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

General Comment:TO:
 Mr. Zeller

IN REGARDS TO:
 The Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491.
I am writing on behalf of myself, and am requesting that the comment period for the Proposed Rule be EXTENDED by the FDA for an additional 105 days, from its current 75-day period, to 180 days.
The Proposed Rule raises a number of extremely important issues and questions, relevant to me, and could potentially have a crucial negative effect for consumers of products that are proposed for regulation under the Proposed Rule.
This Proposed Rule seems to have dozens, if not hundreds of different questions I want to respond to. The limited amount of time available to thoroughly and effectively research all areas pertaining to the Proposed Rule is insufficient. It took years to draw up the Proposed Rule, and I feel that requesting a 105 day extension (6 months) is not only reasonable and appropriate, but necessary. The impact of not allowing consumers and affected businesses extended time to effectively research, understand and provide feedback and concerns could prove to be a devastating blow to the FDA in terms of negative public perceptions of what the FDA stands for.
The community of those who vape feel very strongly and are passionate about what E-cigs can do for people. Quite simply, they are saving lives. There is an undeniable correlation between E-cigs and the number of people who have successfully quit smoking. I hope you will acknowledge that E-cigs have had a tremendous positive effect for this nation’s large number of smokers, and I hope you will take the time to read and enjoy the personal testimonies of those who have found success. Upon the approval of an extension deadline, I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 84, Number 227 (Monday, November 25, 2019)]
[Notices]
[Pages 64882-64883]
[FR Doc No: 2019-25528]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-386-000]

Sundance Wind Project Holdings LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced Sundance Wind
Project Holdings LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is December 9, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC

Online service, please email<EMAIL_ADDRESS>or call (866)
208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 19, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-25528 Filed 11-22-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 156 (Tuesday, August 15, 2023)]
[Rules and Regulations]
[Pages 55394-55401]
[FR Doc No: 2023-17367]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 271 and 272

[EPA-R08-RCRA-2023-0033; FRL-10606-02-R8]

Montana: Final Authorization of State Hazardous Waste Management
Program Revisions and Incorporation by Reference

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: The State of Montana Department of Environmental Quality has
applied to the Environmental Protection Agency (EPA) for final
authorization of the changes to its hazardous waste program under the
Resource Conservation and Recovery Act (RCRA). The EPA has determined
that these changes satisfy all requirements needed to qualify for final
authorization, and is authorizing the State's changes through this
direct final action. The EPA uses the regulations entitled ``Approved
State Hazardous Waste Management Programs'' to provide notice of the
authorization status of State programs and to incorporate by reference
those provisions of State statutes and regulations that will be subject
to the EPA's inspection and enforcement. This rule also codifies in the
regulations the approval of Montana's hazardous waste management
program and incorporates by reference the authorized provisions of the
State's regulations.

DATES: This direct final rule is effective on October 16, 2023 unless
EPA receives adverse written comment by September 14, 2023. If the EPA
receives any such comment, we will publish a timely withdrawal of this
direct final rule in the Federal Register informing the public that the
rule will not take effect. The Director of the Federal Register
approves the incorporation by reference as of October 16, 2023, in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
RCRA-2023-0033; FRL-10606-02-R8 by one of the following methods:
    1. Federal eRulemaking Portal: https://www.regulations.gov. Follow
the on-line instructions for submitting comments.
    2. Email: [email protected].
    3. Fax:<PHONE_NUMBER> (prior to faxing, please notify the EPA
contact listed below).
    4. Mail, Hand Delivery or Courier: Moye Lin, Resource Conservation
and Recovery Act Branch, EPA Region 8, Mailcode 8P-R, 1595 Wynkoop
Street, Denver, Colorado 80202-1129. Courier or hand deliveries are
only accepted during the Regional Office's normal hours of operation.
The public is advised to call in advance to verify business hours.
Special arrangements should be made for deliveries of boxed
information.
    Instructions: EPA must receive your comments by September 14, 2023.
Direct your comments to EPA-R08-RCRA-2023-0033; FRL-10606-02-R8. The
EPA's policy is that all comments received will be included in the
public docket without change and may be available online at https://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information

whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through https://regulations.gov, or email. The Federal https://www.regulations.gov
website is an ``anonymous access'' system, which means the EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an email comment directly to the EPA
without going through https://www.regulations.gov, your email address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment with any
CD you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: All documents in the docket are listed in the https://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available electronically
through https://www.regulations.gov. For alternative access to docket
materials, please contact the person identified in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Moye Lin, Resource Conservation and
Recovery Act Branch, EPA Region 8, 1595 Wynkoop Street, Denver,
Colorado 80202-1129; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Authorization of Revisions to Montana's Hazardous Waste Program

A. Why are revisions to State programs necessary?

    States which have received final authorization from EPA under RCRA
section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste
program that is equivalent to, consistent with, and no less stringent
than the Federal program. As the Federal program changes, States must
change their programs and ask EPA to authorize the changes. Changes to
State programs may be necessary when Federal or State statutory or
regulatory authority is modified or when certain other changes occur.
Most commonly, States must change their programs because of changes to
EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124,
260 through 268, 270, 273 and 279.

B. What authorization decisions has the EPA made in this rule?

    On May 31, 2022, Montana submitted a final complete program
revision application seeking authorization of changes to its hazardous
waste program. The EPA concludes that Montana's application to revise
its authorized program meets all of the statutory and regulatory
requirements established by RCRA. Therefore, we grant Montana final
authorization to operate its hazardous waste program with the changes
described in the authorization application. Montana has responsibility
for permitting Treatment, Storage, and Disposal Facilities (TSDFs), and
for carrying out the aspects of the RCRA program described in its
revised program application, subject to the limitations of the
Hazardous and Solid Waste Amendments of 1984 (HSWA), for all areas
within the State, except for (1) lands located within formal Indian
Reservations within or abutting the State of Montana, including
Blackfeet Indian Reservation, Crow Tribe of Montana Indian Reservation,
Flathead Indian Reservation, Fort Belknap Indian Reservation, Fort Peck
Indian Reservation, Northern Cheyenne Indian Reservation, Rocky Boy's
Indian Reservation, (2) any land held in trust by the United States for
an Indian tribe, (3) and any other land, whether on or off a
reservation that qualifies as ``Indian country'' within the meaning of
18 U.S.C. 1151. New Federal requirements and prohibitions imposed by
Federal regulations that EPA promulgates under the authority of HSWA
take effect in authorized States before they are authorized for the
requirements. Thus, EPA will implement those requirements and
prohibitions in Montana, including issuing permits, until Montana is
authorized to do so.

C. What is the effect of today's authorization decision?

    The effect of this decision is that a facility in Montana subject
to RCRA will have to comply with the authorized State requirements
instead of the equivalent Federal requirements in order to comply with
RCRA. The State of Montana will continue to have enforcement
responsibilities under its State hazardous waste program for violations
of such program, but the EPA retains its authority under RCRA sections
3007, 3008, 3013, and 7003, which include, among others, authority to:
     Conduct inspections and require monitoring, tests,
analyses, or reports;
     Enforce RCRA requirements; suspend or revoke permits; and
     Take enforcement actions after notice to and consultation
with the State.
    This action to approve these provisions would not impose additional
requirements on the regulated community because the regulations for
which the State of Montana is requesting authorization are already
effective under State law and are not changed by the act of
authorization.

D. Why is the EPA using a direct final rule?

    The EPA is publishing this rule without a prior proposal because we
view this as a noncontroversial action and anticipate no adverse
comment. However, in the ``Proposed Rules'' section of this Federal
Register, we are publishing a separate document that will serve as the
proposed rule allowing the public an opportunity to comment. We will
not institute a second comment period on this action. Any parties
interested in commenting must do so at this time. For further
information about commenting on this rule, see the ADDRESSES section of
this document.

E. What happens if EPA receives comments opposing this action?

    If EPA receives comments that oppose this authorization, we will
publish a timely withdrawal in the Federal Register informing the
public that this direct final rule will not take effect. We will
address all public comments in a later Federal Register. You will not
have another opportunity to comment, therefore, if you want to comment
on this action, you must do so at this time.

F. For what has Montana previously been authorized?

    Montana initially received final authorization on July 11, 1984,
effective July 25, 1984 (49 FR 28245) to implement the RCRA hazardous
waste management program. We granted authorization for changes to their
program on: January 19, 1994, effective March 21, 1994 (59 FR 2752);
October 25, 1996, effective December 24, 1996 (61 FR 55223); December
26, 2000, effective December 26, 2000 (65 FR 81381); September 30,
2005, effective November 29, 2005 (70 FR 57152); and,

April 27, 2009, effective June 26, 2009 (79 FR 18997).

G. What changes is EPA authorizing with this action?

    On May 31, 2022, the State of Montana submitted a final complete
program revision application, seeking authorization of their changes in
accordance with 40 CFR 271.21. We now make a final decision, subject to
receipt of written comments that oppose this action, that Montana's
hazardous waste program satisfies all of the requirements necessary to
qualify for final authorization. Therefore, we grant Montana final
authorization for the following changes:
1. Program Revision Changes for Federal Rules
    The State of Montana revisions consist of regulations which
specifically govern Federal hazardous waste revisions promulgated
between July 1, 2006 and June 30, 2021, Revision Checklists 214, 215,
217, 218, 220, 222 and 223, Rule 225, and Revision Checklists 226
through 243 (RCRA Clusters XVII through XXIX). The State requirements
from its Hazardous Waste Rules, Administrative Rules of Montana (ARM),
Environmental Quality, Title 17, Chapter 53, sections 17.53.101 through
17.53.1502 are listed in the chart below.

------------------------------------------------------------------------
     Description of Federal        Federal Register     Analogous State
           requirement               date and page         authority
------------------------------------------------------------------------
1. Corrections to Errors in the   71 FR 40254; 07/14/ Administrative
 Code of Federal Regulations       06.                 Rules of Montana
 (Checklist 214).                                      (ARM) Title 17,
                                                       Chapter 53,
                                                       17.53.301(1),
                                                       17.53.404(1),
                                                       17.53.405(5),
                                                       17.53.501(1),
                                                       17.53.601(1),
                                                       17.53.801(1),
                                                       17.53.901(1),
                                                       17.53.1001(1),
                                                       17.53.1501(1),
                                                       17.53.1101(1),
                                                       17.53.1201(1),
                                                       17.53.1301(1),
                                                       17.53.1401(1).
2. Cathode Ray Tubes Rule         74 FR 42928; 07/28/ ARM 17.53.301(1),
 (Checklist 215).                  06.                 17.53.501(1),
                                                       17.53.107(3).
3. NESHAP: Final Standards for    73 FR 18970; 04/08/ ARM 17.53.801(1),
 Hazardous Waste Combustors        08.                 17.53.1001(1).
 (Phase I Final Replacement
 Standards and Phase II)
 Amendments (Checklist 217).
4. F019 Exemption for Wastewater  73 FR 31756; 06/04/ ARM 17.53.501(1).
 Treatment Sludges from Auto       08.
 Manufacturing Zinc Phosphating
 Processes (Checklist 218).
5. Academic Laboratories          73 FR 72912; 12/1/  ARM 17.53.501(1),
 Generator Standards (Checklist    08.                 17.53.601(1).
 220).
6. OECD Requirements; Export      75 FR 1236; 01/08/  ARM 17.53.601(1),
 Shipments of Spent Lead-Acid      10.                 17.53.107(3),
 Batteries (Checklist 222).                            17.53.602(7),
                                                       17.53.602(10),
                                                       17.53.701(1),
                                                       17.53.801(1),
                                                       17.53.107(3),
                                                       17.53.901(1),
                                                       17.53.1001(1).
7. Hazardous Waste Technical      75 FR 1298; 03/18/  ARM 17.53.301(1),
 Corrections and Clarifications    10 75 FR 31713-     17.53.501(1),
 (Checklist 223).                  31717; 06/04/10.    17.53.601(1),
                                                       17.53.701(1),
                                                       17.53.801(1),
                                                       17.53.901(1),
                                                       17.53.1001(1),
                                                       17.53.1101(1),
                                                       17.53.1201(1).
8. Removal of Saccharin and Its   75 FR 78918; 12/17/ ARM 17.53.501(1),
 Salts from the List of            10.                 17.53.1101(1).
 Hazardous Constituents (Rule
 225).
9. Academic Laboratories          75 FR 79304; 12/20/ ARM 17.53.601(1).
 Generator Standards Technical     10.
 Corrections (Checklist 226).
10. Revision of the Land          76 FR 34147; 06/13/ ARM 17.53.1101(1).
 Disposal Treatment Standards      11.
 for Carbamate Wastes (Checklist
 227).
11. Hazardous Waste Technical     77 FR 22229; 04/13/ ARM 17.53.501(1),
 Corrections and Clarifications    12.                 17.53.1001(1).
 Checklist 228).
12. Solvent Contaminated Wipes    78 FR 46448; 07/31/ ARM 17.53.301(1),
 (Checklist 229).                  13.                 17.53.501(1).
13. Conditional Exclusion for     79 FR 350; 1/3/14.  ARM 17.53.301(1),
 Carbon Dioxide (CO2) Streams in                       17.53.501(1).
 Geologic Sequestration
 Activities (Checklist 230).
14. Hazardous Waste Electronic    79 FR 7518; 02/07/  ARM 17.53.107(2),
 Manifest Rules (Special           14.                 17.53.107(3),
 Consolidated Checklist for       83 FR 420; 01/03/    17.53.201,
 Checklists 231 and 239A).         18.                 17.53.404(1),
                                                       17.53.405,
                                                       17.53.601(1),
                                                       17.53.602(11)
                                                       (removed),
                                                       17.53.701(1),
                                                       17.53.801(1),
                                                       17.53.802(5),
                                                       17.53.901(1),
                                                       17.53.902(6).
15. Revisions to the Export       79 FR 36220; 6/26/  ARM 17.53.107(3),
 Provisions of the Cathode Ray     14.                 17.53.301(1),
 Tube (CRT) Rule (Checklist 232).                      17.53.501(1).
16. Revisions to the Definition   80 FR 1694-1814;    ARM 17.53.301(1),
 of Solid Waste (Checklists        01/13/15.           17.53.404(1),
 233A, B, C, D2, and E).                               17.53.501(1),
                                                       17.53.1201(1).
                                  83 FR 24664-24671;
                                   05/30/18.
17. Response to Vacaturs of the   80 FR 18777; 4/8/   ARM 17.53.501(1).
 Comparable Fuels Rule and the     15.
 Gasification Rule (Checklist
 234).
18. Disposal of Coal Combustion   80 FR 21302; 4/17/  ARM 17.53.501(1).
 Residuals from Electric           15.
 Utilities (Checklist 235).
19. Imports and Exports of        81 FR 85696; 11/28/ ARM 17.53.105(3),
 Hazardous Waste (Checklist 236).  16.                 17.53.107(3),
                                  82 FR 41015; 8/29/   17.53.301(1),
                                   17.                 17.53.404(1),
                                  83 FR 38263; 8/6/    17.53.501(1),
                                   18.                 17.53.601(1),
                                                       17.53.602(7),
                                                       17.53.602(8),
                                                       17.53.602(9),
                                                       17.53.602(10),
                                                       17.53.701(1),
                                                       17.53.702(1),
                                                       17.53.801(1),
                                                       17.53.901(1),
                                                       17.53.1001(1),
                                                       17.53.1501(1),
                                                       17.53.1301(1).

20. Hazardous Waste Generator     81 FR 85732; 11/28/ ARM 17.53.111(2)
 Improvements Rule (Checklist      16.                 introductory
 237).                                                 paragraph and
                                                       (2)(a),
                                                       17.53.301(1),
                                                       17.53.301(2)(q),
                                                       17.53.404(1),
                                                       17.53.405(5),
                                                       17.53.501,
                                                       17.53.502(5),
                                                       17.53.601(1),
                                                       17.53.602(2)
                                                       through (4), (7),
                                                       and (9) through
                                                       (13), 17.53.603,
                                                       17.53.604,
                                                       17.53.701(1),
                                                       17.53.702(1),
                                                       17.53.801(1),
                                                       17.53.802(3),
                                                       (4), and (6),
                                                       17.53.803,
                                                       17.53.901(1),
                                                       17.53.902(4)
                                                       through (6),
                                                       17.53.903,
                                                       17.53.1001(1),
                                                       17.53.1101(1),
                                                       17.53.1201(1),
                                                       17.53.1301(1),
                                                       17.53.1401(1),
                                                       17.53.1501(1).
21. Confidentiality               83 FR 60894; 12/26/ ARM 17.53.107(3),
 Determinations for Hazardous      17.                 17.53.201,
 Waste Export and Import                               17.53.404,
 Documents (Checklist 238).                            17.53.501(1),
                                                       17.53.601(1),
                                                       17.53.602(7).
22. Safe Management of Recalled   83 FR 61552; 11/30/ ARM 17.53.301(1),
 Airbags (Checklist 240).          18.                 17.53.501(1),
                                                       17.53.601(1).
23. Management Standards for      84 FR 5816; 02/22/  ARM 17.53.111(7),
 Hazardous Waste Pharmaceuticals   19.                 17.53.501(1),
 and Amendment to the P075                             17.53.601(1),
 Listing for Nicotine (Checklist                       17.53.801(1),
 241).                                                 17.53.901(1),
                                                       17.53.1001(1),
                                                       17.53.1002(9),
                                                       17.53.1101(1),
                                                       17.53.1201(1),
                                                       17.53.1301(1).
24. Universal Waste Regulations;  84 FR 67202; 12/9/  ARM 17.153.301(1),
 Addition of Aerosol Cans          19.                 17.53.501(1),
 Checklist 242).                                       17.53.801(1),
                                                       17.53.901(1),
                                                       17.53.1101(1),
                                                       17.53.1201(1),
                                                       17.53.1301(1).
25. Modernizing Ignitable         85 FR 40594; 07/7/  ARM 17.53.105(3),
 Liquids Determinations            20.                 17.53.404(1),
 (Checklist 243).                                      17.53.501(1).
------------------------------------------------------------------------

2. State-Initiated Changes
    Montana has made amendments to its regulations that are not
directly related to any of the Federal rules addressed in Item G.1
above. These State-initiated changes are either conforming changes made
to existing authorized provisions, or the adoption of provisions that
clarify and make the State's regulations internally consistent. The
State's regulations, as amended by these provisions, provide authority
which remains equivalent to and no less stringent than the Federal laws
and regulations. These State-initiated changes are submitted under the
requirements of 40 CFR 271.21(a) and include the following provisions
from the Administrative Rules of Montana (ARM), as amended, effective
May 14, 2022: ARM 17.53.105(4); 17.53.107(1) introductory paragraph;
17.53.111(1); 17.53.111(3); 17.53.111(4) (except phrase addressing
fees); 17.53.111(5); 17.53.406; 17.53.602(1); 17.53.1202(1);
17.53.1202(21); and 17.53.1303. In addition, effective December 25,
2009, Montana made State-initiated changes to adopt 40 CFR part 267 by
reference at ARM 17.53.1501 and 17.53.1502. The State had previously
adopted the final rule, Standardized Permit for RCRA Hazardous Waste
Management Facilities, (September 8, 2005, 70 FR 53419) without the 40
CFR part 267 provisions. Sections 17.53.1501 and 17.53.1502 have been
reviewed by EPA and are acceptable to be authorized.

H. Where are the revised State rules different from the Federal rules?

    The Montana revisions being authorized in this rule include
provisions that contain purely Federal functions which are not
delegable to States. The non-delegable Federal program areas include
import/export requirements reserved as part of the Federal foreign
relations function, and manifest registry and electronic manifest
functions administered solely by the EPA. Montana has appropriately
adopted these provisions by leaving the authority with the EPA for
implementation and enforcement.
    When revised State rules differ from the Federal rules in the RCRA
State authorization process, EPA determines whether the State rules are
equivalent to, more stringent than, or broader in scope than the
Federal program. Pursuant to RCRA section 3009, 42 U.S.C. 6929, State
programs may contain requirements that are more stringent than the
Federal regulations. Such more stringent requirements can be federally
authorized and, once authorized, become federally enforceable. Although
the statute does not prevent States from adopting regulations that are
broader in scope than the Federal program, States cannot receive
Federal authorization for such regulations, and they are not federally
enforceable.
    We consider the following State requirements to be more stringent
than the Federal requirements: ARM 17.53.502(5), 17.53.602(3), (10),
(11), and (12), 17.53.603(1) introductory paragraph, 17.53.603(2), (3),
and (4) because Montana requires an annual report in lieu of the
Federal biennial reporting requirement. Additionally, we consider the
following State requirement to be broader in scope than the Federal:
ARM 17.53.111(6) because Montana requires transporters obtain a
registration from the State.

I. Who handles permits after the authorization takes effect?

    The State of Montana will continue to issue permits for all the
provisions for which it is authorized and will administer the permits
it issues. The EPA will continue to administer any RCRA hazardous waste
permits or portions of permits, which we issued prior to the effective
date of this authorization, until Montana has equivalent instruments in
place. EPA will continue to implement and issue permits for HSWA
requirements for which Montana is not yet authorized.

J. How does today's action affect Indian Country (18 U.S.C.1151) in
Montana?

    Montana is not authorized to carry out its hazardous waste program
in Indian country, as defined in 18 U.S.C. 1151. This includes, but is
not limited to:
    1. Lands within the exterior boundaries of the following Indian
Reservations located within or abutting the State of Montana:

a. Blackfeet Tribe of the Blackfeet Indian Reservation
b. Crow Tribe of Montana
c. Confederated Salish and Kootenai Tribes of the Flathead Reservation

d. Fort Belknap Indian Community of the Fort Belknap Reservation of
Montana
e. Assiniboine and Sioux Tribes of the Fort Peck Indian Reservation
f. Northern Cheyenne Tribe of the Northern Cheyenne Indian Reservation
g. Chippewa Cree Indians of the Rocky Boy's Reservation
    2. Any land held in trust by the U.S. for an Indian tribe; and
    3. Any other land, whether on or off a reservation that qualifies
as Indian country within the meaning of 18 U.S.C. 1151.
    Therefore, this program revision does not extend to Indian country
where the EPA will continue to implement and administer the RCRA
program.

II. Incorporation by Reference

A. What is codification?

    Codification is the process of including the statutes and
regulations that comprise the State's authorized hazardous waste
management program into the CFR. Section 3006(b) of RCRA, as amended,
allows the Environmental Protection Agency (EPA) to authorize State
hazardous waste management programs. The State regulations authorized
by EPA supplant the Federal regulations concerning the same matter with
the result that after authorization, EPA enforces the authorized
regulations. Infrequently, State statutory language which acts to
regulate a matter is also authorized by EPA with the consequence that
EPA enforces the authorized statutory provision. EPA does not authorize
State enforcement authorities and does not authorize State procedural
requirements. EPA codifies the authorized State program in 40 CFR part
272 and incorporates by reference State statutes and regulations that
make up the approved program, which is Federally enforceable in
accordance with sections 3007, 3008, 3013, and 7003 of RCRA, 42 U.S.C.
6927, 6928, 6934 and 6973, and any other applicable statutory and
regulatory provisions.

B. What is the history of the codification of Montana's hazardous waste
management program?

    The EPA first incorporated by reference Montana's authorized
hazardous waste program effective January 31, 1986 (51 FR 3954) and
program revisions effective March 8, 2006 (71 FR 11536). In this
action, EPA is revising Subpart BB of 40 CFR part 272 to include the
authorization revision actions described in this document.

C. What codification decisions have we made in this rule?

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference of the authorized hazardous waste management
program of the State of Montana. In accordance with requirements of 1
CFR 51.5, EPA is finalizing the incorporation by reference of the
Montana rules described in section I.G. of this preamble and set forth
in the amendments to 40 CFR 272.1351. The EPA has made, and will
continue to make, these documents available electronically through
https://www.regulations.gov. For alternative access to docket
materials, please contact the person identified in the ADDRESSES
section of this preamble.
    This action codifies EPA's authorization of Montana's base
hazardous waste management program and its revisions to that program.
The codification reflects the State program that would be in effect at
the time EPA's authorized revisions to the Montana hazardous waste
management program addressed in this direct final rule become final.
This action does not reopen any decision EPA previously made concerning
the authorization of the State's hazardous waste management program.
EPA is not requesting comments on its decisions published in the
Federal Register documents referenced in section I.F. of this document
concerning revisions to the authorized program in Montana.
    The EPA is incorporating by reference EPA's approval of Montana's
hazardous waste management program by amending Subpart BB to 40 CFR
part 272. The action amends Sec.  272.1351 and incorporates by
reference Montana's authorized hazardous waste regulations, as amended,
effective May 14, 2022. Section 272.1351 also references the
demonstration of adequate enforcement authority, including procedural
and enforcement provisions, which provide the legal basis for the
State's implementation of the hazardous waste management program. In
addition, Sec.  272.1351 references the Memorandum of Agreement, the
Attorney General's Statements and the Program Description, which are
evaluated as part of the approval process of the hazardous waste
management program in accordance with Subtitle C of RCRA.

D. What is the effect of Montana's codification on enforcement?

    EPA retains the authority under statutory provisions, including but
not limited to, RCRA sections 3007, 3008, 3013 and 7003, and other
applicable statutory and regulatory provisions to undertake inspections
and enforcement actions and to issue orders in all authorized States.
With respect to enforcement actions, EPA will rely on Federal
sanctions, Federal inspection authorities, and Federal procedures
rather than the State analogs to these provisions. Therefore, the EPA
is not incorporating by reference Montana's inspection and enforcement
authorities, nor are those authorities part of Montana's approved State
program which operates in lieu of the Federal program. 40 CFR
272.1351(c)(2) lists these authorities for informational purposes, and
because EPA also considered them in determining the adequacy of
Montana's procedural and enforcement authorities. Montana's authority
to inspect and enforce the State's hazardous waste management program
requirements continues to operate independently under State law.

E. What State provisions are not part of the codification?

    The public is reminded that some provisions of Montana's hazardous
waste management program are not part of the federally authorized State
program. These non-authorized provisions include:
    (1) Provisions that are not part of the RCRA subtitle C program
because they are ``broader in scope'' than RCRA subtitle C (see 40 CFR
271.1(i));
    (2) State procedural and enforcement authorities which are
necessary to establish the ability of the State's program to enforce
compliance but which do not supplant the Federal statutory enforcement
and procedural authorities.
    State provisions that are ``broader in scope'' than the Federal
program are not incorporated by reference in 40 CFR part 272. For
reference and clarity, EPA lists in 40 CFR 272.1351(c)(3) the Montana
statutory provisions which are ``broader in scope'' than the Federal
program and which are not part of the authorized program being
incorporated by reference. While ``broader in scope'' provisions are
not part of the authorized program and cannot be enforced by EPA, the
State may enforce such provisions under State law.

F. What will be the effect of codification on Federal HSWA
requirements?

    With respect to any requirement(s) pursuant to HSWA for which the
State has not yet been authorized, and which EPA has identified as
taking effect immediately in States with authorized hazardous waste
management programs, EPA will enforce those Federal HSWA

standards until the State is authorized for those provisions.
    The codification does not affect Federal HSWA requirements for
which the State is not authorized. EPA has authority to implement HSWA
requirements in all States, including States with authorized hazardous
waste management programs, until the States become authorized for such
requirements or prohibitions, unless EPA has identified the HSWA
requirement(s) as an optional or as a less stringent requirement of the
Federal program. A HSWA requirement or prohibition, unless identified
by EPA as optional or as less stringent, supersedes any less stringent
or inconsistent State provision which may have been previously
authorized by EPA (50 FR 28702, July 15, 1985).
    Some existing State requirements may be similar to the HSWA
requirements implemented by EPA. However, until EPA authorizes those
State requirements, EPA enforces the HSWA requirements and not the
State analogs.

III. Administrative Requirements

    The Office of Management and Budget (OMB) has exempted this action
from the requirements of Executive Orders 12866 (58 FR 51735, October
4, 1993) and 13563 (76 FR 3821, January 21, 2011). Therefore, this
action is not subject to review by OMB. This action authorizes and
codifies State requirements for the purpose of RCRA 3006 and imposes no
additional requirements beyond those imposed by State law. Accordingly,
I certify that this action will not have a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.). Because this action authorizes
and codifies pre-existing requirements under State law and does not
impose any additional enforceable duty beyond that required by State
law, it 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). For the same reason, this
action also does not significantly or uniquely affect the communities
of Tribal governments, as specified by Executive Order 13175 (65 FR
67249, November 9, 2000). This action 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, as specified
in Executive Order 13132 (64 FR 43255, August 10, 1999), because it
merely authorizes and codifies State requirements as part of the State
RCRA hazardous waste program without altering the relationship or the
distribution of power and responsibilities established by RCRA.
    This action also is not subject to Executive Order 13045 (62 FR
19885, April 23, 1997), because it is not economically significant, and
it does not make decisions based on environmental health or safety
risks. This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001), because it is not a
significant regulatory action under Executive Order 12866.
    Under RCRA 3006(b), EPA grants a State's application for
authorization as long as the State meets the criteria required by RCRA.
It would thus be inconsistent with applicable law for EPA, when it
reviews a State authorization application, to require the use of any
particular voluntary consensus standard in place of another standard
that otherwise satisfies the requirements of RCRA. Thus, the
requirements of section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required
by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996),
in issuing this rule, EPA has taken the necessary steps to eliminate
drafting errors and ambiguity, minimize potential litigation, and
provide a clear legal standard for affected conduct. EPA has complied
with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining
the takings implications of the rule in accordance with the ``Attorney
General's Supplemental Guidelines for the Evaluation of Risk and
Avoidance of Unanticipated Takings'' issued under the executive order.
This rule does not impose an information collection burden under the
provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.).
    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States. Because this rule authorizes pre-
existing State rules which are at least equivalent to, and no less
stringent than existing Federal requirements, and imposes no additional
requirements beyond those imposed by State law, and there are no
anticipated significant adverse human health or environmental effects,
the rule is not subject to Executive Order 12898.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. The EPA will submit a report containing this document
and other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication in the Federal Register. A major rule cannot take effect
until 60 days after it is published in the Federal Register. This
action is not a ``major rule'' as defined by 5 U.S.C. 804(2). This
action will be effective October 16, 2023.

List of Subjects

40 CFR Part 271

    Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous waste, Hazardous waste
transportation, Indian lands, Intergovernmental relations, Penalties,
Reporting and recordkeeping requirements.

40 CFR Part 272

    Environmental protection, Hazardous materials transportation,
Hazardous waste, Incorporation by reference, Intergovernmental
relations, Water pollution control, Water supply.

    Authority: This rule is issued under the authority of sections
2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act as
amended, 42 U.S.C. 6912(a), 6926, 6974(b).

    Dated: August 8, 2023.
KC Becker,
Regional Administrator, Region 8.

    For the reasons set forth in the preamble, under the authority at
42 U.S.C. 6912(a), 6926, and 6974(b), EPA is granting final
authorization under 40 CFR part 271 to the State of Montana for
revisions to its hazardous waste program under the Resource
Conservation and Recovery Act and is amending 40 CFR part 272 as
follows:

PART 272--APPROVED STATE HAZARDOUS WASTE MANAGEMENT PROGRAMS

0
1. The authority citation for part 272 continues to read as follows:

    Authority:  Secs. 2002(a), 3006, and 7004(b) of the Solid Waste
Disposal Act, as amended by the Resource Conservation and Recovery
Act, as amended, 42 U.S.C. 6912(a), 6926, and 6974(b).

0
2. Revise Sec.  272.2 to read as follows:

Sec.  272.2  Incorporation by reference.

    (a) Material listed as incorporated by reference in part 272 was
approved for incorporation by reference by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Material
is incorporated as it exists on the date of the approval, and notice of
any change in the material will be published in the Federal Register.
    (b) Copies of materials incorporated by reference may be inspected
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email:
[email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html. Copies of materials incorporated by
reference may be obtained or inspected at the EPA Docket Center, Office
of Land and Emergency Management Docket (by scheduled appointment
only), located at WJC West Building, Room 3334, 1301 Constitution
Avenue NW, Washington, DC 20004, or send mail to Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460, and at the library of the
appropriate Regional Office listed below:
    (1) Region 1 (Connecticut, Maine, Massachusetts, New Hampshire,
Rhode Island, Vermont): 5 Post Office Square, 1st floor, Boston, MA
02109-3912; phone number:<PHONE_NUMBER>,
    (2) Region 2 (New Jersey, New York, Puerto Rico, Virgin Islands):
Federal Office Building, 290 Broadway, 23rd Floor, New York, NY 10007-
1866; phone number:<PHONE_NUMBER>),
    (3) Region 3 (Delaware, District of Columbia, Maryland,
Pennsylvania, Virginia, West Virginia): Four Penn Center, 1600 John F.
Kennedy Blvd., Philadelphia, PA 19103-2852; phone number: (215) 814-
5254,
    (4) Region 4 (Alabama, Florida, Georgia, Kentucky, Mississippi,
North Carolina, South Carolina, Tennessee): 61 Forsyth Street SW, Sam
Nunn Atlanta Federal Center, 9th Floor, Atlanta, GA 30303, (513) 569-
7703,
    (5) Region 5 (Illinois, Indiana, Michigan, Minnesota, Ohio,
Wisconsin): 77 West Jackson Boulevard, Chicago, IL 60604; phone number:
(312) 886- 6822,
    (6) Region 6 (Arkansas, Louisiana, New Mexico, Oklahoma, Texas):
1201 Elm Street, Suite 500, Dallas, Texas 75270-2102; phone number:
(214) 665-853,
    (7) Region 7 (Iowa, Kansas, Missouri, Nebraska); 11201 Renner
Boulevard, Lenexa, Kansas 66219; phone number:<PHONE_NUMBER>,
    (8) Region 8 (Colorado, Montana, North Dakota, South Dakota, Utah,
Wyoming): 1595 Wynkoop St., Denver, CO 80202-2405; phone number: (303)
312-6667,
    (9) Region 9 (Arizona, California, Hawaii, Nevada, Guam, American
Samoa, Commonwealth of the Northern Mariana Islands): 75 Hawthorne
Street, San Francisco, CA 94105; phone number:<PHONE_NUMBER>,
    (10) Region 10 (Alaska, Idaho, Oregon, Washington): 1200 Sixth
Avenue, Seattle, WA 98101; phone number:<PHONE_NUMBER>.
    (c) For an informational listing of the state and local
requirements incorporated in this part, see appendix A to this part.

0
3. Revise Sec.  272.1351 to read as follows:

Sec.  272.1351  Montana State-Administered Program: Final
Authorization.

    (a) History of the State of Montana authorization. Pursuant to
section 3006(b) of RCRA, 42 U.S.C. 6926(b), Montana has final
authorization for the following elements as submitted to EPA in
Montana's base program application for final authorization which was
approved by EPA effective on July 25, 1984. Subsequent program revision
applications were approved effective on March 21, 1994, December 24,
1996, December 26, 2000, November 29, 2005, June 26, 2009, and October
16, 2023.
    (b) Enforcement authority. The State of Montana has primary
responsibility for enforcing its hazardous waste management program.
However, EPA retains the authority to exercise its inspection and
enforcement authorities in accordance with sections 3007, 3008, 3013,
7003 of RCRA, 42 U.S.C. 6927, 6928, 6934, 6973, and any other
applicable statutory and regulatory provisions, regardless of whether
the State has taken its own actions, as well as in accordance with
other statutory and regulatory provisions.
    (c) State statutes and regulations--(1) Incorporation by reference.
The Montana regulations cited in paragraph (c)(1)(i) of this section
are incorporated by reference as part of the hazardous waste management
program under Subtitle C of RCRA, 42 U.S.C. 6921 et seq. The Director
of the Federal Register approves this incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. For the availability
of this information at the National Archives and Records Administration
and at the EPA, see Sec.  272.2(b). You may obtain copies of the
Montana regulations that are incorporated by reference in this
paragraph from Montana Secretary of State, Administrative Rules
Services, P.O. Box 202801 Helena, MT 59620-2801, Phone:<PHONE_NUMBER>.
    (i) EPA-Approved Montana Regulatory Requirements Applicable to the
Hazardous Waste Management Program, dated November 2022.
    (ii) [Reserved]
    (2) Legal basis. The following provisions provide the legal basis
for the State's implementation of the hazardous waste program, but they
are not being incorporated by reference and do not replace Federal
authorities:
    (i) Montana Code Annotated (MCA) 2021, Title 2, ``Government
Structure and Administration,'' Chapter 3, Public Participation in
Governmental Operations, sections 2-3-102 introductory paragraph
through 2-3-102(2), 2-3-103(1), 2-3-104, 2-3-105, 2-3-111, 2-3-112, 2-
3-221, 2-3-301; Chapter 4, Administrative Procedure Act, sections 2-4-
103, 2-4-307, 2-4-315; Chapter 6, Public Records, sections 2-6-1003 and
2-6-1006; Chapter 15, Executive Branch Officers and Agencies, sections
2-15-3501 and 2-15-3502.
    (ii) Montana Code Annotated (MCA) 2022, Title 25, Civil Procedure:
Chapter 20, Rules of Civil Procedure, Rule 24(a) and (b).
    (iii) Montana Code Annotated (MCA) 2021, Title 27, Civil Liability,
Remedies, and Limitations: Chapter 30, Nuisances, section 27-30-204.
    (iv) Montana Code Annotated (MCA) 2021, Title 30, Trade and
Commerce: Chapter 14, Unfair Trade Practices and Consumer Protection,
sections 30-14-402, et seq.
    (v) Montana Code Annotated (MCA) 2021, Title 75, Environmental
Protection: Chapter 10, Waste and Litter Control, sections 75-10-107,
75-10-203, 75-10-402(3), 75-10-403 (except 75-10-403(13)), 75-10-404(1)
introductory paragraph and (1)(a), 75-10-404(1)(b) through (e), 75-10-
404(2), 75-10-405 (except 75-10-405(1)(i), (1)(j) and (2)(a)), 75-10-
406, 75-10-408, 75-10-409, 75-10-410, 75-10-411, 75-10-413, 75-10-414,
75-10-415, 75-10-416, 75-10-417, 75-10-418, 75-10-419, 75-10-420, 75-
10-421, 75-10-422, 75-10-424, 75-10-425, 75-10-426, 75-10-427, 75-10-
441 and 75-10-442; Chapter 20, Major Facility Siting.

    (vi) Administrative Rules of Montana (ARM), effective May 14, 2022,
Title 17, Environmental Quality: Chapter 53, Hazardous Waste, sections
17.53.104, 17.53.201, 17.53.202, 17.53.206, 17.53.207, 17.53.208,
17.53.212, 17.53.213, 17.53.214, 17.53.215, 17.53.1202(6)(m) and (n),
17.53.1202(7).
    (3) Related legal provisions. The following statutory and
regulatory provisions are broader in scope than the Federal program,
are not part of the authorized program, are not incorporated by
reference and are not federally enforceable:
    (i) Montana Code Annotated (MCA) 2021, Title 75, Environmental
Protection: Chapter 10, Waste and Litter Control, sections 75-10-
403(13), 75-10-405(1)(i) and (j), 75-10-405(2)(a), 75-10-431, 75-10-
432, 75-10-433, and 75-10-434.
    (ii) Administrative Rules of Montana (ARM), effective May 14, 2022,
Title 17, Environmental Quality, Chapter 53, Hazardous Waste, sections
17.53.111(4) (phrase addressing fees), 17.53.111(6), 17.53.112,
17.53.113, 17.53.301(2)(p) (phrase addressing fees), 17.53.703,
17.53.1202(6)(l), and 17.53.1202(18).
    (4) Memorandum of agreement. The Memorandum of Agreement between
EPA Region 8 and the State of Montana, signed by the State of Montana
Department of Environmental Quality on August 22, 2018, and by the EPA
Regional Administrator on August 2, 2018, although not incorporated by
reference, are referenced as part of the authorized hazardous waste
management program under subtitle C of RCRA, 42 U.S.C. 6921 et seq.
    (5) Statement of legal authority. Independent Legal Counsel
Statement, accompanied by an Attorney General concurrence letter signed
by the Attorney General of Montana on December 27, 1983 as amended June
7, 1984 and revisions, supplements and addenda to that Statement
accompanied by Attorney General concurrence letters dated September 23,
1993, March 28, 1995, June 29, 1995, April 4, 2005, January 31, 2008
and May 31, 2022, although not incorporated by reference, are
referenced as part of the authorized hazardous waste management program
under subtitle C of RCRA, 42 U.S.C. 6921 et seq.
    (6) Program description. The Program Description and any other
materials submitted as supplements thereto, although not incorporated
by reference, are referenced as part of the authorized hazardous waste
management program under subtitle C of RCRA, 42 U.S.C. 6921 et seq.

0
3. Appendix A to part 272 is amended by revising the entry ``Montana''
to read as follows:

Appendix A to Part 272--State Requirements

* * * * *

Montana

    The regulatory provisions include: Administrative Rules of
Montana, Title 17, Environmental Quality, Chapter 53, Hazardous
Waste, effective May 14, 2022, sections 17.53.101, 17.53.102,
17.53.105, 17.53.107, 17.53.111(1), 17.53.111(2), 17.53.111(3),
17.5.111(4) (except the phrase ``and receives the registration fee
required by ARM 17.53.113''), 17.53.111(5), 17.53.111(7), 17.53.301
(except the phrase addressing fees at 17.53.301(2)(p)), 17.53.404,
17.53.405, 17.53.406, 17.53.501, 17.53.502, 17.53.601, 17.53.602,
17.53.603, 17.53.604, 17.53.701, 17.53.702, 17.53.704, 17.53.706,
17.53.707, 17.53.708, 17.53.801, 17.53.802, 17.53.803, 17.53.901,
17.53.902, 17.53.903, 17.53.1001, 17.53.1002, 17.53.1003,
17.53.1004, 17.53.1101, 17.53.1102, 17.53.1201, 17.53.1202 (except
17.53.1202(6)(l), (6)(m), (6)(n), (7) and (18)), 17.53.1203,
17.53.1301, 17.53.1302, 17.53.1303, 17.53.1401, 17.53.1402,
17.53.1501, and 1502.
    Copies of the Montana regulations that are incorporated by
reference are available from the Montana Secretary of State,
Administrative Rules Services, P.O. Box 202801, Helena, MT 59620-
2801 (Phone:<PHONE_NUMBER>)
* * * * *
[FR Doc. 2023-17367 Filed 8-14-23; 8:45 am]
BILLING CODE 6560-50-P


 From:
Keith Barnett/RTP/USEPA/US
 To:
"O'Hare, Andrew"<EMAIL_ADDRESS> Date:
10/25/2010 02:14 PM
 Subject:
RE: Cement Correction Notice

I think I sent the wrong table.  Here is the corrected version.

Steve Silverman and I discussed this issue with Hector. (We called Hector because he was the first person to raise the issue and had already sent information).  As a result of that conversation Steve and I believe this can be dealt with as more of an interpretative issue as to the meaning of calibration, and don't believe is would be a good idea to try and address this in the technical correction notice.

Keith W. Barnett
USEPA/OAQPS/SPPD/MMG
Mail Code D243-02
Research Triangle Park, NC  27711
919-541-5605
<EMAIL_ADDRESS>


           2015 Ozone Transport and Reliability Discussion with FERC
Title:	EPA-FERC Meeting on Reliability Topics
Date/Time: January 9, 2023 (11AM  -  12PM)
Agenda/Meeting Summary:
This meeting between EPA and sister Federal Agency, the Federal Energy Regulatory Commission (FERC) was held so that EPA could share with FERC a high-level overview of what EPA heard from the RTOs/ISOs and other balancing authorities on reliability during the public comment period for the proposed Good Neighbor Plan (GNP) rulemaking and in meetings EPA held with the RTOs/ISOs and other balancing authorities to further discuss their comments, and to discuss any reliability-related topics or feedback from FERC staff.
Participants/Affiliations:
Name
Affiliation
Stenhouse, Jeb
EPA
Birnbaum, Rona
EPA
Evans, DavidA
EPA
Corcoran, Katherine
EPA
Emma Nicholson
FERC
Edward Gross
FERC
Lifland, David
EPA
Schillo, Bruce
EPA
Profeta, Timothy
EPA
Lauren Campbell
FERC
Lalani, Imran
EPA
Deepak Ramlatchan
FERC
Lacount, Melanie
EPA
Murray, Beth
EPA
Selbst, Elizabeth
EPA
Maria Hanley
FERC
Carbonell, Tomas
EPA
Fisher, Brian
EPA
Louise Nutter
FERC
Sorrels, Larry
EPA
Schramm, Daniel
EPA
Alfred Corbett
FERC


[Federal Register: June 2, 2008 (Volume 73, Number 106)]
[Notices]
[Page 31459]
[DOCID:fr02jn08-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER08-836-000; ER08-836-001]

Champion Energy Marketing LLC; Notice of Issuance of Order

May 23, 2008.
    Champion Energy Marketing LLC (Champion Marketing) filed an
application for market-based rate authority, with an accompanying
tariff. The proposed market-based rate tariff provides for the sale of
energy, capacity and ancillary services at market-based rates. Champion
Marketing also requested waivers of various Commission regulations. In
particular, Champion Marketing requested that the Commission grant
blanket approval under 18 CFR Part 34 of all future issuances of
securities and assumptions of liability by Champion Marketing.
    On May 22, 2008, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development-West, granted the requests
for blanket approval under Part 34 (Director's Order). The Director's
Order also stated that the Commission would publish a separate notice
in the Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard concerning the
blanket approvals of issuances of securities or assumptions of
liability by Champion Marketing, should file a protest with the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426, in accordance with Rules 211 and 214 of the Commission's Rules
of Practice and Procedure. 18 CFR 385.211, 385.214 (2004). The
Commission encourages the electronic submission of protests using the
FERC Online link at http://www.ferc.gov.
    Notice is hereby given that the deadline for filing protests is
June 20, 2008.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, Champion Marketing is authorized to
issue securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of Champion Marketing, compatible
with the public interest, and is reasonably necessary or appropriate
for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Champion Marketing's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the
docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
 Secretary.
 [FR Doc. E8-12211 Filed 5-30-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 121 (Monday, June 26, 2023)]
[Notices]
[Pages 41405-41407]
[FR Doc No: 2023-13513]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-2034]

Alternative Procedures for the Manufacture of Cold-Stored
Platelets Intended for the Treatment of Active Bleeding When
Conventional Platelets Are Not Available or Their Use Is Not Practical;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of an immediate in effect guidance entitled
``Alternative Procedures for the Manufacture of Cold-Stored Platelets
Intended for the Treatment of Active Bleeding when Conventional
Platelets Are Not Available or Their Use Is Not Practical.'' FDA is
issuing this guidance to provide a notice of exceptions and
alternatives to certain requirements in the biologics regulations
regarding blood and blood components. This notice is being issued to
respond to a public health need and address the urgent and immediate
need for platelets for the treatment of active bleeding when
conventional platelets are not available, or their use is not
practical. In addition, the guidance document provides recommendations
to blood establishments for the manufacture and labeling of cold-stored
platelets (CSP).

DATES: The announcement of the guidance is published in the Federal
Register on June 26, 2023.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-2034 for ``Alternative Procedures for the Manufacture of
Cold-Stored Platelets Intended for the Treatment of Active Bleeding
when Conventional Platelets Are Not Available or Their Use Is Not
Practical; Guidance for Industry; Availability.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), 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 the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

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

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of an immediate in effect
guidance entitled ``Alternative Procedures for the Manufacture of Cold-
Stored Platelets Intended for the Treatment of Active Bleeding when
Conventional Platelets Are Not Available or Their Use Is Not
Practical.'' FDA is issuing this guidance to provide a notice of
exceptions and alternatives to certain requirements in subchapter F of
chapter I of title 21 of the CFR (21 CFR parts 600-680) regarding blood
and blood components. This notice is being issued under 21 CFR
640.120(b) to respond to a public health need and address the urgent
and immediate need for platelets for the treatment of active bleeding
when conventional platelets are not available, or their use is not
practical. Maintaining platelet availability in the face of logistical
challenges (e.g., in military, prehospital, or austere settings) or
other threats to blood availability (e.g., mass casualty events or
public health emergencies) is critical to assure that platelets are
available to patients with active bleeding.
    In addition, this guidance document provides recommendations to
blood establishments for the manufacture and labeling of CSP. The
guidance also discusses the need for additional data on the efficacy of
CSP, in particular, to address whether their use is supported when
conventional platelets are available, and their use is practical.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec.  10.115 (21 CFR 10.115)). FDA is issuing
this guidance for immediate implementation in accordance with Sec.
10.115(g)(3) without initially seeking prior comment because the Agency
has determined that prior public participation is not feasible or
appropriate (see Sec.  10.115(g)(2)). Specifically, we are not seeking
comments before implementing this guidance because of the urgent and
immediate need for platelets for the treatment of active bleeding when
conventional platelets are not available, or their use is not
practical.
    The guidance represents the current thinking of FDA on alternative
procedures for the manufacture of cold-stored platelets intended for
the treatment of active bleeding when

conventional platelets are not available, or their use is not
practical. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 211.100 and 211.160(b) have been approved
under OMB control number 0910-0139; the collections of information in
21 CFR 601.12 and Form FDA 356h have been approved under OMB control
number 0910-0338; and the collections of information in 21 CFR 606.121
and 21 CFR 606.122 have been approved under OMB control number 0910-
0116.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.

    Dated: June 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13513 Filed 6-23-23; 8:45 am]
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[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Notices]
[Pages 6458-6459]
[FR Doc No: 2011-2484]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Intent to File Competing License Applications, Filing
of Pre-Application Documents (PADs), Commencement of Pre-Filing
Process, and Scoping; Request for Comments on the PADs and Scoping
Document, and Identification of Issues and Associated Study Requests

January 28, 2011.

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

------------------------------------------------------------------------
FirstEnergy Generation Corporation.......  P-2280-013
Seneca Nation of Indians.................  P-13889-000
------------------------------------------------------------------------

    a. Type of Filing: Notices of Intent to File Competing License
Applications for a New License and Commencing Pre-Filing Process.
    b. Project Nos.: 2280-013 & 13889-000.
    c. Dated Filed: November 30, 2010.
    d. Submitted By: Existing licensee--FirstEnergy Generation
Corporation (FirstEnergy); and Competitor--Seneca Nation of Indians
(Seneca Nation).
    e. Name of Project: Existing Project--Kinzua Pumped Storage
Project; Competing Project--Seneca Pumped Storage Project.
    f. Location: On the United States Army Corps of Engineers Kinzua
Dam, and the United States Forest Service Allegheny National Forest,
adjacent to the Allegheny River and the Allegheny Reservoir near the
City of Warren, in Warren County, Pennsylvania. The project occupies
221.59 acres of Federal lands.
    g. Filed Pursuant to: 18 CFR Part 5 of the Commission's Regulations
    h. Potential Applicants' Contacts:
    For Project No. 2280-013: Morgan Parke, Federal Regulatory
Attorney, FirstEnergy Corporation, 76 South Main Street, Akron, Ohio
44308.
    For Project No. 13889-000: Wendy Huff, Executive Director Kinzua
Dam Relicensing Commission, Seneca Nation of Indians, P.O. Box 231, 90
Ohi:yo' Way, Salamanca, NY 14779.
    i. FERC Contact: Gaylord Hoisington at<PHONE_NUMBER> or e-mail at
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, State, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item o below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See 94 FERC ]
61,076 (2001).
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, Part 402; and (b) the State Historic
Preservation Officer, as required by section 106, National Historical
Preservation Act, and the implementing regulations of the Advisory
Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating FirstEnergy and the Seneca
Nation as the Commission's non-Federal representatives for carrying out
informal consultation pursuant to section 7 of the Endangered Species
Act and section 106 of the National Historic Preservation Act.
    m. FirstEnergy and the Seneca Nation filed Pre-Application
Documents (PADs; including a proposed process plan and schedule),
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. Copies of both PADs are available for review at the Commission
in the Public Reference Room or may be viewed on the Commission's Web
site (http://www.ferc.gov), using the ``eLibrary'' link. Enter the
docket number, excluding the last three digits in the docket number
field to access the documents. For assistance, contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Copies are also available for inspection
and reproduction at the addresses in paragraph h.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via e-mail of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    o. With this notice, we are soliciting comments on the PADs, the
Commission staff's scoping document (SD) issued January 28, 2011, as
well as study requests. All comments on the PADs, SD, and study
requests should be sent to the addresses above in paragraph h. In
addition, all comments on the PADs, SD, study requests, requests for
cooperating agency status, and all communications to and from
Commission staff related to the merits of the potential applications
must be filed with the Commission. Documents may be filed
electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the
instructions on the
    Commission's Web site (http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    All filings with the Commission must include, on the first page,
the project name (Kinzua Pumped Storage Project) and number (P-2280-
013), for FirstEnergy and/or (Seneca Pumped Storage Project) and number
(P-13889-000), for the Seneca Nation, and bear the heading: ``Comments
on Pre-Application Document,'' ``Study Requests,'' ``Comments on
Scoping Document,'' ``Request for Cooperating Agency Status,'' or
``Communications to and from Commission Staff.'' Any individual or
entity interested in submitting study requests, commenting on the PADs
or SD, and any agency requesting cooperating status must do so by March
30, 2011.
    p. Although our current intent is to prepare an environmental
assessment (EA), there is the possibility that an Environmental Impact
Statement (EIS) will be required. Nevertheless, this meeting will
satisfy the NEPA scoping requirements, irrespective of whether an EA or
EIS is issued by the Commission.

Scoping Meetings

    Commission staff will hold three scoping meetings in the vicinity
of the project at the time and place noted below. The morning and
afternoon meetings will focus on resource agency,

Indian tribes, and non-governmental organization concerns, while the
evening meeting is primarily for receiving input from the public. We
invite all interested individuals, organizations, and agencies to
attend one or all three of the meetings, and to assist staff in
identifying particular study needs, as well as the scope of
environmental issues to be addressed in the environmental document. The
times and locations of these meetings are as follows:

Morning Scoping Meeting

    Date: Wednesday, February 23, 2011.
    Time: 9 a.m. to 12 p.m.
    Location: Holiday Inn, 210 Ludlow Street, Warren, Pa. 16365.
    Phone:<PHONE_NUMBER>.

Evening Scoping Meeting

    Date: Wednesday, February 23, 2011.
    Time: 7 p.m. to 9 p.m.
    Location: Holiday Inn, 210 Ludlow Street, Warren, Pa 16365.

Afternoon Scoping Meeting

    Date: Thursday, February 24, 2011.
    Time: 3 p.m. to 6 p.m.
    Location: Salamanca City Central School District, 50 Iroquois
Drive, Salamanca, NY 14779.
    Phone:<PHONE_NUMBER> ext. 3184.
    The SD, which outlines the subject areas to be addressed in the
environmental document, was mailed to the individuals and entities on
the Commission's mailing lists and the distribution lists for
FirstEnergy's and the Seneca Nation's PADs. Copies of the SD will be
available at the scoping meetings, or may be viewed on the Web at
http://www.ferc.gov, using the ``eLibrary'' link. Follow the directions
for accessing information in paragraph n. Based on all oral and written
comments, a Revised Scoping Document (RSD) may be issued. A RSD may
include any revised process plan and schedule, as well as a list of
issues, identified through the scoping process.

Site Visit

    The potential applicants and Commission staff will conduct a site
visit of the project facilities on Wednesday afternoon, February 23,
2011, starting at 1:30 p.m. All participants should meet at the Kinzua
Project powerhouse. All participants will be responsible for providing
their own method of transportation. The time and location of the site
visit is as follows:
    Date: Wednesday, February 23, 2011.
    Time: 1:30 p.m. to 4 p.m.
    Location: Kinzua Project Powerhouse, Warren, PA 16365.
    Name: Laura Cowan.
    Phone:<PHONE_NUMBER>.

Meeting Objectives

    At the scoping meetings, staff will: (1) Initiate scoping of the
issues; (2) review and discuss existing conditions and resource
management objectives; (3) review and discuss existing information and
identify preliminary information and study needs; (4) review and
discuss the process plan and schedule for pre-filing activity that
incorporates the time frames provided for in Part 5 of the Commission's
regulations and, to the extent possible, maximizes coordination of
federal, state, and tribal permitting and certification processes; and
(5) discuss the appropriateness of any federal or state agency or
Indian tribe acting as a cooperating agency for development of an
environmental document.
    Meeting participants should come prepared to discuss their issues
and/or concerns. Please review the PADs in preparation for the scoping
meetings. Instructions on how to obtain copies of the PADs and SD are
included in item n. of this document.

Meeting Procedures

    The meetings will be recorded by a stenographer and will become
part of the formal record of the Commission proceeding on the project.

Kimberly D. Bose,
Secretary.
[FR Doc. 2011-2484 Filed 2-3-11; 8:45 am]
BILLING CODE 6717-01-P