Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Rules and Regulations 91253 

4This finding also satisfies the requirements of 5 

U.S.C. 808(2), allowing the amendments to become 

effective notwithstanding the requirement of 5 

U.S.C. 801 (if a Federal agency finds that notice and 

public comment are impractical, unnecessary or 

contrary to the public interest, a rule shall take 

effect at such time as the Federal agency 

promulgating the rule determines). The 

amendments also do not require analysis under the 

Regulatory Flexibility Act. See 5 U.S.C. 604(a) 

(requiring a final regulatory flexibility analysis only 

for rules required by the APA or other law to 

undergo notice and comment). 

5See 5 U.S.C. 553(d)(3). 

1William T. McDermott, DEA Dear Registrant 

letter, Drug Enforcement Administration (March 25, 

2020), https://www.deadiversion.usdoj.gov/GDP/ 

(DEA-DC-018)(DEA067)%20DEA%20state%20

reciprocity%20(final)(Signed).pdf. 

The technical amendments do not 

impose any new substantive regulatory 

requirements on any person and merely 

reflect the vacatur of the Private Fund 

Adviser Rules. For these reasons, for 

good cause, the Commission finds that 

notice and public comment are 

unnecessary.4

For similar reasons, although the APA 

generally requires publication of a rule 

at least 30 days before its effective date, 

the Commission finds there is good 

cause for the amendments to take effect 

on [INSERT DATE OF PUBLICATION 

IN THE FEDERAL REGISTER].5

Pursuant to the Congressional Review 

Act, the Office of Information and 

Regulatory Affairs has designated these 

amendments as not a ‘‘major rule,’’ as 

defined by 5 U.S.C. 804(2). 

List of Subjects in 17 CFR Part 275 

Administrative practice and 

procedure, Reporting and recordkeeping 

requirements, Securities. 

Text of Amendments 

For the reasons set forth in the 

preamble, title 17, chapter II of the Code 

of Federal Regulations is amended as 

follows: 

PART 275—RULES AND 

REGULATIONS, INVESTMENT 

ADVISERS ACT OF 1940 

■ 1. The authority citation for part 275 

continues to read in part as follows: 

Authority: 15 U.S.C. 80b–2(a)(11)(G), 80b– 

2(a)(11)(H), 80b–2(a)(17), 80b–3, 80b–4, 80b– 

4a, 80b–6(4), 80b–6a, 80b–11, 1681w(a)(1), 

6801–6809, and 6825, unless otherwise 

noted. 

* * * * * 

Section 275.204–2 is also issued under 15 

U.S.C. 80b–6. 

* * * * * 

§ 275.204–2 [Amended] 

■ 2. Amend § 275.204–2 by: 

■ a. Removing the ‘‘; and’’ at the end of 

paragraph (a)(7)(iv)(B) and adding a 

period in its place; 

■ b. Removing paragraph (a)(7)(v); and 

■ c. Removing and reserving paragraphs 

(a)(20) through (24). 

* * * * * 

§ 275.206(4)–9, § 275.206(4)–10 [Removed] 

■ 3. Remove §§ 275.206(4)–9 and 

275.206(4)–10. 

* * * * * 

§ 275.206(4)–7 [Amended] 

■ 4. Amend § 275.206(4)–7 by revising 

paragraph (b) to read as follows: 

* * * * * 

(b) Annual review. Review, no less 

frequently than annually, the adequacy 

of the policies and procedures 

established pursuant to this section and 

the effectiveness of their 

implementation; and 

* * * * * 

§ 275.211(h)(1)–1 through § 275.211(h)(2)–3 

[Removed] 

■ 5. Remove §§ 275.211(h)(1)–1, 

275.211(h)(1)–2, 275.211(h)(2)–1, 

275.211(h)(2)–2, and 275.211(h)(2)–3. 

Dated: November 8, 2024. 

Sherry R. Haywood, 

Assistant Secretary. 

[FR Doc. 2024–26524 Filed 11–18–24; 8:45 am] 

BILLING CODE 8011–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1307 

[Docket No. DEA–407] 

RIN 1117–AB40, 1117–AB78, and 1117– 

ZA06 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 12 

Third Temporary Extension of COVID– 

19 Telemedicine Flexibilities for 

Prescription of Controlled Medications 

AGENCY: Drug Enforcement 

Administration, Department of Justice; 

Substance Abuse and Mental Health 

Services Administration, Department of 

Health and Human Services. 

ACTION: Temporary rule. 

SUMMARY: The Drug Enforcement 

Administration (DEA) in concert with 

the Department of Health and Human 

Services (HHS) is issuing a third 

extension of telemedicine flexibilities 

for the prescribing of controlled 

medications, through December 31, 

2025. 

DATES: This rule is effective January 1, 

2025, through December 31, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Heather E. Achbach, Diversion Control 

Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, VA 

22152, Telephone: (571) 776–3882. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Overview 

Under the Ryan Haight Online 

Pharmacy Consumer Protection Act of 

2008 (the Ryan Haight Act), a 

prescribing practitioner—subject to 

certain exceptions—may prescribe 

controlled medications to a patient only 

after conducting an in-person evaluation 

of that patient. In response to the 

COVID–19 Public Health Emergency 

(COVID–19 PHE), as declared by the 

Secretary (the Secretary) of the 

Department of Health and Human 

Services (HHS) on January 31, 2020, 

pursuant to the authority under section 

319 of the Public Health Service Act (42 

U.S.C. 247), the Drug Enforcement 

Administration (DEA) granted 

temporary exceptions to the Ryan 

Haight Act and DEA’s implementing 

regulations under 21 U.S.C. 802(54)(D). 

In order to prevent lapses in care, 

these exceptions allowed for the 

prescribing of controlled medications 

via telemedicine encounters even when 

the prescribing practitioner had not 

conducted an in-person medical 

evaluation of the patient. These 

telemedicine flexibilities authorized 

practitioners to prescribe schedule II–V 

controlled medications via audio-video 

telemedicine encounters, including 

schedule III–V narcotic controlled 

medications approved by the Food and 

Drug Administration (FDA) for 

maintenance and withdrawal 

management treatment of opioid use 

disorder via audio-only telemedicine 

encounters, provided that such 

prescriptions otherwise comply with the 

requirements outlined in DEA guidance 

documents, DEA regulations, and 

applicable Federal and State law. DEA 

granted those temporary exceptions to 

the Ryan Haight Act and DEA’s 

implementing regulations via two letters 

published in March 2020: 

• A March 25, 2020 ‘‘Dear Registrant’’ 

letter signed by William T. McDermott, 

DEA’s then-Assistant Administrator, 

Diversion Control Division (the 

McDermott Letter); 1 and 

• A March 31, 2020 ‘‘Dear Registrant’’ 

letter signed by Thomas W. Prevoznik, 

DEA’s then-Deputy Assistant 


ddrumheller on DSK120RN23PROD with RULES1
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2Thomas W. Prevoznik, DEA Dear Registrant 

letter, Drug Enforcement Administration (March 31, 

2020), https://www.deadiversion.usdoj.gov/GDP/ 

(DEA-DC-022)(DEA068)%20DEA%20SAMHSA%20

buprenorphine%20telemedicine%20%20

(Final)%20+Esign.pdf. 

3 88 FR 12875 (Mar. 1, 2023). 

4 88 FR 12890 (Mar. 1, 2023). 

5Temporary Extension of COVID–19 

Telemedicine Flexibilities for Prescription of 

Controlled Medications, 88 FR 30037 (May 10, 

2023). 

6Second Temporary Extension of COVID–19 

Telemedicine Flexibilities for Prescription of 

Controlled Medications, 88 FR 69879 (October 10, 

2023). 

7 21 U.S.C. 829(e). 

8 21 U.S.C. 802(54)(A)–(G). The Attorney General 

has delegated his rulemaking authority under this 

provision to the Administrator of DEA via 28 CFR 

0.100. The Secretary delegated his rulemaking 

authority under 21 U.S.C. 802(54)(G) to the 

Assistant Secretary for Mental Health and 

Substance Use within the Substance Abuse and 

Mental Health Services Administration on May 4, 

2023. 

9 21 U.S.C. 802(54)(G). 

Administrator, Diversion Control 

Division (the Prevoznik Letter).2

On March 1, 2023, DEA, in concert 

with HHS, promulgated two notices of 

proposed rulemaking (NPRMs) in the 

Federal Register—‘‘Telemedicine 

Prescribing of Controlled Substances 

When the Practitioner and the Patient 

Have Not Had a Prior In-Person Medical 

Evaluation’’ 3 (the General Telemedicine 

NPRM) and ‘‘Expansion of Induction of 

Buprenorphine via Telemedicine 

Encounter’’ 4 (the Buprenorphine 

NPRM)—which proposed to expand 

patient access to prescriptions for 

controlled medications via telemedicine 

encounters relative to the pre-COVID–19 

PHE landscape. The purpose of the two 

proposed rules was to make permanent 

some of the telemedicine flexibilities 

established during the COVID–19 PHE 

in order to facilitate patient access to 

controlled medications via telemedicine 

when consistent with public health and 

safety, while maintaining effective 

controls against diversion. The 

comment period for these two NPRMs 

closed on March 31, 2023. Those 

NPRMs generated a total of 38,369 

public comments—35,454 comments on 

the General Telemedicine NPRM and 

2,915 comments on the Buprenorphine 

NPRM. Many of those comments 

requested changes of varying degrees to 

the proposed regulations in the two 

March 2023 NPRMs. 

On May 10, 2023 DEA, jointly with 

HHS (with the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) acting on behalf of HHS), 

issued the first temporary extension 

(First Temporary Rule), which extended 

the full set of telemedicine flexibilities 

regarding the prescribing of controlled 

medications, as had been in place under 

the COVID–19 PHE, through November 

11, 2023.5 The First Temporary Rule 

also provided a one-year grace period, 

through November 11, 2024, to any 

practitioner-patient telemedicine 

relationships that had been or would be 

established on or before November 11, 

2023. In other words, under the First 

Temporary Rule, if a patient and a 

practitioner had established a 

telemedicine relationship on or before 

November 11, 2023, the same 

telemedicine flexibilities that had 

governed the relationship to that point 

would continue to apply through 

November 11, 2024. 

On August 7, 2023, DEA announced 

that it would host Telemedicine 

Listening Sessions on September 12 and 

13, 2023, in order to receive additional 

input concerning the practice of 

telemedicine with regards to prescribing 

controlled medications and potential 

safeguards that could effectively prevent 

and detect diversion of controlled 

substances prescribed via telemedicine. 

On October 10, 2023, DEA, jointly with 

HHS, issued a second temporary 

extension (Second Temporary Rule) 

extending the full set of telemedicine 

flexibilities regarding prescription of 

controlled medications as were in place 

during the COVID–19 PHE, through 

December 31, 2024.6 This extension 

authorized all DEA-registered 

practitioners to prescribe schedule II–V 

controlled medications via telemedicine 

through December 31, 2024, whether or 

not the patient and practitioner 

established a telemedicine relationship 

on or before November 11, 2023. In 

other words, the grace period provided 

in the First Temporary Rule was 

effectively subsumed by this Second 

Temporary Rule, which continued the 

extension of the current flexibilities for 

all practitioner-patient relationships— 

not just those established on or before 

November 11, 2023—until the end of 

2024. 

On June 13 and 27, 2024, DEA held 

virtual Tribal Consultations with 

numerous Tribal governments and 

organizations in order to elicit further 

comment from interested Tribal parties 

regarding the prescribing of controlled 

medications via telemedicine and its 

impact on Tribal persons. Additionally, 

in June 2024, DEA transmitted a new 

draft telemedicine NPRM to the Office 

of Management and Budget (OMB) for 

review under Executive Order (E.O.) 

12866. Since then, DEA has also 

attended several meetings with 

interested parties coordinated by OMB 

pursuant to E.O. 12866, which have 

provided interested parties with the 

opportunity to provide further views to 

OMB. 

With the deadline of December 31, 

2024, granted by the Second Temporary 

Rule quickly approaching, DEA, jointly 

with HHS, is now issuing a third 

temporary extension (Third Temporary 

Rule) to ensure a smooth transition for 

patients and practitioners that have 

come to rely on the availability of 

telemedicine for controlled medication 

prescriptions. This additional time will 

allow DEA (and also HHS, for rules that 

must be issued jointly) to promulgate 

proposed and final regulations that are 

consistent with public health and safety, 

and that also effectively mitigate the risk 

of possible diversion. Furthermore, this 

Third Temporary Rule will allow 

adequate time for providers to come into 

compliance with any new standards or 

safeguards eventually adopted in a final 

set of regulations. DEA remains 

committed to carefully evaluating the 

comments received in response to the 

prior NPRMs, as well as the information 

and perspectives presented at the 

Telemedicine Listening Sessions, the 

Tribal Consultations, and the E.O. 12866 

meetings. 

II. Legal Authority 

The Ryan Haight Act amended the 

Controlled Substances Act (CSA) to 

generally require that the dispensing of 

controlled medications by means of the 

internet be predicated on a valid 

prescription involving at least one inperson medical evaluation.7 At the same 

time, it also established excepted 

categories of telemedicine pursuant to 

which a practitioner may prescribe 

controlled medications for a patient 

despite never having evaluated that 

patient in person, provided that, among 

other things, such practice is in 

accordance with applicable Federal and 

State laws.8

One of these categories authorizes the 

Attorney General and the Secretary to 

jointly promulgate rules that would 

allow practitioners to prescribe 

medications for patients via 

telemedicine without having had an inperson evaluation when such 

telemedicine practice is in accordance 

with applicable Federal and State laws, 

uses an approved telecommunications 

system, and is ‘‘conducted under . . . 

circumstances that the[y have] . . . 

determined to be consistent with 

effective controls against diversion and 

otherwise consistent with the public 

health and safety.’’ 9

Pursuant to this authority, DEA, 

jointly with HHS, is hereby 

promulgating this Third Temporary 

Rule specifying certain circumstances 

under which practitioners may 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Rules and Regulations 91255 

10 5 U.S.C. 553(b)(B). 

11 88 FR 30037 (May 10, 2023) and 88 FR 69879 

(October 10, 2023). 

prescribe controlled medications, for the 

time period described above, to patients 

whom the practitioner has never 

evaluated in person. This Third 

Temporary Rule, like the First and 

Second Temporary Rules, covers the 

portions of the March 2023 NPRMs 

related to extensions of the telemedicine 

flexibilities in place during the COVID– 

19 PHE, and it extends, through 

December 31, 2025, the telemedicine 

flexibilities that have been in place 

since March 2020 for prescribing 

controlled medications via the practice 

of telemedicine. 

As noted previously, DEA and, for 

rules that must be issued jointly, HHS 

anticipate implementing a final set of 

regulations that are consistent with the 

public health and safety and that also 

effectively mitigate the risk of possible 

diversion. However, given the 

impending expiration of the flexibilities 

provided in the Second Temporary Rule 

and the additional consideration of the 

input received during the Telemedicine 

Listening Sessions, the Tribal 

Consultations, and the E.O. 12866 

meetings, DEA, jointly with HHS, has 

elected to again extend those 

flexibilities to maintain access to care 

during a limited window of time as the 

agencies consider the appropriate 

pathway forward. 

As explained further below, because 

this is an extension of limited duration 

of flexibilities that existed during the 

COVID–19 PHE, DEA and HHS have 

determined that this Third Temporary 

Rule is consistent ‘‘with effective 

controls against diversion and otherwise 

consistent with the public health and 

safety’’ as required under 21 U.S.C. 

802(54)(G). Thus, DEA, jointly with 

HHS, is promulgating this temporary 

rule pursuant to 21 U.S.C. 802(54)(G). 

HHS has advised DEA that no 

additional rulemaking by HHS is 

necessary as it pertains to the 

promulgation of these provisions 

pursuant to 21 U.S.C. 802(54)(G). 

III. Purpose and Need for Regulatory 

Changes 

The purpose of this rulemaking is to 

further extend, for a limited period of 

time, the telemedicine flexibilities that 

existed during the COVID–19 PHE in 

order to: 

• Prevent a reduction in access to 

care for patients who do not yet have an 

existing telemedicine relationship with 

their practitioners pending 

promulgation of a final rule or rules 

addressing telemedicine more generally; 

• For relationships established both 

during the COVID–19 PHE and those 

established during the prior extensions, 

prevent backlogs with respect to inperson medical evaluations in the 

months shortly before and after the 

expiration of the telemedicine 

flexibilities and ensure the availability 

of telemedicine for practitioners and 

patients who have come to rely on it; 

• Address the urgent public health 

need for continued access to 

buprenorphine as medication for opioid 

use disorder in the context of the 

continuing opioid public health crisis; 

• Allow patients, practitioners, 

pharmacists, service providers, and 

other stakeholders sufficient time to 

prepare for the implementation of any 

future regulations that apply to 

prescribing of controlled medications 

via telemedicine; 

• Enable DEA to continue considering 

the presentations made at the 

Telemedicine Listening Sessions, the 

Tribal Consultations, and the E.O. 12866 

meetings; 

• Enable DEA, with HHS for rules 

that must be issued jointly, to conduct 

a thorough evaluation of regulatory 

alternatives in order to promulgate 

regulations that most effectively expand 

access to telemedicine encounters in a 

manner that is consistent with the 

public health and safety, while also 

effectively mitigating against the risk of 

possible diversion; and 

• Avoid incentivizing the investment 

necessary to develop new telemedicine 

companies that might encourage or 

enable problematic prescribing practices 

by limiting the third extension of 

flexibilities to a short, time-limited 

period. 

IV. Summary of Third Temporary Rule 

Changes 

This Third Temporary Rule amends 

portions of 21 CFR 1307.41 and 42 CFR 

12.1 through December 31, 2025. 

Paragraph (a) is amended to state that 

the authorization granted in the 

amended paragraph (c) expires at the 

end of December 31, 2025, instead of 

December 31, 2024. 

Current paragraph (b) is deleted. 

Current paragraph (c) is redesignated 

as paragraph (b) and is amended to 

reflect that current paragraph (d) has 

been deleted and to extend the COVID– 

19 telemedicine prescribing flexibilities 

through December 31, 2025, provided 

all the conditions listed in current 

paragraph (e) are met. 

Current paragraph (d) is deleted. 

Current paragraph (e) is redesignated 

as paragraph (c) and is amended to 

reflect that current paragraphs (b) and 

(d) have been deleted. 

DEA and HHS are using the revise 

and republish instruction to reflect 

these changes as parts of newly 

redesignated paragraph (c) are not 

changing. 

V. Regulatory Analyses 

Administrative Procedure Act 

DEA and HHS are issuing this rule 

without prior notice and an opportunity 

to comment pursuant to the 

Administrative Procedure Act’s (APA’s) 

‘‘good cause’’ exception. In certain 

circumstances, agencies may forgo 

notice-and-comment rulemaking when a 

rulemaking is published in the Federal 

Register and the agency ‘‘for good cause 

finds . . . that notice and public 

procedure thereon are impracticable, 

unnecessary, or contrary to the public 

interest.’’ 10

As discussed earlier, DEA, jointly 

with HHS, is publishing this third 

temporary extension of certain 

exceptions to existing DEA regulations, 

granted in March 2020 as a result of the 

COVID–19 PHE, in order to prevent 

reduced access to care for patients that 

do not yet have an existing telemedicine 

relationship with their practitioners 

pending promulgation of a final rule or 

rules addressing telemedicine more 

generally. It would be impracticable for 

DEA and HHS to publish a notice of 

proposed rulemaking; await, review, 

and respond to new comments; and 

issue a rule in the time remaining before 

the second extension expires on 

December 31, 2024. Further, the 

reduction in access to care that patients 

would experience if the existing 

telemedicine flexibilities ended on 

December 31, 2024 would be contrary to 

the public interest, as it could lead to 

potential patient harm—due to an 

inability to access appropriate care—in 

some instances. 

As noted above, in March 2023, DEA 

received 38,369 comments on two 

proposed rules regarding the flexibilities 

that would be extended by this rule. 

DEA considered those comments in 

publishing the First Temporary Rule 

and Second Temporary Rule.11

Moreover, any final rule or rules that 

DEA and, for rules that must be issued 

jointly, HHS promulgate addressing 

telemedicine more generally would 

reflect viewpoints and information from 

comments received in response to the 

proposed rules, the Telemedicine 

Listening Sessions, the Tribal 

Consultations, the E.O. 12866 meetings, 

and any further comments that may be 

collected during additional rounds of 

public comment. Because DEA and, for 

rules that must be issued jointly, HHS 

continue to consider information that 


ddrumheller on DSK120RN23PROD with RULES1
91256 Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Rules and Regulations 

12 5 U.S.C. 804(2). 

was provided in those comments and 

presentations, and that may be provided 

in the near future before issuing a final 

set of regulations, further opportunity 

for public comment on these flexibilities 

at this time would serve little, if any, 

purpose. 

For these reasons, each of which 

individually constitutes good cause, 

DEA, jointly with HHS, finds that notice 

and public comment on this rule are 

impracticable, unnecessary, and 

contrary to the public interest. 

Executive Orders 12866 (Regulatory 

Planning and Review), 13563 

(Improving Regulation and Regulatory 

Review), and 14094 (Modernizing 

Regulatory Review) 

This Third Temporary Rule was 

developed in accordance with the 

principles of E.O. 12866, as amended by 

E.O. 14094 and E.O. 13563. E.O. 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health, and safety 

effects; distributive impacts; and 

equity). E.O. 13563 is supplemental to 

and reaffirms the principles, structures, 

and definitions governing regulatory 

review established in E.O. 12866. 

The economic, interagency, 

budgetary, legal, and policy 

implications of this temporary rule have 

been examined, and DEA has 

determined that it is a significant 

regulatory action under E.O. 12866, but 

not a Section 3(f)(1) significant 

regulatory action. Accordingly, this rule 

has been submitted to OMB for review. 

DEA, jointly with HHS, is publishing 

this Third Temporary Rule to further 

extend certain exceptions DEA granted 

to its existing regulations in March 2020 

as a result of the COVID–19 PHE in 

order to avoid a lapse of care for 

patients. The additional extension of the 

COVID–19 flexibilities until December 

31, 2025, is necessary to thoroughly 

consider the presentations made at the 

Telemedicine Listening Sessions, the 

Tribal Consultations, the E.O. 12866 

meetings, as well as the comments made 

to the proposed rules set forth in the 

March 2023 NPRMs. 

Without this Third Temporary Rule, 

the COVID–19 PHE telemedicine 

flexibilities are scheduled to expire on 

December 31, 2024. This rule extends 

the expiration of those flexibilities 

through December 31, 2025. Because 

this rule does not create or remove any 

regulatory requirements, DEA and HHS 

estimate that there is no cost associated 

with this Third Temporary Rule. 

However, DEA and HHS believe this 

extension creates a benefit in the form 

of cost savings to prescribers and 

patients and reduced transfer payments 

to the Federal Government, similar to 

those described in the General 

Telemedicine NPRM. However, DEA is 

unable to quantify the cost savings and 

reduction in transfer payments. 

Executive Order 12988, Civil Justice 

Reform 

The Third Temporary Rule 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 Third Temporary Rule does not 

have federalism implications warranting 

the application of E.O. 13132. The rule 

does not have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or the distribution of power 

and responsibilities among the various 

levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

This Third Temporary Rule does not 

have substantial direct effects on the 

Tribes, on the relationship between the 

national government and the Tribes, or 

the distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes. 

However, DEA has determined that 

there is a reasonable basis that the 

March 2023 NPRMs may have Tribal 

implications, consistent with the 

definition in E.O. 13175. As such, DEA 

engaged in virtual consultations with 

numerous Tribal governments and 

organizations on June 13 and 27, 2024. 

DEA plans to incorporate the concerns 

raised during those virtual consultations 

when a final set of regulations is 

promulgated. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act (5 

U.S.C. 601–612) (RFA), has reviewed 

this Third Temporary Rule and by 

approving it certifies that it will not 

have a significant economic impact on 

a substantial number of small entities. 

This Third Temporary Rule, as 

discussed above, merely extends for a 

limited time the status quo with respect 

to the current flexibilities allowed 

during the COVID–19 PHE, in order to 

avoid lapses in coverage for patients. 

Without this Third Temporary Rule, 

the COVID–19 PHE telemedicine 

flexibilities would expire on December 

31, 2024. While this Third Temporary 

Rule does not create or remove any 

regulatory requirements, this Third 

Temporary Rule extends the expiration 

of those flexibilities through December 

31, 2025. DEA and HHS believe this 

extension creates a benefit in the form 

of cost savings to prescribers and 

patients and reduced transfer payments 

to the Federal Government. 

In accordance with the RFA, DEA will 

be evaluating the impact on small 

entities at the time the final rule or rules 

are issued as part of these rulemakings. 

Unfunded Mandates Reform Act of 1995 

The estimated annual impact of this 

rule is minimal. Thus, DEA has 

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. 

Congressional Review Act 

This temporary rule is not a major 

rule as defined by Subtitle E of the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (known as the 

Congressional Review Act or CRA).12

However, pursuant to the CRA, DEA is 

submitting a copy of this temporary rule 

to both Houses of Congress and to the 

Comptroller General. 

Paperwork Reduction Act of 1995 

This temporary rule will not impose 

a new collection or modify an existing 

collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3521). Also, this temporary 

rule does not impose recordkeeping or 

reporting requirements on State or local 

governments, individuals, businesses, or 

other organizations. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a valid 

OMB control number. 


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Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Rules and Regulations 91257 

List of Subjects 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1307 

Administrative practice and 

procedure, Drug traffic control, 

Prescription drugs. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 12 

Administrative practice and 

procedure, Drug traffic control, 

Prescription drugs. 

Drug Enforcement Administration 

For the reasons set out above, the 

Drug Enforcement Administration 

amends 21 CFR part 1307 as follows: 

PART 1307—MISCELLANEOUS 

■ 1. The authority citation for part 1307 

continues to read as follows: 

Authority: 21 U.S.C. 821, 822(d), 871(b), 

unless otherwise noted. 

■ 2. Revise and republish § 1307.41 to 

read as follows: 

§ 1307.41 Temporary extension of certain 

COVID–19 telemedicine flexibilities for 

prescription of controlled medications. 

(a) This section is in effect until the 

end of the day December 31, 2025. The 

authorization granted in paragraph (b) of 

this section expires at the end of 

December 31, 2025. 

(b) During the period May 12, 2023, 

through December 31, 2025, a DEAregistered practitioner is authorized to 

prescribe schedule II–V controlled 

substances via telemedicine, as defined 

in 21 CFR 1300.04(i), to a patient 

without having conducted an in-person 

medical evaluation of the patient if all 

of the conditions listed in paragraph (c) 

of this section are met. 

(c) A practitioner is only authorized to 

issue prescriptions for controlled 

substances pursuant to paragraph (b) of 

this section if all of the following 

conditions are met: 

(1) The prescription is issued for a 

legitimate medical purpose by a 

practitioner acting in the usual course of 

professional practice; 

(2) The prescription is issued 

pursuant to a communication between a 

practitioner and a patient using an 

interactive telecommunications system 

referred to in 42 CFR 410.78(a)(3); 

(3) The practitioner is: 

(i) Authorized under their registration 

under 21 CFR 1301.13(e)(1)(iv) to 

prescribe the basic class of controlled 

substance specified on the prescription; 

or 

(ii) Exempt from obtaining a 

registration to dispense controlled 

substances under 21 U.S.C. 822(d); and 

(4) The prescription is consistent with 

all other requirements of 21 CFR part 

1306. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

For the reasons set out above, the 

Department of Health and Human 

Services amends 42 CFR part 12 as 

follows: 

PART 12—TELEMEDICINE 

FLEXIBILITIES 

■ 1. The authority citation for part 12 

continues to read as follows: 

Authority: 21 U.S.C. 802(54)(G). 

■ 2. Revise and republish § 12.1 to read 

as follows: 

§ 12.1 Temporary extension of certain 

COVID–19 telemedicine flexibilities for 

prescription of controlled medications. 

(a) This section is in effect until the 

end of the day December 31, 2025. The 

authorization granted in paragraph (b) of 

this section expires at the end of 

December 31, 2025. 

(b) During the period May 12, 2023, 

through December 31, 2025, a Drug 

Enforcement Administration (DEA)- 

registered practitioner is authorized to 

prescribe schedule II–V controlled 

substances via telemedicine, as defined 

in 21 CFR 1300.04(i), to a patient 

without having conducted an in-person 

medical evaluation of the patient if all 

of the conditions listed in paragraph (c) 

of this section are met. 

(c) A practitioner is only authorized to 

issue prescriptions for controlled 

substances pursuant to paragraph (b) of 

this section if all of the following 

conditions are met: 

(1) The prescription is issued for a 

legitimate medical purpose by a 

practitioner acting in the usual course of 

professional practice; 

(2) The prescription is issued 

pursuant to a communication between a 

practitioner and a patient using an 

interactive telecommunications system 

referred to in 42 CFR 410.78(a)(3); 

(3) The practitioner is: 

(i) Authorized under their registration 

under 21 CFR 1301.13(e)(1)(iv) to 

prescribe the basic class of controlled 

substance specified on the prescription; 

or 

(ii) Exempt from obtaining a 

registration to dispense controlled 

substances under 21 U.S.C. 822(d); and 

(4) The prescription is consistent with 

all other requirements of 21 CFR part 

1306. 

Signing Authority 

This document of the Drug 

Enforcement Administration and the 

Department of Health and Human 

Services was signed on November 14, 

2024, by DEA Administrator Anne 

Milgram and the HHS Assistant 

Secretary for Mental Health and 

Substance Use. Those documents with 

the original signatures and dates are 

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. 

Miriam E. Delphin-Rittmon, 

Assistant Secretary for Mental Health and 

Substance Use, Department of Health and 

Human Services. 

[FR Doc. 2024–27018 Filed 11–15–24; 4:15 pm] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 926 

[SATS No. MT–040–FOR; Docket No. OSM– 

2023–0001; S1D1S SS08011000 SX064A000 

231S180110; S2D2S SS08011000 

SX064A000 23XS501520] 

Montana Regulatory Program/ 

Reclamation Plan 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement, Interior. 

ACTION: Final rule; approving, in part. 

SUMMARY: We, the Office of Surface 

Mining Reclamation and Enforcement 

(OSMRE), are approving, in part, an 

amendment to the Montana regulatory 

program under the Surface Mining 

Control and Reclamation Act of 1977 

(SMCRA or the Act). During the 2019 

legislative session, Montana updated its 

Montana Strip and Underground Mine 

Reclamation Act codified in the 

Montana Code Annotated. Accordingly, 

Montana submitted this amendment to 

OSMRE on its own initiative. The 

amendment requires a permit 

applicant’s compliance information to 

be updated and approved if a 

bankruptcy or reorganization results in 


ddrumheller on DSK120RN23PROD with RULES1