as currently
identified in the OMB Inventory of Approved Burdens.  This increase is
not due to any program changes.  There is an increase in the number of
new sources, also a revised hourly labor rate.

There is also an increase in the capital/startup and operations and
maintenance (O&M) cost which is due to an increase in the number of new
sources.

6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 195 hours per response.  Burden
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, or disclose or provide information to or
for a Federal agency.  This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a valid OMB
Control Number.  The OMB Control Numbers for EPA’s regulations are
listed at 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-OECA-2007-0049.  An electronic version of the public docket is
available at http://www.regulations.gov which may be used to obtain a
copy of the draft collection of information, submit or view public
comments, access the index listing of the content of the docket, and to
access those documents in the public docket that are available
electronically.  When in the system, select “search” than key in the
docket ID number identified in this document.  The documents are also
available for public viewing at the Enforcement and Compliance Docket
and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Avenue, N.W., Washington, DC.  The EPA Docket
Center 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
Reading Room is<PHONE_NUMBER>, and the telephone number for the
Enforcement and Compliance Docket and Information Center Docket is (202)
566-1752.  Also, you can send comments to the Office of Information and
Regulatory Affairs, Office of Management and Budget, 725 17th Street,
N.W., Washington, DC 20503, Attention: Desk Officer for EPA.  Please
include the EPA Docket ID Number EPA-HQ-OECA-2007-0049 and OMB Control
Number 2060-0363 in any correspondence.

Part B of the Supporting Statement

This part is not applicable because no statistical methods were used in
collecting this information.

Table 1:  Annual Respondent Burden and Cost – NSPS for
Hospital/Medical/infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec)

 	(A)	(B)	(C)	(D)	(E)	(F)	(G)	 (H)

 Burden item 	Person- hours per occurrence	No. of occurrences per
respondent per year	Person- hours per respondent per year (C=AxB)
Respondents per year (a)	Technical person- hours per year (E=CxD)
Management person-hours per year (Ex0.05)

	Clerical person-hours per year

(Ex0.1)

	Cost ($) (b)

1. Applications	N/A

2. Survey and Studies	N/A

3. Reporting requirements

    Non-pathological HMIWI

    A. Read instructions	1	1	1	1	1	0.05	0.1	$102.43

    B. Required activities

       Initial performance test for CMS c	13	1	13	1	13	0.65	1.3
$1,331.66

       Repeat performance test CMS c	13	1	13	0.2 d	2.6	0.13	0.26	$266.33

   Development of operating information e	160	1	160	1	160	8	16
$16,389.60

       Annual update of operating information f	20	1	20	8 g	160	8	16
$16,389.60

       Review of operating information with

       each operator h	8	2	16	9	144	7.2	14.4	$14,750.64

    C.  Create information	See 3B

	    D.  Gather existing information	See 3B

	    E.  Write report

    Non-pathological HMIWI

         Notification of intent to construct	2	1	2	1	2	0.1	0.2	$204.87

         Notification of actual startup	2	1	2	1	2	0.1	0.2	$204.87

         Notification of waste to be combusted	2	1	2	1	2	0.1	0.2	$204.87

         Notification of HMIWI capacity	2	1	2	1	2	0.1	0.2	$204.87

         Notification of initial performance test	2	1	2	1	2	0.1	0.2
$204.87

         Notification of initial CMS

         demonstration	2	1	2	1	2	0.1	0.2	$204.87

         Initial report for the site selection

         analysis i	460	1	460	1	460	23	46	$47,120.10

         Waste reduction plan j	160	1	160	1	160	8	16	$16,389.60

        Report of initial performance test k	40	1	40	1	40	2	4	$4,097.40

        Report of initial CMS demonstration	See 3B

	        Semiannual reports l	74	2 n	148	8 m	1,184	59.2	118.4
$121,283.04

        Annual reports	64	1 n	64	8	512	25.6	51.2	$52,446.72

Pathological and co-fired combustors

        Notification of relative amounts of

        hospital, medical/infectious and other

        waste charged	2	1	2	8	16	0.8	1.6	$1,638.96

        Notification of exemption claim	2	1	2	8 o	16	0.8	1.6	$1,638.96

    F.  Time to enter information

     (Non-pathological HMIWI)

        Records of startup, shutdown or

        malfunction	2	52	104	9	936	46.8	93.6	$95,877.16

        Records of persons completing review	2	2	4	9	36	1.8	3.6
$3,687.66

        Records of annual testing fugitive

        emissions	See 3E

	        Records of process and control device	1.5	52	78	9	702	35.1	70.2
$105,350.54

        Records of CMS operations and

        maintenance	0.2	272 q	54.4	9	489.6	24.48	48.96	$50,152.18

        Records of emissions exceedances	1.5	52	78	9	702	35.1	70.2
$105,350.54

        Records of annual compliance tests	See 3E

	5.  Recordkeeping requirements

    A.  Read instructions	See 3A

	    B.  Plan activities	N/A

	    C.  Implement activities	N/A

	    D.  Develop record system	N/A

	    E.  Time to enter information

  Non-pathological HMIWI

Documents produced as a result of

siting requirements	See 3E

	        Records of operators training

        completion	2	2 h	4	1	4	0.2	0.4	$409.74

    Records of HMIWI qualified operators	2	2 h	4	1	4	0.2	0.4	$409.74

    Records of initial performance test	See 3E

	    F.  Time to train personnel	N/A

	    G. Time for audits	N/A

	Subtotal

	5,754.2	287.71	574.62	$656,311.82

TOTAL ANNUAL BURDEN AND COST (rounded)

6,617

  $656,312

Assumptions:

a.  We have estimated that an average of  nine facilities have been
built or reconstructed after June 20, 1996, and therefore, are subject
to NSPS subpart Ec.  It is estimated that there are eight existing
respondents and one additional respondent over the next three years.

b.  This ICR uses the following labor rates: $105.86 per hour for
Executive, Administrative, and Managerial labor; $92.61 per hour for
Technical labor, and $45.32 per hour for Clerical labor.  These rates
are from the United States Department of Labor, Bureau of Labor
Statistics, December 2006, “Table 2.  Civilian Workers, by
occupational and industry group.” The rates are from column 1,
“Total compensation.”  The rates have been increased by 110 percent
to account for the benefit packages available to those employed by
private industry.

c.  We have assumed that it will take thirteen hours to perform a CMS
performance test.

d.  We have assumed that 20 percent of initial performance tests must be
repeated due to failure.

e.  Assume it will take 160 hours to develop the operating information.

f.   Assume it will take 20 hours to update the operating information
each year.

g.  This activity will not be performed for the first year of a new
source.

h.  Assume it will require two operators at each facility.

i.  Assume it will take 460 hours to develop the site selection
analysis.

j.  Assume it will take 160 hours to develop a waste reduction plan.

k.  Assume it will take 40 hours to review report of initial performance
test.

l.  Assume it will take 74 hours to prepare semiannual which includes a
compilation of the CMS operations parameters.

m.  Respondents must submit semiannual reports.

n.  An annual report is submitted once per year and demonstrates the
overall compliance status of an affected facility over a two-year
period.  Semiannual reports comprised of detail operation parameter
information, exceedances and other data are submitted twice per year.

o.  Assume that an additional eight sources (pathological and co-fired
combustors) are also projected each year, but are considered exempt from
the rule.  It is assumed that there will be one affected facility per
respondent.

p.  The pathological combustors would be required to keep records on a
quarterly basis of the period of time when it applies, and the co-fired
combustors would be required to keep records of the amount of hospital
waste, medical/infectious waste and other fuels and waste to be
combusted, and the weight of the waste combusted on a quarterly basis.

q.  Assume that it takes 272 days-per-year to record CMS operation and
maintenance.

Table 2:  Average Annual EPA Burden – NSPS for
Hospital/Medical/infectious Waste Incinerators (40 CFR Part 60, Subpart
Ec)

 	(A)	(B)	(C)	(D)	(E)	(F)	(G)	 (H)

Activity 	EPA person- hours per occurrence	No. of occurrences per plant

per year	EPA person- hours per plant per year (C=AxB)	Plants per year
(a)	Technical person- hours per year (E=CxD)	Management person-hours per
year (Ex0.05)

	Clerical person-hours per year

(Ex0.1)

	Cost ($) (b)

Activity

1.  Attend initial performance test	32	1	32	0.08c	2.56	0.128	0.256
$123.94

2.  Repeat performance test

     A.  Retesting preparation	12	1	12	0.2d	2.4	0.12	0.24	$116.20

     B.  Attend retesting	32	1	32	0.1e	3.2	0.16	0.32	$154.92

3.  Excess emissions	32	1	32	0.1f	3.2	0.16	0.32	$154.92

4.  Report review

     Review notification of intent to construct	2	1	2	1	2	0.1	0.2	$96.83

     Review notification of actual startup	2	1	2	1	2	0.1	0.2	$96.83

 Review notification of type(s) of waste to

 be combusted	2	1	2	1	2	0.1	0.2	$96.83

     Review notification of HMIWI capacity	2	1	2	1	2	0.1	0.2	$96.83

     Review notification of initial performance

     test	8	1	8	1	8	0.4	0.8	$387.32

     Review notification of initial CMS

     demonstration	5	1	5	1	5	0.25	0.5	$242.07

     Review notification of relative amounts of

     hospital, medical/infectious, and other

     waste charged for pathological and co-fired

     combustors	2	1	2	8g	16	0.8	1.6	$774.64

     Review notification of exemption claim for

     pathological and co-fired combustors	2	1	2	8g	16	0.8	1.6	$774.64

     Review study addressing siting requirements	24	1	24	1	24	1.2	2.4
$1,161.96

     Review waste reduction plan	8	1	8	1	8	0.4	0.8	$387.32

     Review report of initial performance test	42h	1	42	1	42	2.1	4.2
$2,033.43

     Review report of initial CMS demonstration	64i	1	64	1	64	3.2	6.4
$3,098.56

     Review notification of exemption claim	1	1	1	1	1	0.05	0.1	$48.42

     Review performance tests results	18	1	18	8j	144	7.2	14.4	$6,728.82

     Review annual report	4	1	4	8	32	1.6	3.2	$1,549.28

Review semiannual reports	12	2 k	24	8j	192	9.6	19.2	$9,295.68

TOTAL ANNUAL BURDEN AND COST (rounded)

657

$27,419

Assumptions:

a.  We have estimated that an average of  nine facilities have been
built or reconstructed after June 20, 1996, and therefore, are subject
to NSPS subpart Ec.  It is estimated that one additional respondent will
become subject over the next three years.

b.  The cost is based on the following labor rate which incorporates a
1.6 benefits multiplication factor to account for government overhead
expenses.  Managerial rates of $58.18 (GS-13, Step 5, $36.36x1.6),
Technical rate of $43.17 (GS-12, Step 1, $26.98 x 1.6), and Clerical
rate of $23.36 (GS-6, Step 3, $14.60 x 1.6).  These rates are from the
Office of Personnel Management (OPM) “2007General Schedule” which
excludes locality rates of pay.

c.  Each year a total of one HMIWI performs an initial performance test.
 It is assumed that EPA personnel will attend eight percent of these
tests.

d.  It is assumed that 20 percent will fail the initial performance
test, and will have to repeat the test.

e.  Assume 10 percent of retests are attended by EPA personnel.

f.  Assume 10 percent of the affected facilities are required to retest
as a result of excess emissions, with 10 percent of these tests being
attended by EPA personnel.

g.  Assume that an additional six sources (pathological and co-fired
combustors) are also projected each year, but are considered exempt from
the rule.  It is assumed that there will be one affected facility per
respondent.

h.  Assume it takes six persons-hours per report to review each
pollutant.  For initial tests there are seven pollutants that are
subject to this rule (PM, CO, CDD/CDF, HCI, metals, stack opacity, and
fugitive emissions.

i.  Assume it takes eight person-hours per report to review each CMS
demonstration.  There are eight CMS that are subject to this rule
(temperature, gas flow, charge weight, pH, liquid flow, pressure drop,
carbon flow, and lime flow).

j.  This activity will not be performed for the first year of a new
source.

k.  Respondents must submit semiannual reports.

 PAGE

 PAGE   13

 PAGE


[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8871-8872]
[FR Doc No: 2015-03416]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1399]

Guidance for Entities Considering Whether To Register as
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Entities
Considering Whether to Register as Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance
is intended to inform entities that are considering registering as
outsourcing facilities under section 503B of the Federal Food,

Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and
Security Act (DQSA), of the regulatory implications of registration as
an outsourcing facility.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 20, 2015.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sara Rothman, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Guidance for Entities Considering Whether to Register as
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.'' On November 27, 2013, President Obama signed the
DQSA (Pub. L. 113-54) into law. The DQSA added a new section 503B to
the FD&C Act that created a category of entities called ``outsourcing
facilities.'' Section 503B(d)(4) of the FD&C Act (21 U.S.C. 353b(d)(4))
defines an outsourcing facility, in part, as a facility that complies
with all of the requirements of section 503B, including registering
with FDA as an outsourcing facility and paying associated fees. If the
conditions outlined in section 503B(a) of the FD&C Act are satisfied, a
drug compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility is exempt from certain sections
of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with adequate directions for use) and
section 505 (21 U.S.C. 355) (concerning the approval of human drug
products under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)). Drugs compounded in outsourcing facilities are
not exempt from the requirements of section 501(a)(2)(B) of the FD&C
Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing
practice for drugs).
    FDA has received questions about whether entities engaged in
various types of activities (e.g., a facility that is compounding only
non-sterile drugs or only repackaging biological products) should
register as an outsourcing facility. Because entities that register as
outsourcing facilities in fiscal year 2015 (beginning October 1, 2014)
must pay a registration fee and FDA has determined that fees paid
pursuant to sections 503B and 744K of the FD&C Act will not be
refunded, FDA is issuing this guidance to answer some of these
questions and to provide potential registrants additional information
about the regulatory impact of registering as an outsourcing facility.
    Elsewhere in this volume of the Federal Register, FDA is announcing
the availability of separate FDA guidance documents on (1) mixing,
diluting, or repackaging biological products outside the scope of an
approved biologics license application, and (2) repackaging certain
human drug products by pharmacies and outsourcing facilities. These
guidance documents describe FDA's compliance policies with respect to
biological products that are mixed, diluted, or repackaged outside the
scope of an approved biologics license application and repackaged human
drugs.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on registering
as an outsourcing facility under section 503B of the FD&C Act. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Comments

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

III. Electronic Access

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

    Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03416 Filed 2-18-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 131 (Tuesday, July 9, 2019)]
[Notices]
[Page 32767]
[FR Doc No: 2019-14585]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4438-DR; Docket ID FEMA-2019-0001]

Oklahoma; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Oklahoma (FEMA-4438-DR), dated June 1, 2019, and
related determinations.

DATES: This amendment was issued June 8, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Oklahoma is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of June 1, 2019.

    Canadian, Creek, Logan, Ottawa, Rogers, and Washington Counties
for Individual Assistance.
    Osage County for Individual Assistance (already designated for
emergency protective measures [Category B], limited to direct
federal assistance under the Public assistance program).

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-14585 Filed 7-8-19; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: April 8, 2009 (Volume 74, Number 66)]
[Notices]
[Page 15964-15965]
[DOCID:fr08ap09-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AC09-50-000]

Colorado Interstate Gas Company; Notice of Filing

April 1, 2009.
    Take notice that on March 16, 2009, Colorado Interstate Gas Company
(CIG) submitted a request for approval of its accounting treatment for
changes in deferred tax balances. These adjustments result from the
formation of a master limited partnership, El Paso Pipeline Partners,
L.P., and its acquisition of approximately a 2 percent

partnership interest in CIG during the formation process, along with a
corresponding Internal Revenue Code Section 754 election. CIG states
these adjustments reduce its deferred tax balances and increase its
equity by approximately $3 million.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on April 16, 2009.

Kimberly Bose,
Secretary.
[FR Doc. E9-7894 Filed 4-7-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 43 (Tuesday, March 7, 2017)]
[Notices]
[Pages 12809-12810]
[FR Doc No: 2017-04376]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1966-054]

Wisconsin Public Service Corporation; Notice of Application
Accepted for Filing, Soliciting Motions To Intervene and Protests,
Ready for Environmental Analysis, and Soliciting Comments,
Recommendations, Preliminary Terms and Conditions, and Preliminary
Fishway Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Major New License.
    b. Project No.: 1966-054.
    c. Date filed: March 28, 2016.
    d. Applicant: Wisconsin Public Service Corporation.
    e. Name of Project: Grandfather Falls Hydroelectric Project.
    f. Location: The existing project is located on the Wisconsin River
in Lincoln County, Wisconsin. The project does affect federal lands.
There are non-reservation federal lands within the Project Boundary.
One Bureau of Land Management (BLM)-owned island (0.1 acres) is located
in the tailrace of the project boundary.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Todd Jastremski, Asset Manager Hydro
Operations, We Energies, 800 Industrial Park Drive, Iron Mountain, MI
49801, Telephone<PHONE_NUMBER>.
    i. FERC Contact: Lee Emery, Telephone<PHONE_NUMBER>, and email
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests, comments,
recommendations, preliminary terms and conditions, and preliminary
prescriptions: 60 days from the issuance date of this notice; reply
comments are due 105 days from the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
motions to intervene, protests, comments, recommendations, preliminary
terms and conditions, and preliminary fishway prescriptions using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-1966-054.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted for filing and is now ready
for environmental analysis.
    l. The existing Grandfather Falls Hydroelectric Project consists
of: (1) A 36-foot-high and 762-foot-long reinforced concrete dam
consisting of a 52-foot-long masonry retaining wall, a 263-foot-long
concrete spillway section, a 147-foot-long non-overflow masonry dam,
and a 300-foot-long rockfill embankment; (2) a 108-foot-long, 12-foot-
wide timber (concrete pier supported) canal bridge that crosses the
upstream end of the canal, three intake canal embankments totaling
3,400 feet in length, a 4,000-foot-long, 300-foot-wide intake canal,
and a 55.5-foot-wide intake structure; (3) an existing 340-acre
reservoir at elevation 1,397.1 National Geodetic Vertical Datum (NGVD)
and a gross storage capacity of 2,200 acre-feet with the pool elevation
maintained between 1,396.1 and 1,397.1 feet NGVD; (4) two 55.5-foot-
wide, 30.5-foot-high trashracks with clear bar spacing of 2.5 inches;
(5) an 11-foot-diameter, 1,317-foot-long wood-stave penstock that
transitions into a 30-foot-long steel penstock and a 13.5-foot-diameter
1,310-foot-long wood-stave penstock that transitions into a 30-foot-
long steel penstock; (6) a 51-foot-diameter surge tank with a 37.87-
foot-high internal riser and a 39-foot-diameter surge tank with a
33.43-foot-high internal riser that are connected to the steel portion
of the penstocks; (7) a 67-foot-wide, 53-foot-long, 46-foot-high
concrete and masonry powerhouse containing two generating units with a
total installed capacity of 17.24 megawatts (MW); (8) a 50-foot-long,
60-foot-wide bedrock excavated tailrace; (9) a 300-foot-long, 46
kilovolt overhead transmission power line; and (10) appurtenant
facilities. The project is estimated to generate an average of
72,031.72 megawatt-hours annually.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.

    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit comments, a protest, or a motion to intervene
in accordance with the requirements of Rules of Practice and Procedure,
18 CFR 385.210, .211, and .214. In determining the appropriate action
to take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) bear in all capital letters the title
``PROTEST'', ``MOTION TO INTERVENE'', ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``PRELIMINARY TERMS AND CONDITIONS,'' or
``PRELIMINARY FISHWAY PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. A copy of any protest or
motion to intervene must be served upon each representative of the
applicant specified in the particular application. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.
    o. Procedural Schedule: The application will be processed according
to the following revised Hydro Licensing Schedule. Revisions to the
schedule may be made as appropriate.

------------------------------------------------------------------------
              Milestone                           Target date
------------------------------------------------------------------------
Filing of recommendations,             April, 2017.
 preliminary terms and conditions,
 and preliminary fishway
 prescriptions.
Commission issues EA.................  September, 2017.
Comments on EA or EIS................  October, 2017.
Modified terms and conditions........  December, 2017.
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.
    q. A license applicant must file no later than 60 days following
the date of issuance of the notice of acceptance and ready for
environmental analysis provided for in Sec.  5.22: (1) A copy of the
water quality certification; (2) a copy of the request for
certification, including proof of the date on which the certifying
agency received the request; or (3) evidence of waiver of water quality
certification.

    Dated: March 1, 2017.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2017-04376 Filed 3-6-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 206 (Thursday, October 24, 2013)]
[Proposed Rules]
[Pages 63431-63433]
[FR Doc No: 2013-24975]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0866; Directorate Identifier 2013-NM-131-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500
series airplanes. This proposed AD was prompted by reports of cracks
found in the aft support fitting, the rear spar upper chord, and the
rear spar web. This proposed AD would require repetitive inspections
for cracking of the aft support fitting for the main landing gear (MLG)
beam, and the rear spar upper chord and rear spar web in the area of
rear spar station (RSS) 224.14; and repair if necessary. We are
proposing this AD to detect and correct such cracks, which could grow
and result in a fuel leak and possible fire.

DATES: We must receive comments on this proposed AD by December 9,
2013.

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 http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     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 service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced service
information at the FAA, at the FAA, Transport Airplane Directorate,
1601 Lind Avenue SW., Renton, Washington. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Nancy Marsh, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: 425-
917-6440; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2013-0866;
Directorate Identifier 2013-NM-131-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received five reports of cracks found in the aft support
fitting for the MLG beam, and the rear spar upper chord and rear spar
web in the area of rear spar station (RSS) 224.14. One report was of a
vertical crack found in the rear spar web, along with cracks in the aft
support fitting and rear spar upper chord. A second report indicated
cracks found in two holes in the rear spar upper chord and rear spar
web. A third report was of a crack in the rear spar upper chord that
extended downward to the edge of the vertical flange and upward to the
horizontal flange. The affected airplanes had accumulated between
42,988 and 66,572 total flight hours, and between 29,015

and 60,238 total flight cycles. Analysis shows that cracks in the aft
support fitting, rear spar web, and rear spar upper chord are caused by
operating load fatigue. Such cracks, if not corrected, could grow and
result in a fuel leak and possible fire.

Related Rulemaking

    AD 2005-18-08, Amendment 39-14248 (70 FR 52899, September 6, 2005)
(``AD 2005-18-08''), affects certain Model 737-100, -200, -200C, and -
300 series airplanes. AD 2005-18-08 requires--as one of two options for
corrective action--replacement of the support fitting of the MLG beam
in accordance with Boeing Special Attention Service Bulletin 737-57-
1216. This replacement also terminates the inspections required by AD
2005-18-08. The compliance times for certain inspections specified in
this proposed AD depend on accomplishment of that optional action in AD
2005-18-08.

Relevant Service Information

    We reviewed Boeing Special Attention Service Bulletin 737-57-1318,
dated May 15, 2013. For information on the procedures and compliance
times, see this service information at http://www.regulations.gov by
searching for Docket No. FAA-2013-0866.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information identified previously, except as discussed
below.

Differences Between the Proposed AD and the Service Information

    Boeing Special Attention Service Bulletin 737-57-1318, dated May
15, 2013, specifies to contact the manufacturer for instructions on how
to inspect certain airplanes, and how to repair cracks detected on all
airplanes, but this proposed AD would require that those actions be
done in one of the following ways:
     In accordance with a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) whom we have
authorized to make those findings.

Costs of Compliance

    We estimate that this proposed AD affects 353 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost         Parts cost     Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspection.....................  Up to 86 work-hours x             $0   Up to $7,310 per     Up to $2,580,430
                                  $85 per hour = $7,310                  inspection cycle.    per inspection
                                  per inspection cycle.                                       cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.

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.
    We are 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

    We 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) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The 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 (AD):

The Boeing Company: Docket No. FAA-2013-0866; Directorate Identifier
2013-NM-131-AD.

(a) Comments Due Date

    We must receive comments by December 9, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 737-100, -200, -
200C, -300, -400, and -500 series airplanes, certificated in any
category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by reports of cracks found in the aft
support fitting for the main

landing gear (MLG) beam, and the rear spar upper chord and rear spar
web. We are issuing this AD to detect and correct such cracks, which
could grow and result in a fuel leak and possible fire.

(f) Compliance

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

(g) Inspections: Group 1

    For airplanes identified in Group 1 of Boeing Special Attention
Service Bulletin 737-57-1318, dated May 15, 2013: At the applicable
time specified in paragraph 1.E., ``Compliance,'' of Boeing Special
Attention Service Bulletin 737-57-1318, dated May 15, 2013, except
as required by paragraph (i) of this AD, do inspections and
applicable corrective actions using a method approved in accordance
with the procedures specified in paragraph (j) of this AD.

(h) Inspection: Groups 2-7

    For airplanes identified in Groups 2 through 7 of Boeing Special
Attention Service Bulletin 737-57-1318, dated May 15, 2013: At the
applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Special Attention Service Bulletin 737-57-1318, dated May 15,
2013, except as required by paragraph (i) of this AD, do high
frequency eddy current inspections to detect cracking of the aft
support fitting for the MLG beam, and the rear spar upper chord and
rear spar web in the area of rear spar station 224.14, as
applicable, in accordance with Option 1, 2, or 3 of the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 737-57-1318, dated May 15, 2013.
    (1) If no crack is found, repeat the inspection thereafter at
the time specified in paragraph 1.E., ``Compliance,'' of Boeing
Special Attention Service Bulletin 737-57-1318, dated May 15, 2013,
as applicable. Accomplishment of the inspection of the 12 fastener
holes (locations 1-12) in accordance with Option 2, Action 3; or
Option 3, Action 3; as specified in note (b) of tables 2 through 5
of paragraph 1.E., ``Compliance,'' of Boeing Special Attention
Service Bulletin 737-57-1318, dated May 15, 2013, terminates only
the corresponding inspections that include note (b) in the ``Repeat
Interval'' column of the applicable table.
    (2) If any crack is found during any inspection required by this
paragraph, repair before further flight using a method approved in
accordance with the procedures specified in paragraph (j) of this
AD.

(i) Exception to Service Information Specifications

    Where Boeing Special Attention Service Bulletin 737-57-1318,
dated May 15, 2013, specifies a compliance time ``after the original
issue date of this service bulletin,'' this AD requires compliance
within the specified compliance time after the effective date of
this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
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 ACO, send it to the
attention of the person identified in the Related Information
section of this AD. Information may be emailed to<EMAIL_ADDRESS>    (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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA), which has been authorized by the Manager, Seattle ACO, to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.

(k) Related Information

    (1) For more information about this AD, contact Nancy Marsh,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office (ACO), 1601 Lind Avenue SW., Renton, Washington
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, Washington. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on October 17, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-24975 Filed 10-23-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: December 27, 2007 (Volume 72, Number 247)]
[Notices]
[Page 73393-73394]
[DOCID:fr27de07-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56975; File No. SR-NYSEArca-2007-87]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a
Proposed Rule Change, as Modified by Amendment No. 2 Thereto, To Amend
Listing Fees for Structured Products

December 17, 2007.
    On August 16, 2007, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
amend its Schedule of Fees and Charges (``Fee Schedule'') to revise the
listing fees applicable to Structured Products \3\ listed on NYSE Arca,
LLC (``NYSE Arca Marketplace''), the equities facility of NYSE Arca
Equities, Inc. (``NYSE Arca Equities''). The proposed revisions would
apply retroactively as of October 3, 2007. On October 30, 2007, the
Exchange filed Amendment No. 1 to the proposed rule change. On November
7, 2007, the Exchange filed Amendment No. 2 to the proposed rule
change.\4\ The proposed rule change and Amendment Nos. 1 and 2 thereto
was published for comment in the Federal Register on November 15,
2007.\5\ No comments regarding the proposed rule change have been
received. This order approves the proposed rule change, as modified by
Amendment No. 2.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ For purposes of this proposal, Structured Products include
securities qualified for listing and trading on NYSE Arca under the
following NYSE Arca Equities Rules: Rule 5.2(j)(1) (Other
Securities), 5.2(j)(2) (Equity Linked Notes), Rule 5.2(j)(4) (Index-
Linked Exchangeable Notes), Rule 5.2(j)(6) (Equity Index-Linked
Securities, Commodity-Linked Securities and Currency-Linked
Securities) and Rule 8.3 (Currency and Index Warrants), as these
rules may be amended from time to time.
    \4\ Amendment No. 2 replaced and superseded Amendment No. 1 in
its entirety.
    \5\ Securities Exchange Act Release No. 56767 (November 7,
2007), 72 FR 64265 (``Notice'').
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    NYSE Arca proposes to revise its schedules for listing and annual
fees for Structured Products to harmonize its fees with those of the
New York Stock Exchange LLC (``NYSE'').\6\ The fees for each Structured
Product would depend on the number of shares outstanding for such
product.\7\ The proposed rule change also clarifies the types of
products defined as ``Structured Products.'' The proposed revisions
would apply retroactively as of October 3, 2007.
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    \6\ See Securities Exchange Act Release No. 56842 (November 27,
2007), 72 FR 67990 (December 3, 2007) (approving retroactively as of
October 3, 2007 identical listing and annual fees for structured
products listed on the NYSE).
    \7\ For a detailed description of the revised fees, see Notice,
supra at note 5.
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    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\8\ In
particular, the Commission believes that the proposal is consistent
with section 6(b)(4) of the Act,\9\ which requires, among other things,
that the rules of a national securities exchange be designed to provide
for the equitable allocation of reasonable dues, fees, and other
charges among its members and issuers and other persons using its
facilities. The Commission notes that no comments have been received
regarding the proposed rule change, and that the proposed fees are
similar to those it approved for other national securities
exchanges.\10\
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    \8\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(4).
    \10\ See supra at note 6.
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    IT IS THEREFORE ORDERED, pursuant to section 19(b)(2) of the
Act,\11\ that the proposed rule change (File No.

SR-NYSEArca-2007-87), as modified by Amendment No. 2 thereto, be, and
hereby is, approved.
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    \11\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-24986 Filed 12-26-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: January 31, 2008 (Volume 73, Number 21)]
[Notices]
[Page 5903-5904]
[DOCID:fr31ja08-119]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activity Seeking OMB Approval

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget's (OMB) revision of a current
information collection. The Federal Register Notice with a 60-day
comment period soliciting comments on the following collection of
information was published on October 29, 2007, vol. 72, no. 208, page
61199-61200. Information collected is used to determine certification
eligibility of Flight Engineers and Flight Navigators.

DATES: Please submit comments by March 3, 2008.

FOR FURTHER INFORMATION CONTACT: Carla Mauney at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Flight Engineers and Flight Navigators.
    Type of Request: Extension without change of a currently approved
collection.
    OMB Control Number: 2120-0007.
    Form(s): FAA form 8400-3.
    Affected Public: An estimated 1,036 Respondents.
    Frequency: This information is collected on occasion.
    Estimated Average Burden Per Response: Approximately 30 minutes per
response.
    Estimated Annual Burden Hours: An estimated 505 hours annually.
    Abstract: Information collected is used to determine certification
eligibility of Flight Engineers and Flight Navigators.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to Nathan Lesser, Desk Officer, Department of Transportation/
FAA, and sent via electronic mail to<EMAIL_ADDRESS>or
faxed to<PHONE_NUMBER>.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility, and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on January 23, 2008.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 08-428 Filed 1-30-08; 8:45 am]

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