Medication Assisted Treatment for Opioid Use Disorders; Correction, 62403-62404 [2016-21674]
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62403
Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Rules and Regulations
TABLE 1—GENERAL SUPERFUND SECTION
City/county
Notes a
State
Site name
*
CA ....................
*
*
*
*
Argonaut Mine ............................................................................................................
Jackson.
*
CO ....................
*
*
*
*
Bonita Peak Mining District ........................................................................................
*
San Juan County.
*
*
IN ......................
*
*
*
*
West Vermont Drinking Water Contamination ...........................................................
*
Indianapolis.
*
*
LA .....................
MT ....................
NY ....................
*
*
*
*
SBA Shipyard .............................................................................................................
Anaconda Aluminum Co Columbia Falls Reduction Plant ........................................
Wappinger Creek .......................................................................................................
*
Jennings.
Columbia Falls.
Dutchess County.
*
*
OH ....................
*
*
*
*
Valley Pike VOCs .......................................................................................................
Riverside.
*
PR ....................
*
*
*
*
Dorado Ground Water Contamination .......................................................................
Dorado.
*
TX .....................
WV ....................
*
*
*
*
Eldorado Chemical Co., Inc. ......................................................................................
North 25th Street Glass and Zinc ..............................................................................
*
*
*
*
*
*
*
Live Oak.
Clarksburg.
*
a A = Based on issuance of health advisory by Agency for Toxic Substances and Disease Registry (if scored, HRS score need not be greater
than or equal to 28.50).
*
*
*
*
*
[FR Doc. 2016–21615 Filed 9–8–16; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 8
[Docket No. 2016–0001]
RIN–0930–AA22
Medication Assisted Treatment for
Opioid Use Disorders; Correction
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Correcting amendment.
AGENCY:
The Health and Human
Services Department (HHS) is correcting
a final rule that appeared in the Federal
Register on July 8, 2016. The final rule
increased the maximum number of
patients to whom an individual
practitioner may dispense or prescribe
certain medications, including
buprenorphine, from 100 to 275.
Practitioners are eligible for the
increased patient limit if they have
prescribed covered medications to up to
100 patients for at least one year
pursuant to secretarial approval,
provided that they meet certain criteria
and adhere to several additional
requirements aimed at ensuring that
patients receive the full array of services
that comprise evidence-based
medication-assisted treatment (MAT)
ehiers on DSK5VPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
15:26 Sep 08, 2016
Jkt 238001
and minimize the risks that medications
provided for treatment are misused or
diverted. One pathway through which
practitioners may become eligible to
increase their patient limit is by
obtaining additional credentialing from
one of several credentialing bodies. In
the final rule, the name of one of the
credentialing bodies listed was
incorrect. This action provides the
correct name.
DATES: Effective on September 9, 2016.
FOR FURTHER INFORMATION CONTACT:
Jinhee Lee, Division of Pharmacologic
Therapies, Center for Substance Abuse
Treatment, SAMHSA, 5600 Fishers
Lane, Rockville, MD 20857, (240) 276–
2700, email: Jinhee.Lee@
samhsa.hhs.gov.
On July 8,
2016 (81 FR 44711), HHS published a
final rule in the Federal Register, which
increased the maximum number of
patients to whom an individual
practitioner may dispense or prescribe
certain medications, including
buprenorphine, from 100 to 275. One of
the pathways through which
practitioners can become eligible to
increase their patient limit is by
receiving additional credentialing.
In the final rule, the American
Osteopathic Academy of Addiction
Medicine (AOAAM), which provides
training but not certification, was
mistakenly included in the definition
for ‘‘additional credentialing.’’ HHS
intended to include the American
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00051
Fmt 4700
Sfmt 4700
Osteopathic Association (AOA) in this
definition, not AOAAM. This intention
was evident in HHS’s Notice of
Proposed Rulemaking (NPRM),
published on March 30, 2016, which
proposed defining ‘‘board certification’’
so as to include ‘‘subspecialty board
certification in addiction medicine from
the American Osteopathic Association
(AOA) . . . .’’ AOAAM, on the other
hand, was not referenced within the
NPRM. Accordingly, HHS gave the
public notice and an opportunity to
comment on its proposal to include
AOA board certification as one of the
credentials that would make
practitioners eligible to practice at the
higher patient cap. No public comments
were received that related to AOA’s role
in the proposed rule.
HHS’s intention to reference AOA
(not AOAAM) was also reflected in the
preamble of the final rule; AOA board
certification was referenced in Section B
of the Regulatory Impact Analysis,
which stated that ‘‘[t]he training
requirement may be satisfied in several
ways: One may hold board certification
in . . . addiction medicine from the
American Osteopathic Association
. . . .’’ HHS also explained in the
preamble of the final rule that, ‘‘HHS
removed the term ‘board certification’
and added ‘additional credentialing’ to
clarify that all practitioners who
currently qualify to treat up to 100
patients are eligible for the higher
patient limit if they are included as
specialists as described in 21 U.S.C. 823
E:\FR\FM\09SER1.SGM
09SER1
ehiers on DSK5VPTVN1PROD with RULES
62404
Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Rules and Regulations
(g)(2)(G)(ii)(I)–(III).’’ Notably, AOA
board certification is specifically listed
in 21 U.S.C. 823(g)(2)(G)(ii)(III), as
amended by the Comprehensive
Addiction and Recovery Act of 2016
(CARA), Public Law 114–198. As a
result, the listing of AOAAM instead of
AOA was the result of a technical error
that needs to be corrected immediately.
If this error is not immediately
corrected, practitioners who have
received training from AOAAM, and
who do not satisfy any of the other
‘‘additional credentialing’’ requirements
under the final rule, may argue that they
are eligible to increase their patient
limit even though they do not possess
the qualifications that HHS has deemed
necessary to dispense or prescribe
relevant medications safely and
effectively at the higher patient cap. In
addition, the error has resulted in
SAMHSA receiving numerous questions
seeking clarification regarding the
credentials that osteopathic providers
need to have in order to be eligible for
the higher patient limit. Failure to
correct this error could, therefore,
significantly compromise the quality of
care delivered to patients in need of
MAT and could pose a substantial threat
to public safety.
The technical error at issue will
therefore be fixed by removing the
reference to the ‘‘American Osteopathic
Academy of Addiction Medicine’’ in the
final rule’s definition of ‘‘additional
credentialing,’’ and inserting a reference
to the ‘‘American Osteopathic
Association.’’ It should be noted that
although reference was made to
‘‘subspecialty board certification’’ by
AOA in the NPRM, the term
‘‘subspecialty’’ will not be included in
the final rule’s definition of ‘‘additional
credentialing’’ because CARA amended
the Controlled Substances Act by
removing the term ‘‘subspecialty’’ from
the description of AOA board
certification under 21 U.S.C.
823(g)(2)(G)(ii)(III). CARA was enacted
on July 22, 2016, after the final rule was
published on July 8, 2016. As explained
in the preamble of the final rule, HHS’s
reason for changing the definition of
‘‘board certification’’ in the NPRM to
‘‘additional credentialing’’ in the final
rule was to ensure that the training
credentials described in 21 U.S.C.
823(g)(2)(G)(ii)(I)–(III) (which include
AOA board certification) were included
as eligible pathways for practicing at the
higher patient cap. Therefore, the
technical fix made to the definition of
‘‘additional credentialing’’ in the final
rule reflects HHS’s continuing intention
to include the type of training described
in 21 U.S.C. 823(g)(2)(G)(ii)(I)–(III), as
amended by CARA.
VerDate Sep<11>2014
15:26 Sep 08, 2016
Jkt 238001
List of Subjects in 42 CFR Part 8
Health professions, Methadone,
Reporting and recordkeeping
requirements.
Accordingly, 42 CFR part 8 is
corrected by making the following
correcting amendment:
PART 8—MEDICATION ASSISTED
TREATMENT FOR OPIOID USE
DISORDERS
1. The authority citation for part 8
continues to read as follows:
■
Authority: 21 U.S.C. 823; 42 U.S.C. 257a,
290bb–2a, 290aa(d), 290dd–2, 300x–23,
300x–27(a), 300y–11.
2. In § 8.2, revise the definition of
Additional Credentialing to read as
follows:
■
§ 8.2
Definitions.
*
*
*
*
*
Additional Credentialing means board
certification in addiction medicine or
addiction psychiatry by the American
Board of Addiction Medicine, the
American Board of Medical Specialties,
or the American Osteopathic
Association or certification by the
American Board of Addiction Medicine,
or the American Society of Addiction
Medicine.
*
*
*
*
*
Dated: September 2, 2016.
Wilma Robinson,
Deputy Executive Secretary, U.S. Department
of Health and Human Services.
[FR Doc. 2016–21674 Filed 9–8–16; 8:45 am]
BILLING CODE P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 20
[Docket No. FWS–HQ–MB–2015–0034;
FF09M21200–167–FXMB1231099BPP0]
RIN 1018–BA70
Migratory Bird Hunting; Migratory Bird
Hunting Regulations on Certain
Federal Indian Reservations and
Ceded Lands for the 2016–17 Season
Fish and Wildlife Service,
Interior.
ACTION: Final rule.
AGENCY:
This rule prescribes special
migratory bird hunting regulations for
certain Tribes on Federal Indian
reservations, off-reservation trust lands,
and ceded lands. This rule responds to
tribal requests for U.S. Fish and Wildlife
Service (hereinafter Service or we)
SUMMARY:
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
recognition of their authority to regulate
hunting under established guidelines.
This rule allows the establishment of
season bag limits and, thus, harvest at
levels compatible with populations and
habitat conditions.
DATES: This rule takes effect on
September 9, 2016.
ADDRESSES: You may inspect comments
received on the special hunting
regulations and Tribal proposals during
normal business hours at U.S. Fish and
Wildlife Headquarters, 5275 Leesburg
Pike, Falls Church, VA 22041–3803, or
at https://www.regulations.gov at Docket
No. FWS–HQ–MB–2015–0034.
FOR FURTHER INFORMATION CONTACT: Ron
W. Kokel, U.S. Fish and Wildlife
Service, Department of the Interior, MS:
MB, 5275 Leesburg Pike, Falls Church,
VA 22041–3803; (703) 358–1967.
SUPPLEMENTARY INFORMATION:
Background
The Migratory Bird Treaty Act of July
3, 1918 (16 U.S.C. 703 et seq.),
authorizes and directs the Secretary of
the Department of the Interior, having
due regard for the zones of temperature
and for the distribution, abundance,
economic value, breeding habits, and
times and lines of flight of migratory
game birds, to determine when, to what
extent, and by what means such birds or
any part, nest, or egg thereof may be
taken, hunted, captured, killed,
possessed, sold, purchased, shipped,
carried, exported, or transported.
In the May 27, 2016, Federal Register
(81 FR 34226), we proposed special
migratory bird hunting regulations for
the 2016–17 hunting season for certain
Indian tribes, under the guidelines
described in the June 4, 1985, Federal
Register (50 FR 23467). The guidelines
respond to tribal requests for Service
recognition of their reserved hunting
rights, and for some tribes, recognition
of their authority to regulate hunting by
both tribal members and nonmembers
on their reservations. The guidelines
include possibilities for:
(1) On-reservation hunting by both
tribal members and nonmembers, with
hunting by nontribal members on some
reservations to take place within Federal
frameworks but on dates different from
those selected by the surrounding
State(s);
(2) On-reservation hunting by tribal
members only, outside of usual Federal
frameworks for season dates and length,
and for daily bag and possession limits;
and
(3) Off-reservation hunting by tribal
members on ceded lands, outside of
usual framework dates and season
length, with some added flexibility in
E:\FR\FM\09SER1.SGM
09SER1
Agencies
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Rules and Regulations]
[Pages 62403-62404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21674]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 8
[Docket No. 2016-0001]
RIN-0930-AA22
Medication Assisted Treatment for Opioid Use Disorders;
Correction
AGENCY: Substance Abuse and Mental Health Services Administration, HHS.
ACTION: Correcting amendment.
-----------------------------------------------------------------------
SUMMARY: The Health and Human Services Department (HHS) is correcting a
final rule that appeared in the Federal Register on July 8, 2016. The
final rule increased the maximum number of patients to whom an
individual practitioner may dispense or prescribe certain medications,
including buprenorphine, from 100 to 275. Practitioners are eligible
for the increased patient limit if they have prescribed covered
medications to up to 100 patients for at least one year pursuant to
secretarial approval, provided that they meet certain criteria and
adhere to several additional requirements aimed at ensuring that
patients receive the full array of services that comprise evidence-
based medication-assisted treatment (MAT) and minimize the risks that
medications provided for treatment are misused or diverted. One pathway
through which practitioners may become eligible to increase their
patient limit is by obtaining additional credentialing from one of
several credentialing bodies. In the final rule, the name of one of the
credentialing bodies listed was incorrect. This action provides the
correct name.
DATES: Effective on September 9, 2016.
FOR FURTHER INFORMATION CONTACT: Jinhee Lee, Division of Pharmacologic
Therapies, Center for Substance Abuse Treatment, SAMHSA, 5600 Fishers
Lane, Rockville, MD 20857, (240) 276-2700, email:
Jinhee.Lee@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION: On July 8, 2016 (81 FR 44711), HHS published
a final rule in the Federal Register, which increased the maximum
number of patients to whom an individual practitioner may dispense or
prescribe certain medications, including buprenorphine, from 100 to
275. One of the pathways through which practitioners can become
eligible to increase their patient limit is by receiving additional
credentialing.
In the final rule, the American Osteopathic Academy of Addiction
Medicine (AOAAM), which provides training but not certification, was
mistakenly included in the definition for ``additional credentialing.''
HHS intended to include the American Osteopathic Association (AOA) in
this definition, not AOAAM. This intention was evident in HHS's Notice
of Proposed Rulemaking (NPRM), published on March 30, 2016, which
proposed defining ``board certification'' so as to include
``subspecialty board certification in addiction medicine from the
American Osteopathic Association (AOA) . . . .'' AOAAM, on the other
hand, was not referenced within the NPRM. Accordingly, HHS gave the
public notice and an opportunity to comment on its proposal to include
AOA board certification as one of the credentials that would make
practitioners eligible to practice at the higher patient cap. No public
comments were received that related to AOA's role in the proposed rule.
HHS's intention to reference AOA (not AOAAM) was also reflected in
the preamble of the final rule; AOA board certification was referenced
in Section B of the Regulatory Impact Analysis, which stated that
``[t]he training requirement may be satisfied in several ways: One may
hold board certification in . . . addiction medicine from the American
Osteopathic Association . . . .'' HHS also explained in the preamble of
the final rule that, ``HHS removed the term `board certification' and
added `additional credentialing' to clarify that all practitioners who
currently qualify to treat up to 100 patients are eligible for the
higher patient limit if they are included as specialists as described
in 21 U.S.C. 823
[[Page 62404]]
(g)(2)(G)(ii)(I)-(III).'' Notably, AOA board certification is
specifically listed in 21 U.S.C. 823(g)(2)(G)(ii)(III), as amended by
the Comprehensive Addiction and Recovery Act of 2016 (CARA), Public Law
114-198. As a result, the listing of AOAAM instead of AOA was the
result of a technical error that needs to be corrected immediately.
If this error is not immediately corrected, practitioners who have
received training from AOAAM, and who do not satisfy any of the other
``additional credentialing'' requirements under the final rule, may
argue that they are eligible to increase their patient limit even
though they do not possess the qualifications that HHS has deemed
necessary to dispense or prescribe relevant medications safely and
effectively at the higher patient cap. In addition, the error has
resulted in SAMHSA receiving numerous questions seeking clarification
regarding the credentials that osteopathic providers need to have in
order to be eligible for the higher patient limit. Failure to correct
this error could, therefore, significantly compromise the quality of
care delivered to patients in need of MAT and could pose a substantial
threat to public safety.
The technical error at issue will therefore be fixed by removing
the reference to the ``American Osteopathic Academy of Addiction
Medicine'' in the final rule's definition of ``additional
credentialing,'' and inserting a reference to the ``American
Osteopathic Association.'' It should be noted that although reference
was made to ``subspecialty board certification'' by AOA in the NPRM,
the term ``subspecialty'' will not be included in the final rule's
definition of ``additional credentialing'' because CARA amended the
Controlled Substances Act by removing the term ``subspecialty'' from
the description of AOA board certification under 21 U.S.C.
823(g)(2)(G)(ii)(III). CARA was enacted on July 22, 2016, after the
final rule was published on July 8, 2016. As explained in the preamble
of the final rule, HHS's reason for changing the definition of ``board
certification'' in the NPRM to ``additional credentialing'' in the
final rule was to ensure that the training credentials described in 21
U.S.C. 823(g)(2)(G)(ii)(I)-(III) (which include AOA board
certification) were included as eligible pathways for practicing at the
higher patient cap. Therefore, the technical fix made to the definition
of ``additional credentialing'' in the final rule reflects HHS's
continuing intention to include the type of training described in 21
U.S.C. 823(g)(2)(G)(ii)(I)-(III), as amended by CARA.
List of Subjects in 42 CFR Part 8
Health professions, Methadone, Reporting and recordkeeping
requirements.
Accordingly, 42 CFR part 8 is corrected by making the following
correcting amendment:
PART 8--MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDERS
0
1. The authority citation for part 8 continues to read as follows:
Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290bb-2a, 290aa(d),
290dd-2, 300x-23, 300x-27(a), 300y-11.
0
2. In Sec. 8.2, revise the definition of Additional Credentialing to
read as follows:
Sec. 8.2 Definitions.
* * * * *
Additional Credentialing means board certification in addiction
medicine or addiction psychiatry by the American Board of Addiction
Medicine, the American Board of Medical Specialties, or the American
Osteopathic Association or certification by the American Board of
Addiction Medicine, or the American Society of Addiction Medicine.
* * * * *
Dated: September 2, 2016.
Wilma Robinson,
Deputy Executive Secretary, U.S. Department of Health and Human
Services.
[FR Doc. 2016-21674 Filed 9-8-16; 8:45 am]
BILLING CODE P