[Federal Register Volume 82, Number 147 (Wednesday, August 2, 2017)]
[Proposed Rules]
[Pages 35922-35924]
[FR Doc No: 2017-16276]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2017-0411; FRL-9965-51-Region 9]

Approval and Promulgation of Implementation Plans; Enhanced
Monitoring; California

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
State of California on November 10, 1993. This SIP revision concerns
the establishment of a Photochemical Assessment Monitoring System
(PAMS) network in six ozone nonattainment areas within California. The
EPA is proposing this action under the Clean Air Act based on the
conclusion that all applicable statutory and regulatory requirements
related to PAMS SIP revisions have been met.

DATES: Any comments must arrive by September 1, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2017-0411 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow the
online instructions for submitting comments. Once submitted, comments
cannot be edited or removed from Regulations.gov. For either manner of
submission, 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 the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Doris Lo, EPA Region IX, (415) 972-
3959<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to the EPA.

Table of Contents

I. Background Information
II. Analysis of State Submission
III. Proposed Action and Request for Public Comment
IV. Statutory and Executive Order Reviews

I. Background Information

    The Clean Air Act (CAA or ``Act'') requires the EPA to establish
National Ambient Air Quality Standards (NAAQS or ``standards'') for
certain widespread pollutants, such as ozone, that cause or contribute
to air pollution that is reasonably anticipated to endanger public
health or welfare.\1\ In 1979, we promulgated an ozone NAAQS of 0.12
parts per million (ppm), one-hour average (``1-hour ozone
standard'').\2\
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    \1\ See sections 108 and 109 of the Act.
    \2\ See 44 FR 8202, February 8, 1979.
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    The Act, as amended in 1990, required the EPA to designate as
nonattainment any ozone areas that were still designated nonattainment
under the 1977 Act Amendments, and any other areas violating the 1-hour
ozone standard, generally based on air quality monitoring data from the
1987 through 1989 period.\3\ The 1990 CAA Amendments further classified
these areas, based on the severity of their nonattainment problem, as
Marginal, Moderate, Serious, Severe or Extreme.
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    \3\ See section 107(d)(4) of the Act. See also 56 FR 56694,
November 6, 1991.
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    The control requirements and date by which attainment of the one-
hour ozone

standard was to be achieved varied with an area's classification.
Marginal areas were subject to the fewest mandated control requirements
and had the earliest attainment date while higher classified areas were
subject to more stringent planning requirements and were provided more
time to attain the standard.
    In 1991, we published the initial ozone classifications for
nonattainment areas within each state, and within California, we
classified six ozone nonattainment areas as Serious, Severe, or
Extreme: Los Angeles-South Coast Air Basin (``South Coast''),
Sacramento Metro, San Diego County, San Joaquin Valley, Southeast
Desert Modified AQMA (``Southeast Desert'') and Ventura County.\4\ Such
areas were subject to many requirements, including those related to
enhanced monitoring in CAA section 182(c)(1).
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    \4\ See 56 FR 56694, November 6, 1991.
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    Section 182(c)(1) of the CAA requires that the EPA promulgate rules
for enhanced monitoring of ozone, oxides of nitrogen (NOX),
and volatile organic compounds (VOC) no later than 18 months after the
date of the enactment of the 1990 CAA Amendments. These rules are
intended to provide a mechanism for obtaining more comprehensive and
representative data on ozone air pollution in areas designated
nonattainment and classified as Serious, Severe or Extreme.
    The final PAMS rule was promulgated by the EPA on February 12, 1993
(58 FR 8452). Section 58.40(a) of the revised rule requires the State
to submit a PAMS network description, including a schedule for
implementation, to the Administrator within six months after
promulgation or by August 12, 1993.\5\
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    \5\ Since 1993, EPA has significantly amended and re-organized
the monitoring network requirements in 40 CFR part 58. For the
purposes of this action, the citations to part 58 refer to the July
1, 1993 version of 40 CFR part 58, not the current version because
the California PAMS network description submitted in 1993 was
intended to address the regulatory requirements that applied at the
time.
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    On August 12, 1993, the California Air Resources Board (CARB)
submitted proposed PAMS network plans to the EPA that included a
schedule for implementation for each of the six subject areas in
California. This submittal was reviewed and approved in stages for the
different areas.\6\ In each case, the EPA concluded that the submitted
network plans satisfy the requirements of 40 CFR 58.40(a). Since
network descriptions may change annually, they are not part of the SIP
as recommended by the document, ``Guideline for the Implementation of
the Ambient Air Monitoring Regulations, 40 CFR part 58.'' However, the
network description is negotiated and approved during the annual review
via the grant process under section 105 of the Act, as required by 40
CFR 58.20(d), 58.25, 58.36, and 58.46.
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    \6\ See, e.g., memorandum from William F. Hunt, Jr., Director,
Emissions, Monitoring, and Analysis Division, EPA Office of Air
Quality Planning and Standards (OAQPS) to David P. Howekamp,
Director, Air and Toxics Division, EPA Region IX, dated September
22, 1995 (reference to approval in part of the PAMS Network Plan for
the South Coast and Southeast Desert); memorandum from William F.
Hunt, Jr., Director, Emissions, Monitoring, and Analysis Division,
EPA OAQPS to David Howekamp, Director, Air and Toxics Division, EPA
Region IX, dated August 15, 1995 (reference to approval in part of
the PAMS Network Plan for Sacramento County); letter from David P.
Howekamp, Air Division Director, EPA Region IX, to Richard J.
Sommerville, Air Pollution Control Officer (APCO), San Diego County
Air Pollution Control District (APCD), March 9, 1994 (approval in
part of the PAMS Network Plan for San Diego County); memorandum from
William F. Hunt, Jr., Director, Emissions, Monitoring, and Analysis
Division, EPA OAQPS to David Howekamp, Director, Air and Toxics
Division, EPA Region IX, dated August 16, 1995 (reference to
approval in part of the PAMS Network Plan for San Joaquin Valley);
and letter from David P. Howekamp, Air Division Director, EPA Region
IX, to Richard H. Baldwin, APCO, Ventura County APCD, March 9, 1994
(approval in part of the PAMS Network Plan for Ventura County).
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    Section 182(c)(1) also requires that the SIP be revised to contain
measures to improve the ambient monitoring of ozone, NOX,
and VOC in ozone nonattainment areas classified as Serious, Severe or
Extreme. The final PAMS rule requires that SIP revisions under section
182(c)(1) provide for the establishment and maintenance of a PAMS
network.
    On November 10, 1993, CARB submitted to the EPA a SIP revision for
PAMS in California (``California PAMS SIP revision''). The California
PAMS SIP revision consists of PAMS commitments from five California air
districts with jurisdiction within the six relevant ozone nonattainment
areas: the South Coast Air Quality Management District(for South Coast
and Southeast Desert areas); Sacramento Metro AQMD (for the Sacramento
Metro area); San Diego County Air Pollution Control District (for the
San Diego County area); San Joaquin Valley Unified APCD (for the San
Joaquin Valley area), and Ventura County APCD (for the Ventura County
area), as well as CARB Executive Orders approving the commitments, and
public process documentation. The California PAMS SIP revision is
intended to meet the requirements of section 182(c)(1) of the Act and
affect compliance with the PAMS regulations, codified at 40 CFR part
58, as promulgated on February 12, 1993.

II. Analysis of State Submission

    The criteria used to review the SIP revision submittal are derived
from the CAA, and include: The General Preamble; \7\ the PAMS
regulations, codified at 40 CFR part 58; ``Guideline for the
Implementation of the Ambient Air Monitoring Regulations: 40 CFR part
58--Guideline Series'' (EPA-450/4-78-038, Office of Air Quality
Planning and Standards, November 1979); and the September 2, 1993,
memorandum from G.T. Helms titled, ``Final Boilerplate Language for the
PAMS SIP Submittal.''
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    \7\ EPA, General preamble for future proposed rulemakings, State
Implementation Plans; General Preamble for the Implementation of
Title I of the Clean Air Act Amendments of 1990, 57 FR 13498 (April
16, 1992) (``General Preamble''). The enhanced monitoring
requirement in CAA section 182(c)(1) is addressed on page 13515 of
the General Preamble.
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    The September 2, 1993, Helms boilerplate memorandum stipulates that
the PAMS SIP, at a minimum, must: Provide for monitoring of criteria
pollutants, such as ozone and nitrogen dioxide and non-criteria
pollutants, such as nitrogen oxides, speciated VOCs, including
carbonyls, as well as meteorological parameters; provide a copy of the
approved (or proposed) PAMS network description, including the phase-in
schedule, for public inspection during the public notice and/or comment
period provided for in the SIP revision or, alternatively, provide
information to the public upon request concerning the State's plans for
implementing the rules; make reference to the fact that PAMS will
become a part of the State or local air monitoring stations (SLAMS)
network; and provide a statement that SLAMS will employ federal
reference or equivalent methods (FRMs or FEMs) while most PAMS sampling
will be conducted using methods that are not FRMs or FEMs but approved
by the EPA.
    The California PAMS SIP revision provides that each of the five
relevant air districts will implement PAMS as required in 40 CFR part
58, as amended February 12, 1993. Each district will amend its SLAMS
and its National Air Monitoring Stations monitoring systems to include
the PAMS requirements. Each district will develop its PAMS network
design and establish monitoring sites pursuant to 40 CFR part 58 in
accordance with an approved network description and as negotiated with
the EPA through the CAA section 105 grant process on an annual basis.
Each district also provided the public with an opportunity to inspect
the proposed network description during the public review process for
the proposed SIP revision prior to

forwarding the adopted version to CARB for approval and submittal to
the EPA as a revision to the California SIP.
    The five California air districts have implemented their PAMS
networks as required in 40 CFR part 58. Each relevant air district also
includes a provision to meet quality assurance requirements as
contained in 40 CFR part 58, appendix A and a provision to assure that
the PAMS monitors will meet monitoring methodology requirements
contained in 40 CFR part 58, appendix C. Lastly, the air districts
provided assurance that the PAMS network within their respective
jurisdictions will be phased in over a period of not more than five
years as required in 40 CFR 58.44.
    As such, we conclude that the PAMS SIP revision submitted by CARB
on November 10, 1993, meets the relevant statutory and regulatory
requirements, and we propose to approve it as part of the California
SIP.

III. Proposed Action and Request for Public Comment

    Under CAA section 110(k)(3) and for the reasons discussed above,
the EPA proposes to approve the California PAMS SIP revision submitted
on November 10, 1993, for six ozone nonattainment areas in California.
We will accept comments from the public on the proposed approval for
the next 30 days.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely approves a state plan as
meeting federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed 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 Clean Air Act; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the proposed action 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, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

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

    Dated: July 14, 2017.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2017-16276 Filed 8-1-17; 8:45 am]
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[Federal Register Volume 86, Number 111 (Friday, June 11, 2021)]
[Notices]
[Pages 31328-31330]
[FR Doc No: 2021-12256]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0987]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
the Collection of Qualitative Data on Tobacco Products and
Communications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 July 12, 2021.

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 0910-0796. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Generic Clearance for the Collection of Qualitative Data on Tobacco
Products and Communications

OMB Control Number 0910-0796--Extension

    Under section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 393(d)(2)(D)), FDA is authorized to conduct educational
and public information programs.
    In conducting studies relating to the regulation and communications
related to tobacco products, FDA will need to employ formative
qualitative research, including focus groups, usability testing, and/or
indepth interviews (IDIs) to assess knowledge and perceptions about
tobacco-related topics with specific target audiences. The information
collected will serve three major purposes. First, formative research
will provide critical knowledge about target audiences. FDA must first
understand people's knowledge and perceptions about tobacco-related
topics prior to developing survey/research questions as well as stimuli
for experimental studies. Second, by collecting communications
usability information, FDA will be able to serve and respond to the
ever-changing demands of consumers of tobacco products. Additionally,
we will be able to determine the best way to present messages. Third,
initial testing will allow FDA to assess consumer understanding of
survey/research questions and study stimuli. Focus groups and/or IDIs
with a sample of the target audience will allow FDA to refine the
survey/research questions and study stimuli while they are still in the
developmental stage. FDA will collect, and interpret information
gathered through this generic clearance in order to: (1) Better
understand characteristics of the target audience--its perceptions,
knowledge, attitudes, beliefs, and behaviors--and use these in the
development of appropriate survey/research questions, study stimuli, or
communications; (2) more efficiently and effectively design survey/
research questions and study stimuli; and (3) more efficiently and
effectively design experimental studies.
    FDA is requesting approval of an extension of this generic
clearance for collecting information using qualitative methods (i.e.,
individual interviews, small group discussions, and focus groups) for
studies involving all tobacco products regulated by FDA. This
information will be used as a first step to explore concepts of
interest and assist in the development of quantitative study proposals,
complementing other important research efforts in the Agency. This
information may also be used to help identify and develop communication
messages, which may be used in education campaigns. Focus groups play
an important role in gathering information because they allow for an
indepth understanding of individuals' attitudes, beliefs, motivations,
and feelings. Focus group research serves the narrowly defined need for
direct and informal public opinion on a specific topic.
    The number of respondents to be included in each new pretest may
vary, depending on the nature of the material or message being tested
and the target audience. Table 1 provides examples of the types of
studies that may be administered and estimated burden levels during the
3-year period. Time to read, view, or listen to the message being
tested is built into the ``Hours per Response'' figures. Our estimated
burden for the information collection reflects an overall increase of
5,641 hours and a corresponding increase of 16,585 responses. We
attribute this adjustment to the number of study responses used during
the current approval and now estimated for the next 3 years.
    In the Federal Register of September 29, 2020 (85 FR 60999), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments; however, only one
was PRA-related.
    (Comment) The comment expressed support for FDA's collection of
qualitative research on tobacco products. The comment stated further
that while FDA indicates that this research will meet the ``narrowly
defined need for direct and informal public opinion on a specific
topic,'' the Agency has recently used this work for broader purposes,
including informing the Proposed Rule for graphic health warnings.''
    (Response) FDA appreciates the support for conducting qualitative
research on tobacco products. FDA disagrees with the comment suggesting
that the Agency has used its qualitative generic collection for
``broader purposes'' than contemplated by the generic collection.
Review of a generic collection occurs in two stages: (1) A full PRA
review of the generic clearance ICR, which includes the general
approach and methodology, at least once every 3 years and (2) an
expedited review of the individual collections that fall within the
scope of the generic clearance. OMB reviewed the individual
collection[s] that this comment cites and approved the collection,
having determined that it was appropriately within the scope of the
generic clearance.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
              Type of interview                  Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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In-Person Individual IDIs...................           1,092               1           1,092  1.........................................           1,092
IDI Screener................................           1,800               1           1,800  0.083 (5 minutes).........................             150
Focus Group Screener........................          19,385               1          19,385  0.25 (15 minutes).........................           4,846
Focus Group Interviews......................           5,897               1           5,897  1.5.......................................           8,846
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          14,934
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12256 Filed 6-10-21; 8:45 am]
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[Federal Register: March 13, 2007 (Volume 72, Number 48)]
[Notices]
[Page 11344]
[DOCID:fr13mr07-33]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. CP07-93-000]

Columbia Gas Transmission Corporation; Notice of Application

March 7, 2007.
    Take notice that on February 28, 2007, Columbia Gas Transmission
Corporation (Columbia), 1700 MacCorkle Avenue, SE., Charleston, West
Virginia 25314, filed in Docket No. CP07-93-000, an application
pursuant to section 7(c) of the Natural Gas Act (NGA), to: (1) uprate
approximately \1/3\ mile of its Line WB between its Inventory Station
No. 0+00 to 16+54 from 750 psig to 809 psig, and (2) increase the
discharge of its Cobb Compressor Station from 750 psig to 809 psig.
Columbia states that its proposal is intended to improve its system
operations and the modifications will not increase capacity available
for sale due to the short length of pipeline involved. Columbia also
states that all of its facilities are located in Kanawha County, West
Virginia, all as more fully set forth in the application which is on
file with the Commission and open to public inspection. This filing may
also be viewed on the Commission's Web site at http://www.ferc.gov

using the ``eLibrary'' link. Enter the docket number, excluding the
last three digits, in the docket number field to access the document.
For assistance, call<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to
counsel for Columbia, Fredric J. George, Lead Counsel, Columbia Gas
Transmission Corporation, P.O. Box 1273, Charleston, West Virginia
25325-1273; telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments
protests and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
(http://www.ferc.gov) site under the ``e-Filing'' link.

    Comment Date: 5 p.m. Eastern Standard Time, March 28, 2007.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-4472 Filed 3-12-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 64 (Tuesday, April 6, 2021)]
[Notices]
[Pages 17830-17831]
[FR Doc No: 2021-07007]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER15-705-008.
    Applicants: Pacific Gas and Electric Company.
    Description: Compliance filing: Compliance filing CCSF IA and TFAs
Following Order on Compliance (TO SA 284) to be effective 7/23/2015.
    Filed Date: 3/30/21.
    Accession Number: 20210330-5158.
    Comments Due: 5 p.m. ET 4/20/21.

    Docket Numbers: ER15-705-009.
    Applicants: Pacific Gas and Electric Company.
    Description: Compliance filing: Compliance filing CCSF IA and TFAs
Following Order on Compliance (TO SA 284) to be effective 7/1/2015.
    Filed Date: 3/30/21.
    Accession Number: 20210330-5159.
    Comments Due: 5 p.m. ET 4/20/21.

    Docket Numbers: ER15-2013-010; ER12-2510-009; ER15-2014-005; ER10-
2435-016; ER10-2440-012; ER10-2442-014; ER12-2512-009; ER19-481-002;
ER15-2018-005; ER18-2252-001; ER10-3286-013; ER15-2022-005; ER10-3299-
012; ER10-2444-016; ER10-2446-012; ER15-2026-005; ER15-2020-008; ER10-
2449-014; ER19-2250-002.
    Applicants: Talen Energy Marketing, LLC, Brandon Shores LLC,
Brunner Island, LLC, Camden Plant Holding, L.L.C., Dartmouth Power
Associates Limited Partnership, Elmwood Park Power, LLC, H.A. Wagner
LLC, LMBE Project Company LLC, Martins Creek, LLC, MC Project Company
LLC, Millennium Power Partners, LP, Montour, LLC, New Athens Generating
Company, LLC, Newark Bay Cogeneration Partnership, L.P, Pedricktown
Cogeneration Company LP, Susquehanna Nuclear, LLC, Talen Montana, LLC,
York Generation Company LLC, TrailStone Energy Marketing, LLC.
    Description: Supplement to April 27, 2020 Notification of Change in
Status of the Indicated MBR Sellers.
    Filed Date: 3/29/21.
    Accession Number: 20210329-5273.
    Comments Due: 5 p.m. ET 4/19/21.

    Docket Numbers: ER21-772-000.
    Applicants: Resi Station, LLC.
    Description: Response to February 24, 2021 Deficiency Letter of
Resi Station, LLC.
    Filed Date: 3/26/21.
    Accession Number: 20210326-5228.
    Comments Due: 5 p.m. ET 4/16/21.

    Docket Numbers: ER21-787-001
    Applicants: ISO New England Inc.
    Description: Tariff Amendment: ISO New England Inc.; Response to
Commission Deficiency Notice; ER21-787-000 to be effective 5/29/2021.
    Filed Date: 3/30/21.
    Accession Number: 20210330-5269.
    Comments Due: 5 p.m. ET 4/20/21.

    Docket Numbers: ER21-1553-000.
    Applicants: Luna Storage, LLC.
    Description: Sec.  205(d) Rate Filing: Luna Storage, LLC MISA
Certificate of Concurrence to be effective 3/31/2021.
    Filed Date: 3/30/21.
    Accession Number: 20210330-5002.
    Comments Due: 5 p.m. ET 4/20/21.

    Docket Numbers: ER21-1554-000.
    Applicants: Luna Storage, LLC.
    Description: Sec.  205(d) Rate Filing: Luna Storage, LLC LGIA
Certificate of Concurrence to be effective 3/31/2021.
    Filed Date: 3/30/21.
    Accession Number: 20210330-5003.
    Comments Due: 5 p.m. ET 4/20/21.

    Docket Numbers: ER21-1555-000.
    Applicants: New Mexico Wind, LLC.
    Description: Baseline eTariff Filing: Reactive Power Compensation
Filing to be effective 3/31/2021.
    Filed Date: 3/30/21.
    Accession Number: 20210330-5004.
    Comments Due: 5 p.m. ET 4/20/21.

    Docket Numbers: ER21-1556-000.
    Applicants: TGE Pennsylvania 202, LLC, TGE Pennsylvania 203, LLC.
    Description: Petition for Waiver, et al. of TGE Pennsylvania 202,
LLC, et al.
    Filed Date: 3/29/21.
    Accession Number: 20210329-5316.
    Comments Due: 5 p.m. ET 4/8/21.

    Docket Numbers: ER21-1557-000.
    Applicants: Leeward Renewable Energy, LLC.
    Description: Petition for Limited Waiver, et al. of Leeward
Renewable Energy, LLC.
    Filed Date: 3/29/21.
    Accession Number: 20210329-5317.
    Comments Due: 5 p.m. ET 4/8/21.

    Docket Numbers: ER21-1558-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1276R23 Evergy Metro NITSA
NOA to be effective 3/1/2021.
    Filed Date: 3/30/21.
    Accession Number: 20210330-5118.
    Comments Due: 5 p.m. ET 4/20/21.

    Docket Numbers: ER21-1559-000.
    Applicants: Duke Energy Indiana, LLC.
    Description: Sec.  205(d) Rate Filing: DEI--Revisions to FERC
Electric Tariff Volume No. 10, Reactive Tariff to be effective 6/1/
2021.
    Filed Date: 3/30/21.
    Accession Number: 20210330-5194.
    Comments Due: 5 p.m. ET 4/20/21.

    Docket Numbers: ER21-1560-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2021-03-30_SA 2294 ATC-DTE
Garden Wind Farm 5th Rev GIA (J060 J061 J557 J928) to be effective 3/
11/2021.
    Filed Date: 3/30/21.

    Accession Number: 20210330-5195.
    Comments Due: 5 p.m. ET 4/20/21.

    Docket Numbers: ER21-1561-000.
    Applicants: Duke Energy Florida, LLC.
    Description: Sec.  205(d) Rate Filing: Revised DEF Rate Schedule
No. 226 (Seminole Electric Cooperative, Inc.) (Second) to be effective
6/1/2021.
    Filed Date: 3/30/21.
    Accession Number: 20210330-5268.
    Comments Due: 5 p.m. ET 4/20/21.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:

    Docket Numbers: QM21-13-000.
    Applicants: Upper Peninsula Power Company.
    Description: Application of Upper Peninsula Power Company to
Terminate Mandatory Purchase Obligation under the Public Utility
Regulatory Policies Act of 1978.
    Filed Date: 3/26/21.
    Accession Number: 20210326-5284.
    Comments Due: 5 p.m. ET 4/23/21.

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

    Dated: March 30, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-07007 Filed 4-5-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Notices]
[Pages 65769-65771]
[FR Doc No: 2018-27618]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84830; File No. SR-CboeBYX-2018-025]

Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Extend
the Pilot Period for the Exchange's Retail Price Improvement Program

December 17, 2018.
    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 December 11, 2018, Cboe BYX Exchange, Inc. (the ``Exchange'' or
``BYX'') 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 Exchange. The Exchange
filed the proposal as a ``non-controversial'' proposed rule change
pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-
4(f)(6) thereunder.\4\ The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    Cboe BYX Exchange, Inc. (``BYX'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (the ``Commission'') a
proposed rule change to extend the pilot period for the Exchange's
Retail Price Improvement Program.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatory
Home.aspx), at the Exchange's Office of the Secretary, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to extend the pilot
period for the Exchange's Retail Price Improvement Program (the
``Program''). The Program is currently set to expire on the earlier of
approval of the filing to make the Program permanent or December 31,
2018.\5\ The Exchange now proposes to extend the Program until the
earlier of approval of the filing to make the Program permanent or June
30, 2019.
---------------------------------------------------------------------------

    \5\ The Exchange has filed to make the pilot program permanent.
See Securities Exchange Act Release No. 83831 (August 13, 2018), 83
FR 41128 (August 17, 2018) (SR-CboeBYX-2018-014).
---------------------------------------------------------------------------

Background
    In November 2012, the Commission approved the Program on a pilot
basis.\6\ The Program is designed to attract retail order flow to the
Exchange, and allows such order flow to receive potential price
improvement. The Program is currently limited to trades occurring at
prices equal to or greater than $1.00 per share. Under the Program, all
Exchange Users \7\ are permitted to provide potential price improvement
for Retail Orders \8\ in the form of non-displayed interest that is
better than the national best bid that is a Protected Quotation
(``Protected NBB'') or the national best offer that is a Protected
Quotation (``Protected NBO'', and together with the Protected NBB, the
``Protected NBBO'').\9\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 68303 (November 27,
2012), 77 FR 71652 (December 3, 2012) (``RPI Approval Order'') (SR-
BYX-2012-019).
    \7\ A ``User'' is defined in BYX Rule 1.5(cc) as any member or
sponsored participant of the Exchange who is authorized to obtain
access to the System.
    \8\ A ``Retail Order'' is defined in Rule 11.24(a)(2) as an
agency order that originates from a natural person and is submitted
to the Exchange by a RMO, provided that no change is made to the
terms of the order with respect to price or side of market and the
order does not originate from a trading algorithm or any
computerized methodology. See Rule 11.24(a)(2).
    \9\ The term Protected Quotation is defined in BYX Rule 1.5(t)
and has the same meaning as is set forth in Regulation NMS Rule
600(b)(58). The terms Protected NBB and Protected NBO are defined in
BYX Rule 1.5(s). The Protected NBB is the best-priced protected bid
and the Protected NBO is the best-priced protected offer. Generally,
the Protected NBB and Protected NBO and the national best bid
(``NBB'') and national best offer (``NBO'', together with the NBB,
the ``NBBO'') will be the same. However, a market center is not
required to route to the NBB or NBO if that market center is subject
to an exception under Regulation NMS Rule 611(b)(1) or if such NBB
or NBO is otherwise not available for an automatic execution. In
such case, the Protected NBB or Protected NBO would be the best-
priced protected bid or offer to which a market center must route
interest pursuant to Regulation NMS Rule 611.
---------------------------------------------------------------------------

    The Program was approved by the Commission on a pilot basis running
one year from the date of implementation.\10\ The Commission approved
the Program on November 27, 2012.\11\ The Exchange implemented the
Program on January 11, 2013, and has extended the pilot period six
times.\12\ The pilot period for the Program is currently set to expire
on the earlier of approval of the filing to make this rule permanent or
December 31, 2018. This filing seeks to extend the pilot until the
earlier of approval of the filing to make the Program permanent or June
30, 2019.
---------------------------------------------------------------------------

    \10\ See RPI Approval Order, supra note 6 at 71652.
    \11\ Id.
    \12\ See Securities Exchange Act Release Nos. 71249 (January 7,
2014), 79 FR 2229 (January 13, 2014) (SR-BYX-2014-001); 74111
(January 22, 2015), 80 FR 4598 (January 28, 2015) (SR-BYX-2015-05);
76965 (January 22, 2016), 81 FR 4682 (January 27, 2016) (SR-BYX-
2016-01); 78180 (June 28, 2016), 81 FR 43306 (July 1, 2016) (SR-
BatsBYX-2016-15); 81368 (August 10, 2017), 82 FR 38960 (August 16,
2017) (SR-BatsBYX-2017-18); 83758 (August 1, 2018), 83 FR 38757
(August 7, 2018) (SR-CboeBYX-2018-015).
---------------------------------------------------------------------------

Proposal To Extend the Operation of the Program
    The Exchange established the Program in an attempt to attract
retail order flow to the Exchange by potentially providing price
improvement to such order flow. The Exchange believes that the Program
promotes competition for retail order flow by allowing Exchange members
to submit Retail Price Improvement Orders (``RPI Orders'') \13\ to
interact with Retail Orders. Such competition has the ability to
promote efficiency by facilitating the price discovery process and
generating

additional investor interest in trading securities, thereby promoting
capital formation. The Exchange believes that extending the pilot is
appropriate because it will allow the Exchange and the Commission
additional time to gather and analyze data regarding the Program that
the Exchange has committed to provide.\14\ As such, the Exchange
believes that it is appropriate to extend the current operation of the
Program.\15\ Through this filing, the Exchange seeks to extend the
current pilot period of the Program until the earlier of approval of
the filing to make the Program permanent or June 30, 2019.
---------------------------------------------------------------------------

    \13\ A ``Retail Price Improvement Order'' is defined in Rule
11.24(a)(3) as an order that consists of non-displayed interest on
the Exchange that is priced better than the Protected NBB or
Protected NBO by at least $0.001 and that is identified as such. See
Rule 11.24(a)(3).
    \14\ See RPI Approval Order, supra note 6 at 71655.
    \15\ Concurrently with this filing, the Exchange has submitted a
request for an extension of the exemption under Regulation NMS Rule
612 previously granted by the Commission that permits it to accept
and rank the RPI orders in sub-penny increments. See Letter from
Anders Franzon, SVP, Deputy General Counsel, Cboe BYX Exchange, Inc.
to Brent J. Fields, Secretary, Securities and Exchange Commission
dated December 11, 2018.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\16\ In particular,
the Exchange believes the proposed change furthers the objectives of
Section 6(b)(5) of the Act,\17\ in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system. The Exchange believes that
extending the pilot period for the Program is consistent with these
principles because the Program is reasonably designed to attract retail
order flow to the exchange environment, while helping to ensure that
retail investors benefit from the better price that liquidity providers
are willing to give their orders. Additionally, as previously stated,
the competition promoted by the Program may facilitate the price
discovery process and potentially generate additional investor interest
in trading securities. The extension of the pilot period will allow the
Commission and the Exchange to continue to monitor the Program for its
potential effects on public price discovery, and on the broader market
structure.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b).
    \17\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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. The proposed rule change
extends an established pilot program, thus allowing the Program to
enhance competition for retail order flow and contribute to the public
price discovery process.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from Members or other interested parties.

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

    Because the foregoing proposed rule change does not: (A)
Significantly affect the protection of investors or the public
interest; (B) impose any significant burden on competition; and (C) by
its terms, 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 \18\ and
paragraph (f)(6) of Rule 19b-4 thereunder,\19\ the Exchange has
designated this rule filing as non-controversial.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4. As required under Rule 19b-4(f)(6)(iii),
the Exchange has given 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. 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of the filing.\20\
However, pursuant to Rule 19b-4(f)(6)(iii),\21\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposed
rule change may become operative upon filing. The Exchange states that
waiver of the operative delay is consistent with the protection of
investors and the public interest and will allow the Exchange to extend
the Program, which will ensure that the Program continues while the
Exchange and Commission continue to analyze data regarding the Program.
---------------------------------------------------------------------------

    \20\ 17 CFR 240.19b-4(f)(6).
    \21\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The Commission believes that waiving the 30-day operative delay for
the instant filing is consistent with the protection of investors.
Accordingly, the Commission designates the proposed rule change as
operative upon filing with the Commission.\22\
---------------------------------------------------------------------------

    \22\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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: (1)
Necessary or appropriate in the public interest; (2) for the protection
of investors; or (3) 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 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-CboeBYX-2018-025 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-CboeBYX-2018-025. 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-
CboeBYX-2018-025 and should be submitted on or before January 11, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2018-27618 Filed 12-20-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 212 (Friday, November 1, 2019)]
[Notices]
[Page 58710]
[FR Doc No: 2019-23920]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-195-000]

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

    This is a supplemental notice in the above-referenced proceeding of
Diamond Leaf Energy, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 18, 2019.
    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
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: October 28, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-23920 Filed 10-31-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Notices]
[Pages 21838-21840]
[FR Doc No: 2014-08691]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2014-0003 (PDA-37(R)]

New York City Permit Requirements for Transportation of Certain
Hazardous Materials

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Public notice and invitation to comment.

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

SUMMARY: Interested parties are invited to comment on an application by
the American Trucking Associations, Inc. (ATA) for an administrative
determination whether Federal hazardous material transportation law
preempts requirements of the New York City Fire Department for a permit
to transport certain hazardous materials by motor vehicle through New
York City, or for transshipment from New York City, and the fee for the
permit.

DATES: Comments received on or before June 2, 2014 and rebuttal
comments received on or before July 16, 2014 will be considered before
an administrative determination is issued by PHMSA's Chief Counsel.
Rebuttal comments may discuss only those issues raised by comments
received during the initial comment period and may not discuss new
issues.

ADDRESSES: ATA's application and all comments received may be reviewed
in the Docket Operations Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590. The application and all
comments are available on the U.S. Government Regulations.gov Web site:
http://www.regulations.gov.
    Comments must refer to Docket No. PHMSA-2014-0003 and may be
submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-202-493-2251.
     Mail: Docket Operations Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Docket Operations Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9:00 a.m. and
5:00 p.m., Monday through Friday, except Federal holidays.
    A copy of each comment must also be sent to (1) Boyd Stephenson,
Director, Hazardous Materials & Licensing Policy, American Trucking
Associations, 950 Glebe Road, Suite 210, Arlington, VA 22203, and (2)
Salvatore J. Cassano, Commissioner, New York City Fire Department, 9
Metrotech Center, New York, NY 11201. A certification that a copy has
been sent to these persons must also be included with the comment. (The
following format is suggested: ``I certify that copies of this comment
have been sent to ATA and the New York City Fire Department at the
addresses specified in the Federal Register.'')
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing a comment submitted on behalf of an
association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78), or you may visit http://www.regulations.gov.
    A subject matter index of hazardous materials preemption cases,
including a listing of all inconsistency rulings (IRs) and preemption
determinations (PDs), is available through PHMSA's home page at http://phmsa.dot.gov. From the home page, click on ``Regulations,'' then on
``Preemption of State and Local Laws'' (in the ``Hazmat Safety''
column). A paper copy of the index will be provided at no cost upon
request to Mr. Hilder or Mr. Lopez, at the address and telephone number
set forth in FOR FURTHER INFORMATION CONTACT below.

FOR FURTHER INFORMATION CONTACT: Frazer C. Hilder or Vincent Lopez,
Office of Chief Counsel (PHC-10), Pipeline and Hazardous Materials
Safety Administration, U.S. Department of Transportation, 1200 New
Jersey Avenue SE., Washington, DC 20590; telephone No.<PHONE_NUMBER>;
facsimile No.<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Application for a Preemption Determination

    ATA has applied to PHMSA for a determination whether Federal
hazardous material transportation law, 49 U.S.C. 5101 et seq., preempts
the provisions in Section 2702-02 of Title 3 of the Rules of the City
of New York which allow ``motor vehicles for which a permit has been
issued'' to transport

flammable liquids, combustible liquids, compressed gases, and
explosives, including fireworks in interstate and intrastate
commerce, through the city without pickup or delivery, and with
respect to deliveries of such materials to wharfs or piers, airports
and shipping terminals for transshipment out of the city . . .
without conforming to the routing, time, escort and other
requirements of this section.\1\
---------------------------------------------------------------------------

    \1\ Section 2707-02(a), (b)(2) (emphasis supplied; other italics
omitted). Small arms ammunition and paints, varnishes, and other
paint products are ``not subject to this section.'' The ``other
requirements of this section'' include (a) prohibitions against
fueling the motor vehicle in the City, or parking, standing, or
transferring hazardous material from one container or vehicle to
another except in the case of emergency, and (b) requirements to
avoid congested areas and notify the Fire and Police Departments in
the event of a breakdown or collision.
    ATA has also applied for a determination whether Federal
hazardous material transportation law preempts permit and fee
requirements of Pittsburgh, Pennsylvania. See Docket No. PHMSA-2014-
0002 (PDA-36(R)).

    ATA states that motor carriers ``must file a separate application
for each tractor or trailer,'' and pay a $210 fee ``for each tractor or
trailer to be inspected, and, if approved, must be ready to present
copies of the permit to enforcement officials at their request.'' \2\
The copy of the permit form provided by ATA contains spaces for the
truck and trailer numbers and the date of inspection of the vehicle or
trailer, and also indicates that the ``Permit expires (1) one year from
the above date'' and ``This letter shall be carried in the cab of the
truck and it shall be presented upon request to Fire Department
representative.''
---------------------------------------------------------------------------

    \2\ ATA states that the ``$210 fee to inspect each tractor or
trailer'' is ``far above the prevailing norm'' and that ``[o]ther
hazardous materials transportation permits cost significantly less.
For instance, the entire state of California mandates only $100 per
motor carrier.''
---------------------------------------------------------------------------

    In summary, ATA contends that the:

    City of New York's regulatory regime is deficient in several
ways. Only motor carriers are required to obtain City of New York's
permit, which imposes an unfair burden on a single mode of
transportation. The permit requirements apply only to some carriers
and impedes their drivers' ability to comply with 49 CFR 177.800(d),
which mandates that ``hazardous materials must be transported
without unnecessary delay.'' Finally, City of New York cannot show
that it is using funds generated from its permit fees for hazardous
materials enforcement and emergency response training.

II. Federal Preemption

    Section 5125 of Title 49, United States Code (U.S.C.), contains
express preemption provisions relevant to this proceeding. Subsection
(a) provides that a requirement of a State, political subdivision of a
State, or Indian tribe is preempted--unless the non-Federal requirement
is authorized by another Federal law or DOT grants a waiver of
preemption under Sec.  5125(e)--if:

    (1) complying with a requirement of the State, political
subdivision, or tribe and a requirement of this chapter, a
regulation prescribed under this chapter, or a hazardous materials
transportation security regulation or directive issued by the
Secretary of Homeland Security is not possible; or
    (2) the requirement of the State, political subdivision, or
tribe, as applied or enforced, is an obstacle to accomplishing and
carrying out this chapter, a regulation prescribed under this
chapter, or a hazardous materials transportation security regulation
or directive issued by the Secretary of Homeland Security.\3\
---------------------------------------------------------------------------

    \3\ These two paragraphs set forth the ``dual compliance'' and
``obstacle'' criteria that are based on U.S. Supreme Court decisions
on preemption. Hines v. Davidowitz, 312 U.S. 52 (1941); Florida Lime
& Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963); Ray v.
Atlantic Richfield, Inc., 435 U.S. 151 (1978). PHMSA's predecessor
agency, the Research and Special Programs Administration, applied
these criteria in issuing inconsistency rulings under the original
preemption provisions in Section 112(a) of the Hazardous Materials
Transportation Act (HMTA), Public Law 93-633, 88 Stat. 2161 (Jan. 3,
1975).

    Subsection (b)(1) of 49 U.S.C. 5125 provides that a non-Federal
requirement concerning any of the following subjects is preempted--
unless authorized by another Federal law or DOT grants a waiver of
preemption--when the non-Federal requirement is not ``substantively the
same as'' a provision of Federal hazardous material transportation law,
a regulation prescribed under that law, or a hazardous materials
security regulation or directive issued by the Department of Homeland
---------------------------------------------------------------------------
Security:

    (A) the designation, description, and classification of
hazardous material.
    (B) the packing, repacking, handling, labeling, marking, and
placarding of hazardous material.
    (C) the preparation, execution, and use of shipping documents
related to hazardous material and requirements related to the
number, contents, and placement of those documents.
    (D) the written notification, recording, and reporting of the
unintentional release in transportation of hazardous material.
    (E) the designing, manufacturing, fabricating, inspecting,
marking, maintaining, reconditioning, repairing, or testing a
package, container, or packaging component that is represented,
marked, certified, or sold as qualified for use in transporting
hazardous material.\4\
---------------------------------------------------------------------------

    \4\ To be ``substantively the same,'' the non-Federal
requirement must conform ``in every significant respect to the
Federal requirement. Editorial and other similar de minimis changes
are permitted.'' 49 CFR 107.202(d).

    In addition, 49 U.S.C. 5125(f)(1) provides that a State, political
subdivision, or Indian tribe ``may impose a fee related to transporting
hazardous material only if the fee is fair and used for a purpose
related to transporting hazardous material, including enforcement and
planning, developing, and maintaining a capability for emergency
response.'' \5\
---------------------------------------------------------------------------

    \5\ See also 49 U.S.C. 5125(c) containing standards which apply
to preemption of non-Federal requirements on highway routes over
which hazardous materials may or may not be transported.
---------------------------------------------------------------------------

    The preemption provisions in 49 U.S.C. 5125 reflect Congress's
long-standing view that a single body of uniform Federal regulations
promotes safety (including security) in the transportation of hazardous
materials. Some forty years ago, when considering the HMTA, the Senate
Commerce Committee ``endorse[d] the principle of preemption in order to
preclude a multiplicity of State and local regulations and the
potential for varying as well as conflicting regulations in the area of
hazardous materials transportation.'' S. Rep. No. 1102, 93rd Cong. 2nd
Sess. 37 (1974). A United States Court of Appeals has found uniformity
was the ``linchpin'' in the design of the Federal laws governing the
transportation of hazardous materials. Colorado Pub. Util. Comm'n v.
Harmon, 951 F.2d 1571, 1575 (10th Cir. 1991).

III. Preemption Determinations

    Under 49 U.S.C. 5125(d)(1), any person (including a State,
political subdivision of a State, or Indian tribe) directly affected by
a requirement of a State, political subdivision or tribe may apply to
the Secretary of Transportation for a determination whether the
requirement is preempted. The Secretary of Transportation has delegated
authority to PHMSA to make determinations of preemption, except for
those concerning highway routing (which have been delegated to the
Federal Motor Carrier Safety Administration). 49 CFR 1.97(b).
    Section 5125(d)(1) requires notice of an application for a
preemption determination to be published in the Federal Register.
Following the receipt and consideration of written comments, PHMSA
publishes its determination in

the Federal Register. See 49 CFR 107.209(c). A short period of time is
allowed for filing of petitions for reconsideration. 49 CFR 107.211. A
petition for judicial review of a final preemption determination must
be filed in the United States Court of Appeals for the District of
Columbia or in the Court of Appeals for the United States for the
circuit in which the petitioner resides or has its principal place of
business, within 60 days after the determination becomes final. 49
U.S.C. 5127(a).
    Preemption determinations do not address issues of preemption
arising under the Commerce Clause, the Fifth Amendment or other
provisions of the Constitution, or statutes other than the Federal
hazardous material transportation law unless it is necessary to do so
in order to determine whether a requirement is authorized by another
Federal law, or whether a fee is ``fair'' within the meaning of 49
U.S.C. 5125(f)(1). A State, local or Indian tribe requirement is not
authorized by another Federal law merely because it is not preempted by
another Federal statute. Colorado Pub. Util. Comm'n v. Harmon, above,
951 F.2d at 1581 n.10. In addition, PHMSA does not generally consider
issues regarding the proper application or interpretation of a non-
Federal regulation, but rather how such requirements are actually
``applied or enforced.'' Rather, ``isolated instances of improper
enforcement (e.g., misinterpretation of regulations) do not render such
provisions inconsistent'' with Federal hazardous material
transportation law, but are more appropriately addressed in the
appropriate State or local forum. PD-14(R), Houston, Texas, Fire Code
Requirements on the Storage, Transportation, and Handling of Hazardous
Materials, 63 FR 67506, 67510 n.4 (Dec. 7, 1998), decision on petition
for reconsideration, 64 FR 33949 (June 24, 1999), quoting from IR-31,
Louisiana Statutes and Regulations on Hazardous Materials
Transportation, 55 FR 25572, 25584 (June 21, 1990), appeal dismissed as
moot, 57 FR 41165 (Sept. 9, 1992), and PD-4 (R), California
Requirements Applicable to Cargo Tanks Transporting Flammable and
Combustible Liquids, 58 FR 48940 (Sept. 20, 1993), decision on
reconsideration, 60 FR 8800 (Feb. 15, 1995).
    In making preemption determinations under 49 U.S.C. 5125(d), PHMSA
is guided by the principles and policies set forth in Executive Order
No. 13132, entitled ``Federalism'' (64 FR 43255 (Aug. 10, 1999)), and
the President's May 20, 2009 memorandum on ``Preemption'' (74 FR 24693
(May 22, 2009)). Section 4(a) of that Executive Order authorizes
preemption of State laws only when a statute contains an express
preemption provision, there is other clear evidence Congress intended
to preempt State law, or the exercise of State authority directly
conflicts with the exercise of Federal authority. The President's May
20, 2009 memorandum sets forth the policy ``that preemption of State
law by executive departments and agencies should be undertaken only
with full consideration of the legitimate prerogatives of the States
and with a sufficient legal basis for preemption.'' Section 5125
contains express preemption provisions, which PHMSA has implemented
through its regulations.

IV. Public Comments

    All comments should be directed to whether 49 U.S.C. 5125 preempts
the City of New York's requirements for a permit for transporting these
hazardous materials by motor vehicle through the City, or for
transshipment from the City, and the fee for obtaining the permit.
Comments should specifically address the preemption criteria discussed
in Part II above and set forth in detail the manner in which these
requirements are applied and enforced, including:
     Any requirements or conditions for issuance of a permit,
other than completion of the application form, payment of the permit
fee, and inspection of the tractor or trailer;
     the amount of time taken by the City to conduct the
inspection and issue a permit; and
     for each of the past three calendar (or fiscal) years, the
total amount of permit fees collected by the City and all purposes for
which these fees have been used (including an identification of the
specific accounts into which the permit fees were deposited).

    Issued in Washington, DC, on April 11, 2014.
Vanessa L. Allen Sutherland,
Chief Counsel.
[FR Doc. 2014-08691 Filed 4-16-14; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register: December 18, 2007 (Volume 72, Number 242)]
[Notices]
[Page 71673]
[DOCID:fr18de07-40]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR08-8-000]

Magic Valley Pipeline, L.P.; Notice of Petition for Rate Approval

December 11, 2007.
    Take notice that on November 30, 2007, Magic Valley Pipeline, L.P.
(Magic Valley) filed a petition for approval of rates for
transportation services, pursuant to section 284.123(b)(2) of the
Commission's regulations. Magic Valley requests that the Commission
approve a maximum monthly reservation charge of $1.1669 per Dth, with a
maximum firm commodity charge of $0.00 per Dth, and the equivalent
interruptible transportation rate of $0.0384 per Dth.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time December 27, 2007.

 Kimberly D. Bose,
Secretary.
[FR Doc. E7-24412 Filed 12-17-07; 8:45 am]

BILLING CODE 6717-01-P


Panel Members for the Meeting of the Federal Insecticide, Fungicide and
Rodenticide Act Scientific Advisory Panel (FIFRA SAP)

to consider and review

The Use of Structure Activity Relationships of Estrogen Binding Affinity
to Support Prioritization of Pesticide Inert Ingredients and
Antimicrobial Pesticides for Screening and Testing

August 25-27, 2009

EPA-HQ-OPP-2009-0322				OPP Docket Tel:<PHONE_NUMBER>

FIFRA SAP Session Chair

Janice E. Chambers, Ph.D., DABT, ATS

William L. Giles Distinguished Professor

Director, Center for Environmental Health Sciences

College of Veterinary Medicine

Mississippi State University

Mississippi State, Mississippi

Designated Federal Official

Sharlene Matten, Ph.D.

US Environmental Protection Agency

Office of Science Coordination & Policy

FIFRA Scientific Advisory Panel

EPA East Building, MC 7201M

1200 Pennsylvania Avenue, NW

Washington, DC 20460

Tel:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>,   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
FIFRA Scientific Advisory Panel Members

John R. Bucher, Ph.D., DABT

Associate Director

Environmental Toxicology Program

National Institute of Environmental Health Sciences

Research Triangle Park, North Carolina

Carey N. Pope, Ph.D.

Professor, Head & Sitlington Chair of Toxicology

Department of Physiological Sciences

Oklahoma State University College of Veterinary Medicine

Stillwater, Oklahoma

Kenneth M. Portier, Ph.D.

Program Director, Statistics

American Cancer Society

National Home Office

Atlanta, Georgia

Daniel Schlenk, Ph.D.

Professor of Aquatic Ecotoxicology & Environmental Toxicology

Department of Environmental Sciences

University of California, Riverside

Riverside, California

FQPA Science Review Board Members

Mark T. D. Cronin, Ph.D.

Professor of Predictive Toxicology

School of Pharmacy and Biomolecular Sciences

Liverpool John Moores University

Liverpool, UK

Nancy Derrick Denslow, Ph.D.

Professor

Department of Physiological Sciences

University of Florida

Gainesville, Florida

Miriam Jacobs, Ph.D.

Scientific Officer

European Food Safety Authority - EFSA

Assessment Methodology Unit

Parma, ITALY

Bette Meek, M.Sc.

Associate Director

Chemical Risk Assessment

McLaughlin Centre for Population Health Risk Assessment

University of Ottawa

Ottawa, Ontario, CANADA

Reynaldo Patiño, Ph.D.

Unit Leader and Professor

USGS Texas Cooperative Fish & Wildlife Research Unit

Texas Tech University

Lubbock, Texas

Terry Schultz, Ph.D.

Professor Emeritus

Department of Comparative Medicine

College of Veterinary Medicine

University of Tennessee

Knoxville, Tennessee

Leming Shi, Ph.D.

Computational Chemist – Principal Investigator

National Center for Toxicological Research

U.S. Food and Drug Administration

Jefferson, Arkansas


[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Notices]
[Pages 47478-47479]
[FR Doc No: 2013-18917]

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

SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

 In the Matter of Zenergy International, Inc., Order of
Suspension of Trading

August 1, 2013.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Zenergy International, Inc. because it has not filed any periodic
reports since the period ended June 23, 2009.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed company is suspended for
the period from 9:30 a.m. EDT on August 1, 2013, through 11:59 p.m. EDT
on August 14, 2013.

    By the Commission.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2013-18917 Filed 8-1-13; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register: October 13, 2005 (Volume 70, Number 197)]
[Notices]
[Page 59743]
[DOCID:fr13oc05-82]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-682-000]

SCG Pipeline, Inc.; Notice of Penalty Revenue Report

October 5, 2005.

    Take notice that on September 29, 2005, SCG Pipeline, Inc. (SCG)
submitted for filing its Penalty Revenue Report covering the time
period from the start of SCG's operations in November 2003 through July
31, 2004.
    SCG states that it did not assess or collect any penalty revenues
during that time period. SCG further requests that the Commission grant
any waivers of its regulations that may be deemed necessary to accept
this report beyond the time periods described in section 25 of the
general terms and conditions of the SCG Tariff.
    SCG states that copies of the filing are being mailed to its
customers and interested state commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on October 13, 2005.

Magalie R. Salas,
Secretary.
[FR Doc. E5-5621 Filed 10-12-05; 8:45 am]

BILLING CODE 6717-01-P


Additional Responses to Environmental Defense Arguments

From May 22, 2006 Letter to Ann Klee

Environmental Defense Comment:

As noted in the Conference Report accompanying TSCA's enactment:

"[T]he most desirable time to determine the health and environmental
effects of a

substance, and to take action to protect against any potential adverse
effects, occurs before commercial production begins. Not only is human
and environmental harm avoided or alleviated, but the cost of any
regulatory action in terms of loss of jobs and capital investments is
minimized. For these reasons the conferees have given the Administrator
broad authority to act during the notification period."

It is inconceivable that Congress would have intended to accompany that
broad grant of

authority with a narrow interpretation of which chemicals qualify as
"new" under TSCA.

EPA Response:

The quoted legislative history identifies the benefits of new chemical
review.  However, Congress also contemplated that EPA could take action
after manufacture.  Significant new use rules under TSCA §5(a)(2) is
just one example of such authority.  At present, EPA has not concluded
that pre-manufacture review is necessary or appropriate for all
nanomaterials.  EPA hopes to use information it obtains from the NMSP
and other activities to help inform judgments regarding appropriate
regulatory approaches for nanomaterials.  Had Congress desired that EPA
have the kind of broad authority to characterize chemical substances as
now urged by ED, Congress could have enacted TSCA without a definition
of chemical substance, or with a more expansive definition.  That
Congress put in a definition that is tied to molecular identity
indicates that Congress intended to put some limits on what may be
reviewed as a new chemical, notwithstanding the benefits of
premanufacture review.

EPA disagrees with the suggestion that the Agency’s approach to the
definition of “chemical substance” is narrow.  EPA considers
differences at the molecular level as giving rise to different chemical
substances.  However, EPA does not believe that substances with
molecules that are identical in every respect have different molecular
identities.

Environmental Defense Comment:

Nothing in TSCA precludes the definition of “chemical substance”
from including physical and chemical properties....[T]he definition of a
chemical substance never mentions physical or chemical properties, which
is true. The...conclusion that the definition thus somehow excludes such
properties...is wholly unsupported.

EPA Response:

TSCA §3(2)(A) defines a chemical substance as a substance of “a
particular molecular identity.”  EPA therefore considers a substance
that is identical at the molecular level to a substance on the TSCA
Inventory to be the same chemical substance, regardless of physical or
chemical properties.

Environmental Defense Comment:

[TSCA] Section 26(c)(2)(A)’s definition of chemical identity...does
refer to physical and chemical (as well as biological) properties. By
noting that such properties can be similar, thereby supporting the
grouping of chemical substances into a category, Congress implicitly
recognizes the converse: that physical and chemical properties can also
be used to distinguish chemical substances.

EPA Response:

Section 26(c)(1) provides in part, “Any action authorized or required
to be taken by the Administrator under any provision of this chapter
with respect to a chemical substance or mixture may be taken by the
Administrator in accordance with that provision with respect to a
category of chemical substances or mixtures.” Section 26(c)(2)(A)
provides that a category may be created to include, among other things,
chemical substances or mixtures that are “similar in molecular
structure, in physical, chemical, or biological properties.” In
EPA’s view, this does not imply that substances with different
properties but identical molecules should be considered to have
different molecular identities.

Environmental Defense Comment:

In describing its “Inventory Review,” an explicit step in EPA’s
PMN review procedure, EPA makes clear [in Chemistry Assistance Manual
for Premanufacture Notification Submitters, EPA 744-R-97-003, March
1997, Chapter 1, p. 15, available online at
www.epa.gov/opptintr/newchems/pubs/chem-pmn/] that it considers factors
beyond chemical structure, including process-related factors, in
establishing a chemical substance’s name for purposes of listing it on
the Inventory:

“The Inventory review is an extremely important component of the PMN
review process, from both legal and technical standpoints. The Inventory
review, performed by chemists within ICB [the Industrial Chemicals
Branch], has two major functions. The first is to establish a complete
and accurate chemical name for the new substance. The chemist compares
the chemical structure, molecular formula, the reactants, and the
reaction scheme for consistency with the CAS name submitted in the
PMN.” (emphases added [by ED])

Hence, factors such as the reaction process are considered by EPA in the
fundamental practice of naming a chemical substance for TSCA purposes.

EPA Response

Factors such as reactants and reaction scheme are used with respect to
UVCB substances, to characterize the complex combination of species that
is a UVCB substance.  These attributes serve as a practical approach to
set the boundaries of a combination that contains many different
molecules (and which is often variable).  The Inventory guidance cited
by the submitter does not serve as precedent for using such factors to
divide a single molecular identity into several different chemical
substances.


[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63586-63587]
[FR Doc No: 2023-19951]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-2654]

Informed Consent Forms for Studies that Enroll Client-Owned
Companion Animals; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #282 entitled
``Informed Consent Forms for Studies that Enroll Client-Owned Companion
Animals.'' As used in this guidance, informed consent is a documented
process by which an owner or owner's agent voluntarily confirms the
owner's willingness to allow their animal(s) to participate in a
particular study, after having been informed of all aspects of the
study that may be relevant to the owner's decision to participate. A
sponsor or investigator should ensure the owner is provided with
adequate information and time to allow for an informed decision about
voluntary participation in a clinical investigation. This draft
guidance provides recommendations on informed consent forms (ICF) used
for studies that enroll client-owned companion animals (dogs, cats, and
horses). FDA's Center for Veterinary Medicine (CVM) recommends all
studies conducted with client-owned companion animals use an ICF and be
conducted in accordance with Good Clinical Practice (GCP) guidelines.

DATES: Submit either electronic or written comments on the draft
guidance by November 14, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-2654 for ``Informed Consent Forms for Studies that Enroll
Client-Owned Companion Animals.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See

the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Steven Fleischer, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft GFI #282 entitled
``Informed Consent Forms for Studies that Enroll Client-Owned Companion
Animals.'' As used in this guidance, informed consent is a documented
process by which an owner or owner's agent voluntarily confirms the
owner's willingness to allow their animal(s) to participate in a
particular study, after having been informed of all aspects of the
study that may be relevant to the owner's decision to participate. A
sponsor or investigator should ensure the owner is provided with
adequate information and time to allow for an informed decision about
voluntary participation in a clinical investigation. This draft
guidance provides recommendations on ICFs used for studies that enroll
client-owned companion animals (dogs, cats, and horses). CVM recommends
all studies conducted with client-owned companion animals use an ICF
and be conducted in accordance with GCP guidelines.
    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
``Informed Consent Forms for Studies that Enroll Client-Owned Companion
Animals.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 514 and section 571 of the Federal Food,
Drug, and Cosmetic Act have been approved under OMB control number
0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19951 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P