Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Rules and Regulations 3071 

303 of title 16, Code of Federal 

Regulations, as follows: 

PART 303—RULES AND 

REGULATIONS UNDER THE TEXTILE 

FIBER PRODUCTS IDENTIFICATION 

ACT 

■ 1. The authority citation for part 303 

continues to read: 

Authority: 15 U.S.C. 70 et seq. 

■ 2. Amend § 303.19 by revising 

paragraph (a) to read as follows: 

§ 303.19 Name or other identification 

required to appear on labels. 

(a) The name required by the Act to 

be used on labels shall be the name 

under which the person is doing 

business. Where a person has a word 

trademark, used as a house mark, 

registered in the United States Patent 

Office, such word trademark may be 

used on labels in lieu of the name 

otherwise required. No trademark, trade 

names, or other names except those 

provided for above shall be used for 

required identification purposes. 

* * * * * 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. 2018–01202 Filed 1–22–18; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1301 

[Docket No. DEA–450] 

RIN 1117–AB42 

Implementation of the Provision of the 

Comprehensive Addiction and 

Recovery Act of 2016 Relating to the 

Dispensing of Narcotic Drugs for 

Opioid Use Disorder 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: The Comprehensive 

Addiction and Recovery Act (CARA) of 

2016, which became law on July 22, 

2016, amended the Controlled 

Substances Act (CSA) to expand the 

categories of practitioners who may, 

under certain conditions on a temporary 

basis, dispense a narcotic drug in 

Schedule III, IV, or V for the purpose of 

maintenance treatment or detoxification 

treatment. Separately, the Department of 

Health and Human Services, by final 

rule effective August 8, 2016, increased 

to 275 the maximum number of patients 

that a practitioner may treat for opioid 

use disorder without being separately 

registered under the CSA for that 

purpose. The Drug Enforcement 

Administration (DEA) is hereby 

amending its regulations to incorporate 

these statutory and regulatory changes. 

DATES: Effective: January 22, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Michael J. Lewis, Diversion Control 

Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: It has been 

determined this is a major rule within 

the meaning of the Congressional 

Review Act (CRA). 5 U.S.C. 804(2). 

Major rules generally cannot take effect 

until 60 days after the date on which the 

rule is published in the Federal 

Register. 5 U.S.C. 801(a)(3). However, 

the CRA provides that ‘‘any rule for 

which an agency for good cause finds 

(and incorporates the finding and a brief 

statement of reasons therefor in the rule 

issued) that notice and public procedure 

thereon are impracticable, unnecessary, 

or contrary to the public interest, shall 

take effect at such time as the Federal 

agency promulgating the rule 

determines.’’ 5 U.S.C. 808. As is 

discussed below, DEA finds there is 

good cause to issue these amendments 

as a final rule without notice and 

comment, because these amendments 

merely conform the implementing 

regulations with recent amendments to 

the CSA contained in CARA that have 

already taken effect. Accordingly, DEA 

has determined this rule will take effect 

January 22, 2018. 

Background and Legal Authority 

Pertinent Provisions of the CARA 

On July 22, 2016, the President signed 

the Comprehensive Addiction and 

Recovery Act (CARA) into law as Public 

Law 114–198. Section 303 of the CARA 

amended certain provisions of 21 U.S.C. 

823(g)(2), which is the subsection of the 

Controlled Substance Act (CSA) that 

sets forth the conditions under which a 

practitioner may, without being 

separately registered under subsection 

823(g)(1), dispense a narcotic drug in 

Schedule III, IV, or V for the purpose of 

maintenance treatment or detoxification 

treatment. Maintenance treatment is the 

dispensing of a narcotic drug, in excess 

of twenty-one days, for the treatment of 

dependence upon heroin or other 

morphine-like drugs (21 U.S.C. 802(29)). 

A detoxification treatment is the term 

given when a narcotic drug is dispensed 

in decreasing doses, not exceeding one 

hundred and eighty days, ‘‘to alleviate 

adverse physiological or psychological 

effects incident to withdrawal from the 

continuous or sustained use of a 

narcotic drug,’’ with the ultimate goal of 

bringing a patient to a narcotic drug-free 

state (21 U.S.C. 802(30)). 

Specifically, section 303 of the CARA 

temporarily expands the types of 

practitioners who may dispense a 

narcotic drug in Schedule III, IV, or V 

for the purpose of maintenance 

treatment or detoxification treatment 

without being separately registered as a 

narcotic treatment program. Whereas 

prior to the CARA, only qualified 

physicians were permitted to dispense 

narcotic drugs in this manner, the 

CARA now temporarily permits certain 

nurse practitioners and physician 

assistants to qualify to do so. The CARA 

achieves this result by (1) inserting the 

term ‘‘qualifying practitioner’’ in place 

of ‘‘qualifying physician’’ in 21 U.S.C. 

823(g)(2)(B)(i) and (2) defining 

‘‘qualifying practitioner’’ to include not 

only a physician, but also (until October 

1, 2021) a ‘‘qualifying other 

practitioner,’’ which includes a nurse 

practitioner or physician assistant who 

meets certain qualifications set forth in 

paragraph 823(g)(2)(G)(iv). More 

precisely, section 303 of the CARA 

defines ‘‘qualifying other practitioner’’ 

as a nurse practitioner or physician 

assistant who satisfies each of the 

following criteria: 

(I) The nurse practitioner or physician 

assistant is licensed under State law to 

prescribe schedule III, IV, or V 

medications for the treatment of pain; 

(II) The nurse practitioner or 

physician assistant must complete not 

fewer than 24 hours of initial training. 

(III) The nurse practitioner or 

physician assistant is supervised by, or 

works in collaboration with, a 

qualifying physician, if the nurse 

practitioner or physician assistant is 

required by State law to prescribe 

medications for the treatment of opioid 

use disorder in collaboration with or 

under the supervision of a physician; 

and 

The Secretary determines in 

collaboration with, a qualifying 

physician, if the nurse practitioner or 

physician assistant is supervised by, or 

works in collaboration with, a 

qualifying physician, if the nurse 

practitioner can treat and manage 

opiate-dependent patients. The 

Secretary may, by regulation, revise the 

requirements for being qualifying other 

practitioner. 

This section of the CARA further 

provides that the Secretary of Health 

and Human Services (HHS) may, by 

regulation, revise the foregoing 


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3072 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Rules and Regulations 

1The HHS final rule further provides that the 

approval by HHS to treat up to 275 patients is for 

a term of three years and that the practitioner must 

submit a renewal request with HHS every three 

years to continue to treat up to 275 patients. 42 CFR 

8.625–8.655. 

requirements for being a qualifying 

other practitioner. 

The CARA also makes some technical 

revisions to 21 U.S.C. 823(g)(2) that do 

not materially alter the meaning of this 

subsection. Nonetheless, because the 

DEA regulations currently contain the 

older statutory language, DEA is hereby 

revising this part of the regulations to 

reflect the new statutory language. 

HHS Final Rule Increasing the Patient 

Limit for Purposes of 21 U.S.C. 823(g)(2) 

Under the CSA, the Secretary of HHS 

may, by regulation, increase the 

maximum number of patients that a 

practitioner may treat pursuant to 21 

U.S.C. 823(g)(2). 21 U.S.C. 

823(g)(2)(B)(iii)(III). On July 8, 2016, the 

Secretary issued a final rule increasing 

this number to 275. 81 FR 44712. As 

stated therein, to be eligible for the 

patient limit of 275, the practitioner 

must possess a current waiver to treat 

up to 100 patients under 21 U.S.C. 

823(g)(2) and meet additional criteria set 

forth in 42 CFR 8.610–8.625.1 DEA is 

hereby amending its regulations to 

reflect these new limits. 

Good Cause for Issuing This Rule as a 

Final Rule Without Notice and 

Comment 

As indicated, this final rule amends 

the DEA regulations only to the extent 

necessary to be consistent with current 

federal law (as modified by the CARA) 

and current federal regulations issued 

by HHS. The qualifying practitioner 

amendments in the CARA alter the 

provisions of the CSA that DEA 

previously implemented in its 

regulations, and DEA is therefore 

obligated to update those regulations. 

With respect to the HHS regulations, the 

CSA gives sole authority to HHS to 

change the maximum number of 

patients per practitioner under 21 U.S.C. 

823(g)(2), and where HHS does so, DEA 

is obligated to apply that number. As a 

result, DEA has no discretion not to 

amend its regulations as is being done 

in this final rule. Indeed, the new 

provisions issued under this final rule 

are already in effect by virtue of the 

CARA and the HHS final rule regarding 

patient limits. This final rule simply 

updates the DEA regulations to reflect 

these new provisions. Public comment 

on these amendments to the DEA 

regulations would therefore serve no 

purpose. Because notice and public 

comment are unnecessary, DEA finds 

there is good cause within the meaning 

of the Administrative Procedure Act 

(APA) to issue these amendments as a 

final rule without notice and comment, 

because these amendments merely 

conform the implementing regulations 

with recent amendments to the CSA 

contained in CARA that have already 

taken effect (see 5 U.S.C. 553(b)(B), 

relating to notice and comment 

procedures). ‘‘[W]hen regulations 

merely restate the statute they 

implement, notice-and-comment 

procedures are unnecessary’’. Gray 

Panthers Advocacy Committee v. 

Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 

1991); see also Komjathy v. Nat. Trans. 

Safety Bd., 832 F.2d 1294, 1296 (D.C. 

Cir. 1987) (when a rule ‘‘does no more 

than repeat, virtually verbatim, the 

statutory grant of authority’’ notice-andcomment procedures are not required). 

Therefore, we are issuing these 

amendments as a final rule, effective 

upon publication in the Federal 

Register. This rule constitutes final 

action on these changes under the APA 

(5 U.S.C. 553). 

Regulatory Analysis 

As explained above, DEA is obligated 

to issue this final rule to revise its 

regulations so that they are consistent 

with the provisions of the CSA that 

were amended by the CARA and the 

HHS final rule increasing the patient 

limit under 21 U.S.C. 823(g)(2). In 

issuing this final rule, DEA has not gone 

beyond the statutory text enacted by 

Congress or the final rule issued by 

HHS. Thus, DEA would have to issue 

this final rule regardless of the outcome 

of the agency’s regulatory analysis. 

Nonetheless, DEA conducted this 

analysis as discussed below. 

Executive Orders 12866 (Regulatory 

Planning and Review) and 13563, 

(Improving Regulation and Regulatory 

Review) 

This final rule was developed in 

accordance with the principles of 

Executive Orders 12866 and 13563. 

Executive Order 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). Executive Order 13563 is 

supplemental to and reaffirms the 

principles, structures, and definitions 

governing regulatory review as 

established in Executive Order 12866. 

Executive Order 12866 classifies a 

‘‘significant regulatory action,’’ 

requiring review by the Office of 

Management and Budget (OMB), as any 

regulatory action that is likely to result 

in a rule that may: (1) Have an annual 

effect on the economy of $100 million 

or more or adversely affect in a material 

way the economy, a sector of the 

economy, productivity, competition, 

jobs, the environment, public health or 

safety, or State, local, or tribal 

governments or communities; (2) create 

a serious inconsistency or otherwise 

interfere with an action taken or 

planned by another agency; (3) 

materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) raise novel 

legal or policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the Executive 

Order. 

1. The DEA expects that this final rule 

will have an annual effect on the 

economy of $100 million or more in at 

least one year and therefore is an 

economically significant regulatory 

action. The analysis of benefits and 

costs is below. 

2. This regulatory action is not likely 

to result in a rule that may create a 

serious inconsistency or otherwise 

interfere with an action taken or 

planned by another agency. This final 

rule amends the DEA regulations only to 

the extent necessary to be consistent 

with current federal law (as modified by 

the CARA) and current federal 

regulations issued by HHS. The 

qualifying practitioner amendments in 

the CARA alter the provisions of the 

CSA that DEA previously implemented 

in its regulations, and DEA is therefore 

obligated to update those regulations. 

With respect to the HHS regulations, the 

CSA gives sole authority to HHS to 

change the maximum number of 

patients per practitioner under 21 U.S.C. 

823(g)(2), and where HHS does so, DEA 

is obligated to apply that number. 

3. This regulatory action is not likely 

to result in a rule that may materially 

alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof. The Diversion 

Control Fee Account, which the DEA 

administers and which involves 

registration fees, is not directly affected. 

This regulatory action temporarily 

expanding the types of practitioners and 

increasing the maximum number of 

patients that a practitioner may treat as 

described in detail above represents a 

minor modification to the registration 

procedures within the Diversion Control 

Program and does not necessitate a 

change in registration fees. 

4. This regulatory action is not likely 

to result in a rule that may raise novel 


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Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Rules and Regulations 3073 

2Christopher M. Jones, PharmD, MPH, Melinda 

Campopiano, MD, Grant Baldwin, Ph.D., MPH, and 

Elinore McCance-Katz, MD, Ph.D., ‘‘National and 

State Treatment Need and Capacity for Opioid 

Agonist Medication-Assisted Treatment,’’ Am J 

Public Health, August 2015. Vol 105. No. 8. 

3Christine Vestal, ‘‘Few Doctors Are Willing, 

Able to Prescribe Powerful Anti-Addiction Drugs,’’ 

January 15, 2016. 

4The Coming Economic Bonanza In Addiction 

Treatment, Anson, Pat, (May 25, 2016), https://

www.painnewsnetwork.org/stories/2016/5/25/thecoming-economic-bonanza-in-addiction-treatment. 

5Roger A. Rosenblatt, MD, MPH, MFR1, C. Holly 

A. Andrilla, MS, Mary Catlin, BSN, MPH, Eric H. 

Larson, Ph.D. ‘‘Geographic and Specialty 

Distribution of U.S. Physicians Trained to Treat 

Opioid Use Disorder,’’ Annals of Family Medicine, 

Vol. 13, No. 1, January/February 2015. 

legal or policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the Executive 

Order. This final rule amends the DEA 

regulations only to the extent necessary 

to be consistent with current federal law 

(as modified by the CARA) and current 

federal regulations issued by HHS. The 

qualifying practitioner amendments in 

the CARA alter the provisions of the 

CSA that DEA previously implemented 

in its regulations, and DEA is therefore 

obligated to update those regulations. 

With respect to the HHS regulations, the 

CSA gives sole authority to HHS to 

change the maximum number of 

patients per practitioner under 21 U.S.C. 

823(g)(2), and where HHS does so, DEA 

is obligated to apply that number. This 

regulatory action therefore does not 

raise novel legal or policy issues. 

The economic, interagency, 

budgetary, legal, and policy 

implications of this final rule have been 

examined and it has been determined to 

be a significant regulatory action under 

Executive Order 12866, and therefore, 

has been submitted to the OMB for 

review. 

I. Need for the Rule 

On July 22, 2016, the Comprehensive 

Addiction and Recovery Act of 2016 

(CARA) became law. One section of the 

CARA amended the Controlled 

Substances Act (CSA) to expand the 

categories of practitioners who may, 

under certain conditions on a temporary 

basis, dispense a narcotic drug in 

Schedule III, IV, or V for the purpose of 

maintenance treatment or detoxification 

treatment. Separately, the Department of 

Health and Human Services (HHS), by 

final rule effective August 8, 2016, 

increased to 275 the maximum number 

of patients that a practitioner may treat 

for opioid use disorder without being 

separately registered under the CSA for 

that purpose. The DEA is amending its 

regulations to incorporate these 

statutory and regulatory changes. 

In addition to the legal requirement to 

implement the statute, this rule also 

implements one of the objectives of the 

statute; expand availability of 

medication-assisted treatment (MAT) for 

opioid addiction. As supported by 

research, there is a gap between those 

who need treatment for opioid addition 

and treatment providers (‘‘treatment 

gap’’). An increase in treatment 

availability is expected to result in more 

patients treated. 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

independently researched the issue of 

the treatment gap in its recent rule: 

Medication Assisted Treatment for 

Opioid Use Disorders, 81 FR 44712, 

44729 (July 8, 2016). SAMHSA found 

that ‘‘. . . there is significant unmet 

need for MAT treatment among 

individuals with opioid use disorders 

. . . Evidence suggests that utilization 

of buprenorphine is limited directly by 

the existence of treatment limits.’’ A 

research article in American Journal of 

Public Health concluded that there are 

significant gaps between treatment need 

and capacity at the state and national 

levels, with 96% of states and District 

of Columbia having opioid abuse or 

dependence rates higher than their 

buprenorphine treatment capacity 

rates.2 According to research by The 

Pew Charitable Trust, ‘‘[i]n the U.S. only 

49 percent of people with an opioid 

dependence can potentially receive 

treatment because too few doctors 

prescribe the medicine, and those that 

do can serve only a limited number of 

patients because of federal 

restrictions.’’ 3 Also, patients located in 

rural areas are negatively impacted by 

the limits because there are fewer 

doctors certified to prescribe 

buprenorphine.4 One research article 

examined the availability of MAT by 

U.S. counties and determined that more 

than 30 million persons live in counties 

without access to buprenorphine 

treatment.5

II. Alternative Approaches 

This final rule amends the DEA 

regulations only to the extent necessary 

to be consistent with current federal law 

(as modified by the CARA) and current 

federal regulations issued by HHS. The 

qualifying practitioner amendments in 

the CARA alter the provisions of the 

CSA that DEA previously implemented 

in its regulations, and DEA is therefore 

obligated to update those regulations. 

With respect to the HHS regulations, the 

CSA gives sole authority to HHS to 

change the maximum number of 

patients per practitioner under 21 U.S.C. 

823(g)(2), and where HHS does so, DEA 

is obligated to apply that number. As a 

result, DEA has no discretion not to 

amend its regulations as is being done 

in this final rule. Indeed, the new 

provisions issued under this final rule 

are already in effect by virtue of the 

CARA and the HHS final rule regarding 

patient limits. This final rule simply 

updates the DEA regulations to reflect 

these new provisions; thus, no 

alternative approaches are possible. 

III. Analysis of Benefits and Costs 

This analysis is limited to the 

provisions associated with the section of 

the CARA that amended the CSA to 

expand the categories of practitioners 

who may, under certain conditions on a 

temporary basis, dispense a narcotic 

drug in schedule III, IV, or V for the 

purpose of maintenance treatment or 

detoxification treatment. The HHS rule 

that increased to 275 the maximum 

number of patients that a practitioner 

may treat for opioid use disorder 

without being separately registered 

under the CSA was promulgated under 

HHS’ authority; therefore, that section of 

the CARA was excluded from this 

analysis. This is a summary; a detailed 

economic analysis of the proposed rule 

can be found in the rulemaking docket 

at http://www.regulations.gov. 

Benefits, in the form of economic 

burden (health care costs, criminal 

justice costs, and lost productivity costs) 

reductions, are expected to be generated 

from the expansion of the categories of 

practitioners who may dispense a 

narcotic drug in schedule III, IV, or V for 

the purpose of maintenance treatment or 

detoxification treatment. The DEA 

anticipates the expansion of the 

categories of practitioners will lead to 

an increase in the number of treatment 

providers, which will lead to an 

increase in the number of patients (who 

did not have access to treatment prior to 

this rule) treated, resulting in the 

reduction in the economic burden due 

to opioid abuse. 

Cost of the rule is associated with 

treatment cost and the cost to 

practitioners of obtaining authority to 

dispense a narcotic drug in schedule III, 

IV, or V for the purpose of maintenance 

treatment or detoxification treatment. 

While these costs are not directly 

attributable to this rule, obtaining 

dispensing authority and treating 

patients are required to generate the 

benefits of the rule, and thus, included 

in this analysis. Although the new 

treatment providers in the expanded 

category, qualifying other practitioners, 

will also need to comply with 

treatment-specific recordkeeping 

requirements, the cost of compliance is 

included in the estimated cost of 

treatment. Finally, there is potential for 

added risk of diversion from more 


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3074 Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Rules and Regulations 

6See Office of Mgmt. & Budget, Exec. Office of 

the President, OMB Circular A–4, Regulatory 

Analysis (2003). 

practitioners having the authority to 

dispense narcotic drug in schedule III, 

IV, or V for the purpose of maintenance 

treatment or detoxification treatment. 

The DEA estimates the total benefit 

(economic burden reduction) is $208 

million, $374 million, $467 million, 

$560 million, and $654 million in years 

1, 2, 3, 4, and 5, respectively; the total 

cost of treatment is $133 million, $238 

million, $298 million, $358 million, and 

$417 million in years 1, 2, 3, 4, and 5, 

respectively; and the total cost of 

obtaining DATA-waived status is $7 

million and $4 million in years 1 and 2, 

respectively; resulting in a net benefit of 

$68 million, $132 million, $169 million, 

$202 million, and $237 million in years 

1, 2, 3, 4, and 5, respectively. The table 

below contains the summary of benefits 

and costs. 

Year 1 Year 2 Year 3 Year 4 Year 5 

Total economic burden reduction ($MM) ............................. 208 374 467 560 654 

Cost of treatment ($MM) ...................................................... 133 238 298 358 417 

Cost of obtaining DATA-waived status ($MM) .................... 7 4 ........................ ........................ ........................

Total cost ($MM) .................................................................. 140 242 298 358 417 

Annual net benefit ($MM) .................................................... 68 132 169 202 237 

Figures are rounded. 

At 3% discount rate, the present value 

of benefits is $2,044 million, the present 

value of costs is $1,315 million and the 

net present value (NPV) is $729 million. 

At 7% discount rate, the present value 

of benefits is $1,796 million, the present 

value of costs is $1,156 million and the 

NPV is $640 million.6 The net benefits 

in years 1 to 5 equate to an annualized 

net benefit of $159 million at 3% and 

$156 million at 7% over five years. The 

table below summarizes the present 

value and annualized benefit 

calculations. 

3% 7% 

Present value of benefits 

($MM) ................................ 2,044 1,796 

Present value of costs 

($MM) ................................ 1,315 1,156 

Net present value ($MM) .. 729 640 

Annualized net benefit—5 

years ($MM) ...................... 159 156 

Figures are rounded. 

Executive Order 12988, Civil Justice 

Reform 

This final rule meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of Executive Order 12988, Civil 

Justice Reform to eliminate ambiguity, 

minimize litigation, establish clear legal 

standards, and reduce burden. 

Executive Order 13132, Federalism 

This rulemaking does not have 

federalism implications warranting the 

application of Executive Order 13132. 

The final 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 final 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 between the Federal 

Government and Indian tribes. 

Executive Order 13771, Reducing 

Regulation and Controlling Regulatory 

Costs 

This final rule is considered an E.O. 

13771 deregulatory action. The rule is 

an enabling rule which expands the 

options for opioid treatment. Details on 

the expected economic effects of this 

rule can be found in the rule’s economic 

impact analysis. 

Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) applies to rules that 

are subject to notice and comment 

under section 553(b) of the APA. As 

explained above, the DEA determined 

that there was good cause to exempt this 

final rule from notice and comment. 

Consequently, the RFA does not apply 

to this final rule. 

Unfunded Mandates Reform Act of 1995 

This final rule will not 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, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed under the 

provisions of the Unfunded Mandates 

Reform Act of 1995, 2 U.S.C. 1532. 

Congressional Review Act 

This rule is a major rule as defined by 

the Congressional Review Act. 5 U.S.C. 

804. This rule will result in an annual 

effect on the economy of $100 million 

or more as a result of economic burden 

reductions. However, it will not cause a 

major increase in costs or prices; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of the United States-based 

companies to compete with foreign 

based companies in domestic and 

export markets. The DEA has submitted 

a copy of this final rule to both Houses 

of Congress and to the Comptroller 

General. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information requirement 

under the Paperwork Reduction Act of 

1995. 44 U.S.C. 3501–3521 

List of Subjects in 21 CFR Part 1301 

Administrative practice and 

procedure, Drug traffic control, Exports, 

Imports, Security measures. 

For the reasons set out above, the DEA 

amends 21 CFR part 1301 as follows: 

PART 1301—REGISTRATION OF 

MANUFACTURERS, DISTRIBUTORS 

AND DISPENSERS OF CONTROLLED 

SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1301 is revised to read as follows: 

Authority: 21 U.S.C. 821, 822, 823, 824, 

831, 871(b), 875, 877, 886a, 951, 952, 956, 

957, 958, 965 unless otherwise noted. 

■ 2. In § 1301.28, revise paragraphs 

(b)(1)(i), (ii), and (iii) to read as follows: 

§ 1301.28 Exemption from separate 

registration for practitioners dispensing or 

prescribing Schedule III, IV, or V narcotic 

controlled drugs approved by the Food and 

Drug Administration specifically for use in 

maintenance or detoxification treatment. 

* * * * * 

(b)(1) * * * 

(i) The individual practitioner is 

registered under § 1301.13 as an 

individual practitioner and is a 

‘‘qualifying physician’’ as defined in 

section 303(g)(2)(G)(ii) of the Act (21 


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Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 / Rules and Regulations 3075 

U.S.C. 823(g)(2)(G)(ii)), or during the 

period beginning on July 22, 2016 and 

ending on October 1, 2021, a ‘‘qualifying 

other practitioner’’ as defined in section 

303(g)(2)(G)(iv) of Act (21 U.S.C. 

823(g)(2)(G)(iv)). The Secretary of 

Health and Human Services may, by 

regulation, revise the requirements for 

being a qualifying other practitioner. 

(ii) With respect to patients to whom 

the practitioner will provide such drugs 

or combinations of drugs, the individual 

practitioner has the capacity to provide 

directly, by referral, or in such other 

manner as determined by the Secretary 

of Health and Human Services: 

(A) All drugs approved by the Food 

and Drug Administration for the 

treatment of opioid use disorder, 

including for maintenance, 

detoxification, overdose reversal, and 

relapse prevention; and 

(B) Appropriate counseling and other 

appropriate ancillary services. 

(iii)(A) The total number of patients to 

whom the individual practitioner will 

provide narcotic drugs or combinations 

of narcotic drugs under this section at 

any one time will not exceed the 

applicable number. Except as provided 

in paragraphs (b)(1)(iii)(B) and (C) of 

this section, the applicable number is 

30. 

(B) The applicable number is 100 if, 

not sooner than 1 year after the date on 

which the practitioner submitted the 

initial notification, the practitioner 

submits a second notification to the 

Secretary of Health and Human Services 

of the need and intent of the practitioner 

to treat up to 100 patients. 

(C) The applicable number is 275 for 

a practitioner who has been approved 

by the Secretary of Health and Human 

Services under 42 CFR part 8 to treat up 

to 275 patients at any one time, and 

provided further that the practitioner 

has renewed such approval to the extent 

such renewal is required under this part 

of the HHS regulations. 

* * * * * 

Dated: January 18, 2018. 

Robert W. Patterson, 

Acting Administrator. 

[FR Doc. 2018–01173 Filed 1–22–18; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF THE INTERIOR 

Office of Natural Resources Revenue 

30 CFR Part 1218 

[Docket No. ONRR–2016–0003; DS63644000 

DR2PS0000.CH7000 178D0102R2] 

RIN 1012–AA22 

Repeal of Regulatory Amendment and 

Restoration of Former Regulatory 

Language Governing Service of 

Official Correspondence 

AGENCY: Office of the Secretary, Office 

of Natural Resources Revenue, Interior. 

ACTION: Final rule. 

SUMMARY: The Office of Natural 

Resources Revenue (ONRR) is 

publishing this rule to repeal a 2013 

direct final rule and restore the former 

regulatory language governing service of 

official correspondence. 

DATES: This rule is effective January 23, 

2018. 

FOR FURTHER INFORMATION CONTACT: For 

questions on procedural issues, contact 

Luis Aguilar, Regulatory Specialist, at 

(303) 231–3418 or by email to 

luis.aguilar@onrr.gov. For questions on 

technical issues, contact Bonnie Robson, 

Program Manager, Appeals & 

Regulations, by email to bonnie.robson@

onrr.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

II. Explanation of Amendments 

III. Procedural Matters 

I. Background 

ONRR’s ‘‘official correspondence’’ 

includes significant documents we send 

to industry, such as invoices, notices of 

audit, orders, and notices of 

enforcement. Historically, Department 

of the Interior (Department) regulations 

authorized ONRR to serve official 

correspondence by conventional 

means—U.S. mail, personal delivery, or 

private mailing service, such as FedEx 

or U.P.S. On August 23, 2013, ONRR 

published in the Federal Register a 

direct final rule amending its 

regulations on service of official 

correspondence (78 FR 52431). The 

2013 direct final rule augmented the 

authorized methods of service to 

include electronic service, as long as the 

electronic service was secure and 

provided for a receipt. 

The 2013 direct final rule provided 

for a 30-day public comment period. In 

the 2013 direct final rule, we stated that 

if we received significant adverse 

comment during that period, we would 

withdraw the rule. During the public 

comment period, we received 

significant adverse comments. We 

attempted to withdraw the 2013 direct 

final rule before it went into effect on 

October 22, but had insufficient time to 

do so due to the October 2013 

government shutdown. Because the rule 

should have been withdrawn, we 

consider the rule legally defective, and 

we have not enforced it. We would 

withdraw the 2013 direct final rule now, 

but the time limit for withdrawal has 

expired. Instead, we are publishing this 

rule to repeal the defective 2013 direct 

final rule and restore the former 

regulatory language governing service of 

official correspondence. 

Because this rule makes no changes to 

the legal obligations or rights of nongovernmental entities, the Department 

finds that good cause exists under 5 

U.S.C. 553(d)(3) to make this rule 

effective immediately upon publication 

in the Federal Register rather than 30 

days after publication. 

This is a final rulemaking with no 

request for comments. Under section 

553(b), ONRR generally publishes a rule 

in a proposed form and solicits public 

comment on it before issuing the final 

rule. However, section 553(b)(3)(B) 

provides an exception to the public 

comment requirement if the agency 

finds good cause to omit advance notice 

and public participation. Good cause is 

shown when public comment is 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ We find that in 

this case, because we are simply 

restoring the former noncontroversial 

regulatory language, public comment is 

unnecessary. 

II. Explanation of Amendments 

This rule repeals the direct final rule 

(78 FR 52431) and restores the former 

regulatory language governing service of 

official correspondence in sections 

1218.540(a) and (d) of title 30 of the 

Code of Federal Regulations (CFR). This 

rule removes the language that currently 

appears in section 1218.540(a) allowing 

ONRR to serve official correspondence 

using any electronic method of delivery 

that provides for a receipt of delivery, 

or, if there is no receipt, the date of 

delivery otherwise documented. This 

rule also removes mention of electronic 

service from section 1218.540(d), which 

pertains to constructive service. This 

rule does not make any substantive 

changes to the regulations or 

requirements in section 1218.540(a) or 

(d). It simply restores the original 

procedures for ONRR’s service of 

official correspondence—removing the 

amendments made in the previously 

published direct final rule. 


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