[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Rules and Regulations]
[Pages 63686-63687]
[FR Doc No: 2022-22706]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2022-D-1126]

Laboratory Accreditation for Analyses of Foods; Small Entity
Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a guidance for industry entitled
``Laboratory Accreditation for Analyses of Foods: What You Need to Know
About the FDA Regulation: Guidance for Industry--Small Entity
Compliance Guide.'' The small entity compliance guide (SECG) is
intended to help small entities comply with the final rule entitled
``Laboratory Accreditation for Analyses of Foods.''

DATES: The announcement of the guidance is published in the Federal
Register on October 20, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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): 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-2022-D-1126 for ``Laboratory Accreditation for Analyses of Foods:
What You Need to Know About the FDA Regulation: Guidance for Industry--
Small Entity Compliance Guide.'' 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 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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the SECG to the Office
of Strategic Planning and Operational Policy, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element
Building, Rockville, MD 20857. Send two self-addressed adhesive labels
to assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT: Stacie Hammack, Food and Feed
Laboratory Operations, Office of Regulatory Affairs, Food and Drug
Administration, 60 8th Street NE, Atlanta, GA 30309,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 3, 2021 (86 FR 68728), we
issued a final rule establishing a program for the testing of food in
certain circumstances by accredited laboratories, as required under the
Federal Food, Drug, and Cosmetic Act (the final rule). Establishing
this program will help FDA improve the safety of the U.S. food supply
and protect U.S. consumers by helping to ensure that certain food
testing of importance to public health is conducted subject to
appropriate oversight and in accordance with appropriate model
standards to produce reliable and valid test results. The final rule,
which is codified at 21 CFR part 1, subpart R (21 CFR 1.1101 through
1.1201), became effective February 1, 2022.
    We examined the economic implications of the final rule as required
by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined
that the final rule will have a significant economic impact on a
substantial number of small entities. In compliance with section 212 of
the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-
121, as amended by Pub. L. 110-28), we are making available the SECG to
explain the actions that a small entity must take to comply with the
rule.
    We are issuing the SECG consistent with our good guidance practices
regulation (21 CFR 10.115(c)(2)). The SECG represents the current
thinking of FDA on this topic. 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. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 1, subpart R have been approved under OMB
control number 0910-0898.

III. Electronic Access

    Persons with access to the internet may obtain the SECG at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA
website listed in the previous sentence to find the most current
version of the guidance.

    Dated: October 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22706 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 155 (Monday, August 12, 2013)]
[Notices]
[Pages 48917-48918]
[FR Doc No: 2013-19407]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 19b-5 and Form PILOT; SEC File No. 270-448, OMB Control No.
3235-0507.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rule 19b-
5 (17 CFR 240.19b-5) and Form PILOT (17 CFR 249.821) under the
Securities Exchange Act of 1934, as amended (``Act'') (15 U.S.C. 78a et
seq.).
    Rule 19b-5 provides a temporary exemption from the rule-filing
requirements of Section 19(b) of the Act (15 U.S.C. 78s(b)) to self-
regulatory organizations (``SROs'') wishing to establish and operate
pilot trading systems. Rule 19b-5 permits an SRO to develop a pilot
trading system and to begin operation of such system shortly after
submitting an initial report on Form PILOT to the Commission. During
operation of any such pilot trading system, the SRO must submit
quarterly reports of the system's operation to the Commission, as well
as timely amendments describing any material changes to the system.
After two years of operating such pilot trading system under the
exemption afforded by Rule 19b-5, the SRO must submit a rule filing
pursuant to Section 19(b)(2) of the Act (15 U.S.C. 78s(b)(2)) in order
to obtain permanent approval of the pilot trading system from the
Commission.
    The collection of information is designed to allow the Commission
to maintain an accurate record of all new pilot trading systems
operated by SROs and to determine whether an SRO has properly availed
itself of the exemption afforded by Rule 19b-5, is operating a pilot
trading system in compliance with the Act, and is carrying out its
statutory oversight obligations under the Act.
    The respondents to the collection of information are national
securities exchanges and national securities associations.
    While there are 17 national securities exchanges and national
securities associations that may avail themselves of the exemption
under Rule 19b-5 and the use of Form PILOT, it is estimated that
approximately three respondents will file a total of 3 initial reports
(for a 72 hour estimated annual burden), 12 quarterly reports (for a 36
hour estimated annual burden), and 6 amendments (for an 18 hour
estimated annual burden) on Form PILOT per year, with an estimated
total annual response burden of 126 hours. At an average hourly cost of
$350.07, the aggregate related cost of compliance with Rule 19b-5 for
all respondents is $44,109 per year (126 burden hours multiplied by
$350.07/hour = $44,109).
    Although Rule 19b-5 does not in itself impose recordkeeping burdens
on SROs, it relies on existing requirements imposed by Rule 17a-1 under
the Act (17 CFR 240.17a-1) to require SROs to retain all the rules and
procedures

relating to each pilot trading system operating pursuant to Rule 19b-5,
and to make such records available for Commission inspection for a
period of not less than five years, the first two years in an easily
accessible place.
    The filing of a Form PILOT is mandatory for any SRO seeking a
temporary exemption under Rule 19b-5 from the rule filing requirements
of Section 19(b) of the Act in connection with the operation of a pilot
trading system. It is also mandatory that an SRO operating a pilot
trading system file with the Commission notices of material systems
changes and quarterly transaction reports on Form PILOT. Information
provided on Form PILOT is deemed confidential and shall be available
only for examination by the Commission, other agencies of the federal
government, and state securities authorities.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.
    The public may view background documentation for this information
collection at the following Web site, www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503, or by sending an email to<EMAIL_ADDRESS>and (ii) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100
F Street NE., Washington, DC 20549 or send an email to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: August 6, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-19407 Filed 8-9-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Proposed Rules]
[Page 41449]
[FR Doc No: 2015-17306]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 35

[Docket No. RM15-21-000]

Generator Interconnection Rules and Procedures

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Opportunity to comment on petition for rulemaking.

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SUMMARY: Take notice that on June 19, 2015, the American Wind Energy
Association filed a petition requesting that the Commission initiate a
rulemaking to revise provisions of the pro forma Large Generator
Interconnection Procedures and pro forma Large Generator
Interconnection Agreement.

DATES: Comments are due August 6, 2015.

FOR FURTHER INFORMATION CONTACT:
Tony Dobbins (General Information), Federal Energy Regulatory
Commission, Office of Energy Policy and Innovation, 888 First Street
NE., Washington, DC 20426,<PHONE_NUMBER>
Adam Pan (Legal Information), Federal Energy Regulatory Commission,
Office of the General Counsel, 888 First Street NE., Washington, DC
20426,<PHONE_NUMBER>

SUPPLEMENTARY INFORMATION:

Opportunity To Comment on Petition for Rulemaking

    Take notice that on June 19, 2015, the American Wind Energy
Association, pursuant to sections 205 and 206 of the Federal Power Act,
16 U.S.C. 824d and 824e (2012), and Rule 207(a)(4) of the Federal
Energy Regulatory Commission's (Commission) Rules of Practice and
Procedure, 18 CFR 385.207(a)(4) (2014), filed a petition requesting
that the Commission initiate a rulemaking to revise provisions of the
pro forma Large Generator Interconnection Procedures and pro forma
Large Generator Interconnection Agreement.
    Any person that wishes to comment in this proceeding must file
comments in accordance with Rule 211 of the Commission's Rules of
Practice and Procedure, 18 CFR 385.211 (2014). Comments will be
considered by the Commission in determining the appropriate action to
be taken. Comments must be filed on or before the comment date.
    The Commission encourages electronic submission of comments in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons
unable to file electronically should submit an original and 5 copies of
the comments to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on August 6, 2015.

    Dated: July 7, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-17306 Filed 7-14-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: November 27, 2006 (Volume 71, Number 227)]
[Notices]
[Page 68652-68654]
[DOCID:fr27no06-131]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54777; File No. SR-Amex-2006-89]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing of Proposed Rule Change and Amendment No. 1 Thereto To
Establish Fees for the Receipt and Use of Proprietary Market Data
Disseminated by the Exchange

 November 17, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 22, 2006, the American Stock Exchange LLC (``Amex''
or ``Exchange'') 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. On
November 15, 2006, the Exchange filed Amendment No. 1 to the proposed
rule change.\3\ The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaces the original filing in its
entirety.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Amex Fees Schedule to establish
fees for the receipt and use of proprietary market data disseminated by
the Exchange. 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, Amex 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Through the new Auction and Electronic Market Integration trading
platform (known as AEMI), the Exchange's hybrid trading system, the
Exchange plans to make available for dissemination on a real-time basis
\4\ a compilation of all visible limit orders resident in the AEMI
central limit order book (``AEMI Depth of Book''). The Exchange
proposes that AEMI Depth of Book information be made available to
market data vendors, broker-dealers, private network providers, and
other entities by means of data feeds. The Exchange believes that, by
making the AEMI Depth of Book available, the Exchange would be
enhancing market transparency and fostering competition among orders
and markets. With the adoption of Regulation NMS, the Commission
rescinded ``the prohibition on SROs and their members from
disseminating their trade reports independently.'' The Commission
requires such dissemination to be fair, reasonable and not unreasonably
discriminatory. The Exchange believes that the Exchange's data
distribution and proposed fees would be consistent with these standards
and reflect an equitable allocation of the Exchange's overall costs to
users of its facilities.
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    \4\ It should be noted that the Exchange makes available to
vendors the best bids and offers that are included in the AEMI limit
order book data no earlier than it makes those best bids and offers
available to the processors under the CQ Plan and the Reporting Plan
for Nasdaq/National Market System Securities Traded on an Exchange
on an Unlisted or Listed Basis (the ``UTP Plan'').
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    The Exchange proposes to establish the Market Data Fee Schedule for
the receipt and use of various forms of Amex market data. The Market
Data Fee Schedule being proposed is limited to market data for equities
and exchange-traded fund shares (``ETFs'') trading on the AEMI system.
Amex plans to implement use of the AEMI system over a period of time,
commencing with four products. The Exchange will monitor the operation
of AEMI and will deploy additional products when appropriate. It is
anticipated that all equity and ETF products will be trading on AEMI
prior to the implementation of Regulation NMS in February 2007. The
Exchange would begin charging for the AEMI Depth of Book data once all
products are trading on the AEMI system and the market data is
available for all products. When AEMI is expanded to other product
lines, such as options, the Exchange may further amend its fee schedule
to include fees for the receipt and use of Amex market data for those
products. As the Market Data Fee Schedule details, the Exchange is
proposing to assess data access fees and professional and
nonprofessional device fees for the AEMI Depth of Book. The Exchange
states that these categories of fees are consistent with fees the New
York Stock Exchange's (``NYSE'') charges for the receipt and use of
their market data through the NYSE OpenBook \5\ and the fees proposed
to be charged for the NYSE Arca, Inc.'s (``NYSE Arca'') ArcaBook.\6\
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    \5\ NYSE OpenBook provides information relating to limit orders.
    \6\ The ArcaBook provides a compilation of all limit orders
resident in the NYSE Arca limit order book. See Securities Exchange
Act Release No. 53952 (June 7, 2006), 71 FR 33496 (June 9, 2006)
(notice of filing of proposed rule change for SR-NYSEArca-2006-21).
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     Data Access Fees. Direct Access.--The Exchange proposes to
impose a monthly fee of $2,000 for a data recipient to gain direct
access to the data feeds through which the Exchange makes AEMI market
data available.
     Indirect Access.--The Exchange proposes to impose a
monthly fee of $1,500 for a data recipient to gain indirect access to
the data feeds through which the Exchange makes AEMI market data
available. ``Indirect access'' refers to access to an AEMI market data

feed indirectly through one or more intermediaries, rather than by
means of a direct connection or linkage with the Exchange's facilities.
    The Exchange believes that these Data Access Fees compare favorably
with fees charged by other exchanges for similar products. For example,
NYSE charges $5,000 per month for direct and indirect access to NYSE
OpenBook. While NYSE Arca proposes to charge only $750 per month for
direct access to ArcaBook, that access is limited to four ``Logons.''
Amex does not propose to place any limitation on the number of
``Logons.''
     Device Fees.--The Exchange proposes to establish device
fees for professional and nonprofessional subscribers for the display
of AEMI Depth of Book. In differentiating between professional and
nonprofessional subscribers, the Exchange proposes to apply the same
criteria for nonprofessional qualification as used by the CTA and CQ
Plan Participants.
    a. Professional Subscribers. For professional subscribers, the
Exchange is proposing to establish a monthly fee of $20 per device for
the receipt of AEMI Depth of Book data relating to all securities
traded on AEMI. The Exchange believes this fee compares favorably with
fees charged by other exchanges for similar products. For example, for
professional subscribers, Nasdaq charges $76 for its combined TotalView
\7\ and OpenView \8\ products and NYSE charges $60 for NYSE
OpenBook.\9\ In addition, NYSE Arca proposes to charge a combined
monthly professional subscriber device fee of $30 for receipt of
ArcaBook data.\10\
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    \7\ Through TotalView, Nasdaq provides information relating to
the displayed quotes and orders of Nasdaq participants in UTP Plan
Securities. TotalView displays quotes and orders at multiple prices
and is similar to AEMI Depth of Book.
    \8\ Through OpenView, Nasdaq provides information relating to
the displayed quotes and orders of Nasdaq participants in CTA Plan
Securities. OpenView displays quotes and orders at multiple prices
and is similar to AEMI Depth of Book.
    \9\ Through NYSE OpenBook, NYSE provides information relating to
limit orders.
    \10\ See Securities Exchange Act Release No. 53952 (June 7,
2006), 71 FR 33496 (June 9, 2006) (notice of filing of proposed rule
change for SR-NYSEArca-2006-21).
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    b. Nonprofessional subscribers. For nonprofessional subscribers,
the Exchange is proposing to reduce those monthly fees to $10 per
device for the receipt of AEMI Depth of Book data for securities traded
on AEMI. NYSE Arca proposes to charge a combined monthly
nonprofessional subscriber device fee of $10 for receipt of ArcaBook
data.\11\
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    \11\ See id.
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    The Exchange would require each recipient of a data feed containing
AEMI market data to enter into the form of ``vendor'' agreement into
which the CTA and CQ Plans require recipients of the Network B data
feeds to enter. The agreement would authorize the data feed recipient
to provide AEMI Market Data services to its customers or to distribute
the data internally.
    In addition, the Exchange would require each professional end-user
that receives AEMI market data displays from a vendor or broker-dealer
to enter into the form of professional subscriber agreement into which
the CTA and CQ Plans require end users of Network B data to enter into.
The Exchange would also require vendors and broker-dealers to subject
nonprofessional subscribers to the same contract requirements as the
CTA and CQ Plan Participants require of Network B nonprofessional
subscribers.
    The Exchange proposes to provide its market data under the same
contracts that the CTA and CQ Plans use since those contracts are
drafted as generic, one-size-fits-all agreements and explicitly apply
to the receipt and use of certain market data that individual exchanges
make available in the same way as they apply to data made available
under the CTA and CQ Plans. According to the Exchange, no amendments to
those contracts are needed to cause them to govern the receipt and use
of the Exchange's market data. Moreover, the Exchange is not imposing
restrictions on the use or display of the AEMI market data beyond those
set forth under these preexisting agreements.
    The Exchange believes that the proposed market data fees would
reflect an equitable allocation of its overall costs to users of its
facilities. As described above, the Exchange believes that the fees are
fair and reasonable because they compare favorably to fees that other
markets charge for similar products.
2. Statutory Basis \12\
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    \12\ See E-mail to David Hsu, Special Counsel, Division of
Market Regulation, Commission, from Claire McGrath, Senior Vice
President and General Counsel, Amex, dated November 17, 2006
(clarifying the statutory basis of the proposed rule change).
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    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations under the Act applicable to a
national securities exchange and, in particular, the requirements of
Section 6(b) of the Act.\13\ Specifically, the Exchange believes the
proposed rule change is consistent with the requirements of Section
6(b)(5) of the Act \14\ that the rules of an exchange be designed to
promote just and equitable principles of trade, to prevent fraudulent
and manipulative acts and practices, and, in general, to protect
investors and the public interest. In addition, the Exchange believes
that the proposed rule change is consistent with the provisions of
Section 6(b)(4) of the Act, \15\ which requires that the rules an
exchange provide for the equitable allocation of reasonable dues, fees,
and other charges among its members and issuers and other persons using
its facilities.
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    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
    \15\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change would impose no burden on competition that
is not necessary or appropriate in furtherance of the purposes of the
Act.

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

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

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding, or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve the proposed rule change or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml
); or

     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Amex-2006-89 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-2006-89. 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 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-2006-89 and should be submitted on or before December 18, 2006.

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\16\
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    \16\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E6-19980 Filed 11-24-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Rules and Regulations]
[Pages 51975-51977]
[FR Doc No: 2019-21277]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[USCG-2019-0818]
RIN 1625-AA00

Safety Zone; San Jacinto River, Channelview, TX

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule; request for comments.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the San Jacinto River from the southern end of
Southwest Shipyard, extending north of the I-10 bridge, just abreast of
Buoy #14. The safety zone is needed to protect personnel, vessels, and
the marine environment from potential hazards created by salvage and
over-water bridge repairs. Entry of vessels or persons into this zone
is prohibited unless specifically authorized by the Captain of the Port
Houston-Galveston.

DATES: This rule is effective without actual notice from October 1,
2019 through December 24, 2019. For the purposes of enforcement, actual
notice will be used from September 25, 2019, through October 1, 2019.
Comments and related material must be received before October 31, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0818 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule. You may submit
comments identified by docket number USCG-2019-0818 using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
Participation and Request for Comment'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments. To
view documents mentioned in this

preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2019-0818 in the ``SEARCH'' box and
click ``SEARCH.'' Click on Open Docket Folder on the line associated
with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LCDR Sarah Rousseau, Sector Houston-Galveston Waterways
Management Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable and contrary to
the public interest. We must establish this safety zone immediately in
order to ensure the safety of the public and lack sufficient time to
provide a reasonable comment period and then consider those comments
before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because immediate action is needed to respond to the potential safety
hazards associated with salvage and over-water bridge repairs of the I-
10 bridge.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Houston-
Galveston (COTP) has determined that potential hazards associated with
salvage and over-water bridge repairs that began on September 19, 2019,
are a safety concern for vessel traffic transiting the navigable
waterway of the San Jacinto River from the southern end of Southwest
Shipyard, extending north of the I-10 bridge, just abreast of Buoy #14.
This rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the safety zone from
potential hazardous from salvage and over-water bridge repairs.

IV. Discussion of the Rule

    This rule establishes a safety zone from September 25, 2019,
through December 24, 2019. The safety zone will cover the navigable
waters of the San Jacinto River from the southern end of Southwest
Shipyard, extending north of the I-10 bridge, just abreast of Buoy #14.
The duration of the zone is intended to protect personnel, vessels, and
the marine environment in the navigable waters within the safety zone
from potential hazardous from salvage and over-water bridge repairs. No
vessel or person will be permitted to enter the safety zone without
obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. This rule will
impact a small designated area of the San Jacinto River in order to
support salvage and over-water bridge repairs from September 25, 2019
through December 24, 2019. Moreover, the Coast Guard would issue a
Broadcast Notice to Mariners via VHF-FM marine channels 13 and 16 about
the zone, and the rule would allow vessels to seek permission to enter
the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct

effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. We have
analyzed this rule under that Order and have determined that it is
consistent with the fundamental federalism principles and preemption
requirements described in Executive Order 13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone that will prohibit entry
to the navigable waters of the San Jacinto River from the southern end
of Southwest Shipyard, extending north of the I-10 bridge, just abreast
of Buoy #14, without prior approval from Coast Guard Sector Houston-
Galveston COTP. It is categorically excluded from further review under
paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental
Planning Implementing Procedures. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping, requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0818 to read as follows:

Sec.  165.T08-0818  Safety Zone; San Jacinto River, Channelview, TX.

    (a) Location. The following area is a safety zone: The navigable
waters of the San Jacinto River from the southern end of Southwest
Shipyard, extending north of the I-10 bridge, just abreast of Buoy #14,
in Channelview, TX in approximate location 29[deg]47'33.5'' N,
095[deg]03'41.2'' W.
    (b) Enforcement period. This section will be enforced from
September 25, 2019, through December 24, 2019, or until all hazardous
conditions associated with salvage and over-water bridge repairs have
been mitigated.
    (c) Regulations. (1) Transit of the safety zone is open to limited
traffic with the following restrictions:
    (i) Only light boats and single barge tows may transit.
    (ii) Transit only during daylight hours (sunrise to sunset).
    (iii) There shall be no meeting or overtaking.
    (iv) All vessels must check in and out with Vessel Traffic Service
Houston/Galveston at least 15 minutes prior to entering the safety
zone.
    (2) Persons and vessels desiring to enter the safety zone must
request permission from the COTP or a designated representative. They
may be contacted through Vessel Traffic Service (VTS) on channels 13 or
16 VHF-FM, or by telephone at<PHONE_NUMBER>.
    (3) Permission to transit through the bridge will be based on
weather, tide and current conditions, vessel size, horsepower, and
availability of assist vessels. All persons and vessels permitted to
enter this temporary safety zone shall comply with the lawful orders or
directions given to them by COTP or a designated representative.
    (4) Intentional or unintentional contact with any part of the
bridge or associated structure, including fendering systems, support
columns, spans or any other portion of the bridge, is strictly
prohibited. Report any contact with the bridge or associated structures
immediately to VTS Houston/Galveston on channels 13 or 16 VHF-FM or by
telephone at<PHONE_NUMBER>.
    (d) Informational broadcasts. The Coast Guard will inform the
public through public of the effective period of this safety zone
through VTS Advisories, Broadcast Notices to Mariners (BNMs), Local
Notice to Mariners (LNMs), and/or Marine Safety Information Bulletins
(MSIBs) as appropriate.

    Dated: September 25, 2019.
Richard E. Howes,
Captain, U.S. Coast Guard, Acting Captain of the Port Sector Houston-
Galveston.
[FR Doc. 2019-21277 Filed 9-30-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 190 (Monday, October 3, 2022)]
[Rules and Regulations]
[Pages 59666-59667]
[FR Doc No: 2022-21359]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0572; Airspace Docket No. 21-ANM-66]
RIN 2120-AA66

Establishment of Class E Airspace; McCarley Field, ID

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace extending upward from
700 feet above the surface at McCarley Field, ID. This action contains
all instrument flight rule (IFR) arrival and departure operations at
the airport.

DATES: Effective 0901 UTC, December 29, 2022. The Director of the
Federal Register approves this incorporation by reference under 1 CFR
part 51, subject to the annual revision of FAA Order JO 7400.11,
Airspace Designations and Reporting Points, and publication of
conforming amendments.

ADDRESSES: FAA Order JO 7400.11G, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Gerald DeVore II, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S. 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority,
as it establishes Class E airspace at McCarley Field, Blackfoot, ID, to
support IFR operations at the airport.

History

    The FAA published a notice of proposed rulemaking (NPRM) in the
Federal Register for FAA-2022-0572 (87 FR 38306; June 28, 2022) that
proposed to establish Class E airspace extending upward from 700 feet
above the surface at McCarley Field, ID. Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. No comments were received.
    Class E5 airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11F, dated August 19, 2022, and effective September
15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designation listed in this document will be published
subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11G, Airspace Designations
and Reporting Points, dated August 19, 2022, and effective September
15, 2022. FAA Order JO 7400.11G is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11G lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    The FAA is amending 14 CFR part 71 by establishing Class E airspace
extending upward from 700 feet above the surface at McCarley Field, ID.
This airspace is designed to accommodate arriving IFR operations below
1,500 feet above the surface and departing IFR operations until they
reach 1,200 feet above the surface.
    Class E5 airspace designations are published in paragraph 6005 of
FAA Order JO 7400.11G, dated August 19, 2022, and effective September
15, 2022,

which is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document will be published subsequently in
FAA Order JO 7400.11.
    FAA Order JO 7400.11 is published annually and becomes effective on
September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial, and unlikely to result in adverse or negative
comments. It therefore: (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures,
paragraph 5-6.5a. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant the preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the FAA amends 14 CFR part 71 as
follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022 and effective September 15, 2022, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANM ID E5 Blackfoot, ID [New]

McCarley Field, ID
    (Lat. 43[deg]12'33'' N, long. 112[deg]20'59'' W)

    That airspace extending upward from 700 feet above the surface
within a 4.2 mile radius of the McCarley Field, and within 2 miles
each side of the 030[deg] bearing extending from the 4.2 mile radius
to 7 miles northeast of the airport, and within 2.3 miles each side
of the 213[deg] bearing extending from the 4.2 mile radius to 6.4
miles southwest of the airport, and within 1.6 miles each side of
the 213[deg] bearing extending from the 4.2 mile radius to 13.6
miles southwest of the airport.

    Issued in Des Moines, Washington, on September 27, 2022.
B.G. Chew,
Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2022-21359 Filed 9-30-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 30, 2008 (Volume 73, Number 126)]
[Notices]
[Page 36858]
[DOCID:fr30jn08-60]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR08-11-000]

Nexen Marketing U.S.A. Inc. Complainant, v. Enbridge Pipelines
(North Dakota) LLC, Respondent; Notice of Complaint

June 20, 2008.
    Take notice that on June 18, 2008, Nexen Marketing U.S.A. Inc.
(Nexen) filed a formal complaint against Enbridge Pipelines (North
Dakota) LLC (Enbridge North Dakota), pursuant to Rule 206 of the Rules
of Practice and Procedures of the Commission's regulations, 18 CFR
385.206. Nexen alleges that Enbridge North Dakota has unfairly and
unreasonably imposed penalties that substantially reduce the quantity
of crude oil that Nexen is able to ship on its pipeline. Nexen alleges
that a force majeure event occurred and Enbridge North Dakota's
interpretation and application of the force majeure provision of its
tariff was unjust and unreasonable and violated its obligation under
the Interstate Commerce Act to treat shippers in a just, reasonable and
nondiscriminatory manner.
    Nexen certifies that copies of the complaint were served on the
issuing officer of Enbridge North Dakota's tariff.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of Respondent's
answer, protests and interventions in lieu of paper using the
``eFiling'' link at http://www.ferc.gov. Persons unable to file
electronically should submit an original and 14 copies of the protest
or intervention to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 18, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-14684 Filed 6-27-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27376-27377]
[FR Doc No: 2011-11573]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2011-0040]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt seventeen individuals
from its rule prohibiting persons with insulin-treated diabetes
mellitus (ITDM) from operating commercial motor vehicles (CMVs) in
interstate commerce. The exemptions will enable these individuals to
operate CMVs in interstate commerce.

DATES: The exemptions are May 11, 2011. The exemptions expire on May
13, 2013.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room W64-224,
Department of Transportation, 1200 New Jersey Avenue, SE., Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

Background

    On March 29, 2011, FMCSA published a notice of receipt of Federal
diabetes exemption applications from seventeen individuals and
requested comments from the public (76 FR 17478). The public comment
period closed on April 28, 2011 and one comment was received.
    FMCSA has evaluated the eligibility of the seventeen applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current standard for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible.
    The September 3, 2003 (68 FR 52441) Federal Register notice in
conjunction with the November 8, 2005 (70 FR 67777) Federal Register
notice provides the current protocol for allowing such drivers to
operate CMVs in interstate commerce.

    These seventeen applicants have had ITDM over a range of 1 to 28
years. These applicants report no severe hypoglycemic reactions
resulting in loss of consciousness or seizure, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning symptoms, in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the past 5 years.
In each case, an endocrinologist verified that the driver has
demonstrated a willingness to properly monitor and manage his/her
diabetes mellitus, received education related to diabetes management,
and is on a stable insulin regimen. These drivers report no other
disqualifying conditions, including diabetes-related complications.
Each meets the vision standard at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the March 29, 2011, Federal Register
notice and they will not be repeated in this notice.

Discussion of Comment

    FMCSA received one comment in this proceeding. The comment was
considered and discussed below.
    The Pennsylvania Department of Transportation stated that it had
reviewed the driving record for Edward D. Boyer and are in favor of
granting him a Federal diabetes exemption.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. The exemption allows the applicants
to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes standard in 49 CFR 391.41(b)(3) is likely
to achieve a level of safety equal to that existing without the
exemption.

Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

Conclusion

    Based upon its evaluation of the seventeen exemption applications,
FMCSA exempts, Peter N. Amendola, Edward D. Boyer, Steven V. Callison,
Douglas A. Carroll, Bradley J. Frazier, Tamara S. Folsom, Gerald W.
Fryar, Richard P. Inott, Ernest Martinelli, Jonathan C. Morgan,
Benjamin D. Phelps, Richard J. Rasch, Philip J. Regan, Paul E. Regelin,
II, David R. Smith, Adam J. Stegenga and Donald D. Willard from the
ITDM standard in 49 CFR 391.41(b)(3), subject to the conditions listed
under ``Conditions and Requirements'' above.
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will
be valid for two years unless revoked earlier by FMCSA. The exemption
will be revoked 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. If the exemption is
still effective at the end of the 2-year period, the person may apply
to FMCSA for a renewal under procedures in effect at that time.

    Issued on: May 5, 2011.
Larry W. Minor,
Associate Administrator of Policy.
[FR Doc. 2011-11573 Filed 5-10-11; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Rules and Regulations]
[Pages 48383-48384]
[FR Doc No: 2018-20748]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0020; FRL-9984-23--Region 4]

Air Plan Approval; North Carolina; Inspection and Maintenance
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of North
Carolina on November 17, 2017, through the North Carolina Department of
Environmental Quality, Division of Air Quality (DAQ), for the purpose
of removing 26 counties from North Carolina's expanded inspection and
maintenance (I/M) program, which was previously approved into the SIP
for use as a component of the State's Nitrogen Oxides (NOX)
Budget and Allowance Trading Program. The EPA has determined that North
Carolina's November 17, 2017, SIP revision is approvable because it is
consistent with the Clean Air Act (CAA or Act) and with the EPA's
regulations.

DATES: This rule will be effective September 25, 2018.

ADDRESSES: The EPA has established a docket for this action under
Docket Identification No. EPA-R04-OAR-2018-0020. All documents in the
docket are listed on the www.regulations.gov website. Although listed
in the index, some information is not publicly available, i.e.,
Confidential Business Information 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 either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Kelly Sheckler, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, Region 4, U.S. Environmental
Protection Agency, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960.
The telephone number is<PHONE_NUMBER>. Ms. Sheckler can also be
reached via electronic mail at [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On November 17, 2017, DAQ submitted a SIP revision seeking to
remove 26 counties from the expanded I/M program contained in the North
Carolina SIP. This removal consequently removes reliance on the I/M
reduction credits gained from the 26 counties' participation in the
expanded I/M program from the State's NOX emissions budget--
a component of the State's response to the NOX SIP Call.
North Carolina indicated that it no longer needs these reduction
credits in order to meet its obligations under the NOX SIP
Call. In addition, North Carolina provided a technical demonstration
showing that removing the 26 counties from the expanded I/M program
will not interfere with North Carolina's attainment or maintenance of
any National Ambient Air Quality Standard (NAAQS) or with any other
applicable requirement of the CAA.
    The EPA published a proposed rulemaking on July 26, 2018 (83 FR
35444), proposing to approve this SIP revision. The proposed approval
was based on the EPA's proposed findings that the removal of the 26
counties from the State's expanded I/M program will not interfere with
North Carolina's obligations under the NOX SIP Call and will
not interfere with North Carolina's attainment or maintenance of any
NAAQS or with any other applicable requirement of the CAA. The details
of North Carolina's submittal and the rationale for the EPA's action
are explained in the proposed rulemaking. The comment period for this
proposed rulemaking closed on August 27, 2018. The EPA received two
comments supporting the proposed action. The remaining comments
received were not relevant.

II. Final Action

    The EPA is taking final action to approve the November 17, 2017,
revision to the North Carolina SIP. Specifically, the EPA is approving
the removal of Brunswick, Burke, Caldwell, Carteret, Catawba, Chatham,
Cleveland, Craven, Edgecombe, Granville, Harnett, Haywood, Henderson,
Lenoir, Moore, Nash, Orange, Pitt, Robeson, Rutherford, Stanly, Stokes,
Surry, Wayne, Wilkes, and Wilson counties from the SIP-approved
expanded I/M program. Additionally, the EPA is finding that North
Carolina's removal of the 26 counties from the SIP-approved expanded I/
M program (and the removal of reliance on the I/M emissions reductions
generated from those counties as part of the ``credits'' in North
Carolina's NOX emissions budget) will not interfere with the
State's obligations under the NOX SIP Call to meet its
Statewide NOX emissions budget. The EPA is also finding that
the removal of the 26 counties from the SIP-approved I/M program will
not interfere with continued attainment or maintenance of any
applicable NAAQS or with any other applicable requirement of the CAA,
and that North Carolina has satisfied the requirements of section
110(l) of the CAA.
    The EPA has determined that this action is effective immediately
upon publication under the authority of 5 U.S.C. 553(d)(1). The purpose
of the 30-day waiting period prescribed in section 553(d) is to give
affected parties a reasonable time to adjust their behavior and prepare
before the final rule takes effect. Section 553(d)(1) allows an
effective date less than 30 days after publication if a substantive
rule ``relieves a restriction.'' This action qualifies for the
exception under section 553(d)(1) because it relieves the 26 counties
identified above from the requirements of North Carolina's SIP-approved
expanded I/M program.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 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 CAA. 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 2,
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 CAA; 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).
    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 as specified by Executive Order
13175 (65 FR 67249, November 9, 2000), nor will it impose substantial
direct costs on tribal governments or preempt tribal law.
    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 CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 26, 2018. 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: September 11, 2018.
Onis ``Trey'' Glenn, III,
Regional Administrator, Region 4.

    40 CFR part 52 is amended 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 II--North Carolina

0
2. In Sec.  52.1770, the table in paragraph (e) is amended by adding
the entry ``North Carolina Removal of 26 Counties from Inspection and
Maintenance Program and 110(l) Non-Interference Demonstration'' at the
end of the table to read as follows:

Sec.  52.1770  Identification of plan.

* * * * *
    (e) * * *

                              EPA-Approved North Carolina Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                      State       EPA approval    Federal Register
           Provision             effective date       date            citation               Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
North Carolina Removal of 26         11/17/2017       9/25/2018  [insert Federal    ............................
 Counties from Inspection and                                     Register
 Maintenance Program and 110(l)                                   citation].
 Non-Interference Demonstration.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2018-20748 Filed 9-24-18; 8:45 am]
 BILLING CODE 6560-50-P


Comment Info: =================

General Comment:I am opposed to regulation of vaping sales and activity beyond restrictions to minors. Vaping has allowed me to finally become free of cigarettes and to enjoy a new tinkering hobby as well as the opportunity to meet some cool people I otherwise would not have had the opportunity to meet.

In addition, a 75 day comment period is insufficient time for the vaping industry and the wider vaping community to comment on the proposed deeming regulations. I would respectfully request that the period for comment be extended to 180 days.