[Federal Register: January 23, 2006 (Volume 71, Number 14)]
[Notices]
[Page 3595-3598]
[DOCID:fr23ja06-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53124; File No. SR-NYSE-2005-37]

Self-Regulatory Organizations; New York Stock Exchange, Inc.;
Order Approving a Proposed Rule Change and Amendments No. 1 and 2
Thereto and Notice of Filing and Order Granting Accelerated Approval to
Amendment No. 3 Thereto Relating to Amendments to Certain Sections of
the Exchange Constitution Concerning the Exchange's Hearing Board and
Related Amendments to Exchange Rule 475 and Rule 476

January 13, 2006.

I. Introduction

    On May 23, 2005, the New York Stock Exchange, Inc. (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Article IX of the Exchange's Constitution
and Exchange Rules 475 and 476 to modify certain aspects of the
Exchange's disciplinary procedures and to provide a structure for a
summary suspension hearing and a ``call up'' procedure for review by
members of the Board of Directors (``Board''), certain members of the
Board of Executives listed in NYSE Rule 476(f), any member of the
Regulation, Enforcement and Listing Standards Committee, and either the
Division of the Exchange that initiated the proceedings or the
respondent. On September 9, 2005, the NYSE filed Amendment No. 1 to the
proposed rule change. The proposed rule change, as amended by Amendment
No. 1, was published for comment in the Federal Register on October 26,
2005.\3\ The Commission received no comments regarding the proposal, as
amended. On November 28, 2005 and December 2, 2005, the NYSE filed
Amendments No. 2 \4\ and 3,\5\ respectively, to the proposed rule
change. This order approves the proposed rule change, as amended by

Amendments No. 1 and 2, grants accelerated approval to Amendment No. 3,
and solicits comments from interested persons on Amendment No. 3 to the
proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 52638 (October 19,
2005), 70 FR 61866.
    \4\ In Amendment No. 2, the Exchange makes minor, non-
substantive changes to the rule text contained in Exhibit 5 of the
proposed rule change. This was a technical amendment and is not
subject to notice and comment.
    \5\ In Amendment No. 3, the Exchange proposes that the proposed
rule change, as amended, be implemented on or about April 1, 2006
and attaches a revised Exhibit 5 to reflect changes made to the rule
text in Amendments No. 1 and 2.
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II. Description of the Proposal

    The Exchange proposes to amend Article IX of the Exchange's
Constitution and NYSE Rules 475 and 476 to modify certain aspects of
the Exchange's disciplinary procedures and to provide a structure for a
summary suspension hearing and a ``call-up'' procedure for review by
members of the Board, certain members of the Board of Executives listed
in NYSE Rule 476(f), any member of the Regulation, Enforcement and
Listing Standards Committee, and either the Division of the Exchange
that initiated the proceedings or the respondent.

Amendment to NYSE Rule 475

    NYSE Rule 475 currently provides a process for the Exchange: (i) To
prohibit or limit a person with respect to access of services offered
by the Exchange, or (ii) to summarily suspend an Exchange member or
member organization facing certain circumstances, such as financial or
operating difficulties, or expulsion or suspension by another self-
regulatory organization. The proposed rule change would provide a
structure for such a hearing and for a ``call-up'' procedure for review
by members of the Board and certain members of the Board of
Executives,\6\ any member of the Regulation, Enforcement and Listing
Standards Committee, and either the Division of the Exchange that
initiated the proceedings or the respondent.
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    \6\ These are members of the Board of Executives representing
the groups referenced in clauses (ii) and (iii) of Article V,
Section 2(b) of the Exchange's Constitution, namely, members who
spend a substantial part of their time on the trading floor.
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Amendments to Article IX of the Constitution and NYSE Rule 476

Composition of the Hearing Panel
    The Exchange currently requires that disciplinary hearings be
conducted before a Hearing Panel consisting of a Hearing Officer (an
Exchange staff member) and two peer panelists. The Exchange believes
that this ``trial by peers'' requirement raises a concern about bias
and perception of bias, especially in cases involving charges against
individuals on the trading floor because of the relatively small floor
community. Accordingly, the Exchange proposes that a Hearing Panel
consist of at least one member who is engaged in securities activities
differing from that of the respondent. In any disciplinary proceeding
involving activities on the floor of the Exchange, the Exchange also
proposes that no more than one of the persons serving on the Hearing
Panel be, or if retired, has been, active on the floor. For example,
with respect to cases involving the trading floor, the intent of the
proposal is such that charges against a specialist or floor broker
would be heard before a panel consisting of no more than one individual
employed on the trading floor. In addition, the Exchange proposes that
a Hearing Panel could include only one retired person.
Composition of the Hearing Board and Hearing Officers
    The Exchange also proposes to eliminate the requirement that
Exchange Hearing Officers be employees or officers of the Exchange,
thereby enabling the Exchange to retain outside professionals to serve
as Hearing Officers, if needed. However, under the amendments to the
Exchange's Constitution and NYSE Rule 476, an individual who is, or was
within the last three years, a member, allied member, or registered or
non-registered employee of a member or member organization would not be
eligible to serve as a Hearing Officer. The proposed rule change also
would allow former members, allied members, and registered and non-
registered employees of members and member organizations to be
appointed to the Hearing Board within five years of their
retirement.\7\
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    \7\ The Exchange also proposes to amend NYSE Rule 476 to conform
this rule with language in Article IX, Section 3 of the Exchange's
Constitution prohibiting members of the Board or the Board of
Executives from serving on the Hearing Board. Members of the Hearing
Panel, other than the Hearing Officer, are selected from members of
the Hearing Board. See Article 14, Secs. 2-4 of the Exchange's
Constitution.
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Hearing Officer's Authority
    The Exchange also proposes to permit Hearing Officers to handle
stipulations and uncontested cases without the full Hearing Panel. At
present, all disciplinary hearings (including settled cases, in which a
respondent consents to a penalty, and uncontested cases, in which a
respondent does not file an answer to the charges) must be heard before
a full Hearing Panel. The Exchange proposes to confer authority on an
Exchange Hearing Officer to act alone in considering such uncontested
and settled cases and impose penalties, without a hearing, in order to
expedite resolution of such matters. Under the proposal, the Hearing
Officer would convene a panel and hold a hearing if either the
Enforcement Division or the respondent requests a hearing before a full
panel, or if the Hearing Officer, on his or her own initiative, calls
for a hearing. Moreover, the Hearing Officer could not reject a
stipulated penalty without convening a Hearing Panel.
    Furthermore, the proposed rule change would permit the Hearing
Officer to resolve substantive legal motions, such as motions to
dismiss and motions for summary judgment, by no longer requiring that a
Hearing Panel resolve such motions. The proposed rule change also would
clarify the Hearing Officer's authority to order pre-hearing discovery
of documents from the Division of Enforcement and from the respondent.
    Finally, the proposal would clarify the Hearing Officer's authority
to penalize contemptuous participants and permit the Hearing Officer to
impose fines on a party for inappropriate behavior of either the party
or the party's representative. This authority would not be limited to
dealing with such behavior during a hearing, but would allow for
sanctions to be imposed at any time during the course of proceedings.
The Hearing Officer could also exclude, in extreme situations, any such
persons from further participation in the proceeding.
Conferring Jurisdiction on the Hearing Board Upon Filing of the Charge
Memorandum
    Under current procedures, the hearing in a disciplinary matter is
scheduled only upon request of the Division of Enforcement, after a
respondent's answer is received or the time to file an answer has
expired. The Hearing Board has no jurisdiction to resolve any issues
that arise until the Division of Enforcement requests a hearing, and a
respondent has no avenue of recourse if the respondent believes there
has been an unreasonable or prejudicial delay. The proposed rule change
would require the filing of charges with the Hearing Board at the time
they are served on the respondent. The Hearing Board would assume
jurisdiction of the matter at that juncture and be able to schedule
expeditiously hearings, as well as rule on pre-hearing motions.
``Call Up'' Authority Reallocated
    At present, all members of the Board of Executives (as well as all
Directors other than the Chief Executive Officer) have the right and
the responsibility to ``call up'' disciplinary decisions for review.
The Exchange proposes amendments to its Constitution and NYSE Rule 476
to reallocate this responsibility to members of the Board, Board of
Executives' members representing the trading floor, members of the
Regulation, Enforcement and

Listing Standards Committee, the Exchange Division that initiated the
proceedings or the respondent, but would preserve the Board's right to
designate, by rule, categories of members of the Board of Executives
with this responsibility, if warranted.

Amendment No. 3

    In Amendment No. 3, the Exchange proposes to implement the proposed
rule change, as amended, on or about April 1, 2006 and attached an
Exhibit 5 to reflect changes made to the rule text in Amendments No.1
and 2.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning Amendment No. 3, including whether Amendment No. 3
is consistent with the Act. Comments may be submitted by any of the
following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-NYSE-2005-37 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-9303.

All submissions should refer to File Number SR-NYSE-2005-37. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the NYSE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NYSE-2005-37 and should be submitted on or before
February 13, 2006.

IV. Discussion

    After careful consideration, the Commission finds that the proposed
rule change, as amended, is consistent with the requirements of the Act
and the rules and regulations thereunder applicable to a national
securities exchange.\8\ In particular, the Commission finds that, the
proposed rule change, as amended, is consistent with Section 6(b)(1) of
the Act \9\ which requires that the exchange be ``so organized and
[have] the capacity to carry out the purposes of [the Act]'' and to
``enforce compliance by its members and persons associated with its
members with the provisions of [the Act].'' The Commission also finds
that the proposed amendments relating to the composition of the Hearing
Panel comport with the requirements of Section 6(b)(3) of the Act,\10\
which requires that the rules of a national securities exchange assure
the fair representation of its members in the selection of its
directors and administration of its affairs, and provide that one or
more directors shall be representative of issuers and investors and not
be associated with a member of the exchange, broker, or dealer. The
Commission also finds that the proposed rule change, as amended, is
consistent with Section 6(b)(5) of the Act \11\ in that it is designed,
among other things, 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 regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest.
Further, the Commission finds that the proposed rule change is
consistent with Section 6(b)(7) of the Act,\12\ which, among other
things, requires that the rules of a national securities exchange
provide a fair procedure for the disciplining of members and persons
associated with members.
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    \8\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(1).
    \10\ 15 U.S.C. 78f(b)(3).
    \11\ 15 U.S.C. 78f(b)(5).
    \12\ 15 U.S.C. 78f(b)(7).
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    Specifically, the Commission believes that the proposed changes to
the Exchange's disciplinary procedures should help strengthen the
Exchange's ability to carry out its oversight and enforcement
responsibilities as a self-regulatory organization. The Commission also
believes that the proposal is reasonably designed to improve the
timeliness, fairness, and efficiency of the disciplinary process to
address violations of the Exchange's rules and the federal securities
laws by the Exchange's members and persons associated with members.
    In particular, the Commission believes that it is appropriate for
the Exchange to provide a structure in NYSE Rule 475 for a summary
suspension hearing to prohibit or limit a person's access to services
and to provide a ``call-up'' procedure for Board review of such
proceedings by members of the Board, certain specified members of the
Board of Executives, any member of the Regulation, Enforcement and
Listing Standards Committee, and either the Division of the Exchange
that initiated the proceeding or the respondent. In addition, the
Commission believes that it is appropriate for the Exchange to revise
Article IX of its Constitution to permit the ``call up'' for Board
review of any disciplinary determination or penalty (other than a
proceeding involving a written consent to a specified penalty) by any
member of the Board, certain specified members of the Board of
Executives, any member of the Regulation, Enforcement and Listing
Standards Committee, as well as the Exchange Division that brought the
charges or the respondent. The Commission notes, however, that the
proposed revision to this ``call up'' procedure contained in the
Exchange's Constitution would preserve the Board's right to designate,
by rule, other categories of members of the Board of Executives that
can require such review by the Board.
    In addition, the Commission believes that the proposed changes to
Article IX of the Exchange's Constitution and NYSE Rule 476 with
respect to the composition of the Hearing Panel should expand the
available pool of panelists with the requisite knowledge of the
securities industry to serve on the Hearing Panel. At the same time,
the Commission believes that the proposed requirement that a Hearing
Panel have at least one member who is engaged in securities activities
differing from that of the respondent is designed to mitigate

the perception of bias that may have occurred when a majority of the
panel members in the same line of business as the respondent was not
precluded from serving on such panel. Similarly, the Commission
believes that the proposed changes to allow recently retired members
and employees of members to serve on the Hearing Board and to allow
non-NYSE employees to serve as Hearing Officers should enlarge the pool
of individuals with the requisite expertise to hear and adjudicate
cases and with the ability to readily serve during regular business
hours, thereby potentially allowing cases to be resolved more
expeditiously. Moreover, the Commission notes that the proposal
specifies that, in any disciplinary proceeding involving activities on
the floor of the Exchange, no more than one person on the Hearing Panel
shall have been active on the floor of the Exchange, which also is
intended to reduce the perception of bias in the Exchange's
disciplinary process.
    In addition, the Commission believes that the Exchange's proposal
to expand the Hearing Officer's authority to handle stipulations and
uncontested cases, procedural and evidentiary matters, and substantive
legal motions is designed to expedite the hearing process by allowing
the Hearing Officer to resolve efficiently certain matters that
currently require action by the full Hearing Panel. The Commission
notes that, according to the Exchange, these motions often involve
legal issues that the Hearing Officer is best suited to resolve.
    Finally, the Commission believes that the Exchange's proposal to
require that the filing of charges be made with the Hearing Board at
the time they are served on the respondent will allow the Hearing Board
to immediately assume jurisdiction of the matter and to be able to
expeditiously schedule hearings, as well as rule on pre-hearing
motions.

Accelerated Approval of Amendment No. 3

    The Commission finds good cause to approve Amendment No. 3 to the
proposed rule change, as amended, prior to the thirtieth day after the
amendment is published for comment in the Federal Register pursuant to
Section 19(b)(2) of the Act.\13\ Amendment No. 3 clarifies that the
Exchange intends to implement the proposed rule change, as amended, on
or about April 1, 2006. The Commission notes that the Exchange has
represented that it will issue an Information Memo to alert its members
of the proposed rule change and its implementation date which is
scheduled to occur on or about April 1, 2006.\14\
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    \13\ 15 U.S.C. 78s(b)(2).
    \14\ Telephone conversation between Peggy Kuo, Chief Hearing
Officer, NYSE, and Cyndi N. Rodriguez, Special Counsel, Division of
Market Regulation, Commission, on January 11, 2006.
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    Specifically, the Commission finds that Amendment No. 3 provides
clarification to members and other appropriate parties of the intended
implementation date of the proposed changes to the Exchange's
disciplinary procedures that are contained in Article IX of the
Exchange's Constitution and NYSE Rules 475 and 476 and raises no new
issues of regulatory concern. For these reasons, the Commission
believes that good cause exists to accelerate approval of Amendment No.
3.

IV. Conclusion

    For the foregoing reasons, the Commission finds that the proposed
rule change, as amended, is consistent with the Act and the rules and
regulations thereunder applicable to a national securities exchange,
and, in particular, with Sections 6(b)(1), 6(b)(5), and 6(b)(7) of the
Act.\15\
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    \15\ 15 U.S.C. 78f(b)(1), 15 U.S.C. 78f(b)(5), and 15 U.S.C.
78f(b)(7).
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\16\ that the proposed rule change (SR-NYSE-2005-37) and Amendments
No. 1 and 2 thereto are approved, and that Amendment No. 3 thereto is
approved on an accelerated basis.
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    \16\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-674 Filed 1-20-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 88, Number 246 (Tuesday, December 26, 2023)]
[Rules and Regulations]
[Pages 88825-88832]
[FR Doc No: 2023-28500]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 84

[EPA-HQ-OAR-2021-0643; FRL-11594-02-OAR]

Phasedown of Hydrofluorocarbons: Technology Transitions Program
Residential and Light Commercial Air Conditioning and Heat Pump
Subsector

AGENCY: Environmental Protection Agency (EPA).

ACTION: Interim final rule and request for comments.

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SUMMARY: The U.S. Environmental Protection Agency is amending a
provision of the recently finalized Technology Transitions Program
under the American Innovation and Manufacturing Act (AIM Act). This
action allows one additional year, until January 1, 2026, solely for
the installation of new residential and light commercial air
conditioning and heat pump systems using components manufactured or
imported prior to January 1, 2025. The existing January 1, 2025,
compliance date for the installation of certain residential and light
commercial air conditioning and heat pump systems may result in
significant stranded inventory that was intended for new residential
construction. EPA is promulgating this action to mitigate the potential
for significant stranded inventory in this subsector. In addition, EPA
is clarifying

that residential ice makers are not included in the household
refrigerator and freezer subsector under the Technology Transitions
Rule and are not subject to the restrictions for that subsector. EPA is
requesting comments on all aspects of this rule.

DATES: This interim final rule is effective on December 26, 2023.
Comments on this rule must be received on or before February 9, 2024.

ADDRESSES: You may send comments, identified by docket identification
number EPA-HQ-OAR-2021-0643, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov
(our preferred method). Follow the online instructions for submitting
comments.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Air and Radiation Docket, Mail Code 2822T, 1200 Pennsylvania
Avenue NW, Washington, DC 20460.
     Hand Delivery or Courier (by scheduled appointment only):
EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution
Avenue NW, Washington, DC 20004. The Docket Center's hours of
operations are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal
Holidays).
    Instructions: All submissions received must include the Docket ID
number for this rulemaking. Comments received may be posted without
change to https://www.regulations.gov, including any personal
information provided.
    You may find the following suggestions helpful for preparing your
comments: Direct your comments to specific sections of this rulemaking
and note where your comments may apply to future separate actions where
possible; explain your views as clearly as possible; describe any
assumptions that you used; provide any technical information or data
you used that support your views; provide specific examples to
illustrate your concerns; offer alternatives; and, make sure to submit
your comments by the comment period deadline. Please provide any
published studies or raw data supporting your position. 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. EPA will
generally not consider comments or comment contents located outside of
the primary submission (e.g., on the web, cloud, or other file sharing
system).
    Do not submit any information you consider to be Confidential
Business Information (CBI) through https://www.regulations.gov. For
submission of confidential comments, please work with the person listed
in the FOR FURTHER INFORMATION CONTACT section. For additional
submission methods, the full EPA public comment policy, information
about CBI or multimedia submissions, and general guidance on making
effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Allison Cain, Stratospheric Protection
Division, Office of Atmospheric Programs (Mail Code 6205A),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; email address:
[email protected]. You may also visit EPA's website at https://www.epa.gov/climate-hfcs-reduction for further information.

SUPPLEMENTARY INFORMATION: EPA is taking this action as an interim
final rule without prior proposal and public comment because EPA finds
that the good cause exemption from the notice and comment rulemaking
requirement of the Administrative Procedure Act (APA), 5 U.S.C. 551 et
seq., applies here.
    Subsection (k)(1)(C) of the American Innovation and Manufacturing
Act (AIM Act) provides that Clean Air Act (CAA) sections 113, 114, 304,
and 307 apply to the AIM Act and any regulations EPA promulgates under
the AIM Act as though the AIM Act were part of title VI of the CAA.
However, section 307(d) does not apply to any rule referred to in
subparagraphs (A) or (B) of section 553(b) of the APA. See CAA section
307(d)(1). Section 553(b)(B) of the APA, 5 U.S.C. 553(b)(B), provides
that, when an agency for good cause finds (and incorporates the finding
and a brief statement of reasons therefor in the rule issued) that
notice and comment public procedures are impracticable, unnecessary or
contrary to the public interest, the agency may issue a rule without
providing notice and an opportunity for public comment.
    EPA has determined there is good cause for promulgating this rule
without prior proposal and opportunity for comment. After signature of
EPA's October 2023 final rule that established, among other things, a
prohibition beginning on January 1, 2025, of the installation of new
residential and light commercial air conditioning and heat pump systems
using regulated substances with a global warming potential of 700 or
more, stakeholders brought to the Agency's attention that builders
order equipment in this subsector well in advance of installation,
often even before the installation date is known, and that the final
rule's compliance date would potentially strand a significant amount of
inventory. EPA is issuing this rule to address these concerns and to
mitigate the harm that would be caused by unintentionally stranding
inventory as a result of the January 1, 2025, compliance date for the
installation of certain air conditioning and heat pump systems.
Subsection (i)(6) of the AIM Act states that ``[n]o rule under this
subsection may take effect before the date that is 1 year after the
date on which the Administrator promulgates the applicable rule under
this subsection.'' In order to provide relief for entities subject to
the January 1, 2025, compliance date, and in light of subsection
(i)(6)'s one-year delay between promulgation and compliance date, EPA
is taking this rulemaking action prior to January 1, 2024, one year in
advance of the existing compliance date. It is impossible for the
Agency to conclude a notice-and-comment rulemaking to provide this
needed relief by January 1, 2024, and therefore EPA finds that this
impracticability constitutes good cause for dispensing with the
required procedures under 5 U.S.C. 553(b)(B). Nonetheless, EPA is
providing 45 days for submission of public comments following today's
action. EPA will consider all written comments submitted in the
allotted time period to determine if any change is warranted. Because
the rule revisions relieve a restriction and advance notice is not
needed, the rule is effective upon publication.
    Throughout this document, whenever ``we,'' ``us,'' ``the Agency,''
or ``our'' is used, we mean EPA. Acronyms that are used in this
rulemaking that may be helpful include:

AC--Air Conditioning
AHRI--Air-Conditioning, Heating, and Refrigeration Institute
AIM Act--American Innovation and Manufacturing Act of 2020
APA--Administrative Procedure Act
CAA--Clean Air Act
EPA--U.S. Environmental Protection Agency
FR--Federal Register
HARDI--Heating, Air-conditioning & Refrigeration Distributors
International
HFC--Hydrofluorocarbon
OEM--Original Equipment Manufacturer
SNAP--Significant New Alternatives Policy
VRF--Variable Refrigerant Flow

I. Executive Summary

A. What is the purpose of this regulatory action?

    The U.S. Environmental Protection Agency (EPA) is implementing
provisions of the American Innovation and Manufacturing Act of 2020,
codified

at 42 U.S.C. 7675 (AIM Act or the Act). Subsection (i) of the Act,
entitled ``Technology Transitions,'' authorizes EPA, by rulemaking, to
restrict the use of regulated substances (used interchangeably with
``HFCs'' in this document) \1\ in sectors or subsectors where the
regulated substances are used.
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    \1\ The Act lists 18 saturated HFCs, and by reference any of
their isomers not so listed, that are covered by the statute's
provisions, referred to as ``regulated substances'' under the Act.
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    On October 24, 2023, EPA's final rule establishing the Technology
Transitions Program was published in the Federal Register (88 FR 73098,
hereafter ``Technology Transitions Rule''). That rule restricted the
use of higher-GWP HFCs in over 40 subsectors in which they are used. It
also prohibited, among other things, the manufacture and import of
factory-completed products and the installation of certain
refrigeration, air conditioning, and heat pump systems using higher-GWP
HFCs. The compliance dates for these restrictions vary by subsector and
range from January 1, 2025, to January 1, 2028. The rule also
prohibited the sale, distribution, and export of factory-completed
products that do not comply with the relevant restrictions three years
after the prohibition on manufacture and import.
    After issuance of the Technology Transitions Rule, manufacturers,
importers, and distributors of residential and light commercial air
conditioning and heat pump equipment informed EPA that the compliance
date for the restriction on installation will result in substantial
stranded inventory in that subsector for residential new construction,
including both single-family and multi-family dwellings, where builders
order heating and cooling equipment well in advance of knowing the
exact date of installation. This rule narrowly addresses the unique
circumstances of that particular subsector to prevent such equipment
from being stranded.

B. What is the summary of this regulatory action?

    This interim final rulemaking provides one additional year for the
installation of new residential and light commercial air conditioning
and heat pump systems when using components that were manufactured or
imported before January 1, 2025. Specifically, this rule allows for
pre-2025 condensing units, evaporators, and air handlers using R-410A,
or other regulated substances and blends of regulated substances not
meeting the Technology Transitions Rule's restrictions, to be assembled
into new systems (i.e., installed), so long as those systems are
assembled prior to January 1, 2026.
    We also clarify that residential ice makers are not included in the
household refrigerator and freezer subsector and are not subject to the
restrictions for that subsector under the Technology Transitions Rule.
The preamble to the Technology Transitions Rule incorrectly included
them as an example of a product in that subsector.

C. What is the summary of the costs and benefits?

    This rule will reduce regulatory burden associated with the
Technology Transitions Program while having a negligible environmental
impact. Original equipment manufacturers (OEMs) have indicated that
collectively, over $1 billion of inventory could go unsold without an
extension of the installation date. Stranding significant amounts of
equipment that does not meet the new restrictions is counter to the
overall approach EPA has taken in the Technology Transitions Rule.
Extending the installation date for these systems will not have an
impact on the benefits modeled in the Technology Transitions Rule
because EPA is limiting the extension to equipment manufactured or
imported before the existing compliance date of January 1, 2025.

II. General Information

A. Does this action apply to me?

    You may be potentially affected by this rule if you manufacture,
import, export, sell or otherwise distribute, or install residential
and light commercial air conditioning and heat pump equipment.
Potentially affected categories, by North American Industry
Classification System code, include:

 Plumbing, Heating, and Air Conditioning Contractors (238220)
 Air Conditioning and Warm Air Heating Equipment and Commercial
and Industrial Refrigeration Equipment Manufacturing (333415)
 Major Household Appliance Manufacturing (335220)
 Household Appliances, Electric Housewares, and Consumer
Electronics Merchant Wholesalers (423620)
 Plumbing and Heating Equipment and Supplies (Hydronics)
Merchant Wholesalers (423720)
 Warm Air Heating and Air Conditioning Equipment and Supplies
Merchant Wholesalers (423730)
 Appliance Stores, Household-Type (449210)
 Appliance Repair and Maintenance (811412)

    This list is not intended to be exhaustive, but rather provides a
guide for readers regarding entities that EPA expects could potentially
be affected by this action. Other types of entities not listed could
also be affected. To determine whether your entity may be affected by
this action, you should carefully examine the regulatory text at the
end of this notice. If you have questions regarding the applicability
of this action to a particular entity, consult the person listed in the
FOR FURTHER INFORMATION CONTACT section.

B. What is EPA's authority for taking this action?

    On December 27, 2020, the AIM Act was enacted as section 103 in
Division S, Innovation for the Environment, of the Consolidated
Appropriations Act, 2021 (codified at 42 U.S.C. 7675). Subsection
(k)(1)(A) of the AIM Act provides EPA with the authority to promulgate
necessary regulations to carry out EPA's functions under the Act,
including its obligations to ensure that the Act's requirements are
satisfied. Subsection (k)(1)(C) of the AIM Act also provides that CAA
sections 113, 114, 304, and 307 apply to the AIM Act and any
regulations EPA promulgates under the AIM Act as though the AIM Act
were part of title VI of the CAA.
    The AIM Act authorizes EPA to address HFCs by providing new
authorities in three main areas: phasing down the production and
consumption of listed HFCs; managing these HFCs and their substitutes;
and facilitating the transition to next-generation technologies by
restricting use of these HFCs in the sector or subsectors in which they
are used. This rulemaking focuses on the third area: the transition to
next-generation technologies by restricting use of these HFCs in the
sector or subsectors in which they are used. Subsection (i) of the AIM
Act, ``Technology Transitions,'' provides that ``the Administrator may
by rule restrict, fully, partially, or on a graduated schedule, the use
of a regulated substance in the sector or subsector in which the
regulated substance is used.'' 42 U.S.C. 7675(i)(1). The Act lists 18
saturated HFCs, and by reference any of their isomers not so listed,
that are covered by the statute's provisions, referred to as
``regulated substances'' under the Act.\2\ (42 U.S.C. 7675(c)(1)).
Through this rule, EPA is amending recently finalized restrictions on
the use

of certain HFCs in the residential and light commercial air
conditioning and heat pump subsector.
---------------------------------------------------------------------------

    \2\ As noted previously in this notice, ``regulated substance''
and ``HFC'' are used interchangeably in this notice.
---------------------------------------------------------------------------

C. How is EPA considering negotiated rulemaking?

    Prior to proposing a rule, subsection (i)(2)(A) of the Act directs
EPA to consider negotiating with stakeholders in the sector or
subsector subject to the potential rule in accordance with negotiated
rulemaking procedures established under subchapter III of chapter 5 of
title 5, United States Code (commonly known as the ``Negotiated
Rulemaking Act of 1990''). If EPA makes a determination to use the
negotiated rulemaking procedures, subsection (i)(2)(B) requires that
EPA, to the extent practicable, give priority to completing that
rulemaking over completing rulemakings under subsection (i) that are
not using that procedure. If EPA does not use the negotiated rulemaking
process, subsection (i)(2)(C) requires the Agency to publish an
explanation of the decision not to use that procedure before
commencement of the rulemaking process.
    EPA noted in the final Technology Transitions Rule that, where
appropriate, EPA will consider recent Agency actions and decisions
related to restrictions on the use of HFCs in sectors and subsectors
when considering using negotiated rulemaking procedures. EPA provided
the example of not issuing a separate notice to consider using
negotiated rulemaking for four petitions received after a first round
of petitions had received public notice. EPA's reasoning was that these
petitions were received well ahead of the final action and the
requested restrictions are in the same sectors and subsectors contained
in petitions for which a determination had already been made. EPA
stated that nothing in those four petitions caused EPA to reconsider
that decision and that it was unnecessary for the Agency to reconsider
whether to use negotiated rulemaking procedures.
    Upon considering recent Agency action, specifically the Technology
Transitions Rule, today's interim final rulemaking does not merit a
reconsideration of the prior determination not to use negotiated
rulemaking procedures. This rule is a direct and immediate response to
a specific concern arising from the recent agency action to establish a
compliance date for the installation of certain systems within the
residential and light commercial air conditioning and heat pump
subsector. EPA is not addressing a new subsector nor even establishing
a new restriction. Instead, this rule provides targeted relief to
address concerns about stranded inventory in a particular subsector
subject to a recently finalized restriction.
    Furthermore, this action has been requested through a November 13,
2023, letter signed jointly by the Air-Conditioning, Heating, and
Refrigeration Institute (AHRI), the Alliance for Responsible
Atmospheric Policy (the Alliance), and Heating, Air-conditioning &
Refrigeration Distributors International (HARDI), which together
represents a majority of the stakeholders in the subsector subject to
the rule.\3\ EPA does not believe that the rule would benefit from the
negotiated rulemaking procedure especially because timeliness is a
concern universally shared by stakeholders in this subsector.
---------------------------------------------------------------------------

    \3\ This letter can be found in the docket for this interim
final rule at EPA docket number EPA-HQ-OAR-2021-0643.
---------------------------------------------------------------------------

III. Final Rule

A. Addressing Stranded Inventory

    The November 13, 2023, letter to the EPA from AHRI, the Alliance,
and HARDI requested clarification of the provisions of the rule
regarding two categories of equipment: Residential and Light Commercial
Air Conditioning and Heat Pump Systems and Variable Refrigerant Flow
(VRF) Systems. The letter states that these organizations understand
that components for systems in these two categories manufactured or
imported before January 1, 2025, and January 1, 2026, respectively,
using a regulated substance with a GWP of 700 or more, cannot be
installed as new systems after each such compliance date. 40 CFR
84.54(a)-(c). They note that this would be ``particularly problematic
for residential new construction, including both single-family and
multi-family dwellings, where builders order heating and cooling
equipment well in advance of knowing the exact date of install. Such
equipment is not installed until construction is nearly complete, but
at time of order builders do not know when this date will be.'' The
letter further articulates that allowing the use of components
manufactured or imported prior to the compliance date to be installed
as part of new systems for one year after the compliance date would
provide some relief to the economic and practical burdens.
    An important consideration in the final rule was avoiding the
stranding of inventory of existing equipment. This includes systems
that are already installed and operating as well as unsold equipment in
the manufacturing and distribution chain. EPA stated that ``[w]e
recognize that the production and purchase of products or components
that are unable to be sold to consumers is an economic and
environmental outcome no parties desire, and the proposed rule's
forward-looking compliance dates were intended to allow all parties in
the market supply chain sufficient time to avoid that outcome.'' 88 FR
73123. In response to concerns about stranded inventory raised during
the public comment period on the proposed rule, EPA made two
significant adjustments in the final rule.
    First, EPA removed the applicability of the rule's use restrictions
to components. EPA explained that components are pieces of equipment
that, unlike factory-completed products, do not function independently
and must be assembled together in the field in order to function for
its intended purpose. Components are replaceable and a faulty component
can be swapped out to avoid replacing an entire system. Recognizing the
ongoing need for servicing and updating previously installed systems,
EPA allowed for the continued manufacture, import, sale, distribution,
offer for sale and distribution, and export of components that rely on
regulated substances, which would not meet the new restrictions.
Components are therefore not subject to the restrictions in the
Technology Transitions Rule, except insofar as those components may not
be installed in new systems on or after the installation compliance
dates.
    Second, the rule imposed a date by which factory-completed
products, more narrowly defined as an item that is functional upon
completion of manufacturing, could no longer be distributed, sold, and
offered for sale or distribution, and extended that date in the final
rule. EPA proposed that the ``sell-through'' limitation for such
products would be one year after the compliance date for manufacturing
and importing. The Agency received many comments on this topic,
including from those that considered one year to be insufficient
especially for certain seasonal products. In the final rule, EPA
provided a sell-through for factory-completed products for three years
after the manufacture and import compliance date.
    Through these two modifications in the final rule, EPA believed it
had minimized the potential for stranded inventory. Specifically, with
respect to components, the Agency's view was that there would continue
to be a market for components not meeting the GWP limit thresholds for
new systems, because

those components could continue to enter the market to service existing
systems. However, since the rule's signature, stakeholders representing
the air conditioning and heat pump subsector have raised concerns
indicating that certain aspects of the rule's compliance date structure
may result in unintended stranded inventory. EPA has reevaluated the
specific circumstances for residential and light commercial air
conditioning and heat pumps, and for the reasons articulated below is
extending the installation compliance date for that subsector from
January 1, 2025, to January 1, 2026, when using components that were
manufactured or imported prior to January 1, 2025. In this interim
final rule, the Agency is not considering the January 1, 2026,
installation compliance date applicable to VRF systems; however, EPA
intends to consider VRF systems in a separate notice and comment
action.
    EPA has evaluated the planning, purchasing, and installation
timeframes for residential new construction as referenced in the
November 13, 2023, letter from industry stakeholders. We recognize that
it is common in the residential new construction industry for
communities and dwellings to be planned well in advance, including
plans for the heating and cooling systems intended to be installed in
that new construction. Builders of residential new construction may
order those planned heating and cooling systems in concert with the
planning process without knowing when those systems will be installed.
As noted by stakeholders, installation of these systems is often one of
the final steps in residential construction. We acknowledge that it may
therefore be the case that for new residential construction planned to
occur in 2025, builders may have already taken action with respect to
the heating and cooling systems that are planned to be installed in
that new construction. Specifically, for construction occurring during
2025, components of residential and light commercial air conditioning
and heat pump systems may have already been ordered or purchased by
builders, such that leaving the January 1, 2025, installation
compliance date unaltered could result in builders of new residential
construction being left with stranded inventory--residential and light
commercial air conditioning and heat pump components--that could not be
used. In particular, because such equipment may already be well along
the distribution chain, including in the possession of the end-user
builder, it would be challenging to redirect that equipment to another
user who would be in a different segment of the market, such as those
servicing existing systems. As discussed, EPA made changes to the final
Technology Transitions Rule specifically to avoid stranding inventory,
as this outcome is undesirable economically and environmentally, and
the issue addressed in this rule was not brought to the Agency's
attention until after the final rule was signed. This action's
extension of the January 1, 2025, new installation compliance date to
January 1, 2026, for components that were manufactured or imported
prior to January 1, 2025, is intended to avoid stranding those
components in the distribution chain.
    We also acknowledge that some areas of the residential and light
commercial air conditioning and heat pump subsector are experiencing
rapid growth. In 2022, sales of heat pumps in the United States
outpaced gas furnaces for the first time ever, following a 50% increase
from 2015 to 2020. For certain technologies with extremely limited
historic use in the United States, such as mini-split and multi-split
systems, the final Technology Transitions Rule's continued allowance of
high-GWP HFCs in components for repair and servicing only may be
insufficient to absorb projected inventory of those components.
Anticipated manufacture and import of mini-split systems, for example,
is much larger than the stock of installed systems that are old enough
to need components for repair or replacement. The nascent and rapid
expansion of certain subsets of the residential and light commercial
air conditioning and heat pump subsector therefore further supports the
extension of the January 1, 2025, compliance date to January 1, 2026,
for installation of components manufactured or imported prior to
January 1, 2025.

B. Limiting the Environmental Impact of This Action

    EPA is narrowly tailoring this rule to respond to stakeholder
concerns about stranded inventory in this subsector while maintaining
the environmental benefits of the Technology Transitions Rule. To do
so, EPA is extending the installation compliance date only for new
systems installed from specified components (e.g., condensing units and
indoor evaporators) that were manufactured or imported prior to January
1, 2025. This restriction means that the total number of higher-GWP
systems installed in 2024 and 2025 would match what the Agency modeled
for installation in 2024. The extra year for installation would not
increase demand for HFCs in this subsector but rather could shift some
of the demand from 2024 into 2025.
    EPA is not extending the original compliance date for new
installations in this subsector beyond January 1, 2025, when using
components manufactured or imported on or after January 1, 2025. These
components remain subject to the original restrictions of the
Technology Transitions Rule. Specifically, if they contain an HFC with
a GWP of 700 or greater their use is limited to servicing previously
installed systems. As elaborated on more below, all the existing
labeling, reporting, and recordkeeping requirements also continue to
apply to components using, or intended to use, any HFC. Extending the
compliance date for all installations in the subsector by one year is
not warranted based on EPA's prior analysis of the availability of
substitutes within this subsector, as described in the Technology
Transitions Rule and supporting documents in the docket for that rule.
    EPA finds that this approach effectively responds to stakeholder
concerns about stranded inventory while remaining protective of the
environment. This approach was suggested by industry stakeholders in
their letter dated November 13, 2023, and it aligns with industry's
plans to transition in this subsector.
    This interim final rule provides an additional year for
installation only if all ``specified components'' of that system are
manufactured or imported prior to January 1, 2025. The term ``specified
component'' is defined under the Technology Transitions Rule as
``condensing units, condensers, compressors, evaporator units, and
evaporators.'' Other components of an air conditioning or heat pump
system such as valves or refrigerant piping are not restricted by the
Technology Transitions Rule and can be installed regardless of
manufacture or import date.

C. How do the labeling, recordkeeping, and reporting provisions apply?

    The Technology Transitions Rule requires labels on products and
certain components that use HFCs. The labeling requirement takes effect
for each subsector at the same time as the manufacture and import
prohibition for products or the installation prohibition for systems.
This timing reflects the primary purpose of the labels, which is for
assessing compliance of products and systems in sectors and subsectors
with active HFC restrictions.

    This action does not require any specific labeling for components
that are manufactured or imported prior to January 1, 2025. Nameplates
typically include the date that a component is manufactured, which is
sufficient for the purposes of this rule. Furthermore, it would be
impractical to require entities that are not OEMs to relabel components
that are already within the distribution chain.
    This action does not change the existing labeling requirements
related to components that are effective January 1, 2025. For specified
components of systems, the Technology Transitions Rule required labels
as of the applicable installation compliance date. This means that for
specified components manufactured or imported on or after January 1,
2025, the final Technology Transition Rule's requirements continue to
apply. These requirements include, among other things, that such
components must be labeled with the statement ``For servicing existing
equipment only.'' This labeling is particularly important to
distinguish components manufactured or imported before January 1, 2025,
from those that are not.
    The Technology Transitions Rule established recordkeeping and
reporting requirements for any entity that manufactures or imports
products or specified components that use or are intended to use HFCs
in the sectors and subsectors covered in that rule. The reporting
period for all sectors and subsectors starts on January 1, 2025, and
the first reports must be submitted to the Agency by March 31, 2026.
    This action does not add to nor modify the existing reporting and
recordkeeping requirements for specified components. EPA is not
establishing new reporting and recordkeeping requirements related to
the sale or installation of components manufactured or imported prior
to January 1, 2025. Reporting and recordkeeping is still required for
specified components that are manufactured or imported on or after
January 1, 2025.

D. Evaluation of the Subsection (i)(4) Factors

    Subsection (i)(4) of the AIM Act directs EPA to factor in, to the
extent practicable and using best available data, various
considerations when carrying out a rulemaking under subsection (i). As
discussed in detail in the preamble to the final Technology Transitions
Rule, EPA views subsection (i)(4)(A) through (D) as providing
overarching direction for setting restrictions under subsection (i). 88
FR at 73129-73141. EPA is not in this rule reconsidering the
interpretations provided in the final Technology Transitions Rule
regarding how it considers the factors laid out in subsection (i)(4).
Nor is the Agency revisiting its analysis of the (i)(4) factors with
respect to the residential and light commercial air conditioning and
heat pump subsector as set forth in the final rule preamble. 88 FR
73177-73180. However, in issuing this narrow adjustment to the January
1, 2025, compliance date for the residential and light commercial air
conditioning and heat pump subsector, we have considered the (i)(4)
factors to the extent practicable, as applicable to the Agency's
adjustment of that compliance date.
    The issue being addressed by this interim final rule was brought to
the Agency's attention by stakeholders impacted by the Technology
Transitions Rule. As noted in EPA's discussion of subsection (i)(4)(A),
in addition to information generated by other governing bodies and
agencies, the Agency does also take into account information provided
by industry, environmental organizations, trade associations, and
academia, to name a few. See 88 FR 73129. We acknowledge that in some
cases, regulated entities may be best situated to identify best
available information regarding implementation challenges. We are as
part of this action providing an opportunity for comment and invite
stakeholders who may have information relevant to this action to weigh
in.
    With respect to the Agency's evaluation of the availability of
substitutes under subsection (i)(4)(B), EPA previously determined that
substitutes with a GWP less than 700 are available effective January 1,
2025, for the residential and light commercial air conditioning and
heat pump subsector. EPA has not changed that determination and
continues to find that substitutes with a GWP less than 700 will be
available January 1, 2025, across this subsector. Manufacturers and
importers in this subsector are currently making air conditioning and
heat pump systems and components with lower-GWP refrigerants for other
markets and are prepared to meet the January 1, 2025, installation
compliance date for such systems. This action is not reconsidering the
Agency's prior evaluation of the availability of substitutes for
meeting the use restrictions issued in the final Technology Transitions
Rule for this subsector; rather, this action is narrowly tailored to
address the disposition of components manufactured or imported prior to
January 1, 2025.
    EPA's action to adjust the installation compliance date for certain
installations within this subsector is motivated in large part by the
policy goal of avoiding stranding inventory where possible. We believe
this goal to be consistent with the direction in subsection (i)(4)(C),
which instructs the Agency to factor in, to the extent practicable,
overall economic costs and environmental impacts, as compared to
historical trends. As discussed in the Technology Transitions Rule, EPA
interprets (i)(4)(C) as purposefully accommodating different types and
degrees of analysis of economic costs and environmental impacts,
including costs and impacts that may be difficult to quantify. The
narrow adjustment made in this interim final rule reduces the potential
to unintentionally strand components. This action will not affect the
overall consumption of HFCs and thus is not anticipated to have
environmental impacts compared to the recently finalized Technology
Transitions Rule. Further discussion of environmental impacts can be
found in Section III.B.
    EPA requests comment on the incremental costs and benefits
associated with this action, including avoiding impacts such as
stranded inventory (e.g., number and type of units affected) and on the
incremental impacts to regulated entities regarding compliance (e.g.,
avoiding redistribution of equipment, avoiding revisions or new permits
to replace previously secured building permits).
    Finally, subsection (i)(4)(D) directs the Agency to factor in, to
the extent practicable, the remaining phasedown period for regulated
substances under the allowance allocation program. The reduction in the
supply of HFCs is an important factor supporting compliance dates and
GWP limits that are as stringent as feasible under the analysis of all
the (i)(4) factors. EPA finds that this rule will not materially affect
the demand for HFCs because it limits installations to components that
were manufactured or imported prior to January 1, 2025. The effect of
this rule is to extend the installations that EPA modeled to occur in
2024 over the two-year period of 2024 and 2025. EPA does not anticipate
an increase from the total number of installed systems modeled in the
Technology Transitions Rule's Regulatory Impact Assessment Addendum.
Were the Agency to allow for the installation of new systems using
components manufactured or imported through January 1, 2026, for
instance, EPA would then find an effect on the

number of new systems and increased demand for HFCs.

IV. Other Matters

    This interim rule is also providing a clarification regarding the
scope of equipment within the household refrigerators and freezers
subsector. For the reasons discussed below, household ice makers are
not included within that subsector for purposes of the Technology
Transitions Rule.
    The proposed Technology Transitions Rule provided a functional
description of the equipment found in each subsector and a non-
exhaustive list of examples. EPA did not list all of the applications
within a particular subsector given the variety of equipment types and
end-uses. The proposed rule listed residential refrigeration systems as
household refrigerators, freezers, and combination refrigerator/
freezers and described the subsector as follows: ``The designs and
refrigeration capacities of equipment vary widely. Household freezers
only offer storage space at freezing temperatures, while household
refrigerators only offer storage space at non-freezing temperatures.
Products with both a refrigerator and freezer in a single unit are most
common. For purposes of this proposed rule, other small refrigerated
household appliances such as chilled kitchen drawers, wine coolers, and
minifridges also fall within this subsector.'' 87 FR 76785.
    The final rule incorrectly added ``household ice makers'' to the
list of examples. 88 FR 73173. The functional description of this
subsector in the Technology Transitions Rule remained the same between
proposal and final and was equipment that offers storage space at
freezing and non-freezing temperatures. Residential ice makers merit
additional consideration because they are primarily designed to produce
the ice in addition to providing storage for that ice at freezing
temperatures. The types of ice and processes used to make them may
differ from the other equipment covered by the restrictions for this
subsector and additional analysis of available substitutes for
household ice makers is warranted. As such, EPA does not consider
residential ice makers to be within the scope of the household
refrigerators and freezers subsector or the requirements of the
Technology Transitions Rule.

V. Statutory and Executive Order Review

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 14094: Modernizing Regulatory Review

    This action is a ``significant regulatory action'' under Executive
Order 12866, as amended by Executive Order 14094. Nevertheless, the
Office of Management and Budget waived review of this action. The EPA
prepared an analysis of the potential impacts associated with this
action. This analysis, Regulatory Impact Analysis of the Proposed Waste
Emission Charge, is available in docket EPA-HQ-OAR-2023-0434 to this
rulemaking and is briefly summarized in Section V of this preamble.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA because it does not contain any information collection
activities.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, EPA concludes that the impact of concern for
this rule is any significant adverse economic impact on small entities
and that the agency is certifying that this rule will not have a
significant economic impact on a substantial number of small entities
because the rule relieves regulatory burden on the small entities
subject to the rule. This rule prevents the stranding of components
used to install residential and light commercial air conditioning and
heat pump systems. We have therefore concluded that this action will
relieve regulatory burden for all directly regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. It will not have substantial direct effects on
tribal governments, on the relationship between the Federal government
and Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that EPA has reason to believe may disproportionately affect children,
per the definition of ``covered regulatory action'' in section 2-202 of
the Executive Order. This action is narrowly tailored to prevent the
stranding of certain air conditioning and heat pump equipment while not
affecting the demand for HFCs. Therefore, this action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk. Since this action does not concern human
health, EPA's Policy on Children's Health also does not apply.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution or use of energy. This action applies to certain regulated
substances and certain applications containing regulated substances,
none of which are used to supply or distribute energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and
Executive Order 14096: Revitalizing Our Nation's Commitment to
Environmental Justice for All

    The EPA believes that this type of action does not concern human
health or environmental conditions and therefore cannot be evaluated
with respect to potentially disproportionate

and adverse effects on communities with environmental justice concerns.
This action is narrowly tailored to prevent the stranding of inventory
of air conditioning and heat pump equipment while not affecting the
demand for HFCs.
    Although this action does not concern human health or environmental
conditions, the EPA identified and addressed environmental justice
concerns within the Technology Transitions Rule (88 FR 73098; October
24, 2023).

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. The CRA allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency makes
a good cause finding that notice and comment rulemaking procedures are
impracticable, unnecessary or contrary to the public interest (5 U.S.C.
808(2)). The EPA has made a good cause finding for this rule as
discussed in the supplementary information section of the preamble
where this is discussed, including the basis for that finding.

List of Subjects in 40 CFR Part 84

    Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Climate change, Emissions, Imports,
Reporting and recordkeeping requirements.

Michael S. Regan,
Administrator.

    For the reasons stated in the preamble, EPA amends 40 CFR part 84
as follows:

PART 84--PHASEDOWN OF HYDROFLUOROCARBONS

0
1. The authority citation for part 84 continues to read as follows:

    Authority:  Pub. L. 116-260, Division S, Sec. 103.

0
2. Amend Sec.  84.54 by revising paragraph (c)(1) as follows:

Sec.  84.54  Restrictions on the use of hydrofluorocarbons.

* * * * *
    (c) * * *
    (1) Effective January 1, 2025, residential or light commercial air-
conditioning or heat pump systems using a regulated substance, or a
blend containing a regulated substance, with a global warming potential
of 700 or greater, except for variable refrigerant flow air-
conditioning and heat pump systems. New residential and light
commercial air-conditioning and heat pump systems using a regulated
substance, or a blend containing a regulated substance, with a global
warming potential of 700 or greater may be installed prior to January
1, 2026, where all specified components of that system are manufactured
or imported prior to January 1, 2025.
* * * * *
[FR Doc. 2023-28500 Filed 12-22-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 158 (Thursday, August 15, 2019)]
[Proposed Rules]
[Pages 41672-41674]
[FR Doc No: 2019-17350]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2019-0331; FRL-9998-03-Region 5]

Air Plan Approval; Illinois; NAAQS Update

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state submission as a revision to the Illinois state
implementation plan (SIP). The revision, submitted on May 30, 2019,
incorporates several revisions to Illinois's air pollution control
rules entitled ``Ambient Air Quality Standards'' and is related to the
National Ambient Air Quality Standards (NAAQS). The revision updates
the ``List of Designated Reference and Equivalent Methods'' in response
to EPA rulemakings. In addition, Illinois addresses EPA's revocation of
the 1971 sulfur dioxide (SO2) and the 1978 lead (Pb) NAAQS.

DATES: Comments must be received on or before September 16, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2019-0331 at http://www.regulations.gov or via email to
[email protected]. 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, 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. 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: Charles Hatten, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What are the State rule revisions?
II. What is EPA's analysis of the State's submittal?
III. What action is EPA taking?
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. What are the State rule revisions?

    On May 30, 2019, the Illinois Environmental Protection Agency
(IEPA) submitted a request to EPA to incorporate revisions to the
Illinois air pollution control rules in Title 35 of the Illinois
Administrative Code, Part 243--Air Quality Standards (Part 243). The
submission updates the following rules in Part 243: Sections 243.108,
243.120, 243.122, 243.125, and 243.126. Part 243 includes Illinois's
regulation adoption of ambient air quality standards related to the
NAAQS.

II. What is EPA's analysis of the State's submittal?

    Illinois revised Part 243 to reflect amendments to EPA's ``List of
Designated References and Equivalent Methods'' used to determine
compliance with the NAAQS (fine particulate matter (PM2.5)
and coarse particulate matter (PM10), SO2, carbon
monoxide (CO), Pb, oxides of nitrogen (NOX), and ozone
(O3)). In addition to these changes Illinois updated
existing rule language to address EPA's revocation of the 1971
SO2 and the 1978 Pb NAAQS.
    Other revisions to Part 243 include a range of administrative
changes, such as making grammatical corrections to language updates;
removing the unnecessary version date from the Code of Federal
Regulations (CFR) citations and updating the CFR citations to the
latest version available.
    EPA is proposing to approve the revisions to Part 243 which are
described below:
    Section 243.108 Incorporation by Reference--incorporates by
reference EPA's ``List of Designated Reference and Equivalent Methods''
for measuring ambient concentrations to demonstrate compliance with the
NAAQS (PM2.5 and PM10, SO2, CO, Pb,
NOX, and O3).
    EPA designated two new Federal reference monitoring methods on
February 13, 2018 (83 FR 6174) and on June 1, 2018 (83 FR 13198) for
nitrogen dioxide (NO2) in ambient air. On June 15, 2018, EPA
updated the ``List of Designated Reference and Equivalent Methods'' to
include these new Federal reference monitoring methods for
NO2. The proposed SIP revision would update section 243.108
to incorporate the changes based on EPA's action dated June 15, 2018.
    Additionally, Illinois updated section 243.108, to incorporate by
reference the following monitoring methods: Appendices A-1, A-2, B, C,
D, F, G, H, I, J, K, L, N, O, P, Q, R, S, T and U of 40 CFR part 50, to
the 2018 edition of the CFR.

    Section 243.120 PM10 and PM2.5--contains the
1987 and 1997 primary and secondary standards and measurement methods
for PM10 and PM2.5. In this section, the
revisions are administrative changes.
    Section 243.122 Sulfur Oxides (Sulfur Dioxide)--contains the 1971
primary and secondary standards and measurement methods for sulfur
oxide (as SO2), respectively, in subsections 243.122(a) and
(b).
    In this section, Illinois revised subsection 243.122(a)(5) by
updating the ``Board note'' listing the specific areas where the 1971
NAAQS no longer applies. These areas in Illinois have been designated
nonattainment for the more stringent 2010 primary SO2 NAAQS.
Thus, the proposed revision will only revoke the 1971 standard where
EPA has adopted Round 1 and Round 2 area designations for the 2010
NAAQS for SO2 (78 FR 47191; 81 FR 45039).
    Section 243.125 Ozone--contains the 2008 and 2015 primary and
secondary 8-hour standards and measurement methods for O3.
In this section the revisions are administrative changes.
    Section 243.126 Lead--contains the 1978 and 2008 primary and
secondary standards and measurement methods for Pb, respectively, in
subsections 243.126(a) and 243.126(b). In this section, Illinois
proposed to revoke the 1978 NAAQS for Pb by removing the provision in
subsection 243.126(a).
    EPA's final 2008 Pb regulation states that the 1978 NAAQS for Pb no
longer applies one year after the effective date. (November 12, 2008,
73 FR 66964). Illinois updated a Board note explaining the reason for
the removal of the 1978 NAAQS based on EPA designation of the Granite
City area nonattainment for the 2008 primary and secondary three-month
average NAAQS for Pb effective December 31, 2011 and an area of Chicago
effective December 31, 2012. See 75 FR 71033, 71042 (Nov. 22, 2010); 76
FR 72097, 79108 (Nov. 22, 2011)). The remaining areas of the state were
designated as ``unclassifiable/attainment'', effective December 31,
2012.

Section 110(l) Analysis of the State's Submittal

    EPA is proposing to approve the revisions to Part 243 discussed
above because the revisions meet all applicable requirements under the
Clean Air Act (CAA), consistent with section 110(k)(3) of the CAA.
Furthermore, Illinois has shown that the revisions to Part 243 do not
interfere with any applicable requirement concerning attainment and
reasonable further progress or any other applicable CAA requirement,
consistent with section 110(l) of the CAA.
    Under Section 110(l) of the CAA, EPA shall not approve a SIP
revision if it would interfere with any applicable requirement
concerning attainment and reasonable further progress (as defined in
section 171 of the CAA) or any other applicable requirement of the CAA.
The proposed SIP revision would not interfere with any applicable CAA
requirements based on technical analysis submitted by Illinois. Part
243 contains the state's ambient air quality standards, which are
consistent with the NAAQS. The changes to the ambient air quality
standards in Part 243 rules will have no effect on actual or allowable
emissions as they only clarify EPA's rulemaking related to the NAAQS.
    Illinois has shown there is no impact of revising Part 243 that
would hinder Illinois's ability to maintain and meet the NAAQS for
NO2, O3, Pb, PM2.5, PM10,
SO2, and CO. Therefore, these revisions to Part 243 are
approvable as they update Part 243 to be consistent with EPA's
rulemaking related to the NAAQS. The revisions will not increase any
emissions to the atmosphere because they do not impact on any source
applicability or emissions.

III. What action is EPA taking?

    EPA is proposing to approve revisions to Illinois's Part 243
submitted on May 30, 2019, as a revision to the Illinois SIP. EPA is
also proposing approval of a revision removing the provisions of the
1978 NAAQS for Pb, specifically, section 243.126(a)(1) and (2) from
Part 243.

IV. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA proposes to incorporate by
reference revisions to 35 Illinois Administrative Code Part 243 ``Air
Quality Standards'', sections 243.108, 243.120, 243.122, 243.125, and
243.126, effective February 19, 2019. EPA has made, and will continue
to make, these documents generally available through
www.regulations.gov and at the EPA Region 5 Office (please contact the
person identified in the For Further Information Contact section of
this preamble for more information).

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as

specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Sulfur oxides, Volatile organic compounds.

    Dated: July 30, 2019.
Cheryl L. Newton,
Acting Regional Administrator, Region 5.
[FR Doc. 2019-17350 Filed 8-14-19; 8:45 am]
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[Federal Register Volume 84, Number 90 (Thursday, May 9, 2019)]
[Notices]
[Pages 20368-20370]
[FR Doc No: 2019-09529]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1263]

Submitting Documents Using Real-World Data and Real-World
Evidence to the Food and Drug Administration for Drugs and Biologics;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Submitting
Documents Using Real-World Data and Real-World Evidence to FDA for
Drugs and Biologics.'' This draft guidance is intended to encourage
sponsors and applicants who are using real-world data (RWD) to generate
real-world evidence (RWE) as part of their regulatory submissions to
provide certain information to FDA so that FDA can internally track the
submissions. The purpose of this guidance is to provide instructions on
how to document that a submission includes RWE.

DATES: Submit either electronic or written comments on the draft
guidance by July 8, 2019 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-2019-D-1263 for ``Submitting Documents Using Real-World Data and
Real-World Evidence to FDA for Drugs and Biologics.'' 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.
     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.gpo.gov/fdsys/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.
    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 draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 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: Lauren Milner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6323, Silver Spring, MD 20993-0002, 301-
796-5114; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Submitting Documents Using Real-World Data and Real-World
Evidence to FDA for Drugs and Biologics.'' The availability of RWD and
evolving analytic techniques to generate RWE has created interest
within the research and medical communities to use RWD/RWE to enhance
clinical research and support regulatory decision making. Exploring the
potential for RWE to inform regulatory decisions is mandated by the
21st Century Cures Act (Cures Act) (Pub. L. 114-255). Section 3022 of
the Cures Act requires FDA to establish a program to evaluate the
potential use of RWE to help to support the approval of a new
indication for a drug approved under section 505(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) and to help to support
or satisfy postapproval study requirements.
    To inform FDA's RWE program under the Cures Act and to help FDA
understand the scope and use of RWE submitted to support regulatory
decisions regarding safety and/or effectiveness, the Center for Drug
Evaluation and Research and the Center for Biologics Evaluation and
Research intend to identify and track certain types of submissions
using RWE under an investigational new drug application (IND), a new
drug application (NDA), or a biologics license application (BLA). The
draft guidance provides instructions on how to document that the
submission uses RWE, including a sample presentation to include in a
cover letter.
    This 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 ``Submitting
Documents Using Real-World Data and Real-World Evidence to FDA for
Drugs and Biologics.'' 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. This

guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
part 314 have been approved under OMB control number 0910-0001; and the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: May 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09529 Filed 5-8-19; 8:45 am]
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[Federal Register: November 15, 2006 (Volume 71, Number 220)]
[Notices]
[Page 66511-66512]
[DOCID:fr15no06-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-55-000]

Texas Eastern Transmission, LP; Notice of Proposed Changes in
FERC Gas Tariff

November 7, 2006.
    Take notice that on November 2, 2006, Texas Eastern Transmission,
LP (Texas Eastern) tendered for filing as

part of its FERC Gas Tariff, Seventh Revised Volume No. 1, the revised
tariff sheets listed in Appendix A to the filing, with an effective
date of December 3, 2006.
    Texas Eastern states that copies of its filing have been served
upon all affected customers of Texas Eastern 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 in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
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>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-19224 Filed 11-14-06; 8:45 am]

BILLING CODE 6717-01-P