[Federal Register Volume 72, Number 182 (Thursday, September 20, 2007)]
[Proposed Rules]
[Pages 53734-53736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18531]



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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

[Docket No. DEA-275P]
RIN 1117-AA99


Changes to Patient Limitation for Dispensing or Prescribing 
Approved Narcotic Controlled Substances for Maintenance or 
Detoxification Treatment by Qualified Individual Practitioners

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Notice of Proposed Rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) is proposing to 
conform its regulations to recent statutory amendments to the 
Controlled Substances Act that changed certain patient limitations for 
practitioners who dispense or prescribe certain narcotic drugs for 
maintenance or detoxification treatment.

DATES: Written comments must be postmarked, and electronic comments 
must be sent, on or before November 19, 2007.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-275'' on all written and electronic correspondence. 
Written comments being sent via regular mail should be sent to the 
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration, Washington, DC 20537, Attention: DEA 
Federal Register Representative/ODL. Written comments sent via express 
mail should be sent to DEA Headquarters, Attention: DEA Federal 
Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, 
VA 22301. Comments may be sent directly to DEA electronically by 
sending an electronic message to [email protected]. 
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. DEA will accept attachments to 
electronic comments in Microsoft word, WordPerfect, Adobe PDF, or Excel 
file formats only. DEA will not accept any file formats other than 
those specifically listed here.
    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 Drug 
Enforcement Administration'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 posted online and placed in the Drug Enforcement Administration's 
public docket file. 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: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:

Overview

    On August 2, 2005, the President signed amendments to the 
Controlled Substances Act to increase the patient limitation on 
prescribing drug addiction treatments by qualified medical 
practitioners in group practices from 30 patients for each group to 30 
patients for each qualified practitioner in a group (Pub. L. 109-56; 
119 Stat. 591) (21 U.S.C. 823(g)(2)).
    On December 29, 2006, the President signed amendments to the 
Controlled Substances Act to permit certain qualifying physicians to 
dispense and prescribe Schedule III, IV, and V narcotic controlled 
substances approved by the Food and Drug Administration specifically 
for use in maintenance or detoxification treatment to up to 100 
patients at any one time, after the practitioner submits to the 
Secretary of Health and Human Services a notification of the 
practitioner's need and intent to treat the increased number of 
patients. The amendment was made as part of the Office of National Drug 
Control Policy Reauthorization Act of 2006 (ONDCPRA) (Sec.  1102 of 
Pub. L. 109-469, 120 Stat. 3502).
    This Notice of Proposed Rulemaking (NPRM) would conform DEA 
regulations to Pub. L. 109-56 by removing the requirement in 21 CFR 
1301.28(b)(iv) that limits to 30 the number of patients that could 
receive maintenance or detoxification treatment through a group 
practice. This change means that each qualifying practitioner whether 
working individually or in a group practice may offer maintenance and 
detoxification treatment to 30 patients at any one time. This NPRM 
would also conform DEA regulations to Sec.  1102 of Pub. L. 109-469 by 
permitting certain qualifying physicians to treat up to 100 patients. 
To qualify to treat the additional patients, not sooner than one year 
after the practitioner submitted the initial notification, the 
practitioner must submit a second notification to the Secretary of 
Health and Human Services of the need and intent of the practitioner to 
treat up to 100 patients. Further, the practitioner must be a 
``qualifying physician'' under 21 U.S.C. 823(g)(2)(G) and must have the 
capacity to refer the patients to whom the individual practitioner will 
provide narcotic drugs or combinations of narcotic drugs for 
appropriate counseling and other appropriate ancillary services (21 CFR 
1301.28(b)(1)(i) and (ii)). These proposed amendments would not change 
the requirement that each practitioner must first qualify to prescribe 
and dispense these medications for maintenance and detoxification 
treatment, or must be prescribing these approved substances using the 
``good faith'' exception, found within current regulations at 21 CFR 
1301.28(e).

Background

    On October 17, 2000, Congress passed the Drug Addiction Treatment 
Act of 2000 (DATA), amending the Controlled Substances Act (CSA) (21 
U.S.C. Sec.  801 et seq.) to establish ``waiver authority for 
physicians who dispense or prescribe certain narcotic drugs for 
maintenance

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treatment or detoxification treatment'' (Pub. L. 106-310, title XXXV; 
114 Stat. 1222, codified at 21 U.S.C. 823(g)(2)). Prior to DATA, the 
Controlled Substances Act and DEA regulations required practitioners 
who wanted to conduct maintenance or detoxification treatment using 
narcotic controlled drugs to be registered as a Narcotic Treatment 
Program (NTP) in addition to the practitioner's individual 
registration. The separate NTP registration authorized the practitioner 
to dispense or administer, but not prescribe, narcotic drugs.
    With passage of DATA, DEA published a NPRM (68 FR 37429; June 24, 
2003) proposing to amend the regulations affecting maintenance and 
detoxification treatment for narcotic treatment by establishing an 
exemption from the separate registration requirement. After 
consideration of the comments received on the NPRM, DEA published a 
Final Rule on June 23, 2005 (70 FR 36338). The June 23, 2005, Final 
Rule permitted the following:
    (1) Qualifying physicians to dispense and prescribe Schedule III, 
IV, and V narcotic controlled drugs approved by the Food and Drug 
Administration specifically for use in maintenance or detoxification 
treatment.
    (2) Narcotic-dependent patients to have one-on-one consultations 
with a practitioner in a private practice setting.
    (3) Pharmacies to fill prescriptions for Schedule III, IV, and V 
narcotic controlled drugs approved by the Food and Drug Administration 
specifically for use in maintenance or detoxification treatment.
    (4) Practitioners to offer maintenance and detoxification treatment 
with Schedule III, IV, and V narcotic controlled drugs approved by the 
Food and Drug Administration specifically for use in maintenance or 
detoxification treatment to no more than 30 patients in their private 
practices without having a second registration as a NTP.
    The exemption and other amendments established by the Final Rule 
apply to individual practitioners working in traditional NTPs as well 
as any other practice setting. The rule does not affect the existing 
prohibition against prescribing any Schedule II narcotic controlled 
drugs for maintenance or detoxification treatment.
    Under the provisions of DATA implementing regulations as codified 
in 21 CFR 1301.28(b)(1)(iii) and (iv), the 30-patient limitation 
applied equally to individual practices and to group practices (i.e., 
30 patients per group), severely limiting the number of patients that 
could be treated by physicians in group practices.
    Pursuant to Pub. L. 109-56 effective on August 2, 2005, and Sec.  
1102 of Pub. L. 109-469 effective on December 29, 2006, this NPRM would 
make conforming changes to DEA's regulations at 21 CFR 
1301.28(b)(1)(iii) and (iv). Specifically, paragraph (b)(1)(iii) is 
proposed to be amended to permit the treatment of up to 100 patients by 
a qualifying practitioner if the necessary criteria are met and 
notification is submitted to the Secretary of Health and Human 
Services. Further, paragraph (b)(1)(iii) is proposed to be amended by 
removing the phrase ``Where the individual practitioner is not a member 
of a group practice,'' since there is no longer a distinction between 
practitioners in group practices and those practicing independently. 
Finally, paragraph (b)(1)(iv) is proposed to be deleted to remove 
language regarding members of group practices.
    Relevant to the change regarding the treatment of up to 100 
patients, the Director of the Center for Substance Abuse Treatment in 
the Department of Health and Human Services issued a letter announcing 
the statutory change as follows:

    Under ONDCPRA (effective December 29, 2006), physicians who meet 
the following criteria may notify the Secretary of Health and Human 
Services (HHS) of their need and intent to treat up to 100 patients 
at any time: (1) The physician must currently be qualified under 
DATA 2000; (2) at least one year must have elapsed since the 
physician submitted the initial notification for authorization; (3) 
the physician must certify their capacity to refer patients for 
appropriate counseling and other appropriate ancillary services; and 
(4) the physician must certify that the total number of patients at 
any one time will not exceed the applicable number.

    DEA emphasizes that practitioners must meet these HHS criteria 
before prescribing a Schedule III, IV, or V controlled substance for 
narcotic maintenance or detoxification treatment to more than 30 
patients at any one time.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator, Office of Diversion Control, 
has reviewed this regulation and hereby certifies that it has been 
drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 
601-612) and that it will not have a significant economic impact on a 
substantial number of small entities. This NPRM would relieve a 
restriction on practitioners desiring to treat narcotic dependent 
patients by removing the 30 patient limit for group practices and by 
permitting certain qualifying physicians to treat up to 100 patients 
after certain criteria are met. Thus the changes would provide greater 
access to care for patients due to increased patient limits.

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this rule 
has been drafted in accordance with the principles in Executive Order 
12866 Sec.  1(b). It has been determined that this is a significant 
regulatory action and, therefore, this action has been reviewed by the 
Office of Management and Budget. This rule will not impose additional 
costs on practitioners as it simply increases the number of patients 
that a practitioner may treat for narcotic dependence. As previously 
noted, this change would provide greater access to care for patients 
due to the increased patient limits.

Executive Order 12988

    This rule meets the applicable standards set forth in Sec. Sec.  
3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform.

Executive Order 13132

    This rule does not preempt or modify any provision of State law; 
nor does it impose enforcement responsibilities on any State; nor does 
it diminish the power of any State to enforce its own laws. 
Accordingly, this rulemaking does not have Federalism implications 
warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$120,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995.

Congressional Review Act

    This rule is not a major rule as defined by Sec.  804 of the Small 
Business Regulatory Enforcement Fairness Act of 1996 (Congressional 
Review Act). This rule will not result in an annual effect on the 
economy of $100,000,000 or more; a major increase in costs or prices; 
or significant adverse effects on competition, employment, investment, 
productivity, innovation, or on the ability of United States-based 
companies to compete with foreign

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based companies in domestic and export markets.

List of Subjects in 21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Security measures.

    For the reasons set out above, 21 CFR part 1301 is proposed to be 
amended as follows:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

    1. The authority citation for part 1301 continues to read as 
follows:

    Authority: 21 U.S.C. Sec. Sec.  821, 822, 823, 824, 871(b), 875, 
877, 886a, 951, 952, 953, 956, 957.

    2. Sec.  1301.28 is proposed to be amended by revising paragraph 
(b)(1)(iii) and removing paragraph (b)(1)(iv) to read as follows:


Sec.  1301.28  Exemption from separate registration for practitioners 
dispensing or prescribing Schedule III, IV, or V narcotic controlled 
drugs approved by the Food and Drug Administration specifically for use 
in maintenance or detoxification treatment.

* * * * *
    (b)(1) * * *
    (iii) The total number of patients to whom the individual 
practitioner will provide narcotic drugs or combinations of narcotic 
drugs under this section will not exceed 30 at any one time unless, not 
sooner than 1 year after the date on which the practitioner submitted 
the initial notification to the Secretary of Health and Human Services, 
the practitioner submits a second notification to the Secretary of the 
need and intent of the practitioner to treat up to 100 patients. A 
second notification under this subparagraph shall contain the 
certifications required by subparagraphs (i) and (ii) of this 
paragraph. The Secretary of Health and Human Services may promulgate 
regulations to change the total number of patients.
* * * * *

    Dated: September 13, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E7-18531 Filed 9-19-07; 8:45 am]
BILLING CODE 4410-09-P