[Federal Register Volume 68, Number 99 (Thursday, May 22, 2003)]
[Rules and Regulations]
[Pages 27937-27939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11469]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

42 CFR Part 8

RIN 0910-AA52


Opioid Drugs in Maintenance and Detoxification Treatment of 
Opiate Addiction; Addition of Buprenorphine and Buprenorphine 
Combination to List of Approved Opioid Treatment Medications

AGENCY: Substance Abuse and Mental Health Services Administration 
(SAMHSA), Department of Health and Human Services.

ACTION: Interim final rule.

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SUMMARY: This interim final rule amends the Federal opioid treatment 
program regulations by adding buprenorphine and buprenorphine 
combination products to the list of approved opioid treatment 
medications that may be used in federally certified and registered 
opioid treatment programs. The Food and Drug Administration (FDA) 
recently approved Subutex[reg] (buprenorphine) and Suboxone[reg] 
(buprenorphine in fixed combination with naloxone) for the treatment of 
opiate dependence. These two products will join methadone and 
ORLAAM[reg] as medications that may be used in opioid treatment 
programs for the maintenance and detoxification treatment of opioid 
dependence. Opioid treatment programs that choose to use these new 
products in the treatment of opioid dependence will adhere to the same 
Federal treatment standards established for methadone and ORLAAM[reg]. 
The Secretary invites public comments on this action.

DATES: This interim final rule is effective May 22, 2003. This interim 
final rule is also being presented here for public comments. Written 
comments must be received by the Substance Abuse and Mental Health 
Services Administration (SAMHSA) on or before July 21, 2003.

ADDRESSES: Comments should be submitted to the Division of 
Pharmacologic Therapy, Center for Substance Abuse Treatment, Rockwall 
II, Room 6-18, 5600 Fishers Lane, Rockville, MD, 20857; Attention: DPT 
Federal Register Representative.

FOR FURTHER INFORMATION CONTACT: Nicholas Reuter, Center for Substance 
Abuse Treatment (CSAT), Division of Pharmacologic Therapy, SAMHSA, 
Rockwall II Room 6-18, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
0457, email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    In a rule document published in the Federal Register of January 17, 
2001 (66 FR 4076, January 17, 2001), the Substance Abuse and Mental 
Health Services Administration (SAMHSA) issued final regulations for 
the use of narcotic drugs in maintenance and detoxification treatment 
of opioid addiction. That final rule established an accreditation-based 
regulatory system under 42 CFR part 8 (``Certification of Opioid 
Treatment Programs,'' ``OTPs''). The regulations also established 
(under Sec.  8.12) the Secretary's standards for the use of opioid 
medications in the treatment of addiction, including standards 
regarding the quantities of opioid drugs which may be provided for 
unsupervised use.
    Section 8.12(h) sets forth the standards for medication 
administration, dispensing and use. Under this section, OTPs shall use 
only those opioid agonist treatment medications that are approved by 
the Food and Drug Administration under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment of 
opioid addiction. The regulation listed methadone and levomethadyl 
acetate (ORLAAM[reg]) as the opioid agonist treatment medications 
considered to be approved by the FDA for use in the treatment of opioid 
addiction.
    On October 8, 2002, FDA approved two new opioid treatment 
medications, buprenorphine and buprenorphine combination for the 
treatment of opioid addiction. These medications are controlled under 
schedule III of the Controlled Substances Act (``CSA,'' 21 U.S.C. 812). 
See final rule published October 7, 2002 (67 FR 62354). By adding these 
two medications to the previous list of approved opioid treatment 
medications, the Secretary allows OTPs to use buprenorphine and 
buprenorphine combination for the treatment of opioid addiction. OTPs 
will apply the same treatment standards that were finalized on January 
17, 2001, for methadone and ORLAAM[reg].

Summary of Regulation

    The opioid treatment program regulations (42 CFR part 8) establish 
the procedures by which the Secretary will determine whether a 
practitioner is qualified under section 303(g) of the CSA (21 U.S.C. 
823(g) (1)) to dispense certain therapeutic narcotic drugs in the 
treatment of individuals suffering from narcotic addiction. These 
regulations

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also establish the Secretary's standards regarding the appropriate 
quantities of narcotic drugs that may be provided for unsupervised use 
by individuals undergoing such treatment (21 U.S.C. 823(g) (3)). (See 
also 42 U.S.C. 257a.)
    This interim final rule does not change any of the provisions in 
subpart A (Accreditation) or subpart C (Procedures for Review of 
Suspension or Proposed Revocation of OTP Certification, and of Adverse 
Action Regarding Withdrawal of Approval of an Accreditation Body). 
Instead, the rule provides for a minor amendment to subpart B, 
Certification and Treatment Standards. The rule amends only one section 
of subpart B, section 8.12(h)(2) Medication administration, dispensing, 
and use.
    Under 42 CFR 8.12(h)(2), OTPs are limited to using only those 
opioid agonist treatment medications that are approved by the Food and 
Drug Administration under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355). This section notes that ``currently the 
following medications will be considered to be approved by the Food and 
Drug Administration for use in the treatment opioid addiction: (i) 
Methadone; and (ii) levomethadyl acetate (LAAM).'' The effect of this 
rule is to add buprenorphine and buprenorphine combination to this list 
by adding a new item (iii).

Justification for Interim Final Rule

    The Administrative Procedure Act (5 U.S.C. 553) requires agencies 
to follow certain procedures for informal rulemaking, including 
publication of proposed rules in the Federal Register with an 
opportunity for public comment. Section 553(b)(B) allows agencies to 
dispense with prior notice and opportunity for public comment if the 
agency finds for good cause that use of such procedures is 
impracticable, unnecessary, or contrary to the public interest. Section 
553(d)(3) permits the Secretary to waive the 30 day effective date if 
it is contrary to the public interest.
    The Secretary has determined that good cause exists for publication 
of this rule without prior notice and opportunity for public comment 
and without a delayed effective date since such procedures are contrary 
to the public interest and unnecessary. It is contrary to the public 
interest to deny OTPs' access to this important new medication for the 
treatment of persons addicted to opioids. As compared to methadone and 
ORLAAM [reg], buprenorphine and buprenorphine combination are 
particularly useful in treating patients who have had a shorter course 
of addiction. Similarly, it would be contrary to the public interest to 
deny patients access to such prescription drugs from OTPs particularly 
in areas in which there are no physicians who have obtained a waiver 
under the Drug Addiction Treatment Act of 2000 (``DATA,'' section 3502 
of Pub. L. 106-310).
    To further elaborate, while OTPs may continue to use methadone and 
ORLAAM [reg] for medicated assisted treatment, buprenorphine and 
buprenorphine combinations will provide OTPs with an important 
additional option for the treatment of addiction. Indeed, because of 
its ``partial'' agonist pharmacology, buprenorphine will provide 
programs with more flexibility in finding the most appropriate 
medication for each patient. It would thus be contrary to the public 
interest to delay the availability of buprenorphine products.
    In addition to the public interest in having buprenorphine and 
buprenorphine combination products available for treatment use as soon 
as possible, prior notice and comment procedures are unnecessary. 
Currently, the rule states: ``OTPs shall use only those opioid agonist 
treatment medications that are approved by the Food and Drug 
Administration * * * for use in the treatment of opioid addiction * * 
*. Currently the following opioid agonist treatment medications will be 
considered to be approved by the Food and Drug Administation for use in 
the treatment of opioid addiction: (i) Methadone; and (ii) Levomethadyl 
acetate (LAAM).'' Because the buprenorphine products have been approved 
by the FDA as required by section 8.12(h)(2), the proposed modification 
is technical in nature in that it simply adds buprenorphine and 
buprenorphine combination to the list of FDA-approved medications that 
may be used by OTPs. Thus, comment is not necessary before finalizing 
this change to the regulation.
    Although we are making the rule effective immediately without first 
obtaining public comment, we are providing for a 60-day comment period 
after publication. Specifically, we seek comments on the applicability 
of the existing OTP rules to these newly approved medications.

Analysis of Economic Impacts

    The Secretary has examined the impact of this interim final rule 
under Executive Order 12866. Executive Order 12866 directs Federal 
agencies to assess all costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health and safety, and other advantages, 
distributive impacts, and equity). This interim final rule does not 
establish additional regulatory requirements, it allows an activity 
that is otherwise prohibited. According to Executive Order 12866, a 
regulatory action is ``significant'' if it meets any one of a number of 
specified conditions, including having an annual effect on the economy 
of $100 million; adversely affecting in a material way a sector of the 
economy, competition, or jobs; or if it raises novel legal or policy 
issues. A detailed discussion of the Secretary's analysis is contained 
in the recent opioid treatment final rule published in the Federal 
Register of January 17, 2001 (66 FR 4086-4090). That notice described 
the impact of the opioid treatment regulations, analyzed alternatives, 
and considered comments from small entities.
    The Secretary also finds that this rule is a not a significant 
regulatory action as defined by Executive Order 12866. The rule merely 
adds buprenorphine and buprenorphine combination products to the list 
of medications that may be used in the detoxification or maintenance 
treatment of opioid dependence. If opioid treatment programs choose to 
use the new medications, the new medications will be used in accordance 
with the standards set forth in the January 17, 2001, final rule (66 FR 
4090). No new regulatory requirements are imposed by this interim final 
rule.
    For the reasons outlined above, the Secretary has determined that 
this interim final rule will not have a significant impact upon a 
substantial number of small entities within the meaning of the 
Regulatory Flexibility Act (5 U.S.C. 605(b)). Therefore an initial 
regulatory flexibility analysis is not required for this interim final 
rule.
    The Secretary has determined that this rule is not a major rule for 
the purpose of congressional review. For the purpose of congressional 
review, a major rule is one which is likely to cause an annual effect 
on the economy of $100 million; a major increase in costs or prices; 
significant effects on competition, employment, productivity, or 
innovation; or significant effects on the ability of U.S.-based 
enterprises to compete with foreign-based enterprises in domestic or 
export markets. This is not a major rule under the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA).
    The Secretary has examined the impact of this rule under the 
Unfunded Mandates Reform Act of 1995 (UMRA)

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(Pub. L. 104-4). This rule does not trigger the requirement for a 
written statement under section 202(a) of the UMRA because it does not 
impose a mandate that results in an expenditure of $100 million 
(adjusted annually for inflation) or more by State, local, and tribal 
governments in the aggregate, or by the private sector, in any one 
year.

Environmental Impact

    The Secretary has previously considered the environmental effects 
of this rule as announced in the final rule (66 FR 4076 at 4088). No 
new information or comments have been received that would affect the 
agency's previous determination that there is no significant impact on 
the human environment and that neither an environmental assessment nor 
an environmental impact statement is required.

Executive Order 13132: Federalism

    The Secretary has analyzed this interim final rule in accordance 
with Executive Order 13132: Federalism. Executive Order 13132 requires 
Federal agencies to carefully examine actions to determine if they 
contain policies that have federalism implications or that preempt 
State law. As defined in the Order, ``policies that have federalism 
implications'' refer to regulations, legislative comments or proposed 
legislation, and other policy statements or actions that have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government.
    The Secretary is publishing this interim final rule to modify 
minimally treatment regulations that provide for the use of approved 
opioid agonist treatment medications in the treatment of opiate 
addiction. The Narcotic Addict Treatment Act (the NATA, Pub. L. 93-281) 
modified the Controlled Substances Act (CSA) to establish the basis for 
the Federal control of narcotic addiction treatment by the Attorney 
General and the Secretary. Because enforcement of these sections of the 
CSA is a Federal responsibility, there should be little, if any, impact 
from this rule on the distribution of power and responsibilities among 
the various levels of government. In addition, this interim final rule 
does not preempt State law. Accordingly, the Secretary has determined 
that this interim final rule does not contain policies that have 
federalism implications or that preempt State law.

Paperwork Reduction Act of 1995

    This interim final rule adds buprenorphine and buprenorphine 
combination products to the list of approved medications that may be 
used in SAMHSA-certified opioid treatment programs. The interim final 
rule establishes no new reporting or recordkeeping requirements beyond 
those discussed in the January 17, 2001, final rule (66 FR 4076 at 
4088). The Office of Management and Budget has approved the information 
collection requirements of the final rule under control number 0930-
0206.

Executive Order 13175: Consultation and Coordination With Indian Tribal 
Governments

    Executive Order 13175 (65 FR 67249, November 6, 2000) requires us 
to develop an accountable process to ensure ``meaningful and timely 
input by tribal officials in the development of regulatory policies 
that have tribal implications.'' ``Policies that have tribal 
implications'' defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.''
    This interim final rule does not have tribal implications. It will 
not have substantial direct effects on tribal governments, on the 
relationship between the Federal government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175.

    Dated: May 5, 2003.
Tommy G. Thompson,
Department of Health and Human Services.

List of Subjects in 42 CFR Part 8

    Health professions, Levo-Alpha-Acetyl-Methadol (LAAM), Methadone, 
Reporting and recordkeeping requirements.

0
For the reasons set forth above, part 8 of title 42 of the Code of 
Federal Regulations is amended as follows:

PART 8--CERTIFICATION OF OPIOID TREATMENT PROGRAMS

0
1. The authority citation for part 8 continues to read as follows:

    Authority: 21 U.S.C. 823; Sections 301(d), 543, and 1976 of the 
42 U.S.C. 257a, 290aa(d), 290 dd-2, 300x-23, 300x-27(a), 300y-ll.


0
2. Section 8.12(h) (2) is revised to read as follows:


Sec.  8.12  Federal opioid treatment standards.

* * * * *
    (h)* * *
    (2) OTPs shall use only those opioid agonist treatment medications 
that are approved by the Food and Drug Administration under section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in 
the treatment of opioid addiction. In addition, OTPs who are fully 
compliant with the protocol of an investigational use of a drug and 
other conditions set forth in the application may administer a drug 
that has been authorized by the Food and Drug Administration under an 
investigational new drug application under section 505(i) of the 
Federal Food, Drug, and Cosmetic Act for investigational use in the 
treatment of opioid addiction. Currently the following opioid agonist 
treatment medications will be considered to be approved by the Food and 
Drug Administration for use in the treatment of opioid addiction:
    (i) Methadone;
    (ii) Levomethadyl acetate (LAAM); and
    (iii) Buprenorphine and buprenorphine combination products that 
have been approved for use in the treatment of opioid addiction.
* * * * *

[FR Doc. 03-11469 Filed 5-21-03; 8:45 am]
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