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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 § 8.3(b)(4)(vii).

3. Response times in § 8.26(a), (b) and (c) have been lengthened, as have the oral presentation timeframes in § 8.27(d), and expedited procedures in § 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

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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

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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 

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Table 1.-- Annual Reporting Burden For Treatment Program --Continued

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.

Back to Table 1

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

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 § 8.12 include maintenance of the following: A patient's medical evaluation and other assessments when admitted to treatment, and periodically throughout treatment § 8.12(f)(4)); the provision of needed services, including any prenatal support provided the patient (§ 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 (§ 8.12(h)(4)); and the rationale for decreasing a patient's clinic attendance (§ 8.12(i)(3)).

In addition, § 8.4(c)(1) will require accreditation bodies to keep and retain for 5 years certain records pertaining to their respective accreditation activities.

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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, § 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 § 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 09/30/2002. 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.

 Subpart B--Certification and Treatment Standards

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

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

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