Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Proposed Rules 29153 

Order 13175, Consultation and 

Coordination with Indian Tribal 

Governments, because it would not have 

a substantial direct effect on one or 

more Indian tribes, 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. 

Energy Effects 

We have analyzed this proposed rule 

under Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’ 

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This proposed rule does not use 

technical standards. Therefore, we did 

not consider the use of voluntary 

consensus standards. 

Environment 

We have analyzed this proposed rule 

under Department of Homeland 

Security Management Directive 023–01 

and Commandant Instruction 

M16475.1D, which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have made a preliminary determination 

that this action is one of a category of 

actions which do not individually or 

cumulatively have a significant effect on 

the human environment. A preliminary 

environmental analysis checklist 

supporting this determination is 

available in the docket where indicated 

under ADDRESSES. This proposed rule 

involves the establishment of safety 

zones and as such should be 

categorically excluded, under figure 

2–1, paragraph 34(g) of the Instruction 

from further environmental 

documentation. 

We seek any comments or information 

that may lead to the discovery of a 

significant environmental impact from 

this proposed rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine Safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard proposes to 

amend 33 CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Public Law 107–295, 116 Stat. 2064; 

Department of Homeland Security Delegation 

No. 0170.1 

2. In § 165.939 revise paragraph (a) 

introductory text and add paragraphs 

(a)(27) through (32) to read as follows: 

§ 165.939 Safety Zones; Annual Fireworks 

Events in the Captain of the Port Buffalo 

Zone. 

(a) Safety Zones: 

* * * * * 

(27) Independence Celebration 

Fireworks, Lake Ontario, Oswego 

Harbor, Oswego, NY—(i) Location. All 

waters of Lake Ontario at within an 800- 

foot radius of position 43°28′05′′ N, 

076°31′01′′ W; in Oswego Harbor, 

Oswego, NY. (DATUM: NAD 83). 

(ii) Enforcement date. One day in the 

first week of July. 

(28) Rochester Harborfest, Lake 

Ontario at the Genesee River, Rochester, 

NY—(i) Location. All waters of Lake 

Ontario at Genesee River, within a 500- 

foot radius of position 43°15′21′′ N, 

077°36′19′′ W; in Rochester, NY. 

[DATUM: NAD 83]. Located on the 

Ontario Beach West pier. 

(ii) Enforcement date. One weekend 

after Fathers Day weekend in June. 

(29) A Salute to Our Hero’s, Lake 

Ontario, Hamlin, NY—(i) Location. All 

waters of Lake Ontario within a 300-foot 

radius of position 43°16′27′′ N, 

076°58′27′′ W; off Hamlin Beach State 

Park Area 1. (DATUM: NAD 83). 

(ii) Enforcement date. One day in the 

first week of July. 

(30) Olcott NY Fireworks, Lake 

Ontario, Olcott, NY—(i) Location. All 

waters of Lake Ontario within a 600-foot 

radius of position 43°20′24′′ N, 

078°43′09′′ W; located on the West 

Federal Pier in Olcott, NY. (DATUM: 

NAD 83). 

(ii) Enforcement date. One day in the 

first week of July. 

(31) Erie Summer Festival of the Arts, 

Lake Erie, Presque Isle Bay, Erie, PA— 

(i) Location. All waters of Lake Erie, 

Presque Isle Bay within a 420-foot 

radius of position 42°07′45′′ N, 

080°06′20′′ W; in Erie, PA (DATUM: 

NAD 83). 

(ii) Enforcement date. One day in the 

last week of June. 

(32) Mercyhurst College ‘‘Old Fashion 

4th of July,’’ Lake Erie, Presque Isle Bay, 

Erie, PA—(i) Location. All waters of 

Lake Erie, Presque Isle Bay 1,000 feet 

NW of the Chestnut Street Boat Launch 

in a 400-foot radius of position 

42°08′41′′ N, 080°06′40′′ W; in Erie, PA. 

(DATUM: NAD 83). 

(ii) Enforcement date. One day in the 

first week of July. 

Dated: June 4, 2009. 

R.S. Burchell, 

Captain, U.S. Coast Guard, Captain of the 

Port Buffalo. 

[FR Doc. E9–14381 Filed 6–18–09; 8:45 am] 

BILLING CODE 4910–15–P 

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. 


cprice-sewell on PRODPC61 with PROPOSALS
29154 Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Proposed Rules 

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 

dpt_interimrule@samhsa.hhs.gov. 

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, email: Nicholas.Reuter@samhsa.hhs.gov. 

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 

§ 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® and Suboxone®) 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 


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Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Proposed Rules 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 


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29156 Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Proposed Rules 

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 drugrelated 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 DrugRelated 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, 


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National Center for Health Statistics, 

Office of Analysis and Epidemiology. 

6. Substance Abuse and Mental 

Health Services Administration, Drug 

Abuse Warning Network, OpiateRelated 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, 

§ 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 


cprice-sewell on PRODPC61 with PROPOSALS
29158 Federal Register / Vol. 74, No. 117 / Friday, June 19, 2009 / Proposed Rules 

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-AlphaAcetyl-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: 

§ 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 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Parts 300 and 665 

[Docket No. 080225267–9319–02] 

RIN 0648–AW49 

International Fisheries Regulations; 

Fisheries in the Western Pacific; 

Pelagic Fisheries; Hawaii-based 

Shallow-set Longline Fishery 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Proposed rule; request for 

comments. 

SUMMARY: This proposed rule would 

remove the annual limit on the number 

of fishing gear deployments (sets) for the 

Hawaii-based pelagic longline fishery. 

The rule would also increase the current 

limit on incidental interactions that 

occur annually between loggerhead sea 

turtles and shallow-set longline fishing. 

The proposed rule is intended to 

increase opportunities for the shallowset fishery to sustainably harvest 

swordfish and other fish species, 

without jeopardizing the continued 

existence of sea turtles and other 

protected resources. This proposed rule 

would also make several administrative 

clarifications to the regulations. 

DATES: Comments on the proposed rule 

must be received by August 3, 2009. 

ADDRESSES: Comments on this proposed 

rule, identified by 0648–AW49, may be 

sent to either of the following addresses: 

• Electronic Submission: Submit all 

electronic public comments via the 

Federal e-Rulemaking Portal 

www.regulations.gov; or 


cprice-sewell on PRODPC61 with PROPOSALS