[Federal Register: June 7, 2007 (Volume 72, Number 109)]
[Notices]
[Page 31572-31573]
[DOCID:fr07jn07-43]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

June 1, 2007.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC07-98-000.
    Applicants: James A. Goodman.
    Description: Brick Power Holdings LLC submits an application
requesting authorization and approval to transfer existing control over
assets to himself in his anticipated capacity as the sole Managing
Member.
    Filed Date: 05/24/2007.
    Accession Number: 20070531-0127.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 14, 2007.

    Docket Numbers: EC07-99-000.
    Applicants: Great Plains Energy Incorporated, Kansas City Power &
Light Company, Aquila, Inc., and Black Hills Corporation.
    Description: Great Plains Energy Inc., et al request for approval
of a two-step transaction in which Aquila will sell its jurisdictional
electric utility assets located in Colorado.
    Filed Date: 05/25/2007.
    Accession Number: 20070531-0175.
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

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

    Docket Numbers: ER07-576-001.
    Applicants: Baltimore Gas and Electric Company.
    Description: Baltimore Gas and Electric Company submits its
responses to the information requested in FERC's Deficiency Letter
dated 5/4/07.
    Filed Date: 05/25/2007.
    Accession Number: 20070531-0085.
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

    Docket Numbers: ER07-939-000.
    Applicants: Columbia Utilities Power, LLC.
    Description: Columbia Utilities Power, LLC's Petition for
Acceptance of Initial Tariff, Waivers and Blanket Authority, FERC
Electric Tariff, Original Volume No.1.
    Filed Date: 05/25/2007.
    Accession Number: 20070530-0121.
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

    Docket Numbers: ER07-941-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits notice of
termination of the revised Service Agreement for Wholesale Distribution
Service and Letter Agreement with Modesto Irrigation District.
    Filed Date: 05/25/2007.
    Accession Number: 20070530-0135.
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

    Docket Numbers: ER07-942-000.
    Applicants: ISO New England Inc., New England Power Pool.
    Description: ISO New England Power Pool Participants Committee et
al submits its Market Rule 1 changes relating to support payments for
the cost of Internet Based Communication System etc.
    Filed Date: 05/29/2007.
    Accession Number: 20070531-0101.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 19, 2007.

    Docket Numbers: ER07-943-000.
    Applicants: Black Hills Power, Inc., Cheyenne Light Fuel & Power
Company.
    Description: Black Hills Power Inc and Cheyenne Light, Fuel and
Power Co submit a Generation Dispatch and Energy Management Agreement.
    Filed Date: 05/29/2007.
    Accession Number: 20070531-0102.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 19, 2007.

    Docket Numbers: ER07-944-000, ER07-945-000.
    Applicants: Florida Power & Light Company, FPL Energy Power
Marketing, Inc.
    Description: Florida Power & Light Co and FPL Energy Power
Marketing, Inc submits proposed amendments to their market based rate
tariffs.
    Filed Date: 05/29/2007.
    Accession Number: 20070531-0099.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 19, 2007.

    Docket Numbers: ER07-946-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits Second Revised Sheet No. 1
et al. of First Revised Rate Schedule FERC No. 226 with the City of
Holton, Kansas.
    Filed Date: 05/29/2007.
    Accession Number: 20070531-0093.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 19, 2007.

    Docket Numbers: ER07-947-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits Second Revised Sheet No. 1
and First Revised Sheet No. 4 of First Revised Rate Schedule No. 235, a
Wholesale Electric Service Agreement with the City of Sabetha, Kansas.
    Filed Date: 05/29/2007.
    Accession Number: 20070531-0097.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 19, 2007.

    Docket Numbers: ER07-948-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits Second Revised Sheet No. 1
et al. of First Revised FERC Rate Schedule No. 211, a Wholesale
Electric Service Agreement with the City of Minneapolis, Kansas.
    Filed Date: 05/29/2007.
    Accession Number: 20070531-0098.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 19, 2007.

    Docket Numbers: ER07-949-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc on behalf of Kansas Gas and
Electric Co submits Third Revised Sheet No.1 et al of Rate Schedule
FERC No. 152 with Missouri Public Service Co.
    Filed Date: 05/25/2007.
    Accession Number: 20070531-0100.
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

    Docket Numbers: ER07-950-000.
    Applicants: Saracen Energy MB L.P.
    Description: Saracen Energy MB, LP submits petition for acceptance
of initial

rate schedule, waivers, and blanket authorization.
    Filed Date: 05/25/2007.
    Accession Number: 20070531-0094.
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

    Docket Numbers: ER07-951-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits revised
sheets to the Sunkist Wholesale Distribution Load Interconnection
Facilities Agreement and the Service Agreement for Wholesale
Distribution Service.
    Filed Date: 05/25/2007.
    Accession Number: 20070531-0095.
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

    Docket Numbers: ER07-952-000.
    Applicants: Maine Public Service Company.
    Description: Maine Public Service Company submits proposed
revisions to its FERC OATT to reflect minor ministerial modifications
to the sheets used to calculate the open access transmission charges.
    Filed Date: 05/25/2007.
    Accession Number: 20070531-0096.
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

    Docket Numbers: ER07-954-000.
    Applicants: American Transmission Company, LLC.
    Description: American Transmission Company LLC submits an executed
and amended Distribution-Transmission Interconnection Agreement with
the City of Menasha dated 10/19/06.
    Filed Date: 05/25/2007.
    Accession Number: 20070531-0104
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

    Docket Numbers: ER96-2495-029, ER97-4143-017, ER97-1238-024, ER98-
2075-023, ER98-542-019.
    Applicants: AEP Power Marketing Inc AEP Service Corporation; AEP
Energy Partners, LP; CSW Energy Services, Inc. Central; and South West
Services, Inc.
    Description: AEP Power Marketing, Inc et al submit notice of Change
in Status in connection with their authority to make sales at
negotiated market-based rates.
    Filed Date: 05/25/2007.
    Accession Number: 20070531-0125.
    Comment Date: 5 p.m. Eastern Time on Friday, June 15, 2007.

    Docket Numbers: ER99-3426-007.
    Applicants: San Diego Gas & Electric Company.
    Description: San Diego Gas & Electric Company submits a notice of
change in status in connection with a net increase in its generation
capacity pursuant to section 35.27(c) of FERC's Regulations.
    Filed Date: 05/30/2007.
    Accession Number: 20070531-0086.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 20, 2007.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-10995 Filed 6-6-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 68 (Monday, April 12, 2021)]
[Notices]
[Pages 19052-19053]
[FR Doc No: 2021-07388]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-91485; File No. SR-ISE-2021-05]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Extend the Pilot
To Permit the Listing and Trading of Options Based on \1/5\ the Value
of the Nasdaq-100 Index

April 6, 2021.
    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 March 24, 2021, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to extend the pilot to permit the listing and
trading of options based on \1/5\ the value of the Nasdaq-100 Index
(``Nasdaq-100'') currently set to expire on May 4, 2021.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/ise/rules, at the
principal office of the Exchange, 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
    ISE filed a proposed rule change to permit the listing and trading
of index options on the Nasdaq 100 Reduced Value Index (``NQX'') on a
twelve month pilot basis \3\ (``Program'').
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    \3\ See Securities Exchange Act Release No. 82911 (March 20,
2018), 83 FR 12966 (March 26, 2018) (SR-ISE-2017-106) (Approval
Order).
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    NQX options trade independently of and in addition to NDX options,
and the NQX options are subject to the same rules that presently govern
the trading of index options based on the Nasdaq-100, including sales
practice rules, margin requirements, trading rules, and position and
exercise limits. Similar to NDX, NQX options are European-style and
cash-settled, and have a contract multiplier of 100. The contract
specifications for NQX options mirror in all respects those of the NDX
options contract listed on the Exchange, except that NQX options are
based on \1/5\ of the value of the Nasdaq-100, and are P.M.-settled
pursuant to Options 4A, Section 12(a)(6).
    The Exchange proposes to amend ISE Options 4A, Section 12(a)(6) to
extend the current NQX pilot period to November 4, 2021. This pilot was
previously extended with the last extension through May 4, 2021.\4\ The
Exchange continues to have sufficient capacity to handle additional
quotations and message traffic associated with the proposed listing and
trading of NQX options. In addition, index options are integrated into
the Exchange's existing surveillance system architecture and are thus
subject to the relevant surveillance processes. The Exchange also
continues to have adequate surveillance procedures to monitor trading
in NQX options thereby aiding in the maintenance of a fair and orderly
market. Additionally, there is continued investor interest in these
products and this extension will provide additional time to collect
data related to the pilot.
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    \4\ See Securities Exchange Act Release Nos.86071 (June 10,
2019), 84 FR 27822 (June 14, 2019) (SR-ISE-2019-18); 87379 (October
22, 2019), 84 FR 57793 (October 28, 2019) (SR-ISE-2019-27); 88683
(April 17, 2020), 85 FR 22768 (April 23, 2020) (SR-ISE-2020-18); and
90257 (October 22, 2020), 85 FR 68387 (October 28, 2020) (SR-ISE-
2020-33).
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    The Exchange believes that the proposed extension of the Program
will not have an adverse impact on capacity.

Pilot Report
    The Exchange currently makes public on its website the data and
analysis previously submitted to the Commission on the Program and will
continue to make public any data or analysis it submits under the
Program in the future. The Exchange will be submitting a rule change to
request that the Program become permanent. In lieu of submitting any
additional annual reports, the Exchange would provide additional
information requested by the Commission in connection with the
permanency rule change for this Program.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\5\ in general, and furthers the
objectives of Section 6(b)(5) of the Act,\6\ in particular, in that it
is designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general to protect
investors and the public interest. In particular, the Exchange believes
that the Program has been successful to date. The Exchange has not
encountered any problems with the Program. By extending the pilot, the
Exchange believes it will attract order flow to the Exchange, increase
the variety of listed options, and provide a valuable hedge tool to
retail and other investors. Specifically, the Exchange believes that
the pilot will provide additional trading and hedging opportunities for
investors while providing the Commission with data to monitor for and
assess any potential for adverse market effects of allowing P.M.-
settlement for NQX options, including on the underlying component
stocks.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. NQX options would be
available for trading to all market participants and therefore would
not impose an undue burden on intra-market competition.
    The Exchange believes that the proposed rule change will not impose
an undue burden on inter-market competition as this rule change will
continue to facilitate the listing and trading of a new option product
that will enhance competition among market participants, to the benefit
of investors and the marketplace. The continued listing of NQX will
enhance competition by providing investors with an additional
investment vehicle, in a fully-electronic trading environment, through
which investors can gain and hedge exposure to the Nasdaq-100.
Furthermore, this product could offer a competitive alternative to
other existing investment products that seek to allow investors to gain
broad market exposure. Finally, it is possible for other exchanges to
develop or license the use of a new or different index to compete with
the Nasdaq-100 and seek Commission approval to list and trade options
on such an index.

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

    No written comments were either solicited or received.

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

    Because the proposed rule change does not: (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, it has become effective pursuant to Section
19(b)(3)(A) of the Act \7\ and subparagraph (f)(6) of Rule 19b-4
thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    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 shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2021-05 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2021-05. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (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 website 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. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-ISE-2021-05, and should be submitted on
or before May 3, 2021.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
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    \9\ 17 CFR 200.30-3(a)(12).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-07388 Filed 4-9-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 46 (Friday, March 10, 2017)]
[Notices]
[Pages 13337-13338]
[FR Doc No: 2017-04681]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-R04-OAR-2016-0782; FRL-9959-75-Region 4]

Adequacy Status of the Knoxville, TN 1997 Annual PM2.5
Maintenance Plan Motor Vehicle Emission Budgets for Transportation
Conformity Purposes

AGENCY: Environmental Protection Agency.

ACTION: Notice of adequacy.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is notifying
the public that it has found that the motor vehicle emissions budgets
(MVEBs) contained in the State Implementation Plan (SIP) revision
pertaining to the Knoxville, Tennessee 1997 Annual fine particulate
matter (PM2.5) nonattainment area are adequate for
transportation conformity purposes. This SIP revision was submitted on
December 20, 2016, by the Tennessee Department of Environment and
Conservation (TDEC) and requests that EPA redesignate the area to
attainment for the 1997 annual PM2.5 national ambient air
quality standards (NAAQS), and that EPA approve a maintenance plan for
the continued attainment of the Area. The Knoxville 1997 Annual
PM2.5 nonattainment area (hereafter referred to as ``the
Knoxville Area''), for which MVEBs are established in this notice, is
comprised of the entire counties of Anderson, Blount, Knox, and Loudon,
as well as a portion of Roane County. On March 2, 1999, the United
States Court of Appeals for the District of Columbia Circuit (D.C.
Circuit) ruled that submitted SIPs cannot be used for transportation
conformity determinations until EPA has affirmatively found that the
MVEBs are adequate. As a result of EPA's finding, the Knoxville Area
must use the MVEBs for future conformity determinations for the 1997
Annual PM2.5 NAAQS.

DATES: These MVEBs are effective March 27, 2017.

FOR FURTHER INFORMATION CONTACT: Kelly Sheckler, U.S. Environmental
Protection Agency, Region 4, Air Regulatory Management Section, 61
Forsyth Street SW., Atlanta, Georgia 30303. Ms. Sheckler can also be
reached by telephone at<PHONE_NUMBER>, or via electronic mail at
<EMAIL_ADDRESS>The finding is available at EPA's conformity
Web site: http://www.epa.gov/otaq/stateresources/transconf/currsips.htm.

SUPPLEMENTARY INFORMATION: This notice is simply an announcement of a
finding that EPA has already made. EPA, Region 4, sent a letter to TDEC
on February 15, 2017, stating that the MVEBs identified for Knoxville
in Tennessee's maintenance SIP revision, submitted on December 20,
2016, are adequate and must be used for transportation conformity
determinations in the Knoxville Area.
    EPA posted the availability of the Knoxville Area MVEBs on EPA's
Web site on December 22, 2016, as part of the adequacy process, for the
purpose of soliciting comments. The adequacy comment period ran until
January 23, 2017. During EPA's adequacy comment period, no comments
were received on the Knoxville Area MVEBs. Through this notice, EPA is
informing the public that these MVEBs are adequate for transportation
conformity. This finding has also been announced on EPA's conformity
Web site: http://www.epa.gov/otaq/stateresources/

transconf/pastsips.htm. The adequate MVEBs are provided in Table 1
below:

          Table 1--Knoxville, Tennessee 1997 Annual PM2.5 MVEBS
                         [Tons per year or tpy]
------------------------------------------------------------------------
                                                    2014         2028
------------------------------------------------------------------------
PM2.5.........................................       444.78     * 245.00
NOX...........................................    15,597.73   * 7,171.14
------------------------------------------------------------------------
* This includes a safety margin of 10.39 tpy for PM2.5 and 2,613.27 tpy
  for NOX in 2028.

    Transportation conformity is required by section 176(c) of the
Clean Air Act. EPA's conformity rule, 40 CFR part 93, requires that
transportation plans, programs, and projects conform to state air
quality implementation plans and establishes the criteria and
procedures for determining whether or not they do so. Conformity to a
SIP means that transportation activities will not produce new air
quality violations, worsen existing violations, or delay timely
attainment of the NAAQS.
    The criteria by which EPA determines whether a SIP's MVEBs are
adequate for transportation conformity purposes are outlined in 40 CFR
93.118(e)(4). We have also described the process for determining the
adequacy of submitted SIP budgets in our July 1, 2004 (69 FR 40004),
final rulemaking entitled, ``Transportation Conformity Rule Amendments
for the New 8-Hour Ozone and PM2.5 National Ambient Air
Quality Standards and Miscellaneous Revisions for Existing Areas;
Transportation Conformity Rule Amendments: Response to Court Decision
and Additional Rule Changes.'' Please note that an adequacy review is
separate from EPA's completeness review, and it should not be used to
prejudge EPA's ultimate approval of Tennessee's 1997 Annual
PM2.5 SIP revision for the Knoxville Area. Even if EPA finds
a budget adequate, the SIP revision could later be disapproved.
    Within 24 months from the effective date of this notice or until
such time that the 1997 PM2.5 NAAQS is revoked for the
Knoxville Area, the transportation partners will need to demonstrate
conformity to the new MVEBs, if the demonstration has not already been
made, pursuant to 40 CFR 93.104(e). See 73 FR 4419 (January 24, 2008).

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

    Dated: February 15, 2017.
Kenneth R. Lapierre,
Acting Regional Administrator, Region 4.
[FR Doc. 2017-04681 Filed 3-9-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 188 (Thursday, September 29, 2022)]
[Notices]
[Pages 59077-59078]
[FR Doc No: 2022-21169]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-SFUND-2015-0100; FRL-10265-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Continuous Release Reporting Requirement
Including Analysis for Use of Continuous Release Reporting Form
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Continuous Release Reporting
Requirement Including Analysis for Use of Continuous Release Reporting
Forms (EPA ICR Number 1445.15, OMB Control Number 2050-0086) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through November 30,
2022. Public comments were previously requested via the Federal
Register on February 24, 2022 during a 60-day comment period. This
notice allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. 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: Additional comments may be submitted on or before October 31,
2022.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-
SFUND-2015-0100, online using www.regulations.gov (our preferred
method), 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.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Wendy Hoffman, Office of Emergency
Management, Mail Code 5104A, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202)
564-8794; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. 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 EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Pursuant to section 3506(c)(2)(A) of the PRA, in the
first FR notice (87 FR 10361 published on February 24, 2022, EPA
solicited comments and information pertaining to the Continuous Release
Reporting Requirements (CRRR) under Section 103(a) of CERCLA, as
amended. CRRR requires the person in charge of a vessel or facility
immediately to notify the National Response Center (NRC) of a hazardous
substance release into the environment if the amount of the release
equals or exceeds the substance's reportable quantity (RQ) (found in
Table 302.4 of 40 CFR 302.4). If the source and chemical composition of
the continuous release do not change and the level of the continuous
release does not significantly increase, a follow-up written report to
EPA Headquarters one year after submission of the initial written
report is also required. The person in charge must notify the NRC and
EPA Region of a change in the source or composition of the release, and
under section 103(a) of CERCLA, a significant increase must be reported
immediately to the NRC. Finally, any change in information submitted in
support of a continuous release notification must be reported to EPA
Headquarters. Section 103(f)(2) of CERCLA provides facilities relief
from per-occurrence notification release requirements if the subject
release is continuous and stable in quantity and rate.
    CRRR allows the Federal government to determine whether a Federal
response action is required to control or mitigate any potential
adverse effects to public health, welfare or the environment. The
release information is also available to EPA program offices and other
Federal agencies who evaluate the potential need for additional
regulations, new permitting requirements for specific substances or
sources, or improved emergency response planning. State and local
government authorities and facilities subject to the CRRR use the
release information for local emergency response planning. The public,
which has access to release information through the Freedom of
Information Act, may request release information on what types of
releases are occurring in different localities and what actions, if
any, are being taken to protect public health, welfare and the
environment.
    Form Numbers: EPA Form 6100-10, Continuous Release Reporting Form.
    Respondents/affected entities: Entities potentially affected by
this action are not defined. The use and release of hazardous
substances are pervasive throughout industry. EPA expects many
different industrial categories to report hazardous substance releases
under the provisions of the CRRR. No one industry sector or group of
sectors is disproportionately affected by the information collection
burden.
    Respondent's obligation to respond: Mandatory if respondents want
reduced reporting for continuous releases.
    Estimated number of respondents: 4,250, including 25 State and
local government agencies.
    Frequency of response: On occasion.
    Total estimated burden: 38,625 hours (average per year, including
75 hours for State and local government agencies). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $2,487,450 (average per year), including
$8,200 annualized capital or operation & maintenance costs (average per
year) and $4,178 in State and local government agency costs (average
per year).
    Changes in Estimates: Compared to the previous ICR renewal, the
estimated respondent unit burden per CRRR submission has remained the
same and the estimated annual total respondent burden has decreased by
88 percent,

from an estimated 334,472 average annual hours in the previous ICR
renewal to an estimated 38,625 average annual hours in this renewal.
This ICR renewal was updated to reflect the review of available
information gathered while moving the program submissions from EPA
Regions to a central location at EPA HQ. The previous ICRs had
overestimated the burden on both industry and governments. The typical
facility does not make an average of eight separate submissions, as
previously estimated, but rather, one. While the burden to generate a
CRRR submission remains the same, the overall submissions and number of
chemicals reported are reduced. This reduces the labor burden for both
industry and governments.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-21169 Filed 9-28-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 187 (Thursday, September 28, 2023)]
[Rules and Regulations]
[Pages 66681-66683]
[FR Doc No: 2023-21103]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1403; Project Identifier MCAI-2023-00479-T;
Amendment 39-22548; AD 2023-18-07]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2020-03-
19, which applied to certain Dassault Aviation Model MYSTERE-FALCON 20-
C5, 20-D5, 20-E5, and 20-F5 airplanes. AD 2020-03-19 required revising
the existing maintenance or inspection program, as applicable, to
incorporate new or more restrictive airworthiness limitations. This AD
continues to require the actions in AD 2020-03-19 and requires revising
the existing maintenance or inspection program, as applicable, to
incorporate additional new or more restrictive airworthiness
limitations; as specified in a European Union Aviation Safety Agency
(EASA) AD, which is incorporated by reference. This AD was prompted by
a determination that new or more restrictive airworthiness limitations
are necessary. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective November 2, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 2,
2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 2,
2020 (85 FR 11280, February 27, 2020).

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-1403; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For EASA material incorporated by reference in this AD,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; website easa.europa.eu. You
may find this material on the EASA website at ad.easa.europa.eu. It is
also available at regulations.gov under Docket No. FAA-2023-1403.
     For Dassault service information incorporated by reference
in this AD, contact Dassault Falcon Jet Corporation, Teterboro Airport,
P.O. Box 2000, South Hackensack, NJ 07606; telephone<PHONE_NUMBER>;
website dassaultfalcon.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2023-1403.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aviation Safety
Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2020-03-19, Amendment 39-19843 (85 FR
11280, February 27, 2020) (AD 2020-03-19). AD 2020-03-19 applied to
certain Dassault Aviation Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and
20-F5 airplanes. AD 2020-03-19 required revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive airworthiness limitations. The FAA issued AD 2020-03-
19 to address fatigue cracking, damage, and corrosion in principal
structural elements, which could result in reduced structural integrity
of the airplane.
    The NPRM published in the Federal Register on July 11, 2023 (88 FR
44065). The NPRM was prompted by EASA AD 2023-0058, dated March 16,
2023, issued by EASA, which is the Technical Agent for the Member
States of the European Union (referred to after this as the MCAI). The
MCAI states that new or more restrictive airworthiness limitations have
been developed.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-1403.
    In the NPRM, the FAA proposed to continue to require the actions in
AD 2020-03-19. In the NPRM, the FAA also proposed to require revising
the existing maintenance or inspection program, as applicable, to
incorporate additional new or more restrictive airworthiness
limitations, as specified in an EASA AD. The FAA is issuing this AD to
address fatigue cracking, damage, and corrosion in principal structural
elements. The unsafe condition, if not addressed, could result in
reduced structural integrity of the airplane.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data and determined
that air safety requires adopting this AD as proposed. Accordingly, the
FAA is issuing this AD to address the unsafe condition on this product.
Except for minor editorial changes, this AD is adopted as proposed in
the NPRM. None of the changes will increase the economic burden on any
operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed EASA AD 2023-0058. This service information
specifies procedures for airworthiness limitations for safe life limits
and certification maintenance requirements.
    This AD also requires Chapter 5-40-00, Airworthiness Limitations,
of the Dassault Falcon 20 Retrofit 731 Maintenance Manual, Revision 13,
dated January 1, 2019, which the Director of the Federal Register
approved for incorporation by reference as of April 2, 2020 (85 FR
11280, February 27, 2020).
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 56 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2020-03-19 to be $7,650 (90 work-hours x $85 per work-
hour).
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate.
    The FAA estimates the total cost per operator for the new actions
to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2020-03-19, Amendment 39-19843
(85 FR 11280, February 27, 2020); and
0
b. Adding the following new AD:

2023-18-07 Dassault Aviation: Amendment 39-22548; Docket No. FAA-
2023-1403; Project Identifier MCAI-2023-00479-T.

(a) Effective Date

    This airworthiness directive (AD) is effective November 2, 2023.

(b) Affected ADs

    (1) This AD replaces AD 2020-03-19, Amendment 39-19843 (85 FR
11280, February 27, 2020) (AD 2020-03-19).
    (2) This AD affects AD 2010-26-05, Amendment 39-16544 (75 FR
79952, December 21, 2010) (AD 2010-26-05).

(c) Applicability

    This AD applies to Dassault Aviation Model MYSTERE-FALCON 20-C5,
20-D5, 20-E5, and 20-F5 airplanes, certificated in any category, as
identified in European Union Aviation Safety Agency (EASA) AD 2023-
0058, dated March 16, 2023 (EASA AD 2023-0058).

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Unsafe Condition

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address fatigue cracking, damage, and corrosion
in principal structural elements. The unsafe condition, if not
addressed, could result in reduced structural integrity of the
airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Revision of the Existing Maintenance or Inspection
Program, With a New Terminating Action

    This paragraph restates the requirements of paragraph (g) of AD
2020-03-19, with a new terminating action. Within 90 days after
April 2, 2020 (the effective date of AD 2020-03-19), revise the
existing maintenance or inspection program, as applicable, to
incorporate the information specified in Chapter 5-40-00,
Airworthiness Limitations, of the Dassault Falcon 20 Retrofit 731
Maintenance Manual, Revision 13, dated January 1, 2019. The initial
compliance time for doing the tasks is at the time specified in
Chapter 5-40-00, Airworthiness Limitations, of the Dassault Falcon
20 Retrofit 731 Maintenance Manual, Revision 13, dated January 1,
2019, or within 90 days after April 2, 2020, whichever occurs later.
Accomplishing the revision of the existing maintenance or inspection
program required by paragraph (i) of this AD terminates the
requirements of this paragraph.

(h) Retained Restrictions on Alternative Actions, Intervals, With a New
Exception

    This paragraph restates the requirements of paragraph (h) of AD
2020-03-19, with a new exception. Except as required by paragraph
(i) of this AD, after the existing maintenance or inspection program
has been revised as required by paragraph (g) of this AD, no
alternative actions (e.g., inspections) or intervals are allowed
unless the actions or intervals are approved as an alternative
method of compliance (AMOC) in accordance with the procedures
specified in paragraph (m)(1) of this AD.

(i) New Revision of the Existing Maintenance or Inspection Program

    Except as specified in paragraph (j) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2023-0058. Accomplishing the revision of
the existing maintenance or inspection program required by this
paragraph terminates the requirements of paragraph (g) of this AD.

(j) Exceptions to EASA AD 2023-0058

    (1) This AD does not adopt the requirements specified in
paragraphs (1) and (2) of EASA AD 2023-0058.
    (2) Paragraph (3) of EASA AD 2023-0058 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after the effective date of this AD.
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2023-0058 is at the applicable
``limitations'' as incorporated by the requirements of paragraph (3)
of EASA AD 2023-0058, or within 90 days after the effective date of
this AD, whichever occurs later.
    (4) This AD does not adopt the provisions specified in
paragraphs (4) and (5) of EASA AD 2023-0058.
    (5) This AD does not adopt the ``Remarks'' section of EASA AD
2023-0058.

(k) New Provisions for Alternative Actions and Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (i) of this AD, no alternative
actions (e.g., inspections) and intervals are allowed unless they
are approved as specified in the provisions of the ``Ref.
Publications'' section of EASA AD 2023-0058.

(l) Terminating Action for Certain Actions in AD 2010-26-05

    Accomplishing the actions required by paragraph (g) or (i) of
this AD terminates all requirements of paragraph (g)(1) of AD 2010-
26-05 for Dassault Aviation Model MYSTERE-FALCON 20-C5, 20-D5, 20-
E5, and 20-F5 airplanes, except those on which the Dassault Aviation
MYSTERE-FALCON 20 Supplemental Structural Inspection Program has
been embodied, only.

(m) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (n) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Dassault Aviation's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(n) Additional Information

    For more information about this AD, contact Tom Rodriguez,
Aviation Safety Engineer, 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; phone:<PHONE_NUMBER>; email: [email protected].

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
November 2, 2023.
    (i) European Union Aviation Safety Agency (EASA) AD 2023-0058,
dated March 16, 2023.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
April 2, 2020 (85 FR 11280, February 27, 2020).
    (i) Chapter 5-40-00, Airworthiness Limitations, of the Dassault
Falcon 20 Retrofit 731 Maintenance Manual, Revision 13, dated
January 1, 2019.
    (ii) [Reserved]
    (5) For EASA AD 2023-0058, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (6) For Dassault service information incorporated by reference
in this AD, contact Dassault Falcon Jet Corporation, Teterboro
Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-
440-6700; website dassaultfalcon.com.
    (7) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (8) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 22, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-21103 Filed 9-27-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Proposed Rules]
[Pages 49727-49731]
[FR Doc No: 2014-19888]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 610 and 680

[Docket No. FDA-2014-N-1110]

Revocation of General Safety Test Regulations That Are
Duplicative of Requirements in Biological License Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the biologics regulations by removing the general safety test (GST)
requirements for biological products. FDA is proposing this action
because the existing codified GST regulations are duplicative of
requirements that are also specified in biologics licenses, or are no
longer necessary or appropriate to help ensure the safety, purity, and
potency of licensed biological products. FDA is taking this action as
part of its retrospective review of its regulations to promote
improvement and innovation, in response to an Executive order.

DATES: Submit either electronic or written comments on this proposed
rule by November 20, 2014. See section V of this document for the
proposed effective date of any final rule that may publish based on
this proposal.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand Delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include Docket No. FDA-
2014-N-

1110 for this rulemaking. All comments received may be posted without
change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Request for Comments'' heading in section X of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose and Coverage of the Proposed Rule

    The proposed rule would eliminate the codified GST \1\ regulations
for biological products. FDA is proposing this action because the
existing codified GST regulations are duplicative of requirements that
are also specified in biologics license applications (BLAs) or are no
longer necessary or appropriate to help ensure the safety, purity, and
potency of licensed biological products. FDA is taking this action as
part of its retrospective review of its regulations to promote
improvement and innovation, in response to Executive Order (E.O.) 13563
of January 18, 2011.
---------------------------------------------------------------------------

    \1\ For purposes of this proposed rulemaking, the terms
``general safety test'' or ``GST'' refer to the requirements found
under Title 21 of the Code of Federal Regulations (CFR), subchapter
F, parts 600 through 680 (21 CFR parts 600 through 680),
specifically 21 CFR 610.11, 21 CFR 610.11a and 21 CFR 680.3(b).
---------------------------------------------------------------------------

Summary of the Major Provisions of the Proposed Rule

    The proposed rule would remove the requirements contained in 21 CFR
610.11, 610.11a, and 680.3(b) from the regulations. Section 610.11
concerns a GST for the detection of extraneous toxic contaminants in
biological products intended for administration to humans. Section
610.11a concerns the GST regulations for inactivated influenza vaccine.
Section 680.3(b) concerns GST regulations for allergenic products.
Removal of these regulations would not remove GST requirements
specified in individual BLAs, however. A biological product
manufacturer would continue to be required to follow the GST
requirements specified in its BLA unless the BLA were revised to
eliminate or modify the test through a supplement in accordance with 21
CFR 601.12(c). FDA would review proposed changes to a manufacturer's
approved biologics license on a case-by-case basis so that we could
ensure that any such action is appropriate.

Costs and Benefits

    FDA is proposing this action because the existing codified GST
regulations are duplicative of requirements that are also specified in
BLAs, or are no longer necessary or appropriate to help ensure the
safety, purity, and potency of licensed biological products. Because
this proposed rule would impose no additional regulatory burdens, this
regulation is not anticipated to result in any compliance costs and the
economic impact is expected to be minimal.

I. Background

    On January 18, 2011, President Barack Obama issued E.O. 13563,
``Improving Regulation and Regulatory Review'' (76 FR 3821, January 21,
2011). One of the provisions in the E.O. is the affirmation of
retrospective reviews of existing significant regulations. As one step
in implementing the new E.O., FDA published a notice in the Federal
Register on April 27, 2011 (76 FR 23520), entitled ``Periodic Review of
Existing Regulations; Retrospective Review Under E.O. 13563.'' In that
notice, FDA announced that it was conducting a review of existing
regulations to determine, in part, whether they can be made more
effective in light of current public health needs and to take advantage
of, and support, advances in innovation that have occurred since those
regulations took effect. As part of this initiative, FDA is proposing
to eliminate the codified GST regulations as specified in this rule. We
believe this action is appropriate because in many instances, the GST
regulations duplicate requirements that are also specified in the BLA
required for biological products intended for human use under section
351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262), or they
are outmoded or otherwise unnecessary to help ensure the continued
safety, purity, and potency of biological products. For a number of
years, FDA has not codified specific requirements for licensed
biological products, in part because codifying specific requirements
for biological products can diminish the ability of the Agency and
industry to respond to technological developments. Instead the Agency
has described the required tests for particular products in
manufacturers' BLAs.
    The GST is one of several tests listed in part 610, General
Biological Product Standards, that is intended to help ensure the
safety, purity, and potency of biological products administered to
humans. Manufacturers of biological products are currently required to
perform this test for general safety on biological products intended
for administration to humans under Sec.  610.11, on inactivated
influenza vaccines under Sec.  610.11a, and on allergenic products
under Sec.  680.3(b), unless exempted by regulation or an exemption is
granted under Sec.  610.11(g)(2).
    The GST was intended to be a final check designed to detect any
toxic contaminants present in the final product. The test was cited as
early as 1909 (Ref. 1), and appeared in the first Code of Federal
Regulations in 1938, before the establishment of Current Good
Manufacturing Practices (cGMPs) for drug manufacture in the CFR, which
occurred in 1963. The GST was subsequently revised to, among other
things, ``reflect the best current testing procedures established by
the scientific community as well as to promote uniformity and
specificity in the safety testing of licensed biological products''
(March 15, 1976, 41 FR 10888).
    A product that meets the requirements for general safety will
comply with the criteria found in Sec.  610.11(d) of the GST
regulation, i.e., injected animals survive the test period; they do not
exhibit any response that is not specific for or expected from the
product and which may indicate a difference in quality of the product;
and they weigh no less at the end of the test period than they did at
the time of injection.
    While originally a useful approach, as time has passed, the Agency
has periodically explored the utility and efficiency of this approach.
In the Federal Register of May 14, 1996 (61 FR 24227), FDA published a
final rule exempting certain biotechnology-derived and synthetic
biological products from a number of regulations applicable to
biological products, including the GST (see Sec.  601.2(c)). This
action was in response to technical advances that greatly increased the
ability of manufacturers to control the manufacture of, and to more
fully analyze the physical and biological characteristics of, many
biotechnology-derived biological products.

    Approximately 2 years later, in the Federal Register of April 20,
1998, FDA issued a direct final rule (DFR) and a companion proposed
rule (63 FR 19399 and 19431, respectively) to expand the exceptions in
Sec.  610.11(g) to include ``cellular therapy products'' because, among
other reasons, the Agency believed that the procedures and materials
used to manufacture these products are stringently controlled and
monitored. In addition, FDA provided for in the DFR and the companion
proposed rule an administrative procedure for manufacturers of other
biological products to request and obtain exemptions from conducting
the GST. FDA took this action ``. . . because the GST may not be
relevant or necessary for biological products . . . currently in
various stages of development'' and as part of FDA's continuing efforts
at that time ``to reduce the burden of unnecessary regulations on
biological products without diminishing the protection of the public
health'' (63 FR 19399 at 19400) (FDA refers readers to the preamble of
the April 20, 1998, proposed rule should they wish to obtain additional
details on the history of this rulemaking).
    In the Federal Register of August 5, 1998 (63 FR 41718) (August
1998 Notice), FDA published a DFR confirming in part, and withdrawing
in part, the provisions in the DFR that published April 20, 1998.
Specifically, FDA confirmed a revision to Sec.  610.11(g)(1) to add
``cellular therapy products'' to the list of products exempted from the
GST. However, because the Agency received significant adverse comments
concerning Sec.  610.11(g)(2), the provision of the rule that required
administrative procedures for requesting an exemption from the GST
regulations, Sec.  610.11(g)(2) was withdrawn. As discussed in the
August 1998 Notice, the comments were applied to the corresponding
portion of the companion proposed rule and considered in developing the
final rule.
    After considering the comments to the DFR and companion proposed
rule, in the Federal Register of March 4, 2003 (68 FR 10157 at 10158)
(March 2003 Final Rule), FDA again provided for an administrative
procedure under which manufacturers of biological products may request
and obtain exemptions from conducting the GST (Sec.  610.11(g)(2)). In
the preamble to the March 2003 Final Rule, FDA again noted that the GST
may not be relevant or necessary for certain biological products (68 FR
10157).
    Accordingly, Sec.  610.11 currently includes a provision allowing
manufacturers to request an exemption from the GST. Note that this
exemption provision requires manufacturers to provide supporting
documentation when making their request (see 68 FR 10157 through
10159). Specifically, when requesting such an exemption, manufacturers
must submit information as part of a BLA or supplement to an approved
BLA establishing that because of the mode of administration, the method
of preparation, or the special nature of the product, a test for
general safety is unnecessary to assure the safety, purity, and potency
of the product, or cannot be performed (Sec.  610.11(g)(2)).
    Since FDA issued the March 2003 Final Rule, it has become
increasingly clear that the codified GST regulations are too
restrictive for certain additional biological products because they
specify particular methodologies or requirements when alternatives may
be available that provide the same or greater level of assurance of
safety. Thus, the Agency believes that the regulations may no longer
reflect the best current testing procedures established by the
scientific community as a general matter (although the testing
procedures may still be appropriate in certain circumstances) and that
the more efficient way of prescribing testing requirements for
particular products would be to allow such requirements to be specified
in the BLA to enhance flexibility to make appropriate changes to
testing methods.

II. Appropriate Controls Would Remain in Place

    FDA believes that if this rulemaking becomes finalized as proposed,
we would be able to continue to ensure that appropriate controls remain
in place. For example, manufacturers of all products derived from
inherently toxic substances would be required to continue to use the
safety tests that are prescribed in their BLAs to control and monitor
toxicity. These product-specific tests (performed in animals, cell
cultures, or other systems) in conjunction with physical, chemical, and
biological characterization tests define and monitor the production
process and alert manufacturers to potential problems. Because these
tests are tailored to the proprietary manufacturing process and are
appropriate for the detection of intrinsic or extraneous toxic
contaminants for a particular product or product class, they are more
appropriately specified in the manufacturer's BLA or BLA supplement
than codified as regulations.
    Furthermore, we anticipate that the proposal to eliminate the
codified GST regulations would encourage the implementation of the
principles of the ``3Rs,'' to reduce, refine, and replace animal use in
testing, thus addressing the need to minimize the use of animals in
such testing and promoting more humane, appropriate, and specific test
methods for assuring the safety of biological products.\2\
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    \2\ Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) Authorization Act of 2000 (42 U.S.C.
2851-3). Additional information on the Federal Government's
implementation of the principles of the 3Rs may be found at the
ICCVAM Web site at http://ntp.niehs.nih.gov/go/iccvam.
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    If the proposed rule is finalized and the GST regulations are
eliminated, manufacturers would continue to be required to perform a
particular safety test for certain products that present specific
safety concerns, for example, testing for a specific toxicity, as set
forth in an approved BLA or BLA supplement. As discussed previously,
although this rulemaking proposes to eliminate the codified GST from
the biologics regulations, FDA recognizes that all manufacturers that
currently conduct a GST have this test described in their BLAs for
their licensed products. As a result, if this proposed rule is
finalized, these manufacturers would continue to be required to perform
the GST unless the manufacturer's BLA were revised through a supplement
to eliminate or modify the test. FDA would review these proposed
changes to a manufacturer's approved BLA on a case-by-case basis so
that we could ensure that any such action is appropriate. Thus, the
removal of these biologics regulations, should this proposed rule be
finalized, would not automatically revise a manufacturer's BLA or BLA
supplement.
    The requirements for a licensed biological product manufacturer to
report changes in its product, product labeling, production process,
quality controls, equipment, facilities, or responsible personnel, as
established in its approved BLA, are detailed in Sec.  601.12. Under
this regulation, manufacturers must report each change to the Agency in
one of several different types of submissions. The applicable
submission category depends on the potential for the change(s) at issue
to have an adverse effect on the identity, strength, quality, purity,
or potency of the particular biological product as it may relate to the
safety or effectiveness of the product. A BLA supplement for a change
that has a moderate potential to have an adverse effect on the
identity, strength, quality, purity, or potency of the product as it
may relate to the safety

or effectiveness of the product must be submitted under Sec.  601.12(c)
(Changes requiring supplement submission at least 30 days prior to
distribution of the product made using the change).
    As a general matter, should a manufacturer wish to no longer
perform the GST described in its BLA, the Agency would consider the
discontinuation of the GST to have a moderate potential to have an
adverse effect on the identity, strength, quality, purity, or potency
of the product as it may relate to the safety or effectiveness of the
product. Accordingly, a manufacturer who desires to discontinue the GST
in the approved BLA or utilize an alternative method other than the GST
approved in its BLA must submit a BLA supplement reporting the change
in accordance with Sec.  601.12(c). Within 30 days of the date FDA
receives the submission, FDA will determine if the change has been
reported in the proper category and will notify the manufacturer if it
has not. If FDA has not notified the manufacturer otherwise within 30
days after FDA receives the supplement, the manufacturer may distribute
its product using the change described in the supplement. If, however,
FDA determines that the information submitted in the supplement fails
to demonstrate the continued safety or effectiveness of the product
made using the change, FDA will try to resolve the problems with the
manufacturer. For example, in the event that the Agency determines that
for a particular manufacturer's unique product a GST is still necessary
to assure the continued safety or effectiveness of the product (e.g.,
for products with concerns related to residual toxin activity/reversion
to toxicity, or if the alternative method proposed is unacceptable),
the Agency would notify the manufacturer of its decision within 30 days
following receipt of the supplement and would work with the
manufacturer to resolve the issue.

III. Highlights of the Proposed Rule

    The proposed rule would remove Sec. Sec.  610.11, 610.11a, and
680.3(b), the regulations that require that manufacturers of biological
products perform a specified test for general safety of biological
products. FDA is taking this action because the existing codified GST
regulations are duplicative, outmoded, or are otherwise unnecessary to
help ensure the continued safety, purity, and potency of licensed
biological products.

IV. Legal Authority

    FDA is issuing this regulation under the biological products
provisions of the PHS Act (42 U.S.C. 262 and 264), and the drugs and
general administrative provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 321 et seq.). Under these provisions
of the PHS Act and the FD&C Act, we have the authority to issue and
enforce regulations designed to ensure that biological products are
safe, effective, pure, and potent, and to prevent the introduction,
transmission, and spread of communicable disease.

V. Proposed Effective Date

    FDA is proposing that any final rule that may issue based on this
proposal be effective 90 days after the date of its publication in the
Federal Register.

VI. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under E.O. 12866,
E.O. 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders
12866 and 13563 direct Agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this proposed rule is not a significant regulatory action as defined by
E.O. 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this proposed rule generally increases
flexibility for safety testing and would result in the reduction of
certain regulatory burdens and does not add any new regulatory
responsibilities, the Agency proposes to certify that the final rule
will not have a significant economic impact on a substantial number of
small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    This rule proposes to amend the biologics regulations by removing
GST regulations for biological products found in Sec. Sec.  610.11,
610.11a and 680.3(b). FDA is proposing this action because the current
codified GST regulations are duplicative of requirements that are also
specified in biologics licenses, or are no longer necessary or
appropriate to help ensure the safety, purity, and potency of licensed
biological products. The removal of the GST regulations for biological
products would not remove GST requirements specified in individual
biologics license applications, however. All manufacturers that
currently conduct a GST are already required, as part of the
requirements specified in their biologics license applications, to
perform the GST and would thus continue to be required perform the GST
unless the BLA were revised to eliminate or modify the test through a
supplement in accordance with Sec.  601.12(c). Because this proposed
rule would impose no additional regulatory burdens, this regulation is
not anticipated to result in any compliance costs and the economic
impact is expected to be minimal.

VII. The Paperwork Reduction Act of 1995

    This proposed rule refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3520). The collections of information in Sec.  601.12 have been
approved under OMB control number 0910-0338. Therefore, FDA tentatively
concludes that the proposed requirements in this document are not
subject to review by OMB because they do not constitute a ``new
collection of information'' under the PRA.

VIII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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.

IX. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in E.O. 13132. FDA has

determined that the proposed rule, if finalized, would not contain
policies that would have substantial direct effects 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. Accordingly, the Agency tentatively concludes that the
proposed rule does not contain policies that have federalism
implications as defined in the E.O. and, consequently, a federalism
summary impact statement is not required.

X. Request for Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XI. Reference

    FDA has placed the following reference on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday and are
available electronically at http://www.regulations.gov.

1. Anderson, J. F., ``The Influence of Concentration (Gibson's
Method) On the Presence of Tetanus Toxin in Blood Serum,'' Journal
of Experimental Medicine: 1909 September 2; 11(5): 656-658.

List of Subjects

21 CFR Part 610

    Biologics, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 680

    Biologics, Blood, Reporting and recordkeeping requirements.
    Therefore under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR parts 610
and 680 be amended as follows:

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
1. The authority citation for 21 CFR part 610 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.

Sec.  610.11  [Removed and Reserved]

0
2. Remove and reserve Sec.  610.11.

Sec.  610.11a  [Removed and Reserved]

0
3. Remove and reserve Sec.  610.11a.

PART 680--ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

0
4. The authority citation for 21 CFR part 680 continues to read as
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42
U.S.C. 216, 262, 263, 263a, 264.

Sec.  680.3  [Amended]

0
5. Remove and reserve paragraph (b).

    Dated: August 18, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-19888 Filed 8-21-14; 8:45 am]
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[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12928-12929]
[FR Doc No: 2023-04179]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OEJECR-2023-0099; FRL-10687-01-OA]

White House Environmental Justice Advisory Council; Notification
of Virtual Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification for a public meeting.

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SUMMARY: Pursuant to the Federal Advisory Committee Act (FACA), the
U.S. Environmental Protection Agency (EPA) hereby provides notice that
the White House Environmental Justice Advisory Council (WHEJAC) will
meet on the date and times described below. Due to unforeseen
administrative circumstances, EPA is announcing this meeting with less
than 15 calendar days public notice. The meeting is open to the public.
For additional information about registering to attend the meeting or
to provide a public comment, please see ``REGISTRATION'' under
SUPPLEMENTARY INFORMATION. Pre-registration is required.

DATES: The WHEJAC will convene a virtual public meeting on Wednesday,
March 1, 2023, at approximately 3:00 p.m. to 7:30 p.m. Eastern Time.
Meeting discussions will focus on several topics including, but not
limited to, workgroup activity, proposed recommendations for the
Council on Environmental Quality's (CEQ) consideration, CEQ briefings,
new charges, and interaction between the White House Interagency
Council on Environmental Justice (IAC) and WHEJAC. A public comment
period relevant to current WHEJAC charges will be considered by the
WHEJAC at the meeting (See SUPPLEMENTARY INFORMATION). Members of the
public who wish to participate during the public comment period must
register by 11:59 p.m., Eastern Time, February 27, 2023.

FOR FURTHER INFORMATION CONTACT: Karen L. Martin, WHEJAC Designated
Federal Officer, U.S. EPA; email: [email protected]; telephone (202)564-
0203. Additional information about the WHEJAC is available at https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council.

SUPPLEMENTARY INFORMATION: The Charter of the WHEJAC states that the
advisory committee will provide independent advice and recommendations
to the Chair of the CEQ and to the IAC. The WHEJAC will provide advice
and recommendations about broad cross-cutting issues, related but not
limited to, issues of environmental justice and pollution reduction,
energy, climate change mitigation and resiliency, environmental health,
and racial inequity. The WHEJAC's efforts will include a broad range of
strategic, scientific, technological, regulatory, community engagement,
and economic issues related to environmental justice.

I. Registration

    Individual registration is required for the public meeting.
Information on how to register is located at https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council. Registration for the meeting is available throughout the
scheduled end time of the meeting. Registration to speak during the
public comment period will close 11:59 p.m., Eastern Time, on February
27, 2023. When registering, please provide your name, organization,
city and state, and email address for follow up. Please also indicate
whether you would like to provide public comment during the meeting, or
whether you are submitting written comments.

A. Public Comment

    The WHEJAC is interested in receiving public comments relevant to
the following charges, topics, and questions currently under
consideration: (1) the Climate and Economic Justice Screening Tool; (2)
the Environmental Justice Scorecard; (3) Indigenous Peoples and Tribal
Nations; (4) Adverse health impacts from a changing climate
disproportionally affects disadvantaged communities. What are the
policies or programs that can address adverse health impacts before,
during, and after extreme climate events?; (5) Tribal communities are
disproportionately impacted by the ecosystem collapse caused by climate
change that is destroying subsistence hunting, fishing, and growing
traditional foods. How can Federal Government policies and programs
prevent or address these impacts?; (6) What are the core elements of a
multi-agency strategy apart from Carbon Capture Utilization and
Sequestration (CCUS) that can address potential use of carbon
management while protecting

communities? More information on WHEJAC charges is located online at:
https://www.epa.gov/environmentaljustice/white-house-environmental-justice-advisory-council under WHEJAC Membership and Workgroups.
Priority to speak during the meeting will be given to public commenters
with comments relevant to the topics and questions listed above. Every
effort will be made to hear from as many registered public commenters
during the time specified on the agenda. Individuals or groups making
remarks during the public comment period will be limited to three (3)
minutes. Please be prepared to briefly describe your issue and your
recommendation relevant to the current charges, topics, and questions
under consideration by the WHEJAC. Submitting written comments for the
record is strongly encouraged. You can submit your written comments in
three different ways: (1) by creating comments in the Docket ID No.
EPA-HQ-OEJECR-2023-0099 at http://www.regulations.gov, (2) by using the
webform at https://www.epa.gov/environmentaljustice/forms/white-house-environmental-justice-advisory-council-whejac-public-comment, and (3)
by sending comments via email to [email protected]. Written comments can
be submitted through March 15, 2023.

B. Information About Services for Individuals With Disabilities or
Requiring English Language Translation Assistance

    For information about access or services for individuals requiring
assistance, please contact Karen L. Martin via email at [email protected]
or contact by phone at<PHONE_NUMBER>. To request special
accommodations for a disability or other assistance, please submit your
request at least five (5) working days prior to the meeting to give EPA
sufficient time to process your request. All requests should be sent to
the email listed in the FOR FURTHER INFORMATION CONTACT section.

Matthew Tejada,
Deputy Assistant Administrator for Environmental Justice, Office of
Environmental Justice and External Civil Rights.
[FR Doc. 2023-04179 Filed 2-28-23; 8:45 am]
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