[Federal Register: January 17, 2001 (Volume 66, Number 11)]
[Rules and Regulations]               
[Page 4075-4102]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17ja01-9]                         


[[Page 4075]]

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Part II





Department of Health and Human Services





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Substance Abuse and Mental Health Services Administration



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21 CFR Part 291

42 CFR Part 8



Opioid Drugs in Maintenance and Detoxification Treatment of Opiate 
Addiction; Final Rule


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Service Administration

21 CFR Part 291

42 CFR Part 8

[Docket No. 98N-0617]
RIN 0910-AA52

 
Opioid Drugs in Maintenance and Detoxification Treatment of 
Opiate Addiction;

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Department of Health and Human Services and the Substance 
Abuse and Mental Health Services Administration (SAMHSA) are issuing 
final regulations for the use of narcotic drugs in maintenance and 
detoxification treatment of opioid addiction. This final rule repeals 
the existing narcotic treatment regulations enforced by the Food and 
Drug Administration (FDA), and creates a new regulatory system based on 
an accreditation model. In addition, this final rule shifts 
administrative responsibility and oversight from FDA to SAMHSA. This 
rulemaking initiative follows a study by the Institute of Medicine 
(IOM) and reflects recommendations by the IOM and several other 
entities to improve opioid addiction treatment by allowing for 
increased medical judgment in treatment.

DATES: This final rule will become effective on March 19, 2001.

FOR FURTHER INFORMATION CONTACT: Nicholas Reuter, Center for Substance 
Abuse Treatment (CSAT), SAMHSA, Rockwall II, 5600 Fishers Lane, Rm 12-
05, Rockville, MD 20857, 301-443-0457, email: nreuter@samhsa.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 22, 1999, (64 FR 39810, July 22, 
1999, hereinafter referred to as the July 22, 1999, notice or July 22, 
1999, proposal) SAMHSA, FDA, and the Secretary, Health and Human 
Services (HHS), jointly published a Notice of Proposed Rulemaking 
(NPRM) to revise the conditions for the use of narcotic drugs in 
maintenance and detoxification treatment of opioid addiction. The 
agencies also proposed the repeal of the existing narcotic treatment 
regulations enforced by the FDA, the creation of a new regulatory 
system based on an accreditation model under new 42 CFR part 8, and a 
shift in administrative responsibility and oversight from FDA to 
SAMHSA.
    The July 22, 1999, notice traced the history of Federal regulatory 
oversight of Opioid Treatment Programs (``OTPs,'' also known as 
narcotic treatment programs, or, methadone programs), focusing on 
Federal regulations enforced by FDA since 1972. The July 22, 1999, 
notice summarized the periodic reviews, studies, and reports on the 
Federal oversight system, culminating with the 1995 Institute of 
Medicine (IOM) Report entitled, Federal Regulation of Methadone 
Treatment (Ref. 1). As noted in the July 22, 1999, proposal, the IOM 
report recommended that the existing FDA process-oriented regulations 
should be reduced in scope to allow more clinical judgment in treatment 
and greater reliance on guidelines. The IOM report also recommended 
designing a single inspection format, having multiple elements, that 
would (1) provide for consolidated, comprehensive inspections conducted 
by one agency (under a delegation of Federal authority, if necessary), 
which serves all agencies (Federal, State, local) and (2) improve the 
efficiency of the provision of methadone services by reducing the 
number of inspections and consolidating their purposes.
    To address these recommendations, SAMHSA proposed a 
``certification'' system, with certification based on accreditation. 
Under the system, as set forth in the July 22, 1999, proposal, a 
practitioner who intends to dispense opioid agonist medications in the 
treatment of opiate addiction must first obtain from SAMHSA, a 
certification that the practitioner is qualified under the Secretary's 
standards and will comply with such standards. Eligibility for 
certification will depend upon the practitioner obtaining accreditation 
from a private nonprofit entity, or from a State agency, that has been 
approved by SAMHSA to accredit OTPs. Accreditation bodies would base 
accreditation decisions on a review of an application for accreditation 
and on surveys (on site inspections) conducted every three years by 
addiction treatment experts. In addition, accreditation bodies will 
apply specific opioid treatment accreditation elements that reflect 
``state-of-the-art'' opioid treatment guidelines. Moreover, 
accreditation standards will require that OTPs have quality assurance 
systems that consider patient outcomes.
    As noted in the July 22, 1999, proposal, this new system would 
replace the existing FDA regulatory system. The existing system 
provides for FDA ``approval'' of programs, with direct government 
inspection in accordance with more detailed process-oriented 
regulations. These process-oriented regulations are less flexible and 
prescribe many aspects of treatment. The existing regulations do not 
require that programs have quality assurance systems. Finally, under 
the existing system, programs are not subject to periodic certification 
and there is no set schedule for inspections.
    Proposed Subpart A addressed accreditation and included steps that 
accreditation bodies will follow to achieve approval to accredit OTPs 
under the new system. It also set forth the accreditation bodies' 
responsibilities, including the use of accreditation elements during 
accreditation surveys. Proposed Subpart B established the sequence and 
requirements for obtaining certification. This section addressed how 
and when programs must apply for initial certification and renewal of 
their certification. Finally, Subpart C of proposed part 8 established 
the procedures for review of the withdrawal of approval of the 
accreditation body or the suspension and proposed revocation of an OTP 
certification.
    In addition to proposing an entirely new oversight system, the July 
22, 1999, proposal included several other new provisions. For example, 
the Federal opioid treatment standards were significantly reduced in 
scope to allow more flexibility and greater medical judgment in 
treatment. Certain restrictions on dosage forms were eliminated so that 
OTPs may now use solid dosage forms. Under the previous rules, OTPs 
were limited to the use of liquid dosage forms. Several reporting 
requirements and reporting forms were eliminated, including the 
requirements for physician notifications (FDA Reporting Form 2633) and 
the requirement that programs obtain FDA approval prior to dosing a 
patient above 100 milligrams. The proposal included a more flexible 
schedule for medications dispensed to patients for unsupervised use, 
including provisions that permit up to a 31-day supply. Under the 
current regulations, patients are limited to a maximum 6-day supply of 
medication. Many of these regulatory requirements had been in place 
essentially unchanged for almost 30 years.
    SAMHSA distributed the July 22, 1999, notice to each OTP listed in 
the current FDA inventory, each State Methadone Authority, and to other 
interested parties. Interested parties were given 120 days, until 
November 19, 1999, to comment on the July 22,

[[Page 4077]]

1999, proposal. In addition, on November 1, 1999, SAMHSA, FDA, the 
Office of National Drug Control Policy (ONDCP), the Drug Enforcement 
Administration (DEA), and other Federal agencies convened a Public 
Hearing on the proposal. The Public Hearing was announced in the 
Federal Register published October 19, 1999, (64 FR 59624, October 19, 
1999), and was held in Rockville, MD. On January 31 and May 10, 2000, 
the SAMHSA/CSAT National Advisory Council Subcommittee on Accreditation 
met to assist SAMHSA/CSAT in its review of data and information from 
SAMHSA/CSAT's ongoing accreditation project. The SAMHSA/CSAT National 
Advisory Council convened to discuss the opioid accreditation project 
on May 12, 2000. The May 12, 2000, Council meeting provided an 
opportunity for comments from the public (65 FR 25352, May 1, 2000).

II. Comments and Agency Response

    In response to the July 22, 1999, proposal, SAMHSA received almost 
200 submissions, each containing one or more comments. The comments 
were from government, industry, industry trade associations, academia, 
health professionals, professional organizations, patient advocacy 
organizations, and individual patients.

A. General Comments

    1. Many comments agreed in principle that the shift to an 
accreditation-based system will encourage OTPs to use individualized, 
clinically determined treatment plans that are guided by current, best-
practice medical and clinical guidelines and to evaluate clinical 
outcomes. Other comments noted that the accreditation proposal 
recognizes that opiate addiction is a medical condition. Several 
comments affirmed that a major segment of the healthcare system in the 
United States is being reviewed through accreditation systems. As such, 
these comments stated that applying accreditation requirements to OTPs 
provides the potential for mainstream medicine to embrace opioid 
treatment.
    While not opposing the proposal, some comments stated there should 
be no Federal regulations in this area. Other comments expressed 
concerns about additional costs to OTPs and, ultimately patients, for 
accreditation and duplicative assessments, noting that some States will 
continue to enforce process-oriented regulations, supported by 
considerable licensing fees. Based upon these ``uncertainties,'' these 
comments suggest that SAMHSA wait for the results of further study 
before implementing new regulations.
    The Secretary agrees that the SAMHSA-administered accreditation-
based regulatory system will encourage the use of best-practice 
clinical guidelines and require quality improvement standards with 
outcome assessments. As set forth below, the Secretary does not agree 
that comments on the uncertainty about accreditation costs or State 
regulatory activities warrant additional study before implementing 
these new rules.
    2. Several comments addressed the costs associated with 
accreditation and challenged the estimates provided in the July 22, 
1999, proposed rule. One comment included the results from a survey of 
OTPs with accreditation experience to indicate the indirect costs of 
accreditation will be considerable. According to the comment, these 
OTPs have had to spend considerable sums to hire consultants and 
additional staff, upgrade computers, develop infection control manuals, 
and make physical plant improvements. In some cases these costs were 
reported to approach $50,000. Some of these comments suggested that 
SAMHSA await the completion of the ``accreditation impact study'' to 
obtain additional information on costs, before proceeding. Other 
comments stated that accreditation can lead to increased treatment 
capacity, but only if additional funds are provided. One comment 
suggested that SAMHSA create a capital improvement fund, while another 
suggested that SAMHSA allow block grant funds to be used to pay for 
accreditation.
    The Secretary believes that the estimated costs as set forth in the 
July 22, 1999, notice remain reasonably accurate. As discussed in 
greater detail below, information on accreditation developed under the 
accreditation impact study, together with other ongoing SAMHSA 
technical assistance programs, indicates that the accreditation system 
will not produce an excessive burden to programs to warrant delaying 
the implementation of this final rule.
    There are many components to SAMHSA's accreditation project that 
have been proceeding concurrently with this rulemaking. In April 1999, 
SAMSHA's Center for Substance Abuse Treatment (CSAT) issued 
``Guidelines for the Accreditation of Opioid Treatment Programs.'' 
These guidelines are up-to-date best-practice guidelines that are based 
upon the Federal opioid treatment standards set forth under proposed 
section 8.12 as well as SAMHSA/CSAT's Treatment Improvement Protocols 
(TIPs) that address opiate addiction treatment. Two accreditation 
bodies, the Commission for the Accreditation of Rehabilitation 
Facilities (CARF) and the Joint Commission for the Accreditation of 
Healthcare Organizations (JCAHO), under contract to SAMHSA/CSAT, used 
these guidelines to develop ``state-of-the-art'' accreditation 
elements. These two accreditation bodies have surveyed dozens of 
programs with these new accreditation standards.
    The July 22, 1999, proposal described an ongoing accreditation 
impact study. Under the accreditation impact study, CARF and JCAHO 
trained over 170 participating OTPs. In addition, more than 50 OTPs 
have been accredited under this system with technical assistance 
provided through a contract funded by SAMHSA/CSAT. None of the 
accredited programs have had to incur the kind of ``physical plant'' 
and other costly expenses predicted by some of the comments previously 
discussed. This direct and up-to-date information indicates that the 
cost estimates in the July 22, 1999, notice are up-to-date and 
reasonable. On the other hand, the survey discussed above that was 
submitted with one comment reflected accreditation surveys performed 
over 10 years ago. And, in some cases, the accreditation experiences 
discussed in these comments reflect accreditation of psychiatric 
hospitals, not OTPs.
    The accreditation-based system which is the subject of this rule 
includes safeguards to reduce the risk of unnecessary and overly 
burdensome accreditation activities relating to OTPs. For example, 
SAMHSA will approve each accreditation body after reviewing its 
accreditation elements, accreditation procedures, and other pertinent 
information. SAMHSA will convene periodically an accreditation 
subcommittee, as part of the SAMHSA/CSAT National Advisory Council. The 
subcommittee will review accreditation activities and accreditation 
outcomes and make recommendations to the full SAMHSA/CSAT Council, and 
ultimately to SAMHSA on accreditation activities and guidelines. 
Finally, SAMHSA/CSAT has been providing technical assistance to OTPs in 
the accreditation impact study that has helped programs in achieving 
accreditation. SAMHSA/CSAT intends to continue providing technical 
assistance on accreditation during the 3-5 year transition period and 
possibly longer.
    The Secretary does not agree that it is necessary to establish a 
special fund to help programs pay for accreditation fees and indirect 
``physical plant'' improvements in order for OTPs to be

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able to achieve accreditation. As noted above, the Secretary believes 
that the estimates in the July 22, 1999, proposal for the cost of 
accreditation are reasonably accurate (approximately $4-5 million per 
year, $5400 per OTP per year, $39 per patient per year). Nonetheless, 
the Secretary has taken steps to minimize the potential effects of this 
burden to OTPs, especially to OTPs that are small businesses or that 
operate in under-served communities. First, the Secretary has 
determined that States could use funds provided by SAMHSA under their 
Substance Abuse Prevention and Treatment (SAPT) Block Grants to offset 
costs of accreditation for programs qualified to receive assistance 
under the State's SAPT block grant. Second, SAMSHA has included in its 
budget, a plan to continue funding accreditation. Finally, SAMHSA will 
continue to provide technical assistance which will aid those programs 
that need help in achieving accreditation.
    3. One OTP that is participating in the accreditation impact study, 
while commending the accreditation experience and accreditation in 
general, commented that the proposed change is premature. Some comments 
suggested that SAMHSA postpone implementation for an indefinite period 
to allow for an unspecified number of CARF and JCAHO accreditation 
results. Another comment stated that the first series of surveys will 
determine the utility of the first generation of standards, noting that 
the process can be focused and modified in response to results from the 
impact study. A few comments questioned whether all providers can make 
the transition.
    On the other hand, many comments stated that the field has been 
subject to regulatory neglect long enough, and that SAMHSA should 
minimize the delay in finalizing rules. One comment submitted the 
results of a survey that suggested that as many as 155 OTPs currently 
need technical assistance in order to provide treatment in accordance 
with standards and regulations.
    The Secretary does not believe that these final regulations should 
be delayed until the completion of the accreditation impact study. As 
stated in the July 22, 1999, proposal, the Department of Health and 
Human Services (HHS) has determined that accreditation is a valid and 
reliable system for providing external monitoring of the quality of 
health care--including substance abuse and methadone treatment. The 
SAMHSA/CSAT study is designed to provide additional information on the 
processes, barriers, administrative outcomes, and costs associated with 
an accreditation-based system. In addition, the study is expected to 
provide important information to allow SAMHSA to keep its guidelines, 
and its accreditation program, as responsive and up-to-date as 
possible. Among other things, the study will allow HHS to continuously 
monitor the monetary costs of accreditation, to ensure that successful 
OTPs are not precluded from operating by the costs of accreditation, 
and that patients are not denied treatment based on costs. The full 
study, which compares a representative sample of OTPs 6 months 
following accreditation to their baseline status across several 
variables, will require a few years to complete. Regulations can be 
modified at any time. If SAMHSA believes that the results of the study 
merit changes in the regulations, then such changes will be the subject 
of a future rulemaking.
    The Secretary has reviewed preliminary results from the 
accreditation study by two accreditation bodies, CARF and JCAHO, of 
almost 10 percent (approximately 80 OTPs) of the entire inventory of 
approved outpatient OTPs. Well over 90 percent of the OTPs surveyed 
achieved accreditation under the ``methadone specific'' accreditation 
standards. Only a very few programs required a follow-up survey to 
achieve accreditation. And, to date, only one OTP failed to achieve 
accreditation. These accreditation outcome results are comparable to 
the historical compliance rate under the previous FDA process-oriented 
regulatory system. In addition, these rates correspond to the assumed 
accreditation resurvey rate stated in the July 22, 1999, proposal for 
estimating the indirect costs of accreditation.
    These accreditation outcome results have been analyzed and 
presented to SAMHSA/CSAT's National Advisory Council's Accreditation 
Subcommittee (NACAS). As discussed in the July 22, 1999, proposal, 
SAMHSA/CSAT augmented NACAS with consultants representing OTPs (both 
large and small programs), medical and other substance abuse 
professionals, patients, and State officials. The subcommittee has met 
twice, on January 31 and May 10, 2000, and the public was provided an 
opportunity to participate in this advisory process. On May 12, 2000, 
the SAMHSA/CSAT National Advisory Council urged SAMHSA/CSAT to move 
expeditiously to finalize the July 22, 1999, proposal.
    The Secretary believes that the interim results from the 
accreditation impact study confirm that the accreditation guidelines, 
along with the accreditation process itself, are a valid and reliable 
method for monitoring the quality of care provided by OTPs. The results 
indicate that most OTPs can achieve accreditation and that treatment 
capacity has not declined as a result. While SAMHSA intends to continue 
the study to fulfill its objectives, the Secretary does not believe 
that it is appropriate or necessary to delay implementation of these 
new rules until the full study is complete.
    4. Many comments, especially from current and past OTP patients, 
questioned the impact of revised Federal regulations in light of State 
regulations. These comments contend that State regulations are much 
more restrictive on medical and clinical practices than Federal 
regulations, and that State regulatory authorities have expressed 
little or no interest in changing their regulations or the way State 
regulations are enforced. Comments from OTP sponsors stated that 
accreditation costs would add to State licensing fees, which, in some 
States, exceed several thousand dollars annually.
    The Secretary shares the concerns expressed in these comments about 
State regulations and licensing requirements. Indeed, the July 22, 
1999, proposal discussed State licensure and regulatory issues. The 
proposal also noted that there was considerable variation in the nature 
and extent of oversight at the State level. Some States have 
regulations and enforcement programs that exceed Federal regulations. 
Others have relied exclusively upon FDA and DEA regulatory oversight. 
An increasing number of States rely on accreditation, by nationally 
recognized accreditation bodies, for all or part of their healthcare 
licensing functions.
    The Secretary believes that SAMHSA's ongoing coordination 
activities with States will minimize the impact of Federal-State 
regulatory disparities upon OTPs. One objective of these activities is 
to increase State authorities' acceptance of the new accreditation-
based system. First, SAMHSA/CSAT's OTP accreditation guidelines were 
developed by a consensus process that included representation from 
State Methadone Authorities. In addition, some State officials have 
accompanied CARF and JCAHO accreditation survey teams to observe site 
visits. Finally, SAMHSA/CSAT has distributed information on 
accreditation to each State. This information includes the SAMHSA/CSAT 
OTP accreditation guidelines, the CARF OTP accreditation standards and 
the JCAHO OTP accreditation standards. SAMHSA/CSAT convened three 
national meetings of State officials

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between 1997 and 2000 and intends to continue coordinating activities 
with State authorities and national organizations such as the National 
Association of State Alcohol and Drug Abuse Directors (NASADAD).
    This final rule includes provisions that would permit any State to 
apply for approval as an accreditation body and, if approved, accredit 
OTPs under the new Federal opioid treatment standards. Based on the 
above, the Secretary expects that many states will consider OTP 
accreditation and Federal certification requirements as sufficient to 
fulfill all or a substantial part of their licensing requirements. 
Taken together, the Secretary believes that these measures will 
minimize significantly the existing disparity between Federal and State 
regulation of OTPs.
    5. Office-Based Treatment. The July 22, 1999, proposal discussed 
the concept of ``office-based opioid treatment'' and specifically 
solicited comments on how the Federal opioid treatment standards might 
be modified to accommodate office-based treatment and on whether a 
separate set of Federal opioid treatment standards should be included 
in this rule for office-based treatment.
    The Secretary received many diverse comments on the office-based 
treatment issue. Several comments from patients and individual 
physicians believed that office-based treatment provided an excellent 
opportunity to expand opioid agonist treatment. These comments 
reference opioid treatment delivery systems in other countries and 
suggest that the U.S. should adopt similar systems. A few comments 
recommended that community pharmacies be encouraged to dispense 
methadone and LAAM as ``medication units'' as a way to make treatment 
more convenient for patients.
    While many comments suggested separate standards for office-based 
treatment, others feared that different standards would result in a 
two-tiered system of treatment. Overall many comments stated that 
existing and proposed rules do not facilitate the development of the 
office-based practice model. As such, accreditation and certification 
would be prohibitively expensive for individual physicians.
    On the other hand, many comments expressed concerns with the 
concept of ``office-based'' treatment and prescribing methadone and 
LAAM. Many of these comments reflected concern about the lack of 
trained and experienced practitioners. One comment referenced 
literature reports that described experiences in Australia and the 
United Kingdom with deaths from iatrogenic methadone toxicity 
associated with patients early in treatment. The experiences in these 
two countries were associated with an accelerated rate of patient 
admissions and the involvement of new, inexperienced practitioners. One 
comment cited research on methadone medical maintenance that indicated 
that approximately 15 percent of the patients treated in physicians 
offices were referred back to OTPs after ``relapsing'' to illicit 
opiate use.
    Generally, most comments on this issue stated that there was not 
enough information on office-based practice. These comments suggest 
that based on the available information, office-based treatment 
warrants a gradual, step-wise approach, along with more use of 
medication units. This approach would serve to ``diffuse opioid agonist 
maintenance treatment into traditional settings.''
    After carefully considering the diverse comments, as well as other 
legal and regulatory factors, the Secretary is not including in this 
rule specific standards that would permit physicians to prescribe 
methadone and LAAM in office-based settings without an affiliation with 
an OTP. Instead, until additional information is generated, the 
Secretary is announcing administrative measures to facilitate the 
treatment of patients under a ``medical maintenance'' model.
    Current regulations enforced by DEA do not permit registrants to 
prescribe narcotic drugs, including opioid agonist medications such as 
methadone and LAAM for the treatment of narcotic addiction (see 21 CFR 
1306.07(a)). In addition, the Secretary agrees that, at the present 
time, there should be some linkage between OTPs and physicians who 
treat stable patients with methadone and LAAM in their offices to 
address patients' psychosocial needs in the event of relapse. The 
Secretary agrees with the comments about the lack of trained and 
experienced practitioners to diagnose, admit, and treat opiate addicts 
who are not sufficiently stabilized, without the support of an OTP.
    The Secretary has taken steps to facilitate ``medical 
maintenance,'' that will result in more patients receiving treatment 
with methadone and LAAM in an office-based setting. Medical maintenance 
refers to the treatment of stabilized patients with increased amounts 
of take-home medication for unsupervised use and fewer clinic visits 
for counseling or other services. First, the ``take home'' provisions 
in these rules have been revised from the previous regulations under 21 
CFR Sec. 291.505 to permit stabilized patients up to a one-month supply 
of treatment medication. In addition, SAMHSA/CSAT has developed 
treatment guidelines and training curricula for practitioners to 
increase the information and education for practitioners in this area. 
Finally, SAMHSA/CSAT has issued announcements to the field explaining 
how patients and treatment programs can obtain authorizations for 
medical maintenance. These authorizations were developed to address 
program-wide exemptions under 21 CFR 291.505; however, SAMHSA/CSAT 
envisions a similar approach will be used under the program-wide 
exemption provisions of 42 CFR 8.11(h).
    Under the medical maintenance model, office-based physicians 
maintain formal arrangements with established OTPs. Typically, patients 
who have been determined by a physician to be stabilized in treatment 
may be referred to office-based physicians. It has been estimated that 
over 12,000 current patients would be eligible for medical maintenance 
treatment. The Secretary believes that this is a reasonable approach 
that will expand treatment capacity gradually while additional 
information and experience is developed to evaluate and refine office-
based treatment models.

B. Comments on Subpart A--Definitions and Accreditation

    Proposed subpart A sets forth definitions as well as procedures, 
criteria, responsibilities and requirements relating to accreditation.
    1. A comment from a State authority suggested that the treatment 
plan definition under Sec. 8.2 should be modified to require a 
reference to the services determined necessary to meet the goals 
identified in the plan. The Secretary agrees with this suggestion and 
has revised the treatment plan definition accordingly.
    2. One comment suggested that the proposed definition of 
detoxification treatment specifies agonist and therefore precludes the 
use of mixed agonist or agonists in combination with other drugs. The 
Secretary has announced plans to develop new rules specifically for 
partial agonist medications for the treatment of opiate addiction (See 
65 FR 25894, May 4, 2000). Therefore, use of the term ``agonist'' is 
appropriate in this context.
    The use of ``other drugs'' (interpreted to mean non-narcotic 
substances) in combination with methadone and LAAM are not subject to 
the regulatory requirements of this rule.

[[Page 4080]]

    3. Several comments were submitted on the proposed definition of 
opiate addiction. Some comments suggested that the definition should be 
revised to remove behavior-oriented concepts and rely on medical 
constructs only. One comment suggested substituting the definition of 
opiate addiction contained in the recent NIH consensus panel report. 
The Secretary concurs, and has revised the definition of opiate 
addiction to be more consistent with the recent NIH Consensus panel's 
recommendations.
    4. A few comments were concerned that there would be only two 
accreditation bodies, CARF and JCAHO. In addition, these comments 
reflect concern that accreditation would be an additional requirement 
on top of existing FDA regulations.
    As proposed in the July 22, 1999, notice (section 8.3(a)) any 
private nonprofit organization, State governmental entity, or political 
subdivision thereof, capable of meeting the requirements of subpart A 
is eligible to apply to become an accreditation body under the new 
rules. As discussed elsewhere in this final rule, some State 
authorities have contacted SAMHSA and expressed interest in becoming an 
accreditation body under subpart A. In addition, a number of non-
governmental entities have expressed similar interest. Accordingly, the 
Secretary believes that there will be more than two accreditation 
bodies that seek and obtain approval to become an accreditation body 
under these rules.
    The requirements for accreditation and SAMSHA certification under 
this final rule will replace the requirements for FDA approval of OTPs 
under previous regulations. The previous regulations in place under 21 
CFR 291.505 will be rescinded on March 19, 2001.
    5. The Secretary received a considerable number of diverse comments 
from State authorities, OTPs, and patients on the provision proposed 
under section 8.3(a) that would permit States to serve as accreditation 
bodies under the new rules. The preamble to the July 22, 1999, notice 
emphasized the need for States to consider serving as accreditation 
bodies. This emphasis was based upon the recommendation in the IOM 
Report that strongly suggested that the Federal Government design a 
consolidated inspection system that reduces the burden on OTPs from 
multiple (Federal, State, local) inspections.
    State authorities provided a mixed response in their comments on 
this issue. As discussed below, several States expressed an interest in 
becoming accrediting bodies under the new rules but believed that they 
were ineligible because they could not accredit 50 OTPs a year under 
proposed section 8.3. On the other hand, many States indicated that 
they were not interested in becoming accreditation bodies, while 
several indicated that they were undecided and would await additional 
information.
    Comments from OTPs, for the most part, reflect a longstanding 
cooperative relationship with State regulatory authorities. OTPs, in 
general, did not appear to oppose the concept of State authorities 
serving as accreditation bodies under the proposed new system. Indeed, 
some OTPs, located within States that assess extensive licensing fees, 
commented that it would be imperative that States take on the role of 
accreditation bodies under the new system in order to eliminate the 
financial impact of licensing and accreditation fees.
    Comments from patients on this issue suggested caution. Many 
patients sensed that State regulators would retain strict, ``process-
oriented'' regulations or philosophies. These comments urged that if 
SAMHSA permitted States to serve as accreditation bodies then the 
agency should carefully monitor accreditation standards and practices 
to assure that they conform with the Federal opioid treatment 
standards.
    After considering the comments on this issue, the Secretary is 
retaining the provision that allows States to serve as accreditation 
bodies under the new rules. The Secretary acknowledges that many States 
will choose not to participate as accreditation bodies. Some of these 
States already accept accreditation by recognized accreditation bodies 
for licensing purposes. It is expected that more States, especially 
States with relatively few OTPs, will also choose to accept 
accreditation as meeting State licensure requirements in time. Indeed, 
legislation enacted recently in New Hampshire to allow methadone 
maintenance treatment incorporated a requirement for CARF accreditation 
(Ref. 2). Finally, some States will apply accreditation reviews and 
findings to complement their licensing activities. The Secretary 
recognizes that the States' role in adapting to the new system will 
change over time as additional information on accreditation is 
developed.
    The Secretary believes that there are adequate safeguards to 
address patient concerns about overly restrictive State regulations and 
oversight. Under section 8.3(b)(3), SAMHSA will review each applicant 
accreditation body's proposed accreditation standards. As part of this 
review, SAMHSA will determine the extent to which the accreditation 
standards are consistent with the Federal opioid treatment standards. 
In addition, under section 8.5, SAMHSA will evaluate periodically the 
performance of accreditation bodies by inspecting a selected sample of 
the OTPs accredited by the accreditation body. As part of this effort 
SAMHSA may also consider follow-up inspections in cases where 
accreditation activities identify public health, public safety, and 
patient care issues.
    The Secretary continues to believe, as outlined in the July 22 
proposal, that there are benefits to States serving as accreditation 
bodies under this rule. This feature provides the potential to reduce 
the overall number of OTP inspections. It also permits the use and 
application of the vast expertise available within many State oversight 
agencies.
    6. A number of State authorities and an accreditation body 
questioned the restriction under proposed section 8.3(b)(3) that would 
require accreditation bodies to be able to survey no less than 50 OTPs 
annually. Some comments contend that this would unfairly and 
inappropriately exclude smaller States or States with fewer OTPs from 
participating. These comments suggested that other requirements should 
be considered and applied or a waiver provision added. One 
accreditation body commented that accreditation bodies recognized by 
the Health Care Financing Administration are not subject to such 
arbitrary limitations. Other comments suggested that the 50 survey per 
year minimum was not necessary to achieve its stated purpose--to ensure 
the quality of accreditation services and minimize the variability of 
accreditation standards.
    The Secretary concurs with these comments. The provisions of 
section 8.3(b)(3) (submission and review of proposed accreditation 
standards) and section 8.5 (periodic evaluation of accreditation 
bodies) are adequate to enable SAMHSA to ensure the quality of 
accreditation services and minimize the potential variability in 
accreditation standards. Accordingly, section 8.3(b) has been modified 
to remove this requirement.
    7. A few comments suggested that State authorities and patient 
advocates should be permitted to participate in the approval of 
accreditation bodies under the new rules and in the accreditation 
process in general. These comments believe that they can make 
substantial contributions to the process.
    The Secretary agrees that patients and State authorities can 
contribute

[[Page 4081]]

substantially to the successful operation of the new system. State 
authorities and patients have participated in the committees that have 
developed SAMHSA/CSAT's Accreditation Guidelines. In addition, 
representatives from both these groups have served on the Accreditation 
Subcommittee of the SAMHSA/CSAT National Advisory Council. 
Accreditation standards include several provisions designed to solicit 
and consider individual patient views regarding treatment planning and 
other areas. Some, though not all, accreditation bodies also have 
patient hotlines that allow patients to convey concerns directly to 
accreditation bodies. Finally, SAMHSA and State authorities will 
continue to consult and interact under the new rules. The Secretary 
believes that these measures are adequate to assure the appropriate 
level of State authority and patient input into the accreditation 
process.
    8. Several comments addressed proposed section 8.3(b)(6), 
pertaining to the qualifications of accreditation body personnel and 
proposed section 8.4(h) on accreditation teams. One State authority 
objected that the requirement that there be a licensed physician on the 
accreditation body staff was an unnecessary expense to accreditation 
bodies. Another comment recommended that accreditation teams should 
include a physician certified for dispensing opioids. Some patients 
advocated that the accreditation team should include a current patient.
    The Secretary believes the requirements for accreditation personnel 
and accreditation teams as set forth in the July 22, 1999, proposal are 
sufficient. It is not clear that every OTP would benefit from having a 
physician or opioid agonist patient on the accreditation team. The 
Secretary has reviewed the results of accreditation surveys under the 
SAMHSA/CSAT methadone accreditation project. Based on these reviews, 
the requirements set forth under section 8.4(h) are adequate to assure 
that accreditation bodies carefully consider the qualifications of 
accreditation surveyors and accreditation teams.
    9. A considerable number of comments were submitted, mostly by 
State authorities, concerning the absence of a definition for State 
authority. These comments suggested that adding a definition for state 
authority could reduce confusion in States that serve as accreditation 
bodies. In addition, these comments reflect a belief that this change 
would help clarify the Federal-State consultation process set forth in 
the proposed rule. The Secretary agrees with these comments and has 
added a definition of State Authority. This definition tracks closely 
with the definition contained in the previous regulations under section 
21 CFR 291.505.

C. Subpart B--Certification

    Subpart B establishes the criteria and procedures for the 
certification of OTPs. This section also addresses the conditions for 
certification and the interaction between the Federal Government and 
State authorities under the new rules.
    1. Many comments from State regulators noted that there was no 
reference to a requirement that OTPs obtain a license or permit from 
States before receiving certification from the Federal Government. 
These comments reflect a concern that SAMHSA may certify a program in a 
State where no methadone authority exists, or without the knowledge of 
the State authority. Other comments urged Federal certification to pre-
empt State licensing, noting that ``initial State approval will remain 
a de facto requirement.''
    The Secretary believes that the conditions for certification as set 
forth in the July 22, 1999, proposal, including the provisions relating 
to State licensure, are adequate and appropriate to fulfill the 
objectives of this rule. The Secretary's role in the oversight of 
narcotic treatment is to set standards for the appropriate use of 
narcotic drugs in the treatment of addiction, and then to ensure 
compliance with those standards. The States, on the other hand, have a 
broader set of responsibilities, including regional and local 
considerations such as the number and distribution of treatment 
facilities, the structural safety of each facility, and issues relating 
to the types of treatment services that should be available. Nothing in 
this part is intended to restrict State governments from regulating the 
use of opioid drugs in the treatment of opioid addiction. The Secretary 
notes that many States exercise this authority by choosing not to 
authorize methadone treatment at all.
    The Secretary does not believe that OTPs will open and begin 
treating patients without State notification, review, and approval. The 
Secretary has been careful to state throughout this rule that OTPs 
(including medication units) must comply with all pertinent State and 
local laws as a condition of Federal certification. As such, OTPs will 
also be responsible for assuring that they have the necessary approvals 
and licensure at the State. Moreover, OTPs must obtain DEA registration 
prior to accepting opioid addiction treatment drugs for the treatment 
of opiate addiction. DEA registration is explicitly contingent upon 
State authority approval. Importantly, as noted below, there will be 
extensive consultation, coordination, and cooperation between SAMHSA 
and relevant State authorities.
    2. One State regulator requested that the regulation be modified at 
section 8.11(c)(1) to add a requirement that SAMSHA notify the State 
upon receipt of applications for certification as well as approval and 
withdrawal. This comment was based upon a concern that provisionally 
certified programs could operate without a State's knowledge.
    The Secretary agrees that it is imperative for States to be 
notified of significant certification activities, including new program 
applications, program suspensions and withdrawals. SAMHSA intends to 
notify States of all such developments under the provisions of section 
8.11(c)(1). The Secretary believes that the rules are sufficiently 
clear on this point.
    3. Some State authorities suggested revising proposed section 
8.11(h), which states that SAMHSA ``may'' consult with State 
authorities prior to granting exemptions from a requirement under 
sections 8.11 or 8.12.
    Section 8.11(h) permits OTPs to request exemptions from the 
requirements set forth under the regulation. This represents a 
continuation of a long-standing provision from the previous regulation 
under 21 CFR 291.505. The Secretary anticipates that most exemption 
requests under the new rule will be to permit variations from the 
treatment standards, including program-wide exemptions for medical 
maintenance. The Secretary agrees that it is appropriate and necessary 
to consult with State authorities on requests for variations from 
existing standards. Accordingly, section 8.11(h) is revised to require 
consultation with the State authority prior to granting an exemption.
    4. Several comments from patients suggested that Federal 
regulations should prevent States from imposing additional regulatory 
requirements beyond the Federal regulations. Many of these comments 
contend that State regulations prevent treatment expansion, hinder 
accountability for quality treatment, limit patient access, and lead to 
patient abuses.
    As noted above, the Secretary acknowledges the authority within 
State government to regulate the practice of medicine. This rule does 
not pre-empt States from enacting regulations necessary to carry out 
these important responsibilities.

[[Page 4082]]

    Many State regulations closely resemble the previous Federal 
regulations under 21 CFR 291.505. In addition, many States are 
currently reevaluating their regulations to determine if modifications 
are necessary to reflect the changes in Federal rules. The Secretary 
encourages States to consider the new information on changes in the 
opioid addiction treatment field, including phases of treatment, 
measuring accountability for improving the quality of patient care, and 
modern medication dosing practices, as States proceed in revising their 
regulations.
    The Secretary also invites States to continue to enhance their 
partnership with Federal authorities in this area. As noted above, the 
final rule includes a new feature--the opportunity for States to serve 
as accreditation bodies. This new activity adds to existing partnership 
opportunities, such as the participation in the SAPT Block Grant 
program and its related technical assistance program. The Secretary 
hopes that these actions collectively will continue the regulatory 
reform started with the July 22, 1999, proposal.
    5. A few comments expressed concern about proposed section 8.11(e), 
which permits provisional certification for one year, while a program 
obtains accreditation. These comments believe that one year was ``too 
long for a program to go without accreditation.''
    The Secretary believes that the maximum 1-year term (not including 
the 90-day extension allowed under section 8.11(e)(2)) for provisional 
certification is reasonable and customary with accreditation in other 
areas of healthcare. The purpose of this provision is to permit new 
OTPs to initiate operations and generate patient records to aid in the 
accreditation application, survey, and review process. It should be 
noted that OTPs will be subject to SAMHSA, DEA, and State oversight 
during the tenure of provisional accreditation. These OTPs must comply 
with Federal opioid treatment regulations and are subject to compliance 
actions at any time.
    6. Section 8.11(i)(2) proposed that certification as an OTP would 
not be required for the maintenance or detoxification treatment of a 
patient who is admitted to a hospital or long-term care facility for 
the treatment of medical conditions other than addiction. One comment 
noted that, as written, patients admitted to hospitals for cocaine or 
alcohol addiction would not be eligible for treatment under this 
provision. The comment suggested that adding the word ``opioid'' before 
``addiction'' would help to clarify this issue. The Secretary concurs 
and the section 8.11(i)(2) has been changed to reflect this change.

D. Subpart B--Treatment Standards

    1. A number of comments were submitted on proposed section 8.12 in 
general. These comments stated that the Federal Opioid Treatment 
standards are vague and lack specificity. As such, these comments 
contend that the standards are unenforceable as regulations. One 
comment suggested that the SAMHSA/CSAT Accreditation Guidelines be 
incorporated as regulations.
    The Secretary believes that the Federal Opioid Treatment Standards 
are enforceable, and do not need to be modified to accomplish their 
purpose under the new rules. The July 22, 1999, proposal noted that in 
the past, HHS has attempted to write all facets of treatment, including 
required services, into regulation. In addition, the proposal 
acknowledged that it is now accepted that (a) different patients, at 
different times, may need vastly different services, and (b) the state 
of the clinical art has changed, to reflect scientific developments and 
clinical experience, and is likely to continue to change and evolve as 
our understanding of more effective treatment methods increases. 
Accordingly, the Secretary proposed a more flexible approach with a 
greater emphasis on performance and outcome measurement. With guidance 
from SAMHSA, the accreditation bodies will develop the elements needed 
to determine whether a given OTP is meeting patient needs for required 
services. SAMHSA will review these elements as part of the 
accreditation body's initial and renewal applications to ensure that 
accreditation bodies have incorporated the Federal opioid treatment 
standards into their accreditation elements. SAMHSA will also review 
accreditation body elements to ensure that the elements do not exceed 
Federal expectations in terms of opioid agonist treatment. 
Incorporating accreditation guidelines into regulations would subvert 
this approach.
    As noted in the July 22, 1999, proposal, the Secretary believes 
that the standards are ``enforceable regulatory requirements that 
treatment programs must follow as a condition of certification (64 FR 
39810, July 22, 1999).'' While the new regulations increase the 
flexibility and clinical judgement in the way OTPs meet the regulatory 
requirements, they are set forth under section 8.12 as the services, 
assessments, procedures, etc., that OTPs ``must'' and ``shall'' 
provide. As such, the new standards are as enforceable as the previous 
regulations under 21 CFR 291.505. OTPs that do not substantially 
conform with the Federal Opioid Treatment standards set forth under 
section 8.12 will risk losing SAMHSA certification.
    2. One comment recommended that proposed section 8.12(b) should be 
modified to require a standard that OTPs should have adequate 
facilities. The comment stated that this provision existed in the 
previous regulation. The Secretary agrees and has added a requirement 
that OTP's must maintain adequate facilities. The Secretary notes, 
however, that SAMHSA/CSAT accreditation guidelines and accreditation 
standards used in the SAMHSA accreditation impact study, address the 
adequacy of the OTP's facility. These accreditation standards, in 
conjunction with treatment outcomes, will help determine whether 
facilities are adequate under the new rules.
    3. One comment addressed proposed section 8.12(b), stating that 
rules should expressly require compliance with civil rights laws, not 
just ``pertinent'' Federal laws. As such, the comment suggests that the 
standards should require detailed patient grievance procedures, 
including appeals to neutral parties. The Secretary believes that it is 
not necessary to modify the rule to reflect civil rights laws 
specifically. These laws are included under the requirement as written. 
In addition, SAMHSA/CSAT Accreditation Guidelines, as well as the 
accreditation standards developed from them include provisions for 
accepting and acting upon patient grievances.
    4. A number of respondents commented on proposed section 8.12(d) 
which addresses OTP staff credentials. Under the July 22, 1999, 
proposal, the Secretary proposed that each person engaged in the 
treatment of opiate addiction must have sufficient education, training, 
or experience or any combination thereof, to enable that person to 
perform the assigned functions. Further, all licensed professional care 
providers must comply with the credentialing requirements of their 
professions. The proposal encouraged, but did not require, that 
treatment programs retain credentialed staff.
    Some comments requested that this standard be clarified to require 
American Society of Addiction Medicine (ASAM)-certified medical 
professionals. Another comment questioned whether personnel had to be 
licensed in the State where the treatment program is located. Another 
comment from a State Authority, recommended that the regulations

[[Page 4083]]

specify the license, training, experience, as well as the number of 
licensed counselors in a program, including a minimum counselor-to-
patient ratio. On the other hand, an OTP medical director commented 
that none of the cited credentials ``conferred competence in dealing 
with opioid dependent patients, per se.'' According to this comment, 
SAMHSA/CSAT should instead develop curricula for medical directors and 
other care givers.
    Except for the requirements of section 8.12(h), which relate to the 
qualifications for practitioners who administer or order medications, 
the Secretary does not believe that it is appropriate to further 
prescribe the qualifications for health professionals in this 
regulation. Under sections 8.12(b), (d), (e), (f) services must be 
provided by professionals qualified by education and training. The 
Secretary does not believe that one credentialing organization should 
be specified as a requirement for qualifications. Instead, the 
Secretary intends to rely on guidelines and accreditation standards 
together with patient outcome assessments to determine the adequacy of 
training and education level of professionals in OTPs. SAMHSA/CSAT is 
actively developing model training curricula in this area.
    5. A few comments suggested that the regulations specify the 
outcome measures for quality assessment plans under section 8.12(c)(1). 
Similarly, some comments suggested that diversion control plans, which 
OTPs are required to develop under section 8.12(c)(2), should also be 
spelled out in regulations.
    The Secretary believes that the regulation as proposed provides 
sufficient detail on outcome measures and diversion control plans. In 
keeping with the intent of the regulation reform, these general 
requirements are elaborated in best-practice guidelines and in ``state-
of-the-art'' accreditation standards. Indeed, following a review of the 
accreditation standards that are based upon SAMHSA/CSAT's opioid 
treatment accreditation guidelines, the Secretary has determined that 
they are adequate to ensure that OTPs will be able to develop 
meaningful outcome assessment and diversion control plans. In addition, 
these SAMHSA/CSAT accreditation guidelines and accreditation standards 
reflect the latest research findings in this area. Unlike the Federal 
regulations, these guidelines and standards will be updated 
periodically to reflect new research and clinical experience.
    6. The Secretary received a considerable number of comments on the 
proposed definition and the standards for short-and long-term 
detoxification treatment. Most of these comments suggested that the 
word ``detoxification'' is a pejorative non-medical term and does not 
constitute treatment, because few, if any, patients can be stabilized 
in such a short period of time. These comments suggested that all 
references to detoxification should be deleted from the regulations, or 
at least renamed.
    These comments fail to recognize the distinction between opiate 
dependence, for which detoxification treatment is appropriate, and 
opiate addiction, for which maintenance treatment is appropriate. The 
Narcotic Addiction Treatment Act of 1974 (NATA) and regulations have 
long recognized these distinctions. While a majority of the available 
treatment research, including recent studies, concludes that 
maintenance treatment is much more effective than detoxification 
regimens, the Secretary believes that it is still necessary to retain 
distinct standards for maintenance and detoxification treatment (Ref. 
3).
    7. Several comments were submitted in response to the Secretary's 
specific request for comments on proposed section 8.12(e)(4) which set 
forth minimum requirements for detoxification treatment. The July 22, 
1999, proposal retained the requirement from the existing regulation 
that ``a patient is required to wait no less than 7 days between 
concluding one detoxification episode before beginning another.'' 
Essentially, while sympathetic to the need for limits on detoxification 
treatment, all the comments on this item opposed continuing any waiting 
period between detoxification episodes. These respondents believe that 
seven days is ``artificial * * * or more time than is needed.'' In 
addition, these comments indicate that OTPs often request and are 
granted exemptions from the waiting period requirement under the 
existing regulation, creating an unnecessary paperwork burden for OTPs, 
as well as State and Federal regulators. Instead, the comments 
suggested a limit on the number of unsuccessful detoxification episodes 
in one year before the patient is assessed for opioid agonist 
maintenance or other treatment. In addition, these comments recommended 
that an unsuccessful detoxification attempt be defined to include any 
relapse to abuse.
    The Secretary agrees with the recommendations that the intent of 
the restrictions on detoxification can be accomplished without a 
mandated time interval between detoxification admissions. The standards 
for detoxification treatment set forth under section 8.12(e)(2) and (4) 
have been revised to state that patients with two or more unsuccessful 
detoxification episodes within a 12-month period must be assessed by 
the OTP physician for other forms of treatment. This change is 
consistent with SAMHSA/CSAT accreditation guidelines which also 
elaborate on unsuccessful detoxification treatment attempts.
    8. A considerable number of diverse comments addressed proposed 
section 8.12(f) relating to required services. This section of the July 
22, 1999, proposal requires that ``adequate medical, counseling, 
vocational, educational and assessment services are fully and 
reasonably available to patients enrolled in an OTP.''
    Two comments strongly recommended that the regulation require 
integrated, simultaneous treatment by specially cross-trained staff, 
for co-occurring opioid treatment and mental illness. These respondents 
believe that integrated services for persons with an addiction(s) and a 
psychiatric disorder are crucial. These dually-diagnosed patients 
represent 50-80 percent of substance dependent populations.
    The Secretary agrees with the importance of providing adequate 
integrated services for opiate-addicted patients who also suffer from 
psychiatric disorders. Indeed, the SAMHSA/CSAT Accreditation 
Guidelines, along with the accreditation standards developed by CARF 
and JCAHO all address the need to evaluate patients for co-occurring 
illnesses, including mental illness. CARF Opioid Treatment Program 
Accreditation Standards state that services for co-occurring illness 
should be provided on site or by referral. However, the same standards 
note that ``coexisting conditions, especially in persons from 
disenfranchised populations, are most effectively treated at a single 
site.'' The Secretary takes note that these provisions for co-occurring 
disorders under these new rules will be a vast improvement over the 
previous regulatory system, which did not address co-occurring opiate 
addiction and psychiatric disorders at all. As such, under the new 
rules, patients' access to effective treatment for co-occurring 
disorders will be enhanced substantially. However, the Secretary 
believes that it would be prohibitively expensive to require every OTP 
to hire and retain specialists in the treatment of co-occurring 
disorders.
    Other comments on this section stated that the regulations should 
specify a schedule for services. Some comments

[[Page 4084]]

recommended that the regulations require OTPs to document that patients 
actually receive services when they are referred to off-site providers. 
Other comments suggested that accreditation bodies should monitor the 
extent to which services are provided as part of their periodic onsite 
surveys. Still other comments, mostly from patients, suggested the 
requirement for services be eliminated, maintaining that medication is 
all they needed.
    The Secretary believes that the requirements for services as stated 
in the July 22, 1999, proposal, together with the accreditation 
process, provide adequate assurance that patients enrolled in OTPs 
receive the services that they have been assessed to need. The July 22, 
1999, proposal emphasized the need for these services as an essential 
part of treatment. However, in shifting to an accreditation approach 
with an emphasis on performance outcomes, the Secretary was no longer 
attempting to ``write all facets of these required services into 
regulation.'' OTPs must initially and periodically assess each patient 
and ensure that adequate services are available to patients determined 
to need them. SAMHSA/CSAT Accreditation Guidelines and accreditation 
standards will elaborate on the standards for services. OTPs will be 
accountable through the accreditation process to assure that patients 
receive the appropriate services they need for successful treatment 
outcomes; for some patients, medication services may be sufficient to 
produce positive outcomes.
    9. A number of respondents submitted comments on proposed section 
8.12(f)(2), which requires a complete medical examination within the 
first 30 days following admission. Some of these comments noted that 
this provision, as proposed, permitted patients to enter treatment 
while tests, some of which required several days, are completed. Others 
commented that the 30 days was too long to wait for a medical exam to 
be completed, noting that information from the exam is crucial to the 
first few days of treatment. Finally, some comments suggested that 
regulations should specify the contents of the medical exam.
    The intent of proposing 30 days for the completion of the physical 
exam was to allow patients into treatment while OTPs wait for the 
results of serology and other tests that require, in some cases, 
several days to complete. Section 8.12(f)(2) has been revised to 
clarify the requirement for a physical exam upon admission, with 
serology and other tests results completed w/in 14 days. The Secretary 
does not agree that regulations should specify the contents of the 
medical examination. Instead, the Secretary believes that accreditation 
guidelines should express the state-of-the-art content for a medical 
exam appropriate for the treatment of opiate addiction.
    10. The July 22, 1999, notice proposed that OTPs conduct at least 
eight random drug abuse tests per year for each patient. Many comments 
suggested that the Federal standards specify more frequent drug abuse 
tests, including weekly testing, to balance the more flexible proposed 
take-home schedule. Other comments suggested that Federal regulations 
should specify measures to prevent adulteration. On the other hand, 
some comments suggested that quarterly drug abuse testing is 
appropriate. Moreover, one comment recommended substituting an ``honor 
system'' because patients can corrupt the testing process and falsify 
results.
    After considering the comments on this issue, the Secretary is 
retaining the requirement for a minimum of eight random drug abuse 
tests per year for maintenance treatment. The Secretary believes that 
this is an adequate and balanced standard for drug abuse testing. There 
is extensive discussion on drug abuse testing issues in the SAMHSA/CSAT 
Treatment Improvement Protocols and the SAMHSA/CSAT Accreditation 
Guidelines. In addition, these guidelines elaborate on measures to 
address the corruption and falsification of results. Finally, as the 
Federal standard is a minimum, OTPs can require more frequent tests if 
desired.
    11. The Secretary received many comments on proposed section 
8.12(g)(2) which requires OTPs to determine and document that patients 
are not enrolled in other programs. Most respondents question how such 
determinations could be made without a patient registry. One comment 
stated that multiple enrollments are attributable to inadequate 
medication dosing practices.
    The July 22, 1999, proposal retained the provisions relating to 
multiple enrollments from the previous regulations under 21 CFR 
291.505. In proposing to retain the requirement, the Secretary noted 
that there have been cases of patients enrolling in more than one 
treatment program; however, the extent of this practice is undetermined 
but not considered to be widespread. The intent of this provision is 
for OTPs to make a good faith effort, using available resources and 
mechanisms to ascertain whether or not a prospective patient was 
currently enrolled in another OTP. Some individual States with OTPs 
concentrated within a community have established a patient registry and 
require OTPs to report new patients and patients who have discontinued 
in treatment. In other jurisdictions, patient registries are developed 
and maintained voluntarily by OTPs. OTPs also often contact other OTPs 
in the vicinity to determine if the patient is currently enrolled in an 
OTP, or they ask the patient. If used, these mechanisms must be used in 
accordance with the provisions at 42 CFR 2.34, regarding disclosures to 
prevent multiple enrollments. The Secretary acknowledges that none of 
these mechanisms can determine with complete certainty whether or not a 
patient is enrolled in more than one OTP. Accordingly, the Secretary 
expects that OTPs will document in each patient's record that the OTP 
made a good faith effort to review whether or not the patient is 
enrolled in any other OTP. Section 8.12(g)(2) has been revised 
accordingly.
    12. The Secretary received many comments on proposed section 
8.12(j), relating to interim methadone maintenance. Most of these 
comments were from patients who suggested interim maintenance as a 
model for long standing patients who have been stabilized in treatment. 
As such, these comments suggested that the term for interim methadone 
maintenance be extended beyond 120 days.
    These comments reflect a misunderstanding of interim methadone 
maintenance. Interim methadone maintenance was mandated by the ADAMHA 
Reorganization Act of 1992 as a measure to address shortages in 
treatment capacity and documented waiting lists (Pub. L. 102-321, See 
also 58 FR 495, January 5, 1993). The legislation included several 
restrictions which were incorporated and retained into Federal 
regulations. Although very few programs have applied for authorization 
to provide interim methadone maintenance, the Secretary does not at 
this time believe it is necessary or appropriate to change the 
standards. Instead, as discussed elsewhere in this notice, the 
Secretary believes that medical maintenance provides a more reasonable 
approach for expanding treatment capacity.
    13. The Secretary received comments on proposed section 8.11(h), 
which provides for exemptions from treatment standards or certification 
requirements. One comment suggested that the examples in the previous 
regulation for exemptions, be retained in the final new regulations. 
The comment suggests that this would encourage individual physicians, 
pharmacists, or both to

[[Page 4085]]

provide methadone treatment in rural areas where methadone treatment is 
scarce or unavailable. Another comment suggested that SAMHSA streamline 
the exemption process and do more to publicize the availability of such 
regulatory options. The Secretary accepts both of these suggestions, 
and section 8.11(h) has been revised accordingly. In addition, SAMHSA 
has already taken steps to streamline the exemption process and 
publicize the availability of certain exemptions (Ref. 4).
    14. Most comments strongly supported the provisions in proposed 
section 8.12(h)(3)(i) which permits OTPs to use solid dosage forms. 
Some patients reported spoilage and decomposition problems with 14-day 
supplies of liquid dosage form. Other comments suggested that the use 
of solid medication will reduce treatment cost modestly by eliminating 
the need for dosage bottles for solutions. The Secretary agrees that 
permitting OTPs to use solid medication will reduce treatment costs and 
increase treatment convenience to patients.
    15. The Secretary received many comments on proposed section 
8.11(h)(3)(iii) that would have required the program physician to 
justify in the patient record all doses above 100 mg. Most comments 
viewed this requirement as an inappropriate ``value judgement'' that 
hampers clinical judgement. The Secretary agrees that the requirement 
to justify a dose above 100 mg, which is a modification of a 
requirement under the previous regulation, is not necessary to reduce 
the risk of medication diversion. Accordingly, this requirement has 
been eliminated from the final rule.
    16. The Secretary specifically requested and received comments on 
proposed changes to the requirements under section 8.12(i) pertaining 
to medications dispensed for unsupervised use (hereinafter ``take-
homes''). The July 22, 1999, proposal set forth four options for 
addressing take-homes. These options ranged from retaining the previous 
requirements to a scheme based on a maximum dose. Option number 2 was 
discussed as the option preferred by HHS and endorsed by DEA. This 
option resembles the requirement under the previous regulations and 
retains the 8-point take-home criteria. However, option number 2 
permitted patients in stable treatment for one year to receive up to a 
31-day supply of medication, while the previous regulation included a 
maximum take-home supply of 6 days.
    Most comments supported proposed option 2, with modifications. In 
supporting option 2, current patients stated that less frequent clinic 
attendance will make treatment much more convenient. In addition, 
Option 2 will eliminate travel hardships and facilitate employment 
commitments, ultimately increasing retention in treatment and 
rehabilitation. Option 1, which encompassed the take-home schedule from 
the previous regulation, was viewed by many comments as too 
restrictive. Many comments opposed option 3, which proposed a set 2-
week maximum milligram amount for take-homes, because it unfairly 
penalized patients receiving higher doses.
    On the other hand, a form letter circulated and submitted by 
several treatment programs stated that no patients should be eligible 
for a 31-day take-home supply. According to these comments, all 
patients must report to clinics often so that their rehabilitation can 
be monitored appropriately. In addition, these comments stated that 
allowing any patient a 31-day take-home supply presents an unacceptable 
risk of diversion.
    The Secretary does not agree with these comments. Indeed, there is 
considerable evidence that many patients can responsibly handle 
supplies of take-home medications beyond the 6-day maximum allowed 
under the previous regulations. In addition, FDA has permitted hundreds 
of patients to receive monthly take-home supplies of methadone through 
exemptions or Investigational New Drug Applications. These 
investigations have been analyzed and reported in scientific literature 
and indicate that patients successfully continue in rehabilitation 
(Ref. 5). Moreover, these cases indicate that rehabilitation is 
enhanced through these ``medical maintenance'' models. Accordingly, and 
in response to an increased interest in this issue, FDA and SAMHSA/CSAT 
issued a ``Dear Colleague'' letter on March 30, 2000, that advised the 
field on procedures for obtaining OTP exemptions for medical 
maintenance, which include a provision for up to a 31-day supply of 
take-home medication (Ref 4).
    The Secretary notes that many comments provided suggestions on 
refining the basic schedule for take-home eligibility outlined in 
proposed option 2. For example, many comments suggested that one year 
of stable treatment was still too short a period of time to evaluate 
whether patients can responsibly handle a 31-day supply of take-home 
medication. These comments suggested an interim step that permits a 14-
day take-home supply after one year of stable treatment before a 
patient is eligible for a 31-day supply.
    The Secretary concurs with these comments. The 2-year time in 
treatment requirement is more consistent with the studies and 
exemptions for medical maintenance granted to date under the previous 
rules. In addition, this schedule is more consonant with the schedule 
set forth in the SAMHSA/CSAT Accreditation Guidelines and the 
accreditation body standards. Accordingly, section 8.12(i)(3) has been 
revised to reflect a 14-day take-home step after one year of stable 
treatment and to reflect that patients are eligible for a take-home 
supply up to 31 days after two years of stable treatment. The language 
in other parts of section 8.12(i)(3) has been modified slightly for 
clarity to lengthen the duration of the steps within the first year of 
treatment, and to remove some requirements for observed ingestion.
    17. Comments overwhelmingly supported the proposal to permit take-
home use of LAAM and suggest that the Secretary apply the same schedule 
as methadone, e.g. option 2. A comment from a practitioner who has 
treated over 500 patients, stated that patients dislike being switched 
from LAAM to methadone when necessary for travel purposes. Most 
comments suggested that diversion of LAAM is no more likely than the 
diversion of methadone which generally is not problematic. One comment 
submitted the results of a 149-patient study on LAAM take-home use. 
Patients were randomized into take-home and clinic only groups. As part 
of the study, 545 take-home doses of LAAM were distributed to patients, 
and patients were subject to random ``callbacks.'' There was no 
evidence of tampering, diversion, or interest in obtaining LAAM take-
home supplies illicitly. In addition, there were no differences between 
the two groups in the measured outcome variables. The investigator 
concluded that methadone and LAAM should be subject to the same take-
home requirements. The Secretary concludes that LAAM should be 
available for take-home use under this rule.
    18. A comment submitted by a physician discussed his successful 
experience using LAAM for detoxification treatment, finding LAAM to be 
superior to methadone for detoxification with some patients. The 
comment suggested that the regulations should be modified to permit the 
use of LAAM for detoxification.
    Although previous Federal Register notices may have suggested that 
LAAM was not available for use in detoxification treatment (58 FR 
38704, July 20, 1993), the July 22, 1999, proposal does not prohibit 
the use of

[[Page 4086]]

methadone or LAAM for detoxification treatment. Indeed, the current FDA 
approved labeling for LAAM discusses and provides guidance on 
withdrawing patients from LAAM therapy:

    ORLAAM is indicated for the management of opiate dependence * * 
* There is a limited experience with detoxifying patients from 
ORLAAM in a systematic manner, and both gradual reduction (5 to 10% 
a week) and abrupt withdrawal schedules have been used successfully. 
The decision to discontinue ORLAAM therapy should be made as part of 
a comprehensive treatment plan.

    The Secretary believes that the regulations are adequately clear on 
this point.
    19. A few respondents commented upon the proposed implementation 
plan and whether OTPs could be expected to comply with the timetables 
for achieving accreditation. Under proposed section 8.11(d), treatment 
programs approved under the previous regulations are deemed certified 
under the new rules. This ``transitional certification'' would expire 
on June 18, 2001 unless the OTPs certify with a written statement 
signed by the program sponsor that they will apply for accreditation 
within 90 days of the date SAMHSA approves the first accreditation 
body. Transitional certification, in that case, will expire on March 
19, 2003. SAMHSA may extend transitional certification on a case-by-
case basis for up to one year under certain conditions. The comments 
questioned whether SAMHSA had empirical evidence that OTPs could meet 
this timetable.
    The Secretary believes that the timetables proposed in the July 22, 
1999, notice remain reasonable. A significant number of OTPs have 
already had experience with accreditation. This includes programs 
located in Department of Veterans Affairs Medical Centers, as well as 
OTPs located in the several States that require accreditation of OTPs 
(Maryland, Indiana, North Carolina, Georgia, South Carolina, and 
Michigan). Moreover, as discussed previously, as part of SAMHSA/CSAT's 
accreditation implementation plan, two accreditation bodies conducted 
accreditation surveys of OTPs and accredited over 50 OTPs in just a few 
months. SAMHSA/CSAT has planned additional training and technical 
assistance to enable OTPs to understand and comply with the new 
regulations. In addition, the regulations have been streamlined with 
fewer reporting and recordkeeping requirements. OTPs have had ample 
opportunity to prepare for this final rule, and the SAMHSA/CSAT 
Accreditation Guidelines as well as the CARF and JCAHO accreditation 
standards have been widely available for years. Taken together, these 
factors provide the Secretary with reasonable confidence that OTPs can 
apply for and achieve accreditation within two years from the effective 
date of this rule.
    The Secretary is sensitive to concerns about OTPs contacting 
accreditation bodies and scheduling accreditation reviews in a 
convenient manner. Therefore, while not changing the timetables for 
achieving accreditation under the final rule, the Secretary has 
modified section 8.11(d) to state that programs will agree to apply for 
accreditation within 90 days from the date SAMSHA announces the 
approval of the second accreditation body. The Secretary believes that 
tying this certification for OTPs to apply from the date SAMHSA 
announces the approval of the first accreditation body to the date 
SAMHSA announces approval of the second accreditation body will 
facilitate OTPs contacting and achieving accreditation under the final 
rule.
    20. A few comments requested that OTPs that have been previously 
accredited by JCAHO and CARF should be ``grandfathered'' somehow under 
the new final regulations.
    There are no provisions in the final rule to accept accreditation 
by accreditation bodies that have not been approved by SAMHSA under 
section 8.3(d). These accreditation bodies did not develop and apply 
accreditation standards that were based upon the opioid agonist 
treatment standards set forth under section 8.12. SAMHSA, however, will 
consider on a case-by-case basis, whether OTPs that achieved 
accreditation under the SAMHSA/CSAT implementation initiative can be 
exempted from re-accreditation under this final rule, pursuant to 
section 8.11(h).

E. 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

    1. One comment recommended that subpart C should be revised to add 
discovery provisions. This would enable OTPs to obtain crucial 
information on how ``accreditation bodies conducted their 
investigation.'' The Secretary believes that the provisions of subpart 
A that require that accreditation bodies have appeals procedures in 
their accreditation decision-making process is adequate to assure that 
OTPs can obtain the information they need on accreditation activities.
    2. One comment suggested that subpart C should be revised to allow 
applicant OTPs to appeal decisions to deny approval of an initial 
application. The Secretary does not agree and points out that OTPs will 
be able to appeal denials of accreditation by accreditation bodies 
under Sec. 8.3(b)(4)(vii).
    3. Response times in Sec. 8.26(a), (b) and (c) have been 
lengthened, as have the oral presentation timeframes in Sec. 8.27(d), 
and expedited procedures in Sec. 8.28(a) and (d).

F. Conclusion and Delegation of Authority

    After considering the comments submitted in response to the July 
22, 1999, proposal, along with the information presented during the 
November 1, 1999, Public Hearing, the Secretary has determined that the 
administrative record in this proceeding supports the finalization of 
new rules under 42 CFR part 8.
    In a notice to be published in a future issue of the Federal 
Register, the Secretary will announce the delegation of authority to 
the Administrator of SAMHSA, with the authority to redelegate, 
responsibility for the administration of 42 CFR part 8.

III. Analysis of Economic Impacts

    The Secretary has examined the impact of this 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). 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. 
While this rule is not a significant economic regulation, the Secretary 
finds that this rule is a significant regulatory action as defined by 
Executive Order 12866. As such, this rule has been reviewed by the 
Office of Management and Budget (OMB) under the provisions of that 
Executive Order. In addition, it has been 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

[[Page 4087]]

innovation; or significant effects on the ability of U.S.-based 
enterprises to compete with foreign-based enterprises in domestic or 
export markets.

A. Introduction

    As noted in the July 22, 1999, proposal, approximately 900 OTPs 
provide opioid agonist treatment to approximately 140,000 patients in 
the U.S. For almost 30 years, FDA has applied process-oriented 
regulations with periodic inspections to approve and monitor these 
OTPs. This final rule establishes an accreditation-based regulatory 
system, administered by SAMHSA, to carry out these responsibilities. In 
addition, this final rule includes changes that will make the 
regulations more flexible, and provide the opportunity to increase 
treatment capacity. OTPs will incur additional costs under the new 
accreditation-based system, but these additional costs are modest, and 
the Secretary believes are offset by benefits set forth under the new 
rules.
    The additional costs under these new rules are attributable to the 
costs of accreditation. FDA did not assess fees for inspections under 
the previous regulations. Under the new rules, private not-for-profit 
accreditation bodies will assess accreditation survey fees, and if 
necessary, reinspection fees. The July 22, 1999, proposal estimated 
that the direct and indirect costs of accreditation at $4.9 million per 
year. These annual cost equal approximately $5,400 per facility and $39 
per patient. The cost estimates were based on discussions with three 
accreditation bodies. Overall, the net costs of the new system over the 
existing FDA system, factoring in SAMHSA's estimated annual oversight 
costs of $3.4 million, was $4.4 million. The July 22, 1999, proposal 
noted that additional information on accreditation costs would be 
derived from SAMHSA/CSAT ongoing accreditation implementation project 
and requested specific comments on the estimates provided.
    As discussed above, although a number of comments submitted in 
response to the July 22, 1999, proposal predicted that accreditation 
costs could be higher, these predictions were based upon accreditation 
experiences in the past, not associated with the specific accreditation 
standards set forth under the new system. The results from 
approximately 50 accreditation surveys under the SAMHSA accreditation 
impact study suggest that the costs, as estimated in the July 22, 1999, 
proposal, are reasonably accurate.
    The July 22, 1999, proposal discussed the benefits of the proposed 
rule in terms of the advantages of accreditation and in terms of 
relapse rates as a function of retention in treatment. Although 
difficult to quantify, the Secretary believes that the accreditation-
based system will provide more frequent quality surveys of OTPs and 
allow greater flexibility in the delivery of opioid treatment. In 
addition, patients have commented that the increased flexibility of the 
new regulations, particularly in the standards for medications 
dispensed for unsupervised use, will increase patient convenience, 
increase patient satisfaction, and increase patient retention in 
treatment. Importantly, changes in the regulations will facilitate and 
expand medical maintenance treatment freeing resources to expand 
treatment capacity. As noted in the July 22, 1999, proposal, increasing 
retention in treatment and increasing the number of patients in 
treatment will lead to decreases in mortality and morbidity associated 
with opiate addiction, decrease health expenditures, and decrease 
criminal activity. These benefits are likely to be significantly 
greater than the costs of these new regulations.

B. Small Entity Analysis

    The Regulatory Flexibility Act (RFA) requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on a substantial number of small entities. SAMHSA included such an 
analysis in the July 22, 1999, proposal.
1. Description of Impact
    The July 22, 1999, proposal provided an extensive description of 
the industry, and concluded that, although the regulations were 
streamlined under the proposal with fewer forms and reporting 
requirements, the proposed rule constituted a significant impact on a 
substantial number of small entities. This impact is attributable to 
the requirement that all OTPs, regardless of size, must be accredited 
and maintain accreditation in order to continue to treat patients. 
Overall, the July 22, 1999, proposal estimated that the cost per 
patient for a ``small'' OTP (defined as an OTP treating 50 or fewer 
patients) would increase slightly more than the industry average ($50 
compared to $39).
2. Analysis of Alternatives
    The July 22, 1999, notice included a brief discussion of 
alternatives to the proposed accreditation-based regulatory scheme. In 
the analysis set forth initially in the July 22, 1999 notice, the 
Department discussed but dismissed the alternative of continuing the 
existing direct, FDA monitored, regulatory system because of the 
findings and criticisms of that system identified in the Institute of 
Medicine Report and elsewhere. In addition, the alternative of allowing 
self-certification was discussed, but rejected due to concerns about 
diversion and insufficient enforceability.
    The preamble to the proposed rule also included a brief discussion 
of alternatives that would minimize the economic impact of the new 
regulations on small businesses and other small entities. For example, 
the notice discussed the alternative of exempting small facilities from 
some requirements. It was also noted that small facilities could seek 
arrangements with larger facilities that could lower costs with 
economy-of-scale features.
    The issues in this initial analysis were highlighted for specific 
comment, and the notice itself was sent to every OTP identified in the 
FDA inventory of approved programs. Except to say that small programs 
should not have to close under the new rules, or that small programs 
should be exempt from accreditation, very few comments addressed the 
issue specifically, or provided information on alternatives. Therefore, 
this initial analysis does not require changing and is adopted as the 
final regulatory flexibility analysis.
3. Response to Comments From Small Entities
    These issues were highlighted for specific comment, and the notice 
itself was sent to every OTP identified in the FDA inventory of 
approved programs. Except to say that small programs should not have to 
close under the new rules, or that small programs should be exempt from 
accreditation, very few comments addressed the issue specifically, or 
provided information on alternatives.
    As discussed above, SAMHSA has evaluated the results of 
accreditation surveys of OTPs conducted pursuant to the proposed 
Federal opioid treatment standards. As such, SAMHSA has a better 
understanding of how accreditation will work in both large and small 
OTPs. Moreover, SAMHSA has provided technical assistance to 
participating programs to help them achieve accreditation. SAMHSA 
expects to continue providing technical assistance to programs during 
and after the transition to the new system.
    The accreditation-based system, the subject of these new rules, 
includes flexibility measures for small OTPs. The Secretary anticipates 
that there will be a number of approved accreditation bodies to choose 
from, including those

[[Page 4088]]

that will adjust accreditation fees on a sliding scale tied to the 
patient census. In addition, SAMHSA will retain the authority to 
certify programs without accreditation and could apply this provision, 
if necessary, to address burdens to OTPs with low patient censuses. 
SAMHSA prefers this case-by-case approach to a blanket exemption from 
accreditation requirements for programs below an arbitrary size. Such a 
blanket exemption would not be consistent with the intent of this 
regulatory initiative--to enhance the quality of opioid agonist 
treatment. The Secretary believes that, taken together, these 
considerations can mitigate the impact on small entities, while still 
meeting the objectives of this rulemaking.

C. Unfunded Mandates Reform Act of 1995

    The Secretary has examined the impact of this rule under the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 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.

IV. Environmental Impact

    The Secretary has previously considered the environmental effects 
of this rule as announced in the proposed rule (64 FR 39810 at 39825). 
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.

V. Executive Order 13132: Federalism

    The Secretary has analyzed this 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 final rule to set forth 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 regulation does not 
preempt State law. Accordingly, the Secretary has determined that this 
final rule does not contain policies that have federalism implications 
or that preempt State law.

VI. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions which 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA)(44 U.S.C. 3507(d)). 
The title, description and respondent description of the information 
collections are shown in the following paragraphs with an estimate of 
the annual reporting burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    Title: Narcotic Drugs in Maintenance and Detoxification Treatment 
of Narcotic Dependence; Repeal of Current Regulations and Adoption of 
New Regulations.
    Description: The Secretary is issuing regulations to establish an 
accreditation-based regulatory system to replace the current system 
that relies solely upon direct Federal inspection of treatment programs 
for compliance with process-oriented regulations.
    These new rules are intended to enhance the quality of opioid 
treatment by allowing increased clinical judgment in treatment and by 
the accreditation process itself with its emphasis on continuous 
quality assessment. As set forth in this final rule, there will be 
fewer reporting requirements and fewer required forms under the new 
system. The total reporting requirements are estimated at 2,071 hours 
for treatment programs, and 341 hours for accrediting organizations as 
outlined in Tables 1 and 2.
    The regulation requires a one-time reporting requirement for 
transitioning from the old system to the new system. The estimated 
reporting burden for ``transitional certification'' is approximately 
475 hours. The proposal also requires ongoing certification on a 3-year 
cycle, with an estimated reporting burden of approximately 300 hours.
    Description of Respondents: Business or other for-profit; Not-for-
profit institutions; Federal Government; State, local or tribal 
government.
    No comments were submitted in response to the Secretary's 
invitation in the July 22, 1999, proposal to comment on the information 
collection requirements.

                            Table 1.--Annual Reporting Burden for Treatment Programs
----------------------------------------------------------------------------------------------------------------
                                                            Number of    Responses/      Hours/
        42 CFR citation                  Purpose           respondents   respondent     response     Total hours
----------------------------------------------------------------------------------------------------------------
8.11(b)........................  New programs approval              75             1          1.50        112.50
                                  (SMA-162).
8.11(b)........................  Renewal of approval               300             1          1.00        300.00
                                  (SMA-162) \1\.
8.11(b)........................  Relocation of program              35             1          1.17         40.83
                                  (SMA-162).
8.11(d)........................  Application for                   300             1          1.58        475.00
                                  transitional
                                  certification (SMA-
                                  162) \2\.
8.11(e)(1).....................  Application for                    75             1           .50         37.50
                                  provisional
                                  certification.
8.11(e)(2).....................  Application for                    30             1           .25          7.50
                                  extension of
                                  provisional
                                  certification.
8.11(f)(5).....................  Notification of sponsor            60             1           .33         20.00
                                  or medical director
                                  change.
8.11(g)(2).....................  Documentation to SAMHSA             1             1             2          2.00
                                  for interim
                                  maintenance.
8.11(h)........................  Request to SAMHSA for             800             3          .438       1050.00
                                  Exemption from 8.11
                                  and 8.12.

[[Page 4089]]


8.11(i)(1).....................  Notification to SAMHSA              3             1           .25           .75
                                  Before Establishing
                                  Medication Units.
8.12(j)(2).....................  Notification to State               1             1           .33           .33
                                  Health Officer When
                                  Patient Begins Interim
                                  Maintenance.
8.24...........................  Contents of Appellant               2             1           .25           .50
                                  Request for Review of
                                  Suspension.
8.25(a)........................  Informal Review Request             2             1          1.00          2.00
8.26(a)........................  Appellant's Review File             2             1          5.00         10.00
                                  and Written Statement.
8.28(a)........................  Appellant's Request for             2             1          1.00          2.00
                                  Expedited Review.
8.28(c)........................  Appellant's Review File             2             1          5.00         10.00
                                  and Written Statement.
                                                                                                   -------------
      Total....................  .......................  ............  ............  ............     2,070.91
----------------------------------------------------------------------------------------------------------------
\1\ Applications for renewal of certification are required every 3 years.
\2\ Transitional Certification is a one-time requirement and will be included in the total annualized burden but
  averaged over the 3-year period of the OMB collection activity approval.

    The final rule does not increase the estimated annualized burden. 
Certain reporting requirements have been eliminated, such as 
submissions for authorizations to use LAAM, the requirement to submit a 
physician responsibility statement (FDA Form 2633), and elimination of 
the requirement to obtain Federal approval for take-home doses of 
methadone in excess of 100 mg that exceed a 6-day supply. The new rule 
adds a one-time requirement for existing programs to apply for 
transitional certification, and a requirement to apply for 
certification renewal every third year. The annualized burdens 
associated with these new reporting requirements offset the burdens 
eliminated, resulting in no estimated net change.
    Accreditation bodies will also require treatment programs to submit 
information as part of the standard operating procedures for 
accreditation. As mentioned earlier in this notice, accreditation 
bodies, under contract to SAMHSA, have accredited existing OTPs as part 
of an initiative to gain more information on the accreditation of OTPs. 
SAMHSA prepared a separate OMB Paperwork Reduction notice and analysis 
for that information collection activity (63 FR 10030, February 27, 
1998, OMB approval number 0930-0194).

                        Table 2.--Annual Reporting Burden for Accreditation Organizations
----------------------------------------------------------------------------------------------------------------
                                                             No. of      Responses/      Hours/
        42 CFR citation                  Purpose           respondents   respondent     response     Total hours
----------------------------------------------------------------------------------------------------------------
8.3 (b) (1-11).................  Initial approval (SMA-             10             1           3.0          30.0
                                  163).
8.3 (c)........................  Renewal of approval                 3             1           1.0           3.0
                                  (SMA-163).
8.3 (e)........................  Relinguishment                      1             1           0.5           0.5
                                  notification.
8.3 (f) (2)....................  Non-renewal                         1            90           0.1           9.0
                                  notification to
                                  accredited OTP's.
8.4 (b) (1) (ii)...............  Notification to SAMHSA              2             2           1.0           4.0
                                  for serious
                                  noncompliant programs.
8.4 (b) (1) (iii)..............  Notification to OTP for             2             2           1.0           4.0
                                  serious noncompliance.
8.4 (d) (1)....................  General document and               10             2           0.5          10.0
                                  information to SAMHSA
                                  upon request.
8.4 (d) (2)....................  Accrediation survey to             10             6           0.2          12.0
                                  SAMHSA upon request.
8.4 (d) (3)....................  List of surveys,                   10             6           0.2          12.0
                                  surveyors to SAMHSA
                                  upon request.
8.4 (d) (4)....................  Less than full                     10           7.5           0.5          37.5
                                  accrediation report to
                                  SAMHSA.
8.4 (d) (5)....................  Summaries of                       10            30           0.5         150.0
                                  Inspections.
8.4 (e)........................  Notifications of                   10             1           0.5           5.0
                                  Compliants.
8.6 (a) (2) and (b) (3)........  Revocation notification             1            90           0.3          27.0
                                  to Accredited OTP's.
8.6 (b)........................  Submission of 90-day                1             1            10          10.0
                                  Corrective plan to
                                  SAMHSA.
8.6 (b) (1)....................  Notification to                     1            90           0.3          27.0
                                  accredited OTP's of
                                  Probationary Status.
                                                         --------------                            -------------
      Total....................  .......................            82  ............  ............          341
----------------------------------------------------------------------------------------------------------------
Note: Because some of the numbers underlying these estimates have been rounded, figures in this table are
  approximate. There are no maintenance and operation costs nor start up and capital costs.

    Recordkeeping--The recordkeeping requirements for OTPs set forth in 
sec. 8.12 include maintenance of the following: A patient's medical 
evaluation and other assessments when admitted to treatment, and 
periodically throughout treatment Sec. 8.12(f)(4)); the provision of 
needed services, including any prenatal support provided the patient 
(Sec. 8.12(f)(3) and (f)(4)) justification of exceptional initial 
doses; changes in a patient's dose and dosage schedule; justification 
for variations from the approved product labeling for LAAM and future 
medications (Sec. 8.12(h)(4)); and the rationale for decreasing a 
patient's clinic attendance (Sec. 8.12(i)(3)).
    In addition, sec. 8.4(c)(1) will require accreditation bodies to 
keep and retain for 5 years certain records pertaining to their 
respective accreditation activities.

[[Page 4090]]

These recordkeeping requirements for OTPs and accreditation bodies are 
customary and usual practices within the medical and rehabilitative 
communities, and thus impose no additional response burden hours or 
costs.
    Disclosure--This final rule retains requirements that OTPs and 
accreditation organizations disclose information. For example, sec. 
8.12(e)(1) requires that a physician explain the facts concerning the 
use of opioid drug treatment to each patient. This type of disclosure 
is considered to be consistent with the common medical practice and is 
not considered an additional burden. Further, the new rules require 
under sec. 8.4(i)(1) that each accreditation organization shall make 
public its fee structure. The Secretary notes that the preceding 
section of this notice contains publicly available information on the 
fee structure for each of three accreditation bodies. This type of 
disclosure is standard business practice and is not considered a burden 
in this analysis.
    Individuals and organizations may submit comments on these burden 
estimates or any other aspect of these information collection 
provisions, including suggestions for reducing the burden, and should 
direct them to: SAMHSA Reports Clearance Officer, Room 16-105, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857.
    The information collection provisions in this final rule have been 
approved under OMB control number 0930-0206. This approval expires 09/
30/2003. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

Nelba Chavez,
Administrator, Substance Abuse and Mental Health Services, 
Administration.
    Dated: January 5, 2001.
Donna E. Shalala,
Secretary of Health and Human Services.

VII. References

    The following references have been placed on display at SAMHSA/CSAT 
Reading Room (7-220), 5515 Security Lane, Rockville, MD 20852.

    1. Institute of Medicine, Federal Regulation of Methadone 
Treatment, National Academy Press, 1995.
    2. ``New Hampshire Legislature Allows Methadone Treatment,'' 
Copyright 2000, Alcoholism & Drug Abuse Weekly, Manisses 
Communications Group, Inc., Vol. 12, No. 23, Monday, June 5, 2000.
    3. Sees, K.L., D.O., et al., ``Methadone Maintenance vs 180-Day 
Psychosocially Enriched Detoxification for Treatment of Opioid 
Dependence, A Randomized Controlled Trial,'' Journal of the American 
Medical Association, Vol 283, No. 10 p1303-1310, March 8, 2000.
    4. Clark, H. Westly, M.D., Lepay, David, M.D., ``Dear Colleague 
Letter on Medical Maintenance'', March 30, 2000.
    5. Schwartz, M.D., et al., ``A 12-Year Follow-Up of a Methadone 
Medical Maintenance Program, Am J Addiction, Vol. 8, pp 293-299, 
1999.

List of Subjects

21 CFR Part 291

    Health professions, Methadone, Reporting and recordkeeping 
requirements.

42 CFR Part 8

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

    Therefore, under the Comprehensive Drug Abuse Prevention and 
Control Act of 1970, the Controlled Substances Act as amended by the 
Narcotic Addict Treatment Act of 1974, the Public Health Service Act, 
and applicable delegations of authority thereunder, titles 21 and 42 of 
the Code of Federal Regulations are amended as follows:

21 CFR Chapter I

PART 291--[REMOVED]

    1. Under authority of sections 301(d), 543, 1976 of the Public 
Health Service Act (42 U.S.C. 241(d), 290dd-2, 300y-11); 38 U.S.C. 
7332, 42 U.S.C. 257a; and section 303(g) of the Controlled Substances 
Act (21 U.S.C. 823(g)), amend title 21 of the Code of Federal 
Regulations by removing part 291.

42 CFR Chapter I

    2. Amend 42 CFR Chapter I by adding part 8 to subchapter A to read 
as follows:

PART 8--CERTIFICATION OF OPIOID TREATMENT PROGRAMS

Subpart A--Accreditation

Sec.
8.1  Scope.
8.2  Definitions.
8.3  Application for approval as an accreditation body.
8.4  Accreditation body responsibilities.
8.5  Periodic evaluation of accreditation bodies.
8.6  Withdrawal of approval of accreditation bodies.
Subpart B--Certification and Treatment Standards
8.11  Opioid treatment program certification.
8.12  Federal opioid treatment standards.
8.13  Revocation of accreditation and accreditation body approval.
8.14  Suspension or revocation of certification.
8.15  Forms.
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
8.21   Applicability.
8.22  Definitions.
8.23  Limitation on issues subject to review.
8.24  Specifying who represents the parties.
8.25  Informal review and the reviewing official's response.
8.26  Preparation of the review file and written arguments.
8.27  Opportunity for oral presentation.
8.28  Expedited procedures for review of immediate suspension.
8.29  Ex parte communications.
8.30  Transmission of written communications by reviewing official 
and calculation of deadlines.
8.31  Authority and responsibilities of the reviewing official.
8.32  Administrative record.
8.33  Written decision.
8.34  Court review of final administrative action; exhaustion of 
administrative remedies.

    Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 
300x-23, 300x-27(a), 300y-11.

Subpart A--Accreditation


Sec. 8.1  Scope.

    The regulations in this part establish the procedures by which the 
Secretary of Health and Human Services (the Secretary) will determine 
whether a practitioner is qualified under section 303(g) of the 
Controlled Substances Act (21 U.S.C. 823(g)) to dispense opioid drugs 
in the treatment of opioid addiction. These regulations also establish 
the Secretary's standards regarding the appropriate quantities of 
opioid drugs that may be provided for unsupervised use by individuals 
undergoing such treatment (21 U.S.C. 823(g)(1)). Under these 
regulations, a practitioner who intends to dispense opioid drugs in the 
treatment of opioid addiction must first obtain from the Secretary or 
by delegation, from the Administrator, Substance Abuse and Mental 
Health Services Administration (SAMHSA), a certification that the 
practitioner is qualified under the Secretary's standards and will 
comply with such standards. Eligibility for certification will depend 
upon the practitioner obtaining accreditation from an accreditation 
body that has been approved by SAMHSA. These regulations establish the 
procedures whereby an entity can apply to become an approved 
accreditation body. This

[[Page 4091]]

part also establishes requirements and general standards for 
accreditation bodies to ensure that practitioners are consistently 
evaluated for compliance with the Secretary's standards for opiate 
addiction treatment with an opioid agonist treatment medication.


Sec. 8.2  Definitions.

    The following definitions apply to this part:
    Accreditation means the process of review and acceptance by an 
accreditation body.
    Accreditation body means a body that has been approved by SAMHSA 
under Sec. 8.3 to accredit opioid treatment programs using opioid 
agonist treatment medications.
    Accreditation body application means the application filed with 
SAMHSA for purposes of obtaining approval as an accreditation body, as 
described in Sec. 8.3(b).
    Accreditation elements mean the elements or standards that are 
developed and adopted by an accreditation body and approved by SAMHSA.
    Accreditation survey means an onsite review and evaluation of an 
opioid treatment program by an accreditation body for the purpose of 
determining compliance with the Federal opioid treatment standards 
described in Sec. 8.12.
    Accredited opioid treatment program means an opioid treatment 
program that is the subject of a current, valid accreditation from an 
accreditation body approved by SAMHSA under Sec. 8.3(d).
    Certification means the process by which SAMHSA determines that an 
opioid treatment program is qualified to provide opioid treatment under 
the Federal opioid treatment standards.
    Certification application means the application filed by an opioid 
treatment program for purposes of obtaining certification from SAMHSA, 
as described in Sec. 8.11(b).
    Certified opioid treatment program means an opioid treatment 
program that is the subject of a current, valid certification under 
Sec. 8.11.
    Comprehensive maintenance treatment is maintenance treatment 
provided in conjunction with a comprehensive range of appropriate 
medical and rehabilitative services.
    Detoxification treatment means the dispensing of an opioid agonist 
treatment medication in decreasing doses to an individual to alleviate 
adverse physical or psychological effects incident to withdrawal from 
the continuous or sustained use of an opioid drug and as a method of 
bringing the individual to a drug-free state within such period.
    Federal opioid treatment standards means the standards established 
by the Secretary in Sec. 8.12 that are used to determine whether an 
opioid treatment program is qualified to engage in opioid treatment. 
The Federal opioid treatment standards established in Sec. 8.12 also 
include the standards established by the Secretary regarding the 
quantities of opioid drugs which may be provided for unsupervised use.
    For-cause inspection means an inspection of an opioid treatment 
program by the Secretary, or by an accreditation body, that may be 
operating in violation of Federal opioid treatment standards, may be 
providing substandard treatment, or may be serving as a possible source 
of diverted medications.
    Interim maintenance treatment means maintenance treatment provided 
in conjunction with appropriate medical services while a patient is 
awaiting transfer to a program that provides comprehensive maintenance 
treatment.
    Long-term detoxification treatment means detoxification treatment 
for a period more than 30 days but not in excess of 180 days.
    Maintenance treatment means the dispensing of an opioid agonist 
treatment medication at stable dosage levels for a period in excess of 
21 days in the treatment of an individual for opioid addiction.
    Medical director means a physician, licensed to practice medicine 
in the jurisdiction in which the opioid treatment program is located, 
who assumes responsibility for administering all medical services 
performed by the program, either by performing them directly or by 
delegating specific responsibility to authorized program physicians and 
healthcare professionals functioning under the medical director's 
direct supervision.
    Medical and rehabilitative services means services such as medical 
evaluations, counseling, and rehabilitative and other social programs 
(e.g., vocational and educational guidance, employment placement), that 
are intended to help patients in opioid treatment programs become and/
or remain productive members of society.
    Medication unit means a facility established as part of, but 
geographically separate from, an opioid treatment program from which 
licensed private practitioners or community pharmacists dispense or 
administer an opioid agonist treatment medication or collect samples 
for drug testing or analysis.
    Opiate addiction is defined as a cluster of cognitive, behavioral, 
and physiological symptoms in which the individual continues use of 
opiates despite significant opiate-induced problems. Opiate dependence 
is characterized by repeated self-administration that usually results 
in opiate tolerance, withdrawal symptoms, and compulsive drug-taking. 
Dependence may occur with or without the physiological symptoms of 
tolerance and withdrawal.
    Opioid agonist treatment medication means any opioid agonist drug 
that is 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 opiate addiction.
    Opioid drug means any drug having an addiction-forming or 
addiction-sustaining liability similar to morphine or being capable of 
conversion into a drug having such addiction-forming or addiction-
sustaining liability.
    Opioid treatment means the dispensing of an opioid agonist 
treatment medication, along with a comprehensive range of medical and 
rehabilitative services, when clinically necessary, to an individual to 
alleviate the adverse medical, psychological, or physical effects 
incident to opiate addiction. This term encompasses detoxification 
treatment, short-term detoxification treatment, long-term 
detoxification treatment, maintenance treatment, comprehensive 
maintenance treatment, and interim maintenance treatment.
    Opioid treatment program or ``OTP'' means a program or practitioner 
engaged in opioid treatment of individuals with an opioid agonist 
treatment medication.
    Patient means any individual who undergoes treatment in an opioid 
treatment program.
    Program sponsor means the person named in the application for 
certification described in Sec. 8.11(b) as responsible for the 
operation of the opioid treatment program and who assumes 
responsibility for all its employees, including any practitioners, 
agents, or other persons providing medical, rehabilitative, or 
counseling services at the program or any of its medication units. The 
program sponsor need not be a licensed physician but shall employ a 
licensed physician for the position of medical director.
    Registered opioid treatment program means an opioid treatment 
program that is registered under 21 U.S.C. 823(g).
    Short-term detoxification treatment means detoxification treatment 
for a period not in excess of 30 days.
    State Authority is the agency designated by the Governor or other 
appropriate official designated by the

[[Page 4092]]

Governor to exercise the responsibility and authority within the State 
or Territory for governing the treatment of opiate addiction with an 
opioid drug.
    Treatment plan means a plan that outlines for each patient 
attainable short-term treatment goals that are mutually acceptable to 
the patient and the opioid treatment program and which specifies the 
services to be provided and the frequency and schedule for their 
provision.


Sec. 8.3  Application for approval as an accreditation body.

    (a) Eligibility. Private nonprofit organizations or State 
governmental entities, or political subdivisions thereof, capable of 
meeting the requirements of this part may apply for approval as an 
accreditation body.
    (b) Application for initial approval. Three copies of an 
accreditation body application form [SMA-163] shall be submitted to 
SAMHSA at rm. 12-105, 5600 Fishers Lane, Rockville, MD 20857, and 
marked ATTENTION: OTP Certification Program. SAMHSA will consider and 
accept the electronic submission of these materials when electronic 
submission systems are developed and available. Accreditation body 
applications shall include the following information and supporting 
documentation:
    (1) Name, address, and telephone number of the applicant and a 
responsible official for the accreditation body. The application shall 
be signed by the responsible official;
    (2) Evidence of the nonprofit status of the applicant (i.e., of 
fulfilling Internal Revenue Service requirements as a nonprofit 
organization) if the applicant is not a State governmental entity or 
political subdivision;
    (3) A set of the accreditation elements or standards and a detailed 
discussion showing how the proposed accreditation elements or standards 
will ensure that each OTP surveyed by the applicant is qualified to 
meet or is meeting each of the Federal opioid treatment standards set 
forth in Sec. 8.12;
    (4) A detailed description of the applicant's decisionmaking 
process, including:
    (i) Procedures for initiating and performing onsite accreditation 
surveys of OTPs;
    (ii) Procedures for assessing OTP personnel qualifications;
    (iii) Copies of an application for accreditation, guidelines, 
instructions, and other materials the applicant will send to OTPs 
during the accreditation process, including a request for a complete 
history of prior accreditation activities and a statement that all 
information and data submitted in the application for accreditation is 
true and accurate, and that no material fact has been omitted;
    (iv) Policies and procedures for notifying OTPs and SAMHSA of 
deficiencies and for monitoring corrections of deficiencies by OTPs;
    (v) Policies and procedures for suspending or revoking an OTP's 
accreditation;
    (vi) Policies and procedures that will ensure processing of 
applications for accreditation and applications for renewal of 
accreditation within a timeframe approved by SAMHSA; and
    (vii) A description of the applicant's appeals process to allow 
OTPs to contest adverse accreditation decisions.
    (5) Policies and procedures established by the accreditation body 
to avoid conflicts of interest, or the appearance of conflicts of 
interest, by the applicant's board members, commissioners, professional 
personnel, consultants, administrative personnel, and other 
representatives;
    (6) A description of the education, experience, and training 
requirements for the applicant's professional staff, accreditation 
survey team membership, and the identification of at least one licensed 
physician on the applicant's staff;
    (7) A description of the applicant's training policies;
    (8) Fee schedules, with supporting cost data;
    (9) Satisfactory assurances that the body will comply with the 
requirements of Sec. 8.4, including a contingency plan for 
investigating complaints under Sec. 8.4(e);
    (10) Policies and procedures established to protect confidential 
information the applicant will collect or receive in its role as an 
accreditation body; and
    (11) Any other information SAMHSA may require.
    (c) Application for renewal of approval. An accreditation body that 
intends to continue to serve as an accreditation body beyond its 
current term shall apply to SAMHSA for renewal, or notify SAMHSA of its 
intention not to apply for renewal, in accordance with the following 
procedures and schedule:
    (1) At least 9 months before the date of expiration of an 
accreditation body's term of approval, the body shall inform SAMHSA in 
writing of its intent to seek renewal.
    (2) SAMHSA will notify the applicant of the relevant information, 
materials, and supporting documentation required under paragraph (b) of 
this section that the applicant shall submit as part of the renewal 
procedure.
    (3) At least 3 months before the date of expiration of the 
accreditation body's term of approval, the applicant shall furnish to 
SAMHSA three copies of a renewal application containing the 
information, materials, and supporting documentation requested by 
SAMHSA under paragraph (c)(2) of this section.
    (4) An accreditation body that does not intend to renew its 
approval shall so notify SAMHSA at least 9 months before the expiration 
of the body's term of approval.
    (d) Rulings on applications for initial approval or renewal of 
approval. (1) SAMHSA will grant an application for initial approval or 
an application for renewal of approval if it determines the applicant 
substantially meets the accreditation body requirements of this 
subpart.
    (2) If SAMHSA determines that the applicant does not substantially 
meet the requirements set forth in this subpart. SAMHSA will notify the 
applicant of the deficiencies in the application and request that the 
applicant resolve such deficiencies within 90 days of receipt of the 
notice. If the deficiencies are resolved to the satisfaction o