[Federal Register Volume 79, Number 222 (Tuesday, November 18, 2014)]
[Notices]
[Page 68682]
[FR Doc No: 2014-27246]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP15-147-000]

Comisi[oacute]n Federal de Electricdad; Notice of Petition for
Clarification Regarding Continuation of Prior Authorization of Gas
Supply and Transportation Arrangements

    Take notice that on November 3, 2014, pursuant to Rule 207(a)(5) of
the Commission's Rules of Practices and Procedure, 18 CFR
385.207(a)(5)(2014), the Comisi[oacute]n Federal de Electricdad (CFE),
Mexico's nationally-owned electric utility, filed a petition for
clarification that prior authorization of certain gas supply and
transportation arrangements on behalf of CFE will continue following
permanent release by the current shipper (MexGas Supply, S.L., formerly
known as MGI Supply Ltd. [MexGas]), to CFE of transportation capacity
on the Samalayuca Lateral of the El Paso Natural Gas Company, L.L.C.
Additionally, CFE requests such other waivers or permissions the
Commission finds necessary to allow the arrangement to take effect, all
as more fully explained in the petition.
    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. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on November 13, 2014.

    Dated: November 5, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-27246 Filed 11-17-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11181-11184]
[FR Doc No: 2012-4282]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66421; File No. SR-NYSE-2012-05]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change Amending NYSE Rule 476A To
Update Its ``List of Exchange Rule Violations and Fines Applicable
Thereto Pursuant to Rule 476A''

February 17, 2012.
    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 February 7, 2012, 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
and II 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 amend NYSE Rule 476A to update its ``List
of Exchange Rule Violations and Fines Applicable Thereto Pursuant to
Rule 476ARule XX [sic]. The text of the proposed rule change is
available at the Exchange, the Commission's Public Reference Room, and
www.nyse.com.

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
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend NYSE Rule 476A to update its ``List
of Exchange Rule Violations and Fines Applicable Thereto Pursuant to
Rule 476A'' (``Rule 476A List'') to (i) make technical, non-substantive
changes to conform the list to previously-approved changes in Exchange
rules, (ii) update the rules relating to conduct by Designated Market
Makers (``DMM''), and (iii) add rules relating to conduct by DMMs.
Background
    Under the Exchange's Minor Rule Violation Plan, NYSE Rule 476A, the
Exchange may impose a fine, not to exceed $5,000, on any member, member
organization, approved person or registered or non-registered employee
\4\ of a member or member organization for a minor violation of certain
specified Exchange rules (a ``summary fine''). Summary fines provide a
meaningful sanction for rule violations when the violation calls for
stronger discipline than an admonition or cautionary letter, but the
facts and circumstances of the violation do not warrant initiation of a
formal disciplinary proceeding under Rule 476.\5\
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    \4\ Rule 476A(a) includes a reference to ``allied member''. The
Exchange proposes to replace that term with ``principal executive,''
which is consistent with a prior rule change eliminating the
category of ``allied member'' on the Exchange. See Securities
Exchange Act Release No. 58549 (September 15, 2008), 73 FR 54444
(September 19, 2008) (SR-NYSE-2008-80).
    \5\ The Exchange's Minor Rule Violation Plan, Rule 476A, was
originally adopted by the Exchange and approved by the Commission in
1985. See Exchange Act Release No. 34-21688 (January 25, 1985), 50
FR 5025 (February 5, 1985). It has been amended numerous times since
its adoption.
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Proposed Non-Substantive Changes to Rule 476A List
    The Exchange proposes the following non-substantive changes to
update the Rule 476A List to conform it to approved changes to Exchange
rules, as follows:
     Update the titles of Rules 15, 15A, and 105
     Update rule references that have been renumbered or
harmonized with a FINRA rule: Rule 72(b) to 72(d); 79A.30 to 79A.20;
103.12 to 103.11; and 346(b) to 3270
     Delete references to rules that have been deleted: Rules
97.40 (reporting rule violation); 104.12 (DMM investment account rule);
107A.30 (reporting rule violation); 112A.10 (reporting rule violation);
123A.30 (percentage orders); 304(h)(2) (reporting rule violation);
346(c), (e), and (f) (Limitations on member organization employment and
failure to obtain Exchange approval rule violations); 421 (reporting
rule violation); 440F (reporting rule violation); and 440G (reporting
rule violation) \6\
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    \6\ The Exchange also proposes to fix a typographical error in
the entry concerning Rule 343 and replace the term ``officer'' with
``office.''
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     Update the description to rules that have been amended:
Rules 123C \7\ (deleting references to expiration Fridays and quarterly
expiration days); 411(b) (replacing the description to reflect the
amended rule); and 345(a) (deleting the reference to Securities Trader
Supervisor)
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    \7\ The Exchange also proposes to add a reference to ``Rule
123C'' to the amended description, and move it up on the Rule 476A
List.
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Proposed Updates to Rule 476A List for DMM Conduct Rules
    The current Rule 476A List includes rules that govern DMM conduct,
e.g., Rules 104(a)(1)(A), 104.10, and Exchange policies regarding
procedures to be followed in delayed opening situations. The Exchange
proposes to update the Rule 476A List with current rules governing DMM
conduct, and in particular, to include Rules 104 and 123D in the Rule
476A List. The Exchange further proposes to expand the references to
Rules 104 and 123D to add new elements to the Rule 476A List [sic]
    The Exchange believes that the updates proposed below will provide
the Exchange with sufficient flexibility to address DMM failure to meet
their obligations. The Exchange recognizes that DMMs may, for many
reasons, fail to meet their affirmative obligations as prescribed under
Rules [sic] 104 or duties under Rule 123D. In some circumstances,
formal disciplinary measures in accordance with Rule 476 are warranted.
However, in other instances, formal discipline may be unwarranted, and
the Exchange believes that the addition of these Rules to Rule 476A
List will provide a more flexible and appropriate tool to enforce
potential failure by DMMs to adhere to the requirements set forth in
those rules, while preserving the Exchange's discretion to seek formal
discipline under the appropriate circumstances. The Exchange believes
that the proposed updated rule references cover the same subject matter
as are already addressed in the Rule 476A List, albeit in outdated
references. In addition, the Exchange believes it is also appropriate
to add new elements relating to Rule [sic] 104 and 123D to the Rule
476A List.
Rule 104
    NYSE Rule 104 requires, inter alia, DMMs registered in one or more
securities traded on the Exchange to engage in a course of dealings for
their own account to assist in the maintenance of a fair and orderly
market, insofar as reasonably practicable, by contributing liquidity
when lack of price continuity and depth, or disparity between supply
and demand exists or is reasonably to be anticipated.\8\
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    \8\ Rule 104 currently operates on a pilot basis, set to end on
July 31, 2012. The Exchange believes that the Rule 476A List should
reference those rules that are currently operational, even if
operating on a pilot basis.
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    The Rule 476A List currently includes Rule 104(a)(1)(A), which
requires DMMs to maintain a bid or an offer at the National Best Bid
and National Best Offer (``inside'') at least 15% of the trading day
for securities in which the DMM unit is registered with a consolidated
average daily volume of less than one million shares, and at least 10%
for securities in which the DMM unit is registered with a consolidated
average daily volume equal to or greater than one million shares.
    The Rule 476A List also includes an outdated reference to Rule
104.10. When the Exchange adopted the New Market Model, it adopted
current Rule 104 (on a pilot basis), which does not include a rule
reference of 104.10 that is the same as the former Rule 104.10.\9\
However, the subject matter formerly covered in Rule 104.10 continues
in the current Rule 104. For example, the text of former Rules
104.10(5) and (6) has been moved in substantially similar form to
current Rules 104(g), (h), and (i).
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    \9\ See Exchange Act Release No. 58845 (October 24, 2008), 73 FR
64379 (October 29, 2008) (SR-NYSE-2008-46).
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    More generally, although the Exchange has deleted former Rule
104.10(1)-(3), the subject matter of those rules has been carried
forward in various sections of current Rule 104. For example, former
Rule 104.10 specified the functions of DMMs, including the maintenance,
in so far as reasonably practicable, of a fair and orderly market. This
topic is now covered by Rules 104(a) and (f).
    More specifically, former Rule 104.10(1) stated that the
maintenance of a fair and orderly market implies the

maintenance of price continuity with reasonable depth and the
minimizing of the effects of temporary disparity between supply and
demand. This subject matter is now covered in Rule 104(f)(ii). Former
Rule 104.10(2) concerned a DMM trading for his or her own account when
there is [sic] lack of price continuity, lack of depth, or disparity
between supply and demand exists or is reasonably to be anticipated.
This subject matter is similarly covered in Rule 104(f)(ii). Finally,
former Rule 104.10(3) provided that DMM dealings for his own account
must constitute a course of dealings reasonably calculated to
contribute to the maintenance of price continuity with reasonable
depth, and to minimizing the effects of temporary disparity between
supply and demand. This is similarly covered in Rule 104(f)(ii). The
Exchange further believes that Rule 104(f)(iii), which provides more
details about Depth Guidelines, is also related to former Rule
104.10(3). In particular, the Exchange was publishing Depth Guidelines
when Rule 104.10 was in effect and the only change in the New Market
Model's version of the rule is to codify this aspect of DMM
obligations.
    The Exchange also believes that the subject matter of former Rules
104.10(1)-(3) is now covered in current Rules 104(a)(2)-(5). Current
Rules 104(a)(2)-(5) describe with specificity how a DMM can meet his or
her responsibilities and duties to maintain a fair and orderly market,
including facilitating openings and re-openings, the close of trading,
trading when a liquidity replenishment point is reached, and trading
when a ``gap'' quote procedure is being used. These rule provisions
simply provide detail of how a DMM is to meet its fair and orderly
obligation. These were functions that specialists formerly performed
when they were subject to former Rule 104.10(1)-(3), the difference now
being that these functions have been codified in the rule text.
    The Exchange further proposes to add to the Rule 476A list Rules
104(b), (c), (d), and (e). The Exchange believes that, similar to Rule
104(a), (f), (g), (h), and (i), the requirements applicable to DMMs in
Rules 104(b), (c), (d), and (e) relate to the functions of the DMMs.
Because these are DMM obligations for which potential violations can
range in severity, including these elements of Rule 104 in the Rule
476A List is consistent with the current inclusion of other aspects of
Rule 104.
    In addition, the Exchange believes it is appropriate to add Rule
104(a)(1)(B) to the Rule 476A List. Rule 104(a)(1)(B) governs the DMM's
new pricing obligations, which were implemented by all equities markets
on December 6, 2010.\10\ Accordingly, this provision was not previously
included in the Minor Rule Violation Plan. The Exchange believes it is
appropriate to add this element of Rule 104 to the Minor Rule Violation
Plan to provide greater flexibility with respect to the type of
disciplinary measures that may be invoked if there were a violation of
this rule. For example, a potential situation that may warrant a
summary fine rather than formal disciplinary action could be if a DMM
fails to maintain a quote consistent with Rule 104(a)(1)(B), but which
does not result in any harm to the market.
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    \10\ See Exchange Act Release No. 63255 (Nov. 5, 2010), 75 FR
69484 (Nov. 12, 2010) (SR-NYSE-2010-69).
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    As noted above, summary fines provide the Exchange with flexibility
to impose an appropriate level of discipline for violations that are
more serious than an admonition letter, but for which the facts and
circumstances do not warrant formal discipline. The Exchange believes
that providing flexibility for violations related to the DMM's new
pricing obligations and Rules 104(b), (c), (d), and (e) is in keeping
with the spirit of the existing Rule 476A List, which already includes
DMM conduct rules.
    To reflect these changes, the Exchange proposes to include a single
reference to ``Rule 104 requirements for the dealings and
responsibilities of DMMs'' to the Rule 476A List, which would include
all of the subsections of Rule 104 as described above.\11\ The Exchange
further notes that these summary fines may be imposed, as applicable,
on either an individual DMM, or the DMM unit, as specified in the
subsections to Rule 104.
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    \11\ The Exchange notes that it has separately proposed to
delete NYSE Rule 104(a)(6). See Securities Exchange Act Release No.
65736 (Nov. 10, 2011) (SR-NYSE-2011-56). The Exchange further notes
that other elements of Rule 104, i.e., Rule 104(j) and supplementary
material .05 and .10, are not related to DMM obligations, but rather
reflect operational aspects of the Exchange.
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Rule 123D
    The Exchange also proposes to update the reference relating to
delayed openings in the Rule 476A list to instead reference a specific
rule, i.e., Rule 123D, and to add all elements of Rule 123D as they
relate to DMM conduct as being eligible under the Minor Rule Violation
Plan.
    The Rule 476A List currently provides that ``violations of Exchange
policies regarding procedures to be followed in delayed opening
situations'' are eligible for summary fines under the Minor Rule
Violation Plan. Such Exchange policies are codified in Rule 123D.
Accordingly, the Exchange proposes to delete the general statement of
``violations of Exchange policies regarding procedures to be followed
in delayed opening situations'' and replace it with a reference to Rule
123D. In so doing, the Exchange further proposes to add the other
requirements of DMMs that are set forth in Rule 123D relating to
openings, re-openings, trading halts, and tape indications. The
Exchange believes that the additional flexibility of determining the
appropriate level of discipline for DMM violations of Rule 123D
conforms to the purpose of the existing Rule 476A List. In particular,
the Exchange notes that adding Rule 123D in its entirety as it relates
to DMM conduct is consistent with the existing inclusion of Rule 15 in
the Rule 476A List, which similarly governs DMM's conduct with respect
to pre-opening indications.
2. Statutory Basis
    The Exchange believes that the proposed rule changes are consistent
with, and further the objectives of, Section 6(b)(5) of the Securities
Exchange Act of 1934, as amended,\12\ (the ``Act''), in that they are
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system and, in general, to protect investors and the public
interest. The proposed rule changes also further the objectives of
Section 6(b)(6),\13\ in that they provide for appropriate discipline
for violations of provisions of the Act, the rules and regulations
thereunder, and Exchange rules and regulations.
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    \12\ 15 U.S.C. 78f(b)(5).
    \13\ 15 U.S.C. 78f(b)(6).
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    The Exchange believes that the proposed rule changes are designed
to prevent fraudulent and manipulative acts and practices because they
will provide the Exchange with greater regulatory flexibility to
enforce the DMM requirements set forth in NYSE Rules 104 and 123D in a
more informal manner while also preserving the Exchange's discretion to
seek formal discipline for more serious transgressions as warranted. In
addition, the proposed rule change removes impediments to and perfects
the mechanism of a free and open market by updating the Minor Rule
Violation Plan by updating rule cite references, deleting references to
obsolete rules, and for DMM-related rules, both updating the rule
references to reflect

the current rules that govern the topics currently identified in
outdated rule references in the Minor Rule Violation Plan as well as
adding additional elements of the rules governing DMM conduct.

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

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2012-05 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2012-05. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2012-05 and should be
submitted on or before March 16, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-4282 Filed 2-23-12; 8:45 am]
BILLING CODE 8011-01-P


An estimated six mobile incinerators operating at remediation sites

Table 1: Number of Hazardous Waste Combustion Units Impacted by ICR

Combustion Unit Type	# of Units	# of

Facilities

Cement Kilns	25	14

Lightweight Aggregate Kilns	9	3

Commercial Incinerators	15	10

On-Site Incinerators	98	65

Liquid Fuel Boilers	104	53

Solid Fuel Boilers	12	4

HCl Production Furnaces	10	8

Total	273	151

	There may be a few other facilities not known to us through our
databases and a few new facilities that may have started burning
hazardous waste after the database was developed.  However, we estimate
that the number of such facilities will be smaller than those that will
cease burning hazardous waste

TOTAL BURDEN AND COSTS

The following discusses the type and number of sources for which each of
the specific ICR requirements is estimated to apply.  Exhibit 1 shows
the labor hours and labor category estimates, and the O&M and annualized
capital costs, required for each of the specific ICR activities.

WHO IS SUBJECT TO THESE REGULATIONS

All HWCs will read the regulations at 40 CFR Part 63, Subparts A and
EEE.

STANDARDS FOR HAZARDOUS WASTE BURNING INCINERATORS, CEMENT KILNS, AND
LIGHTWEIGHT AGGREGATE KILNS

Emission Averaging for Cement Kilns with In-line Kiln Raw Mills

 tc \l4 "Emission Averaging for Cement Kilns with In-line Kiln Raw Mills

We estimate that 3 cement kilns with in-line kiln raw mills will comply
with the emission averaging requirements for kilns of this type.  Thus,
they will conduct a performance test when the raw mill is on-line and
when the mill is off-line, and include the averaging procedures in their
Notification of Compliance and operating record.  We note that these
procedures are similar to that currently required under RCRA BIF
regulations.

No specific additional recordkeeping or reporting requirements beyond
those required of the current RCRA regulations

COMPLIANCE WITH THE STANDARDS AND OPERATING REQUIREMENTS

Compliance with Alternative MACT Standards

It is estimated that 5% of sources will document in the operating record
compliance with alternative applicable Clean Air Act requirements and
standards.

Extension of Compliance with Emission Standards

It is estimated that 20% of all facilities will apply for an extension
of compliance with emission standards, of which all will be granted
extensions

Changes in Design, Operation, or Maintenance

It is estimated that 50% of the sources will be making design,
operation, and maintenance changes to comply with the MACT rule and
document change in operating record.  These changes will not initiate
additional comprehensive performance testing beyond the initial testing
that is required.

Use of Previous DRE Test Results to Demonstrate Compliance with DRE MACT
Standards

It is estimated that 75% of sources will request the use of previous DRE
test results for demonstrating compliance with the MACT DRE standard.

Applicability of Particulate Matter and Opacity Standards during
Particulate Matter CEMS Correlation Tests

At is anticipated that 39 sources (among all HWC) will conduct PM CEMS
correlation testing and request a waiver of PM and opacity standards
during the testing. (This includes all units with fabric filters and
about 10% of sources with electrostatic precipitators or ionizing wet
scrubbers). It is estimated that none of these sources will request an
extension of the 96 hours allowed for the waiver.

Hazardous Waste Residence Time

All sources will include an estimate of hazardous waste residence time
in the comprehensive performance test plan.  However, we anticipate that
all sources (with the exception of 25% of the Phase I sources) have
already submitted comprehensive test plans.

Startup, Shutdown, and Malfunction Plan

All sources will develop a startup, shutdown, and malfunction plan.

Automatic Waste Feed Cutoff (AWFCO)

It is estimated that:

All sources will have 2 AWFCO per year;

10% will have to file an excessive exceedances report (i.e., >10 AWFCOs
in any 60-day block period) per year;

50% will conduct weekly AWFCO system inspections, while 50% will conduct
monthly system testing.

All will document in the operating record the use of ramp down
procedures.

ESV Openings

It is estimated that 50% of hazardous waste incinerators have ESVs, and
will develop an ESV operating plan.  On average, each unit will have 3
ESV openings per year.

Combustion System Leaks

It is estimated that 50% of all sources will request approval to use an
alternative means to provide control of combustion system leaks (control
through a positively sealed combustion chamber). These facilities must
specify in their operating record and comprehensive performance test
plan the method used for control of combustion system leaks.

Operator Training and Certification

It is estimated that all commercial incinerators and 75% of other
sources currently have a sufficient operating training and certification
program.  Other facilities will likely develop a site-specific training
and certification program.

Operation and Maintenance Plan

All facilities will develop an operation and maintenance plan.

BLDS/PMDS Requirements

All units with fabric filters (about 34 sources), will have to purchase,
install, and operate bag leak detection systems.  It is estimated that
of the sources with ESPs or IWSs (about 45 sources), 90% will request to
use operating parameter limits instead of continuous particulate
detectors.

PERFORMANCE TESTING REQUIREMENTS

Comprehensive Performance Test

All HWCs are required conduct a comprehensive performance testing to
meet the Replacement Rule.  We conduct a comprehensive during the period
of  effectiveness of the ICR.

Comprehensive Performance testing  could be combined withrequired under
current RCRA requirements, but the performance standards will vary.
Moreover, methods used to establish operating parameter limits will vary
between the RCRA and MACT. Therefore we estimate additional costs for
HWC associated with the CPT.

Additionally that units that do not have a numerical PCDD/PCDF standards
(all HCl Production furnaces, solid boilers and liquid boilers that do
not have dry air pollution control devices) (and which have not yet made
PCDD/PCDF measurements) – 6 solid boilers and 37 liquid boilers, 1 HCl
Production Furnace -- will be required to conduct a one time PCDD/PCDF
test.  Additionally, it is estimated that all LWAKs will choose to
comply with the requirement of rapidly quenching their exhaust gases to
below 400°F at the kiln exit instead of the numerical dioxin/furan
standards. However, all these LWAKs have made PCDD/PCDF measurements and
thus it is estimated that they would not require an additional one time
PCDD/PCDF test.

Confirmatory Performance Test

For all sources that have a numerical PCDD/PCDF standard – all
Incinerators, Cement Kilns and, and dry APCD equipped liquid boilers-
confirmatory testing for PCDD/PCDF is required 2 ½ years after the
Comprehensive performance test.  WE estimate that  all  Phase II Units
(w/ numerical PCDD/F standards) will perform a confirmatory test during
the period of effectiveness of the ICR.

Data in Lieu of the Comprehensive Performance Test

It is estimated that 10% of all sources will submit a request to use
previous emissions test data to serve as documentation of compliance
with emission standards.

Notification of Performance Test and CMS Performance Evaluation, and
Approval of Test Plan and CMS Performance Evaluation Plan

All facilities will submit a notification of intent to conduct a
performance test.  These facilities will also be required to prepare and
submit and a site-specific comprehensive performance and CMS performance
test plan. However, it is estimated that 90% of facilities have already
met this requirement

It is estimated that 1 source per year will reschedule their performance
test date and thus be required to submit a rescheduled notification of
intent to conduct a performance test.

Additionally, 25% of submitting a site-specific performance test plan
will be requested to submit additional relevant information.

Notification of Compliance

All facilities will submit a Notification of Compliance every time they
complete a comprehensive performance test.

Waiver or Time Extension of Performance Test

It is estimated that 10% of facilities conducting the comprehensive
performance test will apply for a waiver or time extension.

MONITORING REQUIREMENTS

Continuous Emissions Monitoring Systems (CEMS) and Continuous Opacity
Monitoring Systems (COMS)

All facilities are already required to monitor for carbon monoxide (CO)
or hydrocarbons (HC) and oxygen under current regulatory requirements,
thus there is no capital investment burden to the Replacement Rule MACT
requirements.

Continuous Monitoring Systems

All facilities are currently equipped with all CMS required with the
Replacement Rule.  Thus, there is no capital investment burden.  No
additional requirements for Phase I sources.

Feedstream Analysis Plan

	All HWCs already have developed and implemented feedstream analysis
plans under current RCRA requirements (referred to as the waste analysis
plan). There is no incremental burden for this requirement.

Alternative Compliance Monitoring Requirements for Standards other than
those Monitored with a CEMS

It is estimated that 10% of all facilities will apply for and receive
approval to use alternative monitoring requirements to document
compliance with the emission standards of Subpart EEE other than CO or
HC which are monitored with a CEMS.

Use of CEMS in lieu of Operating Parameter Limits; or Alternative
Methods in lieu of CEMS

It is estimated that no facilities will make a request to use
alternatives to CEMS or CEMS in lieu of operating parameters.

Destruction and Removal Efficiency

It is estimated that all currently operating HWCs have equipment needed
for the MACT DRE monitoring requirements.

Dioxins and Furans

It is estimated that all currently operating HWCs have equipment needed
for the MACT PCDD/PCDF monitoring requirements.  It is estimated that no
facilities will chose to use a CEMS for compliance monitoring.

Mercury

It is estimated that all currently operating HWCs have equipment needed
for the MACT Hg monitoring requirements.  It is estimated that no source
will chose to use a CEMS for compliance monitoring and that 10% of
sources will make a request to set feedrate limits with extrapolation.

Particulate Matter

For all sources, it is estimated that all currently operating HWCs have
the equipment needed to comply with the MACT PM monitoring requirements.

Semivolatile Metals and Low Volatile Metals

It is estimated that all currently operating HWCs have the equipment
needed to comply with the MACT SVM and LVM monitoring requirements.  It
is estimated that 10% of facilities will make a request to set feedrate
limits with extrapolation and no facilities will chose to use a CEMS for
compliance monitoring.

Total Chlorine (HCl and Chlorine Gas)

It is estimated that all currently operating HWCs have the equipment
needed for the MACT total chlorine monitoring requirements.  It is
estimated that no facilities will chose to use a CEMS for compliance
monitoring.

Combustion Chamber Pressure

It is anticipated that all facilities will comply with the combustion
leak requirements through a request to keep the combustion chamber fully
sealed.

Operating under Different Modes of Operation

It is estimated that 50% of all facilities will perform the
comprehensive performance test under two or more operating modes. These
facilities will be required to document what operating mode they are in
during subsequent on-going day to day operations.

CMS PERFORMANCE EVALUATION

As part of the comprehensive performance test, HWCs will submit a CMS
quality control program, notification of performance evaluation and
additional notification requirements, We estimate that 50% of sources
have already complied with this requirement. HWC are also required to
submit performance evaluation test plan, and conduct a CMS performance
test.  We estimate 60% of sources would submit test plans and conduct
performance testing along with their comprehensive performance testing.

Also, it is estimated that EPA will also request additional relevant
information for the site-specific CMS performance test plan from 10% of
the sources performing the test.

NOTIFICATION REQUIREMENTS

Notification of Intent to Comply

All Phase II and Phase I sources will prepare a draft NIC, notify the
public about a NIC meeting, conduct the NIC meeting, prepare a final NIC
with meeting comments, and submit the NIC to EPA.  All Phase II and
Phase I sources will complete the progress report. However, we estimate
that 90% of the facilities will have completed this requirement at the
time this ICR is in place.

Initial Notifications

All facilities will submit an initial notification.  However, we
estimate that 90% of the facilities will have completed this requirement
at the time this ICR is in place.

Adjustment to Time Periods or Postmark Deadlines for Submittal and
Review of Required Communications

We estimate that 25% of all facilities will submit a request for an
adjustment to a time period or postmark deadline.

Change in Information Already Provided

It is estimated that 25% of all facilities will submit change(s) to
information already provided.

Request to Reduce Frequency of Excess Emissions and CMS Performance
Reports

It is estimated that 10% of facilities will submit a request to reduce
frequency of excess emissions and continuous system performance reports
from a quarterly (or more frequent basis).

Waiver of Recordkeeping or Reporting Requirements

It is estimated that 1% of all facilities will submit a waiver of
recordkeeping or reporting requirements.

RECORDKEEPING AND REPORTING REQUIREMENTS

Periodic and Immediate Startup, Shutdown, and Malfunction Reports

It is anticipated that 25% of facilities will take actions during a
startup, shutdown, or malfunction that are consistent with the
procedures specified in the facility's startup, shutdown, or malfunction
plan. These facilities are required to submit a periodic startup,
shutdown, and malfunction report.  Another 10% of facilities will take
actions that are not consistent with procedures specified in their
plans. These facilities acquired to submit an immediate startup,
shutdown, and malfunction report.

Excess Emissions and Continuous Monitoring System Performance Report and
Summary Report

It is anticipated that all facilities will submit an excess emissions
and continuous monitoring system performance report and summary report.

General Recordkeeping Requirements

It is estimated that it will take 40 hours each year for each of the HWC
facilities to maintain copies of all required information (information
must be retained for five years). Additionally, it is estimated that to
maintain files for the required five years, facilities will purchase
file cabinets.

Additional Recordkeeping Requirements for Sources with Continuous
Monitoring Systems

All sources will need to maintain copies of all required information for
continuous monitoring systems.

Documentation of Compliance

It is anticipated that all facilities will develop a Documentation of
Compliance to be included in their operating records

Data Compression

It is estimated that 25% of facilities will submit a request for
approval to use data compression techniques.

COMPLIANCE DATE BE EXTENDED TO INSTALL POLLUTION PREVENTION OR WASTE
MINIMIZATION CONTROLS

It is estimated that 10% of sources will submit a one-time request for a
compliance extension due to the installation of controls, and that
another 10% will submit a one-time request for a compliance extension
for waste minimization purposes.

QUALITY ASSURANCE PROCEDURES FOR CONTINUOUS EMISSIONS MONITORS USED FOR
HAZARDOUS WASTE COMBUSTORS

Performance Evaluation

All sources must meet the QA requirements for CEMS.  These requirements
are very similar to those currently required under RCRA.

Use of Alternative CEMS Spans

It is estimated that no source will submit requests to use an
alternative CEMS span.

MISCELLANEOUS REQUIREMENTS

Alternative Risk Based Chlorine Standards

It is estimated that 25% of Phase I and Phase II facilities will request
to comply with the alternative risk based chlorine standards.

Additional HCl Production Furnaces Requirements

It is estimated that 10% of the HCl Production Furnaces will be required
to comply with HCl product management requirements of 40 CFR Part 63
Subpart NNNNN.

6(e). 	BOTTOM LINE BURDEN HOUR AND COST TABLES

Respondent Tally

	Exhibit 1 shows the estimated total annual burden and cost to
respondents.  The annual respondent burden is 194,265 labor hours.
Capital/startup costs and O&M costs are estimated to be $105,459and
$5,577,717 respectively. Table 1 summarizes the information presented in
Exhibit 1.

Table 1:

	For reasons discussed below this respondent burden is about 7,300 hours
lower than the 2005 estimate. Capital Costs are slightly lower than the
2005 estimates while O& M costs are slightly higher.

Agency Tally

Some of the Agency burden will be shared by the States authorized to
administer their own RCRA program (under section 3006 of RCRA). We
estimate that 2/3rd of this burden and costs will be incurred by the
federal government (i.e., EPA regional offices) while 1/3rd will be
incurred by the authorized States.  Exhibits 2 and 3 list these hours
and costs for the States and the federal government. Tables 2 and 3
summarize this information of Exhibits 2 and 3. As shown in Table 2, the
burden on the states is 5632 hours with and additional $2962 in Capital
and O&M Costs.  The federal burden, as indicated in Table 3 is 11,265
labor hours and a capital/O&M cost of $5925.

Table 2: Hour and Cost Burden-States

Table 3: Hour and Cost Burden- Federal Government

6(f). 	REASONS FOR CHANGE IN BURDEN

The decrease in labor hour burden from the existing approved ICR
#1773.08 is small (about 3%).  The MACT rule was promulgated in 2005,
and we estimate that:

Most sources have completed several actions involving one-time costs
such as initial notification, notice of the intent to comply, as well as
public meetings related to these actions.

Smaller number of sources would conduct a confirmatory test in the 2008
thru 2011 time period as compared to 2005 thru 2008 time period of the
earlier ICR.

Smaller number of sources would submit a comprehensive performance test
plan.

There is a small increase (about 8%) in the capital and O&M cost of this
ICR from the previous ICR due to our newer estimates of the number of
affected sources, and inflation in three years. Our estimate now
includes the “data in lieu” or sister units at several facilities as
well as mobile incinerator type units at clean-up sites; and that they
will also conduct monitoring and recordkeeping activities similar to the
regular hazardous waste combustion sources.

6(g). 	BURDEN STATEMENT

  SEQ CHAPTER \h \r 1 	  The annual public reporting and recordkeeping
burden on each of the 273 units covered by this ICR is estimated to
average 710 hours. The annual capital and O&M cost is estimated to be $
20,820.  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 currently valid OMB
control number.  The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9.

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-OAR-2008-0246, which is available for online viewing at
www.regulations.gov, or in person viewing at the Air & Radiation (OAR)
Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Avenue, NW, Washington, D.C.  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
(202) 566-1744, and the telephone number for the OAR Docket is (202)
566-1742.  An electronic version of the public docket is available at
www.regulations.gov.  This site can be used to submit or view public
comments, access the index listing of the contents of the public docket,
and to access those documents in the public docket that are available
electronically.  When in the system, select “search,” then key in
the Docket ID Number identified above.  Also, you can send comments to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk
Officer for EPA.  Please include the EPA Docket ID Number
EPA-HQ-OAR-2008-0246 and OMB Control Number 2050-0171 in any
correspondence.

 Based on a reported increase of 0.8% from January through March 2008
and an estimated increase of 1.5% from March through June.

 http://www.epa.gov/epaoswer/hazwaste/combust/finalmact/source.htm

 Numbers in the table include “sister” data-in-lieu units.  For
facilities containing this unit, average reporting and recordkeeping
costs per source may be lower than what we have estimated.

 Numbers in column do not add up to the total because some facilities
have more than one type of source category

 PAGE

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[Federal Register Volume 87, Number 230 (Thursday, December 1, 2022)]
[Notices]
[Pages 73762-73763]
[FR Doc No: 2022-26132]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER23-495-000.
    Applicants: AES CE Solutions, LLC.
    Description: Baseline eTariff Filing: AES CE Solutions, LLC MBR
Tariff to be effective 11/24/2022.
    Filed Date: 11/23/22.
    Accession Number: 20221123-5182.
    Comment Date: 5 p.m. ET 12/12/22.

    Docket Numbers: ER23-496-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Sec.  205(d) Rate Filing: Amendment to BP Products
North America, Inc to be effective 10/1/2019.
    Filed Date: 11/23/22.
    Accession Number: 20221125-5000.
    Comment Date: 5 p.m. ET 12/12/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 25, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-26132 Filed 11-30-22; 8:45 am]
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[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76693-76694]
[FR Doc No: 2015-31097]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-E-0308 and FDA-2014-E-0309]

Determination of Regulatory Review Period for Purposes of Patent
Extension; FULYZAQ

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for FULYZAQ and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
February 8, 2016. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by June 7, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2014-E-0308 and FDA-2014-E-0309 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; FULYZAQ.'' Received
comments will be placed in the dockets and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in

its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product FULYZAQ
(crofelemer). FULYZAQ is indicated for the symptomatic relief of non-
infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral
therapy. Subsequent to this approval, the USPTO received a patent term
restoration application for FULYZAQ (U.S. Patent No. 7,323,195) from
Napo Pharmaceuticals, Inc., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated May 23, 2014, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of FULYZAQ represented the first permitted commercial marketing or use
of the product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
FULYZAQ is 7,784 days. Of this time, 7,391 days occurred during the
testing phase of the regulatory review period, while 393 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: September 11, 1991. The applicant claims August 14, 1991, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was September 11, 1991, which was 30 days after FDA receipt of the
first IND from the sponsor for this new drug.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
5, 2011. The applicant claims December 16, 2011, as the date the new
drug application (NDA) for FULYZAQ (NDA 202292) was initially
submitted. However, FDA records indicate that NDA 202292 was submitted
on December 5, 2011.
    3. The date the application was approved: December 31, 2012. FDA
has verified the applicant's claim that NDA 202292 was approved on
December 31, 2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31097 Filed 12-9-15; 8:45 am]
 BILLING CODE 4164-01-P