[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Notices]
[Pages 4857-4858]
[FR Doc No: 2023-01402]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96717; File No. SR-NYSEAMER-2023-07]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
the NYSE American Options Fee Schedule

January 19, 2023.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby given
that, on January 12, 2023, NYSE American LLC (``NYSE American'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 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 amend the NYSE American Options Fee
Schedule (the ``Fee Schedule'') with respect to certain regulatory fees
related to the Central Registration Depository (``CRD'' or ``CRD
system''), which are collected by the Financial Industry Regulatory
Authority, Inc. (``FINRA''). The Exchange proposes to implement the fee
change on January 12, 2023. The proposed rule change is available on
the Exchange's website at www.nyse.com, 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 self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend the Fee Schedule with respect to
certain regulatory fees collected by FINRA for use of CRD.\4\ The
Exchange proposes to implement the fee changes effective January 12,
2023.\5\
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    \4\ CRD is the central licensing and registration system for the
U.S. securities industry. The CRD system enables individuals and
firms seeking registration with multiple states and self-regulatory
organizations to do so by submitting a single form, fingerprint
card, and a combined payment of fees to FINRA. Through the CRD
system, FINRA maintains the qualification, employment, and
disciplinary histories of registered associated persons of broker-
dealers.
    \5\ The Exchange originally filed to amend the Price List on
January 3, 2023 (SR-NYSEAmer-2023-02). On January 12, 2023, SR-
NYSEAmer-2023-02 was withdrawn and replaced by this filing.
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    FINRA collects and retains certain regulatory fees via CRD for the
registration of associated persons of Exchange ATP Holders that are not
FINRA members (``Non-FINRA ATP Holders'').\6\ CRD fees are user-based,
and there is no distinction in the cost incurred by FINRA if the user
is a FINRA member or a Non-FINRA ATP Holders.
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    \6\ The Exchange originally adopted fees for use of the CRD
system in 2003 and amended those fees in 2013 and 2022. See
Securities Exchange Act Release No. 48066 (June 19, 2003), 68 FR
38409 (June 27, 2003) (SR-Amex-2003-49); Securities Exchange Act
Release No. 68589 (January 4, 2013), 78 FR 2465 (January 11, 2013)
(SR-NYSEMKT-2012-89); Securities Exchange Act Release No. 93901
(January 5, 2022), 87 FR 1453 (January 11, 2022) (SR-NYSEAmer-2021-
48). While the Exchange lists these fees in its Fee Schedule, it
does not collect or retain these fees.
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    FINRA recently amended two of the fees assessed for use of the CRD
system.\7\ Accordingly, the Exchange proposes to amend the Fee Schedule
to mirror the fees assessed by FINRA, which will be implemented
concurrently with the amended FINRA fee as of January 2023.\8\
Specifically, the Exchange proposes to amend the Fee Schedule to modify
the fee charged to Non-FINRA ATP Holders for additional processing of
each initial or amended Form U4, Form U5 or Form BD that includes the
initial reporting, amendment, or certification of one or more
disclosure events or proceedings from $110 to $155 \9\ and the fee for
processing and posting to the CRD system each set of fingerprints
submitted electronically to FINRA, plus any other charge that may be
imposed by the U.S. Department of Justice for processing each set of
fingerprints, from $15 to $20.\10\
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    \7\ See Securities Exchange Act Release No. 90176 (October 14,
2020), 85 FR 66592 (October 20, 2020) (SR-FINRA-2020-032).
    \8\ The Exchange notes that it has only adopted the CRD system
fees charged by FINRA to Non-FINRA ATP Holders when such fees are
applicable. In this regard, certain FINRA CRD system fees and
requirements are specific to FINRA members, but do not apply to NYSE
American-only ATP Holders. Non-FINRA ATP Holders have been charged
CRD system fees since 2003. See note 5, supra. ATP Holders that are
also FINRA members are charged CRD system fees according to Section
4 of Schedule A to the FINRA By-Laws.
    \9\ See Section (4)(b)(3) of Schedule A to the FINRA By-laws.
    \10\ See Section (4)(b)(4) of Schedule A to the FINRA By-laws.
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    The Exchange notes that the proposed change is not otherwise
intended to address any other issues surrounding regulatory fees, and
the Exchange is not aware of any problems that ATP Holders would have
in complying with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\11\ in general, and furthers the
objectives of Section 6(b)(4) \12\ of the Act, in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees, and other charges. The Exchange also believes that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\13\
in that it is designed to promote just and equitable principles of
trade, to foster cooperation and

coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest and is not designed to permit
unfair discrimination between customers, issuers, brokers, or dealers.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(4).
    \13\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed fee change is reasonable
because the fee will be identical to that adopted by FINRA as of
January 2023 for use of the CRD system to submit an initial or amended
Form U4, Form U5 or Form BD that includes the initial reporting,
amendment, or certification of one or more disclosure events or
proceedings and the posting to CRD each set of fingerprints submitted
electronically to FINRA. The costs of operating and improving the CRD
system are similarly borne by FINRA when a Non-FINRA ATP Holder uses
the CRD system; accordingly, the fees collected for such use should, as
proposed by the Exchange, mirror the fees assessed to FINRA members. In
addition, as FINRA noted in amending its fees, it believes that its
proposed pricing structure is reasonable and correlates fees with the
components that drive its regulatory costs to the extent feasible. The
Exchange further believes that the change is reasonable because it will
provide greater specificity regarding the CRD system fees that are
applicable to Non-FINRA ATP Holders. All similarly situated ATP Holders
are subject to the same fee structure, and every ATP Holder must use
the CRD system for registration and disclosure. Accordingly, the
Exchange believes that the fees collected for such use should likewise
increase in lockstep with the fees assessed to FINRA members, as is
proposed by the Exchange.
    The Exchange also believes that the proposed fee change provides
for the equitable allocation of reasonable fees and other charges, and
does not unfairly discriminate between customers, issuers, brokers, and
dealers. The fee applies equally to all individuals and firms required
to report information the CRD system, and the proposed change will
result in the same regulatory fees being charged to all ATP Holders
required to report information to CRD and for services performed by
FINRA regardless of whether such ATP Holders are FINRA members.
Accordingly, the Exchange believes that the fee collected for such use
should increase in lockstep with the fee adopted by FINRA as of January
2023, as is proposed by the Exchange.

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

    In accordance with Section 6(b)(8) of the Act,\14\ the Exchange
believes that the proposed rule change would not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. Specifically, the Exchange believes that the
proposed change will reflect fees that will be assessed by FINRA as of
January 2023 and will thus result in the same regulatory fees being
charged to all ATP Holders required to report information to the CRD
system and for services performed by FINRA, regardless of whether or
not such ATP Holders are FINRA members.
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    \14\ See 15 U.S.C. 78f(b)(8).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

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

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \15\ of the Act and subparagraph (f)(2) of Rule
19b-4 \16\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
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    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such 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 under
Section 19(b)(2)(B) \17\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \17\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NYSEAMER-2023-07 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-NYSEAMER-2023-07. 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-NYSEAMER-2023-07, and should be
submitted on or before February 15, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
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    \18\ 17 CFR 200.30-3(a)(12).
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Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-01402 Filed 1-24-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Proposed Rules]
[Pages 14396-14398]
[FR Doc No: 2021-05329]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2020-0713; FRL-10020-73-Region 6]

Air Plan Approval; Texas; Revisions to the Texas Diesel Emissions
Reduction Incentive Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is proposing to approve a
revision to the Texas State Implementation Plan (SIP) that pertains to
the Texas Diesel Emissions Reduction Incentive Program, submitted on
August 13, 2020.

DATES: Written comments must be received on or before April 15, 2021.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2020-0713, at https://www.regulations.gov or via email to
<EMAIL_ADDRESS>Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, please contact Carl Young,<PHONE_NUMBER>,
<EMAIL_ADDRESS>For the full EPA public comment policy, information
about CBI or multimedia submissions, and general guidance on making
effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov. While all documents in the
docket are listed in the index, some information may not be publicly
available due to docket file size restrictions or content (e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Carl Young, EPA Region 6 Office,
Infrastructure and Ozone Section,<PHONE_NUMBER><EMAIL_ADDRESS>Out
of an abundance of caution for members of the public and our staff, the
EPA Region 6 office will be closed to the public to reduce the risk of
transmitting COVID-19. We encourage the public to submit comments via
https://www.regulations.gov, as there will be a delay in processing
mail and no courier or hand deliveries will be accepted. Please call or
email the contact listed above if you need alternative access to
material indexed but not provided in the docket.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

I. Background

    Section 110 of the CAA requires states to develop and submit to the
EPA a SIP to ensure that state air quality meets National Ambient Air
Quality Standards (NAAQS). These ambient standards currently address
six criteria pollutants: Carbon monoxide, nitrogen dioxide, ozone,
lead, particulate matter, and sulfur dioxide. Each federally-approved
SIP protects air quality primarily by addressing air pollution at its
point of origin through air pollution regulations and control
strategies. The EPA approved SIP regulations and control strategies are
federally enforceable.
    An Economic Incentive Program (EIP) is a program that uses market-
based strategies to reduce emissions of air pollutants.\1\ The Texas
Diesel Emissions Reduction Incentive Program (DERIP) for On-Road and
Non-Road Vehicles is part of the Texas Emissions Reduction Program
(TERP) that was established by the Texas Legislature in 2001 and
approved in the Texas SIP as an economic incentive program (70 FR
48647, August 19, 2005). DERIP provides grants to eligible individuals,
businesses, or local governments to reduce emissions from diesel-
powered vehicles and equipment in areas designated as nonattainment for
a NAAQS or other counties identified by the Texas Legislature.\2\
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    \1\ For more information on EIPs see ``Improving Air Quality
with Economic Incentive Programs'', EPA-452/R-01-001, January 2001,
available at https://www.epa.gov/sites/production/files/2015-07/documents/eipfin.pdf.
    \2\ For more information on TERP and DERIP please see ``Texas
Emissions Reduction Plan Biennial Report (2019-2020), Report to the
87th Texas Legislature, December 2020, SFR-079/20''. The document is
available at: https://www.tceq.texas.gov/assets/public/comm_exec/pubs/sfr/079-20.pdf.
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    In 2019 the Texas Legislature revised the eligibility requirements
for DERIP. As a result, the Texas Commission on Environmental Quality
(TCEQ) revised the DERIP regulations found in Title 30, Chapter 114
(Control of Air Pollution from Motor Vehicles) of the Texas
Administrative Code (30 TAC 114). The revisions were adopted on June
10, 2020 and submitted to the EPA as a SIP revision on August 13, 2020.
Specifically, the TCEQ revisions: (1) Changed the minimum required
usage for grant-funded vehicles and equipment in the eligible area from
75% to 55% (30 TAC 114.622), and (2) removed Victoria County from the
list of counties eligible for DERIP grants (30 TAC 114.629). A copy of
the SIP revision submitted to EPA is available in the electronic docket
for this action.

II. The EPA's Evaluation

    We approved DERIP regulations into the Texas SIP in 2005 (70 FR
48647, August 19, 2005). More recently, we approved updates to DERIP
regulations in 2018 (83 FR 50018, October 4, 2018). This SIP revision
further updates DERIP regulations. The effect of this update is to: (1)
Allow more diesel vehicles and equipment in nonattainment areas or

affected counties to be eligible for grant funding (30 TAC 114.622) and
(2) exclude Victoria County from eligibility for DERIP grants (30 TAC
114.629).
    Section 110(l) of the CAA requires that EPA shall not approve a SIP
revision if the revision would interfere with any applicable
requirement concerning attainment and reasonable further progress (as
defined in Section 171 of the CAA) or any other applicable requirements
of the CAA. DERIP is a voluntary incentive program for reducing
emissions and is not a requirement of the Act. The inclusion of DERIP
in the SIP, therefore, is discretionary and as such, revisions can be
made as long as they do not contribute to nonattainment or interfere
with maintenance. Reductions from the TERP program were part of the
emission reductions in SIP revisions relied upon to provide for
attainment of (1) the 1997 ozone standard in the Dallas-Fort Worth area
(70 FR 15592, March 28, 2005) and (2) the 1-hour ozone standard in the
Houston-Galveston-Brazoria area (71 FR 52670, September 6, 2006). The
reductions relied upon in these plans have long been achieved through
grants and rebates that have already been issued and none of the
subsequent ozone attainment plans submitted by the State have relied
upon reductions from the TERP or DERIP programs. However, the State
could use DERIP as a tool in future SIP revisions to obtain needed
emission reductions.
    As noted above, revisions to 30 TAC 114.622 changed the amount of
time equipment needs to operate in the affected counties. This change
will provide for an increase in the pool of vehicles and equipment
eligible for this program and potentially generate more emission
reductions through future state grants. Some of these reductions,
however, will likely be outside of designated nonattainment areas. As
Texas is not relying on emission reductions from future DERIP grants,
it is not necessary for the reductions to occur exactly in an affected
nonattainment area.
    As stated previously, DERIP and TERP are not mandated by the Clean
Air Act. The implementation of these programs is discretionary. The
Texas legislature originally adopted the programs to apply in
nonattainment areas and other affected areas deemed near-nonattainment
areas. None of the reductions that will be achieved by these programs
going forward are being relied upon in any plan for any affected area
in Texas. The Texas legislature decided that it no longer should
implement the program in Victoria County which is meeting all current
NAAQS. Not providing grants to reduce emissions from diesel equipment
will not cause emissions to increase in Victoria county. Instead
emissions in the county will not be impacted by this SIP revision.
Therefore, approval of the revision to 30 TAC 114.629 will not
contribute to nonattainment or interfere with maintenance in Victoria
County. As more diesel equipment become eligible, the concentration of
the DERIP program in nonattainment areas will likely result in
additional emission reductions. As additional grants are issued to
reduce emissions from diesel equipment, the air quality will benefit,
which will assist in maintenance and attainment of the NAAQS.
Therefore, the proposed approval of the SIP revision is consistent with
the CAA section 110(1). Also, because the program is discretionary, it
will not interfere with any applicable requirement for attainment and
reasonable further progress, or any other applicable requirement of the
CAA. Because the revised program will continue to achieve additional
reductions not relied upon by any plan for attainment or maintenance,
the revisions will not contribute to nonattainment or interfere with
maintenance.

III. Proposed Action

    We are proposing to approve the revisions to 30 TAC 114.622 and
114.629 adopted on June 10, 2020 and submitted on August 13, 2020.

IV. Incorporation by Reference

    In this action, we are proposing to include in a final rule
regulatory text that includes incorporation by reference. In accordance
with the requirements of 1 CFR 51.5, we are proposing to incorporate by
reference revisions to the Texas regulations as described in the
Proposed Action section above. We have made, and will continue to make,
these documents generally available electronically through
www.regulations.gov (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).

V. 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. 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. Accordingly, this
action merely proposes to approve 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);
     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 EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements.

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

    Dated: March 10, 2021.
David Gray,
Acting Regional Administrator, Region 6.
[FR Doc. 2021-05329 Filed 3-15-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48677-48678]
[FR Doc No: 2022-17154]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0961]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Environmental Impact
Considerations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Submit written comments (including recommendations) on the
collection of information by September 9, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently Under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0322. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Environmental Impact Considerations

OMB Control Number 0910-0322--Revision

    This information collection helps support implementation of the
National Environmental Policy Act (NEPA), consistent with FDA's
authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and
the Public Health Service Act. All applications or petitions requesting
FDA action require the submission of an environmental assessment (EA)
or a claim of categorical exclusion (CE). A CE applies to Agency
actions that usually have little or no potential to cause significant
environmental effects and are excluded from the requirements to prepare
an EA or environmental impact statement (EIS). Regulations in part 25
(21 CFR part 25) set forth FDA procedures with regard to NEPA
requirements (part 25, subpart A); identify actions that require the
preparation of an EA (part 25, subpart B); explain CEs (part 25,
subpart C); and discuss the preparation of documents (part 25, subpart
D). The regulations also supplement procedural provisions of NEPA that
were published by the Council on Environmental Quality (CEQ) in 40 CFR
parts 1500 through 1508 and the procedures included in the ``HHS
General Administration Manual, part 30: Environmental Protection'' (45
FR 76519 to 76534, November 19, 1980).
    In the Federal Register of August 25, 2021 (86 FR 47501), we
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
On our own initiative and for efficiency of Agency operations, we are
revising the information collection to account for burden that may
result from recommendations found in Agency guidance and currently
approved in OMB control number 0910-0541. The guidance document
entitled, ``Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety
and Applied Nutrition'' identifies, interprets, and clarifies existing
requirements imposed by applicable statutes and regulations, consistent
with the CEQ regulations (40 CFR 1507.3). It consists of
recommendations that do not themselves create requirements; rather,
they are explanatory guidance for FDA's own procedures in order to
ensure full compliance with the purposes and provisions of NEPA. The
guidance document is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparing-claim-categorical-exclusion-or-environmental-assessment-submission-cfsan, and was issued consistent with our Good Guidance Practice
regulations in 21 CFR 10.115, which provide for public comment at any
time.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
           21 CFR part 25; activity               Number of     responses per   Total annual          Average burden  per response          Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Section 25.40(c); actions excluded from the requirement to prepare EA or EIS:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Drug Evaluation and Research                    14          0.9285              13  3,400....................................          44,200
 (CDER).
Center for Devices and Radiological Health                  0  ..............               0  .........................................               0
 (CDRH).
Center for Biologics Evaluation and Research                4               1               4  3,400....................................          13,600
 (CBER).
Center for Veterinary Medicine (CVM).........               9               1               9  2,160....................................          19,440
Center for Tobacco Products (CTP)............              14               1              14  80.......................................           1,120
Center for Food Safety and Applied Nutrition               57               1              57  180......................................          10,260
 (CFSAN).
                                              ----------------------------------------------------------------------------------------------------------
    Subtotal.................................  ..............  ..............              97  .........................................          88,620
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Section 25.15(d); actions subject to CE:
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER.........................................           5,186          4.2273          21,923  8........................................         175,384
CDRH.........................................              62               1              62  6........................................             372
CBER.........................................           3,575               2           7,150  8........................................          57,200
CVM..........................................             114              10           1,140  2,160....................................           3,420
CTP..........................................               0  ..............               0  .........................................               0

CFSAN........................................              51               1              51  8........................................             408
                                              ----------------------------------------------------------------------------------------------------------
    Subtotal.................................  ..............  ..............          30,326  .........................................         236,784
--------------------------------------------------------------------------------------------------------------------------------------------------------
        Total................................  ..............  ..............          30,423  .........................................         325,404
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital, or operational and maintenance costs associated with the information collection.

    CDER:
    Under Sec. Sec.  312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and
314.94(a)(9)(i) (21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and
314.94(a)(9)(i)), each investigational new drug application (IND), new
drug application (NDA), and abbreviated new drug application (ANDA)
must contain a claim for CE under Sec.  25.30 or Sec.  25.31, or an EA
under Sec.  25.40.
    CDRH:
    Under Sec.  814.20(b)(11) (21 CFR 814.20(b)(11)), premarket
approvals (PMAs) (original PMAs and supplements) must contain a claim
for CE under Sec.  25.30 or Sec.  25.34 or an EA under Sec.  25.40.
    CBER:
    Under 21 CFR 601.2(a), biologic license applications (BLAs) as well
as INDs (Sec.  312.23), NDAs (Sec.  314.50), ANDAs (Sec.  314.94), and
PMAs (Sec.  814.20) must contain either a claim of CE under Sec.  25.30
or Sec.  25.32 or an EA under Sec.  25.40.
    CVM:
    Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs); 21 CFR 514.8(a)(1)
supplemental NADAs and ANADAs; 21 CFR 511.1(b)(10) investigational new
animal drug applications and generic investigational new animal drug
applications, and 21 CFR 571.1(c) food additive petitions must contain
a claim for CE under Sec.  25.30 or Sec.  25.32 or an EA under Sec.
25.40.
    CTP:
    Under sections 905, 910, and 911 of the FD&C Act (21 U.S.C. 387e,
387j, and 387k), product applications and supplements, premarket
tobacco applications (PMTAs), substantial equivalences (SEs), exemption
from SEs, and modified risk tobacco product applications must contain a
claim for a CE or an EA. Upon evaluation, we have concluded that the
majority of the EA burden for tobacco products is accounted for in
other information collections currently approved by OMB. The burden we
attribute to SEs is currently approved in OMB control number 0910-0673;
the burden we attribute to PMTAs is currently approved in OMB control
number 0910-0768; and the burden we attribute to SE exemptions is
currently approved in OMB control number 0910-0684.
    CFSAN:
    The estimates for respondents and numbers of responses are based on
the annualized numbers of petitions and notifications qualifying for
CEs listed under Sec.  25.32(i) and (q) that the Agency has received in
the past 3 years. To avoid counting the burden attributed to Sec.
25.32(o) as zero, we have estimated the burden for this claim of CE at
one respondent making one submission a year for a total of one annual
submission. The burden for submitting a claim of CE is captured under
Sec.  25.15(a) and (d).
    As a result of revising the information collection to include
submissions made to CFSAN, it reflects an increase in burden of 108
responses and 10,668 hours annually.

    Dated: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17154 Filed 8-9-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 30, 2010 (Volume 75, Number 125)]
[Notices]
[Page 37787-37788]
[DOCID:fr30jn10-52]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings  1

June 23, 2010.
    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC10-68-000.
    Applicants: Allegheny Energy Inc., FirstEnergy Corp.
    Description: FirstEnergy Corp and Allegheny Energy, Inc. submit
their response to the FERC's 6/10/10 letter requesting additional
information re an application.
    Filed Date: 06/21/2010.
    Accession Number: 20100622-0005.
    Comment Date: 5 p.m. e.t. on Monday, July 12, 2010.
    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG06-73-000.
    Applicants: BG Dighton Power, LLC.
    Description: Notice of Self-Recertification of Exempt Wholesale
Generator Status of Dighton Power, LLC.
    Filed Date: 06/10/2010.
    Accession Number: 20100610-5020.
    Comment Date: 5 p.m. e.t. on Friday, July 2, 2010

    .Docket Numbers: EG98-79-000.
    Applicants: MASSPOWER.
    Description: Notice of Self-Recertification of Exempt Wholesale
Generator Status of MASSPOWER.
    Filed Date: 06/10/2010.
    Accession Number: 20100610-5022.
    Comment Date: 5 p.m. e.t. on Friday, July 2, 2010.

    Docket Numbers: EG99-220-000.
    Applicants: Lake Road Generating Company, LP.
    Description: Notice of Self-Recertification of Exempt Wholesale
Generator Status of Lake Road Generating Co., L.P.
    Filed Date: 06/10/2010.
    Accession Number: 20100610-5021.
    Comment Date: 5 p.m. e.t. on Friday, July 2, 2010.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER02-537-027; ER03-983-024; ER06-738-024; ER06-739-
024; ER07-501-023; ER07-758-020; ER08-649-016.
    Applicants: Cogen Technologies Linden Venture, L.P., Fox Energy
Company LLC, Birchwood Power Partners, L.P., Shady Hills Power Company,
L.L.C., East Coast Power Liden Holding, LLC, EFS Parlin Holdings, LLC,
Inland Empire Energy Center, LLC.
    Description: Third Supplement to Notice of Non-Material Changes in
Status of East Coast Power Linden Holding, LLC, et al.
    Filed Date: 06/22/2010.
    Accession Number: 20100622-5112.
    Comment Date: 5 p.m. e.t. on Tuesday, July 13, 2010.

    Docket Numbers: ER09-412-013.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits Substitute Fifth
Revised Sheet 572 et al to FERC Electric Tariff, Sixth Revised Volume
1.
    Filed Date: 06/22/2010.
    Accession Number: 20100623-0201.
    Comment Date: 5 p.m. e.t. on Tuesday, July 13, 2010.

    Docket Numbers: ER10-549-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits compliance filing in
order to clarify the inclusion of certain baseline upgrades as
reliability project in the PJM Regional Expansion Plan.
    Filed Date: 06/22/2010.
    Accession Number: 20100622-0204.
    Comment Date: 5 p.m. e.t. on Tuesday, July 13, 2010.

    Docket Numbers: ER10-882-000.
    Applicants: ISO New England Inc., New England Power Pool.
    Description: ISO New England Inc provides responses to the
Commission Deficiency Letter issued on May 14, 2010 re a proposal to
revise the Forward Capacity Market rules.
    Filed Date: 06/14/2010.
    Accession Number: 20100615-0005.
    Comment Date: 5 p.m. e.t. on Tuesday, July 6, 2010.

    Docket Numbers: ER10-1316-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits an executed Large
Generator Interconnection Agreement with Western Farmers Electric
Cooperative etc.
    Filed Date: 05/25/2010.
    Accession Number: 20100525-0234.
    Comment Date: 5 p.m. e.t. on Wednesday, June 30, 2010.

    Docket Numbers: ER10-1522-000.
    Applicants: Occidental Chemical Corporation.
    Description: Occidental Chemical Corporation submits tariff filing
per 35.12: Baseline Tariff Filing, to be effective 6/22/2010.
    Filed Date: 06/22/2010.
    Accession Number: 20100622-5048.
    Comment Date: 5 p.m. e.t. on Tuesday, July 13, 2010.

    Docket Numbers: ER10-1523-000.
    Applicants: New Hampshire Transmission, LLC.
    Description: New Hampshire Transmission, LLC submits Notice of
Succession and a revised rate schedule.
    Filed Date: 06/22/2010.
    Accession Number: 20100622-0212.
    Comment Date: 5 p.m. e.t. on Tuesday, July 13, 2010.

    Docket Numbers: ER10-1524-000.
    Applicants: California Independent System Operator Corporation.
    Description: The California Independent System Operator Corporation
submits Second Revised

Sheet 802B et al. to FERC Electric Tariff, Fourth Replacement Volume 1
to be effective 8/23/10.
    Filed Date: 06/22/2010.
    Accession Number: 20100623-0202.
    Comment Date: 5 p.m. e.t. on Tuesday, July 13, 2010.

    Docket Numbers: ER10-1525-000.
    Applicants: KGen Hot Spring LLC.
    Description: KGen Hot Spring LLC submits tariff filing per 35.12:
Initial Baseline Market Based Rate Tariff Filing to be effective 6/23/
2010 under ER10-01525-000 Filing Type: 400.
    Filed Date: 06/23/2010.
    Accession Number: 20100623-5028.
    Comment Date: 5 p.m. e.t. on Wednesday, July 14, 2010.

    Docket Numbers: ER10-1526-000.
    Applicants: KGen Hinds LLC.
    Description: KGen Hinds LLC submits tariff filing per 35.12:
Initial Baseline Market Based Rate Tariff Filing to be effective 6/23/
2010 under ER10-01526-000 Filing Type: 400.
    Filed Date: 06/23/2010.
    Accession Number: 20100623-5029.
    Comment Date: 5 p.m. e.t. on Wednesday, July 14, 2010.

    Docket Numbers: ER10-1527-000.
    Applicants: KGen Murray I and II LLC.
    Description: KGen Murray I and II LLC submits tariff filing per
35.12: Initial Baseline Market Based Rate Tariff to be effective 6/23/
2010 under ER10-1527 Filing Type: 400.
    Filed Date: 06/23/2010.
    Accession Number: 20100623-5030.
    Comment Date: 5 p.m. e.t. on Wednesday, July 14, 2010.

    Docket Numbers: ER10-1528-000.
    Applicants: New York State Electric & Gas Corp.
    Description: New York State Electric & Gas Corporation supplement
to Rate Schedule 200--Facilities Agreement between NYSEG and the NYPA.
    Filed Date: 06/23/2010.
    Accession Number: 20100623-0203.
    Comment Date: 5 p.m. e.t. on Wednesday, July 14, 2010.

    Docket Numbers: ER10-1529-000.
    Applicants: Northern Iowa Windpower, LLC.
    Description: Northern Iowa Windpower, LLC submits tariff filing per
35.12: Baseline Filing of Northern Iowa Windpower, LLC to be effective
6/23/2010.
    Filed Date: 06/23/2010.
    Accession Number: 20100623-5091.
    Comment Date: 5 p.m. e.t. on Wednesday, July 14, 2010.
    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES10-41-000.
    Applicants: National Grid USA.
    Description: Supplement to Application of National Grid USA for
authorization to issue Securities under Section 204 of the Federal
Power Act.
    Filed Date: 06/22/2010.
    Accession Number: 20100622-5108.
    Comment Date: 5 p.m. e.t. on Friday, July 02, 2010.

    Docket Numbers: ES10-47-000.
    Applicants: Indianapolis Power & Light Company.
    Description: Indianapolis Power & Light Company submits its Amended
Application for Issuance of Short-Term Debt Instruments pursuant to
Section 204 of the FPA.
    Filed Date: 06/22/2010.
    Accession Number: 20100622-5109.
    Comment Date: 5 p.m. e.t. on Friday, July 2, 2010.

    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 e.t. 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.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-15850 Filed 6-29-10; 8:45 am]
BILLING CODE 6717-01-P