[Federal Register Volume 90, Number 32 (Wednesday, February 19, 2025)]
[Rules and Regulations]
[Pages 9841-9843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02793]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 90, No. 32 / Wednesday, February 19, 2025 /
Rules and Regulations
[[Page 9841]]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1306
[Docket No. DEA-948; DEA-407VA]
RIN 1117-AB78; 1117-AB40; 1117-AB88
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 12
Expansion of Buprenorphine Treatment via Telemedicine Encounter
and Continuity of Care via Telemedicine for Veterans Affairs Patients
AGENCY: Drug Enforcement Administration, Department of Justice;
Substance Abuse and Mental Health Services Administration, Department
of Health and Human Services.
ACTION: Final rule; delay of effective dates and request for comments.
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SUMMARY: In the January 17, 2025, issue of the Federal Register, the
Drug Enforcement Administration and the Department of Health and Human
Services published two final rules related to the practice of
telemedicine, titled ``Expansion of Buprenorphine Treatment via
Telemedicine Encounter'' and ``Continuity of Care via Telemedicine for
Veterans Affairs Patients.'' These final rules were scheduled to become
final on February 18, 2025. In accordance with the Presidential
Memorandum of January 20, 2025, titled ``Regulatory Freeze Pending
Review,'' the Drug Enforcement Administration and the Department of
Health and Human Services are delaying the effective dates of these two
final rules to March 21, 2025, and are soliciting public comments
specifically regarding this delayed effective date.
DATES:
Effective date delay: As of February 14, 2025, the effective date
of the two final rules amending CFR part 1306 and 42 CFR part 12
published in the Federal Register on January 17, 2025, at 90 FR 6504
and 90 FR 6523, respectively, are delayed to March 21, 2025.
Comment date: Electronic comments must be submitted, and written
comments must be postmarked, on or before February 28, 2025.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-948'' or ``Docket No. DEA-407VA'' on all
correspondence, including any attachments.
Electronic comments: DEA encourages that all comments be
submitted electronically through the Federal eRulemaking Portal, which
provides the ability to type comments directly into the comment field
on the web page or to attach a file containing comments. Please go to
https://www.regulations.gov and follow the online instructions at that
site for submitting comments. Upon completion of your submission, you
will receive a Comment Tracking Number for your comment generated by
https://www.regulations.gov. Please be aware that submitted comments
are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number,
your comment has been successfully submitted, and there is no need to
resubmit the same comment. Commenters should be aware that the
electronic Federal Docket Management System will not accept comments
after 11:59 p.m. Eastern Time on the last day of the comment period.
Paper comments: Paper comments that duplicate the
electronic submission are discouraged. Should you wish to mail a paper
comment in lieu of submitting a comment electronically, it should be
sent via regular or express mail to: Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152. Hand-delivered comments will not be
accepted.
FOR FURTHER INFORMATION CONTACT: Heather Achbach, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 776-3882.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received, including attachments and
other supporting materials, in response to this docket are considered
part of the public record. The Drug Enforcement Administration (DEA)
generally will make all comments available for public inspection online
at https://www.regulations.gov. The Freedom of Information Act applies
to all comments received. Confidential information or personal
identifying information (PII), such as account numbers or Social
Security numbers, or names of other individuals, should not be
included. Submissions will not be edited to remove any identifying or
contact information.
Comments with confidential information, which should not be made
publicly available, should be submitted as written/paper submissions.
Two written/paper copies should be submitted. One copy will include the
confidential information with a heading or cover sheet that states
``CONTAINS CONFIDENTIAL INFORMATION.'' DEA will review this copy,
including the claimed confidential information, in its consideration of
comments. The second copy should have the claimed confidential
information redacted/blacked out. DEA will make this copy available for
public inspection online at https://www.regulations.gov. Other
information, such as name and contact information, that should not be
made available, may be included on the cover sheet but not in the body
of the comment, and must be clearly identified as ``confidential.'' Any
information clearly identified as ``confidential'' will not be
disclosed except as required by law.
Discussion
On January 17, 2025, DEA and the Department of Health and Human
Services (HHS) published two final rules titled ``Expansion of
Buprenorphine Treatment via Telemedicine Encounter'' (90 FR 6504) and
``Continuity of Care via Telemedicine for Veterans Affairs Patients''
(90 FR 6523). These rules, respectively, amended their regulations to
expand the circumstances under which: (1) practitioners registered by
DEA are authorized to prescribe schedule III-V controlled substances
approved by the Food and Drug
[[Page 9842]]
Administration for the treatment of opioid use disorder via a
telemedicine encounter, including an audio-only telemedicine encounter
\1\ and (2) Department of Veterans Affairs practitioners acting within
the scope of their Veterans Affairs employment are authorized to
prescribe schedule II-V controlled substances via telemedicine to a
Veterans Affairs patient with whom they have not conducted an in-person
medical evaluation, if another VA practitioner has, at any time,
previously conducted an in-person medical evaluation of the VA patient,
subject to certain conditions.\2\
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\1\ 90 FR 6504 (Jan. 17, 2025).
\2\ 90 FR 6523 (Jan. 17, 2025).
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On January 20, 2025, the President of the United States issued a
memorandum to all executive departments and agencies titled
``Regulatory Freeze Pending Review'' (the Freeze Memo).\3\ Paragraph 3
of the Freeze Memo ordered agencies to ``consider postponing for 60
days from the date of this memorandum the effective date for any rules
that have been published in the Federal Register, or any rules that
have been issued in any manner but have not taken effect, for the
purpose of reviewing any questions of fact, law, and policy that the
rules may raise.'' The purpose of this delay is ``to allow interested
parties to provide comments about issues of fact, law, and policy
raised by the rules postponed under this memorandum, and consider
reevaluating pending petitions involving such rules.'' In addition,
this delay will allow Department of Justice and Department of Health
and Human Services officials further opportunity to review any
potential questions of fact, law, and policy raised by those two final
rules.
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\3\ 90 FR 8249 (Jan. 28, 2025).
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This document extends the effective date of the final rules in the
January 17, 2025, issue of the Federal Register, titled ``Expansion of
Buprenorphine Treatment via Telemedicine Encounter'' \4\ and
``Continuity of Care via Telemedicine for Veterans Affairs Patients,''
\5\ from February 18, 2025, to March 21, 2025, consistent with
paragraph 3 of the January 20, 2025, Freeze Memo. These new effective
dates will not delay or limit the ability of the practitioners covered
by these two rules to prescribe via telemedicine, because the
``Temporary Extension of COVID-19 Telemedicine Flexibilities for
Prescription of Controlled Medications,'' which has been in effect
since May 10, 2023, permits practitioners to prescribe via telemedicine
through December 31, 2025.\6\
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\4\ 90 FR 6504 (Jan. 17, 2025).
\5\ 90 FR 6523 (Jan. 17, 2025).
\6\ 88 FR 30037 (May 10, 2023), as extended by 88 FR 30037 (May
10, 2023) and 89 FR 91253 (Nov. 19, 2024).
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DEA is soliciting comments on the extension of the effective date
of these two final rules to March 21, 2025. DEA also is soliciting
comments on whether there may be a need for their effective dates to be
extended beyond that date, and address issues of fact, law, and policy
raised by these rules, for consideration by officials of the two
agencies.
Regulatory Analyses
Change to the effective date of these final rules does not affect
the economic impact calculated in the final rules. Per Office of
Management and Budget (OMB) Circular A-4, analysis is conducted on a
time frame which includes all important benefits and costs, and such
time frame generally begins at the point when the final rule is
expected to begin to have effects.\7\ No portion of the analysis
conducted in these final rules was dependent on the original effective
date, and therefore the change in the time frame is not expected to
change any part of the analysis.
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\7\ OMB Circular A-4, section 3(b): ``The time frame for your
analysis should include a period before and after the date of
compliance that is long enough to encompass all the important
benefits and costs likely to result from the regulation. A logical
beginning point for your stream of estimates would be the point in
which the regulation will begin to have effects . . .''
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To the extent that 5 U.S.C. 553 applies to this action, it is
exempt from notice and comment because it constitutes a rule of
procedure under 5 U.S.C. 553(b)(A). In addition, the agencies find good
cause that the usual notice and comment procedures are impracticable
because the very limited time available for action to delay the
February 18th effective dates forecloses the opportunity for a full
notice and comment process. 5 U.S.C. 553(b)(B). Furthermore, because
this rule is procedural rather than substantive, the usual requirement
of 5 U.S.C. 553(d) that a rule not be effective until at least 30 days
after publication in the Federal Register is inapplicable. DEA also
finds good cause to provide an immediate effective date for this rule,
because the temporary delay in the effective date until March 21, 2025,
is necessary to give Agency officials the opportunity for further
review and consideration of the new regulation, consistent with the
memorandum described previously. DEA and HHS believe that affected
entities need to be informed as soon as possible of the extension and
its length to plan and adjust their implementation process accordingly.
Nonetheless, DEA and HHS are soliciting comments on the delay of
the effective date to March 21, 2025.
Executive Orders 12866 and 13563 (Regulatory Review)
The change to the effective date is expected to have no change on
the analysis conducted in this section in these two rules. This
document merely effectuates a limited delay in the effective dates of
two rules, previously scheduled to take effect February 18, 2025. There
is no change to the substance of these two final rules.
Regulatory Flexibility Act
The change to the effective date is expected to have no change on
the analysis conducted in this section in the final rules.
Paperwork Reduction Act of 1995
The change to the effective date is expected to have no change on
the analysis conducted in this section in the final rules.
Executive Order 12988, Civil Justice Reform
This document meets the applicable standards set forth in sections
3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors and
ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism
This document does not have federalism implications warranting the
application of E.O. 13132. The document does 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.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
DEA and HHS are committed to the principles of collaboration and
consultation with Tribal governments, as demonstrated through its plans
to conduct the appropriate Executive Order 13175 Tribal consultations
and recognizes the significance of these consultations and their role
in shaping regulations that impact Tribal communities. Relevant issues
regarding Tribal Consultation were discussed in the two final rules
published on January 17, 2025.
[[Page 9843]]
Unfunded Mandates Reform Act of 1995
The estimated annual impact of this notice is minimal. Thus, DEA
and HHS have determined in accordance with the Unfunded Mandates Reform
Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.) that this action would not
result in any Federal mandate that may result in the expenditure by
State, local, and Tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted for inflation) in any
one year. Therefore, neither a Small Government Agency Plan nor any
other action is required under provisions of UMRA.
Signing Authority
This document of the Drug Enforcement Administration was signed on
February 12, 2025, by Acting Administrator Derek Maltz. That document
with the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
Dorothy A. Fink,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2025-02793 Filed 2-14-25; 8:45 am]
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