[Federal Register: May 22, 2003 (Volume 68, Number 99)]
[Rules and Regulations]
[Page 27937-27939]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my03-14]
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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: nreuter@samsha.gov.
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
[[Page 27938]]
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)
[[Page 27939]]
(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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