[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Pages 27221-27222]
[FR Doc No: 2012-11168]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

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

    Docket Numbers: ER12-1695-000.
    Applicants: Liberty Electric Power, LLC.
    Description: Compliance to be effective 5/3/2012.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5080.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-1696-000.
    Applicants: Michigan Electric Transmission Company.
    Description: Filing of Certificate of Concurrence to be effective
4/27/2012.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5088.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-1697-000.
    Applicants: Louisville Gas and Electric Company.
    Description: Att M LGIA LGIP Rev to be effective 5/3/2012.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5089.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-1698-000.
    Applicants: New Mexico Renewable Energy Transmission Authority,
Power Network New Mexico, LLC.
    Description: Application for Authorization to Sell Transmission
Rights at Negotiated Rates, Approval of Capacity Allocation, and
Request for Waivers of Power Network New Mexico, LLC, et al.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5101.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-1699-000.
    Applicants: Public Service Company of New Mexico, Power Network New
Mexico, LLC, New Mexico Renewable Energy Transmission Authority.
    Description: Request for Limited Waiver of Public Service Company
of New Mexico, et al.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5106.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-1700-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Amendments to Schedule 12--Appendix re RTEP approved
by PJM Board April 2, 2012 to be effective 7/31/2012.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5115.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-1701-000.
    Applicants: PacifiCorp.
    Description: WAPA NITSA Rev 4 to be effective 5/1/2012.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5140.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-1702-000.
    Applicants: Sunoco Power Marketing, LLC.
    Description: Baseline Tariff Filing to be effective 7/2/2012.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5142.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-1703-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Electric Transmission Reassignment (delete cap) to be
effective 4/25/2012.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5159.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-1704-000.
    Applicants: San Diego Gas & Electric Company.
    Description: San Diego Gas & Electric Company's Annual Filing of
Revised Costs and Accruals for Post-Employment Benefits Other than
Pensions (``PBOP'').
    Filed Date: 5/2/12.
    Accession Number: 20120502-5160.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-1705-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Revisions to the OATT & OA re the elimination of LMP-
G&T to be effective 7/1/2012.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5165.
    Comments Due: 5 p.m. ET 5/23/12.

    Docket Numbers: ER12-652-001.
    Applicants: EWO Marketing, LLC.
    Description: EWOM Cmpl ER12-652 to be effective 11/30/2011.
    Filed Date: 5/2/12.
    Accession Number: 20120502-5164.
    Comments Due: 5 p.m. ET 5/23/12.

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

    Docket Numbers: ES11-30-002.
    Applicants: System Energy Resources, Inc.
    Description: System Energy Resources, Inc. submits request to amend
the November 11, 2011 order under ES11-30.
    Filed Date: 5/1/12.
    Accession Number: 20120501-5458.
    Comments Due: 5 p.m. ET 5/22/12.

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

    Dated: May 2, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-11168 Filed 5-8-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 166 (Tuesday, August 29, 2017)]
[Notices]
[Pages 41079-41080]
[FR Doc No: 2017-18241]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81468; File No. SR-BatsEDGX-2017-29]

Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice
of Designation of Longer Period for Commission Action on Proposed Rule
Change To Adopt New Rules That Describe the Trading of Complex Orders
on the Exchange

August 23, 2017.
    On June 30, 2017, Bats EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to adopt new rules that describe the trading of
complex orders on the Exchange's equity options platform. The proposed
rule change was published for comment in the Federal Register on July
19, 2017.\3\ The Commission has received no comment letters regarding
the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 81137 (July 13,
2017), 82 FR 33170.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day for this filing is September 2, 2017.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider and
take action on the Exchange's proposed rule change.
    Accordingly, pursuant to Section 19(b)(2) of the Act \5\ and for
the reasons stated above, the Commission designates October 17, 2017,
as the date by which the Commission should either approve or
disapprove, or institute proceedings to determine whether to

disapprove, the proposed rule change (File No. SR-BatsEDGX-2017-29).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-18241 Filed 8-28-17; 8:45 am]
 BILLING CODE 8011-01-P


SAFE PESTICIDES/SAFE PRODUCTS (SP2) SUBCOMMITTEE

MEETING AGENDA

April 25, 2007

3:00 pm – 5:00 pm Eastern Time

CONFERENCE CALL

Participation by Teleconference Only

866-299-3188

code:<PHONE_NUMBER>#

3:00-3:15 pm	Welcome	Dr. Anna Harding,

	- Roll call	Subcommittee Chair

	- Overview of Progress

3:15-3:20 pm	Administrative Procedures	Lorelei Kowalski

BOSC Executive Committee DFO

3:20-3:25 pm 	Public Comment

3:25-5:00 pm	Subcommittee Discussion	Dr. Anna Harding

	- Summary of Draft Report Progress	Subcommittee Chair

	- Draft Report Discussion

	- Draft Report Next Steps and Schedule

5:00 pm	Adjourn

            A Federal Advisory Committee for the U.S. Environmental Protection Agency’s Office of Research and Development


[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Page 86329]
[FR Doc No: 2023-27329]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER24-541-000]

Kiowa County Solar Project, 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
Kiowa County Solar Project, 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 December 27, 2023.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TTY,<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: December 7, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-27329 Filed 12-12-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 98 (Wednesday, May 21, 2014)]
[Notices]
[Pages 29264-29265]
[FR Doc No: 2014-11666]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2014-0053]

Technical Report Evaluating Fatality Reduction by Electronic
Stability Control

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Request for comments on technical report.

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

SUMMARY: This notice announces NHTSA's publication of a technical
report evaluating the fatality-reducing effectiveness of electronic
stability control for passenger cars and LTVs. The report's title is:
Updated Estimates of Fatality Reduction by Electronic Stability
Control.

DATES: Comments must be received no later than September 18, 2014.

ADDRESSES:
    Report: The technical report is available on the Internet for
viewing in PDF format at http://www-nrd.nhtsa.dot.gov/Pubs/812020.pdf.
You may obtain a copy of the report free of charge by sending a self-
addressed mailing label to Nathan K. Greenwell (NVS-431), National
Highway Traffic Safety Administration, Room W53-312, 1200 New Jersey
Avenue SE., Washington, DC 20590.
    Comments: You may submit comments [identified by Docket Number
NHTSA-2014-0053] by any of the following methods:
     Internet: To submit comments electronically, go to the
U.S. Government regulations Web site at http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: Written comments may be faxed to<PHONE_NUMBER>.
     Mail: Send comments to Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue SE., West Building
Ground Floor, Room W12-140, Washington, DC 20590.
     Hand Delivery: If you plan to submit written comments by
hand or courier, please do so at 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC between 9 a.m. and
5 p.m. Eastern Time, Monday through Friday, except federal holidays.
     You may call Docket Management at 1-800-647-5527.
    Instructions: For detailed instructions on submitting comments and
additional information see the Comments heading of the SUPPLEMENTARY
INFORMATION section of this document. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the Privacy Act heading
in the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Nathan K. Greenwell, Mathematical
Statistician, Evaluation Division, NVS-431, National Center for
Statistics and Analysis, National Highway Traffic Safety
Administration, Room W53-312, 1200 New Jersey Avenue SE., Washington,
DC 20590. Telephone:<PHONE_NUMBER>. Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Electronic stability control (ESC) systems
use automatic computer-controlled braking of individual wheels to
assist the driver in maintaining control in critical driving
situations. Federal Motor Vehicle Safety Standard No. 126 has required
ESC on all new passenger cars, multipurpose passenger vehicles, trucks,
and buses with a GVWR of 10,000 pounds or less: 100 Percent of new
vehicles since September 1, 2011 (72 FR 17236). NHTSA issued
statistical evaluations of ESC in 2004, 2007, and 2011, based on the
most recent crash data available at the time (72 FR 41582, 76 FR
49532), which showed statistically significant reductions of fatal
rollovers and impacts with fixed objects. The technical report updates
the analyses with Fatal Accident Reporting System data through calendar
year 2011. The analyses show the following statistically significant
reductions of fatal crash involvements. Fatal first-event rollovers are
reduced by 60 percent in cars and by 74 percent in LTVs. Other fatal
single-vehicle crashes (excluding collisions with pedestrians or
bicyclists) are reduced by 31 percent in cars and 45 percent in LTVs.
Involvements as the culpable vehicle in fatal multi-vehicle crashes are
reduced by 16 percent in cars and LTVs.

Comments

How can I influence NHTSA's thinking on this subject?

    NHTSA welcomes public review of the technical report. NHTSA will
submit to the Docket a response to the comments and, if appropriate,
will supplement or revise the report.

How do I prepare and submit comments?

    Your comments must be written and in English. To ensure that your
comments are correctly filed in the Docket, please include the Docket
number of this document (NHTSA-2014-0053) in your comments.
    Your primary comments must not be more than 15 pages long (49 CFR
553.21). However, you may attach additional documents to your primary
comments. There is no limit on the length of the attachments.
    Please submit one copy of your comments, including the attachments,
to Docket Management at the address given above under ADDRESSES.
    Please note that pursuant to the Data Quality Act, in order for
substantive data to be relied upon and used by the agency, it must meet
the information quality standards set forth in the OMB and DOT Data
Quality Act guidelines. Accordingly, we encourage you to consult the
guidelines in preparing your comments. OMB's guidelines may be accessed
at http://www.whitehouse.gov/omb/fedreg_reproducible. DOT's guidelines
may be accessed at http://www.rita.dot.gov/bts/sites/rita.dot.gov.bts/files/subject_areas/statistical_policy_and_research/data_quality_guidelines/index.html.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://www.regulations.gov.

How can I be sure that my comments were received?

    If you wish Docket Management to notify you upon its receipt of
your comments, enclose a self-addressed,

stamped postcard in the envelope containing your comments. Upon
receiving your comments, Docket Management will return the postcard by
mail. You may also periodically access http://www.regulations.gov and
enter the number for this docket (NHTSA-2014-0053) to see if your
comments are on line.

How do I submit confidential business information?

    If you wish to submit any information under a claim of
confidentiality, you should submit three copies of your complete
submission, including the information you claim to be confidential
business information, to the Chief Counsel, NHTSA, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590. In
addition, you should submit a copy, from which you have deleted the
claimed confidential business information, to Docket Management at the
address given above under ADDRESSES. When you send a comment containing
information claimed to be confidential business information, you should
include a cover letter setting forth the information specified in our
confidential business information regulation. (49 CFR Part 512.)

Will the agency consider late comments?

    In our response, we will consider all comments that Docket
Management receives before the close of business on the comment closing
date indicated above under DATES. To the extent possible, we will also
consider comments that Docket Management receives after that date.

How can I read the comments submitted by other people?

    You may read the comments received by Docket Management at the
address given above under ADDRESSES. The hours of the Docket are
indicated above in the same location.
    You may also see the comments on the Internet. To read the comments
on the Internet, take the following steps:
    (1) Go to the Federal Docket Management System (FDMS) at http://www.regulations.gov.
    (2) FDMS provides two basic methods of searching to retrieve
dockets and docket materials that are available in the system: (a)
``Quick Search'' to search using a full-text search engine, or (b)
``Advanced Search,'' which displays various indexed fields such as the
docket name, docket identification number, phase of the action,
initiating office, date of issuance, document title, document
identification number, type of document, Federal Register reference,
CFR citation, etc. Each data field in the advanced search may be
searched independently or in combination with other fields, as desired.
Each search yields a simultaneous display of all available information
found in FDMS that is relevant to the requested subject or topic.
    (3) You may download the comments. However, since the comments are
imaged documents, instead of word processing documents, the ``pdf''
versions of the documents are word searchable.
    Please note that even after the comment closing date, we will
continue to file relevant information in the Docket as it becomes
available. Further, some people may submit late comments. Accordingly,
we recommend that you periodically check the Docket for new material.

    Authority: 49 U.S.C. 30111, 30181-83 delegation of authority at
49 CFR 1.95 and 501.8.

    Issued in Washington, DC, on May 15, 2014.
Terry Shelton,
Associate Administrator for the National Center for Statistics and
Analysis.
[FR Doc. 2014-11666 Filed 5-20-14; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: December 2, 2010 (Volume 75, Number 231)]
[Notices]
[Page 75187]
[DOCID:fr02de10-33]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold an Open Meeting on December 3, 2010
at 10 a.m., in the Auditorium, Room L-002.
    The subject matter of the Open Meeting will be:

    The Commission will consider a recommendation to propose joint
rules with the Commodity Futures Trading Commission relating to the
definitions of ``Swap Dealer,'' ``Security-Based Swap Dealer,'' ``Major
Swap Participant,'' Major Security-Based Swap Participant,'' and
``Eligible Contract Participant.''

    Commissioner Aguilar, as duty officer, determined that no earlier
notice thereof was possible.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: November 30, 2010.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-30407 Filed 11-30-10; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 110 (Friday, June 7, 2013)]
[Notices]
[Pages 34421-34423]
[FR Doc No: 2013-13505]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69681; File No. SR-CBOE-2013-056]

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

June 3, 2013.
    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 May 20, 2013, 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.
---------------------------------------------------------------------------

    \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 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 recently amended its Fees Schedule to add to Footnote
25 the statement that any Floor Broker Trading Permit Holder that
executes an average of 15,000 customer open-outcry contracts per day
(``CPD'') over the course of a calendar month in multiply-listed
options classes will receive a rebate of $7,500 on that Floor Broker
Trading Permit Holder's Floor Broker Trading Permit fees (the
``Rebate'').\3\ Footnote 25 describes Floor Broker Trading Permit Fees
and the Floor Broker Trading Permit Sliding Scale, and states that the
Floor Broker Trading Permit Sliding Scale will be available for all
Floor Broker Trading Permits held by affiliated Trading Permit Holders
and TPH organizations.\4\ As such, the Exchange believed that it was
implied that the trading volume of all Floor Broker Trading Permit
Holders affiliated with a single TPH organization would be aggregated
for the purposes of reaching the 15,000-contract threshold, and that
each TPH organization would receive one $7,500 rebate (as opposed to a
rebate for each affiliated Floor Broker Trading Permit Holder that
reached the 15,000-contract threshold).
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 69569 (May 14, 2013)
(SR-CBOE-2013-049).
    \4\ See CBOE Fees Schedule, Footnote 25.
---------------------------------------------------------------------------

    However, in an effort to make the Rebate program's details clear,
the Exchange now proposes to add the following clarifying language to
the end of Footnote 25: For purposes of determining the rebate, the
qualifying volume of all Floor Broker Trading Permit Holders affiliated
with a single TPH organization will be aggregated, and, if such total
meets or exceeds the 15,000 customer open-outcry contracts per day
threshold in multiply-listed options classes, that TPH organization
will receive a single $7,500 rebate, regardless of the number of Floor
Broker Trading Permits affiliated with that TPH organization. The
purpose of aggregating the qualifying volume of all Floor Broker
Trading Permit Holders affiliated with a single TPH organization is to
make it easier for such TPH organizations that have a number of Floor
Broker Trading Permit Holders affiliated with them to be able to reach
the threshold. The purpose of stipulating that each TPH organization
will receive a single rebate is to ensure that the Rebate program is
economically viable for the Exchange.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
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 Section 6(b)(4) of the Act,\6\ 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. The Exchange believes that aggregating
the qualifying volume of all Floor Broker Trading Permit Holders
affiliated with a single TPH organization is reasonable because it will
allow more TPH organizations to reach the threshold and therefore
receive the Rebate. The Exchange believes that this is equitable and
not unfairly discriminatory because it will incentivize TPH
organizations with affiliated Floor Broker Trading Permit Holders to
encourage such Floor Broker Trading Permit Holders to transact more
qualifying volume, which should increase volume, which would benefit
all market participants (including Floor Broker Trading Permit Holders
and TPH organizations with affiliated Floor Broker Trading Permit
Holders who do not hit the 15,000 contracts-per-day threshold (indeed,
this increased volume could make it possible for some such Floor
Brokers and/or TPH organizations to hit the 15,000 contracts-per-day
threshold)). The Exchange believes that it is reasonable to limit TPH
organizations to receiving one $7,500 rebate per month because this is
necessary to ensure that the Rebate program is economically viable for
the Exchange. The Exchange believes that this limitation is equitable
and not unfairly discriminatory because it applies to all qualifying
TPH organizations.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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. CBOE does not believe that
aggregating the qualifying volume of all Floor Broker Trading Permit
Holders affiliated with a single TPH organization will impose any
burden on intramarket competition that is not necessary or appropriate
in furtherance of the purposes of the Act because it will incentivize
TPH organizations with affiliated Floor Broker Trading Permit Holders
to encourage such Floor Broker Trading Permit Holders to transact more
qualifying volume, which should increase volume, which would benefit
all market participants (including Floor Broker Trading Permit Holders
and TPH organizations with affiliated Floor Broker Trading Permit
Holders who do not hit the 15,000 contracts-per-day threshold (indeed,
this increased volume could make it possible for some such Floor
Brokers and/or TPH organizations to hit the 15,000 contracts-per-day
threshold)). CBOE does not believe that limiting TPH organizations to
receiving one $7,500 rebate per month will impose any burden on
intramarket competition that is not necessary or appropriate in
furtherance of the purposes of the Act because this limitation applies
to all qualifying TPH organizations.
    CBOE does not believe that the proposed rule change will impose any
burden on intermarket competition that is not necessary or appropriate
in furtherance of the purposes of the Act because the proposed changes
only apply to Floor Brokers at CBOE. To the extent that aggregating the
qualifying volume of all Floor Broker Trading Permit Holders affiliated
with a single TPH organization proves attractive to market participants
on other exchanges, such Floor Brokers or market participants may elect
to become Floor Brokers or market participants at CBOE.

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-CBOE-2013-056 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-2013-056. 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-CBOE-2013-056 and should be
submitted on or before June 28, 2013.

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

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-13505 Filed 6-6-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Page 18950]
[FR Doc No: 2020-07020]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP20-683-000.
    Applicants: Bison Pipeline LLC.
    Description: Bison Pipeline LLC submits tariff filing per 154.203:
Company Use Gas Annual Report 2020.
    Filed Date: 03/26/2020.
    Accession Number: 20200326-5037.
    Comment Date: 5 p.m. ET 4/07/2020.

    Docket Numbers: RP20-684-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Trailblazer Pipeline Company LLC submits tariff filing
per 154.203: TPC 2019 Annual Purchases and Sales Report.
    Filed Date: 03/26/2020.
    Accession Number: 20200326-5103.
    Comment Date: 5 p.m. ET 4/07/2020.

    Docket Numbers: RP20-685-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Rockies Express Pipeline LLC submits tariff filing per
154.203: REX 2019 Annual Purchases and Sales Report.
    Filed Date: 03/26/2020.
    Accession Number: 20200326-5105.
    Comment Date: 5 p.m. ET 4/07/2020.

    Docket Numbers: RP20-686-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America LLC submits
tariff filing per 154.204: Negotiated Rate Filing--NIPSCO to be
effective 4/1/2020.
    Filed Date: 03/26/2020.
    Accession Number: 20200326-5130.
    Comment Date: 5 p.m. ET 4/07/2020.

    Docket Numbers: RP20-687-000.
    Applicants: Cheniere Corpus Christi Pipeline L.P.
    Description: Annual Operational Transaction Report of Cheniere
Corpus Christi Pipeline, L.P. under RP20-687.
    Filed Date: 03/26/2020.
    Accession Number: 20200326-5139.
    Comment Date: 5 p.m. ET 4/07/2020.

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

    Dated: March 30, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-07020 Filed 4-2-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 131 (Tuesday, July 9, 2019)]
[Notices]
[Page 32767]
[FR Doc No: 2019-14588]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

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

Oklahoma; Amendment No. 4 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

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

DATES: This amendment was issued June 17, 2019.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this disaster is closed effective June 9, 2019.

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

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-14588 Filed 7-8-19; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57178-57179]
[FR Doc No: 2021-22394]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4610-DR; Docket ID FEMA-2021-0001]

California; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of California (FEMA-4610-DR), dated August 24,
2021, and related determinations.

DATES: The declaration was issued August 24, 2021.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated August 24, 2021, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of California resulting from wildfires beginning on July 14, 2021,
and continuing, is of sufficient severity and magnitude to warrant a
major disaster declaration under the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''). Therefore, I declare that such a major disaster
exists in the State of California.
    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 disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and
emergency protective measures (Category B), limited to direct
Federal assistance, under the Public Assistance program in the
designated areas, Hazard Mitigation throughout the State, and any
other forms of assistance under the Stafford Act that you deem
appropriate subject to completion of Preliminary Damage Assessments
(PDAs).
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance, Hazard Mitigation, and Other Needs Assistance
under section 408 will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Andrew Grant, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of California have been designated
as adversely affected by this major disaster:

    Lassen, Nevada, Placer, and Plumas Counties for Individual
Assistance.
    Lassen, Nevada, Placer, and Plumas Counties for emergency
protective measures (Category B), limited to direct federal
assistance, under the Public Assistance program.
    All areas within the State of California are eligible for
assistance under the Hazard Mitigation Grant 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.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22394 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


Date:	September 8, 2016

To:	Brenda Shine, EPA/OAQPS/SPPD

From:	Jonathan Witt, EPA/OAQPS/SPPD

Subject:	Meeting Record for September 8, 2016 meeting between
Representatives of EDF and Representatives of OAQPS (U.S. EPA)

On September 8, 2016, representatives of the U.S. Environmental
Protection Agency (EPA) participated in a call with representatives of
the Environmental Defense Fund (EDF), the Natural Resources Defense
Council (NRDC), the Sierra Club, and the Clean Air Task Force (CATF).
The names and affiliations of the participants are included in
Attachment 1. The purpose of the meeting was to discuss the existing
source oil and gas information collection request (ICR) comments
provided to the EPA by CATF on August 2, 2016. The following topics were
discussed.

Part 2 Survey Production Segment Sampling Protocol. EDF representatives
began by requesting that the EPA leverage existing data (e.g. studies,
past data collections, reported data), ensure that data collected is
representative of the entire oil and gas industry, collect data swiftly,
move forward with existing source standards, and ensure transparency and
public disclosure throughout the entire process. EDF reviewed the
production segment stratification options for the Part 2 survey that EPA
proposed in the Federal Register notice on June 3, 2016 (81 FR 35763).
EDF representatives reiterated suggestions within the CATF comments to
change the stratification by sampling facilities from high-producing
basins. There would be eighteen strata: sixteen for basins (3 - 12% of
emissions individually, 92% collectively), one for "other basins", one
for marginal oil wells, and one for marginal gas wells. They also
suggested the stratification of reporters v. non-reporters. EPA
representatives pointed out that comments from trade associations were
also in favor of a separate category for low-producing wells.

Part 1 Survey. EDF representatives asked that the EPA include additional
questions related to flares, combustors, electricity, well completions,
and workovers on the Part 1 survey. EPA representatives explained that
some of the questions that were originally asked in the Part 1 survey
may be too broad and are considering moving these questions to the Part
2 survey, where more detailed questions can be asked. They further
explained that the purpose of the revised Part 1 is to know how the
production segment is configured and to learn what the major equipment
counts are.

Part 2 Survey: Tanks and Separators. EDF representatives asked that more
information be requested on the “Tanks Separators” tab, including
information on stuck dump valves and the number of days that each tank
has spent operating. EPA representatives explained that they would like
information on pressure relief devices, thief hatches, monitoring
systems, and alarms. They further explained that they are primarily
looking at flashing emissions from when pressurized liquids are dumped
into storage tanks at atmospheric pressure. They also explained the
importance of requiring a standardized method for looking at flashing
emissions.

	Part 2 Survey: Pneumatic Devices. EDF representatives asserted that the
breakdown of pneumatic device classifications into snap-acting v.
throttling and continuous v. intermittent was important for the purposes
of this ICR. EPA representatives agreed, but also explained that the
granular level of detail that was requested in the CATF comments might
not be feasible to include at the time. However, they explained that
they plan to request more granular information wherever they ask for
emissions test data on pneumatic devices. EPA representatives also
pointed out that several studies on pneumatic devices are currently
underway, including one by Eben Thoma in the EPA’s Office of Research
and Development that will be conducted in the Uintah basin.

Part 2 Survey: Miscellaneous. EPA representatives reiterated that if
respondents report facility-level data in the Greenhouse Gas Reporting
Program (GHGRP) that is also being requested in the ICR, then they do
not have to report that data in the ICR, provided they report their
GHGRP ID. EDF representatives asked for an update on the EPA’s plans
regarding addressing comments on dehydrators. EPA representatives
explained that they did not have any responses to those comments at the
time. With regards to equipment leaks, EDF representatives asked the EPA
to request actual emissions data in the ICR and to combine that data
with 40 CFR Part 98 Subpart W emission factors. EPA representatives
explained that they are requesting emissions data if the respondent
already has it, since it would not be an additional burden for them to
report it. They also explained that wherever they ask for information on
volatile organic compound emissions in the ICR, they also plan to ask
for emissions of benzene, toluene, ethyl benzene, and xylene, as well as
hexane and methanol where applicable. In addition, EPA representatives
explained that they plan to introduce a methodology for reducing the
sampling burden on the transmission and storage segments and asking more
questions on compressor drivers.

	Timing. EDF representatives asked if there was an update on the timing
requirements for responding to the ICR. EPA representatives explained
that no timing decisions had been made.

Attachment 1

Participants in September 8, 2016 EPA/EDF Meeting

EDF Representatives

David Lyon

Hillary Hull

Peter Zalzal

NRDC Representatives

Briana Mordick

Meleah Geertsma

Sierra Club Representatives

Andres Restrepo

CATF Representatives

Darin Schroeder

U.S. EPA Representatives

Alison Davis

Amy Hambrick

Angie Carey

Beth Miller

Brenda Shine

Jonathan Witt

Lisa Thompson

Mark DeFigueiredo

 PAGE

 PAGE   2

  PAGE   \* MERGEFORMAT  2


[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50073-50074]
[FR Doc No: 2017-23513]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-5719]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Streptococcus SPP. Nucleic Acid-Based Assay

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the Streptococcus spp. nucleic acid-based assay into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the Streptococcus spp. nucleic acid-based assay's classification. We
are taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices, in part by reducing regulatory burdens.

DATES: This order is effective October 30, 2017. The classification was
applicable on April 16, 2014.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the Streptococcus spp. nucleic
acid-based assay as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug
Administration Modernization Act of 1997 established the first
procedure for De Novo classification (Pub. L. 105-115). Section 607 of
the Food and Drug Administration Safety and Innovation Act modified the
De Novo application process by adding a second procedure (Pub. L. 112-
144). A device sponsor may utilize either procedure for De Novo
classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device
was automatically within class III, the De Novo classification is
considered to be the initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or PMA in order to market a substantially equivalent device (see 21
U.S.C. 360c(i), defining ``substantial equivalence''). Instead,
sponsors can use the less-burdensome 510(k) process, when necessary, to
market their device.

II. De Novo Classification

    For this device, FDA issued an order on March 20, 2014, finding the
Lyra Direct Strep Assay not substantially equivalent to a predicate not
subject to a premarket application approval (PMA). Thus, the device
remained in class III in accordance with section 513(f)(1) of the FD&C
Act when we issued the order.
    On March 28, 2014, Quidel Corp. submitted a request for De Novo
classification of the Lyra Direct Strep Assay. FDA reviewed the request
in order to classify the device under the criteria for classification
set forth in section 513(a)(1) of the FD&C Act. We classify devices
into class II if general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls that, in
combination with the general controls, provide reasonable assurance of
the safety and effectiveness of the device for its intended use (see 21
U.S.C. 360c(a)(1)(B)). After review of the information submitted in the
request, we determined that the device can be classified into class II
with the establishment of special controls. FDA has determined that
these special controls, in addition to general controls, will provide
reasonable assurance of the safety and effectiveness of the device.
    Therefore, on April 16, 2014, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.2680. We have named
the generic type of device Streptococcus spp. nucleic acid-based assay,
and it is identified as a qualitative in vitro diagnostic device that
is intended to simultaneously detect and

identify various Streptococcus spp. nucleic acids extracted directly
from clinical specimens. The device detects specific nucleic acid
sequences for organism identification. The identification aids in the
diagnosis of diseases caused by bacteria belonging to the genus
Streptococcus and provides epidemiological information on these
diseases. Pathogenic streptococci are associated with infections, such
as sore throat, impetigo (an infection characterized by small pustules
on the skin), urinary tract infections, rheumatic fever, and kidney
disease.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

     Table 1--Streptococcus SPP. Nucleic Acid-Based Assay Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Incorrect identification of a            Special controls (1), (2), (3),
 pathogenic microorganism by the device   (4), (5) and (6) (21 CFR
 can lead to improper patient             866.2680(b)(1); 21 CFR
 management.                              866.2680(b)(2); 21 CFR
                                          866.2680(b)(3); 21 CFR
                                          866.2680(b)(4); 21 CFR
                                          866.2680(b)(5); and 21 CFR
                                          866.2680(b)(6)).
Failure to correctly interpret test      Special control (7) (21 CFR
 results.                                 866.2680(b)(7)).
Failure to correctly operate the         Special control (8) (21 CFR
 instrument.                              866.2680(b)(8)).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, and the collections
of information in 21 CFR parts 801 and 809, regarding labeling have
been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  866.2680 to subpart C to read as follows:

Sec.  866.2680   Streptococcus spp. nucleic acid-based assay.

    (a) Identification. A Streptococcus spp. nucleic acid-based assay
is a qualitative in vitro diagnostic device intended to simultaneously
detect and identify various Streptococcus spp. nucleic acids extracted
directly from clinical specimens. The device detects specific nucleic
acid sequences for organism identification. The identification aids in
the diagnosis of diseases caused by bacteria belonging to the genus
Streptococcus and provides epidemiological information on these
diseases. Pathogenic streptococci are associated with infections, such
as sore throat, impetigo (an infection characterized by small pustules
on the skin), urinary tract infections, rheumatic fever, and kidney
disease.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must include detailed device
description documentation, including the device components, ancillary
reagents required but not provided, and a detailed explanation of the
methodology including primer/probe sequence, design, and rationale for
sequence selection.
    (2) Premarket notification submissions must include detailed
documentation from the following analytical and clinical performance
studies: Analytical sensitivity (Limit of Detection), reactivity,
inclusivity, precision, reproducibility, interference, cross
reactivity, carry-over, and cross contamination.
    (3) Premarket notification submissions must include detailed
documentation from a clinical study. The study, performed on a study
population consistent with the intended use population, must compare
the device performance to results obtained from well-accepted reference
methods.
    (4) Premarket notification submissions must include detailed
documentation for device software, including, but not limited to,
software applications and hardware-based devices that incorporate
software.
    (5) Premarket notification submissions must include database
implementation methodology, construction parameters, and quality
assurance protocols, as appropriate.
    (6) The device labeling must include limitations regarding the need
for culture confirmation of negative specimens, as appropriate.
    (7) A detailed explanation of the interpretation of results and
acceptance criteria must be included in the device's 21 CFR
809.10(b)(9) compliant labeling.
    (8) Premarket notification submissions must include details on an
end user device training program that will be offered while marketing
the device, as appropriate.

    Dated: October 25, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-23513 Filed 10-27-17; 8:45 am]
 BILLING CODE 4164-01-P


(b) Classification. (1) Class II (special controls) for condoms
made of materials

other than natural rubber latex, including natural membrane (skin) or
synthetic.
    (2) Class II (special controls) for natural rubber latex condoms.
The guidance document entitled ``Class II Special Controls Guidance
Document: Labeling for Natural Rubber Latex Condoms Classified Under 21
CFR 884.5300'' will serve as the special control. See Sec.  884.1(e)
for the availability of this guidance document.

    Dated: October 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26825 Filed 11-7-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Pages 34715-34717]
[FR Doc No: 2020-12146]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2013-0445; FMCSA-2018-0052]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew exemptions for three
individuals from the requirement in the Federal Motor Carrier Safety
Regulations (FMCSRs) that interstate commercial motor vehicle (CMV)
drivers have ``no established medical history or clinical diagnosis of
epilepsy or any other condition which is likely to cause loss of
consciousness or any loss of ability to control a CMV.'' The exemptions
enable these individuals who have had one or more seizures and are
taking anti-seizure medication to continue to operate CMVs in
interstate commerce.

DATES: Each group of renewed exemptions were applicable on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below. Comments must be received on or before July 6,
2020.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2013-0445 or Docket No.
FMCSA-2018-0052 using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/docket?D=FMCSA-2018-0052 or http://www.regulations.gov/docket?D=FMCSA-2013-0445. Follow the online
instructions for submitting comments.
     Mail: Docket Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2013-0445 or Docket No. FMCSA-2018-0052),
indicate the specific section of this document to which each comment
applies, and provide a reason for each suggestion or recommendation.
You may submit your comments and material online or by fax, mail, or
hand delivery, but please use only one of these means. FMCSA recommends
that you include your name and a mailing address, an email address, or
a phone number in the body of your document so that FMCSA can contact
you if there are questions regarding your submission.

    To submit your comment online, go to http://www.regulations.gov/docket?D=FMCSA-2013-0445 or http://www.regulations.gov/docket?D=FMCSA-2018-0052. Click on the ``Comment Now!'' button and type your comment
into the text box on the following screen. Choose whether you are
submitting your comment as an individual or on behalf of a third party
and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D= FMCSA-2013-0445 or http://www.regulations.gov/docket?D=FMCSA-2018-0052 and choose the document to review. If you do not have access
to the internet, you may view the docket online by visiting Docket
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9
a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. To
be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Docket Operations.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding epilepsy
found in 49 CFR 391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

    The three individuals listed in this notice have requested renewal
of their exemptions from the epilepsy and seizure disorders prohibition
in Sec.  391.41(b)(8), in accordance with FMCSA procedures.
Accordingly, FMCSA has evaluated these applications for renewal on
their merits and decided to extend each exemption for a renewable 2-
year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the
three applicants has satisfied the renewal conditions for obtaining an
exemption from the epilepsy and seizure disorders prohibition. The
three drivers in this notice remain in good standing with the Agency,
have maintained their medical monitoring and have not exhibited any
medical issues that would compromise their ability to safely operate a
CMV during the previous 2-year exemption period. In addition, for
Commercial Driver's License (CDL) holders, the Commercial Driver's
License Information System and the Motor Carrier Management Information
System are searched for crash and violation data. For non-CDL holders,
the Agency reviews the driving records from the State Driver's
Licensing Agency. These factors provide an adequate basis for
predicting each driver's ability to continue to safely operate a CMV in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of 2 years is likely
to achieve a level of safety equal to that existing without the
exemption.
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of July and
are discussed below.
    As of July 1, 2020, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following two individuals have satisfied the renewal
conditions for obtaining an exemption from the epilepsy and seizure
disorders prohibition in the FMCSRs for interstate CMV drivers:

Jesse Hansen (MN) and Nicholas Ramirez (AL)

    The drivers were included in docket number FMCSA-2018-0052. Their
exemptions are applicable as of July 1, 2020, and will expire on July
1, 2022.
    As of July 14, 2020, and in accordance with 49 U.S.C. 31136(e) and
31315(b), the following individual has satisfied the renewal conditions
for obtaining an exemption from the epilepsy and seizure disorders
prohibition in the FMCSRs for interstate CMV drivers:

    Ronald Blount (GA)

    The driver was included in docket number FMCSA-2013-0445. His
exemption is applicable as of July 14, 2020, and will expire on July
14, 2022.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must remain seizure-free and maintain a stable
treatment during the 2-year exemption period; (2) each driver must
submit annual reports from their treating physicians attesting to the
stability of treatment and that the driver has remained seizure-free;
(3) each driver must undergo an annual medical examination by a
certified ME, as defined by Sec.  390.5; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keep a copy of his/her
driver's qualification file if he/she is self-employed. The driver must
also have a copy of the exemption when driving, for

presentation to a duly authorized Federal, State, or local enforcement
official. The exemption will be rescinded if: (1) The person fails to
comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based on its evaluation of the three exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the epilepsy
and seizure disorders prohibition in Sec.  391.41(b)(8). In accordance
with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for
2 years unless revoked earlier by FMCSA.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-12146 Filed 6-4-20; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Pages 27981-27983]
[FR Doc No: 2018-13027]

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

[EPA-HQ-OW-2011-0465; FRL-9979-51-OW]

Proposed Information Collection Request; Comment Request; Water
Quality Standards Regulation (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Water Quality Standards
Regulation (Renewal)'' (EPA ICR No. 0988.13, OMB Control No. 2040-0049)
to the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. Before doing so, the EPA
is soliciting public comments on specific aspects of the proposed
information collection as

described below. This ICR renews the Water Quality Standards Regulation
ICR (most recently approved in 2016) and consolidates the burden and
costs associated with activities previously reported in ICRs for two
recent rules affecting the WQS program: The Water Quality Standards
Regulatory Revisions (approved in 2015), and the Revised Interpretation
of Clean Water Act Tribal Provision (approved in 2016). An Agency may
not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Comments must be submitted on or before August 14, 2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2011-0465, online using www.regulations.gov (our preferred method), by
email to [email protected], or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    The EPA's policy is that all comments received will be included in
the public docket without change including any personal information
provided unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Tanyan Bailey, Office of Water, Office
of Science and Technology, Standards and Health Protection Division,
(4305T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
566-0409; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA would be collecting are available in the
public docket for this Information Collection Request (ICR) (Docket ID
No. EPA-HQ-OW-2011-0465). The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave., NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about the EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act
(PRA), the EPA is soliciting comments and information to enable it to:
(i) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the Agency,
including whether the information will have practical utility; (ii)
evaluate the accuracy of the Agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (iii) enhance the quality, utility,
and clarity of the information to be collected; and, (iv) minimize the
burden of the collection of information on those who are to respond,
including through the use of appropriate automated electronic,
mechanical, or other technological collection techniques or other forms
of information technology, e.g., permitting electronic submission of
responses. The EPA will consider the comments received and amend the
proposed ICR as appropriate. The final ICR package will then be
submitted to OMB for review and approval. At that time, the EPA will
issue another Federal Register notice to announce the submission of the
ICR to OMB and the opportunity to submit additional comments to OMB.
    Abstract: Water quality standards (WQS) under the Clean Water Act
(hereafter referred to as ``the Act'') are provisions of state,\1\
tribal,\2\ or federal law which consist of designated uses for waters
of the United States, water quality criteria to protect those uses, and
antidegradation requirements. WQS are established to protect public
health or welfare, protect and enhance the quality of water, and serve
the purposes of the Clean Water Act. Such standards serve the dual
purposes of establishing the water quality goals for water bodies and
serving as the regulatory basis for the establishment of water quality-
based treatment controls and strategies beyond technology-based levels
of treatment required by sections 301(b) and 306 of the Act. The WQS
Regulation establishes the framework for states and authorized tribes
to adopt standards, and for the EPA to review and approve or disapprove
them. For the purposes of this ICR, the WQS Regulation consists of 40
CFR part 131 (Water Quality Standards), and portions of part 132 (Water
Quality Guidance for the Great Lakes System) that are related to
WQS.\3\ This ICR is for information collections needed to implement the
WQS Regulation and required to obtain or retain benefits (e.g., relaxed
regulatory requirements) under the WQS Regulation.
---------------------------------------------------------------------------

    \1\ ``States'' in the EPA's WQS Regulation and in this document
includes the 50 states, the District of Columbia, Guam, the
Commonwealth of Puerto Rico, the Virgin Islands, American Samoa, and
the Commonwealth of the Northern Mariana Islands.
    \2\ ``Tribes'' in this document refers to federally recognized
tribes and ``authorized tribes'' refers to those federally
recognized Indian tribes with authority to administer a CWA WQS
program.
    \3\ These portions include 40 CFR 132.3, appendices A, B, C, D,
E, and Procedures 1 and 2 of appendix F.
---------------------------------------------------------------------------

    This ICR renews the WQS Regulation ICR, OMB control no. 2040-0049,
expiration date 6/30/2019, and consolidates the burden and costs
associated with activities previously reported in two related ICRs,
which upon OMB approval will be discontinued as separate ICRs:
    [ssquf] The WQS Regulatory Revisions ICR, OMB control no. 2040-
0286, expiration date 12/31/2018; and,
    [ssquf] The Revised Interpretation of Clean Water Act Tribal
Provision ICR, OMB control no. 2040-0289, expiration date 7/31/2019.
    This ICR renewal and consolidation describes the estimated burden
for states, authorized tribes and certain Great Lakes dischargers
associated with the information collections related to: Implementation
of the requirements of 40 CFR part 131 (Water Quality Standards);
implementation of the WQS portions of the 40 CFR part 132 (Water
Quality Guidance for the Great Lakes System); tribal applications to be
treated in a similar manner as a state (TAS); and, tribal requests for
dispute resolution under CWA section 518(e). This ICR also covers
periodic requests for voluntary WQS information from, or voluntary
participation in workgroups by, state and tribes to ensure efficient
and effective administration of the WQS program and further cooperative
federalism.
    Form Numbers: None.
    Respondents/affected entities: Potential respondents to this ICR
include: The 50 states, the District of Columbia, five territories,
authorized tribes with EPA-approved Water Quality Standards (44 tribes
as of May 2018), and a total of 18 additional tribal respondents over
the three-year duration of the ICR (based on six additional tribal
respondents expected to apply per year for TAS to administer the WQS
program). In addition, an estimated total of 258 dischargers located in
the Great Lakes watershed over the three-year duration of this ICR
(based on an estimated 86 dischargers per year) could apply for certain
forms of regulatory relief. The total number of potential respondents
is thus 376. This corresponds to 2,693 responses per year (see draft
Supporting Statement in the docket for this ICR).
    Respondent's obligation to respond: Some collections in this ICR
are mandatory; some are required to obtain or retain benefits (e.g.,
relaxed regulatory requirements) pursuant to the

WQS Regulation; and, some are voluntary.
    Estimated number of respondents: 2,693.
    Frequency of response: Variable depending on type of information
collected (once every three years; annually; on occasion or as
necessary; or, only once).
    Total estimated burden: From 376,097 to 514,987 hours per year.
Burden is defined at 5 CFR 1320.03(b).
    Total estimated cost: From $17,103,064 to $23,173,945 of labor
costs per year, and $263,520 of operations and maintenance costs per
year. There are no annualized capital costs.
    Changes in Estimates: There is a decrease of 226,040 hours in the
total upper estimates of respondent burden compared with the combined
burden of the three ICRs currently approved by OMB and consolidated in
this ICR. This decrease reflects adjustments made to the EPA's burden
estimates based on experience gained since the previous ICRs were
approved.

    Dated: June 6, 2018.
Deborah G. Nagle,
Acting Director, Office of Science and Technology.
[FR Doc. 2018-13027 Filed 6-14-18; 8:45 am]
BILLING CODE 6560-50-P