[Federal Register Volume 74, Number 117 (Friday, June 19, 2009)]
[Proposed Rules]
[Pages 29153-29158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14286]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 8

RIN 0930-AA14


Opioid Drugs in Maintenance and Detoxification Treatment of 
Opiate Addiction; Buprenorphine and Buprenorphine Combination; Approved 
Opioid Treatment Medications Use

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

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: This proposed rule amends the Federal opioid treatment program 
regulations by modifying the dispensing requirements for buprenorphine 
and buprenorphine combination products approved by FDA for opioid 
dependence and used in federally certified and registered opioid 
treatment programs. Opioid treatment programs that use these products 
in the treatment of opioid dependence will adhere to all other Federal 
treatment standards established for methadone.

[[Page 29154]]


DATES: Written comments must be received by the Substance Abuse and 
Mental Health Services Administration (SAMHSA) on or before August 18, 
2009.

ADDRESSES: To assure proper handling of comments, please reference 
``Docket No. CSAT 001'' on all written and electronic correspondence. 
Written comments may be submitted to the Division of Pharmacologic 
Therapies, Center for Substance Abuse Treatment, 1 Choke Cherry Road, 
Room 2-1063, Rockville, MD 20857; Attention: DPT Federal Register 
Representative. Alternatively, comments may be submitted directly to 
SAMHSA by sending an electronic message to <a href="/cdn-cgi/l/email-protection#325642466d5b5c4657405b5f40475e577241535f5a41531c5a5a411c555d44"><span class="__cf_email__" data-cfemail="d0b4a0a48fb9bea4b5a2b9bda2a5bcb590a3b1bdb8a3b1feb8b8a3feb7bfa6">[email protected]</span></a>. Comments may also be sent electronically 
through http://www.regulations.gov using the electronic comment form 
provided on that site. An electronic copy of this document is also 
available at the http://www.regulation.gov Web site. Comments may also 
be sent electronically through http://www.regulations.gov using the 
electronic comment form provided on that site. An electronic copy of 
this document is also available at the http://www.regulations.gov Web 
site. SAMHSA will accept attachments to electronic comments in 
Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. 
SAMHSA will not accept any file formats other than those specifically 
listed here.
    Please note that SAMHSA is requesting that electronic comments be 
submitted before midnight Eastern time on the day the comment period 
closes because http://www.regulations.gov terminates the public's 
ability to submit comments at midnight Eastern time on the day the 
comment period closes. Commenters in time zones other than Eastern time 
may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.
    Posting of public comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://www.regulations.gov and in the SAMHSA's 
public docket. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the SAMHSA's public docket file. Please note that the Freedom of 
Information Act applies to all comments received. If you wish to 
inspect the agency's public docket file in person by appointment, 
please see the FOR FURTHER INFORMATION CONTACT paragraph.

FOR FURTHER INFORMATION CONTACT: Nicholas Reuter, Center for Substance 
Abuse Treatment (CSAT), Division of Pharmacologic Therapies, SAMHSA, 1 
Choke Cherry Road, Room 2-1063, Rockville, MD 20857, (240) 276-2716, e-
mail: <a href="/cdn-cgi/l/email-protection#84caede7ecebe8e5f7aad6e1f1f0e1f6c4f7e5e9ecf7e5aaececf7aae3ebf2"><span class="__cf_email__" data-cfemail="602e0903080f0c01134e3205151405122013010d0813014e0808134e070f16">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    In a document published in the Federal Register of January 17, 2001 
(66 FR 4076, January 17, 2001), SAMHSA issued final regulations for the 
use of narcotic drugs in maintenance and detoxification treatment of 
opioid addiction. That final rule established an accreditation-based 
regulatory system under 42 CFR part 8 (``Certification of Opioid 
Treatment Programs (OTPs)''). The regulations also established (under 
Sec.  8.12) the Secretary's standards for the use of opioid medications 
in the treatment of addiction, including standards regarding the 
quantities of opioid drugs which may be provided for unsupervised use. 
The SAMHSA regulations establish the standards for determining that 
practitioners (programs) are qualified for Drug Enforcement 
Administration (DEA) registration under 21 U.S.C. 823(g)(1).
    Section 8.12(h) sets forth the standards for medication 
administration, dispensing and use. Under this Section, OTPs shall use 
only those opioid agonist treatment medications that are approved by 
the Food and Drug Administration (FDA) under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment 
of opioid addiction. The regulation listed methadone and levomethadyl 
acetate (``ORLAAM'') as the opioid agonist treatment medications 
considered to be approved by the FDA for use in the treatment of opioid 
addiction.
    A. Interim Final Rule--SAMHSA/CSAT expanded the list of approved 
medications for use in certified opioid treatment programs by issuing 
an Interim Final Rule on May 22, 2003 (68 FR 27937, May 22, 2003, 
``Interim Final Rule''). This document was preceded by the Food and 
Drug Administration's approval of two buprenorphine products 
(Subutex[supreg] and Suboxone[supreg]) on October 8, 2002, and the Drug 
Enforcement Administration's (DEA) rescheduling of bulk buprenorphine, 
as well as all approved medical products containing buprenorphine from 
Schedule V to Schedule III (see Federal Register of October 7, 2002 (67 
FR 62354)).
    The May 22, 2003, Interim Final Rule added the two FDA-approved 
buprenorphine addiction treatment products to the previous list of 
approved opioid treatment medications under 42 CFR 8.12(h)(2). 
Effective upon publication, the Interim Final Rule allowed OTPs to use 
buprenorphine and buprenorphine combination for the treatment of opioid 
addiction. In addition, the Interim Final Rule required OTPs to apply 
the same treatment standards that were finalized on January 17, 2001, 
for methadone and ORLAAM. These requirements included the restrictions 
for treatment medications dispensed for unsupervised use, e.g., ``take-
home'' medication. Finally, the Interim Final Rule solicited comments 
on the new provisions.
    The ``take-home'' provisions are intended to reduce the risk of 
abuse and diversion of opioid treatment medications that have abuse 
potential. The rules tie the amount of ``take home'' medication that a 
program may dispense to patient characteristics, such as their 
stability, responsibility and time in treatment. For example, under 42 
CFR 8.12(i)(3), a patient would have to be stable in treatment for 9 
months to be eligible for a 6-day supply of medication

[[Page 29155]]

(either methadone or buprenorphine). In addition to the time in 
treatment eligibility, program physicians must still evaluate and 
document every patient's stability for take-home medication by applying 
the factors set forth under 42 CFR 8.12(i)(2).
    B. Buprenorphine in Office-Based Opioid Treatment--The Drug 
Addiction Treatment Act of 2000, (Section 3502 of the Children's Health 
Act of 2000, Public Law 106-310, 21 U.S.C. 823(g)(2)), ``DATA 2000'') 
permits qualified physicians to dispense certain opioid treatment 
medications for the treatment of opioid dependence. Under DATA 2000, 
qualifying physicians are ``certified'' to obtain waivers from the 
requirement to obtain approval from SAMHSA as OTPs. Qualifying 
physicians are permitted to dispense, including prescribe, Schedule 
III, IV, and V narcotic controlled drugs approved by the Food and Drug 
Administration specifically for maintenance or detoxification treatment 
without being separately registered as a narcotic treatment program by 
DEA (21 U.S.C. 823(g)(2)(A)).
    Certified physicians are subject to certain limits. For example, 
certified physicians are authorized to prescribe only opioid 
medications that are specifically approved by FDA for dependence or 
addiction treatment. These medications must be controlled in Schedules 
III through V. This excludes the Schedule II medication methadone. 
Physicians must be ``qualified'' by credentialing or experience. In 
addition, physicians are subject to limits on how many patients they 
can treat at any one time. Importantly, DATA 2000 did not include 
restrictions on the amount of an approved drug that may be prescribed 
to a patient at any one time.
    DATA 2000 assigned new responsibilities to both the Department of 
Health and Human Services (HHS) and the Department of Justice (DOJ). 
The DEA issued regulations to carry out the DOJ responsibilities, while 
HHS delegated implementation responsibilities to SAMHSA. SAMHSA has 
implemented the Department's new responsibilities without new rules. 
The DEA's final regulation removed the regulatory prohibition on 
prescribing narcotic treatment drugs, outlined the process for the 
interagency review of ``notifications'' under the new law and how the 
``unique identification number'' will be assigned, and established 
recordkeeping requirements for certified physicians. The DEA rule did 
not establish new requirements or limits for dispensing or prescribing 
buprenorphine products (70 FR 36338, June 23, 2005).
    In sum, DEA, FDA and SAMHSA actions to implement DATA 2000 and 
SAMHSA's May 22, 2003 Interim Final Rule distinguished how the same 
medications (buprenorphine and buprenorphine combination products) are 
dispensed in different settings (OTP versus certified physician. (Ref 
1)).
    C. Analysis of Comments--In response to the Interim Final Rule, 
SAMHSA received two comments from individuals representing hundreds of 
OTPs providing treatment in several States. While the comments support 
the Secretary's immediate action to make the new treatment medication 
available to OTPs expeditiously, the comments questioned the rationale 
for applying the treatment standards in place for methadone to the new 
buprenorphine products. One commenter noted that buprenorphine has the 
same pharmacological properties whether administered by OTPs or 
``waived physicians.''
    The commenter did not believe that the regulations should preclude 
OTPs from dispensing buprenorphine in the same manner as private 
physicians. They stated that it was an error to impose uniquely 
stringent treatment standards on those clinics best placed to 
administer buprenorphine products to treat addiction. Because of these 
dispensing restrictions, the interim final rule ``in short, will 
significantly limit if not completely suppress the availability of 
buprenorphine therapy in OTPs.''
    The comments also suggested that the restriction would impact 
patient care. Whether used in an OTP or in a private office, 
buprenorphine therapy should not be subject to the dispensing 
restrictions developed to deal with the special risks posed by Schedule 
II methadone. From the patient's perspective, the critical advantage of 
buprenorphine is the possibility of avoiding the long-term daily 
attendance for dosing that is required with methadone therapy. The 
commenters stated that ``OTPs have substantial experience in treating a 
particularly challenging population of patients. Requiring Schedule II 
type procedures for OTP-based buprenorphine treatment--and by 
precluding OTPs from administering buprenorphine in the same manner 
that the drug is available to private physicians--risks suppression of 
addicts entering treatment.''
    The commenters requested that SAMHSA provide OTPs with the same 
take-home prescribing authority which is currently in force for 
qualified physicians under DATA 2000. In this way, there will be no 
artificial difference in how OTPs prescribe buprenorphine as compared 
to qualified physicians under DATA 2000. The comments did not suggest 
changing the OTP dispensing restriction for methadone.
    The Secretary agrees with the comments supporting the modification 
of the dispensing regime for buprenorphine in OTPs. Based on the 
information available, the Department believes that the experience with 
buprenorphine use in addiction treatment over the last several years, 
together with the pharmacological properties of the approved 
buprenorphine treatment products, distinguishes Schedule III 
buprenorphine products from Schedule II methadone products. These 
distinctions strongly support the establishment of a less restrictive 
distribution scheme for Schedule III buprenorphine products approved to 
treat opioid dependence.
    D. Discussion--In contrast to 2003, there is now extensive 
experience with buprenorphine in the treatment of opioid dependence. 
Since 2002, over 16,000 physicians have sought and obtained the Federal 
certification to prescribe buprenorphine products. Over 73 million 
dosage units were distributed to pharmacies in 2007, millions of 
prescriptions have been issued, and hundreds of thousands of patients 
have been treated. Almost all the buprenorphine used in addiction 
treatment has come from physician prescriptions. These prescriptions 
have been issued without the mandatory time in treatment schedule 
currently in place for methadone products.
    The Secretary has assessed the public health implications 
associated with physician prescribed buprenorphine as part of a formal 
``Determinations Report.'' That report indicates that the DATA 2000 
physician waiver program has expanded access to treatment and produced 
effective treatment outcomes without producing negative public health 
issues (Ref. 2). According to the DEA's Automation of Reports and 
Consolidated Orders System (ARCOS), the amount of buprenorphine 
distributed each year has increased from 3 million dosage units in 2003 
to over 70 million dosage units in 2007 (Ref. 3).
    While buprenorphine products are abused and diverted, according to 
information from published literature reports and from long-standing 
monitoring systems maintained by FDA, SAMHSA, and DEA, the scope and 
nature of abuse and diversion are considerably less than that of 
methadone and other Schedule II opioid

[[Page 29156]]

drug products. FDA, SAMHSA, and DEA will continue to monitor the abuse 
and diversion of buprenorphine products and intervene if needed to 
address increases.
    The FDA Adverse Drug Monitoring System--MedWatch, is in place to 
receive and review adverse drug events on marketed prescription drugs. 
Since the buprenorphine addiction treatment products were approved in 
late 2002, FDA has received approximately 50 buprenorphine-associated 
fatal adverse events. Similar numbers have been reported by the drug 
manufacturer.
    Another monitoring system is SAMHSA's Drug Abuse Warning Network 
(DAWN). DAWN is a public health surveillance system that monitors drug-
related visits to hospital emergency departments (EDs). Hospital 
emergency department (ED) visits involving the nonmedical use (or 
misuse/abuse) of buprenorphine are increasing with the increased 
availability of buprenorphine products; however, ED visits involving 
the nonmedical use (or misuse/abuse) of buprenorphine are relatively 
rare. According to the 2006 DAWN report, out of an estimated 741,425 
drug-related ED visits involving the nonmedical use of pharmaceuticals 
in 2006, there were an estimated 4,440 (95 percent confidence interval 
[CI] 823 to 8,057) visits involving buprenorphine/combinations. DAWN 
estimates for 2004 and 2005 could not be published for buprenorphine 
because the estimates for buprenorphine were too imprecise for 
publication. The wide confidence interval for 2006 illustrates the 
relative imprecision of a national estimate based on few reports (Ref. 
4). In contrast, the ED visits for other opioids for 2006 are as 
follows: Oxycodone/combinations--64,888 visits (95 percent C.I. 49,746-
80,030); Hydrocodone/combinations--57,550 visits (95 percent C.I. 
43,701-71,398); Fentanyl/combinations--16,012 visits (95 percent C.I. 
7,441-24,582); Hydromorphone/combinations--6,780 (95 percent C.I. 
3,649-9,911); and, Methadone 45,130 (95 percent C.I. 35,870-54,389).
    In contrast, DAWN estimates from 2006 revealed that methadone was 
one of the top three opioid analgesics (along with hydrocodone/
combinations and oxycodone/combinations) associated with ED visits 
involving the nonmedical use of pharmaceuticals. Opioid analgesics were 
involved in 32 percent of visits involving nonmedical use of 
pharmaceuticals. According to the 2006 DAWN ED publication, methadone 
was associated with an estimated 45,000 ED visits involving nonmedical 
use. The consequences of methadone abuse, misuse, and diversion can be 
severe. Methadone-associated deaths [between 2001 and 2003] increased 
in many States including Maine, Florida, and North Carolina. Methadone-
detected deaths in Maine doubled between 1999 and 2000, while North 
Carolina noted a 5-fold increase between 1997 and 2001. Data from the 
National Center for Health Statistics (NCHS), National Vital Statistics 
System indicate that the rate at which methadone was listed on death 
certificates as contributing to deaths increased almost 4-fold between 
1999 and 2003 (Ref. 5).
    Finally, a DAWN medical examiner report from 2005 indicates that 
methadone contributed to deaths more frequently than other prescribed 
opioid medications in 5 out of 6 States (Ref 6). DAWN-Medical Examiner 
(DAWN-ME) collects data on all deaths where drugs played a role, either 
directly (such as an overdose) or indirectly (such as a fatal car crash 
where drugs were involved). A drug misuse death is defined as a drug-
related death caused by homicide by drugs, overmedication, all other 
accidental causes, and where the cause could not be determined. There 
are limitations with the DAWN-ME system. For example, the drugs 
acquired through legitimate prescriptions cannot be differentiated from 
diverted prescription medications or illicit drugs because information 
on the source is not available.
    It is imperative to note, however, that following an extensive 
national assessment, a 2003 SAMHSA Methadone-Associated Mortality 
report did not associate increases in methadone distribution, 
diversion, morbidity and mortality with methadone administered and 
dispensed by OTPs. Indeed, the report indicated that Federal OTP 
regulations reduce the risk of methadone in-treatment mortality (Ref. 
7). While the Secretary has no immediate plans to revise methadone 
``take-home'' regulations, it may be appropriate to revisit the 
methadone dispensing restrictions under 42 CFR 8.12(i) at some point in 
the future.
    The differences between buprenorphine and methadone are also 
evident in their international and domestic control status. While 
buprenorphine is controlled under Schedule III of the Convention on 
Psychotropic Substances (1971), methadone is controlled in Schedule II 
of the Single Convention on Narcotic Drugs, the same level of control 
as morphine, cocaine, hydrocodone, and oxycodone. The international 
control status of buprenorphine was reaffirmed in September 2006 by the 
World Health Organization's 34th Expert Committee on Drug Control. The 
Committee, after reviewing evidence ``demonstrating unique 
pharmacological actions of buprenorphine, which distinguish it from 
other opioids'' such as methadone, concluded that buprenorphine's 
unique spectrum of pharmacological actions, did not warrant control 
under the Single Convention (Ref. 8).
    Domestically, buprenorphine is controlled in Schedule III of the 
Controlled Substances Act (CSA). Methadone is controlled domestically 
in Schedule II, along with cocaine, morphine, oxycodone and other 
potent narcotic substances. Under the CSA, Schedule III substances must 
be found to have less abuse potential and less potential to produce 
dependence when compared to Schedule II substances (21 U.S.C. 
812(b)(3)). Specifically, in controlling buprenorphine in Schedule III, 
the DEA found, based upon a recommendation from the Department of 
Health and Human Services, that buprenorphine has a potential for abuse 
less than the drugs or other substances in Schedules I and II. These 
important pharmacologic differences support a different regulatory 
distribution scheme for buprenorphine products (Ref. 9).
    Based upon the discussion above, the Secretary is proposing to 
eliminate the take-home dispensing schedule for buprenorphine products 
as set forth in Section III.

II. References

    1. Food and Drug Administration, approved product labeling, 
Suboxone and Subutex, October 2002, http://www.fda.gov/cder/foi/label/2002/20732lbl.pdf.
    2. Substance Abuse and Mental Health Services Administration, The 
Determinations Report: A Report On the Physician Waiver Program 
Established by the Drug Addiction Treatment Act of 2000. Submitted by 
the Center for Substance Abuse Treatment, Substance Abuse and Mental 
Health Services Administration, U.S. Department of Health and Human 
Services, March 30, 2006.
    3. Drug Enforcement Administration Automation of Reports and 
Consolidated Order System, 2006, Special Report.
    4. Drug Abuse Warning Network, 2006: National Estimates of Drug-
Related Emergency Department Visits, U.S. Department of Health and 
Human Services, Substance Abuse and Mental Health Services 
Administration, http://DAWNinfo.samhsa.gov, 2006.
    5. Fingerhut, L.A., Increases in Methadone-Related Deaths: 1999-
2004,

[[Page 29157]]

National Center for Health Statistics, Office of Analysis and 
Epidemiology.
    6. Substance Abuse and Mental Health Services Administration, Drug 
Abuse Warning Network, Opiate-Related Drug Misuse Deaths in Six States: 
2003, Issue 19, 2006.
    7. Center for Substance Abuse Treatment, Methadone-Associated 
Mortality: Report of a National Assessment, May 8-9, 2003. SAMHSA 
Publication No. 04-3904. Rockville, MD: Center for Substance Abuse 
Treatment, Substance Abuse and Mental Health Services Administration, 
2004.
    8. WHO Technical Report Series, 942, WHO Expert Committee On Drug 
Dependence, Thirty-Fourth Report, 2006, p 6.
    9. Drug Enforcement Administration, 67 FR 62354, October 7, 2002, 
Schedules of Controlled Substances: Rescheduling of Buprenorphine From 
Schedule V to Schedule III, Final rule.

III. Summary of Proposed Regulation

    The opioid treatment program regulations (42 CFR part 8) establish 
the procedures by which the Secretary will determine whether a 
practitioner is qualified under Section 303(g) of the CSA (21 U.S.C. 
823(g)(1)) to dispense certain therapeutic narcotic drugs in the 
treatment of individuals suffering from narcotic addiction. These 
regulations also establish the Secretary's standards regarding the 
appropriate quantities of narcotic drugs that may be provided for 
unsupervised use by individuals undergoing such treatment (21 U.S.C. 
823(g)(1)(c)). (See also 42 U.S.C. 257a.)
    SAMHSA is not proposing at this time to change any of the 
provisions in Subpart A (Accreditation) or Subpart C (Procedures for 
Review of Suspension or Proposed Revocation of OTP Certification and of 
Adverse Action Regarding Withdrawal of Approval of an Accreditation 
Body). Instead, SAMHSA is proposing a minor amendment to subpart B, 
Certification and Treatment Standards. If finalized, the rule would 
amend only one section of subpart B, Sec.  8.12(i). Unsupervised or 
``take-home'' use.
    Under 42 CFR 8.12(i), OTPs must adhere to requirements for 
dispensing treatment medications for unsupervised or ``take-home'' use. 
These restrictions are in place to limit or reduce the potential for 
diversion of these medications to the illicit market. The effect of 
this proposed rule is to remove the restrictions for dispensing 
buprenorphine and buprenorphine combination products for unsupervised 
or ``take-home'' use while retaining those requirements for methadone 
products. This proposed change would be incorporated by adding the 
following language to 42 CFR 8.12(i)(3): ``The dispensing restrictions 
set forth in paragraphs (i) through (vi) do not apply to buprenorphine 
and buprenorphine products listed under 42 CFR section 
8.12(h)(2)(iii).''
    It should be noted that OTPs would still be required to assess and 
document each patient's responsibility and stability to handle opioid 
drug products for unsupervised use set forth under 42 CFR 8.12(i)(2) 
and 8.12(i)(3).

IV. Request for Comments

    Under the rulemaking provisions of the Administrative Procedure Act 
(APA), an agency must provide the public with notice of certain 
proposed rules it wishes to promulgate (through publication in the 
Federal Register), and must afford the public an opportunity to comment 
on those proposed rules before they become final [5 U.S.C. 553(b)].
    Instructions for submitting comments to this proposed rule are 
discussed above. SAMHSA will consider comments submitted during the 60-
day comment period. All comments are welcome; however, information and 
evidence specific to this issue of buprenorphine and buprenorphine 
dispensing by certified OTPs will be especially useful.

V. Analysis of Economic Impacts

    The Secretary has examined the impact of this proposed rule under 
Executive Order 12866, which directs Federal agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages, distributive impacts, and 
equity). This proposed rule does not establish additional regulatory 
requirements; it allows an activity that is otherwise prohibited. 
According to Executive Order 12866, a regulatory action is 
``significant'' if it meets any one of a number of specified 
conditions, including having an annual effect on the economy of $100 
million; adversely affecting in a material way a sector of the economy, 
competition, or jobs; or if it raises novel legal or policy issues. A 
detailed discussion of the Secretary's analysis is contained in the 
opioid treatment Final Rule published in the Federal Register of 
January 17, 2001 (66 FR 4086-4090). That document described the impact 
of the opioid treatment regulations, analyzed alternatives, and 
considered comments from small entities. In addition, a Federal 
Register notice published April 17, 2006, offered the opportunity for 
comments on this information collection activity.
    The Secretary also finds that this proposed rule is not a 
significant regulatory action as defined by Executive Order 12866. The 
rule merely permits OTPs to dispense buprenorphine and buprenorphine 
combination products without adhering to the dispensing schedule 
established for Schedule II medications like methadone. If opioid 
treatment programs choose to use these products, the new medications 
will be used in accordance with all other standards set forth in the 
January 17, 2001, Final Rule (66 FR 4090). No new regulatory 
requirements are imposed by this proposed rule; however, some 
regulatory requirements will be reduced.
    The Secretary anticipates that there will be an overall reduction 
in societal costs if treatment is expanded under this proposal. Indeed, 
the National Institutes of Health estimates conservatively that every 
$1 invested in addiction treatment programs yields a return of between 
$4 and $7 in reduced drug-related crime, criminal justice costs, and 
theft. When savings related to health care are included, total savings 
can exceed costs by a 12 to 1 ratio.
    For the reasons outlined above, the Secretary has determined that 
this proposed rule will not have a significant impact upon a 
substantial number of small entities within the meaning of the 
Regulatory Flexibility Act (5 U.S.C. 605(b)). Therefore, an initial 
regulatory flexibility analysis is not required for this proposed Rule.
    The Secretary has determined that this rule is not a major rule for 
the purpose of congressional review. For the purpose of congressional 
review, a major rule is one which is likely to cause an annual effect 
on the economy of $100 million; a major increase in costs or prices; 
significant effects on competition, employment, productivity, or 
innovation; or significant effects on the ability of U.S.-based 
enterprises to compete with foreign-based enterprises in domestic or 
export markets. This is not a major rule under the Small Business 
Regulatory Enforcement Fairness Act (SBREFA) of 1996.
    The Secretary has examined the impact of this rule under the 
Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This rule 
does not trigger the requirement for a written statement under section 
202(a) of the UMRA because it does not impose a mandate that results in 
an expenditure of $100 million (adjusted annually for

[[Page 29158]]

inflation) or more by either State, local, and tribal governments in 
the aggregate or by the private sector in any 1 year.

Environmental Impact

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

Executive Order 13132: Federalism

    The Secretary has analyzed this proposed 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'' refers 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 proposed rule to modify treatment 
regulations that provide for the use of approved opioid agonist 
treatment medications in the treatment of opiate addiction. The 
Narcotic Addict Treatment Act (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 proposed rule does not 
preempt State law. Accordingly, the Secretary has determined that this 
proposed rule does not contain policies that have federalism 
implications or that preempt State law.

Paperwork Reduction Act of 1995

    This proposed rule modifies 42 CFR 8.12(i) by reducing regulatory 
dispensing requirements for buprenorphine and buprenorphine combination 
products that may be used in SAMHSA-certified opioid treatment 
programs. The proposed rule establishes no new reporting or 
recordkeeping requirements beyond those discussed in the January 17, 
2001, Final Rule (66 FR 4076 at 4088). On January 10, 2007, the Office 
of Management and Budget approved the information collection 
requirements of the Final Rule under control number 0930-0206.

Executive Order 13175: Consultation and Coordination With Indian Tribal 
Governments

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

    Dated: May 1, 2009.
Eric B. Broderick,
Acting Administrator, SAMHSA, Assistant Surgeon General.
    Dated: May 13, 2009.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.

List of Subjects in 42 CFR Part 8

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

    For the reasons set forth above, part 8 of Title 42 of the Code of 
Federal Regulations is proposed to be amended as follows:
    1. The authority citation for part 8 continues to read as follows:

    Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2, 
300x-23, 300x-27(a), 300y-11.
    2. Section 8.12(i)(3) introductory text is revised to read as 
follows:


Sec.  8.12  Federal opioid treatment standards.

* * * * *
    (i) * * *
    (3) Such determinations and the basis for such determinations 
consistent with the criteria outlined in paragraph (i)(2) of this 
section shall be documented in the patient's medical record. If it is 
determined that a patient is responsible in handling opioid drugs, the 
dispensing restrictions set forth in paragraphs (i)(3)(i) through (vi) 
of this section apply. The dispensing restrictions set forth in 
paragraphs (i)(3)(i) through (vi) of this section do not apply to 
buprenorphine and buprenorphine products listed under 42 CFR 
8.12(h)(2)(iii).
* * * * *
[FR Doc. E9-14286 Filed 6-18-09; 8:45 am]
BILLING CODE 4160-20-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>