Changes to Patient Limitation for Dispensing or Prescribing Approved Narcotic Controlled Substances for Maintenance or Detoxification Treatment by Qualified Individual Practitioners, 53734-53736 [E7-18531]
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Federal Register / Vol. 72, No. 182 / Thursday, September 20, 2007 / Proposed Rules
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
Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of Proposed Rulemaking.
pwalker on PROD1PC71 with PROPOSALS
AGENCY:
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 https://
www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
document is also available at the
https://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
VerDate Aug<31>2005
17:12 Sep 19, 2007
Jkt 211001
online at https://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
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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) (§ 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
§ 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. § 801 et
seq.) to establish ‘‘waiver authority for
physicians who dispense or prescribe
certain narcotic drugs for maintenance
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pwalker on PROD1PC71 with PROPOSALS
Federal Register / Vol. 72, No. 182 / Thursday, September 20, 2007 / Proposed Rules
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
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17:12 Sep 19, 2007
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53735
that could be treated by physicians in
group practices.
Pursuant to Pub. L. 109–56 effective
on August 2, 2005, and § 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:
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.
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.
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.
Executive Order 12866
The Deputy Assistant Administrator
further certifies that this rule has been
drafted in accordance with the
principles in Executive Order 12866
§ 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 §§ 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice
Reform.
Executive Order 13132
Unfunded Mandates Reform Act of 1995
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.
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.
Regulatory Certifications
Congressional Review Act
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
This rule is not a major rule as
defined by § 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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Federal Register / Vol. 72, No. 182 / Thursday, September 20, 2007 / Proposed Rules
based companies in domestic and
export markets.
DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
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. §§ 821, 822, 823, 824,
871(b), 875, 877, 886a, 951, 952, 953, 956,
957.
2. § 1301.28 is proposed to be
amended by revising paragraph
(b)(1)(iii) and removing paragraph
(b)(1)(iv) to read as follows:
§ 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.
*
*
*
*
*
pwalker on PROD1PC71 with PROPOSALS
*
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
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23 CFR Part 950
[FHWA Docket No. FHWA–06–23597]
RIN 2125–AF07
Interoperability Requirements,
Standards, or Performance
Specifications for Automated Toll
Collection Systems
Federal Highway
Administration (FHWA); DOT.
ACTION: Notice of proposed rulemaking
(NPRM); request for comments.
AGENCY:
SUMMARY: As required under section
1604(b)(6) of the Safe, Accountable,
Flexible, Efficient Transportation Equity
Act: A Legacy for Users (SAFETEA–LU),
this proposed rule specifies the
interoperability requirements for
automated toll collection systems for the
facilities that are tolled under any of the
tolling programs contained in section
1604 of SAFETEA–LU. Specifically, this
notice proposes to require facilities
operating with authority under section
1604 of SAFETEA–LU to use electronic
toll collection systems and for these
systems to address their interoperability
with other toll facilities. Although a
nationwide interoperability standard
has not yet been established, this
proposed rule seeks to accelerate
progress toward achieving nationwide
interoperability by requiring these
facilities to upgrade their electronic toll
collection systems to the national
standards whenever adopted. This
document also provides notice of public
meetings on this proposed regulation.
DATES: The public meeting will be held
on Thursday, October 11, 2007, from
1:30 p.m. to 5 p.m., at the U.S.
Department of Transportation
headquarters conference center.
Comments must be received on or
before November 19, 2007. Late-filed
comments will be considered to the
extent practicable, but the FHWA may
issue a final rule at any time after the
close of the comment period.
ADDRESSES: The October 11, 2007,
public meeting will be held at the U.S.
Department of Transportation
headquarters conference center, 1200
New Jersey Avenue, SE., Washington,
DC 20590.
Mail or hand deliver comments to the
U.S. Department of Transportation,
Dockets Management Facility, Room
PL–401, 1200 New Jersey Avenue, SE.,
Washington, DC 20590, or submit
electronically at https://dmses.dot.gov/
submit or fax comments to (202) 493–
PO 00000
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2251. Alternatively, comments may be
submitted to the Federal eRulemaking
portal at https://www.regulations.gov.
All comments should include the
docket number that appears in the
heading of this document. All
comments received will be available for
examination and copying at the above
address from 9 a.m. to 5 p.m., e.t.,
Monday through Friday, except Federal
holidays. Those desiring notification of
receipt of comments must include a selfaddressed, stamped postcard or you
may print the acknowledgment page
that appears after submitting comments
electronically. Anyone is able to search
the electronic form of all comments in
any one of our dockets by the name of
the individual submitting the comment
(or signing the comment, if submitted
on behalf of an association, business, or
labor union). You may review the DOT’s
complete Privacy Act Statement in the
Federal Register published on April 11,
2000 (Volume 65, Number 70, Pages
19477–78) or you may visit https://
dms.dot.gov.
For
technical questions or information about
this notice of proposed rulemaking,
contact Mr. Robert Rupert, FHWA Office
of Operations, (202) 366–2194. For legal
questions, please contact Mr. Michael
Harkins, Attorney Advisor, FHWA
Office of the Chief Counsel, (202) 366–
4928, Federal Highway Administration,
1200 New Jersey Avenue, SE.,
Washington, DC 20590. Office hours for
the FHWA are from 7:45 a.m. to 4:15
p.m., e.t., Monday through Friday,
except Federal holidays.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Electronic Access and Filing
You may submit or retrieve comments
online through the Document
Management System (DMS) at: https://
dmses.dot.gov/submit. Electronic
submission and retrieval help and
guidelines are available under the help
section of the Web site. Alternatively,
internet users may access all comments
received by the DOT Docket Facility by
using the universal resource locator
(URL) https://dms.dot.gov. It is available
24 hours each day, 365 days each year.
Please follow the instructions. An
electronic copy of this document may
also be downloaded by accessing the
Office of the Federal Register’s home
page at: https://www.archives.gov or the
Government Printing Office’s Web page
at https://www.gpoaccess.gov/nara.
Introduction
Section 1604 of SAFETEA–LU (Pub.
L. 109–59, 119 Stat. 1144) includes
provisions related to tolling of highways
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]]>Agencies
[Federal Register Volume 72, Number 182 (Thursday, September 20, 2007)]
[Proposed Rules]
[Pages 53734-53736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18531]
[[Page 53734]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://
www.regulations.gov using the electronic comment form provided on that
site. An electronic copy of this document is also available at the
https://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 https://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
[[Page 53735]]
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
[[Page 53736]]
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
