[Federal Register: September 20, 2007 (Volume 72, Number 182)]
[Proposed Rules]
[Page 53734-53736]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se07-21]
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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 dea.diversion.policy@usdoj.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.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