Changes to Patient Limitation for Dispensing or Prescribing Approved Narcotic Controlled Substances for Maintenance or Detoxification Treatment by Qualified Individual Practitioners, 29685-29688 [E8-11471]
Download as PDF
<![CDATA[
29685
Rules and Regulations
Federal Register
Vol. 73, No. 100
Thursday, May 22, 2008
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage
Form New Animal Drugs; Cefovecin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
Under section 512(c)(2)(F)(i) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(i)), this
approval qualifies for 5 years of
marketing exclusivity beginning on the
date of approval.
The agency has determined under 21
CFR 25.33(d)(1) that these actions are of
a type that do not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
(8 mg/kilograms (kg)) body weight as a
single subcutaneous injection. A second
subcutaneous injection of 3.6 mg/lb (8
mg/kg) may be administered if response
to therapy is not complete.
(ii) Indications for use. For the
treatment of skin infections (secondary
superficial pyoderma, abscesses, and
wounds) in dogs caused by susceptible
strains of Staphylococcus intermedius
and Streptococcus canis (Group G).
(2) Cats—(i) Amount. Administer 3.6
mg/lb (8 mg/kg) body weight as a single,
one-time subcutaneous injection.
(ii) Indications for use. For the
treatment of skin infections (wounds
and abscesses) in cats caused by
susceptible strains of Pasteurella
multocida.
Dated: May 13, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–11515 Filed 5–21–08; 8:45 am]
BILLING CODE 4160–01–S
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
application (NADA) filed by Pfizer, Inc.
The NADA provides for the veterinary
prescription use of a solution of
cefovecin sodium in cats and dogs by
subcutaneous injection for the treatment
of skin infections.
DATES: This rule is effective May 22,
2008.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pfizer,
Inc., 235 East 42d St., New York, NY
10017, filed NADA 141–285 that
provides for the veterinary prescription
use of CONVENIA (cefovecin sodium)
Injectable in cats and dogs by
subcutaneous injection for the treatment
of skin infections. The application is
approved as of April 25, 2008, and the
regulations are amended in 21 CFR part
522 to reflect approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
rfrederick on PROD1PC67 with RULES
SUMMARY:
VerDate Aug<31>2005
15:18 May 21, 2008
Jkt 214001
List of Subjects in 21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 522 is amended as follows:
I
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
§ 522.311
I
[Redesignated as § 522.300]
2. Redesignate § 522.311 as § 522.300.
§ 522.312
[Redesignated as § 522.304]
3. Redesignate § 522.312 as § 522.304.
I 4. Add new § 522.311 to read as
follows:
I
§ 522.311
Cefovecin.
(a) Specifications. Each milliliter of
constituted solution contains 80
milligrams (mg) cefovecin as the sodium
salt.
(b) Sponsor. See No. 000069 in
§ 510.600(c) of this chapter.
(c) Special considerations. Federal
law restricts this drug to use by or on
the order of a licensed veterinarian.
(d) Conditions of use—(1) Dogs—(i)
Amount. Administer 3.6 mg/pound (lb)
PO 00000
Frm 00001
Fmt 4700
Sfmt 4700
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA–275F]
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: Final rule.
AGENCY:
SUMMARY: On September 20, 2007, the
Drug Enforcement Administration
(DEA) published a Notice of Proposed
Rulemaking (NPRM) in the Federal
Register (72 FR 53734) 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. DEA received one comment
in support of this rulemaking. DEA is
finalizing the rule as proposed.
DATES: Effective Date: This rule is
effective June 23, 2008.
E:\FR\FM\22MYR1.SGM
22MYR1
29686
Federal Register / Vol. 73, No. 100 / Thursday, May 22, 2008 / Rules and Regulations
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
(FDA) 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
(HHS) 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) (Section 1102 of Pub. L.
109–469, 120 Stat. 3502).
rfrederick on PROD1PC67 with RULES
Notice of Proposed Rulemaking
On September 20, 2007 (72 FR 53734),
DEA published a Notice of Proposed
Rulemaking (NPRM) proposing to
conform DEA regulations to Public Law
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.
That NPRM also proposed to conform
DEA regulations to Section 1102 of
Public Law 109–469 by permitting
certain qualifying physicians to treat up
to 100 patients. As discussed in 21
U.S.C. 823(g)(2)(B) and (D) (and not
modified by this rule), to be a
‘‘qualifying physician’’ the practitioner
must submit to the Secretary of HHS
notification of the practitioner’s intent
to begin dispensing the drugs approved
by FDA specifically for maintenance or
detoxification treatment. The
VerDate Aug<31>2005
15:18 May 21, 2008
Jkt 214001
notification must contain the following
certifications:
• The practitioner is registered with
DEA as an individual practitioner.
• The practitioner is a ‘‘qualifying
physician.’’ A practitioner is a
‘‘qualifying physician’’ if he is licensed
under State law and has specific
medical certification, training, or
experience in maintenance or
detoxification treatment as specified in
the CSA.
• With respect to patients to whom
the practitioner will provide such drugs
or combinations of drugs, the
practitioner has the capacity to refer the
patients for appropriate counseling and
other appropriate ancillary services.
• The total number of such patients of
the practitioner at any one time will not
exceed the applicable number. The
applicable number is 30, unless, not
sooner than one year after the date on
which the practitioner submitted the
initial notification, the practitioner
submits a second notification to the
Secretary of HHS of the need and intent
of the practitioner to treat up to 100
patients.
• The notification to the Secretary of
HHS must be in writing and must state
the name and DEA registration number
of the practitioner.
• If the practitioner is a member of a
group practice, the notification states
the names of the other practitioners in
the practice and identifies the
registrations issued for the other
practitioners.
As noted, certain qualifying
physicians may treat up to 100 patients,
instead of the thirty permitted for all
qualifying physicians. 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 HHS 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) as discussed above
(21 CFR 1301.28(b)(1)(i) and (ii)). These
amendments do 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).
The ‘‘good faith’’ exception was
established by the Drug Addiction
Treatment Act of 2000, and is not
affected by this Final Rule. The
Controlled Substances Act (CSA) (21
U.S.C. 823(g)(2)(D)) states that not later
than 45 days after the Secretary of HHS
PO 00000
Frm 00002
Fmt 4700
Sfmt 4700
receives a notification discussed above,
the Secretary shall make a
determination of whether the
practitioner meets all requirements for a
waiver of the requirement of separate
registration. Upon the expiration of the
45-day time period, a practitioner who
in good faith submits a notification
discussed above and reasonably believes
that the conditions specified in 21
U.S.C. 823(g)(2)(B) through (D) have
been met shall, in dispensing narcotic
drugs in schedule III, IV, or V or
combinations of such drugs for
maintenance treatment or detoxification
treatment, be considered to have a
waiver until notified otherwise by the
Secretary of HHS. The practitioner may
commence to prescribe or dispense such
narcotic drugs for maintenance or
detoxification treatment prior to the
expiration of the 45-day period if it
facilitates the treatment of an individual
patient and both the Secretary and the
Attorney General are notified by the
practitioner of the intent to commence
prescribing or dispensing such narcotic
drugs.
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
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
E:\FR\FM\22MYR1.SGM
22MYR1
rfrederick on PROD1PC67 with RULES
Federal Register / Vol. 73, No. 100 / Thursday, May 22, 2008 / Rules and Regulations
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 Public Law 109–56
effective on August 2, 2005, and Section
1102 of Public Law 109–469 effective on
December 29, 2006, this Final Rule
makes conforming changes to DEA’s
regulations at 21 CFR 1301.28(b)(1)(iii)
and (iv). Specifically, paragraph
(b)(1)(iii) is amended to permit the
treatment of up to 100 patients by a
qualifying practitioner if the necessary
criteria are met (i.e., the practitioner
previously was granted authority to
dispense or prescribe Schedule III, IV,
or V narcotic controlled drugs or
combinations of narcotic controlled
drugs approved by the Food and Drug
Administration specifically for use in
maintenance or detoxification treatment
without being separately registered as a
narcotic treatment program, and, not
sooner than one year after the
submission of the initial notification,
the practitioner submits a second
notification to the Secretary of HHS of
the need and intent of the practitioner
to treat up to 100 patients) and
notification is submitted to the
Secretary of Health and Human
Services. Further, paragraph (b)(1)(iii) is
amended by removing the phrase
VerDate Aug<31>2005
15:18 May 21, 2008
Jkt 214001
‘‘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 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.
29687
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 rule
relieves 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
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
Section 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 provides greater access to care
for patients due to the increased patient
limits.
Comments Received
Executive Order 12988
DEA received one comment to its
NPRM published September 20, 2007 at
72 FR 53734 from an association
representing physicians. The
commenter supported the rulemaking as
proposed. The commenter strongly
supported the proposed change to
conform DEA regulations to the
statutory changes made by Public Law
109–56, believing that the previous
requirement limiting the number of
patients who could receive treatment
through a group practice to 30 was a
barrier to treatment access. Further, the
commenter supported the proposed
change to conform DEA regulations to
Section 1102 of Public Law 109–469,
believing that the requirement for
physicians to submit a supplemental
notification to the Secretary of HHS of
their need and intent to treat up to 100
patients, not sooner than one year after
the practitioner submitted the initial
notification, is ‘‘a reasonable
compromise at this time.’’ Therefore,
DEA is finalizing this rulemaking as
proposed.
This rule meets the applicable
standards set forth in Sections 3(a) and
3(b)(2) of Executive Order 12988, Civil
Justice Reform.
PO 00000
Frm 00003
Fmt 4700
Sfmt 4700
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.
E:\FR\FM\22MYR1.SGM
22MYR1
29688
Federal Register / Vol. 73, No. 100 / Thursday, May 22, 2008 / Rules and Regulations
Congressional Review Act
This rule is not a major rule as
defined by Section 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 foreignbased companies in domestic and
export markets.
List of Subjects in 21 CFR Part 1301
Administrative practice and
procedure, Drug traffic control, Security
measures.
I For the reasons set out above, 21 CFR
part 1301 is 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:
I
Authority: 21 U.S.C. 821, 822, 823, 824,
871(b), 875, 877, 886a, 951, 952, 953, 956,
957.
2. Section 1301.28 is amended by
revising paragraph (b)(1)(iii) and
removing paragraph (b)(1)(iv) to read as
follows:
I
§ 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.
rfrederick on PROD1PC67 with RULES
*
*
*
*
*
(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.
*
*
*
*
*
VerDate Aug<31>2005
15:18 May 21, 2008
Jkt 214001
Dated: May 13, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control.
[FR Doc. E8–11471 Filed 5–21–08; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[USCG–2008–0339]
Drawbridge Operation Regulation;
Illinois Waterway, Lockport, IL; Repair
and Maintenance
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
ACTION:
SUMMARY: The Commander, Eighth
Coast Guard District has issued a
temporary deviation from the regulation
governing the operation of the Elgin,
Joliet, and Eastern Railroad Drawbridge,
across the Illinois Waterway, Mile
290.1, at Lockport, Illinois. The
deviation is necessary for the bridge to
remain closed-to-navigation unless 1
hour advance notice is given. This
deviation allows the bridge owner time
to perform necessary repairs to the
bridge.
DATES: This deviation is effective from
7 a.m. to 5 p.m., May 20, 2008, through
June 2, 2008.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2008–
0339 and are available online at
https://www.regulations.gov. They are
also available for inspection or copying
at two locations: The Docket
Management Facility (M–30), U.S.
Department of Transportation, West
Building Ground Floor, Room W12–140,
1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays, and the Robert
A. Young Federal Building, Room
2.107F, 1222 Spruce Street, St. Louis,
MO 63103–2832, between 8 a.m. and 4
p.m., Monday through Friday, except
Federal holidays.
FOR FURTHER INFORMATION CONTACT:
Roger K. Wiebusch, Bridge
Administrator, (314) 269–2378.
SUPPLEMENTARY INFORMATION: The Elgin,
Joliet, and Eastern Railway requested a
temporary deviation for the Elgin, Joliet,
and Eastern Railroad Drawbridge, mile
290.1, at Lockport, Illinois across the
Illinois Waterway to perform needed
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
maintenance and repairs. The Elgin,
Joliet, and Eastern Railroad Drawbridge
currently operates in accordance with
33 CFR 117.393(d), which states the
bridge is remotely operated and
normally maintained in the open-tonavigation position, closing only to pass
rail traffic and then reopening promptly
for navigation. In order to facilitate the
needed maintenance and repairs, the
drawbridge must be kept in the closedto-navigation position. This deviation
allows for the bridge to remain closedto-navigation unless 1 hour advance
notice is given, from 7 a.m. to 5 p.m.,
May 20, 2008, through June 2, 2008.
There are no alternate routes for
vessels transiting this section of the
Illinois Waterway.
The Elgin, Joliet, and Eastern Railroad
Drawbridge, in the closed-to-navigation
position, provides a vertical clearance of
24.6 feet above pool stage. Navigation
on the waterway consists primarily of
commercial tows and recreational
watercraft. This temporary deviation has
been coordinated with waterway users.
No objections were received.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the designated time period. This
deviation from the operating regulations
is authorized under 33 CFR 117.35.
Dated: May 5, 2008.
Roger K. Wiebusch,
Bridge Administrator.
[FR Doc. E8–11441 Filed 5–21–08; 8:45 am]
BILLING CODE 4910–15–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2008–0010]
RIN 1625–AA09
Drawbridge Operation Regulations;
Mill Neck Creek, Oyster Bay, NY
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard has changed
the drawbridge operation regulations
that govern the operation of the Bayville
Bridge, mile 0.1, across Mill Neck Creek
at Oyster Bay, New York. This final rule
will allow the bridge to open on signal
between 7 a.m. and 11 p.m. from May
1 through October 31 and between 7
a.m. and 5 p.m., Monday through
Friday, from November 1 through April
30. At all other times the bridge will
open after a two-hour advance notice is
E:\FR\FM\22MYR1.SGM
22MYR1
]]>Agencies
[Federal Register Volume 73, Number 100 (Thursday, May 22, 2008)]
[Rules and Regulations]
[Pages 29685-29688]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11471]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-275F]
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: Final rule.
-----------------------------------------------------------------------
SUMMARY: On September 20, 2007, the Drug Enforcement Administration
(DEA) published a Notice of Proposed Rulemaking (NPRM) in the Federal
Register (72 FR 53734) 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. DEA
received one comment in support of this rulemaking. DEA is finalizing
the rule as proposed.
DATES: Effective Date: This rule is effective June 23, 2008.
[[Page 29686]]
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 (FDA)
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 (HHS) 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) (Section 1102 of
Pub. L. 109-469, 120 Stat. 3502).
Notice of Proposed Rulemaking
On September 20, 2007 (72 FR 53734), DEA published a Notice of
Proposed Rulemaking (NPRM) proposing to conform DEA regulations to
Public Law 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. That NPRM also proposed to conform DEA
regulations to Section 1102 of Public Law 109-469 by permitting certain
qualifying physicians to treat up to 100 patients. As discussed in 21
U.S.C. 823(g)(2)(B) and (D) (and not modified by this rule), to be a
``qualifying physician'' the practitioner must submit to the Secretary
of HHS notification of the practitioner's intent to begin dispensing
the drugs approved by FDA specifically for maintenance or
detoxification treatment. The notification must contain the following
certifications:
The practitioner is registered with DEA as an individual
practitioner.
The practitioner is a ``qualifying physician.'' A
practitioner is a ``qualifying physician'' if he is licensed under
State law and has specific medical certification, training, or
experience in maintenance or detoxification treatment as specified in
the CSA.
With respect to patients to whom the practitioner will
provide such drugs or combinations of drugs, the practitioner has the
capacity to refer the patients for appropriate counseling and other
appropriate ancillary services.
The total number of such patients of the practitioner at
any one time will not exceed the applicable number. The applicable
number is 30, unless, not sooner than one year after the date on which
the practitioner submitted the initial notification, the practitioner
submits a second notification to the Secretary of HHS of the need and
intent of the practitioner to treat up to 100 patients.
The notification to the Secretary of HHS must be in
writing and must state the name and DEA registration number of the
practitioner.
If the practitioner is a member of a group practice, the
notification states the names of the other practitioners in the
practice and identifies the registrations issued for the other
practitioners.
As noted, certain qualifying physicians may treat up to 100
patients, instead of the thirty permitted for all qualifying
physicians. 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 HHS 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) as discussed above (21 CFR
1301.28(b)(1)(i) and (ii)). These amendments do 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).
The ``good faith'' exception was established by the Drug Addiction
Treatment Act of 2000, and is not affected by this Final Rule. The
Controlled Substances Act (CSA) (21 U.S.C. 823(g)(2)(D)) states that
not later than 45 days after the Secretary of HHS receives a
notification discussed above, the Secretary shall make a determination
of whether the practitioner meets all requirements for a waiver of the
requirement of separate registration. Upon the expiration of the 45-day
time period, a practitioner who in good faith submits a notification
discussed above and reasonably believes that the conditions specified
in 21 U.S.C. 823(g)(2)(B) through (D) have been met shall, in
dispensing narcotic drugs in schedule III, IV, or V or combinations of
such drugs for maintenance treatment or detoxification treatment, be
considered to have a waiver until notified otherwise by the Secretary
of HHS. The practitioner may commence to prescribe or dispense such
narcotic drugs for maintenance or detoxification treatment prior to the
expiration of the 45-day period if it facilitates the treatment of an
individual patient and both the Secretary and the Attorney General are
notified by the practitioner of the intent to commence prescribing or
dispensing such narcotic drugs.
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 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
[[Page 29687]]
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 Public Law 109-56 effective on August 2, 2005, and
Section 1102 of Public Law 109-469 effective on December 29, 2006, this
Final Rule makes conforming changes to DEA's regulations at 21 CFR
1301.28(b)(1)(iii) and (iv). Specifically, paragraph (b)(1)(iii) is
amended to permit the treatment of up to 100 patients by a qualifying
practitioner if the necessary criteria are met (i.e., the practitioner
previously was granted authority to dispense or prescribe Schedule III,
IV, or V narcotic controlled drugs or combinations of narcotic
controlled drugs approved by the Food and Drug Administration
specifically for use in maintenance or detoxification treatment without
being separately registered as a narcotic treatment program, and, not
sooner than one year after the submission of the initial notification,
the practitioner submits a second notification to the Secretary of HHS
of the need and intent of the practitioner to treat up to 100 patients)
and notification is submitted to the Secretary of Health and Human
Services. Further, paragraph (b)(1)(iii) is 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 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.
Comments Received
DEA received one comment to its NPRM published September 20, 2007
at 72 FR 53734 from an association representing physicians. The
commenter supported the rulemaking as proposed. The commenter strongly
supported the proposed change to conform DEA regulations to the
statutory changes made by Public Law 109-56, believing that the
previous requirement limiting the number of patients who could receive
treatment through a group practice to 30 was a barrier to treatment
access. Further, the commenter supported the proposed change to conform
DEA regulations to Section 1102 of Public Law 109-469, believing that
the requirement for physicians to submit a supplemental notification to
the Secretary of HHS of their need and intent to treat up to 100
patients, not sooner than one year after the practitioner submitted the
initial notification, is ``a reasonable compromise at this time.''
Therefore, DEA is finalizing this rulemaking as proposed.
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 rule relieves 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 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 Section 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 provides greater access to care for patients due to
the increased patient limits.
Executive Order 12988
This rule meets the applicable standards set forth in Sections 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.
[[Page 29688]]
Congressional Review Act
This rule is not a major rule as defined by Section 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-based companies
in domestic and export markets.
List of Subjects in 21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
0
For the reasons set out above, 21 CFR part 1301 is amended as follows:
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
0
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.
0
2. Section 1301.28 is 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: May 13, 2008.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. E8-11471 Filed 5-21-08; 8:45 am]
BILLING CODE 4410-09-P
