[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Notices]
[Pages 56415-56418]
[FR Doc No: 2014-22336]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73100; File No. SR-CBOE-2014-070]

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

September 15, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 2, 2014, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') 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 Exchange. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend its Fees Schedule. The text of the
proposed rule change is available on the Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's
Office of the Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend its Fees Schedule. The Exchange
always strives for clarity in its rules and Fees Schedule, so that
market participants may best understand how rules and fees apply. As
such, the Exchange proposes a number of changes to clarify its Fees
Schedule. First, the Exchange proposes to delete all references to
``SPXQ'' in the Fees Schedule. On July 3, 2014, the options symbol for
the SPX End-Of-Quarter option series changed from SPXQ to SPXW. The
SPXW symbol now includes both End-of-Week and End-of-Quarter PM-settled
options series. Accordingly, the symbol ``SPXQ'' is now obsolete and
therefore unnecessary to maintain in the Fees Schedule. The Exchange
proposes to remove all such references to maintain clarity in the Fees
Schedule and avoid potential confusion.
    Next, the Exchange proposes to make certain amendments to Footnote
5 of the Fees Schedule. First, the Exchange proposes to reorganize
Footnote 5 and separate the contents of the footnote into two separate
footnotes. Specifically, Footnote 5 currently addresses both floor
brokerage fees and PAR Official fees. The Exchange proposes to address
floor brokerage fees and PAR Official fees separately by removing the
language in current Footnote 5 relating to PAR Official fees and
relocating that language to new Footnote 33. The Exchange believes the
proposed change would make the Fees Schedule easier to read and reduce
potential confusion. The Exchange notes that the language relating to
PAR Official fees that is being relocated to Footnote 33 is the same
language currently in Footnote 5, with one exception. Particularly,
Footnote 5 currently provides that ``PAR Official Fees are waived for
all classes for February 2011 and for all classes except VIX, VXST and
Volatility Index Options for March 2011.'' The Exchange proposes to
eliminate this sentence and not carry it over to new Footnote 33 as it
is no longer applicable. The Exchange believes deletion of outdated
language further maintains clarity in the Fees Schedule.
    The Exchange also proposes to make a clarifying amendment to
Footnote 24 of the Fees Schedule. The first sentence of Footnote 24
provides that the Market-Maker Trading Permit Sliding Scale is
available for all Market-Maker Trading Permits held by affiliated
Trading Permit Holders (TPHs) and TPH Organizations that are used for
appointments in any options classes other than ``SPX, SPXpm, VIX, VXST,
OEX and XEO.'' The second sentence of Footnote 24 however, states ``Any
Market-Maker Trading Permits used for these four classes, whether in
whole or in part, are excluded from this sliding scale and will be
priced at $5,000/month [sic].'' The Exchange proposes to delete the
word ``four'' from Footnote 24 as it does not correspond with the six
classes mentioned in the previous sentence. The Exchange notes that the
reference to the number of classes excluded from the sliding scale was
inadvertently not updated when fees for both SPXpm and VXST were
incorporated into the Fees Schedule. The Exchange believes the removal
of the inaccurate reference to the excluded classes avoids potential
confusion as to which classes are excluded for purposes of the Market-
Maker Trading Permit Sliding Scale.
    Next, the Exchange proposes to make certain clarifying changes
related to the Floor Broker Trading Permit Sliding Scale (``Sliding
Scale'') table. The Exchange recently amended its Fees Schedule to add
Footnote 32, which provides ``The Exchange will assess no transaction
fees or surcharges for subcabinet trades (limit orders with a price of
at least $0 but less than $1 per options contract, per Exchange Rule
6.54, Interpretation and Policy .03). Subcabinet trades will also not
count towards any volume thresholds or volume threshold calculations.''
\3\ Footnote 32 was appended to all fee-related programs that provide
for reduced or limited fees based on achieving certain volume
thresholds. The Exchange notes that Footnote 25 (which is appended to
the Sliding Scale table), describes a program that provides rebates to
Floor Broker Trading Permit Holders for executing certain amounts of
customer open outcry contracts in multiply-listed options in a month.
As such, Footnote 32 was also appended to the Sliding Scale table to
make clear that subcabinet trades would not count towards those volume
thresholds. The Exchange notes that although Footnote 25, which is
applicable to the Sliding Scale, references a volume based rebate
program, the Floor Broker Sliding Scale itself is not based upon volume
thresholds but rather number of actual Trading Permits held by a
Trading Permit Holder. The Exchange believes that as such, it may be
confusing to append a footnote that relates to volume thresholds (as
well as unrelated transaction fees for subcabinet trades) to a table
referencing a sliding scale that itself is not based upon volume
thresholds. The Exchange therefore proposes to eliminate the reference
to Footnote 32 from the Sliding Scale table and in its place amend
Footnote 25 to explicitly state that subcabinet trades do not count
towards the volume thresholds for the rebate program described in
Footnote 25. The Exchange notes that no substantive changes are being
made by the proposed rule change. The Exchange is proposing this change
to merely alleviate potential confusion and make the Fees Schedule
easier to read.
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    \3\ See Securities Exchange Act Release No. 71423 (January 28,
2014) 79 FR 6251 (February 3, 2014) (SR-CBOE-2014-008).
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    Finally, the Exchange proposes to increase the Linkage fee for non-
customers orders from $0.55 per contract to $0.65 per contract. The
purpose of this proposed change is to cover increased costs associated
with routing orders through Linkage and paying the transaction fees for
such executions at other exchanges. The Exchange notes that the amount
of this fee is lower than corresponding non-

customer Linkage fees assessed by other exchanges.\4\
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    \4\ See, e.g., NASDAQ OMX PHLX LLC (``PHLX'') Pricing, Non-
Customer Routing Fee of $0.97 per contract.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\5\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \6\ requirements that the rules of an exchange be
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 regulating, clearing,
settling, processing information with respect to, and facilitation
[sic] 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.
Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \7\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers. The Exchange also believes the
proposed rule change is consistent with Section 6(b)(4) of the Act,\8\
which requires that Exchange rules provide for the equitable allocation
of reasonable dues, fees, and other charges among its Trading Permit
Holders and other persons using its facilities.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
    \7\ Id.
    \8\ 15 U.S.C. 78f(b)(4).
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    In particular, the Exchange believes that the proposed
clarifications to the Fees Schedule will make the Fees Schedule easier
to read and alleviate potential confusion. The alleviation of potential
confusion will remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general,
protect investors and the public interest.
    The Exchange's proposal to increase the non-customer Linkage fee
from $0.55 to $0.65 is reasonable because such increase will help
offset the costs associated with routing orders through Linkage and
paying the transaction fees for such executions at other exchanges.
Additionally, the amount of the proposed increase is lower than
corresponding non-customer Linkage fees assessed by other exchanges.\9\
This fee amount will be assessed to all non-customer orders routed via
Linkage. The Exchange believes that this proposed change is equitable
and not unfairly discriminatory because Non-Customer (e.g., broker-
dealer proprietary) orders originate from broker-dealers who are by and
large more sophisticated than public customers and can readily control
the exchange to which their orders are routed. While there may be some
sophisticated customers who are capable of directing the exchange to
which their orders are routed, generally, retail customers submit
orders to their brokerages but do not or cannot specify the exchange to
which a customer order is sent. Therefore, non-customer order flow can,
in most cases, more easily route directly to other markets if desired
and thus avoid Linkage Fees. Therefore, it is equitable to assess a
reasonable fee to cover the costs incurred for processing non-customer
Linkage orders while continuing to exempt such customer orders.
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    \9\ See supra note 2 [sic].
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. In particular, the increase to
the non-customer Linkage Fee will apply equally to all non-customers.
Additionally, although different linkage fees are assessed to different
market participants (i.e., non-customers vs customers), as described
above, non-customer order flow can, in most cases, more easily route
directly to other markets if desired and thus avoid Linkage Fees.
Therefore, it is equitable to assess a reasonable fee to cover the
costs incurred for processing non-customer Linkage orders while
continuing to exempt such customer orders. The Exchange believes that
the proposal to increase the linkage fee amount assessed to non-
customers will not cause an unnecessary burden on intermarket
competition because the fee amount is lower than assessed at other
exchanges.\10\ To the extent that the proposed changes make CBOE a more
attractive marketplace for market participants at other exchanges, such
market participants are welcome to become CBOE market participants.
Finally, the proposed changes to alleviate confusion are not intended
for competitive reasons and only apply to CBOE.
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    \10\ Id.
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and paragraph (f) of Rule 19b-4 \12\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(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-CBOE-2014-070 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2014-070. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written

communications relating to the proposed rule change between the
Commission and any person, other than those that may be withheld from
the public in accordance with the provisions of 5 U.S.C. 552, will be
available for Web site viewing and printing in the Commission's Public
Reference Room, 100 F Street NE., Washington, DC 20549 on official
business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of
such filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-CBOE-2014-070, and should be submitted on or before
October 10, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-22336 Filed 9-18-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Pages 78738-78740]
[FR Doc No: 2013-30575]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2013-0071; FRL-9904-04]

Pendimethalin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the current tolerance for combined
residues of pendimethalin and its metabolite, expressed as
pendimethalin equivalents in or on almond, hulls. BASF Corporation, 26
Davis Drive, Research Triangle Park, NC 27709 requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 27, 2013. Objections and
requests for hearings must be received on or before February 25, 2014,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0071, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0071 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
February 25, 2014. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0071, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 27, 2013 (78 FR 13295) (FRL-
9380-2), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2F8133) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.361 be amended by
establishing a tolerance for the combined residues of the herbicide
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6- dinitrobenzenamine,
and its 3,5-dinitrobenzyl alcohol metabolite (CL202347), in or on
almond, hulls at 6.0 parts per million (ppm). That document referenced
a summary of the petition prepared by BASF Corporation, the registrant,
which is available in the docket, http://www.regulations.gov. There
were no comments received in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
..''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for pendimethalin including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pendimethalin
follows.
    The toxicity database for pendimethalin is complete. On August 29,
2012, the Agency published a final rule (77 FR 52240) (FRL-9360-5)
establishing tolerances for combined residues of pendimethalin and its
metabolite in or on various commodities. In the risk assessment
supporting that action, EPA assessed the toxicity of pendimethalin.
Since that assessment, EPA's hazard characterization of pendimethalin
has not changed, and no additional data were needed to assess an
increase in the tolerance of pendimethalin on almond hulls (see
``Pendimethalin: Human Health Risk Assessment to Support an Amended Use
on Almonds''; in docket ID number EPA-HQ-OPP-2013-0071).
    In the 2012 assessment, EPA assessed the dietary risk from residues
of pendimethalin on almond hulls, which are an animal feed item. Based
on that assessment, EPA concluded that there is no reasonable
expectation of finite residues in meat, milk, poultry, and eggs.
Because EPA expects residues of pendimethalin on almond hulls to be
higher under this revised tolerance, EPA recalculated the ruminant
reasonable dietary burden with the new tolerance levels for almond
hulls and concluded that there would be no increase in the ruminant
dietary burden. Furthermore, the increase in tolerance on almond hulls
will not impact the residential exposure and risk assessments that the
Agency conducted in 2012. As there is no change to the residential and
dietary risk assessments, a new aggregated risk assessment was not
needed.
    Therefore, based on the findings of the 2013 risk assessment and
the 2012 final rule and risk assessment, the Agency concludes that
there is a reasonable certainty that no harm will result to the general
population, or to infants and children, from aggregate exposure to
pendimethalin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    PAM Volume II lists four Gas Chromatography/Electron Capture
Detector (GC/ECD), methods for the determination of pendimethalin and
its 3,5-dinitrobenzyl alcohol metabolite in plant commodities. Methods
I and III determine residues of the parent, whereas Methods II and IV
determine residues of the 3,5-dinitrobenzyl alcohol metabolite.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is

different from a Codex MRL; however, FFDCA section 408(b)(4) requires
that EPA explain the reasons for departing from the Codex level.
    The Codex has not established a MRL for almond hulls for
pendimethalin.

C. Revisions to Petitioned-For Tolerances

    Although the petitioner requested that EPA establish a new
tolerance for residues of pendimethalin on almond hulls, there is
already a tolerance for almond hulls at 0.4 ppm. Therefore, EPA is
simply revising that existing tolerance, rather than establishing a new
tolerance.

V. Conclusion

    Therefore, 40 CFR 180.361 is amended by revising the established
tolerance for the combined residues of the herbicide pendimethalin and
its metabolite, in or on almond, hulls from 0.4 ppm to 6.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule modifies a tolerance under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 16, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.361, in the table in paragraph (a), revise the
tolerance level for ``Almond, hulls'' to read as follows:

Sec.  180.361  Pendimethalin; tolerances for residues.(a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Almond, hulls..............................................          6.0

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-30575 Filed 12-26-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 17, 2008 (Volume 73, Number 181)]
[Notices]
[Page 53888]
[DOCID:fr17se08-106]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-3289-EM]

Louisiana; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Louisiana (FEMA-3289-EM), dated August 29,
2008, and related determinations.

DATES: Effective Date: August 29, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 29, 2008, the President declared an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in the State of
Louisiana resulting from Hurricane Gustav beginning on August 27,
2008, and continuing, are of sufficient severity and magnitude to
warrant an emergency declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206
(the Stafford Act). Therefore, I declare that such an emergency
exists in the State of Louisiana.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives, protect property and public health and
safety, or to lessen or avert the threat of a catastrophe in the
designated areas. Specifically, you are authorized to provide
assistance for emergency protective measures (Category B), including
direct Federal assistance, under the Public Assistance program. This
assistance excludes regular time costs for subgrantees' regular
employees. In addition, you are authorized to provide such other
forms of assistance under Title V of the Stafford Act as you may
deem appropriate.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Michael
J. Hall, of FEMA is appointed to act as the Federal Coordinating
Officer for this declared emergency.
    The following areas of the State of Louisiana have been designated
as adversely affected by this declared emergency:

    All 64 parishes in the State of Louisiana for emergency
protective measures (Category B), including 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.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-21682 Filed 9-16-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register: November 21, 2008 (Volume 73, Number 226)]
[Notices]
[Page 70631-70632]
[DOCID:fr21no08-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

November 14, 2008.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER08-321-002.
    Applicants: New York Independent System Operator, Inc.
    Description: Motion for extension of waiver and extension of
Commission instruction by the New York Independent System Operator,
Inc.
    Filed Date: 11/12/2008.
    Accession Number: 20081114-0195.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 19, 2008.

    Docket Numbers: ER09-185-000.
    Applicants: Weyerhaeuser NR Company.
    Description: Weyerhaeuser NR Co. submits a Petition for Acceptance
of Initial Rate Schedule, Waivers and Blanket Authority.
    Filed Date: 11/07/2008.
    Accession Number: 20081110-0260.
    Comment Date: 5 p.m. Eastern Time on Friday, November 28, 2008.

    Docket Numbers: ER09-252-000.
    Applicants: Mid-Continent Area Power Pool.
    Description: Mid-Continent Area Power Pool submits clarifying
revisions to FERC Electric Tariff, First Revised Volume No. 1 in
compliance with Order No. 676-C.
    Filed Date: 10/31/2008.
    Accession Number: 20081110-0246.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-273-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits
tariff revisions to its Market Administration and Control Area Services
Tariff to replace the current method of calculating the amount of
Unforced Capacity that Limited Control Run etc.
    Filed Date: 11/12/2008.
    Accession Number: 20081113-0102.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Docket Numbers: ER09-274-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Company submits the Operating Agreement
Between Tampa Electric Company and Progress Energy Florida Corporation
for the Union Hall-Trilby Interconnection, dated 10/31/08.
    Filed Date: 11/12/2008.
    Accession Number: 20081113-0101.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Docket Numbers: ER09-275-000.
    Applicants: Calpine Bethpage 3, LLC.
    Description: Calpine Bethpage 3, LLC submits notice of cancellation
of its FERC Electric Tariff, First Revised Volume 1.
    Filed Date: 11/12/2008.
    Accession Number: 20081114-0126.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Docket Numbers: ER09-276-000.
    Applicants: Calpine Energy Management, L.P.
    Description: Calpine Energy Management, LP submits notice of
cancellation of its FERC Electric Tariff, First Revised Volume 1.
    Filed Date: 11/12/2008.
    Accession Number: 20081114-0125.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Docket Numbers: ER09-277-000.
    Applicants: Calpine California Equipment Finance Company.
    Description: Calpine California Equipment Finance Company, LLC
submits notice of cancellation of its FERC Electric Tariff, First
Revised Volume 1.
    Filed Date: 11/12/2008.
    Accession Number: 20081114-0124.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Docket Numbers: ER09-278-000.
    Applicants: Calpine Merchant Services Company, Inc.
    Description: Calpine Merchant Services Company, Inc. submits notice
of cancellation of its FERC Electric Tariff, First Revised Volume 1.
    Filed Date: 11/12/2008.
    Accession Number: 20081114-0123.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Docket Numbers: ER09-280-000.
    Applicants: Calpine Northbrook Energy Marketing, LLC.
    Description: Calpine Northbrook Energy Marketing, LLC submits a
notice of cancellation of its FERC Electric Tariff, First Revised
Volume 1.
    Filed Date: 11/12/2008.
    Accession Number: 20081114-0122.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Docket Numbers: ER09-283-000.
    Applicants: Entergy Services, Inc.
    Description: Entergy Operating Companies submits Eighth Revised
Network Integration Transmission Service Agreement with East Texas
Electric Cooperative, Inc. et al.
    Filed Date: 11/12/2008.
    Accession Number: 20081114-0120.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Docket Numbers: ER09-287-000.
    Applicants: Alliant Energy Corporate Services, Inc.
    Description: Alliant Energy Corporate Services, Inc. request for
waiver/suspension and notice of cancellation of Ancillary Service
Schedules of Open Access Transmission Tariffs.
    Filed Date: 11/12/2008.
    Accession Number: 20081114-0116.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Docket Numbers: ER09-290-000.
    Applicants: Maine Electric Power Company, Inc.
    Description: Maine Electric Power Company, Inc. et al. submits
revised Attachment H of the ISO New England Open Access Transmission
Tariff etc, to be effective 12/1/08 under ER09-290.
    Filed Date: 11/12/2008.
    Accession Number: 20081114-0174.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.
    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA07-19-004; OA07-43-005; ER07-1171-005.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Company submits its
Supplemental Annual Compliance Report on Penalty Assessments and
Distributions.
    Filed Date: 10/30/2008.
    Accession Number: 20081030-5127.
    Comment Date: 5 p.m. Eastern Time on Thursday, November 20, 2008.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on

or before the comment deadline need not be served on persons other than
the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-27726 Filed 11-20-08; 8:45 am]

BILLING CODE 6717-01-P


## 11.6.2019: Production version of TP-chl model
## 12.17.2019Cleaned and commented
ntumodel <- function(df1, varout = NULL, runmod = T) {
    source("logtick.exp.R")
    source("binv.R")

    require(rstan)

    nchains <- 6    # select number of chains

    depthsel <- 3.2              # lake depth
    ecosel <- 65                # Level III ecoregion code
    credint <- 0.80             # Credible interval for criterion calc
    chltarg <- 10               # Chl target

    ## omit records that are missing data
    incvec <- ! is.na(df1$ptl.result) & ! is.na(df1$turb.result) &
         ! is.na(df1$chl) & ! is.na(df1$index.site.depth)
    cat("N omitted due to missing records:", sum(!incvec), "\n")
    df1 <- df1[incvec,]

    ## select index sites
    df1 <- subset(df1, sample.type == "MICX")

    ## drop below detection limit turb and tp
    norig <- nrow(df1)
    incvec <- df1$turb.result > 0.01
    df1 <- df1[incvec,]
    incvec <- df1$ptl.result > 1
    df1 <- df1[incvec,]
    incvec <- df1$chl >0
    df1 <- df1[incvec,]
    cat("N dropped for detection limit:", norig - nrow(df1), "\n")

    ## scale chl
    chlmn <- mean(log(df1$chl))
    chlsc <- exp(chlmn)
    df1$chl.sc <- df1$chl/chlsc

    ## define 30 depth classes based on quantiles
    cutp.depth <- quantile(log(df1$index.site.depth), prob = seq(0, 1,length = 31))
    cutm <- 0.5*(cutp.depth[-1] + cutp.depth[-length(cutp.depth)])
    df1$dclass <- cut(log(df1$index.site.depth), cutp.depth, include.lowest = T)
    names(cutm) <- levels(df1$dclass)
    df1$dclassnum <- as.numeric(df1$dclass)

    ##drop HI, only dealing with conterminous US
    incvec <- df1$st.nla2012 == "HI"
    df1 <- df1[!incvec,]

    ## reset factor levels for state
    df1$state <- factor(df1$st.nla2012)
    df1$statenum <- as.numeric(df1$state)

    ## reset L3 ecoregion codes
    df1$us.l3code <- factor(df1$us.l3code)
    df1$econum <- as.numeric(df1$us.l3code)

    ## save data out to disk
    tpchldat <- df1
    save(tpchldat, chlsc, cutp.depth, file = "tpchldat.rda")

    datstan <- list(n = nrow(df1),
                    ndepth = max(df1$dclassnum),depthnum = df1$dclassnum,
                    neco = max(df1$econum), econum = df1$econum,
                    ntu = df1$turb.result,
                    tp = df1$ptl.result,
                    chl = df1$chl.sc)

    print(str(datstan))

    modstan <- '
        data {
            int n;                 // number of samples
            int ndepth;            // number of depth classes
            int depthnum[n];       // depth class assignment
            int neco;              // number of L3 ecoregions
            int econum[n];         // ecoregion assigment
            vector[n] ntu;         // NTU
            vector[n] tp;          // TP
            vector[n] chl;         // Scaled Chl
        }
        parameters {
            real muu_mn;             // grand mean ntu_np
            real<lower= 0> sigu[2];  // standard deviation of ntu_np
            vector[ndepth] eta_u1;
            vector[n] eta_u2;
            real<lower = 0> signtu;  // measurement error of ntu
            real mub;                // mean coef of chl-ntu relationship
            real<lower = 0> sigb;    // standard deviation of b among ecoregions
            vector[neco] etab;
            real<lower = 0> muk[3];  // exponents on chl and u in models
            vector[3] mud;           // mean coef for tp model
            vector<lower = 0>[3] sigd;// SD of ecoregion- or depth-specific coef
            vector[ndepth] etad1;
            vector[neco] etad2;
            vector[neco] etad3;
            real<lower = 0> sigtp;    // measurement error of tp

        }
        transformed parameters {
            vector[ndepth] muu;
            vector[neco] b;
            vector[n] u;
            // dropped depth specific d1 because no sig
            // difference among depths. just using mud[1]
            vector[ndepth] d1;
            vector[neco]  d2;
            vector[neco] d3;

            b = mub + etab*sigb;

            muu = muu_mn + eta_u1*sigu[1];
            u = muu[depthnum] + eta_u2*sigu[2];
            d1 = mud[1] + sigd[1]*etad1;
            d2 = mud[2] + sigd[2]*etad2;
            d3 = mud[3] + sigd[3]*etad3;
        }
        model {
            matrix[n,2] chlk;
            vector[n] uk;

            muu_mn ~ normal(0,3);    // weakly informative priors
            sigu ~ cauchy(0,3);
            eta_u1 ~ normal(0,1);
            eta_u2 ~ normal(0,1);
            signtu ~cauchy(0,3);
            mub ~ normal(0,4);
            sigb ~ cauchy(0,3);
            etab ~ normal(0,1);

            muk ~ normal(1,0.3);    // muk should be somewhere around 1
            mud ~ normal(0,4);
            sigd ~ cauchy(0,3);
            etad1 ~ normal(0,1);
            etad2 ~ normal(0,1);
            etad3 ~ normal(0,1);
            sigtp ~ cauchy(0,3);

           for (i in 1:n) chlk[i,1] = chl[i]^muk[1];
           for (i in 1:n) uk[i] = (u[i] - muu_mn)*muk[2];
           for (i in 1:n) chlk[i,2] = chl[i]^muk[3];

            ntu ~ lognormal(log(exp(b[econum]) .* chlk[,1] + exp(u)), signtu);
            tp ~ lognormal(log(exp(d1[depthnum]) +
                 exp(d2[econum]) .* exp(uk) +
                 exp(d3[econum]) .* chlk[,2]),sigtp);
        }
    '

    if (runmod) {

        rstan_options(auto_write = TRUE)
        options(mc.cores = nchains)
        fit <- stan(model_code = modstan,
                    data = datstan, iter = 900, chains = nchains,
                    warmup = 300, thin = 2)
        return(fit)
    }

    ## post processing
    grey.t <- adjustcolor("grey39", alpha.f = 0.5)

    muk <- apply(varout$muk, 2, mean)
    d1 <- apply(varout$d1, 2, mean)
    d2 <- apply(varout$d2, 2, mean)
    d3 <- apply(varout$d3, 2, mean)
    muu <- apply(varout$muu, 2,mean)
    muumn <- mean(varout$muu_mn)
    d3raw <- d3 - muk[3]*log(chlsc)
    d2raw <- d2-muk[2]*muumn
    mud <- apply(varout$mud, 2, mean)

    mub <- mean(varout$mub)
    mubraw <- mub - muk[1]*log(chlsc)

    ## PLOT: relationship between Chl and turbidity (Fig 24)
    png(width = 3, height = 2.5, pointsize = 8, units = "in", res = 600,
        file = "chlturb.png")
    par(mar = c(4,4,1,1), mfrow = c(1,1), mgp = c(2.3,1,0))
    plot(log(df1$chl), log(df1$turb.result), axes = F,
         xlab = expression(Chl~italic(a)~(mu*g/L)),
         ylab = "Turbidity (NTU)", pch = 21, col = "grey",
         bg="white")
    logtick.exp(0.001, 10, c(1,2), c(F,F))
    abline(mubraw, muk[1])
    dev.off()

    b <- apply(varout$b, 2, mean)
    braw <- b - muk[1]*log(chlsc)

    ## PLOT: predicted values for Pdiss and muu (Fig 25)
    png(width = 6, height = 2.5, pointsize = 8, units = "in", res = 600,
        file = "Pdiss.turb.depth.png")
    par(mar = c(4,4,1,1), mgp = c(2.3, 1, 0), mfrow= c(1,2))
    plot(cutm, exp(muu), xlab = "Depth (m)", axes = F,
         ylab = expression(Turb[np]~(NTU)),
         pch = 21, col = "grey39", bg="white")
    axis(2)
    logtick.exp(0.001, 10, c(1), c(F,F))

    plot(cutm, exp(d1), xlab = "Depth (m)", axes = F,
         ylab = expression(P[diss]~(mu*g/L)),
         pch = 21, col = "grey39", bg="white")
    axis(2)
    logtick.exp(0.001, 10, c(1), c(F,F))
    dev.off()

    ## load in ntu_np mean values into main data
    df1$umean <- umean

    ## merge ecoregion and depth specific coefficients into main data
    dfd <- data.frame(num = 1:length(muu),  muu)
    names(dfd) <- c("dclassnum",  "muu")
    print(nrow(df1))
    df1 <- merge(df1, dfd, by = "dclassnum")
    print(nrow(df1))
    dfd3 <- data.frame(num = 1:length(d3), d3, d3raw, d2, d2raw)
    print(dim(dfd3))
    names(dfd3) <- c("econum", "d3", "d3raw", "d2", "d2raw")
    df1 <- merge(df1, dfd3, by = "econum")

    ## save ecoregion coefficients to file for mapping
    dfd3 <- merge(dfd3, unique.data.frame(df1[, c("econum", "us.l3code")]),
                  by = "econum")
    save(dfd3, file= "dfd3.rda")  # output to different script for mapping

        ## compute mean predicted TP
    df1$predout <- exp(mud[1]) + exp(df1$d2)*exp(df1$umean - muumn)^muk[2] +
        exp(df1$d3)*df1$chl.sc^muk[3]

    png(width = 4, height = 4, pointsize = 10, units = "in", res = 600,
        file = "pred.v.obs.all.png")
    par(mar = c(4,4,1,1), mgp = c(2.3,1,0), bty = "l")
    plot(log(df1$predout), log(df1$ptl.result), xlab = "Predicted TP",
         ylab = "Observed TP",  pch = 21, col = "grey39",
         bg = "white", axes = F)
    logtick.exp(0.001, 10, c(1,2), c(F,F))
    abline(0,1)
    dev.off()

    rmsfnc <- function(x,y) {
        return(sqrt(sum((x-y)^2)/length(x)))
    }
    cat("Whole data RMS:",rmsfnc(log(df1$predout), log(df1$ptl.result)), "\n")

    ## print numerical summaries of parameters
    print("mub")
    print(exp(quantile(varout$mub - varout$muk[,1]*log(chlsc),
                   prob = c(0.05, 0.5, 0.95))))
    print("k distribution")
    print(apply(varout$muk, 2, quantile, prob = c(0.05, 0.5, 0.95)))
    mud <- apply(varout$mud, 2, mean)

    print("mud[2]")
    print(exp(quantile(varout$mud[,2] - varout$muk[,2]*varout$muu_mn,
                       prob = c(0.05, 0.50, 0.95))))
    print("mud[3]")
    print(exp(quantile(varout$mud[,3] - varout$muk[,3]*log(chlsc),
                       prob = c(0.05, 0.5, 0.95))))

    # PLOT: NTU_np vs TP, Chl vs TP (fig 27)
    png(width = 6, height = 2.5, pointsize = 8, units = "in", res = 600,
        file = "tpchl.png")

    par(mar = c(4,4,1,1), mfrow = c(1,2), mgp = c(2.3,1,0))
    plot(df1$umean, log(df1$ptl.result), xlab = expression(Turb[np]~(NTU)),
         ylab = expression(TP~(mu*g/L)), pch = 21, col = "grey",
         bg="white", axes = F)
    logtick.exp(0.000001, 10, c(1,2), c(F,F))
    x <- seq(min(df1$umean), max(df1$umean), length = 40)
    predout <- matrix(NA, ncol = 3, nrow = length(x))
    for (i in 1:length(x)) {
        y <- varout$mud[,2] + varout$muk[,2]*x[i] - varout$muu_mn*varout$muk[,2]
        predout[i,] <- quantile(y, prob = c(0.05, 0.5, 0.95))
    }
    polygon(c(x, rev(x)), c(predout[,1], rev(predout[,3])),
            col = grey.t, border = NA)
    lines(x, predout[,2])

    plot(log(df1$chl), log(df1$ptl.result),
         xlab = expression(Chl~italic(a)~(mu*g/L)),
         ylab = expression(TP~(mu*g/L)), pch= 21, col = "grey",
         bg = "white", axes = F)
    logtick.exp(0.001, 10, c(1,2), c(F,F))
    x <- seq(min(log(df1$chl)), max(log(df1$chl)), length = 40)
    predout <- matrix(NA, ncol = 3, nrow = length(x))
    for (i in 1:length(x)) {
        y <- varout$mud[,3] - varout$muk[,3]*log(chlsc) +
            varout$muk[,3]*x[i]
        predout[i,] <- quantile(y, prob = c(0.05, 0.5, 0.95))
    }
    polygon(c(x, rev(x)), c(predout[,1], rev(predout[,3])),
            col = grey.t, border = NA)
    lines(x, predout[,2])

    dev.off()

    ## Plot criterion derivation figure

    ## find ecoregion index number
    ieco <- which(levels(df1$us.l3code) == ecosel)

    ## find correct depth class
    idepth <- 1
    while(exp(cutp.depth[idepth]) < depthsel & (idepth < length(cutp.depth)))
        idepth <- idepth + 1
    print(idepth)

    grey.t <- adjustcolor("grey39", alpha.f = 0.5)

    ## calculate mean parameter values
    muk <- apply(varout$muk, 2, mean)
    d3 <- apply(varout$d3, 2, mean)
    d3 <- d3 - muk[3]*log(chlsc)

    incvec <- df1$econum == ieco

    ## define regularly spaced values along chl gradient
    ## for computing predictions
    x <- seq(min(log(df1$chl)), max(log(df1$chl)), length = 50)
    xsc <- x - log(chlsc)

    ## compute predicted ambient and limiting values
    predout <- matrix(NA, ncol = 3, nrow = length(x))
    predout2 <- matrix(NA, ncol = 3, nrow = length(x))
    for (i in 1:length(x)) {
        y <- varout$d3[,ieco] - varout$muk[,3]*log(chlsc) +
            varout$muk[,3]*x[i]
        predout[i,] <- quantile(y, prob = c(0.5*(1-credint),
                                       0.5, 1- 0.5*(1-credint)))
        y2 <-  exp(varout$d2[,ieco])*
                (exp(varout$muu[, idepth] -
                         varout$muu_mn))^varout$muk[,2] +
                             exp(varout$d3[, ieco])*exp(xsc[i])^varout$muk[,3]
        predout2[i,] <- quantile(log(y2), prob = c(0.5*(1-credint),
                                              0.5, 1-0.5*(1-credint)))
    }

    dev.new()
    par(mgp = c(2.3,1,0), bty = "l", mar = c(4,4,1,1))
    plot(log(df1$chl), log(df1$ptl.result), type = "p",
         axes = F, xlab = expression(Chl~italic(a)~(mu*g/L)),
         ylab = expression(TP~(mu*g/L)), col = "grey80",
         pch = 21, bg = "white")
    logtick.exp(0.001, 10, c(1,2), c(F,F))
    ## highlight points in the selected ecoregion
    points(log(df1$chl)[incvec], log(df1$ptl.result)[incvec],
           pch = 21, col = "black", bg = "grey")

    cat("Median depth:", median(df1$index.site.depth[incvec]), "\n")

    polygon(c(x, rev(x)), c(predout[,1], rev(predout[,3])),
            col  = grey.t, border = NA)
    lines(x, predout[,2])
    polygon(c(x, rev(x)), c(predout2[,1], rev(predout2[,3])),
            col  = grey.t, border = NA)
    lines(x, predout2[,2], lty = "dashed")

    crit1 <- approx(x, predout[,1], log(chltarg))$y
    crit2 <- approx(x, predout2[,1], log(chltarg))$y

    ylo <- min(log(df1$ptl.result)) - 0.04*diff(range(log(df1$ptl.result)))
    xlo <- min(log(df1$chl)) - 0.04*diff(range(log(df1$chl)))
    segments(xlo, crit1,
             log(chltarg), crit1,  col = "red")
    segments(xlo, crit2,
             log(chltarg), crit2,  col = "red")
    segments(log(chltarg), crit2,
             log(chltarg), ylo, col = "red")
    segments(xlo, crit1,
             xlo, crit2, col = "red", lwd = 3)

    cat("TP criterion:", round(exp(crit2)), "\n")

}

## runmod variable set to T to run simulation and set to F to
##  run post processing.
#fitout <- ntumodel(dat.merge.all, runmod = T)
## post processing
#varout <- extract(fitout, pars = c("muk", "mub", "b", "d1", "d2", "d3",
#                              "muu", "muu_mn", "u", "mud"))
#umean <- apply(varout$u, 2, mean)
ntumodel(dat.merge.all, varout.p, runmod = F)


[Federal Register: February 24, 2009 (Volume 74, Number 35)]
[Notices]
[Page 8296-8298]
[DOCID:fr24fe09-103]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59406; File No. SR-CBOE-2009-006]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Amend CBOE Rules Relating to DPMs and LMMs

February 13, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 11, 2009, the Chicago Board Options Exchange,
Incorporated (the ``Exchange'' or ``CBOE'') 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 Exchange. The Exchange filed the proposal as a ``non-
controversial'' proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The Exchange proposes to amend CBOE rules relating to relating to
[sic] DPMs and LMMs. The text of the proposed rule change is available
on the Exchange's Web site (http://www.cboe.org/Legal), at the
Exchange's Office of the Secretary, and at the Commission'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
    DPMs are member organizations that function in option classes
allocated to them as a Market-Maker, and also are subject to the
obligations under Rule 8.85 or as otherwise provided in CBOE's Rules.
LMMs, similarly, function in option classes allocated to them as a
Market-Maker, and also are subject to other obligations under Rule
8.15A (for Hybrid classes) or as otherwise provided in CBOE's Rules.
Recently, CBOE amended its rules to provide DPMs with the flexibility
to operate remotely away from CBOE's trading floor as a so-called
``Off-Floor DPM.'' (See, e.g., Rules 8.80 and 8.83.) The purpose of
this rule filing is to amend CBOE's rules to provide that CBOE in its
discretion may appoint an ``On-Floor LMM'' in option classes in which
an ``Off-Floor DPM'' is appointed. Although CBOE does not believe it is
necessary for an On-Floor LMM to be appointed in each option class in
which an ``Off-Floor DPM'' is appointed, CBOE believes that having an
On-Floor LMM in an option class in which an Off-Floor DPM has been
appointed provides additional flexibility and may be beneficial.
    In connection with this change, CBOE also proposes to amend its
rules relating to the obligations of LMMs and LMM participation
entitlements, in option classes in which both an On-Floor LMM and an
Off-Floor DPM have been appointed. First, CBOE proposes to amend
paragraph (b)(i) of Rule 8.15A to provide that in option classes in
which both an On-Floor LMM and an Off-Floor DPM have been appointed,
the On-Floor LMM shall be obligated to comply with the quoting
obligations of Market-Makers in Hybrid classes as set forth in Rule
8.7(d). These obligations generally include a continuous open outcry
quoting obligation and the obligation to continuously quote
electronically in 60% of the series with less than nine months to
expiration of each allocated class. The Off-Floor DPM would continue to
be required to meet the continuous electronic quoting obligation set
forth in Rule 8.85(a)(i), namely, to continuously quote in at least 90%
of the series of each multiply-listed option class allocated to it and
in 100% of the series of each singly-listed option class allocated to
it. CBOE does not believe it is necessary to require the On-Floor LMM
to satisfy the more extensive electronic quoting obligation of DPMs
given that the Off-Floor DPM will be performing this function and the
On-Floor LMM will not be eligible to receive a participation
entitlement for transactions executed electronically. (See Rule
8.15B(b).)
    CBOE also proposes to amend paragraphs (b)(iv) and (b)(vi) of Rule
8.15A to provide that the obligations set forth therein will be
assigned to the Off-Floor DPM in those option classes in which both an
On-Floor LMM and an Off-Floor DPM have been appointed. CBOE believes
that it is appropriate that these two obligations, which pertain to the
prompt initiation of an opening trading rotation and the use of a DPM's
account for Linkage, be the responsibility of the Off-Floor DPM given
that it will have the principal electronic quoting obligation in the
option class and will be eligible to receive a participation
entitlement for electronic transactions.
    CBOE also proposes to amend Rule 8.15A and Rule 8.15B to provide
that in option classes in which both an On-Floor LMM and an Off-Floor
DPM have been appointed, the On-Floor LMM may receive a participation
entitlement with respect to orders represented in open

outcry on CBOE's trading floor. CBOE believes that it is appropriate
for the On-Floor LMM to receive a participation entitlement for orders
represented in open outcry given that the On-Floor LMM will have a
continuous open outcry quoting obligation,\5\ is expected to be
continually present at the trading station and resolve disputes
relating to transactions in the option classes in which the LMM is
appointed, make competitive open outcry markets, and promote CBOE in a
manner likely to enhance CBOE's ability to compete successfully for
order flow in the classes it trades, among other obligations. CBOE
notes that its rules currently provide that an Off-Floor DPM shall not
receive a participation entitlement with respect to orders represented
in open outcry on CBOE's trading floor, so it is reasonable for an On-
Floor LMM to receive an entitlement for open outcry transactions given
its obligations including the continuous open outcry quoting
obligation.
---------------------------------------------------------------------------

    \5\ Rule 8.7(d) provides that Market-Makers have a continuous
open outcry quoting obligation. Specifically, it states ``in
response to any request for quote by a floor broker, in-crowd
Market-Makers must provide a two-sided market complying with the
quote width requirements contained in Rule 8.7(b)(iv) for a minimum
number of contracts determined by the Exchange on a class by class
basis, which minimum shall be at least one contract and which
minimum can vary for non-broker-dealer orders and broker-dealer
orders.''
---------------------------------------------------------------------------

    Finally, CBOE notes that the provisions of Rule 8.15A not being
amended by this proposed rule change will continue to apply to the On-
Floor LMM that is appointed in option classes in which an Off-Floor DPM
is appointed. For example, the On-Floor LMM will continue to be
obligated to honor its displayed quotations (See Rule 8.15A(b)(ii));
perform these obligations for a period of one expiration cycle (See
Rule 8.15A(b)(iii)); respond to open outcry requests for quotes by a
floor broker (See Rule 8.15A(b)(v)); and maintain information barriers
that are reasonably designed to prevent the misuse of material, non-
public information with any affiliates that conduct a brokerage
operation in classes allocated to the On-Floor LMM or act as a
specialist or Market-Maker in any security underlying options allocated
to the LMM, and otherwise comply with the requirements of Rule 4.18
regarding the misuse of material, non-public information (See Rule
8.15A(b)(vii)).
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations under the Act applicable to a national securities exchange
and, in particular, the requirements of Section 6(b) of the Act.
Specifically, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) Act \6\ requirements that the rules
of an exchange be designed to promote just and equitable principles of
trade, in that allowing CBOE to appoint an On-Floor LMM in an option
class in which an Off-Floor DPM has been appointed provides additional
flexibility and, therefore, could be beneficial and contribute to the
maintenance of a fair and orderly market.
---------------------------------------------------------------------------

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

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

    CBOE does not believe that the proposed rule change will impose any
burden on competition 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

    The Exchange neither solicited nor received comments on the
proposal.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
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, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6)(iii) thereunder.\10\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires the Exchange to give the Commission written
notice of the Exchange's intent to file the proposed rule change
along with a brief description and the text of 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. The Exchange has satisfied the pre-filing requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2009-006 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2009-006. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying 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 self-regulatory
organization. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
CBOE-2009-006 and should be submitted on or before March 17, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-3861 Filed 2-23-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 180 (Friday, September 16, 2011)]
[Notices]
[Pages 57726-57727]
[FR Doc No: 2011-23749]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Take Notice That the Commission Has Received the Following
Natural Gas Pipeline Rate and Refund Report Filings:

Filings Instituting Proceedings

    Docket Numbers: RP11-2558-000.
    Applicants: Big Sandy Pipeline, LLC.
    Description: Big Sandy Pipeline, LLC submits tariff filing per
154.204: 2011-09-01 Negotiated Rate Agreements--EQT Energy to be
effective 9/1/2011.
    Filed Date: 09/08/2011.
    Accession Number: 20110908-5021.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 20, 2011.

    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
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP11-2442-001.
    Applicants: Central Kentucky Transmission Company.
    Description: Central Kentucky Transmission Company submits tariff
filing per 154.205(b): ACA Errata 2011 to be effective 10/1/2011.
    Filed Date: 09/01/2011.
    Accession Number: 20110901-5201.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 13, 2011.

    Docket Numbers: RP11-2469-001.
    Applicants: Eastern Shore Natural Gas Company.
    Description: Eastern Shore Natural Gas Company submits tariff
filing per 154.205(b): 2011 ACA Revised to be effective 10/1/2011.
    Filed Date: 09/07/2011.
    Accession Number: 20110907-5146.
    Comment Date: 5 p.m. Eastern Time on Monday, September 19, 2011.

    Docket Numbers: RP11-2470-001.
    Applicants: Transcontinental Gas Pipe Line Company, LLC
    Description: Transcontinental Gas Pipe Line Company, LLC submits
tariff filing per 154.205(b): Pascagoula Expansion Non-Conforming
Superseding Service Agreement to be effective 9/30/2011.
    Filed Date: 09/07/2011.
    Accession Number: 20110907-5129.
    Comment Date: 5 p.m. Eastern Time on Monday, September 19, 2011.

    Docket Numbers: RP11-2308-002.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Algonquin Gas Transmission, LLC submits tariff filing
per 154.203: Winter Operations Compliance Filing to be effective 9/1/
2011.
    Filed Date: 09/08/2011.
    Accession Number: 20110908-5043.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 20, 2011.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service 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 (202) 502-
8659.

    Dated: September 8, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-23749 Filed 9-15-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18998-19000]
[FR Doc No: 2020-07000]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1619]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Good Manufacturing
Practice in Manufacturing, Packaging, Labeling, or Holding Operations
for Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by May 4, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0606. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements--21 CFR Part
111; OMB Control Number 0910-0606--Revision

    The Dietary Supplement Health and Education Act (Pub. L. 103-417)
added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of
Health and Human Services may, by regulation, prescribe good
manufacturing practice for dietary supplements. Section 402(g) of the
FD&C Act also stipulates that such regulations will be modeled after
current good manufacturing practice (CGMP) regulations for food and may
not impose standards for which there are no current, and generally
available, analytical methodology. Section 402(g)(1) of the FD&C Act
states that a dietary supplement is adulterated if it has been
prepared, packed, or held under conditions that do not meet current
good manufacturing practice regulations.
    Accordingly, we have promulgated regulations in part 111 (21 CFR
part 111) establishing minimum CGMP requirements pertaining to the
manufacturing, packaging, labeling, or holding of dietary supplements
to ensure their quality. Included among the requirements is
recordkeeping, documenting, planning, control, and improvement
processes of a quality control system. Implementation of these
processes in a manufacturing operation serves as the backbone to CGMP.
The records must show what is being manufactured and whether the
controls

in place ensure the product's identity, purity, strength, and
composition, and that limits on contaminants and measures to prevent
adulteration are effective. Further, records must show whether and what
deviations from control processes occurred, facilitate evaluation and
corrective action concerning these deviations (including, where
necessary, whether associated batches of product should be recalled
from the marketplace), and enable a manufacturer to assure that the
corrective action was effective. We believe the regulations in part 111
establish the minimum manufacturing practices necessary to ensure that
dietary supplements are manufactured, packaged, labeled, or held in a
manner that will ensure the quality of the dietary supplements during
manufacturing, packaging, labeling, or holding operations.
    Specifically, the recordkeeping requirements of the regulations in
part 111 include establishing written procedures and maintaining
records pertaining to: (1) Personnel; (2) sanitation; (3) calibration
of instruments and controls; (4) calibration, inspection, or checks of
automated, mechanical, or electronic equipment; (5) maintaining,
cleaning, and sanitizing equipment and utensils and other contact
surfaces; (6) water used that may become a component of the dietary
supplement; (7) production and process controls; (8) quality control;
(9) components, packaging, labels, and product received for packaging
and labeling; (10) master manufacturing and batch production; (11)
laboratory operations; (12) manufacturing operations; (13) packaging
and labeling operations; (14) holding and distributing operations; (15)
returned dietary supplements; and (16) product complaints.
    Section 111.75 (21 CFR 111.75) reflects FDA's determination that
manufacturers that test or examine 100 percent of the incoming dietary
ingredients for identity can be assured of the identity of the
ingredient. However, we recognize that it may be possible for a
manufacturer to demonstrate, through various methods and processes in
use over time for its particular operation, that a system of less than
100 percent identity testing would result in no material diminution of
assurance of the identity of the dietary ingredient as compared to the
assurance provided by 100 percent identity testing. Section 111.75
provides an opportunity for a manufacturer to make such a showing and
reduce the frequency of identity testing of components that are dietary
ingredients from 100 percent to some lower frequency. Section 111.75
sets forth the information a manufacturer is required to submit for an
exemption from the requirement of 100 percent identity testing when a
manufacturer petitions the Agency for such an exemption to 100 percent
identity testing under 21 CFR 10.30, and the Agency grants such
exemption. This reporting burden is currently accounted for under OMB
control number 0910-0608, Petition to Request an Exemption from 100
Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing,
Packaging, Labeling or Holding Operations for Dietary Supplements. With
this notice, we propose to consolidate information collection under
Sec.  111.75 into the instant and related information collection.
    Description of Respondents: Manufacturers, dietary supplement
manufacturers, packagers and repackagers, labelers and re-labelers,
holders, distributors, warehousers, exporters, importers, large
businesses, and small businesses engaged in the dietary supplement
industry.
    In the Federal Register of December 5, 2019 (84 FR 66678), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average  burden
   21 CFR section; activity        Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
111.14; records of personnel            15,000               4          60,000  1...............          60,000
 practices, including
 documentation of training.
111.23; records of physical             15,000               1          15,000  0.2 (12 minutes)           3,000
 plant sanitation practices,
 including pest control and
 water quality.
111.35; records of equipment               400               1             400  12.5............           5,000
 and utensils calibration and
 sanitation practices.
111.95; records of production              250               1             250  45..............          11,250
 and process control systems.
111.140; records that quality              240           1,163         279,120  1...............         279,120
 control personnel must make
 and keep.
111.180; records associated                240           1,163         279,120  1...............         279,120
 with components, packaging,
 labels, and product received
 for packaging and labeling as
 a dietary supplement.
111.210; requirements for what             240               1             240  2.5.............             600
 the master manufacturing
 record must include.
111.260; requirements for what             145           1,408         204,160  1...............         204,160
 the batch record must include.
111.325; records that quality              120               1             120  15..............           1,800
 control personnel must make
 and keep for laboratory
 operations.
111.375; records of the                    260               1             260  2...............             520
 written procedures
 established for manufacturing
 operations.
111.430; records of the                     50               1              50  12.6............             630
 written procedures for
 packaging and labeling
 operations.
111.475; records of product             15,000               1          15,000  0.4 (24 minutes)           6,000
 distribution and procedures
 for holding and distributing
 operations.
111.535; records for returned              110               4             440  13.5............           5,940
 dietary supplements.
111.570; records regarding                 240             600         144,000  0.5 (30 minutes)          72,000
 product complaints.

    Total.....................  ..............  ..............  ..............  ................         929,140
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                     21 CFR section; activity                         Number of      responses per     Total annual     Average burden     Total hours
                                                                     respondents       respondent       responses        per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.75; petition for exemption from 100 percent identity testing.               1                1                1                  8                8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We have made no changes to our estimate of the information
collection based on our most recent review. However, in consolidating
burden from information collection previously accounted for under OMB
control number 0910-0608, the information collection reflects an
increase of 8 hours and one response annually.

    Dated: March 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07000 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 16, 2006 (Volume 71, Number 221)]
[Notices]
[Page 66769-66770]
[DOCID:fr16no06-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2082-027]

PacifiCorp, Oregon and California; Notice of Intent To Hold an
Additional Public Meeting for Discussion of the Draft Environmental
Impact Statement for the Klamath Hydroelectric Project

November 9, 2006.
    On September 25, 2006, Commission staff delivered the Draft
Environmental Impact Statement (DEIS) for the relicensing of the
Klamath Hydroelectric project to the Environmental Protection Agency
and mailed it to resource and land management agencies, interested
organizations, and individuals.
    The DEIS was noticed in the Federal Register on September 29, 2006
(71 FR 57503). The DEIS evaluates the environmental consequences of the
issuance of a new license for the continued operation and maintenance
of the Klamath Hydroelectric, located primarily on the Klamath River,
in Klamath County, Oregon and Siskiyou County, California. The existing
project occupies a total of 219 acres of land administered by the U.S.
Bureaus of Land Management and Reclamation. It

also evaluates the environmental effects of implementing the licensee's
proposals, agency and NGO recommendations, staff's recommendations, and
the no-action alternative. The comment deadline is December 1, 2006.
    On October 6, 2006, and November 2, 2006, we noticed a total of
five public meetings to receive comments on the DEIS, which will be
recorded by an official stenographer, as follows.

    Date: Tuesday, November 14, 2006.
    Time: 9 a.m.-12 noon (PST).
    Place: Shilo Inn.
    Address: 2500 Almond Street, Klamath Falls, Oregon.

    Date: Wednesday, November 15, 2006.
    Time: 9 a.m.-12 noon (PST).
    Place: Yreka Community Theatre.
    Address: 812 North Oregon Street, Yreka, California.

    Date: Wednesday, November 15, 2006.
    Time: 7-10 p.m. (PST).
    Place: Yreka Community Theatre.
    Address: 812 North Oregon Street, Yreka, California.

    Date: Thursday, November 16, 2006.
    Time: 7-10 p.m. (PST).
    Place: Red Lion Hotel.
    Address: 1929 Fourth Street, Eureka, California.
    Date: Wednesday, November 29, 2006.
    Time: 7-10 p.m. (PST).
    Place: North Bend Community Center.
    Address: 2222 Broadway Street, North Bend, Oregon.

    We are now providing notice that we will be holding one additional
meeting to receive comments on our DEIS:
    Date: Thursday, November 30, 2006.
    Time: 7-10 p.m. (PST).
    Place: Shilo Inn.
    Address: 536 SW Elizabeth, Newport, Oregon.

    At these meetings, resource agency personnel and other interested
persons will have the opportunity to provide oral and written comments
and recommendations regarding the DEIS for the Commission's public
record.
    For further information, please contact John Mudre at e-mail
address<EMAIL_ADDRESS>or by telephone at<PHONE_NUMBER>.

Magalie R. Salas,
Secretary .
 [FR Doc. E6-19356 Filed 11-15-06; 8:45 am]

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