[Federal Register Volume 78, Number 157 (Wednesday, August 14, 2013)]
[Notices]
[Page 49507]
[FR Doc No: 2013-19654]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-2069-000]

OriGen Energy LLC ; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
OriGen Energy LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 27, 2013.
    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 Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding 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 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>.

    Dated: August 7, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-19654 Filed 8-13-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Rules and Regulations]
[Pages 3816-3817]
[FR Doc No: 2020-28018]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2020-0435; FRL-10017-70-Region 9]

Air Plan Approval; California; Placer County Air Pollution
Control District, Antelope Valley Air Quality Management District,
Mariposa County Air Pollution Control District, and Eastern Kern Air
Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve revisions to the Placer County Air Pollution Control
District (PCAPCD), Antelope Valley Air Quality Management District
(AVAQMD), Mariposa County Air Pollution Control District (MCAPCD), and
Eastern Kern Air Pollution Control District (EKAPCD) portions of the
California State Implementation Plan (SIP). These revisions concern
negative declarations for the Control Techniques Guidelines (CTG) for
the Oil and Natural Gas Industry (Oil and Natural Gas CTG). We are
approving the negative declarations into the California SIP.

DATES: This rule will be effective on February 16, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2020-0435. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information. If you need assistance
in a language other than English or if you are a person with
disabilities who needs a reasonable accommodation at no cost to you,
please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section.

FOR FURTHER INFORMATION CONTACT: Sina Schwenk-Mueller, EPA Region IX,
75 Hawthorne St., San Francisco, CA 94105, by phone:<PHONE_NUMBER> or
by email at<EMAIL_ADDRESS>or Rebecca Newhouse, EPA
Region IX, 75 Hawthorne St., San Francisco, CA 94105, by phone: (415)
972-3004 or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Statutory and Executive Order Reviews

I. Proposed Action

    On October 6, 2020 (85 FR 63064), the EPA proposed to approve the
following negative declarations into the CA SIP.

----------------------------------------------------------------------------------------------------------------
                Local agency                            Document title                Adopted        Submitted
----------------------------------------------------------------------------------------------------------------
PCAPCD.....................................  Negative Declaration for the               12/12/19    \1\ 01/23/20
                                              Control Techniques Guidelines for
                                              the Oil and Natural Gas Industry
                                              Source Category.
AVAQMD.....................................  Federal Negative Declaration for           01/21/20    \2\ 05/01/20
                                              Control Techniques Guidelines
                                              (CTG) for the Oil and Natural Gas
                                              Industry Source Category.
MCAPCD.....................................  Negative Declaration for the               03/10/20    \3\ 05/01/20
                                              Control Techniques Guidelines for
                                              the Oil and Natural Gas Industry
                                              Source Category.
EKAPCD.....................................  Reasonably Available Control               05/11/17        08/09/17
                                              Technology (RACT) State
                                              Implementation Plan (SIP) for the
                                              2008 Ozone National Ambient Air
                                              Quality Standards--Negative
                                              Declaration for Oil and Natural
                                              Gas CTG.\4\
----------------------------------------------------------------------------------------------------------------
\1\ This submittal was transmitted to the EPA by a letter from CARB dated January 21, 2020.
\2\ This submittal was transmitted to the EPA by a letter from CARB dated April 30, 2020.
\3\ This submittal was transmitted to the EPA by a letter from CARB dated April 30, 2020.
\4\ The EPA is only acting on the negative declaration for the Oil and Natural Gas CTG in Table 6--CTG
  Categories with No Applicable Source (Negative Declarations) of the EKAPCD RACT SIP Submittal. At this time,
  the EPA is not proposing any action on the remainder of the EKAPCD RACT SIP that was submitted on August 9,
  2017. The EPA will propose a separate action on the remainder of the EKAPCD RACT SIP at a future date.

    We proposed to approve these negative declarations because we
determined that they comply with the relevant CAA requirements. Our
proposed action contains more information on the negative declarations
and our evaluation.

II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period.
During this period, we received no comments.

III. EPA Action

    No comments were submitted. Therefore, as authorized in section
110(k)(3) of the Act, the EPA is fully approving these revisions into
the California SIP.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 3,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described

in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this action 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. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by March 16, 2021. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Volatile organic compounds.

    Dated: December 11, 2020.
John Busterud,
Regional Administrator, Region IX.

    For the reasons stated in the preamble, the Environmental
Protection Agency amends Part 52, chapter I, title 40 of the Code of
Federal Regulations as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--CALIFORNIA

0
2. Section 52.220 is amended by adding paragraphs (c)(503)(ii),
(c)(548), and (c)(549) to read as follows:

Sec.  52.220  Identification of plan-in part.

* * * * *
    (c) * * *
    (503) * * *
    (ii) Additional materials. (A) Eastern Kern Air Pollution Control
District.
    (1) Reasonably Available Control Technology (RACT) State
Implementation Plan (SIP) for the 2008 Ozone National Ambient Air
Quality Standards--Negative Declaration for Oil and Natural Gas CTG
only, as adopted on May 11, 2017.
    (2) [Reserved]
    (B) [Reserved]
* * * * *
    (548) Additional materials were submitted on January 23, 2020 by
the Governor's designee as an attachment to a letter dated January 21,
2020.
    (i) [Reserved]
    (ii) Additional materials. (A) Placer County Air Pollution Control
District.
    (1) Negative Declaration for the Control Techniques Guidelines for
the Oil and Natural Gas Industry Source Category as adopted on December
12, 2019.
    (2) [Reserved]
    (B) [Reserved]
    (549) Additional materials were submitted on May 1, 2020 by the
Governor's designee as an attachment to a letter dated April 30, 2020.
    (i) [Reserved]
    (ii) Additional materials. (A) Antelope Valley Air Quality
Management District.
    (1) Federal Negative Declaration for Control Techniques Guidelines
(CTG) for the Oil and Natural Gas Industry Source Category as adopted
on January 21, 2020
    (2) [Reserved]
    (B) Mariposa County Air Pollution Control District.
    (1) Negative Declaration for the Control Techniques Guidelines for
the Oil and Natural Gas Industry Source Category as adopted on March
10, 2020.
    (2) [Reserved]

0
3. Section 52.222 is amended by adding paragraphs (a)(4)(v),
(a)(6)(xii), and (a)(15) and (16) to read as follows:

Sec.  52.222  Negative declarations.

    (a) * * *
    (4) * * *
    (v) The following negative declaration for the 2008 ozone standard
was adopted by the District on December 12, 2019, and submitted to the
EPA on January 23, 2020, as an attachment to a letter dated January 21,
2020: The Control Techniques Guidelines for the Oil and Natural Gas
Industry (EPA 453/B-16-001).
* * * * *
    (6) * * *
    (xii) The following negative declaration for the 2008 ozone
standard was adopted by the District on January 21, 2020 and submitted
to the EPA on May 1, 2020, as an attachment to a letter dated April 30,
2020: The Control Techniques Guidelines for the Oil and Natural Gas
Industry (EPA 453/B-16-001).
* * * * *
    (15) Mariposa County Air Pollution Control District.
    (i) The following negative declaration for the 2008 ozone standard
was adopted by the District on March 10, 2020, and submitted to the EPA
on May 1, 2020, as an attachment to a letter dated April 30, 2020: The
Control Techniques Guidelines for the Oil and Natural Gas Industry (EPA
453/B-16-001).
    (ii) [Reserved]
    (16) Eastern Kern Air Pollution Control District
    (i) The following negative declaration for the 2008 ozone standard
was adopted by the District on May 11,2017 and submitted to the EPA on
August 9, 2017: The Control Techniques Guidelines for the Oil and
Natural Gas Industry (EPA 453/B-16-001).
    (ii) [Reserved]

[FR Doc. 2020-28018 Filed 1-14-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: February 23, 2006 (Volume 71, Number 36)]
[Notices]
[Page 9392-9394]
[DOCID:fr23fe06-101]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53318; File No. SR-Amex-2006-12]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Establish a Technology Assessment Fee for the Use of Legacy Options
Trading Systems

February 15, 2006.

    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on February 6, 2006, the American Stock Exchange LLC (``Exchange'' or
``Amex'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. Amex has
designated this proposal as one establishing or changing a due, fee, or
other charge imposed by Amex under section 19(b)(3)(A)(ii) of the Act
\3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders the proposed rule
change effective upon filing with the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to adopt a Technology Assessment Fee to be
assessed on its members for the continued use of legacy options trading
systems. The text of the proposed rule change is available on Amex's
Web site (http://www.amex.com), at Amex's principal office, 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
    On May 20, 2004, the Commission approved the Amex's proposal to
implement a new options trading platform known as the Amex New Trading
Environment (the ``ANTE System'' or ``ANTE'').\5\ ANTE is intended to
replace the following legacy options trading systems: the Amex Options
Display Book (AODB), Amex's theoretical price calculator (XTOPS), and
Auto-Ex. On May 25, 2004, the Amex began rolling out the ANTE System on
its trading floor on a specialist's post-by-specialist's post basis. At
that time it was anticipated the roll-out would be completed by the end
of the second quarter of 2005. The implementation date for the full
roll-out of the ANTE System was subsequently extended to June 30,
2006.\6\ Amex has rolled out the ANTE System to all its option classes
except one--the Nasdaq 100 Index options (``NDX''). NDX has the largest
notional value of any option class, with average premiums of $40. The
specialist for this product is concerned that the theoretical price
calculator provided by the ANTE System may not accurately price the
options on this index. The specialist has installed its own theoretical
index price calculator, which currently calculates prices for the
firm's other options products, including the Mini Nasdaq Index (MNX),
an index valued at one-tenth the value of NDX.
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    \5\ See Securities Exchange Act Release No. 49747, 69 FR 30344
(May 27, 2004) (File No. SR-Amex-2003-89).
    \6\ In a separate filing submitted February 6, 2006, for
immediate effectiveness pursuant to Section 19(b)(3)(A)(iii) of the
Act, 15 U.S.C. 78s(b)(3)(A)(iii), the Exchange proposed to extend
the deadline for implementation of ANTE System for all option
classes from December 31, 2005, to June 30, 2006. See File No. SR-
Amex-2006-13, notice of which the Commission is separately
publishing for comment today (Securities Exchange Act Release No.
53319).
---------------------------------------------------------------------------

    The specialist firm continues to resist moving NDX off the legacy
options trading systems and onto the ANTE System as it seeks to gain
experience using its proprietary price calculator. The NDX specialist
is concerned about the magnitude of errors that could occur using a
theoretical price calculator with NDX, given its large notional value
and the size of the underlying index.
    Although the Exchange is mindful of the specialist's concerns,
maintaining two platforms for the trading of options--the legacy
options trading systems and ANTE--is costly for the Exchange.
Therefore, the Exchange is proposing to assess the specialist firm a
fee to cover the Exchange's costs for maintaining its legacy options
trading systems at the Securities Industry Automation Corporation
(``SIAC''). The Exchange currently pays a monthly maintenance fee to
SIAC of $12,000. The proposal will require the specialist firm to
reimburse the Exchange for these maintenance costs until it transitions
all of its options classes to the ANTE System.\7\
---------------------------------------------------------------------------

    \7\ The Exchange expects that the NDX specialist will move NDX
onto the ANTE System by June 30, 2006, the new deadline for
implementation of the ANTE System. See supra note 6.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b) of the Act \8\ in general and furthers the objectives
of section 6(b)(4) \9\ in particular in that it is intended to provide
for the equitable allocation of reasonable dues, fees, and other
charges among its members and issuers and other persons using its
facilities. Specifically, the Exchange is proposing to assess the one
member organization continuing to use its legacy options trading
systems in order to recover its costs for maintaining these systems.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

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

    The foregoing proposed rule change has become effective pursuant to
section 19(b)(3)(A) of the Act \10\ and Rule 19b-4(f)(2) \11\
thereunder because it establishes or changes a due, fee, or other
charge imposed by the Exchange. 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.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-Amex-2006-12 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-Amex-2006-12. 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. Copies of such filing also will be available for inspection and
copying at the principal office of the Amex. 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-Amex-2006-12 and should be submitted on
or before March 16, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
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J. Lynn Taylor,
Assistant Secretary.
 [FR Doc. E6-2521 Filed 2-22-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 158 (Friday, August 14, 2020)]
[Notices]
[Pages 49657-49660]
[FR Doc No: 2020-17876]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1677]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Recordkeeping and Reporting Requirements for Human
Food and Cosmetics Manufactured From, Processed With, or Otherwise
Containing Material From Cattle

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of existing FDA regulations concerning FDA-regulated human
food, including dietary supplements, and cosmetics manufactured from,
processed with, or otherwise containing material derived from cattle.

DATES: Submit either electronic or written comments on the collection
of information by October 13, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 13, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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 No.
FDA-2020-N-1677 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Recordkeeping and Reporting
Requirements for Human Food and Cosmetics Manufactured From, Processed
With, or Otherwise Containing Material From Cattle.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Recordkeeping and Reporting Requirements for Human Food and Cosmetics
Manufactured From, Processed With, or Otherwise Containing Material
from Cattle--21 CFR 189.5 and 700.27

OMB Control Number 0910-0623--Extension

    FDA's regulations in Sec. Sec.  189.5 and 700.27 (21 CFR 189.5 and
700.27) set forth bovine spongiform encephalopathy (BSE)-related
restrictions applicable to FDA-regulated human food and cosmetics. The
regulations designate certain materials from cattle as ``prohibited
cattle materials,'' including specified risk materials (SRMs), the
small intestine of cattle not otherwise excluded from being a
prohibited cattle material, material from nonambulatory disabled
cattle, and mechanically separated (MS) beef. Sections 189.5(c) and
700.27(c) set forth the requirements for recordkeeping and records
access for FDA-regulated human food, including dietary supplements, and
cosmetics manufactured from, processed with, or otherwise containing
material derived from cattle. We issued these recordkeeping regulations
under the adulteration provisions in sections 402(a)(2)(C), (a)(3),
(a)(4), (a)(5), 601(c), and 701(a) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 342(a)(2)(C), (a)(3), (a)(4),
(a)(5), 361(c), and 371(a)). Under section 701(a) of the FD&C Act, we
are authorized to issue regulations for the FD&C Act's efficient

enforcement. With regard to records concerning imported human food and
cosmetics, we relied on our authority under sections 701(b) and 801(a)
of the FD&C Act (21 U.S.C. 371(b) and 381(a)). Section 801(a) of the
FD&C Act provides requirements with regard to imported human food and
cosmetics and provides for refusal of admission of human food and
cosmetics that appear to be adulterated into the United States. Section
701(b) of the FD&C Act authorizes the Secretaries of Treasury and
Health and Human Services to jointly prescribe regulations for the
efficient enforcement of section 801 of the FD&C Act.
    These requirements are necessary because once materials are
separated from an animal it may not be possible, without records, to
know the following: (1) Whether cattle material may contain SRMs
(brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the transverse processes of the
thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal
root ganglia from animals 30 months and older and tonsils and distal
ileum of the small intestine from all animals of all ages); (2) whether
the source animal for cattle material was inspected and passed; (3)
whether the source animal for cattle material was nonambulatory
disabled, or MS beef; and (4) whether tallow in human food or cosmetics
contain less than 0.15 percent insoluble impurities.
    FDA's regulations in Sec. Sec.  189.5(c) and 700.27(c) require
manufacturers and processors of human food and cosmetics manufactured
from, processed with, or otherwise containing material from cattle
establish and maintain records sufficient to demonstrate that the human
food or cosmetics are not manufactured from, processed with, or
otherwise contain prohibited cattle materials. These records must be
retained for 2 years at the manufacturing or processing establishment
or at a reasonably accessible location. Maintenance of electronic
records is acceptable, and electronic records are considered to be
reasonably accessible if they are accessible from an onsite location.
Records required by these sections and existing records relevant to
compliance with these sections must be available to FDA for inspection
and copying. Existing records may be used if they contain all of the
required information and are retained for the required time period.
    Because we do not easily have access to records maintained at
foreign establishments, FDA regulations in Sec. Sec.  189.5(c)(6) and
700.27(c)(6), respectively, require that when filing for entry with
U.S. Customs and Border Protection, the importer of record of human
food or cosmetics manufactured from, processed with, or otherwise
containing, cattle material must affirm that the human food or
cosmetics were manufactured from, processed with, or otherwise
contains, cattle material and must affirm that the human food or
cosmetics were manufactured in accordance with the applicable
requirements of Sec. Sec.  189.5 or 700.27. In addition, if human food
or cosmetics were manufactured from, processed with, or otherwise
contains cattle material, the importer of record must provide within 5
business days records sufficient to demonstrate that the human food or
cosmetics were not manufactured from, processed with, or otherwise
contains prohibited cattle material, if requested.
    Under FDA's regulations, we may designate a country from which
cattle materials inspected and passed for human consumption are not
considered prohibited cattle materials, and their use does not render
human food or cosmetics adulterated. Sections 189.5(e) and 700.27(e)
provide that a country seeking to be designated must send a written
request to the Director of the Center for Food Safety and Applied
Nutrition. The information the country is required to submit includes
information about a country's BSE case history, risk factors, measures
to prevent the introduction and transmission of BSE, and any other
information relevant to determining whether SRMs, the small intestine
of cattle not otherwise excluded from being a prohibited cattle
material, material from nonambulatory disabled cattle, or MS beef from
the country seeking designation should be considered prohibited cattle
materials. We use the information to determine whether to grant a
request for designation and to impose conditions if a request is
granted.
    Sections 189.5 and 700.27 further state that countries designated
under Sec. Sec.  189.5(e) and 700.27(e) will be subject to future
review by FDA to determine whether their designations remain
appropriate. As part of this process, we may ask designated countries
to confirm their BSE situation and the information submitted by them,
in support of their original application, has remained unchanged. We
may revoke a country's designation if we determine that it is no longer
appropriate. Therefore, designated countries may respond to periodic
FDA requests by submitting information to confirm their designations
remain appropriate. We use the information to ensure their designations
remain appropriate.
    Description of Respondents: Respondents to this information
collection include manufacturers, processors, and importers of FDA-
regulated human food, including dietary supplements, and cosmetics
manufactured from, processed with, or otherwise containing material
derived from cattle, as well as, with regard to Sec. Sec.  189.5(e) and
700.27(e), foreign governments seeking designation under those
regulations.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
            21 CFR section; activity                Number of     responses per   Total annual         Average burden per response          Total hours
                                                   respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
189.5(c)(6) and 700.27(c)(6); affirmation of             54,825               1          54,825  0.033 (2 minutes)......................           1,809
 compliance.
189.5(e) and 700.27(e); request for designation               1               1               1  80.....................................              80
189.5(e) and 700.27(e); response to request for               1               1               1  26.....................................              26
 review by FDA.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................           1,915
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
             Type of  respondent                 Number of      records per    Total annual         Average burden per recordkeeper         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Domestic facilities.........................             697              52          36,244  0.25 (15 minutes).........................           9,061
Foreign facilities..........................             916              52          47,632  0.25 (15 minutes).........................          11,908
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          20,969
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: August 10, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17876 Filed 8-13-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44176-44177]
[FR Doc No: 2015-18130]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75492; File No. SR-C2-2015-019]

Self-Regulatory Organizations; C2 Options Exchange, Incorporated;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to the Options Regulatory Fee

July 20, 2015.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of
1934,\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that on
July 10, 2015, C2 Options Exchange, Incorporated (the ``Exchange'' or
``C2'') 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend the Options Regulatory Fee. The text
of the proposed rule change is available on the Exchange's Web site
(http://www.c2exchange.com/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 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 increase the Options Regulatory Fee
(``ORF'') from $.0002 to $.0051 per contract in order to help offset
increased regulatory costs. The proposed fee change would be operative
on August 1, 2015.
    The ORF is assessed by the Exchange to each Permit Holder for all
options transactions executed or cleared by the Permit Holder that are
cleared by The Options Clearing Corporation (``OCC'') in the customer
range (i.e., transactions that clear in a customer account at OCC)
regardless of the exchange on which the transaction occurs. In other
words, the Exchange imposes the ORF on all customer-range transactions
executed by a Permit Holder, even if the transactions do not take place
on the Exchange. The ORF also is charged for transactions that are not
executed by a Permit Holder but are ultimately cleared by a Permit
Holder. In the case where a Permit Holder executes a transaction and a
different Permit Holder clears the transaction, the ORF is assessed to
the Permit Holder who executed the transaction. In the case where a
non-Permit Holder executes a transaction and a Permit Holder clears the
transaction, the ORF is assessed to the Permit Holder who clears the
transaction. The ORF is collected indirectly from Permit Holders
through their clearing firms by OCC on behalf of the Exchange.
    The ORF is designed to recover a material portion of the costs to
the Exchange of the supervision and regulation of Permit Holder
customer options business, including performing routine surveillances,
investigations, examinations, financial monitoring, as well as policy,
rulemaking, interpretive and enforcement activities. The Exchange
believes that revenue generated from the ORF, when combined with all of
the Exchange's other regulatory fees and fines, will cover a material
portion, but not all, of the Exchange's regulatory costs. The Exchange
notes that its regulatory responsibilities with respect to Permit
Holder compliance with options sales practice rules have largely been
allocated to FINRA under a 17d-2 agreement. The ORF is not designed to
cover the cost of that options sales practice regulation.
    The Exchange will continue to monitor the amount of revenue
collected from the ORF to ensure that it, in combination with its other
regulatory fees and fines, does not exceed the Exchange's total
regulatory costs. The Exchange monitors its regulatory costs and
revenues at a minimum on a semi-annual basis. If the Exchange
determines regulatory revenues exceed or are insufficient to cover a
material portion of its regulatory costs, the Exchange will adjust the
ORF by submitting a fee change filing to the Commission. The Exchange
notifies Permit Holders of adjustments to the ORF via regulatory
circular. The Exchange endeavors to provide Permit Holders with such
notice at least 30 calendar days prior to the effective date of the
change.
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.\3\ Specifically, the
Exchange believes the proposed rule change is consistent with section
6(b)(4) of the Act,\4\ which provides that Exchange rules may provide
for the equitable allocation of reasonable dues, fees, and other
charges among its Permit Holders and other persons using its
facilities. Additionally, the Exchange believes the proposed rule
change is consistent with the section 6(b)(5) \5\ requirement that the
rules of an exchange not be designed to permit unfair discrimination
between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4).
    \5\ Id.
---------------------------------------------------------------------------

    The Exchange believes the proposed fee change is reasonable because
it would help the Exchange offset increased regulatory costs but would
not result in total regulatory revenue exceeding total regulatory
costs. Moreover, the Exchange believes the ORF ensures fairness by
assessing

higher fees to those Permit Holders that require more Exchange
regulatory services based on the amount of customer options business
they conduct. Regulating customer trading activity is much more labor
intensive and requires greater expenditure of human and technical
resources than regulating non-customer trading activity, which tends to
be more automated and less labor-intensive. As a result, the costs
associated with administering the customer component of the Exchange's
overall regulatory program are materially higher than the costs
associated with administering the non-customer component (e.g., Permit
Holder proprietary transactions) of its regulatory program.\6\ The
Exchange believes the proposed fee change is equitable and not unfairly
discriminatory in that it is charged to all Permit Holders on all their
transactions that clear in the customer range at the OCC.
---------------------------------------------------------------------------

    \6\ If the Exchange changes its method of funding regulation or
if circumstances otherwise change in the future, the Exchange may
decide to modify the ORF or assess a separate regulatory fee on
Permit Holder proprietary transactions if the Exchange deems it
advisable.
---------------------------------------------------------------------------

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

    C2 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, because it applies to all
Permit Holders. The proposed ORF is comparable to fees charged by other
options exchanges for the same or similar service. The Exchange
believes any burden on competition imposed by the proposed rule change
is outweighed by the need to help the Exchange adequately fund its
regulatory activities to ensure compliance with the Exchange 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
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 \7\ and paragraph (f) of Rule 19b-4 \8\
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.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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-C2-2015-019 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-C2-2015-019. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-C2-2015-019 and should be
submitted on or before August 14, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-18130 Filed 7-23-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: May 11, 2006 (Volume 71, Number 91)]
[Notices]
[Page 27489-27490]
[DOCID:fr11my06-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

May 5, 2006.
    Take notice that the Commission received the following electric
rate filings:
    Docket Number: ER01-1418-005; ER02-1238-006; ER01-2928-008; ER01-
1419-005; ER01-1310-006; ER03-398-006.
    Applicants: Effingham County Power, LLC; MPG Generating, LLC;
Progress Ventures, Inc.; Rowan County Power, LLC; Walton County Power,
LLC; Washington County Power, LLC.
    Description: Progress Energy Service Co on behalf of Effingham
County Power, LLC et al. submits revisions to the market-based rate
tariffs of the Progress Affiliates.
    Filed Date: April 28, 2006.
    Accession Number: 20060503-0155.
    Comment Date: 5 p.m. Eastern Time on Friday, May 19, 2006.

    Docket Numbers: ER02-2551-003.
    Applicants: Cargill Power Markets, LLC.
    Description: Cargill Power Markets, LLC submits a revision to its
triennial market power analysis filed February 28, 2006 and a revised
page to its market-based rate wholesale power sale tariff, Original
Rate Schedule FERC No. 1.
    Filed Date: April 25, 2006.
    Accession Number: 20060428-0379.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 16, 2006.

    Docket Numbers: ER03-1341-003.
    Applicants: Michigan Electric Transmission Co., LLC.
    Description: Michigan Electric Transmission Company, LLC submits
schedules showing its actual weighted average cost of long-term debt
for the calendar year 2005 and actual average capital structure for
2005.
    Filed Date: April 28, 2006.
    Accession Number: 20060503-0154.
    Comment Date: 5 p.m. Eastern Time on Friday, May 19, 2006.

    Docket Numbers: ER06-18-003.
    Applicants: Midwest Independent Transmission System Operator, Inc.

     Midwest Independent Transmission System Operator, Inc submits
Second Substitute Original Sheet No. 1849 to FERC Electric Tariff,
    Third Revised Volume No. 1.Filed Date: April 28, 2006.
    Accession Number: 20060501-0366.
    Comment Date: 5 p.m. Eastern Time on Friday, May 19, 2006.

    Docket Numbers: ER06-439-001.
    Applicants: Otter Tail Corporation.
    Description: Otter Tail Power Co submits a filing in compliance
with letter order dated February 24, 2006.
    Filed Date: April 25, 2006.
    Accession Number: 20060501-0339.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 16, 2006.

    Docket Numbers: ER06-538-002.
    Applicants: Llano Estacado Wind, LP.
    Description: Llano Estacado Wind, LP submits a tariff amendment to
the Second Substitute Original Sheet 1 designated as FERC Electric
Tariff, First Revised Volume 1 under ER06-538.
    Filed Date: April 25, 2006.
    Accession Number: 20060428-0119.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 16, 2006.

    Docket Numbers: ER06-549-001.
    Applicants: Wheelabrator Ridge Energy Inc.
    Description: Wheelabrator Ridge Energy Inc submits revised tariff
sheets and additional information regarding the notice of succession
filed on January 25, 2006 under ER06-549.
    Filed Date: April 28, 2006.
    Accession Number: 20060501-0368.
    Comment Date: 5 p.m. Eastern Time on Friday, May 19, 2006.

    Docket Numbers: ER06-557-001.
    Applicants: EL Paso Electric Company.
    Description: El Paso Electric Co responds to FERC's March 23, 2006
request for additional information re its January 27, 2006 filing of a
Power Purchase and Sale Agreement.
    Filed Date: April 20, 2006.
    Accession Number: 20060427-0133.
    Comment Date: 5 p.m. Eastern Time on Thursday, May 11, 2006.

    Docket Numbers: ER06-619-002; ER96-110-019; ER99-2774-011; ER03-
956-008; ER03-185-006; ER03-17-006; ER01-545-008; ER00-1783-008; ER02-
795-006; ER96-2504-013; ER05-1367-002; ER05-1368-002; ER05-1369-003;
ER00-826-005; ER00-828-005; ER98-421-016; ER98-4055-013; ER01-1337-008;
ER02-177-009; ER03-1212-007.
    Applicants: Duke Power Company LLC; Duke Energy Trading and
Marketing, L.L.C.; Duke Energy Marketing America, LLC; Duke Energy
Fayette, LLC; Duke Energy Hanging Rock, LLC; Duke Energy Lee, LLC; Duke
Energy Vermillion, LLC; Duke Energy Washington, LLC; Cincinnati Gas &
Electric Co.; PSI Energy, Inc.; Union Light Heat & Power Company,
Cinergy Marketing & Trading, LP; Brownsville Power I, L.L.C.; Caledonia
Power I, L.L.C.; CinCap IV, LLC; CinCap V, LLC; Cinergy Capital &
Trading, Inc.; Cinergy Power Investments, Inc.; St. Paul Cogeneration,
LLC.
    Description: Duke Power Company, LLC et al. submits Substitute
Original Sheet 6 et al to FERC Electric Tariff, Third Revised Volume
No. 3.
    Filed Date: April 18, 2006.
    Accession Number: 20060426-0255.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 9, 2006.

    Docket Numbers: ER06-669-001.
    Applicants: TME Energy Services.
    Description: TME Energy Services submits revised FERC Electric Rate
Schedule No. 1.
    Filed Date: April 26, 2006.
    Accession Number: 20060503-0153.
    Comment Date: 5 p.m. Eastern Time on Wednesday, May 17, 2006.

    Docket Numbers: ER06-895-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Co submits revised rate schedule sheets
pursuant to section 205 of the Federal Power Act.
    Filed Date: April 28, 2006.
    Accession Number: 20060501-0340.
    Comment Date: 5 p.m. Eastern Time on Friday, May 19, 2006.

    Docket Numbers: ER06-896-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Puget Sound Energy, Inc submits an interconnection and
parallel operations agreement with Public Utility District No. 1 of
Chelan County, Washington.
    Filed Date: April 28, 2006.
    Accession Number: 20060501-0380.
    Comment Date: 5 p.m. Eastern Time on Friday, May 19, 2006.

    Docket Numbers: ER06-897-000.
    Applicants: Texas-New Mexico Power Company.
    Description: Texas-New Mexico Power Co submits an executed service
agreement between TNMP and Tri-State Generation & Transmission
Association Inc under PNM Resources OATT, effective April 1, 2006.
    Filed Date: April 28, 2006.
    Accession Number: 20060501-0381.
    Comment Date: 5 p.m. Eastern Time on Friday, May 19, 2006.

    Docket Numbers: ER06-898-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Co submits revised rate schedule sheets
for its agreement to provide qualifying facility transmission service
w/ Mosaic Fertilizer, LLC et al.
    Filed Date: April 28, 2006.
    Accession Number: 20060501-0382.
    Comment Date: 5 p.m. Eastern Time on Friday, May 19, 2006.

    Docket Numbers: ER06-899-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Co submits Fifth Revised Sheet Nos. 70
and 71 to First Revised Schedule 62, effective May 1, 2006.

    Filed Date: April 28, 2006.
    Accession Number: 20060501-0383.
    Comment Date: 5 p.m. Eastern Time on Friday, May 19, 2006.

    Docket Numbers: ER06-901-001.
    Applicants: DeGreeff DP, LLC.
    Description: DeGreeff DP, LLC submits a notice of non-material
change in status in compliance with the reporting requirements of Order
652.
    Filed Date: April 25, 2006.
    Accession Number: 20060501-0373.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 16, 2006.

    Docket Numbers: ER97-2846-009.
    Applicants: Florida Power Corporation.
    Description: Florida Power Corp dba Progress Energy Florida Inc
notifies FERC that they have entered into a contract effective March
17, 2006 for the purchase of capacity from Reliant Energy.
    Filed Date: April 25, 2006.
    Accession Number: 20060501-0384.
    Comment Date: 5 p.m. Eastern Time on Tuesday, May 16, 2006.

    Docket Numbers: ER98-1643-009.
    Applicants: Portland General Electric Company.
    Description: Portland General Electric Co submits notice of change
in status.
    Filed Date: April 28, 2006.
    Accession Number: 20060503-0152.
    Comment Date: 5 p.m. Eastern Time on Friday, May 19, 2006.

    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 dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-7202 Filed 5-10-06; 8:45 am]

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 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
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REGION 8
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1595 Wynkoop Street
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Denver, CO  80202-1129
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Phone<PHONE_NUMBER>
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www.epa.gov/region8
Ref: 8ARD-PM

Mr. Danny Powers
Air Quality Program Manager
Southern Ute Indian Tribe Environmental Programs
P.O. Box 737, Mail Slot #84
Ignacio, Colorado  81137-0737
Via email<EMAIL_ADDRESS>
Re:	Red Cedar Gathering Company, South Ignacio Central Delivery Point,
Permit #SMNSR-SU-000031-2019.004, Proposed Synthetic Minor New Source Review Permit

Dear Mr. Powers:

The U.S. Environmental Protection Agency Region 8 is proposing to issue a revised synthetic minor New Source Review (MNSR) permit for the existing Red Cedar Gathering Company (Red Cedar), South Ignacio Central Delivery Point (South Ignacio CDP) on the Southern Ute Indian Reservation. As requested by Red Cedar, this permit would incorporate several changes. First, it would reflect the removal of facility-wide Hazardous Air pollutant (HAP) and formaldehyde (CH2O) emission limits. Second, it would remove benzene emissions limits for the dehydration units. Third, it would correct the listed site horsepower (hp) rating and remove the CH2O emissions limit for the rich-burn compressor engine and remove the carbon monoxide (CO) and CH2O emissions limitations for each of the seven lean-burn engines. As a result of the requested changes, the four-stroke rich-burn reciprocating internal combustion engine (4SRB RICE) will now be subject to the compliance requirements of 40 CFR part 63, subpart ZZZZ (new, greater than 500 hp, 4SRB RICE, located at a major source of HAP). To better align compliance requirements with subpart ZZZZ, we are proposing to replace the quarterly nitrogen oxides (NOX) and CO monitoring requirements with semiannual NOX and CO performance test requirements. The monitoring frequency of the pressure drop across the catalyst bed would also be changed from once every seven days to once every 30 days.

A public comment period for the proposed permit will begin on June 19, 2020, and end on July 20, 2020.

The proposed permit and supporting documentation are available in the electronic docket at Regulations.gov (Docket ID #EPA-R08-OAR-2019-0290), and we ask that you please assist members of the public who contact you with instructions on how to access the material available for public review until the end of the public comment period. Comments may be submitted via mail, via email to<EMAIL_ADDRESS>or through https://www.regulations.gov (Docket ID #EPA-R08-OAR-2019-0290). In addition, we have provided copies of the bulletin board public notice announcement and would appreciate it if you could post this announcement in prominent locations in your area. All of these documents will also be available for review in electronic format on our website at: https://www.epa.gov/caa-permitting/caa-permit public-comment-opportunities-region-8.

If you have any questions concerning the enclosed proposed permit or technical support documents, please contact Suman Kunwar, of my staff, at<PHONE_NUMBER>.

                                       Sincerely,

                                      Carl Daly
                                      Acting Director
                                      Air and Radiation Division

Enclosures


[Federal Register Volume 82, Number 77 (Monday, April 24, 2017)]
[Notices]
[Pages 18913-18914]
[FR Doc No: 2017-08199]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidance for Naloxone Hydrochloride; New Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a new draft guidance for industry on
generic naloxone hydrochloride nasal spray entitled ``Draft Guidance on
Naloxone Hydrochloride.'' The new draft guidance, when finalized, will
provide product-specific recommendations on, among other things, the
design of bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for naloxone hydrochloride nasal spray.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final versions of the
guidance, submit either electronic or written comments on the draft
guidances by June 23, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 No.
FDA-2007-D-0369 for ``Draft Guidance on Naloxone Hydrochloride.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://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 https://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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific
guidances available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process to develop
and disseminate product-specific guidances and to provide a meaningful
opportunity for the public to consider and comment on the guidances.
This notice announces the availability of a new draft guidance for
generic naloxone hydrochloride nasal spray.
    FDA initially approved new drug application 208411 for NARCAN
(naloxone hydrochloride) nasal spray in November 2015. We are now
issuing a new draft guidance for industry on generic naloxone
hydrochloride nasal spray (``Draft Guidance on Naloxone
Hydrochloride'').
    In November 2016, Adapt Pharma Operations Limited (APOL),
manufacturer of the reference listed drug NARCAN nasal spray, submitted
a citizen petition requesting that FDA refrain from approving any ANDA
referencing NARCAN nasal spray unless certain conditions are satisfied,
including conditions related to demonstrating BE. FDA has reviewed the
issues raised in the citizen petition and is responding to it
separately in the docket for that citizen petition (Docket No. FDA-
2016-P-4094, available at https://www.regulations.gov).\1\
---------------------------------------------------------------------------

    \1\ On January 31, 2017, Mucodel Pharma LLC (Mucodel) submitted
a citizen petition requesting that FDA ``refrain from approving any
[intranasal] naloxone drug application (whether an NDA or ANDA) for
the emergency treatment of a known or suspected opioid overdose
until the FDA considers whether such application adequately
addresses the reliability of [intranasal] naloxone in actual field
use.'' (Docket No. FDA-2017-P-0663). This petition remains under
review and FDA's issuance of the naloxone hydrochloride nasal spray
product-specific guidance and its response to the citizen petition
from APOL are not intended in any way to address the merits of the
Mucodel citizen petition.
---------------------------------------------------------------------------

    The new draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The new draft guidance,
when finalized, will represent the current thinking of FDA on the
design of BE studies to support ANDAs for naloxone hydrochloride nasal
spray. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

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

    Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08199 Filed 4-21-17; 8:45 am]
 BILLING CODE 4164-01-P