83 FR 3071 - Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 15 (January 23, 2018)

Page Range		3071-3075
FR Document		2018-01173

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.

Federal Register, Volume 83 Issue 15 (Tuesday, January 23, 2018)

[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Rules and Regulations]
[Pages 3071-3075]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-01173]

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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.

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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

[[Page 3072]]

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.
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\1\ The 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.
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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-and-comment 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

[[Page 3073]]

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\
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\2\ Christopher 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.
\3\ Christine Vestal, ``Few Doctors Are Willing, Able to
Prescribe Powerful Anti-Addiction Drugs,'' January 15, 2016.
\4\ The Coming Economic Bonanza In Addiction Treatment, Anson,
Pat, (May 25, 2016), https://www.painnewsnetwork.org/stories/2016/5/25/the-coming-economic-bonanza-in-addiction-treatment.
\5\ Roger 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.
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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

[[Page 3074]]

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 208 374 467 560 654
($MM)..........................
Cost of treatment ($MM)......... 133 238 298 358 417
Cost of obtaining DATA-waived 7 4 .............. .............. ..............
status ($MM)...................
Total cost ($MM)................ 140 242 298 358 417
Annual net benefit ($MM)........ 68 132 169 202 237
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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.
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\6\ See Office of Mgmt. & Budget, Exec. Office of the President,
OMB Circular A-4, Regulatory Analysis (2003).

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3% 7%
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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
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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

0
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.

0
2. In Sec. 1301.28, revise paragraphs (b)(1)(i), (ii), and (iii) to
read as follows:

Sec. 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 Sec. 1301.13
as an individual practitioner and is a ``qualifying physician'' as
defined in section 303(g)(2)(G)(ii) of the Act (21

[[Page 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

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

requirements for being a qualifying there is good cause within the meaning Management and Budget (OMB), as any
other practitioner. of the Administrative Procedure Act regulatory action that is likely to result
The CARA also makes some technical (APA) to issue these amendments as a in a rule that may: (1) Have an annual
revisions to 21 U.S.C. 823(g)(2) that do final rule without notice and comment, effect on the economy of $100 million
not materially alter the meaning of this because these amendments merely or more or adversely affect in a material
subsection. Nonetheless, because the conform the implementing regulations way the economy, a sector of the
DEA regulations currently contain the with recent amendments to the CSA economy, productivity, competition,
older statutory language, DEA is hereby contained in CARA that have already jobs, the environment, public health or
revising this part of the regulations to taken effect (see 5 U.S.C. 553(b)(B), safety, or State, local, or tribal
reflect the new statutory language. relating to notice and comment governments or communities; (2) create
HHS Final Rule Increasing the Patient procedures). ‘‘[W]hen regulations a serious inconsistency or otherwise
Limit for Purposes of 21 U.S.C. 823(g)(2) merely restate the statute they interfere with an action taken or
implement, notice-and-comment planned by another agency; (3)
Under the CSA, the Secretary of HHS procedures are unnecessary’’. Gray materially alter the budgetary impact of
may, by regulation, increase the Panthers Advocacy Committee v. entitlements, grants, user fees, or loan
maximum number of patients that a Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. programs or the rights and obligations of
practitioner may treat pursuant to 21 1991); see also Komjathy v. Nat. Trans. recipients thereof; or (4) raise novel
U.S.C. 823(g)(2). 21 U.S.C. Safety Bd., 832 F.2d 1294, 1296 (D.C. legal or policy issues arising out of legal
823(g)(2)(B)(iii)(III). On July 8, 2016, the Cir. 1987) (when a rule ‘‘does no more mandates, the President’s priorities, or
Secretary issued a final rule increasing than repeat, virtually verbatim, the the principles set forth in the Executive
this number to 275. 81 FR 44712. As statutory grant of authority’’ notice-and- Order.
stated therein, to be eligible for the comment procedures are not required). 1. The DEA expects that this final rule
patient limit of 275, the practitioner Therefore, we are issuing these will have an annual effect on the
must possess a current waiver to treat amendments as a final rule, effective economy of $100 million or more in at
up to 100 patients under 21 U.S.C. upon publication in the Federal least one year and therefore is an
823(g)(2) and meet additional criteria set Register. This rule constitutes final economically significant regulatory
forth in 42 CFR 8.610–8.625.1 DEA is action on these changes under the APA action. The analysis of benefits and
hereby amending its regulations to (5 U.S.C. 553). costs is below.
reflect these new limits. 2. This regulatory action is not likely
Regulatory Analysis to result in a rule that may create a
Good Cause for Issuing This Rule as a
Final Rule Without Notice and As explained above, DEA is obligated serious inconsistency or otherwise
Comment to issue this final rule to revise its interfere with an action taken or
regulations so that they are consistent planned by another agency. This final
As indicated, this final rule amends with the provisions of the CSA that rule amends the DEA regulations only to
the DEA regulations only to the extent were amended by the CARA and the the extent necessary to be consistent
necessary to be consistent with current HHS final rule increasing the patient with current federal law (as modified by
federal law (as modified by the CARA) limit under 21 U.S.C. 823(g)(2). In the CARA) and current federal
and current federal regulations issued issuing this final rule, DEA has not gone regulations issued by HHS. The
by HHS. The qualifying practitioner beyond the statutory text enacted by qualifying practitioner amendments in
amendments in the CARA alter the Congress or the final rule issued by the CARA alter the provisions of the
provisions of the CSA that DEA HHS. Thus, DEA would have to issue CSA that DEA previously implemented
previously implemented in its this final rule regardless of the outcome in its regulations, and DEA is therefore
regulations, and DEA is therefore of the agency’s regulatory analysis. obligated to update those regulations.
obligated to update those regulations. Nonetheless, DEA conducted this With respect to the HHS regulations, the
With respect to the HHS regulations, the analysis as discussed below. CSA gives sole authority to HHS to
CSA gives sole authority to HHS to change the maximum number of
change the maximum number of Executive Orders 12866 (Regulatory
patients per practitioner under 21 U.S.C.
patients per practitioner under 21 U.S.C. Planning and Review) and 13563,
823(g)(2), and where HHS does so, DEA
823(g)(2), and where HHS does so, DEA (Improving Regulation and Regulatory
is obligated to apply that number.
is obligated to apply that number. As a Review) 3. This regulatory action is not likely
result, DEA has no discretion not to This final rule was developed in to result in a rule that may materially
amend its regulations as is being done accordance with the principles of alter the budgetary impact of
in this final rule. Indeed, the new Executive Orders 12866 and 13563. entitlements, grants, user fees, or loan
provisions issued under this final rule Executive Order 12866 directs agencies programs or the rights and obligations of
are already in effect by virtue of the to assess all costs and benefits of recipients thereof. The Diversion
CARA and the HHS final rule regarding available regulatory alternatives and, if Control Fee Account, which the DEA
patient limits. This final rule simply regulation is necessary, to select administers and which involves
updates the DEA regulations to reflect regulatory approaches that maximize registration fees, is not directly affected.
these new provisions. Public comment net benefits (including potential This regulatory action temporarily
on these amendments to the DEA economic, environmental, public health, expanding the types of practitioners and
regulations would therefore serve no and safety effects; distributive impacts; increasing the maximum number of
purpose. Because notice and public and equity). Executive Order 13563 is patients that a practitioner may treat as
sradovich on DSK3GMQ082PROD with RULES

comment are unnecessary, DEA finds supplemental to and reaffirms the described in detail above represents a
principles, structures, and definitions minor modification to the registration
1 The HHS final rule further provides that the governing regulatory review as procedures within the Diversion Control
approval by HHS to treat up to 275 patients is for established in Executive Order 12866. Program and does not necessitate a
a term of three years and that the practitioner must
submit a renewal request with HHS every three
Executive Order 12866 classifies a change in registration fees.
years to continue to treat up to 275 patients. 42 CFR ‘‘significant regulatory action,’’ 4. This regulatory action is not likely
8.625–8.655. requiring review by the Office of to result in a rule that may raise novel

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

practitioners having the authority to $560 million, and $654 million in years million and $4 million in years 1 and 2,
dispense narcotic drug in schedule III, 1, 2, 3, 4, and 5, respectively; the total respectively; resulting in a net benefit of
IV, or V for the purpose of maintenance cost of treatment is $133 million, $238 $68 million, $132 million, $169 million,
treatment or detoxification treatment. million, $298 million, $358 million, and $202 million, and $237 million in years
The DEA estimates the total benefit $417 million in years 1, 2, 3, 4, and 5, 1, 2, 3, 4, and 5, respectively. The table
(economic burden reduction) is $208 respectively; and the total cost of below contains the summary of benefits
million, $374 million, $467 million, obtaining DATA-waived status is $7 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 Executive Order 13175, Consultation reductions. However, it will not cause a
of benefits is $2,044 million, the present and Coordination With Indian Tribal major increase in costs or prices; or
value of costs is $1,315 million and the Governments significant adverse effects on
net present value (NPV) is $729 million. This final rule does not have competition, employment, investment,
At 7% discount rate, the present value substantial direct effects on the States, productivity, innovation, or on the
of benefits is $1,796 million, the present on the relationship between the national ability of the United States-based
value of costs is $1,156 million and the government and the States, or the companies to compete with foreign
NPV is $640 million.6 The net benefits distribution of power and based companies in domestic and
in years 1 to 5 equate to an annualized responsibilities between the Federal export markets. The DEA has submitted
net benefit of $159 million at 3% and Government and Indian tribes. a copy of this final rule to both Houses
$156 million at 7% over five years. The of Congress and to the Comptroller
table below summarizes the present Executive Order 13771, Reducing General.
value and annualized benefit Regulation and Controlling Regulatory
Costs Paperwork Reduction Act of 1995
calculations.
This final rule is considered an E.O. This action does not impose a new
3% 7% 13771 deregulatory action. The rule is collection of information requirement
an enabling rule which expands the under the Paperwork Reduction Act of
Present value of benefits 1995. 44 U.S.C. 3501–3521
($MM) ................................ 2,044 1,796 options for opioid treatment. Details on
Present value of costs the expected economic effects of this List of Subjects in 21 CFR Part 1301
($MM) ................................ 1,315 1,156 rule can be found in the rule’s economic
Administrative practice and
impact analysis.
procedure, Drug traffic control, Exports,
Net present value ($MM) .. 729 640
Annualized net benefit—5
Regulatory Flexibility Act Imports, Security measures.
years ($MM) ...................... 159 156 The Regulatory Flexibility Act (RFA) For the reasons set out above, the DEA
(5 U.S.C. 601–612) applies to rules that amends 21 CFR part 1301 as follows:
Figures are rounded.
are subject to notice and comment
Executive Order 12988, Civil Justice PART 1301—REGISTRATION OF
under section 553(b) of the APA. As
Reform MANUFACTURERS, DISTRIBUTORS
explained above, the DEA determined
AND DISPENSERS OF CONTROLLED
that there was good cause to exempt this
This final rule meets the applicable SUBSTANCES
final rule from notice and comment.
standards set forth in sections 3(a) and Consequently, the RFA does not apply
3(b)(2) of Executive Order 12988, Civil ■ 1. The authority citation for 21 CFR
to this final rule. part 1301 is revised to read as follows:
Justice Reform to eliminate ambiguity,
minimize litigation, establish clear legal Unfunded Mandates Reform Act of 1995 Authority: 21 U.S.C. 821, 822, 823, 824,
standards, and reduce burden. This final rule will not result in the 831, 871(b), 875, 877, 886a, 951, 952, 956,
957, 958, 965 unless otherwise noted.
Executive Order 13132, Federalism expenditure by state, local, and tribal
governments, in the aggregate, or by the ■ 2. In § 1301.28, revise paragraphs
This rulemaking does not have private sector, of $100,000,000 or more (b)(1)(i), (ii), and (iii) to read as follows:
federalism implications warranting the (adjusted for inflation) in any one year, § 1301.28 Exemption from separate
application of Executive Order 13132. and will not significantly or uniquely registration for practitioners dispensing or
The final rule does not have substantial affect small governments. Therefore, no prescribing Schedule III, IV, or V narcotic
direct effects on the States, on the actions were deemed under the controlled drugs approved by the Food and
relationship between the national provisions of the Unfunded Mandates Drug Administration specifically for use in
government and the States, or the Reform Act of 1995, 2 U.S.C. 1532. maintenance or detoxification treatment.
sradovich on DSK3GMQ082PROD with RULES

distribution of power and * * * * *
Congressional Review Act (b)(1) * * *
responsibilities among the various
levels of government. This rule is a major rule as defined by (i) The individual practitioner is
the Congressional Review Act. 5 U.S.C. registered under § 1301.13 as an
6 See Office of Mgmt. & Budget, Exec. Office of 804. This rule will result in an annual individual practitioner and is a
the President, OMB Circular A–4, Regulatory effect on the economy of $100 million ‘‘qualifying physician’’ as defined in
Analysis (2003). or more as a result of economic burden 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 DEPARTMENT OF THE INTERIOR significant adverse comments. We
period beginning on July 22, 2016 and attempted to withdraw the 2013 direct
ending on October 1, 2021, a ‘‘qualifying Office of Natural Resources Revenue final rule before it went into effect on
other practitioner’’ as defined in section October 22, but had insufficient time to
303(g)(2)(G)(iv) of Act (21 U.S.C. 30 CFR Part 1218 do so due to the October 2013
823(g)(2)(G)(iv)). The Secretary of [Docket No. ONRR–2016–0003; DS63644000 government shutdown. Because the rule
Health and Human Services may, by DR2PS0000.CH7000 178D0102R2] should have been withdrawn, we
regulation, revise the requirements for consider the rule legally defective, and
RIN 1012–AA22 we have not enforced it. We would
being a qualifying other practitioner.
Repeal of Regulatory Amendment and withdraw the 2013 direct final rule now,
(ii) With respect to patients to whom
Restoration of Former Regulatory but the time limit for withdrawal has
the practitioner will provide such drugs expired. Instead, we are publishing this
or combinations of drugs, the individual Language Governing Service of
Official Correspondence rule to repeal the defective 2013 direct
practitioner has the capacity to provide final rule and restore the former
directly, by referral, or in such other AGENCY: Office of the Secretary, Office regulatory language governing service of
manner as determined by the Secretary of Natural Resources Revenue, Interior. official correspondence.
of Health and Human Services: ACTION: Final rule. Because this rule makes no changes to
(A) All drugs approved by the Food the legal obligations or rights of non-
and Drug Administration for the SUMMARY: The Office of Natural
Resources Revenue (ONRR) is governmental entities, the Department
treatment of opioid use disorder, finds that good cause exists under 5
publishing this rule to repeal a 2013
including for maintenance, U.S.C. 553(d)(3) to make this rule
direct final rule and restore the former
detoxification, overdose reversal, and effective immediately upon publication
regulatory language governing service of
relapse prevention; and official correspondence. in the Federal Register rather than 30
(B) Appropriate counseling and other days after publication.
DATES: This rule is effective January 23,
appropriate ancillary services. 2018. This is a final rulemaking with no
(iii)(A) The total number of patients to FOR FURTHER INFORMATION CONTACT: For request for comments. Under section
whom the individual practitioner will questions on procedural issues, contact 553(b), ONRR generally publishes a rule
provide narcotic drugs or combinations Luis Aguilar, Regulatory Specialist, at in a proposed form and solicits public
of narcotic drugs under this section at (303) 231–3418 or by email to comment on it before issuing the final
any one time will not exceed the luis.aguilar@onrr.gov. For questions on rule. However, section 553(b)(3)(B)
applicable number. Except as provided technical issues, contact Bonnie Robson, provides an exception to the public
in paragraphs (b)(1)(iii)(B) and (C) of Program Manager, Appeals & comment requirement if the agency
Regulations, by email to bonnie.robson@ finds good cause to omit advance notice
this section, the applicable number is
onrr.gov. and public participation. Good cause is
30.
shown when public comment is
(B) The applicable number is 100 if, SUPPLEMENTARY INFORMATION:
‘‘impracticable, unnecessary, or contrary
not sooner than 1 year after the date on I. Background to the public interest.’’ We find that in
which the practitioner submitted the II. Explanation of Amendments this case, because we are simply
III. Procedural Matters
initial notification, the practitioner restoring the former noncontroversial
submits a second notification to the I. Background regulatory language, public comment is
Secretary of Health and Human Services ONRR’s ‘‘official correspondence’’ unnecessary.
of the need and intent of the practitioner includes significant documents we send II. Explanation of Amendments
to treat up to 100 patients. to industry, such as invoices, notices of
(C) The applicable number is 275 for audit, orders, and notices of This rule repeals the direct final rule
a practitioner who has been approved enforcement. Historically, Department (78 FR 52431) and restores the former
by the Secretary of Health and Human of the Interior (Department) regulations regulatory language governing service of
Services under 42 CFR part 8 to treat up authorized ONRR to serve official official correspondence in sections
to 275 patients at any one time, and correspondence by conventional 1218.540(a) and (d) of title 30 of the
provided further that the practitioner means—U.S. mail, personal delivery, or Code of Federal Regulations (CFR). This
has renewed such approval to the extent private mailing service, such as FedEx rule removes the language that currently
such renewal is required under this part or U.P.S. On August 23, 2013, ONRR appears in section 1218.540(a) allowing
published in the Federal Register a ONRR to serve official correspondence
of the HHS regulations.
direct final rule amending its using any electronic method of delivery
* * * * * regulations on service of official that provides for a receipt of delivery,
Dated: January 18, 2018. correspondence (78 FR 52431). The or, if there is no receipt, the date of
Robert W. Patterson, 2013 direct final rule augmented the delivery otherwise documented. This
authorized methods of service to rule also removes mention of electronic
Acting Administrator.
include electronic service, as long as the service from section 1218.540(d), which
[FR Doc. 2018–01173 Filed 1–22–18; 8:45 am]
electronic service was secure and pertains to constructive service. This
BILLING CODE 4410–09–P rule does not make any substantive
provided for a receipt.
sradovich on DSK3GMQ082PROD with RULES

The 2013 direct final rule provided changes to the regulations or
for a 30-day public comment period. In requirements in section 1218.540(a) or
the 2013 direct final rule, we stated that (d). It simply restores the original
if we received significant adverse procedures for ONRR’s service of
comment during that period, we would official correspondence—removing the
withdraw the rule. During the public amendments made in the previously
comment period, we received published direct final rule.

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Document Created: 2018-01-23 01:08:35
Document Modified: 2018-01-23 01:08:35

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		Effective: January 22, 2018.
Contact		Michael J. Lewis, Diversion Control
FR Citation		83 FR 3071
RIN Number		1117-AB42
CFR Associated		Administrative Practice and Procedure; Drug Traffic Control; Exports; Imports and Security Measures

83 FR 3071 - Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use Disorder

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 83, Issue 15 (January 23, 2018)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration